Policy and Medicine

Physician Payment Sunshine: Rockpointe a Medical Education Company Comments to CMS

Rockpointe, Inc. recently submitted comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.  

Founded in 1995, Rockpointe is a privately held business with twenty-eight employees located in Columbia, Maryland.  Through its subsidiary company, Potomac Center for Medical Education (PCME), and other accredited organizations, Rockpointe/PCME plans and implements accredited continuing medical education (CME) activities for physicians, pharmacists and nurses.   

Rockpointe/PCME is accredited by the Accreditation Council of Continuing Medical Education (ACCME) and the Accreditation Council for Pharmacy Education (ACPE) and strictly adheres to the ACCME Standards for Commercial Support and other relevant guidelines to ensure the independence of CME/CE activities. 

Comments on Sunshine Act 

Rockpointe expressed its concern that as written, the proposed regulations will have a detrimental, albeit unintended, effect on the professional training and education of medical professionals, and ultimately, patient care.  They noted, as many others have, that it was never Congress’s intent to expand the public reporting requirements to include transactions related to the provision of continuing medical education when such payments are made from commercial interests to CME providers without allowing the supporting entity to exercise control regarding presenters, curriculum, or attendees of a given educational program. 

As a result, Rockpointe recommended that CMS exempt from reporting any payments to accredited CME providers.  

Moreover, Rockpointe noted its concern that CME providers will have to report the names of health care professionals who participate in their programs, which they said will deter overall participation and ultimately harm patients.  Many of the CME programs Rockpointe does around the country take place at hospitals and are supported by multiple companies.  Rockpointe noted that, if CME providers are required to report the names and information of participants at programs held at teaching hospitals because the supporter became aware of the identity of the hospital and knew the staff and physicians who worked at the hospital and attended our program, this would be a huge disincentive for the hospital to participate. 

Specifically, the hospital would have to run a conflict of interest screening for all of the attendees and then check the accuracy of the payment data that is submitted for those who attended the program.  There would also be difficulty calculating whether staff attending a CME program at a teaching hospital consumed food.  To reduce the burden on CME providers and teaching hospitals, and to encourage greater participation in these programs, which will lead to better clinical practices and improved patient outcomes, Rockpointe urged CMS to exclude from reporting payments made to accredited CME providers. 

Consequently, as a CME provider, Rockpointe’s comments specifically focused on the nature of the company, its role in providing CME, and the various internal policies, standards and procedures the company goes through to ensure compliance with various CME regulations.  Rockpointe explained how it manages the whole CME process: from applying and drafting educational grant requests, managing funds, developing evidence-based content, recruiting faculty, and everything in between.  

Rockpointe’s description of their robust and transparent procedures clearly demonstrate that the overwhelming majority of CME providers have in place significant firewalls to address any concerns the Sunshine Act was created to address.   In addition, Rockpointe provided its detailed and structured procedures for addressing potential conflicts of interest and managing such potential conflicts through management, mitigation, and disclosure.  

Conclusion 

Rockpointe/PCME’s mission is to create clinically relevant and evidence-based educational interventions, which are objective and balanced.  These interventions seek to bridge professional practice gaps and enhance physician competency. 

The content of the activities designed and developed by Rockpointe/PCME include primary care and specialty topics within the field of medicine.  All content is based upon evidence and addresses the body of knowledge and skills within medical science, the discipline of clinical medicine, and the provision of appropriate patient care.  Moreover, as we have noted, Rockpointe programs have had positive patient outcomes in cardiovascular risk management, chronic heart failure, COPD, and hypertension.  

Ultimately, Rockpointe concluded that, “the proposed reporting provisions of the Sunshine Act create a plethora of issues that were not considered upon inception.”

These conflicts may severely affect the ability of CME providers to produce effective educational activities. 

Accordingly, they urged CMS to consider the burden on accredited providers to report to each covered manufacturer.  Additionally, they noted that faculty payment disclosure has the potential to grossly misrepresent relationships between accredited CME providers, faculty, and manufacturers.  Finally, they recognized that reporting information required by new guidelines also put accredited CME providers at risk of direct non-compliance with ACCME requirements.

Physician Payment Sunshine: PriMed Survey Showed Proposed Rules Could Lead to Misinformation and Negative Impact on CME

PriMed recently submitted comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act. 

Pri-Med is a leading source of CME and clinical information for a community of over 250,000 health care clinicians, the majority of whom are physicians, across the United States.  pmiCME/Pri-Med delivers a network of conferences and digital, multimedia content and online tools designed to help narrow gaps between research and practice and advance the health and health outcomes of patients and communities. 

Comments on Sunshine Act 

PriMed urged CMS to modify the proposed rules to exclude those that require applicable manufacturers to record and report payments that have been independently made by accredited continuing medical education (CME) providers to covered recipients who serve as faculty or contributors when that CME provider is using grant support provided by the applicable manufacturer.  Pried also strongly urged that the proposed rules by CMS completely exclude educational materials provided by accredited CME providers to covered recipients from the reporting provisions as CME activities, are, by definition, conducted for the “direct benefit of patients”. These educational materials include both CME and non-CME materials that are produced by an accredited CME provider that is completely independent from any supporting covered manufacturer. 

PriMed asserted that the proposed rules go beyond the intent of Congress and that the legislation does not include public reporting requirements of transactions related to the provision of CME when such payments are made from covered manufacturers to accredited CME providers.  Accredited CME providers are not covered recipients under PPACA. In addition, to be in compliance with the requirements of the ACCME, accredited CME providers can never be in the position to provide direct or indirect payments on behalf of a covered manufacturer. 

They noted how, “providers must act and implement their activities completely independently of any funder and this means that, by definition, the covered manufacturer cannot in anyway direct or influence any activity or action by an accredited provider, including what payment to make to any faculty. Thus, payments made by an accredited provider can never fulfill the definition of a “direct payment” or payment made by a “third party” at the direction of a covered manufacturer.” 

PriMed emphasized how the ACCME requirements are clear: there can be no involvement of the covered manufacturer beyond providing grant support, which is only made to the accredited provider upon their action of submitting a request for funding to a covered manufacturer.  As a result, they noted that the proposed rules will result in payments made by accredited CME providers being reported in ways that mirror reporting of payments that are actually under the direct control of the covered manufacturers.  As a consequence, the credibility of accredited CME providers will be irreversibly diminished. 

If the proposed rules are codified, PriMed noted that a payment by accredited providers to faculty or participants who are covered recipients will inaccurately be reported as a payment from the covered manufacturer and attributed to a specific drug, device or service of that covered manufacturer, even though such reporting violates the terms under which accredited providers could have accepted such funding from the covered manufacturer. 

Further, they added that, “The reporting will be erroneous because the covered manufacturer, in fact, never made such a payment to a covered recipient.”  Importantly, the proposed rules will undermine the very independence that accredited CME providers must operate within in order to be in compliance with the requirements of the ACCME. 

They also noted how the proposed rules will create reporting burdens on accredited CME providers, many of whom are not staffed and/or resourced sufficiently to meet these requirements.  This will also create reporting relationships between CME providers and covered manufacturers that will result in misleading and erroneous information being communicated to the medical community, patients and consumers. 

Overall, pmiCME/Pri-Med said it was very concerned that the proposed rules will be detrimental, in both the short and long term, to accredited CME providers, the faculty they work with, the healthcare practitioners who they serve, the healthcare system they support and the patients whose healthcare they are committed to improving through education. 

PriMed Survey 

Following the announcement of the proposed rules, PriMed polled their faculty members (i.e. covered recipients) asking them if they were in favor of or opposed to the proposed regulations. Over 188 responded, most within 48 hours after receiving the survey. The feedback that they provided revealed significant insights: 

• 88% believe that classifying CME as a direct payment as stated in the rules will lead to misrepresentation and misinformation of the relationship between commercial supporters and faculty.
• Nearly half the respondents (45%) said they were would not be willing to serve as faculty or contribute to the development of content in any grant-funded CME activities if the HHS’ proposed rules on reporting of physician payments from industry are enforced. 

Overall, the faculty (through open ended comments) expressed deep concern about the ruling and the impact that such a decline in faculty participation would have on patient care and health care quality. They recognized CME as a bridge to health care professional community and patient care, and believe that today’s complex health care environment requires physicians to be even more in tune to the latest advances in science and medicine.  Faculty expressed three main concerns: 

• Concern #1: The regulations will create a financial relationship between the applicable manufacturer and faculty, who is a covered recipient, by reporting a direct payment relationship under the direction of the manufacturer, when the payment was not received from that manufacturer 
• Concern #2: Reluctance to serve as faculty because the reporting requirements would result in incorrect perception that they are receiving a direct benefit from industry 
• Concern #3: Negative impact such requirements would have on the quality and overall availability of CME and interaction with expert faculty, and ultimately patient care 

Ultimately, to meet the demands ahead, PriMed noted that the clinician community needs more, not fewer, opportunities for CME across the continuum of live, online and mobile formats that is easily accessible in order to bring the best care to those who need it.  Therefore, they recommended exempting payments to accredited CME providers from reporting. 

Physician Payment Sunshine: Links to Comments to CMS

Mid-February marked the deadline for stakeholders to submit their comments on the proposed regulations from the Centers for Medicare and Medicaid Services (CMS) that would implement Section 6002 of the Affordable Care Act (ACA)—also known as the Physician Payment Sunshine Act.  A large group of organizations submitted comments, and we have the privilege of reviewing many of them.  

We have prepared links to select comments on the proposed rule and summaries of several comments.    

Accreditation Council for Continuing Medical Education

 AdvaMed

Alliance for Continuing Education in the Health Professions

American Academy of Allergy, Asthma & Immunology (AAAAI)

American Academy of Dermatology

American Academy of Family Physicians (AAFP)

American Academy of Hospice and Palliative Medicine (AAHPM)

American Academy of Neurology (AAN)

American Academy of Ophthalmology (AAO)

American Academy of Orthopedic Surgeons (AAOS)

American Academy of Otolaryngology-Head and Neck Surgery (AAOHNS)

American Academy of Pediatrics (AAP)

American Academy of Physical Medicine and Rehabilitation (AAPMR)

American Association for the Study of Liver Disease (AASLD)

American Association of Clinical Endocrinologists (AACE) 

American Association of Family Physicians (AAFP)

American Association of Medical Colleges

American College of Cardiology (ACC)  

 American College of Chest Physicians (ACCP)

American College of Emergency Physicians (ACEP)

American College of Medical Genetics (ACMG)

American College of Obstetricians & Gynecologists (ACOG)

American College of Occupational and Environmental Medicine (ACOEM)

American College of Physicians (ACP)

American College of Preventive Medicine (ACPM)

American College of Radiology (ACR)

American College of Rheumatology (ACR)

American College of Surgeons (ACS)

American Geriatrics Society (AGS)

American Medical Association

American Medical Informatics Association (AMIA)

American Pharmacist Association

American Psychiatric Association

American Society for Clinical Pathology (ASCP)

 American Society for Reproductive Medicine (ASRM)

American Society of Clinical Oncology (ASCO)

 American Society of Clinical Pathologists (ASCP)

American Society of Colon and Rectal Surgeons (ASCRS)

American Society of Hematology (ASH)

American Society of Nephrology (ASN)

American Society of Nuclear Cardiology

American Society of Plastic Surgeons (ASPS)

American Society of Transplant Surgeons ASTS

American Thoracic Society (ATS)

American Urological Association (AUA)

Annenberg Center for Health Sciences

Association for Hospital Medical Education

Association of Black Cardiologists (ABC)

Association of Clinical Research Organizations (ACRO)

Association of Clinical Researchers and Educators (ACRE)

Association of Community Cancer Centers

Association of Health Systems Pharmacists

BIO

California Association of Family Physicians (CAFP)

Clinical and Patient Educators Association

CME Outfitters

Coalition for Healthcare Communications

Continuing Medical Education (CME) Coalition

Council for Medical Specialty Societies (CMSS)

CSL Behring

Endocrine Society

Federation of State Medical Boards

Genentech

Global Education Group

Healthcare Institute of New Jersey

Heart Rhythm Society

Illionis State Medical Society

 IMEDEX

Life Science Alley (Minnesota Device Community)

Medical College of Wisconsin

Medical Communication Media

Medical Device Manufacturers Association

Medical Imaging and Technology Alliance

Medical Society of New Jersey

Meeting Resources Unlimited

Mercy Hospitals

NAACME

National Association of Medical Education Companies (NAMEC)

National Medical Association
North American Spine Society (NASS)

Novartis

Pfizer

PhRMA

PRIME Oncology

PriMed

Rockpointe, Inc.

Society of Academic Continuing Medical Education (SACME)

Society of Critical Care Medicine

Society of Critical Care Medicine (SCCM)

Society of Hospital Medicine (SHM)

Society of Neurological Surgeons (SNS)

Society of Nuclear Medicine (SNM)

Society of Thoracic Surgeons (STS)

Southern Medical Association

Teva Pharmaceuticals

Texas Alliance for CME

Transparency Coalition

Washington University in St. Louis

Below is just a brief summary of several organizations comments.  If your organization would like to be included in this list of comments please leave a comment. 

Alliance for Continuing Education in the Health Professions (Alliance)

The Alliance offered its support for CMS’ efforts to shed light on direct payments from product manufacturers to physicians and other medical practitioners.   However, after careful review, the Alliance urged CMS to exclude from reporting (1) indirect payments related to the provision of accredited and certified continuing medical education (CME) and (2) educational materials provided to healthcare providers that directly benefit patients.

American Association of Family Physicians (AAFP)

The AAFP asserted that the proposed rule “fails to address adequately the need for robust safeguards so that CMS posts only accurate information online.”  Erroneous and potentially negligent reporting practices could be misleading and have severe implications for a physician's credibility with patients.  The AAFP therefore encouraged CMS to reexamine the agency’s role and responsibilities to prevent the dissemination of inaccurate or disputed data. 

They urged CMS to establish a uniform, national, and mandatory data verification and arbitration process.  This should involve an ongoing pre-review ability so physicians can easily identify and quickly resolve conflicts before inaccurate information becomes publicly available.  AAFP does “not support any proposals that attempt to sidestep inevitable disputes by merely publishing both the applicable entity’s reported value and the physician's self-reported amount.” In addition, AAFP wants CMS to structure the review and arbitration process such that physicians do not incur legal fees to defend themselves from erroneous manufacturer reporting. 

AAFP also strongly urged CMS to clarify in the final rule that all certified and accredited CME activities are excluded from reporting. AAFP also expressed its concern that reporting requirements could deter physicians’ willingness to conduct medical research.  AAFP encouraged CMS to specify that reporting requirements do not apply to clinical research when funds are indirectly made to the researcher.  In addition, AAFP also urged CMS to specify in the final rule that approved clinical research subject to “human subjects IRB review” is excluded from these reporting requirements since most clinical research already requires that financial ties to manufacturers be disclosed. 

American Association of Clinical Endocrinologists (AACE) 

AACE noted that, given the volume of data that will be collected, reported and publicly disclosed, there is great potential for errors in reporting, and misinterpretation and misunderstanding of the reported information among patients. ACCE is “extremely concerned the ensuing confusion will impugn the inherent trust that we share with our patients and unnecessarily undermine the physician-patient relationship, with secondary adverse impact on the delivery of healthcare in this country.”

Accordingly, they urged CMS to adopt the following recommendations in the final rule promulgated for Section 6002 of the ACA to alleviate what we believe are significant adverse consequences that will result from provisions contained in the proposed rule:

1. The public website should explain the nature of relationships between physician and industry; why they exist and affirm that these relationships have been overwhelmingly consistent with ethical standards and have resulted in tremendous benefits for patients, healthcare professionals and public health.
2. The rule should be consistent and follow the statutory provisions and the intent of Congress. The definition of “covered recipient” does not include third parties, and, therefore, payments received by third parties from an applicable manufacturer(s) should be exempt from Section 6002 reporting requirements.  
3. CMS should recognize the current safeguards in place under the ACCME® Essential Areas, Their Elements and Standards for Commercial Support and not create new burdens that will complicate and compromise the ability of ACCME® accredited CME providers to sponsor high-quality objective CME.  
4. The proposed rule is very ambiguous with respect to defining what terms mean, e.g. an agent of the manufacturer, and providing specific guidance on the collection and reporting of data to ensure payments and transfers of value to covered recipients are accurately attributed. They strongly urged CMS to more precisely define terms and provide specific guidance on issues related to the collection and reporting of data in the final rule.  
5. It will be equally important to monitor the impact of the new transparency reporting requirements to ensure they do not impede medical education, healthcare quality and the innovation that has become the hallmark of American medicine and has made American healthcare the envy of the world. Indeed, CMS states in the proposed rule that it has “no empirical basis for estimating the frequency of such problems, the likelihood that transparent reporting will reduce them, or the likely resulting effects on reducing the costs of medical care.”

American College of Cardiology(ACC)

The ACC echoed others in noting that CMS interpreted Sec. 6002 too broadly, and its proposed method of implementation demonstrates a lack of understanding regarding the current state of these relationships and industry donations to physicians and physician-involved activities.  Specifically, they noted that if adopted as currently drafted, the regulations could hinder the ability of medical speciality societies such as ACC to obtain commitments from physicians to volunteer and participate in collaborative activities whose purpose is to improve patient care because there may somehow be industry funding for the activity or the organization, no matter how tangential that funding is to such activity.  ACC urged CMS to redraft the rule to indicate that volunteerism is to be encouraged and that industry funding of organizations or activities does not automatically taint said organizations or participants. 

ACC also urged that CMS limit the reporting of indirect payments or transfers of value to those made at the behest of or designated on behalf of a covered recipient.  They also strongly recommended that CMS limit indirect payments or transfers of value requiring reporting to those that truly are under the control of a covered recipient and truly have the potential to affect the covered recipient’s neutrality as intended by the statute.  

ACC also stated its belief that funding for accredited and certified educational programs should not be considered a source of indirect funding for those participating in CE, regardless of capacity, and should not be attributed to faculty.  They urged CMS to make clear that recipients of funding for certified CME programs are not required to provide applicable manufacturers with attendee lists.   

Association of Black Cardiologists (ABC)

ABC noted that the information that is disclosed must be relevant, placed in the proper context, and organized in a way that is understandable to the general public.  They expressed their concern that the provisions of this proposed rule do not accomplish this objective.  ABC is concerned that the proposed rule goes far beyond congressional intent and the statute because it would impose substantial and sweeping reporting and record-keeping requirements across a community of stakeholders not intended by Congress, including medical professional societies that offer Continuing Medical Education (CME) programs to members.   

ABC believes that the proposed rule has the potential to interfere with legitimate relationships between industry and professional associations, and could have the unintended consequence of severing legitimate relationships between manufacturers and individual members of a medical professional society. Further, they are concerned that the rule has inadequate safeguards to prevent the dissemination of misleading or false information regarding payments from manufacturers to individual physicians, and there is no adequate process in the rule to allow physicians to correct potential misinformation. 

ABC also believes that CMS has not taken into account the complexity of complying with the proposed rule’s provisions and therefore has not given adequate thought to the administrative burden that would be placed on physicians and third parties. 

Association of Clinical Researchers and Educators (ACRE)  

ACRE requested that CMS consider the manifest benefits Americans have received from physician-industry collaboration and the threats the proposed regulations pose for these relationships.  They urged CMS more vividly to envision the important and necessary collaboration that physician, academia and industry must have in order to produce new life saving medicines and the chilling effects of this Act on collaboration. 

ACRE asked that CMS reevaluate the proposed regulations, particularly in light of the significant disproportion between their manifest costs and their uncertain, remote and speculative benefits.  

They noted how the “Regulatory compliance will consume resources that would be better directed to enhancing the value of care physicians provide to patients through development of better medicines and devices.”  It is ACRE’s view “that these regulations will impose undue regulatory burdens on medical products companies, discourage research, severely discourage scientific progress, and deny patients of benefit from the innovations that would be slowed down or eliminated as a result of the increased scrutiny and focus on administration over research.”  

ACRE noted that, “The intimidating and burdensome consequences of implementing the Sunshine Act will be detrimental to the speed of the process and in many instances may curtail it entirely. Furthermore, the evidence that there is harm in these collaborations is nil to nonexistent, while the benefits are large and easily demonstrable.” 

They explained how, “Very few people and especially patients come even close to having the experience or training to comprehend the minute and complex information that will accumulate under the Sunshine regulations.” 

Association of Clinical Research Organizations (ACRO)

ACRO expressed its concern that that CMS did not seek sufficient consultation and feedback from the affected industry, particularly in regards to payments to covered recipients for research; an impression strongly supported by the inadequate and confusing explanations relating to payments and transfers of value for research in the above-referenced proposed rule. 

ACRO strongly believes that payments made by manufacturers to fund (support or purchase) legitimate research activities, including those activities related to the conduct of clinical trials should have been exempted from the Act (and from the implementing regulation) as there is no evidence that such payments bias prescribing or other practice behavior.

ACRO asserted that payments made to support or purchase clinical research activities from physicians and teaching hospitals are, simply, fair-market payments for goods (e.g., laboratory tests) and services (e.g., physical examinations) and should be exempted.  It is for this reason that several State “sunshine” statutes, such as Vermont’s, exclude from reporting payments made for bona fide research activities, and ACRO strongly believes that such payments should no more be included in a public database than should payments made to physicians and teaching hospitals by CMS itself to purchase goods and services for Medicare beneficiaries. 

ACRO noted that a 2010 survey of US physicians who conduct clinical trials (investigators) showed that 24 percent would be less likely to participate in research or would not participate at all if the revenues (note: not revenues in excess of expenses or ‘profits’, but gross revenues – which is what the proposed rule would require) were disclosed by HHS. One reason for this, we believe, is physician concern that the data will be highly susceptible to misinterpretation. 

ACRO believes that CMS should replace the proposed standard for research payments or transfers of value with a regulation that provides that in instances where a manufacturer (or CRO on its behalf) does not know the value of specific payments or imputed benefits that are presumed to flow to individual covered recipients and the payment or transfer is not made at the request of a covered recipient or designated on behalf of a covered recipient, such payments or transfers are not reportable. 

Council for Medical Specialty Societies (CMSS)

CMSS noted how in the context of Accredited and Certified CME, direct payments to physicians (either in the role of faculty or attendees) by applicable manufacturers are prohibited, cannot occur, and therefore would be irrelevant when it comes to disclosure under the PPSA.  Furthermore, applicable manufacturers will not be in a position to report, as they have no relationships with CME faculty, either directly or indirectly, even if they subsequently become aware of the identities of the faculty members.  They maintained that Payments made by a CME Provider to faculty of Accredited and Certified CME activities are not reportable under Sec. 6002 of the PPACA. 

CMSS maintained that the final rule needs to clarify that grants from applicable manufacturers to CME Providers for Accredited and Certified CME activities do not constitute an indirect transfer of value, either to faculty independently selected and paid by the CME Provider, or to participants in the Accredited and Certified CME activity. Neither faculty nor participants in Accredited and Certified CME activities have relationships established with applicable manufacturers by virtue of the manufacturer making an educational grant to the CME Provider under the ACCME Standards for Commercial Support of continuing medical education. 

CME Community Leaders 

Comments were submitted on behalf of:

• Murray Kopelow, MD, MS(Comm), FRCPC, Chief Executive and Secretary, Accreditation Council for Continuing Medical Education (ACCME)
• Andrew T. Filak, Jr., MD, President Association for Hospital Medical Education (AHME)
• Martin S. Levine, DO, President American Osteopathic Association (AOA)
• Norman Kahn, MD, Executive Vice President and CEO, Council of Medical Specialty Societies (CMSS)
• Humayun J. Chaudhry, DO, FACP, President and Chief Executive Officer Federation of State Medical Boards (FSMB)
• Gabrielle Kane, MB, EdD, FRCPC, President, Society for Academic Continuing Medical Education (SACME)
• James L. Madara, MD, Executive Vice President, CEO, American Medical Association (AMA)
• Roland A. Goertz, MD Chair, Board of Directors, American Academy of Family Physicians (AAFP); and
• Damon K. Marquis, MA, MS, FACME, President, Alliance for Continuing Education in the Health Professions (ACEHP) 

This group of leaders noted that language of the PPSA as adopted appropriately addressed a few specific issues, which appear in the proposed rule to need clarification and modification, to avoid unintended consequences. These issues include: 

1. Distinguishing between Accredited and Certified CME offered by CME providers, and promotional education offered by pharmaceutical and medical device manufacturers;
2. Recognizing the roles and relationships that faculty in Accredited and Certified CME programs have with CME Providers and not with companies which may provide grants to CME Providers; and
3. Recognizing that attendees at or participants in Accredited and Certified CME programs have no relationships with companies which may provide grants to CME Providers. 

Continuing Medical Education (CME) Coalition

The Coalition asserted how it “was never the intent of Congress to expand the public reporting requirements to include transactions related to the provision of continuing medical education when such payments are made from commercial interests to CME providers without allowing for the supporting entity to enjoy any control regarding either the presenters, the curriculum, or the attendees of a given educational program.”  

In a very detailed and comprehensive review of the CME industry, CME stakeholders, and CME regulations, standards and rules, the Coalition addressed a number of concerns to CMS.  The Coalition cited the declining amount of commercial support for CME and the impact this has had on both CME providers and CME participants.  The comment also focused on the positive outcomes commercially supported CME has produced by improving patient outcomes in areas such as COPD and hypertension.   

Additionally, the Coalition provided an in depth analysis of the FDA, AMA, PhRMA, AdvaMed, ACCME Standards for Commercial Support, and HHS OIG, rules, standards, guidance, and regulations regarding commercially supported CME.  The Coalition pointed to the important role CME plays in meeting FDA’s required risk evaluation and mitigation strategy (REMS).   

The comment also discussed findings from a 2007 U.S. Senate Finance Committee report on use of educational grants by manufactures.  The Finance Committee report found, amount other things, that “the pharmaceutical industry is paying increased attention to educational grants and its compliance with fraud and abuse laws,” and that “major drug companies have limited the direct involvement of field sales representatives and sales and marketing departments in the educational grant-making process.” The Coalition also referenced how compliance with the Sunshine regulations for CME providers would be overly burdensome and contrary to Executive Order 13563, which called on agencies to propose or adopt regulations that “impose the least burden on society.”  

Coalition for Healthcare Communications

CHC expressed its concern that the current proposal by HHS leads to many unnecessary and significant complexities, increases costs and creates public perception issues that must be addressed fully before final rules are adopted.  They noted that publishing the data will almost certainly lead to unintended consequences, particularly a tendency by medical professionals to avoid activities that trigger reporting. Moreover, the reports themselves may mislead patients, caregivers and professionals by casting a negative pall over these relationships. The result could well be decreased collaboration between medical professional and industry, leading to less research, longer drug development and adoption times, and less education for prescribers – all of which are detrimental to the public health. 

As a result, they recommended that further notice and comment are needed to ensure proper context and accuracy of the data.  They also noted that the current proposals are not adequate to ensure that the reports will be accurate.  Accordingly, CHC strongly urged a further notice and comment period on contextual and accuracy issues. 

CHC was also concerned that the HHS uses its rulemaking discretion to broaden the reporting requirements and in some cases increase, rather than decrease, the cost and reach of the statute. Instead, the CHC urged HHS to hone the rules to more accurately reflect the legislative intent and specific language of the statute and, wherever possible, narrow its burdens and reach.  Specifically, CHC urged HHS to abandon its attempt to include indirect payments because not doing so is not in the best interest of the public health, is inconsistent with the statute and will invite litigation that is unnecessary and expensive. 

National Association of Medical Education Companies (NAMEC)

The Alliance expressed its concern with the intent to assign applicable manufacturers with responsibility for reporting and recording payments independently made by accredited CME providers to covered recipients who serve as faculty for CME activities conducted by those accredited CME provider using grant support provided by the applicable manufacturer.  NAMEC urged CMS to exclude from reporting payments made to accredited CME providers.  

NAMEC Survey 

In addition to their overall comments, NAMEC also conducted an online survey of their members in early February.  54 Member Organizations responded.  Respondents also provided data and quotes from surveys that they fielded to their faculty.  The survey asked questions related to the impact of the proposed Sunshine rules relative to CME providers and reporting of payments to CME faculty and educational materials.  The survey indicated that NAMEC members highly concerned about proposed rules: 

• Reporting burdens and corresponding expenses (> 85% agree or strongly agree)
• Loss of CME funding (76.5% of agree or strongly agree) and resultant loss of CME positions in their organizations
• Loss of expert faculty participating in CME activities funded by covered manufacturers
• Loss of reputation /credibility of CME providers and of CME
• Reduction in quality of CME and resulting negative impact on healthcare
• Misrepresentation of how CME providers and faculty manage funding from covered manufacturers; inability to meet accrediting organization requirements if accept funding from covered manufacturers (>95% agree or strongly agree) 

Faculty are also highly concerned and share many of the concerns of CME providers:

Misrepresentation of financial relationship between CME faculty and covered manufacturers

• Decreased willingness to participate as CME faculty if proposed rules implemented
• Limitations to participating in CME activities
• Healthcare will be adversely impact if faculty educators reduce or eliminate participation in CME if proposed rules are implemented (78.8% of members) 

Almost all members responded that the proposed rules will have significant financial impact on their organizations, with approximately 47% estimating this cost to be at least $50,000 and escalating to >$150,000. 

PhRMA Comments on Physician Payment Sunshine Proposed Rule (coming soon) 

PriMed Comments on Physician Payment Sunshine Proposed Rules 

PriMed urged CMS to modify the proposed rules to exclude those that require applicable manufacturers to record and report payments that have been independently made by accredited continuing medical education (CME) providers to covered recipients who serve as faculty or contributors when that CME provider is using grant support provided by the applicable manufacturer.  PriMed also strongly urged that the proposed rules by CMS completely exclude educational materials provided by accredited CME providers to covered recipients from the reporting provisions as CME activities, are, by definition, conducted for the “direct benefit of patients”. These educational materials include both CME and non-CME materials that are produced by an accredited CME provider that is completely independent from any supporting covered manufacturer. 

PriMed asserted that the proposed rules go beyond the intent of Congress and that the legislation does not include public reporting requirements of transactions related to the provision of CME when such payments are made from covered manufacturers to accredited CME providers.  Accredited CME providers are not covered recipients under PPACA. In addition, to be in compliance with the requirements of the ACCME, accredited CME providers can never be in the position to provide direct or indirect payments on behalf of a covered manufacturer. 

They noted how, “providers must act and implement their activities completely independently of any funder and this means that, by definition, the covered manufacturer cannot in anyway direct or influence any activity or action by an accredited provider, including what payment to make to any faculty. Thus, payments made by an accredited provider can never fulfill the definition of a “direct payment” or payment made by a “third party” at the direction of a covered manufacturer.” 

Rockpointe, Inc. Comments on Physician Payment Sunshine Proposed Rule 

Rockpointe expressed its concern that as written, the proposed regulations will have a detrimental, albeit unintended, effect on the professional training and education of medical professionals, and ultimately, patient care.  They noted, as many others have, that it was never Congress’s intent to expand the public reporting requirements to include transactions related to the provision of continuing medical education when such payments are made from commercial interests to CME providers without allowing the supporting entity to exercise control regarding presenters, curriculum, or attendees of a given educational program. 

As a result, Rockpointe recommended that CMS exempt from reporting any payments to accredited CME providers.  

Moreover, Rockpointe noted its concern that CME providers will have to report the names of health care professionals who participate in their programs, which they said will deter overall participation and ultimately harm patients.  Many of the CME programs Rockpointe does around the country take place at hospitals and are supported by multiple companies.  Rockpointe noted that, if CME providers are required to report the names and information of participants at programs held at teaching hospitals because the supporter became aware of the identity of the hospital and knew the staff and physicians who worked at the hospital and attended our program, this would be a huge disincentive for the hospital to participate. 

Society of Academic Continuing Medical Education SACME Comments on Physician Payment Sunshine Proposed Rule 

SACME asserted that, “more clarity is needed to ensure that the interpretation of the Sunshine Act does not go beyond the intent of the original Act.”  They maintained that, “Movement from the original intent of PPSA would have a chilling effect on the lifelong learning process of physicians and thus be contrary to the best interest of the public.” 

SACME noted how “the proposed Rules [as they] relate to Continuing Medical Education (CME) … do not take into account the processes that currently exist for independent, accredited and certified CME.”  They pointed to the Accreditation Council for CME (ACCME) Standards for Commercial Support, which they noted, “mandate clear separation between commercial interests and development, delivery and evaluation of any certified CME activity developed by an ACCME accredited provider.” 

Accordingly, SACME asserted that, “The inclusion of independent, accredited and certified CME with industry developed and presented instruction loses sight of the elemental difference between the two: independent, accredited and certified CME has as its primary goal the improvement of the health of patients and populations through the education of their healthcare providers while industry provided instruction is often designed to promote drug or device company business interests in addition to inform physicians about company products.” 

Consequently, SACME urged CMS to exclude independently developed, accredited and certified CME from reporting.

Physician Payment Sunshine: Over 100 Organizations ask CMS to Scrap the Current Dispute Resolution Process

As we have noted over the past few weeks, many health care groups and organizations have been submitting comments on the proposed regulations that would implement Section 6002 of the Patient Protection and Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act. 

As reported by MassDevice.com, almost 100 groups last week submitted comments expressing their concern about the proposed regulations and the impact they will have on practicing physicians.  These groups, including the American Medical Association (AMA) and the Society for Vascular Surgery pushed back against the current format of the Sunshine Act, “warning that the rule doesn't do enough to protect the reputations of physicians in case of a dispute.”   

These groups urged the Centers for Medicare and Medicaid (CMS) to make changes to the provision, which requires drug and device manufacturers to begin reporting gifts or payments worth more than $10. The reporting will begin at a time determined once CMS publishes the final rule.  The result, a searchable database containing the names and addresses of each recipient and the details of the payments, will be made publicly available sometime in 2013.

 

The act also mandates stiff penalties for companies that fail to comply. Companies found to inadvertently omit reports could ring up civil fines of between $1,000 and $10,000 "for each payment or other transfer of value or ownership or investment interest not reported," according to the act.  Companies found to knowingly skirt the reporting rules could be slapped with fines of $10,000 to $100,000.  The total amount of fines can't exceed $1 million, or 0.1 percent of total annual revenues, in a single year. 

While AMA and other health groups supported the intention of the act, “they warned that physicians need better safeguards and pathways to challenge payments.”  The proposed rule excludes CMS from involvement in any disputes between manufacturers and physicians, a hands-off approach that has industry groups worried.  Instead, CMS noted that it would basically put an asterisk (*) next to a doctors name for the specific payment, indicating that the physician or teaching hospital had challenged the payment.  Not many other details were provided or proposals indicating a formal or administrative grievance process to challenge such mistakes. 

 

"False, misleading, and inaccurate information could be publicly posted on a government website while denying physicians basic due process rights to challenge such information," according to the letter, signed by groups including the American College of Cardiology, the American Assn. of Orthopedic Surgeons and the Society of Thoracic Surgeons. 

The groups urged rule-makers to establish an independent arbiter to mediate disagreements and provide physicians with an avenue to dispute entries in the public database with a written response in the interest of protecting a physician's good name.

 

"A few disputes between a manufacturer and a handful of physicians are unlikely to ruin a manufacturer/GPO's standing or even subject the manufacturer/GPO to civil money penalties," the groups wrote. "In contrast, physicians may have their careers and professional reputations damaged as a result of one disputed report, and physicians may incur significant expenses to resolve a dispute with a manufacturer/GPO." 

"We strongly urge CMS to re-structure the process the agency has outlined," the health groups wrote. "The proposed rule opens the door to the real possibility that a large number of physicians could become the victims of false, inaccurate, or misleading reporting and suffer significant damages including investigation by government and private entities, potential disciplinary actions, public censure, ridicule, and destruction of professional reputation and livelihood."

 

The full list of co-signers of the letter includes: 

American Medical Assn.
Aerospace Medical Assn.
American Academy of Dermatology Assn.
American Academy of Family Physicians
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Physical Medicine and Rehabilitation
American Assn. of Clinical Endocrinologists
American Assn. of Clinical Urologists
American Assn. of Neurological Surgeons
American Assn. of Neuromuscular and Electrodiagnostic Medicine
American Assn. of Orthopaedic Surgeons
American College of Cardiology
American College of Chest Physicians
American College of Emergency Physicians
American College of Mohs Surgery
American College of Osteopathic Family Physicians
American College of Osteopathic
American College of Osteopathic Surgeons
American College of Phlebology
American College Radiology
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Gastroenterological Assn.
American Medical Group Assn.
American Osteopathic Academy of Orthopedics
American Osteopathic Assn.
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Pediatric Nephrology
American Society for Radiation Oncology
American Society of Cataract and Refractive Surgery
American Society of Echocardiography
American Society of Hematology
American Society of Nuclear Cardiology
American Society of Plastic Surgeons
American Thoracic Society
American Urogynecologic Society
American Urological Assn.
College of American Pathologists
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council of Allergy, Asthma and Immunology
Medical Group Management Assn.
Renal Physicians Assn.
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery
Society of Gynecologic Oncology
The Endocrine Society
The Society of Thoracic Surgeons
Medical Assn. of the State of Alabama
Alaska State Medical Assn.
Arkansas Medical Society
California Medical Assn.
Connecticut State Medical Society
Medical Society of Delaware
Medical Society of the District of Columbia
Florida Medical Assn. Inc
Hawaii Medical Assn.
Idaho Medical Assn.
Illinois State Medical Society
Iowa Medical Society
Kansas Medical Society
Kentucky Medical Assn.
Louisiana State Medical Society
Maine Medical Assn.
MedChi, The Maryland State Medical Society
Massachusetts Medical Society
Michigan State Medical Society
Minnesota Medical Assn.
Mississippi State Medical Assn.
Missouri State Medical Assn.

Montana Medical Assn.
Nebraska Medical Assn.
Nevada State Medical Assn.
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 Assn.
Ohio State Medical Assn.
Oregon Medical Assn.
Pennsylvania Medical Society
Rhode Island Medical Society
South Dakota State Medical Assn.
Tennessee Medical Assn.
Texas Medical Assn.
Utah Medical Assn.
Vermont Medical Society
Medical Society of Virginia
West Virginia State Medical Assn.
Wyoming Medical Society

Physician Payment Sunshine: Association of Clinical Researchers and Educators asks CMS to Reevaluate the Proposed Regulations

The Association of Clinical Researchers and Educators (ACRE), recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.   

ACRE, founded in 2009, is a non-profit organization of medical professionals who recognize that physician-industry collaborations and relationships benefit patients and advance science.  ACRE provides a forum for physicians and industry partners to further such collaborations, and to advocate on behalf of better patient care. ACRE is lead by a steering committee of physicians from major medical institutions.  

ACRE members include active practitioners of diverse medical specialties and subspecialties, medical society leaders and distinguished educators and researchers at academic centers and others in industry, who are engaged in promoting excellence in medical service, education, and innovation with substantive records of accomplishment in these endeavors. 

Comments on Sunshine 

ACRE requested that CMS consider the manifest benefits Americans have received from physician-industry collaboration and the threats the proposed regulations pose for these relationships.  They urged CMS more vividly to envision the important and necessary collaboration that physician, academia and industry must have in order to produce new life saving medicines and the chilling effects of this Act on collaboration. 

ACRE asked that CMS reevaluate the proposed regulations, particularly in light of the significant disproportion between their manifest costs and their uncertain, remote and speculative benefits. 

They noted how the “Regulatory compliance will consume resources that would be better directed to enhancing the value of care physicians provide to patients through development of better medicines and devices.”  It is ACRE’s view “that these regulations will impose undue regulatory burdens on medical products companies, discourage research, severely discourage scientific progress, and deny patients of benefit from the innovations that would be slowed down or eliminated as a result of the increased scrutiny and focus on administration over reaseach.” 

ACRE noted that, “The intimidating and burdensome consequences of implementing the Sunshine Act will be detrimental to the speed of the process and in many instances may curtail it entirely. Furthermore, the evidence that there is harm in these collaborations is nil to nonexistent, while the benefits are large and easily demonstrable.” 

They explained how, “Very few people and especially patients come even close to having the experience or training to comprehend the minute and complex information that will accumulate under the Sunshine regulations.” 

Accordingly, ACRE’s concern “is that companies and physicians will spend countless hours ensuring the accuracy of information that has not been shown to have any benefit to patients. Literally billions will be spend to Sunshine compliance that will never be utilized by patients. The likelihood is just like the computer software, the vast majority of American’s will simply ignore the information even if presented at their point of care as no one really cares.” 

The maintained that, “the most destructive aspect of Sunshine is its flawed premise that every payment presents a conflict of interest. The fact is that payment information can serve either good or bad purposes.” 

The “good” outcome “sunshine” advocates claim is that “transparency” will rein in medical care costs based on the absolutely unproven and arguably false premise that industry payments to physicians drive overprescribing of unnecessary and overly expensive brand products.  ACRE noted how products constitute less than 10% of health care spending and practitioners prescribe generics over 75% of the time.”  In addition, third party payers routinely limit payment and reimbursement to those medical products which have demonstrated both safety and efficacy in the diseases for which they are prescribed. More importantly, “innovative medical products, acquired through paid collaborations between physicians and industry, help prolong life and improve life quality, considerations as or more important than costs.” 

ACRE also recognized how “Payment data of the kind that will be published under the Sunshine Act has already been published for several years under various corporate integrity agreements that manufacturers have negotiated with the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS). However, ACRE said it was “not aware of any study showing that patients have benefited in any way, nor have savings in health care costs been achieved.” 

For example, they noted how payment data have been published in Massachusetts for two years now however, “There has been no research or evidence indicating that patients have benefited from the publication of such payments or the State has reduced its medical costs or improved health outcomes.”  More to the point – there have been negative effects of these regulations as relates to innovation and physician education – see Wolf DW. 

ACRE maintained that, “How these data are to be taken in the context of analyzing scientific research is unknown and merely will serve the interests of fascinated individuals (certainly not patients or researchers). Without context, these data cannot be interpreted; intentionality, influence, alleged corruption and causality cannot be defined by the data alone.” 

ACRE also expressed its concern, “that the tremendous burden of additional work that manufacturers, physicians, and teaching hospitals will have to do, and the amount of money and time they will have to allocate to compliance is an immense diversion of already limited and diminishing resources better spent on innovation and education. Money spent on implementing Sunshine regulations will not improve patient or clinical outcomes or reduce health care system costs, and will unnecessarily divert resources away from more productive activities.” 

They noted further how “the publication of such payments without any context will discourage physicians from productive collaborations with industry. This will only further accelerate clinical research leaving the U.S.” 

ACRE also provided specific comments, echoing many of the same concerns that other organizations have expressed, with regard to exempting third parties and accredited CME providers from reporting; providing adequate context on the public website; etc. 

Ultimately, ACRE noted that, “The academic and scientific return on investment for sunshine is negative. The evidence of risk or harm is nil but the bureaucratic consequences of implementation will lead to diversion of increasingly limited resources for these new reporting requirements.”  They concluded by noting that, “Americans need jobs today, and current clinicians and researchers need to maintain the relationships they have with industry to ensure that new scientific advances and technological breakthroughs continue.”

Physician Payment Sunshine: CME Coalition Comments Sunshine May Cost CME Providers $170 Million

The CME Coalition (“Coalition”), recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.  The Coalition estimates that the rule as proposed could cost CME providers almost $170 million over three years.

The CME Coalition represents a collection of continuing medical education provider companies, in addition to other supporters of CME and the vital role it plays in our health care system. Their member organizations manage and support development of healthcare continuing education programs that impact more than 500,000 physicians, nurses and pharmacists annually. 

Comments on Sunshine 

The Coalition asserted how it “was never the intent of Congress to expand the public reporting requirements to include transactions related to the provision of continuing medical education when such payments are made from commercial interests to CME providers without allowing for the supporting entity to enjoy any control regarding either the presenters, the curriculum, or the attendees of a given educational program.” 

“If left unaddressed, the Sunshine Act reporting requirements will create the erroneous impression that CME instructors have an inappropriate relationship with the commercial organizations that support the programs that include them through grants and other means,” said the Coalition.  It will also foster the impression that attendees of commercially supported CME programs are inappropriately benefiting from these commercial companies.

“These misimpressions, and the stigma that attaches to them,” said the Coalition, “will severely chill participation in educational programming among leading practitioners and academics, and will undermine the credibility and integrity of all accredited CME.” Additionally, “it will be virtually impossible to effectively meet the reporting requirements of the Sunshine Act in the CME context without making it practicably unworkable for the private sector supporters of CME to continue to participate.” 

In a very detailed and comprehensive review of the CME industry, CME stakeholders, and CME regulations, standards and rules, the Coalition addressed a number of concerns to CMS.  The Coalition cited the declining amount of commercial support for CME and the impact this has had on both CME providers and CME participants.  The comment also focused on the positive outcomes commercially supported CME has produced by improving patient outcomes in areas such as COPD and hypertension.  

Additionally, the Coalition provided an in depth analysis of the FDA, AMA, PhRMA, AdvaMed, ACCME Standards for Commercial Support, and HHS OIG, rules, standards, guidance, and regulations regarding commercially supported CME.  The Coalition pointed to the important role CME plays in meeting FDA’s required risk evaluation and mitigation strategy (REMS).  

The comment also discussed findings from a 2007 U.S. Senate Finance Committee report on use of educational grants by manufactures.  The Finance Committee report found, amount other things, that “the pharmaceutical industry is paying increased attention to educational grants and its compliance with fraud and abuse laws,” and that “major drug companies have limited the direct involvement of field sales representatives and sales and marketing departments in the educational grant-making process.” 

The Committee staff found “some promising trends in pharmaceutical manufacturers’ use of educational grants,” such as companies adopting “corporate policies that, on their face, do not allow educational grants to be awarded for unlawful purposes.” Moreover, the report found that, the overwhelming majority of companies are not “overtly giving educational grants to provide kickbacks to individual physicians or physician group practices” who attend educational programs and that this practice “has decreased over time.” The report recognized that, “major pharmaceutical companies now conduct their educational grants activities in a way that is less likely to involve the direct transfer of remuneration from the company to physicians.” 

The Coalition also referenced how compliance with the Sunshine regulations for CME providers would be overly burdensome and contrary to Executive Order 13563, which called on agencies to propose or adopt regulations that “impose the least burden on society.” 

Importantly, the Coalition also recognized the important role FDA plays in its guidance to CME providers and industry.  FDA has not regulated and does not intend to regulate industry-supported scientific and educational activities that are independent of the promotional influence of the supporting company. This distinction is important because in addition to following ACCME SCS, accredited CME providers must also ensure that all programs meet the definitions and factors FDA proscribed for an industry-supported activity to be “independent.” 

If CME providers do not follow FDA’s guidance, there is potential for the CME provider’s activity to be deemed promotional and to fall under FDA’s jurisdiction with risk of penalties for any improper promotional materials or statements.  Given FDA’s decision not to regulate independent industry-supported activities, the Coalition encouraged CMS to similarly avoid promulgating Sunshine rules that will have the impact of regulating the nature of reporting and payments involving independent CME providers and faculty. 

FDA stated that the provider ensure meaningful disclosure of to the audience, at the time of the program, of: (1) the company’s funding of the program; (2) any significant relationship between the provider (an entity, other than a regulated company, that produces the activity or program), presenters or moderators, and the supporting company (e.g., employee, grant recipient, owner of significant interest or stock); and (3) whether any unapproved uses of products will be discussed.  FDA defined “meaningful disclosure” as “disclosure that is reasonably calculated to reach the relevant audience in a manner that will alert them to potential biases” and to ensure that the audience is in a position to fully evaluate the information presented, in order to avoid being misled, confused, or deceived.” 

FDA defined “significant relationships” as “relationships that may give rise to actual or perceived conflicts of interest.” Where there is a question as to whether a relationship is significant, FDA recommended that providers, presenters, and supporting companies disclose the existence of the relationship. FDA specifically asserted that, “the provider should determine how to ensure that disclosure is meaningful.” 

The Coalition recommended that CMS’ proposed regulations should follow FDA’s preference for allowing the CME providers to “determine how to ensure that disclosure is meaningful” to the audience, rather than attempting to publish payments on CME faculty and providers.  Furthermore, FDA envisioned that any potential conflict of interest risk could “be satisfied by disclosing the existence of and characterizing significant relationships, and need not include further detail such as the amount of compensation or funding received.” 

Moreover, FDA clearly recognized that “disclosure should impose only a minimal burden on providers, presenters, and supporting companies.”  In addition, FDA’s assertion that disclosure “of any significant relationship between the provider, supporting company, and presenters or moderators would be sufficient,” suggests that further disclosure from CMS would be unnecessary, duplicative and burdensome. 

Accordingly, the Coalition suggested that CMS follow FDA’s recognition that the amount of compensation or funding received is unnecessary for disclosure at CME activities. Moreover, they implored CMS to adopt FDA’s reasoning, which noted that disclosure for CME activities “should impose only a minimal burden on providers, presenters, and supporting companies.” 

Finally, the Coalition also estimated that the regulation could cost hospitals, associations and other CME providers a total of $169,733,813 for three years ($64,151,271 for the first year, and $53,791,271 for years two and three).  The Coalition provided a detailed description and analysis of how it came to this estimate.  

Ultimately, the Coalition asserted that payments made to CME providers for education fall outside of the Sunshine Act’s intentions because CME providers are not covered recipients.  They noted that if CMS believes that CME providers should be treated as covered third parties, then payments to CME providers should be exempted from reporting because of the ACCME’s Standards of Commercial Support or the safeguards, firewalls, and transparency protections already required for certified CME. 

Otherwise, publication of such grants and payments would be detrimental to CME providers in many ways, such as finding sufficient subject-matter expert faculty, planning and budgeting high cost and high quality CME, and soliciting funding.

Physician Payment Sunshine: NAMEC Survey Predicts Job Losses from Proposed Rule

Last week, The National Association of Medical Education Companies, Inc. (NAMEC) recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.  

NAMEC is the trade organization representing U.S. medical education companies, as well as the clinical faculty, expert contributors, physicians, and allied healthcare professionals who participate in the many thousands of member-developed certified continuing medical education (CME) initiatives.  NAMEC’s mission is to promote best practices in CME that meet the many and detailed requirements set forth by accrediting organizations for the conduct of continuing education activities for physicians, as well as other healthcare professionals, with the goal of providing evidence-based education that improves patient care outcomes. 

In addition to their overall comments, NAMEC also conducted an online survey of their members in early February.  54 Member Organizations responded.  Respondents also provided data and quotes from surveys that they fielded to their faculty.  The survey asked questions related to the impact of the proposed Sunshine rules relative to CME providers and reporting of payments to CME faculty and educational materials.  The survey indicated that NAMEC members highly concerned about proposed rules: 

• Reporting burdens and increases corresponding expenses (> 85% agree or strongly agree)
• Loss of CME funding (76.5% of agree or strongly agree) and resultant loss of CME jobs in their organizations
• Loss of expert faculty participating in CME activities funded by covered manufacturers
• Loss of reputation /credibility of CME providers and of CME
• Reduction in quality of CME and resulting negative impact on healthcare
• Misrepresentation of how CME providers and faculty manage funding from covered manufacturers; inability to meet accrediting organization requirements if accept funding from covered manufacturers (>95% agree or strongly agree) 

Faculty are also highly concerned and share many of the concerns of CME providers: 

• Misrepresentation of financial relationship between CME faculty and covered manufacturers
• Decreased willingness to participate as CME faculty if proposed rules implemented
• Limitations to participating in CME activities
• Healthcare will be adversely impact if faculty educators reduce or eliminate participation in CME if proposed rules are implemented (78.8% of members) 

Almost all members responded that the proposed rules will have significant financial impact on their organizations, with approximately 47% estimating this cost to be at least $50,000 and escalating to >$150,000.  

Members responded that the proposed rules will result in reduced funding and, consequently, loss of jobs in their organizations and, possibly, resulting in their having to close their operations.  Members also strongly disagreed (80.9%) with CMS’ proposal to associate CME payments to faculty with a specific drug.  

Members are very concerned about the negative impact the proposed rules  on their faculty: 72% indicated  that faculty will no longer participate in their activities that are funded any level of support from covered manufacturers if the proposed rules on CME payments recording and reporting are implemented as written.  In addition, almost 95% of members believed that if CME is classified as a direct payment that it will reduce the number of CME activities produced per year. 

Comments from NAMEC Members 

“Readers of CMS-collected data will make no distinction between the widely different worlds of accredited CME and FDA-enforced promotional education. Therefore, just as we've seen CME-dedicated faculty and researchers leave paid positions as speakers and members of boards, we will see them leave CME. The public will not understand the distinction between CME and promotion, particularly if CMS inaccurately or misleadingly portrays the data collected (whether by accident or not). ……When one considers the serious morbidity and mortality of many disease states addressed by accredited CME providers in learner activities, every month’s or year’s delay has potentially great effects on quality of life and patients’ survival.” 

“In my experience, faculty are participating in CME because they love to teach; they're not doing it for the money. Having their names associated with a supporter (with whom they may or may not have a bona fide relationship) when their real relationship is with the CME provider will not be worth the scrutiny and aggravation. I believe that many will simply elect not to participate.”

 

Physician Payment Sunshine: Alliance for Continuing Education in the Health Professions Submits Comments to CMS

We have just hours to go before the deadline to submit comments to Centers for Medicare and Medicaid Services (CMS) on the proposed Physician Payment Sunshine rules at 5pm Eastern tonight is up. 

The Alliance for Continuing Education in the Health Professions (“the Alliance”), formerly known as the Alliance for Continuing Medical Education, recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.  

The Alliance represents the nation’s top experts in continuing education for healthcare professionals and would be pleased to meet with CMS staff to provide further explanation, documentation and perspectives. 

The Alliance offered its support for CMS’ efforts to shed light on direct payments from product manufacturers to physicians and other medical practitioners.   However, after careful review, the Alliance urged CMS to exclude from reporting (1) indirect payments related to the provision of accredited and certified continuing medical education (CME) and (2) educational materials provided to healthcare providers that directly benefit patients. 

The Alliance, echoing many other comments, noted how the original drafting of the Sunshine Act excluded indirect payments, such as industry support for continuing CME activities.   Including payments to accredited CME providers could result in “serious unintended consequences for CME, and ultimately for patient care,” the Alliance said. Specifically, the Alliance noted that the potential consequences include: 

1. Reluctance on the part of physicians to serve as faculty or even to participate in industry-supported CME because the reporting requirements could result in the incorrect perception that these individuals are receiving some direct benefit from industry support;
2. Burdensome reporting requirements for CME providers who already operate with limited resources and tight margins and would be required to determine the value of benefits that accrue to covered recipients attending CME programs; and
3. A reluctance on the part of commercial supporters to fund CME activities due to the difficulty in calculating, tracking and reporting the indirect benefit of their support on faculty and participants.  

The Alliance also urged CMS to make an explicit distinction between accredited and certified CME and promotional education, both in the final rules and any background materials provided on physician-industry collaboration.  They noted how Promotional activities are controlled by manufacturers and may include both educational and marketing information.  Whereas accredited and certified CME are evidence-based educational activities that are totally controlled by accredited CME providers from start to finish, and, if commercial support is involved, strictly follow the Standards for Commercial Support from the ACCME.  No manufacturer is allowed to influence the design or offering of an accredited and certified CME activity in any way. 

The Alliance produced a chart in its comment to CMS that illustrates how accredited and certified CME maintains its independence and how accredited and certified CME differs from promotional activities regulated by the FDA.   

Their comment explains how, “Accredited providers select and reimburse all faculty members directly,” and that “applicable manufacturers are not allowed any input whatsoever regarding the selection of faculty, participants or content of these programs.” Accordingly, the Alliance asserted that, “reporting a link between applicable manufacturers and individual physicians who participate in CME activities (as faculty or participants) would result in a misrepresentation of these relationships as a direct benefit to the CME participant when, in fact, the benefit accrues to patients in the form of improved care. 

Additionally, the Alliance recognized how commercial support of CME—which accounted for about 37% of the total revenue for over 19 million CME activities in 2010—is important to approximately 80% of CME providers and “allows them to foster quality patient care by disseminating knowledge and addressing performance gaps.” 

“We believe an unintended consequence of the proposed rule would be to create burdensome tracking and reporting requirements both for CME providers and for applicable manufacturers. These requirements would harm CME business practices by diverting resources away from education and to administration and are likely to result in fewer educational opportunities for healthcare providers who treat patients.” 

The Alliance also recommend that under exclusions, the definition of “educational materials that directly benefit patients” include an exclusion “for any enduring material that is accredited and certified for CME credit and for any educational material that is provided to supplement a certified activity.” 

Conclusion  

Ultimately, the Alliance emphasized how accredited CME providers already employ a system of checks and balances to ensure transparency, disclosure and resolution of conflicts of interest for accredited and certified CME by following regulations, guidelines and policies from the ACCME, the Food and Drug Administration, the Office of the Inspector General, the American Medical Association, and industry groups such as AdvaMed and PhRMA.” 

They recognized how CME “content is developed independently, without input from applicable manufacturers, and it is reviewed prior to dissemination to ensure that there is no commercial bias. Serious penalties and consequences for violation of these requirements exist, including the potential loss of accreditation.  Most importantly, these accredited and certified activities, as well as the educational material that supplements and supports the activities, result in improved patient care and health outcomes.” 

In the end, the Alliance noted how, “assigning, calculating, tracking and reporting a value to individual faculty members and/or participants of accredited and certified CME would divert precious resources from education to administration (both for CME providers and applicable manufacturers).”  Moreover, the reporting could result in a perception of a financial relationship between a healthcare provider and manufacturers that does not exist, perhaps implying impropriety on the part of the healthcare provider who participates in CME with the intent of teaching and/or learning how to improve patient care.

Accordingly, the Alliance strongly recommended exclusions for accredited and certified CME activities and supporting educational material in the final rule.

Physician Payment Sunshine: Friday Deadline Approaching and AAFP Comments Raising Concerns to CMS

This week marks the last week that the public can submit comments on the proposed regulations that will implement the Physician Payment Sunshine Act—Section 6002 of the Patient Protection and Affordable Care Act (PPACA).  Comments are due this Friday, February 17, 2012.  It is simple to submit a comment by simply pressing here. 

Consequently, groups have already begun submitting their comments, including the American Academy of Family Physicians (AAFP), which represents more than 100,300 family physicians and medical students nationwide. 

The AAFP supports and values transparency and the goal of the Sunshine Act as it can help the public and policymakers understand the dynamic relationships between health care professionals and the medical industry. AAFP recognized however, that the proposed reporting requirements create significant complexities, such that CMS estimates it will cost healthcare companies and health care providers $224 million in the first year, and over $163 million annually thereafter to comply. AAFP offered the following recommendations to improve the final regulation. 

Need to Ensure Accuracy 

The AAFP policy on transparency explicitly states that any reported information needs to be easily verified for accuracy.  The group asserted that the proposed rule “fails to address adequately the need for robust safeguards so that CMS posts only accurate information online.”  Erroneous and potentially negligent reporting practices could be misleading and have severe implications for a physician's credibility with patients.  The AAFP therefore encouraged CMS to reexamine the agency’s role and responsibilities to prevent the dissemination of inaccurate or disputed data. 

They urged CMS to establish a uniform, national, and mandatory data verification and arbitration process.  This should involve an ongoing pre-review ability so physicians can easily identify and quickly resolve conflicts before inaccurate information becomes publicly available.  AAFP does “not support any proposals that attempt to sidestep inevitable disputes by merely publishing both the applicable entity’s reported value and the physician's self-reported amount.” In addition, AAFP wants CMS to structure the review and arbitration process such that physicians do not incur legal fees to defend themselves from erroneous manufacturer reporting. 

Indirect payments 

Section 6002 of the law specifically states that reportable transfers of value do, “not include a transfer of anything of value that is made indirectly to a covered recipient through a third party in connection with an activity or service in the case where the applicable manufacturer is unaware of the identity of the covered recipient.”  Accordingly, AAFP expressed its concern “that CMS commentary in the proposed rule discusses indirect transfers of value.” 

AAFP was involved in legislative negotiations that ultimately resulted in the Affordable Care Act, and is aware that previous versions of the underlying bill included language that considered indirect payments a reportable event.  However, since the statute was intentionally finalized to specify that indirect transfers of value are not reportable events, the AAFP asserted that CMS does not have the authority to expand beyond the scope of the law and propose policies that require in any circumstance that an indirect transfer of value be reported. 

AAFP explained its commitment to supporting physicians’ continuing professional development and lifelong learning, including participation in certified or accredited Continuing Medical Education (CME), some of which are supported by industry through a rigorous grant review process.  AAFP recognized how 1) direct payments to physicians (either in the role of faculty or attendees) by companies, in the context of Accredited and Certified CME, are prohibited and therefore are irrelevant when it comes to disclosure under Section 6002; and 2) manufacturers have no relationships with CME faculty, either directly or indirectly.  They also noted how AAFP strictly adheres to the “Standards for Commercial Support (SCS): Standards to Ensure the Independence of CME Activities” of the Accreditation Council for Continuing Medical Education (ACCME). 

AAFP strongly supports having safeguards in place to ensure CME independence, validity and relevance and has instituted guidelines and policies to provide for physicians, whether learners or faculty, the assurance to clearly identify CME programs that are ethically sound, evidence-based, scientifically objective, clinically relevant, and educationally effective. The AAFP has consistently implemented a variety of strategies and mechanisms to manage relationships between CME and industry, in order to identify, disclose, and mitigate real or potential conflicts of interest. The AAFP closely monitors its adherence to the ACCME SCS, and compliance with SCS is a requirement for their credit certification.  In addition, the AAFP adheres to other pertinent standards, laws, regulations, ethical codes, guidelines and considerations that enhance our ability to ensure the identification, disclosure, and resolution of real or perceived conflicts of interest. 

As a result, AAFP strongly urged CMS to clarify in the final rule that all certified and accredited CME activities are excluded from reporting.  

In addition, AAFP recognized how it receives support from industry for programs that aim to advance the value of family medicine by promoting humanitarian, educational, and scientific initiatives that improve the health of all.  AAFP maintained that, “If funds from the medical industry are contributed to the AAFP or the AAFP Foundation they are considered reportable under Section 6002, these important efforts could be hampered because physician interest would likely decrease.”  For example, efforts that could be less appealing to members might be: 

• The AAFP Vaccine Science Fellowship - funding supports focus group research designed to identify barriers to immunizations.
• The Office Champions Tobacco Cessation Project - funding covers clinical time spent on chart reviews, evaluations, staff training, writing clinical content for practice manuals, or leading training sessions. Participants’ practices complete a W-9 form and provide their Employer identification number.
• Americans In Motion—Healthy Interventions (AIM-HI) – grant funds are used to pay family physicians to present at AAFP conventions and conferences on the subject of fitness. The AAFP (not the funding entity) decides which physician is selected to present. 

Accordingly, AAFP urged CMS to specify that only direct transfers of value to physicians are reportable events because this would establish a clear distinction between reportable and non-reportable transfers of value and significantly simplify compliance with Section 6002 requirements. 

Meetings and Conventions 

AAFP commended CMS for eliminating the reporting of any offering of meals, snacks, or coffee at medical industry conferences, booths or events where CME certified or accredited educational materials are offered.  However, AAFP stated that CMS should clarify in the final rule that speaker fees for accredited and certified CME programs should not be considered reportable events since these are indirect payments and covered under ACCME SCS. 

The Medical Practice 

AAFP requested that CMS expound further and offer supplementary examples of both reportable and non-reportable events that can occur when a manufacturer’s representative meets with the medical practice.  

In addition, AAFP strongly objected to the CMS proposal that, in instances where group meals are being provided in a group setting (for example, buffet style food in a physician’s office), applicable manufacturers report the cost per covered recipient receiving the meal even if the covered recipient does not actually partake of the meal. AAFP asserted that this kind of reporting “will result in inaccurate and misleading reporting.”  As a result, AAFP urged CMS to specify that Section 6002 reporting requirements only apply to physicians that personally decide to accept such transfers of value from applicable entities. 

AAFP also expressed its extreme concern with the proposed 45-day review period.  For such a new and complicated program, that time-frame “is simply too brief for a practicing physician to access, review, and then potentially appeal a detailed financial document.”  The AAFP appreciates that CMS recognizes this is problematic since the proposed rule discusses that “it may be difficult for CMS to contact covered recipients and physician owners or investors, since they do not actively participate in the data submission process with CMS prior to their review, so we propose to notify covered recipients and physician owners or investors in a few ways.”

Consequently, AAFP said “it unreasonable to suggest that practices must habitually find and check various CMS websites or electronic newsletters for updates on their transparency reports.  Placing this unnecessary responsibility onto the practice will consume a tremendous amount of valuable time and resources that should be spent on patient care.”  Instead, the AAFP urged CMS to work with physician organizations to strengthen and lengthen the review process. 

Research 

AAFP also expressed its concern that reporting requirements could deter physicians’ willingness to conduct medical research.  It is the AAFP’s position that shedding light on the nature and extent of financial relationships between physicians and applicable entities in “no way should interfere or disrupt clinical research.” 

Physicians conducting clinical medical research have direct financial relationships with their academic institutions.  These institutions may receive support from applicable entities, but the AAFP encouraged CMS to specify in the final rule that Section 6002 reporting requirements do not apply to clinical research when funds are indirectly made to the researcher. 

In addition to specifying that indirect transfers of value are not reportable events, the AAFP also urged CMS to specify in the final rule that approved clinical research subject to “human subjects IRB review” is excluded from these reporting requirements since most clinical research already requires that financial ties to manufacturers be disclosed. 

Consumer Website 

AAFP strongly urged that the content of the information published on the website be promulgated as a proposal with the opportunity for public comment to be sure that the information is useful and unbiased.  AAFP maintained that “CMS must avoid casting an unfavorable or incomplete light on the appropriate collaboration that exists among physicians, teaching hospitals, and industry manufacturers.”