Consumer advocates, doctors, employers and leaders in Congress alike have all written letters this month urging the Centers for Medicare & Medicaid Services (CMS) to implement the Physician Payment Sunshine Act (PPSA), making drug industry payments to doctors public and transparent. Passed into law as part of the Affordable Care Act (ACA) in 2010, the PPSA requires manufacturers of drugs, medical devices and biologics to report payments they make to doctors and teaching hospitals to the Department of Health and Human Services (HHS), which must disclose these payments in a publicly available, searchable online database.
While Congress intended for CMS to have final rules in place back in January 2012, the agency faced understandable obstacles to that goal. When CMS published its proposed rule on November 15, 2011, it received an unprecedented flood of stakeholder comments, forcing it to push back all associated deadlines so it would have time to take all of the input into consideration. During the first half of 2012, CMS also faced uncertainty on whether the ACA would be ruled unconstitutional, taking the PPSA down with it. However, any larger questions about the ACA were settled in June, and instead of issuing a second draft of its guidance in July, CMS sat on its hands all summer. The agency promised rules by the end of 2012, which would allow companies to collect data January 1, 2013 and disclose all financial relationships with doctors to the public by September 1 of this year. Bloomberg News reports that CMS spokesperson Brian Cook has promised the regulations “soon.” Yet, the agency refrains from saying when we can expect final regulations and begin bringing transparency to doctors’ conflicts of interest.
Due to the ongoing delay, patients remain in the dark about whether their doctors are accepting lavish dinners or travel from drugmakers, and whether those relationships may be affecting their patient care. In his letter to White House Chief of Staff Jacob Lew, PPSA co-author Sen. Charles Grassley (R-IA) pointed out that CMS won't be able to collect data on time, now that the statutory deadline is 15 months past due. “At best, the public may miss an entire year’s worth of data collection—perhaps more,” he noted. “This is unacceptable.”
On January 14, Community Catalyst organized 18 consumer, patient and labor organizations in urging the Obama Administration to issue the final rules. Others weighing in on the delay include medical student and physician advocates, a number of high-profile doctors, Senator Grassley and Rep. Sharon Treat (D-ME). Even drug and device manufacturers have been calling on CMS to publish the final rules, in order to gain clarity.
While all sides agree the rules should be out soon, how quickly the rules are put in place may be controversial. Patients want this information as soon as possible, but industry is on record asking for as long as half a year. Such an additional delay is unacceptable for two reasons. First, nearly all the drug and device manufacturers have been reporting their payments under state law requirements in Vermont, Massachusetts and Minnesota for years. Secondly, nearly half the biggest drug manufacturers have been tracking and reporting payments to the federal government under settlement of criminal and civil prosecutions for illegal marketing.
Unfortunately, even after CMS issues PPSA rules, consumers will still have to wait until April 1, 2014 for the first public disclosures, a full year later than originally planned by Congress. We cannot wait any longer.
– Khadijah M. Britton, JD, Program Associate, Prescription Access and Quality