CurrentEmblemHealthPolicy N/A

Non‑FDA‑Approved Drug Use and/or Dose Request Form — Coverage Criteria

Form and instructions for prescribers to request coverage for off‑label drug use or non‑standard dosing from EmblemHealth's Clinical Pharmacy. Affects prescribers submitting requests and patients whose drugs/doses are not FDA‑approved for the intended indication or dose.

Policy Summary

PayerEmblemHealth

PolicyNon‑FDA‑Approved Drug Use and/or Dose Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed Non‑FDA‑Approved Drug Use and/or Dose Request Form with supporting documentation to EmblemHealth Clinical Pharmacy for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2peer‑reviewed citations required

1fax submissions

1email submissions

1phone for questions

Coverage Criteria

Required submission elements

Request will be reviewed when the following are provided:

Submission completeness: Completed form with patient and prescriber identifiers; requested drug (dose, route, duration); requested diagnosis; history supporting the request including concurrent diseases and labs; prior medications for the same indication with reasons for discontinuation; prescriber signature and date; and a minimum of two peer‑reviewed journal articles/abstracts with full citations.

Submit via fax to Clinical Pharmacy at 1-877-300-9695, by email to clinicalpharmacy@emblemhealth.com, or by mail to EmblemHealth, Attn: Clinical Pharmacy Department, 441 Ninth Avenue, New York, NY 10001. For questions call 1-877-362-5670.

Provider Submission and Documentation Requirements

Documentation Required

Required form fields and documentation

Please complete the Non‑FDA‑Approved Drug Use and/or Dose Request Form with the following required fields and attach requested documentation. Incomplete submissions may delay review.

Policy Summary

PayerEmblemHealth

PolicyNon‑FDA‑Approved Drug Use and/or Dose Request Form — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit the completed Non‑FDA‑Approved Drug Use and/or Dose Request Form with supporting documentation to EmblemHealth Clinical Pharmacy for review.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Patient identifiers: Today's date, patient name, EmblemHealth ID #, patient date of birth
Prescriber information: prescriber's name, specialty, address, phone number, fax number, email, prescriber's signature and date
Requested drug details: drug name, dose, route, and requested duration
Requested diagnosis: indication for the off‑label drug use or off‑label dose
Prior therapy documentation: list other medications (formulary and non‑formulary) tried for this indication and reason for discontinuation for each
Clinical rationale: patient history supporting the request (concurrent disease states, pertinent lab tests, and other relevant clinical information). Attach clinical records as appropriate
Supporting literature: attach a minimum of two peer‑reviewed journal articles or abstracts (include full citation) that support the drug for the intended off‑label use and/or dose
Attachments: any relevant chart notes, labs, imaging, or specialists' notes that substantiate medical necessity

Background

This form is used when a prescriber requests coverage for a drug or dosing regimen that is not approved by the U.S. Food and Drug Administration for the intended indication or dose. EmblemHealth requires clinical justification and supporting evidence to evaluate such requests.

To be considered for review, submit the completed Non‑FDA‑Approved Drug Use and/or Dose Request Form including patient and prescriber identifiers, the requested drug (dose, route, duration), the requested diagnosis, pertinent patient history and documentation (for example concurrent disease states and relevant labs), prior medications tried for the same indication with reasons for discontinuation, and the prescriber’s signature and date. Attach a minimum of two peer‑reviewed journal articles or abstracts (full citations) supporting the off‑label use or dose.

Send the completed form and supporting documentation to EmblemHealth Clinical Pharmacy by fax to 1‑877‑300‑9695, by email to clinicalpharmacy@emblemhealth.com, or by mail to EmblemHealth, Attn: Clinical Pharmacy Department, 441 Ninth Avenue, New York, NY 10001. For questions, call 1‑877‑362‑5670.

Definitions

Non‑FDA‑approved use / off‑label use — definition

DefinitionUse of a drug or dose that has not been approved by the U.S. Food and Drug Administration for the requested indication or dosing regimen.

Required supporting evidenceAttach a minimum of two peer‑reviewed journal articles/abstracts (full citation) supporting the off‑label use and/or dose.

Form purposeRequest form used to request coverage for a drug or dose when the intended indication or dosing is not FDA‑approved.

Submission contentProvide clinical justification and supporting documentation including patient identifiers, prescriber information, requested drug (dose, route, duration), requested diagnosis, prior medications for the same indication with reasons for discontinuation, and prescriber signature and date.

Review riskRequests lacking at least two peer‑reviewed citations in support of the off‑label use or dose may be insufficient for review and risk denial.