December 3, 2018
The Honorable Seema Verma
Centers for Medicare and Medicaid Services
7500 Security Boulevard Baltimore, MD 21244
Dear Administrator Verma:
The undersigned physician organizations representing both national medical societies and state medical societies are writing in response to the Centers for Medicare & Medicaid Services (CMS) request for feedback about the reporting requirements under the Open Payments Program for educational materials, such as peer-reviewed journals, journal reprints and abstracts, and medical textbooks, as well as continuing medical education (CME) programs. We have long believed that the Agency’s decision to include educational materials and CME programs as reportable transfers of value is contrary to both the statute and congressional intent and has harmed patient care by impeding ongoing efforts to improve the quality of care through timely medical education. Our concerns, which have been well documented in previous correspondence and discussions with Agency officials, are summarized below.
CMS’ decision to require reporting of medical textbooks and journal reprints make it more difficult for busy physicians to stay abreast of the latest advances in medical care.
The Sunshine Act excludes several types of “payments” from the reporting requirements, 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 not consistent with the reality of clinical practice where patients benefit directly from improved physician medical knowledge and is not supported by the statutory language on its face or congressional intent.
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