Ezetimibe Troubles Hit Home
Schering-Plough reported in its most recent quarterly filing with the Securities and Exchange Commission that its joint venture with Merck & Co. on ezetimibe (Zetia) and ezetimibe/simvastatin (Vytorin) is the subject of multiple lawsuits and legal inquiries. In a May 6 filing, Schering stated that it has received “several subpoenas from state officials, including state attorneys general, and requests for information from U.S. Attorneys,” all seeking information on the ENHANCE clinical trial, the sale and promotion of ezetimibe/simvastatin, and stock sales by corporate officer since April 2006, when ENHANCE was completed. Since mid-January, the company has been served with class action lawsuits alleging fraud in conjunction with the sale and marketing of the two products. The company is also looking at several securities-related class action suits, according to the filing.
CMS Covers Artificial Heart
Artificial hearts will be covered by Medicare when they are implanted as part of a study, according to a national coverage decision issued in May. The decision was not a surprise, as CMS telegraphed its intention to do so in a February proposal. According to a statement, the agency “believes there is now sufficient scientific evidence on the use of artificial hearts to allow coverage of these devices for beneficiaries in the carefully controlled clinical environment of an [Food and Drug Administration]-approved study.” The devices are for use in severe heart failure, where patients are at imminent risk of death.
Gainsharing Cuts Stent Costs
A study of gainsharing programs sanctioned by CMS at six cardiac catheterization labs has found that costs declined for coronary stent patients relative to nongainsharing hospitals. The gainsharing hospitals reduced costs by 7.4% per patient; 91% of the savings came from lower prices, and 9% from lower utilization, according to authors Jonathan Ketcham, Ph.D., and Michael Furukawa, Ph.D., of Arizona State University, Tempe. Under the programs, savings are shared equally by the hospital and the physician practice. From 2001 to 2006, the average cost per patient increased from $3,338 to $4,644, but the gainsharing hospitals were able to reduce that by $315 per patient, or 7.4%. The study appears in the May/June 2008 issue of Health Affairs.
Self-Referrals Drive Imaging Hike
Physicians who refer patients to their own facilities or machines for scans account for much of the increase in diagnostic imaging ordered for privately insured patients, according to a commentary in the journal Medical Care. The increases in imaging were seen mainly in privately insured patients with fee-for-service plans, according to by Dr. Vivian Ho, professor of medicine at Baylor College of Medicine, Houston. “Physicians seem to choose the self-referral option, meaning they do the imaging in their own office, because they are reimbursed by private insurance companies,” Dr. Ho wrote. If they don't have the equipment in their office, she said, they lease an imaging center's facilities and employees for a fixed period each week. This creates revenue for both parties involved, but raises questions about the necessity of the testing conducted, Dr. Ho wrote, adding, “The current reimbursement system lacks incentives to provide high quality imaging in a cost-effective manner.”