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August 06, 2014

Physician Payments Sunshine Act: Over 100 Medical Associations and Societies Urge CMS To Reconsider CME Exemption and Open Payments Timeline

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Medial associations and specialty societies have been understandably frustrated with the way the Physician Payments Sunshine Act has rolled out so far.

Yesterday, over 100 medical societies including the American Medical Association--49 state medical societies and 64 medical specialty societies--sent a letter to Marilyn Tavenner, Administrator of the Centers for Medicare and Medicaid Services (CMS) asking for redress over three problematic issues: (1) the expansion of reporting requirements for educational activities, (2) Open Payments’ condensed timeframe for physician registration, and (3) the complicated registration process for dispute, including manufacturer discretion to dismiss disputes.

1.    Expansion of Reporting for Educational Activities: CME Exemption 

We have been keeping close tabs on CMS’ proposal to remove the existing continuing medical education (CME) exemption from the Sunshine Act. The American Medical Association (AMA) and the co-signing associations are concerned that revoking the existing reporting exclusion for CME would have a “significant chilling effect” on continuing education (CE). 

As we have reported, CMS is proposing to replace the CME exemption with the “indirect payment” provision. CME grants would now only be exempt where an industry donor is unaware of the physician recipients before and 18 months after the funds are transferred. The medical associations believes this is a tenuous exemption because “industry could learn the identities of speakers/faculty and potentially participants after the funds have been transferred through brochures, programs, and other publications, or through their physician-employees’ participation in CE activities (either as speakers/faculty or attendees).”

The associations recommend that CMS modifies their proposal to state that the indirect payment exemption applies “when an applicable manufacturer provides funding to a CE provider, but does not select or pay the covered recipient speaker/faculty directly, or provide the CE provider with a distinct, identifiable set of covered recipients to be considered as speakers/faculty for the CE program.” The letter notes that “[t]he agency can include the guidance in the regulation or preamble that the foregoing is achieved where the industry donor is unaware of the speakers/faculty and other participants before committing to fund the activity under [the indirect payments section].”

“This accomplishes CMS’ goal while eliminating the potential for negatively impacting CE. To allow CE providers time to ensure that their processes comply with the modified exemption, we urge CMS to make this change effective six months after the final rule is issued.”

The associations also takes issue with CMS’ interpretation of medical textbooks and journal reprints. The Sunshine Act lists as one of its exclusions "educational materials that directly benefit patients or are intended for patient use," which do not have to be reported. However, CMS has stated that they do not believe medical textbooks and journal articles fall within this educational carve out. CMS stated these items only have "downstream benefits" for patients as compared to "wall models and anatomical models," which are intended to be used with the patient and are excluded from reporting requirements. The letter notes: “The Agency’s decision to not cover these materials under the educational materials exclusion 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.”

While CMS’ proposal to get rid of the CME exemption is very recent, doctors, pharmaceutical companies, patient-groups, and members of Congress have urged CMS to clarify the textbook aspect of the law for close to a year.

2.    Condensed Open Payments Timeline

The medical associations and societies note in their letter that “[t]here are widespread concerns that the implementation of this new system for data collection—without minimally a six month period to upload the data, process registrations, generate aggregated individualized reports, and manage the dispute communications and updates—will not be ready and will likely lead to the release of inaccurate, misleading, and false information.”

CMS waited until the last minute to set a date for physicians to register in Open Payments to review their data. Now, with only three weeks left in the dispute process, CMS has recently shut down Open Payments due to technical malfunctions.

Thus, the letter “strongly urge[s] CMS and the Office of Management and Budget (OMB) to postpone for six months, until March 31, 2015, the publication of the information collected in the Open Payments System, to compensate for this year’s six months delay in providing the opportunity for physicians to register, contrary to Agency communications throughout 2013 representing that physicians would be permitted to do so beginning January 1.”

3.    Complicated and Incomplete Guidance

Perhaps most troubling,” states the letter, “many physicians are expressing frustration at an overly complex registration process which, combined with the condensed timeframe, makes the task of reviewing and disputing reports by August 27 effectively impossible for the Agency’s estimated 224,000 covered physician recipients.”

We wrote about the complexities in the system a few weeks ago.

While “CMS has suggested that it will take 30-45 minutes to complete the 5-step process of registering in the Open Payments system,” the process is actually a “substantially more complex 11-step registration process, which does not include the pre-registration step of verifying identity in Medicare’s Enterprise Identity Management (EIDM) System. Moreover, when the post-registration time it takes to review and dispute data is factored in, there are an additional 5 steps layered on top of the already cumbersome registration process.”

“This process must be streamlined and physicians must be given adequate time to review and dispute their reports. Thus, we repeat our request that CMS and OMB delay for six months the publication of the information collected in the Open Payments System until March 31, 2015.”

The letter concludes with the medical associations reiterating their displeasure over the fact that manufacturers can “unilaterally dismiss disputes” that physicians and teaching hospitals initiate.

It will be interesting to see whether CMS responds to the concerns raised by the medical associations. With technical problems plaguing the Open Payments system as time winds down on the dispute resolution process, we expect CMS to hear from a lot of displeased stakeholders. 

 Medical Societies Letter to CMS

Organizations Signing the Letter

American Medical Association
AMDA – The Society for Post-Acute and Long-Term Care Medicine
American Academy of Allergy, Asthma and Immunology
American Academy of Child & Adolescent Psychiatry
American Academy of Dermatology Association
American Academy of Disability Evaluating Physicians
American Academy of Emergency Medicine
American Academy of Hospice and Palliative Medicine
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Otolaryngology – Head and Neck Surgery
American Academy of Physical Medicine and Rehabilitation
American Association for Geriatric Psychiatry
American Association of Neuromuscular and Electrodiagnostic Medicine
American Association of Orthopaedic Surgeons
American Clinical Neurophysiology Society
American College of Chest Physicians
American College of Emergency Physicians
American College of Medical Genetics
American College of Occupational and Environmental Medicine
American College of Osteopathic Internists
American College of Osteopathic Surgeons
American College of Phlebology
American College of Radiology
American College of Rheumatology
American Congress of Obstetricians and Gynecologists
American Gastroenterological Association
American Psychiatric Association
American Society for Aesthetic Plastic Surgery
American Society for Clinical Pathology
American Society for Dermatologic Surgery Association
American Society for Radiation Oncology
American Society for Reproductive Medicine American Society for Surgery of the Hand
American Society of Anesthesiologists
American Society of Bariatric Physicians
American Society of Cataract & Refractive Surgery
American Society of Dermatopathology
American Society of Hematology
American Society of Neuroradiology
American Society of Nuclear Cardiology
American Society of Transplant Surgeons
American Thoracic Society
American Urological Association
American Women’s Association
American Society of Echocardiography
College of American Pathologists
Digestive Health Physicians Association
Infectious Diseases Society of America
Large Urology Group Practice Association
Medical Group Management Association
Renal Physicians Association
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery
Society of Critical Care Medicine
Society of Hospital Medicine
Society of Interventional Radiology
Society of Thoracic Surgeons
The Endocrine Society
Medical Association of the State of Alabama
Arizona Medical Association
Arkansas Medical Society
California Medical Association
Colorado Medical Society
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
Indiana State Medical Association
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 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
Vermont Medical Society
Medical Society of Virginia
Washington State Medical Association
West Virginia State Medical Association
Wyoming Medical Society

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