Penn Medicine Clinical Research

Coverage Analysis Review

A Coverage Analysis Review (CAR) is required for all clinical research studies (device and drug) in which tests, procedures and interventions associated with a clinical trial can potentially be billed to third party payors, or when research procedures are paid for by sponsors. A CAR is comprised of two forms: the Prospective Reimbursement Analysis (PRA) and the Medicare Coverage Analysis (MCA).

Coverage Analysis  Review at University of Pennsylvania Health System

Coverage Analysis review at Penn is performed by the Finance department in Office of Clinical Research within the Pearlman School of Medicine (PSOM).

Coverage Analysis Review Objectives

Ensure every clinical research study has a completed PRA. Ensure all qualifying clinical trials in which tests, procedures and interventions could potentially be billed to third party payors  or subjects has a sufficiently detailed and accurate MCA. In addition, Finance will:

  • Review study to determine if a submission to Center for Medicare and Medicaid Services (CMS) is needed.
  • Review budget to ensure CPT codes are correct and billable together or separately
  • Review language in Informed Consent Forms, Budget Exhibit, and/or Contract to ensure Medicare or financial compliance

Prospective Reimbursement Analysis (PRA)

A PRA determines the underlying eligibility of the study for Medicare coverage i.e., if the study meets the criteria of a Qualifying Clinical Trial (QCT). Medicare covers the routine costs of qualifying clinical trials per the National Coverage Determination for Routine Costs in Clinical Trials, 310.1 and the items and services used to diagnose and treat complications arising from participation in clinical research. Routine costs in a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries.

Any clinical trial receiving Medicare coverage of routine costs must meet the following three requirements:

  1. The subject or purpose of the trial must be the evaluation of an item or service that falls within a Medicare benefit category (e.g., physicians' service, durable medical equipment, diagnostic test) and is not statutorily excluded from coverage (e.g., cosmetic surgery, hearing aids).
  2. The trial must not be designed exclusively to test toxicity or disease pathophysiology, it must have therapeutic intent.
  3. Trials of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Trials of diagnostic interventions may enroll healthy patients in order to have a proper control group.

Please see Related Guidance for further education resources:

Medicare Coverage Analysis (MCA)

A MCA identifies the clinical events specified in the protocol and the payor  for each event. The clinical events will be organized in a study activity grid which lists the event itself, the visits at which the event(s) take place, and the payor  of each of the study related event. A MCA will define the items and services that are:

  • Paid for by the sponsor
  • Billable to Medicare as routine care
  • Not billable to Medicare as routine care without documentation as to medical necessity
  • Non-reimbursable
  • Patient/research subject’s responsibility (costs incurred for participating in clinical trial)

How Routine Costs are Determined

The Centers for Medicare & Medicaid Services (CMS) provide guidance to help differentiate Routine Costs from Study Costs. National and Local Coverage Determinations, professional medical association guidance, and nationally recognized peer-reviewed publications are often utilized as resources to support Coverage Analysis billing designations. Additional Guidance can be found from National Coverage Determination for Routine Costs in Clinical Trials, 310.1.

Coverage Analysis Review in PennCRMS

The PRA and the MCA form can be developed in the CRMS system. These forms can also be linked directly to an active study in CRMS. The PRA form can be found in the CRMS.

The MCA is converted into study calendar which includes all items and services required to conduct the study. In CRMS, it is directly linked to a patient and can be managed as patient completes their visits. Benefits of Study Calendar include:

  • Convenience to manage the patient features all in one platform’
  • PennCRMS registration
  • Able to manage patient visit and payer status
  • Track patient activity and schedules
  • Develop Budget and Milestone information
  • Extract Quick reports on
    • Patient schedule
    • PennCRMS study status
    • Future Visit dates

OCR Finance will initially build the calendars in CRMS. After study team reviews the calendar, OCR Finance will then transfer the calendar from training to the production site and associate it to the corresponding study. The study team will be then responsible for associating the calendars to their patients in the study.

  1. Medicare Coverage Analysis Workshop
  2. Prospective Reimbursement Analysis (PRA) and Medicare Coverage Analysis (MCA) Budget Template
  3. NCD 310.1
  4. Research billing modifiers
  5. CMS IDE study submission and coverage
  6. Medicare Coverage Centers
  7. Medicare Benefit Manual (includes information about services that are a benefit of Medicare).
  8. Managed Care Benefit Manual (includes information about Medicare Advantage Patients)
  9. Overview of Medicare coverage Determination