Published 2/1/2012

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.

Supreme Court case could define limits of medical patents
The U.S. Supreme Court has heard arguments in a case that could determine the limits of so-called “personalized medicine” patents. At issue is a blood test that helps physicians determine the proper patient dose for the drug thiopurine. A patented test is on the market, but physicians at the Mayo Clinic developed their own test with the intention of marketing it. A lower court judge ruled in Mayo’s favor because the patented test makes use of a natural phenomenon and mental process, neither of which can be patented under U.S. law. However, the decision was overturned on appeal, leading to the Supreme Court challenge. An attorney for Mayo Clinic argues that allowing such a patent would “wipe out a whole field so no one else can have a competing test.”

CDC: HCV infection spread via tissue donation
The U.S. Centers for Disease Control and Prevention (CDC) has conducted an investigation into possible Hepatitis C virus (HCV) spread through tissue donation, based on reports of two patients who tested positive for HCV infection approximately 6 months after receiving kidney transplants from a deceased donor. Donated tissue included 43 musculoskeletal grafts distributed to healthcare facilities in several states. The CDC report finds several areas in which current detection and notification might be improved to prevent similar future transplant transmission events, including the following:

Consideration of the use of HCV nucleic acid testing for organ donors

Use of algorithms or other procedures to ensure accurate reading of test results and reduce human error

Timely feedback of possible disease transmission in organ or tissue recipients to organ procurement organizations, tissue banks, public health authorities, and regulators.

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp(member login required)