Blue Cross Blue Shield MA Pharmacy Prior Auth

Coverage Criteria

inv-01: Formulary Exception — Clinical Criteria

BCBSMA may authorize a non-formulary drug when the member meets one of the following clinical criteria:

Formulary Exception Criteria: (1) Documented treatment failure with two covered formulary drugs (if only one covered formulary drug exists, documented failure with that alternative); OR (2) Documented adverse effects to two covered formulary drugs significant enough to preclude use (if only one covered formulary drug exists, documented adverse effect to that alternative); OR (3) Other specified clinical basis supported by documentation.two treatment failures/adverse effects

Providers should submit supporting documentation with the Formulary Exception request (use the Formulary Exception form or contact Pharmacy Operations).

inv-02: Off-Label Use — Evidence Requirements

When applying this policy to off-label uses (or when no drug-specific policy exists), coverage requires supporting evidence:

Off-label Evidence Requirements: Use must be supported by well-designed peer-reviewed literature or recognized compendia; demonstrate measurable clinical improvement; show benefit-risk favorable compared with established alternatives; be endorsed by professional associations or compendia; and be used in routine medical practice (not investigational).compendia/category support where applicable

CMS-recognized compendia (e.g., AHFS, DRUGDEX, USP-NF) or NCCN/DrugDex categories define medically-accepted off-label uses for certain populations; drug-specific policies take precedence when present.

inv-03: Index-level coverage patterns

Coverage and authorization for listed drugs are governed by the referenced medical policy numbers; common patterns include:

General prior authorization: Prior authorization is required for listed medications per the referenced medical policy (many entries state 'Prior authorization required for all plans').

See the individual Medical Policy number listed for the medication for the full clinical criteria and applicability.

Step therapy: For policies designated as Step Therapy Policy, coverage requires documented failure of specified preferred agents before authorization of non-formulary medication.

Refer to the cited Medical Policy for the specific required steps, permitted exceptions, and point-of-sale edits.

Home infusion restriction: Some medications are covered only as a home infusion therapy benefit (per diem charges not covered by Medex).

See the referenced Medical Policy for details on home infusion coverage and administrative requirements.

The policy excludes coverage for products that are not FDA‑approved or that have no FDA‑approved indications. Examples specifically listed include medical marijuana products and non‑FDA approved cannabidiol (CBD) products. The exclusions section also names certain proprietary or removed‑market products (for example, Procuren™) and identifies multiple categories of cosmetic or non‑covered uses such as depigmenting agents, hair‑growth stimulants, most retinoic acid derivatives (except where listed under prior authorization), prescription multivitamins (with standard prenatal and pediatric exceptions), and botulinum toxin when used for cosmetic purposes.

Certain items referenced in the drug index are covered only in the context of home infusion therapy; the policy notes that per diem charges are not covered by Medex. The index also points to a Non‑covered Drug List (Medical Policy 433) that applies to closed formularies and to multiple drug‑specific policies where prior authorization and site‑of‑care limitations (including home infusion only) are described.

Use of products that are not FDA‑approved, or products explicitly listed in the policy’s exclusions, is considered not covered / not medically necessary under this policy. Requests for such products are expected to be denied unless exceptional documentation meets the policy’s criteria for an authorized exception.

Coding and Reference Numbers

Chlorhexidine mail-order limit — inv-08: Chlorhexidine mail-order limit

Mail-order limit (22-day rolling)1,440 mL per rolling 22 days

Mail-order limit (67-day rolling)4,320 mL per rolling 67 days

Applies toChlorhexidine gluconate (including Peridex)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required — Prior authorization is required for certain listed drugs and applies to pharmacy or medical benefit drugs as specified; see drug-specific policies.

For certain drugs and drug classes listed in this policy, prior authorization is required before reimbursement. This applies to pharmacy or medical benefit drugs as specified in the drug-specific entries. Patients must have pharmacy benefits under their subscriber certificate for outpatient retail pharmacy requests.

Providers may submit requests by phone, fax, or mail using the Formulary Exception / Prior Authorization form included in this document.
BCBSMA Pharmacy Operations: Phone: 1-800-366-7778; Fax: 1-800-583-6289; Address: 25 Technology Place, Hingham, MA 02043.

Note

Plan-specific Prior Authorization — Some prior authorizations apply to all plans; certain drugs require prior authorization only for specific Medicare/Managed Senior plans.

Some prior authorizations or coverage rules apply to all membership types; certain drugs require prior authorization only for specific Medicare/Managed Senior plans in order to coordinate benefits with Medicare. Check the drug-specific coverage note for plan applicability.

Background

Off‑label prescribing is recognized as part of medical practice, but BCBSMA requires that off‑label uses meet the policy’s evidence standards. To be considered medically necessary, an off‑label use must be supported by peer‑reviewed literature or recognized compendia, demonstrate measurable clinical improvement compared with alternatives, show a favorable benefit‑risk profile, and reflect routine clinical practice rather than investigational use. CMS‑recognized compendia or other established compendia (for example, NCCN or DrugDex where applicable) may be used to identify medically accepted off‑label indications.

Definitions

Definition — inv-19: Off-label use

DefinitionUse of an FDA-approved drug for an indication, population, or regimen not included in the FDA-approved labeling; may be considered medically necessary when supported by evidence or compendia.

Evidence requiredSupport from peer-reviewed literature, well-designed studies demonstrating measurable clinical improvement, favorable benefit–risk, or inclusion in recognized compendia (e.g., CMS-recognized compendia, NCCN where applicable).

When to applyUsed when a drug-specific policy is silent for an off-label use or when evaluating off-label requests; drug-specific policies take precedence.

Definition — inv-20: Home infusion therapy benefit

DefinitionCoverage limited to medications administered as part of home infusion therapy; per diem not covered by Medex.

Step Therapy

Requirement	Scope / Notes
Step therapy edits apply at point-of-sale for many drug classes
Applies to multiple classes (examples in drug list include antihyperlipidemics, asthma/COPD leukotriene/inhaled combination products, anti-Parkinsonism drugs, CNS stimulants and certain diabetes agents). See the referenced drug-specific Medical Policy for required steps and Quality Care Dosing limits.

Policy / Topic	Step therapy requirement (summary)
Heart Failure and Hypertrophic Cardiomyopathy (Medical Policy 063)
Step Therapy Policy requiring documented treatment failures before use of non-formulary medication; see Medical Policy 063 for details.
Methotrexate Step Therapy (Medical Policy 840)
Step Therapy Policy requiring treatment failures before use of non-formulary medication; see Medical Policy 840 for details.
Multiple Sclerosis Step Therapy
Step therapy required per the listed Medical Policy entries (see the Multiple Sclerosis policy for specific preferred agents and failure criteria).
Vascular Endothelial Growth Factor (VEGF) Inhibitors Step Therapy (Medical Policy 092)
Medical prior authorization and step therapy required according to benefits; see Medical Policy 092 for required trial/failure steps.
Veozah Policy Step (Medical Policy 014)
Step Therapy Policy requiring treatment failures before use of non-formulary medication; see Medical Policy 014 for details.

Quantity Limits

inv-23: chlorhexidine gluconate (including Peridex) — 1,440 mL

Drugchlorhexidine gluconate (including Peridex)

Quantity limit1,440 mL

ContextLimit applies when using the mail-order benefit (see related coverage note).

inv-24: chlorhexidine gluconate (including Peridex) — 4,320 mL

Drugchlorhexidine gluconate (including Peridex)

Quantity limit4,320 mL

Context

Site of Care

Prior Authorization

Prior authorization for outpatient botulinum toxin and home infusion

Prior authorization is required for botulinum toxin for all outpatient sites of service; home infusion therapy medications also require prior authorization.

Note

Drugs covered only as home infusion therapy benefit

Certain medications are covered only as part of the home infusion therapy benefit and require prior authorization; note that per diem charges are not covered by Medex.

All medications for home infusion therapy require prior authorization
Per diem charges not covered by Medex

OpenPayer

Pharmacy Prior Authorization and Formulary Exception Policy