CurrentmhnPolicy N/A

2025 Medicare Step Therapy Part B (PDF)

List of Part B drugs subject to step therapy requirements for Medicare members; describes step therapy definition, exception process, and 365-day lookback rule for prior use.

Policy Summary

Payermhn

Policy2025 Medicare Step Therapy Part B (PDF)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionFor drugs listed, providers must ensure the member has trialed the required alternative drug(s) (different or less expensive) before requesting coverage for the listed drug unless an exception is approved.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes

43Drugs listed for step therapy

Step Therapy Scope & Requirements

Defines step therapy for Medicare Part B drugs: members must try a different or less expensive drug before the plan will cover certain Part B drugs. The policy lists specific Part B drugs subject to step therapy, including biologics, immunoglobulins, oncology agents, and other injectable therapies shown on the Part B Step Therapy drug list.

Scope: Applies to the Medicare Part B drugs listed on the Part B Step Therapy drug list and implements a step therapy requirement that members must try a specified alternative before coverage of the listed drug is approved.

Step Therapy Requirement

ALL of the following

The drug is listed on the Medicare Part B Step Therapy drug list in this policy.
The drug has NOT been used by the member in the past 365 days.365 days
Step therapy applies only if the drug has not been used in the past 365 days.
Member must try a specified alternative (different or less expensive) drug before coverage of the listed drug is approved.
If the first drug does not work, the plan will cover the second drug.

Exception Process

Exceptions to step therapy may be requested when clinical justification exists:

ANY of the following

Member requests an exception.
Prescriber requests an exception.
Authorized representative requests an exception.
Instructions for how to request are in the plan's Evidence of Coverage.

Drugs Subject to Part B Step Therapy

Drugs subject to Medicare Part B step therapymixed

	Filgrastim (Neupogen®, Zarxio®, Nivestym™, Granix®, Releuko®, Nypozi™)
	Golimumab (Simponi®, Simponi Aria®)
	Hyaluronate derivatives: sodium hyaluronate (Euflexxa®, Gelsyn-3™, GenVisc® 850, Hyalgan®, Supartz FX™, Synojoynt™, Triluron™, TriVisc™, VISCO-3™), hyaluronic acid (Durolane®), cross-linked hyaluronate (Gel-One®), hyaluronan (Hymovis®, Orthovisc®, Monovisc®), hylan polymers A and B (Synvisc®, Synvisc One®)
	Idecabtagene vicleucel (Abecma™)
	Imetelstat (Rytelo™)
	Immune globulins (Alyglo™, Asceniv™, Bivigam®, Cutaquig®, Cuvitru™, Flebogamma® DIF, GamaSTAN®, GamaSTAN® S/D, Gammagard® liquid, Gammagard® S/D, Gammaked™, Gammaplex®, Gamunex®-C, Hizentra®, HyQvia®, Octagam®, Panzyga®, Privigen®, Xembify®)
	IncobotulinumtoxinA (Xeomin®)
	Infliximab-ayyb (Zymfentra®)
	Lanreotide (Somatuline® Depot)
	Lisocabtagene maraleucel (Breyanzi®)

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What Providers Must Do

Step Therapy

Step therapy prior trial requirement

For drugs listed, providers must ensure the member has trialed the required alternative drug(s) (a different or less expensive drug) before requesting coverage for the listed drug unless an exception is approved.

Step therapy applies if the drug has not been used in the past 365 days — plan looks back 365 days.
Member must trial the specified alternative (different or less expensive) drug before coverage of the listed drug is approved.

Prior Authorization

Exception request

Providers or authorized representatives may request an exception to step therapy per the plan's Evidence of Coverage; the request must include clinical justification as described in the Evidence of Coverage.

Instructions for how to request an exception are in the plan's Evidence of Coverage.
Clinical justification must be submitted with the exception request.

Definitions & Notes

Step therapy: Requirement to try one drug before the plan will cover another drug; members must try a different or less expensive drug first and, if the first drug does not work, the plan will cover the second drug.

Note: The plan allows requests for exceptions; prescribers, members, or authorized representatives may request an exception and instructions for how to request an exception are contained in the plan's Evidence of Coverage. Effective and review dates were not provided in the brief.