CMS Mulls Carotid Stent Change
The Centers for Medicare and Medicaid Services is considering a request from the American College of Cardiology, the Society for Cardiovascular Angiography and Interventions, the Society of Vascular and Interventional Neurology, and the Society for Vascular Medicine to change its current coverage policy for carotid artery stenting. The groups have requested coverage for patients who are at high risk for carotid endarterectomy because of defined anatomic factors, and who have symptomatic carotid artery stenosis of 50%–90% or greater or asymptomatic carotid artery stenosis of greater than or equal to 80%, according to CMS. The requesting organizations said there is a compelling clinical rationale to stent these patients, whose number they estimate to account for 30% of the overall high surgical risk population. The comment period closed March 2; a final decision is expected in August.
Artificial Heart Coverage Proposed
CMS is also proposing to cover artificial hearts implanted as part of clinical studies that meet CMS and Food and Drug Administration standards. The only such device, the AbioCor, made by Abiomed of Danvers, Mass., is being implanted under the FDA's humanitarian device exemption. AbioCor is covered by three insurers, but Medicare payment has been elusive, according to the company. “Our proposal relaxes a long-standing noncoverage policy, gives access to our beneficiaries, and promotes evidence development through FDA-approved studies of this advanced technology,” said CMS Acting Administrator Kerry Weems in a statement. CMS is expected to make a final coverage announcement by May 1.
Jarvik Lipitor Ad Pulled
Pfizer Inc. says that it is withdrawing all Lipitor (atorvastatin) ads that feature Dr. Robert Jarvik as a spokesman. The company defended its use of Dr. Jarvik, calling him a “well-respected heart expert” in a statement. But Pfizer President of Worldwide Pharmaceutical Operations Ian Read also acknowledged that “the way in which we presented Dr. Jarvik in these ads has, unfortunately, led to misimpressions and distractions from our primary goal of encouraging patient and physician dialogue….” The Jarvik ad campaign has been under scrutiny by the House Energy and Commerce Committee. In February that panel released the contract between the physician and Pfizer. According to the terms of the contract, dated April 13, 2006, Dr. Jarvik was due to receive $1.35 million. His work was to include up to 9 12-hour days of work on television, radio, and print ads, plus additional voice over work and 3 days of personal appearances. The committee wants to know whether stunt doubles were employed during the TV ads, which include scenes of Dr. Jarvik rowing. Letters were sent to nine advertising companies that sought records on payments to such alleged doubles, and all records associated with the campaign.
ACC on Vytorin Queries
The American College of Cardiology said it is cooperating with the same House committee mentioned above on its requests to furnish information on funds the college has received from Merck & Co./Schering-Plough Corp., the joint venture that makes and sells Vytorin (ezetimibe/simvastatin). The drug combination has been the subject of intense scrutiny by the committee, largely because of delays in releasing data from the ENHANCE study. The committee said it wanted to know the nature of financial contributions made by the drug companies because the ACC and the American Heart Association had issued statements urging patients not to stop taking Vytorin without talking to their physician first. The committee also requested data from the American Heart Association. Rep. Bart Stupak (D-Mich.), chairman of the oversight and investigations subcommittee, said his panel would look at “how they use this funding and any potential conflicts of interest.” An ACC spokesperson said the organization had delivered boxes of material to the committee, adding that, “industry support in no way affects our policies.”
Don't Blame Technology for Costs
Medical devices and in vitro diagnostics account for a relatively small 6% ($112 billion) of the nation's overall health expenditures and should not be blamed for rising health costs, said officials from the device industry's lobby, AdvaMed, at a briefing in February. The group released what it called one of the first-ever studies to examine device cost trends. The study—paid for by AdvaMed—was conducted by Roland Guy King, a former chief actuary for the Medicare and Medicaid programs. Devices and diagnostics accounted for a steady 6% of expenses from 1989 to 2004. Prices grew more slowly—1.2% annually—than the medical consumer price index, or the consumer price index, according to the study. “The highly competitive medical device marketplace is working and delivering tremendous value both in patient care and in economic terms,” said Stephen J. Ubl, AdvaMed president and CEO.