CurrentMass General Brigham Health PlanPolicy N/A

Massachusetts Step Therapy Protocol Exception

Defines criteria and process for exceptions to step therapy for pharmacy and medical benefit drugs for Commercial/Exchange members in Massachusetts, aligning with Massachusetts Acts of 2022 Chapter 254.

Policy Summary

PayerMass General Brigham Health Plan

PolicyMassachusetts Step Therapy Protocol Exception

Policy CodePolicy N/A

Change TypeNo material change

Effective DateOct 1, 2023

Next Review DateN/A

Key ActionSubmit a prior authorization/step therapy exception request with supporting documentation (medical charts, chart notes, lab work) to request approval for up to 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard approval duration

Commercial/Exchangeapplicable plan

Pharmacy & Medicalbenefits covered

Acts of 2022 Ch.254legislation

Step Therapy Exception Coverage Criteria

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Step therapy exception — initial and reauthorization

Authorization and reauthorization may be granted when ALL of the following are met:

Primary conditions

Exception conditions: a. An alternate drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the member; b. Alternate drug(s) are expected to be ineffective based on the member's clinical characteristics and the known characteristics of the alternative regimen; c. The member previously tried the alternate drug(s) under the current or prior health benefit plan (or another drug in the same pharmacologic class or with the same mechanism of action) and discontinued due to lack of efficacy/effectiveness, diminished effect, or an adverse event; d. The member is stable on the requested drug (excluding samples and manufacturer patient assistance program supply) and switching drugs will likely cause an adverse reaction or physical or mental harm to the member.

Step Therapy Policy Rules

Step	Criteria / Requirement	Coverage status
1	Requested drug is prescribed for an FDA‑approved indication or an indication supported in accepted compendia (e.g., AHFS, Micromedex, current accepted guidelines).	Exception granted when criteria met and documentation submitted
2	Prescribed dose and quantity fall within FDA‑approved labeling or dosing guidelines found in accepted compendia of current literature.	Exception granted when criteria met and documentation submitted
3	One of the following exception conditions is met: a) alternate drug is contraindicated or likely to cause an adverse reaction or physical/mental harm; b) alternate drug(s) are expected to be ineffective for the member based on clinical characteristics; c) member previously tried alternate drug(s) (including drugs in same class/mechanism) and discontinued due to lack of efficacy, diminished effect, or adverse event; d) member is stable on the requested drug (excluding samples/PAP) and switching is likely to cause adverse reaction or harm.	Exception granted when criteria met and documentation submitted

Provider Requirements and Operational Details

Prior Authorization

Prior authorization / approval duration

Initial approvals and reauthorizations will be granted for 12 months.

Step Therapy

Step therapy exception criteria — one of listed clinical criteria permits exception

Step therapy exceptions may be granted when ONE of the listed clinical criteria below is met. Providers must document which exception criterion applies and submit supporting clinical information.

The alternate drug is contraindicated or will likely cause an adverse reaction or physical or mental harm to the member.
The alternate drug(s) is expected to be ineffective based on the member's known clinical characteristics and the known characteristics of the prescription drug regimen.
The member previously tried the alternate drug(s) (under the current or a previous health benefit plan) or another drug in the same pharmacologic class or with the same mechanism of action and it was discontinued due to lack of efficacy, diminished effect, or an adverse event.
The member is stable on the requested drug (excluding samples and manufacturer patient assistance program supply), and switching drugs will likely cause an adverse reaction or physical or mental harm to the member.

Documentation Required

Required documentation — submit supporting documentation (charts, labs, notes)

Submit clinical documentation to support the request, including but not limited to medical charts, chart notes, lab results, prior medication history, dates and reasons for discontinuation, and any relevant specialist notes. Clearly indicate which step therapy exception criterion is being asserted.

Denial Risk

Grounds for denial — not FDA/compendia supported indication, dose/quantity issues, etc.

Requests may be denied if the indication is not FDA‑approved or not supported by recognized compendia; if prescribed dose/quantity exceed FDA labeling or compendia dosing guidelines; or if supporting documentation is insufficient to demonstrate one of the step therapy exception criteria.

Definitions

inv-07: Definition of an alternative medication in same pharmacologic class / mechanism of action

DefinitionAn alternative medication in the same pharmacologic class or with the same mechanism of action that would normally be required by step therapy prior to covering the requested drug.

Role in step therapyServes as the first-line agent(s) that must typically be tried before the requested drug will be covered unless an exception criterion is met.

Common exception reasonsMay be bypassed if the alternate drug is contraindicated, likely to cause an adverse reaction or harm, or is expected to be ineffective based on the member's clinical characteristics.

Evidence of prior trialA prior trial of the alternate drug (or another drug in the same class/mechanism) that was discontinued for lack of efficacy, diminished effect, or adverse event supports an exception request.

DocumentationSupporting documentation (e.g., medical charts, chart notes, lab work) must be submitted to justify why the alternate drug is not appropriate or was unsuccessful.

Background and Scope

This policy implements the Massachusetts step therapy protocol exception requirements established by state law to ensure members have access to prescribed medications when clinically justified. It was developed to align with Massachusetts Session Laws - Acts of 2022 Chapter 254 and became effective 10/01/2023. The policy applies to Commercial/Exchange plans and covers both the pharmacy and medical benefits where step therapy is used to manage medication selection.["1","5","0"]

Under this policy, an exception to step therapy may be granted when the prescriber documents that the requested drug meets clinical criteria (for example, FDA-approved indication or accepted compendia support), dosing falls within FDA labeling or compendia guidance, and at least one defined exception condition is met (such as contraindication, expected ineffectiveness, prior trial with failure, or that the member is stable on the requested drug and switching would cause harm). Supporting documentation (e.g., medical charts, chart notes, lab work) is required with requests.["2"]

Initial approvals and reauthorizations consistent with these requirements are issued for up to 12 months. The policy references accepted compendia (e.g., AHFS, Micromedex) and FDA labeling as standards for indications and dosing when reviewing exceptions.["3","2"]