Managing Your Practice

Sunshine Act – a reminder


 

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Last year, when the Physician Payment Sunshine Act became law, I recommended that all physicians involved in any sort of financial relationship with the pharmaceutical industry review the data reported about them prior to public posting of the information. Since that posting is due to occur at the end of this month, a reminder is in order.

Under a new bureaucracy created by the Affordable Care Act – formally called the Open Payments program – all manufacturers of drugs, devices, and medical supplies covered by federal health care programs must report any financial interactions with physicians and teaching hospitals to the Centers for Medicare & Medicaid Services (CMS).

Reportable interactions include consulting; food; ownership or investment interest; direct compensation for speakers at education programs; and research. Compensation for conducting clinical trials must be reported, but will not be posted on the website until the product receives approval from the Food and Drug Administration or until 4 years after the payment, whichever is earlier. Payments for trials involving a new indication for an approved drug will be posted immediately.

There are a number of specific exclusions, such as certified and accredited continuing medical education activities funded by manufacturers, and product samples for patient use. Medical students and residents are excluded entirely.

Under the law, you are allowed to review your data and seek corrections before it is published. Publication is scheduled to occur on Sept. 30, so if you have not yet done this, there is no time to waste. Although you will have an additional 2 years to pursue corrections after the online content goes live, any erroneous information will remain on the site until corrections can be made, so the best time to find and fix errors is now.

If you don’t see drug reps, accept sponsored lunches, or give sponsored talks, don’t assume that you won’t be on the website. Check anyway; you might be indirectly involved in a compensation situation that you were not aware of, or you may have been reported in error.

To review your data, register at the CMS Enterprise Portal, and request access to the Open Payments system.

Once you are satisfied that your interactions have been reported accurately, the question of what effect the law will have on research, continuing education, and private practice remains. The short answer is that no one knows. Much will depend on how the public interprets the data – if they take notice at all.

Sunshine laws have been in effect for several years in six states: California, Colorado, Massachusetts, Minnesota, Vermont, and West Virginia; plus the District of Columbia. (Maine repealed its law in 2011.) Observers disagree on their impact. Studies in Maine and West Virginia showed no significant public reaction or changes in prescribing patterns, according to a 2012 article in Archives of Internal Medicine (Arch. Intern. Med. 2012;172:819-21).

Potential effects on physician-patient interactions are equally unclear. Do patients think less of doctors who accept the occasional industry-sponsored lunch for their employees? Do they think more of doctors who speak at meetings or conduct industry-sponsored clinical research? There are no objective data, as far as I know.

My guess is that attorneys, activists, and the occasional reporter will data-mine the website on a regular basis, and perhaps use their findings as ammunition in any agenda that they might be pushing, but few patients will ever bother to visit. Nevertheless, you should review each year’s reportage to ensure the accuracy of anything posted about you.

The data must be reported to CMS by March 31 each year, so you will need to set aside time each April or May to review it. If you have many or complex industry relationships, you should probably contact each company in January or February and ask to see the data before it is submitted. Then, review it again once CMS gets it, to be sure nothing was changed. A free app is available to help physicians track payments and other reportable industry interactions; search for "Open Payments" at your favorite app store.

Maintaining accurate financial records has always been important, but it will be even more so now, to effectively dispute any inconsistencies. While the extra work may turn out to have been unnecessary, it is still a prudent precaution, given the possible consequences of any increased government or public scrutiny that may (or may not) result.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Skin & Allergy News.

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