By Alan M. Kirschenbaum -
Today drug and device manufacturers and other stakeholders had an opportunity to provide comments to CMS during an Open Door Forum teleconference on how the physician payment sunshine provisions of the Patient Protection and Affordable Care Act ("ACA") should be implemented. As explained in our memo summarizing the drug and device provisions of the ACA, section 6002 of that statute requires each manufacturer of a covered drug, device, biological, or medical supply that is operating in the U.S. or its territories or possessions annually to electronically report information on payments or other transfers of value made during the prior year to physicians and teaching hospitals. The first report must be submitted by March 31, 2013 for payments made in calendar year 2012.
CMS officials were in self-described listening mode during the Open Door Forum, and did not provide any guidance or answer any questions on how the law will be implemented, other than to say that the agency will initiate notice and comment rulemaking with a proposed regulation later this year. The purpose of the session was to enable CMS to be more focused in its initial proposal. CMS sought comments during the call on several pre-published questions, which fell into three general categories.
The first category of questions asked whether CMS should require disclosure of additional forms of payment and additional specific categories of payments beyond those specified in the statute. The unanimous consensus of participants on the call, which included representatives from PhRMA, BIO, and AdvaMed, was that no new requirements should be added, but CMS should instead focus on establishing clear rules for disclosure of the 14 categories of payments already required by statute. Participants emphasized the need for narrow and detailed definitions of reportable categories in order to ensure uniformity of reporting, prevent double counting of payments, and avoid confusion on how to report payments that conceivably might fall into multiple categories. Examples were given of travel expenses paid to researchers to attend an investigator meeting, which might be considered payments for either research or travel, or payments to members of a data safety monitoring board, which might be viewed as either research payments or consulting fees.
The second category of CMS questions focused on usability of the reported data by the public. Industry trade association representatives all emphasized that the published data reports must be accompanied by background material explaining the vital role of industry-physician interactions in contributing to the design and development of products, the conduct of research, the training and education of practitioners in products and their uses, and other facets of appropriate product use.
Thirdly, CMS asked questions concerning the format of submissions and the process for corrections. Participants recommended the spreadsheet submission format currently used by states, with CMS specifying the reporting template. Several participants urged that manufacturers should have a mechanism for checking CMS’ reports on their payments before the reports are posted on the CMS web site, and at any time after they are posted.
Manufacturers and other stakeholders may submit feedback on CMS’s questions by sending an email to email@example.com by April 7. Manufacturers will have an opportunity to comment on CMS’ proposed rule when it is issued, but early input at this stage will help ensure that the proposed regulation is clear, appropriately detailed, and balanced.