Frequently Asked Questions

Coverage Analysis and Routine Costs of Qualified C What is a “Qualified Clinical Trial”? A Qualified Clinical Trial is a clinical trial that is “Qualified” for coverage of routine costs under the Medicare Clinical Trial Policy by meeting both of the following criteria: The “3 requirements”: The study evaluates an item/service within a Medicare benefit category that is not statutorily excluded, and The study has therapeutic intent, and The study enrolls patients with diagnosed disease (but may enroll healthy control group.) *AND: “Deemed” to meet the additional required 7 Desirable Characteristics because it falls into one of the following:* 4. Funded by NIH, CDC, AHRQ, CMS, DOD, and VA 5. Supported by centers or cooperative groups funded by NIH, CDC, AHRQ, CMS, DOD,VA 6. Conducted under an investigational new drug application (IND) reviewed by the FDA 7. Exempt from having an IND under 21 CFR 312.2(b)(1) Self-certification by the Principal Investigator was initially contemplated but never implemented by CMS and may not be used to determine whether a study qualifies for coverage. <ahref="http: www.cms.gov="" medicare-coverage-database="" details="" ncd-details.aspx?ncdid="1&ncdver=2&fromdb=true"">http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&fromdb=true 1

Coverage Analysis and Routine Costs of Qualified C

What is a “Qualified Clinical Trial”?

A Qualified Clinical Trial is a clinical trial that is “Qualified” for coverage of routine costs under the Medicare Clinical Trial Policy by meeting both of the following criteria:

The “3 requirements”:

The study evaluates an item/service within a Medicare benefit category that is not statutorily excluded, and
The study has therapeutic intent, and
The study enrolls patients with diagnosed disease (but may enroll healthy control group.)

AND: “Deemed” to meet the additional required 7 Desirable Characteristics because it falls into one of the following:

4. Funded by NIH, CDC, AHRQ, CMS, DOD, and VA

5. Supported by centers or cooperative groups funded by NIH, CDC, AHRQ, CMS, DOD,VA

6. Conducted under an investigational new drug application (IND) reviewed by the FDA

7. Exempt from having an IND under 21 CFR 312.2(b)(1)

Self-certification by the Principal Investigator was initially contemplated but never implemented by CMS and may not be used to determine whether a study qualifies for coverage.

<ahref="http: www.cms.gov="" medicare-coverage-database="" details="" ncd-details.aspx?ncdid="1&ncdver=2&fromdb=true"">http://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1&ncdver=2&fromdb=true

Office of Compliance Services

Office of Compliance Services