Qualifying Clinical Trials

The CMS has issued a National Coverage Determination (NCD) which allows Medicare coverage for the routine costs of qualifying clinical trial services as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials.

Payment for Qualifying Clinical Trial Services

For dates of service on or after September 19, 2000, pay for covered services furnished to beneficiaries participating in qualifying clinical trials. Payment is based on the payment methodology applicable for the service that was furnished (e.g., physician fee schedule, lab fee schedule, DME fee schedule, reasonable charge, etc.). With the exception of managed care enrollees, applicable deductibles and coinsurance rules apply to clinical trial items and services. The Part A and Part B deductibles are assumed to be met for covered clinical trial services billed on a fee service basis for managed care enrollees.

Medical Records Documentation Requirements

The billing provider must include in the beneficiary's medical record the following information: trial name, sponsor, and sponsor-assigned protocol number. This information does not need to be submitted with the claim but must be provided if requested for medical review. 

Billing Requirements – General
Instruct practitioners and institutional providers to enter clinical trial and non-clinical trial services on separate line items when billing both types of services on the same claim. For services that require a Certificate of Medical Necessity (CMN), continue to require CMNs. Items and services provided free of charge by research sponsors generally may not be billed to be paid by Medicare, and providers are not required to submit the charge to Medicare. If it is necessary for a provider to show the items and services that are provided free of charge in order to receive payment for the covered routine costs (e.g. administration of a non-covered chemotherapeutic agent), providers are instructed to submit such charges as non-covered at the time of entry, while also assuring that the beneficiary is not held liable. This instruction applies to all hospitals including hospitals located in Maryland under the jurisdiction of the Health Services Cost Review Commission (HSCRC).

Requirements for Billing Routine Costs of Clinical Trials

Claims with dates of service before January 1, 2008:

• HCPCS modifier ‘QV’
• Diagnosis code V70.7 (Examination of participant in clinical trial) reported as the secondary diagnosis
Claims with dates of service on or after January 1, 2008:
• HCPCS modifier ‘Q1’ (numeral 1 instead of the letter i) ; and
• Diagnosis code V70.7 (Examination of participant in clinical trial) reported as the secondary diagnosis

If the QV or Q1 modifier is billed and diagnosis code V70.7 is submitted by practitioners as a secondary rather than the primary diagnosis, do not consider the service as having been furnished to a diagnostic trial volunteer. Instead, process the service as a therapeutic clinical trial service.

Effective for claims processed after September 28, 2009, with dates of service on or after January 1, 2008, claims submitted with either the modifier QV or the modifier Q1 shall be returned as unprocessable if the diagnosis code V70.7 is not submitted on the claim.

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