CMSS Submits Comments to HHS-CMS on Sunshine Provisions

The Council of Medical Specialty Societies (CMSS), whose 37 member organizations represent 700,000 physicians in the US, recently submitted comments to the Centers for Medicare and Medicaid (CMS) on proposed rule-making for the Physician Payments Sunshine Act (PPSA) or Section 6002 of the Affordable Care Act (ACA).

The comments first noted that CMSS operates under two strategic priorities, both of which enable the organization to support the PPSA:

• CMSS and its member organizations facilitate a Culture of Performance Improvement in medical practice
• CMSS and its member organizations model Professionalism, as measured by Altruism (putting the needs of patients first), Self‐regulation, and Transparency.

In addition, CMSS recently adopted the CMSS Code for Interactions with Companies, providing guidance to medical specialty societies, representing most physicians in the US, in their relationships with industry.  The CMSS Code was “adopted to reinforce core principles which guide specialty societies in maintaining actual and perceived independence. The CMSS Code helps to ensure that a specialty society’s interactions with industry will be for the benefit of patients and for the improvement of medical care.”

Consequently, CMSS noted the importance of Congress not including indirect relationships (such as grants to providers of certified continuing medical education [CME]) in the act because such payments do not involve direct financial relationships between physicians and companies.

Forms and Nature of Payment and Transfer of Value

CMSS agreed that direct payments and transfers of value from companies that should be disclosed include cash, stock, stock options, ownership interests, dividends, consulting fees, gifts, entertainment, food, travel, research support, royalties, license fees and other direct compensation.  However, they noted that it was “unclear what Congress intended as it relates to “honoraria,” which could include a payment that is made as direct compensation to a physician from a company; but this is a term which is not often used in this context.

Their comments also noted that the term “education” is not usually used to reflect a direct financial relationship between a physician and a company.  Accordingly, CMSS recognized that “education in the sense of certified continuing medical education (CME) is governed by the Standards for Commercial Support: Standards to Ensure the Independence of CME (SCS), promulgated by the Accreditation Council for Continuing Medical Education (ACCME), to which the entire profession of medicine adheres. The SCS (most recently revised in 2004) set standards for relationships between providers of certified CME and the companies which provide grants to the providers to support CME.”

As a result, CMSS asserted that, “in the context of certified CME, direct payments to physicians (either in the role of faculty or attendees) by companies are prohibited, cannot occur, and therefore would be irrelevant when it comes to disclosure under the PPSA.”

CMSS also recognized that the AMA Code of Medical Ethics (specifically the Ethical Opinions on Gifts to Physicians from Industry, and Ethical Issues in CME) address individual physician responsibilities as well as provide guidance for providers offering continuing medical education activities.

Therefore, they acknowledged that under the PPSA, only direct payments to physicians for serving as speakers at company sponsored promotional educational programs would be covered, which are distinct from certified CME programs, and which are instead overseen by the Food and Drug Administration (FDA).

Additional Information for Consumers – Context:

Next, CMSS recommended that the context of direct financial relationships between physicians and companies be described when disclosed to the public.  Specifically, they noted that the public will not likely understand the nature of many disclosed relationships, not all of which are equivalent.  For example, there is a wide array of “consulting” that a physician could do with industry.  Accordingly, CMSS asserted that the information disclosed to patients contain a description of the context of the relationship.

Reporting of Data – Consistency:

CMSS recommended that a standardized set of information be collected on the relationships between physicians and companies, for purposes of reporting through the PPSA.  They urged CMS to require a standardized set of data to be collected and reported by companies because a standard set of expectations promulgated by CMS can decrease the burden and “hassle factor” on physicians.  Therefore, standardized categories and data elements must be established in the regulations by CMS as an expectation of reporting by companies.

Moreover, CMSS asserted that standardized expectations of how collected information will be used should be communicated in the regulations to enhance the trust of physicians whose individual professional relationships are to be disclosed.  CMSS noted that, “limiting the use of collected information to standardized disclosure of covered relationships, the intent of the PPSA, is critical.”  Otherwise, additional use of collected information by companies (i.e. for marketing purposes) or by CMS (i.e. to determine compensation levels) “will destroy the trust of physicians, and would not serve the interests of the public for which the PPSA was created.”

Finally, CMSS recommended that a mechanism be established whereby physicians may contact the reporting body through an appeals process to correct erroneous information, which has been disclosed.

Conclusion

Ultimately, CMSS noted that CMS “should attend to clarifying the direct financial relationships between physicians and industry for purposes of reporting, requiring companies to describe the context of relationships so that consumers understand them, and requiring companies to consistently collect and report data in a standardized and uniform fashion.”

They noted that, “following these “three C’s” will meet the intent of the PPSA without adding to the burden of the system, detracting from the ability of physicians to enhance the quality of care they provide to patients.”