Clinical Trials

View the below related information on this page.

Coverage

Medicare may pay for items and services in clinical research studies under three policies.

  1. Clinical Trial Policy (CTP)
    • A National Coverage Determination (NCD) that allows payment of routine items/services, and payment of investigational item/service if it is normally covered outside of trial and meets medical necessity requirements, in clinical trials that qualify for coverage
    • See CMS Routine Costs in Clinical Trials (310.1) NCD for details
  2. Coverage with Evidence Development (CED)
    • Medicare may issue an NCD that requires participation in certain clinical trials, longitudinal studies, or registries for coverage of an item/service and routine and related items/services
    • See all CED studies on CMS Coverage with Evidence Development webpage
  3. Investigational Device Exemption (IDE) Policy
    • Medicare may cover certain items/services in Food and Drug Administration (FDA)-approved IDE trials
    • Trials initially approved by FDA before January 1, 2015, Medicare Administrative Contractors (MACs) review IDE studies to determine coverage
    • Trials approved by FDA after January 1, 2015, view listing on CMS Approved IDE Studies webpage. MACs may require additional information to facilitate claims payment

Clinical Trials, Prospective Studies, and Registries Coverage

Coverage Elements CTP IDE CED
CMS approval required No. Must qualify under NCD 310.1 Yes. Each specific study approved by FDA before 1/1/15, requires MAC approval; studies approved by FDA after 1/1/15 require CMS approval Yes. Requires CMS approval for each specific study
Public notification No. Provider determines qualification Each study approved by FDA after 1/1/15 appears on CMS IDE Website Each study approved by CMS appears on CMS CED Website
Routine services (Q1) Covered if otherwise coverable by Medicare in qualified study Covered if study is approved by CMS and otherwise coverable by Medicare Covered if study is approved by CMS and otherwise coverable by Medicare
Investigational item/ service (Q0) Covered if otherwise covered by Medicare in qualified study Covered if item/service is Category B, and approved by CMS Covered if study is approved by CMS

 

CMS-1500 Claim Form Completion

Claims must contain the proper components when billing Medicare.

  • Item 19 (preceded by ‘CT'); or 837 P–Loop 2300, REF02, REF01=P4 (do not use ‘CT' on electronic claim)
    • Enter eight-digit National Clinical Trial (NCT) number (numeric characters only) on electronic claims
    • For NCT number, see Clinical Trials website
  • Item 21: ICD-10 diagnosis code Z00.6
    • Primary or secondary positions
    • Must be reported on all clinical trial claims
  • Item 24D: Modifier Q0 (zero)
  • Item 23: Enter IDE number when an investigational device is used in an FDA-approved clinical trial. Post Market Approval number should also be placed here, when applicable

Billing Scenarios

Case Number Scenario Solution
1A Patient is admitted for sepsis, dehydration, or pain control because of the clinical trial. Do providers still bill with NTC number? No. Complications stemming from participation in a clinical trial do not need an NCT number.
1B Patient has a Medicare Advantage (MA) plan. Who should providers bill? Medicare will reimburse qualifying clinical trial claims on behalf of MA members and will waive the Part A and Part B deductibles. MA plans are responsible for remaining original Medicare coinsurance minus the plan's normal member copays for the incurred types of service, with exception to CEDs listed in CMS Change Request (CR)10238; in those instances, the MA plan is responsible.
1C Patient has completed a clinical trial; however, they are being seen yearly for observation. Do providers still bill with NCT number? No. Once the patient has completed the clinical trial, there is no requirement to report the NCT number.
1D Provider does not know NCT number. Can providers still bill with 999999999, per CMS Medicare Learning Network (MLN) Matters Special Edition (SE)1344? Yes; however, actual NCT identifier numbers are required if they are known. If the study is an IDE study or a CED study, the NCT number is always required.

Trial-related claims will be returned if they do not contain either the actual clinical trial identifier number or the 8-digit generic number 99999999 – these fields cannot be left blank. (SE1344 outlines those instructions)
1E Patient started as inpatient with an inpatient facility. They went to a different outpatient facility, partway through their inpatient stay, for clinical trial procedure. Patient returned to inpatient facility before midnight the same day (of the procedure).

How should the inpatient facility bill for this?
Regardless if clinical trial procedure is related or not to inpatient admission, the inpatient facility is not able to bill for clinical procedure (performed by outpatient facility), if they are not enrolled to perform it themselves.
Bill for all inpatient services related to admission

Do not bill for clinical trial procedure If a payment arrangement is made with the other facility, your facility may be out that money, as Medicare cannot reimburse for this.

 

Routine Services Outpatient Claims

Routine Costs Submitted by Practitioners/Suppliers

  • Modifier Q1 (numeral 1)
    • Outpatient claims only
    • Append on all line items that are routine clinical services provided in an approved clinical research study
  • If ICD-10-CM is applicable, ICD-10 diagnosis code Z00.6
  • CMS covers costs of healthy volunteers in a qualified clinical trial if it meets the following conditions.
    • Trial is not designed exclusively to test toxicity or disease pathophysiology
    • Trial must have therapeutic intent
    • If trial has therapeutic interventions, it must enroll patients with diagnosed disease rather than healthy volunteers
    • If trial is studying diagnostic interventions, it may enroll healthy patients to have a proper control group

Required Documentation

The billing provider must include the following in the beneficiary's medical record.

  • Trial name, sponsor, and sponsor-assigned protocol number

This information is not required to be submitted with the claim but it must be provided if requested for medical review.

Investigational Device Exemption (IDE)

  • Category A (Experimental) device refers to a device for which "absolute risk" of the device type has not been established (that is, initial questions of safety and effectiveness have not been resolved) and the FDA is unsure whether the device type can be safe and effective. This device shall not be reported on practitioner claims since these devices are not eligible for payment under Medicare.
  • Category B (Non-experimental/investigational) device refers to a device for which the incremental risk is the primary risk in question (that is, initial questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA premarket approval or clearance for that device type. This device can be reported on a practitioner's claim. (See additional information on IDE on the link below)

Resources

Last Updated Jan 19, 2018