Published 11/1/2007

Second Look: Regulatory/Reimbursement

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FDA issues MedWatch safety alert on bisphosphonate use
The U.S. Food and Drug Administration (FDA) has posted a MedWatch safety alert regarding a possible association of atrial fibrillation with the use of bisphosphonates. Two studies published in the New England Journal of Medicine recently examined this possible association. FDA states: ā€œUpon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time.ā€ The bisphosphonates are marketed as alendronate (Fosamax, Fosamax Plus D), etidronate (Didronel), ibandronate (Boniva), pamidronate (Aredia), risedronate (Actonel, Actonel with Calcium), tiludronate (Skelid), and zoledronic acid (Reclast, Zometa).

FTC approves second integrated physician network
According to American Medical News, the U.S. Federal Trade Commission (FTC) has favorably reviewed a proposal for a physician and hospital network to contract jointly with health plans under a clinical integration program. In general, antitrust laws prohibit physicians from engaging in collective negotiation with insurers, but FTC guidelines allow for some limited exceptions to that rule. According to the FTC, a key to the approved deal was that the Rochester, N.Y.-based network will operate on a nonexclusive basis, so individual physicians can still contract separately with health plans. The physicians will also need to adhere to a set of clinical guidelines, such as disease management protocols, and refer within the network so that the network can monitor treatment outcomes. The only other similar FTC approval came in 2002, for a network based in the Denver area.

Healthcare lobbying dollars rose sharply in first six months of 2007
According to Congressional Quarterly, the healthcare sector spent a record $227 million lobbying the federal government during the first half of 2007, and healthcare interest groups accounted for five of the 10 highest-spending lobbying organizations over that same time. This was the first time that healthcare lobbying funds rose above $200 million for a 6-month period and marked a 17 percent increase from the second half of 2006.

At $10.7 million, the largest single lobbyist was the Pharmaceutical Research and Manufacturers of America (PhRMA), followed by the American Medical Association at $10.3 million. A spokesperson for PhRMA believes that the increase was largely due to the political shift in Congress, as well as a large number of healthcare issues currently being addressed by the government.