CurrentEmblemHealthPolicy MG.MM.AD.19a

Clinical Trials/Experimental/Investigational Procedure/Treatments/Rare Disease Treatment - Commercial and Medicaid

Governs coverage of routine patient costs for members participating in approved clinical trials and the review of experimental, investigational, or rare disease treatments for EmblemHealth commercial and Medicaid members.

Policy Summary

PayerEmblemHealth

PolicyClinical Trials/Experimental/Investigational Procedure/Treatments/Rare Disease Treatment - Commercial and Medicaid

Policy CodePolicy MG.MM.AD.19a

Change TypeAdded coverage of Category B investigational devices

Effective Date

Next Review Date

Key ActionSubmit clinical evidence that the patient meets the criteria to allow prior authorization review.

SourceLink

POLICY UPDATE CHANGES

Added coverage of category B Investigational Devices as an exception to non-covered costs

Phase I-IVClinical trial phases defined

PPACA Sec. 10103(c)Statutory requirement

7Non-routine exclusions listed

1Qualified individual requirement

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Covered routine costs for qualified individuals

Covered when ALL of the following apply:

Qualified individual and approved clinical trial: Member is a qualified individual participating in an approved clinical trial as defined by statute (Phase I-IV; federally funded or approved trials; trials conducted under an FDA investigational new drug application; or drug trials exempt from FDA IND requirements).

See Appendix - Title XXVII - Public Health Service Act Sec. 2709 for full definition of approved clinical trial.

Routine costs: Items and services that would otherwise be covered under the member's plan for treatment of the condition if the member were not enrolled in the clinical trial (including medically necessary conventional care).

Includes items and services required for provision of the investigational item/service (e.g., administration of a non-covered chemotherapeutic agent), clinically appropriate monitoring of effects or prevention of complications, and care to diagnose or treat complications arising from the investigational item/service.

The investigational item or service itself is not covered. An exception is made for medically necessary Category B investigational devices (for example, ARTIA Reconstructive Tissue Matrix, PulseSelect™ PFA System, TREO Stent‑Graft System) and certain promising investigational interventions for terminal illnesses in specific trial contexts. Other exclusions include items with no benefit category, statutorily excluded items, items falling under state/federal non‑coverage policies, items customarily provided free by trial sponsors, and services provided solely to determine trial eligibility.

Items and services furnished solely to satisfy data collection and analysis needs that are not used in the direct clinical management of the patient are excluded from routine cost coverage. An example is repeated imaging (e.g., monthly CT scans) performed only for data collection when the condition would ordinarily require a single scan.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization for Trial Enrollment

All experimental/investigational clinical trial or rare disease treatments will be reviewed for medical necessity. However, no prior authorization is required for a member to enroll in a qualified clinical trial as defined by TITLE XXVII-PUBLIC HEALTH SERVICE ACT Sec. 2709.

Applies to Qualified Commercial and Medicaid individuals
No prior approval required for enrollment in a qualified clinical trial

Documentation Required

Clinical Evidence Submission

The treating physician or primary care provider must submit clinical evidence that the patient meets the criteria for the treatment or surgical procedure. Without this documentation and information, EmblemHealth will not be able to properly review the request for prior authorization.

Treating physician/PCP must provide clinical evidence demonstrating criteria are met
Failure to submit required documentation will prevent proper review of prior authorization requests

Denial Risk

Prohibited Basis for Denial

EmblemHealth may not deny a member participation in an approved clinical trial, deny or limit coverage of routine patient costs associated with participation, or discriminate against a member based on participation in an approved clinical trial.

Do not deny coverage or participation based on trial enrollment
Routine costs associated with approved clinical trials must be covered as they would be if the member were not in the trial

Note

Provider action: submit required clinical documentation to support prior authorization requests and ensure member participation in qualified clinical trials is not delayed by unnecessary authorization requirements.

Ensure documentation accompanies prior authorization submissions
Contact EmblemHealth if there is uncertainty whether a clinical trial is a qualified trial

Background and Statutory Context

Under the Patient Protection and Affordable Care Act (PPACA Sec. 10103(c)), group and individual health plans are required to cover routine patient costs associated with approved clinical trials for qualified individuals. Routine costs are defined as those services that would otherwise be covered under the member’s plan if the member were not enrolled in the trial and exclude investigational items themselves except as noted (for example, certain Category B devices and specified exceptions).

Key Definitions

Experimental Treatment definition

DefinitionA treatment that has not been tested in human beings; or that is being tested but has not yet been approved for general use; or that is subject to review or approval by an institutional review board.

ContextMay include interventions not yet evaluated for safety or efficacy in humans.

Review implicationTreated as experimental for coverage determinations and subject to medical necessity review.

Investigational Treatment definition

DefinitionA treatment that includes but is not limited to services or supplies which are under study or in a clinical trial to evaluate their toxicity, safety, and efficacy for a particular diagnosis or set of indications.

ScopeEncompasses services or supplies provided solely for research evaluation in clinical trials.

Coverage noteInvestigational items themselves are not routine costs and typically are excluded from coverage, unless otherwise specified (e.g., certain Category B devices).

Qualified Individual definition

DefinitionAn individual who is enrolled or participating in EmblemHealth and who is eligible to participate in an approved clinical trial according to the trial protocol with respect to treatment of cancer or another life-threatening disease or condition.

Additional requirementA determination must be made that participation in the approved clinical trial is appropriate to treat the disease or condition; this can be based on the referring provider's conclusion during prior approval or on medical/scientific information submitted to EmblemHealth for review.

Coverage implicationQualified individuals are eligible for coverage of routine medical costs that would otherwise be covered if not in the trial (see Coverage Statement).

Rare Disease Treatment definition

DefinitionA life‑threatening or disabling condition that is, or was, subject to review by the NIH Rare Disease Council, or affects <200,000 U.S. residents per year.

Treatment standardNo standard health service or treatment is more beneficial than the requested health service or treatment.

Certification requirementRequires certification by an outside physician specialized in an area appropriate to treat the disease in question; all rare disease treatments will be reviewed for medical necessity.