Competitive Drug Acquisition
Starting April 3, 2006, physicians can begin the initial vendor election process as part of Medicare's Competitive Acquisition Program (CAP) for physician-administered drugs covered under Medicare Part B. The voluntary program allows physicians to obtain Part B drugs from vendors who are selected in a competitive bidding process. Vendors would then bill Medicare and collect any applicable deductible and coinsurance from beneficiaries for the drugs. Physicians would continue to be paid for the cost of drug administration. Physicians can obtain drugs through the program starting on July 1, 2006. Officials at the Centers for Medicare and Medicaid Services announced refinements to the CAP process last month, including establishing a process for approved vendors to furnish additional drugs under the program and establishing a framework for vendors to enter into arrangements with CAP physicians for the collection of coinsurance.
Alternative Medicine Centers
The National Center for Complementary and Alternative Medicine (NCCAM) is funding five new research centers to study complementary and alternative approaches to HIV/AIDS, arthritis, asthma, and pain. Three of the new centers will focus on therapies used in traditional Chinese medicine, such as acupuncture and Chinese herbal mixtures. The other centers will study millimeter wave therapy—a type of energy medicine—and botanical therapies used by traditional healers in Africa. For example, NCCAM has awarded $1.2 million in first-year funding to the Center for Arthritis and Traditional Chinese Medicine at the University of Maryland in Baltimore. Researchers there will conduct a clinical trial of an 11-herb Chinese formula known as HLXL for osteoarthritis of the knee; assess acupuncture's effect on inflammatory pain in an animal model; and study the efficacy of HLXL in an animal model of autoimmune arthritis. NCCAM is a component of the National Institutes of Health.
The Research Pipeline
Drug researchers are currently developing 446 medicines aimed at diseases that disproportionately affect women in the United States, according to a report from the Pharmaceutical Research and Manufacturers of America (PhRMA). Seventy-two of the drugs are being developed for arthritis or musculoskeletal disorders. The 41 million women with arthritis in the United States account for 70% of rheumatoid arthritis sufferers and 60% of osteoarthritis sufferers, according to PhRMA. In addition, researchers are working on 47 drugs for autoimmune diseases including lupus, fibromyalgia, psoriasis, and multiple sclerosis. These medicines are either in clinical trials or awaiting approval by the Food and Drug Administration.
Unproven Health Claims
The Food and Drug Administration issued warning letters to 29 companies for making unproven claims that their products treat or prevent disease. The letters were issued to companies that manufacture, market, or distribute products made from cherries and other fruits. The companies made a range of claims about diseases including arthritis, cancer, and heart disease. Under the Federal Food, Drug, and Cosmetic Act, products intended for use in the “diagnosis, cure, mitigation, treatment, or prevention of disease” are considered drugs and must be approved for safety and effectiveness by the FDA.
Cream Skimming Continues
Specialty hospitals are under scrutiny once again. A study found that Arizona heart physicians who partly owned cardiac specialty hospitals were more likely than were physicians with no ownership stake to treat low-acuity, high-profit cases in their own facilities and refer the more complex, lower-profit cases to community hospitals. Jean Mitchell, Ph.D., a professor of public policy at Georgetown University, Washington, analyzed 6 years of inpatient discharge data to compare the practice patterns of physicians who were owners of cardiac specialty hospitals in Phoenix and Tucson with those of physicians who only treated patients in full-service community hospitals with an accredited cardiac care program. She found that physician-owners treated higher percentages of patients with Medicare fee-for-service or commercial PPOs, and lower percentages of patients enrolled in Medicaid and HMOs. The American Medical Association endorses the existence of such hospitals, although the Center for Medicare and Medicaid Services has reinstituted a freeze on the approval of new specialty hospitals until it completes a review next year. The study appeared as a Health Affairs Web-exclusive article.
HHS Considers Investigation
The Department of Health and Human Services' Office of Inspector General is looking into the circumstances surrounding the resignation of former Food and Drug Administration Commissioner Lester M. Crawford, D.V.M., Ph.D., to determine if an investigation should be opened, an OIG spokeswoman said. In a response to a query from Rep. Maurice Hinchey (D-N.Y.), HHS Inspector General Daniel R. Levinson said that the OIG is doing an initial review of the facts, not an investigation in any regulatory sense, according to the spokeswoman. “After reviewing the facts, the OIG will determine if an investigation is formally launched,” she said. “Dr. Crawford's departure, a mere 2 months after confirmation to his position, raises significant questions,” Rep. Hinchey and several fellow members of Congress wrote in their request.