Oct. 28, 2013 – On Monday, 33 physician organizations and 41 national and state medical societies sent a letter to Department of Health and Human Services (HHS) Secretary Kathleen Sebelius to express their “serious concerns” about Sunshine Act regulations that consider journal reprints and medical textbooks to be “transfers of value” which are reportable under the Act.
“We believe the regulations in this regard are 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,” stated the letter, which was signed by the American Medical Association, the American Academy of Family Physicians and the American Society for Clinical Oncology, among others (for full list of signatories, see below).
“The Coalition for Healthcare Communication has been trying to explain to the administration the importance of scientific, peer-reviewed journal reprints and medical textbooks to patient care ever since the regulations were published,” said Coalition Executive Director John Kamp. “Hearing our position strongly stated by 74 physician and medical organizations should help convince HHS that these materials are needed for patient care,” he said.
The groups contend that Congress clearly meant to exclude from reporting those educational materials that directly benefit patients or are intended for patient use, even though the Centers for Medicare & Medicaid Services (CMS) concluded that these materials are not directly beneficial to patients or 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,” they said.
The letter to Sebelius stated that the Food and Drug Administration issued a guidance document in 2009 on reprints, in which it noted the “important public health and policy justification supporting dissemination of truthful and non-misleading medical journal articles and medical or scientific reference publications.” The FDA guidance document also establishes parameters for medical reprints, stating that they should be distributed separately from promotional information.
Textbooks 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 organizations asserted in their letter, also commenting that the current reporting requirement “presents a clear disincentive for clinicians to accept” them.
Bottom line, the 74 organizations “are concerned that the final regulations could inadvertently prevent the timely distribution of rigorous, scientifically reviewed medical information to clinicians and patients and thereby undermine efforts to improve the quality of care provided to patients,” according to the letter, which requests that the current regulations on these materials be reversed.
“Companies, physicians and medical societies all are coming together to voice the same concerns,” Kamp said. “As these voices get louder, let’s hope that the folks at CMS really hear what we are saying: High-quality patient care depends on the information contained in reprints and textbooks. In the words of these diverse physician and medical society groups, ‘these materials provide a direct benefit to patients and are critical for patient care.’”
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Signatories to the Oct. 28 letter to HHS:
American Academy of Child and Adolescent Psychiatry
American Academy of Facial Plastic and Reconstructive Surgery
American Academy of Family Physicians
American Academy of Neurology
American Academy of Otolaryngology-Head and Neck Surgery
American Association of Clinical Endocrinologists
American Association of Neurological Surgeons/ Congress of Neurological Surgeons
American Association of Orthopaedic Surgeons
American Association for Geriatric Psychiatry
American College of Cardiology
American College of Emergency Physicians
American College of Radiology
American College of Rheumatology
American Geriatrics Society
American Medical Association
American Medical Directors Association
American Podiatric Medical Association
American Psychiatric Association
American Society of Anesthesiologists
American Society for Clinical Oncology
American Society for Clinical Pathology
American Society for Dermatologic Surgery Association
American Society for Gastrointestinal Endoscopy
American Society of Nephrology
American Society of Nuclear Cardiology
American Thoracic Society
American Urological Association
Endocrine Society, The
Heart Rhythm Society
Infectious Diseases Society of America
International Society for the Advancement of Spine Surgery
Medical Group Management Association
Society for Vascular Surgery
Arizona Medical Association
California Medical Association
Colorado Medical Society
Connecticut State Medical Society
Medical Society of Delaware
Medical Society of the District of Columbia
Florida Medical Association
Medical Association of Georgia
Hawaii Medical Association
Illinois State Medical Society
Iowa Medical Society
Kansas Medical Society
Kentucky Medical Association
Louisiana State Medical Society
Maine Medical Association
MedChi, The Maryland State Medical Society
Massachusetts Medical Society
Michigan State Medical Society
Minnesota Medical Association
Mississippi State Medical Association
Missouri State Medical Association
Montana Medical Association
Nebraska Medical Association
Nevada State Medical Association
New Hampshire Medical Society
Medical Society of New Jersey
New Mexico Medical Society
Medical Society of the State of New York
North Dakota Medical Association
Ohio State Medical Association
Oregon Medical Association
Pennsylvania Medical Society
South Carolina Medical Association
South Dakota State Medical Association
Tennessee Medical Association
Texas Medical Association
Vermont Medical Society
Medical Society of Virginia
Washington State Medical Association
West Virginia State Medical Association
Wyoming Medical Society