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Legislation for physician payment disclosure
Sen. Chuck Grassley (R-Iowa) and Sen. Herb Kohl (D-WI) have introduced legislation that would require not only pharmaceutical companies, but also makers of medical devices and biologics, to publicly report any money over $100 that they give to physicians within a year.
In a news release, Grassley's office said the Physician Payments Sunshine Act of 2009 "would establish a nationwide standard requiring drug, device, and biologic makers to report payments to doctors to the Department of Health and Human Services." The legislation also would require that any payments be posted online for the public to review.
The legislation sets penalties as high as $1 million for those who knowingly fail to disclose payments. Grassley's release said the proposal incorporates many of the new recommendations of the Medicare Payment Advisory Commission (MedPac), an independent congressional agency that advises Congress on issues affecting the Medicare program.
Grassley's news release said this latest legislation is along the lines of S.2029, a bill that was introduced two years ago, which the 110th Congress never considered.
"Shedding light on industry payments to physicians would be good for the system," Grassley said in the statement. "Transparency fosters accountability, and the public has a right to know about financial relationships. Patients rely on their doctors' advice. Taxpayers spend billions every year on prescription drugs and medical devices through Medicare and Medicaid. They also fund tens of billions of dollars of medical research each year, and the doctors conducting that research have a big influence on the practice of medicine."
In addition, the release noted, Sen. Kohl is the author of legislation to create a federal "academic detailing" program to provide physicians and other prescribers with an objective source of information on all prescription drugs, based on independent, scientific research.
Thomas Novelli, director of federal affairs and policy for the Medical Device Manufacturers Association (MDMA) in Washington DC, tells MEA that he thinks "the movement toward transparency is a very good step in the right direction. I think there have been some legitimate concerns about some of the unfortunate players in the market, while the majority of the relationships, I believe, are legitimate relationships between device manufacturers and clinicians and physicians."
Novelli says, "I think some of the bad actors have really, unfortunately, put a gray area in the public perceptions about whether there's a level of impropriety in these relationships, and so I think that if it's crafted and implemented in the correct way, then that is beneficial to the practice of medicine in general."
Novelli noted that the $100 limit is probably "more appropriate" for pharmaceutical companies. He says the legislation was originally aimed at the items typically given to physicians with drug branding.
But he notes that the relationship between medical device companies and physicians is different. Often, he said, "it is the physicians and the surgeons who help the device manufacturers develop the product, where you don't necessarily have that sort of relationship with a pharmaceutical company and a study."
Another issue of concern to MDMA is the ability to keep developmental information proprietary.
"Oftentimes, products are in the development stage, and we wouldn't necessarily call for a real-time disclosure of those sorts of relationships [between physicians and device makers]," Novelli said.
Another organization representing medical device makers weighed in on the legislation as well. On the same day the legislation was introduced, Stephen J. Ubl, president and CEO of the Advanced Medical Technology Asociation (AdvaMed) released a statement in response to the proposed act, stating: "AdvaMed and its member companies support the appropriate disclosure of payments made to physicians and were pleased to have supported S. 2029 as revised last year."
In the statement, Ubl said that AdvaMed was reviewing the proposed legislation, but "believe it is important that any federal disclosure legislation create a uniform national standard to prevent a patchwork approach by all 50 states."
The statement adds: "Physicians play a critical role in the continued innovation and advancement of medical technology, and federal disclosure legislation should be written in a way that allows for our unique research and development process to thrive."