Several members of the United States House of Representatives (House) recently sent a letter to Marilyn Tavenner, Acting Administrator of the Centers for Medicare and Medicaid Services (CMS), requesting a delay in issuing the final rule implementing the "Transparency Reports and Reporting of Physician Ownership or Investment Interests" section of the Patient Protection and Affordable Care Act, commonly referred to as the Sunshine Act. Specifically, the House members request that CMS delay issuing the final rule until the “appropriate congressional committees of jurisdiction have had a chance to review the proposed rule and its impact on patients and the U.S. health system.” In the letter, the House members identified several areas of the Sunshine Act and the proposed regulations that would “negatively impact patient care and the practice of medicine in this country,” including the following:
- Complexities involved in tracking the actions of providers during meetings will force companies to expend limited resources for compliance efforts, instead of developing strategies to improve patient care and outcomes;
- Failure to exempt payments made for accredited Continuing Medical Education (CME) events and non-CME speaking engagements from the reporting requirements would end company participation in CME events, which provide medical providers with education and advancements in patient care;
- Physicians who conduct research and clinical trials for industry would be less likely to participate if their payments from such work are made public, as the reporting requirement may provide a distorted view of provider compensation; and
- The low reporting threshold and potential for high penalties due to noncompliance with the law and implementing regulations may cause companies to over report, thereby costing CMS billions of dollars to maintain a database capable of sharing these payments with the public.
Pursuant to the Sunshine Act, drug, device, biological product, and medical supply applicable manufacturers must annually disclose certain information regarding payments and other transfers of value to physicians and teaching hospitals valuing $10 or more. An additional provision requires manufacturers and group purchasing organizations ("GPOs") to disclose all ownership or investment interests held by physicians or members of their family. CMS has indicated that it intends to release the final rule implementing the Sunshine Act later this year (2012), and that it will not require data collection by applicable manufacturers and applicable GPOs before January 1, 2013. To date, CMS has not issued a response to the House members’ letter.
To view the House members’ letter, click here.