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Research Billing Compliance Program

Research Billing Compliance Program - Departments & Programs, Programs and Initiatives

UW Health is a world class academic medical center, and our family of caregivers works at the leading edge of clinical research. Every day, UW Health clinicians and patients are involved in hundreds of research studies. 

Clinical research studies add a layer of complexity to clinical billing practices. Federal regulations prohibit billing for services that are provided as part of a research protocol, but services that fall outside the protocol may be billable. The UW Health Research Billing Compliance Program works with researchers and other staff to ensure that we bill appropriately and follow the law. 

The UW Health Research Billing Compliance Program strives to:

  1. Standardize the billing procedures used in clinical research.
  2. Centralize the review of research study budgets and protocols for compliance with the Centers for Medicare/Medicaid clinical trial billing rules.
  3. Streamline research billing processes with the UWHC and UWMG patient account offices. 

Focus

Do's and Don'ts of Research Billing

Under Medicare regulations, UW Health providers:

The Research Billing Compliance Checklist provides more detail on what may and may not be billed for patients enrolled in a clinical trial.

FAQ

What is a Medicare Qualified Clinical Trial (MQCT)?

A MQCT is a clinical trial eligible to receive Medicare coverage of routine costs. A MQCT must meet  three requirements:

  1. The subject/purpose of the trial must be the evaluation of an item/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.

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 following desirable characteristics:

  1. The principal purpose of the trial is to test whether the intervention potentially improves the participants' health outcomes.
  2. The trial is well-supported by available scientific and medical information or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.
  3. The trial does not unjustifiably duplicate existing studies.
  4. The trial design is appropriate to answer the research question being asked in the trial.
  5. The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully.
  6. The trial is in compliance with Federal regulations relating to the protection of human subjects.
  7. All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Some clinical trials are presumed to have the above characteristics and automatically qualify to receive Medicare coverage:

  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.
  4. Drug trials exempt from having an IND under 21 CFR 312.2(b)(1) with PI certification.

See the NCD for Routine Costs in Clinical Trials for additional information.

Resources

Forms

Policies

UW Health Charges for Patients in Research Studies

UW Resources

Oncore

UW Institute for Clinical and Translational Research Website

Websites

National Coverage Determination (NCD) for Routine Costs in Clinical Trials

Medicare Clinical Trial Policies Overview

Navigating the Clinical Trial Billing Maze, James B. Pfadenhauer, Journal of Oncology Practice 2(6) 2006

Related

Compliance (UWHC)

Compliance (UWMF)

Legal Services (UWHC)

Legal Services (UWMF)

Risk Management (UWHC)

Worker's Compensation