Non-Covered Drug List & Non-Coverary Formulary Exception
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Defines BCBSMA's non-covered drug list and the formulary-exception/prior authorization process for commercial pharmacy benefits; applies to commercial members covered under BCBSMA pharmacy plans and describes when non-formulary drugs may be authorized.
No material clinical or coverage changes in this revision.
Coverage Criteria & Non‑Covered Drug List
Formulary Exception Coverage Criteria
BCBSMA may authorize coverage of a non‑formulary drug when ANY ONE of the primary successful‑maintenance criteria is met OR, if not successfully maintained, when ALL of the secondary criteria are satisfied as specified below.
Successful maintenance
- Provider documents via clinical records or medication history that the member has been successfully maintained on the current medication and that switching to a formulary alternative would result in instability of the medical condition; documentation required.
Source: criteria #1 (chunk 7)
- Member is actively using a medical device (e.g., continuous subcutaneous insulin infusion pump) and requires use of non‑covered supplies (e.g., diabetic test strips).
Source: criteria #2 (chunk 8)
Secondary criteria when not successfully maintained
- Requested drug is for an FDA‑approved indication or an indication supported in recognized compendia or current treatment guidelines (e.g., AHFS, Micromedex) or peer‑reviewed standard of care.
Source: chunk 8
- For non‑covered combination medications, member has had a trial of the individual ingredients when available and covered on the formulary, or trials of preferred agents in the same therapeutic class when individual agents are non‑covered (including OTC alternatives when applicable).
Source: chunk 9
Formulary alternative trials and failures
- Member has tried and failed at least 2 covered formulary alternatives in the same therapeutic class (documentation of name, strength, and specifics of failure required).
Source: chunk 10
- If only one covered formulary alternative exists, member has tried and failed that single alternative (documentation required).
Source: chunk 10
- Unable to switch member to a covered formulary alternative because switching would cause instability (e.g., narrow therapeutic index) or other specified clinical basis; documentation required.
Source: chunk 10
- Requested non‑covered drug is due to a documented drug supply shortage.
Source: chunk 10
- If a brand product is requested where an FDA‑approved generic is a formulary alternative, documentation demonstrating trial/failure or contraindication to the generic is required for approval.
Source: chunk 10
This policy identifies two Other Policy Conditions categories for products appearing on the Non‑covered Drug List: INVESTIGATIONAL and NOT MEDICALLY NECESSARY. Drugs designated in either category are not covered under the standard pharmacy benefit unless an approved formulary exception exists.
The document window lists multiple therapeutic classes and individual products that are designated non‑covered, including examples from antifungal (oral and topical), antiviral (including Hepatitis C agents), biologics/monoclonal antibodies, and botulinum toxin categories. Specific branded examples appearing in this segment include Aemcolo®, Augmentin XR™/Moxatag™, Solosec®, Xifaxan™ and a range of topical antifungals and related agents.
This excerpt explicitly lists multiple biologic and botulinum toxin products as non‑covered, for example Ustekinumab (and multiple variants/brands such as Wezlana®, Yuflyma®, Yusimry®), Adalimumab and its biosimilar variants, and botulinum toxin products including Daxxify®, Myobloc®, Xeomin®. Several migraine/triptan products are also enumerated in the same segments (e.g., Imitrex®, Maxalt®, Relpax®).
Additional non‑covered entries in these chunks include anticonvulsant and CNS agents such as Keppra XR™, Lamictal® (including XR and ODT), Depakote® (various formulations), Neurontin®, and numerous antiparkinsonian agents like Mirapex®/Mirapex ER, Requip®/Requip XL, Neupro®, Rytary ER®, Sinemet®, Stalevo®.
The list further enumerates atypical and other antidepressants and migraine agents as non‑covered — examples include Auvelity® (including ER and titration pack), Brintellix®, Caplyta®, Fetzima®, Forfivo XL, Zembrace®, Reyvow® — together with repeated mentions of botulinum toxins and anticonvulsant products across these chunks.
Repeated entries across these segments reinforce that many anticonvulsant and antiparkinsonian products are non‑covered (for example, Topamax®, Trileptal®, Zonegran®, gabapentin 200mg capsules, Gocovri®) as well as continued listing of CNS 5HT agonists and migraine therapies (Sumavel™, Treximet™, Zomig/ZMT®).
These chunks repeat non‑covered antiparkinsonian and anticonvulsant entries and include other product examples such as Aplenzin™, Wellbutrin® (SR/XL), Remeron®, Drizalma Sprinkle®, and additional triptan/5HT agonist products (Alsuma®, Axert®, Frova™).
The non‑covered roster here continues with antiparkinsonian and atypical antidepressant listings and emphasizes that multiple branded migraine and anticonvulsant products remain designated non‑covered in this portion of the list (examples restated: Mirapex ER®, Neupro®, Depakote ER®, Lamictal ODT™).
Specific Parkinson/neurology agent examples called out as non‑covered across these chunks include Gocovri®, Mirapex® and Mirapex ER®, Requip® and Requip XL, Neupro®, Osmolex ER®, Rytary ER®, Sinemet®, Stalevo®, Xadago®, Zelapar®.
This section enumerates multiple therapeutic classes and branded agents designated non‑covered, including atypical antipsychotics (e.g., Abilify® including Discmelt and MYCITE, Seroquel®/Seroquel XR, Zyprexa® including IM and Zydis), and numerous anticonvulsants and 5HT agonists/migraine therapies (e.g., Maxalt®/MLT, Relpax®, Zembrace®, Reyvow®, Zomig/ZMT®), all listed as non‑covered in these chunks.
Additional branded products and classes explicitly listed as non‑covered in these segments include Gocovri®, Mirapex® (and ER), Requip® (and XL), Abilify® (and Discmelt), Geodon®, Invega®, Latuda®, Rexulti®, Saphris®, Seroquel® (and XR), Zyprexa® variants, together with repeated anticonvulsant and Alzheimer’s agent mentions (e.g., Adlarity®, Memantine/Donepezil, Namzaric®).
These chunks continue to identify non‑covered entries across multiple classes: anticonvulsants (e.g., Depakote® variants, Lamictal ODT™), antiparkinsonian agents (e.g., Neupro®, Rytary ER®), benzodiazepines (e.g., Klonopin™, Ativan®), hypnotics (e.g., Ambien®, Ambien CR™), and numerous atypical antipsychotics and antidepressants listed as non‑covered.
Other policy conditions noted in this listing reaffirm that drugs and product formulations appearing on the Non‑covered Drug List are designated non‑covered across many therapeutic areas — examples shown across these chunks include Abilify®, Ambien®, Klonopin™, numerous antiparkinsonian agents, opioids/analgesics, stimulants, SSRIs/SNRIs and other branded products which are explicitly identified as non‑covered in the document.
Provider Steps, Prior Authorization & Exception Process
Use Formulary Exception/Prior Authorization Form #434 and submit to Pharmacy Operations
Submit all formulary exception or prior authorization requests using the Formulary Exception/Prior Authorization Form (Form #434) to BCBSMA Pharmacy Operations (phone, fax, or mail) per the policy instructions.
- Use Formulary Exception/Prior Authorization Form #434.
- Submit to BCBSMA Pharmacy Operations by phone, fax, or mail (see Pharmacy Operations contact in policy).
Non-covered items are not eligible for standard coverage — route via formulary exception
Items appearing on the Non-covered Drug List are not eligible for standard coverage; providers should submit a formulary exception request when coverage is clinically necessary.
- Non-covered drugs are not covered because safe, comparably effective alternatives or generics exist.
- Submit a formulary exception request per the payer process when applicable.
Non-covered drugs may require formulary exception/prior authorization for consideration
Drugs listed as non-covered will generally require a formulary exception or prior authorization per the payer procedures; consult the exception process because standard PA alone may not result in approval.
- Drugs on the Non-covered Drug List are not covered and formulary exception/prior authorization may be needed.
- Standard prior authorization for non-covered agents is unlikely to approve without an exception.
Non-covered drugs require use of the formulary exception process for reimbursement
Drugs designated non-covered will not be reimbursed under standard coverage; providers must follow the plan's formulary exception process to request reimbursement consideration.
- Non-covered segment drugs are not covered under standard prior authorization.
- Follow the formulary exception procedures for reimbursement consideration.
Non-covered drug list provided (no PA rules specified here)
This section lists non-covered drugs; no specific prior authorization rules are provided in these chunks — the listing itself signals non-coverage status.
- The section enumerates non-covered products but does not define PA rules within these excerpts.
- Refer to the broader policy or the formulary exception process for PA procedures.
Non-covered drugs listed — PA/coverage status not detailed in these chunks
Drugs identified as non-covered in this part of the policy are designated as not covered; the excerpt does not specify prior authorization workflows or allowable codes.
- Listed drugs are identified as non-covered in this section.
- No PA process details or billing codes are provided in these chunks.
Non-covered drugs require a formulary exception for coverage
Drugs on the Non-covered Drug List require a formulary exception for coverage consideration; providers must submit exception requests per the payer procedure to pursue reimbursement.
- Non-covered drugs are non-reimbursable except via an approved formulary exception.
- Submit required documentation with the exception request (see documentation callouts).
Non-covered agents: PA requests expected to require exception documentation
Prior authorization requests for agents on the Non-covered Drug List are expected to require exception documentation; requests for these agents are likely to be denied without following the exception process.
- Drugs on the non-covered list are not covered under the formulary.
- Prior authorization for these agents will generally be denied unless a specific exception is approved.
Formulary exception likely required for non-covered drugs
For drugs listed as non-covered, follow the plan's formulary exception process; these items generally require an exception rather than approval through routine coverage.
- Non-covered drugs generally require a formulary exception rather than standard coverage.
- Use the Formulary Exception Form #434 and submit to Pharmacy Operations for consideration.
Formulary exception required for reimbursement of non-covered drugs
Drugs designated non-covered are not reimbursed except when an approved non-covered formulary exception is granted; providers should submit an exception request when clinically necessary.
- Non-covered drugs are not reimbursed under standard benefits.
- Providers should request an approved formulary exception with supporting documentation for payment consideration.
Non-covered drugs require an exception or will be denied without approval
Products listed as non-covered will be denied without an approved exception; submit a formulary exception to avoid denial of coverage.
- Non-covered designation generally results in denial unless an approved exception exists.
- Exception requests must follow payer procedures and include required documentation.
Non-covered drugs will not meet standard PA without an approved exception
Drugs included in the Non-covered Drug List are not covered and would not meet standard prior authorization approval unless a formulary exception is requested and approved per payer procedures.
- Non-covered products do not meet standard PA approval.
- A formulary exception must be requested per the policy to obtain coverage.
Document trials/failures of formulary alternatives (typically 2 failures or 1 if only one available)
BCBSMA may require documented trials of formulary alternatives before authorizing coverage of a non-covered drug; typically providers must show trial and failure of at least 2 covered alternatives (or 1 if only one is available).
- Document name and strength of alternatives tried and failed and specifics regarding treatment failure.
- Prescription claim records may be used to support trials when available.
Provider action
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Follow step therapy/PA rules for formulary alternatives before requesting non-covered product
Where step therapy rules apply for covered alternatives, prescribers should follow those prior authorization/step edits rather than requesting the listed non-covered product.
- Step edits for formulary alternatives take precedence; request exceptions only when step therapy criteria are met or exceptions apply.
- Document trials and failures as required for exception consideration.
Step therapy not specified in this excerpt
No step therapy rules are specified in these chunks of the document; the content lists non-covered drugs without explicit step requirements.
- This excerpt does not define step therapy edits for the listed non-covered products.
- Refer to other policy sections for step therapy specifics.
Step therapy not specified here
Step therapy is not detailed in this portion of the policy; the non-covered lists are provided without explicit staged-coverage rules.
- No explicit step therapy requirements are present in these chunks.
- Consult the complete policy for any step therapy provisions.
Step therapy not specified in this non-covered list segment
This segment provides non-covered drug listings only and does not include step therapy rules; providers should reference other policy sections for step requirements.
- Non-covered lists are enumerated without step therapy details.
- Use the formulary exception process if step therapy prevents coverage of the requested drug.
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No step therapy rules specified — non-covered drugs enumerated
This portion lists non-covered drugs only and does not provide step therapy rules; providers should note non-coverage status when preparing requests or claims.
- Enumerates non-covered products without step therapy detail.
- Submit exception requests with supporting documentation when necessary.
Stimulant and CNS agents listed — follow step-therapy rules if applicable elsewhere
Many stimulant and CNS agents are listed as non-covered in the policy; where step therapy or staged coverage policies apply, those requirements are detailed elsewhere in the full policy.
- Stimulant and antidepressant classes appear in the non-covered lists; consult the full policy for any applicable step edits.
- When step therapy applies, follow the PA/step edit rules for formulary alternatives.
Non-covered classes may be subject to formulary management elsewhere
Drug classes and branded agents listed as non-covered may be subject to formulary management (e.g., step therapy) elsewhere in the policy; this excerpt does not include those operational rules.
- The non-covered list includes many classes that may have step therapy edits in other sections.
- Refer to the full policy for specific formulary management requirements.
Step therapy not specified for respiratory and other groups here
Step therapy is not specified for the respiratory and other groups listed as non-covered in this excerpt; providers should consult the complete policy for any staged-coverage rules.
- Respiratory inhaled beta-adrenergic and combination products are listed as non-covered without step details.
- Check the broader policy for step therapy or PA edits for these classes.
Document name/strength of formulary alternatives tried and reasons for failure
Document the name and strength of the formulary alternatives tried and failed and provide specifics regarding the treatment failure when requesting an exception; prescription claim records may be used to support maintenance or trials.
- Include name and strength of alternatives tried and failed.
- Describe specifics of treatment failure or clinical reasons preventing trial/switch.
Provider action
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Document use of alternative covered therapy or clinical justification for exception
Provider documentation should reflect use of an alternative covered therapy or provide clinical justification when requesting a formulary exception for a non-covered drug.
- If alternatives were tried, provide documentation of name/strength and reasons for failure.
- If switching is contraindicated, provide clinical rationale and specifics to support the exception.
Non-covered list provided — documentation/exception pathways noted elsewhere
This non-covered list segment provides product names only; supporting documentation requirements and exception pathways are referenced elsewhere in the policy.
- The excerpt enumerates non-covered drugs but does not detail documentation workflow here.
- Refer to the policy's Provider Documentation Requirements for required supporting information.
Non-covered drug list (no PA workflow here) — use exception form and Pharmacy Operations
The non-covered drug list itself does not specify a prior authorization workflow or documentation in these chunks; providers should use the formulary exception form and follow Pharmacy Operations instructions.
- List is non-covered; use Form #434 and submit to Pharmacy Operations for exception requests.
- Documentation expectations are described in the Provider Documentation Requirements section.
Include supporting documentation for exception requests for branded drugs/formulations
Documentation supporting exception requests is expected for listed branded drugs and formulations; include clinical information that justifies why formulary alternatives are not appropriate.
- Provide clinical justification when requesting an exception for branded products despite generic/formulary alternatives.
- Include prescription claim history when available to support maintenance or trials.
Reference the Non-covered Drug List when preparing exception requests
When preparing an exception request, reference the Non-covered Drug List in the policy to confirm the product's non-covered status and to anticipate documentation needs.
- Use the non-covered list to verify that the product is designated non-covered.
- Reference the list to determine whether a formulary exception is required.
Reference non-covered list when requesting exceptions or filing claims
Refer to the Non-covered Drug List when requesting exceptions or submitting claims; the lists identify specific drug names and classes that are designated non-covered.
- Providers should consult the enumerated lists to ensure correct identification of non-covered products.
- Use the list to plan documentation and exception submissions.
Include supporting clinical documentation with formulary exception requests for non-covered drugs
Include clinical documentation to support a formulary exception request for drugs listed as non-covered; the policy requires documentation that justifies why alternatives cannot be used or why the member is successfully maintained.
- Provide documentation that the requested drug is for an FDA‑approved indication or supported in recognized compendia when applicable.
- If maintenance applies, supply clinical records or medication history demonstrating successful maintenance.
Provide required supporting clinical information with exception/PA requests for listed non-covered drugs
Exception or prior authorization requests for non-covered products must include the supporting clinical information described in the policy (e.g., trials/failures, maintenance documentation) to be considered.
- The document lists products as non-covered; any exception requires supporting clinical documentation per payer procedures.
- Use prescription claim records when available to demonstrate trials/maintenance.
Reference the non-covered product list for claims and exception submissions
When requesting a formulary exception or submitting a claim, reference the Non-covered Drug List to confirm product designation and to ensure you include the correct supporting materials.
- The policy lists product and brand names that are designated non-covered.
- Refer to these lists when preparing exception requests or claims.
Denial risk if trials/failures, maintenance, or FDA‑supported indication are not documented
Failure to document required trials/failures of formulary alternatives, lack of documentation of successful maintenance, or absence of FDA‑approved/compendia‑supported indication may result in denial of the exception or claim.
- Document name/strength of alternatives tried and specifics of failures.
- Provide clinical justification for maintenance or inability to switch; otherwise, requests risk denial.
Non-covered items face risk of denial when submitted
Drugs on the Non-covered Drug List risk denial when submitted for coverage; providers should submit an approved formulary exception to avoid denial.
- Non-covered designation places submissions at risk of denial.
- Submit exception requests with required documentation to pursue coverage.
Claims for listed non-covered drugs will be denied without approved exception
Claims for drugs listed on the Non-covered Drug List will be denied or considered non-covered unless an approved exception is in place.
- Listed drugs are designated non-covered by the payer.
- An approved formulary exception is required to prevent denial.
Denial risk for drugs on the Non-covered Drug List
Claims for drugs designated as non-covered are at risk of denial because these products are specifically identified as non-covered in the policy.
- The Non-covered Drug List identifies products that are not covered under standard benefits.
- Ensure exception documentation is provided to mitigate denial risk.
Non-covered list items are subject to claim denial
Drugs listed on the Non-covered Drug List are not covered; claims for these products are subject to denial when billed without an approved exception.
- Non-covered designation applies to the enumerated products.
- Submit formulary exceptions with supporting documentation to seek coverage.
Non-covered designation creates potential for denial
Products designated non-covered in the policy carry the potential for denial when submitted; providers should file exception requests and include required documentation to avoid denial.
- Requests for listed drugs are subject to denial per the policy.
- Follow formulary exception procedures to pursue payment.
Denial risk for non-covered drugs without approved exception
Non-covered drugs on the list are subject to denial unless an approved formulary exception is obtained; submit exception requests with the policy-required documentation to be considered.
- Claims or exception requests for non-covered drugs are subject to non-coverage/denial.
- Provide clinical documentation per the Formulary Exception criteria to support approval.
Non-covered drugs will be denied without approved exception
Drugs listed as non-covered will be denied when submitted for reimbursement unless an approved exception exists; providers should submit exception requests per the policy to avoid denial.
- Non-covered designation results in denial absent an approved exception.
- Complete the formulary exception process with required documentation to request coverage.
Requests for listed non-covered drugs may be denied
Requests for drugs on the Non-covered Drug List may be denied because the policy identifies these drugs as non-covered; obtain an approved exception to mitigate denial risk.
- Non-covered items may be denied when submitted.
- Use the exception process and include supporting clinical documentation.
Non-covered drugs subject to denial without approved formulary exception
Coverage will be denied for drugs and specific branded products listed on the Non-covered Drug List when submitted for reimbursement without an approved formulary exception.
- Ensure exception requests include documentation of trials/failures, maintenance, or clinical rationale as required.
- Prescription claim records may be used to demonstrate criteria when available.
Denial risk for requests involving non-covered drugs
Requests for coverage of drugs listed on the Non-covered Drug List are subject to denial because they are identified as non-covered products; follow the formulary exception process to seek coverage.
- Non-covered designation subjects requests to denial.
- Submit exception requests with the required supporting documentation.
Non-covered drugs may be denied when submitted for reimbursement
Use of drugs listed on the Non-covered Drug List may be denied as not covered by the payer when submitted for reimbursement; providers should obtain an approved exception to seek payment.
- Listed drugs may be denied as not covered.
- Follow the policy's exception procedures and include clinical documentation to support the request.
Key Definitions
Continuation / Approval Duration
Continuation / Approval Duration
Length of approval for authorized formulary exceptions.
Length of Approval (chunk 7)
Step Therapy & Trial Requirements
| Step | Requirement | Failure / Documentation Requirements |
|---|---|---|
| 1 | Trials of formulary alternatives are required prior to approval of a non‑covered / non‑formulary drug unless the member meets successful‑maintenance criteria or another exception applies. | Provider must document name and strength of alternatives tried and failed and specifics regarding treatment failure. The plan may use prescription claim records to support trials/maintenance. If claim history is insufficient, additional provider documentation is required. |
| Exceptions to step requirement | Coverage may be authorized when the member is successfully maintained on the requested medication (documentation of maintenance/stability required) or when other specified exceptions apply (e.g., drug shortage, clinical basis preventing switch, or brand requested despite available FDA‑approved generic with documentation). | When exceptions are asserted, provider must supply supporting clinical documentation; for clinical reasons preventing switch, specifics must be provided. For brand requests where a generic exists, documentation of trial/failure/contraindication is required. |
| Step failure threshold | If formulary alternatives are available, member must have tried and failed at least 2 covered alternatives — or 1 if only one formulary alternative is covered in the same class for the diagnosis — before exception is approved. | Reasons for failure may include inadequate response, intolerance, contraindication, allergic/adverse reaction. Documentation to support reason is required; prescription claim records may be used to substantiate trials/failures. |
| Step | Note | Examples (selected non-covered stimulant/CNS agents) |
|---|---|---|
| 1 | Many stimulant and other CNS agents are listed as non‑covered in the payer's Non‑covered Drug List. Where step therapy or staged coverage rules apply for agents in these classes, the detailed edits are maintained elsewhere in the policy or benefits system. | Adderall®, Adhansia XR®, Adzenys®, Azstarys®, Daytrana™, Dexedrine®, Focalin®/Focalin XR®, Jornay PM®, Kapvay®, Methylphenidate ER (capsules/ODT), Mydayis®, Nuvigil™, Provigil®, Qelbree®, Quillichew® ER, Quillivant XR™, Ritalin® (SR/LA), Strattera®, Sunosi®, Vyvanse® (selected examples). |
Site of Care / Operational Scope
Policy applies to pharmacy benefit — handled by Pharmacy Operations for outpatient prescriptions
This policy pertains to the pharmacy benefit and is handled by the Pharmacy Operations department; it applies to outpatient prescription settings for commercial members.
- Contact Pharmacy Operations (see policy for phone/fax/address) for submissions and questions.
- Applies to commercial members in outpatient prescription settings.
Background
Background: BCBSMA maintains a Non‑covered Drug List to promote clinically appropriate and cost‑effective prescribing. Products are placed on the list when readily available, safe, FDA‑approved alternatives or generics are available and comparably effective, or when clinical and cost considerations support exclusion. The policy permits coverage via an approved formulary exception when criteria are met (for example, documented successful maintenance on the current medication or required trials/documentation per the formulary exception criteria).
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