Blue Cross Blue Shield MA Pharmacy Prior Auth Update

Coverage Criteria and Non-Covered Items

Clinical Coverage Criteria for Non-Formulary Drug Authorization

BCBSMA may authorize coverage for non‑formulary prescription medications when ANY one of the following is met:

Documented treatment failure: Member has documented treatment failure with two covered formulary drugs (if only one covered formulary drug exists, documented treatment failure with that alternative is required)two drugs or one if only one available

Supports formulary exception; providers should document prior therapies and outcomes

Documented adverse effects: Member has documented adverse effects to two covered formulary drugs that are significant enough to preclude use (if only one covered formulary drug exists, documented adverse effect to that alternative is required)two drugs or one if only one available

Supports formulary exception; include clinical details of adverse reactions

Other clinical basis (individual consideration): There is some other specified clinical basis supporting use of the non‑formulary drugN/A

Individual consideration allowed; submit supporting clinical documentation

General Prior Authorization and Coverage

Coverage and prior authorization apply according to the referenced medical policy numbers and plan type. Items are covered only when meeting the criteria in their specific Medical Policy.

General prior authorization requirement: Prior authorization is required for the listed drugs and drug classes as noted (requirement and applicability vary by plan: all plans, Standard plans, Medex, Medicare where specified)

See each referenced Medical Policy number for exact clinical criteria, step therapy requirements, and Quality Care Dosing limits

BCBSMA excludes coverage for several product types. Non‑FDA‑approved products or products with no FDA‑approved indication are not covered. Medical marijuana and non‑FDA‑approved cannabidiol (CBD) products are excluded. Products that are available over‑the‑counter (OTC) are not covered unless the member’s subscriber certificate specifically indicates coverage. The policy also lists specific cosmetic drugs, certain prescription multivitamins (with prenatal and pediatric exceptions), and specific appetite suppressants (Phen‑Fen related agents) as exclusions.

For members enrolled in the BCBSMA Focused formulary, GLP‑1 and GLP‑1/GIP medications for the treatment of obesity and other FDA‑approved indications are not a covered benefit and are not eligible for medical necessity review. For Standard plans and other plan types these agents are subject to prior authorization and Quality Care Dosing limits as specified in the referenced Medical Policies (for example, Medical Policy 056 for GLP‑1 receptor agonists).

RU486 (mifepristone) is not covered for members whose plans do not include a voluntary termination of pregnancy benefit. Coverage of RU486 and other drugs is governed by the member’s subscriber certificate and applicable benefit design; when a voluntary termination benefit is not present the medication is excluded.

Some items are subject to limits or site‑of‑care restrictions depending on benefit design. Per diem home infusion» charges are not covered by Medex; separately, certain home infusion drugs are covered only under the home infusion benefit and require prior authorization. Prior authorization is required for home infusion services and for many medications listed in the prior authorization sections; providers should confirm coverage and prior authorization requirements per the member’s plan and the referenced Medical Policy.

Referenced Medical Policies, Codes, and Dosing Limits

Referenced Medical Policy Documents / Prior Authorization Listmixed

251	Antifungal Therapy for onychomycosis; Chlorhexidine; Cyclophosphamide; others referenced under Document 251
013	Antihyperlipidemics
021	Anti-Migraine Policy
054	Anti-Parkinsonism Drugs
027	Antisense Oligonucleotide Medications
011	Asthma and COPD Medication Management
006	Botulinum toxin
579	Compound Medications
704	Compound Medications Inclusion Drug List
705	Compound Medications

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Referenced Medical Policiesmixed

041	Diabetes Step Therapy - 2nd Step Agents
426	Cyclosporine ophthalmic solution (Restasis®)

Referenced Medical Policies (continued)mixed

056	GLP-1 Receptor Agonists for Type 2 Diabetes
572	GLP-1 and GLP-1/GIP Agonist Drugs for Anti-Obesity Management and Other Non-Obesity Conditions
093	Soliris, Ultomiris, Myasthenia Gravis, PNH, and Neuromyelitis Optica Policy

Prior Authorization Forms/Policiesmixed

049	Retail Pharmacy Prior Authorization Policy
434	Massachusetts Standard Form for Prior Authorization Requests
442	Medicare Part D Coverage Determination Request Form
033	MedUM & Pharmacy Prior Authorization
034	Medical Benefit Prior Authorization Medication List

inv-11: Quality Care Dosing (QCD) Guidelines

QCD applicabilityQuality Care Dosing (QCD) dosing limits apply as specified in the referenced Medical Policies; see each Medical Policy for specific drug limits

Reference policiesQCD limits are referenced throughout the drug lists and Medical Policies (for example Medical Policy 004 and others) where specific per-product limits are defined

Enforcement pointsQCD and step therapy edits may be applied at point-of-sale and via prior authorization review per the applicable policy

Plan variationQCD limits apply according to the member's benefit and referenced Medical Policy; coverage notes vary by plan type

Provider Actions, Authorization Steps, and Documentation

Prior Authorization

Prior Authorization and Exception Request Process

Providers must contact BCBSMA Pharmacy Operations to request prior authorization or formulary exceptions. Requests may be submitted by calling Pharmacy Operations at 1-800-366-7778 or faxing to 1-800-583-6289, or by mailing the completed Formulary Exception/Prior Authorization form included in this document to: Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department, 25 Technology Place, Hingham, MA 02043. Members must have pharmacy benefits under their subscriber certificates. Response to written exception requests will be provided within two business days of receipt.

Phone: 1-800-366-7778
Fax: 1-800-583-6289
Mail: BCBSMA Pharmacy Operations, 25 Technology Place, Hingham, MA 02043

Step Therapy

Step Therapy Requirements and Point-of-Sale Edits

Step therapy edits apply to multiple drug groups and are enforced at point-of-sale where noted. Examples include anti-Parkinsonism drugs, asthma/COPD leukotrienes and inhaled combination products, diabetes second-step agents, CNS stimulants for patients over age 17, overactive bladder medications, ophthalmic prostaglandins, and several specialty step policies (e.g., VEGF inhibitors, Veozah, Methotrexate step therapy, Heart Failure and Hypertrophic Cardiomyopathy). Where step therapy is required, documentation of treatment failure with required preferred agents may be used during prior authorization or exception review.

Policy Background and Scope

BCBSMA manages its commercial formulary through prior authorization, step therapy, and Quality Care Dosing processes. Newly approved brand drugs are initially treated as non‑formulary while Pharmacy & Therapeutics evaluates them. The policy references recognized compendia and peer‑reviewed evidence when considering off‑label indications, noting that compendia‑identified medically accepted uses and well‑designed published investigations are used to support coverage decisions. Individual consideration (an exception review) is available when standard criteria are unlikely to be effective for the member, but decisions follow the clinical evidence and the applicable Medical Policy requirements.

Definitions and Terminology

inv-23: Off-label Indications

DefinitionOff-label indications are uses of an FDA-approved drug outside the indications, populations, dosing, or regimens included in the FDA-approved labeling (commonly called 'off-label' uses).

Evidence standardOff-label use may be considered when supported by well-designed, peer-reviewed investigations, reputable clinical journals, national association opinions, or inclusion in recognized compendia (AHFS, DrugDex, NCCN, Clinical Pharmacology).

Compendia criteriaA compendium identifies a use as medically accepted when it meets specified categories (e.g., Category 1 or 2A in NCCN; Class I/IIa/IIb in DrugDex) or supportive narrative in AHFS/Clinical Pharmacology.

inv-24: Individual consideration

DefinitionIndividual consideration (exception request) is a provider-initiated review when standard coverage criteria are unlikely to be clinically effective for the individual member.

Initial Therapy Criteria

Initial therapy for onychomycosis

Initial antifungal treatment for onychomycosis that does not require prior authorization when given as the initial course:

Initial antifungal options: No prior authorization required for initial treatment with itraconazole and terbinafine for 12 weeks, and ciclopirox nail lacquer for 48 weeksitraconazole/terbinafine: 12 weeks; ciclopirox lacquer: 48 weeks

Brand-name formulations listed in the policy are non‑covered for initial therapy; continued treatment past the initial course requires individual consideration and supporting documentation

Step Therapy Edits

Drug class / agent	Point-of-sale edit
Anti-Parkinsonism drugs
Step therapy edits apply at Point-of-Sale (prior authorization required). See Medical Policy 054 for details.
Obstructive pulmonary disease medications (Leukotrienes and inhaled combination products)
Step therapy edits apply at Point-of-Sale; Quality Care Dosing limits may apply. See Medical Policy 011 for details.
CNS stimulants and psychotherapeutic agents (Amphetamines) — patients over age 17
Step therapy edits apply at Point-of-Sale for patients over age 17; prior authorization required for adults. See Medical Policy 019 for details.
Botulinum toxin
Step therapy not specifically noted, but prior authorization required for all outpatient sites of service; Point-of-Sale edits apply for certain classes elsewhere. See Medical Policy 006.

Drug class / agent	Point-of-sale edit
Factor and non-factor anti-hemophilia drugs
Prior authorization required for all plans; covered only as a home infusion therapy benefit. Step therapy requirements apply where specified in referenced policy. See Medical Policy 360.
Fentanyl, oral/transmucosal
Quality Care Dosing limits apply; prior authorization required for Standard plans. See Medical Policy 113 for details.
GLP-1 and GLP-1/GIP agonist drugs
Prior authorization required per referenced policy; applicability limited by formulary coverage (not covered for Focused formulary members). See Medical Policy 572.
Ophthalmic prostaglandin agents
Step therapy edits apply at Point-of-Sale; prior authorization required for all plans. See Medical Policy 346 for details.
VEGF inhibitors and Veozah
VEGF inhibitors: step therapy (Medical Policy 092) and prior authorization per benefits. Veozah: Step Therapy Policy requiring treatment failures before non-formulary use (Medical Policy 014).

Quantity Limits and Quality Care Dosing

inv-28: Chlorhexidine gluconate (including Peridex)

ProductChlorhexidine gluconate (including Peridex)

QCD limit — 22-day window1,440 mL per rolling 22 days

QCD limit — 67-day window4,320 mL per rolling 67 days

Benefit noteThese limits apply if using the mail order benefit as specified in the policy coverage note.

inv-29: Various (see Quality Care Dosing list)

ScopeVarious outpatient drugs listed in the policy are subject to Quality Care Dosing (QCD) limits as detailed in their referenced Medical Policies.

Site of Care Rules and Coverage Restrictions

Billing Rule

Home infusion benefit only: factor and non-factor anti-hemophilia drugs

Factor and non-factor anti-hemophilia drugs are covered only as a home infusion therapy benefit; obtain prior authorization and ensure the claim is billed under the home infusion benefit.

Coverage limited to home infusion therapy benefit
Prior authorization required for all plans (see Medical Policy 360)