Patient Training From Medicare
Starting this month, Medicare will pay for self-management training for diabetes patients, the Centers for Medicare and Medicaid Services (CMS) announced. The program will pay for up to 10 hours of initial training, with an additional 2 hours of follow-up training every year after that. Training must be ordered by a physician or qualified nonphysician practitioner, and the must be provided by “a certified provider who meets certain quality standards,” according to CMS regulations. More information is available at
FDA Forms Risk Communication Panel
Following an Institute of Medicine recommendation, the Food and Drug Administration has created a new advisory committee that will be charged with helping the agency better communicate the risks and benefits of pharmaceuticals and other products it regulates. In 2006, the IOM's report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public,” urged Congress to establish a new advisory panel that would weigh in on the FDA's communications about safety and efficacy to health care providers and the public. The agency found an administrative process that let it establish the committee without congressional action. The FDA is now seeking 15 members to serve on the Risk Communication Advisory Committee, including experts on risk communication, social marketing, health literacy, journalism, bioethics, and cultural competency.
AAPPO Launches Diabetes Initiative
The American Association of Preferred Provider Organizations (AAPPO) has started a new program to help PPOs provide high-quality diabetes care and encourage diabetes prevention efforts. The ACT on Diabetes Initiative provides tools and education for PPOs, physicians, and patients to help them use “best practices” in diabetes care. The association is also developing a tool kit that will include diabetes quality-improvement strategies for PPOs, links to consumer Web sites, and suggestions for talking with employers on health benefit designs that improve access to diabetes services. “With more than 158 million people enrolled in a PPO, our industry has a strong platform on which to reach a wide audience. As such, we are asking each of our members to take action to address diabetes,” said AAPPO President Karen Greenrose.
Investors Sue Over Avandia
GlaxoSmithKline Inc. is facing more headaches with its diabetes drug Avandia (rosiglitazone). A Texas man's relatives filed suit in the U.S. District Court for Eastern Texas in late June and claimed that the company failed to warn of cardiac risks. The 60-year-old, who was taking Avandamet (a combination of Avandia and metformin), died on May 21, the day a meta-analysis showing increased heart risks, by Dr. Steven Nissen of the Cleveland Clinic, was published in the New England Journal of Medicine. And Kaplan Fox & Kilsheimer LLP, a New York-based law firm, has filed a class-action lawsuit against the drugmaker on behalf of anyone who purchased shares between October 27, 2005, and May 21, 2007. The lawsuit alleges that although GlaxoSmithKline submitted partial data to the FDA in September 2005 and August 2006, it did not adequately disclose to the public that it had conducted a meta-analysis that showed an increased risk of heart attacks. When the results of Dr. Nissen's analysis were published on May 21, GlaxoSmithKline's share price dropped $4.53 (7.8%), according to the law firm.