Prior Authorization of Antibiotics, Inhaled - Pharmacy Services
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Requirements and clinical review guidelines for prior authorization of inhaled antibiotic prescriptions for providers in the Pennsylvania Medical Assistance fee-for-service program.
No material clinical or coverage changes in this revision.
Coverage Criteria
Medical necessity criteria
Covered when ALL of the following are met
ALL of the following
Primary criteria
- The beneficiary is being treated for a diagnosis that is indicated in the U.S. Food and Drug Administration (FDA)-approved package labeling OR a medically accepted indication.
- The beneficiary is age-appropriate according to FDA-approved package labeling, nationally recognized compendia, or peer-reviewed medical literature.
- The prescribed dose and duration of therapy are consistent with FDA-approved package labeling, nationally recognized compendia, or peer-reviewed medical literature.
For a non-preferred Antibiotic, Inhaled, one of the following must be met:
- Option A: History of therapeutic failure, contraindication, or intolerance to the preferred inhaled antibiotics approved for the beneficiary's diagnosis.
- Option B: Culture and sensitivity test results documenting that only a non-preferred inhaled antibiotic will be effective.
- If the prescription quantity exceeds the quantity limit, the determination will also take into account the guidelines set forth in the Quantity Limits Chapter.
Preferred Drug List (PDL) preferred inhaled antibiotics do not require prior authorization unless the prescription meets other requirement triggers. Specifically, prescriptions for inhaled antibiotics that are non-preferred or that have a prescribed quantity that exceeds the DHS quantity limits must be submitted for prior authorization. See the PDL for preferred agents and the DHS Quantity Limits List for drug-specific limits and quantities.
Prior authorization requests are first reviewed against the clinical guidelines in Section B by prior authorization personnel. If a request does not meet those Section B guidelines, it will be referred to a physician reviewer; the request may be denied if the physician reviewer does not determine, in their professional judgment, that the services are medically necessary.
Coding & Quantity Limits
Provider Actions & Prior Authorization
Prior authorization required for non‑preferred agents or quantities over limits
Prescriptions for inhaled antibiotics that are non‑preferred on the PDL or that exceed DHS quantity limits must be prior authorized before dispensing. Follow the handbook procedures in SECTION I when submitting these requests.
- Non‑preferred Antibiotic, Inhaled requires prior authorization (see PDL).
- Antibiotic, Inhaled with a prescribed quantity that exceeds the DHS Quantity Limits List requires prior authorization.
Document prior therapeutic failure, contraindication, intolerance, or culture/sensitivity
For non‑preferred inhaled antibiotics, prior authorization must include documentation that the beneficiary has had therapeutic failure of, a contraindication to, or intolerance of preferred inhaled antibiotics for the diagnosed condition — or culture/sensitivity results showing only a non‑preferred agent will be effective.
- History of therapeutic failure to preferred inhaled antibiotics for the beneficiary's diagnosis.
- Documented contraindication or intolerance to preferred inhaled antibiotics.
- Culture and sensitivity test results demonstrating only a non‑preferred inhaled antibiotic will be effective.
Follow handbook submission procedures and include required clinical elements
Providers must follow the procedures in SECTION I of the Prior Authorization of Pharmaceutical Services Handbook and include the elements specified in the clinical review guidelines (SECTION II chapter for Antibiotics, Inhaled) when submitting prior authorization requests.
- Use the submission procedures described in Section I of the Provider Handbook (Prior Authorization of Pharmaceutical Services).
- Include the clinical information elements listed in the SECTION II chapter for Antibiotics, Inhaled so DHS can determine medical necessity.
Requests failing guidelines are referred and may be denied
If a request does not meet the clinical guidelines in Section B, prior authorization personnel will refer it to a physician reviewer; if the physician reviewer does not find the request medically necessary, it may be denied.
- Requests failing to meet Section B clinical criteria are escalated to a physician reviewer.
- Physician reviewer may deny the request if, in their professional judgment, the services are not medically necessary.
Step Therapy Requirements
| Requirement | Documentation needed |
|---|---|
| History of therapeutic failure, contraindication, or intolerance to preferred inhaled antibiotics for the beneficiary's diagnosis | |
| Documentation of failure, intolerance, or contraindication (e.g., clinical notes, prior trial details) showing preferred agents were ineffective or not tolerated | |
| Culture and sensitivity results showing only a non-preferred inhaled antibiotic will be effective | |
| Positive culture/sensitivity report demonstrating susceptibility only to the requested non-preferred agent |
Definitions
Background
Arikayce (amikacin liposome inhalation suspension) is included in the inhaled antibiotics class and is FDA-approved for treatment of adults with Mycobacterium avium complex who have limited or no alternative treatment options. The Department updated the medical necessity guidelines to align Arikayce use with FDA labeling and other medically accepted sources to ensure appropriate patient age, dose, and duration when considering coverage.
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