CurrentMass General Brigham Health PlanPolicy N/A

Medical Necessity

Defines prior authorization review procedures and medical necessity criteria for drugs used for gender-affirming care and for members under 21 (EPSDT), including drug-specific criteria for a list of named products and continuity/authorization durations. Applies to MassHealth UPPL pharmacy benefit prior authorization program.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Necessity

Policy CodePolicy N/A

Change TypeRevised (multiple updates including 04/01/2026 effective)

Effective DateApr 1, 2026

Next Review Date

Key ActionPA review is required for the listed drugs under the MassHealth UPPL pharmacy benefit; requests must be reviewed against P&T-approved guidelines if present and meet the policy's medical necessity criteria.

SourceLink

POLICY UPDATE CHANGES

Policy reviewed and updated 3/11/26: Bausch and Lomb added Cabtreo to be available on the patient assistance program (PAP); EPSDT (<21) review still applies for drugs that have PA with PAP available.

11/12/25 update included drugs that require additional EPSDT review following B&L update; effective 10/15/25.

04/10/24 update modified criteria for cosmetic or hair growth agents and set initial approval duration to 12 months.

9/13/23 - Created for P&T in response to the EPSDT requirement by MassHealth; effective 10/2/23.

12+Named drugs with specific EPSDT criteria

12 months

Initial authorization duration

12 monthsReauthorization duration

Coverage Summary

Scope: This policy defines prior authorization (PA) review procedures and medical necessity criteria for drugs used for gender-affirming care and for members under 21 years of age (EPSDT), and lists drug-specific criteria for named products. It applies to the MassHealth UPPL pharmacy benefit PA program. Coverage stance: covered_with_criteria — therapies may be approved when policy-specified medical necessity and drug-specific EPSDT criteria are met. Policy purpose: to clarify PA review for gender-affirming drugs and EPSDT (<21) drug requests and to ensure documentation of trials of alternatives and rebate rationale when non-rebate products are used. Effective date: 04/01/2026. Last review: 03/11/2026.

Authorization durations and EPSDT scope

Initial authorization duration12 months

Reauthorization duration12 months

Named drugs with specific EPSDT criteria12+ (see policy list for Arazlo, Aplenzin, Cabtreo, Xifaxan 550 mg, Jublia, Tasmar, Zelapar, Relistor, Trulance, Bryhali, Duobrii, Siliq, Uceris, Luzu)

General Authorization Criteria

Authorization of requested drug therapy may be approved when the following criteria have been met:

Top-level check: There are no P&T-approved coverage guidelines for the requested drug and indication; if guidelines exist, review against those first
ONE of the following
- Requests for gender-affirming care drugs
  - Gender-affirming: core requirements: Documentation of a severe and persistent or widespread condition
  - Gender-affirming: rationale/no other options
    ONE of

Drug-specific EPSDT (<21) Criteria

For listed drugs when member is <21 years of age, must meet the drug-specific criteria below:

Arazlo (tazarotene 0.045% lotion)

Indication: Diagnosis of ONE of: Acne (grade II or greater); Cutaneous warts; Folliculitis/pseudofolliculitis (razor bumps/shave bumps)
Prior trials: Medical records documenting inadequate response or an adverse reaction to a topical tretinoin agent and topical tazarotene agent
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Aplenzin (bupropion hydrobromide ER)

Continuation of Therapy (Reauthorization)

Reauthorization requires physician documentation of continuation of therapy and the following criteria:

Reauthorization criteria: Medical records or pharmacy history supporting that the member has been successfully maintained and compliant on current drug therapy; Member had a positive therapeutic response to current drug therapy; Documentation of clinical rationale, or provider attestation, that a change in therapy would result in instability of the member's medical condition

Provider Actions & Prior Authorization Requirements

Prior Authorization

Prior authorization required

PA review required for the listed drugs under the MassHealth UPPL pharmacy benefit; requests must be reviewed against P&T‑approved guidelines if present and meet the policy's medical necessity criteria.

Documentation Required

Trials and clinical documentation required

Prescribers must submit medical records documenting diagnosis, trials of alternatives (including drug name, dose, duration, and reason for failure or discontinuation), and documentation of rebate or clinical rationale for use of a non‑rebate product.

Document diagnosis in medical records
Document trials of alternatives: drug name, dose, duration, reason for failure/discontinuation

Applicable Codes

Program and Benefitmixed

MassHealth UPPL

Program applicability (checked)

Background & Definitions

Background: MassHealth regulation 130 CMR 406.413(B) lists categories of drug exclusions (e.g., cosmetic, cough/cold, fertility, experimental) but includes the caveat that drugs used for cosmetic purposes or for hair growth are not paid for unless medically necessary. The policy was created to implement consistent PA review procedures recognizing that those exclusions do not apply to medically necessary drugs for members under 21 (EPSDT). For members under 21, PA requests must meet EPSDT medical necessity criteria and, where present, be reviewed against any P&T‑approved coverage guidelines first. The policy requires prescribers to document diagnosis and trials of alternatives (drug name, dose, duration, and reason for failure or discontinuation) and to provide a rebate rationale or clinical rationale when a non‑rebate product is used. The review history documents iterative updates clarifying cosmetic/hair growth coverage, specifying gender‑affirming care review procedures, and noting that EPSDT review still applies even when a patient assistance program (PAP) is available (most recently effective 04/01/2026).

Definitions: EPSDT — Early and Periodic Screening, Diagnostic, and Treatment; applies to members under 21 years of age.

Clinical Evidence & Rationale

Evidence notes: The brief does not list formal external evidence citations; clinical decision‑making is operationalized through the policy's criteria and P&T review process. Drug‑specific clinical rationale in this policy is implemented via requirements such as documented inadequate response or contraindication to specified alternatives, defined trial durations (for example, ≥ 4 weeks for Aplenzin; ≥ 24 consecutive weeks for ciclopirox on Jublia pathway; ≥ 3 weeks for Uceris), and dosing thresholds (for example, Xifaxan 550 mg three times daily for 14 days). When no P&T‑approved guideline exists, approval depends on meeting the trials‑of‑therapy requirements and providing rebate or clinical rationale for use of non‑rebate products rather than on cited randomized trial data.

Revision History

2026-04-01updatedLatest

Policy reviewed 03/11/26: Bausch and Lomb added Cabtreo to be available on the patient assistance program (PAP); EPSDT (<21) review still applies for drugs that have PA with PAP available. Marked material change.

2025-10-15updated

11/12/25 review: Updated criteria following the Bausch & Lomb update and included drugs that require additional EPSDT review. Marked material change.

2024-05-06updated

Policy Summary

PayerMass General Brigham Health Plan

PolicyMedical Necessity

Policy CodePolicy N/A

Change TypeRevised (multiple updates including 04/01/2026 effective)

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Hair reduction agent for AMAB/biologic male: An agent for the reduction of hair growth in a person with male sex assigned at birth/biologic male (transgender male to female)

Other gender-affirming indications - BOTH

Provider attestation: The provider attests the drug is necessary to the member's identity
Impact on life: Documentation that the condition to be treated is negatively affecting the member's life as a transgender individual

Requests for other drugs due to medical necessity (EPSDT) for members <21

EPSDT: diagnosis: Appropriate diagnosis
EPSDT: age: Member is less than 21 years of age
EPSDT: ONE of the following
- Inadequate response to alternatives: Medical records documenting an inadequate response, adverse reaction, or contraindication to ALL available appropriate formulary alternatives and/or drugs considered standard of care (document drug name, dose, duration, reason for failure or discontinuation)
- No formulary alternatives: Member has condition for which there are no other formulary alternatives
- Combination drugs: For combination drugs, documentation of inadequate response, adverse reaction, or contraindication to individual ingredients used together when available
- Drug shortage: Prescriber is requesting drug due to a drug shortage (must document drug shortage and anticipated duration)

Indication: Diagnosis of ONE of: Anxiety disorder; Bipolar disorder; Depressive disorder; Obsessive-compulsive disorder; Panic disorder; PTSD; Other psychiatric or neurologic condition requiring treatment with an antidepressant
Age: Member is ≥ 18 and < 21 years of age
Inadequate response: Medical records documenting an inadequate response (defined as ≥ 4 weeks of therapy) or adverse reaction to bupropion XL at an equivalent dose≥ 4 weeks
Quantity limit: Requested quantity is ≤ 1 unit/day
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Cabtreo topical gel (clindamycin/adapalene/benzoyl peroxide)

Indication: Diagnosis of ONE of: Acne (grade II or greater); Folliculitis/pseudofolliculitis; Hidradenitis suppurativa; Rosacea
Combination necessity: Medical necessity for the combination product instead of the commercially available separate agents
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Xifaxan (rifaximin) 550 mg - indications

Hepatic encephalopathy (high ammonia levels)
- Age: Member is ≥ 18 and < 21 years of age
- Prior trial lactulose: Inadequate response, adverse reaction or contraindication to lactulose
- Quantity limit: Requested quantity is ≤ 2 unit/day
- Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product
IBS with diarrhea
- Age: Member is ≥ 18 and < 21 years of age
- Prior trials: Inadequate response or adverse reaction to THREE or contraindication to ALL of: bile acid sequestrant; bismuth subsalicylate; bulk-forming agent; diphenoxylate/atropine; loperamide; TCAs
- Dosing: Appropriate dosing: 550 mg three times daily for 14 days550 mg TID x14 days
- Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product
SIBO
- Age: Member is ≥ 12 and < 21 years of age
- Prior trials: Inadequate response or adverse reaction to ONE or contraindication to ALL of: amoxicillin-clavulanate; ciprofloxacin; doxycycline; metronidazole; neomycin; norfloxacin; tetracycline; trimethoprim/sulfamethoxazole
- Dosing: Appropriate dosing: 550 mg three times daily for 14 days550 mg TID x14 days
- Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Jublia (efinaconazole)

Indication: Diagnosis of onychomycosis
ONE of the following
- Oral therapy trial: Inadequate response or adverse reaction to itraconazole OR terbinafine oral tablets
- Topical necessity: Medical necessity for topical formulation AND inadequate response (defined as ≥ 24 consecutive weeks of therapy) or adverse reaction to ciclopirox nail solution≥ 24 weeks
- Contraindications to all: Contraindication to ALL of: ciclopirox nail solution; itraconazole oral therapy; terbinafine oral tablets
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Tasmar (tolcapone) - brand only

Indication: Diagnosis of Parkinson's disease
Concomitant therapy: Member is concurrently taking carbidopa/levodopa
Prior trial entacapone/opicapone: Inadequate response, adverse reaction, or contraindication to entacapone AND Ongentys (opicapone)
Generic tolcapone trial and rebate rationale: Medical records documenting an inadequate response or adverse reaction to the generic tolcapone AND trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Zelapar (selegiline ODT)

Indication: Diagnosis of Parkinson's disease
Concomitant therapy: Member is concurrently taking carbidopa/levodopa
Formulation necessity: Medical necessity for the ODT formulation instead of conventional formulations (e.g., swallowing disorder or dysphagia)
Not using other solids: Member is not utilizing other solid oral formulations
Quantity limit: Requested quantity is ≤ 2 units/day
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Relistor (methylnaltrexone) indications

OIC with advanced illness receiving palliative care
- Age: Member is ≥ 18 and < 21 years of age
- Dosing: Appropriate dosing
- Prior laxative trials: Inadequate response, adverse reaction, or contraindication to ONE agent from THREE of the four traditional laxative therapy classes (bulk forming; osmotic; saline; stimulant)
- Formulation necessity injection: For injection formulation, medical necessity for injection instead of tablet formulation
- Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product
OIC with chronic non-cancer pain
- Age: Member is ≥ 18 and < 21 years of age
- Dosing: Appropriate dosing
- Prior laxative trials: Inadequate response, adverse reaction, or contraindication to ONE agent from THREE of the four traditional laxative therapy classes
- Prior opioid antagonist trials: Inadequate response, adverse reaction, or contraindication to Movantik AND Symproic
- Linzess/lubiprostone trial: Inadequate response, adverse reaction, or contraindication to ONE or contraindication to Linzess AND lubiprostone

Trulance (plecanatide)

Indication: Diagnosis of CIC or IBS-C
Quantity/medical necessity: Medical necessity for exceeding quantity limit
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Bryhali (halobetasol)

Indication: Diagnosis of plaque psoriasis
Age: Member is ≥ 18 and < 21 years of age
ONE of
- Inadequate response to topical corticosteroids: Inadequate response or adverse reaction to ALL topical corticosteroids of the same formulation and potency range available without prior authorization: augmented betamethasone; betamethasone dipropionate; clobetasol propionate; fluocinonide 0.1% cream; halobetasol
- Formulation necessity: Medical necessity for the requested formulation
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Duobrii (halobetasol/tazarotene)

Indication: Diagnosis of plaque psoriasis
Age: Member is ≥ 18 and < 21 years of age
Prior steroid trial: Inadequate response or adverse reaction to ONE superpotent or potent topical corticosteroid available without prior authorization (e.g., augmented betamethasone, betamethasone propionate, clobetasol propionate, halobetasol etc.)
Combination necessity: Medical necessity for the combination product instead of the commercially available separate agents
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Siliq (brodalumab)

ONE of
- Conventional therapy failure: Inadequate response or adverse reaction to ONE or contraindication to ALL conventional therapies: topical agent; phototherapy; systemic agent
- Biologic trial: Inadequate response or adverse reaction to ONE biologic DMARD that is FDA-approved for plaque psoriasis
Appropriate dosing must be met
Anti-TNF trial: Inadequate response, adverse reaction, or contraindication to ALL of: Stelara; Skyrizi; Taltz
Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product

Siliq additional indications

Anti-TNF plaque psoriasis: Inadequate response or adverse reaction to ONE or contraindication to ALL anti-TNF agents FDA-approved for plaque psoriasis
PRP indication: Diagnosis of pityriasis rubra pilaris (PRP) requires inadequate response or adverse reaction to ONE topical corticosteroid or contraindication to ALL topical corticosteroids AND clinical rationale for use instead of Stelara and Taltz

Uceris (budesonide rectal foam) - brand name only

Indication: Diagnosis of ulcerative colitis
Age: Member is ≥ 18 and < 21 years of age
Prior trials: Inadequate response (defined as ≥ 3 weeks of therapy) or adverse reaction to ONE or contraindication to BOTH: hydrocortisone enema; hydrocortisone foam≥ 3 weeks
Rebate/clinical rationale: Medical records documenting an inadequate response or adverse reaction to the generic budesonide rectal foam AND trials of alternatives with rebate or clinical rationale for use of a nonrebate product

Numeric dosing and threshold items

Aplenzin - inadequate response definitionInadequate response defined as ≥ 4 weeks of therapy

Jublia - ciclopirox trial requirementInadequate response to ciclopirox defined as ≥ 24 consecutive weeks of therapy

Uceris - inadequate response definitionInadequate response defined as ≥ 3 weeks of therapy

Xifaxan - IBS dosing550 mg three times daily for 14 days

Xifaxan - SIBO dosing550 mg three times daily for 14 days

Provide rebate documentation or clinical rationale when using a non‑rebate product

Prior Authorization

Drug-specific quantity limits and dosing constraints

PA includes drug‑specific quantity limits and dosing constraints; requests must reflect these maximums.

Aplenzin: requested quantity ≤ 1 unit/day (Aplenzin criteria)
Zelapar ODT: requested quantity ≤ 2 units/day (Zelapar criteria)
Xifaxan for hepatic encephalopathy: requested quantity ≤ 2 unit/day
Xifaxan for IBS or SIBO: dosing 550 mg three times daily for 14 days

Billing Rule

Formulation medical necessity

For certain products the prescriber must document medical necessity for a specific formulation instead of alternative formulations.

Zelapar ODT: medical necessity for ODT formulation instead of conventional formulations (e.g., swallowing disorder or dysphagia)
Relistor injection: for injection formulation, document medical necessity for injection instead of tablet formulation
Cabtreo topical gel: medical necessity for the combination product instead of separate agents
Duobrii: medical necessity for the combination product instead of commercially available separate agents

Documentation Required

EPSDT (<21) special review

Requests for members under 21 require EPSDT-specific review: use EPSDT review criteria and follow the policy's drug‑specific EPSDT criteria and documentation requirements.

Ensure member is <21 and include EPSDT rationale
Provide medical records documenting inadequate response, adverse reaction, or contraindication to formulary alternatives (include drug name, dose, duration, reason)
Adhere to the drug‑specific criteria listed in the policy for EPSDT drugs

04/10/24 review: Modified criteria for cosmetic or hair growth agents and removed verbiage regarding medical necessity for non-gender-affirming care requests; updated initial approval duration to 12 months. Marked material change.

2023-10-02created

Policy created 09/13/23 for P&T in response to the EPSDT requirement by MassHealth to allow consistent review for certain drugs where 130 CMR 406.413(B) exclusions do not apply to members under 21. Marked material change.

Formulation necessity injection: For injection formulation, medical necessity for injection instead of tablet formulation

Rebate/clinical rationale: Prescriber must submit documentation of trials of alternatives with rebate or clinical rationale for use of a non-rebate product