CurrentMass General Brigham Health PlanPolicy N/A

Massachusetts Step Therapy Protocol Exception (MassHealth UPPL)

Defines criteria and documentation required for prior authorization and reauthorization of drugs under the MassHealth UPPL pharmacy and medical benefits to satisfy Massachusetts Acts of 2022 Chapter 254. Affects providers requesting exceptions to step therapy for covered members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMassachusetts Step Therapy Protocol Exception (MassHealth UPPL)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2023

Next Review DateN/A

Key ActionSubmit a prior authorization request with supporting documentation (medical charts, chart notes, lab work) demonstrating the drug meets indication, dosing, and one exception condition.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MassHealth UPPLPlan covered by this policy

12 monthsApproval duration

Pharmacy & MedicalBenefits covered

Acts of 2022 Ch.254Regulatory basis

Coverage Criteria

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Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for requests under this protocol. Submit PA requests to the appropriate benefit channel (Medical Benefit: Phone 833-895-2611, Fax 888-656-6671; Pharmacy Benefit: Phone 800-711-4555, Fax 844-403-1029). Expect review only after all required documentation is provided.

MassHealth UPPL program; effective 10/1/2023
Medical Benefit PA: Phone 833-895-2611 | Fax 888-656-6671
Pharmacy Benefit PA: Phone 800-711-4555 | Fax 844-403-1029

Step Therapy

Allowable Step Therapy Exception Reasons

Step therapy exceptions are allowed when one or more of the following apply to the member: contraindication, intolerance/adverse reaction, clinical ineffectiveness based on member characteristics, prior trial and failure on the alternate agent(s), or clinical stability on the requested drug where switching would cause harm.

Alternate drug is contraindicated or will likely cause an adverse reaction or physical/mental harm
Alternate drug expected to be ineffective based on member-specific clinical characteristics
Member previously tried alternate drug(s) under current or prior plan or another agent in same class and discontinued for lack of efficacy, diminished effect, or adverse event
Member is clinically stable on the requested drug (excluding samples or manufacturer assistance) and switching would likely cause harm

Documentation Required

Required Documentation

Providers must submit supporting clinical documentation with the PA request. Include pertinent medical records that justify the exception and demonstrate medical necessity.

Relevant medical charts and chart notes documenting diagnosis and treatment history
Laboratory results supporting the clinical rationale
Medication history including prior trials, dates, doses, and reasons for discontinuation
Clinical notes demonstrating stability on requested therapy when applicable

Denial Risk

Denial Triggers and Risks

Requests may be denied if criteria are not met or documentation is insufficient. Common denial triggers include unsupported indication, dosing outside accepted guidelines, lack of documented prior trial/failure where required, or missing/contradictory clinical evidence.

Requested use is not FDA-approved or supported by recognized compendia (e.g., AHFS, Micromedex, accepted guidelines)
Prescribed dose or quantity outside FDA labeling or compendia dosing guidance
No documentation of contraindication, intolerance, prior trial/failure, or clinical stability supporting the exception
Incomplete medical records, missing labs, or absent medication history

Definitions

Compendia (authoritative drug information sources)

Defined compendiaAHFS; Micromedex; current accepted guidelines (as examples of compendia of current literature)

PurposeUsed to support indications and dosing when an FDA-approved indication or labeling is not available

Dosing guidancePrescribed dose and quantity must fall within FDA-approved labeling or dosing guidelines found in the compendia

Examples of acceptable evidenceCitable compendia entries or current accepted clinical guidelines demonstrating the indication or dosing

Documentation requirementInclude supporting documentation (e.g., medical charts, chart notes, lab work) that references compendia guidance when relied upon

Step Therapy Requirements

Prior trial or clinical rationale	Required documentation	Coverage determination
Alternate drug contraindicated or likely to cause adverse reaction or physical/mental harm	Clinical documentation showing contraindication or evidence that alternate would cause harm (e.g., allergy history, prior adverse reaction notes, specialist statement)	Requests meeting this rationale with supporting documentation: covered
Alternate drug expected to be ineffective for this member based on clinical characteristics	Clinical rationale linking member-specific factors to expected ineffectiveness (e.g., pharmacogenomic data, comorbidities, prior treatment response), with chart notes or specialist input	Requests meeting this rationale with supporting documentation: covered
Prior trial of alternate drug or same-class agent discontinued due to lack of efficacy, diminished effect, or adverse event	Documentation of prior trial (medication name, dates, reason for discontinuation) from current or prior benefit plan; chart notes or pharmacy records preferred	Requests meeting this rationale with supporting documentation: covered
Member is stable on the requested drug and switching would likely cause harm (excluding samples or manufacturer assistance)	Evidence of stability on therapy (treatment duration, clinical assessments, outcome measures) and explanation why switching is harmful; exclude reliance on samples/PAPs	Requests meeting this rationale with supporting documentation: covered

Background

This policy implements the Massachusetts step therapy protocol exception requirements effective 10/1/2023, established under state law (Acts of 2022 Chapter 254) to govern exceptions to step therapy for covered drugs. It applies to the MassHealth UPPL program across both the pharmacy and medical benefits and sets the clinical and documentation standards that must be met for a prior authorization or reauthorization to be approved.

Specifically, authorization and reauthorization are granted when the requested drug is prescribed for an FDA‑approved indication or an indication supported by recognized compendia, dosing is within FDA labeling or compendia guidance, and the request meets one of the policy’s specified exception conditions (for example, contraindication to the alternate, expected ineffectiveness, prior trial failure, or clinical stability where switching would cause harm). Initial approvals and reauthorizations are limited to 12 months, and prior authorization is required for requests under this program. Providers must submit supporting documentation (e.g., chart notes, lab work) to demonstrate these criteria are met.

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