HCFA's decision to provide coverage for clinical trial routine care costs will not affect its current policy allowing coverage for category B device trials, the agency clarifies in a Sept. 19 notice.

"This policy does not withdraw Medicare coverage for items and services that may be covered according to local medical review policies or the regulations on category B investigational device exemptions," the national coverage decision states.

HCFA's definition of routine care costs excludes the cost of the investigational service or device itself, as well as data collection efforts, from coverage. However, those costs are currently reimbursed for category B device trials that local carriers have decided to cover.

After reviewing comments on its Aug. 4 proposal, the agency moved swiftly to finalize the coverage decision. Under the policy, Medicare will cover routine care costs of trials that fall within a benefit category and meet other qualifying criteria. To be eligible, trials must enroll patients with diagnosed disease, and must not be "designed exclusively to test toxicity or disease pathophysiology."

Under the decision, routine care costs are defined to include conventional care, services "required solely for the provision of the investigational item or service," and treatments of complications arising from the investigational operation.

HCFA has indicated it will provide further guidance to distinguish routine care costs from those associated with data collection or the service itself.

For example, if a patient required an annual CT scan for typical monitoring of a disease, the agency would cover an annual scan following an investigational procedure. However, CT scans performed as part of the clinical trial protocol at three and six months post operation would not be covered.

"The goals are to increase Medicare patients' participation in trials and...to increase the evidence we need," HCFA Coverage and Analysis Group Director Sean Tunis, MD, stated at a Sept. 20 AdvaMed/MassMedic briefing in Boston. "This clinical trials policy is really...going to elevate the level of evidence that we have to make our coverage decisions."

"The scoring on this is something on the order of $5 bil. over five years," Tunis added, referring the agency's estimate of the cost of routine care coverage. "It is a pretty generous policy."

While the routine care coverage decision is effective immediately for trials that receive funding or support from government agencies, other trials will have to wait until the agency establishes a trial "self certification" process.

The agency will not establish the trial certification process until the Agency for Healthcare Research and Quality convenes a multi-agency panel to recommend appropriate criteria for trials seeking coverage. While the panel will not review trial applications on a case-by-case basis, it will "meet periodically to review and evaluate the program and recommend any necessary refinements to HCFA."

According to HCFA, the multi-agency panel has already convened once to review which trials should automatically be deemed for coverage. A second meeting to establish self-certification criteria is expected in early October, but will not be open to the public, according to HCFA.

Once the certification process has been established, principal trial investigators will be able to certify that a trial meets the criteria without waiting for HCFA approval. However, HCFA's Chief Clinical Officer, currently Office of Clinical Standards and Quality Director Jeffrey Kang, MD, has the ability to retroactively disqualify a trial that does not satisfy criteria.

All routine care costs for pharmaceutical trials will be covered by Medicare, effective immediately. Drug trials under FDA investigational new drug applications automatically qualify for coverage, as do all trials funded or supported by federal agencies.

Those drug trials that are exempt from having an IND "will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place," the national coverage decision states. No parallel provision is included for device trials that do not automatically qualify, however.

It is expected that HCFA will make all trials under an IDE automatically eligible for routine care coverage. However, the agency must first initiate rulemaking to allow category A devices to receive Medicare coverage.

The Sept. 19 decision failed to elaborate on HCFA's intention to not cover routine care costs for trials that "unjustifiably duplicate existing studies." Because of this language, it remains a possibility that HCFA's policy would only apply to trials of the first device of a kind. In Aug. 30 comments, AdvaMed urged the agency to drop the stipulation, stating that "it would be unwise to assume that only one study deserved support."

While the coverage memo has been welcomed by the device industry, some have feared that it could jeopardize the existing coverage of category B trials at the local level.

HCFA allowed Medicare coverage of category B IDEs by local contractors after instituting an interagency agreement with the FDA in 1995. FDA designates an IDE as category B if it concerns a Class I or II device, or a Class III device for which "underlying questions of safety and effectiveness of that device type have been resolved."

Because category B devices have already established a level of safety and efficacy, reimbursement of those clinical trials may be considered "reasonable and necessary" by HCFA, the interagency agreement notes.

It is estimated that 95% of device trials are considered category B. Acquiring coverage of multi-center category B trials can be a cumbersome process, however, requiring separate agreements from multiple local HCFA carriers.

Under the final decision, it appears that trial coverage will be a two-tiered policy, with local carriers deciding whether to fully cover a category B trial and with HCFA handling the certification process for routine care coverage.

HCFA does not allow category B investigational services or devices to be reimbursed if they are subject to an existing national non-coverage decision. However, the routine care costs of these trials will be covered under the Sept. 19 decision.

While HCFA plans to enroll all trials in a "clinical trials registry," which is still under development, the database is not intended to collect patient information. Providers are instructed to maintain basic documentation, such as trial name, sponsor, and trial protocol number, but are not required to submit the information for all clinical trial routine care cost claims.

HCFA Rolls Out "Generous" Clinical Trials Coverage Policy

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