FDA-approved, for example:

• Advanced adenocarcinoma of the uterine corpus
• Management of amenorrhea (primary and secondary)
• Production of secretory endometrium and desquamation
• Progestin challenge for the diagnosis of secondary amenorrhea
• Test for endogenous estrogen production

Non-FDA-approved, for example:

• Maintenance of pregnancy/placental support through gestational week 12 after positive pregnancy test
• Prevention of miscarriage with history of recurrent miscarriages through gestational week 12
• Prevention of spontaneous preterm birth
• Short cervix

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 prior-authorization 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.

Crinone

• Documentation of all the following is required for requests for Crinone 4% or 8% gel for progestin challenge for the diagnosis of secondary amenorrhea: 
  • appropriate diagnosis; and
  • inadequate response or adverse drug reaction to one or contraindication to all of the following: medroxyprogesterone, norethindrone, oral progesterone (micronized); and
  • requested dose is ≤ six doses; and
  • for the 8% gel, inadequate response or adverse reaction to the 4% gel.
• Documentation of all the following is required for requests for Crinone 8% gel for all other diagnoses:
  • indication of one of the following:
    • prevention of spontaneous preterm birth with one of the following:
      • both of the following:
        • history of spontaneous singleton delivery and/or premature rupture of membranes; and
        • gestational age ≥ 18 weeks to < 23 weeks; and
      • both of the following: diagnosis of short cervix and gestational age ≥ 18 weeks to < 23 weeks; or
    • maintenance of pregnancy/placental support through gestational week 12 after positive pregnancy test; or
    • prevention of miscarriage with history of recurrent miscarriages through gestational week 12; and
  • inadequate response or adverse reaction to one or contraindication to all of the following: compounded progesterone suppository, intramuscular progesterone, oral progesterone capsule, Endometrin (progesterone vaginal insert); and
  • appropriate dosing and treatment duration.

Endometrin

• Documentation of all the following is required for the diagnosis of prevention of spontaneous preterm birth:
  • appropriate diagnosis; and
  • gestational age ≥ 18 weeks to < 23 weeks; and
  • one of the following:
    • member has a history of spontaneous singleton delivery and/or premature rupture of membranes; or
    • short cervix.

hydroxyprogesterone caproate injection (generic Delalutin)

• Documentation of all the following is required: 
  • indication of one of the following:
    • treatment of advanced adenocarcinoma of the uterine corpus (stage III or IV); or
    • management of amenorrhea (primary and secondary); or
    • member requires a test for endogenous estrogen production; or
    • production of secretory endometrium and desquamation; and
  • appropriate dosing.

Please note: The MassHealth agency does not pay for any drug when used to promote fertility 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