Regulations on Physician/Industry Interaction Must Include Clarification, Context, Consistency

The AAFP has joined with other members of the Council of Medical Specialty Societies, or CMSS, to urge CMS to ensure that regulations for the Physician Payments Sunshine Act, or PPSA (pp. 571-8 of 906-page PDF; About PDFs), which was enacted as part of the Patient Protection and Affordable Care Act last year, are clear, contextual and consistent.

"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," said CMSS in comments (3-page PDF; About PDFs) to CMS. "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."

The PPSA requires that, in 2012, companies start recording any payments, cash equivalents, in-kind items or services, or other value transfers to physicians of more than $10. Such items include stock options, research grants, knickknacks, consulting fees and travel to medical conferences. According to the legislation, details of any such items are to be made available via a searchable database by Sept. 30, 2013.

Although CMSS, which represents more than 700,000 physicians nationwide, agreed that "direct payments and transfers of value," including cash, stock options, ownership interests, dividends, consulting fees, gifts, food and travel, from companies should be disclosed, "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," said CMSS.

In addition, CMSS pointed out that the term "education" usually isn't used to reflect a direct financial relationship between a physician and a company. CME is governed by the Accreditation Council for Continuing Medical Education's Standards for Commercial Support: Standards to Ensure the Independence of CME Activities (3-page PDF; About PDFs). The entire medical profession adheres to these standards, said CMSS.

According to the standards, "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 stressed that the PPSA covers only direct payments to physicians who serve as speakers for company-sponsored, promotional educational programs. These events, which are overseen by the FDA, are distinct from certified CME programs, said the council, pointing out that this critical distinction was made when the PPSA was being crafted.

CMSS also called on CMS to provide additional information about financial relationships between physicians and companies for consumers, noting that, "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.'" In such cases, said CMSS, there is a "need for the information disclosed to patients to contain a description of the context of the relationship."

Consistency in how data in the program are collected also should be addressed, according to the letter. "We urge CMS to require a standardized set of data to be collected and reported by companies," said CMSS. This would decrease the burden and "hassle factor" on physicians.

As marketplace competitors, many companies legally may not be able to collectively determine standardized reporting data, so it is important that CMS establish standardized categories and data elements in the regulations, said CMSS.

In addition, "Limiting the use of collected information to standardized disclosure of covered relationships, the intent of PPSA, is critical," said CMSS. "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 called for an appeals process that would allow physicians to contact the reporting body to correct erroneous information.