Life Science Compliance Update

September 08, 2014

Physician Payments Sunshine Act: Organizations Respond to CMS

  Crowd of people holding hands

September 2nd marked the last day for comments on CMS’ proposed rule to eliminate the accredited continuing medical education (CME) exemption from Sunshine Act reporting.  In an overwhelming display of support for the exemption, over 800 comments were submitted encouraging the agency to either maintain or expand the current exclusion.

-Total comments supporting maintenance or expansion of the CME exemption:  820
-Total comments supporting elimination of the CME exemption:  approximately 20
-Percentage of comments supporting the CME exemption: 98%

We have followed this issue closely, and recently analyzed the CME Coalition’s comments and recommendations, as well as the American Medical Association and Accreditation Council for Continuing Medical Education (ACCME).

Leading Medical Societies Submit Comments

In addition to the AMA, the major medical societies commented in favor of the CME exemption, including the American College of Physicians, the American College of Surgeons, the American Osteopathic Association (AOA), the American Academy of Pediatrics (AAP), and the American Dental Association (ADA). 

Over 200 leading medical societies have submitted or signed onto comments to CMS urging the maintenance or expansion of the CME reporting exemption, including the following:  

American Medical Association: On August 5, over 100 medical societies including the American Medical Association (AMA) wrote a letter to CMS urging them to modify the exemption slightly, so that the exemption applies to cases where the manufacturer doesn't select the speaker and doesn't know who the speaker is beforehand -- without addressing what happens afterward.

“Our organizations believe that this raises concerns as 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 [continuing education] activities (either as speakers/faculty or attendees)… Our organizations are concerned that this would have a significant, chilling impact on CE, which runs contrary to the public interest.”

American Academy of Family Physicians: The American Academy of Family Physicians (AAFP) “strongly disagrees” with CMS’ proposal to eliminate the continuing medical education exemption from the Sunshine Act. AAFP, which represents 115,900 family physicians and medical students across the country, wrote to CMS to outline their concerns that the proposal would create “an inadvertent barrier to the development and delivery of high quality certified or accredited CME with the final result of negatively affecting care provided to patients.”

“Physicians must stay up to date on the latest medical research and medications so they can provide the most appropriate care to their patients…Each year, this research results in new treatment breakthroughs, medications, diagnostic procedures, and clinical guidelines." Collaboration between physicians, device manufacturers, and pharmaceutical companies is critical, they argue, if "physicians are to remain current with the latest research and provide state-of-the-art care that the public deserves.”

Council of Medical Specialty Societies: The Council of Medical Specialty Societies (CMSS) submitted comments to CMS regarding the proposed elimination of the Sunshine Act’s CME exemption on August 19.  The comments—on behalf of 41 medical specialty societies representing 750,000 physicians—advocate for the preservation of the February 2013 Final Rule to “retain in the Open Payments program the safeguards to distinguish independent accredited and certified continuing medical education from promotional education.” CMSS’ comments specifically address concerns regarding attendees at accredited CME events.

“While attendees might not be identified in advance of a CME program, they are certainly identifiable during and after the program,” the letter states. “However, CMS has always recognized that attendees have no relationship with companies which might choose to provide grants of commercial support to CME providers for accredited and certified CME. Therefore, it is not necessary to establish an arbitrary timing proxy for attendees. Attending accredited and certified CME does not establish a reportable relationship with any supporting companies.”

Accreditation Council for Continuing Medical Education: The Accreditation Council for Continuing Medical Education (ACCME) believes that CMS should not rescind the Sunshine Act's continuing medical education exclusion, according to a letter sent to the Centers for Medicare and Medicaid Services (CMS). ACCME, the membership based organization responsible for accrediting institutions that offer continuing medical education, expresses support for CMS' original position of excluding accredited CME from required reporting under the Open Payments program. 

“The continuing education accreditation, activity approval, and credit systems of the American Academy of Family Physicians, the American Academy of Physician Assistants, the American Dental Association, the American Medical Association, the American Nurses Credentialing Center, the American Osteopathic Associations, and the Association of Regulatory Boards of Optometry already base their requirements on ACCME [Standards for Commercial Support].  Verification could be a next step in order to ensure unity in requirements and interpretation... We believe this would establish a valid mechanism to (a) retain a list of accreditation systems in which the [ACCME standards] are implemented... and (b) provide verification of this implementation using already existing processes within the system of professional self-regulation in accredited continuing education."

Pharmacists Groups: Four leading pharmacists groups—the Academy of Managed Care Pharmacy, the College of Psychiatric & Neurologic Pharmacists, the International Academy of Compounding Pharmacists, and the National Community Pharmacists Association—submitted comments to CMS.  As representatives of pharmacy stakeholders, the organizations encourage the agency to “maintain a strong reporting exemption for accredited CME and to extend that exemption to programs for continuing pharmacist education (CPE) programs that are certified by bona fide [accrediting] bodies.”

“We believe that replacing the clear CME exemption with the category of 'indirect payments,' as your proposal suggests, will effectively eliminate the reporting exemption because commercial supporters will automatically report all of these payments rather than risking later discovery of the identity of these physician speakers…  “[CMS should] promulgate very clear guidance under Open Payments that specifically exempts the reporting of all indirect support or transfers of value related to physician participation or attendance in an accredited CME program.”

Many other colleges and associations weighed in as well, offering thoughtful commentary in favor of maintaining the CME exemption.

The Medical College of Wisconsin noted that requiring manufacturers to report indirect payments to CME providers would have several unintended consequences, including misleading the public.

“The covered recipient and the applicable manufacturer are not contractually engaged. The covered recipient does not determine who the funders of CME activities are, the amount of funding, nor the allocation of said funding. The applicable manufacturer does not determine who the covered recipients are who participate in the CME activity, the nature of the participation nor the amount of participation. Given the unpremeditated nature of this circumstance, reporting CME would mislead the public in to presuming a relationship between covered recipients and applicable manufacturers where there is none.”

Furthermore, their letter states: “Any report generated as a result of the proposed rule, on monies received from applicable manufacturers that are not presented within a context of clinical /research performance may be detrimental to certain physicians. A physician may have a higher dollar amount attributed to her because she is renowned in her field with exceptional patient outcomes and has invented methods that not only improve patient care, but reduce healthcare costs. Another physician may also have a high dollar amount attributed to his practice, but he is not considered a leader in the field, does not keep current by attending CME activities and /or has poor patient outcomes. Yet without a proper context, patients will be misled into assuming there is no distinction between the physicians.”

The American Medical Informatics Association (AMIA), a medical specialty society with an interdisciplinary membership of 5,000 professionals and students committed to the science and practice of biomedical and health informatics, brought an interesting perspective to their comments, by stating that they don't currently accept commercial support. AMIA still urges CMS to reconsider their proposal:

“AMIA does not current (sic) accept commercial support for its certified CE activities. However, with the economic stresses impacting the practice of medicine today—such as implementation of electronic health record systems, already burdensome reporting requirements such as Meaningful Use, hiring of additional staff to manage the health insurance process, and ever-greater educational requirements to maintain competency—commercial support of our educational activities is certainly something we consider. We are sensitive to the fact that our members are paying significant sums to implement so many of the other changes that health reform demands and at a certain point will simply not be able to keep paying on their own for all of their continuing education and maintenance of certification materials.

“...CME providers are in jeopardy of losing their ACCME accreditation if they do not adhere strictly to these guidances. If the ACCME ascertains that an education provider is not in compliance, there is already a process in place to remove accreditation from that violator...Therefore, the proposed CMS expansion of the reporting requirement to include commercially supported CME activities does not recognize an already well-established divide between education and promotion. This level of reporting would jeopardize the commercial support funding of education that is essential to ensuring that today’s physicians remain competent."

“AMIA also urges exclusion of CME activities where the industry donor is unaware of the speakers and participants before committing to fund the activity. The commercial support landscape has changed greatly over the last decade. In fact, many commercial supporters do not want to know the name of faculty before awarding a grant for educational support lest this be interpreted as influence. Once CME providers have issued activity announcements, a commercial supporter’s knowledge of the faculty is inevitable. Commercial supporters’ knowledge of faculty after a grant has been awarded does not demonstrate influence any more than physician learners’ knowledge of faculty does.”

Hundreds of Individual Practitioners Voice Concerns

Hundreds of individual practitioners also reached out to CMS to voice their concerns regarding the proposed rule.  Indeed, CME providers and medical specialists from around the country have submitted comments to CMS telling them that the proposed rule could have a chilling effect on CME, and could negatively impact patient care. Below is a small sample of public outcry elicited by CMS’ proposal, and the full archive of comments submitted on the entire proposed rule are available here:

Justine Gunvalsen, Ohio

“We develop valuable educational programs that are based on the latest evidence and guidelines. CME/CE is not a marketing tool but a highly regulated and important means of continuing education for healthcare providers. The goal of every activity that we develop is to provide clinicians with the tools needed to narrow their practice gaps and improve their clinical care while also empowering patients in their own care. We conduct the research and measure the educational outcomes to measure our achievement of this goal.”

Richard Martin, Chairman of the Department of Medicine, National Jewish Health

“As the leading respiratory hospital in the U.S., our world renowned faculty are well-respected educators. I have spoken with faculty who say that if their involvement in CME activities, including honoraria payments, are reported under the Open Payments system, they likely will not participate as it implies they are doing something ‘wrong’… The proposed changes will cause confusion for physician learners who may find it harder to discern certified education from promotional activities if their participation is viewed in the same manner by CMS and the public.”

Maureane Hoffman, North Carolina

“I have already seen that the ‘Sunshine Act’ has discouraged international organizations from inviting US physicians to participate as speakers or attendees, because of the massive amount of paperwork involved in reporting ‘payments’ to US physicians. Misplaced regulation such as this decreases the availability of continuing education activities to US physicians and cuts us out of the mainstream of medical advances.”

 

Comments Calling for the Retention or Expansion of the CME Exemption

Academy of General Dentistry

Academy of Managed Care Pharmacy

Accreditation Council for Continuing Medical Education

Accreditation Council for Graduate Medical Education 

AdvaMed

Alabama Cancer Congress

Alliance for Continuing Education in the Health Professions (ACEhp)

American College of Physicians (ACP)

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 CME

American Academy of Dermatology

American Academy of Disability Evaluating Physicians 

American Academy of Emergency Medicine 

American Academy of Family Physicians (AAFP)

American Academy of Hospice and Pallative Medicine

American Academy of Neurology (AAN)

American Academy of Ophthalmology (AAO)

American Academy of Otolaryngology – Head and Neck Surgery 

American Academy of Pediatrics (AAP)

American Academy of Physical Medicine and Rehabilitation 

American Association for Geriatric Psychiatry 

American Association for the Study of Liver Disease (AASLD)

American Association of Clinical Endocrinologists 

American Association of Colleges of Osteopathic Medicine (AACOM)

American Association of Neurological Surgeons 

American Association of Neuromuscular and Electrodiagnostic Medicine 

American Association of Orthopaedic Surgeons 

American Board of Medical Specialties 

American Cancer Society - Cancer Action Network

American Clinical Neurophysiology Society 

American College of Allergy, Asthma and Immunology (ACAAI)

American College of Cardiology 

American College of Chest Physicians 

American College of Emergency Physicians (ACEP) 

American College of Foot and Ankle Surgeons

American College of Gastroenterology

American College of Medical Genetics 

American College of Mohs Surgery

American College of Occupational and Environmental Medicine 

American College of Osteopathic Internists 

American College of Osteopathic Surgeons 

American College of Phlebology 

American College of Physicians 

American College of Preventive Medicine 

American College of Radiology (ACR)

American College of Rheumatology 

American College of Surgeons 

American Congress of Obstetricians and Gynecologists 

American Council on Pharmacy Education (ACPE)

American Dental Association

American Gastroenterological Association 

American Geriatrics Society 

American Hospital Association

American Medical Association (AMA) (Sign on Letter)

American Medical Association (AMA) (Final Comments)

American Medical Informatics Association (AMIA) 

American Nurses Association and American Nurses Credentialing Center

American Osteopathic Association (AOA)

American Podiatric Medical Association

American Psychiatric Association 

American Society for Aesthetic Plastic Surgery 

American Society of Anesthesiologists

American Society for Clinical Pathology 

American Society for Dermatologic Surgery Association 

American Society for Gastrointestinal Endoscopy

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 and Refractive Surgery

American Society of Clinical Oncology

American Society of Colon and Rectal Surgeons 

American Society of Dermatopathology 

American Society of Echocardiography 

American Society of Hematology

American Society of Nephrology

American Society of Neuroradiology 

American Society of Nuclear Cardiology

American Society of Plastic Surgeons

American Society of Radiation Oncology

American Society of Retina Specialists

American Society of Transplant Surgeons

American Speech Language Hearing Association

American Transplant Society

American Thoracic Society

American Urogynecologic Society

American Urological Association

American Women’s Association 

Annenberg Center for Health Sciences

Aplastic Anemia and International MDS Foundation

Arizona Medical Association 

Arkansas Medical Society 

Association for Hospital Medical Education (AHME)

Association for Molecular Pathology

Association of Community Cancer Centers

Association of American Medical Colleges 

Association of Health System Pharmacists (ASHP)

Bayer

Biotech Industry Association (BIO)

California Association of Family Physicians (CAFP)

California Medical Association

Chinese American Medical Association of So. California

Clinical Care Options

CME Coalition

Coalition for Healthcare Communications

Coalition for State Rheumatology Associations

College of American Pathologists 

College of Psychiatric and Neurologic Pharmacists

Colorado Medical Society

Community Oncology Alliance

Connecticut Medical Association

Council of Medical Specialty Societies (CMSS)

Council on Podiatric Medical Education

DermaSciences

Dickson Consulting

Digestive Health Physicians Association 

Dignity Health

Educational Measures

Endocrine Society

Federation of State Medical Boards 

Florida Medical Association, Inc. 

Global Education Group

Hawaii Medical Association 

Healthcare Leadership Council

Heart Failure Society of America

Heart Rhythm Society Letter to CMS

Idaho Medical Association 

Illinois State Medical Society 

Indiana State Medical Association 

Infectious Diseases Society of America

International Academy of Compounding Pharmacists

Iowa Medical Society

Iowa Oncology Society

Johnson and Johnson

Joint Council of Allergy Asthma and Immunology

Kansas Medical Society 

Kentucky Medical Association 

Large Urology Group Practice Association 

Louisiana State Medical Society 

Maine Medical Association 

Massachusetts Medical Society 

MedChi, The Maryland State Medical Society 

Med-IQ

Medical Association of Georgia 

Medical Association of the State of Alabama

Medical College of Wisconsin

Medical Device Manufacturers Association

Medical Group Management Association 

Medical Society of Delaware 

Medical Society of New Jersey

Medical Society of the District of Columbia 

Medical Society of the State of New York 

Medical Society of Virginia 

Memorial Hermann Health System

Mercy Health System

Michigan State Medical Society 

Minnesota Medical Association 

Minnesota Society of Clinical Oncology

Mississippi State Medical Association

Missouri State Medical Association 

Montana Medical Association 

National Board of Medical Examiners

National Community Pharmacists Association

National Comprehensive Cancer Network

National Hemophilia Foundation

National Lipid Association

Nebraska Medical Association 

Nevada State Medical Association 

New Hampshire Medical Society 

New Jersey Academy of Family Physicians

New Mexico Medical Society 

North American Center for Medical Education

North American Spine Society 

North Carolina Academy of Family Physicians

North Carolina Medical Society 

North Dakota Medical Association 

Ohio Academy of Family Physicians

Ohio Foot and Ankle Medical Association

Ohio State Medical Association 

Oklahoma State Medical Association 

Oregon Medical Association 

PAH Foundation

Pan American Allergy Society

Pennsylvania Academy of Family Physicians

Pennsylvania Medical Society 

Pfizer

PhRMA

Post Graduate Institute of Medicine

Premier

Reed Elsevier

Renal Physicians Association 

Rhode Island Medical Society 

Rockpointe

Society for Cardiovascular Angiography and Interventions (SCAI)

Society for Translational Oncology

Society for Vascular Surgery

Society of Academic Continuing Medical Education (SACME)

Society of Critical Care Medicine 

Society of General Internal Medicine

Society of Gynecologic Oncology

Society of Hospital Medicine 

Society of Interventional Radiology 

Society of Nuclear Medicine and Molecular Imaging 

Society of Thoracic Surgeons

South Carolina Medical Association 

South Dakota State Medical Association 

Stryker

Summa Health System

Tennessee Medical Association

Texas Alliance for CME

Texas Health Resources

Texas Medical Association 

The Endocrine Society 

Utah Medical Association 

Vermont Medical Society

Virginia Association of Hematologists and Oncologists

Washington State Medical Association 

West Virginia Oncology Society

West Virginia State Medical Association 

Wyoming Medical Society

July 07, 2014

Physician Payments Sunshine Act: CMS Proposes Removing CME Exemption, Some Speaker Pay May Still Fall Under "Indirect Payment" Exclusion

The evening before the Fourth of July holiday weekend, the Centers for Medicare and Medicaid Services (CMS) released the CY 2015 Medicare Physician Fee Schedule proposed rule. The 609-page document proposes a number of changes to the Physician Payments Sunshine Act, including deleting the specific exemption for payments made to speakers at accredited continuing medical education (CME) events.

Background on the CME Exemption

The Sunshine Act requires pharmaceutical and device manufacturers to report to CMS their direct and indirect payments or other transfers of value made to healthcare providers and teaching hospitals (covered recipients). In February 2013, CMS released the Final Rule of the Sunshine Act.

As we have detailed on Policy and Medicine numerous times, the Final Rule contains an exemption for payments to healthcare providers who serve as speakers for accredited continuing education programs, under section §403.904(g):

Payments or transfers of value provided as compensation for speaking at a CME program are not required to be reported, if all the following conditions are met:

  • (1) The event at which the covered recipient is speaking meets the accreditation or certification requirements and standards for continuing education of one of the following:
    • (A) Accreditation Council for Continuing Medical Education
    • (B) American Academy of Family Physicians
    • (C) American Dental Association's Continuing Education Recognition Program
    • (D) American Medical Association
    • (E) American Osteopathic Association
  • (2) The applicable manufacturer does not pay the covered recipient speaker directly.
  • (3) The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, special rule for payments related to continuing medical education programs.

CMS notes that speaker payments that do not meet the requirements must be reported under certain categories depending on which aspects of the exemption they lack. For example, payments that don't meet requirement (1) must be reported under the category "Compensation for serving as a faculty or as a speaker for an unaccredited and non-certified continuing education program." 

In the final rule preamble, CMS noted that "industry support for accredited or certified continuing education is a unique relationship." CMS initially agreed with the many commenters who stated that accredited or certified continuing education payments to speakers should not be reported because there are safeguards already in place, and they are not direct payments to a covered recipient.

Proposed Changes Related to CME

On July 3, 2014, CMS proposed to remove the above CME exemption, §403.904(g), "in its entirety" (at page 242).

As the Final Rule above shows, CMS picked five bodies which can accredit programs to fit under the reporting exemptions. However, CMS notes that since the Final Rule, other accrediting organizations have requested that payments made to speakers at their events also be exempted from reporting. "These organizations have stated that they follow the same accreditation standards as the organizations specified in the Final Rule."

Furthermore, other stakeholders have recommended removing the exclusion because removal would "allow for consistent reporting for compensation provided to physician speakers at all continuing education events, as well as transparency regarding compensation paid to physician speakers."

"Many stakeholders raised concerns that the reporting requirements are inconsistent because certain continuing education payments are reportable, while others are not," CMS states. "CMS' apparent endorsement or support to organizations sponsoring continuing education events was an unintended consequence of the final rule."

CMS states that part of its motivation in proposing to remove the CME exclusion is to avoid the redundancy in another section of the Final Rule. §403.904(i)(1) excludes indirect payments or other transfers of value where the applicable manufacturer is "unaware" of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.

Most notably, CMS states that they will consider speaker payments to be excluded from reporting "[W]hen an applicable manufacturer or applicable GPO provides funding to a continuing education provider, but does not either:

[1] select or pay the covered recipient speaker directly, or

[2] provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program."

In explaining its rationale for the change, CMS states: "This approach is consistent with our discussion in the preamble to the final rule, in which we explained that if an applicable manufacturer conveys 'full discretion' to the continuing education provider, those payments are outside the scope of the rule." In contrast, "when an applicable manufacturer conditions its financial sponsorship of a continuing education event on the participation of particular covered recipients, or pays a covered recipient directly for speaking at such an event, those payments are subject to disclosure."

CMS notes that they considered two alternative approaches to address this issue. First, CMS explored expanding the list of accrediting organizations by name. CMS believes "this approach might imply CMS's endorsement of the named continuing education providers over others." Second, CMS considered "articulating accreditation or certification standards that would allow a CME program to qualify for the exclusion." This is also problematic to CMS "because it would require evaluating both the language of the standards, as well as the enforcement of the standards of any organization professing to meet the criteria." 

CMS seeks comments on both alternatives presented, including commenters' suggestions about what standards, if any, CMS should incorporate.

Analysis:

This proposed change to the Sunshine Act disrupts a year and a half's worth of planning since the Final Rule. While much of the Sunshine Act remains mired in confusion, CMS' continuing education exemption specifically stated the accrediting criteria for companies looking to develop well-defined policies surrounding CME programs. This actually offered companies and physicians certainty that many other Sunshine Act provisions could use.

Why, for example, would CMS not have addressed the ambiguity surrounding how to report group meals? The proposed rule does not mention §403.904(h), which states that group meals are unreportable if the recipient's meal is "not separately identifiable" or if the meal is a "buffet." Companies have struggled with these terms all year.

Reporting for Speakers/Faculty at CME Events

In looking at the proposed CME changes and reading CMS' rationale for the changes, CME speaker and faculty fees appear to remain unreportable. CMS is proposing less definition and certainty surrounding the "proper" accrediting bodies, but this may not expand what companies must report.

In the proposal, CMS states that they will consider speaker payments to be excluded from reporting "[W]hen an applicable manufacturer or applicable GPO provides funding to a continuing education provider, but does not either:

[1] select or pay the covered recipient speaker directly, or

[2] provide the continuing education provider with a distinct, identifiable set of covered recipients to be considered as speakers for the continuing education program."

If you look at the Final Rule language in the Background section above, notice that this is the exact same requirements as (2) and (3). In other words, the proposal is essentially the same speaker/faculty policy as the current Final Rule, except CMS isn't specifically saying education events must be accredited by one of the specific five bodies (ACCME, AAFP, ADA, AMA, AOA). 

CMS said nothing to suggest they have changed their attitudes about the importance of CME or the aptitude of accrediting organizations to provide conflict-free education. CMS' main issue, according to the proposed rules, is that they do not want to appear to endorse a particular sponsoring organization, such as the ACCME, when other accrediting bodies follow similarly strict accrediting procedures, which may allow for the same firewalls between commercial support and educational content.

Large Concerns Remain

Unfortunately, absent the CME exemption, the proposed rule leaves too much ambiguity for CME stakeholders. CMS is proposing to replace the CME language with §403.904(i)(1), which excludes indirect payments or other transfers of value where the applicable manufacturer is "unaware" of the identity of the covered recipient during the reporting year or by the end of the second quarter of the following reporting year.

The problem is that CMS has not yet offered a specific definition of "indirect payments" or "awareness." CMS' examples of "awareness" in the Final Rule are so strict that by simply not asking for the names of participants at accredited CME events, a manufacturer may not meet the standard. Furthermore, the example used in the Final Rule for unaccredited grants states that companies who support programs for specialists in a specific city would have to report if they could figure out who those doctors were.  This would wreak havoc on local hospital based programs.

Without any clarity, and without any precedent in CMS' auditing discretion, we don't know how to interpret many vital aspects of the Sunshine Act.

The Final Rule recognized the ACCME standards for commerical support and the HHS OIG's Compliance Guidance.  The writers of this proposed rule may have changed, and thus be unaware of those strict guidances. CMS may be trying to compare accredited CME with ad boards and promotional speaker programs. But one big difference is in the contracting. Manufacturers have a signed direct contract with the HCP for ad boards and speaker programs.  Manufacturers do not engage in any contracting for CME other than with the CME provider. CMS' comments in the proposed rule seem to recognize that accredited programs do not directly pay speakers or select educational content, but we want to make sure this point is very clear. 

The CME exemption is  very important for CME attendees. CME providers who receive commercial support as part of the educational activity may also provide educational items, such as slides, abstracts, and handouts. Currently, the CME exemption excludes reporting of those items.  Without the specific exemption, learners may be less willing to participate in sessions where the value of the CME is being reported against them, despite the fact that the support for the program was independent. CMS may be unaware that collecting information on attendees to accredited CME events and assigning value to their attendance may severely hinder the free flow of medical information. 

Another impact of the proposed guidance would be on medical conventions. At conventions, for example, manufacturers become "aware" of participants through their exhibits. Any commercial support for those annual meetings, including general meeting support, may be considered reportable to anyone who visits the exhibit hall. This could also have the same effect to online sites that mimic conventions and have areas where "participants" visit on line exhibits.

Industry-supported CME remains a vitally important resource for doctors to learn cutting edge information at a rapid pace. Diminishing support has been shown to hinder the adoption of important new therapies. Our concern is that continuing medical education may significantly suffer because CMS has removed this one bit of certainty from the Sunshine Act Open Payments Program.

Comments

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 2, 2014. In commenting, please refer to file code CMS-1612-P.

  • Electronically. You may submit electronic comments on this regulation to www.regulations.gov. Follow the instructions for "submitting a comment."
  • By regular mail. You may mail written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, 2 Attention: CMS-1612-P, P.O. Box 8013, Baltimore, MD 21244-8013.
  • By express or overnight mail. You may send written comments to the following address ONLY: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1612-P, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

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