FDA-approved, for example:

• Diabetes mellitus

non-FDA-approved, for example:

• Hypoglycemia due to a diagnosis other than diabetes mellitus

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.

All requests for blood glucose testing reagent strips at quantities above established quantity limits

• Documentation of one of the following is required:  
  • for members utilizing a continuous glucose monitoring device, both of the following:
    • medical necessity for increased testing; and
    • treatment plan describing self-testing frequency.
  • for members not utilizing a continuous glucose monitoring device, one of the following:
    • medical necessity for increased testing; or
    • treatment plan describing self-testing frequency.

SmartPA: Claims for Freestyle, Freestyle Lite, Freestyle Insulinx, or Precision Xtra brand blood glucose testing reagent strips for > 100 strips/30 days but ≤ 200 strips/30 days will usually process at the pharmacy without a PA request if the member has a paid MassHealth pharmacy claim for injectable insulin or a prenatal vitamin within the last 90 days.^† 

Cequr Simplicity

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 21 years of age; and
  • one of the following:
    • member’s current treatment plan involves testing blood glucose at least four times per day; or
    • use of continuous glucose monitoring; and
  • member is currently receiving at least three daily insulin injections or an insulin pump; and
  • one of the following:
    • member’s A1c > 7.0% or does not meet documented target treatment; or
    • frequent hypoglycemia; or
    • fluctuations of more than 100 mg/dL in blood glucose before mealtime; or
    • dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or
    • history of severe glycemic excursions; and
  • one of the following:
    • requested quantity is ≤ one patch/three days; or
    • both of the following:
      • requested quantity is ≥ one patch/one day; and
      • medical necessity for > one patch/two days as noted as daily insulin requirement > 100 units; or
    • both of the following:
      • requested quantity is one patch/two days; and
      • medical necessity for > one patch/three days as noted as one of the following:
        • daily insulin requirement is > 66 units; or
        • injection site irritation and inadequate response to at least one mitigation strategy; or
        • history of adhesion failure and inadequate response to at least one mitigation strategy; or
        • member has lipoatrophy or lipohypertrophy at the injection site; or 
        • pooling of insulin at the injection site.

Dexcom G6, Dexcom G7, Freestyle Libre 2, Freestyle Libre 3, Freestyle Libre 14 Day

• Documentation of all of the following is required for a diagnosis of diabetes mellitus:
  • appropriate diagnosis; and
  • member's treatment regimen includes insulin; and
  • one of the following:
    • A1c ≥ 7% or that does not meet documented target treatment goal; or
    • frequent hypoglycemia (or nocturnal hypoglycemia); or
    • history of hypoglycemic unawareness; or
    • dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or
    • history of emergency room visit or hospitalization related to ketoacidosis or hypoglycemia; or
    • use with compatible insulin pump to achieve glycemic control; or
    • pregnancy; and
  • for Dexcom G6 or Dexcom G7, one of the following: 
    • for receiver, requested quantity is ≤ one unit/365 days; or
    • for sensor, requested quantity is ≤ one unit/ten days; or
    • for Dexcom G6 transmitter, requested quantity is ≤ one unit/90 days; and
  • for Freestyle Libre 14 day, Libre 2, or Libre 3, one of the following:
    • for receiver, requested quantity is ≤ one unit/365 days; or
    • for sensor, requested quantity is ≤ one unit/14 days.

• Documentation of all of the following is required for a diagnosis of hypoglycemia due to a diagnosis other than diabetes mellitus:
  • appropriate diagnosis; and
  • clinical rationale for use of continuous glucose monitoring instead of capillary blood glucose monitoring using test strips and a blood glucose meter.

Freestyle Neo

• Documentation of all of the following is required:
  • documentation that member is using compatible continuous glucose monitoring device; and
  • requested quantity is ≤ 100 strips/30 days. 

SmartPA:  Claims for Freestyle Neo test strips at less than or equal to 100 strips/30 days will usually process and pay at the pharmacy without a PA request if the member has a paid MassHealth pharmacy claim for Freestyle Libre 2, Freestyle Libre 3, or Freestyle Libre 14 Day sensors within the last 90 days.† 

Non-preferred blood glucose testing reagent strips

• Documentation of all of the following is required:
  • medical necessity for a non-preferred product; and
  • requested quantity is ≤ 100 strips/30 days.

SmartPA: Claims for Prodigy brand blood glucose testing reagent strips for ≤ 100 strips/30 days will usually process at the pharmacy without a PA request if the member has a history of MassHealth medical claims for visual impairment. Claims for Prodigy brand blood glucose testing reagent strips for > 100 strips/30 days but ≤ 200 strips/30 days will also usually process at the pharmacy without a PA request if the member has a history of a paid MassHealth pharmacy claim for injectable insulin or a prenatal vitamin within the last 90 days in addition to a history of MassHealth medical claims for visual impairment.^† 

Omnipod 5, Omnipod Classic, Omnipod Dash, V-Go

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • for V-Go, both of the following:
    • member is ≥ 18 years of age; and
    • requested quantity is ≤ one unit/one day; and
  • one of the following:
    • member’s current treatment plan involves testing blood glucose at least four times per day; or
    • use of continuous glucose monitoring; and
  • member is currently receiving at least three daily insulin injections or an insulin pump; and
  • one of the following:
    • member’s A1c > 7.0% or does not meet documented target treatment; or
    • frequent hypoglycemia; or
    • fluctuations of more than 100 mg/dL in blood glucose before mealtime; or
    • dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or
    • history of severe glycemic excursions; and
  • for Omnipod 5, Omnipod Classic, or Omnipod Dash, one of the following:
    • requested quantity is ≤ one pod/three days; or
    • both of the following:
      • requested quantity is ≥ one pod/one day; and
      • medical necessity for > one pod/two days as noted as daily insulin requirement > 100 units; or
    • both of the following:
      • requested quantity is one pod/two days; and
      • medical necessity for > one pod/three days as noted as one of the following:
        • member is < 19 years of age; or
        • daily insulin requirement is > 66 units; or
        • injection site irritation and inadequate response to at least one mitigation strategy; or
        • history of adhesion failure and inadequate response to at least one mitigation strategy; or
        • member has lipoatrophy or lipohypertrophy at the injection site; or 
        • pooling of insulin at the injection site.

Omnipod Go

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ 18 years of age; and
  • one of the following:
    • member’s current treatment plan involves testing blood glucose at least four times per day; or
    • use of continuous glucose monitoring; and
  • member is currently receiving long-acting insulin or NPH insulin; and
  • one of the following:
    • member’s A1c > 7.0% or does not meet documented target treatment; or
    • frequent hypoglycemia; or
    • fluctuations of more than 100 mg/dL in blood glucose before mealtime; or
    • dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or
    • history of severe glycemic excursions; and
  • one of the following:
    • requested quantity is ≤ 1 pod/3 days; or
    • medical necessity for one pod/two days as noted by one of the following:
      • injection site irritation and inadequate response to at least one mitigation strategy; or
      • history of adhesion failure and inadequate response to at least one mitigation strategy; or
      • member has lipoatrophy or lipohypertrophy at the injection site; or 
      • pooling of insulin at the injection site.

^†Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.