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Medicare Coverage Analysis Worksheet

Effective as of 2007, Medicare has offered coverage for routine costs in clinical trials. However, in order to be eligible for extended coverage under a clinical trial, several requirements must be met. The checklist below offers a step-by-step process to determine whether your clinical trial meets the requirements of the National Coverage Determination (NCD) for Routine Costs in Clinical Trials. In addition, several insights are highlighted to best prepare you for the road ahead.

To print this checklist, right-click and select ‘Print’. You can then use this checklist offline as a PDF if desired.

Step One: Documents Needed


Informed Consent

Sponsor Budget

Optional Documents

Step Two: Medicare Eligibility

Is a Medicare Coverage Analysis (MCA) Required?

Are there any protocol-required assessments to be billed to Medicare, insurance, or the patient?
If the answer is no, an MCA may not be needed as no items are being billed to Medicare. However, this may continue to be of use to identify all costs associated with the clinical trial.

Determining the Qualifying Status

If an MCA is required, does this clinical trial qualify for Medicare coverage?

The following requirements are needed according to the National Coverage Determination (NCD) 310.1, “Routine Costs in Clinical Trials.” The exact requirements terms can be found on the CMS website.

Step Three: Covered Items and Services

The following indications and limitations are listed in NCD 310.1 for assessments required under a protocol.



Further Considerations

Non-qualifying Trials

Select studies may continue to receive coverage under Medicare, even if determined to be “non-qualifying.” Consultation from a Medicare expert in the research field is required to confirm coverage status.

“Seven Desirable Characteristics”

Additional Medicare Statutes

Coverage is subject to NCDs, region-specific Local Coverage Determinations (LCDs), and other Medicare rulings (ex., Medicare Benefit Policy Manual). Even if the clinical trial qualifies under NCD 310.1 and a specific item/service is indicated for coverage under the points above, coverage is continually subject to these Medicare resources. NCD 310.1 does not trump any NCD or LCD determinations.

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