Tightening the Noose around the Necks of Physicians
Under the guise of “transparency,” the Sunshine Act as part of the Patient Protection and Affordable Care Act requires pharmaceutical manufacturers and medical device companies to report in a public database, the CMS Open Payments System, so-called “transfers of value” ($10 or more) to physicians. The implication is that a physician who accepts anything that costs $10 or more will be manipulated into prescribing that manufacturer’s product. No other ethical profession has been scrutinized in this manner.
Officially, the Sunshine Act was implemented on February 8, 2013 (published in the Federal Register). But on July 3, 2014, CMS proposed to eliminate the CME exemption. That means CME funded by an unrestricted educational grant by a pharmaceutical manufacturer likewise needs to be reported in a public database for those speaking or participating in the CME activity. At present, under the CME exemption, speaker fees and attendee tuition expenses are not reportable.
Currently, 49 states, the District of Columbia, Guam, Puerto Rico, and the Virgin Islands require physicians to earn a specified number of CME credits over 1 to 3 years. With the budgets of hospitals and medical schools dwindling, the pharmaceutical companies have provided unrestricted educational grants for CME events. The planning, writing, and production of these activities are regulated by agencies such as ACCME, AOA, AMA, AAFP, and ADA CERP to ensure that content is balanced, evidence-based, and relevant for optimal patient care. All CME, with or without industry support, must be fair and balanced, with zero input from any sponsor.
Primary Care Network is an ACCME accredited CME provider. According to ACCME’s Standards for Commercial Support, a signed contract between the CME provider and the Sponsor is necessary that states that the grant is unrestricted and educational and the Sponsor has no input concerning the content, speakers, or audience. Without the CME exemption, physicians may be less willing to participate and will not benefit from the educational items associated with the CME activity, such as slides, abstracts, and handouts. Industry-supported CME is an important medical resource for cutting edge information that can be rapidly assimilated into a clinician’s practice. PCN and other independent CME providers produce educational activities that are practical for community healthcare providers and clinically relevant in the real world. Without this education, data show that physicians are slower to adopt new diagnostic approaches and therapies possibly resulting in poorer patient outcomes.
Another question, without pharmaceutical support, who will fund CME education? CMS? The irony in this debate is that CMS assumes that industry-funded CME must be biased toward their products. In reality, the regulations currently surrounding CME are adequate to ensure a balanced educational event. The basic issue seems to be independence; that is, a physician should not be given the opportunity to choose the type of CME education that meets his or her needs. PCN surveys members annually about the type of medical education needed for primary care. The members decide, not the funders. Who will decide the physicians’ medical educational need if this CME exemption is eliminated. CMS? Hospitals? Medical schools? Where does that put the independent physician? Will the direction of CME come from meta-analyses, randomized placebo-controlled clinical trials of highly selected patient populations, consensus opinions of academic leaders, or practicing clinicians? These are but a few of the important questions that are not being addressed by those forces advocating the demise of patient-centered, clinician-driven, industry-sponsored CME.
According to the ACCME 2013 Summary, 26% of income for 1,950 CME accredited providers was from commercial sources. Without industry support, it is estimated that 507 companies will probably fail if this CME exemption is eliminated, thus removing this critical element of physician education