Non-Oncology General Prior Authorization
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Governs prior authorization requirements and approval criteria for non-oncology medications (Medicare and Medicaid lines of business) for Aloha Care members, including Medicare Part B rules and transition provisions.
No material clinical or coverage changes in this revision.
Non-Oncology Coverage Criteria
Non-oncology approval criteria
Approval criteria for non-oncology drugs (Medicaid/Medicare):
ALL of the following
ANY of the following
- Drug is being used for an FDA-approved indication (non-cancer) with chart notes or lab reports confirming diagnosis.
- For Medicaid/Medicare: drug is being used for an off-label non-cancer use supported by recognized compendia or two peer-reviewed medical literatures (examples: AHFS-DI; Micromedex DrugDex Class I/IIa/IIb; Clinical Pharmacology; UptoDate; Drug Facts & Comparison rated 'Evidence Level A').
- Medication dose and frequency is appropriate for the indication and patient factors (e.g., age, weight, renal/hepatic function).
ALL of the following
- Requested dose does not exceed the maximum FDA‑approved daily dose.
- Requested quantity is the lowest number of commercially available units (consolidate dosing; avoid combining different strengths where possible).
- Documented trial and failure, intolerance, or contraindication to two formulary alternatives (or fewer if only one or none are available), with evidence such as paid claims or chart notes.
ALL of the following
- Initial and renewal requests may be approved for up to 12 months as appropriate.
- Drugs with acquisition cost over $10,000 must be reviewed by a pharmacist prior to approval.
For Medicare Part B new starts, Step Therapy criteria must be met in addition to these coverage criteria unless the request falls within the 90‑day Medicare Part B transition period.
Initial Therapy Requirements
INITIAL THERAPY CRITERIA
Initial approval expectations
ALL of the following
- Initial and renewal requests may be approved for up to 12 months as appropriate.
- Documentation of the indication and prior trials (formulary alternatives) is required for approval.
ALL of the following
- Drugs with acquisition cost over $10,000 must be reviewed by a pharmacist.
ALL of the following
- Dose, frequency, and requested quantity must comply with FDA‑approved limits and use the lowest number of commercially available units.
- If the request is for an off‑label non‑cancer use, supporting evidence from recognized compendia or two peer‑reviewed articles is required.
Continuation and Transition Criteria
Medicare Part B transition — criteria for continuation/ongoing therapy
Transition for ongoing therapy
ALL of the following
- If a member is on an active course of treatment at the time of Medicare enrollment, coverage and Step Therapy requirements do not apply for the first 90 days; continued provision of that therapy should be allowed during this period.
- After the 90‑day transition period, Coverage and Step Therapy Criteria must be met for continued coverage or renewal of therapy.
For Medicare Part B new starts (outside the 90‑day transition), Step Therapy criteria must be met in addition to general coverage criteria.
Provider Requirements & Prior Authorization
Prior authorization and review requirements
Prior authorization is required for non-oncology drugs listed as requiring authorization. Initial and renewal requests may be approved for up to 12 months as appropriate. Drugs with a cost over $10,000 must be reviewed by a pharmacist.
- Prior authorization required for products that require authorization without drug‑specific criteria (non-oncology).
- Approval duration for initial/renewal requests: as appropriate, up to 12 months.
- Drugs over $10,000 require pharmacist review.
Medicare Part B 90-day transition for new members
For new Medicare members, a 90-day transition period applies during which an active course of the requested treatment (including out-of-network provision) is continued without application of Coverage and Step Therapy criteria. After 90 days, Coverage and Step Therapy criteria must be met for continued coverage.
- Transition applies for the first 90 days after Medicare enrollment.
- Coverage and Step Therapy do not apply to ongoing treatment during this period; they apply thereafter.
Medicare Part B review and step therapy requirements
Medicare Part B requests must be reviewed using the most current LCD, NCD, or LCA applicable to the Hawaii region; if none exist, review using the policy's General Coverage Criteria. For Medicare Part B new starts, Step Therapy criteria must be met in addition to Coverage Criteria before a request may be approved.
- Use CMS Medicare Coverage Database guidance (LCD/NCD/LCA) applicable to the Hawaii region for Part B reviews.
- For new Part B starts, meet Step Therapy requirements in addition to Coverage Criteria prior to approval.
Coding & Cost Thresholds
Key Definitions
Step Therapy Requirements
| Requirement | Notes |
|---|---|
| Medicare Part B new starts | Step therapy criteria must be met in addition to Coverage Criteria before a request may be approved. |
| Exception / transition | 90-day transition for new Medicare members applies; during this period coverage and step therapy do not apply to an active course of treatment. |
Quantity Limits
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