MEDICARE COVERS NEW TREATMENTS, WITH A CATCH

For the first time in its history, Medicare has systematically begun to make payments for new and expensive treatments and diagnostic tests conditional on agreement by companies or other groups to pay for studies on whether these new methods actually work on the Medicare patients who get them….

The new initiatives began this year when Dr. (Mark) McClellan (Medicare’s Director), who is both an internist and an economist, decided that evaluating treatments for elderly Americans falls under Medicare's purview to pay for whatever is medically necessary. If the treatment does not work, he argues, then it really is not medically necessary, and Medicare should not be paying…

…Medicare officials say, they are forced to take the lead because…no one else is getting the information that patients and doctors need to decide on treatments. Medicare itself has no research budget, the National Institutes of Health can only do so much with its budget and private companies often have a narrow focus in studies they pay for….

The problem arises because while drugs and devices are tested and evaluated by the Food and Drug Administration before they come on the market, those tests often leave huge gaps in doctors' knowledge of how well they work, and for whom.

The tests to gain F.D.A. approval….do not tell doctors or patients whether an older and cheaper drug is as good as or better than a newer one, for example. And they do not reveal whether older people, with many medical conditions, will fare as well as the generally younger and healthier people on whom the drugs or devices were tested….

The agency decided to use its influence to speed up research on off-label uses of four new drugs approved for colorectal cancer - Oxaliplatin, Irinotecan, Bevacizumab and Cetusimab.

On Monday (November 1, 2004) Medicare said it would …pay for off-label uses of the drugs for patients in any of nine clinical trials being started by the National Cancer Institute….

For PET scans for people with suspected Alzheimer's disease, Medicare announced on September 15 that it would pay only if patients are in a clinical trial in which they will be randomly assigned to have a PET scan of the brain, or not. ….

On Sept. 28, Medicare issued a proposal to pay for implantable defibrillators for … patients with severe heart disease, but who have not had a heart attack, but only if they are in a national registry to follow the outcomes….

In September, the agency proposed similar restrictions on paying for stents to open blocked carotid arteries in the neck for patients…who are at high risk of stroke from such an obstruction, but who cannot tolerate surgery.

…Medicare officials said they were thinking of requiring a registry for (weight loss surgery) as well….

-Abridged from: NYT, November 5, 2004, "Medicare Covers New Treatments With a Catch”, By Gina Kolata.