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Table 79: Pharmaceutical Compounds


A    B    C    D    E    F    G    H    I    J    K    L    M    N    O    P    Q    R    S    T    U    V    W    X    Y    Z


Drug Category: Compounding Agents

Medication Class/Individual Agents: Various

I. Prior-Authorization Requirements

 Pharmaceutical Compounds

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

cherry syrup test   *
compounded pharmaceutical product with a total allowed ingredient cost ≥ $100 PA   CP
compounded pharmaceutical product with a total allowed ingredient cost < $100 and non-topical / non-transdermal ROA test   CP
compounded pharmaceutical product with topical or transdermal ROA PA   CP
gelatin capsule, empty test   *
glycerin test   *
hydrophilic ointment test   *, A90
lanolin test   *
Ora-Plus suspending vehicle test   *
Ora-Sweet oral syrup test   *
Ora-Sweet-SF oral syrup test   *
petrolatum test   *, A90
simple syrup test   *
zinc oxide test   *

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.

This Table does not represent the complete list of drugs that can be used for pharmaceutical compounding. For information regarding the management of other drugs that could be used in pharmaceutical compounding, please see the appropriate Therapeutic Class Table. Compounded pharmaceutical products utilizing covered ingredients with a total allowed ingredient cost < $100 and non-topical/non-transdermal route of administration are covered without PA.

Please note, the following compounding ingredients are not covered. This list is subject to change at any time:

  • benzodiazepine powders (alprazolam, clonazepam, diazepam, lorazepam, midazolam powders)
  • chorionic gonadotropin, human, powder
  • clomiphene powder
  • cocaine crystals, powder
  • diethylpropion powder
  • flibanserin powder
  • ketamine powder
  • methylphenidate powder
  • opioid powders (apomorphine, buprenorphine, cocaine, codeine, fentanyl, hydrocodone, hydromorphone, levorphanol, methadone, morphine sulfate, oxycodone, sufentanil powders)
  • papaverine
  • PCCA compounding inactive ingredients
  • phentolamine
  • tadalafil powder

 

 
Table Footnotes
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without PA.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
CP Compounded pharmaceutical products with a total allowed ingredient cost greater than or equal to $100 require PA. In addition, compounded pharmaceutical products with topical route or transdermal route of administration (ROA) require PA. The following ROAs are excluded from the PA requirement for products with a total allowed ingredient cost greater than or equal to $100: infusion, intravenous, intravenous piggyback, intravenous push, subcutaneous. Compounded pharmaceutical products utilizing any PA-requiring agent or not covered ingredient as part of the compound require PA.
 

II. Therapeutic Uses

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.

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III.  Evaluation Criteria for Approval

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

 

 


Original Effective Date: 04/2023

Last Revised Date: 03/2024


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Last updated 05/16/24

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