Setting new standards
In January 2006, a group of leading physicians and researchers from the Institute of Medicine as a Profession (IMAP) and the American Board of Internal Medicine Foundation called for AMCs to take the lead in ending conflicts of interest between physicians and pharmaceutical companies. Writing in the Journal of the American Medical Association (JAMA), the authors outlined several recommendations toward change. (16) The article generated a great deal of interest in the press and from within the medical profession. (17-22) Following its publication, a number of AMCs strengthened their policies. The Prescription Project was launched by The Pew Charitable Trusts in February 2007 with a major goal of promoting the JAMA recommendations.
To assess current conflict of interest policies at—and recommend “best practices” for— AMCs, the Prescription Project conducted an in-depth investigation of policies, or draft policies, at a number of leading AMCs. Using online research and interviews, we collected information on policies as well as implementation histories, successes, failures, and future plans. Drawing on the JAMA recommendations, we used the following specific criteria for assessing policies:
- Gifting: Do AMCs permit gifts to physicians from industry? Are there any restrictions on “giveaway” items, meals, payment for travel to, or time at, meetings, or payment for CME participation?
- Drug samples: Do AMCs permit physicians to accept samples? Or is there a system (e.g. vouchers for low-income patients) that distances the company from the physician? Are samples limited to patient use, or may physicians use samples for themselves and their families?
- Drug formularies: Do AMCs permit physicians with financial ties to drug companies to serve on committees overseeing formularies or the purchase of medical devices?
- Continuing medical education (CME): How do AMCs manage industry funds for CME? What policies are in place to ensure that CME events remain free of influence from donors?
- Funds for physician travel: Do AMCs permit manufacturers to directly fund travel of faculty and trainees? What policies govern funds for physician travel?
- Speakers bureaus and ghostwriting: Do AMCs allow faculty to serve on speakers bureaus or to publish articles or editorials that are ghostwritten by companies?
- Consulting and research grants: How do AMCs oversee grants for consulting and research? Do they require an explicit contract with specific deliverables? Do they allow “no strings attached” grants and gifts to individual researchers?
"The legislation requiring public disclosure of the financial relationships between healthcare vendors and physicians has been widely discussed in policy circles for years. Critics claimed payments for speaking, consulting, research or even the small trinkets and meals delivered during routine sales calls unduly influenced physician choices and inflated healthcare costs. To combat those effects, Congress required public reporting of those payments in a publicly accessible database. The legislation, labeled the Physician Payment Sunshine Act, was included in the 2010 healthcare reform law."
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Prescription project director Danny Carlat identifies issues with the Physician Payments Sunshine Act requiring further clarification and guidance. Addressing those would ensure that manufacturers can appropriately implement the final rule, and enable consumers to benefit from transparency reports published by the Centers for Medicare & Medicaid Services.
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The Pew Charitable Trusts is working to decrease the influence of pharmaceutical marketing on doctors’ practices. With a three-year grant from the Attorney General Consumer and Prescriber Education Grant Program, Pew is collaborating several partners to improve conflict-of-interest policies within the 158 medical schools and 400 major teaching hospitals in the United States.
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The Pew Charitable Trusts appreciates this opportunity to submit comments to CMS's "Information Collection Activities" draft guidance. We suggest that both the research and non-research payment templates be modified in order to make it easier for consumers to identify which drugs, devices, biologicals, or medical supplies are associated with particular transfers of value.
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On Feb. 1, 2013, the Centers for Medicare & Medicaid Services published the final rule guiding implementation of the Physician Payments Sunshine Act, which Congress passed as part of the Affordable Care Act in March 2010 to increase transparency in the relationships between physicians and drug and medical device makers. Here are some of the highlights.
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