Industry Intel with Gary Price

Sunshine Act Forecast

We’ve now been through our first cycle of the Centers for Medicare and Medicaid Services’ (CMS) Open Payments reporting program — better known as the Physician Payments Sunshine Act — and there were a few snafus. This is the federal program that’s designed to provide transparency in financial relationships between medical and dental manufacturers and physicians and dentists. These are called “transfers of value,” and might include speaking fees, gifts, meals, travel or funding for research.

First, the CMS took down its online payment verification system after discovering that a “small number” of doctors had been confused with others with the same name. Then, verification and resolution due dates had to be extended. The CMS also had to return a third of the records it received because of reporting errors. As a result, a number of disclosed payments to doctors from 2013/2014 will not be reported on the database until sometime next year.

While many groups, including the Dental Trade Alliance, are working to modify the reporting requirements, it appears likely that change is forthcoming from CMS itself. Already the agency has stated that it wants to: remove the definition of “covered device,” as it is duplicative of the definition of “covered drug, device, biological or medical supply;” delete the Continuing Education Exclusion in its entirety; require the reporting of the marketed names of covered and noncovered drugs, devices, biologicals or medical supplies associated with a payment; and mandate that applicable manufacturers report stocks, stock options, or any other ownership interest as distinct categories.

In addition, state reporting regulations are likely to change to align with federal requirements. On top of this, the next reports are due in March 2015 — allowing half the reporting time of the prior cycle.

While the final implications of the Open Payments reporting program are not yet fully understood, there’s plenty to keep manufacturing and distribution professionals awake at night. This includes a continued lack of clarity from CMS; worries about divulging sales activities to competitors or how the reported data will be used and perceived by the public; opening the flood gates for donation requests; and, of course, fines for inaccurately reported data.

Considering that transfers of value could include taking dentists out for lunch-and-learns, sales reps and management can make their lives easier — and avoid penalties — by maintaining clear records of all transfers of value to dentists. This not only helps with reporting requirements, but it also backs you up if one of your dentists questions a reported interaction.

Unfortunately, as dentists come to better understand the implications of Open Payment reporting, you may encounter resistance when offering programs or even scheduling a lunch appointment. The onus will be on you to make sure that what you’re offering provides benefits that justify a transfer of value report in the minds of clinicians.

As the forecast for the Sunshine Act is for continuing uncertainty, it behooves sales professionals and management to keep up with developments in the law and maintain detailed records of Open Payment-related activities. This will help ensure that you are serving the best interests of both your company and customers.

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MENTOR November 2014;5(11):10.

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