Defines step therapy, quantity limits, and post‑limit prior authorization criteria for extended‑release opioid analgesics for the payer's pharmacy benefit (CVS Caremark policy content presented). Affects prescribers and pharmacists submitting claims for listed ER opioid products.
Key ActionPrescribe or document prior use of an IR opioid (≥8 days in past 90 days) or evidence of ≥30 days on an ER opioid to avoid prior authorization; otherwise submit prior authorization with required clinical documentation.
No material clinical or coverage changes in this revision.
ER opioid classdrug class governed by policy
<90MME threshold for coverage w/o PA
200authorization threshold
IR ≥8d or ER ≥30dstep therapy requirement
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30/90 day
supply durations referenced
Coverage Criteria for Extended‑Release Opioids
General coverage criteria for ER opioids
Covered when therapy is for ALL of the following (classwide statements present):
Indication and necessity: Patient has severe, persistent pain requiring an extended treatment period with a daily opioid analgesic and alternative treatment options (for example, non‑opioid analgesics or immediate‑release opioids) are ineffective, not tolerated, or otherwise inadequate.
Reserve ER opioids for patients who require around‑the‑clock long‑term opioid therapy; follow lowest effective dose principle.
Not PRN use: Therapy is prescribed as scheduled, around‑the‑clock long‑term opioid treatment and not for as‑needed (PRN) analgesia.
ER opioid formulations are not indicated for PRN use.
Product‑specific opioid‑tolerance requirement (where applicable): For certain agents (e.g., fentanyl transdermal system, hydromorphone ER, other labeled products requiring tolerance), the patient is opioid‑tolerant as defined by receiving specified opioid doses for ≥1 week.See opioid‑tolerant definition (≥60 mg oral morphine/day or equianalgesic doses)
Opioid‑tolerant definition must be met when required by the product labeling.
Chronic Pain — Authorization criteria
Covered when ALL of the following are met for chronic pain:
Chronic pain — baseline assessment and monitoring: Patient has chronic pain (typically >3 months) severe and persistent enough to require an extended treatment period with a daily opioid analgesic; the patient can safely take the requested dose based on opioid use history; pain will be reassessed within the first month after initiation or any dose increase and at least every 3 months thereafter; and the patient will be evaluated and monitored regularly for development of opioid use disorder.
Prescribe the lowest effective dose; reserve higher doses only when benefits outweigh risks.
Prior opioid exposure or continuation: The patient has taken an immediate‑release opioid for at least one week OR the request is for continuation of therapy for a patient who has been receiving an extended‑release opioid agent for at least 30 days.
If neither condition is met, initial step therapy criteria apply and prior authorization will be required.
Methadone exception for addiction treatment: If the request is for a methadone product, it is NOT being prescribed for detoxification or as part of maintenance treatment for opioid/substance abuse or addiction.
Cancer/Sickle Cell/Terminal/Hospice
Authorization may be granted when ANY of the following diagnoses/settings apply:
Cancer/sickle cell/terminal/hospice: Requested drug is prescribed for pain associated with cancer, sickle cell disease, a terminal condition, or for pain being managed through hospice or palliative care.
Medical documentation or presence of relevant ICD‑10 codes/hospice patient residence code in the member profile or claim supports this exception.
MME-tiered coverage criteria
Covered when supply quantity and MME tier meet the rules below and Step Therapy criteria are met:
Tier 1 coverage: Requested supply corresponds to <90 MME/day.<90 MME/day
A 30‑day or 90‑day supply corresponding to <90 MME/day is covered without prior authorization when Step Therapy criteria are met.
Tier 2 coverage requiring authorization: Requested supply corresponds to ≥90 and <200 MME/day (unless the minimum FDA‑labeled strength/dose/frequency for the product exceeds 200 MME/day).>=90 and <200 MME/day
Requires prior authorization even when other coverage conditions are met.
Product-specific quantity limits
Specific product limits (examples — full table present in document):
Per-drug quantity limits (examples): The Opioid Analgesics ER Quantity Limits Chart provides product‑ and strength‑specific monthly and 3‑month quantity limits with corresponding approximate MME/day equivalents (examples shown for Belbuca, Butrans, fentanyl transdermal, hydrocodone ER, hydromorphone ER, Hysingla ER, methadone, morphine ER, etc.).product‑specific
These limits accumulate across drugs with the same unit limit and are enforced as quantity‑versus‑time and daily MME edits; see the chart for numeric values and any initial zero (*** ) entries.
Coverage criteria — quantity/MME limits and prior authorization
Covered when dispensing is within the product-specific quantity and daily MME limits; otherwise prior authorization required as indicated.
Standard quantity/MME limits: Dispense only up to the quantity and daily MME limits specified in the Opioid Analgesics ER Quantity Limits Chart for the product and strength.product‑strength‑specific (see chart)
Limits apply as both quantity‑per‑fill and daily dose (MME) edits; durations use 25 days for 30‑day fills and 75 days for 90‑day fills to allow refill processing.
Post‑limit prior authorization required: If the initial limit for the drug/strength is listed as zero (marked with ***) OR the prescribed quantity or daily MME exceeds the charted limit, a post‑limit prior authorization is required.initial limit = zero OR requested MME > chart limit
All requests for strengths with initial limit = 0 are considered through post‑limit prior authorization.
Injectable methadone products (parenteral methadone) are not approved for outpatient treatment of opioid dependence. Parenteral methadone is indicated only for patients unable to take oral medication (for example, hospitalized patients) and is reserved for management of severe, persistent pain when alternatives are inadequate; outpatient use for opioid detoxification or maintenance of addiction is not permitted under this policy.
Methadone tablets are not indicated as an as‑needed (PRN) analgesic and should be reserved for patients requiring daily, around‑the‑clock long‑term opioid treatment when alternative options are inadequate. When methadone products are used for treatment of opioid addiction (detoxification or maintenance), distribution must follow federal requirements (42 CFR Part 8) and applicable program conditions.
Portions of the source material used to derive these criteria are confidential and proprietary CVS Caremark content. The Opioid Analgesics ER Quantity Limits Chart and related policy materials may not be reproduced, distributed, or printed without written permission from CVS Caremark.
Certain product strengths in the Opioid Analgesics ER Quantity Limits Chart are assigned an initial limit of zero (marked in the chart). These strengths are effectively blocked from automated coverage and require a post‑limit prior authorization for any dispensing to be approved.
Extended‑release opioid formulations (including buprenorphine ER products such as Belbuca and Butrans) should be reserved for patients for whom alternative therapies are ineffective, not tolerated, or otherwise inadequate. Use of ER formulations when non‑opioid options or immediate‑release opioids provide acceptable control is inconsistent with product labeling and the policy's intent.
Extended‑release opioid agents are not indicated for PRN (as‑needed) use. These products are intended for scheduled, around‑the‑clock long‑term opioid therapy; prescribing them on an as‑needed basis or for indications where alternatives are appropriate may trigger denial or require prior authorization.
Coding and Definitions for Determinations
Diagnosis codes indicating cancer, sickle cell disease, palliative care, or hospice statusICD-10
ICD-10
diagnosis codes indicating cancer, sickle cell disease, palliative care, or hospice status referenced for benefit determination
Opioid tolerance threshold
Opioid‑tolerant definitionPatients taking for one week or longer at least 60 mg oral morphine per day (or listed equianalgesic doses such as 25 mcg/h transdermal fentanyl, 30 mg oral oxycodone, 8 mg oral hydromorphone, 25 mg oral oxymorphone, 60 mg hydrocodone).
Duration for tolerance assessmentTolerance is defined based on opioid use for ≥1 week.
Use casesRequired for certain agents (e.g., fentanyl transdermal system, hydromorphone ER) per product labeling and chart notes.
MME/day thresholds
Primary MME tiers< 90 MME/day and < 200 MME/day (tiered thresholds used to determine coverage without PA vs. authorization).
Coverage at lower tier
What Providers Must Do / Authorization Triggers
Prior Authorization
Provider Actions / Authorization Triggers
Coverage and authorization triggers for extended‑release (ER) opioid agents in this policy: many ER opioid strengths have quantity limits; some strengths have an initial limit of zero and therefore require post‑limit prior authorization. Claims will reject and require PA when step‑therapy criteria are not met (no prior IR opioid ≥8 days or ER opioid ≥30 days in the past 90 days) or when requested quantities exceed established limits or MME tiers. Use of ER buprenorphine formulations (e.g., Belbuca, Butrans) and other ER opioids should be reserved for patients for whom alternatives (non‑opioid analgesics or IR opioids) are ineffective, not tolerated, or otherwise inadequate. ER opioid products are not indicated for PRN use and are intended for daily, around‑the‑clock opioid therapy only.
Post‑limit prior authorization required for strengths with initial limit of zero — all requests for those strengths will be evaluated via post‑limit PA.
Step therapy initial requirement — patient must have at least an 8‑day supply of an immediate‑release (IR) opioid in the past 90 days OR be continuing on an ER opioid for ≥30 days to avoid PA.
MME tiers and coverage without PA — coverage without prior authorization is provided for 30‑ or 90‑day supplies that correspond to <90 MME/day once Step Therapy criteria are met.
Higher MME tiers — requests corresponding to ≥90 MME/day up to <200 MME/day (for 30‑ or 90‑day supplies) require prior authorization and will be evaluated against clinical criteria.
Very high doses (≈ ≥200 MME/day) generally require PA and may be denied unless FDA‑labeled dosing exceeds that threshold.
Initial Therapy and Step Therapy Rules
Initial therapy rules
Initial step therapy and initial quantity limits apply to the listed ER opioid agents.
Step therapy requirement: Products are subject to step therapy per Opioids ER Step Therapy with MME Limit and Post Limit Policy (2219‑M); initial quantity limits (Column A/Column B) and post‑limit prior authorization rules apply.
Claims will reject and require PA if initial step therapy criteria are not met.
Initial therapy / Step Therapy
Initial therapy and step therapy requirements:
Initial step therapy / prior use requirement: For patients without qualifying cancer/sickle cell/palliative/hospice indicators, the patient must have at least an 8‑day supply of an immediate‑release (IR) opioid in the past 90 days OR be currently stable on an extended‑release (ER) opioid (≥30 days) to avoid prior authorization; otherwise the claim will reject and a PA is required.IR ≥8 days in past 90 days OR ER ≥30 days
Continuation of Therapy
Continuation therapy exception
Continuation of therapy rules
Continuation on ER opioid (step therapy exception): Request is for continuation of therapy for a patient who has been receiving an extended‑release opioid agent for at least 30 days.ER ≥30 days
Patients meeting this continuation criterion avoid initial step therapy requirements provided ongoing monitoring and reassessment conditions are satisfied.
Step Therapy Details and MME Limits
Requirement
Detail
Step therapy applies to the extended‑release opioid class per policy 2219‑M
Initial quantity limits apply (see Opioid Analgesics ER Quantity Limits Chart) and some strengths have an initial limit of zero requiring post‑limit prior authorization
Post‑limit prior authorization required when requested quantity or MME/day exceeds the charted limit (including strengths with initial limit = 0)
Operational rule
Required condition to avoid PA
Prior IR opioid use
Patient has at least an 8‑day supply of an immediate‑release (IR) opioid in the past 90 days
Prior ER opioid stability
Patient is continuing an extended‑release (ER) opioid and has been receiving it for at least 30 days (continuation exception)
Coverage condition
Authorization implication
Quantity corresponds to <90 MME/day and Step Therapy criteria are met
Applies to all listed ER opioid products in the Opioids ER Step Therapy policy
Products must meet Step Therapy requirements and conform to MME/day edits in the Opioid Analgesics ER Quantity Limits Chart prior to approval for higher quantities/strengths
Requests for strengths with an initial limit of zero are processed via post‑limit prior authorization
Product and Strength Quantity Limits (MME-Based)
Classwide ER opioids — MME reference
Class-level MME referencePolicy applies MME limits across the extended-release opioid class; MME thresholds in the chart determine coverage and edits.
Quantity accumulationQuantity limits accumulate across drugs that share the same unit limit (e.g., 30-unit drugs accumulate together).
Policy identifierOpioids ER Step Therapy with MME Limit and Post Limit Policy 2219-M (UDR 02-2024).
Coverage at <90 MME/daySupplies corresponding to <90 MME/day are covered without prior authorization when Step Therapy criteria are met.
Authorization for up to <200 MME/day
Site of Care Restrictions
Note
Methadone for addiction must be dispensed via certified opioid treatment programs
Methadone used for opioid addiction must be dispensed only by certified opioid treatment programs, except for limited inpatient or emergency exceptions; follow federal distribution and use requirements.
Background
Background: Extended‑release opioid formulations are intended for management of severe, persistent pain that requires an extended period of daily opioid therapy when alternative treatments are inadequate. Because ER/LA opioids carry higher risks of addiction, abuse, overdose, and death compared with immediate‑release opioids, they should be used only for appropriate patients who meet clinical and monitoring requirements.
Definitions
Opioid‑tolerant (definition)
Opioid‑tolerant definition (clinical)Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg morphine per day or equianalgesic doses (examples include 25 mcg/h transdermal fentanyl, 30 mg oral oxycodone, 8 mg oral hydromorphone, 25 mg oral oxymorphone, 60 mg hydrocodone).
RelevanceOpioid‑tolerant status is required for initiation/continuation of certain ER opioid products per labeling and coverage criteria.
Documentation expectationProvider documentation should support opioid tolerance where required for specific agents and strengths.
Methadone distribution conditions
Methadone for addiction — dispensing requirementsMethadone used for treatment of opioid addiction (detoxification/maintenance) must be dispensed only by certified opioid treatment programs approved by SAMHSA and the state; such programs must dispense oral methadone per 42 CFR Part 8 standards.
Key ActionPrescribe or document prior use of an IR opioid (≥8 days in past 90 days) or evidence of ≥30 days on an ER opioid to avoid prior authorization; otherwise submit prior authorization with required clinical documentation.
Methadone for addiction treatment is subject to federal distribution rules and separate dispensing conditions.
30- or 90-day supply corresponding to <90 MME/day may be covered without prior authorization when Step Therapy criteria are met.
Authorization at higher tierQuantities corresponding to ≥90 and <200 MME/day require prior authorization when coverage conditions are met (unless FDA‑labeled dose exceeds 200 MME/day).
MME thresholds
MME threshold set<90 MME/day; <200 MME/day — used throughout the policy to define coverage tiers and authorization triggers.
ApplicationUsed to map product-specific quantity limits in the Opioid ER Quantity Limits Chart.
Exception noteFDA‑labeled minimum strength/dose that exceeds 200 MME/day may alter authorization requirements.
Maximum daily MME edits
Range of maximum daily MME editsVarious MME/day edits applied per product/strength in the chart (examples include 30, 45, 60, 90, 120, 180 MME/day).
Enforcement mechanismLimits enforced as both quantity-versus-time and daily dose (MME) edits; chart rows map unit counts to approximate MME/day.
Impact on fillsSome strengths marked with '***' have an initial limit of zero and require post-limit prior authorization rather than automatic coverage.
Opioid tolerance documentation — documentation must support opioid tolerance where required (example definitions: e.g., ≥60 mg oral morphine daily, 25 mcg/hr transdermal fentanyl, 30 mg oral oxycodone daily, 8 mg oral hydromorphone daily, 25 mg oral oxymorphone daily, 60 mg hydrocodone daily, or equianalgesic dose of another opioid for ≥7 days).
Clinical exceptions — authorization may be granted when member profile/claim contains ICD‑10 codes or claim indicators for cancer, sickle cell disease, palliative care, hospice, or a terminal condition within the past 365 days; document these diagnoses or hospice status in the PA request.
Fill‑duration accommodation — a 30‑day fill is represented operationally as 25 days and a 90‑day fill as 75 days to allow for refill processing when minimum FDA‑labeled strength/dose or packaging affects supply timing.
Applies when no relevant ICD‑10 diagnosis code or hospice residence code is present in the member profile/claim.
Initial quantity limits: Initial fills are subject to the Opioid Analgesics ER Quantity Limits Chart (Column A for 1‑month limits and Column B for 3‑month initial limits) which map to the <90 MME/day band when step therapy criteria are met.see Column A/Column B in chart
If initial limits are exceeded, post‑limit prior authorization is required.
Supplies corresponding to ≥90 and <200 MME/day require prior authorization when coverage conditions are satisfied (unless FDA‑labeled dose exceeds 200 MME/day).
Step Therapy prerequisiteCoverage without PA at the <90 MME/day tier requires meeting initial step therapy (prior IR use ≥8 days or ER use ≥30 days) to avoid PA.
Belbuca examples — initial and post‑limit quantities
Belbuca — Column A (Initial 1 month, <90 MME/day)60 films/month (approx. 2 films/day) for initial 1‑month limit at <90 MME/day.
Belbuca — Column B (Initial 3 months, <90 MME/day)180 films/3 months (2 films/day) for the initial 3‑month limit at <90 MME/day.
Post‑limit (<200 MME/day) examplesPost‑month limit for Belbuca 75/150 mcg: 90 films/month (3 films/day) and 270 films/3 months (3 films/day) at the <200 MME/day band.
Belbuca — strength and MME tier examples
Belbuca — low MME tier example60 films/month (2 films/day) at <90 MME/day for multiple strengths (e.g., 75 mcg, 150 mcg listed in Column A).
Belbuca — higher MME tier example90 films/month (3 films/day) at the <200 MME/day post‑limit band for certain strengths per chart Column C/D.
Strength variabilityQuantity limits vary by Belbuca strength and mapped MME/day values; some higher strengths show initial limit = 0 (blocked) in chart entries.
Butrans — patch limits and examples
Butrans — lower MME band example4 patches/month (~0.144 patch/day) shown for certain MME bands (e.g., Butrans 5–10 mcg/hr entries).
Butrans — higher MME band example8 patches/month (~0.287 patch/day) for higher MME band entries in the chart.
Strength‑specific capsButrans quantity caps vary by mcg/hr strength and are mapped to approximate MME/day in the quantity limits chart.
Fentanyl transdermal — patch limits and MME equivalents
Initial zero limitsSome fentanyl strengths (e.g., 50, 75, 100 mcg/hr) show initial limit = 0 or '***' and require post‑limit prior authorization per chart notes.
3‑month accumulationChart provides both monthly and 3‑month (per 75 days) limits mapped to patch/day and approximate MME/day values.
Hydrocodone ER (Zohydro) & Hydromorphone ER (Exalgo) — examples
Hydrocodone ER / Hydromorphone ER — example capsExamples include 60 caps/month (2 caps/day) for certain hydrocodone ER strengths equating to 40–60 MME/day bands; hydromorphone ER 8 mg example: 30 tabs/month (1 tab/day) mapping to 40 MME/day.
3‑month capsCorresponding 3‑month limits (e.g., 180 caps/3 months) are shown for the same strengths with mapped MME/day values.
Strength‑dependent editsQuantity limits and MME/day equivalents vary by strength and are enforced per-chart for both monthly and 3‑month fills.
Methadone and Morphine ER — conversions and limits
Methadone/morphine conversions and limitsChart provides conversions between tablet/month equivalents and oral solution/injection volumes with mapped MME/day values (examples: Methadone 10 mg: 90 tabs/month = 3 tabs/day ≈ 70.5 MME/day; injection and solution volumes equated to tab counts).
Multiple monthly/3‑month limitsMethadone entries show a variety of monthly and 3‑month quantity mappings tied to different MME/day bands (including 30/90/120/141 MME examples).
Formulation‑specific handlingLimits are provided separately for tablets, Intensol solution, oral solution, and injection formulations with specific volume-to-MME conversions.
Morphine ER — per‑strength quantity limits
Morphine ER — product/strength capsChart lists product- and strength-specific monthly and 3‑month quantity limits with corresponding MME/day values (examples: Avinza 90 mg: 30 caps/month = 90 MME/day; 60 mg entries mapping to 60–120 MME/day).
High‑strength entriesSome morphine ER higher-strength rows are marked with '***' (initial zero) indicating post‑limit prior authorization is required.
Accumulation and packaging notesQuantity limits accumulate across drugs with same unit counts; fill-duration accommodation (25/75 day rule) applies for refill processing.
Nucynta ER / OxyContin — examples of limits
Nucynta ER / OxyContin — monthly & 3‑month limitsChart shows product- and strength-specific monthly and 3‑month limits mapped to MME/day (e.g., Nucynta ER 100 mg: 60 tabs/month = 2 tabs/day = 80 MME/day; OxyContin 20 mg: 60 tabs/month = 2 tabs/day = 60 MME/day).
Higher‑strength blocksSome Nucynta ER strengths are marked '***' or 0 indicating initial block and requiring post‑limit prior authorization.
Dose-to-MME mappingLimits reflect both per-day tablet caps and resulting approximate MME/day used to determine tiered coverage/authorization.
Oxymorphone ER & Tramadol ER — quantity and MME limits
Oxymorphone ER / Tramadol ER — strength examplesChart lists strength-specific quantity and MME/day limits; some oxymorphone strengths have initial limit = 0 (e.g., 20 mg entries) and higher strengths map to 90–180 MME/day bands.
Tramadol ER entriesTramadol ER 100 mg: 30 tabs/month = 1 tab/day (20 MME/day); some tramadol strengths show 0 or '***' initial limits requiring post‑limit authorization.
Post‑limit requirementsWhere initial limit = 0 or '***', requests must go through post‑limit prior authorization per policy notes.
Xtampza ER — strength‑specific limits and notes
Xtampza ER — strength and quantity mappingChart provides strength-specific monthly and 3‑month quantities with mapped MME/day values (examples: Xtampza ER 9 mg: 60 caps/month = 2 caps/day = 30 MME/day; Xtampza ER 36 mg: 90 caps/month = 3 caps/day = 180 MME/day).
Initial zero strengthsCertain Xtampza strengths are marked with '***' indicating an initial limit of zero and requiring post‑limit prior authorization.
Duration accommodation25‑day/75‑day rules apply for 30‑ and 90‑day fills respectively to accommodate refill processing and packaging constraints.
Regulatory exceptionsLimited inpatient or emergency exceptions to certification requirements may apply as described in federal rules.
Criminal/regulatory riskFailure to comply with distribution/use regulations may result in prosecution, seizure, or revocation of program approval.
Chronic pain — definition & authorization context
Chronic pain definitionChronic pain is generally defined as pain typically lasting greater than 3 months; authorization for ER opioids for chronic pain requires meeting specific monitoring and prior-use criteria.
Monitoring requirementsPatient's pain must be reassessed within 1 month after initiation or dose increase and every 3 months thereafter; patient must be evaluated and monitored for opioid use disorder.
Prior-use requirementApproval requires either prior use of an IR opioid for at least one week or continuation of an ER opioid for at least 30 days (step therapy exception).
MME — definition and role
MME definitionMorphine milligram equivalent (MME) — daily dose metric used throughout the chart to set limits and edits.
Role in policyMME/day calculations determine coverage tier (<90 vs <200 MME/day), quantity edits, and prior authorization triggers.
Chart mappingsQuantity limits in the Opioid ER Quantity Limits Chart are mapped to approximate MME/day values to enforce daily dose edits.