Count it as a health-care deadline missed. The federal government has yet to write rules — mandated as part of last year’s health-care law — that would force drug and medical-device companies to disclose their gifts, fees and payments to doctors.
Last year’s Affordable Care Act required that disclosure rules be drafted “not later than October 1, 2011,” a deadline that came and went quietly and without any explanation from the Obama administration.
Since October 2010, ProPublica has been reporting on the ethical issues that can arise when doctors have substantial financial ties to the drug companies that aim to influence their prescribing habits. We put together a database of payments from 12 companies that have already begun disclosing such data — some as result of legal settlements with the federal government. But as we’ve also noted, physician payments from potentially hundreds of drug and device companies operating in the United States are still secret for the time being.
The payment-disclosure rules, once finally implemented, will offer the first complete picture of what’s likely to be billions of industry dollars flowing to doctors each year.
While the health-care law gives the government until the end of September 2013 to make the payments from all companies public and searchable, the companies are supposed to begin collecting the data at the start of next year. But the delay in drafting the rules means companies may have to wait for further instructions about what exactly to collect.
The agency in charge of drafting the rules, the Centers for Medicare and Medicaid Services, recently received a stern letter [PDF] from the two lawmakers who had proposed the specific provision in the health-care law known as the Physician Payments Sunshine Act.
“We write today to express our severe disappointment in the Centers for Medicare and Medicaid Services,” wrote Sens. Charles Grassley and Herb Kohl. “... We are concerned that CMS’s failure to implement the statutory provisions on time with clear guidance, standards and definitions will create confusion among both manufacturers and consumers, potentially placing taxpayer dollars at risk.”
Asked about the rules, CMS declined to explain the delay. “We have received Congressional correspondence on this issue and will respond directly to Senators Grassley and Kohl,” said agency spokeswoman Ellen Griffith. “We will not have anything to say to the press until we have responded to the Senators.”
At the moment, the agency is charged with implementing a number of provisions from the health-care law, acknowledged Allan Coukell, director of the Pew Prescription Project, a consumer safety campaign that advocated the disclosure law.
“I have sympathy for the agency in terms of all the things they have to implement right now. But this is an area that there’s bipartisan consensus, where both industry and consumer groups are saying, ‘Yes, this is a priority,’” Coukell said. “A lot of work went into this provision, and they need to get it done.”