ModifiedColorado Rocky Mountain Health PlansPolicy 2025 P 2141-8

Opioid-containing cough medicines - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Defines prior authorization and medical necessity criteria for opioid-containing cough and cold products (codeine- or hydrocodone-containing) for UnitedHealthcare Commercial Plans; governs approvals, required attestation, contraindications, trial of non-opioid remedies, and authorization duration. Effective date listed as 2025-08-01 in header.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyOpioid-containing cough medicines - Prior Authorization/Medical Necessity - UnitedHealthcare Commercial Plansopen_in_new

Policy CodePolicy 2025 P 2141-8

Change TypeModified (Hycodan added; effective date set)

Effective DateAug 1, 2025

Next Review Date

Key ActionPrescriber must attest awareness of FDA contraindications for use in patients <18 years old and document medical necessity rationale for the requested opioid-containing cough product.

SourceLink

POLICY UPDATE CHANGES

Effective Date set to 8/1/2025 and Hycodan added to scope.

Removed TussiCaps, Tuzistra XR, Obredon, Zutripro as they are no longer on the market.

Annual reviews and reference updates performed on multiple dates (3/2019, 8/2019, 8/2020, 8/2021, 3/2023).

1Authorization Duration

>=18Age threshold for automatic processing

3/2018-5/2025P&T Approval Dates Range

Coverage Summary

Defines prior authorization and medical necessity criteria for opioid-containing cough and cold products (codeine- or hydrocodone-containing) for UnitedHealthcare Commercial Plans; governs approvals, required attestation, contraindications, trial of non-opioid remedies, and authorization duration. Effective date listed as 2025-08-01 in header (Program Number 2025 P 2141-8). Coverage for patients aged >= 18 years will process automatically.

Key thresholds and stats

Age for automatic processing>= 18 years

Authorization Duration1 month

P&T Approval Dates Range3/2018 - 5/2025

Medical-Necessity Criteria

Authorization (Initial and Reauthorization)

Opioid-containing cough and cold products will be approved based on all of the following criteria:

Prescriber attestation: Prescriber attests they are aware of FDA labeled contraindications regarding use of opioid-containing cough and cold products in patients less than 18 years of age and feels the treatment with the requested product is medically necessary (Document rationale for use).
Prescriber attestation and documented rationale required.
Contraindication screening: 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).
Any listed comorbid condition would contraindicate approval.
Prior trial requirement: Patient has tried and failed at least one non-opioid containing cough and cold remedy.
Document trial and failure of non-opioid remedy.

Coding / Scope

In-Scope Medications (examples listed)mixed

Tuxarin ER	Example opioid-containing cough product added to scope (brand name)
codeine/phenylephrine/promethazine	Combination opioid cough product (example)
codeine/promethazine	Combination opioid cough product (example)
hydrocodone/homatropine	Combination opioid cough product (example)
hydrocodone bitartrate/guaifenesin	Combination opioid cough product (example)
hydrocodone polistirex/chlorpheniramine polistirex	Combination opioid cough product (example)
hydrocodone bitartrate/chlorpheniramine	Combination opioid cough product (example)
Hycodan	Added to scope (brand name)

Removed/No Longer Marketed Products (contextual historical list)mixed

Obredon	Removed as no longer on the market
Zutripro	Removed as no longer on the market
Tuzistra XR	Removed as no longer on the market
TussiCaps	Removed as no longer on the market

Provider Actions & Billing Impact

Prior Authorization

Prescriber attestation and documentation required

Prescriber must attest awareness of FDA contraindications for use in patients under 18 and document medical necessity rationale for the requested opioid-containing cough product.

Prior Authorization

Contraindication screening required

Provider must verify and document that the patient does not have comorbid conditions that may increase risk of respiratory depression (examples: asthma, other chronic lung disease, sleep apnea, BMI > 30).

Background & Evidence

FDA labels opioid (codeine or hydrocodone) containing cough and cold products for use in adults 18 years of age and older and advises limiting use in children younger than 18 due to serious risks. For patients >= 18 years, coverage will process automatically; for patients <18 years the prescriber must attest awareness of FDA contraindications, document medical necessity, confirm the patient does not have comorbid conditions that increase risk for respiratory depression (examples: asthma or other chronic lung disease, sleep apnea, BMI > 30), and document trial and failure of at least one non-opioid remedy. Authorization is issued for one month, and UnitedHealthcare may use automated approval based on prior claims/medication history or diagnosis codes where applicable.

Source	Detail
{"text":"FDA Drug Safety Communication","status":""},{"text":"FDA requires labeling changes limiting use to adults 18 years and older (Jan 11, 2018).","status":""}
{"text":"Clinical reference","status":""},{"text":"UpToDate: Approach to Chronic Cough in Children (Oct 2024).","status":""}

Definitions

Opioid-containing cough and cold products: Prescription cough and cold products that contain codeine or hydrocodone.

Revision History

2018-03created

Program created (New program). P&T Approval Date 3/2018.

2019-03review

Annual review and updated references. P&T Approval Date 3/2019.

2019-08update

Annual review and updated references. P&T Approval Date 8/2019.