Consumer advocates are concerned the proposed new policy could be ripe for abuse

Medicare is getting set to expand coverage for patients who enroll in clinical trials, a move that could increase the number of cancer patients with access to experimental therapies, oncology lobbyists say.

The Medicare Coverage Advisory Committee (MCAC) in mid-December voted to broaden the rules issued by President Bill Clinton in September 2000. That order opened the door for Medicare patients to enroll in clinical trials.

Clinton’s order was a response to an Institute of Medicine report warning that seniors were underrepresented in clinical trials, a serious shortcoming since Medicare beneficiaries consume more than half of all prescription drugs. Clinton ordered Medicare to pay for the routine cost of care for patients in a clinical trial as long as the trial was sponsored by a government agency or was registered under a company’s investigative new drug application (INDA) at the Food and Drug Administration.
If the Center for Medicare and Medicaid Services accepts the MCAC’s recommendations, patients in Phase I safety trials with therapeutic intent will also be covered under the policy, as will healthy volunteers who are enrolled as control subjects.
Moreover, privately funded trials that are not part of an INDA will also have their routine care costs covered as long as they meet the other criteria in the policy. They include registering the trial with ClinicalTrials.gov, the government’s public database; specifying in the trial protocol the method and timing of public release of pre-specified outcomes, regardless of results; and making an attempt to enroll patients that demographically reflect the overall Medicare population. The policy will also cover industry-funded post-marketing trials ordered by the FDA.
Some consumer groups expressed concern that the section of the proposed new rules that apply to industry-funded trials could open the door to abuse. CMS officials admitted that under the current system, some CMS-supported trials had more to do with industry marketing than overall patient welfare. “There were trials (funded) that we think were inappropriate,” said Steve Phurrough, the director of the coverage and analysis group at Medicare.
Pressed for examples, he was vague, citing studies that “lacked scientific merit” and one study of a drug “with significant side effects.”
Some industry-funded trials are nothing more than marketing vehicles for drugs that have already been FDA-approved. Such studies, known as seeding trials, add almost nothing to medical science, yet they routinely appear in the medical literature, especially in journals that cater to specialists.
These trials are called seeding trials because its aim is to encourage physicians to continue prescribing the drug for their patients once the trial is over. Another major benefit for the drug firm is that after the study appears in a specialty journal, it can buy thousands of reprints for salesmen to distribute to the offices of physicians in that specialty, even though it hasn’t been approved for the condition they’re actually treating.
Oncology lobbyists who have been pressing for an expansion of CMS clinical trial coverage dismissed such concerns. “We see no evidence of abuse or overreaching, nor does it appear that the policy has added measurably to program costs,” said Joseph Bailes, a senior official at the American Society of Clinical Oncology.
About 125 U.S.-based clinical trials register each week with ClinicalTrials.gov. The National Institutes of Health or other government agencies fund about half. That leaves plenty of industry-funded trials eligible for the program. With the new rule expected early next year, it remains to be seen if CMS will come up with a scheme that puts a halt to the abuses.
Meanwhile, MCAC also tried to come up with better definitions for routine care costs for CMS. CMS auditors recently forced a hospital affiliated with the University of Chicago to repay $1 million for bills submitted under the old guidelines.
“Concerns about submission of false claims have led many institutions to adopt an aggressively conservative approach to the definition of routine costs,” said Bailes. “Uncertainty about which costs are truly routine can serve as a significant burden on the system, both increasing costs of compliance and creating delays in clinical trial accrual.”
The committee recommended that CMS pay for any service that would normally be reimbursed if the experimental product had been FDA-approved. It also suggested that CMS pay for any device designated by FDA as a humanitarian intervention even if there has been no national coverage determination by CMS.
Merrill Goozner is a contributing editor to Bay Area Oncology News.

—By Merrill Goozner

Posted on January 19, 2007 03:16 PM