RXMP-03 Non-Oncology General PA Criteria Form

Non-Oncology General Prior Authorization

Updated on: 12/1/2025

Page 1 of 2 Policy Number RXMP-03 Line of Business Medicaid & Medicare Effective Date 5/19/2019 Revision Date 12/1/2025

Products: Drugs that require authorization, without drug-specific criteria
For Cancer drugs, use the Oncology Medication Clinical Review Guideline

Override(s)
Approval Duration
Prior Authorization
Initial/Renewal Request: As appropriate, up to 12 months Quantity Limit Up to the FDA-approved dose

Medicare Criteria
Medicare Part B Coverage Criteria
Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • If none found, review using General Coverage Criteria below
Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria • For new starts, Medicare Part B Step Therapy Criteria must be met in addition to Coverage Criteria before a request may be approved.
• No step therapy

Approval Criteria Products Drugs that require authorization, without drug-specific criteria Line of Business Medicare and Medicaid Approval Length Initial/Renewal Request: As appropriate, up to 12 months Override Type PA, QL Initial Criteria Note: Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Drugs over $10K must be reviewed by a pharmacist

Criteria:

1. Drug is being used for an FDA-approved indication (non-cancer) with chart notes or lab reports confirming diagnosis OR
2. For Medicaid/Medicare: Drug is being used for an off-label use (non-cancer) supported by compendia, including:
   For non-cancer use:
   a. Micromedex DrugDex: Class I, IIa, or IIb b. American Hospital Formulary Service – Drug Information (AHFS-DI)
   c. Clinical Pharmacology d. Drug Facts & Comparison Evidence: “Use: Off-Label” and rated as “Evidence Level A” e. UptoDate f. Two peer-reviewed medical literatures AND
3. Medication dose and frequency is appropriate (e.g. indication, age, weight, renal/hepatic function)

Non-Oncology General Prior Authorization

Updated on: 12/1/2025

Page 2 of 2 AND

4. Both of the following: a. Requested dose does not exceed the maximum FDA-approved daily dose
   b. Requested quantity is for the lowest number of commercially available units (dose consolidate without using two different strengths – e.g. BID dosing for QD drugs; 20mg + 40mg for a total 60mg dose)
   AND

5. Documented (e.g. paid claims or chart notes) trial and failure, intolerance, or contraindication to two formulary alternatives (FDA-approved indication or compendia supported off-label use). [If only one formulary alternative available, only requires history to that alternative. If no formulary alternatives are available, can skip.]

   Exclusion

6. Drug is a Less Than Effective Drug (DESI 5 or 6)
7. Drug is covered under LTC or ESRD dialysis per diem
8. Cosmetic uses
9. Experimental or investigative uses

10. Drug is not excluded from Medicare or Medicaid coverage.

    References

11. Medicare Benefit Policy Manual. Chapter 15 – Covered Medical and Other Health Services.
    https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c15.pdf

    Review History 5/14/2019 HB: New 12/1/2025 AP: Separated oncology and non-oncology indication