Relationships with drug companies, medical device ...



Policy for interactions with drug companies, medical device companies and durable medical equipment companies and their representatives.

The following policy regarding interactions with drug companies, medical device companies and durable medical equipment companies (medical industries) and their representatives, applies to all ABC Family Clinic entities, practioners and employees.

Background

Interactions with the medical industry provide valuable resource to healthcare professionals insuring that they have the most current and accurate information regarding pharmaceutical, medical devices and equipment. The vast majority of these interactions are or can be structured within the parameters of existing laws, rules and regulations. These laws are, however, complex and must be understood by the healthcare professional to avoid inadvertent violations which are potentionally very costly financially and in terms of exclusion from federally funded healthcare programs.

Arguably of greatest concern is violation of the Federal Anti-Kickback Statute. This statute is a criminal prohibition against payments or the offering of payments, in any form, directly or indirectly, made to induce or reward the referral or generation of federal health care business. The statute applies both to the solicitation and acceptance of such payments. Thus it is imperative that a health care professional insure that any business relationship with the medical industry is within the bounds of the law. Never assume that because an industry representative asserts that their offer is legal (“this has been checked out 16 ways by our legal counsel”) that it is, in fact, legal or within the policy guidelines of ABC Family Clinic.

Policy

1. No more than one visit per week from any representatives of a single company will be allowed unless the representative has a scheduled business appointment with a physician.

2. The furnishing of lunches or snacks is strictly limited to scheduled, educational presentations at which at least one physician is present.

3. Drug samples provided to ABC Family Clinic physicians will be distributed in strict accordance with the Prescription Drug Marketing Act of 1987 (21 U.S.C. 353(c)(1).

4. Drug samples may not be sold nor may they be billed to any federal health care program. It is the policy of ABC Family Clinic that drug samples will not be billed to any patient or health care insurer.

5. All arrangements between medical industry companies and individual ABC Family Clinic physicians or groups of ABC Family Clinic physicians will be reviewed in advance by the Compliance Officer. Such arrangements will be in writing and clearly set forth the amount of compensation; the goods or services being provided; the medical purpose of the arrangement; its duration and the benefit or potential benefit of the arrangement. Such arrangements may include but are not necessarily limited to consulting; clinical research; receipt of honoraria for speeches or attendance at medical industry sponsored events; participation in focus groups; and advisory services.

6. To clearly avoid anti-kickback statue issues, special care must be taken to avoid any arrangement where a physician or ABC Family Clinic is paid, either in cash or other benefits, each time a certain medical device is used or each time a patient’s prescription is switched to a competitor’s pharmaceutical.

7. The Compliance Officer must approve proposed educational grants from medical industry companies to individual or groups of physicians or the ABC Family Clinic in advance. All such grants should be made with out limitations or stipulations as to content of the presentation or the speakers and in a manner that allows the recipient to fully control all aspects of the educational opportunity.

The Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals and the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with Health Care Professionals are incorporated as part of this policy. These documents include a Frequently Asked Questions (FAQs) section which provide scenarios which cover many of the most frequent medical industry interactions which could be problematic.

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