Vested Interest - News and Notes - October 2006 Issue

Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals

The panels of experts assembled by the FDA to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer’s group analysis. The advisory panels often vote unanimously to recommend approval even after members express doubts about the product or say the evidence submitted is insufficient, said the report by the National Research Center for Women & Families, a policy research and advocacy group. The FDA has recently come under fire over drug safety issues, including its decisions to approve the popular arthritis pain medications Vioxx and Celebrex. (ATLA Law News Digest – August 31, 2006)

AMA Racing to Head off Medicare Pay Cuts

Despite a major lobbying campaign that includes a $1.5 million nationwide advertising blitz, the American Medical Association is running out of time in its effort to stop cuts in Medicare reimbursement to doctors. The federal government is planning to cut payments by 40 percent over the next nine years for physicians participating in the federal health insurance program for the elderly. A 5.1 percent payment reduction is projected to take effect January 1, 2007, for next year unless Congress takes action. The Republican-led Congress and the Bush administration are balking at the notion of stopping the cuts. Instead, they are pushing the AMA to join the administration’s effort to tie Medicare payments to the quality of medical care Medicare beneficiaries receive. (Chicago Tribune – September 21, 2006)

Medical Device Industry Fights FDA

Lobbying groups representing Medtronic Inc., Boston Scientific Corp. and other makers of medical devices are fighting with federal regulators over fees they must pay to seek product marketing approval. Industry officials say the FDA has not fulfilled its promise to speed approvals in return for the fees. The FDA says if it doesn’t charge about $281,600 per application it will have to lay off 266 workers next year and take four times as long to issue most approvals. The device companies’ trade groups say Congress, which created the fee program in 2002, has failed to keep its pledge to provide additional money to the FDA, leaving the companies to make of the difference to fund higher review costs. (Chicago Tribune – September 22, 2006)

HeathGrades Offers Medical Cost Reports

For $7.95, individuals can now get medical cost reports, enabling them to compare costs for typical medical procedures. At www.healthgrades.com, you can find out the average “list-prices,” average health plan payments and out of pocket costs on all expenses related to 56 common procedures, including hospital, physician, drug and laboratory costs. Plus, HealthGrades will also reveal the dollar amounts that Medicare pays to reimburse both hospitals and doctors. For example, in the Midwest having a baby with a normal delivery procedure has an average cost of $10,249, including physician and hospital cost. If you have a health plan, it probably has negotiated a payment of only $5,150, of which the patient will pay only about $940. Uninsured patients are often charged the full price list. Now individuals will have this information, so they can either negotiate or make better choices when spending their own money. (Chicago Sun-Times – September 25, 2006)