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Policy No.: 8008
Effective Date: DRAFT
Revised Date:
Reviewed Date: 02/07/17

Clinical Trial Professional and Technical Fee Billing Policy

Policy

University of Nebraska Medical Center is committed to submitting charges for clinical research that are in full compliance with applicable federal laws, regulations and policies.

Basis for Policy

To define procedures for identifying patients who are research subjects and to accurately charge medical procedure costs to a grant, to a third party payer, or to a patient, as appropriate to maintain patient satisfaction and comply with federal laws, regulations and policies.

• This policy applies to all clinical trials that include medical, professional and technical fees conducted at the University of Nebraska Medical Center, including medical device trials (see Medicare Qualifying Clinical Trials Flowchart and Advanced Beneficiary Notice Requirements Flowchart for specific medical device trial procedures and tools). *This policy does not apply to dental clinical trials.

Definitions

Qualified Clinical Trials

Only qualified clinical trials are eligible for reimbursement for routine costs under Medicare. In order to be a qualified trial, the trial must meet three mandatory criteria and have other desirable characteristics Medicare Qualifying Clinical Trials Flowchart.

The three (3) mandatory criteria are:

• Trial evaluates an item or service that falls within a Medicare benefit category (e.g. physicians' service, durable medical equipment, diagnostic test) that is not statutorily excluded from coverage (e.g. cosmetic surgery, hearing aids);
• Trial has therapeutic intent.

• To have therapeutic intent, the trial must, to some extent, assess the effect of the intervention on the patient outcome. The trial must not be designed to exclusively test for toxicity or disease pathophysiology; and

• Participants must be individuals with diagnosed disease rather than healthy volunteers, except for trials involving diagnostic intervention that require proper control groups.
  

The seven (7) desirable characteristics are:

• The principal purpose of the trial is to test whether the intervention potentially improves the participants’ health outcomes;
• 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;
• The trial does not unjustly duplicate existing studies;
• The trial design is appropriate to answer the research question being asked in the trial;
• The trial is sponsored by a credible organization or individual capable of executing the proposed trial successfully;
• The trial is in compliance with federal regulations relating to the protection of human subjects;
• All aspects of the trial are conducted according to the appropriate standards of scientific integrity.

Deeming Criteria

Some clinical trials are automatically qualified to receive Medicare coverage of their routine costs because they have been deemed by the Agency for Healthcare Research and Quality (AHRQ), in consultation with other agencies represented on the multiagency panel to be highly likely to have the above-listed seven desirable characteristics of clinical trials. The principal investigators of these automatically qualified trials do not need to certify that the trials meet the qualifying criteria, but must enroll the trials in the Medicare clinical trials registry (ClinicalTrials.gov) for administrative purposes.

Effective September 19, 2000, clinical trials that are deemed to be automatically qualified are:

• Trials funded by: NIH, CDC, AHRQ, CMS, DOD, or VA
• Trials supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD, and VA;
• Trials conducted under an investigational new drug application (IND) reviewed by the FDA; or
• Drug Trials that are exempt from having an IND number under 21 CFR 312.2(b)(1) will be deemed automatically qualified until 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

Routine costs of a clinical trial include all items and services that otherwise would be 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 control arm of a clinical trial.

Routine costs in clinical trials include:

• Items or services typically provided absent a clinical trial (i.e. conventional care);
• Items or services required solely for the provision of the investigational item or service (e.g. administration of a covered 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.

Research Costs

Patient care costs associated with the research trial.

Examples of items and services that are specifically included as research costs are:

• 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 computed tomography 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.
• Items and services provided solely to determine trial eligibility.

Additional Information

• Contact the Chief Compliance Officer
• Clinical Trial Professional and Technical Fee Billing Procedures
• Medicare Qualifying Clinical Trials Flowchart
• Advanced Beneficiary Notice Requirements Flowchart

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