A Ray of Sunshine: CMS Experts Give an Update on 2 Years of Public Disclosure
Two years into the Open Payments Program, wherein drug and device companies are required to report on a wealth of financial relationships with doctors, two employees of the Centers for Medicare & Medicaid Services (CMS) are giving a progress report on the effort.
Before the Sunshine Act came into being as part of President Obama’s 2010 healthcare plan, “[m]uch of the work done to date has lacked context on the type and scope of [industry-physician] interactions,” write Shantanu Agrawal, MD, and Douglas Brown, MHS (Center for Program Integrity, CMS), in a New England Journal of Medicine perspective published online today.
To fill this gap, they say, CMS has sought to create a “complete, unbiased database to inform public analyses and discourse.”
In 2014, nearly 1,500 companies made payments worth about $6.5 billion to more than 600,000 physicians and 1,100 teaching hospitals. Royalty or license payments made up the largest chunk, representing about one-third of the total, followed by “services other than consulting” at 24.7% and consulting at 14.4%. Other categories covering travel and lodging, food and beverage, grants, honoraria, and speaker’s fees, among others, each made up less than 10% of the total.
Taking Steps to Promote Transparency, Accuracy
A key part of the process is checking to make sure that the numbers reported by companies are in fact accurate, lest they falsely tarnish the reputation of certain doctors, Agrawal and Brown note.
“In the first year of reporting, a substantial number of companies submitted records with inconsistencies in physician identifiers,” they explain, adding, “To address this issue, CMS redacted physician information in nearly 40% of all reported payment records in the first year. We then released educational tools and resources to assist companies and implemented automated algorithms in our reporting system to reject payment records with inconsistent physician identifiers, providing real-time feedback to companies.” With newer 2014 data, the redacted numbers from 2013 could then be validated and properly attributed to the correct physicians, they report.
Beyond categorizing and counting, however, there is a need to balance the goal of transparency with the potential that public reporting could curb innovation, Agrawal and Brown add.
They outline a feature of Open Payments meant to reduce the odds that companies might, out of fears of appearing mercenary, hold back money that would ordinarily be spent to foster new drugs and devices. “Companies may also delay the public release of certain research-related payments for up to 4 years or until the product under development has been approved by the Food and Drug Administration, whichever comes first,” they point out. “Companies made such request for about 370,000 research-related payments valued at more than $1.7 billion in 2013 and 2014.”
Outreach for the program continues in the form of briefings for companies, focus groups and monthly industry forums hosted by CMS, and both continuing medical education (CME) and a mobile app for physicians keeping track of their payments.
Looking forward, Agrawal and Brown predict that the “most significant policy change will occur in 2017, when payments related to all accredited CME activities must be reported, barring any statutory changes currently under consideration. . . . According to the Accreditation Council for Continuing Medical Education, industry provided nearly $660 million in CME support in 2013—about 26% of total CME funding.”
While the full impact of public disclosure has yet to be
felt, one certainty is that the Open Payments data are being accessed, they
say. “To date, more than 6.5 million unique searches have been conducted using
the Open Payments data-search tool, and the full datasets have been downloaded
more than 14,000 times.”
- Agrawal S, Brown D. The Physician Payments Sunshine Act: two years of the Open Payments Program. N Engl J Med. 2016;374:906-909.
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- Agrawal and Brown report no relevant disclosures.