More elderly patients could be encouraged to participate in US research studies following reconsideration by the Centers for Medicare and Medicaid Services (CMS) of its policy to pay for routine costs of clinical trials involving Medicare beneficiaries. The agency is reviewing public comments on areas of ambiguity in the current Clinical Trial Policy with a view to issuing a proposed revised policy, renamed the Clinical Research Policy.

Since 2000, Medicare has covered the costs of routine patient care and those due to medical complications associated with participation in clinical trials. While the policy broadened the scope of Medicare payments and expanded access to clinical trials for Medicare beneficiaries, it nevertheless left considerable uncertainty in the research community concerning which costs are eligible for reimbursement.

Clarification is sought by the pharmaceutical industry that Medicare coverage of a clinical trial is not conditional on the clinical trial sponsor serving as a primary payer for certain medical costs that may be associated with the trial. Current rules have contributed to uncertainty as to whether research sites can look to industry sponsors to reimburse standard care items or services denied Medicare reimbursement. Some flexibility in payment arrangements between sponsors and investigators is called for.

The current requirement that in order to qualify for Medicare coverage a clinical trial must have therapeutic intent requires clarification. Susan Ray, manager of R&D policy at GlaxoSmithKline, points out that many early-stage clinical trials are designed primarily to investigate safety, pharmacokinetics and pharmacodynamics and appropriate doses of an investigational drug, but also have a component of potential therapeutic benefit. "CMS should clarify that a trial which includes measurement of an endpoint to measure direct or indirect (eg a surrogate marker) potential therapeutic benefit should be considered a trial with 'therapeutic intent'," she notes in comments submitted to the CMS.

The CMS' intention to develop criteria to ensure that any Medicare-covered clinical research study includes a representative sample of Medicare beneficiaries, by demographic and clinical characteristics, has given rise to concerns among industry. Setting specific criteria could limit, rather than increase, Medicare beneficiary participation in clinical trials, cautions BIO (Biotechnology Industry Organisation).

Revision of the policy provides the opportunity to permanently include Medicare reimbursement for clinical trials exempt from the investigational new drug (IND) application process. This will reduce uncertainty among patients and providers regarding Medicare coverage for routine medical costs. BIO also urges the CMS to establish a mechanism for other research studies to qualify for Medicare coverage.

The deadline for initial public comments was August 9, 2006. The CMS is expected to solicit further public comments when it releases its proposed revised policy. By Jeanette Marchant