Fix the SGR, Delay Imaging Cuts
Rep. Michael Burgess (R-Tex.), an ob.gyn., has introduced legislation (H.R. 5866) that would put an end to physician fee cuts under Medicare by halting application of the sustainable growth rate by Jan. 1, 2007. Each year, the SGR has contributed to a decrease in payments; in 2007, that cut is slated to be 5.1%. Rep. Burgess is proposing to tie physician fees to one factor only: the Medicare Economic Index minus 1%. According to Rep. Burgess, this places “more value on actual cost inputs.” The bill also would establish a system of quality measures to give patients more information about Medicare providers, delay by 1 year proposed cuts in imaging services reimbursement, and require the Institute of Medicine to study whether imaging saves money. The American Medical Association called the Medicare Physician Payment Reform Bill and Quality Improvement Act of 2006 an “important step toward replacing the flawed Medicare physician payment formula.” Rep. Burgess' bill is the third in the House to delay or repeal the cuts in imaging fees; a similar bill was recently introduced by Sen. Gordon Smith (R-Ore.) and Sen. Jay Rockefeller (D-W.Va.).
Senate Bill to Boost Drug Safety
After months of public discourse, Sen. Edward Kennedy (D-Mass.) and Sen. Mike Enzi (R-Wyo.) have introduced a bill that aims to increase assurances that drugs are safe before they reach the marketplace, or at least have a plan in place to more closely monitor when they need to be withdrawn. The Enhancing Drug Safety and Innovation Act would require pharmaceutical manufacturers to be more proactive about safety problems. Companies would have to establish risk evaluation and management strategies that will be agreed upon by the manufacturer and the Food and Drug Administration before the product is approved. The companies would have to submit adverse event reports every 15 days, quarterly, and annually. If a company knowingly does not comply with the agreed-upon strategy, the FDA can impose monetary penalties. The senators also proposed that manufacturers make clinical trial results public. Fuller disclosure “will help patients and their health care providers make better informed decisions about treatment,” Sen. Kennedy said in a statement. Finally, the bill would overhaul the FDA's process for vetting outside advisory panel members, with a goal of minimizing conflicts of interest and then ensuring that they are fully disclosed.
Gulf War Research
New federally funded research will test the hypothesis that veterans with Gulf War Illness have metabolic, structural, or functional changes in their basal ganglia that are not accounted for by posttraumatic stress disorder, depression, or alcoholism. This is among 24 projects that were funded by the federal government starting in fiscal year 2005 to examine the health of veterans of the Gulf War. The Department of Veterans Affairs is required to report to Congress each year on the status of research into the health consequences of military service in the Persian Gulf region from Aug. 2, 1990, to July 31, 1991. From fiscal year 1992 through 2005, the federal government has sponsored 300 research projects on Gulf War veterans' illnesses, according to the report, available at
www.research.va.gov/resources/pubs/pubs_individual.cfm?Category=Gulf War Reports
Genetic Testing
Officials at the Centers for Medicare and Medicaid Services should establish a genetic testing specialty under the Clinical Laboratory Improvement Amendments (CLIA) of 1998, according to a coalition of 14 women's health groups. In a letter to CMS Administrator Mark McClellan, the groups urged him to move forward with a Notice of Intent of proposed rulemaking issued in 2000 on the development of a genetic testing specialty. The science is outpacing the current regulations, the groups wrote. Currently there are about 1,000 tests for genetic diseases available clinically and several hundred more under development. Signatories to the letter include the Association for Reproductive Health Professionals, the Reproductive Health Technologies Project, and the Society for Women's Health Research.
HIV Vaccine Grants
The Bill and Melinda Gates Foundation has awarded $287 million to researchers in an effort to accelerate development of an HIV vaccine. The sum will fund 16 grants to more than 165 investigators from around the world. “Some of the vaccine concepts that will be pursued have been talked about for years, but have never been adequately studied,” Dr. Nicholas Hellmann, acting director of the Gates Foundation's HIV, TB, and Reproductive Health program, said in a statement. “If successful, they could lead to entirely new paradigms for HIV vaccine development.”
Payment for Part B Drugs