CurrentEmblemHealthPolicy RPC20230049

Pharmacy - Medical Claim Edit

Governs prior approval, documentation and claim-editing requirements for medical-benefit drugs and biologics that lack a specific plan guideline; affects providers submitting medical/drug claims to EmblemHealth.

Policy Summary

PayerEmblemHealth

PolicyPharmacy - Medical Claim Edit

Policy CodePolicy RPC20230049

Change TypeClarifications and template formatting

Effective Date

Next Review DateNov 25, 2025

Key ActionObtain prior approval for medical-benefit drugs with significant safety, clinical, or abuse/diversion concerns and submit required documentation for off-label use.

SourceLink

POLICY UPDATE CHANGES

This policy criteria applicable for dates of service on or before 12/31/2025.

CMS reference links updated.

Policy content was transferred to an individual company-branded template with no changes to title or policy number.

12 monthsLength of authorization for approvals

≥2Rcts generally required for off-label use

8Published evidence guidance levels

NYState law appendix references

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.

Medical-benefit Drug Coverage Criteria

Medical-benefit drug coverage criteria

Coverage and prior-approval criteria for medical-benefit drugs and off-label uses

ALL of the following

Prior approval is required for medical-benefit drugs with significant safety, clinical, or potential abuse/diversion concerns; claim edits will be applied during claim processing to validate appropriate drug-to-therapy mapping and a claim may pend for an inappropriate ICD-10 to HCPCS pairing. If a claim is denied, the provider will be notified and may submit a new or corrected claim for consideration if a coding error occurred.

Off-label evidence standards

Preferred evidence: Off-label use should be supported by clinical research appearing in at least 2 randomized controlled trials on large patient groups (e.g., 300–3,000 or more depending upon the disease/condition) that definitively demonstrate safety and effectiveness.
Alternative evidence: If large randomized trials are unavailable, at least 2 trials with reasonably large patient samples (e.g., 20–300) from different centers showing consistent safety and efficacy may be considered; greater consideration will be given to higher powered studies and stronger study-design levels.

ALL of the following

Studies submitted for Plan review must come from different centers and be published in national or international peer-reviewed journals (with editorial committees comprised of physicians). Peer-reviewed literature excludes in-house manufacturer publications and abstracts (including meeting abstracts).
The Plan will evaluate the broad range and quality of evidence and may consult specialty-specific experts when determining whether off-label use is reasonable and necessary; approvals will specify diagnosis, dosage, route, duration, frequency and appropriate patient population.

ALL of the following

A medically accepted indication can be established via recognized compendia (e.g., AHFS, Clinical Pharmacology, NCCN, Micromedex, Lexi-Drugs) or Articles/LCDs; when an unlabeled use does not appear in at least one major compendium, full-text peer-reviewed articles and additional documentation are generally required for review.

ALL of the following

The Company may request patient records, test results and provider credentials as part of its coverage determination process; additional documentation supporting medical necessity must be made available upon request.
For off-label consideration when a use is not listed in at least one of the major compendia, submit copies of relevant full-text peer-reviewed articles; when FDA has previously found insufficient data or deemed the drug investigational, at least 2 Phase II trials from different centers published in peer-reviewed journals are required along with any requested patient medical records.

ALL of the following

Off-label uses are not covered when identified as not indicated by CMS (for Medicare members) or the FDA, when identified as not indicated in at least one of the major compendia, when peer-reviewed literature shows the drug/biologic is not safe and effective, or when the Plan determines the use is not reasonable and necessary.
If a drug use is not on the FDA label and does not appear in AHFS or USPDI compendia (or applicable Article for Medicare members), coverage will not be provided; services related to noncovered services (e.g., administration) are also not covered.

ALL of the following

Approvals/length of authorization default to 12 months.

Claim Edit Rules and Compendia Requirements

Claim edit rulesmixed

Claims edits applied during claim processing to validate appropriate drug-to-therapy mapping; may pend or deny for inappropriate ICD-10 to HCPCS pairing.

Compendia requirement for off‑label cancer drug coverage

Compendia requirement (NY chemotherapy law)Under New York law, FDA-approved cancer drugs used for an unapproved cancer type must be recognized in NCCN or USPDI (or meet criteria in other major compendia) to be covered; absence from these compendia may result in noncoverage.

Primary compendia listedNCCN Drugs and Biologics Compendium (Category 1 or 2A) and USPDI/AHFS-level references are referenced for determining accepted off-label cancer uses.

Alternative compendia acceptedOther medically recognized compendia cited by the policy include AHFS-DI, Clinical Pharmacology, Micromedex (DrugDex classes I/IIa/IIb), and Lexi-Drugs (Evidence Level A).

Consequence of absence from compendiaIf a proposed off-label cancer use is not recognized in these compendia (or USPDI/AHFS where applicable), coverage may be denied as not medically necessary.

Prior Approval and Off-label Documentation

Prior Authorization

Prior Authorization Required

Prior approval is required for all medical-benefit drugs with significant safety, clinical, or potential abuse/diversion concerns that are billed under the medical benefit. Claim edits will be applied during claim processing to validate appropriate drug-to-therapy use based on FDA guidelines. A claim may pend for further review if the ICD-10 code is inappropriate for the drug HCPCS code. If a claim is denied, the Provider will be notified and may submit a new or corrected claim for consideration of payment if an error in coding occurred in the original submission. The Company reserves the right to request additional documentation to support medical necessity; documentation requested may include patient records, test results, and provider credentials. The Company may deny reimbursement when services are not medically necessary, investigational/experimental, not within the member's benefits, or when a pattern of inappropriate or excessive billing is identified.

Prior approval required for medical-benefit drugs with significant safety, clinical, or abuse/diversion concerns
Claims may pend if ICD-10 code is inappropriate to the drug HCPCS code
Provider notified if claim denied; may submit corrected claim
Company may request additional documentation (patient records, test results, provider credentials)

Documentation Required

Off‑label Coverage Request Documentation

Providers may request coverage for off-label (unlabeled) uses of drugs/biologics. Supportive clinical data must be submitted to the Plan to substantiate the requested off-label use. Acceptable evidence includes high-quality clinical research such as randomized controlled trials or other controlled studies; when large randomized trials are not available, at least two reasonably sized trials demonstrating consistent safety and efficacy may be considered. The Company may require peer-reviewed full-text articles and individual patient medical records to determine whether an off-label use is reasonable and necessary for a particular patient. The Company also reserves the right to request additional documentation and to interpret and apply this policy at its discretion.

Supportive data must include either: 1) at least 2 randomized controlled trials on large patient groups demonstrating safety and effectiveness, OR 2) at least 2 trials with reasonably large samples (e.g., 20–300) showing consistent safety and efficacy
For Plan consideration when unlabeled use is not in major compendia: submit full-text peer-reviewed articles (at least 2 Phase II trials from different centers)
The FDA’s prior determinations about insufficient data or investigational status may affect review
Individual patient medical records may be required to determine medical necessity for the specific patient

Key Definitions

Indication

DefinitionAn indication is a diagnosis, illness, injury, syndrome, condition or other clinical parameter for which a drug may be given.

ScopeCovers the clinical reason a medication is prescribed, including disease state or patient characteristic.

Use in adjudicationIndication is used to map the drug to appropriate ICD-10/HCPCS pairing during claim review.

FDA Approval

DefinitionApproval for marketing by the Food and Drug Administration (FDA) of drugs/biologics considered safe and effective.

RelevanceFDA approval is a primary basis for covered, label-consistent uses under the policy.

Implication for off‑label usesOff‑label uses lack FDA-approved indication and therefore require additional evidence or compendia support for coverage.

FDA‑Approved Indication

DefinitionAn FDA‑Approved Indication is an indication depicted on the drug/biologic's official label with prescribing instructions, including dosage, route, duration, frequency and population.

ContentLabel elements used include dose, route of administration, duration, frequency, and target population.

Coverage implicationUses matching the FDA‑approved indication are considered label‑consistent and generally supported for coverage when other criteria are met.

Off‑label (unlabeled) usage

DefinitionOff‑label (unlabeled) usage is drug/biologic use for an indication not listed on the official label or that deviates significantly from the prescribing information (e.g., dose, route, duration, frequency, or patient population).

Examples of deviationIncludes changes in dosage, route of administration, duration/frequency, or treating populations not in the label.

Coverage consequenceOff‑label uses require compendia support or peer‑reviewed evidence; absent such support they may be deemed not medically necessary.

Medically Accepted Indication

DefinitionA medically accepted indication is supported by articles or Local Coverage Determinations (LCDs) or by usage cited in recognized drug compendia such as AHFS‑DI, Clinical Pharmacology, NCCN, Micromedex, or Lexi‑Drugs.

Accepted compendia examplesAHFS‑DI, Clinical Pharmacology, NCCN Drugs & Biologics Compendium, Micromedex (DrugDex), Lexi‑Drugs.

Evidence thresholdSupport may include ≥1 citation in at least one listed compendium or Articles/LCDs as specified by the policy.

Phase II/III Trials

DefinitionPhase II trials are controlled clinical studies to evaluate effectiveness and common short‑term side effects; Phase III trials are expanded trials intended to gather additional information to evaluate overall benefit–risk and to support labeling.

Role in off‑label evidenceThe policy prefers off‑label uses supported by Phase II/III evidence from peer‑reviewed, multi‑center studies.

Study characteristicsPhase II/III trials are controlled and may be used to assess safety and effectiveness for coverage determinations.