Medicare Calls for Revised Clinical Trials Policy

Future clinical trials may have to conform to new procedural and reporting requirements in order for Medicare beneficiary participants to be eligible for reimbursement, if revisions to the Clinical Trial Policy national coverage determination are implemented.

Changes proposed by the Centers for Medicare and Medicaid Services would include:

• Requiring all trials to be registered on the National Institutes of Health ClinicalTrials.gov Web site before enrollment begins.
• Requiring study investigators to publish their results.
• Requiring the study to explicitly discuss inclusion criteria and relevant subpopulations (as defined by age, gender, race/ethnicity, socioeconomic, or other factors) in the study protocol.
• Adding Food and Drug Administration postapproval studies and coverage with evidence development (CED) to studies that would qualify under this policy.
• Paying for investigational clinical services if they are covered by Medicare outside the trial or are required under CED through the national coverage determination (NCD) process.
• Expanding the agencies that can deem whether a trial has met the general policy standards to include all Department of Health and Human Services agencies, the Veterans Administration, and the Department of Defense.

The 30-day public commentary period began in April. The CMS will review all public comments and suggestions and then will incorporate them into the final published NCD no later than 60 days after the end of the comment period, and the revised policy will become effective with that publication.

The Clinical Trial Policy (to be renamed the Clinical Research Policy) was first developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials. Further details are available from the CMS coverage Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186.