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SHM Joins Multi-Stakeholder Letter to CMS on the Open Payments Program

December 03, 2018

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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. 

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 exclusion for items that directly benefit patients was designed with medical textbooks and scientific medical journal supplements and reprints in mind since these clinical tools are often used side-by-side with a patient as a first resource to help diagnose and treat unfamiliar medical issues. The inclusion of these resources as reportable transfers of value 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 (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.”[1] FDA guidelines provide that medical reprints should be distributed separately from information that is promotional in nature, specifically because the reprints are designed to promote the science of medicine, are educational, and intended to benefit patients. CMS decision not to exclude medical textbooks or journal reprints has not only made doctors less likely to accept these materials but also, according to medical societies that develop many of these educational materials, has made industry less likely to distribute these materials due to the reporting burden. We believe the Sunshine Act was designed to support the dissemination of this type of educational material without unnecessary reporting. We recommend that CMS update its interpretation to include educational materials, such as peerreviewed journals, journal reprints and abstracts, and medical textbooks as “educational materials that directly benefit patients” and, therefore, these items should not be reported under the Open Payments program. 

The reporting guidance pertaining to CME continues to be misinterpreted with many manufacturers overreporting. 

The November 2014 final rule implementing the Sunshine Act correctly excluded independent CME from reporting in the Open Payment System. Unfortunately, what followed was several months of confusing and contradictory subregulatory guidance from CMS. Not until April 2015 did CMS issue clear subregulatory guidance that correctly stated that reporting for independent CME is not triggered unless the manufacturer requires, instructs, directs, or otherwise causes the third party to provide the payment or transfer of value, in whole or in part, to a covered recipient.   

Our hope was that the new guidance would clear the way for our industry partners to continue to play a critical role in helping to meet the educational needs of physicians. Unfortunately, it appears that the reporting requirements are being inconsistently interpreted as some manufacturers view Open Payments Reporting as a compliance risk that leads to overreporting. This has resulted in perverse outcomes where physicians curtail participation in independent CME for fear that it is subject to reporting. This has also led to changes in how industry funds CME activities. As an example, industry has largely shifted its focus away from funding independent satellite symposia at medical society meetings and towards funding more promotional sessions where the reporting requirements are clear. A common reporting methodology, including a common set of definitions on what is reportable, would help to insure more consistency in how industry reports payments and mitigate some of the downstream consequences of overreporting. We urge CMS to make this a priority by engaging more proactively with stakeholders on this issue. 

The Agency’s positions on educational materials and CME have prevented the timely distribution of rigorous scientifically reviewed medical information to clinicians, thereby undermining efforts to improve the quality of care. As clinicians, patients and providers of health care we know that these resources are critical for patient care and we request that you remove the reporting requirements limiting their use. 



American Medical Association

Advocacy Council of ACAAI

American Academy of Allergy, Asthma & Immunology

American Academy of Facial Plastic and Reconstructive Surgery

American Academy of Family Physicians

American Academy of Otolaryngology—Head and Neck Surgery

American Academy of Physical Medicine and Rehabilitation

American Association of Clinical Endocrinologists

American Association of Neurological Surgeons

American Association of Orthopaedic Surgeons

American College of Allergy, Asthma and Immunology

American College of Mohs Surgery

American College of Osteopathic Internists

American College of Osteopathic Surgeons

American Osteopathic Association

American Psychiatric Association

American Society for Clinical Pathology

American Society for Dermatologic Surgery Association

American Society for Gastrointestinal Endoscopy

American Society for Radiation Oncology

American Society of Anesthesiologists

American Society of Cataract and Refractive Surgery

American Society of Clinical Oncology

American Society of Hematology

American Society of Plastic Surgeons

American Thoracic Society

American Urological Association

College of American Pathologists

Congress of Neurological Surgeons

Endocrine Society

Heart Rhythm Society

Infectious Diseases Society of America

Medical Group Management Association

North American Spine Society

Society for Cardiovascular Angiography and Interventions

Society of Hospital Medicine

The Society of Thoracic Surgeons 

Medical Association of the State of Alabama

Arizona Medical Association Arkansas Medical Society

California Medical Association

Connecticut State Medical Society

Medical Society of Delaware

Medical Society of the District of Columbia

Florida Medical Association Inc

Medical Association of Georgia

Hawaii Medical Association

Idaho 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

Mississippi State Medical Association

Missouri State Medical Association

Montana Medical Association

Nebraska Medical Association

Nevada State Medical Association

Medical Society of New Jersey

New Mexico Medical Society

Medical Society of the State of New York

North Carolina Medical Society

North Dakota Medical Association

Ohio State Medical Association

Oklahoma State Medical Association

Oregon Medical Association

Pennsylvania Medical Society

Rhode Island Medical Society

South Carolina Medical Association

South Dakota State Medical Association

Tennessee Medical Association

Texas Medical Association

Utah Medical Association

Medical Society of Virginia

Washington State Medical Association

West Virginia State Medical Association

Wyoming Medical Society

[1] Good Reprint Practices for the Distribution of Medical Journal and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices.  FDA, 2009.