GOVERNMENT and LAW

New Medicare self-injectable policy still seen as wanting

A new program memorandum intended to clarify federal policy on Medicare payments for injectable drugs administered outside of hospitals has left some patient groups thankful and others feeling shortchanged. The mid-May memorandum, from the Centers for Medicare & Medicaid Services (CMS), outlined in broad strokes its interpretation of the December 2000 Benefits Improvement & Protection Act (BIPA), which was meant to increase Medicare coverage of drugs injected in doctors' offices or outpatient clinics.

Congress tried to do just that by broadening the law's language to include payment for drugs that are "not usually self-administered," where previously Medicare had covered only drugs that "cannot be self-administered." The subtle change in the lawmakers' intent was apparently too vague, causing Medicare contractors around the country to interpret the language inconsistently, sometimes denying coverage to frail elderly patients unable to self-inject.

Gary Stein, Ph.D., director of federal regulatory affairs at ASHP, said he was "disappointed" by the CMS program memorandum. "When I attended the town hall meeting a couple of years ago on this issue, we were hoping for a little bit more liberal coverage," he said. "This does not seem to do that. I think there are very few drugs that are going to be covered under this, and it's going to put patients at harm."

One drug that will be covered is interferon beta 1a (Avonex), the medication commonly used to treat relapsing forms of multiple sclerosis. CMS mentioned the drug in a press release it issued when it announced the program memorandum. It specified no other drugs, though CMS anticipates that new drugs in the pipeline will qualify for payment under the new standards. CMS expects that the new rule will cost $100 million in the first year, compared with the $150 million that Congress envisioned when it passed BIPA.

A spokesman for the federal healthcare program said CMS had singled out the MS drug "simply because there's so much interest in it, and it's going to be the biggest chunk." But he also said that Medicare carriers would continue to have leeway in deciding coverage. The program memorandum was issued, he said, to give carriers "some guidance in making their individual drug-by-drug decisions. It doesn't name [the drugs]. Interferon is just an assumption we're making. We're not saying they have to, just that we expect them to."

One reason interferon made the grade was that it is administered by intramuscular injection. CMS assumes that drugs delivered IM or intravenously are "not usually self-administered," while those that are given subcutaneously are more likely to be self-injected by patients. Under the new CMS guideline, the phrase "not usually" refers to drugs that are administered by doctors—or given "incident to" a doctor's care—more than 50% of the time.

That may, however, leave out some medications that are extremely important in cancer care, like human growth factor drugs that stimulate the production of red and white blood cells and platelets in patients whose own ability to manufacture these cells is suppressed by chemotherapy. While agents like epoetin alfa and filgrastim can be administered by IV infusion, they are often injected subcutaneously, and thus their coverage under Medicare remains in question.

Many people were hoping that the individual patient, rather than the drug, would be the determining factor for Medicare payments. In other words, if an elderly patient weren't able to self-inject, his or her therapy would be eligible for payment, even if the drug was self-administered most of the time. But CMS decided to make the drugs the determining factor.

Stein said his wife has MS. "She took Avonex at one time and she self-administered. There were times, however, when her MS exacerbations were so bad she couldn't self-administer." Although Avonex is covered under the new guideline, he wanted to make the point that a patient's condition should be the determining factor in payments.

"We were hoping after the town hall meeting that they would look at individual patients and then determine whether the individual patient could self administer or not," he said. "I think the doctor should make the determination, or the doctor and anyone who is administering the drug," he added.

One positive factor in the new guideline is that CMS will use the Medicare population, rather than the population as a whole, for deciding whether injectables are self-administered more than 50% of the time or not. The use of the older population segment means that there is a greater likelihood that an injectable will be administered in a doctor's office.

Though Medicare carriers now have to base payments on the new CMS guideline, the final rule will not go into effect until Aug. 1. Until then, CMS will be looking for public commentary on its guideline.

Bruce Buckley

The author is a pharmacy journalist based in New York.

Bruce Buckley. New Medicare self-injectable policy still seen as wanting.

Drug Topics

2002;12:44.