CurrentColorado Rocky Mountain Health PlansPolicy N/A

Transmucosal Immediate‑Release Fentanyl (TIRF) Prior Authorization / Coverage Criteria

Coverage and prior authorization requirements for Abstral, Actiq, Fentora, Lazanda, Onsolis, and Subsys (fentanyl sublingual/tablet/film/lozenge/nasal spray) for members; governs prescribers and pharmacies submitting PA for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTransmucosal Immediate‑Release Fentanyl (TIRF) Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with patient and prescriber details, current opioid therapy history (drugs/doses/dates/outcomes), required medical records, labs, and verification of restricted distribution program enrollment when applicable.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsmaximum approval length

5 yearsprovider record retention requirement

1-866-940-7328fax number for PA form

1-800-310-6826Pharmacy PA Call Center

Coverage Criteria for Fentanyl Transmucosal Products

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTransmucosal Immediate‑Release Fentanyl (TIRF) Prior Authorization / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

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Authorization criteria

Covered when ALL of the following are met

PA form and documentation: Completed PA form submitted with patient identifiers and prescriber information and required supporting documentation (copies of medical records, diagnostic evaluations, recent chart notes, and most recent related labs)

Form must be completed in full; incomplete form may be returned. Provider must retain documentation for five years.

Opioid therapy: Patient is currently receiving routine short-acting AND long-acting opioid analgesic therapy and current opioid therapy history is provided (drug names, doses, start/end dates, and outcomes)

Progress notes or medical records must verify history and therapeutic outcomes of trials.

Indication and prescriber specialty: Documentation of existing cancer diagnosis OR prescribing physician specialty related to oncology/pain management as indicated on the form

Form queries both cancer status and prescriber specialty.

Restricted distribution enrollment: Documentation verifying enrollment in restricted drug distribution program submitted when required

Must attach verification of enrollment to the PA when applicable.

The PA form does not include any standalone exclusion statements. There are no explicit entries on the form that list drugs, indications, or circumstances that are categorically excluded from coverage; instead, coverage is conditioned on completion of the form and submission of the required clinical documentation (e.g., opioid therapy history, cancer status, prescriber specialty, and enrollment verification when applicable).

Providers should follow the authorization criteria and submit the requested supporting records; missing or incomplete information may result in return of the form or denial (see provider actions and documentation requirements).

The document contains no explicit "Not Medically Necessary" statements or language labeling any use of the listed transmucosal fentanyl products as non‑medical‑necessity. Instead, approval is determined by whether the form is fully completed and the required clinical information is supplied to demonstrate meeting the authorization criteria.

Prior Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization requires submission of the completed form including patient and prescriber details, current opioid therapy history, documentation of restricted distribution program enrollment when applicable, and the provider's signature. Note: form must be completed in full; an incomplete form may be returned.

Fax completed form to 1-866-940-7328
Pharmacy PA Call Center: 1-800-310-6826
Provider must retain copies of all documentation for five years

Documentation Required

PA Form and Required Clinical Information

Completed PA form must include patient identifiers (Recipient's Medicaid ID#, full name, DOB), prescriber information (full name, NPI, phone, fax), and prescriber's signature and date. An incomplete PA form may be returned and failure to submit required documentation may result in denial.

Patient: Recipient's Medicaid ID#, Full Name, Date of Birth
Prescriber: Full Name, NPI, Phone Number, Fax Number, Signature, Date

Documentation Required

Required Documentation for PA

Required documentation for prior authorization review: the fully completed PA form plus copies of medical records (diagnostic evaluations and recent chart notes), the most recent related laboratory results, and documentation verifying enrollment in a restricted drug distribution program when applicable.

Completed PA form
Copies of medical records (diagnostic evaluations and recent chart notes)
Most recent related labs
Documentation of restricted distribution program enrollment (if applicable)

Documentation Required

Opioid Therapy Documentation

The PA form requests documentation of trials of short-acting and long-acting opioid therapy and the therapeutic outcomes. Providers must list current opioid therapy with drug name, dose, start and end dates, and outcome, and submit progress notes or medical records to verify history and outcomes.

Indicate whether patient is currently receiving both short-acting and long-acting opioid analgesics on a routine basis (Yes/No)
Provide current opioid therapy details: Drug, Dose, Start & End dates, Outcome (repeatable for multiple drugs)
Submit progress notes or medical records for verification of trials and outcomes

Documentation of Prior Opioid Trials and Outcomes

Documentation of trials/outcomes of prior opioid therapy

Required documentation of prior/concurrent opioid therapy and outcomes

Current opioid regimen: Patient currently receiving both short-acting and long-acting opioid analgesics on a routine basis (Yes indicated on form)

Form asks explicitly whether patient is currently receiving both short-acting and long-acting opioids.

Opioid trial history: Provide current opioid therapy details including drug name, dose, start and end dates, and outcomes for each trial

Progress notes or medical records must be provided for verification of history and therapeutic outcomes, as required on the form.

Supporting records for verification: Attach copies of medical records (diagnostic evaluations and recent chart notes) and the most recent related labs to verify opioid trials and outcomes

Required documentation must be submitted with the PA; provider must retain copies for five years.

Approval Length and Frequency Limits

Frequency limits — fentanyl transmucosal products listed on form

Products coveredAbstral, Actiq, Fentora, Lazanda, Onsolis, Subsys (fentanyl sublingual tablet, oral transmucosal lozenge, buccal tablet, nasal spray, buccal soluble film, sublingual spray)

Maximum approval lengthThree months per approval

Approval period noteMaximum Length of Approval = Three Months (as stated on form)

Form completion requirementForm must be completed in full; an incomplete form may be returned

Provider retention of recordsProvider must retain copies of all documentation for five years

Definitions and Restricted Programs

Restricted drug distribution program — enrollment verification required

Program requirementRestricted drug distribution program enrollment must be completed when required; documentation verifying enrollment must be submitted with the PA form

Form questionPA form asks: 'Has restricted drug distribution program enrollment been completed?' with Yes/No response

Required attachmentsDocumentation verifying enrollment must be attached to the PA submission

Consequence of missing documentationAn incomplete form (including missing verification) may be returned, risking denial

Supporting documentation retentionProviders must retain documentation for five years

Background on Transmucosal Immediate-Release Fentanyl (TIRF)

Transmucosal immediate‑release fentanyl (TIRF) products — including Abstral, Actiq, Fentora, Lazanda, Onsolis, and Subsys in their various transmucosal and nasal formulations — are potent opioid analgesics indicated for management of breakthrough pain in opioid‑tolerant patients. The PA form requests confirmation that the patient is receiving routine short‑acting and long‑acting opioid therapy and requires documentation of current opioid therapy (drugs, doses, start/end dates, and outcomes) to verify opioid tolerance and prior treatment trials. The form also queries existing cancer diagnosis, prescriber specialty related to oncology/pain management, and enrollment in any restricted drug distribution program; verification of enrollment must be attached when applicable.

OpenPayer

Transmucosal Immediate‑Release Fentanyl (TIRF) Prior Authorization / Coverage Criteria

Coverage Criteria for Fentanyl Transmucosal Products

Prior Authorization and Documentation Requirements

Documentation of Prior Opioid Trials and Outcomes

Approval Length and Frequency Limits

Definitions and Restricted Programs

Background on Transmucosal Immediate-Release Fentanyl (TIRF)

Not Covered