Prior authorization for hypertonic saline (3% and 7%)
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MedImpact is implementing prior authorization requirements for specified hypertonic saline NDCs effective April 1, 2026 for Kentucky Medicaid; this affects prescribers and pharmacies dispensing the listed products. Grandfathering is provided for members with recent paid claims through May 1, 2026.
Prior authorization (PA) criteria will be implemented for the covered hypertonic saline NDCs effective April 1, 2026.
Members with at least one paid claim for hypertonic saline between Nov 1, 2025 and Feb 1, 2026 are grandfathered through May 1, 2026.
Specific covered NDCs and approval durations/diagnosis criteria are listed for NEBUSAL, PULMOSAL, and multiple sodium chloride 3% and 7% vials.
Coverage Criteria
Product-specific approval criteria
Covered when ALL of the following are met for the specified products:
PA required except for grandfathered members
Grandfathering
Grandfathering:
After May 1, 2026 these members must obtain a new PA or transition therapy
For diagnoses not specifically listed in this policy, prescribers are encouraged to submit a prior authorization request along with supporting clinical literature to demonstrate medical necessity. This encouragement applies to hypertonic saline requests where the member’s diagnosis falls outside the enumerated ICD‑10 groups; submission of evidence may assist review and coverage determination.
This policy implements prior authorization requirements for the listed hypertonic saline NDCs effective April 1, 2026. Members who are new starts or who did not fill hypertonic saline between Nov 1, 2025 and Feb 1, 2026 will require PA beginning on that date. Members with at least one paid claim in that window will be grandfathered through May 1, 2026, after which a new PA or transition to an alternative therapy will be required as appropriate.
Initial Therapy Prior Authorization
Initial therapy PA requirement
New starts on or after Apr 1, 2026
PA required starting April 1, 2026 for listed hypertonic saline NDCs
Continuation / Grandfathering Criteria
Grandfathered continuation
Members with existing paid claims during the specified window are temporarily continued:
Post May 1, 2026 require new PA or therapy transition
Coding and Billing
| 50190014263 | NEBUSAL 3% VIAL |
| 00378699789 | SODIUM CHLORIDE 3% VIAL |
| 50190074060 | PULMOSAL 7% VIAL |
| 50190014123 | SODIUM CHLORIDE 7% VIAL |
| 83490030760 | SODIUM CHLORIDE 7% VIAL |
| 50190014263 | NEBUSAL 3% VIAL — Approval Duration: 12 months |
| 00378699789 | SODIUM CHLORIDE 3% VIAL — Indication: Cystic fibrosis (ICD-10 group E84) |
| 50190074060 | PULMOSAL 7% VIAL — Indication: Cystic fibrosis (ICD-10 group E84) |
| 50190014123 | SODIUM CHLORIDE 7% VIAL — Indication: Bronchiectasis (ICD-10 group J47) or Congenital bronchiectasis (Q33.4) |
| 83490030760 | SODIUM CHLORIDE 7% VIAL — Indication: Acute bronchiolitis (ICD-10 group J21) |
Actions for Prescribers and Pharmacies
Prior authorization required for listed hypertonic saline NDCs
Prior authorization is required beginning April 1, 2026 for the listed hypertonic saline NDCs for members who are new starts or who did not fill hypertonic saline between Nov 1, 2025 and Feb 1, 2026. Members with at least one paid claim during Nov 1, 2025–Feb 1, 2026 are grandfathered through May 1, 2026.
- Covered NDCs: 50190014263, 00378699789, 50190074060, 50190014123, 83490030760
- Grandfathered members with a paid claim between Nov 1, 2025 and Feb 1, 2026 retain PA through May 1, 2026
Provider action: submit PA for new starts or members without recent fills
Prescribers and dispensing providers must submit PA requests for the specified hypertonic saline NDCs for any new start or member without a qualifying paid claim in the Nov 1, 2025–Feb 1, 2026 window on or after the April 1, 2026 effective date.
- Ensure the NDC on the prescription matches one of the covered NDCs listed in the policy.
- If a member has a paid claim in the Nov 1, 2025–Feb 1, 2026 window, note that their PA is grandfathered through May 1, 2026.
Submit supporting clinical literature for unlisted diagnoses
For diagnoses not listed in the policy, prescribers are encouraged to submit a prior authorization request with supporting clinical literature to demonstrate medical necessity.
- Include relevant clinical references and documentation of the patient’s condition when requesting PA for off-list diagnoses.
Timing rule: PA required for prescriptions submitted on/after Apr 1, 2026 for new starts
Prescriptions for the listed hypertonic saline NDCs written on or after April 1, 2026 for new starts or for members without a paid claim between Nov 1, 2025 and Feb 1, 2026 must have an approved PA or they may be denied at claim adjudication.
- Prescriptions for covered NDCs include: 50190014263; 00378699789; 50190074060; 50190014123; 83490030760.
- Members with a paid claim during Nov 1, 2025–Feb 1, 2026 do not require PA until after their grandfathered PA expires on May 1, 2026.
Definitions / Diagnosis Codes
Background
Hypertonic saline inhalation solutions at 3% and 7% concentrations are used as mucolytic and airway clearance adjuncts in respiratory conditions. The policy lists these products for use in conditions such as cystic fibrosis (ICD‑10 group E84), bronchiectasis (J47), congenital bronchiectasis (Q33.4), and acute bronchiolitis (J21). Specific products and associated approval criteria or durations are identified (for example, NEBUSAL 3% vial has an approval duration of 12 months when criteria are met).
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