FDA-approved, for example: 

• Acute otitis media with tympanostomy tubes (Otovel)
• External Otitis (ciprofloxacin 0.2% otic solution)

Note: The above list may not include all 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.

ciprofloxacin 0.2% otic solution

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • one of the following: 
    • medical necessity for unit dosing; or 
    • inadequate response or adverse reaction to two or contraindication to all of the following: Cipro HC, ciprofloxacin/dexamethasone, Cortisporin TC, neomycin/polymyxinB/hydrocortisone otic, ofloxacin otic solution

SmartPA: Claims for ciprofloxacin 0.2% otic solution will usually process at the pharmacy without a PA request if the member has a history of paid MassHealth pharmacy claims for two of the following within the last 30 days: Cipro HC, ciprofloxacin/dexamethasone, Cortisporin TC, neomycin/polymyxinB/hydrocortisone otic, ofloxacin otic solution.^†

Otovel

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • member is ≥ six months of age; and
  • inadequate response, adverse reaction, or contraindication to ciprofloxacin/dexamethasone otic suspension.

SmartPA: Claims for Otovel will usually process at the pharmacy without a PA request if the member is ≥ six months of age and has a history of paid MassHealth pharmacy claims for ciprofloxacin/dexamethasone otic suspension within the past 30 days.^†

† 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.