of ?utme fem-tee?: {6 DEPARTMENT OF HEALTH HUMAN SERVICES Centers for Medicare 8: Medicaid Services be. Administrator Washington. DC 20201 DEC 2 3 2013 The Honorable Tom Price US. House of Representatives Washington, DC 20515 Dear Representative Price: Thank you for your letter to the Centers for Medicare Medicaid Services (CMS) regarding the February 2013 ?nal rule implementing the Physician Payments Sunshine Act, now known as Open Payments (Affordable Care Act Section 6002). In your letter, you expressed concerns with how the rule de?nes medical textbooks and the reprints of medical journal articles, as reportable to the Secretary of Health and Human Services. You also discussed your concern that having these items reported would prevent the timely distribution of the information to clinicians. You asked CMS speci?cally to place textbooks and scienti?c peer-reviewed medical journal materials among the items excluded from Open Payments reporting requirements. We agree that scienti?c peer-reviewed journal reprints, supplements, and medical textbooks are educational to physicians. We also appreciate the importance of reprints, supplements, and medical textbooks in potentially improving quality of patient care. However, we do not believe these materials fall within the statutory exclusion. Section of the Social Security Actallows applicable manufacturers to exclude from the reporting requirements payments or other transfers of value in the form of educational materials that directly bene?t patients or are intended for patient use. As stated in the preamble to the ?nal rule, ?Although these items may have bene?ts for a patient, we believe they are not directly bene?cial to patients nor are they intended for patient use. as required by the statutory exclusion. However, education materials, such as wall models and anatomical models that are intended to be used with the patient?and therefore directly bene?t the patient?are excluded from Open Payments reporting requirements. As discussed in our ?nal rule, the mere existence of a ?nancial relationship between the industry and physicians. does not necessarily signify an inappropriate relationship. Disclosure alone is not suf?cient to differentiate bene?cial ?nancial relationships from those that potentially create con?icts of interest. Nor, for that matter, should the inclusion of any particular type of payment or transaction on Open Payments be interpreted as any comment by the federal government on the societal value or appropriateness of a particular type of payment. Rather, Open Payments provides broad transparency to the nature and extent of relationships, providing consumers with the information needed to ask questions and to make more informed decisions. The Open Payments program is not meant to encourage or discourage any particular transaction or type of transaction; it simply reports the information in a neutral and non-judgmental way for the use of physicians, patients, researchers, or any other member of the public. Page 2 The Honorable Tom Price Applicable manufacturers reporting payments or other transfers of value are required to select the nature of payment category they believe most accurately describes a payment or other transfer of value. One nature of payment category available is the ?education? category. CMS has clari?ed in sub-regulatory guidance that this category generally includes payments or other transfers of value that involve the imparting or acquiring of particular knowledge or skills, which can include medical textbooks and journal reprints provided to physicians. Another nature of payment category available is the ?gift? category, depending on the circumstances of the transfer of value. We are continuously examining this and other issues to ensure policy is aligned with the vision and intention of the A??ordable Care Act section 6002, Transparency Reports and Reporting of Physician Ownership or Investment Interest. Again, thank you for your continued interest in this program. Our response has been sent to each of the co-signers. Please do not hesitate to contact me with any further thoughts or concerns. Sincerely, Marilyn Tavenner at the ?niteh gtatea E01 21.1515 November 22, 2013 Marilyn Tavenner Administrator Centers for Medicare Medicaid Services Attention: CMS-1454-P PO. Box 8013 Baltimore, MD 21244-80 1 3 Dear Administrator Tavenner: The undersigned Members of Congress write to express our concerns with regulations recently promulgated by the Centers for Medicare and Medicaid Services (CMS) under the Sunshine Act and their impact on scienti?c peer reviewed medical journals and textbooks. We believe these regulations are contrary to congressional intent and will adversely impact patient care as well as ongoing medical education. The Sunshine Act was designed to promote transparency for payments and other ?nancial transfers of value between physicians and the medical product industry. As part of this provision, Congress outlined twelve speci?c exclusions from the reporting requirement, including ?[e]ducational materials that directly bene?t patients or are intended for patient use. In its interpretation of the statute, CMS concluded that medical textbooks, reprints of peer-reviewed scienti?c clinical journal articles, journal supplements and abstracts of ournal articles are ?not directly bene?cial 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 bene?t directly from improved physician medical knowledge. The importance of up-to-date, peer-reviewed scienti?c medical information as the foundation for good medical care is well documented. Medical textbooks and scienti?c peer- reviewed journal supplements and reprints 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 reprints represent the gold standard in evidence-based medical knowledge and provide a direct bene?t to patients because better informed clinicians render better care to their patients. Moreover, Congress included a Speci?c exclusion of items that directly bene?t patients, such as reference materials that are often used side-by-side with a patient as a ?rst resource when a patient brings an unfamiliar medical issue to a clinician. Many medical textbooks and scienti?c medical journal reprints are used in this way by physicians. The design of the reporting requirement presents a clear disincentive for clinicians to accept high quality, independent educational materials, an outcome that was unintended when the provision was passed into law. The Food and Drug Administration 2009 industry guidance titled ?Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scienti?c Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices? underscores the importance of this scienti?c peer reviewed information. The FDA PRINTED ON RECYCLED PAPER noted the ?important public health and policy justi?cation supporting dissemination of truthful and non-misleading medical journal articles and medical or scienti?c reference publications.? FDA guidelines for reprints provide that medical reprints should be distributed separately from information that is promotional in nature, speci?cally because the reprints are designed to promote the science of medicine, are educational, and intended to bene?t patients. We believe the Sunshine Act was designed to support the dissemination of this type of educational material. We are concerned that the ?nal regulations could inadvertently prevent the timely distribution of rigorous scienti?cally reviewed medical information to clinicians and patients and thereby undermine efforts to improve the quality of care provided to patients. This was not the intent of Congress when the Sunshine Act was passed, as evidenced by statutory language. We request a meeting with Dr. Jonathan Blum, Principal Deputy Administrator and Director, to discuss these matters, to urge the reversal of this policy, and speci?cally to place textbooks and scienti?c peer reviewed medical journal materials among the items excluded from the Sunshine Act?s reporting requirement. These materials are critical for patient care as intended by Congress. Sincerely, 3 Robert E. Andrews ich C. Burges .D. Member of Congress Mem er of Con llyson . Eichard E. Neal Member of Congress Member of Congress P\ai?Meehan ar?iis; "if. A A Member of Congress Me ber of Congress 8 Paul Broun, MD. Member of Congress a. r/ Tom Price Phil Roe, MD. Member of Congre Member of Congress Michael Turner Member of Congress Member of Congress Marsha Blackburn Member Charles W. Boustany, Jr., MD. Member of Congress WM Dan Benishek, MD. Member of Congress $7 Kathy tor mber of Congress Cc: Secretary Kathleen Sebelius US. Department of Health and Human Services Dr. Jonathan Blum Principal Deputy Administrator and Director Centers for Medicare and Medicaid Services Dr. Shantanu Agrawal Of?ce of Corporate Integrity 5 magmazik?mi? {Mike Fitzpatrick Member of Congress 44AM Cami) Michael E. Capuano Member of Congress Warm? Paul Gosar Member of Congress 7 Charles Rangel Member of Congress ?0 Bill ohnsoL/ Member of Congress Robert Brady Member of Congress