Opioid Analgesics
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Defines medical necessity, prior authorization, and approval criteria for opioid analgesic therapy (short-term, transition to long-term, and continued therapy) for Delaware First Health members (Medicaid line of business). Applies to providers requesting opioid prescriptions and prior authorizations.
By-passing of redirection if state regulations do not allow step therapy in certain oncology settings along with Appendix E was added.
For New Jersey, removed the temporal limitation tying naloxone prescribing to the COVID-19 State of Emergency or the Public Health Emergency; naloxone requirement is now ongoing.
Added by-passing of redirection if state regulations do not allow (step therapy) and added oncology-related exceptions in Appendix D/E updates.
Coverage Criteria for Opioid Analgesics
Initial Short Term Therapy
Covered when ALL of the following are met (Short Term Therapy — prior authorization NOT required):
Initial Cancer/Sickle Cell/Palliative Approval
Covered when ALL of the following are met (special populations):
Transitioning to Long-Term Therapy
Covered when ALL of the following are met (transition to long-term therapy or extended-release agents):
Continued Therapy for Cancer/Sickle Cell/Palliative
Covered when ALL of the following are met (continued therapy for special populations):
Continued Long-Term Therapy
Covered when ALL of the following are met (continued long-term therapy):
The policy does not list any additional "Other diagnoses/indications" that would alter coverage decisions in this section. Specifically, the document states "Other diagnoses/indications - Not applicable" and likewise lists "Diagnoses/Indications for which coverage is NOT authorized: Not applicable", indicating there are no separate excluded diagnoses specified in these portions of the criteria.
Providers should therefore follow the detailed approval criteria for short-term, transition to long-term, and continued therapy (including the cancer/sickle cell/palliative pathways) when determining if a request meets medical necessity; absent a listed exclusion in these sections, denials should be based on failure to meet the stated criteria rather than on diagnosis-based exclusions.
The policy recognizes state-specific restrictions on step therapy (redirection) for oncology indications. A number of states are documented as prohibiting redirection for stage 4/advanced metastatic cancer and associated conditions (examples include FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX), and notes enumerate the specific scope or exceptions for each state.
Operational updates clarify that where state law or regulation disallows step therapy for these oncology situations, the policy will permit by-passing of redirection (see Appendix E). The document also records recent changes to the policy to explicitly add by-passing of redirection when state regulations do not allow step therapy in certain oncology settings.
Conservative Treatment and Trial Requirements
Provider Actions, Prior Authorization, and Documentation
Obtain prior authorization for >28 days or extended‑release agents
Prior authorization is required for opioid requests that do not meet the Short Term Therapy criteria (I.A), for requests >28 days supply, and for extended‑release opioids unless the request is for cancer, sickle cell disease, or palliative care.
- Short Term Therapy (no PA) applies only when ALL I.A criteria met; otherwise PA is required.
- Requests for >28 day supply or for extended‑release agents will be evaluated under transition/long‑term criteria.
Submit required documentation for long‑term therapy approvals
For transition to long‑term therapy and continued long‑term therapy approvals providers must document chronic opioid use history, inability to discontinue (for continued therapy), limits on concurrent opioids, and justification for doses ≥90 MME/day (or >120 MME/day for HI) including attempted taper or pain‑specialist involvement.
- Document prior short‑term therapy history or ≥28 days use in last 90 days as applicable.
- Provide evidence of inability to discontinue for continued therapy.
- For doses ≥90 MME/day (or >120 MME/day for HI) supply dose‑reduction, recent taper attempt (with reasons for failure), medical justification, or pain specialist prescription/consultation.
Follow state‑specific step therapy exceptions for oncology
Step therapy (redirection) is prohibited for specified oncology indications in multiple states; state‑specific exceptions (see Appendix E) bypass redirection when state regulations disallow step therapy for cancer or advanced/metastatic disease.
- State list in Appendix E identifies states and the scope of prohibition (e.g., FL, GA, IA, IN, LA, MS, NV, OH, OK, PA, TN, TX).
- When state regulations prohibit step therapy for oncology indications, step requirements are not required (see policy Appendix E).
Trial of preferred drugs (typically two) required before non‑preferred/long‑acting agents
Many approvals require trial and failure of preferred drugs (typically two) before coverage of non‑preferred or certain long‑acting agents; exceptions apply for cancer, sickle cell disease, palliative care, or state prohibitions.
- Initial and continued approvals often accept either a preferred drug request or documentation that the member failed two or more preferred drugs.
- For transitions to long‑acting or extended‑release agents, documented failure of immediate‑release opioid may also be required.
- Exceptions: cancer/sickle cell/palliative indications or states with oncology step‑therapy prohibitions.
Oncology step therapy is limited in specified states
Several states prohibit redirection/step therapy for stage‑4 or advanced metastatic cancer and related conditions; the policy operationalizes bypass of step therapy in those states and references the Appendix for details.
- States and scope are enumerated (e.g., FL: stage 4 metastatic cancer; GA: stage 4 metastatic cancer; PA/TN: stage 4 advanced metastatic cancer, etc.).
- Appendix D/E contain operational details and exceptions where step therapy may be bypassed.
Submit office chart notes and clinical records with PA requests
Providers must submit supporting clinical documentation—such as office chart notes, lab results, or other clinical information—demonstrating that the member meets all applicable approval criteria.
- Include chart notes, relevant labs, and any documentation showing trials/failures of preferred drugs or taper attempts as applicable.
- Clinical rationale required for concurrent use of >2 opioids.
Document PDMP review for transition and continued long‑term approvals
Documentation that the provider has reviewed the state Prescription Drug Monitoring Program (PDMP) is required for transitioning to long‑term therapy and for continued long‑term therapy approvals.
- Provide PDMP review evidence to identify concurrently prescribed controlled substances.
- PDMP documentation is listed as an explicit criterion for transition and continued long‑term approvals.
Use the drug’s package insert for dosing and availability
Refer to the requested drug’s package insert for information on appropriate dosing, administration, and product availability; the policy directs prescribers to labeling for these details.
- Use manufacturer package insert for dosing and administration guidance.
- Refer to the package insert for product availability questions.
PA required and denial risk if Short Term criteria are unmet
Requests that do not meet the Short Term Therapy criteria (I.A) require prior authorization and may be denied if the approval criteria are not met.
- Short Term Therapy criteria are strict; if any I.A condition is unmet, submit a PA.
- Denial risk exists when PA criteria for long‑term or special populations are not documented.
Risk of redirection or bypass if state step‑therapy rules not followed
Requests may be redirected or bypassed depending on state regulations; failure to comply with state‑specific step therapy exceptions (e.g., oncology exceptions) can result in redirection or denial of the request.
- Policy includes language on bypassing redirection when state regulations disallow step therapy; verify state‑level rules in Appendix E.
- Noncompliance with state exceptions may alter processing (redirection, bypass, or denial).
Dosage Thresholds, Supply Limits, and Coding Notes
Key Definitions
Background
Opioid analgesics act at opiate receptors and are indicated for management of moderate to severe pain. The policy separates short-term and long-term opioid prescribing to reflect differing risks and oversight: short-term therapy (treated as an initial, limited exposure and not requiring prior authorization when all short-term criteria are met) and long-term therapy (treatment courses that extend beyond the short-term limits or involve extended-release products, which require prior authorization and additional documentation).
In operational terms, short-term use is limited by supply and dose thresholds so that requests meeting the Short Term Therapy criteria (including supply duration and a total daily dose ≤ 90 MME/day) do not require prior authorization. Requests that exceed those limits or that seek continued or extended-release therapy move into the long-term pathway and must meet the documented criteria (including trials of conservative treatments, PDMP review, and justification for higher doses or specialist involvement as specified).
Policy Revision History
Added by-passing of redirection when state regulations prohibit step therapy in certain oncology settings and referenced Appendix E; updated references.
Clarified by-passing of redirection if state regulations do not allow step therapy and added oncology-related exceptions (Appendix updates).
Policy effective date recorded as 2022-02-01 with subsequent reviews; (document notes NJ naloxone requirement change during 2Q 2024 review).
2Q 2024 annual review: for New Jersey, removed temporal limitation tying naloxone prescribing to the COVID-19 State of Emergency or Public Health Emergency, making the naloxone requirement ongoing; references reviewed and updated.
2Q 2026 annual review: removed disclaimers referencing a retired fentanyl IR policy, updated Appendix D with revised language and exception for Tennessee, and added Indiana to Appendix D; references reviewed and updated.
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