SHM Signs Letter to Rep. Burgess to Clarify Sunshine Act Reporting

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The Honorable Michael C. Burgess, MD
United States House of Representatives
2336 Rayburn House Office Building
Washington, DC 20515

Dear Dr. Burgess:

The undersigned physician organizations representing both national specialty medical societies and state medical societies are writing to express our strong support for H.R. 293, which 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 (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). 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.

The Sunshine Act was designed to promote transparency with regard to payments and other financial transfers of value between physicians and the medical product industry. As part of this provision, Congress outlined 12 specific exclusions from the reporting requirement, including “[e]ducational materials that directly benefit patients or are intended for patient use.” In its interpretation of the statute, 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 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 Food and Drug Administration’s (FDA) 2009 industry guidance, titled “Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices,” underscores the importance of this scientific peer reviewed information. The FDA noted the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” H.R. 293 clarifies that the Sunshine Act was designed to support the dissemination of this type of educational material. We also support language in the bill clarifying that CME that meets the standard for independence must be exempt from Sunshine Act reporting.

We strongly support passage of H.R. 293 and commend your leadership on this issue. The Institute of Medicine and other major stakeholders have repeatedly expressed concern with the length of time required for clinically validated discovery to become part of 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. H.R. 293 is needed to ensure patients benefit from the most up- to-date and relevant medical knowledge.

Sincerely,