Drug companies will have to report all payments to US doctors from March 2014BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f826 (Published 07 February 2013) Cite this as: BMJ 2013;346:f826
The Obama administration has released final rules on the reporting of financial relations between drug companies, device manufacturers, and healthcare providers.1
The rules are part of the so called “sunshine” provisions of the Affordable Care Act that were designed to create greater transparency in the healthcare marketplace.
They were supposed to have been finalized no later than 1 October 2011,2 3 but they became bogged down under review by the White House’s Office of Management and Budget. They emerged only after a concerted public lobbying effort by medical and ethics figures such as the former editors of the New England Journal of Medicine Marcia Angell and Jerome Kassirer.
The regulations require pharmaceutical and device companies to report to the Centers for Medicare and Medicaid Services all payments made to doctors and teaching hospitals, who will be named. The payments include speaker and consulting fees, research grants, gifts, food and entertainment, royalties and licensing payments, investments, and other things of value. Single payments less than $10 (£6.4; €7.4) won’t have to be reported, unless such payments total $100 or more cumulatively for the year.
Companies must begin to collect the information by 1 August and report it to the Centers for Medicare and Medicaid Services by 31 March 2014. However, the centers do not have to begin posting the information to a public website until 30 September 2014.
Advocates of transparency are concerned about one change from the draft to the final text. This concerns a way that companies could avoid reporting payments to physicians for participating in continuing medical education (CME) programs. A company may fund such activity, but so long as the program’s organizers are accredited or certified to do so, and the company gives the organizers a completely free hand (it cannot directly pay participating physicians or suggest a list of speakers to the organizers), the company does not have to report payments to individual physicians.
Although industry representatives praised the change as common sense, critics questioned how truly independent the organizers of CME programs would be if they hoped to continue to receive company support in underwriting those activities.
Peter Budetti, deputy administrator for program integrity at Centers for Medicare and Medicaid Services, said in a statement accompanying the release of the regulations, “Disclosure of these relationships allows patients to have more informed discussions with their doctors.”
Allan Coukell, director of medical programs for the Pew Charitable Trusts, said in a statement, “The final rule contains a number of improvements over the earlier draft, including the elimination of loopholes that could allow financial transactions to go unreported.”
The American Medical Association “will carefully review” the new regulations, said the association’s president, Jeremy A Lazarus, in a statement. “Our feedback during this rulemaking process was aimed at ensuring the new registry will provide a meaningful picture of physician-industry interactions and give physicians an easy way to correct any inaccuracies.”
Pharmaceutical Research and Manufacturers of America took a similar approach. In a statement attributed to its senior vice president, Matthew Bennett, the trade body said that it was “currently reviewing the final regulation . . . to see how [the Centers for Medicare and Medicaid Services] addressed key concerns that were previously raised.” It reiterated its commitment to the transparent sharing of information.
Currently the Dollars for Docs database (http://projects.propublica.org/docdollars) maintained by the non-profit group Pro Publica has been the best source of such information about company payments to physicians. The information is gathered from what some companies have begun to voluntarily release, as well as information obtained through legal actions.
Cite this as: BMJ 2013;346:f826