FDA-approved, for example:

• Various

Non-FDA-approved, for example:

• Various

Note: The above lists may not include all FDA-approved and non-FDA approved indications.

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

• All PA requests must include clinical diagnosis, drug name, dose, and frequency.
• Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
• A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
• For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
• Additional criteria may apply depending upon diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

compounded pharmaceutical products with allowed ingredient cost ≥ $100, compounded pharmaceutical products with topical or transdermal route of administration, and compounded pharmaceutical products with PA-requiring or not covered ingredients

• Documentation of all of the following is required:
  • individual drug PA criteria must be met first where applicable; and
  • one of the following: 
    • treatment of an FDA-approved indication; or
    • treatment of a clinically-appropriate indication supported by medical literature; and
  • requested indication is not excluded from coverage by MassHealth regulations; and
  • medical necessity for use of the requested compounded product for the requested route of administration; and
  • inadequate response or adverse reaction to two or contraindication to all other commercially available alternatives; and
  • one of the following: 
    • requested compounded product is not commercially available; or
    • commercial product has been discontinued by the pharmaceutical manufacturer for reasons other than lack of safety or effectiveness; or
    • member has a medical necessity for a dosage form or dosage strength that is not commercially available; and
  • medical necessity for the use of inactive ingredients in the requested compounded product.

Please note: The MassHealth agency does not pay for any drug when used for excluded purposes as described in 130 CMR 406.413(B) “Limitations on Coverage of Drugs – Drug Exclusions” (see link below). https://www.mass.gov/regulations/130-CMR-406000-pharmacy-services