CurrentmhnPolicy N/A

Medicare Part B Step Therapy

Defines drugs subject to Medicare Part B step therapy requirements and explains that members must try a specified alternative within the prior 365 days or request an exception; applies to providers and beneficiaries under the payer's Medicare Part B coverage.

Policy Summary

Payermhn

PolicyMedicare Part B Step Therapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber or authorized representative may request a step therapy exception per instructions in the member's Evidence of Coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~50drugs listed on step therapy

365look‑back period for prior use

Medicare Part Bprogram applicability

Coverage Criteria for Medicare Part B Step Therapy

Initial Step Therapy Coverage Criteria

Covered when ALL of the following are met

Step therapy precondition: Requested drug is on the payer's Medicare Part B step therapy list

List provided in document chunks 1-2

Prior therapy requirement: Member has used the required alternative or first-line drug within the past 365 days365 days

If prior use not present, coverage requires approved exception per Evidence of Coverage

Exception process: If the required prior drug was not used within 365 days, prescriber or authorized representative must request and obtain an approved step therapy exception per the member's Evidence of Coverage

Policy Summary

Payermhn

PolicyMedicare Part B Step Therapy

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber or authorized representative may request a step therapy exception per instructions in the member's Evidence of Coverage.

SourceLink

On This Page

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See Evidence of Coverage for instructions to request an exception

None are explicitly listed beyond the step therapy requirements in this policy. Exceptions to step therapy are available: a member, the prescriber, or an authorized representative may request a step therapy exception. For instructions on how to request an exception, refer to the member's Evidence of Coverage.

Initial Therapy

Step therapy initial requirement

Initial therapy requirement: Member must have used the specified prior/first-line drug within the past 365 days for step therapy to be satisfied; otherwise an exception is required.365 days

See Evidence of Coverage for exception request process.

Step Therapy Rules

Requirement	Details
Step therapy requirement	Member must have trialed the required prior/first‑line drug within the past 365 days before we will cover the requested Medicare Part B drug.
Look‑back period	365 days — step therapy applies if the required prior drug has not been used in the past 365 days.
Exception process	Prescriber or authorized representative may request a step therapy exception per the member's Evidence of Coverage; coverage may be denied if prior use is not documented and no approved exception exists.
Drugs subject to step therapy	Medicare Part B drugs listed in the policy document (examples include Injectafer®, Monoferric®, Feraheme®, Filgrastim products, Nivolumab, Pembrolizumab, Rituximab products, and others listed in the document).

Coding & Look-back

inv-03: Prior use look-back — 365 days

Look‑back period for prior use365 days

When look‑back appliesStep therapy applies if the drug has not been used in the past 365 days

Consequence of no prior useCoverage will be denied under step therapy if the requested drug has not been used in the past 365 days and the member has not first tried the required alternative medication(s).

Provider Actions and Exception Process

Step Therapy

Step therapy requirement and exception process

Medicare Part B Step Therapy: The drugs on this list require step therapy. Step therapy means a member must try a specified prior drug before we will cover the requested drug. Step therapy applies if the required prior drug has not been used in the past 365 days.

Step therapy requires the member to have used the required prior drug within the past 365 days.
An exception request is allowed if the prescriber or an authorized representative believes the member needs the step therapy drug.
For instructions on how to request an exception, follow the procedures in the member's Evidence of Coverage.

Note

Step therapy exception instructions

Prescriber or authorized representative may request a step therapy exception on the member's behalf per the member Evidence of Coverage instructions. The exception process must be followed to avoid denial of coverage.

Exception requests follow the member's Evidence of Coverage process.
Requests may be submitted by the prescriber or an authorized representative.

Denial Risk

Denial condition

Coverage will be denied under step therapy if the requested drug has not been used in the past 365 days and a step therapy exception has not been approved.

Denial applies when required prior drug use within 365 days is not documented and no approved exception exists.

Definitions

inv-09: Definition of step therapy — Step therapy means a client must try a specified drug before the payer will cover another drug; exceptions can be requested by the prescriber or authorized representative.

DefinitionStep therapy means you must try one drug before we will cover another drug; before we cover certain drugs, you must first try a different or less expensive drug.

Exception requestYou can ask for an exception if you think you need a step therapy drug; your prescriber or authorized representative may also ask for an exception.

How to requestFor information on how to ask for an exception, please see your Evidence of Coverage.

Background

Step therapy is an administrative coverage process that requires a trial of a specified initial drug before the payer will cover an alternative drug. Under this policy, the listed Medicare Part B drugs require that the member must have used the required prior drug within the past 365 days for step therapy to be satisfied. If the prior drug has not been used in that look‑back period, an exception request may be submitted by the member, prescriber, or authorized representative per the member's Evidence of Coverage.