Physician Organizations Call Out CMS for Overreach in Sunshine Act Regulation

November 01, 2013 12:38 pm News Staff

The AAFP joined dozens of national and state physician organizations in signing on to a letter to HHS Secretary Kathleen Sebelius that highlights their "serious concerns" about CMS' interpretation of a key component of the Physician Payments Sunshine Act.

Specifically, the physician organizations urged Sebelius to reverse the ruling that medical textbooks, reprints of peer-reviewed scientific clinical journal articles -- and even abstracts of such information-rich articles -- are not written for patients, intended for patient consumption or directly beneficial to patients and, therefore, would be subject to the law's reporting requirements.

The Sunshine Act was enacted by Congress as part of the Patient Protection and Affordable Care Act to ensure transparency regarding so-called transfers of value between physicians and those who produce or market medical products. The 2013 value benchmark is $10 or more, but that figure will be adjusted annually for inflation.

The final rule implementing the Sunshine Act(www.gpo.gov) was published in the Feb. 8 Federal Register.

Story Highlights
  • Dozens of physician organizations have signed on to a letter asking HHS Secretary Kathleen Sebelius to exempt medical textbooks and peer-reviewed scientific journal articles from Sunshine Act reporting requirements.
  • The letter maintains that Congress intended such items to be excluded and points to FDA guidance that supports the organizations' viewpoint.
  • The groups oppose HHS' contention that medical textbooks and journal articles are not meant for, or beneficial to, patients; rather, the letter's signatories say that such resources directly benefit patients and, in fact, are crucial to patient care.

The Oct. 28 letter, spearheaded by the AMA and the Massachusetts Medical Society, reiterated to Sebelius that CMS' decision regarding these educational materials is "contrary to both the statute and congressional intent and will potentially harm patient care by impeding ongoing efforts to improve the quality of care through timely medical education."

The signatories argued that "up-to-date, peer-reviewed scientific medical information" builds good medical care and that peer-reviewed medical journal articles and medical texts are "essential tools" that physician rely on to stay abreast of the latest developments in patient care.

According to Robert Bennett, the AAFP's federal regulatory manager, the concern is that some of those educational materials -- or the subscriptions by which physicians obtained them -- could have been paid for by outside entities.

Nonetheless, these items "represent the gold standard in evidence-based medical knowledge and provide a direct benefit to patients," argued the physician groups in the letter.

"Better-informed clinicians render better care to their patients," they added.

The letter pointed out that when members of Congress passed the Affordable Care Act in 2010, they specifically excluded from the Sunshine Act certain items that provide direct benefit to patients. Congress counted reference materials among those hands-off items that physicians use to explore -- often, together with their patients -- medical issues sometimes unfamiliar to even seasoned family physicians.

The letter included a reference to guidance the FDA provided to industry in 2009 that addressed good reprint practices. The FDA guidance "underscores the importance of this scientific peer-reviewed information," said the letter. In fact, the guidance made it clear that medical reprints were entirely different from promotional information and should be distributed separately, "specifically because the reprints are designed to promote the science of medicine, are educational and intended to benefit patients."

"We are concerned that the final regulations could inadvertently prevent the timely distribution of rigorous scientifically reviewed medial information to clinicians and patients and thereby undermine efforts to improve the quality of care provided to patients," said the organizations.

"As clinicians, patients and providers of health care, we know that these materials provide a direct benefit to patients and are critical for patient care," they concluded.


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