CurrentHealth NetPolicy CP.PMN.138

Age Limit Override (Codeine, Tramadol, Hydrocodone) (PDF)

Prior authorization policy for codeine-, tramadol-, and hydrocodone-containing medications when used in age groups for which FDA labeling restricts use; defines initial and continued therapy criteria for pain and cough indications, approval durations, contraindications, and therapeutic alternatives.

Policy Summary

PayerHealth Net

PolicyAge Limit Override (Codeine, Tramadol, Hydrocodone) (PDF)

Policy CodePolicy CP.PMN.138

Change TypeAnnual reviews and HIM-Arkansas disclaimer added

Effective DateMar 13, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria before PA is granted

SourceLink

POLICY UPDATE CHANGES

2Q 2019 annual review: Updated the initial approval duration for cough to 7 days (or health plan-specific limit) to align with the treatment duration for pain; references reviewed and updated.

Added HIM-Arkansas disclaimer re: coverage when the member has a terminal illness.

2Q 2020 annual review: no significant changes; references reviewed and updated.

3Drug classes governed

2Indication categories

2Approval durations types

Coverage Summary

Scope: Prior authorization policy for codeine-, tramadol-, and hydrocodone-containing medications when used in age groups for which FDA labeling restricts use. The policy defines initial and continued therapy criteria for pain and cough, approval durations (e.g., 7 days for non-cancer pain and cough where health-plan limits apply; 12 months for cancer/sickle cell/palliative care), therapeutic alternatives, contraindications, boxed warnings, and dosing references.

Background: FDA communications and labeling changes have restricted pediatric use of these agents and prompted health-plan prior authorization requirements. The policy requires clinical documentation supporting that members meet the approval criteria, references therapeutic alternatives and dosing guidance, and is implemented as a covered_with_criteria policy for the subject: "Age Limit Override for Codeine, Tramadol, Hydrocodone."

Approval Durations / Dates

Initial approval duration - Non-cancer pain7 days

Initial approval duration - Cancer, sickle cell, or palliative care12 months

Initial approval duration - CoughHealth plan-specific, not to exceed 7 days

Policy effective date (dates.effective)2018-03-13

Policy last review date (dates.last_review)2020-05-20

Medical Necessity Criteria

I. Initial Approval Criteria - Pain

Covered when ALL of the following are met:

ALL of the following

Prescribed for pain management
Prescribed agent is FDA-approved for pain management
Member meets one of the following (a or b)
- a: Failure of at least two non-opioid ancillary treatments (e.g., NSAIDs, acetaminophen, anticonvulsants, antidepressants) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced
- b: Prescribed by or in consultation with an oncologist, hematologist, hospice provider, or pain specialist for cancer, palliative care, or sickle cell disease
Failure of at least two age-appropriate opioid analgesics (e.g., morphine, oxycodone), unless contraindicated or clinically significant adverse effects are experienced
Use is not for pain post-tonsillectomy or post-adenoidectomy
Dose does not exceed health plan's approved quantity limit

I. Initial Approval Criteria - Cough

Covered when ALL of the following are met:

ALL of the following

Diagnosis of cough due to viral or bacterial infection
Prescribed agent is FDA-approved for the treatment of cough
Failure of at least two of the following agents at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced: dextromethorphan, benzonatate, guaifenesin
Member is concurrently receiving appropriate therapy for the underlying cause of the cough (e.g., antihistamines, decongestants, bronchodilators, oral and/or inhaled corticosteroids, antibiotics)
Dose does not exceed the FDA-approved maximum recommended dose

II. Continued Therapy - Cancer, Sickle Cell, or Palliative Care Pain

Covered when ALL of the following are met:

ALL of the following

Currently receiving medication via Centene benefit or member has previously met initial approval criteria
Member is responding positively to therapy
If request is for a dose increase, new dose does not exceed health plan's approved quantity limit

II. Continued Therapy - All Other Indications

Continued therapy for cough, or non-cancer, non-sickle cell or non-palliative care pain will not be authorized as the underlying causes of cough and pain must be treated with appropriate therapy

Not Covered / Exclusions

Explicit exclusions: Use for post-tonsillectomy or post-adenoidectomy pain is not authorized (codeine and tramadol contraindicated in patients <18 years for these postoperative indications).

FDA age-based contraindications: codeine-containing medications for pain are contraindicated in pediatric patients younger than <12 years; tramadol is contraindicated in pediatric patients younger than <12 years and not indicated for pain in patients <18 years; and codeine- and hydrocodone-containing cough/cold products are not indicated for use in patients <18 years.

Continued therapy restrictions: Continued therapy for cough or for non-cancer, non-sickle cell, non-palliative care pain will not be authorized (the underlying causes must be treated with appropriate therapy).

Safety warnings: The policy references boxed warnings and contraindications including risks of misuse/abuse/addiction, serious or life-threatening respiratory depression, accidental ingestion, neonatal opioid withdrawal syndrome, interactions with CYP and CNS depressants, and specific contraindicated populations.

Provider Actions & Requirements

Prior Authorization

Prior authorization required for age-limited opioids

Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that member has met all approval criteria before PA is granted.

Include supporting clinical documentation when submitting prior authorization.

Documentation Required

Clinical documentation for failure of alternatives

Document failure of at least two non-opioid ancillary treatments and failure of at least two age-appropriate opioid analgesics for pain, or failure of at least two specified antitussives for cough.

For pain: failure of at least two non-opioid ancillary treatments (e.g., NSAIDs, acetaminophen, anticonvulsants, antidepressants).
For pain: failure of at least two age-appropriate opioid analgesics (e.g., morphine, oxycodone).
For cough: failure of at least two specified antitussives (dextromethorphan, benzonatate, guaifenesin).

Billing Rule

Dose and quantity limits

Dose must not exceed the FDA-approved maximum recommended dose for cough and must not exceed the health plan's approved quantity limit for pain; requests for dose increases must stay within plan limits.

Cough: dose must not exceed the FDA-approved maximum recommended dose.
Pain: dose/quantity must not exceed the health plan's approved quantity limit.
Dose increases: requests for dose increases must remain within the plan's approved quantity limits.

Documentation Required

Specialist prescriber documentation option

If prescribed by or in consultation with an oncologist, hematologist, hospice provider, or pain specialist for cancer, palliative care, or sickle cell disease, include consultation or specialist documentation.

Specialist consultation or documentation is required when therapy is for cancer, palliative care, or sickle cell disease and the agent is prescribed by or in consultation with an oncologist, hematologist, hospice provider, or pain specialist.

Denial Risk

Post-tonsillectomy/adenoidectomy and age exclusions

Requests will be denied if use is for post-tonsillectomy or post-adenoidectomy pain or if use conflicts with FDA age-based contraindications (examples include codeine/tramadol contraindicated <12 years; opioid cough/cold products not indicated <18 years).

Codeine and tramadol are contraindicated in pediatric patients younger than 12 years.
Codeine and tramadol are contraindicated for post-tonsillectomy and post-adenoidectomy pain in patients less than 18 years.
Codeine- and hydrocodone-containing cough/cold products are not indicated for use in patients younger than 18 years.

Background & Evidence

Background summary: FDA Drug Safety Communications restricted the use of prescription codeine and tramadol in children and required labeling changes for opioid cough/cold medicines limiting use to adults ≥18 years, prompting the policy's age-based prior authorization requirements.

The policy includes boxed warnings and contraindications for pediatric use, significant respiratory depression, postoperative pediatric tonsillectomy/adenoidectomy management, and other safety concerns; it also lists therapeutic alternatives (non-opioid analgesics, antitussives, and adjunct agents) and provides pediatric and adult dosing references in appendices.

Supporting evidence: FDA communications and prescribing information are cited as the evidentiary basis for the restrictions and labeling changes.

Definitions

FDA-approvedIndication or agent has approval by the U.S. Food and Drug Administration for the specified use

HIM-Arkansas disclaimerFor HIM-Arkansas, prior authorization shall not be denied if the member has a terminal illness

Revision History

02.27.19revised

2Q 2019 annual review: Updated the initial approval duration for cough to 7 days (or health plan-specific limit) to align with the treatment duration for pain; references reviewed and updated.

12.09.19added

Added HIM-Arkansas disclaimer: If member has a terminal illness, prior authorization shall not be denied for covered prescription pain medications in HIM-Arkansas.

02.04.20revisedLatest

2Q 2020 annual review: no significant changes; references reviewed and updated.

codeine-containing medications	Includes codeine for pain and codeine-containing cough/cold products
tramadol-containing medications	Includes tramadol for pain
hydrocodone-containing medications	Includes hydrocodone for cough and cold indications

OpenPayer

Age Limit Override (Codeine, Tramadol, Hydrocodone) (PDF)

Coverage Summary

Medical Necessity Criteria

Not Covered / Exclusions

Coding

Provider Actions & Requirements

Background & Evidence

Revision History