Neighborhood Health Plan RI ER Opioid Prior Auth | OpenPayer
CurrentNeighborhood Health Plan of Rhode IslandPolicy 2218-M 02-2022
Step Therapy with Quantity Limit and Post Limit Prior Authorization Criteria — Extended‑Release Opioid Analgesics
Defines step therapy, quantity limits, and post-limit prior authorization criteria for extended-release (ER) opioid analgesics for Neighborhood Health Plan of Rhode Island members; applies to prescribing providers and pharmacy benefit management. This brief covers drug indications, limitations of use, and regulatory notes present in Part 1 of the policy.
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyStep Therapy with Quantity Limit and Post Limit Prior Authorization Criteria — Extended‑Release Opioid Analgesics
Policy CodePolicy 2218-M 02-2022
Change TypeNo material clinical or coverage changes in this revision.
Effective DateFeb 1, 2022
Next Review DateN/A
Key ActionSubmit prior authorization when the patient lacks qualifying recent opioid exposure or when requested quantity exceeds listed product limits.
No material clinical or coverage changes in this revision.
~30listed ER opioid products in this section
60 mgcommon opioid-tolerance threshold
30/90-day limitsinitial vs post-treatment quantity limit structure
PRN not allowedPRN not indicated
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42 CFR 8.12methadone regulation cited
Coverage Criteria for ER Opioid Analgesics
inv-01: Indications and Limitations
Covered when product indication and limitations of use are met as described below
Class-level indication: ER/long-acting opioid products are indicated for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment when alternative treatments are inadequate.
Supported for multiple specific products in document.
Limitations of use (general): Reserve ER/long-acting opioids for patients for whom non-opioid analgesics or immediate-release opioids are ineffective, not tolerated, or otherwise inadequate; ER/long-acting formulations are not for as-needed (prn) use.
Stated for multiple products (e.g., Arymo ER, Avinza, Belbuca, Butrans, ConZip, Ultram ER, Dolophine, Duragesic, Exalgo, Hysingla ER, etc.).
Opioid-tolerant patient requirement for select products: Certain products (e.g., Duragesic, Exalgo) are indicated only in opioid-tolerant patients as defined by specified daily opioid dosing for at least one week (see opioid-tolerant definition).see definition
Duragesic and Exalgo specify opioid-tolerance dosing thresholds.
Methadone-specific limitations: Methadone products have specific limitations: injectable methadone is indicated for inpatient use or temporary treatment for patients unable to take oral medication; methadone for addiction treatment must be dispensed only by SAMHSA‑certified opioid treatment programs per 42 CFR 8.2/8.12, with narrow inpatient or short emergency exceptions.
Includes regulatory exceptions and dispensing restrictions.
inv-02: Labeled coverage conditions for ER opioids
Covered when ALL of the following labeled conditions are met
Labeled indication and severity: Patient has pain severe enough to require daily, around-the-clock, long-term opioid treatment and alternative treatments (non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or otherwise inadequate.
Supported by product-specific labeling for multiple ER opioids.
Not as-needed use: ER opioid is prescribed for scheduled, around-the-clock use; not for as-needed (prn) analgesia.
Many ER products explicitly state not indicated for PRN use.
inv-03: Coverage with prior authorization
Covered when ALL of the following are met:
Indication: Requested drug is being prescribed for pain associated with cancer, sickle cell disease, a terminal condition, or pain being managed through hospice or palliative care OR for CHRONIC pain severe enough to require daily, around-the-clock, long-term treatment (chronic pain >3 months).
Supported by labeled coverage criteria.
Safety and monitoring: Patient can safely take the requested dose based on opioid history; patient has been evaluated and will be monitored regularly for development of opioid use disorder; pain will be reassessed in the first month after initial prescription or any dose increase AND every 3 months thereafter.
Monitoring and reassessment requirements documented.
Prior use for continuation/step: Request is for continuation of therapy for a patient who has been receiving an ER opioid for at least 30 days OR the patient has taken an immediate-release opioid for at least one week.
Prior use requirement documented to meet PA or avoid rejection.
inv-04: Quantity limits and accumulation
Coverage is provided without prior authorization for a 30-day or 90-day supply when Step Therapy criteria met and within product-labeled dosing frequency; quantities above initial limit require prior authorization.
Accumulation rule: Quantity limits accumulate across all drugs that share the same unit-limit category (e.g., products limited to 30 units/month accumulate together; products limited to 60 units/month accumulate together).
See Quantity Limits Chart and accumulation statement.
inv-05: Quantity limits (per product)
Covered when the dispensed quantity does not exceed the product-specific limits
Per-product quantity limits: For each listed ER opioid product and strength, the dispensed quantity must be consistent with the product dosing interval and within the specified monthly and 3-month limits; MME/day equivalents provided in the chart must not be exceeded.per product as listed
See Opioid Analgesics ER Quantity Limits Chart for exact numeric limits.
inv-06: Quantity-limited coverage
Covered when the prescription matches the product- and strength-specific quantity limits and does not exceed the stated MME/day maximums.
Per-product-strength limits: For a given ER opioid product and strength, the prescription must match the dosing frequency (e.g., qd, q12h, q8-12h) and the dispensed quantity must be within the listed per-month or per-3-month limits that correspond to 1, 2, or 3 tabs/caps per day mappings; MME/day must not exceed the charted maximum for that strength.
Extended‑release and long‑acting opioid formulations are intended for patients who require daily, around‑the‑clock, long‑term opioid treatment because alternatives (non‑opioid analgesics or immediate‑release opioids) are ineffective, not tolerated, or otherwise inadequate. These products should be reserved for such patients and, per multiple product labels, are not indicated for as‑needed (prn) use.
Injectable methadone is indicated for inpatient pain management and for temporary use when patients cannot take oral medication, but injectable methadone products are not approved for outpatient treatment of opioid dependence. Methadone used for detoxification or maintenance of opioid addiction must be dispensed only by SAMHSA‑certified opioid treatment programs and in accordance with Federal Opioid Treatment Standards (42 CFR 8.12); narrow inpatient and short emergency exceptions are described in the regulations.
Across multiple ER opioid product labels the use of extended‑release opioids as as‑needed (prn) analgesics is not an indicated use. Prescriptions that order ER formulations for PRN dosing are inconsistent with labeled indications and therefore excluded from routine labeled coverage.
When methadone is prescribed for treatment of opioid addiction (detoxification or maintenance), federal regulations require dispensing only by certified opioid treatment programs (OTPs). Methadone for addiction treatment must be dispensed in oral form by SAMHSA‑certified OTPs and follow the distribution and use conditions set out in 42 CFR 8; dispensing outside this framework (except for narrow inpatient or short emergency exceptions) is restricted and may carry regulatory penalties.
Requests for members identified as receiving care for cancer, sickle cell disease, palliative care, or hospice (identified by recent prescription fills, ICD‑10 diagnosis on claim, member profile, or hospice residence codes) will be routed to and paid under the prescription benefit associated with those clinical conditions rather than through the non‑cancer step therapy flow. Documentation of diagnosis or relevant fills may be used to route coverage appropriately.
The policy does not list any product-level exclusions; instead coverage and restrictions are implemented through product‑and‑strength-specific quantity limits and MME/day maxima set out in the Opioid Analgesics ER Quantity Limits Chart.
Any requested quantities or dosing patterns that are not represented in the Quantity Limits Chart — for example, supplies that would produce an MME/day higher than the listed maxima or tablet/capsule counts exceeding the charted 1/2/3 tabs per day mappings — are outside the charted coverage and treated as not conforming to the documented quantity limits.
ER opioid prescriptions intended for scheduled, around‑the‑clock dosing are consistent with labeled use; however, orders that designate ER opioids for as‑needed (prn) analgesia are not consistent with product labeling and would be considered not medically necessary under the labeling statements for multiple ER products.
Requests that exceed the stated monthly or 3‑month quantity limits in the Opioid Analgesics ER Quantity Limits Chart are treated as outside the documented quantity limits and are subject to prior authorization review or denial when no clinical justification is provided.
Coding and Thresholds
Opioid-tolerance dosing thresholds
Morphine equivalence≥60 mg oral morphine per day (opioid‑tolerant defined as receiving this or equianalgesic dose for ≥1 week)
Step therapy applies at the class level: extended‑release (ER) opioid analgesics are reserved for patients with severe, daily, around‑the‑clock, long‑term pain when alternatives are inadequate. Prescribers should attempt alternatives or document intolerance/inadequate response before initiating an ER opioid.
Intent: reserve ER opioid products for patients who have inadequate pain control, intolerance, or inadequate alternatives.
Coverage limited to chronic pain (generally >3 months) severe enough to require daily, around‑the‑clock long‑term opioid treatment; also covered for cancer, sickle cell disease, palliative or hospice care.
Prior Authorization
Initial step‑therapy requirement and PA when not met
Initial step: member must have recent qualifying opioid exposure before standard ER quantity limits apply. If the member has not met one of the prior‑use requirements the claim will reject and a prior authorization (PA) is required.
Qualifying prior use = at least an 8‑day supply of an immediate‑release (IR) opioid in the past 90 days OR at least a 30‑day supply of an ER opioid in the past 90 days.
Initial Therapy and Step Requirements
inv-47: Initial use limitations
General limitation across products
Reserve ER opioids for patients who have failed or cannot tolerate non-opioid analgesics or immediate-release opioids; ER products are not indicated for as-needed (prn) use.
Documented as a consistent limitation across multiple product label sections.
inv-48: Initial therapy labeling constraints
Initial coverage is aligned with labeled indications and limitations
Severity and alternatives trial: Patient has severe, chronic pain requiring daily, around-the-clock ER opioid therapy and non‑opioid or immediate‑release opioid alternatives have been tried and found ineffective, not tolerated, or otherwise inadequate.
Consistent across product labeling for multiple ER opioids.
Scheduled use:
Continuation and Maintenance Therapy
inv-51: Continuation therapy
Continuation therapy allowed when patient is already stable on an ER opioid.
Continuation requirement: Request is for continuation of therapy for a patient who has been receiving an extended-release opioid agent for at least 30 days.
Continuation criterion used to permit continued coverage.
inv-52: Maintenance dosing limits
Continuation/maintenance prescribing must adhere to the same strength-specific quantity limits.
Continuation therapy limits: Ongoing therapy quantities must remain within the monthly or 3-month limits for the specific ER opioid strength and corresponding MME/day values as listed in the Opioid Analgesics ER Quantity Limits Chart; requests exceeding these limits require prior authorization.
Step Therapy Program
Requirement
Notes
Step therapy with quantity limit and post-limit prior authorization applies to the listed extended-release opioid analgesics.
Applies to the ER opioid class and the specific products listed in the Opioid Analgesics ER Quantity Limits Chart (e.g., Arymo ER, Avinza, Belbuca, Butrans, ConZip, Dolophine, Duragesic, Exalgo, Hysingla ER, Kadian, Methadone formulations, MorphaBond ER, MS Contin, Nucynta ER, Opana ER, OxyContin, Targiniq ER, Troxyca ER, Ultram ER, Vantrela ER, Xtampza ER, Zohydro ER).
Requirement
Details / Evidence
Trial or failure of alternatives is expected before approval of ER formulations.
ER opioids are reserved for patients for whom non-opioid analgesics or immediate‑release opioid analgesics are ineffective, not tolerated, or otherwise inadequate; this limitation is stated in product labeling (examples: Methadone Intensol, Nucynta ER).
Requirement
Threshold / Consequence
Patient must have recent opioid exposure to meet the initial step and avoid prior authorization.
Qualifying exposure = filled prescription for ≥8-day supply of an immediate‑release (IR) opioid in the past 90 days OR ≥30-day supply of an extended‑release (ER) opioid in the past 90 days; lacking this exposure causes claim rejection and triggers prior authorization criteria.
Requirement
Comment
This policy is part of a step therapy program that includes labeling limits and post-limit prior authorization for ER opioids.
The policy context is class-level step therapy with quantity limits governed by the Opioid Analgesics ER Quantity Limits Chart; specific step sequences or step-failure lists are not detailed in the cited chunks.
Statement
Implication
Step therapy is referenced in the policy title, but a specific step sequence is not present in these chunks.
The Opioid Analgesics ER Quantity Limits Chart establishes the applicable quantity limits (per day, monthly, and 3-month) for ER opioids and governs allowed dispensing when step therapy criteria are met.
Product- and Strength-specific Quantity Limits
Multiple ER opioid products (by name and strength listed in chart)
Range of ER products listedMultiple named ER opioid products and strengths are listed with per‑product monthly and 3‑month limits (see chart rows for exact values)
Initial vs post limitsEach product/strength includes Column A/B initial 1‑month and 3‑month limits and Column C/D higher post‑1‑month and 3‑month limits for stabilized therapy
MME/day shown per rowMME/day equivalent is shown for each product/strength to indicate potency for the mapped quantity limits
Butrans (various mcg/hr)
Butrans dosing frequencyq7d transdermal dosing (weekly) — patches counted monthly/3‑month as shown in chart
Low patch limit (60 MME/day mapping)
Site of Care and Methadone Dispensing
Note
Note
Definitions
Opioid-tolerant
Definition (opioid‑tolerant)Patients receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, 60 mg oral hydrocodone/day, or an equianalgesic dose of another opioid
Purpose of definitionUsed to identify patients eligible for products labeled specifically for opioid‑tolerant individuals (e.g., Duragesic, Exalgo)
Documentation implicationOpioid‑tolerant status must be documented (prior dosing history or equianalgesic evidence) for applicable product approvals
Extended‑release opioid
Definition (ER opioid)An opioid formulation intended for daily, around‑the‑clock, long‑term opioid treatment for severe pain when alternatives are inadequate (examples: Methadone Intensol, Nucynta ER, Opana ER, OxyContin, Targiniq ER, Troxyca ER, Vantrela ER)
Background
Extended‑release and long‑acting opioid formulations are intended for the management of severe, chronic pain requiring around‑the‑clock opioid treatment when alternatives are inadequate. Because ER formulations carry higher risks of addiction, abuse, misuse, overdose, and death compared with immediate‑release opioids, they should be reserved for patients who have failed or cannot tolerate alternative treatments; specific product labels and the Quantity Limits Chart reinforce scheduled use, opioid‑tolerant requirements for selected agents, and strength‑specific monthly and 3‑month quantity mappings.
Revision History
2022-02-01policy_effectiveLatest
Policy 2218-M 02-2022 became effective (Opioids ER - Step Therapy with Labeling Limit and Post Limit).
Policy Summary
PayerNeighborhood Health Plan of Rhode Island
PolicyStep Therapy with Quantity Limit and Post Limit Prior Authorization Criteria — Extended‑Release Opioid Analgesics
Policy CodePolicy 2218-M 02-2022
Change TypeNo material clinical or coverage changes in this revision.
Effective DateFeb 1, 2022
Next Review DateN/A
Key ActionSubmit prior authorization when the patient lacks qualifying recent opioid exposure or when requested quantity exceeds listed product limits.
Methadone restriction: If request is for a methadone product, it is NOT for detoxification or maintenance treatment of opioid/substance abuse or addiction.
Per‑product initial limits (1 month / per 25 days)
Column A lists initial 1‑month (per 25 days) limits per product/strength (e.g., Arymo ER 15 mg = 90 tabs/25 days; Avinza 30 mg = 30 caps/25 days)
Per‑product initial limits (3 months / per 75 days)Column B lists initial 3‑month (per 75 days) limits per product/strength (e.g., Arymo ER 15 mg = 270 tabs/75 days; Avinza 30 mg = 90 caps/75 days)
Post‑treatment limits (1 month / per 25 days)Column C lists higher post‑1‑month limits for stabilized patients (e.g., Arymo ER 15 mg = 120 tabs/25 days; Avinza 30 mg = 60 caps/25 days)
Post‑treatment limits (3 months / per 75 days)Column D lists higher post‑3‑month limits for stabilized patients (e.g., Arymo ER 15 mg = 360 tabs/75 days; Avinza 30 mg = 180 caps/75 days)
MME/day thresholds
Common MME/day thresholdsChart entries include multiple MME/day thresholds commonly at 60, 80, 120, 160 MME/day (and higher for some strengths)
Product‑linked MME displayEach product/strength row displays the MME/day equivalent adjacent to the monthly/3‑month quantities (used to indicate potency equivalence)
Higher MME tiersCertain high‑strength entries list elevated MME/day maxima (examples in chart up to 360 MME/day and beyond for some products)
If qualifying prior use is present, the initial quantity limit criteria (Column A/B in the ER Quantity Limits Chart) apply.
If qualifying prior use is NOT present the claim will reject with a PA requirement and the PA criteria will be applied for review.
Prior Authorization
Prior authorization for quantities over limit
Prior authorization is required for requests that exceed the product‑ and strength‑specific day, monthly, or 3‑month quantity limits shown in the Opioid Analgesics ER Quantity Limits Chart. Requests exceeding mapped limits may be denied without adequate clinical justification.
Quantity limits are defined per product and strength (daily MME and caps/tablets/patches per month and per 3 months).
When requested quantity exceeds the listed monthly or 3‑month limit, submit a PA with supporting clinical documentation addressing medical necessity and rationale for dose/quantity above the limit.
Documentation Required
Opioid‑tolerant documentation requirement
Opioid‑tolerant status and dosing history must be documented when applicable. Many ER opioid products are indicated only for opioid‑tolerant patients; prescribers must document prior opioid dosing or equianalgesic exposure to support safe dosing.
Definition example: opioid tolerant = taking for ≥1 week at least 60 mg oral morphine/day (or equianalgesic dose) OR other listed thresholds (e.g., 25 mcg/hr transdermal fentanyl/hr, 30 mg oral oxycodone/day, etc.).
Documentation should include prior opioid agent(s), dose, duration, and evidence the patient meets opioid‑tolerant criteria.
If request is continuation of therapy, documentation that patient has been receiving the ER opioid for ≥30 days or has used an IR opioid for at least one week should be provided.
Billing Rule
Alignment with listed limits and chart‑governed prescribing
Ensure prescriptions and authorizations align exactly with the listed product‑and‑strength quantity limits and the charted MME/day maxima. Prescribers and pharmacies should use the Opioid Analgesics ER Quantity Limits Chart to determine allowed day, month, and 3‑month quantities before submitting a claim or PA.
Prescriptions should conform to the charted daily MME limits and the associated monthly and 3‑month maximums for the specific product and strength.
PA requests must explicitly reference the charted limit being exceeded and provide clinical justification tied to the patient’s history and MME calculations.
Denial Risk
Regulatory noncompliance risk for methadone distribution
Methadone used for opioid addiction must be dispensed only by SAMHSA‑certified opioid treatment programs per 42 CFR Part 8; dispensing outside these regulatory requirements (except narrow inpatient or short emergency exceptions) risks criminal prosecution, seizure of drug supply, revocation of program approval, and injunctions.
Methadone for addiction treatment must be dispensed by certified opioid treatment programs and used in oral form per federal standards.
Regulatory exceptions (e.g., inpatient care for non‑addiction primary diagnosis or emergency administration up to 3 days while arranging definitive care) are limited and specific.
The prescription is for scheduled, around-the-clock dosing and not for as‑needed (PRN) use.
ER products explicitly note PRN use is not indicated.
inv-49: Initial therapy / Step
Initial coverage and step therapy prerequisites
Prior use requirement: Patient has filled ≥8-day supply of an immediate-release (IR) opioid in the past 90 days OR has filled ≥30-day supply of an ER opioid in the past 90 days; if neither, claim rejects and prior authorization is required.
Initial step therapy screening logic described in Initial Step Therapy section.
inv-50: Initial therapy quantity guidance
Initial dispensing should follow the lowest applicable tablet/capsule per day mapping and associated monthly limit.
Initial supply limits: For initial therapy, dispense quantities consistent with the lowest applicable tablets/capsules per day mapping (e.g., 1–2 tabs/caps per day where indicated) and corresponding monthly limits such as 60 tabs/month for 2 tabs/day unless clinically justified otherwise.
Example: 4 patches/month for several lower‑mcg strengths (mapped to ~60 MME/day in chart entries)
Higher patch limit (120 MME/day mapping)Example: 8 patches/month at higher MME tier (mapped to ~120 MME/day); 12/24 patches for 3‑month totals shown
ConZip (100/200/300 mg)
ConZip 100/200/300 mg monthly limits30 caps/month at 1 cap/day for each strength (MME/day varies by strength: e.g., 100 mg = 10 MME/day, 200 mg = 20 MME/day, 300 mg = 30 MME/day)
Higher‑use monthly limits60 caps/month corresponds to 2 caps/day (higher MME tier); 90/180 caps shown for 3‑month mappings
3‑month mappingChart provides 90 caps/3 months for 1 cap/day and 180 caps/3 months for 2 caps/day depending on strength tier
Dolophine / Duragesic
Dolophine (methadone) tablets example limitsDolophine 5 mg: 90 tabs/month (3/day) at lower MME tier; 120 tabs/month (4/day) at higher MME tier; corresponding 3‑month totals 270 and 360 tabs
Duragesic patch examplesDuragesic patches listed by mcg/hr show monthly and 3‑month patch totals (e.g., Duragesic 37.5 mcg/hr = 10 patches/month or 30 patches/3 months depending on tier)
Dosing frequencies notedChart records dosing frequency (e.g., q8‑12h for Dolophine tablets, q72h for many Duragesic strengths) which maps to monthly quantities
Exalgo, Hysingla ER
Exalgo monthly limitsExalgo 16 mg: 30 tabs/month (1/day) at lower MME tier; 60 tabs/month (2/day) at higher MME tier; 90/180 tabs for 3‑month mappings
Hysingla ER mappingHysingla ER strengths mapped to 30 tabs/month for 1/day and 60 tabs/month for 2/day with corresponding 3‑month totals and MME/day listed per strength
Kadian
Kadian examplesKadian: common mappings include 60 caps/month (2/day) at lower MME tier and 90 caps/month (3/day) at higher MME tier; 180/270 caps for 3‑month totals per chart
Strength‑dependent MME/dayEach Kadian strength row lists the associated MME/day and corresponding monthly/3‑month caps limits (see chart)
Methadone (tablets, injections, solutions)
Methadone tablet limitsMethadone tablets examples: 90 tabs/month (3/day) at lower tiers; 120 tabs/month (4/day) at higher tiers; 270/360 tabs for 3‑month totals shown
Injection / solution volumesMethadone injections and oral solutions have mL/month and 3‑month quantity mappings with daily mL equivalents listed (e.g., 20–120 mL/month depending on tier)
Regulatory noteMethadone entries are subject to distribution restrictions for addiction treatment per federal regulations (see OTP definitions)
MorphaBond ER / MS Contin
MorphaBond ER / MS Contin examplesTypical mappings: 90 tabs/month (3/day) at lower tiers and 120 tabs/month (4/day) at higher tiers; 270/360 tabs for 3‑month totals depending on strength
High‑strength MME/day entriesSome MorphaBond/MS Contin strengths list very high MME/day maxima in the chart; check the product row for exact MME/day values
Nucynta ER / Opana ER
Nucynta ER / Opana ER mappingNucynta ER: 60 tabs/month (2/day) or 90 tabs/month (3/day) depending on strength; Opana ER: 60–90 tabs/month with corresponding 3‑month totals listed
Nucynta ER higher strengthsNucynta ER 150–250 mg strengths map to 60–90 tabs/month (2–3/day) and 180–270 tabs/3 months (see chart rows)
Opana ER strength rangeOpana ER 5–40 mg strengths show 60 tabs/month for 2/day and 90 tabs/month for 3/day with 180–270 tabs/3 months mappings
Nucynta ER (150-250 mg strengths example)
Nucynta ER 150–250 mg example mapping60–90 tabs/month for 2–3 tabs/day; 180–270 tabs/3 months for corresponding 2–3 tabs/day mappings
MME/day associatesEach tab/day mapping includes an MME/day value for potency equivalence (see chart entries for exact MME/day per strength)
Opana ER (5-40 mg strengths)
Opana ER monthly mappingOpana ER (5–40 mg): 60 tabs/month for 2 tabs/day; 90 tabs/month for 3 tabs/day; 180–270 tabs/3 months correspondingly
High‑MME strengthsHigher Opana ER strengths list higher MME/day maxima (see chart rows for 135–360 MME/day mappings at upper strengths)
OxyContin (10-80 mg strengths)
OxyContin typical limitsOxyContin (10–80 mg): common mappings include 60 tabs/month for 2 tabs/day and 90 tabs/month for 3 tabs/day; 180–270 tabs/3 months correspondingly
Highest MME/day shownChart shows MME/day up to 360 for highest OxyContin strengths (see product rows for exact MME/day per strength)
Strength‑dependent tiersSome strengths have both 1/day and 2–3/day mapped limits with different MME/day tiers and monthly/3‑month totals
Targiniq ER and Tramadol ER
Targiniq ER / Tramadol ER max doseTramadol ER maximum daily dose listed (example: MAX 300 mg/day); Targiniq ER strengths list MAX per day values in chart entries
Monthly/3‑month mappingsMonthly and 3‑month quantities are mapped to 1–3 caps/tabs per day for these products (see chart rows for exact counts)
Troxyca ER, Xtampza ER, Zohydro ER
Troxyca ER, Xtampza ER, Zohydro ER mappingsStrength‑specific monthly and 3‑month caps/tabs with MME/day mappings; Xtampza entries include mappings up to 480 MME/day for some strengths
High‑MME Xtampza exampleXtampza ER 36 mg 3 tabs/day mapping shows up to 480 MME/day at very high caps/month/3‑month totals in the chart
Vantrela ER
Vantrela ER common mappingsVantrela ER: 60 tabs/month for 2 tabs/day; 90 tabs/month for 3 tabs/day with corresponding 180/270 tabs per 3 months as shown
Max mg/day notedChart lists MAX daily mg (e.g., Vantrela ER entries reference maximums such as 180 mg/day for certain strengths)
Labeling limitation
ER opioids are not indicated for as‑needed (PRN) analgesia and are reserved for patients who have inadequate alternatives
Clinical intentUsed for management of severe chronic pain requiring scheduled, around‑the‑clock dosing rather than PRN use
Opioid treatment program (OTP)
Definition (OTP)A SAMHSA‑certified program authorized to dispense methadone for detoxification or maintenance treatment of opioid addiction; certified programs must follow Federal Opioid Treatment Standards (42 CFR 8.12)
Dispensing restrictionMethadone for addiction treatment must be dispensed only by certified OTPs except narrow inpatient or short emergency exceptions
Regulatory consequenceFailure to comply with 42 CFR 8 may result in criminal prosecution, seizure of drug supply, revocation of program approval, and injunction
ER opioid indication and limitation
Indication limitationER opioid products are indicated for daily, around‑the‑clock, long‑term opioid treatment when alternatives are inadequate (examples include Vantrela ER, Xtampza ER, Zohydro ER)
Not PRNThese products are not indicated for as‑needed (PRN) analgesia and should be reserved for patients requiring scheduled dosing
Risk justificationLimitation is due to greater risks of addiction, misuse, overdose, and death with ER formulations compared to immediate‑release opioids
Chronic pain
Chronic pain definedChronic pain is generally defined here as pain that typically lasts greater than 3 months
Coverage contextChronic (non‑cancer) pain meeting criteria may qualify for ER opioid therapy when alternatives are inadequate
MME/day
MME/day termMME/day = morphine milligram equivalent per day displayed alongside each product/strength to indicate opioid potency equivalence
Chart presentationChart lists the MME/day value associated with given tablet/capsule/patch counts for each ER opioid strength
MME/day (chart mapping)
MME/day mapping in chartThe Quantity Limits Chart lists MME/day values associated with specific tablet/capsule counts (e.g., 2 or 3 tabs/day mappings) for each ER opioid strength
Use in authorizationPrescribers and reviewers use MME/day mappings to evaluate potency and ensure requested quantities do not exceed charted maxima