Age Limit Override (Codeine, Tramadol, Hydrocodone)
Customize your policy alerts
Sign up for Peach State Health Plan Policy CP.PMN.138 alerts
Get alerted when Policy CP.PMN.138 changes without checking for updates manually.
Monitor payer policy activity
Defines prior authorization requirements and clinical criteria for use of codeine-, tramadol-, and hydrocodone-containing medications in pediatric and other patients where FDA labeling imposes age limits; applies to Peach State Health Plan lines of business listed in the policy.
Added by-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix D.
Coverage & Clinical Criteria
Initial Therapy - Pain
Covered when ALL of the following are met for pain management
Approval duration: Non-cancer pain - 7 days
Initial Therapy - Cough
Covered when ALL of the following are met for cough treatment
Approval duration: health plan-specific duration of approval, not to exceed 7 days
Continued Therapy
Covered when ALL of the following are met for continued therapy in cancer, sickle cell, or palliative care
Approval duration: 12 months
Not Authorized for Continued Therapy (Other)
Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient supporting documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP.PMN.53 (Medicaid).
Use of codeine-, tramadol-, or hydrocodone-containing products in pediatric patients younger than 12 years of age is a contraindication per this policy and is therefore not authorized. In addition, postoperative management of pain in children younger than 18 years of age following tonsillectomy and/or adenoidectomy is contraindicated and is excluded from coverage. Requests for agents in age groups subject to FDA labeling restrictions require prior authorization and must meet the policy’s stated approval criteria when an override is requested.
Use of these agents for pain following tonsillectomy or adenoidectomy is explicitly disallowed; post‑tonsillectomy/post‑adenoidectomy pain is not an authorized indication under this policy. Additionally, continued therapy requests for cough or for non‑cancer, non‑sickle cell, non‑palliative pain will not be authorized, because underlying causes must be addressed with appropriate therapy.
The policy lists specific contraindicated populations in Appendix C. These include: children younger than 12 years; postoperative management in children younger than 18 years after tonsillectomy/adenoidectomy; significant respiratory depression; acute or severe bronchial asthma in unmonitored settings or without resuscitative equipment; concurrent or recent (14 days) use of monoamine oxidase inhibitors (MAOIs); known or suspected gastrointestinal obstruction including paralytic ileus; and hypersensitivity to the active ingredient. Use in any of these populations is contraindicated and therefore not authorized under this policy.
Provider Responsibilities & Authorization Rules
Prior authorization required for specified pediatric age groups
Prior authorization is required for codeine-, tramadol-, and hydrocodone-containing medications in the specified pediatric age groups due to FDA labeling: codeine-containing medications for pain are contraindicated in pediatric patients younger than 12 years and in patients <18 years for post-tonsillectomy/post-adenoidectomy pain; tramadol-containing medications are not indicated for pain in patients <18 years (contraindicated <12 years and <18 years for post-tonsillectomy/post-adenoidectomy); and codeine- and hydrocodone-containing cough products are not indicated in pediatric patients <18 years.
Approval duration rules by indication
Approval durations vary by indication: approvals for non-cancer pain are limited to 7 days, while approvals for cancer, sickle cell disease, or palliative care are granted for 12 months.
Use age/weight dosing guidance when requesting an override
Age- and weight-based dosing regimens and dose limits are provided in the policy as therapeutic-alternative guidance and may be used to support an override request; providers should reference those dosing tables when proposing dose-based justification.
Step therapy: failure of ≥2 non-opioid agents required
For pain, prior authorization requires documented failure of at least two non-opioid ancillary treatments at up to maximally indicated doses unless clinically significant adverse effects or contraindications exist; for cough, failure of at least two agents (dextromethorphan, benzonatate, guaifenesin) at maximally indicated doses is required unless contraindicated.
- Pain examples: NSAIDs, acetaminophen, anticonvulsants, antidepressants at maximally indicated doses
- Cough examples: dextromethorphan, benzonatate, guaifenesin at maximally indicated doses
Step therapy redirection and state-specific bypasses
Step therapy redirection/bypass exceptions apply where state regulations prohibit step therapy in certain oncology settings (see Appendix D); additionally, Illinois HIM requests are exempt from the step therapy requirements effective 1/1/2026 per IL HB 5395.
- See Appendix D for the list of states and specific cancer-stage notes
- IL HIM bypass per IL HB 5395 (effective 1/1/2026)
Required clinical documentation for prior authorization
Providers must submit clinical documentation (such as office chart notes, laboratory results, or other clinical information) demonstrating that the member has met all approval criteria.
- Include documentation of failed therapies, dosing history, and clinician specialty consults when applicable
Ensure documentation aligns with product labeling
Refer to the respective package inserts for dosing and administration; any documentation submitted to support a request should align with the product labeling.
Triggers for denial if approval criteria are unmet
Requests that do not meet the listed approval criteria will be denied — examples include lack of required prior therapies, doses exceeding the health plan's approved quantity limit, non‑FDA indications without off-label documentation, and use for post-tonsillectomy/post-adenoidectomy pain.
- Failure to document ≥2 failed non-opioid agents (pain) or ≥2 failed cough agents (cough)
- Requests that exceed the plan's approved quantity limits
- Non‑FDA indications without appropriate off-label justification per referenced off-label policies
High-risk pediatric/postoperative uses flagged as non-authorized
Use in high‑risk pediatric and postoperative populations is contraindicated and will be considered not authorized: children younger than 12 years (codeine/tramadol contraindications) and postoperative management in children younger than 18 years following tonsillectomy and/or adenoidectomy are expressly flagged as non-authorized.
- Children <12 years: contraindicated for codeine and tramadol
- Post-tonsillectomy/post-adenoidectomy in patients <18 years: not authorized
Initial Approval Criteria
Initial therapy
Combined initial approval criteria — all conditions listed for the requested indication (pain or cough) must be met
Continuation / Renewal Criteria
Continuation - cancer/sickle cell/palliative
Continuation rules and required conditions for members on therapy for cancer, sickle cell disease, or receiving palliative care
Step Therapy Requirements & Exceptions
| Required prior therapy / condition | Applies to |
|---|---|
| Failure of at least two non-opioid ancillary treatments (e.g., NSAIDs, acetaminophen, anticonvulsants, antidepressants) at up to maximally indicated doses unless clinically significant adverse effects or all are contraindicated | |
| For pain: Failure of at least two age-appropriate opioid analgesics (e.g., morphine, oxycodone), unless clinically significant adverse effects or all are contraindicated | |
| Request is for treatment associated with cancer in a State with regulations against step therapy (see Appendix D) — satisfies step requirement | |
| Failure of at least two of the following for cough at up to maximally indicated doses unless clinically significant adverse effects or all are contraindicated: dextromethorphan, benzonatate, guaifenesin | |
| Use is not for pain post-tonsillectomy or post-adenoidectomy (exclusion) | |
| Dose does not exceed health plan's approved quantity limit |
| State | Redirection/Step therapy bypass notes |
|---|---|
| FL | |
| For stage 4 metastatic cancer and associated conditions; step therapy prohibited per state regulation | |
| GA | |
| For stage 4 metastatic cancer; step therapy prohibited per state regulation | |
| IA | |
| For standard of care stage 4 cancer drug use supported by peer‑reviewed, evidence‑based literature and FDA approval; step therapy prohibited | |
| LA | |
| For stage 4 advanced, metastatic cancer or associated conditions; step therapy prohibited | |
| MS | |
| Applies to HIM requests only; for advanced metastatic cancer and associated conditions; step therapy prohibited | |
| NV | |
| For stage 3 and stage 4 cancer patients for a prescription drug to treat the cancer or any symptom thereof; step therapy prohibited | |
| OH | |
| Applies to Commercial and HIM requests only; for stage 4 metastatic cancer and associated conditions; step therapy prohibited | |
| OK | |
| For stage 4 metastatic cancer and associated conditions; applies to HIM requests only in some provisions; step therapy prohibited | |
| PA | |
| For stage 4 advanced, metastatic cancer; step therapy prohibited | |
| TN | |
| For advanced metastatic cancer and associated conditions; step therapy prohibited | |
| TX | |
| For stage 4 advanced, metastatic cancer and associated conditions; step therapy prohibited | |
| IL (HIM) | |
| Per IL HB 5395: step therapy requirements (redirection) do not apply to HIM requests as of 1/1/2026; policy updated to add this bypass |
Quantity & Dosing Limits
Definitions & Therapeutic Alternatives
Background & Rationale
Codeine- and tramadol-containing medications are indicated for management of mild to moderate pain when alternatives are inadequate; codeine- and hydrocodone-containing products are also used for relief of cough in adults. However, these agents carry important safety concerns including boxed warnings for risks of misuse, abuse, addiction, overdose and life‑threatening respiratory depression. Pediatric safety risks are emphasized: codeine and tramadol are contraindicated in children younger than 12 years, and codeine-/hydrocodone‑containing cough products are not indicated in pediatric patients younger than 18 years. These safety considerations underlie the prior authorization, age‑based restrictions, short approval durations for non‑cancer pain (7 days), and the requirement that continuation beyond initial therapy is reserved for cancer, sickle cell disease, or palliative care where specified.
Policy Changes & Revision History
Updated IL HIM 5395 bypass language by removing phrase 'do not apply to formulary agents' related to step therapy exceptions.
Added by-passing of step therapy redirection in states that prohibit step therapy for certain oncology settings and added Appendix D; added step therapy bypass for IL HIM per IL HB 5395.
2Q 2024 annual review: limitations of use added to FDA approved indications section; references reviewed and updated.
2Q 2023 annual review: references reviewed and updated; no significant clinical changes.
Template changes applied to continued therapy section.
2Q 2022 annual review: references reviewed and updated; no significant clinical changes.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.