Second Look-Advocacy

CMS releases proposed “Sunshine Rule”
The U.S. Centers for Medicare & Medicaid Services (CMS) has released a proposed rule designed to reveal potential conflicts of interest between manufacturers and providers. The Physician Payment Sunshine Act is called for under the Patient Protection and Affordable Care Act, and will require drug, biologics, and medical device manufacturers, as well as group purchasing organizations, to report payments to physicians and teaching hospitals. Payments are defined to include gifts, fees, meals, and travel expenses and exclude items such as certain product samples, educational materials, device loans, and transfers of less than $10 in value, unless the aggregate amount exceeds $100 in a calendar year. Violators of the reporting requirements will be subject to civil monetary penalties capped at $150,000 annually for failing to report, and $1,000,000 for knowingly failing to report. CMS will accept public comments on the proposed rule until Feb. 17, 2012. Data collection was originally to begin on Jan 1, 2012, but will not be required until after a final rule is published.

Spending bill funds orthopaedic research
President Obama has signed into law the Consolidated Appropriations Act of 2012 (HR 2055). The legislation includes $30 million in funding for the Peer Reviewed Orthopaedic Research Program (PRORP)—an increase of 25 percent over the previous year. PRORP was established by the U.S. Congress during 2009 to support military-relevant, peer-reviewed orthopaedic research to aid wounded warriors. (See “Orthopaedic Research Gets Boost in Defense Bill,” page 26.)

Registry initiative making progress
A special online supplement of the Journal of Bone & Joint Surgery—American (Dec. 21, 2011) reports on the International Consortium of Orthopaedic Registries (ICOR)—an initiative established to improve postmarket surveillance of orthopaedic devices. Currently, the most reliable data on devices come from registries such the Kaiser Permanente Implant Registries in the United States and national registries that track 100 percent
of device implants in countries such as Australia and the United Kingdom. While useful, each registry takes a unique approach to monitoring safety. The goal of ICOR is to establish a unified method for analyzing and reporting multinational registry data, improving the usefulness of the information to inform decision-making.

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