April 1, 2011
To: Barbara Cebuhar, Center for Medicare and Medicaid Services

Sent via email to: physiciansunshine@cms.hhs.gov

Re: Proposed Rule-making Comments on Physician Payments Sunshine Act

The Council of Medical Specialty Societies (CMSS), whose 37 member organizations represent 700,000 physicians in the US, is pleased to submit comments on proposed rule-making for the Physician Payments Sunshine Act (PPSA).

CMSS operates under two strategic priorities, both of which enable us to support the PPSA:

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

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.

CMSS appreciated the opportunity to contribute to early drafts of the PPSA. Through that process we saw Congress come to the recognition that the act should focus on disclosure of direct financial relationships between physicians and companies. As such, we appreciate that indirect relationships (such as grants to providers of certified continuing medical education [CME]) are not covered by the act, as these do not involve direct financial relationships between physicians and companies.

Forms and Nature of Payment and Transfer of Value; Categories of Information to

Report – Clarity:

  1. We agree that direct payments and transfers of value from companies which 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.

It is unclear what Congress intended as it relates to other potential relationships. For example, “honoraria” 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.

The term “education” is not usually used to reflect a direct financial relationship between a physician and a company. Indeed, 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. 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.

In addition, 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.

What would be covered under the PPSA would be direct payments to physicians for serving as speakers at company sponsored promotional educational programs, which are distinct from certified CME programs, and which are instead overseen by the Food and Drug Administration (FDA). This is the critical distinction we successfully made with congressional staff during the period of crafting the PPSA.

Additional Information for Consumers – Context:

We recommend that the context of direct financial relationships between physicians and companies be described when disclosed to the public.

It is not likely that the public will understand the nature of many disclosed relationships, not all of which are equivalent. For example, when seeking information about the relationship of their physician with companies, patients will not likely understand the implications of various “consultancies.” Patients will potentially view their physician differently if the description reveals that the physician is a researcher who consults with a company to share cutting edge research results, contrasted with a physician who consults with a company to inform the company of how his or her patients fare when prescribed a particular company’s medication. While both physicians are paid by the company as “consultants”, the nature of the consultancy is substantially different, creating the need for the information disclosed to patients to contain a description of the context of the relationship.

Reporting of Data – Consistency:

We recommend that a standardized set of information be collected on the relationships between physicians and companies, for purposes of reporting through the PPSA.

We urge CMS to require a standardized set of data to be collected and reported by companies. Physicians are supported by CMS to care for patients as a priority. A standard set of expectations promulgated by CMS can decrease the burden and “hassle factor” on physicians. Companies should not collect different information about physicians when the information is used by all companies for the same purpose. Yet companies, as competitors in the marketplace, may not have the legal ability to come together to determine standardized data for reporting. Therefore, standardized categories and data elements must be established in the regulations by CMS as an expectation of reporting by companies.

Moreover, 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. Limiting the use of collected information to standardized disclosure of covered relationships, the intent of the PPSA, is critical. 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, we recommend that a mechanism be established whereby physicians may contact the reporting body through an appeals process to correct erroneous information which has been disclosed.

Summary:

The Council of Medical Specialty Societies (CMSS) enjoyed a productive relationship with Senate staff during the process of crafting the PPSA. During that process, we were able to provide government representatives information on definitions and nuances of relationships, such as the distinction between grants to providers of certified CME, who in turn select faculty, and direct payments to physicians by companies for purposes related to drug development, marketing and promotion. CMSS offers our expertise at this time to government representatives participating in rule-making for the PPSA. We stand ready to assist you in identifying and clearly describing the relevant relationships, and the information needed to present those relationships to the public. We are confident that CMS, through its willingness to hear from stakeholders, will craft regulations which carry out the PPSA without getting in the way of delivering quality care to patients.

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. 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.

We look forward to the opportunity to have further communication with you as we work with you to implement, in a manner we can support, the Physician Payments Sunshine Act, a law we support.

Thank you,

Dr. Kahn Signature

Norman Kahn MD
Executive Vice-president and CEO