ClinicalTrials.gov: Qualifying Clinical Trials

Last revised:

05/14/2015

The National Coverage Decision (NCD) offers specific guidance concerning Clinical Trials Billing.

Under the National Coverage Decision (NCD), Medicare will cover those routine costs of qualifying clinical trials and the costs of items and services that are reasonable and necessary* to diagnose and treat complications arising from participation in all clinical trials (Centers for Medicare and Medicaid Publication 100-3, Ch 1, Part 4, Section 310.1).

**What is a Qualifying Clinical Trial?**
Deemed Automatically Qualifying Trial (Any one criterion must be "Yes"): Is funded/supported by NIH, CDC, AHRQ, CMS, DOD or VA Is supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA Has an IND number: Trial conducted under an investigational new drug application (IND) reviewed by the FDA Trial is exempt from having an IND Qualifying Criteria (All three criteria must be "Yes"): Evaluates a Medicare benefit Has therapeutic intent Enrolls diagnosed beneficiaries *Some commonly ordered tests may not be considered “reasonable and necessary” under the NCD, or may be reasonable and necessary at some frequency less than that required by the sponsor in a protocol. See the NCD Alphabetical Index for CMS’ indications and limitations for common procedures.

What are Routine Costs Provided to Qualifying Clinical Trials?

Routine Costs	Excluded from Routine Costs
Items or services required solely for the provision of the investigational item or service (e.g., infusion)	Items or services provided solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient or not used to monitor the effects of the item or service (e.g., plasma biomarkers)
Items or services typically provided absent a clinical trial	An investigational item or service itself if used in a non-FDA approved way
Clinically appropriate monitoring of the effects of the item or service (e.g., monitoring side effects or complications)	Items or services customarily provided by the sponsors free of charge
Prevention of complications	Items or services provided solely to determine trial eligibility
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service (e.g., hydration fluids as part of chemotherapy treatment)	Treatment of healthy volunteers unless used as controls
	Cosmetic surgery, some prosthetics, herbal remedies, relaxation therapies, etc.

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