October 2004 Bulletin

AAOS comments on changes to proposed 2005 physician fee schedule

The AAOS has submitted comments on the proposed changes to the Medicare 2005 Physician Fee Schedule to the Centers for Medicare and Medicaid Services (CMS). Major areas of concern included several practice expense recommendations, the proposed methodology for revising medical liability relative value units and a proposed provision on durable medical equipment that may preclude physicians with a supplier number from dispensing equipment in their offices. The AAOS also criticized the lack of information in the proposed rule on Medicare drug payments scheduled to go into effect next year and repeated its request that CMS remove Medicare-covered drugs from the sustainable growth rate formula. The final rule is expected to be issued in November.

Merck withdraws Vioxx from world market

Merck & Co. Inc. has voluntary withdrawn Vioxx (rofecoxib) from all markets due to safety concerns of an increased risk of cardiovascular events (including heart attack and stroke) in patients taking the drug. Vioxx was approved by the Food and Drug Administration in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults and for the treatment of menstrual symptoms. It was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children. The 2004 MedWatch safety summary, including links to the Public Health Advisory, press release, and Q&As, is at: http://www.fda.gov/medwatch/SAFETY/2004/safety04.htm - vioxx

Wright recalls hip implant

Wright Medical Group Inc. has recalled defective components used in one of its hip implant systems. The components are used in its Conserve Total and Conserve Plus hip replacement systems. The company said it found a small ridge on the surface of the system’s hip cups that failed to meet specifications and voluntarily recalled the products. No more than 67 patients in the United States and 24 in other countries were implanted with the faulty devices, the company said. So far, five patients have had them surgically removed. Wright said it has notified the U.S. Food and Drug Administration of the action and has pulled the devices from the field.

HIPAA Civil Money Penalty Rule Extended

The Department of Health and Human Services (HHS) published an interim final rule extending enforcement of the civil money penalties for violations of the privacy, electronic transactions and security rules of the Health Insurance Portability and Accountability Act (HIPAA) for one year. The proposed rule was issued in April 2003 and allowed HHS to fine facilities up to $100 for each privacy rule violation and up to $25,000 per year for similar violations of the same prohibition. Furthermore, once determination of a civil monetary penalty is made final, the Secretary of HHS has no discretion in whether to collect the penalty. In its comments on the proposed rule in May 2004, the AAOS Washington Office conveyed its serious concerns about the implications of several of these enforcement provisions. In the interim final rule, CMS explained that the delay of the final rule was designed to “avoid disruption of ongoing enforcement actions” while HHS develops a “more comprehensive enforcement rule.” The interim final rule can be found at: http://www.hhs.gov/ocr/moneypenalties.html

AOA launches new Web site

The American Orthopaedic Association (AOA) has redesigned its Web site to allow for easier navigation and complete, up-to-date information on awards, courses, fellowships and symposia. The site also includes a calendar of events and links to academic and leadership resources. AOA encourages visits to the site, which is located at: http://www.aoassn.org/

AAOS, Alliance for Specialty Medicine working for patient safety bill

AAOS and the Alliance of Specialty Medicine voiced support for passage of the Senate version of patient safety legislation during a lunch with Rep. Chip Pickering Jr. (R-Miss.), the House Energy and Commerce Committee Vice-Chair and a member of the Health Subcommittee, in September. AAOS and the Alliance believe that the Senate version of patient safety legislation, which could pass before the end of this Congress, is preferable to the House bill in its handling of confidentiality protections, privileges against discovery and subpoena of patient safety data, limitations and exceptions affecting these privileges, and the criteria for certification of Patient Safety Organizations. The need for congressional hearings on the Medicare physician payment formula also was discussed.

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