HRPP Manual Section 7-8-A

Clinical Research Billing Compliance Coverage Analysis

Prospective Coverage Analysis
A prospective coverage analysis is required for any new human subject research project that involves a billable event; a billable event is an event that could generate a charge (e.g. clinic visits, procedures, blood draws, labs, radiology, etc.) to a patient or their insurance carrier. For the purposes of conducting a prospective coverage analysis, the Medicare National Coverage Decision (NCD) 310.1 will be applied (see Qualifying Trials section below).

During the prospective coverage analysis process, the research site should be able to:

  • Provide information as needed regarding the determination of whether the study meets the Medicare National Coverage Decision (NCD) criteria for a qualifying clinical trial
  • Understand what items and services may be billed to the patient/insurance
  • Understand which items and services are non-billable
  • Determine the appropriate cost language to use on the study’s Informed Consent Form

A staff member in the Compliance office will conduct a prospective coverage analysis for new human research studies that involve a billable event, regardless of funding source.

Documents needed to start the prospective coverage analysis process may include the following, as applicable: 

  1. Study Protocol
  2. Funding agreement for externally funded studies
  3. Informed Consent Form
  4. Budget Offer
  5. FDA letter(s)

Upon submission and review, Compliance staff will contact the research team to provide the necessary information for clinical research billing compliance. They will also coordinate as needed with those on-campus and off-campus parties for clinical research billing compliance study related needs. Early and continued communication with the Compliance office will facilitate this process. A determination will be made as to whether the study qualifies for coverage under NCD 310.1. The Compliance office will document whether the project meets the U.S. Centers for Medicare and Medicaid Service NCD 310.1* requirements as a qualifying clinical trial. This determination will be provided to the Principal Investigator (PI).

If the project is determined not to meet the criteria as a Medicare Qualifying Clinical Trial, then the Principal Investigator (PI) will be notified. Typically, no further immediate action will be necessary. However, monitoring visits may be performed in accordance with HRPP Manual 8-10 “Monitoring Visits” to assure compliance with clinical research billing requirements and that items have not been billed inappropriately.

If the project is a qualifying clinical trial and there is a billable event being performed as part of the research project or clinical investigation which could generate a charge to the subject or their insurance, a Billing Grid for Coverage Analysis must be finalized by the Compliance office and the PI. The Compliance staff will also review federal qualifying clinical trials to assure compliance with agency requirements for billing.

For qualifying clinical trials, PIs are required to use the Billing Grid for Coverage Analysis and can use the Billing Compliance Plan (BCP) to develop a billing process that is consistent with the Billing Grid for Coverage Analysis, the budget, and any other relevant study documents to assure appropriate billing and compliance with relevant billing laws and regulations.

The finalized Billing Grid for Coverage Analysis’s billable events and the assigned billing designations must be followed. Any requested changes to the study’s initial Billing Grid for Coverage Analysis’s billable events must be submitted as an amendment to the Compliance office for review and finalization before implementation.   

When the first subject is enrolled, the HRPP Compliance office must be notified to ensure that the billing process is consistent with the Billing Compliance Plan.

Overview of NCD 310.1
The National Coverage Determination (NCD) for Routine Costs in Clinical Trials (310.1) states that Medicare covers the routine costs of qualifying clinical trials, as such costs are defined in NCD 310.1, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in all clinical trials. All other Medicare rules apply. NCD 310.1 includes the indications and limitations of coverage, requirements for Medicare coverage of routine costs, and the qualification process for clinical trials. While this section provides an overview of these requirements, see NCD 310.1 for complete requirements.

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

  • 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).
  • The trial must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.
  • 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.

The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Clinical trials also should have the desirable characteristics described in NCD 310.1; however, some trials are presumed to meet these characteristics and are automatically qualified to receive Medicare coverage unless CMS's Chief Clinical Officer subsequently finds that a clinical trial does not meet the qualifying criteria or jeopardizes the safety or welfare of Medicare beneficiaries.

Clinical trials that are deemed to be automatically qualified are:

  1. Trials funded by NIH, CDC, AHRQ, CMS, DOD, and VA;
  2. Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA;
  3. Trials conducted under an investigational new drug application (IND) reviewed by the FDA; and
  4. Drug trials that are exempt from having an IND under 21 CFR 312.2(b)(1) will be deemed automatically qualified until the qualifying criteria are developed and the certification process is in place. At that time the principal investigators of these trials must certify that the trials meet the qualifying criteria in order to maintain Medicare coverage of routine costs. This certification process will only affect the future status of the trial and will not be used to retroactively change the earlier deemed status.

Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries (i.e., there exists a benefit category, it is not statutorily excluded, and there is not a national non-coverage decision) that are provided in either the experimental or the control arms of a clinical trial except:

  • The investigational item or service, itself unless otherwise covered outside of the clinical trial;
  • Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and
  • Items and services customarily provided by the research sponsors free-of-charge for any enrollee in the trial.

Routine costs in clinical trials include:

  • Items or services that are typically provided absent a clinical trial (e.g., conventional care);
  • Items or services required solely for the provision of the investigational item or service (e.g., administration of a noncovered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications; and
  • Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service in particular, for the diagnosis or treatment of complications.

NCD 310.1 does not withdraw Medicare coverage for items and services that may be covered according to Local Coverage Determinations (LCDs) or the regulations on category B investigational device exemptions found in 42 CFR 405.201-405.215, 411.15, and 411.406.

Non-governmental payers (i.e. Blue Cross, Aetna, etc.) or governmental payers other than Medicare may have their own coverage of services policies related to clinical trials.  For non-governmental payers or governmental payers other than Medicare, it is the responsibility of the research site or the research participant to determine if a service provided within a trial is covered. It is also the responsibility of the research site to keep up to date on billing regulations for non-governmental and governmental payers including Medicare, which could affect previous coverage analysis determinations.

This policy and procedure supersedes those previously drafted.

Approved By: Vice President of Research and Graduate Studies, 12-9-2015. Revision 1 approved by VP Research & Graduate Studies on 4-18-2016. Revision 2 approved by VP Research & Graduate Studies on 8-1-2016.

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