Senators Charles Grassley and Herb Kohl have sent a letter to Marilyn Tavenner, Acting Administrator of the Centers for Medicare and Medicaid Services ("CMS"), regarding implementation of the “Transparency Reports and Reporting of Physician Ownership or Investment Interests” section of the Patient Protection and Affordable Care Act (“PPACA”). This section of PPACA, commonly referred to as the Sunshine Act, was co-authored and co-sponsored by Senators Grassley and Kohl.
Under the Sunshine Act, drug, device, biological product, and medical supply manufacturers are required to report annually certain information regarding payments and other transfers of value to physicians and teaching hospitals. An additional provision requires manufacturers and group purchasing organizations to report all ownership or investment interests held by physicians or members of their family. Additionally, the Sunshine Act requires the Secretary of the Department of Health and Human Services to establish procedures for making reported information available to the public through an Internet database.
In the letter dated April 4, 2012, the Senators request that CMS release final rules implementing the Sunshine Act no later than June of this year so that partial data collection for 2012 can begin. CMS previously missed the October 1, 2011, deadline to establish final rules implementing the Sunshine, but did propose draft rules on December 19, 2011. CMS has since indicated that it is aggressively working through the public comments and consulting with stakeholders regarding the proposed rules. CMS also indicated that it is hoping to publish the final rules this year and anticipates that data collection will begin before the end of the year.
The Senators also provide comments on the quality and clearness of the data provided on the publicly accessible website, urging CMS to “be clear on guidelines and context so that the data posted online is meaningful and understandable.” The Senators also urge CMS to develop mechanisms by which errors in data are corrected on a quarterly basis, as opposed to CMS’ proposal to update reporting errors once per calendar year. The Senators ask that CMS consider requiring applicable manufacturers to share the data it plans to report with covered recipients prior to submitting the data to CMS, which would reduce the number of inaccurate payments and disputes reported.
The Senators further request that CMS disclose data on the public website in an “easy-to-use format and with terms and product and manufacturer names recognizable to patients.” The Senators also urge CMS to increase its outreach to physicians and covered recipients to educate them about the Sunshine Act’s provisions to ensure proper implementation.
To view a copy of the Senators' letter, please click on the following link: Senators' Letter