Elements of CMS' interpretation of the Physician Payments Sunshine Act that stand to directly and negatively impact medical education continue to draw the wrath of a large swath of organizations representing America's physicians.
And once again, the AAFP is among them.
Specifically, in a May 29 letter(4 page PDF) to Rep. Michael Burgess, M.D., R-Texas, 70 national medical organizations and 46 state medical associations commended the congressman for his introduction of H.R 293,(www.govtrack.us) which would amend Title XI of the Social Security Act to exempt from manufacturer transparency reporting certain items used for educational purposes as outlined by the Sunshine Act.
"Passage of this bill is urgently needed to remedy onerous and burdensome reporting obligations imposed by CMS that have already chilled the dissemination of medical textbooks, peer-reviewed medical reprints and journals," said the letter. Furthermore, the legislation, if passed, would avert a "similar negative impact" on access to independent certified and/or accredited CME.
- The AAFP recently joined more than 100 other organizations in supporting a House bill that would clarify that certain transfers of value are exempt from reporting under the Physician Payments Sunshine Act.
- The Sunshine Act was created to ensure transparency around financial transfers of value between physicians and the medical product industry.
- In a letter to the bill's sponsor, Rep. Michael Burgess, M.D., R-Texas, the organizations reaffirmed why educational materials such as medical textbooks and peer-reviewed medical reprints and journals should be excluded from reporting requirements.
The Sunshine Act was created to ensure transparency regarding financial transfers of value between physicians and the medical product industry. And even though Congress deliberately created specific exclusions from the reporting requirement -- exclusions that included educational materials that directly benefit patients -- CMS interpreted the law differently in formulating regulations to enforce it.
That agency declared that items such as medical textbooks and reprints of peer-reviewed scientific clinical journals did not benefit patients and were never 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," asserted the letter.
Indeed, peer-reviewed medical textbooks, journal article supplements and reprints have long been seen as "the gold standard in evidence-based medical knowledge," said the organizations. Such educational items "provide a direct benefit to patients because better informed clinicians render better care to their patients."
The letter noted that another agency within HHS -- none other than the FDA -- issued its own industry guidance in 2009 that addressed the issue of good reprint practices for the distribution of medical journal articles and reference publications relevant to unapproved new uses of approved drugs and approved or cleared medical devices.
At that time, the FDA noted the "important public health and policy justification" of allowing the dissemination of truthful medical journal articles and medical or scientific reference publications.
The bill in question "clarifies that the Sunshine Act was designed to support the dissemination of this type of educational material," said the letter.
The organizations also stressed their support for language in the bill that would include CME that meets standards for independence established by the Accreditation Council for Continuing Medical Education as exempt from the Sunshine Act's reporting requirements.
Finally, the letter pointed out that the Institute of Medicine and other major stakeholders have publicly expressed concern on several occasions about the lengthy time interval between clinically validated discovery and its insertion into regular clinical practice.
"The Sunshine Act was not passed to limit or construct additional barriers to the dissemination of new medical knowledge that improves patient health outcomes," said the letter.
Passage of H.R. 293 is necessary "to ensure patients benefit from the most up-to-date and relevant medical knowledge," the signatories concluded.
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AAFP Protests CMS' Proposal to Remove CME Exemption in Open Payments Program
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Joint Letter to HHS on Potential Impacts to Medical Education and Patient Care(3 page PDF)