"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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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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"The Obama administration issued a new rule this month that requires the makers of prescription drugs and other medical products to disclose what they pay doctors for various purposes, like consulting or speaking on behalf of the manufacturer. This overdue rule adds much-needed weight to previous, more limited disclosure requirements."
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Allan Coukell, director of medical programs for The Pew Charitable Trusts, issued the following statement in response to the Centers for Medicare & Medicaid Services' final rule for implementing the Physician Payments Sunshine Act, which will bring transparency to the financial relationships between physicians and drug and medical device companies.
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In 2011, the pharmaceutical industry spent nearly $29 billion on drug promotion — more than $25 billion on marketing directly to physicians and almost $4 billion on advertising directly to consumers (mainly through television commercials). This multi-pronged approach is designed to promote its products by influencing doctors’ prescribing practices.
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"Harmonizing conflict-of-interest standards will depend on the Centers for Medicare & Medicaid Services moving forward to implement the federal Sunshine law, which is now more than a year behind schedule. Industry, consumers and academic stakeholders are all waiting on CMS to issue a final rule."
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The Institute of Medicine (IOM) released a new paper, "Harmonizing Reporting on Potential Conflicts of Interest," which notes that "the current process of disclosure (of financial relationships between healthcare professionals and the medical industry) is fragmented and burdensome" and, as a result, the need for a harmonized system has become "urgent and compelling."
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During a session at the American Psychiatric Association's annual meeting on conflicts of interest, experts delved into the link between psychiatry and the pharmaceutical industry. While several speakers at the session pointed out that other specialties are similarly entangled with industry, "everyone does it" is generally not a valid defense where conflicts of interest are concerned.
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"Big Pharma's image problem, fueled by numerous high-profile scandals, may have made doctors so skeptical of the industry that it's warping their judgment, a new survey suggests."
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Allan Coukell
Gabrielle Cosel
Daniel Carlat
