Qualifying Studies

Like most research institutions in the United States,  UF uses the Medicare rules to determine if a clinical research study qualifies to bill patients/insurance for protocol-required Routine Costs.  Both terms are defined by Medicare.

Qualifying Clinical Trials (QCTs)

In order to qualify for billing participants/insurance for ANY protocol-required items or services (including “standard of care”), the study must meet ALL THREE of the following criteria:

1)  The subject or purpose of the study 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 study must not be designed exclusively to test toxicity or disease pathophysiology. It must have therapeutic intent.

3)  Studies of therapeutic interventions must enroll patients with diagnosed disease rather than healthy volunteers. Studies of diagnostic interventions may enroll healthy patients in order to have a proper control group.

In addition, the study must have federal oversight as demostrated by AT LEAST ONE of the following criteria:

  • The study is funded by NIH, CDC, AHRQ, CMS, DOD, or VA
  • The study protocol has been reviewed and supported by federal centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD and VA
  • The study is being conducted under an investigational new drug application (IND) reviewed by the FDA
  • The study is a drug study that is IND exempt under 21 CFR 312.2(b)(1).

Who Determines if a Study is a QCT?

Pre-approved NCD/CED Studies

  • In recent years, Medicare has issued several national coverage determinations (NCDs) providing expanded coverage for services and procedures of a complex nature.
  • Some of these NCDs include pathways for specific investigational studies to qualify using the Coverage with Evidence Development (CED) process.
  • Medicare determines if a study qualifies for billing Routine Costs using the NCD/CED policies.
  • A study that has been pre-approved by Medicare under these rules is considered to be Qualifying Clinical Trial.
  • Evidence of pre-approval must be submitted to the Office of Clinical Research(OCR) before finalizing the study budget and billing plan.

Pre-approved IDE or CAS Device Studies

  • Routine Costs are billable in qualifying/pre-approved FDA Investigational Device Exemption (IDE) and Carotid Artery Stenting (CAS) device studies.
  • In many FDA IDE category B studies, the investigational device itself may be billable.
  • Medicare determines if an IDE or CAS study qualifies under the IDE and CAS pre-approval processes.
  • Our local Medicare contractor, First Coast Service Options, is also involved in determination and/or preparation for older IDE studies.
  • A study that is pre-approved by Medicare under the IDE and CAS rules is considered to be Qualifying Clinical Trial.
  • Evidence of pre-approval must be submitted to the Office of Clinical Research(OCR) before finalizing the study budget and billing plan.

All Other Studies

What Happens if a UF Study is NOT a Qualifying Clinical Trial (QCT)?

UF has several different approaches to non-QCTs:

  • Negotiate with sponsor to cover all study-required items/services.
  • For investigator-initiated studies, collaborate with investigator(s) to determine if protocol may revised in order to qualify for coverage.
  • Only direct Conventional Care items/services to insurance/patients.