Over 100 physician organizations have written to Rep. Michael Burgess (R-TX) and Rep. Peter DeFazio (D-OR) expressing their “strong support” for H.R. 293, a bill that would clarify that certain applicable manufacturer transfers of value to support independent medical educational programs and materials are exempt from reporting under the Physician Payments Sunshine Act.
“Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by the Centers for Medicare and Medicaid Services (CMS) that have already chilled the dissemination of medical textbooks, peer-reviewed medical reprints and journals, and to avert a similar negative impact on access to independent certified and/or accredited continuing medical education (CME),” the letter states. “H.R. 293 would ensure that efforts to promote transparency do not undermine efforts to provide the most up-to-date independent medical knowledge, which improves the quality of care patients receive through timely dissemination of medical knowledge.”
Congressmen Burgess, Chairman of the House Energy and Commerce Subcommittee on Commerce, Manufacturing and Trade, and Peter DeFazio (D-OR) introduced the Protect Continuing Physician Education and Patient Care Act, H.R. 293, earlier this year. The bill is in response to the Physician Payment Sunshine Act’s “unintended consequence of over-burdensome reporting requirements that made access to educational materials for physicians difficult to obtain,” according to the accompanying Press Release. This bipartisan legislation “would allow physicians full access to the most up-to-date educational materials like textbooks and journals so they may deliver the best care.”
Rep. DeFazio actually introduced the Physician Payments Sunshine Act way back on March 13, 2008, which became a provision in the Affordable Care Act in 2010. Upon release of the Open Payments data in October 2014, DeFazio stated: “Every year, pharmaceutical companies and medical device manufacturers spend billions of dollars promoting their products…However, there’s a difference between educating doctors on the uses and effects of new drugs and devices, versus enticing healthcare professionals with lavish gifts.”
In his statement supporting this amendment to the Sunshine Act, Rep. Defrazio reiterates this difference:
While the Sunshine Act that Congress passed in 2010 is an absolutely essential tool to shine the light on the relationship between the pharmaceutical companies and physicians, our bill ensures the Sunshine Act won’t restrict a physician’s access to the latest medical research and training. This common sense fix is a win for America’s doctors and continuing medical education, but most importantly, for patients.
H.R. 293 (View the language here) would make the Sunshine Act consistent with these goals. Currently there are 12 exclusions from Sunshine reporting, including de minimis payments (under $10) and product samples. Congress also excluded “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, however, CMS concluded that medical textbooks, reprints of peer reviewed scientific clinical journal articles, and abstracts of these articles are not directly beneficial to patients, nor are they intended for patient use. “This conclusion is inconsistent with the statutory language on its face, congressional intent, and the reality of clinical practice where patients benefit directly from improved physician medical knowledge,” the letter to Rep. Burgess states.
The societies write:
The importance of up-to-date, peer reviewed scientific medical information as the foundation for good medical care is well documented. Scientific peer-reviewed journal reprints, supplements, and medical text books have long been considered essential tools for clinicians to remain informed about the latest in medical practice and patient care. Independent, peer reviewed medical textbooks and journal article supplements and reprints represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients because better informed clinicians render better care to their patients.
The Coalition for Healthcare Communication issued a statement on the letter, which acknowledges the broad physician-support H.R. 293 has received. “In stating that peer-reviewed educational materials ‘represent the gold standard in evidence-based medical knowledge,’ these well-known medical organizations, including the American Medical Association, focus on the fact that better informed physicians lead to better treatment for patients,” said CHC Executive Director John Kamp. “Doctors know that access to evidence-based medicine is the key to ensuring that patients have access to the best care. H.R. 293 will restore the intent of Congress,” he said.