Before the Physician Payments Sunshine Act has even been fully implemented, CMS is proposing to change its policy regarding the exemption for reporting indirect payments or transfers of value related to accredited CME events, an action that is causing concern among medical professional organizations and CME sponsors, including the AAFP.
The Physician Payments Sunshine Act, part of the Patient Protection and Affordable Care Act, requires pharmaceutical and medical device manufacturers to report payments or other transfers of value to physicians and teaching hospitals as a means of increasing transparency regarding the relationship between health care providers and industry. CMS was charged with implementing the act, which led to the agency's creating its so-called Open Payments program. Industry is required to report such transfers to CMS for eventual public reporting.
When the agency announced the final rule for the Open Payments program in February 2013, it acknowledged that indirect payments made to faculty at CME activities should not be considered transfers of value for the purposes of the program provided the following conditions were met:
- The event at which a covered recipient speaks meets the accreditation or certification requirements and standards for continuing education of the AAFP, the Accreditation Council for Continuing Medical Education (ACCME), the American Dental Association's Continuing Education Recognition Program, the AMA or the American Osteopathic Association.
- The applicable manufacturer does not pay the covered recipient speaker directly.
- The applicable manufacturer does not select the covered recipient speaker or provide the third party (such as a continuing education vendor) with a distinct, identifiable set of individuals to be considered as speakers.
However, according to a proposal CMS has now included in its proposed 2015 Medicare physician fee schedule(www.federalregister.gov), the agency would eliminate this specific clause in the belief that another clause in the rule adequately provides this exemption from reporting.
- CMS is proposing to change its policy regarding the exemption for reporting indirect payments or transfers of value related to accredited CME events, potentially hindering the reach and effectiveness of those activities.
- In an Aug. 1 letter to CMS Administrator Marilyn Tavenner, M.A., AAFP Board Chair Jeff Cain, M.D., of Denver, laid out the Academy's opposition to the proposed revision.
- CMS is expected to announce its decision on the proposal when the final 2015 Medicare physician fee schedule is released in October or November.
In an Aug. 1 letter(4 page PDF) to CMS Administrator Marilyn Tavenner, M.A., AAFP Board Chair Jeff Cain, M.D., of Denver, laid out the Academy's opposition to the proposed revision.
"The parameters of the CME exemption in Section 403.904(g) are clear and unambiguous, and stakeholders have relied upon them in planning, developing, offering, attending and documenting CME programs over the past eighteen months since the final rule was published," said Cain.
Although overlap may exist between the two sections, he noted, they are not the same. The section CMS has proposed retaining "excludes 'indirect payments' or other transfers of value where the applicable manufacturer is 'unaware' of the covered recipient's identity during the reporting year and for two quarters thereafter," Cain said in the letter. That clause is "imperfectly and inconsistently understood" by stakeholders, he added, and cannot, by itself, "provide the certainty and clarity needed to ensure the continued delivery of properly accredited and certified CME to the physician workforce who needs it."
Furthermore, Cain added, "CMS specified the five organizations in Section 403.904(g) not because of a drafting accident, but because those five organizations had proven track records for adherence to stringent standards to ensure integrity in providing CME by maintaining and guaranteeing the CME provider's discretion and independence from inappropriate industry control."
By relying on a general clause that does not spell out organizations that are recognized as accredited CME providers, CMS could inadvertently open the door for less rigorous CME programs to become commonplace.
"That unnecessary and ill-advised trade may chill participation in valuable CME activities and hinder the adoption and spread of important new therapies and medical information, which, in turn, may negatively impact patients," said the letter.
It's important to note that even if CMS adopts the proposed change, the AAFP will remain exempt from having to submit reports to CMS because its accredited CME programs conform to the ACCME's Standards for Commercial Support.
Still, said Cain, "Attendees may be less willing to participate in those programs -- even if the industry support for the program was completely independent and conflict-free -- if they believe their identity and attendance may become known to the commercial supporters and the value of the CME may thus be reported against them."
CMS is expected to announce its decision on the proposal when the final 2015 Medicare physician fee schedule is released in October or November. CMS is accepting public comment on the issue until Sept. 2.
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