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Policy No.: 8008
Effective Date: 07/20/18 DRAFT
Revised Date: 07/20/18
Reviewed Date: 07/20/18

Clinical Research and 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 research payer, 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 research and clinical trials that include medical, professional and technical fees conducted at the University of Nebraska Medical Center/Nebraska Medicine, 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

Clinical Research

A funded or unfunded project that involves human subjects, where additional laboratory, radiology, or other services are provided and billed, whether alongside regular clinical care or not. This term, clinical research, includes all clinical trials, but the term clinical trial will be identified separately to clarify where special requirements may be in required for them.

Clinical Trial

A federally or other sponsored research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

Qualified Clinical Trials

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

Three mandatory criteria

• 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.

Seven desirable characteristics

• 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 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 that are associated with the research trial or clinical research should be paid by the research grant or contract. These costs are not billable to Medicare and/or a third party payer.

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
• Nebraska Medicine Policy IM10, One Chart Training Classes
• Nebraska Medicine IM41, Chart Research Documentation
• Nebraska Medicine One Chart Tips and Tricks Sheet - Looking Up Grant Charges on Statements
• Nebraska Medicine Policy MI15, Advanced Beneficiary Notice (ABN)
• Nebraska Medicine Policy MI19, Research Billing Process
• Nebraska Medicine Policy MI29, Investigational Devices
• Nebraska Medicine Policy RI06, Admission/Registration to Nebraska Medicine
• Clinical Trial Insurance Predetermination Request Form
• Nebraska Medicine SOP 201.2 Insurance Predetermination Form
• Nebraska Medicine ACCESS-REGSP-110

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