Formulary Exception / Non-covered Drug Prior Authorization
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Defines BCBSMA prior authorization and formulary exception criteria for coverage of non-formulary or non-covered prescription drugs for commercial members under the BCBSMA formulary; excludes Medicare Advantage. Affects prescribers requesting coverage exceptions and pharmacy operations processing prior authorizations.
No material clinical or coverage changes in this revision.
Formulary Exception and Non-covered Drug Coverage Criteria
Formulary Exception / Non-covered Drug Coverage Criteria
Covered when ANY of the following primary conditions are met, or when subsequent criteria are satisfied:
Primary coverage pathways
- Successful maintenance pathway: Provider establishes via documented clinical records or medication history that the Member has been successfully maintained on their current medication regimen and provides clinical justification that a change to a formulary alternative would result in instability of the medical condition.
Documentation required to support reason for clinical justification
- Device-dependent pathway: Member is actively using a medical device (for example, continuous subcutaneous insulin infusion pump) and requires the use of non-covered diabetic test strips.
Documentation required
Plan may use prescription claim records to verify maintenance or trials/failures; provider must supply names, strengths, and specifics of failures
Documentation required to support clinical reasons preventing trial or demonstrating failure; must provide names and strengths of alternatives tried and specifics regarding treatment failure
This policy defines formulary exception and non-covered drug coverage for BCBSMA commercial members under the BCBSMA formulary and does NOT apply to Medicare Advantage members.
The policy identifies multiple therapeutic categories and product classes that are listed as non-covered under the pharmacy benefit, including but not limited to: atypical antidepressants and antipsychotics; benzodiazepines and hypnotics; pain/opioid and topical analgesic agents; stimulants, SNRIs, SSRIs, tricyclic antidepressants; cardiovascular classes (ARB, ACEI, beta blockers, CCBs, combinations); HMG-CoA (statins) and combinations; dermatologic topical products and kits; diabetic supplies and insulins; osteoporosis agents; GI agents and bowel preps; and proton pump inhibitors (PPI) for members ≥ 18 years.
Specific branded and generic products listed as non-covered in this segment include examples such as hyaluronic acid joint replacements (e.g., Durolane, Euflexxa, Gel-One, Hyalgan, Monovisc, Orthovisc, Supartz, Synvisc), numerous NSAID oral and topical formulations (e.g., Voltaren, Naprosyn, Pennsaid, Diclofenac gels), a broad range of OB/GYN and estrogen products and contraceptives, extensive prenatal vitamin brands, ophthalmic anti-infectives and ophthalmic agents (e.g., AzaSite, Besivance, Tobradex, Vigamox, Acular, Restasis), phosphate binder Auryxia, many branded respiratory inhalers and inhaled steroids (e.g., Breo Ellipta, Symbicort, ProAir, Flovent, Arnuity Ellipta), leukotriene modifiers (e.g., Singulair, Accolate, Zyflo), vitamins/minerals, and weight‑loss agents including liraglutide and Zepbound vials. This list in chunks 36–43 is presented as the set of products excluded from coverage.
Per the policy's Other Policy Conditions, products designated as investigational are considered not medically necessary / non‑covered and are excluded from coverage.
Non-covered Product Coding / Lists
| Durolane | Durolane |
| Euflexxa | Euflexxa |
| Gel-One | Gel-One |
| Hyalgan | Hyalgan |
| Hymovis | Hymovis |
| Hymovis One | Hymovis One |
| Monovisc | Monovisc |
| Orthovisc | Orthovisc |
| Sodium Hyaluronate 1% | Sodium Hyaluronate 1% |
| Supartz | Supartz |
| fenoprofen 300mg | fenoprofen 300mg |
| fenoprofen 400mg | fenoprofen 400mg |
| Flector | Flector |
| Flexipak Kit | Flexipak Kit |
| Ibupak | Ibupak |
| ibuprofen 300mg | ibuprofen 300mg |
| ibuprofen/famotidine | ibuprofen/famotidine |
| Indocin suspension | Indocin suspension |
| Indomethacin 20mg | Indomethacin 20mg |
| Inflatherm | Inflatherm |
| Activella | Activella |
| Angeliq | Angeliq |
| Bijuva | Bijuva |
| Duavee | Duavee |
| Estrace | Estrace |
| Prometrium | Prometrium |
| Addyi | Addyi |
| Brisdelle | Brisdelle |
| Divigel | Divigel |
| Imvexxy | Imvexxy |
| OB Complete Petite | OB Complete Petite |
| OB Complete | OB Complete |
| OB Complete Premier | OB Complete Premier |
| OB Complete/DHA | OB Complete/DHA |
| Obstetrx EC | Obstetrx EC |
| Obstetrx Pak DHA | Obstetrx Pak DHA |
| Obstetrx One 38-1-225 | Obstetrx One 38-1-225 |
| Obtrex | Obtrex |
| O-Cal Prenatal | O-Cal Prenatal |
| One Vite 1MG Plus | One Vite 1MG Plus |
| Prenatal Forte | Prenatal Forte |
| Prenatal Low Iron | Prenatal Low Iron |
| Prenatal Plus | Prenatal Plus |
| Prenatal+FE 29-1MG | Prenatal+FE 29-1MG |
| Prenatal-U 106.5-1 | Prenatal-U 106.5-1 |
| Prenate Essential | Prenate Essential |
| Prenatal Pixie | Prenatal Pixie |
| Prenate AM 1MG | Prenate AM 1MG |
| Prenate DHA | Prenate DHA |
| Prenate Mini | Prenate Mini |
| AzaSite | AzaSite |
| Besivance | Besivance |
| Moxeza | Moxeza |
| Tobradex ointment | Tobradex ointment |
| Tobradex ST | Tobradex ST |
| Vigamox | Vigamox |
| Zylet | Zylet |
| Zymaxid | Zymaxid |
| Acular | Acular |
| Alphagan P | Alphagan P |
| Auryxia | Auryxia |
| Tyrvaya | Tyrvaya |
| Vyzulta | Vyzulta |
| Xelpros | Xelpros |
| AirSupra | AirSupra |
| Arformoterol | Arformoterol |
| Albuterol Sulfate HFA (Ventolin Authorized Product) | Albuterol Sulfate HFA (Ventolin Authorized Product) |
| Albuterol Sulfate HFA (ProAir Authorized Product) | Albuterol Sulfate HFA (ProAir Authorized Product) |
| AirDuo DigiHaler | AirDuo DigiHaler |
| AirDuo RespiClick | AirDuo RespiClick |
Prior Authorization, Step Therapy, Documentation, and Denial Risk
Prior Authorization Required
Prior Authorization is required for non-formulary and certain formulary drugs covered under the Rx benefit. To request coverage, providers must submit the Formulary Exception/Prior Authorization form by phone, fax, or mail to the Pharmacy Operations Department (see contact below).
- Submission methods: phone, fax, or mail using the Formulary Exception/Prior Authorization form.
- Pharmacy Operations Department, Blue Cross Blue Shield of Massachusetts, 25 Technology Place, Hingham, MA 02043.
Step Therapy / Trials Required
When formulary alternatives exist, step therapy (trial and failure) requirements apply. The member must have tried and failed at least 2 covered alternatives (or 1 if only one formulary alternative exists within the same therapeutic class for the given diagnosis). Document the name and strength of alternatives tried and specifics regarding treatment failure.
- 2 alternatives required, or 1 if only one formulary alternative is covered in the same therapeutic class.
- Reasons for failure: inadequate treatment response, intolerance, contraindication, allergic/adverse reaction.
Required Provider Documentation
Providers must supply clinical documentation to support exceptions or prior authorization requests. Acceptable documentation includes clinical notes, medication history, prescription claim records, and specifics about treatment failure or clinical justification for not switching to a formulary alternative.
- Include name and strength of alternatives tried and failed and specifics regarding treatment failure when applicable.
- Include clinical notes or supporting clinical statements and any relevant peer-reviewed literature or compendia references for individual consideration.
- Prescription claim records may be used by the plan; provide additional information if historic claim data is unavailable or insufficient.
Non-covered Drugs — Prior Authorization Not Applicable
Drugs listed on the Non-covered Drug List are not eligible for coverage via prior authorization or exception under the pharmacy benefit unless explicitly stated elsewhere in policy. Prior authorization is not applicable to items on the Non-covered Drug List.
- Non-covered lists appear in the policy and include, but are not limited to, specified branded and generic products across therapeutic classes.
- Claims or requests for listed non-covered drugs will not be converted to covered via PA unless policy explicitly indicates otherwise.
Denial Risk for Insufficient Documentation
Requests may be denied if submitted documentation does not demonstrate required clinical justification, successful maintenance, or trial-and-failure of formulary alternatives when applicable. Ensure documentation clearly shows why alternatives are inappropriate or why switching would cause instability.
- Denials may occur for insufficient documentation of treatment failure, lack of medication history, or missing clinical rationale.
- Provide specific details (names/strengths/dates of trials, clinical course) to reduce denial risk.
Denial Risk for Non-covered Drugs
Claims for drugs listed on the Non-covered Drug List will be denied under the pharmacy benefit and are not reimbursable. Inclusion on the Non-covered Drug List is an explicit exclusion from coverage unless another policy section states otherwise.
- Providers should verify whether a drug appears on the Non-covered Drug List before submitting a request.
- Denials for non-covered items will not be overturned by standard prior authorization processes; individual consideration exceptions may be considered only where policy permits and supporting documentation justifies.
- Use the Non-covered Drug List as a reference when preparing documentation.
Policy Background and Rationale
BCBSMA maintains a Non‑Covered Drug List to promote clinically appropriate and cost‑effective prescribing when safe, comparably effective, or generic alternatives exist. Individual formulary exceptions and prior authorization reviews may allow coverage when the provider documents successful maintenance on the non‑formulary drug or submits clinical justification demonstrating that switching to a formulary alternative would cause instability; documentation and medication history are required to support such exceptions.
Key Definitions
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