The idea of transparency enjoys widespread popularity, but in practice things can become a bit murky. Take the example of the Open Payments program, which requires drug and device manufacturers to collect and report on payments they make to physicians and teaching hospitals. I spoke with a number of industry executives who all told me that while the program has a commendable goal, it’s too complicated and imposes an onerous administrative burden on companies.
Rebecca McCarty, senior vice president, chief compliance officer and associate general counsel at United Therapeutics, told me that the collection and reporting process is very hard for the company to accomplish. For example, McCarty said the company recently identified 20 records that had been classified as general payments rather than research payments. Rather than letting United Therapeutics delete the 20 records, the Centers for Medicare & Medicaid Services told the company to delete over 5,000 payment records and then re-submit them, McCarty said.
McCarty also said it’s difficult to manipulate the data contained in the Open Payments database. “The end goal of more transparency is good, but it's just not user-friendly,” McCarty said. United manufactures several hypertension medications, including Remodulin and Tyvaso, among other products, and is based in Silver Spring, Md.
I also spoke with Matthew Wetzel, a vice president and assistant general counsel at AdvaMed, a medical device trade group, who said companies face a number of hurdles when submitting their payment records to the program. He said drug and device companies have invested a lot of resources building compliance programs focused on collecting and validating data, yet the CMS still insists on doing its own internal validation, often using out-of-date data.
Manufacturers generally have the most up-to-date data on physicians, while the CMS data are often not updated for years, Wetzel said.
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