CurrentColorado Rocky Mountain Health PlansPolicy 2025 P 2141-8

Opioid-containing cough and cold products — prior authorization

Defines prior authorization and medical necessity requirements for prescription opioid-containing cough and cold products (codeine- or hydrocodone-containing); primarily affects prescribers and pharmacy benefit administrators. Applies to adults and specifies restrictions for patients under 18.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOpioid-containing cough and cold products — prior authorization

Policy CodePolicy 2025 P 2141-8

Change TypeNo material change

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization with prescriber attestation of FDA contraindication awareness, documentation of medical necessity, absence of specified high‑risk comorbidities, and proof of failure of at least one non‑opioid remedy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Age allowed without prior additional justification

1 monthAuthorization duration

>=1Non‑opioid remedies required

>30 BMIRespiratory risk example

Multiple

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P&T approval history

Coverage Criteria

Initial Approval

Opioid-containing cough and cold products will be approved when ALL of the following are met:

Initial Approval Criteria: (a) Prescriber attests they are aware of FDA labeled contraindications regarding use in patients <18 years and documents medical necessity (include rationale for use).

Authorization will be issued for one month.

Initial Approval Criteria: (b) Patient does not have a comorbid condition that may impact respiratory depression (e.g., asthma or other chronic lung disease, sleep apnea, body mass index > 30).

Initial Approval Criteria: (c) Patient has tried and failed at least one non-opioid containing cough and cold remedy.

Use of opioid-containing cough and cold products is limited by FDA labeling to adults. These products (codeine- or hydrocodone-containing) are labeled for use in persons 18 years of age and older. Prescribers should exercise caution when considering these medications for patients younger than 18 because of documented serious risks; coverage for members age 18 requires additional clinical justification and prescriber attestation.

Definitions

Opioid-containing cough medicines — examples and substances

Example productsTuxarin ER; codeine/phenylephrine/promethazine; codeine/promethazine; hydrocodone/homatropine; hydrocodone bitartrate/guaifenesin; hydrocodone polistirex/chlorpheniramine polistirex; hydrocodone bitartrate/chlorpheniramine; Hycodan

Included opioid substancesCodeine; hydrocodone

Clinical note on ageFDA-labeled for adults 18 years and older; use in patients younger than 18 should be limited due to serious risks

Initial Therapy Criteria

Initial Therapy

Initial coverage requires meeting the authorization criteria below.

Initial: Prescriber attestation of awareness of FDA labeled contraindications for patients <18 and documentation of medical necessity (rationale); absence of comorbid conditions that increase risk of respiratory depression (e.g., asthma, chronic lung disease, sleep apnea, BMI > 30); and trial and failure of >=1 non-opioid cough/cold remedy.

Authorization will be issued for one month.

Step Therapy

Step	Requirement	Notes
1	Patient must have tried and failed at least one non-opioid containing cough and cold remedy	Required prior to approval of opioid-containing cough and cold products; authorization issued for one month when criteria met

Provider Actions & Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Opioid-containing cough and cold products will be approved only when the prescriber attests they are aware of FDA-labeled contraindications for patients <18 years of age and documents the clinical rationale for use.

Authorization will be issued for one month.
Prescriber must document rationale for use and explicitly attest awareness of FDA contraindications regarding patients under 18.

Step Therapy

Step Therapy Requirement

Patient must have tried and failed at least one non-opioid cough/cold remedy prior to approval.

Document prior trial and failure of at least one non-opioid remedy.

Coding & Clinical Thresholds

BMI and related comorbidity thresholds

BMI threshold (comorbidity increasing respiratory depression risk)> 30

Other example comorbidities listedAsthma or other chronic lung disease; sleep apnea

Authorization duration when criteria metAuthorization will be issued for one month

Background

Opioid-containing cough and cold products (codeine or hydrocodone formulations) are subject to FDA age labeling and safety guidance. The FDA-labeled population for these prescription products is adults age 18 years and older, and use in pediatric populations should be limited because of the potential for serious adverse events. For plan processing, requests for patients age 18 will require prescriber documentation and justification, while coverage for patients age 18 years and older will process automatically per the policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOpioid-containing cough and cold products — prior authorization

Policy CodePolicy 2025 P 2141-8

Change TypeNo material change

Effective DateAug 1, 2025

Next Review Date

SourceLink

On This Page

Documentation Required

Prescriber Attestation & Rationale Required

Prescriber must document the clinical rationale for the requested opioid-containing cough product and attest awareness of FDA labeled contraindications for patients <18 years; include documentation that the patient does not have comorbid conditions that increase risk of respiratory depression.

Attestation: prescriber affirms awareness of FDA contraindications for patients <18 years.
Rationale: clinical justification for use must be entered in the medical record and submitted with the request.
Comorbidities to assess: asthma or other chronic lung disease, sleep apnea, BMI > 30.

Denial Risk

Documentation & Denial Triggers

Clinical documentation must demonstrate prior trial and failure of at least one non-opioid remedy and note absence of comorbid conditions that increase risk of respiratory depression. Requests lacking required attestation, rationale, or documentation of prior trial/comorbidities may be denied.

Document prior trial/failure of ≥1 non-opioid remedy.
Document absence of comorbid conditions that increase respiratory depression risk (e.g., asthma, chronic lung disease, sleep apnea, BMI >30).
Requests may be denied if prescriber fails to attest to FDA contraindications for patients <18 years or if comorbid conditions are present.

Note

Automated Approval/Denial

Authorizations may be auto-approved or auto-denied based on prior claim/medication history, diagnosis codes (ICD-10), and other automated criteria as permitted by program logic.

Automated decisions may use prior pharmacy claims, diagnosis codes, and claim logic.
Use of automated approval/reauthorization varies by program/therapeutic class.