Update on New Regulations for Continuing Medical Education and Promotions
By Don Harting, MA, ELS, CCMEP
November 25, 2013
Physicians who earn money as freelance medical writers for drug or device companies may find that their professional lives become a bit more complicated in 2014, thanks to the new National Physician Payment Transparency (NPPT) program, sometimes called the sunshine law. Other health professionals, including nurses, may also be affected in unexpected ways. But so far, it appears faculty honoraria for accredited continuing medical education (CME) activities will largely remain unaffected.
These were 3 key points made by Pam Oestreicher PhD and Marissa Seligman PharmD, CCMEP in their presentation on Friday, November 8, during the AMWA annual conference in Columbus, Ohio. Oestreicher, a science writer with ONS:Edge in Pittsburgh, spoke from her experience organizing promotional education for oncology nurses. Seligman spoke as chief operating officer of Clinical Care Options, a CME provider. Both women agreed the new law will have far-reaching consequences, perhaps in ways that were unintended by federal lawmakers.
The overall intent of the sunshine law is to provide the public with accurate, reliable information about financial ties among physicians, teaching hospitals, and industry. This transparency is meant to discourage inappropriate influence on research, education, standard-setting, and clinical decision-making. The new program is part of the Affordable Care Act, and is administered by the Centers for Medicare and Medicaid Services (CMS).1
In general terms, NPPT requires drug and device companies to report to CMS all payments made to physicians and teaching hospitals. CMS, in turn, verifies the payments and publishes them annually on a public Web site. Industry began collecting payment information in August, and CMS is scheduled to publish partial-year data for 2013 in September of 2014.
The program sounds simple but, as Seligman said, "the devil is in the details."
Physicians who perform services — including medical writing — for a drug or device company will have their payments reported to CMS, Oestreicher said. Under the law, a physician is defined as a doctor of medicine, osteopathy, chiropractic, podiatry, dentistry, or optometry. A wide range of payments, and forms of payment, must be reported. These include consulting fees, food and beverage, entertainment, honoraria, grants, and many other forms of compensation. Physicians are encouraged — but not required — to register with CMS to be notified as their payment information is submitted.1 If the information is inaccurate, physicians will have the option to dispute it.
“If you are not a physician … in theory your payment will not be reported,” Oestreicher told listeners. However, in many cases, payments to other types of health professionals, including nurses, are being collected anyway by drug and device companies that pay for promotional meetings. Oestreicher reported that all of her promotional clients are collecting the same data for nurses as for physicians, just in case it is required in the future. When nurses attend promotional meetings, their badges are scanned, or they are asked to sign in. When they find out their payment information is being collected and tallied, Oestreicher said, "nurses are flabbergasted."
Honoraria paid to physicians serving as faculty members for accredited CME activities remain exempt from the reporting requirements that apply to so many other forms of compensation. To be exempt from reporting, an educational activity must be accredited by one of the following bodies: AAFP, ACCME, ADA, AMA, or AOA, Seligman said. An earlier version of the law made no provision for accredited CME. This is one area where legislators heeded public hearing testimony. Said Seligman, “The regulators listened and they pulled back.”
For more detailed information about the program, along with examples of direct and indirect payments, go to the Medicare Learning Network at http://www.cms.gov/Outreach-and-Education/Outreach/NPC/Downloads/2013-08-07NPC-OpenPayments.pdf.
1. Agrawal S, Budetti P. Are You Ready for the National Physician Payment Transparency Program? 2013; Online educational module supported by Centers for Medicare & Medicaid Services. http://www.medscape.org/viewarticle/780900. Accessed November 11, 2013.
Don Harting is a freelance medical writer specializing in oncology education. He works from his home in Downingtown, PA.