Step Therapy Policy - Medicare Part B
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Defines step therapy requirements for Medicare outpatient (Part B) drugs and certain devices, specifying preferred and non-preferred agents and when trial(s) of preferred alternatives or other policies apply. Applies to Baylor Scott & White Health Plan members subject to Medicare Part B coverage.
No material clinical or coverage changes in this revision.
Coverage Criteria for Non-Preferred Part B Drugs and Devices
inv-01: General criteria for coverage of non-preferred agents
The Plan considers non-preferred medications or devices medically necessary when ALL of the following are met:
Applies to drugs and devices listed in the class tables; for devices provider must submit clinical rationale explaining why preferred devices are not appropriate.
inv-02: Class-specific preferred / non-preferred listings
Coverage is guided by class lists where Class 1 = Preferred, Class 2 = Non-Preferred, Class 3 = CMS or BSWHP policy to follow:
Multiple therapeutic classes and detailed agent lists are provided in the policy chunks 2-5; Class 3 entries reference applicable BSWHP or CMS policies (e.g., policies 215, 219, 310, 311, LCD 33822).
This medical policy does not replace federal or state rules and regulations. Medical necessity as defined by this policy does not ensure the benefit is covered; benefit coverage is ultimately determined by the member’s specific benefit plan document, which supersedes this policy in the event of a discrepancy.
Initial Therapy Rules
inv-13: Initial therapy
Initial therapy requirements for non-preferred Medicare Part B drugs:
Applies to agents listed as non-preferred in the class tables; prior authorization requirements and additional Plan/CMS criteria may apply per the referenced drug or device policy.
Step Therapy Requirements
| Requirement | Details |
|---|---|
| Member status: New start | |
| Member must be a new start (has not received the requested medication for the past 365 days). | |
| Failure/intolerance to preferred agents | |
| Member must have failure of an adequate trial of, or a clinically significant intolerance or contraindication to, ALL preferred drugs that can be used for the requested indication before covering a non-preferred agent. | |
| Additional CMS or Plan criteria | |
| Member must meet any additional clinical coverage criteria per applicable CMS (LCD/NCD) or Baylor Scott & White Health Plan policy as specified for the drug/device class. | |
| Lookback period | |
| Lookback for new-start determination is 365 days. | |
| Prior authorization | |
| Prior authorization is required per the specific drug or device policy referenced; see the specific policy for appropriate prior authorization requirements. | |
| Device requests: clinical rationale | |
| Provider must submit clinical rationale explaining why the non-preferred device is medically necessary and why preferred devices are not appropriate; requests may be denied without this rationale. |
Provider Requirements and Prior Authorization
Prior authorization required
Prior authorization is required per the specific drug or device policy referenced; see the specific policy for appropriate prior authorization requirements.
General step therapy rule
Step therapy applies only when the member is a new start (has not received the requested medication in the prior 365 days) and the member has had failure of an adequate trial of, or clinically significant intolerance or contraindication to, ALL preferred drugs that can be used for the requested indication; additional CMS or Plan clinical criteria may also apply.
Step therapy prerequisites — denial risk
Requests may be denied if the member is not a new start (has received the requested medication in the prior 365 days) or has not had failure of an adequate trial of, or clinically significant intolerance/contraindication to, ALL preferred drugs for the requested indication.
Clinical rationale required for non-preferred devices
For non-preferred devices the provider must submit clinical rationale explaining why the non-preferred device is medically necessary and why preferred devices are not appropriate; this rationale is required as part of the request.
Device requests may be denied without clinical rationale
Device requests for non-preferred devices may be denied if the provider does not submit clinical rationale explaining why preferred devices are not appropriate.
Coding & Lookback
Key Definitions
Applicable Site of Care
Applies to Medicare Part B outpatient drug administration
This policy and its step therapy requirements apply to Medicare outpatient (Part B) drug administration settings per Medicare rules and referenced BSWHP medical policies.
Biosimilar Designations
Infliximab (Remicade) preferred; Avsola non-preferred
Avsola is listed as non-preferred while infliximab (Remicade) is listed as preferred; see BSWHP policy 215 for additional guidance.
Bevacizumab biosimilars non-preferred in some classes
Bevacizumab biosimilars are listed as non-preferred for certain bone antiresorptive and oncology classes; refer to BSWHP policy 219 for class-specific guidance.
Background
Step therapy is a utilization management approach that requires a member to try preferred therapeutic alternatives before coverage is provided for a non-preferred drug or device. Under this policy, step therapy generally applies to Medicare outpatient (Part B) drugs and certain devices and requires that the member be a new start (no receipt of the requested medication in the prior 365 days) and have documented failure of, intolerance to, or contraindication to ALL preferred agents that can be used for the requested indication; additional CMS or Plan-specific clinical criteria may apply as specified per therapeutic class.
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