CurrentUnitedHealthcarePolicy N/A

Oral Cystic Fibrosis Agents Prior Authorization

Prior authorization request form and clinical criteria for coverage of oral cystic fibrosis agents for members in Washington; intended for providers requesting new or continuation therapy.

Policy Summary

PayerUnitedHealthcare

PolicyOral Cystic Fibrosis Agents Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (for new starts or continuation) via fax to 866-940-7328 with required genotype and prior medication trial documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PA requiredRequests for oral CF agents

FaxSubmission route

PhoneProvider questions

Mutation listGenetic mutations referenced

Coverage Criteria for Oral Cystic Fibrosis Agents

Initial Therapy

Covered when ALL of the following are met

Member and request: Member has a diagnosis of cystic fibrosis and provider submitted a complete prior authorization form for either new or continuation therapy.

support: Sections A-C

Genotype requirement: Either confirmation of two copies of F508del (homozygous) OR documentation of at least one CFTR mutation responsive to the requested medication.

support: Clinical and Drug Specific Information

Prior therapy requirement: Patient has demonstrated failure or intolerance to a majority of the preferred oral cystic fibrosis agents; when yes, prior trials must be documented in Section D with medication name, dates of therapy, and reason for discontinuation.

support: Clinical and Drug Specific Information and Section D

Policy Summary

PayerUnitedHealthcare

PolicyOral Cystic Fibrosis Agents Prior Authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form (for new starts or continuation) via fax to 866-940-7328 with required genotype and prior medication trial documentation.

SourceLink

On This Page

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Provider Submission and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for both new starts and continuation of oral cystic fibrosis agents. Submit a completed Prior Authorization Request Form via fax to 866-940-7328 or call 800-310-6826 with questions. Allow at least 24 hours for review. Incomplete submissions or requests missing required form sections (Sections A–E) may be delayed or denied.

Prior authorization required for new starts and continuation of therapy
Fax: 866-940-7328
Phone: 800-310-6826
Allow at least 24 hours for review

Documentation Required

Required Form Fields

The completed form must include member demographics, provider information (including NPI), and full medication details. Required fields include: member name, member ID, address, phone, DOB, allergies, primary insurance; request type (new or continuation) and start/discharge dates if applicable; provider name, address, phone, fax, NPI, specialty; medication name, strength, directions, quantity, ICD-10 diagnosis code; and documentation of prior medication trials in Section D.

Section A: Member demographics (First/Last name, Member ID, DOB, contact, allergies, primary insurance)
Section B: Provider information (Name, M.D./D.O. status, address, phone, fax, NPI #, specialty, office contact)
Section C: Medication details (Medication, strength, directions, quantity, diagnosis and ICD-10 code, pregnancy status)
Section D: Previous medication trials — list medication name, strength, directions, dates of therapy, and reason for failure/discontinuation
Section E: Explanation why preferred medications are not appropriate; reference the patient's PDL for preferred alternatives

Documentation Required

Genetic Testing Documentation

Genetic testing documentation is required to support the requested cystic fibrosis agent. Provide confirmation of CFTR genotype: either documentation that the patient is homozygous for F508del (two copies of F508del) OR documentation of at least one CFTR mutation that is known to be responsive to the requested medication. Include specific mutation(s) and test report details.

Confirm 2 copies of F508del mutation (homozygous F508del) OR
Document at least one CFTR mutation responsive to the requested medication (include mutation notation and lab report)

Step Therapy

Preferred Agent Failure Requirement

Documented failure or intolerance to a majority of preferred oral cystic fibrosis agents is required for approval of non-preferred agents. Complete Section D with each prior trial’s medication, dose, dates of therapy, and specific reason for discontinuation or failure. If the patient meets criteria for continuation of therapy, include objective evidence of benefit (e.g., improved FEV1 or disease stabilization) and the original start date.

Has the patient demonstrated failure or intolerance to a majority of preferred oral CF agents? (Yes/No) — if yes, complete Section D
For each prior trial provide dose, dates, and reason for failure/intolerance
For continuation requests, provide evidence of clinical benefit (e.g., significant FEV1 improvement or disease stabilization) and treatment start date

Definitions

F508del homozygous — Definition & documentation

DefinitionConfirmation that the patient has two copies of the F508del mutation in the CFTR gene (patient is homozygous for F508del).

Required documentationProvider must indicate on the form whether the patient has confirmation of 2 copies of the F508del mutation (Yes/No).

Where to provideDocument the genotype in the Clinical and Drug Specific Information section of the prior authorization form; attach genetic test results as available.

Consequence of absenceLack of confirmation of F508del homozygosity may result in the request not meeting the genotype requirement for coverage consideration.

Responsive CFTR mutation — Definition & documentation

DefinitionAt least one documented mutation in the CFTR gene that is responsive to the requested medication potentiation.

Required documentationProvider must indicate on the form whether the patient has documentation of at least one CFTR mutation responsive to the requested medication (Yes/No).

Where to provideRecord responsive mutation details in the Clinical and Drug Specific Information section and include supporting genetic test results when available.

Role in coverageDocumentation of a responsive CFTR mutation satisfies the genotype requirement alternative to F508del homozygosity for initial coverage consideration.

OpenPayer

Oral Cystic Fibrosis Agents Prior Authorization

Coverage Criteria for Oral Cystic Fibrosis Agents

Diagnosis and Billing Codes

Provider Submission and Documentation Requirements

Background

Definitions