Non-Covered Drug List & Non-Covered Formulary Exception
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This pharmacy medical policy governs coverage and exception criteria for non-formulary or non-covered prescription drugs for BCBSMA commercial members and explains prior authorization and documentation requirements for providers requesting coverage exceptions.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medical Necessity and Exception Criteria
BCBSMA may determine a non-formulary drug to be medically necessary and authorize coverage when ONE of the following is met; if not met, additional ALL criteria must be satisfied:
Documentation required to support clinical justification
Fallback coverage when not successfully maintained
- Approved indication: Requested drug is for an FDA‑approved indication or an indication supported in recognized compendia or accepted treatment guidelines (e.g., AHFS, Micromedex, peer‑reviewed standards of care).
- Combination product trials: For non‑covered combination medications, the member has had a trial of the individual ingredients when available and covered on the formulary, or has tried preferred drugs in the same therapeutic class if individual agents are non‑covered; OTC alternatives considered when appropriate.
- Trial/failure of alternatives: If formulary alternatives are available, the member has tried and failed at least 2 covered alternatives OR 1 covered alternative if only one covered formulary alternative exists for the diagnosis. Reasons for failure (e.g., inadequate response, intolerance, contraindication, allergy) must be documented including name and strength of alternatives and specifics of treatment failure.2 or 1
Provider must document names, strengths, and specifics of failure.
- Clinical basis to prevent switch: There is documented clinical justification that switching to a covered formulary alternative would cause instability of the medical condition (e.g., narrow therapeutic index) or other clinical reason preventing switch.
Documentation required prior to approval.
- Supply shortage: Requested non‑covered drug is due to a documented drug supply shortage.
- Brand vs generic: When a brand is requested and an FDA‑approved generic exists as a formulary alternative, documentation of trial/failure/contraindication to the generic is required for approval.
Non-covered Products
A drug or product included in the Non-covered Drug List is designated non-covered.
Inclusion on the list triggers non‑coverage; the document contains extensive named products and therapeutic classes.
The policy identifies certain conditions and products under the headings INVESTIGATIONAL and NOT MEDICALLY NECESSARY. These designations are listed in the policy’s "Other Policy Conditions" section and apply to items explicitly named there; inclusion under these headings denotes the payer’s exclusion or restricted coverage stance for those items.
There are no additional narrative exclusions beyond the enumerated Non-covered Drug List in the cited sections. Instead, the vendor-provided lists of products and therapeutic categories themselves function as the policy’s exclusion — any drug included on these lists is treated as non-covered unless an exception is approved per the policy’s exception criteria.
The document contains extensive enumerations of specific products and brands designated as non-covered. Examples drawn from the list include numerous insulins and diabetes agents (Admelog®, Apidra®, Basaglar®, Fiasp®, Humalog®, Humulin® except Humulin U500, Insulin Aspart, Insulin Glargine, Levemir®, Lyumjev®, Rezvoglar®, Toujeo Solostar®), multiple growth hormone preparations (Humatrope®, Omnitrope®, Nutropin AQ®, Zomacton®), many branded antifungals, antiemetics, biologics, opioid/pain agents, prenatal vitamin formulations, and assorted ophthalmic, gastrointestinal, and respiratory agents. The lists in the policy include hundreds of individual products across multiple therapeutic classes.
The policy indicates that certain items may be categorized as Not Medically Necessary under the "Other Policy Conditions" heading. Drugs shown on the Non-covered Drug List are understood to be not covered unless a formal exception is granted according to the policy’s criteria and authorization procedures.
Drugs included on the Non-covered Drug List are treated as non-covered by BCBSMA. The policy’s listed products — spanning many classes and specific brand names — are therefore not covered per the list; requests for coverage of these items are subject to denial unless a documented exception meeting the policy’s medical necessity criteria is approved.
Initial Therapy Requirements
Initial Therapy Requirements
Requirements before initial coverage of a non-covered drug when formulary alternatives exist:
Provider must provide names and strengths of alternatives tried and specifics regarding treatment failure (inadequate response, intolerance, contraindication, allergic/adverse reaction).
Step Therapy Requirements
| Requirement | Details / Evidence |
|---|---|
| Trial and failure of formulary alternatives | |
| When formulary alternatives are available, the member must have tried and failed at least 2 covered alternatives (or 1 if only one covered alternative exists). Reasons for failure may include inadequate treatment response, intolerance, clinical contraindication, allergic or adverse reaction. Provider must document the name and strength of alternatives tried and specifics regarding treatment failure; prescription claim records may be used to support the trial/failure when available. |
| Step therapy pathway | Policy note |
|---|---|
| No step therapy pathways specified | |
| The document lists numerous products on the Non-covered Drug List but does not define explicit step therapy sequences or algorithms for these agents in the provided sections; policy focuses on listing non-covered products. |
| Non-covered agent(s) | Step therapy defined? |
|---|---|
| Yupelri; various vitamins/minerals; weight-loss agents (e.g., liraglutide 18mg/3ml, Zepbound vials and Kwikpen) | |
| No — the policy section enumerates these non-covered drugs but does not specify step therapy sequences or required prior steps for these specific agents in the cited chunks. |
Duration of Authorization / Continuation
Duration of Authorization
Length of approval for authorized non‑formulary exceptions:
Member cost share follows the highest copayment level and plan terms as allowed when exception is authorized.
Provider Actions and Requirements
Submit physician-signed Formulary Exception (Form #434)
Prior authorization/formulary exception requests must be submitted by physicians using the Formulary Exception/Prior Authorization form (Formulary Exception Form #434) by phone, fax, or mail to BCBSMA Pharmacy Operations; individual consideration requests follow the policy’s Individual Consideration section.
- Submit Formulary Exception/Prior Authorization form (Form #434)
- Send to BCBSMA Pharmacy Operations by phone, fax, or mail as specified
Non-covered products require formal exception process
Many products on the Non-covered Drug List are designated non-covered; prior authorization is not a substitute for coverage unless a formal formulary exception is pursued under the payer’s exception process.
- If a product is on the Non-covered Drug List it is considered non-covered
- Coverage may only be considered via the formal Non-Covered Formulary Exception process
Non-coverage vs prior authorization — list designation controls
Inclusion on the payer’s Non-covered Drug List designates a product as non-covered; prior authorization alone does not automatically render such products covered.
- Non-covered list inclusion triggers non-coverage per policy
- Prior authorization does not override the non-covered designation without an approved exception
Trial of formulary alternatives required before exception
When formulary alternatives exist, the member must have tried and failed at least 2 covered alternatives (or 1 if only one covered alternative exists) prior to approving coverage for a non-covered drug, unless clinical justification is documented.
- Trial and documented failure of ≥2 covered formulary alternatives, or 1 if only one exists
- Provide names and strengths of alternatives tried and specifics regarding treatment failure
Step therapy not specified for listed non-covered drugs
The policy lists many excluded/non-covered agents but does not define step therapy algorithms for those listed drugs in this section; no explicit step therapy sequences are provided here.
- Non-covered drug listings do not include specific step therapy pathways in these chunks
- When step therapy is not specified, follow documented exception criteria and documentation requirements
Listed agents: no step therapy pathways provided here
This portion of the Non-covered Drug List enumerates non-covered agents across multiple classes but does not specify step therapy requirements for these agents in the listed sections.
- Extensive lists of non-covered products are provided without step therapy sequences
- Follow general exception and documentation rules when requesting coverage
Document names/strengths of alternatives and specifics of failure
Provider must supply documentation that includes the name and strength of formulary alternatives tried and failed, specifics of the treatment failure, and any clinical reasons preventing trial or switch to a formulary alternative.
- Document name and strength of alternatives tried and specifics regarding failure
- Provide clinical rationale if unable to trial or switch to formulary alternatives
- Prescription claim records may be used; provide additional records if claim history is insufficient
Identify drug and indication; provide supporting clinical documentation
Documentation for exceptions must identify the specific non-covered drug and the indication; requests for drugs on the Non-covered Drug List may be denied if documentation does not support the exception.
- Specify the requested drug and clinical indication in the exception request
- Include clinical notes, compendia references, or other supporting documentation when applicable
Non-covered drugs generally not covered — submit exception to pursue coverage
Providers should expect that drugs named in the Non-covered Drug List will not be covered absent an approved exception; supporting documentation or a formulary exception request is required per payer procedures.
- Non-covered designation means drugs are generally not covered
- Submit a formal formulary exception with supporting documentation to pursue coverage
Denial risk if trial/failure of alternatives not documented
Failure to document trial and failure of required formulary alternatives (or provide acceptable clinical justification for not trying them) may result in denial of coverage for the non-covered drug.
- Denial risk if names/strengths and specifics of alternative failures are not provided
- Provide clinical justification if alternatives were not tried to avoid denial
Denial risk for drugs on the Non-covered Drug List
Requests for coverage of drugs included on the Non-covered Drug List are subject to denial because these products are listed as non-covered under the policy.
- Inclusion on the Non-covered Drug List subjects requests to denial without an approved exception
Claims for listed non-covered drugs are at risk for denial
Claims for drugs listed on the Non-covered Drug List are at risk for denial because they are designated non-covered; providers should pursue an approved exception when clinically appropriate.
- Claims for listed products may be denied as non-covered
- Pursue the formal exception process to seek coverage
Background
BCBSMA maintains a Non-covered Drug List because safe, comparably effective alternatives or FDA-approved generic versions are available. The policy permits coverage of a non-formulary or non-covered drug only when the payer’s exception criteria are met (for example, when a member is successfully maintained on a medication and a switch would cause instability), or when other medical necessity conditions are satisfied.
Definitions
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