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Clinical trials may have to conform to new procedural and reporting requirements for Medicare beneficiary participants to be reimbursed, if revisions to the Clinical Trial Policy national coverage determination are implemented.
Changes proposed by the Centers for Medicare and Medicaid Services include:
▸ Requiring clinical trials to be registered on the National Institutes of Health ClinicalTrials Web site before enrollment.
▸ Requiring investigators to publish results.
▸ 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 required under CED through the national coverage determination 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 Clinical Trial Policy (to be renamed the Clinical Research Policy) was developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.
For additional details about the proposal, visit the CMS Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186
Clinical trials may have to conform to new procedural and reporting requirements for Medicare beneficiary participants to be reimbursed, if revisions to the Clinical Trial Policy national coverage determination are implemented.
Changes proposed by the Centers for Medicare and Medicaid Services include:
▸ Requiring clinical trials to be registered on the National Institutes of Health ClinicalTrials Web site before enrollment.
▸ Requiring investigators to publish results.
▸ 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 required under CED through the national coverage determination 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 Clinical Trial Policy (to be renamed the Clinical Research Policy) was developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.
For additional details about the proposal, visit the CMS Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186
Clinical trials may have to conform to new procedural and reporting requirements for Medicare beneficiary participants to be reimbursed, if revisions to the Clinical Trial Policy national coverage determination are implemented.
Changes proposed by the Centers for Medicare and Medicaid Services include:
▸ Requiring clinical trials to be registered on the National Institutes of Health ClinicalTrials Web site before enrollment.
▸ Requiring investigators to publish results.
▸ 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 required under CED through the national coverage determination 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 Clinical Trial Policy (to be renamed the Clinical Research Policy) was developed in 2000 to allow Medicare to pay for certain items and services for Medicare beneficiaries involved in clinical trials.
For additional details about the proposal, visit the CMS Web site at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186