How The Sunshine Act Could Adversely Affect Podiatry Conferences

Beginning August 1, terms of the Sunshine Act mandate the collection of information regarding payments to physicians from pharmaceutical and medical device companies, and subsequent reporting of these payments on a public website in 2014. If you are thinking, “I don’t receive any payments from those entities so it won’t affect me,” think again.

The Sunshine Act defines payments as meals, honoraria, travel expenses, grants from manufacturers and other transactions. One study found that 83 percent of physicians received some sort of gift that would qualify for reporting under this law and 28 percent received payment for professional services (consulting, speaking or research).1

The law requires physicians and manufacturers to report payments (or gifts like attendance at a dinner lecture) greater than $10. Dinners, honoraria, gifts, in-kind services, entertainment, travel, research and more will have to be reported as “cash equivalents.”2 Any prescription drug or device manufacturer operating in the United States must report the payment. After reporting, physicians will have 45 days to review and dispute inaccurate data.

Reporting covers all doctors (MD, DO, DDS, DPM, OD and DC) and not only physicians who are enrolled in Medicare or Medicaid. There is a discrepancy between providers by type since the accrediting bodies for continuing medical education (CME) are different. Physicians who are paid to speak at a CME event are not directly paid by a pharmaceutical or device company, but the data will be reported as a honorarium for the Sunshine Act.

The Centers for Medicare and Medicaid Services (CMS) gave five exclusions to the Accreditation Council for Continuing Medical Education (ACCME), the American Academy of Family Practice, the American Dental Association Continuing Education Recognition Program, the American Medical Association and the American Osteopathic Association.3 Doctors who speak at events accredited by these exempt entities won’t have to report payments. The exempt entities cover MD, DO and DDS providers.

The Council on Podiatric Medical Education (CPME), the only sponsor of CME for podiatrists, is not excluded. The CPME must report payments to DPMs for lecturing at the more than 100 CME events (including the annual conference of the American Podiatric Medical Association) held annually for podiatrists.

Here is the tricky part. The law does not require conferences to directly report so your online disclosure wouldn’t read “$1,500 from the APMA.” As the rule reads now, conferences have to cooperate with the sponsors of the events to assign a dollar amount to the lecturers. For example, if Company X sponsors the conference at $50,000, that money will be assigned to the lecturers and Company X will report that as a payment to the lecturer even though this was a CME lecture. It should be noted that this is in direct conflict with ACCME and CPME rules that the content of CME events is without bias and that sponsors cannot earmark funds toward a speaker.

The impact could be tragic for podiatry conferences. First, MDs or DOs who speak at our events (especially those are affiliated with academic institutions) may not accept invitations since the law requires a drug or device company to report the honorarium. Second, this may reduce sponsorships from drug and device companies since they have an added (and confusing) reporting burden, and it may seem like they are paying physician speakers who are not under contract. Lastly, it is a slap in the face to the CPME as the government feels the need to question the council’s objectivity by requiring personnel to report honoraria as payment.

The Sunshine Act could hinder podiatric education in the future and we need to work to include CPME in the exempt category of continuing education sponsors.

References

1. Campbell EG, Gruen RL, Mountford J, et al. A national survey of physician-industry relationships. N Engl J Med 2007;356(17):1742-1750

2. Agrawal S, Brennan N, Budetti P. The Sunshine Act – Effects on Physicians. N Engl J Med 2013;368(22):2054-2057

3. Sullivan Thomas. Physician Payment Sunshine Act: CMS Posts Round 4 of FAQs: CME Exemption for Only the Five Accreditation Systems Listed, Promotional Speaking Listed as Honorarium or Services other than Consulting - Policy and Medicine. Policy and Medicine. July 8, 2013. Available at: http://www.policymed.com/2013/07/physician-payment-sunshine-act-cms-post... . Accessed July 29, 2013.



Alan Sherman, DPM, CCMEPsays: August 1, 2013 at 9:24 am

Lee,

You say in your article that physicians as well as manufacturers must report non-excepted payments. My understanding is that for physicians, it is to be handled like CME records. You are required to keep the records but only need to produce them if you are audited. If reporting is required, please cite a source.

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Lee Rogerssays: August 1, 2013 at 11:44 am

Alan, thanks for pointing that out. Yes, you are correct. I mis"wrote". It is only manufacturers that have to report. Physicians have an opportunity to dispute the reporting but there is no reporting requirement for physicians or conferences although cooperation will be necessary.

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