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CMS proposes expanded coverage of clinical trials
Under the proposed rules, medical treatments related to phase-1 trials could be reimbursable.
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The Centers for Medicare and Medicaid Services has proposed revisions to its clinical trial reimbursement policy that could expand coverage for patients enrolled in these trials.
Under current Medicare law, the government agency will not pay for care that is not deemed medically necessary, or care that should be paid for by another party.
According to Samuel M. Silver, MD, PhD, director of the University Cancer Center Network at the University of Michigan Cancer Center, and section editor of Hem/Onc Today's Health Policy, Patient and Practice Issues section, that often meant that patients enrolled in clinical trials would lose their coverage.
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If a patient was enrolled in a phase-1 toxicity trial, Medicare might deny coverage claims because such a trial would be deemed to have no therapeutic benefit. If a patient was enrolled in an industry-sponsored trial, Medicare might deny coverage claims under a rule that would require the company to pay for medical care associated with its clinical trial.
"What that meant in real-world practice was that many Medicare contractors denied standard of care coverage when patients went into the trial, so they couldn't even get the normal benefits that come with being in Medicare," Silver said at a recent Hem/Onc Today section editor's retreat.
Medicare updated its policy in 2000, which had the effect of clarifying that Medicare would reimburse for standard care items. Silver said the current proposed revision could further expand reimbursed care.
"Under the rules established in 2000, many phase-1 trials would not qualify because they had no therapeutic benefit," Silver told Hem/Onc Today. "Under these proposed rules, the CMS has changed the language so that phase-1 trials 'whose protocols commit to measuring therapeutic outcomes as one of the objectives' would be qualified for reimbursement."
Controlling publication
Silver is the chair of the subcommittee on reimbursement for the American Society of Hematology, and he sits on a clinical research billing committee at the University of Michigan. He was a signatory on comment letters from both of these organizations that were submitted before the comment period expired in early May.
Based on his previous experience with the CMS, Silver said the agency would not submit its final ruling until the middle of the summer. If the ruling remains in its current form, he has several concerns.
Under the proposed rule, any institution requesting funding for a clinical trial would be required to register the trial at the NIH ClinicalTrials.gov website and to publish their results.
"The concern there is that the CMS wants to control the timing of the release, even if the study is negative or terminated early," Silver said. "The American Society of Hematology supports the release of both positive and negative results, but all data needs to be properly vetted before it becomes public."
Silver said the best place for release of data is in peer-reviewed journals, where the timing is often variable due to a variety of factors.
"If a study is not appropriate for publication in a peer-reviewed journal, whether it has positive or negative results, then it is probably not reasonable to release raw data to the general population through a government agency," Silver said. "We would support perhaps a release of a narrative paragraph, or something similar, rather than simply the release of raw data."
Silver said the proposed rule also does not consider the fact that often a center is one of several participating in a multicenter study, and that single center may not even have control of the data.
"Release of a single site's data may not be statistically significant and may actually not tell the story of the whole protocol," Silver said.
Deeming agencies
Under current Medicare law, to qualify for reimbursement, trials must be conducted by a "deemed" agency.
"If a trial was not qualified by a deemed agency or was not investigational new drug-qualified or an FDA project, then you wouldn't get reimbursed by Medicare," Silver said.
The proposed rule continues the deeming status of agencies in the Department of Health and Human Services, the Veterans Administration and the Department of Defense, however it limits the deeming status of other government agencies.
Silver said he agreed that clinical trials needed to be reviewed by government agencies before receiving any federal funding, but he said the CMS rule was actually more constrictive than the press releases have indicated because it removes the coverage for investigational new drug-exempt trials, which were previously automatically qualified.
Under current law, investigational new drug exemptions are for those trials that evaluate FDA-approved drugs for non-FDA-approved indications.
"This is a very common practice in oncology where researchers may want to test a drug that was used in breast cancer for prostate cancer, and you want to see whether or not the drug is effective," Silver said.
Under the current law, such a trial could qualify even if it did not have a grant from the NIH or the NCI.
"Under this new proposed law, investigational new drug-exempt trials would be non-qualified, which is going to take away a fair number of excellent exploratory trials that may rise to the level of an NCI study at some point," Silver said.
Coverage outside of trial
Another highlight of the proposed policy is that Medicare will pay for investigational clinical services if they are covered by Medicare outside the trial or required under coverage by evidence determination or through a national coverage determination process.
"The two latter coverage issues will apply to only a few trials," Silver said.
The CMS will also add FDA post-approval studies and coverage with evidence development to studies that would qualify under the clinical trial research policy. Silver said ASH took no issue with that decision.
In developing the revised clinical trial policy, the CMS convened the Medicare Evidence Development and Coverage Advisory Committee on December 13, 2006. The advisory panel made several recommendations, and the CMS revised its policy based on those recommendations.
"This proposed clinical research policy exemplifies the agency's commitment to providing access to services for beneficiaries by encouraging the conduct of research studies that add to the knowledge base about the efficient, appropriate, effective and cost-effective use of products and technologies in the Medicare population, thus improving the quality of care that Medicare beneficiaries receive," Leslie Norwalk, acting administrator of the CMS, said in a press release. – by Jeremy Moore
For more information:
- Details of the coverage policy are available at the CMS coverage website at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186.