Currentpriority healthPolicy N/A

Clinical trials prior authorization form

A prior authorization form and coverage checklist for determining whether routine patient care costs associated with participation in clinical trials are covered for Priority Health members; specifies eligibility criteria, required documentation, and notes Medicaid exclusion and self-funded group variability.

Policy Summary

Payerpriority health

PolicyClinical trials prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionProvider must complete and submit the clinical trials prior authorization form including member, provider, facility, clinical information, diagnosis and procedure codes, trial protocol and NCT/clinical trial number.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes.

Medicaid: excludedPriority Health Medicaid coverage

Self-funded: verifySelf-funded group coverage

1Form pages (contains multiple sections)

Coverage Summary — clinical trials routine patient care costs

This is a prior authorization form to request coverage verification for routine patient care costs associated with participation in clinical trials for Priority Health. Note that Clinical trials aren't covered for Priority Health Medicaid, and coverage for members in self-funded groups must be verified with the individual plan document. The form collects required sections including member information, provider information, facility information, clinical trial details (diagnosis/procedure codes, trial protocol, sponsor/funding, NCT/clinical trial number), and supporting documentation (e.g., CMS/NGS approval, informed consent, advance care planning if applicable).

Criteria for coverage of routine patient care costs

Coverage verification — routine patient care costs in clinical trial

Coverage for routine patient care costs in clinical trial may be a covered benefit when ALL of the following are met (check all that apply):

ALL of the following

Eligible condition: Member is eligible to participate in an approved clinical trial for treatment of one of the following: Cancer OR Other life-threatening disease/condition defined as: terminal illness or a chronic, life-threatening, severely disabling disease that is causing serious clinical deterioration.
Provider justification: Member or referring healthcare provider provides medical and scientific information establishing that participation in trial would be appropriate based on the conditions described in (1).
Approved clinical trial phase and approval
- Phase 1: Approved clinical trial is Phase 1
- Phase 2: Approved clinical trial is Phase 2
- Phase 3: Approved clinical trial is Phase 3
- Phase 4: Approved clinical trial is Phase IV
Trial meets one of A, B, or C
- A - Federally funded/approved: A. Federally funded trials approved or funded by one or more of: National Institutes of Health; Centers for Disease Control and Prevention; Agency for Health Care Research and Quality; Center for Medicare and Medicaid Services; Cooperative group or center of any of the entities described; Department of Defense; Department of Veterans Affairs; qualified non‑governmental research entity identified in NIH guidelines; Department of Energy when conditions described in the medical policy are met.
- B - FDA IND: B. The study or investigation is conducted under an investigational new drug application reviewed by the FDA. (Include IND/INDA number.)
- C - IND exempt: C. The study or investigation is a drug trial that is exempt from having an investigational new drug application.
Advance care planning assessment: An advance care planning assessment has been completed by a qualified provider for members with Stage IV cancer or other life‑threatening condition.
Applies if member has Stage IV cancer or other life‑threatening condition

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Required provider actions and documentation

Prior Authorization

Submit clinical trials prior authorization form

Complete and submit the Clinical Trials Prior Authorization form. The form must include member, provider and facility details; clinical information including diagnosis and procedure codes; a brief description of the trial and attached trial protocol; and the NCT/ClinicalTrials.gov or other clinical trial number.

Member information (name, Priority Health ID, DOB, PCP and contact) — see Member information section
Provider information (provider name, Tax ID, address, contact) — see Provider information section
Facility information (facility name, Tax ID, address, contact) — see Facility information section
Clinical information (diagnosis codes, procedure codes, brief trial description, trial protocol attachment, trial sponsor/funding, NCT/clinical trial number)

Documentation Required

Provide supporting documentation for coverage criteria

Include supporting documents with the request: documentation showing the trial is CMS or other National Government Service (NGS) approved when applicable; a completed advance care planning assessment when applicable (e.g., Stage IV cancer or other life‑threatening condition); and a copy of the informed consent agreement. If the study is conducted under an IND/INDA, include the IND/INDA number.

Documentation Required

Provide medical/scientific justification

The member or referring healthcare provider must supply medical and scientific information establishing that participation in the trial is appropriate based on the eligibility criteria (e.g., diagnosis, life‑threatening condition, trial phase and other checklist requirements). This justification should address how the member meets the coverage verification conditions.

Documentation Required

Verify trial funding/approval source

State whether the trial is federally funded/approved (listing agencies provided on the form), conducted under an FDA‑reviewed investigational new drug application (include IND/INDA number), or is a drug trial exempt from an IND. Include the ClinicalTrials.gov identifier (NCT or ClinicalTrials.gov number).

Background and scope

This clinical trials prior authorization form indicates that clinical trials aren't covered for Priority Health Medicaid, but routine patient care costs may be covered when all specified criteria are met (federal/funding/IND conditions, trial phase, member eligibility, and required documentation). The form is used to collect member, provider, and facility information, as well as clinical trial details (diagnosis and procedure codes, brief trial description and protocol, trial sponsor and funding source, and NCT/clinical trial number) and supporting documentation (CMS/NGS approval evidence, informed consent, and advance care planning assessment if applicable).

Life‑threatening disease/condition is defined on the form as a terminal illness or a chronic, life‑threatening, severely disabling disease that is causing serious clinical deterioration.

Policy Summary

Payerpriority health

PolicyClinical trials prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Clinical trials prior authorization form

Coverage Summary — clinical trials routine patient care costs

Criteria for coverage of routine patient care costs

Codes requested on form

Required provider actions and documentation

Background and scope