Practice Management

Medicare Coverage of Clinical Trials

November 1st 2000

The Clinton administration memorandum on coverage of Medicare patient costs in clinical trials, which drew concern from ASCO when the White House published its incipient statement last June, has apparently morphed into a “final national coverage decision”-announced in late September-that most groups are quite happy with. Ellen Stovall, president and CEO of the National Coalition for Cancer Survivorship, says her group is very happy with the coverage document published by HCFA. She does note, however, that there is a need to monitor the new rules HCFA will be developing for coverage of a subgroup of trials-so-called IND-exempt trials run by cancer centers and pharmaceutical companies-that are testing existing drugs for new uses. Some of these trials are extremely legitimate. Some are not. No one in the cancer community wants to see Medicare pay for clinical trials involving the use of tea leaves to cure colon cancer. However, in writing rules meant to exclude Medicare coverage of those kinds of questionable trials, Stovall indicates that it will be important to ensure that those rules, based on imprecise wording, don’t exclude Medicare coverage for legitimate trials.” We will be concerned with how the language develops,” she explained. One other area of possible concern is Medicare’s intention to pay only for trials that have a “therapeutic” objective. That would rule out some phase I trials designed to test the toxicity of a new medication.

HCFA Backs Off of Reimbursement Cuts for Oncology Drugs

November 1st 2000

The Health Care Financing Administration (HCFA) sent a letter to Medicare insurance carriers in September telling them not to cut reimbursement to oncologists for 14 oncology drugs that are administered in the oncologist’s office. This was a reversal of what HCFA said it planned to do, based on pricing data developed by the US Justice Department. Those data showed that drug manufacturers were reporting “average wholesale prices” (AWPs) to Medicare for those 14 drugs that were much higher than the actual AWPs. Medicare reimburses the oncologist for 95% of the AWP. The Justice Department alleges that the drug companies report a very high AWP and then actually sell the drug to the oncologist for a considerably lower price, allowing the oncologist to make a tidy profit after Medicare reimburses at the higher price. The American Society of Clinical Oncology (ASCO) argued that Medicare woefully under-reimburses oncologists for chemotherapy administration, and, therefore, any additional revenue the doctors can generate via AWP reimbursements is warranted. ASCO took that argument to Capitol Hill, and legislators brought pressure to bear on HCFA administrator Nancy-Ann Min DeParle. “We would like to acknowledge HCFA’s willingness to work with the cancer community on this important issue,” said Lawrence H. Einhorn, MD, president of ASCO. Of equal importance is DeParle’s commitment to increase practice expenses for the CPT codes for chemotherapy administration. That will be done in the summer of 2001, when HCFA publishes a proposed Medicare fee schedule for calendar year 2002.