Penn Medicine Clinical Research

Coverage Analysis Review (CAR)

What is Coverage Analysis Review (CAR)?

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 insure 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) – Should link to text below

Medicare Coverage Analysis (MCA) – Should link to text below

Routine Costs Determination – Should link to text below

Coverage Analysis Review in PennCTMS – Should link to text below

Forms:

PRA MCA Budget Template

Related Guidance

  1. Medicare Coverage Analysis workshop
  2. Prospective Reimbursement analysis/Medicare Coverage Analysis (PRA/MCA) form
  3. NCD 310.1
  4. Research billing modifiers
  5. CMS IDE study submission and coverage
  6. Medicare Coverage Database (database of Medicare Policies)
  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

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 PennCTMS

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

The MCA is converted into study calendar which includes all items and services required to conduct the study. In CTMS, 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’
  • PennCTMS 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
    • PennCTMS study status
    • Future Visit dates

OCR Finance will initially build the calendars in CTMS. 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.

Related Guidance

  1. Medicare Coverage Analysis workshop Hyperlink [ARE WE STILL OFFERING THIS WORKSHOP] - rm
  2. Prospective Reimbursement Analysis/Medicare Coverage Analysis (PRA/MCA) form hyperlink [ADD LINK FROM FORMS LIBRARY] = rm
  3. NCD 310.1
  4. Research billing modifiers
  5. CMS IDE study submission and coverage
  6. Medicare Coverage Database (database of Medicare Policies)
  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)