From the August 13, 2007, issue of "The Gray Sheet"
CMS is trying to make it simple for clinical trial sponsors and investigators to get reimbursed by Medicare for routine costs.
"If you can't meet these standards, then you ought to be questioning whether you ought to run the trial," Steve Phurrough, director of CMS' Coverage and Analysis Group, said Aug. 7 during an Open Door Forum on the agency's latest clinical research policy proposal.
The proposal, released July 19, is intended to address confusion that arose after CMS first issued a proposed revision of the original 2000 policy in April (see chart: "Key Proposed Definitions").
Had that proposal been finalized, the device industry feared that hundreds of privately sponsored clinical trials would no longer be eligible for Medicare coverage of "usual patient care" because only trials approved by a federal agency could qualify.
The new proposal clarifies that the policy covers both publicly and privately funded trials, but instead of an automatic approval process, a study's sponsor or principal investigator will need to "self-certify" that the trial meets 13 standards.
The standards include compliance with human subject protection regulations, registration of the trial on the ClinicalTrials.gov Web site, and a study protocol that specifies a plan for public release of the data and discusses whether the results are expected to generalize to the Medicare population.
CMS will provide a template for the self-certification letter that needs to be completed by the study's sponsor or principal investigator. The template's questions should be answered in 250 words or less, Phurrough said.
CMS does not expect to see the study protocol and will only review the self-certification form for completeness - a task that can be completed in a day or two, he said.
CMS Will Not Recoup Mistaken Payments
Phurrough also clarified that CMS will not be able to recoup payments to providers for services covered in a self-certified clinical trial if it later determines that the standards were not actually met. However, he explained, CMS would have the ability to stop future payments for services in a self-certified trial if major safety or other protocol concerns surfaced.
AdvaMed's VP-Payment and Policy Teresa Lee called the new proposal a "significant improvement" over the April proposal, and stakeholders at the meeting welcomed Phurrough's further clarifications.
Heart Rhythm Society President Bruce Lindsay expressed concern that the requirement that a study not "unjustifiably duplicate existing studies" was open to interpretation, while St. Jude Medical's Andra Thomas asked how to demonstrate that a study is "conducted according to the appropriate standards of scientific integrity." In response to both, Phurrough emphasized the flexibility of the standards.
"The goal of these standards is to make sponsors think about them," more than to measure sponsors against a hard and fast checklist, Phurrough said.
Still, AdvaMed's Lee asked for additional guidance on some of the more ambiguous requirements, so that sponsors could have "the needed assurance that they are actually in compliance."
Lee also asked CMS to consider maintaining the existing process whereby trials that are reviewed and approved by a federal agency automatically qualify for coverage without the need for self- certification.
Phurrough demurred, explaining that both the existing policy and the April proposal led to confusion about whether federally sponsored trials were being treated differently than privately sponsored studies; he noted that concerns had been raised that one type of study could be disadvantaged without a consistent certification process.
"There was confusion about 'deeming' for federally funded versus no process for privately funded. The goal was to expand the scope to all trials and not to have different processes in place," he said.
Phurrough said CMS intends to issue a proposed rule related to appropriate certification processes in the near future, though he could not comment on its contents.
Trials Not Covered By The Policy
FDA-approved investigational-device trials do not fall under the clinical research policy and will continue to be covered under FDA's regulations for investigational device exemptions.
The CMS proposal also excludes from meeting the policy's standards: retrospective studies, simple case series, quality assessment or performance improvement studies, and prospective studies designed so that neither patient nor physician behavior is influenced in any way. Phurrough noted that if a study requires informed consent, it likely does not fit into this last category.
CMS clarifies that local coverage decisions are not affected by the clinical research policy. A trial performed at multiple sites could have varying coverage if Medicare contractors have different policies for the services involved.
Comments on the July 19 proposal are due Aug. 18. According to Phurrough, CMS will likely hold another public meeting following the release of the final decision, which is due Oct. 17.
All trials enrolling Medicare beneficiaries that begin after the date of the final decision will fall under the new policy, while costs in ongoing studies would continue to be paid under the existing policy.
- Chloe Taft
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