Radiology&Interventional_P&P

This booklet, Radiology and Interventional Compliance Policies and Procedures (CPP), contains vital rules that you are required to understand and follow. These Policies and Procedures are an essential part of the HealthCare Compliance Program at Radiology and Interventional. The HealthCare Compliance Program includes, among other things, these Policies and Procedures, the Bayer HealthCare Code of Conduct and Division Compliance training. The Program is designed to provide employees, contractors, consultants and agents with the knowledge and training to act ethically, and with proper judgment, in various activities related to sales, marketing and reporting prices for government reimbursed products, both prescription pharmaceutical products and devices, as well as during other interactions between Radiology and Interventional employees, contractors, consultants or agents and healthcare professionals.

Healthcare professionals is very broad and includes individuals who directly interact with patients and/or have a role in the diagnosis and treatment of patients or entities which are involved in the provision of healthcare services and/or items to patients and which may purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Radiology and Interventional products in the U.S. Generally, this definition includes physicians, nurses, nurse practitioners, physician assistants, medical assistants who treat patients, and other allied healthcare professionals, such as pharmacists, technicians, and therapists. However, the definition is not limited to these individuals alone; the term includes any person in a position to recommend or influence the purchase or prescribing of Radiology and Interventional products. In some instances, this may include individuals who do not work directly with patients but who have influence over the recommendation, purchase, or prescribing of Radiology and Interventional products—such as a purchasing agents at hospitals, physician practice managers, management personnel within group purchasing organizations (GPOs), managed care organizations (MCOs), pharmacy benefit managers (PBMs), health plan administrators, wholesalers, distributors, pharmacies, Pharmacy & Therapeutics Committee members, Formulary Committee members, or other customers who do not see patients. Original Equipment Manufacturers (OEMs) are NOT considered to be Healthcare Professionals for purposes of this definition.

The Radiology and Interventional Compliance Program Documents (e.g., Policies and Procedures, Forms) are accessible via the intranet at URL: http://us-wcms01.us.bayer.cnb/apps/BSP/US/BSP-NJ/BSP-NJ.nsf/id/44550041C8BC1607852579B1006813E2?OpenDocument

Importance of Complying with Compliance Policies and Procedures

The laws governing our conduct are enforceable by criminal, civil and administrative penalties. Violations may result in fines, jail sentences and/or exclusion from federal and state healthcare programs, such as Medicare, Medicaid, the Department of Defense and the Department of Veterans Affairs.

Radiology and Interventional is committed to complying with all applicable laws, regulations and industry codes (including the AdvaMed and PhRMA Codes on Interactions with Health Care Professionals) governing the sale and marketing of our prescription pharmaceutical and medical device products as well as laws and regulations governing the reporting of prices and reimbursement information for government reimbursed products. Failure to comply with federal regulations and Radiology and Interventional’s Compliance Policies and Procedures can have direct and severe consequences both to you and to Radiology and Interventional.

Any Radiology and Interventional employee, contractor, consultant or agent who violates, or encourages others to violate, these Compliance Policies and Procedures may be subject to a broad range of discipline, up to and including termination of employment. Each Radiology and Interventional employee, contractor, consultant and agent will be required to include a compliance objective that is relevant and meaningful to his/her job responsibilities in his or her Performance Management Process. Performance on that compliance objective will be evaluated by each employee, contractor, consultant and agent’s manager. Failure to adhere to these Compliance Policies and Procedures will be considered in connection with performance evaluations for all HealthCare Compliance Program Covered Persons (as defined below).

Employees, contractors, consultants and agents are required to report suspected violations of these Compliance Policies and Procedures to their supervisor, the Law and Patents Department or the Bayer HealthCare Compliance Officer. Alternatively, reports may be made anonymously via Bayer’s confidential “Bayer IntegrityLine” at 1-888-765-3846. The “Bayer IntegrityLine” is available 24-hours a day, 7 days a week. There will be no retaliation against any employee contractor, consultant or agent, who, in good faith, reports a suspected violation or otherwise raises a compliance concern.

Corporate Integrity Agreement

Bayer HealthCare LLC (“Bayer HealthCare”), of which Radiology and Interventional is a part, entered into a Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services, Office of Inspector General (OIG) on November 25, 2008. The CIA will be in effect for five (5) years from the date it was signed. These Compliance Policies and Procedures are designed to assist Radiology and Interventional in complying with applicable laws and in meeting its CIA obligations.

Violations of the CIA may result in monetary fines, including fines for each day that Bayer HealthCare does not fully comply with its obligations under the CIA. For example, Bayer HealthCare will be assessed daily fines if Arrangements Procedures are not being followed for each Focus Arrangement. Violations may also lead to exclusion from federal and state healthcare programs such as Medicare, Medicaid and the Department of Defense. Any Bayer HealthCare employee, contractor, consultant or agent who violates, or encourages others to violate, the conditions of the CIA is subject to a broad range of discipline, up to and including termination of employment. If you have any questions regarding your obligations under the CIA, please consult with the Law and Patents Department or Bayer HealthCare Compliance Department.

Anti-Kickback Statute

The CIA puts Policies and Procedures in place to help ensure that Bayer HealthCare does not violate the Anti-Kickback Statute. The Anti-Kickback Statute is a federal law that, among other things, prohibits entities that contract with the Government, such as manufacturers of drugs or medical devices, from offering or giving “remuneration” (e.g., anything of value) in exchange for the purchase of a product, or to induce the purchase of such product – either now, in the future, or as a reward for past purchases. Many states have enacted laws similar to the Federal Anti-Kickback Statute. One of the primary concerns about kickbacks is that they encourage the healthcare professional to make decisions based on personal financial gain and not necessarily on what is best for the patient.

Who is a HealthCare Compliance Program Covered Person?

The CIA uses the term “Covered Persons” to describe who must be included under Bayer Healthcare’s Compliance Program. HealthCare Compliance Program Covered Persons include both Covered Persons and Arrangements Covered Persons.

Covered Persons include:

• All owners of Bayer HealthCare (including Radiology and Interventional) and any Bayer HealthCare Affiliate who are natural persons (other than shareholders who: (1) have an ownership interest of less than 5%; and (2) acquired the ownership interest through public trading);
• All officers, directors and employees of Bayer HealthCare (including Radiology and Interventional) and any Bayer HealthCare Affiliate except (1) any person not reasonably expected to work more than one hundred sixty (160) hours during the calendar year; or (2) any employee engaged solely in manufacturing functions; and
• All contractors, subcontractors, agents, and other persons who perform any of the following functions on behalf of Bayer (including Radiology and Interventional) and any Bayer HealthCare Affiliate and who are expected to work more than 160 hours per year: (1) the promotion, advertising, distribution, marketing, and sale of Government Reimbursed Products; or (2) the development or dissemination of materials or information about, or the provision of services relating to, Government Reimbursed Products.

Arrangements Covered Persons include:

• Each Covered Person involved with the initiation, negotiation, proposal, development, approval, implementation, management, oversight (including accounting functions), or review of arrangements or transactions that involve, directly or indirectly, the offer, payment, solicitation or receipt of anything of value between Bayer HealthCare (including Radiology and Interventional) or any Bayer HealthCare Affiliate and any actual or potential source of referrals or sales of Government Reimbursed Products.

Compliance with these Policies and Procedures is mandatory for all Covered Persons and Arrangements Covered Persons.

Bayer AG Corporate Compliance Policy

In addition to the HealthCare Compliance Program described above, the Corporate Compliance Policypublished by Bayer AG in Germany covers the various Bayer businesses (including Radiology and Interventional) on a global basis. This policy provides guidance regarding important areas of corporate responsibility, including the laws of various countries that impose obligations on Radiology and Interventional and its employees, contractors, consultants or agents. Although the scope of the compliance programs differ, the concepts reflecting the Company’s commitment to ethical behavior are consistent and Radiology and Interventional employees, contractors, consultants or agents are required to comply with all applicable Radiology and Interventional Compliance Policies and Procedures. The Corporate Compliance Policy may be found at:http://www.bayer.co.th/webphp/eng/compliance.php

Bayer HealthCare AG Compliance Manuals

The principles set forth in the Bayer HealthCare AG Compliance Manuals also represent a broad outline of the minimum standards of business conduct that Bayer HealthCare AG expects each of its employees, globally, to follow. These minimum standards are derived from globally applicable laws, industry codes and internal regulations, and are consistent with the laws, regulations, guidelines and Compliance Policies and procedures applicable in the US. However, where stricter local standards exist, such as your business’ Compliance Policies and Procedures, such stricter Policies and Procedures always take precedence.

The Foreign Corrupt Practices Act (FCPA)

Radiology and Interventional conducts its business with the highest legal and ethical standards and will not tolerate corruption. Each employee, contractor, consultant or agent must perform his/her job in full compliance with the Foreign Corrupt Practices Act (FCPA) and must never conduct business through unlawful payments, bribes, kickbacks, gifts, or other questionable inducements.

The FCPA specifically prohibits Radiology and Interventional employees, contractors, consultants or their agents from offering, promising, making, authorizing, or providing directly or indirectly, any payments, gifts, or anything of value to a non-U.S. government official, political party or candidate, or an official of an international organization (such as the World Bank), with the intent to:

• Improperly influence or reward the official’s actions;
• Improperly influence decision-making in order to obtain or retain business; or
• Secure an improper advantage.

Each Radiology and Interventional employee, contractor, consultant and agent has the responsibility to ensure that his/her dealings with non-U.S. government officials—including state-employed health care professionals—comply with the FCPA. Likewise, each employee contractor, consultant and agent is prohibited from making payments to any third party who the employee, contractor, consultant or agent knows will, or believes is likely to, make an unlawful payment related to Radiology and Interventional’s business.

Questions

It is expected that every employee, contractor, consultant and agent will have a working knowledge of the laws affecting his/her responsibilities and the scope of permissible activities involved in his/her work, and will seek guidance from a supervisor, the Law and Patents Department or the Bayer HealthCare Compliance Department concerning any matter on which there is a question.

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1. Operating The Confidential Disclosure Program

The Bayer HealthCare Confidential Disclosure Program which includes Radiology and Interventional allows employees, contractors, consultants or agents to disclose, confidentially and without retaliation, any issues or questions associated with Bayer’s (including Radiology and Interventional) policies, practices, or procedures with respect to any federal healthcare programs believed by the individual in good faith to be a potential violation of criminal, civil or administrative law. The Confidential Disclosure Program is the Bayer IntegrityLine, a toll-free telephone line (1-888-765-3846) administered by a third party vendor, Global Compliance Services, Inc.

Global Compliance Services provides service twenty-four hours per day, seven days per week and prepares reports of all disclosure calls. Each report is assigned a Report Control Number and a PIN code, which is provided to the caller. Callers may be provided a date on which to make a follow-up call for the purpose of receiving a response from Bayer HealthCare or for the caller to provide additional information. The reports are transmitted to the Bayer HealthCare Compliance Officer (or designee) within 24 hours of receipt.

To ensure complete confidentiality, Global Compliance Services will mark any reports that name a designated report recipient or investor (the Bayer HealthCare Compliance Officer or designee) for “Special Handling.” Reports marked for “Special Handling” will therefore not be distributed to the designated report recipient or investigator named in the report. If all designated report recipients or investigators are named within the report, the report will be sent to the Special Handling Report Recipient, who is the General Counsel & Sr. Vice President for Bayer HealthCare.

Publication Of the Confidential Disclosure Program

Information about the Confidential Disclosure Program, or the “Bayer IntegrityLine,” is advertised to all Bayer HealthCare employees, contractors, consultants or agents. The following information is generally included in the notice:

• The toll-free telephone number.
• The fact that the caller need not disclose his/her identity.
• The fact that the Bayer IntegrityLine should be used to report issues or questions associated with Radiology and Interventional’s policies, practices, or procedures with respect to any federal healthcare programs believed by the individual to be a potential violation of criminal, civil or administrative law.
• Reports may be made confidentially and without retaliation for reports made in good faith to the Bayer IntegrityLine.

THE CONFIDENTIAL DISCLOSURE LOG

Global Compliance Services, Inc. provides two (2) reports to Bayer HealthCare Compliance Department each month: one summarizes reporting activity from the prior month, and the other lists all open reports. Global Compliance Services, Inc. assigns the Report Control Number to each report which is recorded on all documents that are added to the disclosure file, as well as those that are maintained in the Human Resource and/or Law and Patents Department. This allows the status of any subsequent investigation to be tracked. The reports from Global Compliance Services, Inc. include all disclosures made to the Bayer IntegrityLine. Reports involving federal healthcare programs and/or Radiology and Interventional Compliance Policies and Procedures will be processed as described below and included in the Annual Report to the OIG.

Reports that do not involve federal healthcare programs or Radiology and Interventional’s Compliance Policies and Procedures, such as those involving employment or human resources issues, will be directed to the Law and Patents Department or the Human Resources Department within the related Bayer Healthcare business.

PROCEDURE UPON RECEIPT OF DISCLOSURE report INVOLVING FEDERAL HEALTHCARE PROGRAMS

Upon receipt of a disclosure report involving federal healthcare programs and/or Radiology and Interventional’s Compliance Policies and Procedures, the Bayer HealthCare Compliance Officer (or designee) makes a preliminary good faith inquiry into the allegations set forth in the disclosure to ensure that he or she has obtained the information necessary to determine whether further review must be conducted.

An internal review is initiated to investigate any disclosure that is sufficiently specific so that it reasonably permits a determination of the appropriateness of the alleged improper practice and provides an opportunity for taking corrective action. The Bayer HealthCare Compliance Officer or designee initiates the investigation by providing a summary of the allegation, including the Report Control Number, to the Law and Patents Department and/or the applicable Human Resource Department, as appropriate.

By the follow up date, Bayer Healthcare Compliance Officer (or designee) will provide a statement of closure or a request for additional information to Global Compliance Services to be provided to the caller. Once all necessary information is obtained and the investigation is finalized, the disclosure report will be documented as closed by Global Compliance Services, Inc.

A final written report is maintained in the Bayer HealthCare Compliance Department and will include, as appropriate, the results of the investigation and corrective actions taken.

Corrective actions may include, but are not limited to, the following:

• Modifications to appropriate policies or procedures.
• Additional or remedial training.
• Disciplinary action, up to and including termination.

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2. Business Activities Requiring Written Notification to the Office of Inspector General (OIG)

WHAT MUST BE REPORTED

Under the CIA, Bayer is required to report certain activities to the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services for all of Bayer HealthCare LLC, including Radiology and Interventional. For all such reports, the Law and Patents Department will work with Bayer HealthCare’s Compliance Officer to ensure proper and timely submission.

CIRCUMSTANCES THAT REQUIRE REPORTING

1. Changes to the Bayer HealthCare Compliance Committee and Bayer HealthCare Compliance Officer

Any changes in the identity or position description of the Bayer HealthCare Compliance Officer, or the composition of the Bayer HealthCare Compliance Committee, or any actions or changes that would affect the Bayer HealthCare Compliance Officer or Bayer HealthCare Compliance Committee’s ability to perform their duties, must be reported to the OIG, in writing, within 15 days of such change.

2. Government Investigations or Legal Proceedings

Any ongoing investigations or legal proceeding known to Bayer HealthCare (including Radiology and interventional conducted or brought by a governmental entity or its agents which involves an allegation that Bayer HealthCare or any Bayer HealthCare Affiliate has committed a crime or has engaged in fraudulent activities must be reported to the OIG, in writing, within 30 days of discovery by Bayer HealthCare. The notification must include a description of the allegation, the identity of the investigating or prosecuting agency, and the status of the investigation or proceeding.

Resolutions of legal proceedings or investigations must be reported to the OIG, in writing, within 30 days of the resolution with a description of the findings and/or results of the investigations or proceedings, if any.

3. Reportable Events

The CIA defines “Reportable Event” as any matter that a reasonable person would consider a probable violation of criminal, civil or administrative laws applicable to any federal healthcare program and/or applicable to any FDA requirements relating to the promotion of products for which penalties or exclusion may be authorized or a filing of bankruptcy petition by Bayer HealthCare (including radiology and Interventional) or any Bayer Affiliate. Bayer HealthCare must notify the OIG in writing within 30 days after making a determination that a Reportable Event exists. The report to the OIG must include the following information:

• Description of the Reportable Event, including the relevant facts, persons involved, and legal and federal healthcare program and/or FDA authorities implicated;
• Description of Bayer HealthCare’s or a Bayer HealthCare Affiliate’s actions taken to correct the Reportable Event; and
• Any further steps Bayer HealthCare or a Bayer HealthCare Affiliate plans to take to address the Reportable Event and prevent from recurring.

4. Changes to Business Locations

Any change or closure of a Bayer HealthCare (including Radiology and Interventional) or Bayer HealthCare Affiliate business unit or location that performs Promotional and Product Services Related Functions or performs Government Pricing and Contracting Functions must be reported to OIG, in writing, within 30 days of the date of change or closure. Any purchase, establishment of a new unit, or sale of a Bayer HealthCare business unit or location that performs Promotional and Product Services Related Functions or performs Government Pricing and Contracting Functions must be reported to OIG, in writing, no later than the date the sale is publicly disclosed. For new units or locations, the notification must include the address of a new operation(s), phone number, fax number, federal healthcare program provider number(s) (if any), and the corresponding contractor’s name and address that issued the provider number. For sales, the notification must include a description of the business unit or location to be sold, a brief description of the terms of the sale, and the name and contact information of the prospective purchaser.

5. Notification of Communications with FDA

In the event Bayer HealthCare (including Radiology and Interventional) or any Bayer Affiliate receives any written report, correspondence, or communication between Bayer HealthCare or any Bayer HealthCare Affiliate and the FDA that materially discusses Bayer HealthCare, a Bayer HealthCare Affiliate or a Bayer HealthCare Covered Person’s actual or potential unlawful or improper promotion of Bayer HealthCare’s products (including any improper dissemination of information about off-label indications), Bayer HealthCare must provide written notice to OIG within 30 days after the date of the report, correspondence or communication and provide to the OIG a copy of the report, correspondence or communication.

In addition, Bayer HealthCare must provide written notice to the OIG within 30 days after a resolution of any such disclosed matter as well as provide a description of the findings and/or results of the matter, if any.

Reminder: Under the CIA, “Promotional and Product Services Related Functions” includes: (a) the promotion, advertising, distribution, marketing, and sale of Government Reimbursed Products; and (b) the development or dissemination of materials or information about, or the provision of services relating to, Government Reimbursed Products.

PROCEDURES

The Bayer HealthCare Compliance Department is responsible for publishing monthly reminders to employees to solicit information that is reportable under this Policy.

Individuals who learn of information that is reportable under this Policy must immediately notify Radiology and Interventional’s Law and Patents Department.

The Radiology and Interventional Law and Patents Department is responsible for communicating to the Bayer HealthCare Compliance Officer any matter for which a report is required under this Policy. Together, Radiology and Interventional and the Bayer HealthCare Compliance Officer will ensure that the report is completed.

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3. Determining Ineligible Persons

Radiology and Interventional does not hire Ineligible Persons -- individuals who are excluded, suspended, debarred or otherwise ineligible to participate in federal healthcare programs or in federal procurement or non-procurement programs; or who have been convicted of a criminal offense related to federal healthcare programs. Radiology and Interventional may not bill federal healthcare programs for items or services furnished, ordered, or prescribed by an Ineligible Person.

SCOPE

This Policy applies to all Radiology and Interventional employees, contractors, consultants and agents.

PROCEDURES

New Hire Self-Disclosure and check against Government websites.

1. The appropriate Human Resource Department or Contract Champion, prior to hiring a Radiology and Interventional employee, contractor, consultant or agents or permitting internal transfers and job changes, must ensure that the applicant signs a Self-Disclosure form that certifies that he or she:

• Is eligible to participate in federal healthcare programs and procurement and non-procurement programs.
• Has not been convicted of a criminal offense involving a state or federal healthcare program.
• Is not excluded, debarred or suspended from participating in any other government programs.
• Will disclose immediately to Radiology and Interventional if he/she becomes an Ineligible Person.

The Self-Disclosure form also contains the applicant’s certification that he or she has received, read, understood and agrees to abide by the Bayer HealthCare Code of Conduct. Radiology and Interventional Human Resources Department must provide the Bayer HealthCare Code of Conduct to the applicant as part of the on boarding process (electronically or manually) before the applicant completes the paper certification.

2. Prior to hiring internal transfers or to approving job changes involving a Radiology and Interventional employee, contractor, consultant or agent, Human Resources or the Contract Champion will provide the Self-Disclosure form and the Bayer HealthCare Code of Conduct to the prospective Radiology and Interventional employee, contractor, consultant or agent. In addition, Human Resources or the Contract Champion will arrange to complete the government exclusion checks for each perspective Radiology and Interventional employee, contractor, consultant or agent. The government exclusion checks required by the CIA involve checking the prospective employee, contractor, consultant or agent’s name against two government exclusion lists: the Department of Health and Human Services/Office of Inspector General’s List of Excluded Individuals/Entities at: http://www.hhs.gov/oig and the General Services Administration’s List of Parties Excluded from Federal Programs at: http://www.sam.gov (formerly www.epls.gov.)
3. The exclusion check and the Self-Disclosure form must be completed, scanned and emailed to Bayer HealthCare Compliance department at: compliance_lms_admin@bayer.com before the hiring process is complete and before the applicant’s first day in the position. If a Radiology and Interventional employee, contractor, consultant or agent is listed on either of the government websites, the Human Resource Representative follows procedures detailed in the following section entitled “Change in Eligibility Status of a Covered Person.”

If any potential Radiology and Interventional employee contractor, consultant or agent fails to satisfy these requirements or is determined to be an Ineligible Person, Radiology and Interventional will not hire that person.

The original Self-Disclosure form and results of the government screenings and exclusion checks are retained by the Radiology and Interventional Human Resources Department. The Bayer HealthCare Compliance Department retains the fax or electronic copy of the Self-Disclosure form in a binder in the Bayer HealthCare Compliance Department. The certifications will be retained for a period of 10 years from the date they are completed. Records are subject to review and audit by Bayer HealthCare and the OIG.

ANNUAL CHECK AGAINST GOVERNMENT WEBSITE for all Radiology and Interventional Employees, contractors, consultants and agents

The Bayer HealthCare Compliance Department will make a request to the Radiology and Interventional Human Resources Department to arrange for the annual government exclusion checks to be conducted for all Radiology and Interventional employees, contractors, consultants or agents. Radiology and Interventional Human Resources prepares a report of all active and inactive Radiology and Interventional employees and submits the report to the Bayer HealthCare Compliance Department to utilize in conducting the government screenings. The Bayer HealthCare Compliance Department will complete the annual exclusion process by February 23rd of each year for all Radiology and Interventional employees, contractors, consultants and agents.

If it is determined that the Radiology and Interventional employee, contractor, consultant or agent is listed as ineligible, written notice records will be forwarded to the Human Resource Department by the Bayer HealthCare Compliance Officer (or designee). For any confirmed match, see section “Change in Eligibility Status of a Radiology and Interventional Employee, contractor, consultant or agent” of this procedure.

Documents used in completing the annual check against government websites will be retained by the Bayer HealthCare Compliance Department for a period of 10 years.

CHANGE IN ELIGIBILITY STATUS OF A Radiology and Interventional Employee

The Bayer HealthCare Compliance Officer (or designee) and the appropriate Human Resource Representative must be notified immediately if a Radiology and Interventional employee:

• becomes an Ineligible Person;
• is proposed to be included on the exclusion list of either the General Service Administration or the Department of Health and Human Services/Office of Inspector General; or
• has been charged with a criminal offense related to a federal healthcare program.

The responsible Human Resource Department will suspend the Radiology and Interventional employee with pay for one week to enable the employee to resolve the issue or correct any identity issues with the Government. If the individual is determined by the Government to be eligible within the one-week suspension, the Radiology and Interventional employee will be reinstated to his/her current position. If the individual is not reinstated during the one-week suspension period, the Radiology and Interventional employee will be terminated or transferred to a position that does not involve responsibility for or involvement with Radiology and Interventional’s business operations related to federal healthcare programs or a position for which the Covered Person’s compensation or the items or services furnished, ordered, or prescribed by the Covered Person are not paid in whole or part, directly or indirectly, by federal healthcare programs or otherwise with federal funds.

Covered Persons WHO ARE NOT Radiology and Interventional EMPLOYEES

The Contingent Labor Program representatives and temporary employee vendors contracted by Radiology and Interventional, consultants and agents must follow similar processes to meet the requirements of determining eligibility. The appropriate Human Resource representative and/or Contingent Labor Program representative are responsible for completing and communicating the eligibility requirements to the temporary staffing vendors and completing the government exclusion checks.

Annual government exclusion checks for Radiology and Interventional contractors, consultants and agents are conducted by the Bayer HealthCare Compliance Department.

The Bayer HealthCare Compliance Department will create a list of all contractors, consultants and agents, based on data from Bayer HealthCare’s internal HealthCare Compliance database and Human Resource and Contingent Labor Program databases, along with manual records of temporary employees. The list will be compared to the government exclusion lists identified above. Additional information will be used in a more refined comparison and research performed for any possible match. Written records will be generated and retained to show why/how the individual was determined not to be ineligible.

Records are subject to review and audit by Bayer HealthCare and the OIG. All agreements and contracts with an effective date of November 25, 2008 or later must reflect Corporate Integrity Agreement requirements. Active vendor contracts with an effective date prior to November 25, 2008 have been adjusted to reflect obligations imposed by the Corporate Integrity Agreement.

REPORTING TO THE OIG

A summary of any personnel action taken as a result of self-disclosures and checks against the government websites will be forwarded to the Bayer HealthCare Compliance Officer (or designee) and included in the Annual Report to the Office of Inspector General.

HEALTHCARE COMPLIANCE PROGRAM SELF DISCLOSURE

Bayer HealthCare / R&I employees, contractors, consultants and agents

Self-Disclosure Certification

I, _______________________, represent that I:

_ have never been convicted of a crime under Section 306(a) or 306(b) of the Generic Drug Enforcement Act of 1992 or as defined or included within 42 U.S.C. section 1320a-7(a) or (b), or
_ am not currently excluded, debarred, suspended, or otherwise ineligible to participate in any Federal health care programs, including Medicare and Medicaid, or in Federal procurement or non-procurement programs.
_ agree to report immediately to my Agency and my Radiology and Interventional contact any change in my status as an individual eligible to participate in federal health care programs or in federal procurement or non-procurement programs.

Code of Conduct Certification

_ I hereby recognize and acknowledge that I have received a HealthCare Compliance Code of Conduct booklet and certify that I have read, understand, and agree to abide by this code.

Printed name:_________________________________ Date: ______________________

Signature: ___________________________________

For Internal Use Only: Please Print Radiology and Interventional

Title: _______________________________________ Supervisor: ____________________________

Department: _________________________________ Location: ______________________________

Cost Center: _________________________________ Hire Date: _____________________________

Exclusions Check Date: _________________________ Match ___________ No Match ____________

HR Rep/Hiring Manager: _______________________

Employee: ________________ Contractor_________________ Consultant: _________________

This form and exclusion check screen shots must be completed, scanned and emailed to the Bayer HealthCare Compliance Department at: compliance_lms_admin@bayer.com before the hiring process is complete and before the applicant’s first day in the position. Original is to be maintained by the HR Department with the Exclusion Check search documentation.

Where applicable, the Contract Champion is responsible for ensuring that the original screen shots (exclusions lists check), completed self-disclosure form, completed contract traveler and executed agreement are uploaded into myGCS in accordance with the MCMP, and for forwarding the originals to the Law and Patents Department.

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4. Supervisor Responsibility

The process described in this procedure is for immediate supervisors of new employees, transferring employees, or employees with changes in responsibilities (includes contractors, consultants and agents) resulting in a new role or position that qualifies the employee, contractor, consultant or agent as a Covered Person or Arrangements Covered Person in the HealthCare Compliance Program. Supervisors must follow this procedure to ensure that Radiology and Interventional meets all the HealthCare Compliance Program requirements for Covered and Arrangements Covered Persons and the requirements of the Corporate Integrity Agreement. Immediate supervisors are primarily responsible for ensuring that training and certification occurs on schedule, as well as for appropriate and timely communication with the Radiology and Interventional Human Resources Department and the Bayer HealthCare Compliance Department.

New Covered Persons and new Arrangements Covered Persons include individuals who have been newly hired, transferred, or promoted into a position that the Bayer HealthCare Compliance Department has determined is a Covered or Arrangements Covered Person in the HealthCare Compliance Program. New Covered Persons and Arrangements Covered Persons also include temporary employees (expected to work more than 160 hours per year), contractors, consultants and agents in positions covered under the HealthCare Compliance Program and the Corporate Integrity Agreement. The supervisor who has hired a temporary employee is referred to as a Radiology and Interventional Sponsor.

If an employee, contractor, consultant or agent who is not a current HealthCare Compliance Program Covered Person is transferred or promoted into a Covered position, the employee, contractor, consultant or agent must meet the same Compliance training and certification requirements as that of a New Hire covered employee, contractor, consultant or agent. A transfer or promoted employee, contractor, consultant or agent who is moving from an active Covered Person position to an Arrangements Covered Person position must comply with the Arrangements training and certification requirements within 21 days of the transfer or promotion. Communication from the Supervisor is relied upon to ensure the HealthCare Compliance Program requirements are met for transferred and promoted employees, contractors, consultants or agents. Covered and Arrangements Covered Persons who do not complete the HealthCare Compliance training and certification requirements within 30 days of becoming a Covered or Arrangements Covered Person are deemed HealthCare Compliance Program exceptions. Bayer HealthCare is required to report all HealthCare Compliance Program exceptions to the OIG. As a result of this reporting obligation, Bayer HealthCare Compliance requires that all assigned training be completed prior to the 30 day OIG requirement and sets the due date for training at their discretion which is 21 days.

PROCEDURES

PRIOR to the Effective Date of Becoming a Covered Person or Arrangements Covered Person

Once the employee, contractor, consultant or agent accepts his/her new position, and prior to his/her effective date of hire, transfer or promotion, the immediate supervisor is required to notify the Human Resources Department and the Bayer HealthCare Compliance Department prior to the effective date of hire or transfer or change in responsibilities.

Following the effective date of hire, transfer or promotion, the Bayer HealthCare Compliance Department electronically and/or manually sends to the new Covered or Arrangements Covered Person a training package that includes training materials, training instructions, the HealthCare Compliance Helpline telephone number, the Radiology an Interventional Compliance Policy and Procedures booklet, and the Bayer IntegrityLine materials.

The immediate supervisor must ensure that the new Covered or Arrangements Covered Person has access to a computer capable of connecting to the Radiology an Interventional intranet or is internet enabled. This may require the immediate supervisor to use his or her credentials to log the new trainee on to the Radiology an Interventional intranet. The new trainee (employee, contractor or consultant) must use his or her own Concern-Wide User Identification (CWID) or assigned unique log in to enter and complete the training session and certification process. Only the employee, contractor, consultant or agent can train and certify completion of training for himself or herself.

The immediate supervisor is responsible for ensuring that the new trainee completes the training and certification process within 21 calendar days of the hire/transfer date. For Arrangements Covered Persons, the immediate supervisor is also responsible for ensuring that he or she reviews the trainee’s work involving Arrangements (as that term is defined in the CIA) until the trainee has completed Arrangements Training and certified completion.

The Bayer HealthCare Compliance Department will monitor training progress and send weekly reminders to the new Covered Person and supervisor if training and certifications are not completed.

Notification is also sent to the Human Resources Department, which will communicate deadlines and consequences to the employee and to the supervisor.

All Covered Persons who do not complete training by the due date will be communicated to by their supervisor and Bayer Human Resources Department. The Human Resources Department will take the appropriate corrective action including the suspension of the new Covered Person from work for a minimum of one-week (seven calendar days), without pay. If training and certifications are not completed within this suspension period, the new trainee will be subject to further disciplinary action, up to and including termination of employment.

Changes in Employment Status of Covered Persons

Supervisors must report immediately any leave of absence (e.g., short-term or long-term medical leave, personal leave) or termination to the Human Resources Department and report to the Human Resources Department and the Bayer HealthCare Compliance Department when the Covered Person returns to work after a leave of absence.

Contractors, Consultants and Agents

Agencies must ensure that the HealthCare Compliance Program requirements are met for all temporary employees placed with Radiology and Interventional Sponsors (supervisors) and the Human Resources Department Representative responsible for Temporary Staffing must communicate with the agency or vendor, as well as the Bayer HealthCare Compliance Department, to assure the HealthCare Compliance Program requirements and the Corporate Integrity Agreement requirements are met.

The Radiology and Interventional Sponsor (supervisor)/Human Resources Representative must:

• Inform the temporary agency or vendor that the position to be filled is a Covered Person position.
• Inform the Bayer HealthCare Compliance Department immediately (prior to the first work day) upon placing a contractor, consultant or agent in a Covered Person position.
• Inform the Bayer HealthCare Compliance Department immediately (the same day) upon a contractor, consultant or agent leaving a Covered Person position.

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5. Compliance Training

General TRAINING

Within 21 days of becoming a HealthCare Compliance Program Covered Person, an employee, contractor, consultant or agent must complete two hours of Compliance General Training. At a minimum, the training covers: (a) Bayer HealthCare’s obligations under the Corporate Integrity Agreement and (b) Bayer HealthCare’s Compliance Program (including the Code of Conduct and the Policies and Procedures, as they pertain to general compliance issues.)

All Covered Persons must complete at least one additional hour of General “refresher” Training annually.

ArrangementS TRAINING

HealthCare Compliance Program Covered Persons who are involved with the initiation, negotiation, proposal, development, approval, implementation, management, oversight (including accounting functions), or review of Radiology and Interventional’s Arrangements must complete three hours of Arrangements Training, in addition to the General Training described above, within 21 days of becoming a Covered Person requiring Arrangements Training. For more information on what constitutes an “Arrangement” as defined by the CIA, please consult Policy and Procedure 8, “Focus Arrangements.” At a minimum, Arrangements Training covers the following:

• Arrangements that potentially implicate the Anti-Kickback Statute, as well as the regulations and other guidance documents related to this statute;
• Radiology and Interventional’s policies, procedures and other requirements relating to Arrangements, including but not limited to the Focus Arrangements Database, the internal Arrangements review and approval process, and the tracking of remuneration to and from sources of referrals or sales;
• The personal obligation of each individual involved in the initiation, negotiation, proposal, development, approval, implementation, management, oversight (including accounting functions), or review of Arrangements to know the applicable legal requirements and Radiology and Interventional’s Compliance Policies and Procedures;
• Legal sanctions under the Anti-Kickback Statute; and
• Examples of violations of the Anti-Kickback Statute.

In addition to the annual general “refresher” Training described above, all individuals involved with Arrangements must complete at least three additional hours of Arrangements “refresher” Training annually.

Supervision of new Arrangements Covered Persons

Until a new Covered Person completes his/her Arrangements Training, a Covered Person who has completed this training will review all of the untrained person’s work related to Arrangements.

CERTIFICATION

All General and Arrangements Covered Persons will be required to complete a certification, which may be in electronic form, confirming that they have completed the applicable training.

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6. Review of Compliance Text Materials

Bayer HealthCare is committed to appropriate and timely communications to all HealthCare Compliance Program Covered Persons regarding significant changes in the Radiology and Interventional’s Compliance Policies and Procedures (“Compliance Policies and Procedures”) and the Bayer HealthCare Code of Conduct (“Code of Conduct”) materials.

Annually (or, more often, as necessary), Bayer HealthCare and Radiology and Interventional will review the Code of Conduct, the Compliance Policies and Procedures, and the Compliance training text to determine if any revisions are appropriate and make any necessary revisions based on such review.

Revisions to the Code of Conduct will be distributed to all Bayer HealthCare (including Radiology and Interventional) employees, contractor, consultant and agent within thirty (30) days of finalizing such changes. Bayer HealthCare (including Radiology and Interventional) employees, contractor, consultant and agent must certify that they have received, read, understood and will abide by such revisions within thirty (30) days of distribution.

Revisions to the Compliance Policies and Procedures will be distributed to all HealthCare Compliance Program Covered Persons whose job functions relate to the revisions within thirty (30) days of the effective date of the revision.

The Compliance training programs are updated as necessary and/or as a result of the text reviews.

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7. Disciplinary Action

General Rule

Radiology and Interventional takes seriously all violations of (1) applicable federal, state or local laws or regulations, (2) applicable industry guidelines, and (3) the Bayer HealthCare Code of Conduct and the Radiology and Interventional Compliance Policies and Procedures. Disciplinary action up to and including termination of employment may be taken against any Radiology and Interventional employee, contractor, consultant or agent who violates applicable federal, state or local laws or regulations, industry guidelines, the Bayer HealthCare Code of Conduct, or the Radiology and Interventional Compliance Policies and Procedures.

Non-Retaliation

Radiology and Interventional will not retaliate, or tolerate retaliation, against any Radiology and Interventional employee, contractor, consultant or agent for reporting in good faith any alleged compliance issue or other inappropriate activity involving applicable federal, state or local laws and/or regulations, industry guidelines, the Bayer HealthCare Code of Conduct or the Radiology and Interventional Compliance Policies and Procedures.

Disciplinary Action, Termination and Referral to Law Enforcement

Radiology and Interventional employees, contractors, consultants or agents who violate applicable federal, state or local laws or regulations, industry guidelines, the Bayer HealthCare Code of Conduct or the Radiology and Interventional Compliance Policies and Procedures may be subject to disciplinary action up to and including termination of employment or other contractual arrangement. Any disciplinary action taken by Radiology and Interventional in response to a violation of the Radiology and Interventional Compliance Policies and Procedures should be commensurate with the severity of the violation, as determined in Radiology and Interventional’s sole discretion. In the case of material violations of federal, state or local laws or regulations, it may be necessary to refer the compliance matter to appropriate law enforcement officials.

Radiology and Interventional Employees, contractors, consultants and agents Subject to Disciplinary Action

Disciplinary action may be taken against any Radiology and Interventional employee, contractor, consultant or agent who: (1) authorizes or participates in a violation of any applicable federal, state or local law or regulation, applicable industry guidelines or the Radiology and Interventional Compliance Policies and Procedures; (2) knowingly withholds relevant and material information concerning an actual or suspected compliance issue or other inappropriate activity; or (3) fails to cooperate with an investigation by the Bayer HealthCare Compliance Officer or the Law and Patents Department.

Any Radiology and Interventional employee, contractor, consultant or agent who fails to report an actual or suspected compliance issue or other inappropriate activity that has been brought to his or her attention may be subject to disciplinary action, up to and including termination of employment.

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8. Focus Arrangements

Under the terms of the Corporate Integrity Agreement (“CIA”), Bayer HealthCare (including Radiology and Interventional) is required to establish a review and approval process, as well as a tracking database, for certain transactions and arrangements involving individuals or entities that may purchase or make referrals for Bayer HealthCare (including Radiology and Interventional) products. This Policy defines those arrangements and outlines the policies and procedures that Radiology and Interventional must follow when entering into these transactions. The specific procedures that must be followed for each type of arrangement (e.g., medical education grant) are incorporated into the individual procedures particular to that arrangement.

CIA DEFINITIONS

Arrangements are defined as every arrangement or transaction that involves, directly or indirectly, the offer, payment, solicitation, or receipt of anything of value between Bayer HealthCare (including Radiology and Interventional) or any Bayer HealthCare Affiliate and any actual or potential source of referrals or sales of Government Reimbursed Products.

Focus Arrangements are defined as every Arrangement between Bayer HealthCare (including Radiology and Interventional) or any Bayer HealthCare Affiliate and any actual source of Government Reimbursed Product referrals or sales that involves, directly or indirectly, the offer, payment or provision of anything of value. Because Radiology and Interventional cannot accurately determine whether any person or entity is an “actual” source of sales or referrals, you should treat any potential source of referrals as an “actual” source for purposes of compliance with the CIA.

Referrals or sales means referring, recommending, arranging for, ordering, prescribing, or purchasing Government Reimbursed Products.

Government Reimbursed Products means all drugs, devices, and other items that are marketed, distributed, sold or promoted by Bayer HealthCare (including Radiology and Interventional) or Bayer Affiliate and reimbursed in whole or in part by federal healthcare programs.

Promotional and Product Services Related Functions includes (a) the promotion, advertising, distribution, marketing, and sale of Government Reimbursed Products; and (b) the development or dissemination of materials or information about, or the provision of services relating to, Government Reimbursed Products.

Source (of referrals or sales) includes, but is not limited to, a distributor, wholesaler, supplier, physician or other healthcare provider, contractor or agent. Because Radiology and Interventional cannot always accurately determine whether any person or entity is an “actual” source of sales or referrals, Radiology and Interventional must treat any potential source of referrals as an “actual” source for purposes of this policy. (Original Equipment Manufacturers (OEMs) are not considered sources for the purpose of these Policies and Procedures).

Third Party Personnel means personnel of the entities with whom Bayer HealthCare (including Radiology and Interventional) or any Bayer HealthCare Affiliate has or may in the future enter into agreements to co-promote a Government Reimbursed Product or engage in joint promotional activities relating to such product.

Examples of Focus Arrangements

Below are examples of activities and Arrangements that could constitute Focus Arrangements to the extent the other party is an actual or potential source of referrals or sales of Government Reimbursed Products.

• Speaker agreements
• Medical education grants
• Consultant arrangements
• Advisory Board arrangements
• Business meals outside the recipient’s normal working hours
• Service agreements with customers
• Data purchases
• Exhibit or display fees
• Advertising fees/promotional funding
• Educational Items provided in excess of one (1) per calendar year (or in excess of $100 per item)
• Contracts for discounted product purchase
• Clinical research or clinical trial grants
• Investigator-sponsored studies
• Vendor credentialing/hospital registration fees paid directly to a customer (e.g., hospital)

The above list is not all inclusive and activities not listed may be Focus Arrangements. If you have any questions about whether a potential activity or transaction may constitute a Focus Arrangement, you must consult Bayer HealthCare Compliance or the Law and Patents Department.

Exceptions to Focus Arrangements

The following activities and arrangements are not considered Focus Arrangements for purposes of the CIA or this policy:

• Bona fide employment arrangements with sales representatives;
• Provision of drug samples free of charge for free distribution to patients pursuant to the Prescription Drug Marketing Act (“PDMA”);
• Provision of one (1) educational item per calendar year valued at $100 or less to a healthcare practitioner and designed primarily for the education of patients or healthcare providers (e.g., anatomical model) if the item does not have value to the healthcare provider outside his or her professional responsibilities;
• Business meals offered in connection with a presentation or discussion of Radiology and Interventional products led by a Radiology and Interventional representative where the presentation is made during the healthcare professional’s working day, including mealtime, where the presentation provides scientific or educational value, and the meal is (a) modest as judged by local standards; (b) not part of an entertainment or recreational event; and (c) provided in a manner conducive to informational communication;
• Bills of sale; and
• Contracts for the purchase of product where the only items of value exchanged are the purchase price and (1) a bona fide fee paid to a GPO (group purchasing organization); and/or (2) a prompt-pay discount or rebate for payment within a designated time period.

The above exceptions are defined by the CIA. Any deviation from the exception as stated above is not acceptable and the Arrangement must be considered a Focus Arrangement for purposes of this policy.

Procedures for Device Arrangements and Focus Arrangements

Radiology and Interventional has established a written review and approval process for Focus Arrangements of a contractual nature. All Focus Arrangements other than business meals and educational items are considered contractual in nature. If you are unsure whether a transaction, contract, program or other activity constitutes a Focus Arrangement, you must consult the Bayer HealthCare Compliance or the Law and Patents Department to ensure proper procedures are followed.

The general Focus Arrangements Procedures are described below. Specific procedures for each type of Focus Arrangement are found in the policy specific to that type of Focus Arrangement (e.g., policy on fee-for-service agreements). The first step in the review and approval process for all Focus Arrangements is to comply with the Radiology and Interventional policy specific to that individual Arrangement.

Radiology and Interventional must also follow the procedures outlined below for all Focus Arrangements. The purpose of these procedures is to help ensure that all new and existing Focus Arrangements do not violate the Anti-Kickback Statute.

1. Each Focus Arrangement must be set forth in writing prior to the services being performed.
2. Each Focus Arrangement must be signed by Radiology and Interventional and the other party(ies) to the Arrangement.
3. The written agreement must include a certification by the parties to the Focus Arrangement that the parties shall not violate the Anti-Kickback Statute with respect to the performance of the Focus Arrangement.
4. The written agreement must include a requirement that all individuals who meet the definition of Covered Person shall comply with all applicable elements of Bayer’s HealthCare Compliance Program, including applicable training related to the Anti-Kickback Statute and provide each party to the Focus Arrangement a copy of Bayer HealthCare’s Code of Conduct and applicable Anti-Kickback Statute Policies and Procedures.

Co-Promotional Contracts

If the party to the Focus Arrangement is a person who is involved in, or an entity whose employees are involved in, the co-promotion of a Government Reimbursed Product or joint promotional activities relating to such products, Bayer HealthCare (including Radiology and Interventional) must send each entity that is a party to the Focus Arrangement a Third Party Personnel Letter, as defined by the CIA, with (1) a copy of Bayer HealthCare’s Code of Conduct and (2) applicable Anti-Kickback Statute policies and procedures attached. The Third Party Personnel Letter and attachments may be sent electronically or by hard copy, and can be included as an exhibit to the contract or sent as separate documents.

The receiving party is required to inform Bayer HealthCare whether it will either: (a) make a copy of Bayer HealthCare’s Code of Conduct and a description of Bayer HealthCare’s Compliance Program available to its Third Party Personnel (or, in the case of an individual, to himself or herself) or (b) represent to Bayer that it has and enforces a substantially comparable code of conduct and compliance program. The required notification can be included as a provision in the contract or in a separate document, and requires the party to the agreement to check the appropriate option. A description of each party’s response to the Third Party Personnel Letter must be noted in the Focus Arrangements Database.

Focus Arrangements Datasheet– Excel® Spreadsheet

In order to obtain all of the required information for the Focus Arrangements Database, a Focus Arrangements Datasheet has been incorporated into the Contract Traveler (the excel spreadsheet). It is the responsibility of the Contract Champion to complete this portion of the Contract Traveler with all required information and serve as the point of contact should the contract be audited.

PROCEDURES FOR Drug ARRANGEMENTS AND FOCUS ARRANGEMENTS

1. Each Focus Arrangement must be set forth in writing prior to the services being performed.
2. Each Focus Arrangement must be signed by Radiology and Interventional and the other party(ies) to the Arrangement.
3. The written agreement must include a certification by the parties to the Focus Arrangement that the parties shall not violate the Anti-Kickback Statute with respect to the performance of the Focus Arrangement.
4. If the party to the Focus Arrangement is a person who is involved in, or an entity whose employees are involved in, Promotional and Product Services Related Functions, Bayer HealthCare Pharmaceuticals must send each entity that is a party to the Focus Arrangement: a Third Party Personnel Letter, as defined by the CIA along with (1) a copy of Bayer HealthCare’s Code of Conduct and (2) applicable Anti-Kickback Statute Policies and Procedures attached. The Third Party Personnel Letter and attachments may be sent electronically or by hard copy, and can be included as an exhibit to the contract or sent as separate documents. The Third Party Personnel Letter requires the receiving party to inform Bayer HealthCare Pharmaceuticals whether it will either: (a) make a copy of Bayer HealthCare’s Code of Conduct and a description of Bayer HealthCare’s Compliance Program available to its Third Party Personnel (or, in the case of an individual, to himself or herself) or (b) represent to Bayer HealthCare Pharmaceuticals that it has and enforces a substantially comparable Code of Conduct and Compliance Program. The required notification can be included as a provision in the contract or in a separate document, and requires the party to the agreement to check the appropriate option. A description of each party’s response to the Third Party Personnel Letter must be noted in the Focus Arrangements Database.
5. If the party to the Focus Arrangement is a person who is not involved in, or an entity whose employees are not involved in, Promotional or Product Services Related Functions, the contract must include a requirement that all individuals who meet the definition of Covered Persons as defined in the CIA shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute. In addition, Bayer HealthCare Pharmaceuticals must provide each individual that is a party to the Focus Arrangement a copy of (1) Bayer HealthCare’s Code of Conduct and (2) applicable Anti-Kickback Policies and Procedures. The Bayer HealthCare Code of Conduct and applicable Anti-Kickback Statute Policies and Procedures may be sent electronically or by hard copy, and can be included as an exhibit to the contract or sent as separate documents.

Focus Arrangements Database Procedures

When the executed contract is returned from the hospital, the Radiology and Interventional representative forwards it to the Law and Patents Department to be entered into Efilia with information required for the Focus Arrangements Database.

Procedures for all Focus Arrangements

Law and Patents Review of Focus Arrangements

The Law and Patents Department evaluates whether each proposed Focus Arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document that this assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department also confirms that the proposed payment (e.g., speaker compensation or fees for a commercial exhibit) represents fair market value. The methodology used to determine fair market value will be based on information in a database of fair market values or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

Proof of Service

The Contract Champion must be able to confirm that the services and/or items required to be provided pursuant to the Focus Arrangement were in fact provided. The form of the proof of service will differ depending on the type of Focus Arrangement (e.g., speaker sign in sheet, slide decks, time sheets, detailed invoice (must include date, time, hours and complete description of service) or exhibit booth attendance forms) so the Radiology and Interventional Compliance Policies and Procedures for the individual Focus Arrangement (e.g., medical education grant) must be consulted.

Proof of Service documentation must be attached to the Check Request Form or payment will not be issued. All proof of service documentation must be retained by the Contract Champion in the event of an audit.

Payment for Focus Arrangements

All fees and expenses associated with a Focus Arrangement must be correctly linked with the contract for reporting purposes. The contract number (MED# for device contracts) assigned to each Focus Arrangement must be used when payment of fees and expenses are requested. Failure to associate such fees with the correct contract number is a violation of this policy.

Focus Arrangements Database

The CIA requires that Bayer HealthCare maintain a database of all existing, new and renewed Focus Arrangements. This Focus Arrangements Database contains certain information to assist Bayer HealthCare (including Radiology and Interventional) to ensure that each Focus Arrangement does not violate the Anti-Kickback Statute. In particular, the database:

• Allows Bayer HealthCare to track remuneration to and from all parties to Focus Arrangements;
• Tracks service and activity logs or other documented proof of performance to ensure that parties to Focus Arrangements are performing the services required; and
• Includes appropriate documentation of all internal controls.

The following information must be included in the database for each Focus Arrangement.

1. Name of each party involved;
2. Type of Focus Arrangement (e.g., medical education grant, research agreement, etc.);
3. Term of Arrangement (if applicable) and any automatic renewal provisions;
4. Compensation to be paid;
5. Means by which compensation is paid (e.g., check, product, periodic payments);
6. Verification of payments made by Radiology and Interventional;
7. Methodology or basis for determining that the compensation represents fair market value;
8. Whether the amount of compensation to be paid is determined based on the volume or value of referrals between the parties;
9. Whether each party has fulfilled the requirements of the CIA, including a description of each response to Third Party Personnel Letters (as described above);
10. Whether the services and/or items to be provided have been provided; and
11. Name and title of attorney who assessed whether the Focus Arrangement satisfies the requirements of an Anti-Kickback Safe Harbor and the date the assessment was made.

Compliance Officer Review

Bayer HealthCare Compliance Officer will review the Focus Arrangements Database, the internal review and approval process, and the Arrangements Procedures on at least a quarterly basis. Bayer HealthCare Compliance Officer will prepare a report on the results of such review and provide it to the Bayer HealthCare Compliance Committee.

Should Bayer HealthCare discover a suspected violation of the Anti-Kickback Statute, Bayer HealthCare will implement an effective responses, including disclosingsuch information to the OIG to the extent required by the CIA.

AUDITS

Bayer HealthCare will retain and make available to OIG, upon request, the Focus Arrangements Database and all supporting documentation of the Focus Arrangements described in this procedure, and (to the extent available) all non-privileged communications relating to the Focus Arrangements and the actual performance of duties under the Focus Arrangements.

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9. Interactions with Government Investigators

GENERAL RULE

Radiology and Interventional may be contacted by, or receive requests for information from, various government agencies, such as the U.S. Food and Drug Administration (FDA), the U.S. Department of Health and Human Services (including the Office of Inspector General (OIG)), the Federal Bureau of Investigation (FBI), or other regulatory agencies. It is Radiology and Interventional’s policy to cooperate fully with any federal or state government officials or agents who conduct an inquiry, audit, or otherwise investigate Radiology and Interventional. Radiology and Interventional expects all employees, contractors, consultants and agents to extend the same cooperation within the guidelines of this Policy.

REPORTING GOVERNMENT INQUIRIES OR AUDITS

All Radiology and Interventional employees, contractors, consultants and agents should immediately report to the Law and Patents Department any notice of government inquiry or audit with respect to Radiology and Interventional related activities. Notice of a government inquiry may include, but is not limited to: (1) telephone calls or letters from government officials or agents to Radiology and Interventional employees, contractors, consultants and agents; (2) presentation of search warrants; (3) on-site visits to, or inspections of, Radiology and Interventional’s premises by government officials or agents; or (4) visits by government officials to the homes of Radiology and Interventional employees, contractors, consultants and agents.

CONTACT BY GOVERNMENT INVESTIGATOR

In the event a Radiology and Interventional employee, contractor, consultant or agent is contacted by a federal or state investigator with respect to Radiology and Interventional related activities, the employee, contractor, consultant or agent should obtain proper identification from the investigator prior to answering questions. Radiology and Interventional employees, contractors, consultants or agents: (1) are not required to answer any questions asked by the government agent without the assistance of the Law and Patents Department; (2) have the right to decide whether or not to consent to an interview; (3) have the right to consult legal counsel, either their own or Radiology and Interventional counsel before answering any questions and to have such counsel present during questioning by a government agent; and (4) may stop the interview at any time.

If a government investigator attempts to contact or interview a Radiology and Interventional employee, contractor, consultant or agent at his/her home and/or any location which is off Radiology and Interventional premises with respect to Radiology and Interventional related activities, the employee, contractor, consultant or agent has the right to either: (1) talk to the government investigator; (2) not talk to the government investigator without representation by an attorney; or (3) request that the appointment be scheduled on Radiology and Interventional’s premises during regular business hours, or at an alternate time and place that is otherwise convenient and to have independent legal counsel present during questioning by a government agent. If so requested by the employee, contractor, consultant or agent, Radiology and Interventional will have an attorney or other representatives attend such interview.

GOVERNMENT INTERVIEWS

If a Radiology and Interventional employee, contractor, consultant or agent decides to be interviewed or respond to questions by a government investigator with respect to Radiology and Interventional related activities, the employee, contractor, consultant or agent must answer all questions completely, accurately and truthfully. Radiology and Interventional employees, contractors, consultants and agents must not guess, speculate or make up answers to questions to which the answers are not known.

In addition, if the employee, contractor, consultant or agent consents to an interview, the employee, contractor, consultant or agent must obtain specific authorization from the Law and Patents Department before discussing the company’s privileged information. The employee, contractor, consultant or agent must refuse to discuss any communications he or she may have had, or of which he or she may be aware, involving the Law and Patents Department or Radiology and Interventional’s outside legal counsel. If the employee, contractor, consultant or agent does not know whether the information being asked to discuss is privileged, the employee, contractor, consultant or agent must consult with the Law and Patents Department for a determination as to whether that information is privileged to ensure that no unauthorized disclosures of privileged information are made.

If you do not know with certainty the answer to any question, it is appropriate to say that you do not know the answer to the question. If an employee, contractor, consultant or agent would like to consult with an attorney, the employee, contractor, consultant or agent may request the presence of Radiology and Interventional counsel. Alternatively, Radiology and Interventional may recommend qualified counsel and, under the appropriate circumstances, will pay for such counsel to represent the Radiology and Interventional employee, contractor, consultant or agent. If at any time, the employee, contractor, consultant or agent feels uncomfortable or uncertain about whether to proceed, or if at any time the employee contractor, consultant or agent feels the need to consult with his/her own attorney or a Radiology and Interventional attorney, the employee, contractor, consultant or agent may stop the interview or tell the investigator that he/she wishes to consult with counsel.

CORPORATE DOCUMENTS

Radiology and Interventional employees, contractors, consultants and agents must contact the Law and Patents Department if asked by a government investigator or anyone outside the company for Radiology and Interventional or Bayer documents. Radiology and Interventional documents include all documents, whether in paper format or electronically stored, that are held or created in connection with your employment at Radiology and Interventional and/or the operation of Radiology and Interventional’s businesses. For example, Radiology and Interventional documents may include, but are not limited to, any (1) files, (2) notes, (3) memoranda, (4) e-mails, (5) correspondence, (6) reports, (7) sales information, (8) marketing information, (9) financial information, (10) project plans, and (11) design documentation. Likewise, your Radiology and Interventional computer itself is company property and is subject to this Policy.

In addition, Radiology and Interventional employees, contractors, consultants and agents must not provide privileged Radiology and Interventional documents to the government or anyone outside the company without specific authorization from the Law and Patents Department. Privileged documents include any documents involving the Law and Patents Department or Radiology and Interventional’s outside legal counsel. If the employee, contractor, consultant or agent does not know whether the documents being requested are privileged, the employee, contractor, consultant or agent must consult with the Law and Patents Department for a determination as to whether that information is privileged to ensure that no unauthorized disclosures of privileged information are made.

SIGNING DOCUMENTS

Radiology and Interventional employees, contractors, consultants or agents may be asked to sign an affidavit or other legal document as the company’s representative during the course of an interview. Radiology and Interventional does not authorize you to sign or initial any such documents or statements as a Radiology and Interventional employee, contractor, consultant or agent unless expressly authorized by the Law and Patents Department. If a Radiology and Interventional employee, contractor, consultant or agent is asked to sign such a document, the employee, contractor, consultant or agent must decline to do so and inform the government investigator of Radiology and Interventional’s policy.

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10. False Claims Act

The Federal Civil False Claims Act (FCA) (31 U.S.C. §3729, et seq.) imposes fines and penalties on individuals and entities that file, or cause others to file, false or fraudulent claims for payment or approval from Medicare, Medicaid or other federal healthcare programs or that knowingly conceal or knowingly and improperly avoid or decrease an obligation to pay money, such as Medicaid drug rebates, to the government. Violators of the FCA are liable for damages up to three (3) times the amount the Government is defrauded plus penalties of $5,500 to $11,000 for each false claim submitted.

Sales and marketing activities that might violate the FCA include, but are not limited to:

• Submitting, or facilitating the submission of, claims for reimbursement for services not performed or items not delivered;
• Failing to report and return an overpayment of federal healthcare program funds (e.g., Medicare or Medicaid funds) to a government agency or contractor within 60 days after the date on which the overpayment is identified or the date any corresponding cost report is due, if applicable; and
• Knowingly reporting false or fraudulent pricing information to government agencies.

The FCA and some state false claims acts include provisions under which individual citizens with evidence of fraud against the government may sue on behalf of the government to recover the lost funds (a.k.a. whistleblower suits). These laws also prohibit retaliation against persons who file such suits.

The federal Deficit Reduction Act of 2005 (DRA) requires healthcare entities that receive $5 million or more annually in Medicaid reimbursement to establish written policies to prevent false claims, and to provide detailed information about the False Claims Act to employees, contractors, consultants and agents. As a result, many of Radiology and Interventional’s customers may submit information to Radiology and Interventional on their policies and procedures related to the FCA. Please direct all such submissions to the Bayer HealthCare Compliance Officer.

Radiology and Interventional has established comprehensive policies and procedures to prevent, detect, and correct violations of law and company policy. Radiology and Interventional employees, contractors, consultants and agents are required to report actual or potential violations of law or company policy. There are several mechanisms to report such issues. First, you may report compliance issues to your supervisor. Second, you may contact anyone in the Law and Patents Department or Bayer HealthCare Compliance Department. Third, you may file an anonymous report via the confidential disclosure process, the Bayer IntegrityLine, at 1-888-765-3846.

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11. Vendor Credentialing (formerly Hospital Registration)

Transactions under this Policy may constitute Focus Arrangements as defined by the CIA. Prior to initiating a transaction covered under this policy you must familiarize yourself with the Policy and Procedure entitled “Focus Arrangements.”

This policy describes the process for complying with vendor credentialing requirements. Many customers, such as hospitals, require manufacturing representatives to go through a credentialing process before obtaining access to a facility and pay a fee for registration. Following registration, the institution may appropriately require representatives to check in and obtain a badge for each sales call. Radiology and Interventional representatives must follow all institutional access policies pertaining to restricted areas as well as restrictions involving, meals and educational items.

Radiology and Interventional Representatives may not sign any documents (hard copy or electronic) or make any representations on behalf of Radiology and Interventional without prior written approval from the Law and Patents Department.

SCOPE

This policy is designed to allow compliance with credentialing requirements imposed by hospitals and other healthcare facilities. Radiology and Interventional is committed to protecting employees, contractor, consultant and agent’s privacy and personal information. Any questions regarding a registration requirement that is not covered by this policy should be addressed to your supervisor and/or the Law and Patents Department. In the event that any field sales, service or clinical applications employee, contractor, consultant or agent believes that a registration requirement is unreasonable, he or she is required to discuss such requirement with his or her manager.

For additional guidance please go to:
Device Representatives: http://sourceone.medrad.com/sites/Credentialing/default.aspx

Drug Representatives:
http://us.pharmatoday.bhc.cnb/APPS/BSP/US/BSP-SalesView/BSP-SalesView.nsf/id/ EN_Credentialing.

As a condition of employment, all field sales, service and clinical applications employees, contractors, consultants and agents are required to comply with registration requirements imposed by their accounts to the extent those requirements comply with Radiology and Interventional policies. Failure to do so may result in discipline, up to and including termination.

Registration Fees paid to Non-Customers

Registration fees to non-customers are permitted only under the following circumstances:

• Registration fees must be reasonable and must not exceed $500 for an Individual Registration (valid for a single representative). Should you be presented with requests for fees that exceed this limit, you must contact the Law and Patents Department before paying the fee.
• Registration fees must be paid directly to a third party vendor (e.g., Vendormate, Reptrax, VendorClear) that manages vendor access programs for the hospital or healthcare entity.
• Fees may only be paid to vendors representing customers to which Radiology and Interventional sales, service or clinical applications employees, contractors, consultants or agents have a legitimate need for access.

Registration Fees paid to Customers

In the rare instance, where registration fees must be paid directly to a customer (e.g., a hospital), the payment of fees constitutes a Focus Arrangement because the hospital or healthcare entity is a potential source of referrals or sales of Radiology and Interventional products. Under no circumstances may registration fees be paid directly or indirectly to a physician practice group or paid to obtain access to a physician practice group. Law and Patents review of Focus Arrangements and the Focus Arrangements Database Procedures below must be followed. Questions regarding whether the payment of registration fees constitutes a Focus Arrangement should be directed to the Law and Patents Department.

Law and Patents Review of Focus Arrangements

The Law and Patents Department generates a written agreement that meets the requirements for Focus Arrangements, or if a contract is provided, reviews the contract to ensure that it meets those same requirements. The written agreement must be signed by both parties to the arrangement (e.g., Radiology and Interventional and the customer) and must contain:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the Focus Arrangement; and
• A requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute.

The Law and Patents Department evaluates whether the proposed arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document that this assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department confirms that the proposed payment represents fair market value. The methodology used to determine fair market value may be based on information in a database of fair market values or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

The Radiology and Interventional Contract Champion or other Radiology and Interventional employee must provide each party to the Focus Arrangement a copy of the approved contract and a copy of (1) Bayer HealthCare’s Code of Conduct and (2) applicable Anti-Kickback Policies and Procedures and must document that these were sent.

Focus Arrangements Datasheet for Device Contracts – Excel® Spreadsheet

Focus Arrangements Database Procedures for Drug Contracts

Proof of Service

The Radiology and Interventional Contract Champion must confirm that the services purchased were performed and/or satisfactorily received before payment is generated. The Contract Champion employee formally confirms proof of service by providing the confirmation of registration or a copy of the badge. The Contract Champion employee must retain the proof of service records for seven (7) years.

Payment

Representatives are permitted to pay a non-source registration fee using their corporate credit card (and seek reimbursement) for payments made directly to a third party (e.g., Vendormate, Reptrax, VendorClear). Payments made directly to a customer constitute a Focus Arrangement and must be paid by a Radiology and Interventional check issued by Accounts Payable. Payments may not be made in cash or with a personal check.

Permissible Activities or Information to Release

Biographical Information

Company Information

- Company name- Radiology and Interventional
- Address 100 Global View Drive Warrendale, PA 15086
- Supervisor information
- Tax ID Number- 25-1151038

Representative Information

- Name
- Address
- Phone number

Immunizations and Immunization Records

Some registrations require that representatives be immunized against certain infectious agents. The representative is responsible for obtaining his or her own records and providing them to the hospital or third party credentialing vendor. If the Representative has not yet obtained all necessary immunizations, he or she should arrange for and obtain the required immunizations from his or her personal healthcare provider. Co-pays for such job-required medical testing and immunization fees will be reimbursed through the employee’s expense report.

Other Requests

Requests for medical information beyond that described above (e.g., request for medical records generally) should be addressed to your supervisor and/or the Law and Patents Department before any such information is provided.

Product Training

Certificates evidencing that a Representative has been trained on relevant product(s) can be obtained from his or her Businesses’ training department. It is the Representative’s responsibility to maintain a copy of product training certificates for submission to entities that may request such documentation.

Background Checks and Drug Testing

Copies of pre-employment background checks and drug testing results are available from your Human Resources representative.

Insurance Certificate

Requests for Radiology and Interventional certificates of insurance are now standardized. The form and instructions to request a certificate of insurance can be found on Radiology and Interventional’s Credentialing intranet:

http://sourceone.MEDRAD.com/sites/Credentialing/default.aspx.

Any questions should be directed to Radiology and Interventional’s Risk Management Department or the Bayer Insurance Department.

Hospital/Institutional Training

Representatives are permitted to take part in additional training that hospitals may require as a function of registration, but any required certifications or agreements must be sent to the Law and Patents Department for review and approval. No fees (beyond the registration fees described above) may be paid for this training without the prior written approval of the Law and Patents Department.

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12. Prescriber Data

Radiology and Interventional uses prescriber data for appropriate purposes such as conducting research, communicating important safety and risk information to prescribers regarding a particular drug or device, tracking adverse events, and focusing appropriate marketing activities on prescribers who may find such information useful. Prescriber data includes information such as the prescriber’s name, address, and specialty, as well as the number of prescriptions for a particular product written by that prescriber. None of the prescriber data used by Radiology and Interventional contains any identifiable patient information.

Radiology and Interventional respects the confidential nature of prescriber data and is committed to using such data responsibly and in accordance with applicable law as well as the AMA PDRP (defined below) and the AdvaMed and PhRMA Codes.

USES OF PRESCRIBER DATA:

Radiology and Interventional may use prescriber data for appropriate purposes only, including to:

• Impart important safety and risk information to prescribers of a particular drug or device;
• Conduct appropriate research such as, for example, evidence-based medical research;
• Comply with FDA mandated risk management plans that require drug companies to identify and interact with physicians who prescribe certain drugs;
• Track adverse events of marketed prescription drugs or devices; and
• Focus appropriate marketing activities on those healthcare professionals who have not “opted out” from receiving information and would most likely benefit from information on a particular drug or device.

Radiology and Interventional does not use for sales purposes Drug Enforcement Administration (DEA) registration numbers (assigned to prescribers who have authority to prescribe controlled substances). The disclosure of a practitioner’s DEA registration number to entities other than those involved in the legal distribution of controlled substances or the enforcement of the laws governing their legal distribution may facilitate the diversion of controlled substances from the legal channels of distribution.

RESTRICTING ACCESS TO PRESCRIBER DATA

Radiology and Interventional respects a physician’s choice in whether his or her prescribing data is used by complying with physician “no contact” requests and any applicable restrictions under state law. As described below, Radiology and Interventional has adopted processes for restricting access to prescriber data following a physician “no contact” request that are in accordance with the AMA Physician Data Restriction Program (PDRP), applicable state laws, and the PhRMA Code.

AMA Physician Data Restriction Program (PDRP)

The PDRP is a large AMA database containing prescribing information on physicians throughout the United States. Health information organizations (HIOs), such as Wolters Kluwer or IMS, match the information from the AMA database (called the Physician Masterfile) to prescribing data from other sources such as pharmacy data clearinghouses, which have removed any identifiable patient information from the prescriber data before transferring it to HIOs or other third parties. The HIOs then license to pharmaceutical companies the combination of prescriber data from the clearinghouses with the information from the AMA Physician Masterfile.

Some physicians do not wish to be contacted by third parties that would otherwise have access to a physician’s prescribing data through the HIO licensing arrangements. Physicians who do not wish to receive marketing communications from pharmaceutical companies or other third parties can opt-out of PDRP by making a “no contact” request to the AMA, thereby restricting third-party access to their prescribing data except in the case of important drug safety and related notifications such as drug recalls. The AMA also provides a mechanism by which physicians may report specific instances of inappropriate behavior by pharmaceutical sales consultants or others.

You must direct any prescriber wishing to opt-out of the AMA PDRP to contact the AMA or the Bayer HealthCare Pharmaceuticals Hotline (which, as discussed below, would generally direct the caller to the AMA). Pharmaceutical companies are required to review the PDRP opt-out list on at least a quarterly basis and have 90 days to comply with each new request.

State Laws

The HealthCare Compliance Department tracks federal and state legislation regarding use of prescriber data. HIOs also regularly monitor legislation relating to the license and use of prescriber data.

A few states have passed laws restricting use of prescriber data for commercial purposes. A number of other states have introduced bills with similar provisions. For those states which have imposed limitations, Radiology and Interventional has added PDRP opt-out flags to the relevant physician profiles in accordance with the process described below.

PhRMA Code

The PhRMA Code encourages pharmaceutical companies to (a) respect the confidential nature of prescriber data, (b) develop policies regarding the use of prescriber data, (c) educate employees, contractors, consultants and agents about those policies, (d) maintain an internal contact person to handle inquiries about the use of the data, and (e) identify appropriate disciplinary actions for the misuse of data. This policy and the processes noted herein are consistent with the PhRMA Code.

Bayer HealthCare Pharmaceuticals Hotline for Prescribers

Bayer HealthCare Pharmaceuticals U.S. Sales Operations makes available a hotline, 888-RxBayer (888-792-2937), to prescribers for a variety of purposes. Consistent with the PhRMA Code, this hotline is available to handle no contact requests, inquiries regarding Bayer’s use of prescriber data, and any concerns regarding contact from sales consultants. For example, a physician caller requesting to opt-out of contact from all pharmaceutical companies would be directed to the AMA PDRP.

A physician caller requesting to opt-out of contact from Radiology and Interventional specifically would have his or her request honored by Radiology and Interventional through the use of a PDRP opt-out flag that is added to the physician profile in the Bayer Enterprise Data Warehouse (EDW), maintained by the Commercial Analytics and Support department. Once the flag is attached to the physician’s record in EDW, it is passed to IMPACT, Bayer Healthcare Pharmaceuticals’ sales force automation system. A PDRP opt-out flag blinds the physician’s prescribing information from views and screens available in IMPACT to Bayer HealthCare Pharmaceuticals Sales Consultants and Regional Sales Managers. Physicians can also opt back in using the same AMA PDRP method.

The hotline is managed by the Sales Administration Manager.

Radiology and Interventional SYSTEM PROCESS FOR PDRP OPT-OUT FLAGS:

On a monthly basis, Radiology and Interventional obtains HIO prescriber data update files, including the AMA PDRP opt-out flag. The updates are processed as follows:

• On a monthly basis, the HIO data, including any PDRP opt-out flags related to specific physician profiles, is loaded into the Bayer EDW.
• On a monthly basis, the HIO data, including any PDRP opt-out flags related to specific physician profiles, is also loaded into IMPACT.
• Additional PDRP opt-out flags based on state laws and Bayer specific opt-out requests received through the Bayer Hotline, if any, are added to the EDW and IMPACT systems as necessary.

TRAINING

Training on proper uses of prescriber data as well as respecting the physician’s choice to opt-out is provided in Sales Training programs to relevant employees, contractors, consultants and agents.

VIOLATIONS AND SANCTIONS

Employees, contractors, consultants and agents misusing prescriber data are subject to disciplinary action up to and including termination of employment.

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13. Special Requirements for Federal Government Employees

The federal laws and regulations governing items of value, including meals and educational items, provided to federal government employees, including part-time federal government employees, are much stricter than the laws and regulations for non-governmental healthcare professionals. This Policy and Procedure will help you avoid any conduct that presents the appearance of impropriety when conducting business with employees of the federal government.

WHO QUALIFIES AS A GOVERNMENT EMPLOYEE

Federal government employees include anyone (military or civilian) who is employed by a facility associated with the Department of Defense (military or DoD), the Department of Veterans Affairs (VA), Federal Public Health Service (PHS), the Indian Health Service (IHS), National Institutes of Health (NIH), or other federal government entities. According to federal law, a government employee includes part-time employees of the government and part-time workers at a government facility.

The following are examples of government employees:

• A resident while he/she is doing a rotation at the VA.
• A physician who works part-time at the VA and part-time at a civilian institution (the amount of time spent at the VA hospital is irrelevant).
• A patient advocate who is employed by the DOD and providing speaker services

Note: You may not avoid the restrictions in this Policy by providing educational items or business meals to a government employee at the civilian location. For example, if a physician works at Johns Hopkins and the Baltimore VA, that physician is still considered a government employee while he or she is physically located at Johns Hopkins.

The following is NOT considered a government employee:

• An individual who works at a civilian facility that has a contract with the government to treat government beneficiaries (e.g., an employee at West Penn Hospital in Pittsburgh) would not be a government employee by virtue of the fact that West Penn has a contract with the federal government to treat Medicare recipients.

GENERAL Rule

You may not offer or provide anything of value, regardless of the amount, to a federal government employee to influence him/her to purchase, order, lease, refer, use or recommend any Radiology and Interventional product(s) or to encourage that employee to take, or not take, any action in his/her official capacity (e.g., signing a contract agreeing to purchase Radiology and Interventional products). Before providing any item of value to a healthcare professional, it is your responsibility to determine whether he or she is a federal government employee.

PROHIBITION OF EDUCATIONAL ITEMS AND BUSINESS MEALS

Federal law prohibits contractors, such as Radiology and Interventional, from providing educational items or meals to federal government employees that exceed $20 per government employee per event, or a total of $50 per government employee in a calendar year. This federal regulation is often referred to as the “20/50 Rule.” These limits apply to the entire Bayer HealthCare (all divisions and subsidiaries), not to an individual sales consultant.

In order to ensure that Radiology and Interventional complies with the law, it is Radiology and Interventional’s policy that Radiology and Interventional employees, contractors, consultants and agents may not provide educational items (e.g., textbooks, anatomical models) or business meals to federal government employees, regardless of dollar value.

Product samples and products provided for evaluation are not considered “educational items” and may be provided to federal employees, if permitted by the government entity and in accordance with applicable Compliance Policies and Procedures. You must check with the relevant authority at the government entity regarding their position on samples and product provided for evaluation before providing such products.

LIMITED EXCEPTIONs

Widely Attended Gatherings

Government officials, other than President Obama appointees, are permitted by federal law to attend certain group events referred to as “widely attended gatherings” sponsored by contractors, such as Radiology and Interventional, even if the cost of these events exceeds the 20/50 Rule. Widely attended gatherings include events sponsored by industry associations that are open to both government and civilian officials (e.g., RSNA conference). In order for a Radiology and Interventional-sponsored event to be considered a “widely attended gathering,” the sponsored event must be open to all attendees of the conference or convention (e.g., a Radiology and Interventional sponsored keynote address at the annual RSNA convention). Note that the sponsored event/meal itself, not just the conference, must be open to all attendees. Thus, you may not invite government employees to attend a Radiology and Interventional sponsored limited target audience event (e.g., dinner at a Radiology and Interventional table at the RSNA conference) or invite individual government physicians to dinner at an AMA conference or similar event.

Fee-for-Service Arrangements

Modest business meals may be provided to a federal government employee if there is a fee-for-service arrangement (consultant or speaker) with the federal employee and the meal is provided in connection with the fee-for-service arrangement (e.g., meal at an investigator meeting, meal at a speaker event). Because this exception is limited, you must consult your supervisor or the Law and Patents department before providing a meal to any federal employee.

Grants for Government Employees to Speak at or Attend Medical Education and Training Events

Federal law requires that entities, such as Radiology and Interventional, follow appropriate procedures before paying for expenses in connection with official travel for education and training activities for federal government employees. This Policy is designed to protect Radiology and Interventional and its employees from criminal and civil penalties that may result from providing improper educational items to government employees.

Grants to support government speakers may only be provided to bona fide third party organizations (such as the Jackson Foundation, True Foundation, Geneva Foundation or similar organization) established for the purpose of accepting and disseminating grant funds on behalf of federal entities including the DoD and the VA. Radiology and Interventional may provide funds to these organizations for various educational purposes, such as sponsoring a government official to speak at or attend a medical conference only if the third party organization, not Radiology and Interventional, determines how the funds are to be allocated. Provision of funds must be consistent with the third party organization’s charter or authority.

All grant requests for funding government speakers and government attendance at medical education and training events must follow the procedures described in “Education Grants (Including Continuing Education/Continuing Medical Education)” in this booklet.

RECORD RETENTION

Records relating to grant requests and payments must be retained for seven (7) years by the Accounts Payable Department.

AUDIT

Education grants are subject to audit by Corporate Auditing and HealthCare Compliance to ensure compliance with these policies. The government (e.g., OIG, IRS) may also request to audit/review payments at any time.

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14. Business Meals with Healthcare Professionals

Note: Transactions under this Policy are reportable to the federal government under the Patient Protection and Affordable Care Act when implemented. It is each employees, contractor, consultant and agent’s responsibility to report accurate, complete and timely data.

Scope

The Radiology and Interventional policy for business meals conforms to the codes relating to interactions with healthcare professionals published by the Advanced Medical Technology Association (“AdvaMed Code of Ethics”), the Pharmaceutical and Research Manufacturers of America (“PhRMA Code”) and the Department of Health and Human Services Office of Inspector General (OIG). The policy covers interactions with all healthcare professionals who may purchase, prescribe, order, refer, use or arrange for a purchase of Radiology and Interventional products.

Bayer Corporation has additional corporate policies regarding business meals and other business interactions that fall outside this policy and do not cover healthcare professionals specifically. You may find these policies at: http://www.bayernet.com/corp/policies/.

Note that the definition of healthcare professionals is very broad and includes individuals who directly interact with patients and/or have a role in the diagnosis and treatment of patients or entities which are involved in the provision of healthcare services and/or items to patients and which may purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Radiology and Interventional products in the U.S. Generally, this definition includes physicians, nurses, nurse practitioners, physician assistants, medical assistants who treat patients, and other allied healthcare professionals, such as pharmacists, technicians, and therapists. However, the definition is not limited to these individuals alone; the term includes any person in a position to recommend or influence the purchase or prescribing of Radiology and Interventional products. In some instances, this may include individuals who do not work directly with patients but who have influence over the recommendation, purchase, or prescribing of Radiology and Interventional products—such as a purchasing agents at hospitals, physician practice managers, management personnel within group purchasing organizations (GPOs), managed care organizations (MCOs), pharmacy benefit managers (PBMs), health plan administrators, wholesalers, distributors, pharmacies, Pharmacy & Therapeutics Committee members, Formulary Committee members, or other customers who do not see patients. Original Equipment Manufacturers (OEMs) are NOT considered to be Healthcare Professionals.

GENERAL RULE

Meals may be provided to healthcare professionals Radiology and Interventional if they are: (1) modest; (2) occasional; (3) incidental to a bona fide presentation or discussion of disease states relevant to Radiology and Interventional products, scientific, educational or business information; (4) take place in a setting conducive to such discussion; and (5) only involve individuals necessary for the conduction of Radiology and Interventional business.

Radiology and Interventional policy prohibits employees, contractors, consultants and agents from offering anything of value, including a business meal, to a healthcare professional to encourage him/her to purchase, order, refer, use or recommend Radiology and Interventional’s products as doing so could violate the federal Anti-Kickback Statue, relevant state statutes, and the AdvaMed and PhRMA Codes.

Providing a healthcare professional with a meal solely for “relationship building” is not acceptable. Further, it is not appropriate for Radiology and Interventional to pay for, or reimburse healthcare professionals for, personal meals. A Radiology and Interventional representative must be present at the location when a meal is offered; providing “take-out” meals is not allowed.

All Radiology and Interventional employees, contractors, consultants and agents must exercise sound judgment and discretion when providing modest food or beverages to HCPs in conjunction with product promotion. The central focus must be the product education provided, with the meal being incidental to that primary purpose. In the event that alcohol is provided, it must accompany a meal, not be excessive and the cost must be included in the total cost of the meal. Providing alcoholic beverages in connection with an in-office or in-hospital meal is prohibited.

If Radiology and Interventional requests that a patient participate in a business meal incidental to a bona fide presentation or discussion of disease states relevant to Radiology and Interventional products, scientific, educational or business information, the requirements for meals with HCPs as outlined in this section could also apply including meal limits and required documentation. Due to the HIPAA Privacy Rule, disclosure of the patient name is not required. Providing alcoholic beverages in connection with any patient meal is prohibited.

SETTING

In conformance with the AdvaMed and PhRMA Codes, meals must be in a setting that is conducive to bona fide scientific, educational or business discussion, such as the healthcare professional’s place of business or, as appropriate, a modest restaurant. All venues for business meals must be modest based on local standards.

• Non-Device Radiology field sales representatives and their immediate managers may provide business meals only in the healthcare practitioner’s office or in the hospital during the healthcare professional’s normal working hours. Appropriate places within a hospital include the cafeteria, coffee shop located within the hospital facility (e.g., Starbucks) or a meeting space conducive to an educational discussion (e.g., conference room). The PhRMA Code prohibits field representatives and their immediate managers from providing or offering meals in connection with these informational presentations to healthcare practitioners in restaurants or any location other than the professional’s office or the hospital. If a meal is being provided in connection with a promotional speaker program that fully complies with the requirements of Compliance Policy and Procedure 17, “Fee-for-Service Arrangements,” a sales consultant and/or immediate manager may attend and pay for the meal, as appropriate. Such a meal must comply with the other requirements of this policy but may take place at a modest venue outside the hospital.
• All other non-device Radiology employees (excluding employees referenced above) may provide business meals in a venue that is conducive to the educational or product discussion. Alcoholic beverages must generally not be offered but, if provided, the cost must be included in the total cost of the meal. Field Sales Representatives may not attend such out-of-office/hospital meals, even if Radiology and Interventional employees host the meal.
• Device Radiology, Interventional and Service representatives Although it is preferred that meals take place in the office or hospital, Device Radiology, Interventional and Service representatives and their immediate manager(s) are not restricted to in-office or in-hospital meals. In all cases, the other principles of this Policy apply to all representatives and their managers (e.g., venues and meals must be modest and conducive to bona fide scientific, educational or business discussions).

FREQUENCY

Consistent with AdvaMed and PhRMA Codes as well as OIG guidelines meals may be provided on an “occasional” basis. For purposes of this Policy, “occasional” means no more than ten (10) meals provided to any one healthcare professional during the calendar year

SPENDING LIMITS

Meals provided to healthcare professionals must be “modest.” “Modest” is defined as moderate based on local standards, but is always less than $125 per person when provided outside of an office environment (e.g., restaurant, hotel, conference center). Any food or drinks provided by Radiology and Interventional personnel to healthcare practitioners prior to and/or after a business meal must be included in the $125 per person limitation. The limit includes food, beverages, tax and tip. A modest business meal for lunch typically should consist of low cost items such as sandwiches, pizza, salads, fruit, cookies and soft drinks and must cost no more than $25 (including tax, gratuity, and delivery charge) per person. This per person charge also includes any paper products or supplies needed for the meal. An independently run restaurant within a hospital is considered an in--office meal and thus may be used by a field sales consultant as a meal setting.

For in-office or in-hospital meals, the amount to be spent must be based upon the number of healthcare professionals in attendance at the educational discussion (e.g., if there are 3 healthcare professionals, the maximum to be spent on the healthcare professionals is $75). Any food that is remaining after the in-office or in-hospital educational discussion with the healthcare professionals may be made available to the remainder of the office staff (e.g., clerical personnel).

It is important to remember that the government may view meals that are provided too frequently or are too expensive as an improper inducement to purchase Radiology and Interventional products

State spending Limits

Some states have laws regarding the provision of business meals and other promotional activities that are more restrictive than Radiology and Interventional’s general Policy described herein. Please refer to the Policy and Procedure entitled “State Laws” in this booklet for details on such restrictions. If you interact with healthcare professionals from any of these states, you must consult the relevant Radiology and Interventional procedures prior to providing any item of value to the healthcare professional.

Retail Value – Amount to be Recorded

The retail value of a meal, not the amount you or Radiology and Interventional paid for it, determines whether the meal is modest and within the guideline dollar limits in this policy. When providing business meals, you or Radiology and Interventional may take advantage of discounts (e.g., discount coupons, 2-for-1 specials), such that the retail value of a meal may be higher than what you or Radiology and Interventional actually paid for it. When listing the value of any meal, you must list its retail value and the amount you or Radiology and Interventional paid for it if the amounts differ. Retail value must also be used to determine if the cumulative value of educational items or meals is appropriate.

Special REQUIREMENTs For Federal Government Employees

There are federal laws that restrict business meals provided to federal Government employees (e.g., military and Department of Veterans Affairs). To ensure that Radiology and Interventional does not violate these laws, Radiology and Interventional employees, contractors, consultants and agents may not provide any business meals or food/drinks of any kind to federal government employees. For more information on this policy, including who constitutes a government employee, consult Policy and Procedure 13, “Special Requirements for Federal Government Employees,” in this booklet.

Other Limits

No Spouses or Guests – Business meals are for legitimate business purposes and therefore, spouses or other guests may not be included.

No Entertainment – You may not provide entertainment – nor must the meal be secondary to or a part of an entertainment or recreational event even if you include an informational presentation as part of the event.

No Cash or Cash Equivalents – You may never give a healthcare professional cash or cash equivalents
(e.g., gift certificates, your credit card) to purchase a meal. Further, under no circumstances can this Policy be circumvented by the use of the employee’, contractor, consultant or agent’s own cash or personal credit card.

ADDITIONAL GUIDANCE

• It is not appropriate to pay or reimburse a healthcare professional for personal meals.
• Radiology and Interventional may only pay for meals of healthcare professionals who actually attend a meeting at which Radiology and Interventional is legitimately sponsoring a meal pursuant to this Policy.
• Meals are only provided to individuals who are necessary for the conduct of Radiology and Interventional business. Leftovers may be provided to office staff at the end of the meal
• It is not appropriate to pay for a meal where the Radiology and Interventional representative is not present while the meal is consumed

EXAMPLES

The following are appropriate business meals:

• Providing breakfast sandwiches, coffee and juice during a demo of CT injectors in a hospital’s Radiology Department.
• Providing breakfast sandwiches, coffee and juice to members of a physician’s office attending a discussion about a new product offering or training on the appropriate use of a new product.

The following are examples of meals that are NOT appropriate for Radiology field sales consultants or their immediate managers:

• Taking a radiologist to dinner at Macaroni Grill to discuss the benefits of the CT injectors (restaurant is not an appropriate venue)
• Taking a radiologist to a modest restaurant around the corner from his/her office for a meal to discuss the benefits of Gadavist™(restaurant is not an appropriate venue)

The following are examples of meals that are NOT appropriate for any Radiology and Interventional employees, contractors, consultants and agents:

• Meeting a physician at a “take-out” restaurant and discussing products while waiting for the food. (Venue/location not conducive to an educational/business discussion; no Radiology and Interventional representative present when meal is consumed)
• Giving your credit card to a radiology tech and telling him/her to “buy lunch” or make some other purchase. (Providing credit card is a prohibited “cash equivalent”; no Radiology and Interventional employee, contractor, consultant or agent present; no conduct of Radiology and Interventional business can be confirmed)
• Taking an interventionalist to lunch at a 5 star restaurant that does not have a quiet area for a product discussion. (Too expensive to be modest; venue not conducive to educational/business discussion)

Procedures

Before providing a business meal, ask yourself:

• Will there be a product or scientific discussion or bona fide educational purpose?
• Is the location of the meal conducive to an educational discussion and, for Radiology sales consultants and their immediate managers, is the setting in either the healthcare practitioner’s office or an appropriate hospital venue?
• Is the amount of the meal modest?
• Is a Radiology and Interventional representative present?
• Is the frequency of meals provided to this healthcare professional occasional (it is Radiology and Interventional’s policy that “occasional” means no more than ten meals per healthcare professional within a calendar year) and is the total value of meals modest?
• Am I reasonably certain that each of the participants in the meal is not a federal government employee?
• Am I reasonably certain that each of the participants in the meal does not practice in a state with special restrictions or reporting requirements?

The answers to all of these must be “yes” for the business meal to be appropriate.

FOCUS ARRANGEMENTS

Business meals are items of value provided to a healthcare professional who is a source of referrals or sales of Government Reimbursed Products. The Corporate Integrity Agreement (“CIA”) carves out, or excludes, from the definition of Focus Arrangements those business meals that meet certain requirements; however such meals must be tracked for state reporting and CIA purposes to ensure accurate data capturing and reporting.

However, any meals that occur outside of the healthcare professional’s normal working hours are considered Focus Arrangements. Examples of such meals include dinner speaker programs or any other meals provided outside the healthcare professional’s normal working day. Note that a “normal working day” should be viewed as the time period the healthcare professional typically works at the hospital, clinic or his/her office. Because business meals are not “contractual in nature,” Radiology and Interventional is not required to follow contractual Focus Arrangements Procedures for business meals. However, Radiology and Interventional is required to track these meals in the Focus Arrangements Database.

Business meals that constitute Focus Arrangements are tracked through review of T&E reports, information provided by the Meetings and Conventions group, and, in the case of third-party payment, from information provided by third-party vendors. It is critical that you fully and accurately complete your T&E reports or other required documentation of business meals so that Radiology and Interventional can include required information in the Focus Arrangements Database.

Meals at Speaker Programs, Speaker Training, Consultant / advisory Board Meetings

Business meals provided in the context of company sponsored and controlled educational meetings, speaker training and/or consultant/advisory boards must also be modest as judged by local standards, but may not exceed $125 (including food, beverage, tax and gratuity) per person and must follow all Concur T&E reporting requirements.

DOCUMENTATION of business meals with Healthcare professionals

Business meals with healthcare professionals and business guests must be recorded through your Concur Travel and Expense Report (“T&E”) under Professional Education Meal. All employees must document the details of business expenses according to IRS rules, Compliance Policies and Procedures and the Corporate T&E Policy. An accurate description of the business purpose (e.g., the product you are detailing and purpose for the detailing visit to the HCP’s office) must be documented. Instructions on how to complete your T&E when providing a business meal to an HCP or Business Guest can be found on the intranet at: http://www.compliance.bayerweb.com/Interactions/

Itemized (detailed) receipts and copies of the attendee sign in sheet must be included and uploaded with every professional education meal expense entered into Concur T&E regardless of the amount. These two requirements supersede the Corporate T&E Policy.

The failure to submit for reimbursement for the business meal does not circumvent the business meal policy.

All business meals where healthcare professionals are in attendance, whether in or out of the office, regardless of amount, require an itemized (detailed) receipt and a completed sign in sheet which documents the attendance of each individual. If the Radiology and Interventional employee pays for the meal on his/her credit card and will expense the meal through the appropriate T&E system, the sign in sheet must be attached to the T&E report. Meals paid on behalf of Radiology and Interventional through a third party vendor (e.g., speaker training, advisory boards, investigator meetings, speaker program) also require sign in sheets. Sign in sheets used at third party meals (such as speaker programs or Ad Boards) must be submitted in accordance with Policy and Procedure 8, “Focus Arrangements.”

The sign in sheet must have the following information:

GENERAL

• Event date
• Event location (in-office or out of office)
• Event type (educational session, dinner speaker program, patient program,
advisory board, speaker training, etc.)
• Program/Event number (if applicable)
• Event host (Radiology and Interventional employee)
• Speaker (if applicable) printed and signature
• Contract number (if applicable)
• Name and address of venue
• Number of licensed HCPs, non-licensed HCPs, Radiology and Interventional employees,
total attendees

PER INDIVIDUAL HCP/NON-HCP

• Contract number (if applicable)
• Printed name
• Title (credentials)
• Affiliated entity or company
• Full address (address, city, state, zip)
• HCP license number http://hcp.sln.bayernet.com/Login.aspx?ReturnUrl=%2fDefault.aspx
• State of license
• Signature: Radiology and Interventional employees may, if necessary, complete information other than the signature. Each HCP must sign for himself/herself. If you are unable to obtain a signature, you must contact the Bayer HealthCare Compliance Department or the Law and Patents Department prior to submitting your expense report.

The Radiology and Interventional sign in sheet can be found at the following link:

http://sourceone.medrad.com/MEDRAD/Departments/CorporateCompliance/GeneralLegalCompliance/
Compliance%20Policies%20and%20Procedures/Bayer%20Event%20Sign-in%20Sheet.pdf

SUPERVISOR REVIEW OF EXPENSE REPORTS

Complying with the expense reporting and approval policies is a critical responsibility for managerial employees within the company to ensure compliance with this policy and proper control of business expenses.

Immediate supervisors are responsible for regularly reviewing expense reports for all employees they oversee to ensure compliance with this Policy and other applicable Radiology and Interventional requirements, including that the dollar limit per person per meal is not exceeded, that the attendees are appropriate, that the venue is appropriate and that the total number and amount of business meals provided to any single healthcare professional are consistent with this Policy.

If the review reveals potential divergence from Radiology and Interventional policy, the supervisor should take appropriate action, including discussing the situation with the employee, documenting any corrective action, and, if necessary, consulting with the next supervisory level. Significant divergence from the Policy may require notifying the Human Resources Department and the Bayer HealthCare Compliance Department.

RECORD RETENTION

Expense report documents are retained by Accounts Payable for a period of seven (7) years.

AUDITS

Spending for business meals is subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy, including proper documentation, spending limits, and company spending policy. The government (e.g., OIG, IRS) may also request to audit or review expense reports.

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15. Educational Items (Prohibition on Gifts for Healthcare Professionals)

Note: Transactions under this Policy are reportable to the federal government under the Patient Protection and Affordable Care Act when implemented. It is each employee, contractor, consultant and agent’s responsibility to report accurate, complete and timely data.

Radiology and Interventional representatives may provide educational items that are modest and designed primarily for the education of patients and healthcare professionals (HCPs). Any other items are prohibited, including practice-related and logo “reminder” items. Radiology and Interventional policy prohibits employees, contractors, consultants and agents from offering anything of value, including an educational item, to an HCP or provider to encourage the HCP or provider to purchase, order, refer, use or recommend Radiology and Interventional product(s) as doing so could lead to a violation of the Federal Anti-Kickback Statute and other relevant state statutes.

Scope

The Radiology and Interventional policy for providing educational items to healthcare professionals conforms to the AdvaMed and PhRMA Codes as well as the guidelines published by the Department of Health and Human Services Office of Inspector General.

The policy covers interactions with all healthcare professionals who may purchase, recommend, order, refer, use, or prescribe Radiology and Interventional products. Note that the definition of “healthcare professionals” is very broad and includes individuals or entities that directly interact with patients and/or have a role in the diagnosis and treatment of patients. or entities which are involved in the provision of healthcare services and/or items to patient and which may purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Radiology and Interventional products in the U.S. Generally, this definition includes physicians, nurses, nurse practitioners, physician assistants, medical assistants who treat the patient, and other allied healthcare professionals, such as pharmacists, technicians, and therapists. However, the definition is not limited to these individuals alone; the term includes any person in a position to recommend or influence the purchase or prescribing of Radiology and Interventional products. In some instances, this may include individuals who do not work directly with patients but who have influence over the recommendation, purchase, or prescribing of Radiology and Interventional products such as a purchasing agents at hospitals, physician practice managers, management personnel within group purchasing organizations (GPOs), managed care organizations (MCOs), pharmacy benefit managers (PBMs), health plan administrator, wholesalers, distributors, pharmacies, Pharmacy & Therapeutics Committee members, Formulary Committee members, or other customers who do not see patients. Original Equipment Manufacturers (OEMs) are NOT considered to be Healthcare Professionals.

MULTIVENDOR SERVICE EXCEPTION

Due to the nature of the MVS business, Bayer HealthCare Compliance has permitted MVS to have one logo “reminder” item that can be given to a non-healthcare professional. This logo item must be simplistic in nature and serve primarily as a business card for MVS. Upon Law and Patents approval, MVS is permitted to choose one item each year to serve as that year’s annual logo “reminder.”

Special REQUIREMENTs For Government Employees

There are federal laws that restrict business gifts or educational items provided to federal government employees (e.g., military and Department of Veterans Affairs). To ensure that Radiology and Interventional does not violate these laws, Radiology and Interventional employees, contractors, consultants and agents may not provide any educational items, including textbooks, to federal government employees, regardless of value. For more information on this policy, including who constitutes a government employee, consult Policy and Procedure 13, “Special Requirements for Federal Government Employees,” in these Policies and Procedures.

SPENDING LIMITS and frequency FOR Educational Items

The retail value of an educational item provided to an HCP in one year may not exceed $100.

Under the AdvaMed and PhRMA Codes, educational items may be offered only “occasionally.” In order to ensure that the provision of educational items are not Focus Arrangements as defined by the CIA, it is Radiology and Interventional’s policy that no more than one educational item be provided to any healthcare practitioner in a calendar year. Textbooks are considered educational items and thus you may give only one item, be it a textbook or another appropriate item, per calendar year. For more information regarding Focus Arrangements, see Policy and Procedure 8, “Focus Arrangements.”

Educational items provided to HCPs solely for distribution to and use of patients, such as patient starter kits and approved disease state brochures; do not count toward the annual limit of one educational item per HCP. However, any item that is intended for use by the healthcare professional, such as an anatomical model, medical textbook, resident handbook, or similar item, counts toward the annual limit of one item per HCP.

State Spending Limits

Some states have laws regarding the provision of items to healthcare professionals that are more restrictive than Radiology and Interventional’s general Policy described here. Please refer to the Policy and Procedure entitled “State Laws” in this booklet for details on such restrictions. You must consult the relevant Radiology and Interventional procedures prior to providing any item of value to healthcare professionals in those states.

Retail Value – Amount To Be Recorded

The retail value of an educational item, and not the amount you or Radiology and Interventional paid for it, determines whether it is within the spending limits. Radiology and Interventional often takes advantage of bulk or other discounts, such that the retail value of some educational items may be higher than what you or Radiology and Interventional actually paid for them. When listing the value of any educational item, you must always list its retail value and the amount you or Radiology and Interventional paid for the item, if the amounts differ. Retail value must also be used to determine if the cumulative value of educational items or meals is appropriate.

The functional areas responsible for distributing educational items and textbooks must include with each shipment a list that indicates the amount Radiology and Interventional paid for each item and the retail value associated with each item. These amounts may be close estimates if the actual cost and/or an exact retail value are not available.

Educational PURPOSE REQUIRED

All educational items provided to an HCP must be designed primarily for the education of the healthcare professional or patients. Examples of appropriate educational items include medical textbooks, educational materials (medical booklets, text materials, and handbooks), anatomical models, patient self-assessment and tracking tools and written materials that inform patients about adherence to medicine regimens. It is Radiology and Interventional’s policy not to provide subscriptions to scientific journals to a healthcare professional. However, Radiology and Interventional may provide transcripts, journal articles or reprints if the value does not exceed the spending limit in this policy and the materials have been reviewed and approved through the LMR process.

Medical textbooks may be offered only through the Marketing Departments and only after they have been pre-approved by the Law and Patents and Clinical Science and Regulatory Departments. You may not procure textbooks on your own through your Concur expense account.

All printed materials must be reviewed and approved through the Radiology and Interventional Legal, Medical and Regulatory (LMR) review process before they can be distributed. Distribution of any printed material, textbook, or any other publication without proper review and approval is prohibited. These materials count toward the one educational item per healthcare professional per calendar year limit.

Examples:

The following are examples of appropriate educational items to healthcare professionals:

• Anatomical models;
• Medical textbooks;
• Resident handbooks; and
• Educational materials and/or books on management of disease.

EXAMPLES OF UNACCEPTABLE Educational Items

Radiology and Interventional policy prohibits employees, contractors, consultants or agents from offering anything of value, including an educational item, to a healthcare professional to encourage him/her to purchase, order, refer, use or recommend Radiology and Interventional’s products as this could violate the federal Anti-Kickback Statue and other relevant state statutes.

Additionally, Radiology and Interventional representatives may not give healthcare professionals any type of practice-related “reminder” items, even if the item is of minimal value and related to the healthcare professional’s work or for the benefit of patients. Examples of such prohibited items include: pens, notepads, mugs, magnets and other similar items that have the Radiology and Interventional name or logo on it, or that have a name or logo of one of Radiology and Interventional’s products. These prohibited items also cannot be offered at third party professional or scientific meetings (such as RSNA).

Radiology and Interventional representatives may never provide healthcare professionals with cash or cash equivalents such as: gift certificates, gas cards, savings bonds, lottery tickets, airline upgrade coupons, loans, etc.

Finally, Radiology and Interventional representatives may not give any “dual-purpose” item, such as a television, DVD player, flash drive or computer equipment, even if the cost is less than $100 and the healthcare professional indicates the item will be used for medical purposes. The AdvaMed and PhRMA Codes prohibit these items because they could also be used by the healthcare professional for personal use unrelated to patient education.

Under no circumstances can this Policy be circumvented by the use of the employee, contractor, consultant or agent’s own cash and/or personal credit card.

Procedures

Before providing an educational item to a healthcare professional, ask yourself:

• Is this the only educational item (including textbooks) that I’m giving this healthcare professional for his/her professional use in this calendar year?
• Is it designed primarily to educate the healthcare professional or to benefit patients?
• Is the retail value of the gift less than $100?
• Am I reasonably certain that the recipient does not require additional considerations, such as whether he/she is a federal government employee or healthcare professional who practices in a state with special restrictions or reporting requirements?

The answers to these must be “yes” for the educational item to be appropriate.

DOCUMENTATION

All items given to healthcare professionals must be recorded through Concur in conformity with the T&E Policy. An accurate description of the educational item’s business purpose must be documented (describe the item left with HCP and what it is used for). Failure to submit the item for reimbursement cannot be used to circumvent the requirements of this Policy. Radiology and Interventional Corporate Travel and Entertainment policy can be found at the following site:

http://sourceone.medrad.com/medrad/departments/corporateservices/travel/
Pages/default.aspx?sdupgwelredir=1

SUPERVISOR REVIEW OF EXPENSE REPORTS

Complying with the expense reporting and approval policies is a critical responsibility for managerial employees to ensure compliance with this policy as well as proper control of business expenses.

Immediate supervisors are responsible for regularly reviewing expense reports for all employees they oversee. If the review reveals potential divergence from Radiology and Interventional policy, the supervisor should take appropriate action, to include discussing the situation with the employee, documenting any corrective action, and, if necessary, consulting with the next supervisory level. Significant divergence from the Policy may require notifying Bayer HealthCare Compliance Department.

RECORD RETENTION

Expense report documents are retained by Accounts Payable for a period of seven (7) years.

AUDITS

Spending for educational items is subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit or review expense reports.

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16. No Entertainment or Recreation for Healthcare Professionals

Consistent with the AdvaMed and PhRMA Codes relating to interactions with healthcare professionals, Radiology and Interventional will not provide or pay for any entertainment or recreational event or activity for any non-employee healthcare professional. Such activities include, by way of example, sporting events, golf, skiing, hunting, theater, and leisure or vacation trips.

The prohibition on entertainment and recreation for healthcare professionals applies regardless of:
(1) the value of entertainment/recreation; (2) whether Radiology and Interventional actually engages the healthcare professional for some agreed upon obligation (e.g., to serve as a speaker or consultant);
or (3) whether the entertainment/recreation is secondary to an educational purpose.

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17. Fee-for-Service Arrangements

The Personal Services Safe Harbor of the Anti-Kickback Statute allows Radiology and Interventional to enter into certain relationships, or fee-for-service arrangements, with healthcare professionals provided certain criteria are met. Radiology and Interventional’s policy on fee-for-service arrangements is consistent with the Personal Services Safe Harbor, the AdvaMed and PhRMA Codes and other applicable laws and industry guidance. Arrangements to compensate healthcare professionals for speaking engagements, participation on advisory boards, consultancies as well as fees for service agreements with customers, data purchases, fees for market research or advertising space, may never be used to encourage the recipients to purchase, order, lease, refer, use or recommend Radiology and Interventional products, nor should these arrangements be used as a reward for doing so.

Fee-for-service transactions include, but are not limited to, speaker agreements, consultant agreements, training agreements, data purchases, service agreements with customers, advisory board participation, agreements with medical writers and related activities where individuals (or the companies that employ them) are compensated by Radiology and Interventional for services rendered.

CLARIFICATION OF TERMINOLOGY AND PROGRAMS

Advertising space in newsletters or other printed materials produced by customers or industry groups, whether or not they are contracted through a third party such as an advertising agency, are not “fee-for-service” arrangements. Payment for advertising space must not be contingent on, or used as a reward for, the purchase or recommendation of any Radiology and Interventional products.

Advisory Board meetings are to obtain expert feedback or advice on commercial or clinical/medical topics. Advisory boards must not be used as a forum for product promotion. An advisory board meeting cannot be designed to: (1) influence or change the prescribing preference of the invited consultants; (2) provide participants merely with an opportunity to meet and mingle with their peers; or (3) have participants passively listen to new information about Diabetes Care products.

Consultants are healthcare professionals paid by Radiology and Interventional to provide the company important and needed information about its products, sales and marketing practices, and related issues (e.g., disease states).

Data purchases include any compiled information offered by a customer that has commercial value, such as product utilization information or clinical or sales data that is necessary for a commercially reasonable business purpose. Permissible data purchases and other arrangements are those designed to (1) foster increased understanding of scientific or clinical issues in order to improve patient care and/or (2) provide information not otherwise available to Radiology and Interventional in areas that are relevant to its business activities. Radiology and Interventional may not purchase data unless it has established a legitimate need for the data and intends to use the data for legitimate business purposes. The purchase of data must not be discussed at the time that Radiology and Interventional is negotiating price terms or other commercial arrangements with the customer.

Market research is designed to obtain information on customer requirements, preferences, product performance and options for use by Radiology and Interventional to develop, evaluate or change its product or service offerings, or marketing, promotional or educational activities. Market research may be conducted in person (e.g., focus groups), by mail (e.g., surveys) or over the internet. Compensation must not exceed fair market value. Participants in market research studies may not be selected or compensated by the sales force or others involved in direct promotion. For example, it is not appropriate for sales personnel to design marketing research questionnaires for physicians or to pay physicians for completing these surveys. Market research or focus groups involving healthcare professionals hired by or on behalf of Radiology and Interventional in which Radiology and Interventional knows the identity of the participant are Focus Arrangements. Market research or focus groups where the participant’s identities are blinded to Radiology and Interventional are not Focus Arrangements.

Promotional Speaker Events includes events where speakers are acting or speaking on Radiology and Interventional’s behalf or where Radiology and Interventional influences or controls any aspect of the program, such as venue, attendees, content or speakers. Such events are considered promotional events. Speaker fees must represent fair market value and be provided pursuant to a written agreement approved by the Law and Patents Department. The total amount of annual compensation to any one healthcare professional in connection with all Radiology and Interventional and other Bayer speaking arrangements across Diabetes Care, Radiology and Interventional, Dermatology and Pharmaceuticals divisions may not exceed Fifty Thousand Dollars ($50,000) annually.

Marketing must ensure that all materials used by speakers at Promotional Speaker Events are reviewed and approved through the LMR process before the event takes place. All materials used by the speaker must relate solely to approved/cleared uses of Radiology and Interventional products. The speaker and the materials must clearly identify that Radiology and Interventional is sponsoring the presentation, that the speaker is presenting on behalf of and is being paid by Radiology and Interventional, and that the speaker is presenting information that is consistent with FDA laws and regulations. A Radiology and Interventional representative must attend each program.

Radiology and Interventional may also enter into Promotional Speaker Event Agreements with speakers who do not wish to be paid. Such arrangements follow the same policies as Radiology and Interventional Promotional Speaker Events including all required approvals and LMR review of presentation content. For information on entering into such agreements, please contact the Law and Patents Department.

Physician Training provides healthcare professionals the opportunity to be trained by other qualified healthcare professionals proficient in the use of Radiology and Interventional products. The content of the training must be designed to develop the skills of healthcare professionals who will provide valuable patient services through the use of Radiology and Interventional products. All training materials must go through the LMR process and be on-label.

Research contractors are healthcare professionals, hospitals, or research institutes that agree to test new clinical uses (e.g., uses not yet approved by FDA) on Radiology and Interventional equipment. Radiology and Interventional provides equipment to the research contractors, who typically produce a white paper or other publication with the results of their evaluations. Contracts with independent research institutes, such as SRI International, or similar entities that do not recommend or purchase Radiology and Interventional products, are not Focus Arrangements.

Service agreements with customers are services whereby Radiology and Interventional pays a fair market value fee to a customer (typically a healthcare organization) to provide certain services in connection with Radiology and Interventional products. Examples include managed care organizations calling patients and reminding them to refill their prescriptions, disease awareness programs, customers mailing physicians information regarding the addition of a Radiology and Interventional product to its formulary, or providing “patient information cards” to patients who may be using a Radiology and Interventional product for the first time. Service agreements with customers may not substitute for, or subsidize, activities that are part of a customer’s normal costs of providing healthcare services or of running its business, nor may fees paid pursuant to an agreement be determined by taking into account pricing terms in product purchase agreements. In addition, service fees paid to customers may not be used to reward the customer for a patient “switch” program (e.g., a program intended to convert patients from a competitor product to a Radiology and Interventional product).

Speaker Training provides qualified speakers with training on Radiology and Interventional products as well as FDA regulatory requirements. The content of the training meetings must be designed to develop speakers who will provide Radiology and Interventional a valuable service. Radiology and Interventional must ensure that the number of speakers trained is closely related to the number of speakers Radiology and Interventional plans to use. All speaker training meetings must be arranged through either the Marketing Department or the Medical Affairs Department and approved through Legal, Medical and Regulatory.

PERMISSIBLE FEE-FOR-SERVICE AGREEMENTS

Fee-for-service arrangements are permitted if ALL of the following are true:

• A legitimate need for the services has been clearly identified in advance of requesting the services.
• Compensation paid does not exceed fair market value for the services rendered.
• The individuals are chosen based upon relevant qualifications, experience or expertise as well as the value their feedback would provide to Radiology and Interventional, not based on the volume or value of business (potential or actual) generated by him/her. Field sales personnel may not be involved in selecting members of the speaker bureau or engaging healthcare professionals to serve as consultants. Those responsible for selecting the speaker or consultant must have the expertise necessary to evaluate whether the healthcare professional has the required qualifications.
• The venue and circumstances of meetings with consultants must be conducive to the consulting services. Exotic and/or resort locales are prohibited. Radiology and Interventional may not provide entertainment or recreational activities in connection with any such meetings.
• Consultant, speaker training and advisory board contracts must be approved by the Law and Patents Department before invitations are sent and before venues are booked.
• The number of speakers, advisors and/or consultants chosen is consistent with the business need.
• A written agreement specifying the nature of the services and the basis of payment for those services is executed. The contract must be approved by the Law and Patents Department before it is signed by the other party. No Radiology and Interventional employee may execute any contract or other legally binding document associated with this policy without prior review and approval from the Law and Patents Department. Healthcare professionals or other parties must sign the agreement provided by the Law and Patents Department prior to the initiating services associated with the contract. If a mutual agreement cannot be reached with approval of the Law and Patents Department, the healthcare professional or other party cannot be retained to provide the service.

PROCEDURES FOR ALL TYPES OF FEE-FOR-SERVICE ARRANGEMENTS

Initial Written Request

The initial request for a fee-for-service arrangement must be made in writing (can be via e-mail) and approved by the Contract Champion’s supervisor. Once the supervisor has approved the request, the Contract Champion must forward the request, along with a completed contract template (available on the Radiology and Interventional Contract Management Procedure (MCMP) website) and all other required documentation, to the Law and Patents Department for approval.

The written request must include the following:

• Name and address of the speaker(s), advisory board member(s), or consultant(s);
• Indication of the speaker’s specialty (e.g., radiologist, radiology technician) and whether the speaker is a national, regional, or community thought leader (as applicable);
• Radiology and Interventional’s legitimate business need for the arrangement, as described by the purpose and nature of the services being purchased;
• A statement of the individual’s qualifications (the individual’s title may be sufficient to reveal the qualifications based on the description of Radiology and Interventional’s need or purpose for the services);
• Term of the agreement, including any automatic renewal provisions;
• Proposed compensation; and
• Description of any expenses to be reimbursed by Radiology and Interventional (if applicable).

No speaker may be paid more than $50,000 for speaking engagements annually. If Radiology and Interventional plans to use the speaker, consultant or advisory board member for more than one event over the course of the next year, and the consultant does not already have an agreement, a new agreement that identifies a maximum value and type of services to be provided must be created.

For Drug Contracts:

The Agreement Request/Transmittal Form is retained by the Contract Compliance Administrator in the Law and Patents Department. The necessary information from the request form is included in the contract for all types of fee-for-service arrangements. The Law and Patents Department’s approved, executed contract must be included in all fee-for-service payment request packages.

Before generating the contract, the Law and Patents Departments will determine whether a Master Services Agreement (“MSA”) exists for the potential speaker or consultant. If a MSA exists, the Law and Patents Department determines whether the new arrangement conforms to the terms of the MSA, including any limit on the number of engagements or maximum amount paid annually.

Contents of the Contract

Each healthcare professional retained as a speaker, consultant or other fee-for-service arrangement must sign a contract or Letter of Agreement that has been approved by the Law and Patents Department.

The agreement must include the following:

- A description of the services to be provided;
- When known in advance, the schedule on which services will be provided;
- The specific duration of the services to be provided, or a contractual term of at least one year;
- The maximum, aggregate compensation to be paid for the services; and
- A certification by the parties to the arrangement that the parties shall not violate the Anti-Kickback Statute with respect to the performance of the Focus Arrangement.

Third Party Contracts

Radiology and Interventional may work with third parties that contract with speakers, moderators, or consultants on behalf of Radiology and Interventional. Third parties are prohibited from entering into contracts with HCPs on Radiology and Interventional’s behalf. The Law and Patents Department will generate all agreements with HCPs, in accordance with the procedures described above. If the third party engages the consultant or speaker, the third party must send to Radiology and Interventional the proposed list of speakers, moderators, or consultants that it plans to use for the event. The Law and Patents Department must verify that each consultant has not exceeded the $50,000 annual limit on speaker fees.

In order to ensure that third party contracts comply with the Anti-Kickback Statute and Radiology and Interventional’s Policies and Procedures, the Law and Patents Department provides the third party a contract(s) to use that includes the terms described above. The contract must be signed by each party to the arrangement and must include a certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the Focus Arrangement.

The reviewing attorney must assess whether the proposed arrangement complies with the Anti-Kickback Statute and assesses compliance with the relevant Safe Harbor(s). This review/assessment must be documented as to his/her name, and the date it was conducted.

Co-Promotion Contracts

If the party to the Focus Arrangement is a person who is involved in, or an entity whose employees are involved in, the co-promotion of a Government Reimbursed Product or in joint promotional activities relating to such products, Radiology and Interventional must send each entity that is a party to the Focus Arrangement a Third Party Personnel Letter, as defined by the CIA, with (1) a copy of Bayer HealthCare’s Code of Conduct and (2) applicable Anti-Kickback Statute Policies and Procedures attached. The Third Party Personnel Letter and attachments may be sent electronically or by hard copy, and can be included as an exhibit to the contract or sent as separate documents.

The receiving party must inform Radiology and Interventional whether it will either: (a) make a copy of Bayer HealthCare’s Code of Conduct and a description of Bayer HealthCare’s Compliance Program available to its Third Party Personnel (or, in the case of an individual, to himself or herself) or (b) represent to Radiology and Interventional that it has and enforces a substantially comparable code of conduct and compliance program. The required notification can be included as a provision in the contract or in a separate document and requires the party to the agreement to check the appropriate option. A description of each party’s response to the Third Party Personnel Letter must be noted in the Focus Arrangements Database.

SPECIAL RULES FOR CONTRACTING WITH A GOVERNMENT EMPLOYEE

Federal government employees include anyone who works (either full-time or part-time) at a facility associated with the Department of Defense (e.g., military), the Department of Veterans Affairs (VA), Federal Public Health Service (PHS) entities, Indian Health Service, any of the National Institutes of Health (NIH), or other federal government entities.

Special rules and limitations apply to fee-for-service arrangements with government employees, including certain State government employees. Prior to any discussions regarding fee-for-service arrangements with a government employee, you must contact the Law and Patents Department (if you are interested in contracting with a federal government employee).

In addition, and to comply with requirements of the Department of Veterans Affairs, certain language (excerpted below) is required to be included in all fee-for-service agreements with VA employees. It is therefore mandatory that any fee-for-service request involving a VA employee clearly state that the party involved is an employee of the Department of Veterans Affairs. To fulfill this requirement, VA employee status must be included on the Speaker or Consultant Approval Form under “A Statement of the Speaker’s Qualifications”.

The following, or similar language, must appear in agreements with VA employees:

Department of Veterans Affairs (VA) Employee Provisions

Services being provided must occur outside of duty hours or during a period of administrative personal leave so as not to affect performance of official duties. Invitations for services are extended solely on the basis of expertise, not as a result of employment with the VA.

Employee may not be compensated for any service in which VA research programs or matters related to official duties are discussed, nor may the employee discuss any research he/she has conducted, participated in, or supervised. Employee may not refer patients to Radiology and Interventional-sponsored clinical trials.

An employee may not receive compensation from Radiology and Interventional if he/she serves in a position of decision-making authority in which purchasing or prescribing decisions that might favor or disfavor Radiology and Interventional’s products are made (other than in the capacity to prescribe products to patients).

The employee’s official title or position may only be used when listed as a biographical detail.

FOCUS ARRANGEMENTS PROCEDURES

Agreements with speakers, consultants, and advisory board participants as well as data purchases, service agreements with customers, and fees for market research and advertising constitute Focus Arrangements under the CIA because they are actual or potential source of sales or referrals of Radiology and Interventional products.

Law and Patents Review

The Law and Patents Department confirms that the proposed payment represents fair market value. The methodology used to determine fair market value will be based on information in a database of fair market values, or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

The written contract may indicate that Radiology and Interventional will reimburse reasonable expenses for travel, lodging, and meals incurred by the speaker or consultant in connection with the services provided to Radiology and Interventional, as described in the approved written contract. Radiology and Interventional will not reimburse incidental expenses, such as gift shop purchases. Radiology and Interventional will not pay for any additional expenses associated with the spouse or guest of a consultant, such as travel or meals. A spouse or guest may share a hotel room with the consultant, provided Radiology and Interventional incurs no additional costs.

Proof of Service

The Radiology and Interventional contract champion must be present or otherwise confirm that the services purchased were performed and/or satisfactorily received before payment is generated. The Radiology and Interventional contract champion formally confirms proof of service by providing documentation (e.g., a timesheet, email, detailed invoice (must include date, time, hours and complete description of service), slide deck or attendee form) related to services being provided. The contract champion must retain the records demonstrating the appropriate use of the services provided by the consultant. Where a tangible deliverable is provided, such as a report, the contract champion must retain the deliverable as proof that the service was performed. The deliverable should be retained for seven (7) years. The contract must permit Radiology and Interventional to observe the services rendered or otherwise obtain proof of service.

Proof of Service documentation must be attached to the Check Request Form or payment will not be generated.

Payment Generation

For all fee-for-service arrangements, payment is contingent upon:

• Approved written contract;
• Documentation as to need for service;
• Completed fair market value analysis; and
• Proof that the service for which payment is sought has been provided.

Focus Arrangements Datasheet for Device Contracts – Excel® Spreadsheet

Focus Arrangements Database Procedures for Drug Contracts

The Focus Arrangement Owner generating the initial fee-for-service request is responsible for preparing the payment request documentation package, obtaining necessary approvals, and submitting it to the Law and Patents Department. The “Internal Payment Demand (IPD),” and/or “Invoice” must contain the contract number (formatted as “Contract #123”). On the “Internal Payment Demand (IPD)” the contract must be in the “GL Text Field” in order to match the payment with the contract in the Focus Arrangements Database. The fee-for-service payment request documentation package must include, at a minimum, a copy of the executed contract approved by the Law and Patents Department, the approved “Internal Payment Demand (IPD)” or “Invoice.”

The direct supervisor reviews the payment request package and determines if the request complies with Bayer HealthCare Pharmaceutical’s policies. The approval process for the payment request package must follow the spending approval levels within Corporate U.S. Authorization Policy 002.20130115.

When the executed contract is returned from the healthcare professional, Law and Patents completes the required data for the Focus Arrangements Database in Efilia. Refer to Policy and Procedure 8, “Focus Arrangements,” for information regarding the Focus Arrangements Datasheet and Focus Arrangements Database Procedures.

procedures specific to DRUG CONTRACTS

Contracting with Consultants, Advisory Board Members, Speaker Training Participants and Others

The Focus Arrangement Owner must follow the Meetings Department procedures if ten (10) or more external and Bayer attendees are invited to an offsite group meeting. The procedures can be found at: http://us.bsp.cnb/apps/BSP/US/BSP-NJ/BSP-NJ.nsf/id/EN_Meetings_Conventions.The online system to initiate a meeting request can be found at: http://www.cvent.com/EVENTS/Websites/Login.aspx?rwstub=b51e9b00-cd4e-4cd8-9c15-25919cf96aba.

RECORD RETENTION

Records relating to fee-for-service arrangements, including the agreement and payment information, will be retained for seven (7) years. For tangible services (e.g.,consultant reports) the Contract Champion must retain the proof of service in the department files (organized by contract number) for a period of seven years.

AUDIT

All fee-for-service arrangements are subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit fee-for-service arrangements. The Radiology and Interventional employee requesting the service must be prepared to demonstrate that the business need was legitimate and was satisfied and/or how the information was used.

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18. Contracting with Members of Formulary or Clinical Practice Committees

Healthcare professionals who are members of committees that set formularies of covered medicines or develop clinical practice guidelines that may influence the prescribing of medicines generally have significant experience in their fields. That experience can be of great benefit to pharmaceutical companies and ultimately to patients if these individuals choose to serve as speakers or consultants.

Consistent with the PhRMA Code, Radiology and Interventional requires any healthcare professional who is a member of a committee that sets formularies or develops clinical practice guidelines and also serves as a speaker or commercial consultant for Radiology and Interventional to disclose to the committee the existence and nature of his or her relationship with Radiology and Interventional during the period of the contract and two years beyond contract termination. If these healthcare professionals serve as speakers or consultants for Radiology and Interventional, they are also required to follow the procedures set forth by the committee(s) of which they are a member, which may include recusing themselves from decisions relating to the products and/or companies for which they have provided speaking or consulting services.

This disclosure requirement and associated expectations must be documented in the Radiology and Interventional contract with the healthcare professional. The specific contract language is as follows:

“The parties acknowledge that Radiology and Interventional conducts its relationships with healthcare professionals in compliance with applicable laws (including, without limitation, 42 C.F.R. §1001.952(d), the “safe harbor” to the U.S. Anti-Kickback Statute, 42 U.S.C. §1320a-7(b), with respect to personal services) and the PhRMA Code on Interactions with HealthCare Professionals (the “PhRMA Code”) promulgated by the Pharmaceutical Research and Manufacturers of America (PhRMA). Consultant, in the performance of Consultation Services on behalf of Radiology and Interventional, shall conduct its relationships with healthcare professionals (and, to the extent applicable, shall cause its employees and subcontractors to conduct their relationships with healthcare professionals) in accordance with all applicable laws and the PhRMA Code.Further, to the extent consultant is a member of a committee that sets formularies or develops clinical practice guidelines, consultant shall disclose to such committee the existence and nature of his or her relationship to Radiologyand Interventional and follow any procedures set forth by the committee in connection therewith; this requirement shall survive expiration or termination of this Agreement for two (2) years.”

Some states, as well as the District of Columbia, have separate laws that prohibit certain interactions with members of formulary or clinical practice committees. Please refer to Policy and Procedure 29, “State Laws,” in this booklet for details of these restrictions.

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19. Medical Practice Training

Radiology and Interventional recognizes the need to provide occasional medical practice training to sales, service and clinical applications representatives and other employees, contractors, consultants and agents to educate them on medical practice and treatment protocols. However, Radiology and Interventional does not engage in private practice preceptorship arrangements.

PROCEDURES

All requests for medical practice training must be processed as fee-for-service arrangements using the procedures described in Policy and Procedure entitled, “Fee-for-Service Arrangements.”

All medical practice training conducted by a third party organization (such as the Prostate Cancer Foundation) must be conducted pursuant to a written contract. The contract must include the following provisions:

• Training must take place in an environment conducive to education. The training may occur in a private practice or clinic office only if the third party training organization is solely responsible for selecting the healthcare professional and the private practice and/or clinic used for the training with no input from Radiology and Interventional.
• Any compensation provided to healthcare professionals in connection with the medical practice training must be made by, and at the sole discretion of, the third party training organization.
• As with all consulting arrangements, payment must represent the fair market value of the teaching services provided.

Radiology and Interventional employees, contractors, consultants and agents may not:

•Select a healthcare professional to participate in a medical practice training to encourage him or her to prescribe or purchase Radiology and Interventional products or to reward a referral source.
• Follow a physician to observe procedures during hospital rounds or in the physician’s office (other than in conjunction with a third party training program that meets the requirements described above).
• Pay an institution or physician to learn about a physician’s billing practices or to get 15 minutes of a physician’s time or pay a physician to critique a “sales pitch.”

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20. Corporate Sponsorships

Radiology and Interventional may provide funds for sponsorships to various trade, medical, professional, patient, scientific and community organizations. The recipient organization’s mission should be to increase understanding of scientific, clinical, or healthcare issues that contribute to the improvement of patient care or continuing education of professionals.

Radiology and Interventional may provide general funding for a professional association’s, patient or other organization’s activities or meetings under appropriate circumstances. The recipient organization must have sole control over the funding paid by Radiology and Interventional. Sponsorship may be recognized by the organization, including the level of sponsorship provided (e.g., platinum, gold, silver) on its meeting brochures or banners, website, or other materials. Sponsorship of meetings or activities that will be attended primarily by healthcare professionals must be open to other pharmaceutical or medical device companies.

Sponsorship funds may not be paid to Radiology and Interventional customers except in limited circumstances approved by Law and Patents where the event is open to all members and provided the same opportunity is given to other similarly situated members. This type of transaction would be considered a Focus Arrangement as defined by the CIA and must comply with all requirements of Policy and Procedure 8, “Focus Arrangements.”

Sponsorships may not be paid to encourage the recipient organization to purchase, order, refer, use or recommend Radiology and Interventional products. It is Radiology and Interventional’s policy to pay the same fee as other corporate sponsors for the same level or type of sponsorship.

Sponsorship funding must not be used to reimburse the travel, lodging, or other personal expenses of attendees, to compensate attendees for their time, or to provide any type of gift to the attendees or presenters and the sponsorship agreement must so state. Sponsorship funding also may not be provided on behalf of any customer, patient, or other individual.

It is important to determine whether a request for support is a charitable contribution, corporate sponsorship or education grants. The terminology used by the entity requesting the funding (e.g., “charitable contribution,” “grant”) is not the determining factor because organizations may submit funding requests using inconsistent or incorrect terminology. The key factors are the type of entity requesting the funding (e.g., non-profit, patient organization, hospital) and focus of the event or activity (e.g., education or fundraising). For example:

• A charitable contribution is funding provided to a non-profit organization to support the organization’s activities where Radiology and Interventional does not expect to receive anything in return and where the primary purpose of the event/activity is fundraising/charity.
• A sponsorship is funding provided to support the activities of an organization where Radiology and Interventional receives something of value, such as banners or signage at a conference or an opportunity to advertise in the organization’s publication. The sponsorship opportunity is offered to other similarly situated sponsors and not just Bayer.
• An education grant is funding provided to support an event where the primary focus is educating the participants/attendees, rather than fundraising.

Key Characteristics: Charitable Contributions vs Corporate Sponsorships vs Education Grant

Characteristics	Charitable Contributions	Corporate Sponsorships	Education Grants
Promotional in nature	No	Yes	No
Payee must be a 501(c)(3) or other tax exempt organization	Yes	No	No
Radiology and Interventional receives something of value in return	No	Yes	No
Payment can be made to an individual HCP or private practice group	No	No	No
Tickets or invitations received as a result can be offered to physicians or other customers	No	No	No
Sales and Marketing Involvement	No	Yes	No

Examples of Permissible Sponsorships

• “Gold” level annual sponsorship of the Vascular Disease Foundation for general educational programs regarding vascular disease prevention and awareness
• Sponsorship funding of appropriate, non-educational activities, such as a modest hospitality suite at national meetings of medical societies or organizations, such as the Radiology Society of North America (RSNA) or the American Heart Association (AHA), or a Wi-Fi Café during medical society meetings
• Accepting a seat on an advisory council to the American Vascular Association, if this benefit is also provided to other pharmaceutical or medical device companies who provide a similar level of sponsorship

Examples of Impermissible Sponsorships

• Sponsorship of a hospitality suite at a disease-state awareness program sponsored by the Society of Interventional Radiology that is intended specifically for a discussion of a disease state for which Radiology and Interventional products are not indicated.
• Sponsorship funding for Association for the Advancement of Medical Instrumentation (AAMI) members to attend a Broadway show one evening during the AAMI meeting. This is impermissible because Radiology and Interventional may not provide funding for entertainment, social, cultural or recreational activities or items at such meeting or event.

REQUIREMENTS

The recipient organization receiving Radiology and Interventional sponsorship funds must support or conduct activities related to healthcare, scientific, or clinical issues that contribute to the improvement of patient care, education, or advocacy. Under no circumstances may sponsorship funds be offered or provided with the intent to, directly or indirectly, encourage the recipient organization to purchase, order, refer, use or recommend Radiology and Interventional products or to reward any recipient organization for a past purchase, prescription, recommendation, or formulary placement of a Radiology and Interventional product or service.

Payment of sponsorship funds may also not be used to provide a direct or indirect discount on product purchases or to influence any recipient’s conduct or decisions in connection with clinical or other research or the dissemination of medical or scientific data.

PROCEDURES

Contract Champion

A medical or professional society or other organization may solicit sponsorship through a website, e-mail, or paper mailing. No Radiology and Interventional employee, contractor, consultant or agent may commit the Company to funding a sponsorship request without review and approval in accordance with this policy.

The Contract Champion, at least six weeks before the sponsorship opportunity, provides a sponsorship request to his or her supervisor and the Law and Patents Department for review. The request must be made in writing from the requesting organization and include, at a minimum, the following information:

The purpose of the request;

• The types of sponsorship opportunities available and the cost(s) thereof;
• The name and address to which the check must be payable;
• The Federal Tax ID number of the payee; and
• Whether the organization is affiliated with a Radiology and Interventional customer.

Supervisor

The Supervisor reviews and approves the request for sponsorship, only after receiving the required documentation. The Supervisor makes an independent judgment as to whether the requested fees represent a reasonable value and whether the sponsorship is consistent with Radiology and Interventional’s policies. If appropriate, the Supervisor approves and then forwards the completed sponsorship request to the Law and Patents Department.

Law and Patents Review of Focus Arrangements

For all requests that are Focus Arrangements, the Law and Patents attorney must verify that the agreement contains:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the sponsorship; and
• The requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute.

The attorney also evaluates whether the proposed arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document that this review and assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department also confirms whether the sponsorship amount represents fair market value in that the proposed amount is fair, reasonable and represents support for necessary expenditures based on the nature and the extent of the event for which the sponsorship requestor seeks support. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

Law and Patents Review of Non-Focus Arrangement

The Law and Patents Department reviews all documentation and makes an independent judgment as to whether the requested fees are reasonable and the request is consistent with Radiology and Interventional’s policies. The Law and Patents Department will follow the normal contracting procedures in accordance with the MCMP. If appropriate, the Law and Patents Department approves the request.

RECORD RETENTION

Records relating to sponsorship opportunities should be retained for seven (7) years by the Laws and Patents Department with copiesmaintained at individual departments.

AUDITS

All sponsorship information is subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit/review product display documentation.

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21. Providing Free Product for Charitable Purposes

Radiology and Interventional may provide free Radiology and Interventional device products for legitimate charitable purposes only in accordance with this Policy. As with any charitable contribution, free device product may not be provided to encourage the recipient to purchase, order, lease, refer, use or recommend Radiology and Interventional device products. Radiology and Interventional does not provide free device products as price terms or in lieu of price discounts.

SCOPE

This Policy covers all free device products provided under Radiology and Interventional’s charitable programs for United States destinations only. Products shipped under a zero dollar invoice to correct billing or shipping errors, or to replace damaged or short-dated product, do not constitute free device product for charitable purposes as defined by this Policy and can be provided as those circumstances require.

Free samples, which are provided free of charge to healthcare professionals for free distribution to patients pursuant to the Prescription Drug Marketing Act, are not “free product” as defined by this policy and must comply with the provisions of Policy and Procedure 27, “Evaluation of Device Products/Drug Sampling.”

SPECIFIC PROGRAMS

Bayer HealthCare Pharmaceuticals operates the following charitable programs that provide free product to qualifying entities:

Bayer Patient Assistance Programs (PAP)

• The Patient Assistance Program provides free product to eligible, financially disadvantaged patients. Patients may register by calling 1-888-84BAYER (1-888-842-2937).
• Patients must: (1) reside in the U.S., (2) be financially disadvantaged, (3) not have coverage for the requested Bayer product, and (4) have a valid prescription from a healthcare provider for the product.
- Bayer manages certain Patient Assistance Programs internally. Personnel who are responsible for the internally managed programs approve all medications requested via the Patient Assistance Program and are responsible for implementing Bayer’s written procedures for the programs. Patient Assistance Program Management reviews all programs’ requests to ensure compliance with Bayer’s procedures.
- In addition, Bayer has contracted with third-party vendors to administer some of our programs. The vendors approve all medications requested via the Patient Assistance Program and are responsible for implementing Bayer’s written procedures for the programs. The Reimbursement and Patient Assistance Program reviews all program requests to ensure compliance with Bayer’s procedures.
• The Medical Relief Program (“Missionary Program”) provides limited quantities of product for physicians treating patients in underdeveloped countries. Physicians must contact the Reimbursement and Patient Assistance Program at 1-800-288-8370 or 1-888-842-2937. Only “acute care” medication, commercially packaged, with good expiration dating is provided.

The Reimbursement and Patient Assistance Program reviews all applications and determines if the request for the medical donation is in compliance with Bayer’s policies. The Medical Communications Department reviews the prescription submitted for donated product to ensure it meets prescription guidelines and confirms that the proposed recipient country is acceptable to Bayer. The program is periodically monitored by reviewing internal transaction reports.

APPROVALS

Requests for contributions of free Radiology and Interventional device products must be approved by the appropriate Charitable Giving Committee.

RECORD RETENTION

Records relating to free product must be retained for seven (7) years.

AUDITS

Transactions involving the provision of free Radiology and Interventional products are subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit or review these transactions.

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22. Displays and Exhibits for Hospitals and Other Customers

Display and exhibit opportunities relating to the promotion of Radiology and Interventional products may implicate prohibitions against off-label promotion under the Federal Food, Drug, and Cosmetic Act, as well as prohibitions on offering illegal remuneration under the Anti-Kickback Statute. This Policy and Procedure is designed to allow Radiology and Interventional to conduct product displays and exhibits while abiding by applicable legal requirements.

SCOPE

This policy covers table-top displays and commercial exhibits where payment is made directly, or indirectly, to an actual or potential source of sales or referrals, such as a hospital or healthcare facility. In all cases, an equal opportunity for participation must be afforded by the event sponsor to other pharmaceutical, medical device or similar manufacturers.

The purpose and business need for a product display or exhibit is for Radiology and Interventional to display products and provide approved disease state and product information to healthcare professionals or other individuals attending the event.

Fees for displays or exhibits that are paid to a source of sales or referrals of Radiology and Interventional products (e.g., a wholesaler or retailer) are Focus Arrangements under the CIA.

Exhibits and displays where payment is made to an entity that is not an actual or potential source of sales or referrals of Radiology and Interventional products, such as trade groups, patient groups, or disease state groups, are not covered by this Policy, unless such entity has been contracted by an actual or potential sources of sales or referrals to plan, organize and run the event. For such non-covered events, please refer to the Policy and Procedure entitled “Displays and Exhibits for Non-Customers.”

Questions regarding whether a product exhibit or display request constitutes a Focus Arrangement should be directed to the Law and Patents Department.

Displays are typically table top units used for educational discussions at hospitals, healthcare facilities, or retailer or wholesaler sponsored educational events.

• An on-site display is used to display approved Radiology and Interventional product information onsite at a hospital or healthcare organization with an educational mission. On-site display opportunities occur within the organization’s own facilities.
• An off-site display is used to display approved Radiology and Interventional product information for healthcare conference attendees at an off-site event organized by a hospital or non-profit healthcare organization with an educational mission. Off-site display opportunities occur at locations such as hotel meeting rooms, convention centers, etc.

Exhibits are booths at conventions or trade shows sponsored by wholesalers, chain pharmacies, GPOs, or PBMs and typically include exhibit property from the exhibit house vendor.

Fees for displays and exhibits to actual or potential customers may not be paid directly by the requesting Radiology and Interventional employee through T&E or other means. Display fees may never be paid to individual physicians or private physician practice groups.

APPROPRIATE PROMOTIONAL ACTIVITIES

Commercial exhibits and displays are promotional forums. All discussions with healthcare professionals must be consistent with the product labeling and the uses for which the Radiology and Interventional products have been cleared or approved (e.g., they must be on-label). Radiology and Interventional personnel may not discuss an unapproved or uncleared product (a drug or device that has not yet received FDA approval or clearance) or an unapproved or uncleared use for an approved or cleared product in a promotional forum. Only promotional materials that have been approved for distribution through the LMR process and are in accordance with the Policy and Procedure entitled “Material for External Use” may be located in and distributed from a Radiology and Interventional exhibit or display.

If a healthcare professional asks an off-label question about a Radiology and Interventional product or a question about a product or use that has not received FDA approval, Radiology and Interventional personnel must refer him/her to the Innovations booth if there is one at the event. If there is no Innovations booth at the event, Radiology and Interventional personnel must refer the question to Radiology and Interventional’s Clinical Science and Medical Affairs Department or non-marketing/non-sales personnel or contractors to whom the Clinical Science and Regulatory Department has delegated such responsibility.

RELATIONSHIP TO GRANTS AND CHARITABLE CONTRIBUTIONS

There may be limited situations where an organization submits a request for an education grant, charitable contribution and/or corporate sponsorship that also offers Radiology and Interventional the opportunity to display or exhibit at the event. These activities should be processed as separate transactions by the requesting entity. However, there may be limited occasions where it may not be possible to separate the product display fee in the documentation submitted by the requesting organization. In these situations, the appropriate Education Grant Committee and Compliance Counsel will make the appropriate determination regarding whether the grant will be approved and/or whether Radiology and Interventional may display at the event.

SEPARATION FROM THE Innovations/Medical BOOTH

Innovations/Medical booths are resource forums for healthcare professionals to obtain clinical, educational, and scientific information about Radiology and Interventional products. Radiology and Interventional personnel may only exchange scientific and/or educational information and may not engage in product promotion in the scientific booth.

At conventions or other venues where Radiology and Interventional has both a commercial exhibit and an Innovations/Medical booth, the commercial exhibit must be physically separated from the Innovations/Medical booth to distinguish promotional activities by Sales and Marketing from non-promotional activities by scientific representatives.

• The Innovations/Medical booth must be separated from the commercial exhibit booth by walls so that one needs to walk out of one booth to enter the other booth.
• The Innovations/Medical booth must have a different look than the commercial exhibit, and must not have any product-specific banners or panels or other promotional materials.
• Sales and Marketing personnel may not be in the Innovations/Medical booth nor distribute promotional literature or detail products in or near the Innovations/Medical booth. Only promotional materials approved for distribution may be located in and distributed from a commercial exhibit or booth. If a healthcare professional asks an off-label question about a Radiology and Interventional product, Sales or Marketing personnel must refer the healthcare professional to the Radiology and Interventional Innovations/Medical booth. The sales or marketing representative may provide directions to the Innovations/Medical booth but may not walk the healthcare professional over to the Innovations/Medical booth. If there is no Innovations/Medical booth, the healthcare professional must be referred to the Clinical Science and Medical Affairs Department for off-label inquiries.
• Only clinical or scientific representatives, new product development or Innovations/Medical personnel and strategic marketing personnel pre-approved by the Law and Patents or Clinical Science and Regulatory Affairs or Medical Affairs Departments may be in or near the Innovation/Medical booth. Likewise, these individuals must not be in or near the commercial booth.

It is acceptable for Radiology and Interventional to invite specific healthcare professionals or other customers into the Innovations/Medical booth to review and comment on new product ideas or enhancements to existing products. Devices for which Radiology and Interventional is seeking approval or clearance from FDA (e.g., a premarket approval application or Section 510(k) notification has been submitted to FDA) may be displayed, however Radiology and Interventional personnel make not make any statements regarding the safety or efficacy of the device, nor take any orders for the device. Invited customers/HCPs should sign a short non-disclosure agreement acknowledging that Radiology and Interventional is sharing confidential new product information with them, and agree not to discuss this information outside of the presentation unless permitted by Radiology and Interventional. All non-disclosure agreements must be collected at the end of each event and turned into the Law and Patents Department as soon as possible.

No money or other consideration will be paid to customers/HCPs for their feedback on new product ideas/product enhancements at the trade show or event; if a customer/HCP requests payment or other consideration, the Focus Arrangements Procedures need to be followed. A written contract and the assessment of fair market value must be undertaken, before the product review can be conducted. The new product reviews with customers/HCPs will be conducted by Radiology and Interventional employees involved in the development of such products, and no Radiology and Interventional marketing or sales personnel will participate in such reviews other than strategic marketing personnel.

TRAINING

All Radiology and Interventional staff representing Radiology and Interventional must be instructed on this Policy during a pre-convention briefing.

PROCEDURES

Contract Champion

The Contract Champion, at least six weeks before the product display or exhibit date, provides a display or exhibit request to his or her supervisor and the Law and Patent Department for review. The request should include, at a minimum, the following information:

• A written request, invitation, brochure, pamphlet, flyer or agenda from the organization containing:
- A brief description of the service offered (display space, exhibit space);
- The date and duration of the event ;
- The amount of the requested fee; and
- A template agreement that the entity hosting the display or exhibit will be asked to execute.

Supervisor

The Supervisor reviews and approves the request for exhibit or display only after receiving the completed exhibit or display request form. The Supervisor reviews all documentation and makes an independent judgment as to whether the requested fees represent a reasonable value and whether the display or exhibit is consistent with Radiology and Interventional’s policies. If appropriate, the Supervisor approves and then forwards the completed exhibit request form to the Law and Patents Department.

If the Supervisor does not approve the request, he/she informs the Contract Champion that the proposed request has been denied.

Law and Patents Review

The Law and Patents Department reviews and approves requests for exhibits and displays only after receiving the completed and approved exhibit or display request form from the Supervisor. The Law and Patents Department generates a written agreement that meets the requirements for Focus Arrangements. If an agreement is provided to Radiology and Interventional by the entity sponsoring the event, the Law and Patents Department confirms that the agreement meets those same requirements. The written agreement must be signed by all parties to the arrangement and must include:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the product display; and
• A requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance program, including applicable training related to the Anti-Kickback Statute.

The Law and Patents Department evaluates whether the proposed arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document that this review and assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department also confirms that the proposed payment represents fair market value. The methodology used to determine fair market value will be based on information in a database of fair market values or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) documented and maintained in the Law and Patens Department.

The Radiology and Interventional Contract Champion, or other Radiology and Interventional employee designated by the Contract Champion, must send each party to the Focus Arrangement (e.g., the entity hosting the display, or exhibit) an approved contract with a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures attached. These attachments may be sent electronically or by hard copy, and can be included as an exhibit to the contract or sent as separate documents. The Radiology and Interventional employee must document on the Focus Arrangements Datasheet that these documents were sent.

Focus Arrangements Datasheet for Device Contracts – Excel® Spreadsheet

Focus Arrangements Database for Drug Contracts

Law and Patents must complete the required data for the Focus Arrangements Database in Efilia. Refer to Policy and Procedure 8, “Focus Arrangements,” for information regarding the Focus Arrangements Database Procedures.

Proof of Service

The Radiology and Interventional Contract Champion must be able to confirm that the display or exhibit was conducted. Proof of service is formally confirmed by proving attendance at the event by completing the Proof of Service Exhibits Form, brochure or email from Radiology and Interventional attendee.

Payment Generation for Drug Contracts

The Focus Arrangement Owner generating the initial display/exhibit request is responsible for preparing the payment request documentation package, obtaining necessary approvals, and submitting it to the Law and Patents Department. The “Internal Payment Demand (IPD),” and/or “Invoice” must contain the contract number (formatted as “Contract #123”). On the “Internal Payment Demand (IPD)” the contract must be in the “GL Text Field” in order to match the payment with the contract in the Focus Arrangements Database. The display/exhibit payment request documentation package must include, at a minimum, a copy of the executed contract approved by the Law and Patents Department, the approved “Internal Payment Demand (IPD)” or “Invoice.”

RECORD RETENTION

Records relating to the purchase of product displays or exhibitsshould be retained for seven (7) years by the Law and Patents Department with copies maintained at individual departments.

AUDITS

All displays and commercial exhibit information is subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit/review product display documentation.

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23. Displays and Exhibits for Non Customers

Display or exhibit opportunities relating to the promotion of Radiology and Interventional products may implicate prohibitions on off-label promotion under the Federal Food, Drug and Cosmetic Act, as well as prohibitions on offering illegal remuneration under the Anti-Kickback Statute. This Policy and Procedure is designed to allow Radiology and Interventional to conduct product displays and exhibits while abiding by applicable legal requirements.

SCOPE

This policy covers table-top product displays, as well as commercial exhibits where payment is made to an entity that is not a customer, potential customer, or source of sales or referrals of Interventional products, or working under contract on behalf thereof. Appropriate recipients of funds for displays or exhibits under this policy include trade groups, patient advocacy groups, disease state groups, medical societies, and similar organizations. In all cases, an equal opportunity for display participation must be afforded by the non-customer entity to other medical device or similar manufacturers.

Exhibits or displays where payment is made to an entity that is a customer or source of sales or referrals, such as a hospital or healthcare facility, are not covered by this policy. For such events, please refer to the Policy and Procedure entitled “Displays, and Exhibits for Hospitals and Other Customers.”

Displays are conducted by sales personnel at educational events sponsored by medical, disease state, or patient organizations.

Exhibits are booths at conventions or trade shows and typically include exhibit property from the exhibit house vendor.

Fees for displays or exhibits may not be paid directly by the requesting Radiology and Interventional employee. Display and exhibit fee requests must not be submitted via a Travel and Entertainment Expense Report.

Payments to non-customer third parties for costs associated with commercial exhibits of Radiology and Interventional products during participation in trade shows, national and/or regional conventions, etc., must be reasonable and may not subsidize any portion of the normal business expense of the requesting entity or a related healthcare professional.

Questions regarding whether a product exhibit or display request constitutes a Focus Arrangement must be directed to the Law and Patents Department.

APPROPRIATE PROMOTIONAL ACTIVITIES

Commercial exhibits and displays are considered promotional forums. All discussions with healthcare professionals or other individuals must be consistent with the product labeling and the uses for which the Radiology and Interventional products have been cleared or approved (e.g., they must be on-label). Radiology and Interventional personnel may not discuss an unapproved or uncleared product (a drug or device that has not yet received FDA approval or clearance) or an unapproved or uncleared use for an approved or cleared product in a promotional forum, such as the commercial exhibit space at a trade show like RSNA or TCT. Only promotional materials that have been approved for distribution through the LMR process and are in accordance with the Policy and Procedure entitled “Material for External Use” may be located in and distributed from a Radiology and Interventional exhibit or display.

If a healthcare professional asks an off-label question about a Radiology and Interventional product or a question about a product or use that has not received FDA approval, Radiology and Interventional personnel must refer him/her to the Innovations/Medical booth if there is one at the event. If there is no Innovations/Medical booth at the event, Radiology and Interventional personnel must refer the question to Radiology and Interventional’s Clinical Science and Regulatory Department or non-marketing/non-sales personnel or contractor to whom the Clinical Science and Regulatory Department has delegated such scientific responsibility.

It is acceptable for Radiology and Interventional to invite specific healthcare professionals or other customers into the Innovations/Medical booth to review and comment on new product ideas or enhancements to existing products. However, no new uses or indications of existing products being considered by Radiology and Interventional may be included in these new product idea discussions. Invited customers/HCPs should sign a short non-disclosure agreement acknowledging that Radiology and Interventional is sharing confidential new product information with them, and agree not to discuss outside of the presentation unless permitted by Radiology and Interventional. All non-disclosure agreements should be collected at the end of each event and turned into the Law and Patents Department as soon as possible.

No money or other consideration will be paid to customers/HCPs for their feedback on new product ideas/product enhancements at the trade show; if a customer/HCP requests payment or other consideration, the Focus Arrangements Procedures need to be followed, including the assessment of fair market value, before the product review can be conducted. The new product reviews with customers/HCPs will be conducted by Radiology and Interventional employees involved in the development of such products, and no Radiology and Interventional marketing or sales personnel will participate in such reviews other than strategic marketing personnel.

SEPARATION FROM THE Innovations/Medical BOOTH

Innovations/Medical booths are resource forums for healthcare professionals to obtain clinical, educational, and scientific information about Radiology and Interventional products. Radiology and Interventional personnel may only exchange scientific and/or educational information —and not engage in product promotion — in the Innovations/Medical booth.

At conventions or other venues where Radiology and Interventional has both a commercial exhibit and Innovations/Medical booth, the commercial exhibit must be physically separated from the Innovations/Medical booth to distinguish promotional activities by Sales and Marketing from non-promotional activities by Innovation/Medical representatives.

The Innovations/Medical booth must be separated from the commercial exhibit booth by walls so that one needs to walk out of one booth to enter the other booth.

The Innovations/Medical booth must have a different look than the commercial exhibit, and must not have any product-specific banners or panels or other promotional materials.

Sales and Marketing personnel may not be in the Innovations/Medical booth nor distribute promotional literature or detail products in or near the Innovations/Medical booth. Only promotional materials approved for distribution may be located in and distributed from a commercial exhibit or booth. If a healthcare professional asks an off-label question about a Radiology and Interventional product, Sales or Marketing personnel must refer the healthcare professional to the appropriate Medical representative or to the Innovations/Medical booth if there is one at the event. The Sales and marketing representative may provide directions to the Innovations/Medical booth but may not walk the healthcare professional over to the Innovations/Medical booth. If there is no Innovations/Medical booth, the healthcare professional must be referred to the Clinical Science Department for off-label inquiries.

Only clinical or scientific representatives, new product development or Innovations/Medical personnel and strategic marketing personnel pre-approved by the Law and Patents or Clinical Science and Regulatory Department may be in or near the Innovations/Medical booth. Likewise, these individuals must not be in or near the commercial booth.

TRAINING

All Radiology and Interventional staff scheduled to work the exhibit booth must be instructed on this Policy during a pre-convention briefing.

PROCEDURES FOR REQUESTING DISPLAYS/exhibits

Contract Champion

The Contract Champion, at least six weeks before the product display date, provides a display or exhibit request to his or her supervisor and the Law and Patents Department for review. The request should include, at a minimum, the following information:

• A written request, invitation, brochure, pamphlet, flyer or agenda from the organization containing:
- A brief description of the service offered (display space, exhibit space);
- The date and duration of the event;
- The amount of the requested fee; and
- A template agreement that the entity hosting the display or exhibit will be asked to execute.

Supervisor

The Supervisor reviews and approves the request for the exhibit or display only after receiving the completed request. The Supervisor reviews all documentation and makes an independent judgment as to whether the requested fees represent a reasonable value and whether the display or exhibit is consistent with Radiology and Interventional’s policies. If appropriate, the Supervisor approves and then forwards the completed display or exhibit request form to the Law and Patents Department.

If the Supervisor does not approve the request, he/she informs the Contract Champion that the proposed request has been denied.

Law and Patents Review

After receiving a completed exhibit or display request from the Supervisor, the Law and Patents Department reviews the request to confirm that the exhibit or display is not a Focus Arrangement. If the request is not a Focus Arrangement, then normal contracting procedures in accordance with the MCMP apply. If it is determined that the request is a Focus Arrangement, Law and Patents will deny the request and the Contract Champion will have to resubmit the request with the Focus Arrangement documentation requirements.

RECORD RETENTION

Records relating to the purchaseof product displays should be retained for seven (7) years by the Law and Patents Department with copies maintained at individual departments.

AUDITS

All display and commercial exhibit information is subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit/review product display documentation.

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24. Corporate Memberships

Radiology and Interventional participates in corporate memberships with various trade, distribution, medical, patient and scientific organizations, as well as legislative policy groups and community organizations, in order to foster increased understanding of scientific, clinical, or healthcare issues that contribute to the improvement of patient care, including support for advocacy groups and/or Radiology and Interventional’s goodwill in the community.

scope

Trade, distribution, medical, patient and scientific organizations (e.g., HealthCare Distribution Management Association (HDMA)), as well as legislative policy groups, may require payment of a fee as a condition of membership. To the extent Radiology and Interventional wishes to become a member of such an organization, it is the policy of Radiology and Interventional to establish these memberships for the Corporation or Division and not for individual Radiology and Interventional employees.

Legislative policy groups offer Radiology and Interventional relevant industry information, provide Radiology and Interventional visibility within the pharmaceutical and device industry, and promote goodwill within organizations that maintain a political voice. Membership in medical and patient organizations allows Radiology and Interventional to support the organization’s educational and advocacy programs as well participate in membership benefits. Membership benefits vary depending on the organization and may include allowing Radiology and Interventional to attend educational meetings and to interact with fellow attendees such as healthcare professionals and/or patients.

This policy does not cover an individual Radiology and Interventional employee’s memberships in professional organizations for the individual’s professional growth and awareness, such as the National Association of Accountants, National Association of Pharmaceutical Sales Representatives, Medical Marketing Association, etc. Upon approval of your supervisor, individual professional organization memberships must be submitted through Concur T&E.

This policy does not cover education grants or charitable contributions Radiology and Interventional may provide to a patient advocacy group or medical organization. Such payments must comply with Policy and Procedure 26, “Education Grants (Including Continuing Education/Continuing Medical Education),” and Policy and Procedure 25, “Charitable Contributions (Other than Free Radiology and Interventional Product for Charitable Purposes),” respectively. Payment for a corporate membership/partnership is not a charitable contribution.

requirements

An organization may solicit membership through a website, e-mail, or paper mailing, or Radiology and Interventional may seek out an organization and request to become a member. The organization’s main focus should be to increase understanding of scientific, clinical, or healthcare issues that contribute to the improvement of patient care, including support for advocacy groups and/or Radiology and Interventional’s goodwill in the community. Membership in organizations that primarily consist of healthcare professionals which are offered to Radiology and Interventional must be open to other pharmaceutical or device companies.

Membership fees cannot be paid to Radiology and Interventional customers, entities controlled or legally affiliated with Radiology and Interventional customers, or other entities that may purchase, order, refer, use, prescribe, or recommend Radiology and Interventional products, such as private practice groups, managed care organizations, pharmacy benefits managers, or hospitals. Paying membership fees to any organization or basing the level of membership/partnership selected (e.g., platinum, gold, silver) may not be contingent on the purchase of Radiology and Interventional products or used as a price term.

It is Radiology and Interventional’s policy to pay fair market value for corporate memberships. Thus, Radiology and Interventional will pay the same fee as other corporate members for the same level or type of membership. The organization has sole control over the membership fees paid by Radiology and Interventional.

The membership must be for a Bayer Division or the Corporation, not an individual employee. Individual Radiology and Interventional employees may attend the organization’s events to gain knowledge of the subject topic, interact with fellow attendees, demonstrate Radiology and Interventional’s general support for the advocacy effort and/or the organization’s mission, etc.

procedures

Requestor

The Radiology and Interventional “Requestor” must be entitled to complete the “Radiology and Interventional Certification for Corporate Membership Form.” Administrative Assistants and other employees in clerical support positions cannot legitimately certify the points listed on the certification form and must not sign as the Requestor.

The Requestor must:

• Complete the “Radiology and Interventional Certification for Corporate Membership” form.
• Include any supporting documentation.
• Forward the completed request package to the Supervisor.

Supervisor

The Supervisor reviews all documentation and makes an independent judgment as to whether the Corporate Membership is consistent with Radiology and Interventional’s policies. If appropriate, the Supervisor approves by signing the “Radiology and Interventional Certification for Corporate Membership” and forwards all documents to the Head of Strategic Partnerships and Government Relations or designee.

If the Supervisor does not approve the request, he/she informs the Requestor that the proposed request has been denied.

Head of Strategic Partnerships and Government Relations

The Head of Strategic Partnerships and Government Relations or designee reviews all documentation and makes an independent judgment as to whether the Corporate Membership is consistent with Radiology and Interventional’s policies. It also confirms that the membership request does not duplicate an existing membership with the same organization. If appropriate, the Public Policy and Government Affairs Department approves by signing the “Radiology and Interventional Certification for Corporate Membership” form and forwards all documents to the Law and Patents Department.

If the Head of Strategic Partnerships and Government Relations or designee does not approve the request, it informs the Requestor that the proposed request has been denied.

Law and Patents Department

The Law and Patents Department reviews all documentation and makes an independent judgment as to whether the contribution is consistent with Radiology and Interventional’s policies. If appropriate, the Law and Patents Department approves by signing the “Radiology and Interventional Certification for Corporate Membership” form and forwards all documents back to the Requestor for processing.

If the Law and Patents Department does not approve the request, it informs the Requestor that the proposed request has been denied.

record retention

The Requestor must maintain the request package for a period of 7 years.

audits

All Corporate Membership payments are subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with these policies. The government (e.g., OIG, IRS) may also request to audit or review corporate memberships.

FORM: Radiology and Interventional CERTIFICATION FOR CORPORATE MEMBERSHIP FEES

Name of Organization: __________________________________

Amount of Membership Fee: $ __________________________________

Indicate by checkmark whether the following apply:

_ The organization’s primary mission is to increase understanding of scientific, clinical, healthcare or community issues that contribute to the improvement of patient care or patient advocacy.
_ Membership in this organization is for Radiology and Interventional and not an individual employee.
_ The membership fee is not being paid to a customer_or other entity that can purchase, prescribe, or recommend Radiology and Interventional products.
_ The organization offers the same membership or membership level to other corporations for the same fee.
_ The organization, not Radiology and Interventional, controls the disbursement of the membership fees.
_ The membership fees are not intended as a charitable contribution or education grant.
_ The membership fee is not contingent on the price or purchase of Radiology and Interventional products.
_ The membership fee is not contingent on lobbying activities on behalf of Radiology and Interventional.
_ To the best of my knowledge, the information contained in this certification form is true.

Requestor Certification

Printed name:_________________________________ Date: ______________________

Signature: ___________________________________

Supervisor Certification and Approval

Printed name:_________________________________ Date: ______________________

Signature: ___________________________________

Public Policy and Government Affairs Certification and Approval

Printed name:_________________________________ Date: ______________________

Signature: ___________________________________

Law and Patents Certification and Approval

Printed name:_________________________________ Date: ______________________

Signature: ___________________________________

RECORD RETENTION INSTRUCTIONS

The Requestor must maintain the request package for a period of 7years.

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25. Charitable Contributions (Other than Providing Radiology and Interventional Products for Charitable Purposes)

Radiology and Interventional provides charitable contributions to support legitimate medical research, indigent care programs, patient education, public education, community and cultural organizations within Radiology and Interventional business communities, and other charitable events that directly benefit patients. Provision of charitable contributions can implicate various laws, such as the Anti-Kickback Statute and the False Claims Act. This Policy is designed to enable Radiology and Interventional and its employees to provide legitimate charitable contributions in a manner that does not create the appearance of impropriety.

SCOPE

A charitable contribution is anything, other than Radiology and Interventional products, provided to an IRS tax-exempt charitable organization for which Radiology and Interventional does not receive anything of value in return. Charitable contributions include, but are not limited to, cash or cash equivalents (e.g., checks, gift certificates) and items contributed for raffles or other fundraising/sponsorship efforts (e.g., event tickets).

It is important to determine whether a request for funding support should be processed as a charitable contribution, corporate sponsorship or education grant. The terminology used by the entity requesting the funding (e.g., “charitable contribution,” “grant”) is not the determining factor because organizations may submit funding requests using inconsistent or incorrect terminology. The key factors are the type of entity requesting the funding (e.g., non-profit, patient organization, hospital) and focus of the event or activity (e.g., education or fundraising).

• A charitable contribution is funding provided to a non-profit organization to support the organization’s activities where Radiology and Interventional does not expect to receive anything in return and where the primary purpose of the event/activity is fundraising/charity rather than education.
• A sponsorship is funding provided to support the activities of a professional, medical or patient association or organization where Radiology and Interventional receives something of value, such as banners or signage at a conference or an opportunity to advertise in the organization’s publication
• An education grant is funding provided to support an event where the primary focus is educating the participants/attendees, rather than fundraising.

Key Characteristics: Charitable Contributions vs Corporate Sponsorships vs Education Grant

Characteristics	Charitable Contributions	Corporate Sponsorships	Education Grants
Promotional in nature	No	Yes	No
Payee must be a 501(c)(3) or other tax exempt organization	Yes	No	No
Radiology and Interventional receives something of value in return	No	Yes	No
Payment can be made to an individual HCP or private practice group	No	No	No
Tickets or invitations received as a result can be offered to physicians or other customers	No	No	No
Sales and Marketing Involvement	No	Yes	No

Charitable contributions may not be provided to Radiology and Interventional customers unless the customer is a non-profit entity and the request is for patient support related programs, such as camps for children. The Radiology and Interventional customer requesting funding for such programs must submit the request for a charitable contribution via the website: http://www.medrad.com/en-us/aboutmedrad/Pages/CorporateGiving.aspx. In the event a charitable contribution request to a potential customer is approved, the transaction would be considered a Focus Arrangement as defined by the CIA and must comply with all the requirements of Policy and Procedure 8, “Focus Arrangements.”

Radiology and Interventional will not make charitable donations to individuals, physician practice groups, political parties or causes, or for religious purposes. In addition, it is Radiology and Interventional policy not to provide charitable donations to Radiology and Interventional customers or to nonprofit entities controlled by or associated with Radiology and Interventional customers, except in the very limited circumstances referenced above.

This policy does not cover the provision of free Radiology and Interventional product for charitable causes. All contributions of free product must comply with Policy and Procedure, “Providing Free Product for Charitable Purposes,” in this booklet.

EXCLUSION OF SALES AND MARKETING PERSONNEL

Under no circumstances may sales or marketing personnel engage in discussions, negotiations or unsolicited requests with a healthcare professional for the support of medical research, indigent care, patient education, public education, community organizations within a Radiology and Interventional business community, or other charitable events that directly benefit patients. Radiology and Interventional’s Charitable Giving Committee is responsible for the review and approval of all charitable contributions. In addition, sales and marketing personnel are not to be included in any communication with a healthcare professional regarding the status of a request for such support. If approached by an organization regarding the status of such a request, sales and marketing personnel must direct the organization to a member of the appropriate Charitable Giving Committee.

REQUIREMENTS

Charitable contributions are permitted only if they meet the following requirements:

• The contribution is intended solely for charitable purposes. (Radiology and Interventional receives nothing of value in return, other than acknowledgement of Radiology and Interventional’s support by the charitable organization); and
• The recipient is a qualified 501(c)(3) or otherwise IRS tax-exempt charitable organization that is not a Radiology and Interventional customer or physician practice group, or an organization controlled by or affiliated with a Radiology and Interventional customer or physician practice group, except in the limited circumstances referenced above. A 501(c)(3) or other tax exempt letter is required for submission of a charitable contribution.

A charitable contribution is NOT permitted if it is any of the following:

• Intended as a price term or offered in place of a price concession.
• Contingent on the purchase of any Radiology and Interventional products.
• Intended to encourage the recipient to use, purchase, or recommend Radiology and Interventional products or to reward the recipient for doing so.
• Made at the request of a healthcare professional in his/her individual capacity (e.g., a request by a physician to fund his/her favorite charity).
• Intended as payment for services or goods.
• Provides a benefit to Radiology and Interventional (other than acknowledgement of Radiology and Interventional’s support).

Any questions regarding charitable contributions must be addressed to your supervisor, a member of the appropriate Charitable Giving Committee, or the Law and Patents Department.

Invitations for Exhibit Space at the Charity Event

It is not appropriate to receive exhibit space or advertising space in return for a charitable contribution. Generally, it is Radiology and Interventional’s practice to request a separate invoice for exhibit fees. However, in certain limited circumstances, it may not be possible to separate the exhibit fee in the documentation submitted by the requesting organization. In these situations, the appropriate Charitable Giving Committee will determine whether the contribution will be approved and/or whether Radiology and Interventional may display at the event.

Limited Attendance at Events

Radiology and Interventional, as a supporter of charitable organizations may be offered tickets to event(s) that were not expected at the time of providing the charitable contribution. Designated Radiology and Interventional employees will be selected to attend the event(s) by the appropriate Charitable Giving Committee or designee. Inviting customers and/or healthcare professionals to these charity events is not permitted. However, spouses and/or guests of the employee may attend upon approval by a Vice-President or above. No more than three Radiology and Interventional representatives from sales and marketing may attend. This three-person restriction does not apply to Radiology and Interventional attendees who are not part of the commercial organization (such as Law and Patents, Government Affairs, Public Policy, Regulatory, or Medical Affairs). The representative(s) of Radiology and Interventional who do attend approved events must not engage in any promotional activity at the event or use the event as a promotional opportunity. Only the designated Radiology and Interventional employees may use the event tickets provided by the event sponsor for admission. Inviting customers, healthcare professionals, or any other non-Radiology and Interventional personnel to these charity events is not permitted.

Contributions for Health Fairs/Medical Screenings

Under certain circumstances, Radiology and Interventional may provide charitable contributions to support health fairs and medical screenings. These events must be offered by charitable organizations free of charge to the general community and promote disease awareness or be intended to detect medical issues. An example is free prostate exams.

Radiology and Interventional may contribute funds to support a health fair or medical screening conducted by a charitable organization if the following requirements are met:

• The request for funds must be received from an independent third party that qualifies as a 501(c)(3) or otherwise IRS tax-exempt charitable organization. Radiology and Interventional cannot provide funds to a healthcare professional, private practice group, hospital or any other customer or any charity that is controlled by a healthcare professional, practice group, hospital/clinic or any other customer.
• More than one medical group or more than one healthcare professional, each from different medical groups, must be taking part in the health fair or medical screening.
• The health fair or medical screening must be free and open to the community at large (e.g., may not limited to patients of a particular hospital, health organization, members of a certain HMO, etc.).
• Any Radiology and Interventional employee who attends the event as a representative of the Company must not engage in any promotional activity at the event or use the event as a promotional opportunity.
• Radiology and Interventional may provide disease state brochures for distribution at the event upon the approval of the organization. However, Radiology and Interventional may not provide product-specific information of any type.
• Radiology and Interventional may provide educational or patient treatment related items to support the event only with prior approval of the Law and Patents Department.

PROCEDURES

Requestor

For Devices:

The requestor (or institution-designated staff member) shall provide all required charitable contribution information and attach a copy of the requestor’s organization 501(c)(3) or other tax exempt letter, indicating its status as a tax-exempt charitable organization. Additional backup documentation may also be required (e.g., agenda, budget). The requestor is responsible for providing all charitable contribution related documentation.

For Drugs:

All Charitable Contribution requests must be submitted electronically by the requestor through the Bayer website: http://grants-contributions.bayerweb.com/en/home/.The requestor (or institution-designated staff member) shall electronically input all required charitable contribution information and attach a copy of the requestor’s organization 501(c)(3) letter indicating its status as a tax-exempt charitable organization. Additional backup documentation (e.g., agenda, budget) may be required. The requestor is responsible for providing all Charitable Contribution related documentation.

The Charitable Contribution request will first be reviewed by the Contribution Manager. If the request is deemed to be complete, within budget and strategic plan, it will be placed on a schedule to be reviewed and approved by the Charitable Contribution Review Committee.

If the Contribution Manager, after attempts to obtain appropriate documentation, finds the request incomplete he/she will inform the requestor of the denial of request.

Charitable Giving Committee for Device Products

The appropriate Charitable Giving Committee provides review and comments consistent with the following:

• There are no legal or compliance issues that would prohibit member’s approval of the contribution request (e.g., no conflict with government or industry guidelines or Compliance Policies and Procedures).
• Approval of the request is based on the support of indigent care, public education, and other charitable activities that benefit patients.
• The request for support must be within the budget.
• The request for support must be aligned with Radiology and Interventional’s strategy, community and diagnostic/therapeutic focus.
• The donation will be used solely for charitable purposes and Radiology and Interventional receives nothing of value in return (except for acknowledgement of the contribution by the charity).

For each such Charitable Contribution request, the appropriate Charitable Giving Committee will approve or decline in conformance with this Policy and Procedure.

Charitable Contribution Review Committee for Drug Products

The Charitable Contribution Review Committee (“Review Committee”) is comprised of members from Medical Affairs, Public Policy and State Government Affairs, and Law and Patents. Sales and Marketing personnel do not participate in the Contribution Review Committee; however, they may provide a strategic plan relating to the subject matter of contributions to be considered.

The Review Committee reviews Charitable Contribution Requests from a regulatory and legal perspective consistent with the following objectives:

• Each Committee member certifies that there are no legal or compliance issues that would prohibit Bayer’s approval of the contribution request (e.g., no conflict with government or industry guidelines or Compliance Policies and Procedures).
• Approval of request is based on the support of indigent care, public education, and other charitable activities that benefit patients.
• The request for support is within the budget.
• The request for support is aligned with Bayer’s strategy, community, and therapeutic focus.
• The request will be used solely for charitable purposes and Bayer expects to receive nothing of value in return.

Upon review of the Charitable Contribution requests, the Review Committee may request that additional questions be answered prior to consideration of the Charitable Contribution request. For each such Charitable Contribution request, the Review Committee will approve or decline in conformance with these Policies and Procedures. If the Law and Patents representative is not present, Law and Patents must review the charitable contribution before it is approved.

Procedures for all Charitable Contributions

Law and Patents Review of Focus Arrangements

For all charitable contribution requests that are Focus Arrangements, the Law and Patents Department must verify that the letter of agreement contains

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the contribution; and
• The requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute.

The amount of the charitable contribution may not depend upon or be based on the value or volume of referrals from the charitable contribution recipient.

Post Approval Documentation

A letter documenting the Charitable Giving Committee’s decision will be provided to the requestor (or institution-designated staff member).

Record Retention

The appropriate Charitable Giving Committee will retain the payment request package for a period of seven (7) years.

Audits

All charitable contributions are subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit or review charitable contributions.

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26. Education Grants (Including Continuing Education/ Continuing Medical Education)

Transactions under this Policy may constitute Focus Arrangements as defined by the CIA. Prior to initiating a transaction covered under this Policy you must familiarize yourself with the Policy and Procedure entitled “Focus Arrangements.”

This Policy describes the appropriate use of grants to fund medical education activities that foster an increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care. This Policy conforms to the AdvaMed and PhRMA Codes and the Accreditation Council for Continuing Medical Education (ACCME) standards for commercial support. Radiology and Interventional prohibits offering a medical education grant to any entity to encourage that entity to purchase, order, lease, use or recommend the purchase of Radiology and Interventional products. In addition, if education grants were to be provided as price terms or in lieu of a price concession, they could affect the accuracy of the prices reported to the government, which could potentially cause Radiology and Interventional to violate the Medicaid Rebate Statute or the False Claims Act.

DEFINITION OF MEDICAL EDUCATION GRANT

Radiology and Interventional may provide funding for activities associated with educational conferences, continuing education (CE),continuing medical education (CME) programs, or professional meetings, if they are sponsored by an a organization other than Radiology and Interventional and they will contribute to the improvement of patient care. All CE/CME programs must be sponsored by an accredited medical organization. All education grants to the military must be provided through the Henry M. Jackson Foundation for the Advancement of Military Medicine (Jackson Foundation) or similar third-party organizations set up to receive grants on behalf of the Department of Defense.

Education grants may only be made to an organization, such as a hospital, medical professional society, conference sponsor or continuing medical education organization. Medical education grants may not be provided to individuals or private physician practice groups. The organization may use the grant funds for overall program expenses or specifically for speaker(s), meal(s), reception, etc. Grant funds cannot be used to offset expenses not directly related to the educational program (e.g., routine office expenses), nor can they be used for expenses of attendees. A grant must never be made if one purpose of the grant is to provide a financial inducement for dispensing or ordering Radiology and Interventional products, to encourage off-label use, or reward referrals for Radiology and Interventional products.

Radiology and Interventional may not directly offer financial assistance to permit medical students, residents, fellows, and other healthcare professionals in training to attend major educational, scientific, or policy-making meetings of national, regional, or specialty medical associations. The CE/CME provider may include such expenses in its request for financial support, and only the CE/CME provider or the training institution selects the individuals to attend the program

It is important to determine whether a request for support is a charitable contribution, corporate sponsorship or education grant. The terminology used by the entity requesting the funding (e.g., “charitable contribution,” “grant”) is not the determining factor because organizations may submit funding requests using inconsistent or incorrect terminology. The key factors are the type of entity requesting the funding (e.g., non-profit, patient organization, hospital) and the focus of the event or activity (e.g., education, fundraising). For example:

• A charitable contribution is funding provided to a non-profit organization to support the organization’s activities where Radiology and Interventional does not expect to receive anything in return and where the primary purpose of the event/activity is fundraising/charity rather than education.
• A sponsorship is funding provided to support the activities of a professional, medical or patient association or organization where Radiology and Interventional receives something of value, such as banners or signage at a conference or an opportunity to advertise in the association’s publication.
• An education grant is funding provided to support an event where the primary focus is educating the participants/attendees, rather than fundraising.

Key Characteristics: Charitable Contributions vs Corporate Sponsorships vs Education Grant

Characteristics	Charitable Contributions	Corporate Sponsorships	Education Grants
Promotional in nature	No	Yes	No
Payee must be a 501(c)(3) or other tax exempt organization	Yes	No	No
Radiology and Interventional receives something of value in return	No	Yes	No
Payment can be made to an individual HCP or private practice group	No	No	No
Tickets or invitations received as a result can be offered to physicians or other customers	No	No	No
Sales and Marketing Involvement	No	Yes	No

EXCLUSION OF SALES AND MARKETING PERSONNEL

Under no circumstances may Sales or Marketing personnel engage in discussions, negotiations or unsolicited requests with a grantee (prospective or actual), including a CE/CME provider, for the support, design or development of a medical education program supported by Radiology and Interventional, or in any way seek to influence the content of the program. In addition, Sales and Marketing personnel are not to be included in any communication regarding the status of a grant request, other than those communications necessary to perform their responsibilities as Contract Champions under the Radiology and Interventional Contract Management Procedure (MCMP). If Sales or Marketing personnel are approached by a customer regarding a medical education grant, they are to direct the customer to:

For Device Related Grants:

website at: http://www.medrad.com/en-us/aboutmedrad/Pages/EducationalGrant Request.aspx or to the email address: RIEducationalgrants@bayer.com, and/or to the Law and Patents Department.

For Pharmaceutical Related Grants:
website at: http://grants-contributions.bayerweb.com/en/home/ and/or the customer service telephone number (1-888-84-Bayer or 1-888-842-2937).

ACCREDITED CE/CME PROGRAMS

Continuing Medical Education (CME) programs are peer-to-peer educational activities sponsored by independent, third-party organizations accredited by the Accreditation Council for Continuing Medical Education (ACCME). Continuing Education (CE) programs may be accredited through other third party accreditation organizations such as the American Commission on Pharmacy Education (ACPE pharmacy continuing education accreditation) or the American Nurse Credentialing Center’s Commission on Accreditations. The purpose of CME/CE is to enhance the healthcare professional’s ability to care for patients. Such programs must be independent, objective, balanced and reflect scientific rigor in content development.

Examples of programs that can be accredited for CE/CME include:

• Grand Rounds
• Medical society meetings
• Medical school symposia
• Speaker program sponsored by an institution or other appropriate third-party intermediary
• Audio conferences
• Web casts and CD-ROMs containing CE/CME program

To remain independent, the sponsoring organization must retain sole responsibility for, and control over, the selection of content, faculty, attendees, educational methods and materials for the CME/CE program or scientific meeting. Accreditation for CME/CE credit adds an additional level of evidence that the program is independent of commercial influence.

Radiology and Interventional-supported CME events must conform to the ACCME guidelines or other applicable accreditation entity’s guidelines. Standards for accredited CME events supported by Radiology and Interventional include:

• There must be a signed contract (or letter of agreement) between Radiology and Interventional and the accredited sponsoring organization.
• The contract must require that the CME/CE provider disclose the following information to all program attendees:
- Radiology and Interventional’s funding of the program and any significant relationship between the vendor and Radiology and Interventional;
- Financial or other relationships between individual presenters or moderators and Radiology and Interventional;
- Any limitations on information that is presented at the programs, such as data that represents ongoing research, interim analysis, preliminary data or unsupported opinion;
- When a Radiology and Interventional product or competitor’s product is to be the subject of substantial discussion, the data must be objectively selected and presented. Both favorable and unfavorable information about the product must be fairly represented and any discussion of the prevailing body of scientific information on the product and of reasonable, alternative treatment options must be balanced; and
- If applicable, disclosure that uses of Radiology and Interventional product(s) that are not approved or cleared by FDA will be discussed .
- Funds from Radiology and Interventional will be provided in the form of an education grant made payable to the accredited provider or joint sponsor to support the program.
- Radiology and Interventional representatives may not, on their own, distribute invitations to a Radiology and Interventional-supported CME/CE event to healthcare professionals. If the CME provider requests Radiology and Interventional’s help in writing (e.g., by letter) to distribute supplemental invitations to generate interest in the program, then Radiology and Interventional may distribute these invitations on the CME provider’s behalf. Such invitations may only be distributed to healthcare professionals who can reasonably use the product for an approved use.
- The focus of any CME/CE program supported by Radiology and Interventional must be the scientific and medical program itself. Meals provided in conjunction with the program must always be modest, reasonable and secondary to the CME/CE program. They must not be used to influence attendance. Radiology and Interventional cannot directly provide meals at a CME/CE event. The CME provider, at its own discretion, may apply the financial support provided by Radiology and Interventional to provide meals to all program attendees.
- Speakers at a Radiology and Interventional-supported CME/CE program must disclose any current or previous relationship with Radiology and Interventional (e.g., consultant, paid investigator, etc.).
- Commercial exhibits may not interfere with the CME/CE activities. No promotional activities may occur in the CME/CE room. No promotional materials may be displayed or distributed in the same room as the CME/CE program before, during or after the program. Additionally, no such materials may be displayed or sales activities conducted within the “obligate path” that attendees must use to enter or exit the room where the CME/CE activity is taking place. Although not specifically defined by regulation, “obligate path” includes for example, the path from the main entry of a hotel to the meeting room or the path to a restroom.

Radiology and Interventional will not directly or indirectly provide compensation or reimbursement for registration, travel, lodging or personal expenses for attendees of any CME/CE event. Pursuant to the AdvaMed and PhRMA Codes, Radiology and Interventional may provide support to the CME/CE provider which, in its own discretion, can use the funds to reduce the overall registration fee for all attendees.

Radiology and Interventional Attendance AT NON-Promotional Events

Attendance

Sales and marketing personnel may only attend CME/CE or other non-promotional events whether or not they are sponsored by Radiology and Interventional if the request has been reviewed and approved, in writing, in advance by the employee’s manager after consultation with the Law and Patents Department. Written approval may be made via e-mail. Separate approval must be obtained for each CME/CE event. Radiology and Interventional may not attend any educational event (e.g., educational events that are not CME or CE accredited) other than promotional speaker programs without such approval.

Radiology and Interventional representatives may not ask or “plant” questions in the audience that are likely to lead to off-label discussion.

Independence

Radiology and Interventional employees may NOT be involved in the following activities associated with any CE/CME or other non-promotional program supported, even partially, by education grants from Radiology and Interventional:

• Selecting or recommending the audience; or
• Selecting or recommending the content, faculty, educational methods, materials or venue.

Promoting Radiology and Interventional Products

Radiology and Interventional employees given permission to attend a CME/CE or other non-promotional program may not engage in formal or informal promotional activities inside or outside the meeting room(s).

Radiology and Interventional employees who are not attending the program may conduct appropriate promotional activities outside program meeting rooms, such as at an adjacent exhibit, provided the exhibit and display opportunities at the event have been provided to device companies other than Radiology and Interventional.

If the program includes events that relate to an approved use of Radiology and Interventional products, and the event sponsor has provided the opportunity to multiple pharmaceutical or device companies to exhibit or display at the event, Radiology and Interventional employees may exhibit at the program. For more information, see the Policies and Procedures “Displays and Exhibits for Hospitals and Other Customers” and “Displays and Exhibits for Non Customers.”

ACCEPTABLE MEDICAL EDUCATION GRANTS

A grant is only permitted if:

• The grant is provided to foster an increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care; and
• It will be used solely for legitimate expenses related to education and training of healthcare professionals or patients in connection with the improvement of patient care. The recipient organization may use the funds for overall program expenses, or specifically for speaker(s), meal(s), reception, etc. (Grant funds cannot be used to offset expenses not directly related to the educational program (e.g., janitorial expenses), nor can they be used for expenses of attendees); and
• It is awarded to an organization such as a hospital, medical professional society, conference sponsor or continuing medical education provider; and
• It is not awarded to an individual or private physician practice group; and
• The organization, not Radiology and Interventional, controls the disbursement of the funds; and
• The responsibility for, and control over, the selection of content, faculty, educational methods, attendees, materials and venue belongs to the organizers of the conference in accordance with their guidelines; and
• The grant is provided in response to a request that:
- Describes the purpose/intended use of the grant or references other documents attached, such as a brochure, pamphlet, flier, agenda, memo that describes the purpose/intended use of the grant. It is not acceptable to list only a generic description (e.g., “education grant”) as the purpose of the expense;
- Confirms the grant will be used for educational purposes;
- Confirms the grant will not be used for general overhead or for expenses of attendees;
- Acknowledges that Radiology and Interventional may audit or review the use of the grant; Radiology and Interventional
- Provides a detailed budget describing planned use of the requested grant; and
- Confirms that Radiology and Interventional’s funding and relationship with program provider, presenters or moderator will be disclosed to attendees.

UNACCEPTABLE MEDICAL EDUCATION GRANTS

An education grant is NOT permitted if it is any one of the following:

• Intended as a price term or offered in lieu of a price concession; or
• Intended to encourage off-label use of Radiology and Interventional products; or
• Contingent on the purchase of Radiology and Interventional products; or
• Intended to encourage the recipient to order, use or recommend Radiology and Interventional products or reward or compensate the recipient for having done so; or
• Made at the request of a healthcare professional in his/her individual capacity (e.g., a request by a physician to fund his/her “pet project”). (A healthcare professional may request a grant in his/her official capacity, such as the head of a hospital department); or
• Made in return for anything of value provided to Radiology and Interventional by the recipient, with the exception of disclosure in program materials that the program is funded by Radiology and Interventional; or
• Provided for the purchase of equipment, educational books, or other items of value to be provided to healthcare professionals; or
• Provided to fund salaries of hospital nurses, residents or other healthcare professionals, or any other routine administrative costs of a healthcare professional (with the exception of certain fellowship programs); or
• Provided to pay for activities that can be covered by a fee-for-service contract as described in the Policy and Procedure “Fee-For-Service Arrangements”; or
• Conditioned on the receipt of exhibit or display opportunities; or
• Not submitted through the Radiology and Interventional website.

Invitations for Exhibit Space at the Educational Event

For displays involving payment to customers, the display and education grant must be processed as separate transactions in order to ensure that the requirements of the relevant policies, including appropriate Focus Arrangements Procedures, are followed.

For displays not involving customers (such as those at medical society meetings), there may be limited situations where an organization submits a request for an education grant that also offers Radiology and Interventional the opportunity to display at the event. These activities must be processed as separate transactions by the requesting entity. However, there may be limited occasions where it may not be possible to separate the product display fee in the documentation submitted by the requesting organization. In these situations, the Compliance Counsel will make the appropriate determination regarding whether the grant will be approved and/or whether Radiology and Interventional may display at the event.

PROCEDURES

All medical education grants (including CE/CME) requests must be approved by the appropriate Education Grant Committee. As part of the review/approval, the Education Grant Committee will ensure that the Law and Patents Department has approved a contract or letter of agreement as specified in this Policy.

All requests for device related education grants must be submitted through the Radiology and Interventional web site
http://www.medrad.com/en-us/aboutmedrad/Pages/EducationalGrantRequest.aspx
or to the email address RIEducationalgrants@bayer.com.

All requests for pharmaceutical related education grants must be submitted through the following web site: http://grants-contributions.bayerweb.com/en/home/

The initial request must:

• Describe the purpose/intended use of the grant or reference other documents attached, such as a study protocol, or memo that describes the purpose/intended use of the grant. It is not acceptable to list only a generic description (e.g., “education grant”) as the purpose of the expense;
• Confirm that the grant will be used for educational purposes or to support a medical education program; and
• Confirm that the grant will not be used for general overhead or for expenses of attendees.

Device Related Grants:

The Education Grant Committee or designated individual initially reviews the grant request submitted through the Radiology and Interventional website. If the appropriate Education Grant Committee, after attempting to obtain appropriate documentation, finds the request incomplete, he/she will inform the requestor that the request is being denied due to insufficient documentation.

Under NO circumstances will a medical education grant request be accepted or reviewed after the event has occurred.

If the grant request is deemed to be complete, within budget and strategic plan, and requests support far enough in advance for it to receive Education Grant Committee consideration prior to occurrence of the sponsored event, it will be considered.

The appropriate Education Grant Committee and the Compliance Counsel reviews the request consistent with the following:

• Ensure that, to the best of his/her knowledge, there are no legal or compliance issues that would prohibit Radiology and Interventional’s approval of the grant request (e.g., no conflict with government or industry guidelines or Compliance Policies and Procedures).
• The request proposes to support medical research, patient education, or other activities that foster increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care.
• The request for support is within the budget for the impacted business.
• The request for support is aligned with Radiology and Interventional’ business strategy.
• The funds will be used solely for legitimate expenses related to medical research, education or training of healthcare professionals or patients to foster increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care.

Law and Patents Review of Focus Arrangements

For all grant requests that are Focus Arrangements, the Law and Patents Department must verify that the Letter of Agreement or contract contains:

• A certification by the parties to the arrangement that the parties shall not violate the Anti-Kickback Statute with respect to the performance of the Focus Arrangement; and
• A requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute.

The Law and Patents Department evaluates whether the proposed arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document that this review and assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department confirms that the proposed amount of grant funds represents fair market value. The methodology used to determine fair market value may be based on information in a database of fair market values or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

The Radiology and Interventional Contract Champion or other Radiology and Interventional employee must send the grant recipient, along with the approved agreement, a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures. These documents may be sent electronically or by hard copy, and can be included as an exhibit to the agreement or sent as separate documents. Radiology and Interventional must document on the Focus Arrangements Datasheet that these documents were sent.

Proof of Service

The Radiology and Interventional Contract Champion, or other Radiology and Interventional employee must be able to confirm that the services or deliverables funded by the grant were actually performed. Acceptable proof of service includes a completed budget, program evaluations, a certification from the grant recipient that the program occurred or the grant funds were otherwise used for their intended purpose, or a completed proof of service form signed by the Radiology and Interventional employee in attendance. The contract Letter of Agreement must permit Radiology and Interventional to obtain proof of service. The deliverable should be retained by the Radiology and Interventional Contract Champion or other Radiology and Interventional employee for seven (7) years.

Law and Patents Review of Non-Focus Arrangements

If the approved grant request is not a Focus Arrangement as determined by the Law and Patents Department, the Radiology and Interventional Contract Champion, or other Radiology and Interventional employee, will send the approved contract or Letter of Agreement to the grant requestor (or institution-designated staff member). The grant requestor is responsible for sending a signed agreement back to the Radiology and Interventional Contract Champion.

Focus Arrangements Datasheet – Excel® Spreadsheet

Pharmaceutical Related Grants:

Requestor

All education grant requests will be received electronically from the requestor through the Bayer website: http://grants-contributions.bayerweb.com/en/home/. The requestor (or institution-designated staff member) must electronically input all required education grant information. Additional backup documentation is also required (e.g., agenda, budget, learning objectives). The requestor is responsible for providing all Education Grant related documentation. Upon approval from the Grant Review Committee of the grant request a signed letter of agreement is required for distribution of funds.

Under NO circumstances will a medical education grant request be accepted or reviewed after the event has occurred.

Grant Manager Initial Review

The Grant Manager will review all grant requests submitted to the Bayer website and makes an initial determination whether the proposed grant request is a potential Focus Arrangement. A grant request should be considered a Focus Arrangement if the potential recipient of the grant is a customer or other source of sales or referrals of Government Reimbursed Products.

Questions regarding whether a grant request may constitute a Focus Arrangement must be directed to the Law and Patents Department, which makes the final determination whether the grant is a Focus Arrangement.

If the grant request is deemed to be complete, within budget and strategic plan, it will be placed on the agenda for review by the Grant Review Committee at the next scheduled meeting.

If the Manager, after attempting to obtain appropriate documentation, finds the request incomplete, he/she will inform the requestor that the request is being denied due to insufficient documentation.

Grant Review Committee

The Grant Review Committee is comprised of members from Medical Affairs, Medical Education, Field Medical Affairs, and Law and Patents. Sales and Marketing personnel do not participate in the Grant Review Committee; however, they may provide a strategic plan relating to the subject matter of grants to be considered.

The Grant Review Committee meets monthly to review Education Grant Requests from a scientific, educational, regulatory and legal perspective. At the Grant Review Committee meeting, members review grant requests consistent with the following:

• Each Committee member certifies that, to the best of his/her knowledge, there are no legal or compliance issues that would prohibit Bayer’s approval of the grant request (e.g., no conflict with government or industry guidelines or Compliance Policies and Procedures).
• The grant will support medical research, patient education, or other activities that foster increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care.
• The request is within the budget for each business area.
• The request is aligned with Radiology and Interventional’s business strategy.
• The funds will be used solely for legitimate expenses related to education or training of healthcare professionals or patients to improve patient care.

If the Grant Review Committee needs additional information in order to determine whether to approve the grant request, it will approve, reject, or table the request in anticipation of receipt of further clarification or information in conformance with these Policies and Procedures. Approval of the request requires consensus among the voting members present at the Grant Review Committee meeting.

Law and Patents Review of Focus Arrangements

For all grant requests that are Focus Arrangements, the Law and Patents attorney participating on the Grant Review Committee must verify that the agreement contains:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the grant; and
• The requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute.

The Law and Patents Department also confirms whether the grant amount represents fair market value in that the proposed amount is fair, reasonable and represents support for necessary expenditures based on the nature and the extent of the event for which the grant requestor seeks support. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

The amount of the grant may not depend upon or be based on the value or volume of referrals from the grant recipient.

If the reviewing attorney is not present at the Grant Review Committee meeting, the attorney may conduct the required review at a later date. However, this review must be completed before the grant is approved and before payment is made.

Grant Manager Post-Meeting Documentation

Minutes will be prepared for each Grant Review Committee meeting. The minutes will include whether or not the grant request was: 1) approved (indicating amount); 2) rejected; or 3) tabled for receipt of further clarification or information or for further discussion.

A letter documenting the Grant Review Committee’s decision will be provided to the grant requestor (or institution-designated staff member) by the Therapeutic Grant Manager following the meeting. The Grant Manager is responsible for updating the electronic system with the decision.

Grant Approval of Focus Arrangements

For approved grant requests that are Focus Arrangements, the Grant Manager must send the grant recipient the approved Letter of Agreement, with a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures attached. These documents may be sent electronically or by hard copy, and can be included as an exhibit to the Letter of Agreement or sent as separate documents. The Letter of Agreement must include:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the grant; and
• The requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer’s Compliance program, including applicable training related to the Anti-Kickback Statute.

The Grant Manager must document that the documents were sent.

Proof of Service

The Grant Manager, or other Bayer employee, must be able to confirm the services or deliverables of the grant. Acceptable proof of performance includes a completed budget reconciled with the proposed budget, program evaluations, or a certification from the grant recipient that the program occurred or the grant funds were otherwise used for their intended purpose. The Letter of Agreement must permit Bayer to observe the services rendered or otherwise obtain proof of service. The proof of service must be retained by the Grant Manager for ten years.

Grant Approval of Non-Focus Arrangements

If the approved grant request is not a Focus Arrangement as determined by the Law and Patents Department, the Grant Manager will send a Letter of Agreement to the requestor (or institution-designated staff member). The Requestor is responsible for sending a signed agreement back to the Grant Manager.

Focus Arrangements Database Procedures

The Grant Manager must complete the required fields for a Focus Arrangement in the Grant database. Refer to Policy 8 “Focus Arrangements” for information regarding the Focus Arrangements Database Procedures

RECORD RETENTION

The Contract Champion must maintain the payment request package for a period of seven (7) years.

AUDIT

All education grants are subject to Corporate Auditing and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit/review educational grant payments.

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27. Evaluation of Device Products/Drug Sampling

Evaluation of Devices

Radiology and Interventional may make a device product available without charge for evaluation for a standard 30-day period to a healthcare professional or facility to permit an evaluation of its use and functionality in order to determine whether to use or buy the product. Evaluations may not exceed 60 days without approval by Law and Patents, or unless a specific evaluation program has been approved by Law and Patents.

Device products may be made available for evaluation to professionals or facilities who do not currently use the specific product being evaluated, or who use a prior version of the specific product being evaluated. If a department within a facility already uses a certain product and a different department expresses interest in evaluating that same product, the interested department may evaluate that product, so long as all other evaluation requirements are met.

If the product is not purchased by the end of the evaluation period, it must be removed or deactivated immediately upon the conclusion of the evaluation. It is the responsibility of the Radiology and Interventional representative to track the location and status of evaluation equipment at all times and removes or deactivates any equipment upon immediate conclusion of the evaluation.

Equipment – Equipment, such as injectors, may be provided for evaluation without transferring title only for a standard 30-day period or for a limited number of uses that is reasonable to permit an adequate evaluation of the equipment. The terms of the evaluation (including duration) must be in writing and include clear notice to the healthcare professional and/or facility that it may not seek reimbursement from or charge Medicare, Medicaid, any other health program, any insurer or patient for equipment and/or supplies provided at no charge by Radiology and Interventional and that the person or facility using the evaluation equipment may have an obligation to notify government or private payors that the evaluation equipment was provided free of charge. The terms of the evaluation must be reflected in a written notification provided to the professional before or at the time the evaluation equipment is provided. The Radiology and Interventional representative assigned to the account must make arrangements for the prompt removal of the equipment at the conclusion of the limited evaluation period unless the healthcare professional has agreed to purchase/lease the equipment.

Single Use/Consumables/Disposables – The number of single use disposable products provided at no charge should be limited to a small number reasonably necessary for the adequate evaluation of the disposables and related equipment by the healthcare professional. The procedures described above for a written notification must be followed.

Jetstream System PV Console Exception: The provisions in this section are not applicable to the PV Console for the Jetstream System (the “Console”). The Console is placed at a site for a defined and documented contractual term to enable system use and is returned at the end of the contract period. The Console is of no independent value apart from the remainder of the Jetstream System, and its placement at a site is not for demonstration or evaluation purposes.

Sampling of Drugs

Radiology and Interventional may provide a limited number of drug product samples of Radiology and Interventional drug products to customers at no charge. Drug product samples are limited to initial customer product evaluation, education, and training and/or for distribution directly to patients. The quantities of drug product samples provided must not exceed an amount that is reasonably necessary for the intended use of the samples. Drug products may only be made available as a sample pursuant to the Prescription Drug Marketing Act requirements.

The Prescription Drug Sample Transparency Provision of the Patient Protection and Affordable Care Act of 2010 (PPACA) require every pharmaceutical manufacturer and authorized distributor of record of an applicable drug to submit to Department of Health and Human Services (“HHS”) for the preceding calendar year:

(1) The identity and quantity of drug samples requested; and

(2) The identity and quantity of drug samples distributed.

Information submitted to HHS must be aggregated by:

• Name, address, professional designation, and signature of the practitioner making the request for samples (or of any individual who makes or signs for the request on behalf of the practitioner)
• Any other information deemed appropriate by HHS

VERMONT DISCLOSURE OF SAMPLES OF PRESCRIBED PRODUCTS

On an annual basis, if a manufacturer of prescribed products reports other allowable expenditures or permitted gifts, the manufacturer must also report certain information relating to samples of prescribed products, including prescription drugs, nonprescription medical devices, nonprescription durable medical equipment, OTC products, provided to Vermont healthcare providers for the preceding calendar year, provided that any public reporting of such information shall not include information that allows for the identification of individual recipients of samples or connects individual recipients with the monetary value of the samples provided.

Samples of prescription drugs that are reported to HHS under the Prescription Drug Sample Transparency Provision of the PPACA do not need to be reported to the Vermont Attorney General if the Attorney General determines that HHS will collect and provide Vermont with recipient-specific distribution of samples. In the event that the Vermont Attorney General does not determine that HHS will provide recipient-specific information to Vermont, manufacturers must report the distribution of samples covered by the PPACA.

Regardless of the Attorney General’s determination, samples of prescribed products that fall outside the reporting requirements the PPACA, such as samplesto health care providers who are not physicians, samples of medical devices and OTC products, and coupons and vouchers that allow a patient to receive product free or at a discounted price, must be reported.

Manufacturers are required to identify the relevant product, recipient, number of units, and dosage of each sample distributed. Unlike other expenditures, the Vermont law does not require manufacturers to report the value of samples.

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28. Patient Protection and Affordable Care Act (PPACA)

Legislative, regulatory, and enforcement authorities are aggressively pursuing greater disclosure and transparency of financial relationshipsbetween HCPs, HCO’s and pharmaceutical, biotech, medical device, and diagnostic companies. On March 23, 2010, the President signed into law what is now known as the Patient Protection Affordable Care Act (PPACA). The final rule for PPACA was published on February 1, 2013. This statute, as amended, sets forth new federal disclosure and transparency requirements including:

• Pharmaceutical and device manufacturers must track payments and other transfers of value to “physicians” and “teaching hospitals,” and report this information to the federal government. This requirement is often referred to as the “Physician Payment Sunshine Act” or simply the “Sunshine Act.” Disclosures are due annually on the 90th day of each year covering payments made in the prior calendar year.
• Pharmaceutical manufacturers also must track prescription drug samples distributed to practitioners. This requirement is referred to as the “Prescription Drug Sample Transparency” provision in this policy. Under the Prescription Drug Sample Transparency provision, a disclosure report is due to the federal government no later than April 1 and covers prescription drug samples distributed during the preceding calendar year.

It is the responsibility of each Bayer HealthCare Radiology and Interventional employee to accurately and completely capture required information and timely report data to the Company. These steps are extremely important so that the Company can meet its obligations to submit accurate, complete and timely reports to the Federal government. Please consult your Division’s State Law Policies and Procedures governing payments to physicians and other health care professionals and entities, among other topics, to determine what payment information must alsobe disclosed in certain states.

Physician Payment Sunshine Act

Under the Physician Transparency Provisions of the PPACA, payments and other transfers of value to “covered recipients” must be disclosed unless one of a limited number of narrow exceptions applies. Additionally, physician ownership and investment interests in the manufacturer held by physicians or their immediate family members must be disclosed unless the ownership or investment interest is in a publically traded security and mutual fund. Under the final rule, the first disclosure to the Federal Government is due March 31, 2014. The disclosure will cover transfers of value made on or after August 1, 2013 thru December 31, 2013. Subsequent disclosures are due annually on the 90th day of each year covering payments made in the prior calendar year. The information disclosed will be made public via a to-be-named website in 2014.

Covered recipients are defined under the Sunshine Act to mean U.S. licensed physicians and teaching hospitals, unless the physician is a physician who is an employee of Bayer HealthCare. The following information must be disclosed in connection with a reportable payment to a covered recipient:

• Name of the physician or teaching hospital;
• Primary business address of the physician or teaching hospital;
• Specialty and National Provider Identifier (NPI), in the case of a physician;
• State professional license number(s) (for at least one State where the physician maintains a license), and the State in which the license is held.
• Amount of the payment or other transfer of value;
• Date that payment or other transfer of value was provided;
• Form of Payment or transfer of value (e.g. cash or cash equivalent, in kind items of services, stock, stock option, or any other ownership interest, dividend, profit or other return on investment)
• Nature of Payment or transfer of value:
- Consulting fee
- Compensation for services other than consulting including serving as faculty or as a speaker at an event other than continuing education program
- Honoraria
- Gift
- Entertainment
- Food and beverages
- Travel and lodging
- Education
- Research
- Charitable contributions
- Royalty or license
- Current or prospective ownership or investment interest
- Compensation for services as faculty or as a speaker at for an unaccredited and non certified continuing education program.
- Compensation for services as faculty or as a speaker at for an accredited and certified continuing education program.
- Grant
- Space rental of facility fees
• Product to which payment or other transfer of value relates (including whether it is related to marketing, education, or research specific to a product);
• For drugs and biological, applicable manufacturers must report the name under which drug is or was marketed and the relevant National Drug Code(s) (NDC);

Excluded Items

There are a limited number of transactions that are excluded from the definition of a covered “payment or other transfer of value,” including (among others):

• A transfer of anything valued under $10, unless the total amount transferred to, requested by, or designated on behalf of the physician or teaching hospital in the same calendar year exceeds $100. Importantly, however, Bayer HealthCare will not be able to determine until the end of the calendar year whether it has exceeded the $100 limit. Accordingly, even payments under $10 must be tracked. (Beginning in 2014, the $100 limit will be indexed to inflation);
• Product samples for patient use that are not intended to be sold;
• Educational materials that directly benefit patients or are intended for patient use;
• Short-term loans for a covered device, unless the trial period exceeds 90 days;
• Discounts (including rebates); and
• In-kind items used for charity care.

Prescription Drug Sample Transparency Provision

The Prescription Drug Sample Transparency provision requires Bayer HealthCare to disclose the quantity of drug samples by product name requested by and distributed to practitioners.The information will be aggregated by name, address, professional designation, and signatureof the practitioner making the request for samples (or of any individual who makesor signs for the request on behalf of the practitioner). The first disclosure was submitted to the Federal Government on October 1, 2012. Subsequently disclosures are made annually on or before April 1st each year.

Please refer to Policy and Procedure “Evaluation of Device Product/Drug Sampling” for more information on sample distribution. Also, guidelines for dispensing product samples may be obtained from the Sales Operations Department.

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29. State Laws - Overview

		State Law Overviews	Bayer Actions
Limits / Prohibitions	California	Annually declare adherence to compliance program including the annual spend limit of $1,000 per HCP for meals, gifts, educational items and other items of value	Track and manage all relevant activities involving spend and adhere to spend limits
	Minnesota	Limits gifts and business meals to a total of $50 per calendar year per HCP	Bayer has instituted a “NO SPEND” policy
	Vermont	Prohibits gifts, including but not limited to meals and charitable donations to HCPs	No meals, gifts or charitable donations to Vermont HCPs
Annual / Quanterly Disclosure	Connecticut	Adopt compliance program; adopt training program; conduct training and regular audits to monitor compliance	Adopt compliance program
	D.C.	Report payments, fee-for-service, expenses, meals and gifts (greater than >$25), provided to HCPs. Additionally report: DTC advertising, salaries of employees	Track and report all relevant spend through internal Bayer Spend Source Systems (e.g., Concur, SAP)
	Massachusetts	Report fees, payments, subsidies or other economic benefit (greater than >$50), and any non-compliance activity
	Minnesota	Report expenditures including fee-for-service payments and expenses, to consultants and compensation to sponsor of medical conference, professional, meeting, educational program (greater than >$100)
	West Virginia	Report expenditures, including fee-for-service payments, expenses, meals and gifts provided to HCPs (less than < $100). Additionally report: DTC advertising, direct promotion, payments to pharmacies and patient groups in West Virginia
	Nevada, Massachusetts	Adopt Marketing Code of Conduct; adopt training program; conduct annual audits to monitor compliance; adopt investigation policies & procedures; includes prescriber data management;	Report annually documentation and certification of annual audits;
	Vermont	Report “allowable expenditures,” including fee-for-service payments, expenses, certain samples, fellowship salary support, discounts and rebates to the extent not preempted by PPACA	Track and report all “allowable expenditures” and disclose annually.
Ethics Reform	Louisiana Exec Branch Lobbying	Prohibits most gifts and other items of value, including fee-for-service payments to state employees including Medicaid P&T Committee members; individuals who make expenditures greater than $500 (e.g., gifts, meals or entertainment) or present before Louisiana executive branch officials to register as lobbyists and to report certain lobbying expenditures	Prohibit meals, gifts or payments of any kind to state employees; no Bayer sales rep may register as a lobbyist in Louisiana
	D.C. SafeRx	Prohibits meals and gifts to Medication Advisory Committee (MAC); licensure of pharmaceutical detailers including medical science liaisons	Prohibit meals to MAC members; ensure all applicable employees are licensed
	Tennessee Ethics Act	Prohibits meals and gifts to all state employees, including political action committee (PAC) members.	Prohibits meals, gifts, and anything of value to an official in the legislative or executive branch, to any candidate for state office, or any immediate family members of such officials or candidates
Price Disclosure	VT AWP	Requires disclosure of AWP of drug product as well as AWP of similar drug in same therapeutic class to HCPs during promotion/ marketing activities	Provide Short Form to Vermont HCPs when discussing Bayer products (applicable to products in pill form only) Provide Long Form via website with an update each quarter.
	California	Manufacturers of blood factors must submit the average sales price (ASP) for each blood factor product on a quarterly basis.	Comply with reporting requirements.
	Maine, New Mexico Texas,	Manufacturers must report AMP and Best Price (BP). TX=AMP & price paid by wholesalers	Comply with reporting requirements.

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29. STATE LAWS - California

Radiology and Interventional is committed to complying with California SB 1765 which requires certain companies to establish:

Compliance Program – A Comprehensive Compliance Program in accordance with the OIG Program Guidance for Pharmaceutical Manufacturers (April 2003). It is important to note that the OIG has also recommended that medical device companies use this guidance when developing their compliance programs.

Policies – Policies that take into account relevant industry guidance on interactions with healthcare professionals, such as the AdvaMed and PhRMA Codes.

Limits on Meals, Educational Items and Other Items of Value Provided to Healthcare Professionals – Adopt specific annual dollar limits on meals, educational items and other items of value provided to healthcare professionals. The annual amount of such meals, gifts and other items of value that can be provided to any particular California healthcare provider in a calendar year is $1,000 for all Bayer divisions. Financial support for continuing medical education and health educational scholarships, along with payment to healthcare professionals for legitimate professional services (e.g., consulting) are specifically exempt from this annual limit provided that such is consistent with fair market value and industry guidance, such as the AdvaMed and PhRMA Codes.

Note: California law defines “healthcare professional” to include any of the following: a) a person licensed by state law to prescribe drugs for human patients; b) a medical student; or c) a member
of a drug formulary committee.

Radiology and Interventional must annually declare, in writing, compliance with its Comprehensive Compliance Program and the California law. The annual declaration, the Comprehensive Compliance Program, and a toll-free number (1-877-256-3562) where one can obtain copies of both items must be published on the company’s website. The Bayer HealthCare Compliance Department is responsible for ensuring that the annual declaration and publication occurs.

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29. STATE LAWS - Connecticut

COMPLIANCE PROGRAM

Connecticut requires pharmaceutical and medical device manufacturers to adopt and implement a compliance program that is consistent with and contains, at a minimum, all of the requirements prescribed in the AdvaMed and PhRMA Codes as such codes were in effect on January 1, 2010. Additionally, pharmaceutical and medical device manufacturers must adopt a comprehensive compliance program in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers,” which was developed by OIG.

Manufacturers are also required to conduct training and regular audits of their compliance program.

As of October 5, 2012, no regulations have been implemented by the Connecticut Department of Consumer Protection, the agency tasked with enforcing the Connecticut compliance program law.

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29. STATE LAWS - District of Columbia

A. Promotional Cost reporting

Title III of the District of Columbia AccessRx Act of 2004 (the “Act”) requires manufacturers of prescription drugs dispensed in the District of Columbia (“D.C.”) that employ or use sales consultants in D.C. to report, on an annual basis (by July 1st of each year), the costs of marketing directed towards D.C. residents and persons and entities licensed to provide healthcare in D.C. The reporting requirements and exemptions are similar to those in the West Virginia marketing disclosure law.

REPORTING REQUIREMENTS

Marketing to D.C. Residents

Each annual report must disclose the value, nature, purpose and recipient of advertising, marketing and direct promotion of prescription drugs to D.C. residents through radio, television, magazines, newspapers, direct mail, and telephone communications.

Marketing to D.C. Healthcare Professionals and Entities

The report must also disclose the value, nature, purpose and recipient of the following expenditures on individuals and entities licensed to provide healthcare in D.C. (including persons employed by them in D.C., carriers, health plans, benefits managers, pharmacies, hospitals, nursing facilities and clinics):

• Educational or informational programs;
• Food, entertainment and gifts valued at more than $25, and anything provided at less than fair market value;
• Trips and travel; and
• Product samples, except those intended for free distribution to patients.
• Cost of Employees

The annual report must also disclose the aggregate cost of employees who engage in these advertising and promotional activities within D.C.

Radiology and Interventional SPONSORED MEETINGS PLANNED THROUGH THIRD PARTY VENDORS OR THE BAYER MEETING PLANNERS

The Radiology and Interventional representatives responsible for planning a company-sponsored meeting must work with the third party vendor to ensure that the vendor reports the required data to the Radiology and Interventional representative. If data cannot be collected and reported, the Radiology and Interventional representative is responsible for excluding from the invitee list all reportable healthcare professionals licensed in D.C. or any State with similar reporting requirements or spending limits. Radiology and Interventional representatives contracting with a third party vendor for meeting planning services must also ensure that the vendor contract clearly states either that: 1) within one month (30 days) from the date of the payment, meal, travel or gift to a healthcare professional, the vendor will provide the required data to the Radiology and Interventional representative; or 2) the vendor will exclude healthcare professionals licensed in D.C. or any State with similar reporting requirements or payment limits.

Exemptions

The following expenses are exempt from these disclosure requirements:

• Expenses of $25 or less;
• Reasonable payments related to bona fide clinical trials; and
• Scholarships and reimbursement of expenses for attendance at a significant educational, scientific or policy-making conference or seminar if the recipient is selected by the association sponsoring the conference or seminar; and
• Payments made to health care practitioners for participation in market research if: (i) the market research is conducted by an independent survey research organization; (ii) Bayer does not know the identity of the practitioners who participate in the research; and (iii) the payments are determined and made directly by the survey research organization.

An “independent survey research organization” is defined as a survey research organization, marketing research organization, or similar entity that is not owned or affiliated, directly or indirectly, with a pharmaceutical company, manufacturer, or labeler, and which does not share employees or independent contractors with a pharmaceutical company, manufacturer, or labeler.

APPLYING THE REPORTING LIMITS

The law describes the $25 dollar per day reporting limit as the “value” of the gift, meal, benefit, etc. The value is what the recipient would pay for the item (e.g., retail value).

Fees and payments that must be disclosed include, but are not limited to, payments for grants, speakers, consultants, advisory boards, data purchases, etc. You also must report the value of medical textbooks given to individuals, institutions, departments, or physician practice groups.

DEADLINE FOR SUBMITTING INFORMATION

Reports are due on July 1 covering the previous calendar year.

Reports must be submitted in the electronic format specified by the Board of Pharmacy. The regulations state that each annual report must also include (i) the name and contact information of the individual responsible for the company’s compliance with the D.C. law and the accuracy of the annual report, and (ii) the name and position of the individual submitting the report. Radiology and Interventional must also separately submit a “wet signature certification” as specified by the regulations. The regulations further require manufacturers to submit a $5,000 fee payable to “D.C. Treasurer,” along with the hard copy filing.

B. Prohibition on Gifts and Remuneration to Medication Advisory Committee Members

The District of Columbia SafeRx Amendment Act of 2008 prohibits pharmaceutical companies and their representatives from offering any gifts or remuneration of any kind to a member of a “medication advisory committee” responsible for the formularies of District-administered health programs. Similarly, such medication advisory committee members are prohibited from accepting such gifts or remuneration from pharmaceutical companies. The sole exception to this prohibition is that pharmaceutical companies may offer, and licensed physician advisory committee members may accept, patient samples. The term “medication advisory committee” is defined as “any committee or panel that is responsible for making recommendations or decisions regarding a formulary to be used by [the District].” The terms “gift” and “remuneration” are not defined in the Act.

The statutory prohibition on offering any gifts or remuneration to medication advisory committee members has been incorporated into a code of ethics established by the District’s Department of Health. Pharmaceutical employees and representatives who are required to obtain a license prior to engaging in interactions with District healthcare professionals (as described in further detail below) must comply with the code of ethics restrictions.

Violators of this prohibition are subject to a $1,000 fine per violation.

C. LICENSURE of Pharmaceutical Manufacturer representatives

The District of Columbia SafeRx Amendment Act of 2008 requires pharmaceutical employees and representatives engaged in certain interactions with healthcare professionals in the jurisdiction, as defined in the Act, to obtain a license prior to engaging in those interactions. Interactions are defined as “the practice by a representative of a pharmaceutical manufacturer or labeler of communicating in person with a licensed health professional, or an employee or representative of a licensed health professional, located in the District of Columbia, for the purposes of selling, providing information about, or promoting a pharmaceutical product.” This definition potentially reaches activities undertaken by a broad array of Radiology and Interventional employees, including those traditionally undertaken by medical education personnel, physician consultants, and promotional speakers.

Individuals who engage in activities covered by the Act without a license may be subject to a monetary penalty imposed by the District of up to $10,000. This includes individuals engaging in activities covered by the Act on a temporary or emergency basis. The Act does not impose penalties directly on pharmaceutical manufacturers whose personnel have violated the Act.

Applying for a New License

New license application instructions and forms are posted on the District of Columbia website at: http://doh.dc.gov/node/185802 and are summarized below.

All applicants must submit the information specified in the application instructions and forms, including the following:

• Completed and signed application form, including your social security number, and relevant supporting documents;
• A check or money order in the amount of $175.00 (for an initial license fee) or $165 (for a biennial renewal fee) made payable to “D.C. Treasurer.” Credit card payment will not be accepted;
• Two (2) identical passport type photographs (2x2 inches in size);
• One (1) photocopy of a government issued photo ID, such as your valid driver’s license;
• Official certificate of graduation from a recognized institution of higher education, in a sealed envelope from the educational institution to the Board, or a completed application for a waiver of educational requirements, if applicable;
• Completed, signed and notarized “Affidavit to Abide by Code of Ethics” Form which promises adherence to the code of ethics, developed by the Board that governs interactions with healthcare professionals; and
• A sealed envelope with criminal background check results from an outside jurisdiction or, alternatively, an appointment request form for a Livescan fingerprinting appointment. Each new applicant for licensure must obtain a criminal background check, and applicants for renewal of a license must obtain State and FBI criminal background checks.

If applicable, applicants also need to include:

1. Sworn affidavit stating that he or she does not have a social security number, if that is the case; and/or
2. Name change documents (e.g., marriage certificate, divorce decree or court order).

If applying for a waiver of educational requirements, an applicant must submit the information specified in the waiver, including the:

1. Notarized statement on “Waiver of Educational Requirement” Form;
2. List of past and current employers for the last three (3) years; and
3. Two (2) attestations from current supervisors or from one supervisor and one professional colleague.

The DC Board of Pharmacy has sixty (60) days after receipt of a complete application package to approve or deny the application. If an application is incomplete or otherwise deficient, this will significantly delay the process and can result in the return of your application materials to you. Upon final approval, you will be issued a license to engage in interactions with healthcare professionals in the District of Columbia. If your license is denied, you will receive a “Notice of Intent to Deny Licensure” document in the mail which will state the basis for the proposed denial and advise you of your right to request a hearing and the procedures for doing so.

License Renewal Activities

All pharmaceutical detailer licenses will expire at 12:00 Midnight, the last day of February of each even numbered year. Therefore, the initial licenses of employees who obtained licensure at the time the law took effect expired on February 28, 2010 and will be up for renewal on February 28, 2012. Such employees will receive a renewal notice from the Board. It is the employee’s responsibility to complete all renewal requirements. A licensee must submit a renewal application by the license expiration date or be subject to late fees and additional renewal requirements.

An applicant for renewal of licensure must:

1. Complete a minimum of fifteen (15) credit hours of approved continuing education during the period preceding the date the license expires;
2. Attest to completion of the required continuing education credits on the renewal application form; and
3. Be available for audit inquiries, which will be conducted at random.

At the conclusion of each renewal period, the Board will conduct a random audit. Those licensees selected in the random audit will be required to submit proof of having completed the required fifteen hours of continuing education.

Proof of completion of required continuing education credits includes the following information with respect to each program:

1. Name and address of the sponsor of the program;
2. Name of the program, its location, a description of the subject matter covered, and the names of the instructors;
3. Dates on which the applicant attended the program;
4. Hours of credit claimed; and
5. Verification by the sponsor of completion, by signature or stamp.

You are responsible for obtaining certificates of completion immediately after completing qualifying training programs. You need to retain these certificates so that you are able to submit them to the District as proof of completing your required continuing education credits.

Continuing Education Courses

Training courses must be approved by the Board of Pharmacy before they can be applied to the 15 credit hours of continuing education requirement. The applicant must verify whether a program is approved by the Board prior to attending the program. Licensees may contact the Board at 202-724-8938 to confirm that a program will be acceptable before attending the course.

To qualify for approval by the Board, a continuing education program must be an educational program covering specific subjects as listed in 17 DCMR 8307.2.

These educational programs may be given at a conference, a lecture, seminar, course of instruction, workshop, or on the Internet, and be prepared, offered or administered by one of the following:

• A nationally or locally accredited program provider;
• A governmental unit;
• A pharmaceutical company; or
• An institution of higher learning.

Radiology and Interventional will submit an application for approval from the Board for many of its mandatory training courses such as HealthCare Compliance, Ethics, and Sales Training Courses. Once these courses are approved, instructions on how to obtain your signed certificate of completion will be published on the Sales intranet site.

Record Requests from the DC Board of Pharmacy

The DC SafeRx Act allows the Board of Pharmacy to collect information from licensed individuals relating to their communications with healthcare professionals, or with employees or representatives of licensed health professionals located in the District. The Board expects a reply within ten (10) business days of their request.

If you receive such a request, you must immediately contact the Bayer HealthCare Compliance Officer or the Law and Patents Department. They will work with you to coordinate your response.

The documentation that needs to be maintained must include: who the detailer visited, the date and time of the visit, the products discussed, whether samples were provided, and the type of materials provided to the healthcare professional. Sales consultants need to maintain this information in the Bayer Impact system. Those not on the Impact system will need to develop a comparable documentation and retention process to capture the required information. A form is provided at the end of this Policy and Procedure for your use.

You must retain, for a period of five (5) years, documents and information relating to your communications with healthcare professionals and those that work for them.

Upon Leaving Radiology and interventional

A licensed individual must notify the Board within ten (10) calendar days of leaving the employ of a pharmaceutical company. This notification must be written and must include the name, address, email, and telephone number of the person within the company (your immediate supervisor) who may be contacted for retrieving the records required to be maintained under this chapter. The notification must be sent to the following address, with a copy provided to your supervisor:

District of Columbia Department of Health Health Regulation and Licensing Administration Board of Pharmacy 899 North Capitol Street, NE Washington, DC 20002

Supervisors of licensed employees who are leaving Radiology and Interventional must be vigilant about obtaining the employee’s records relating to communications with healthcare professionals in the District and reminding the employee of this 10 day written notification requirement.

CHANGE IN INFORMATION

The Board of Pharmacy requires licensees to report all changes of business or residence address to the Board in writing at the following address:

District of Columbia Department of Health Professional Licensing Administration ATTN: Processing Department – Address/Name Change 899 North Capitol Street Washington, DC 20002

Licensees who fail to update their addresses may not receive renewal notices in a timely manner.

Record of Communication

Within the District of Columbia

The DC SafeRx Act allows the Board of Pharmacy to collect information from licensed individuals regarding communications with healthcare professionals, or with employees or representatives of licensed health professionals located in the District. If you are not on the Bayer IMPACT system, you must use this form to document these interactions and retain it for 5 years to meet the requirements of this DC law.

Date of visit: ______________

Time of visit: ______________

Name of facility or entity: __________________________________________

Name(s) of individual(s) visited:

________________________________ ______________________________

Product discussed: _________________ Sample provided: YES or NO

Materials provided to the healthcare professional: _________________________

This documentation must be retained for a period of five (5) years.

If you receive a request for information from the DC Board of Pharmacy, you must contact the Bayer HealthCare Compliance Officer or the Law and Patents Department immediately. They will work with you to coordinate your response. You have only ten (10) business days to reply to the Board.

Upon leaving Bayer, you must provide yourdocumentation files to your immediate supervisor for ongoing record retention. Also, licensed individuals must also provide a written notification to the DC Board of Pharmacy within ten (10) calendar days of leaving Bayer with a copy to your supervisor. Notifications must be sent to the following address:

District of Columbia Department of Health Professional Licensing Administration ATTN: Processing Department – Address/Name Change 899 North Capitol Street Washington, DC 20002

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29. STATE LAWS - Louisiana

Louisiana law prohibits state employees from accepting most gifts and other items of value. It also requires individuals who make expenditures of $500 or more (e.g., for gifts, or entertainment) on Louisiana executive branch officials to register as lobbyists and report certain lobbying expenditures.

Identification of Louisiana Executive Branch Officials

A list of executive branch departments and agencies can be found on the State of Louisiana website at: http://www.govengine.com/stategov/louisiana.html. The list is not all-inclusive, and it is your responsibility to exercise due diligence to determine if your interaction is with a member of a governmental body. If in doubt, ask the healthcare professional whether he/she is an executive branch official before providing any meal, speaker fee, or other fee-for-service payment.

PROHIBITION Of Gifts To STATE EMPLOYEES

You must assume that healthcare professionals working at state facilities, such as state hospitals, universities, clinics and prisons are state employees. Under Louisiana law, they remain state employees even when they are not physically located at a state facility (e.g., on their days off or when working at a civilian facility). It is your responsibility to determine whether a Louisiana healthcare professional is a state employee before offering or providing a meal or entering into a fee-for-service arrangement.

Under Louisiana’s gift law, the only items of value that state employees are permitted to accept are “promotional items” of a nominal value and “food and drink” consumed in the presence of the gift-giver. State employees may not accept medically-related gifts, speaker fees, textbooks, etc. Because both the AdvaMed Code and the “Educational Items (Prohibition on Gifts to Healthcare Professionals) Policy” in this booklet prohibit giving any promotional items, despite the Louisiana law, you may not give ANY educational item – PERIOD – to a state employee in Louisiana.

EVALUATION/DEMONSTRATION UNITS

Medical device evaluation/demonstration units and samples to state employees may raise issues under federal and Louisiana law. Therefore, you must consult the Law and Patents Department before providing any evaluation/demonstration units to Louisiana state employees.

PHARMACEUTICAL SAMPLES

Louisiana law specifies that pharmaceutical samples that comply with the Federal Food, Drug, and Cosmetic Act and the Prescription Drug Marketing Act and that are provided to a physician, healthcare professional, or appropriate public employee for the administration or dispensation to a patient at no cost to the patient are not considered to be items of value. Thus, Bayer may give state-affiliated healthcare professionals free pharmaceutical samples for distribution to patients free of charge, so long as the provision of such samples complies with applicable federal law.

Lobbying Registration and Disclosure

The Louisiana Lobbying Disclosure Act requires those who entertain or present before executive branch officials with the intent to influence executive branch action to register as lobbyists. The term “executive branch action” includes efforts to influence the conduct of the Medicaid Pharmaceutical and Therapeutics (P&T) Committee. Thus, any Radiology and Interventional employee who entertains (e.g., provides a business meal) or appears before Medicaid P&T Committee members or state healthcare practitioners who interact with the P&T Committee may be required to register with the Louisiana Board of Ethics as an executive branch lobbyist.

Because of the stringent reporting requirements as well as additional legal ramifications, no Radiology and Interventional sales force employee should be registered as a lobbyist in Louisiana. (Note that Public Policy and State Government Affairs employees must register as lobbyists as a requirement of their job.)

Under no circumstances should a Radiology and Interventional employee entertain or appear before an executive branch official without first contacting the Public Policy and State Government Affairs Department well in advance of the contemplated activity.

FEE FOR SERVICE EVENTS

Louisiana’s Code of Government Ethics prohibits a state employee from receiving compensation for services rendered by the state employee if such services are compensated for by an entity from which the state employee may not receive a gift under Louisiana law. Accordingly, you must consult the Law and Patents Department before entering Radiology and Interventional into any financial arrangement with, reimbursing travel expenses for, and/or engaging any Louisiana healthcare professional as a consultant, advisor or speaker.

Louisiana law does, however, provide a limited exception for faculty or staff members of a public higher education institution to provide certain consulting services in their field of expertise, provided the consulting arrangement is properly approved according to the process specified by Louisiana law. These Louisiana laws significantly impact the consulting arrangements that manufacturers may enter into with healthcare professionals who are executive branch officials.

The Louisiana Board of Ethics has discussed the application of the gift law to fee-for-service arrangements with manufacturers in a number of Advisory Opinions. Some of the key Advisory Opinions regarding
fee-for-service arrangements with Medicaid P&T Committee members and employees of Louisiana public universities are discussed below.

1. Medicaid Pharmaceutical &Therapeutic Committee Members

Ethics Advisory Opinion No. 2008-424 (May 13, 2008) analyzed fee-for-service arrangements between manufacturers and members of the Louisiana Medicaid P&T Committee. The Board concluded that Louisiana law prohibited the P&T member from providing the following services to manufacturers:

• Service on scientific advisory boards and speakers’ bureaus to provide an opinion about needs in the P&T member’s medical field and the best direction and use of available resources for planning future research and marketing;
• Service on the faculty of a national council which is supported by a grant from a manufacturer, and for which the P&T member receives an honorarium and expenses;
• Service as a consultant and co-principal investigator on a clinical trial for which the P&T member receives an hourly honorarium/consultation fee; and
• Recipient of a grant from a manufacturer to support research endeavors.

2. Louisiana Public University Employees

Ethics Advisory Opinion Nos. 2006-247 (April 18, 2006) and 2006-654 (September 14, 2006) analyzed fee-for-service arrangements between manufacturers and employees of Louisiana public universities. The Board concluded as follows:

• Although Louisiana law does provide a limited exception for faculty or staff members of a public higher education institution to provide certain consulting services in their field of expertise (provided the consulting arrangement is properly approved according to the process specified by Louisiana law), speaking engagements are not considered consulting services. Therefore, executive branch officials who are employees of public universities in Louisiana may not accept compensation or related travel reimbursement for serving as a speaker at a seminar or other speaking engagement.
• Furthermore, the exception that permits executive branch officials to provide consulting services under certain conditions (discussed immediately below) does not apply to speaking engagements.
• Under certain conditions, executive branch officials employed by Louisiana public universities may serve as a paid consultant to a company to serve on an advisory board to assist in product development or advice on other issues particular to the practice of medicine, including developing continuing medical education materials. However, the following conditions must be met:
- The services must be related to the executive branch official’s academic discipline or area of expertise, and
- Proper approval must be granted in writing by the chief administrative officer of the State agency in compliance with Section 1123(9)(b) of the Code of Governmental Ethics.

In circumstances where Bayer has entered a written contract with a State agency to conduct a study or clinical research trial, executive branch officials may be reimbursed for travel expenses related to a study or clinical research trial only if the contract between Bayer and the State agency obligates Bayer to pay for all reasonable travel expenses incurred by participating physicians in connection with trial related meetings.

In summary, the Louisiana gift law places significant restrictions on the fee-for-service arrangements pharmaceutical and medical device manufacturer may enter into with Louisiana executive branch officials. The Louisiana statutory provisions are very complex, and are often amended by the legislature or subject to new interpretations by the Louisiana Board of Ethics. Again, you must contact the Law and Patents Department before entering Radiology and Interventional into a financial arrangement with, reimbursing travel expenses for, and/or engaging any Louisiana healthcare professional as a consultant, advisor or speaker.

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29. STATE LAWS - Massachusetts

Massachusetts law requires pharmaceutical and medical device manufacturing companies that participate in a Massachusetts healthcare program and employ a person to sell or market prescription drugs or medical devices in Massachusetts to (1) adopt a marketing code of conduct as developed by the Massachusetts Department of Public Health (the “Department”) and (2) annually report payments and other economic benefits of $50 or more to healthcare providers, healthcare entities and others.

Because Massachusetts has not yet issued its final regulations that include the definition and the reporting requirements for “modest” meals, we will not be changing the Policy on out of office meals with MA licensed HCPs at this time. Bayer HealthCare Radiology and Interventional’s Policy only allows for in office meals.

Key Definitions

The law defines “healthcare practitioner” as a person, licensed to provide healthcare, who prescribes prescription drugs for any person, or a partnership or corporation comprised of such persons, or an officer, employee, agent or contractor of such persons acting in the course and scope of his employment, agency or contract related to or in support of the provision of healthcare to individuals. Independent contractors who do not have prescribing authority or who are not employed by or agents of physicians or other prescribers do not fall within the Massachusetts’ definition of “healthcare practitioner.”

By definition of the law, a “physician” is a person licensed to practice medicine by the board of registration in medicine who prescribes prescription drugs or an employee or agent of such a licensed practitioner.

On September 19, 2012, the Department passed an emergency rule that temporarily defines “modest meals and refreshments” as food and/or drinks provided by or paid for by a pharmaceutical or medical device manufacturing company or agent to a health care practitioner that, as judged by local standards, are similar to what a health care practitioner might purchase when dining at his or her own expense.

Marketing Code of Conduct

Under the law, pharmaceutical and medical device manufacturers that participate in a Massachusetts healthcare program and employ a person to sell or market prescription drugs or medical devices in Massachusetts are required to adopt and comply with a marketing code of conduct as promulgated by the Department. The Department’s marketing code of conduct is required to be no less restrictive than the most recent versions of the AdvaMed and PhRMA Codes on interactions with healthcare professionals. The Department will update the marketing code of conduct no less than every two years.

A pharmaceutical or medical device manufacturing company that employs a person to sell or market in the state is required to:

• Adopt a marketing code of conduct as developed by the Massachusetts Department of Public Health (the “Department”);
• Adopt a training program to provide regular training on the marketing code of conduct to appropriate employees, including, without limitation, all applicable sales and marketing staff;
• Conduct annual audits to monitor compliance with the marketing code of conduct;
• Adopt policies and procedures for investigating instances of non-compliance with the marketing code of conduct, taking corrective action in response to non-compliance, and reporting of non-compliance to appropriate state authorities;
• Report all incidents of non-compliance to the Department and to the Massachusetts Office of the Attorney General in a format specified by the Department;
• Identify a Compliance Officer responsible for operating and monitoring the marketing code of conduct;
• Annually (by July 1st) report payments and other economic benefits of $50 or more to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, healthcare practitioner or other person authorized to prescribe, dispense or purchase prescription drugs or medical devices in the Commonwealth of Massachusetts;
• Register with the Department annually and pay the annual registration fee; and
• Submit an annual report to the Department describing the above requirements and containing the compliance officer’s certification.

The marketing code expressly prohibits:

• The provision of, or payment for, meals for healthcare practitioners that:
- are part of an entertainment or recreational event;
- are offered without an informational presentation being made, or without a marketing representative being present; or
- are provided to a healthcare practitioner’s spouse or other guest.
• The provision or payment of entertainment or recreational items of any value, including, but not limited to, tickets to the theater or sporting events, sporting equipment or leisure or vacation trips, to any healthcare practitioner who is not a salaried employee of the company;
• Sponsorship or payment for Continuing Medical Education that does not meet the Accreditation Council for Continuing Medical Education Standards for Commercial Support, or that provides payment directly to a healthcare practitioner;
• Financial support for the costs of travel, lodging, or other personal expenses of non-faculty healthcare practitioners attending any CME event, third-party scientific or educational conference, or professional meeting, made either directly to the attendees or indirectly to the event’s sponsor, except in cases as determined by the Department;
• Compensation for the attendees’ time at CME, third-party scientific or educational conferences or professional meetings;
• The provision of, or payment for, meals directly at any CME event, third-party scientific or educational conference, or professional meetings;
• Payments in cash or cash equivalents to healthcare practitioners, either made directly or indirectly, except as compensation for bona fide services; and
• Anything in exchange for prescribing prescription drugs or using devices or for a commitment to continue prescribing prescription drugs or using medical devices.

However, the marketing code expressly permits:

• The distribution of peer reviewed academic, scientific or clinical information;
• The purchase of advertising in peer reviewed scientific or clinical journals;
• The provision of reasonable quantities of medical device demonstration and evaluation units to healthcare practitioners for the purpose of assessing the appropriate use and functionality of the product and determining whether or not and when to use or recommend the product at a future time;
• The provision of prescription drug samples to healthcare practitioners for the use of patients;
• Compensation for professional or consulting services of a healthcare practitioner in connection with a genuine research project or a clinical trial;
• The reimbursement or payment for reasonable expenses necessary for technical training on the use of a medical device, as long as the amounts or categories of reasonable expenses to be paid are part of the vendor’s purchase contract for the device;
• The provision of product reimbursement information and information designed to offer technical or other support intended to assist in the appropriate and efficient use or installation of products; or
• Payment for reasonable compensation and expenses incurred in connection with services provided under a bona fide fee-for-service contract, so long as the compensation and reimbursement is specified in, and paid for under, a written agreement.

Note: Under Massachusetts law, a “healthcare practitioner” is defined as “a person who prescribes prescription drugs for any person and is licensed to provide health care, or a partnership or corporation comprised of such persons, or an officer, employee, agent or contractor of such person acting in the course and scope of his employment, agency or contract related to or in support of the provision of health care to individuals.”

Additional specific limitations are set forth in the Massachusetts code of conduct regulations.

other code of conduct requirements

The law also requires companies to adopt and submit to the Department a description of a training program to provide regular training to appropriate employees, including all sales and marketing staff, on the marketing code of conduct. The training program must ensure that all representatives who are employed by or acting on behalf of the company and who visit Massachusetts health care practitioners have sufficient knowledge of: (i) the marketing code of conduct; (ii) general science; and (iii) product-specific information to provide accurate, up-to-date information that is consistent with state law and FDA requirements. Additionally, companies must regularly assess persons who are employed by or acting on behalf of the companies to ensure that they are in compliance with the Massachusetts code of conduct and other company policies.

Companies must also adopt and submit to the Department Policies and Procedures for investigating non-compliance with the Massachusetts marketing code of conduct law, taking corrective action in response to non-compliance, and reporting instances of non-compliance to the appropriate state authorities. The Department regulations explicitly require companies to report all instances of noncompliance to the Department and to the Massachusetts Office of the Attorney General in a form specified by the Department. As of October 16, 2012, the Department has not yet issued a form for such reports.

Additionally, companies are required to submit to the Department the name, title, address, telephone number and electronic mail address of the compliance officer they have identified as responsible for certifying compliance with the Massachusetts code of conduct law and implementing, monitoring, and enforcing the company’s marketing code of conduct.

Furthermore, in all speaker and commercial consultant contracts, companies must require any healthcare practitioner who is a member of a committee that sets formularies or develops clinical guidelines and also serves as a speaker or commercial consultant for the company to disclose to the committee the nature and existence of his or her relationship with the company. This disclosure requirement must extend for at least two years beyond the termination of any speaker or consultant arrangement.

Companies must also annually conduct an audit by July 1 of each year to monitor compliance with the Massachusetts code of conduct law.

Finally, companies also must submit annually a Code of Conduct Compliance Form, which is available on the Massachusetts Office of Health and Human Services website: http://www.mass.gov/eohhs/provider/licensing/programs/pharm-code-of-conduct/information-for-manufacturers.html.

ANNUAL REPORTING OF PAYMENTS OF $50 OR MORE

The law also requires companies, by July 1 of each year, to disclose to the Department the value, nature, purpose and particular recipient of any fee, payment, subsidy, or other economic benefit with a value of $50 or more which is provided to any physician, hospital, nursing home, pharmacist, health benefit plan administrator, healthcare practitioner or other person authorized to prescribe, dispense, or purchase prescription drugs or medical devices in the state. Pursuant to emergency regulations passed by the Department in September 2012, reporting of such payments is not required under Department regulations after reporting for the calendar year 2012 has closed. Reporting such payments is still required by the applicable Massachusetts statutes, to the extent the disclosures are not required by the federal Physician Payments Sunshine Act or other federal law under which the information disclosed may be obtained by the Department from a federal agency.

For the purposes of computing the $50 threshold, fees, payments, subsidies and other economic benefits relating to separate events or transactions must be calculated on an individual transactional basis and cannot be aggregated. Companies are prohibited from structuring fees, payments, subsidies or other economic benefits to healthcare practitioners to circumvent the reporting requirements.

The Department will make all disclosed data publicly available and easily searchable on its website.

The Department will report to the Attorney General any payment, entertainment, meals, travel, honorarium, subscription, advance, services or anything of value provided in violation of the marketing code of conduct as adopted by the Department.

Fee

Each disclosure report must be accompanied by a $2,000 fee.

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29. STATE LAWS - Minnesota

The State of Minnesota limits gifts and business meals provided to any practitioner to a total of $50 per year. Thus, there is a $50 per person per year spending limit for gifts and business meals and a reporting requirement for all cumulative payments exceeding $100 per year to any practitioner licensed in the State of Minnesota. To ensure that Bayer HealthCare does not exceed the $50 annual limit, you must not provide gifts or meals or other items of value to any practitioner licensed in the State of Minnesota or anyone employed by them.

DEFINITION OF “PRACTITIONER”

For purposes of the Minnesota law, “practitioner” means any licensed:

• doctor of medicine (M.D.);
• doctor of osteopathic medicine (D.O.);
• dentist (D.D.S.);
• doctor of optometry (O.D.);
• podiatrist (D.P.M.);
• veterinarian;
• physician assistant authorized to prescribe, dispense, and administer drugs; or
• advance practice nurse authorized to prescribe, dispense, and administer prescription drugs.

The term “practitioner” also includes licensed practitioners who are not actively practicing (e.g., a non-practicing physician who serves as CEO of a managed care entity). It does not include pharmacists, non-licensed business managers within managed care organizations, patients, wholesalers and distributors.

A. PROMOTIONAL SPENDING LIMITS

The total value of gifts or business meals that all Bayer HealthCare employees and agents can provide to any Minnesota-licensed practitioner in a calendar year cannot exceed $50. To ensure that Bayer HealthCare does not exceed the $50 annual limit, you must not provide gifts, meals, or other items of value – including textbooks to any practitioner licensed in the State of Minnesota or anyone employed by them. Payments to Minnesota practitioners for “marketing surveys” conducted by Radiology and Interventional and/or where Radiology and Interventional pays the healthcare practitioner directly are not permitted because the Minnesota Board of Pharmacy interprets such payments as gifts. However, Minnesota practitioners may be included in bona fide market research conducted by independent market research organizations, where those organizations select and make payment to Minnesota practitioners, because such legitimate research activities qualify as an exception to the gift ban. The Minnesota prohibition does not apply, to fee-for-service arrangements and certain other payments described below in Subsection B, Cost Reporting.

The $50 annual limit applies to practitioners licensed in the State of Minnesota, regardless of where the meal occurs or gift is presented. Thus, you cannot invite a Minnesota-licensed physician to a dinner and speaker program in another state to avoid the $50 limit.

EXCEPTIONS TO THE ANNUAL SPENDING LIMIT

The following expenditures do not count toward the $50 annual spending limit:

• free samples of a drug provided to a prescriber for free distribution to patients;
• payments to the sponsor of a medical conference, professional meeting, or other educational program, provided the payment is not made directly to a practitioner and the payment is used solely for bona fide educational purposes;
• payment of a reasonable speaker fee and reasonable expenses to a practitioner who serves on the faculty at a professional or educational conference or meeting;
• compensation for a practitioner’s professional or consulting services in connection with a genuine research project;
• product or company publications and educational materials; and
• salaries or other benefits paid to employees.

This limit applies to the business groups of Bayer HealthCare combined (Bayer HealthCare Pharmaceuticals, Bayer Dermatology and Animal Health), not to individual Bayer employees.

APPLYING THE LIMITS

To ensure that Bayer HealthCare does not exceed the $50 annual limit, you must not provide gifts or meals or other items of value to any practitioner licensed in the State of Minnesota or anyone employed by them.

Note: Meals and other approved expenses provided in connection with speaker training meetings and advisory boards/consultants meetings do not count toward the annual $50 limit. However, payments to practitioners for these services must be reported to the State as described below.

Textbooks are included in the $50 limit. Thus, textbooks valued at over $50 may be provided only to a hospital department or other educational entity and not to individual practitioners (see Policy and Procedure 15, “Educational Items (Prohibition on Gifts for Healthcare Professionals)

The $50 spending limit does not apply to Bayer HealthCare funds provided to a non-Bayer sponsor of an industry meeting or conference. Bayer HealthCare may also provide funds in excess of $50 to the sponsor of an educational program, provided that the sponsor is not a professional corporation owned by practitioners. Bayer HealthCare hospitality suites at industry meetings must be funded through the meeting sponsor and be open to all meeting attendees.

Bayer HealthCare product samples, product publications and other product educational materials are also excluded from the $50 spending limit.

B. COST REPORTING

Effective January 1, 2012, the Physician Payment Sunshine Act (PPSA), also known as Patient Protection and Affordable Care Act (PPACA) has preempted any state law that requires a manufacturer to disclose the type of information covered by the federal report. Since the vast majority of the data that is reported under the Minnesota law is information covered by the federal report, the Minnesota Board of Pharmacy has determined that for calendar year 2012 it will not require Manufacturers to report any data. However, the Bayer policy prohibiting meals and gifts in Minnesota remains in effect since the gift ban portion of the law has not been preempted.

Bayer employees must internally report all payments, regardless of dollar amount, to Minnesota practitioners (as defined above) via the appropriate reporting method (e.g., Concur)

Thus, Bayer HealthCare (Bayer HealthCare Pharmaceuticals, Bayer Dermatology, and Animal Health) must report cumulative payments of $100 or more to any Minnesota practitioner. In order to capture the relevant data for cumulative reporting purposes, Bayer HealthCare employeesmust internally report all payments, regardless of dollar amount, to Minnesota practitioners (as defined above).

The internal reporting requirement applies to all payments made to practitioners licensed in Minnesota, regardless of where the services were rendered. Payments to be reported include, but are not limited to:

• Speaker fees;
• Consultant fees;
• Advisory board fees;
• Data purchases;
• Market research data; and
• Expense reimbursements.

Note that payments for “marketing surveys” are interpreted by the Minnesota Board of Pharmacy as “gifts.” Therefore, Bayer HealthCare must not utilize Minnesota-licensed practitioners for marketing surveys for which compensation is made by Bayer HealthCare or a third party vendor administering the survey. Underthe Bayer HealthCare Code of Conduct, payments for grants, research projects (clinical trials), and to sponsors of medical education programs must be made to an organization rather than to an individual practitioner or a practice group. Payments to entities unrelated to practitioners generally do not need to be reported under the Minnesota statute.

BAYER HEALTHCARE SPONSORED MEETINGS PLANNED THROUGH THIRD PARTY VENDORS OR THE BAYER MEETING PLANNERS

The Bayer HealthCare representatives responsible for planning a company-sponsored meeting must work with the third party vendor to ensure that the vendor reports the required data to the Bayer HealthCare representative. If data cannot be collected and reported, the Bayer HealthCare representative is responsible for excluding from the invitee list all reportable healthcare professionals licensed in Minnesota or any other State with similar reporting requirements or spending limits. Bayer HealthCare representatives contracting with a third party vendor for meeting planning services must also ensure that the vendor contract clearly states either that: 1) within one month (30 days) from the date of the payment to a healthcare professional, the vendor will provide the required data to the Bayer HealthCare representative; or 2) the vendor will exclude healthcare professionals licensed in Minnesota or any other State with similar reporting requirements or payment limits.

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29. STATE LAWS - Nevada

Nevada law requires Radiology and Interventional to do the following:

1.Written Marketing Code of Conduct – Adopt a written marketing code of conduct that is based on applicable legal standards and incorporates principles of healthcare, including, without limitation, requirements that Radiology and Interventional’s activities be intended to benefit patients, enhance the practice of medicine and not interfere with the independent judgment of healthcare professionals. A marketing code of conduct that incorporates the most recent version of the AdvaMed or PhRMA Code will be deemed to satisfy this element of the Nevada statute.
2.Training – Provide regular training to appropriate employees, including, without limitation, all sales and marketing staff on the marketing code of conduct;
3.Annual audits – Conduct annual audits to monitor compliance with the marketing code of conduct;
4.Policies and Procedures – Adopt policies and procedures for investigating any non-compliance with the marketing code of conduct, including, without limitation:

• Maintenance of effective lines of communication for employees to report non-compliance;
• Investigation of reports of non-compliance;
• Corrective action for confirmed instances of non-compliance; and
• Reporting instances of non-compliance to law enforcement in appropriate circumstances.

5.Compliance Officer – Identify a compliance officer responsible for developing, operating and monitoring the marketing code of conduct.
6.Report to the Nevada State Board of Pharmacy – By June 1st of each year, Radiology and Interventional is required to submit a “Compliance Packet” to the Nevada State Board of Pharmacy that includes:

• A copy of the company’s marketing code of conduct;
• A description of the company’s training program;
• A description of the company’s investigation policies;
• The name, title, address, telephone number, and e-mail address of Bayer HealthCare’s Compliance Officer; and
• A certification that the company has conducted its annual audit and is in compliance with its marketing code of conduct.

Radiology and Interventional’s Law and Patents Department will work with Bayer Healthcare’s Compliance Department to ensure the submission of this annual report.

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29. STATE LAWS - New Mexico

The New Mexico Prescription Drug Pricing Law requires manufacturers of prescription drugs sold in New Mexico to report drug pricing information to the New Mexico Human Services Department (the “Department”).

Manufacturers must report the following pricing information for each of their drugs:

• Average Manufacturer Price (“AMP”): The average price paid to the manufacturer for the drug in New Mexico, including rebates, discounts and market incentives, after deducting customary prompt-pay discounts;
• The price that each wholesaler or pharmacy benefit manager doing business in New Mexico pays the manufacturer to purchase the drug; and
• The price paid to the manufacturer by any entity in an arrangement or contract that purchases prescription drugs in New Mexico without the services of a wholesaler.

Manufacturers must file the pricing information annually by January 15 of each year covering the period from July 1 through September 30 of the prior calendar year (e.g., the third quarter if the prior calendar year) and may submit the information in the same format as it is submitted to CMS. All pricing information submitted is confidential and is not subject to public inspection.

The statute does not describe the reporting procedures, deadlines, or penalties for non-compliance and there are no regulations. However, the Department has mailed detailed information about reporting and the reporting format to all manufacturers.

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29. STATE LAWS - Tennessee

The Tennessee Commissions Act regulates the activities of persons doing business within the state. This legislation does not require vendors and their representatives in Tennessee to register as lobbyists; they must, however, comply with provisions similar to those of a lobbyist.

The law states that vendors shall not offer or attempt to offer anything of value to an official in the legislative or executive branch, to any candidate for state office, or any immediate family members of such officials or candidates. This prohibition includes meals, travel expenses, or lodging. Product samples and product informational materials are not a part of the gift ban and can be given to anyone if otherwise permissible under applicable laws and Radiology and Interventional policies and procedures. Promotional items (e.g., pens, clocks, pads of paper, etc.) that might otherwise be permitted under Tennessee law are prohibited consistent with Radiology and Interventional’s Compliance Policy and Procedure 15, “Educational Items for Healthcare Professionals.”

APPLICATION of the law

A Sales Consultant cannot purchase a meal for any members of the Tennessee legislative or executive branch. This includes state representatives and senators, TennCare officials, Department of Health officials, or anyone directly employed by the state of Tennessee. Also, they may not purchase any meals for physicians appointed to state boards like DUR or PAC committees.

Sales Consultant can provide meals to county health department officials, First Health employees, and any hospital employed physician unless they are on a board stated above to the extent the provision of the meal is consistent with Radiology and Interventional’s Compliance Policy and Procedure 14, “Business Meals to HealthCare Professionals.”

The Tennessee law applies to state employees only. However, local ordinances could prohibit gifts otherwise permitted by Radiology and Interventional in a Tennessee county or city. Sales consultants need to check with local governments for those regulations.

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29. STATE LAWS - Texas

Manufacturers of prescription drugs sold in Texas must report to the Interagency Council on Pharmaceuticals Bulk Pricing (the “Council”):

The Average Manufacturer Price (“AMP”) of each drug sold in Texas; and

The price that each wholesaler in Texas pays the manufacturer to purchase each drug.

The prices must be reported at least annually, or more frequently as determined by the Council. By the 25th of each month, the Council’s designee will submit to the Bureau of Food and Drug Safety (BFDS) within the Texas Department of Health a list of prescription drugs about which it desires pricing information. By the 5th day of the following month, the BFDS will submit the request electronically to all manufacturers selected. Each manufacturer selected must report to BFDS, using a standardized electronic format, the above pricing information no later than 30 days after receiving the request from BFDS.

The disclosed pricing information is confidential and, except as necessary to permit the attorney general to enforce state and federal laws, may not be disclosed by the Health and Human Services Commission or any other state agency in a form that discloses the identity of, or prices charged by, a particular manufacturer.

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29. STATE LAWS - Vermont

SCOPE

The Vermont Prescribed Products Gift Ban and Disclosure Law prohibits certain gifts to healthcare providers and to members of the Green Mountain Care board by manufacturers of pharmaceutical, biological and medical devices (referred to as “prescribed products”). Vermont law also requires manufacturers to annually report to the Vermont Office of Attorney General the value, nature, purpose and recipient information of any allowable expenditure or permitted gift to a Vermont healthcare provider or board member in connection with promotional activities. Additionally, each manufacturer must identify the prescribed product marketed and report certain recipient information, including the healthcare professional’s Vermont license number or other designated identification number.

Beginning April 1, 2012, manufacturers are also required to report certain information related to free samples provided to Vermont healthcare providers for the preceding calendar year.

Under Vermont law, if a company has multiple divisions, some of which market prescribed products to Vermont healthcare providers and institutions, and some of which do not, the entire company is bound by the Vermont gift ban and must report allowable expenditures and permitted gifts.

Additionally, if the manufacturer of prescribed products markets those products through a subsidiary, the expenditures must be reported in the name of the manufacturer. The Compliance Officer Form (discussed below) must also be submitted in the name of the manufacturer.

A “prescribed product” means:

• drugs or medical devices as defined in section 201 of the FDCA (21 U.S.C. §321)), a compound drug or drugs, biological products as defined in 42 U.S.C. §262, for human use, or a combination product as defined in 21 C.F.R. § 3.2(e). The term includes prescription drugs, devices, and over-the-counter (OTC) products, but does not include prescription eyewear.

A “gift” means:

• anything of value provided for free to a healthcare provider or to a member of the Green Mountain Care board;
• any payment, food, entertainment, travel, subscription, advance, service, provided to a health care provider or board member; or
• anything else of value provided to a healthcare provider or board member unless it is reimbursed by the healthcare provider or board member at fair market value or it is an allowable expenditure as noted below.

A “healthcare professional” means:

• (i) a person who is authorized by law to prescribe or to recommend prescribed products, who regularly practices in Vermont, and who either is licensed by Vermont to provide or is otherwise lawfully providing healthcare in Vermont; (ii) a partnership or corporation made up of persons described in romanette (i); or (iii) an officer, employee, agent, or contractor of a person described in romanette (i) who is acting in the course and scope of employment providing healthcare to individuals, including nursing and office staff.

A “healthcare provider” means:

• means a healthcare professional, hospital, nursing home, pharmacist, health benefit plan administrator or any other Vermont authorized dispenser or purchaser of prescribed products. The term “healthcare provider” does not include a hospital foundation that is organized as a nonprofit entity separate from a hospital.

A “sample” means:

• a unit of a prescription drug, biological product, or medical device that is not intended to be sold and is intended to promote the sale of the drug, product, or device, including starter packs and coupons or vouchers that allow an individual to receive a prescribed product for free or at a discounted price. The term does not include prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufacturer-funded patient assistance program.

gift prohibitions

Vermont law prohibits a manufacturer of a prescribed product, or a wholesale distributor of medical devices, from offering or giving a gift to a healthcare provider. The Vermont Attorney General has published guidance for compliance with the gift ban and disclosure laws. Examples of banned items include:

• Monetary donations to a doctor or clinic;
• Charitable contributions to a hospital;
• Sponsoring of a fellowship, even if the company does not select the recipient;
• Marketing surveys;
• Dinner at a seminar, or conference at which the meal is organized and paid for by the manufacturer;
• Food provided at a manufacturer’s display in Vermont other than at of a conference or seminar;
• Meals, drinks, or snacks in the doctor’s office with Vermont HCPs including their staff;
• Dinner provided in another state to a Vermont-licensed physician whose primary office is in Vermont; and
• Driving a Vermont physician to an event in another state.

Note: this is not an all-inclusive list of banned activities. For further information, please review Vermont state link provided in this policy, or contact the Disclosure Law and Transparency Operations Team.

The prohibition applies to all healthcare providers whose primary office is in the state of Vermont, regardless of where the activity occurs.

Allowable Expenditures

Certain expenditures are allowed: (items with asterisks must be reported to the extent they are not preempted by the federal Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h)

1. ** Payment to a sponsor of a “significant” educational, medical, scientific or policy-making conference or seminars as long as the content of the program does not promote specific products and is objective and free from industry control. Payment may not be made directly to a healthcare provider. The payment must be used for a bona fide educational purpose. Effective July 1, 2010, such payment may be used by the sponsor at its discretion to provide meals and other food for all conference participants.
2. ** Certain honoraria and expenses for a healthcare professional who serves on the faculty of a bona fide significant educational, medical, scientific, or policy making conference or seminar provided that there is a specific contract in place that does not include marketing and where the content of the presentation is determined by the healthcare professional.
3. ** Certain expenses associated with a bona fide clinical trial, as further detailed in the Vermont law and applicable guidance.
4. ** Certain expenses associated with research projects. Note that payments for clinical trials (including gross compensation for the Vermont location(s) involved; direct salary support per principal investigator and other healthcare professionals per year; and expenses paid on behalf of investigators or other healthcare professionals paid to review the clinical trial) need not be disclosed until the earlier of: (1) the date of FDA approval or clearance of the prescribed product for the use for which the clinical trial is conducted; or (2) four calendar years after the date the payment was made. For a clinical trial for which disclosure is delayed, the manufacturer shall identify the clinical trial, the start date, and the web link to the clinical trial registration on the national clinical trials registry.
5. ** Effective July 1, 2010, grants for fellowship salary support to an academic institution or hospital, provided that each of the following requirements are met: (i) the grants are applied for by an academic institution or hospital; (ii) the institution or hospital selects the recipient fellows; (iii) the manufacturer imposes no further demands or limits on the institution’s, hospital’s, or fellow’s use of the funds; and (iv) fellowships are not named for a manufacturer, and no individual recipient’s fellowship is attributed to a particular manufacturer of prescribed products.
6. Royalties and licensing fees paid to healthcare providers in return for contractual rights to use or purchase patented or otherwise legally recognized discovery for which the healthcare provider holds an ownership right.
7. ** Certain other reasonable fees, payments, subsidies or other economic benefit provided at fair market value.
8. Effective July 1, 2009, the provision of reasonable quantities of medical device demonstration or evaluation units to a health care provider to assess the appropriate use and function of the product and determine whether and when to use or recommend the product in the future.
9. ** Effective July 1, 2012, samples of a prescribed product or reasonable quantities of an OTC drug, nonprescription medical device, an item of nonprescription durable medical equipment, an item of medical food, or infant formula provided to a healthcare provider for free distribution to patients. However, effective January 2, 2013, the provision of lotions, eye drops and like products to health care providers for free distribution to patients is impermissible.
10. ** Effective July 1, 2012, the provision to a free clinic of financial donations or of free prescription drugs and OTC drugs, medical devices, biological products, combination products, medical food, infant formula, or medical equipment or supplies.
11. Effective July 1, 2011, prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufacturer-funded patient assistance program.
12. Rebates and discounts for prescribed products provided in the normal course of business.
13. Effective July 1, 2010, payment of a healthcare professional’s reasonable interview expenses in connection with a bona fide employment opportunity with the manufacturer or for health care services on behalf of an employee of the manufacturer.
14. Effective July 1, 2010, coffee, snacks and refreshments at a conference or seminar booth.
15. Effective July 1, 2011, payment for the reasonable expenses necessary for technical training of individual health care professionals on the use of a medical device if the commitments to provide such expenses are described in a written agreement between the health care provider and the manufacturer.
16. Effective July 1, 2011, loans of medical devices for short-term trial periods, not to exceed 120 days, to permit evaluation of a medical device by a health care provider or patient, provided the loan results in purchase, lease, or other comparable arrangement.
17. ** The provision or receipt of peer-reviewed academic, scientific, or clinical articles that serve a genuine educational function provided to a health care provider for the benefit of patients.
18. ** Scholarship or other support for medical students, residents, and fellows to attend a significant educational, scientific, or policy-making conference or seminar of a professional association if the recipient is selected by the association.

In order to ensure Radiology and Interventional complies with the Vermont law, Radiology and Interventional personnel may not provide any business meals or food items, regardless of value, to Vermont healthcare providers. Please consult your Supervisor or the Law and Patents Department if you are unsure whether a certain activity with a healthcare provider located in Vermont is either banned or required to be reported.

DISCLOSURE OF PERMITTED AND ALLOWABLE EXPENDITURES (EXCLUDING SAMPLES OF PRESCRIBED PRODUCTS)

Each manufacturer of prescribed products must annually disclose for the preceding calendar year the value, nature, purpose and recipient information regarding any allowable expenditures or permitted gifts made to healthcare providers, to a member of the Green Mountain Care board, to an academic institution, or to a professional, educational or patient organization representing or serving healthcare providers or consumers. The pharmaceutical, biological or medical device being marketed must also be disclosed. Disclosure of samples of prescribed products is discussed separately below.

The disclosure requires the names and types of the recipient to be disclosed including all prescribers, institutions, hospitals, nursing homes, pharmacists, and health benefit plan administrators. For prescribers, the report must include the Vermont license number of the authorized prescriber. Bayer must report all expenditures for actively-licensed Vermont prescribers, even if the expense was not incurred in Vermont and even if the prescriber’s primary practice is outside of Vermont. It is the responsibility of all Bayer employees to track expenses on Healthcare Professionals in the appropriate tracking systems (FADb, Concur, etc.)

Continuing Medical Education programs must also be disclosed. Disclosure is limited to the value, nature, and purpose of the grant and the name of the grantee. The name of the individual participants in a continuing medical education program funded by Radiology and Interventional need not be disclosed.

As of January 1, 2012, some of Vermont’s disclosure requirements are preempted by federal law. The gift ban and samples reporting will not be affected, but the state is prohibited from requiring manufacturers to disclose those expenditures and permitted gifts which would are reportable to the federal government under the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h. The federal law is narrower than Vermont’s law in several ways, however. For example, only physicians and teaching hospitals are covered recipients under the federal law. Therefore, manufacturers must take care to make all non-preempted disclosures regarding allowable expenditures and permitted gifts.

DISCLOSURE OF SAMPLES AND OTHER ITEMS PROVIDED TO A HEALTH CARE PROVIDER FOR FREE DISTRIBUTION

Beginning April 1, 2012, and annually thereafter, a manufacturer of prescribed products shall disclose all samples provided to health care providers during the preceding calendar year, identifying for each sample the product, recipient, number of units, and dosage. If a manufacturer of prescribed products reports other allowable expenditures or permitted gifts, the manufacturer must also report certain information relating to nonprescription medical devices, nonprescription durable medical equipment, medical food, infant formula, and OTC products, provided to Vermont healthcare providers for free distribution to patients during the preceding calendar year. Information on samples and donations to free clinics of prescribed products and of nonprescription medical devices, nonprescription durable medical equipment, medical food, infant formula, and OTC products shall be presented in aggregate form. Donations of prescribed products to free clinics should be included in the samples disclosures form rather than with disclosures of allowable expenditures and permitted gifts. Any public reporting of such information shall not include information that allows for the identification of individual recipients of such items or connects individual recipients with the monetary value of the items provided.

Under Vermont Law, “sample” means: “a unit of a prescription drug, biological product, or medical device that is not intended to be sold and is intended to promote the sale of the drug, product, or device. The term includes starter packs and coupons or other vouchers that enable an individual to receive a prescribed product free of charge or at a discounted price. The term does not include prescribed products distributed free of charge or at a discounted price pursuant to a manufacturer-sponsored or manufacturer-funded patient assistance program.”

Samples that are reported to the Department of Health and Human Services (HHS) under Section 6004 of the Patient Protection and Affordable Care Act of 2010 (PPACA) do not need to be reported to the Vermont Attorney General if the Attorney General determines that HHS will collect and provide Vermont with recipient-specific distribution of samples. The Vermont Attorney General has reported that because it has not been notified whether HHS will provide recipient-specific information, all manufacturers must report directly to the Vermont Attorney General their distribution of all types of samples to all Vermont health care providers.

Regardless of any future Attorney General determinations, samples of prescribed products that fall outside the reporting requirements of Section 6004 of PPACA, such as samples to health care providers who are not physicians, samples of medical devices and OTC products, and coupons and vouchers that allow a patient to receive product free or at a discounted price, must be reported for distributions occurring on or after January 1, 2011.

Effective April 1, 2012, manufacturers are required to identify the relevant product, recipient, number of units, and dosage of each sample distributed. Unlike other expenditures, the Vermont law does not require manufacturers to report the value of samples.

Radiology and Interventional will continue to monitor the future development of the sample reporting requirements.

All reportable permitted or allowable expenditures, regardless of the dollar amount, must be reported.

All Radiology and Interventional employees are responsible for tracking all allowed expenditures within the internal spend source system, (e.g., Concur, IMPACT, etc.).

Compliance Officer Form

Bayer HealthCare must complete and submit a Compliance Officer Form by January 1 of each year. A form identifying the compliance officer is at the Attorney General’s website at: www.atg.state.vt.us/

The Vermont law permits manufacturers to designate a single person responsible for reporting the activities of the entire company, or designate a single person responsible for reporting each of pharmaceutical products, biological products, or medical devices.

In addition to identifying the person responsible for overall compliance, the Compliance Officer Form allows a company to designate an additional person responsible for collecting and reporting the data. Both will receive updates electronically from the Attorney General’s Office.

CONFIDENTIALITY OF TRADE SECRET INFORMATION

Trade secret protection has been removed from the previous version in the law, and marketing reports made will become public information.

PENALTIES FOR FAILURE TO REPORT

Civil Penalties may be imposed in an amount up to $10,000 per violation. Each unlawful gift, or failure to disclose a reportable expenditure, constitutes a separate violation.

REPORTING DEADLINES

Reporting occurs on a calendar year basis, with reports due to the Attorney General by April 1.

January 1 of each year: Bayer HealthCare must submit the name and address of the person responsible for the company’s compliance with the Vermont law using the Compliance Officer Form for all covered Bayer entities (BHCP, Bayer Dermatology, Radiology and Interventional, Diabetes Care, and Consumer Care). The Attorney General refers to that person as the “compliance officer.”

April of each year: Bayer HealthCare must submit marketing disclosure reports for all covered Bayer entities (Pharmaceuticals, Dermatology, Radiology and Interventional, Diabetes Care, and Consumer Care). Bayer HealthCare will report for the preceding calendar year. The state disclosure will be conducted by the Disclosure Law and Transparency Operations Team.

Beginning April 1, 2012 and every April 1 thereafter: Bayer HealthCare must report samples of prescribed products for the preceding calendar year for all covered Bayer entities (Pharmaceuticals, Dermatology, Radiology and Interventional, Diabetes Care, and Consumer Care).

REGISTRATION FEE

Manufacturers of pharmaceuticals who report expenditures above $0 will be required to pay a $250.00 registration fee on January 1, 2012 for the six-month period from July 1, 2011 through December 31, 2011. Beginning January 1, 2013 and annually thereafter, these manufacturers will pay a $500.00 registration fee.

For further information, please refer to the Laws and the Vermont Office of the Attorney General Guidance, which can be found at http://www.atg.state.vt.us/issues/pharmaceutical-manufacturer-payment-disclosure.php

Radiology and Interventional-SPONSORED MEETINGS PLANNED THROUGH THIRD PARTY VENDORS

The Radiology and Interventional representative responsible for the Radiology and Interventional-sponsored meeting must work with the third party vendor to make sure that the data required by Vermont law is reported to the Radiology and Interventional representative. If data cannot be collected and reported, then the Radiology and Interventional representative is responsible for excluding from the invitee list all reportable healthcare providers from Vermont and any other State with reporting requirements or spending limits. In addition, the Radiology and Interventional representative must ensure that contracts with a third party vendor for meeting planning services clearly state either that: 1) within one month (30 days) from the date of payment or gift, the vendor will provide the required data to the Radiology and Interventional representative; or 2) the vendor will exclude providers from Vermont and any other State with special reporting requirements or payment limits.

Radiology and Interventional POLICIES

Radiology and Interventional policies must be followed. However, in situations where state law is more restrictive (e.g., gift ban, prohibitions) than Radiology and Interventional policies, Radiology and Interventional employees must follow the state law requirements.

DRUG PRICE DISCLOSURE REQUIREMENT

Vermont’s prescription drug law requires pharmaceutical manufacturers to report drug pricing information to the state’s medical assistance program, the Office of Vermont Health Access. Manufacturers must disclose on a quarterly basis (i) the price each wholesaler doing business in Vermont pays the manufacturer for the drug, and (ii) the prices required to be provided to the Medicaid program under federal law, including prices defined in the Medicaid Rebate Statute, 42 U.S.C. § 1396r-8.

Along with the quarterly pricing submission, manufacturers must include a summary of the methodology used in determining AMP and best price. Manufacturers are permitted to submit the methodology information in the same format as it is submitted to the Centers for Medicare and Medicaid Services (CMS) pursuant to the Medicaid Drug Rebate Program requirements.

The manufacturer’s president, CEO, or the president or CEO’s “designated employee” must certify that the prices reported to Vermont are the same as those reported on a quarterly basis to CMS. The law defines “designated employee” as an individual “who reports directly to the [CEO] or president and who has been delegated authority to make the certification.”

Information submitted pursuant to this law is confidential. However, data compiled by the Office of Vermont Health Access in aggregate form will constitute a public record, provided the data does not reveal trade information protected by state or federal law.

The drug price disclosure requirement took effect July 1, 2007. The Office of Vermont Health Access issued guidance in 2008 that requires quarterly disclosure of the prices noted above on a form provided by the Office beginning on November 1, 2008 and every quarter thereafter on January 30, May 1, August 1, and November 1.

MANUFACTURER FEE

Vermont imposes an annual fee on pharmaceutical manufacturers. Specifically, pharmaceutical manufacturers or labelers of prescription drugs that are paid for by the Office of Vermont Health Access Program for beneficiaries of federal and Vermont state healthcare programs must pay an annual fee of 0.5 percent of the Office’s prescription drug spending from the previous year. The fee is payable to the Vermont Agency for Human Services.

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29. STATE LAWS - West Virginia

Manufacturers of prescription drugs dispensed in West Virginia who employ direct or use marketing representatives must report their advertising costs to the Governor’s Office of Health Enhancement and Lifestyle Planning (“GOHELP”). Under the Prescription Drug Advertising Expense Reporting 210-01 which became effective April 30, 2010 manufacturers must report all expenditures for advertising and direct promotion of prescription drugs that are made through radio, television, magazines, newspapers, direct mail or telephone communications to consumers, prescribers, pharmacies, patient support or advocacy groups within West Virginia.

West Virginia regulations specify the exact information that must be annually reported to “GOHELP” and contain reporting forms on which the information must be submitted. Information includes:

• The total number of West Virginia prescribers to whom the manufacturer has provided, directly or indirectly, gifts, grants, or payments of any kind in excess of $100.00 for the purpose of advertising prescription drugs. Annual payments that total more than the amount on the reporting form must be reported in increments of $2,500 until all payments of any kind to prescribers have been reported;
• Direct-to-consumer (DTC) advertising reaching or targeting West Virginia consumers to include the type of advertising used (e.g., radio, magazine, direct mail, etc.) and the total amount expended for advertising; and
• Payments to West Virginia consumers, prescribers, pharmacies and patient support and advocacy groups will be included in the total amount spent on advertising and promotion during the calendar year.

To the extent that pharmaceutical manufacturers do not maintain separate records of expenditures for advertising prescription drugs within West Virginia, manufacturers may calculate the advertising expenditures by dividing the West Virginia population (as determined in accordance with data available from the United States Census Bureau) receiving the DTC advertising by the national or regional population for which the manufacturer maintains records. The quotient obtained by this calculation must then be multiplied by the total amount the manufacturer spent on advertising nationally or in a specific region. Manufacturers are required to attach the calculations to the disclosure form.

The following are exempt from the reporting requirements:

• Free drug samples intended for free distribution to patients;
• Payments for “bona fide” clinical trials;
• Scholarship funds or other support for medical students, residents or fellows to attend a significant educational, scientific or policy-making conference of a specialty medical or other professional association if the recipient of the scholarship or support is selected by such association;
• All marketing items of a value less than $100; and
• Any data that identifies any specific drug, individual, physician, or pharmacy.

DEADLINE FOR SUBMITTING INFORMATION

Annual reports are due on April 1 covering the previous calendar year.

Reports must be submitted in the format specified by “GOHELP.” The form must be signed by a company official and notarized.

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30. Restrictions on Interactions with Certain State and Local Executive and Legislative Officials and State and local Employees (Including HealthCare Professionals)

Most states and many municipalities regulate the activities of persons doing business with state officials or state employees through state lobbying and/or ethics reform statutes. Some states and municipalities require vendors and/or their representatives to register as lobbyists. Some states prohibit the receipt of state or municipal contracts if certain campaign contributions have been made to state or local candidates. Some states prohibit vendors from offering anything of value to certain state executive or legislative officials or state employees, and virtually all states prohibit the offering of anything of value to any official in return for an official act.

The categories of state or local officials or employees which may trigger state lobbying, pay to play, procurement or ethics statutes, or similar laws, include:

• State employees, including employees of state hospitals;
• Clinicians with privileges at state-owned hospitals, even if not employed by the state-owned hospital;
• State hospital formulary committee members;
• State Medicaid P&T Committee members;
• State executive branch members and their immediate family members;
• Members of the state legislature and their immediate family members; and
• Other public officials, potentially including local officials and employees.

The lobbying and ethics laws are often complex and vary from state to state. Therefore, sales consultants must, in advance of detailing, providing educational items or meals to, or otherwise interacting with any of the above categories of individuals, contact the Head of Strategic Partnerships and Government Relations to determine whether the contemplated activity triggers any lobbying, procurement or ethics laws in the state or locality in which the activity will occur. If the activity potentially implicates a state lobbying, procurement or ethics law, the sales consultant must receive written approval from the Head of Strategic Partnerships and Government Relations before proceeding with the activity.

If the contemplated activity involves a Louisiana individual who falls into one of the above-referenced categories, please review the Policy and Procedure 29, “State Laws: LOUISIANA – Restrictions on Interactions with State Executive Branch Officials (Including HealthCare Professionals).”

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31. Promotion and Government Reimbursement

Each customer is solely responsible for the accuracy of any billing and coding used by that customer in obtaining reimbursement from the government or private payors. Radiology and Interventional’s Health Policy and Reimbursement Department is responsible for preparing written communications, brochures, and other materials relating to procedural and product coding, billing and reimbursement for Radiology and Interventional products. Written materials must not direct any customer on how to bill but may collate and report information relating to procedural and product coding, billing and reimbursement obtained from authoritative sources, such as the American Medical Association, the Centers for Medicare & Medicaid Services (CMS), regional and local public contractors (carriers, fiscal intermediaries, and durable medical equipment regional carriers) or private insurance contractors. Such written materials must clearly reference the source for any such information. Any materials provided to customers shall be informational only with a goal of providing information to assist them in understanding and complying with CMS and other insurer’s billing, coding and reimbursement policies and requirements. All materials must be submitted and approved through Radiology and Interventional’s LMR process.

Radiology and Interventional employees, contractors, consultants and agents may only provide insurance coding, coverage or payment information for Radiology and Interventional products that satisfies the following requirements:

• The coding, coverage or payment information has been prepared by the Health Policy and Reimbursement Department and approved through the LMR process and relates to an FDA-approved or cleared use of Radiology and Interventional products.
• Radiology and Interventional provides equal access to the same reimbursement information to all purchasers or potential purchasers of Radiology and Interventional products.
• Radiology and Interventional may not in any way add to, delete, or modify third party information and must include a disclaimer that the information was obtained from a third party, is not advice from Radiology and Interventional, and that Radiology and Interventional cannot guarantee reimbursement from a third party.

Subject to the requirements above, Radiology and Interventional may provide the customer with authoritative information regarding billing codes (e.g., CPT, ICD-9 procedure, ICD-9 diagnosis, APC and HCPCS) to use when submitting claims to third party payers for approved or cleared uses of Radiology and Interventional products. The information prepared by the Health Policy and Reimbursement Department and approved through the LMR process may include information relating to national unadjusted published dollar reimbursement amounts assigned the specific code.

You may not offer unsolicited comments regarding the amount of reimbursement a customer may receive for a Radiology and Interventional product or procedure or competitor’s products or procedures, nor may you provide personal opinions or interpretations of coding, coverage or reimbursement information. If a Radiology and Interventional employee, contractor, consultant or agent receives a request for reimbursement information or assistance from a customer, the employee, contractor, consultant or agent may provide the customer with approved reimbursement materials and/or direct the customer to the Health Policy and Reimbursement Department. Radiology and Interventional shall strictly limit any communications relating to billing, coding and reimbursement to communications that comply with this Policy.

It is Radiology and Interventional’s policy to promote products based solely on their efficacy, safety and cost. You must not encourage customers to prescribe or purchase Radiology and Interventional products based on reimbursement levels or any “spread” - that is, the difference between the price the customer paid for the product and the amount the customer receives in reimbursement from government programs, such as Medicare or Medicaid. The Anti-Kickback Statute prohibits offering remuneration to induce someone to purchase your product, and the government could view attempts to market product based on the “spread” as an improper inducement in violation of the Anti-Kickback Statute.

You may not offer comments regarding the amount a customer might receive in reimbursement from Medicare or Medicaid for Radiology and Interventional products or competitors’ products.

You must also not provide customers with values for Average Wholesaler Price (“AWP”) or other prices on which government reimbursement is based. If a customer requests that information, you must suggest the customer consult the Centersfor Medicare and Medicaid Services’ (“CMS”) website, the state Medicaid office, or other publicly available source (such as First Databank) where the information may be obtained.You should also not set or discuss a non-published Average Wholesaler Price (“AWP”) and/or non-published Wholesale Acquisition Costs (“WAC”) with customers or other prices on which government reimbursement is based for those Radiology and Interventional products in which AWP and WAC apply.

If you have any questions regarding promotion of products that are reimbursed by Medicare or Medicaid, contact the Health Policy and Reimbursement Department.

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32. Appropriate Target Audience for Promotional Activities

Radiology and Interventional does not permit the promotion of unapproved or uncleared (e.g., “off-label”) use of its products. All promotional activities with respect to Radiology and Interventional products must be directed only to healthcare professionals who can actually use, influence the use of, order, or recommend the product for an approved (e.g., on-label) use.

The term “healthcare professionals” is very broad and includes individuals who directly interacts with patients and/or have a role in the diagnosis and treatment of patients or entities which are involved in the provision of healthcare services and/or items to patients and which may purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe Radiology and Interventional products in the U.S. Generally, this definition includes physicians, nurses, nurse practitioners, physician assistants, medical assistants who treat patients, and other allied healthcare professionals, such as pharmacists, technicians, and therapists. However, the definition is not limited to these individuals alone; the term includes any person in a position to recommend or influence the purchase or prescribing of Radiology and Interventional products. In some instances, this may include individuals who do not work directly with patients but who have influence over the recommendation, purchase, or prescribing of Radiology and Interventional` products—such as a purchasing agents at hospitals, physician practice managers, management personnel within group purchasing organizations (GPOs), managed care organizations (MCOs), pharmacy benefit managers (PBMs), health plan administrators, wholesalers, distributors, pharmacies, Pharmacy & Therapeutics Committee members, Formulary Committee members, or other customers who do not see patients. Original Equipment Manufacturers (OEMs) are NOT considered to be Healthcare Professionals.

Audiences for promotional activities should not be selected in such a way as to circumvent the prohibition on off-label promotion of Radiology and Interventional product. For example Radiology and Interventional representatives cannot:

•Make sales calls or present product information at a clinic that specializes in disease states that cannotpossibly overlap with the approved or cleared use of a Radiology and Interventional product.
• Display or hand out literature of a product at a convention dealing primarily with off-label topics.
• Host a meal for healthcare a professional whose practice does not, or cannot, include any on-label uses of a Radiology and Interventional product.

Questions regarding the approved use of Radiology and Interventional products should be directed to the Law and Patents or Clinical Science and Regulatory Department.

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33. Promotional Practices Outside the United States

If Radiology and Interventional products are being promoted for use in the United States, even if that promotional activity takes place outside the United States these Compliance Policies and Procedures, as well as the Bayer HealthCare Code of Conduct, apply. This policy is consistent with the AdvaMed and PhRMA Codes.

Additional Guidance

Sales and marketing personnel may not discuss off-label uses of a Radiology and Interventional product with a U.S. physician, or offer prohibited remuneration simply because you are both attending a conference outside of the United States. Use extra care in setting up courtesy suites or exhibit booths abroad. If the product will be used in the United States, you are bound by United States promotional rules.

Radiology and Interventional personnel cannot arrange for the attendance of U.S. healthcare professionals at medical education programs outside the U.S. to discuss uses unapproved in the U.S., even if those uses are approved in the country where the medical education program takes place.

Policies related to unlawful remuneration or kickbacks apply when you are overseas interacting with U.S. customers or healthcare professionals.

Radiology and Interventional personnel must adhere to applicable international industry guidelines (e.g., Eucomed Code) when interacting with international healthcare professionals, who may prescribe, recommend, purchase or lease Radiology and Interventional products.

The US meal and travel policies must be followed when interacting with a US HCP who is outside the US. Please refer to Policy and Procedure “Business Meals with HealthCare Professionals.”

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34. Materials for External Use

Radiology and Interventional employees, contractors, consultants and agents may only distribute promotional and non-promotional materials that have been approved through the Legal, Medical, and Regulatory Affairs (LMR) review process. The use or distribution of any unapproved promotional or advertising materials is prohibited.

Radiology and Interventional employees, contractors, consultants, agents or individuals acting on Radiology and Interventional’s behalf, may provide information to healthcare professionals on the on-label use of Radiology and Interventional products. Such individuals must neither solicit questions about nor provide information on unapproved uses or indications. Employees also may not make suggestions about, or assist in, specific prescribing decisions.

Advertising and PROMOTION MATERIALS

Advertising and promotional materials include, but are not limited to: brochures, advertisements, visual aids, file cards, journal article reprints, journal supplements, article abstracts, pilot study reports, letters to physicians, audiovisual materials, slide or computer presentations, displays, posters, monographs, press materials, consumer materials, computer programs and Internet or Internet-based programs and websites.

SELF-CREATED MATERIALS (“HOMEMADE BREAD”)

Creating your own promotional materials, sometimes known as “homemade bread” – IS STRICTLY PROHIBITED. Self-created materials not only include detailing pieces but also include publically available materials (websites, journals, press releases) and documents containing cost comparisons, reimbursement information or other materials that have not been approved through the LMR process.

Adding to, altering or modifying approved promotional or non-promotional materials by highlighting, deleting, editing, adding notes, changing the order of materials or making any other changes, makes those materials unacceptable for use.

Any changes to approved materials or changes in the contextual use of materials must be resubmitted for approval by the LMR review process.

Non-Promotional Education Materials

Educational or business materials that are used for advisory boards, investigator meetings, speaker training, etc., may not be distributed to healthcare professionals who do not attend the meeting. All such materials must be approved through LMR prior to distribution or use at these meetings.

Comparative Claims

You may not make comparative or superiority claims without substantial supporting clinical evidence as provided in approved materials. Even comparative claims based on competitor package inserts must be supported and approved through the LMR review process.

Medical Materials Containing Off-Label Text

Medical textbooks, booklets, article reprints and pocket guides or other printed or electronic text may contain off-label text. You must obtain these items only through the Marketing Communications Department as discussed in the Policy and Procedure entitled “Educational Items (Prohibition on Gifts for Healthcare Professionals).”

Under certain limited circumstances, the Law and Patents Department may approve the distribution of specific medical journal reprints to physicians for non-promotional purposes only. In these limited cases, Law and Patents reviews and approves the distribution process as well as thereprint to be distributed. Sales representatives involved will be provided writteninstructions for distribution, and the related sales training bulletins will be marked with the followingheader: “The attached reprint MAY be left with physicians.” Removal, obliteration, or any attempt to hide or defeat any restrictive legend or instruction is prohibited.

Soliciting Discussion: Articles approved through the LMR process may contain both on and off-label materials. Such articles may not be distributed to a health care professional with the intent to promote the off-label content, or to solicit or encourage a discussion about off-label content.

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35. Materials For Internal Use Only

Radiology and Interventional permits the distribution among its employees, contractors, consultants and agents of certain educational materials that are intended for employee, contractor, consultant and agent education or general business information (e.g., to promote, discuss or reference Radiology and Interventional products), unless specifically approved for such use through the LMR process.

Communications and materials to Sales Force

Educational or business materials that are to be used for internal purposes only must be clearly marked with language such as “For internal use only, confidential and proprietary information, not to be distributed externally”. It is the obligation of every Radiology and Interventional employee, contractor, consultant or agent providing services to or on behalf of Radiology and Interventional distributing such material to ensure that any distributed material is clearly marked in this manner, including material forwarded by electronic mail. Materials for internal use only may not be distributed to or discussed with customers.

Sharing of Information Gathered from Publicly available sources for Educational Purposes (In ACCORDANCE with copyright restrictions)

Information gathered from the public domain may be shared among Radiology and Interventional employees, contractors, consultants and agents (e.g., from representative to representative, representative to manager, or manager to representative). Examples of industry related information gathered from the public domain includes:

• Competitive intelligence (e.g.,revised package inserts for competitive products, press releases regarding new data or studies on competitive products);
• Industry or product related news or information from the lay press (newspapers, magazines, on-line news services, Gray Sheet, industry publications, medical journals, medical text books);
• Consumer advertisements; and
• Recall notes.

If a Radiology and Interventional representative or manager shares information gathered from the public domain with other Radiology and Interventional employees, contractors, consultants and agents, he/she cannot interpret or analyze the information in any way. The party forwarding the information must include a disclaimer such as: “For Internal Use Only, Do Not Duplicate, Not for Use with Customers.”

Information gathered from the public domain must be forwarded to the Marketing Communications Department who will work with the Law and Patents and Clinical Science and Regulatory Departments to formulate appropriate educational materials for the field as needed.

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36. Inquiries About Off-Label Uses of Radiology and Interventional Products

Radiology and Interventional does not permit the promotion of unapproved (“off-label”) uses of its products. Any unsolicited question regarding an unapproved use of a Radiology and Interventional product must be directed to the appropriate scientific personnel who may respond to such inquiry. Questions regarding unapproved uses may not be solicited by any Bayer employee.

PROCEDURES

If a Radiology and Interventional employee, contractor, consultant or agent receives an unsolicited request for information from anyone outside of Radiology and Interventional (including a healthcare professional, a hospital employee, or an individual from a buying group or patient group) regarding an unapproved (“off-label”) use of a Radiology and Interventional product, you must not answer the question and instead direct that person to:

For Interventional products:

• Clinical Science and Regulatory Department (Attn: Gary Jarvis; Phone: 763-780-4555;
E-mail: Gary.Jarvis@possis.com)

For Radiology device products:

• Fortunato (Tito) Aldape, Regulatory (Phone: 412-767-2400 (x4013);
E-mail: FALDAPE@MEDRAD.COM) or non-marketing/non-sales personnel or contractor to whom the Chief Compliance Officer has delegated such scientific responsibility.

For prescription drug products:

• Refer the inquiry to Medical Communications by providing to the requestor the telephone or telefax number of Medical Communications: 1-888-84BAYER (1-888-842-2937); or
• Complete a Professional Inquiry Request (PIR) form, include the name, address and signature of the requesting healthcare professional, a description of the information being requested and the method by which the healthcare professional wishes to receive the information, then transmit the PIR form to Medical Communications for processing of the request.

The Clinical Science and Regulatory Affairs and Medical Affairs Departments will then provide appropriate information directly to the requestor. No discussions can take place in a public forum pertaining to unapproved uses of Radiology and Interventional products. If a discussion of, or question about, an off-label use of a Radiology and Interventional product is initiated by anyone outside of Radiology and Interventional, employees, contractors, consultants and agents must advise the inquirer that Radiology and Interventional has a separate office that can respond to unsolicited off-label inquires, to which they can be directed, but that Radiology and Interventional policy prohibits the representative from discussing off-label uses. Radiology and Interventional representatives will neither answer these questions, nor solicit this type of inquiry.

ADDITIONAL GUIDANCE

Budgets or Quotas: Budgets or quotas must not to be designed or construed to encourage off-label promotion. Budgets and quotas can properly account for all physician use of a product, including off-label use. However, you cannot generate, or try to generate, sales by off-label promotion.

Requests for Non-Approved Materials: Requests from healthcare professionals or others for materials discussing off-label uses or materials that are not approved for promotion must be directed to the Radiology and Interventional departments or personnel identified above. Please consult the Policy and Procedure entitled “Material for Internal Use Only” for information regarding materials discussing off-label uses.

Medical Science Liaisons (MSLs): MSLs may respond to unsolicited requests from healthcare professionals to discuss unapproved uses of Radiology and Interventional prescription drug products to the extent permitted by the Medical Affairs Guidelines. MSLs, however, may not promote Radiology and Interventional prescription drug products for unapproved uses, nor may MSLs serve as surrogates for sales consultant efforts to elicit “unsolicited” inquiries from healthcare professionals.

Requests for Non-Approved Materials: Requests from healthcare professionals or other Radiology and Interventional customers for product samples for off-label uses, non-promotional materials, materials discussing off-label uses, or materials that are not approved for promotion must be directed to Medical Communications or a Medical Science Liaison. You may not solicit this type of request or inquiry nor provide such information.

INQUIRIES ABOUT EQUIPMENT SETUP

Radiology and Interventional representatives may receive inquiries from healthcare professionals regarding the set up and use of Radiology and Interventional device equipment. Radiology and Interventional personnel may provide instructions on how to set up and use Radiology and Interventional device equipment consistent with the equipment’s labeled instructions for use.

Questions relating to technique or other questions that are not covered in the labeled instructions for use cannot be answered by the representative and must be referred to the Radiology and Interventional personnel identified below:

For Interventional products in emergency situations:

• Clinical Science and Regulatory Department (Attn: Gary Jarvis; Phone: 763-780-4555;
E-mail: Gary.Jarvis@possis.com)

For all Radiology device products:

• Fortunato (Tito) Aldape, Regulatory (Phone: 412-767-2400 (x4013);
E-mail: FALDAPE@MEDRAD.COM) or non-marketing/non-sales personnel or contractor to whom the Chief Compliance Officer has delegated such scientific responsibility.

The Clinical Science and Regulatory Affairs and Medical Affairs Department will then provide appropriate information directly to the requestor. Radiology and Interventional sales representatives must not provide instruction on, or answer any questions concerning, off-label uses of Radiology and Interventional device equipment.

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37. Adverse Events Involving Radiology and Interventional Products

REPORTING REQUIREMENTS

Radiology and Interventional is required to report to FDA adverse drug or device experience information associated with the use of a drug or device manufactured and/or marketed by Radiology and Interventional. If you become aware of adverse drug or device experience information involving a Radiology and Interventional product, you must report this information as promptly as possible, but no later than twenty-four (24) hours after becoming aware of the information.

For prescription drug products, information must be provided to the Medical Communications Department at 1-888-842-2937. For the complete details on what and how to report adverse events, please refer to the website: http://us-wcms01.us.bayer.cnb/apps/BSP/US/BSP-NJ/BSP-NJ.nsf/id/8590DF56D3DA842F
852573D8005A065F?OpenDocument.

This information can also be emailed to the drug safety reporting email box: DrugSafety.GPV.US@bayer.com.

Reports involving interventional products manufactured at the Minnesota facility should be directed to the Minnesota Customer Support Team at 1-801-801-7677, or via e-mail at cm.hanson@possis.com.

Reports involving all other device products should be directed to the Complaint Handling Department at 1-800-633-7231 ext. 4065, or via e-mail at Customercomplaints@medrad.com.

WHAT TO REPORT

You must report:

• Deaths and serious injuries when you become aware of information that one of Radiology and Interventional’s products may have caused or contributed to the event.
• Information that a malfunction of Radiology and Interventional’s product may have caused or contributed to a death or serious injury or, if a malfunction were to recur in the same or similar product, it could cause or contribute to a death or serious injury.
• Information about an adverse drug experience, which is any adverse event associated with the use of a Radiology and Interventional drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.
• Adverse drug experience information associated with the use of a drug manufactured and/or marketed by Radiology and Interventional, whether or not you consider the event to be related to the drug.

NOTE: The following information is necessary when reporting an adverse event:

• Identifiable reporter (name and contact information).
• Identifiable patient (name, DOB, gender)
• Bayer HealthCare Pharmaceuticals suspect drug
• Description of adverse event

Please provide as much detail as possible about the event so that the Pharmacovigilance Department can process the case as accurately as possible.

Note: You must report adverse event information regardless of whether you believe that the facility will report it.

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38. Clinical Research and Clinical Study Support

Note: Transactions under this Policy are reportable to the federal government under the Patient Protection and Affordable Care Act when implemented. It is each employee contractor, consultant and agent’s responsibility to report accurate, complete and timely data.

Radiology and Interventional may provide funding for clinical research and clinical studies that promote legitimate research goals. Radiology and Interventional may enter into an agreement for clinical research or clinical studies for the purpose of developing clinical information about unapproved Radiology and Interventional products or new uses of cleared or approved Radiology and Interventional products, or for other commercially reasonable business purposes.

Support for clinical research and clinical studies may not be provided with the requirement or expectation that such support will induce or encourage a healthcare professional to prescribe, purchase, lease, recommend, or arrange for the prescription, purchase, lease, or recommendation of Radiology and Interventional’s products. It is also not appropriate for Radiology and Interventional to pay a clinical investigator compensation that is based on or related to, the past, present or potential future volume or value of business generated, directly or indirectly, for Radiology and Interventional by that clinical investigator. Radiology and Interventional also may not seek to further the pre-approval or off-label use of a Radiology and Interventional product under the guise of a clinical study that is not based upon proper scientific objectives and protocol.

Any research or clinical study support from Radiology and Interventional must be made pursuant to a written agreement approved by the Law and Patents Department that, at minimum, includes the following:

• A statement of the research or clinical objectives;
• An outline of the research or clinical protocol;
• A written budget detailing the payments to be provided by Radiology and Interventional; and
• A requirement for progress reports and/or a final report, as applicable.

Agreements to fund research may constitute Focus Arrangements under the CIA. An agreement for clinical research or clinical studies is considered a Focus Arrangement if the intended recipient of the funds – such as a hospital or research site – is an actual or potential source of sales or referrals of Radiology and Interventional products.

ADDITIONAL GUIDANCE

Recipients of Radiology and Interventional’s financial support for clinical research and clinical studies must be made aware that Radiology and Interventional reserves the right to audit the use of its funding, and will expect documentation (e.g., progress reports) to show that its financial support has been used properly.

“Investigators Meetings,” where researchers doing clinical research studies meet to discuss the status of their research, are not promotional in nature and must not be used for such purposes. Sales and marketing representatives may not attend these meetings.

Under no circumstances may sales or marketing personnel engage in discussions or negotiations with, or make unsolicited requests of, an investigator, including a research organization or institution, involved in clinical research studies supported by Radiology and Interventional, or in any way seek to influence the study protocol. In addition, Sales and Marketing personnel are not to be included in any communication regarding the status of a request by an investigator or an institution for any type of clinical studies support, including funding or the supply of product, other than those communications required to allow the Contract Champion to perform his or her contract administration duties under the Radiology and Interventional Contract Management Procedure (MCMP). If Sales or Marketing personnel are approached by an investigator or institution requesting support for proposed clinical research or study, they are to direct the investigator or institution to someone in Clinical Affairs or Medical Affairs or the Law and Patents Department.

Law and Patents Review of Focus Arrangements

For all clinical research agreements that are Focus Arrangements, the Law and Patents Department must verify that the agreement contains:

• A certification by the parties that the parties shall not violate the anti-kickback statute with respect to the performance or activities related to the study; and
• A requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance program, including applicable training related to the Anti-Kickback Statute.

The Law and Patents Department evaluates whether the proposed arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document on the Focus Arrangements Datasheet that this review and assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department confirms that the proposed amount of study fees represents fair market value. The methodology used to determine fair market value may be based on information in a database of fair market values, or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

The Radiology and Interventional Contract Champion must send each party to the Focus Arrangement (e.g., the recipient of the funds), a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures. These documents may be sent electronically or by hard copy, and can be included as an exhibit to the agreement or sent as separate documents. The Contract Champion must document on the Focus Arrangements Datasheet that these documents were sent.

Law and Patents Review of Non-Focus Arrangements

If the approved request for clinical research agreement is not a Focus Arrangement as determined by the Law and Patents Department, the Contract Champion will send the approved agreement to the funds recipient (or institution-designated staff member). The Contract Champion is responsible for complying with all requirements of the MCMP, including sending a signed agreement back to the Law and Patents Department.

Focus Arrangements Datasheet for Device Contracts– Excel® Spreadsheet

Proof of Service

The Contract Champion, or other Radiology and Interventional employee, must be able to confirm that the study was performed. Documents confirming proof of service, such as study results or publications, must be retained by the Contract Champion’s department.

Third Party Contracts

Radiology and Interventional may work with third parties who contract with hospitals, research sites, or other entities on behalf of Radiology and Interventional. In order to ensure that third party contracts comply with the Anti-Kickback Statute and Radiology and Interventional’s Compliance Policies and Procedures, the Law and Patents Department will provide a template contract to use for the contracting entities. The reviewing attorney must assess whether the proposed arrangement complies with the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). This assessment, the date it was conducted, and his/her name it must be documented.

The third party contract must include a maximum value for the research or clinical studies support based on information from a database of fair market values or other relevant sources.

The contract provided to the third party must contain:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the grant; and
• The requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance program, including applicable training related to the Anti-Kickback Statute.

The third party must send to each party to the Focus Arrangement, in addition to a copy of the approved contract, a copy of (1) Bayer HealthCare’s Code of Conduct and (2) applicable Anti-Kickback Statute Policies and Procedures and document that these were sent.

When the executed contract is returned from each party to the Law and Patents, the Focus Arrangement Contract Upload Template must be completed. Refer to Policy and Procedure 8, “Focus Arrangements,” for information regarding the Focus Arrangement Database Procedures.

RECORD RETENTION

The Contract Champion’s department must retainproof of payment and proof of the services provided, such as a report on the clinical trials, for a period of seven (7) years.

AUDIT

All clinical research and clinical study agreements are subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit/review clinical research and clinical study payments.

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39. material Transfer Agreements

Radiology and Interventional may respond to requests submitted by independent investigators for access to Radiology and Interventional device products (equipment or disposables) to be used in connection with clinical research and/or trials that foster increased understanding of scientific, clinical, or healthcare issues that contribute to the improvement of patient care. Radiology and Interventional shall only provide Radiology and Interventional device products to investigators under the terms of a written Material Transfer Agreement in connection with clinical research and/or trials. Radiology and Interventional equipment, such as injectors, may be provided without transferring title only for a period of time that is reasonable to permit use of the equipment for the purposes of the study. Such equipment must be returned to Radiology and Interventional upon completion of the clinical research and/or trial. Radiology and Interventional’s policy conforms to the AdvaMed Code of Ethics.

For information regarding clinical research and/or trials, please consult the Policy and Procedure entitled “Investigator-Initiated Research and Clinical Trial Support.”

Requirements of Material Transfer Agreements

Radiology and Interventional may only provide Radiology and Interventional device products pursuant to a Material Transfer Agreement in response to unsolicited requests for Radiology and Interventional device products submitted by independent investigators that describe the research proposal and the rationale for use of the Radiology and Interventional device products. Requests must be submitted by the investigator via a website, e-mail, or other communication directly to Radiology and Interventional. Sales consultants must neither solicit nor obtain and forward requests for Radiology and Interventional device products which are or will be governed by a Material Transfer Agreement.

The decision to provide Radiology and Interventional device products under a Material Transfer Agreement must be based solely on the credentials of the researcher and the merits of the independent research proposal. Radiology and Interventional may not provide device products to induce or reward an investigator for using or purchasing Radiology and Interventional device products. Elements of a bona fide study or clinical trial include:

• Stated research goals are scientifically sound and can be achieved by the clinical protocol;
• Investigator and staff are qualified; and
• Investigator intends to either publish the study results in a journal or use the results for legitimate research purposes.

The terms of the Material Transfer Agreement must be written and signed by the healthcare professional or facility before Radiology and Interventional device equipment is provided. The terms of the agreement must include:

• Notice to the healthcare professional and/or facility that it must not seek reimbursement or charge Medicare, Medicaid, any other health program, any insurer or patient for the equipment and/or supplies provided at no charge by Radiology and Interventional;
• Notice that the person or facility using the evaluation equipment may have an obligation to notify government or private payors that the evaluation equipment was provided free of charge;
• Term of the agreement, which must be limited to a reasonable time period in which to conduct the study;
• Limitation on the use of the Radiology and Interventional device products for purposes related to the study; and
• Provision for the removal of the Radiology and Interventional equipment at the conclusion of the trial unless the healthcare professional has agreed to purchase/lease the equipment.

Involvement of Radiology and Interventional Personnel

Protocols for Radiology and Interventional-supported clinical studies and trials must be written by the investigator. Radiology and Interventional employees, contractors, consultants and agents may not write or assist with writing a protocol for an independent investigator.

Sales and Marketing personnel may not be involved in communications regarding the status of the request for Radiology and Interventional device product under a Material Transfer Agreement, other than those communications required to allow the Contract Champion to perform his or her contract administration duties under the Radiology and Interventional MCMP. Sales and Marketing personnel may also not be involved in:

• Selecting or recommending recipients;
• Discussing Radiology and Interventional’s provision of Radiology and Interventional device product with a customer or assuring a customer about participation in a prospective study;
• Discussing ideas for potential research protocols with customers; or
• Assisting in drafting a research protocol.

If Sales or Marketing personnel are approached by a customer or potential investigator regarding the provision of Radiology and Interventional device product in relation to a clinical study, they must direct the customer to someone in Clinical Affairs or Medical Affairs or the Compliance or Law and Patents Department.

Disclosure of Radiology and Interventional Support

All publications which relate to or result from research supported in whole or in part by Radiology and Interventional device products provided by Radiology and Interventional pursuant to a Material Transfer Agreement or other financial support from Radiology and Interventional must accurately disclose Radiology and Interventional’s provision of products.

PROCEDURES

Material Transfer Agreements are not considered Focus Arrangements and therefore Focus Arrangement Procedures do not need to be followed.

Law and Patents Review

The Law and Patents Department reviews the agreement to determine whether it is consistent with the AdvaMed Code and this Policy. If appropriate, the Legal Department approves the agreement.

RECORD RETENTION

The Contract Champion’s department will retain proof of service documents for a period of seven (7) years.

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40. Investigator Sponsored Studies and Research grants

Transactions under this Policy constitute Focus Arrangements as defined by the CIA. Prior to initiating a transaction covered under this policy you must familiarize yourself with the Policy and Procedure entitled “Focus Arrangements.”

This policy describes the appropriate use of grants to fund independent investigator sponsored studies and research grants that foster increased understanding of scientific, clinical, or healthcare issues that contribute to the improvement of patient care. Radiology and Interventional’s policy conforms to the AdvaMed and PhRMA Codes and other relevant industry guidance. Investigator sponsored studies and research grants are generally conducted on cleared or approved Radiology and Interventional products and are proposed by a single investigator. For information regarding clinical trials on unapproved products, please consult the Policy and Procedure titled “Clinical Research and Clinical Study Support.”

Requirements of Investigator Sponsored Studies and Research Grants

All grants for investigator sponsored studies or research grants provided by Radiology and Interventional must promote legitimate research goals. The decision to fund grants must be based solely on the credentials of the proposed investigator/investigation site and the merits of the research proposals. Radiology and Interventional may not provide an investigator sponsored study grant to induce or reward an investigator for using or purchasing a Radiology and Interventional product or to familiarize an investigator with a Radiology and Interventional product. Elements of a bona fide study include:

• Stated research goals are scientifically sound and can be achieved by the clinical protocol;
• Investigator and staff are qualified; and
• Investigator intends to either publish the study results or use the results for legitimate medical research purposes.

Investigator sponsored study grants must not be provided directly to the individual investigator or to a private physician practice. Grants must be made only to an entity, such as a hospital or research facility. All research grants to the military must be provided through the Henry M. Jackson Foundation for the Advancement of Military Medicine (Jackson Foundation) or similar third-party organizations set up to receive grants on behalf of the Department of Defense.

Involvement of Radiology and Interventional Personnel

Protocols for Radiology and Interventional-supported clinical studies and trials must be written primarily by the investigator. Radiology and Interventional employees, contractors, consultants and agents may not write a protocol for an independent investigator. However, upon request by the investigator, Radiology and Interventional clinical or medical personnel may provide comments, advice and/or assistance with protocols (e.g., Medical Affairs personnel may provide a protocol summary outline). The appropriate review committee, in consultation with the Law and Patents Department, Clinical Affairs and/or Medical Affairs, is responsible for the review and approval of all investigator sponsored studies and research grants within Radiology and Interventional.

Sales and marketing personnel may not be included in any communication regarding the status of a grant request, other than those communications required to allow the Contract Champion to perform his or her contract administration duties under the Radiology and Interventional Contract Management Procedure (MCMP). Sales and marketing personnel also must not:

• Select or recommend recipients;
• Discuss Radiology and Interventional’s provision of investigator sponsored studies with a customer or assure a customer about participation in a prospective study;
• Discuss ideas for potential research protocols with customers; or
• Assist in drafting a research protocol.

If Sales or Marketing personnel for device products are approached by a customer or potential customer regarding a grant, they must direct the customer to someone in Clinical Affairs or Medical Affairs or the Law and Patents Department at the following email address:
RIInvestigator-Sponsored-Studies@bayer.com.

If Sales and Marketing personnel for drug products are approached by a customer or potential investigator regarding a grant, they must direct the customer to the website: https://supportrequest.bayerhealthcare.com and/or the customer service telephone number
(1-888-84-Bayer or 1-888-842-2937).

Disclosure of Radiology and Interventional Support

All publications that relate to or result from research supported in whole or in part by a grant or other financial support from Radiology and Interventional must accurately disclose Radiology and Interventional’s financial and/or editorial support.

UNACCEPTABLE Investigator Sponsored GRANTS

A grant is not permitted if it is any one of the following:

• Intended as a price term, or offered in lieu of a price concession; or
• Intended to encourage unapproved uses of Radiology and Interventional products or use of uncleared Radiology and Interventional products (it is acceptable for unapproved or uncleared uses to be researched as a part of an Investigator Sponsored Grant) ; or
• Contingent on the purchase of Radiology and Interventional products; or
• Intended to encourage the investigator to order, prescribe, or recommend Radiology and Interventional products or reward or compensate the recipient for having done so; or
• Primarily provide to fund salaries of nurses, residents, or other healthcare professionals, or routine administrative costs; or
• Provided to pay for activities that should be covered by fee-for-service contracts as described in the Policy and Procedure entitled “Fee-For Service Arrangements.”

Grants for which Radiology and Interventional retains an institution for clinical trials or medical research are not considered “investigator sponsored” for purposes of this policy and instead must comply with the Policy and Procedure entitled “Clinical Research and Clinical Study Support.”

PROCEDURES for Device Related Requests:

All requests for grant funds for investigator-initiated studies and clinical trials must be submitted to the Law and Patents Department. The initial request must:

• Describe the purpose/intended use of the grant or reference other documents attached, such as a study protocol, or memo that describes the purpose/intended use of the grant. It is not acceptable to list only a generic description (e.g., “investigator sponsored study”) as the purpose of the expense;
• Include a budget; and
• Confirm that the grant will be used to support an investigator sponsored study.

Grant Requestor/ Investigator

The investigator (or designated staff member) is responsible for submitting a grant request and providing any requested grant-related documentation.

Initial Committee and Clinical Affairs or Medical Affairs Review of Request

The appropriate committee and Clinical Affairs or Medical Affairs Department initially reviews the grant request. If the grant request is deemed to be complete, within budget and strategic plan, the appropriate Committee and Clinical Affairs or Medical Affairs Department may approve the request.

If the appropriate Committee and Clinical Affairs or Medical Affairs Department, after attempting to obtain appropriate documentation, finds the request incomplete, they will inform the requestor that the request is being denied due to insufficient documentation.

The appropriate Committee and Clinical Affairs or Medical Affairs Department review the request consistent with the following:

• There are no legal or compliance issues that would prohibit Radiology and Interventional’s approval of the grant request (e.g., no conflict with government or industry guidelines or Compliance Policies and Procedures).
• The request proposes to support medical research that fosters increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care.
• The request for support is within the budget for the impacted business.
• The request for support is aligned with Radiology and Interventional’s mission.
• The funds will be used solely for legitimate expenses related to research that fosters increased understanding of scientific, clinical or healthcare issues that contribute to improvement of patient care.

Law and Patents Review

The Agreement must be submitted to the Law and Patents Department. The Law and Patents Department must verify that the agreement contains:

• A certification by the parties to the arrangement that the parties shall not violate the Anti-Kickback Statute with respect to the performance of the Focus Arrangement; and
• A requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute.

The Law and Patents Department evaluates whether the proposed Focus Arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). The reviewing attorney must document on the Focus Arrangements Datasheet that this assessment was conducted, his/her name, and the date it was conducted.

The Law and Patents Department confirms that the proposed amount of grant funds represents fair market value. The methodology used to determine fair market value may be based on information in a database of fair market values or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Bayer HealthCare Compliance Officer or designated individual and documented and maintained in the Law and Patents Department.

The Contract Champion or other Radiology and Interventional employee must send the grant recipient, along with the approved agreement, a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures. These documents may be sent electronically or by hard copy, and can be included as an exhibit to the agreement or sent as separate documents. Radiology and Interventional must document on the Focus Arrangements Datasheet that these documents were sent.

Focus Arrangements Datasheet – Excel® Spreadsheet

Proof of Service

The Contract Champion must confirm that the services and/or deliverables of the agreement were performed and/or delivered. Acceptable proof of performance includes clinical data, a report of clinical trial results, or a publication containing such results. The agreement must permit Radiology and Interventional to obtain proof of service.

PROCEDURES FOR DRUG RELATED REQUESTS:

All requests for grant funds for investigator sponsored studies must be submitted to the Bayer website: http://stream.bayerhealthcare.com/. The initial request must:

• Describe the purpose/intended use of the grant or reference other documents attached, such as a study protocol, or memo that describes the purpose/intended use of the grant. It is not acceptable to list only a generic description (e.g., “investigator sponsored study”) as the purpose of the expense;
• Include a budget; and
• Confirm that the grant will be used to support an investigator sponsored study.

Grant Requestor

The investigator (or designated staff member) must electronically input all required grant information. The investigator is responsible for providing any requested grant-related documentation.

Grant Manager Review

A Grant Manager initially reviews the grant request. If the grant request is deemed to be complete, within budget and strategic plan, it will be placed on the agenda for review by the ISS Grant Review Committee at the next scheduled meeting.

If the Grant Manager, after attempting to obtain appropriate documentation, finds the request incomplete, he/she will inform the requestor that the request is being denied due to insufficient documentation.

Grant Review Committee

The Grant Review Committee reviews grant requests from a scientific, educational, regulatory and legal perspective consistent with the following:

• Each Committee member certifies that, to the best of his/her knowledge, there are no legal or compliance issues that would prohibit Bayer’s approval of the grant request (e.g., no conflict with government or industry guidelines or Compliance Policies and Procedures).
• The grant will support medical research or other activities that foster increased understanding of scientific, clinical or healthcare issues that contribute to the improvement of patient care.
• The request is within the budget for each therapeutic area.
• The budget is consistent with fair market value.
• The request is aligned with Bayer’s strategy and therapeutic focus.

Law and Patents Review

The Law and Patents attorney participating on the Grant Review Committee must verify that the agreement contains:

• A certification by the parties to the arrangement that the parties shall not violate the Anti-Kickback Statute with respect to the performance of the Focus Arrangement; and
• The requirement that all individuals who meet the definition of Covered Persons shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute; and

The attorney also evaluates whether the proposed arrangement satisfies the requirements of the Anti-Kickback Statute and assesses compliance with relevant Safe Harbor(s). This review/assessment, the date it was conducted, and who conducted it, must be documented.

The Law and Patents Department confirms that the proposed amount of grant funds represents fair market value. The methodology used to determine fair market value will be based on information in a database of fair market values or other relevant sources available to Bayer. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

Grant Manager Post-Meeting Documentation

If approved, a letter documenting the Grant Review Committee’s decision will be provided to the requestor (or institution-designated staff member) by the Grant Manager following the meeting. If denied, a medical science liaison may notify the requestor directly and document the interaction in the appropriate database. The Grant Manager is responsible for updating the electronic system with the decision.

The Grant Manager or other Bayer employee must send the grant recipient, along with the approved agreement, a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures attached. These documents may be sent electronically or by hard copy, and can be included as an exhibit to the agreement or sent as separate documents.

Focus Arrangements Database Procedures

When the executed agreement is returned from the investigator, the Grant Manager, or other Bayer employee, completes the required Focus Arrangement fields in the ISS database. Refer to Policy 8 “Focus Arrangements” for information regarding the Focus Arrangements Database Procedures.

Proof of Service

The Grant Manager, or other Bayer employee, must confirm that the services and/or deliverables of the grant were performed and/or delivered. Acceptable proof of performance includes clinical data, a report of clinical trial results, or a publication containing such results. The agreement must permit Bayer to obtain proof of service.

RECORD RETENTION

The Contract Champion’s department will retain the proof of service documents for a period of 7 years.

AUDIT

All investigator-initiated studies and clinical trials are subject to audit by Corporate Audit and HealthCare Compliance to ensure compliance with this Policy. The government (e.g., OIG, IRS) may also request to audit/review clinical research and clinical study payments.

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41. Price Reporting

It is Radiology and Interventional’s policy to report, completely and accurately, cost, price and sales information about Radiology and Interventional drug products to the extent requested by any federal and/or state government entity relating to a government healthcare program and, as appropriate, to any private price reporting entity Radiology and Interventional maintains detailed desktop standard operating procedures (“SOP”) in the Contracting Department for calculating:

• Medicaid Best Price (“BP”)
• Medicaid Average Manufacturer Price (“AMP”)
• Medicare Average Sales Price (“ASP”)
• Non-Federal Average Manufacturer Price (“Non-FAMP”)
• Federal Ceiling Price
• Public Health Service (“PHS”) Price

These desktop procedures are updated periodically to reflect changes in the statutes, regulations or guidance issued by the Centers for Medicare and Medicaid Services (“CMS”), the Department of Veterans Affairs or other relevant agencies. For further information on these SOPs, contact the Law and Patents or Contracting Department.

Definitions

Government Healthcare Program – Any plan or program that provides health benefits and is funded, in whole or in part, by the federal government or the states. Examples include: Centers for Medicare and Medicaid Services (CMS), Department of Veterans Affairs, US Department of Health and Human Services Pharmacy Affairs Branch, TRICARE, Department of Defense, Public Health Service, and the U.S. Department of Labor programs.

Price Reporting Entity – A private publisher, such as Redbook or First Databank that collects pricing information and makes such information available to healthcare professionals and customers.

General Limits

All information that Radiology and Interventional must report or generate, directly or indirectly, about costs, prices and sales for Radiology and Interventional drug products for submission to or for use by a Government Healthcare Program or a Price Reporting Entity must be accurate, must be complete and not intentionally misleading.

REPORTING PRICE INFORMATION

All Radiology and Interventional reports of price information provided directly or indirectly to Government Healthcare Programs or a Price Reporting Entity must accurately take into account all pricing information, including, to the extent they exist: (1) price reductions; (2) discounts; (3) free goods contingent upon a purchase agreement; (4) rebates; (5) up-front payments; and (6) other price concessions or similar benefits offered to some or all purchasers.

PROCEDURES

Submission Process

Any Radiology and Interventional employee, contractor, consultant or agent who receives a survey or request for pricing information from any Government Healthcare Program or a Price Reporting Entity must forward that request via facsimile to the Director of Contracting for completion. In addition, a copy of all such requests for pricing information must be sent to the Law and Patents Department prior to submitting responses to any such entity.

Any Radiology and Interventional employee, contractor, consultant or agent who reports prices to any agency of the federal or state government or any Price Reporting Entity must submit that pricing data, along with any information pertaining to that request (e.g., instructions for calculating prices) to the Director of Contracting for approval prior to submitting that information to such entity. The Director of Contracting or designate will approve all pricing information prior to its submission.

Completion of Requests for Pricing Information

All prices reported to any Government Healthcare Program or Price Reporting Entity must be accurate.

All responses to requests from the federal or state government for pricing related to Medicaid, Medicare, Department of Defense (“DOD”), Department of Veterans Affairs (“VA”), or Public Health Service (“PHS”) must be completed as follows:

• Submit complete responses, with detailed annotations if necessary. For example, if the request is for “wholesaler” pricing, include, as appropriate, all classes of wholesalers.
• Report any discounts offered to an entire class of trade, such as prompt pay discounts.
• Always include the lowest class of trade price at which Bayer HealthCare Pharmaceuticals sells a product to a commercial customer, even if this information is not specifically requested.

Updates to Pricing Information

Some government and Price Reporting entities request pricing updates when prices change or on a time-specific basis (e.g., once a year). Radiology and Interventional must provide these updates within the time requested by such entity. If no time is specified, you must provide updated information within 30 days of the event that necessitated a change (e.g., price increase). You must state the effective date the price change took effect. All updates to pricing information must be routed through the same review and approval process as the initial response.

RECORD RETENTION

Contracting will maintain copies of all price submissions to any agency of the federal or state government or foreign government or Price Reporting Entity as well as documents (e.g., contracts) supporting those submissions. Documents must be maintained for 10 years following the date of their submission to the agency, or longer as required by law.

Questions

Any questions concerning a response to a request for pricing information from a government entity or a Price Reporting Entity must be directed to the Head of Contracting or the Law and Patents Department.

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42. Reviewing and Approving Customer Purchase Contracts

Radiology and Interventional sells its products pursuant to written contracts that list all discounts and that notify the recipient of its potential obligation to report the arrangement to the government. All discounts, rebates, and other price concessions must be provided to customers in a manner consistent with the discount Safe Harbor to the Anti-Kickback Statute, as determined by the Law and Patents department. Price concessions offered outside of written contracts, whether oral or written, are not allowed.

For detailed information regarding the initiation, review and approval of all device Radiology and Interventional contracts, as well as definitions of relevant terms, please refer to the Radiology and Interventional Contract Management Procedure (MCMP). For contract procedures for Radiology and Interventional prescription drugs, see the procedures below.

SCOPE

This policy sets forth the process for reviewing and approving contracts for the purchase of Radiology and Interventional products as well as associated trade contracts, such as Wholesaler Fee for Services Agreements, Distributor Services Agreements and other trade agreements.

Discounts are typically provided at the time of invoice. Radiology and Interventional must fully and accurately report discounts, if known, on the invoice or other statements submitted to the customer at the time the product is furnished and inform the customer of its potential obligation to report such discounts to payors and insurers.

Rebates The terms of any rebate must be fixed and disclosed in writing to the purchaser at the time of invoice. A rebate may only be furnished based upon products actually sold and purchased and may not be paid or earned prior to the provision and purchase of the Radiology and Interventional products to which the rebate applies without the prior written approval of the Vice President of Business Planning and Administration or designee and the Law and Patents Department. Each rebate paid must clearly indicate to the purchaser those Radiology and Interventional products to which the rebate is to be applied. A rebate on any Radiology and Interventional product(s) may not exceed the sum total of the actual purchase price(s) for the Radiology and Interventional product(s) to which the rebate is to be applied. Radiology and Interventional must fully and accurately report rebates, if known, on the invoice or other statements submitted to the purchaser at the time the product is furnished and inform the customer of its potential obligation to report such rebate to payors and insurers, as appropriate, as a reduction in price on the Radiology and Interventional products purchased. Radiology and Interventional may only pay rebates to customers in the form of an electronic funds transfer, check, product, or credit.

If the value of the discount, rebate, or other price concession is unknown at the time the contract is signed, Radiology and Interventional must disclose the existence of the price concession in the contract. For example, if Radiology and Interventional offers tiered market share performance rebates, the amount of various tiers and the market share required to attain each tier must be disclosed in the contract.

Administrative Fees It is Radiology and Interventional policy to pay administrative fees only to non-possession-takers such as Group Purchasing Organizations (“GPOs”) and Pharmacy Benefits Managers (“PBMs”). In order to be excluded from prices reported to the government, administrative fees must be bona fide, as defined in the Medicaid Rebate Statute and, in particular, must represent fair market value. To the extent Radiology and Interventional is unable to determine whether an administrative fee is bona fide, the value of that fee will be included as a price concession in prices reported to the government.

Bundled Goods The terms “bundled goods” and “bundling” refer to offering a discount on one product that is related to sales of another product or different product strength of the same product, or making the price of one product contingent on the purchase or formulary placement of another product or different product strength of the same product. Any discount potentially involving “bundled goods” must be approved in advance and in writing by the Executive Pricing Committee.

Free Product It is against Radiology and Interventional policy to provide free product as a discount or price term (e.g., “buy 10, get 1 free”).

PROCEDURES For Prescription Drugs

Approval Process

The Radiology and Interventional employee handling the account sends the proposed Request for Contract (“RFC”) to Customer Business Strategies** (Managed Markets) to review the RFC and confirm that:

• A financial analysis has been performed.
• As appropriate, the impact on Medicaid and 340B pricing has been considered.
• Business justification has been made.
• Competitive information has been included.
• Past performance and contract compliance has been documented.
• The proposal matches the potential of the customer.
• If required, a deviation form detailing the need to meet-the-competition or provide a Robinson-Patman defense has been filled out properly by the Account Manager.

** RFCs involving agencies of the federal government or state supplemental rebates are provided to Government Pricing and Reporting. Such contracts follow the procedures outlined in this policy, with Government Pricing and Reporting performing the functions of the Customer Business Strategies Group described in this policy.

For contracts within “guidelines” previously established by the Executive Pricing Committee (EPC) once the above items have been reviewed, Customer Business Strategies presents the proposed custom contract to Contracting (BPA) which will confirm that the above criteria are met.

As determined by the Director of the Contracting (BPA) function, a “custom contract” is a proposed RFC that does one of the following:

• Deviates from but does not exceed current contracting guideline discounts;
• Requires a material change from Radiology and Interventional’s standard legal language (addition, revision, or deletion of standard language), as determined by the Law and Patents Department;
• Appears to conflict with product and/or approved market strategies; or
• Significantly impacts or changes the intent of the approved strategy.

The Director of the Contracting (BPA) or designee function presents any custom contract with applicable justification to the Contract Review Committee (CRC) which is composed of:

• Director, Controlling Director or designee;
• Director of Contract Generation or designee;
• Director, Customer Business Strategies or designee;
• Brand Lead or designee; and
• Law and Patents Department.

The CRC reviews the custom contract and recommends revision, rejection, or approval of the custom contract. As part of its consideration of a requested contract, the CRC representative from the Law and Patents Department will consider the applicability of Robinson-Patman. The CRC may act upon a custom contract by e-mail. The Director of Contracting or the CRC representative from the Law and Patents Department may request that a custom contract proposal be reviewed by the EPC.

A custom contract requires additional approval by the EPC when it has the potential to exceed a previously approved Medicaid best price for a product, if there is not unanimous CRC approval, if a new contracting strategy is proposed or as otherwise required by the EPC. The EPC members include:

• Vice President, Managed Markets;
• Vice President, Law and Patents; and
• Vice President of Business Planning and Administration (BPA).

Requests that are approved by the EPC are subsequently forwarded to the President and Chief Executive Officer who may either approve the EPC’s actions or return the proposed contract for the EPC’s reconsideration.

Once a contract has been approved as outlined above, a copy is returned to the Radiology and Interventional employee handling the account to provide to the customer for signature. The contract must contain:

• A certification by the parties that the parties shall not violate the Anti-Kickback Statute with respect to the performance or activities related to the contract.
• Where applicable, the requirement that all individuals who meet the definition of Covered Persons, as defined in the CIA, shall comply with all applicable elements of Bayer HealthCare’s Compliance Program, including applicable training related to the Anti-Kickback Statute; that the other party has and enforces a code of conduct and compliance program for its personnel substantially comparable to Bayer’s Code of Conduct and Bayer HealthCare Compliance Program; or that the other parties will make copies of a description of Bayer’s Code of Conduct and a description of Bayer HealthCare’s Compliance Program will be made available to personnel who are directly involved in performance of the agreement.
• Where applicable, Contracting must send the customer a copy of Bayer HealthCare’s Code of Conduct and Anti-Kickback Statute Policies and Procedures. These documents may be sent electronically or by hard copy, and can be included as an exhibit to the contract or sent as separate documents. Contracting must document on the Focus Arrangements Datasheet that the documents were sent.

Procedures for ALL Radiology and Interventional products

Focus Arrangements

The CIA carves out, or excludes, from the definition of “Focus Arrangements” contracts where the only remuneration identified in and to be exchanged pursuant to the contract is a price for the product to be paid by the purchaser in exchange for the product provided to the purchaser. A “Carved-Out Purchase Contract” may also require Radiology and Interventional to pay a bona fide GPO fee and/or a prompt pay discount or rebate.

For all Radiology and Interventional contracts which do not meet the CIA definition of a “Carved-Out Purchase Contract,” Radiology and Interventional is required to follow the Focus Arrangements Procedures.

Law and Patents Review and Approval

The contract signed by the customer is returned to Law and Patents, who reviews the proposed contract for compliance with the Anti-Kickback Statute and relevant Safe Harbor(s) before it is signed by Radiology and Interventional. The reviewing attorney must document that this assessment was conducted, his/her name, and the date it was conducted.

Law and Patents also confirms that the proposed payment of any service, data, or administrative fee represents fair market value. The methodology used to determine fair market value will be based on information in a database of fair market values, or other relevant sources available to Radiology and Interventional. Any deviation from the fair market value methodology and the rationale for such deviation must be approved by the Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

With the exception of volume-based purchase contracts, payment must not depend upon or be based on the value or volume of sales.

Awarding the Contract

Upon receipt of the final contract, it is stamped by the Law and Patents Department and signed by the Director of Contracting, the Vice President BPA or designee, or the Chief Executive Officer of Bayer HealthCare, as appropriate, based on the value of the contract.

Radiology and Interventional’s general policy is not to backdate contracts. The effective date for a contract for the purchase of Radiology and Interventional products may not be earlier than the day on which all material business terms are agreed upon by both of the parties and are contemporaneously documented. Material business terms include product pricing and price concessions (including any rebate requirements), the value of administrative or service fees and the underlying services to be performed, or otherwise as may be relevant to the specific agreement. Radiology and Interventional’s agreement to any business term must be consistent with relevant contract guidelines and approval requirements that may be in effect.

On rare occasions generally related to extensive contract negotiations, Radiology and Interventional, with the approval of Law and Patents department, may determine that there is a need to have an effective date prior to the date of agreement as to all material business terms. Circumstances under which such an effective date may be permissible include amendments to correct an error contained in the original agreement or to avoid confusion as to the parties’ original intent, delays resulting from administrative processes, or the need to replace a damaged or missing document.

Provided all material business terms are agreed upon by the parties and contemporaneously documented, further negotiations concerning legal and non-material items may continue prior to the final execution of the contract, without delaying the effective date. Unless expressly approved in writing by the Director of Contracting and the Law and Patents Department, no contract may have an effective date more than one hundred and eighty days prior to the date of execution by Radiology and Interventional. Any deviations from this policy must be approved by the Compliance Officer (or designee) and documented and maintained in the Law and Patents Department.

Under no circumstances may a contract be backdated in order to provide retroactive price concessions or other preferential terms not included in the original agreement.

Proof of Service

The Contract Champion is responsible for assuring performance of all Radiology and Interventional’s obligations under the contract,including obtaining full performance of all obligations from the other party(s) to the contract.

RECORD RETENTION

A copy of the contract must be maintained by the Contract Champion’s department for a period of seven (7) years.

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TOPIC INDEX

	Policy #
Adverse Events	35
Advertising and Promotional Materials	30-32
Advisory Boards	8, 17
Arrangements Covered Persons	Introduction, 4, 5
Arrangements Trainee	5
Bayer IntegrityLine	Introduction, 1, 4
Booths	8, 20, 21
Business Meals	8, 12, 14, 28
Centers for Medicare and Medicaid Services (CMS)	28
Clinical Research	8, 36, 37
Clinical Study Support	8, 36, 37
CME Programs	8, 25
Commercial Exhibits	8, 20, 21
Consultants	8, 17, 18, 25, 28
Corporate Compliance Policy	Introduction
Covered Persons	Introduction, 4, 5
Displays	8, 20-21
Education Grants	8, 12, 25, 28
Educational Items	8, 12, 15, 28, 33
Entertainment	13
Evaluation Products	22
Equipment Set Up Questions	34
Exhibits	8, 20, 21
Free Goods	23
General Trainee	5
Government Employees	12, 13, 14, 17
Government Investigators	9
Grants	8, 12, 25
Health Fairs / Medical Screenings (Contributions)	24
HealthCare Compliance Program	1-6
Ineligible Persons	3
Legislative Officials	28
Logo Items	15, 16, 20-21, 32
Meals	8, 12, 14, 28
Medical Textbooks	12, 15, 28, 33
Meetings	12, 17, 28, 36
Non-Promotional Materials	33
Off-Label Questions/Inquiries	34
OIG Notification	2
Product Displays	8, 20, 21
Promotional Activities	30-32
Record Retention	8, 12, 14-25
Recreation	13
Reprints	33
Research Support	8, 36, 37
Retail Value	12, 14, 15, 28
Self-Disclosure	3
Speaker Training	17, 18, 28
Speakers	8, 12, 17, 18, 28
Third Party Vendors	1, 17, 20-21, 25

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Confidential: Proprietary Information | For Internal Use Only
Radiology & Interventional Compliance Policies and Procedures | July 1, 2013