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.
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.
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 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.
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:
- 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.
- 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.
- 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.
- 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.
- 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.”
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.
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.
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.”
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.
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.
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:
- Distinguishing between Accredited and Certified CME offered by CME providers, and promotional education offered by pharmaceutical and medical device manufacturers;
- 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
- Recognizing that attendees at or participants in Accredited and Certified CME programs have no relationships with companies which may provide grants to CME Providers.
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.”
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.
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.
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.
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 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.
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.