Formulary exception / non-covered drug coverage
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Policy governing prior authorization and formulary exception criteria for non-formulary or non-covered prescription drugs for BCBSMA commercial members; describes documentation, approval criteria, and individual consideration process for prescribers requesting coverage.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
Coverage criteria
BCBSMA may authorize a non-formulary drug as MEDICALLY NECESSARY when ONE of the following primary conditions is met; if not, additional AND/OR criteria apply:
Investigational therapies are considered not medically necessary under Other Policy Conditions and therefore are excluded from coverage unless otherwise specified by an applicable medical policy or exception process.
The following drugs and product categories are explicitly designated as non-covered on BCBSMA's Non-covered Drug List (partial extract): examples include biologics and specialty agents such as ustekinumab and multiple botulinum toxin products; extensive lists of CNS, analgesic, dermatologic, endocrine, ophthalmic, respiratory, obstetric/gynecologic and prenatal vitamin products; and numerous branded and generic agents across therapeutic classes. See the Non-covered Drug List entries in chunks 18–45 for full enumerations.
All drugs and products explicitly listed in chunks 36–45 of the Non-covered Drug List are designated as non-covered by BCBSMA in this partial extract. Example entries in this extract include gastrointestinal agents (e.g., Delzicol®, dicyclomine 40mg, lubiprostone), GOUT treatments (e.g., allopurinol 200mg, Colcrys®), extensive musculoskeletal and NSAID lists, OB/GYN agents and a broad roster of prenatal vitamins, multiple ophthalmic anti-infective and other eye preparations, respiratory inhaled agents and inhaled steroids, and other specified product groups.
Drugs on the Non-covered Drug List are not covered by the plan unless a formulary exception is approved. The Non-covered Drug List spans many therapeutic classes and specific products (examples in the partial extract include acne/oral isotretinoin products, various analgesics and opioids, dermatologic topicals, insulins and diabetes agents, biologics, botulinum toxins, and numerous branded prenatal vitamins). When an exception is requested, BCBSMA’s Formulary Exception process must be followed and supporting clinical documentation provided for individual consideration.
What Providers Must Do / Authorization Process
Use Formulary Exception/Prior Authorization Form #434
Submit all formulary exception or prior authorization requests using the Formulary Exception/Prior Authorization form (Form #434); providers may call, fax, or mail the completed form to Pharmacy Operations as instructed in the policy.
- Formulary Exception Form #434 is the required form.
- Physicians may call, fax, or mail the attached form to Blue Cross Blue Shield of Massachusetts Pharmacy Operations Department.
Non-covered list entries do not specify PA requirements
The non-covered drug lists in this section enumerate drugs and supplies specified as non-covered but do not themselves state prior authorization requirements for those items.
- Chunks listing non-covered products function as an explicit Non-covered Drug List.
- No PA requirements are specified within those list entries.
Non-covered items — no PA specified in list
Items designated as non-covered in the Non-covered Drug List are presented without prior authorization instructions; they are listed as non-covered products.
- The list entries (e.g., Delzicol, Xifaxan and many others) are specified as non-covered in the document.
- Providers should follow the exception/prior authorization process if seeking coverage for listed non-covered drugs.
Require trial and failure of formulary alternatives (2, or 1 if only one exists)
When formulary alternatives exist, the member must have trialed and failed at least 2 covered alternatives (or 1 if only one formulary alternative is available); documentation of the failures is required for approval.
- Failure reasons may include inadequate response, intolerance, contraindication, allergic or adverse reaction.
- The plan may use prescription claim records to establish prior use; additional provider documentation is required if claim data are insufficient.
Document name and strength of alternatives tried and failed
Provider must document the name and strength of any formulary alternatives tried and failed, and provide specifics regarding the treatment failure or clinical rationale preventing trial or switch.
- Documentation must include name and strength of alternatives and specifics about inadequate response, intolerance, contraindication, or other reasons for failure.
- Prescription claim history may be used to support trials; additional provider documentation is required when claim data are unavailable or insufficient.
Denial risk if maintenance or trial/failure documentation is not provided
Requests may be denied if the provider does not document successful maintenance or required trials/failures of formulary alternatives; the plan uses prescription claim records to adjudicate and may request additional information.
- Approval requires documentation that switching would cause instability or evidence of trial/failure when alternatives exist.
- If historic prescription claim data do not establish criteria, additional provider information will be required.
Claims for listed non-covered products may be denied
Claims for drugs and products listed on the Non-covered Drug List may be denied as non-covered because they are explicitly designated as non-covered in the policy.
- The Non-covered Drug List includes many specific brand and generic products (partial extract shown).
- Providers must request a formulary exception using the required form if seeking coverage for listed items.
Step therapy rules not specified in partial non-covered list — follow general step therapy requirements
If formulary alternatives exist but step therapy rules are not specified for items in this partial non-covered list, providers should follow the policy’s general step therapy requirement (trial and failure of alternatives) when applicable and submit supporting documentation for individual consideration when step therapy is not appropriate.
- Chunk 37 explicitly notes that no step therapy rules are included in this partial non-covered list.
- Providers may request individual consideration with supporting clinical documentation when step therapy is not appropriate.
Continuation / Maintenance Coverage
Continuation therapy
Continuation/maintenance coverage
Step Therapy Requirements
| Requirement | Details / Documentation | Coverage status |
|---|---|---|
| Trial and failure of covered alternatives | ||
| Member must have tried and failed at least 2 covered alternatives (or 1 if only one formulary alternative is covered within the same therapeutic class for the given diagnosis) | ||
| Coverage allowed with documented trial/failure | ||
| Reasons for failure | ||
| Reasons may include inadequate treatment response, intolerance, clinical contraindication, allergic or adverse reaction | ||
| Documentation required | ||
| Provider must supply name and strength of alternatives tried and specifics regarding the treatment failure; prescription claims may be used to support prior use; additional clinical information required if claims data are unavailable or insufficient | ||
| Individual consideration / exceptions | ||
| Providers may request an exception (individual consideration) with supporting clinical documentation such as clinical notes, literature, compendia references; submit via Pharmacy Operations (phone/fax/mail) |
Key Definitions
Background and Scope
Background: BCBSMA requires submission of a formulary exception when coverage for a non-covered drug is requested. Non-covered drugs are designated as such because safe, comparably effective formulary alternatives or generic versions are available. The Formulary Exception process (use Formulary Exception Form #434) permits individual consideration when members are successfully maintained on a non-formulary medication or when documented clinical circumstances justify coverage despite non-coverage status.
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