FDA-approved, for example:

• acute pain
• chronic pain

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, frequency, and formulation.
• 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 the member's condition, requested medication, and Duplicate Therapy, High-Dose, High-Dose Short-Acting Monotherapy, and Quantity Limit restrictions (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.
• If MassHealth pharmacy claims history of required trials is not available, medical records documenting such trials may be required.

Please note: PA will be required if it is determined that the member is stable on opioid dependence therapy (≥ 60 days of therapy within the last 90 days of an oral opioid dependence agent, or ≥ 56 days of Sublocade in the last 84 days) for any long-acting opioid agent, any short-acting opioid agent > seven days supply, and any short-acting opioid agent if there is ≥ seven days of a short-acting opioid agent in the last 30 days.

Belbuca

• Documentation of the following is required: 
  • appropriate diagnosis; and
  • one of the following:
    • adverse reaction or contraindication to morphine sulfate extended-release that cannot be expected or managed as a part of opioid therapy; or  
    • medical necessity for buccal formulation; or 
    • prescriber wants to avoid using a full opioid agonist; and
  • requested dose is ≤ 1,800 mcg/day.

benzhydrocodone/acetaminophen, dihydrocodeine/acetaminophen/caffeine, hydrocodone/acetaminophen 300mg, hydrocodone 5 mg, 10 mg/ibuprofen, oxycodone/acetaminophen 300 mg

Please refer to table in Section I. Prior-Authorization Requirements: Clinical Notes above for hydrocodone/acetaminophen and oxycodone/acetaminophen strengths available without PA within dose limits.

• For strengths and formulations that require PA, documentation of the following is required:  
  • appropriate diagnosis; and 
  • medical records documenting an inadequate response, adverse reaction, or contraindication to all of the following:  
    • codeine/acetaminophen; and  
    • hydrocodone/acetaminophen; and 
    • hydrocodone/ibuprofen; and
    • oxycodone/acetaminophen.

Buprenex (buprenorphine injection)

• Documentation of the following is required: 
  • appropriate diagnosis; and
  • clinical rationale why oral pain medications cannot be used; and
  • adverse reaction or contraindication to both of the following: buprenorphine transdermal, fentanyl transdermal

butorphanol nasal spray

• Documentation of the following is required for the diagnosis of acute pain:
  • appropriate diagnosis; and
  • requested quantity is ≤ two canisters/30 days; and
  • medical records documenting one of the following:
    • adverse reaction or contraindication to all other generic short-acting opioids: codeine, hydromorphone, morphine, and oxycodone; or 
    • both of the following:
      • medical necessity for nasal spray formulation; and 
      • adverse reaction or contraindication to both of the following: morphine immediate-release solution, oxycodone immediate-release solution.  

• Documentation of the following is required for the treatment of acute migraine:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response or adverse reaction to two or contraindication to all triptans; and
  • one of the following:
    • medical records documenting an inadequate response, adverse reaction to one additional triptan; or
    • medical records documenting an inadequate response, adverse reaction, or contraindication to one agent from a different anti-migraine medication class.

• Documentation of the following is required for requests noting the member is tapering off butorphanol nasal spray: 
  • indication for the treatment of acute migraine; and
  • medical records documenting the member is on chronic butiorphanol; and
  • treatment plan including taper period for discontinuation.

codeine products for members < 12 years of age

• Documentation of one of the following is required:
  • CYP2D6 genotyping confirms member is not an ultra-rapid CYP2D6 metabolizer; or 
  • member has previously utilized a codeine-containing product without adverse effect that prevents repeat use. 

fentanyl buccal tablet 

• Documentation of the following is required:
  • indication of breakthrough cancer pain; and 
  • adverse reaction or contraindication to all of the following:  
    • hydromorphone immediate-release; and  
    • morphine immediate-release; and  
    • oxycodone immediate-release; and  
    • fentanyl transmucosal system (generic Actiq) (requires PA - see criteria below); and  
  • member is maintained on a long-acting opioid regimen; and 
  • prescriber is an oncologist or pain specialist.

fentanyl 37.5 mcg/hr, 62.5 mcg/hr, 87.5 mcg/hr transdermal system

• Documentation of the following is required:
  • clinical rationale why two patches cannot be combined to obtain the equivalent strength requested.  

fentanyl transmucosal system (Actiq)

• Documentation of the following is required:
  • indication of breakthrough cancer pain; and 
  • adverse reaction or contraindication to all of the following:   
    • hydromorphone immediate-release; and  
    • morphine immediate-release; and  
    • oxycodone immediate-release; and
  • member is maintained on a long-acting opioid regimen; and
  • prescriber is an oncologist or pain specialist.

hydrocodone extended-release capsule, hydrocodone extended-release tablet, hydromorphone extended-release, Nucynta ER (tapentadol extended-release), oxymorphone extended-release, Xtampza (oxycodone extended-release capsule)

• Documentation of the following is required:
  • appropriate diagnosis; and 
  • adverse reaction or contraindication to all of the following that cannot be expected or managed as a part of opioid therapy:    
    • fentanyl transdermal; and 
    • morphine extended-release; and  
    • oxycodone extended-release tablet (requires PA - see criteria below).  

levorphanol tablet

• Documentation of the following is required: 
  • adverse reaction or contraindication to all of the following that cannot be expected or managed as a part of opioid therapy:    
    • fentanyl transdermal; and 
    • morphine extended-release; and  
    • oxycodone extended-release tablet (requires PA - see criteria below); and
  • clinical rationale for use of the requested agent instead of all other long-acting opioids.  

meperidine

• Documentation of the following is required: 
  • appropriate diagnosis; and 
  • allergy to morphine; and 
  • member has not used morphine derivatives since documented date of morphine allergy. 

methadone injection

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical necessity for use instead of oral formulations of methadone. 

methadone tablet

• Documentation of the following is required:
  • appropriate diagnosis; and
  • member is not opioid naïve; and
  • baseline ECG showing normal QTc interval; and
  • one of the following:
    • adverse reaction or contraindication to both of the following: morphine sulfate extended-release, fentanyl transdermal; or
    • clinical rationale for the use of methadone instead of other long-acting opioids. 

morphine extended-release capsules

• Documentation of the following is required: 
  • appropriate diagnosis; and 
  • inadequate response, adverse reaction, or contraindication to morphine extended-release tablets; and
  • medical necessity for once daily dosing.

Nucynta (tapentadol), oxymorphone immediate-release

• Documentation of the following is required:   
  • appropriate diagnosis; and
  • adverse reaction or contraindication to all of the following:   
    • hydromorphone immediate-release; and  
    • morphine immediate-release; and  
    • oxycodone immediate-release.

Olinvyk (oliceridine) 

• Documentation of the following is required: 
  • diagnosis of acute moderate to severe pain; and
  • inadequate response, adverse reaction, or contraindication to all of the following:
    • fentanyl injection; and  
    • hydromorphone injection; and  
    • morphine injection; and
  • appropriate dosing; and
  • total course of therapy is limited to 48 hours.

oxycodone extended-release tablet

• Documentation of the following is required:   
  • appropriate diagnosis; and
  • adverse reaction or contraindication to one of the following: fentanyl transdermal, morphine sulfate extended-release.

pentazocine/naloxone

• Documentation of the following is required:
  • appropriate diagnosis; and
  • adverse reaction or contraindication to all of the following:   
    • one nonsteroidal anti-inflammatory drug (NSAID); and
    • hydromorphone immediate-release; and
    • morphine immediate-release; and
    • oxycodone immediate-release; and
    • tramadol; and
  • requested dose is ≤ 600 mg/day of pentazocine.

Seglentis

• Documentation of the following is required:
  • diagnosis of management of acute pain; and
  • medical necessity for use of the combination product instead of the commercially available separate agents. 

tramadol 100 mg

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical necessity for the use of the 100 mg tablets instead of the 50 mg tablets; and
  • medical records documenting an inadequate response or adverse reaction to tramadol 50 mg tablet (two 50 mg tablets). 

tramadol/acetaminophen

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical necessity for use of the combination product instead of the commercially available separate agents. 

tramadol extended-release capsule, tablet

• Documentation of the following is required:
  • appropriate diagnosis; and
  • medical records documenting an inadequate response or adverse reaction to tramadol immediate-release; and 
  • medical necessity for use of an extended-release formulation. 

tramadol solution

• Documentation of the following is required:
  • diagnosis of moderate to severe pain; and
  • member is ≥ 18 years of age; and
  • one of the following:
    • medical necessity for the oral solution formulation; or 
    • medical records documenting inadequate response or adverse reaction to tramadol immediate-release tablets that are available without prior authorization.

tramadol products for members < 12 years of age

• Documentation of the following is required:
  • individual drug PA criteria must be met first where applicable; and
  • one of the following:
    • CYP2D6 genotyping confirms member is not an ultra-rapid CYP2D6 metabolizer; or 
    • member has previously utilized a tramadol-containing product without adverse effect that prevents repeat use. 

In addition to individual drug PA criteria above, some opioids are subject to additional concomitant opioid and benzodiazepine polypharmacy, duplicate therapy, concurrent therapy with opioid dependence agents, high-dose, high-dose short-acting monotherapy, and quantity limit restrictions.

Concomitant Opioid and Benzodiazepine Polypharmacy (pharmacy claims for ≥ 15 days supply for one or more opioid(s) [new to therapy] and one or more benzodiazepine(s) [clobazam, nasal and rectal diazepam, nasal midazolam, and injectable formulations are not included] for ≥ 15 days supply within the past 45-day period.

• If PA is required for concomitant opioid and benzodiazepine polypharmacy, documentation of the following is required
  • individual drug PA criteria must be met first where applicable; and
  • appropriate diagnosis for the opioid; and
  • appropriate diagnosis for the benzodiazepine; and
  • one of the following:
    • member is currently stable on chronic opioid; or 
    • member's treatment is currently managed by palliative care; or
    • member is currently in hospice or is transitioning to hospice; or
    • member is currently being treated for sickle cell disease or cancer pain; or
    • inadequate response or adverse reaction to three non-opioid therapies (e.g., prescription NSAIDs, topical analgesics, physical therapy); or
    • clinical rationale for the use of opioids instead of non-opioid alternatives; or
    • treatment plan to taper off opioid therapy; or
    • treatment plan to taper off or taper down from benzodiazepine therapy; or 
    • clinical rationale for the concomitant use of opioids and benzodiazepines; and
  • member will be co-prescribed naloxone.

Duplicate Therapy and Concurrent Therapy with Opioid Dependence Agents

The following opioids require PA if there is concurrent use of two long-acting or two short-acting opioids for at least 60 days out of any 180-day period. In addition, PA will be required if it is determined that the member is stable on opioid dependence therapy, for any long-acting opioid agent, any short-acting opioid agent > seven days supply, and any short-acting opioid agent if there is ≥ seven days of a short-acting opioid agent in the last 30 days.

• If PA is required for duplicate therapy, documentation of the following is required: 
  • appropriate diagnosis; and
  • individual drug PA criteria must be met first where applicable; and
  • clinical rationale for not maximizing opioid monotherapy.

• If PA is required for concurrent therapy with opioid dependence agents, documentation of the following is required: 
  • individual drug PA criteria must be met first where applicable; and
  • clinical rationale why concurrent therapy with buprenorphine is clinically appropriate.

High-Dose

The following opioids and analgesics require PA for high-dose if used at doses exceeding the following limits.

The accumulated high dose threshold is 120 mg of morphine or morphine equivalent (MME) per day for an individual agent, and 180 MME per day for the entire regimen. All buprenorphine formulations are excluded from the opioid accumulator.

• If exceeding four grams/day of an acetaminophen- or aspirin-containing product, or 3.2 grams/day of an ibuprofen-containing product, documentation of the following is required:
  • appropriate diagnosis; and
  • individual drug PA criteria must be met first, where applicable; and
  • clinical rationale for utilizing greater than four grams of acetaminophen or aspirin, or greater than 3.2 grams of ibuprofen per day.

• If exceeding the above high-dose limits for other agents, documentation of the following is required: 
  • appropriate diagnosis; and
  • individual drug PA criteria must be met first, where applicable; and
  • one of the following:
    • diagnosis of sickle cell disease; or
    • diagnosis of active cancer pain; or
    • member’s pain control is currently managed by palliative care; or
    • member is currently in hospice or is transitioning to hospice; or
    • one of the following:
      • all of the following:
        • medical records documenting treatment plan, including clinical rationale for high-dose and titration of medication up to current dose; and
        • pain consult from a pain specialist supporting the high-dose of opioid requested (Please note, up to three one-month provisional approvals may be allowed to accommodate pain consult scheduling and completion. If requesting a provisional approval to obtain a pain consult, include the specialist contact information and anticipated date of consult); and
        • signed and dated patient-prescriber agreement for opioid use; or
      • both of the following:
        • medical records documenting treatment plan to initiate a taper of the requested medication within the next 90 days; and
        • signed and dated patient-prescriber agreement for opioid use.

High-Dose, Short-Acting Monotherapy

The following opioids and analgesics require PA for monotherapy if used at doses exceeding the limits listed below.

• If exceeding the above high-dose limits and using as monotherapy, documentation of the following is required: 
  • individual drug PA criteria must be met first, where applicable; and
  • medical records documenting treatment plan, including clinical rationale for high-dose and titration of medication up to current dose; and
  • pain consult from a pain specialist supporting the high-dose of opioid requested (Please note, up to three one-month provisional approvals may be allowed to accommodate pain consult scheduling and completion. If requesting a provisional approval to obtain a pain consult, include the specialist contact information and anticipated date of consult); and
  • clinical rationale for not utilizing a long-acting agent in a member requiring high-dose, short-acting opioid therapy for the treatment of chronic pain; and
  • signed and dated patient-prescriber agreement for opioid use.

Quantity Limits

The following opioids require PA if used at the quantities listed below.

• If exceeding the above quantity limits, documentation of the following is required: 
  • appropriate diagnosis; and
  • individual drug PA criteria must be met first, where applicable; and
  • requested dose cannot be obtained within the established quantity limits.