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, product- and strength-specific quantity limits, and prior authorization rules for extended‑release (ER) opioid analgesics; affects prescribers and pharmacies dispensing listed ER opioids.

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 change

Effective DateFeb 1, 2022

Next Review Date

Key ActionPrior authorization and step therapy apply for ER opioid requests; show required prior opioid exposure or obtain PA when limits or step conditions are not met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

~30ER products listed

60 mgOpioid-tolerance threshold

explicitPRN prohibition

30/90-daySupply options

MME-basedLimits reference

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cancer/hospiceScreen-outs/exemptions

Coverage and Medical Necessity

Coverage criteria (medical necessity) — Covered with prior authorization when ALL of the following groups/conditions are met as specified below:

Covered when ALL of the following are met:

ANY of the following

The 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.
The requested drug is being prescribed for CHRONIC pain severe enough to require daily, around-the-clock, long-term treatment in a patient who has been taking an opioid. Chronic pain is generally defined as pain that typically lasts greater than 3 months.

ALL of the following

The patient can safely take the requested dose based on their history of opioid use.
The patient has been evaluated and will be monitored regularly for the development of opioid use disorder.
The patient's pain will be reassessed in the first month after the initial prescription or any dose increase AND every 3 months thereafter to ensure that clinically meaningful improvement in pain and function outweigh risks to patient safety.
This request is for continuation of therapy for a patient who has been receiving an extended-release opioid agent for at least 30 days OR the patient has taken an immediate-release opioid for at least one week.
If the request is for a methadone product, then it is NOT being prescribed for detoxification treatment or as part of a maintenance treatment plan for opioid/substance abuse or addiction.
These drugs should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

Quantity-limit coverage

Quantity-limit coverage: No coverage beyond the listed labeled quantity limits without prior authorization. Requests exceeding per-product strength or monthly/3-month caps will be considered not medically necessary absent prior authorization.

ALL of the following

Quantity limits published in the Opioid Analgesics ER Quantity Limits Chart apply and are enforced; providers should confirm the applicable per-product and per-strength limits before prescribing.
Requests that exceed the monthly or 3-month caps in the quantity limits chart may be denied as not medically necessary unless a prior authorization justifying the excess is approved.
Extended-release/long-acting opioid products are not indicated for as‑needed (prn) analgesia and should be reserved for long-term use per labeling; PRN use or use when alternatives are adequate may be considered inconsistent with labeling and not meet medical necessity.

Product/strength quantity limits

Product/strength quantity limits (per product labeling and internal quantity limits chart). Covered at doses/quantities up to the limits shown; requests beyond these per-strength limits require prior authorization and may be denied.

ALL of the following

Methadone Intensol, oral solutions, and other methadone formulations have specific volume/day and month/3-month limits per strength (see Opioid Analgesics ER Quantity Limits Chart).
Xtampza ER, Zohydro ER, and other listed ER products have specified caps by strength (daily, monthly, 3-month) — prescribing beyond the per-strength caps (e.g., higher caps for 13.5 mg, 18 mg, 27 mg, 36 mg Xtampza) is subject to prior authorization review.
Requests for strengths or total daily doses that exceed product-specific maximum total daily dose recommendations in labeling (for example, Targiniq ER maximum total daily dose limits) will be evaluated against labeling and may be denied if inconsistent with safe use or labeling.
For methadone products used for opioid addiction: these are restricted to certified opioid treatment programs and are not covered for detoxification or maintenance treatment outside of those programs; methadone prescribed for addiction treatment is not eligible under this coverage unless distributed/used per 42 CFR 8.2/8.12 as applicable.

Clinical Thresholds and Limits (Coding References)

Opioid tolerance thresholds

Opioid tolerance thresholdAt least 60 mg oral morphine per day (or equianalgesic dose) for ≥1 week

Alternate opioid equivalents in labelingExamples listed: 25 mcg/hr transdermal fentanyl; 30 mg oral oxycodone/day; 8 mg oral hydromorphone/day; 25 mg oral oxymorphone/day; 60 mg oral hydrocodone/day

PurposeRequired to qualify as opioid‑tolerant for certain ER opioid indications (e.g., Duragesic, Exalgo)

Monthly and 3-month quantity limits

Belbuca 750 mcg90 films/month or 270 films/3 months; up to 3 films/day

Butrans (various mcg/hr)Common limits: 4 patches/month (12/3 months) at lower MME tiers and 8 patches/month (24/3 months) at higher MME tiers; per-strength monthly/3-month caps provided

What Prescribers and Pharmacies Must Do

Denial Risk

Regulatory noncompliance consequences

Methadone products used for opioid addiction must be dispensed only by SAMHSA‑certified opioid treatment programs (42 CFR Part 8). Failure to comply with these federal requirements may result in criminal prosecution, seizure of the drug supply, revocation of program approval, and injunctions precluding program operation. Regulatory exceptions (short inpatient use or up to 3 days emergency dispensing while arranging definitive care) are described in the CFR and must be followed.

Methadone for addiction: dispense only via certified OTPs per 42 CFR 8.12; inpatient and brief emergency exceptions apply.
Noncompliance consequences: criminal prosecution, drug seizure, revocation of approval, injunctions.

Billing Rule

Product/strength specificity required

Initial Use and Label Restrictions

inv-50: Label restrictions for initial therapy

Coverage quantities follow product-strength specific limits — covered up to the listed monthly or 3-month quantity corresponding to per-day dosing and MME tier.

Quantity adherence: Prescription must not exceed the product-specific daily, monthly, or 3‑month quantity limit listed for that strength and formulation.as listed in chart

Examples: MorphaBond ER 15 mg = 90 tabs/month (3 tabs/day) or 270 tabs/3 months; MS Contin and other products have per-strength caps tied to MME/day tiers.

inv-51: Initial step therapy

Initial therapy requirements for ER opioid coverage

Prior opioid exposure: Patient has filled an ≥8‑day supply of an immediate‑release (IR) opioid in the past 90 days OR has filled a ≥30‑day supply of an ER opioid in the past 90 days (i.e., already stable on ER).

Continuation of Therapy

inv-52: Continuation of ER opioid therapy

Continuation therapy rules and requirements for ongoing coverage.

Continuation: Request is for continuation of therapy for a patient who has been receiving an extended‑release opioid agent for at least 30 days.

Patient monitoring and reassessment requirements apply as described under coverage criteria.

Step Therapy Rules

Requirement	Notes / Evidence
Step therapy applies across the extended‑release (ER) opioid class
Prescribers must demonstrate trial and failure, intolerance, or inadequate response to alternatives (non‑opioid analgesics or immediate‑release opioids) before ER formulations are approved; this class‑level requirement is supported by product labeling reserving ER opioids for when alternatives are ineffective or not tolerated.

Policy statement	Source detail
ER opioid formulations must be reserved for patients who have failed or cannot tolerate alternative analgesic options.
Multiple product Limitations of Use state ER/long‑acting opioids are reserved for patients when non‑opioid analgesics or immediate‑release opioids are ineffective, not tolerated, or otherwise inadequate; ER products are not indicated for as‑needed (PRN) use.

Prior exposure requirement	Effect on authorization
Patient must have filled ≥8 days supply of an immediate‑release (IR) opioid in the past 90 days OR have filled ≥30 days supply of an ER opioid in the past 90 days.
If neither condition is met the claim will reject and prior authorization is required; meeting the prior exposure requirement places the request into initial quantity limits (Columns A/B of the quantity chart).

Quantity limit summary	Example product/strength limits (monthly / 3-month)
Quantity limits are specified per product and strength with corresponding daily MME tiers; coverage is provided up to listed monthly or 3‑month caps as shown in the Opioid Analgesics ER Quantity Limits Chart.
Examples from the chart include: Belbuca 750 mcg = 90 films/month or 270 films/3 months; MorphaBond ER 100 mg = 90 tabs/month (3/day) or 270 tabs/3 months; Xtampza ER entries ranging from 60–360 caps/month and up to 720 caps/3 months; Zohydro ER strengths commonly 60–120 caps/month or 180–270 caps/3 months.

Step therapy presence	Detail / limitation
Step therapy is referenced in the policy title and applies to ER opioids.
Specific step‑by‑step sequences or explicit required trials beyond the class‑level requirement and prior exposure gate are not contained within the extracted chart excerpts; reviewers must refer to the full policy for detailed sequences.

Prescriber responsibilities	Exception process
Prescribers must adhere to step therapy and product/strength quantity limits as specified; prescriptions should conform to the monthly and 3‑month caps for the indicated product and strength.
Exceptions to step therapy or quantity limits require documentation and submission of a prior authorization request for review; claims missing required prior exposure evidence will reject and route to PA evaluation.

Product- and Strength-Specific Quantity Limits

Multiple ER opioid products (chart overview)

Multiple ER opioid productsProduct- and strength-specific initial and post limits provided in the Opioid Analgesics ER Quantity Limits Chart with per-period (30-day/90-day) caps and MME/day conversions

Examples includedArymo ER, Avinza, Belbuca, Butrans, ConZip, Duragesic, Exalgo, Hysingla ER, Kadian, MorphaBond ER, MS Contin, Xtampza ER, Zohydro ER

Limit structureChart includes Column A/B (initial 1 month/3 month) and Column C/D (post 1 month/3 month) caps tied to MME tiers

Belbuca 750 mcg

Belbuca 750 mcg monthly/3-month caps90 films/month or 270 films/3 months; up to 3 films/day

Label max per dosing intervalMaximum per 12-hour dosing listed as 900 mcg/12 hrs in chart context

Key Terms

Opioid-tolerant (definition)

Opioid-tolerant definitionPatients taking for ≥1 week at least 60 mg oral morphine/day (or listed equianalgesic doses such as 25 mcg/hr fentanyl, 30 mg oxycodone/day, 8 mg hydromorphone/day, 25 mg oxymorphone/day, 60 mg hydrocodone/day)

Use in policyOpioid-tolerant status is required for certain ER opioid products and is referenced when assigning appropriate quantity/MME tiers

Source examplesDuragesic and Exalgo labeling explicitly define opioid-tolerant criteria used in coverage determinations

Opioid treatment program (OTP)

Opioid treatment program (OTP)Program certified by SAMHSA and approved by the designated state authority authorized to dispense methadone for addiction treatment under 42 CFR Part 8; certified programs must follow Federal Opioid Treatment Standards (42 CFR 8.12)

Regulatory exceptions

Site-of-Care and Regulatory Requirements

Note

Background and Scope

Extended‑release and long‑acting opioid formulations are indicated for the management of pain severe enough to require daily, around‑the‑clock therapy. The policy’s quantity limits map each product and strength to a corresponding daily MME and allowable monthly or 3‑month supply; these limits and the labeling‑based indications form the clinical basis for coverage determinations.

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 change

Effective DateFeb 1, 2022

Next Review Date

Key ActionPrior authorization and step therapy apply for ER opioid requests; show required prior opioid exposure or obtain PA when limits or step conditions are not met.

SourceLink

On This Page

ConZip 100 mg30 caps/month or 90 caps/3 months (1 cap/day) at lower MME tier; 60 caps/month or 180/3 months (2 caps/day) at higher MME tier

Dolophine (methadone) 5 mg90 tabs/month or 270/3 months (3 tabs/day) at lower MME tier; 120 tabs/month or 360/3 months (4 tabs/day) at higher MME tier

Duragesic (various mcg/hr)Typically 10 patches/month (30/3 months) at lower MME tier and 20 patches/month (60/3 months) at higher MME tier; per-patch/day MME equivalencies listed

MorphaBond ER 15 mg90 tabs/month or 270/3 months (3 tabs/day) at one MME tier; 120 tabs/month or 360/3 months (4 tabs/day) at higher MME tier

Methadone Intensol 10 mg/mLExamples: 90 mL/month (3 mL/day) at an 80 MME/day tier; 270 mL/3 months likewise; other tiered monthly/3-month limits shown

Xtampza ER / Zohydro ERMultiple strength-specific monthly and 3-month caps (examples include 60, 90, 120 caps/month and 180–720 caps/3 months depending on strength/MME tier)

Example MME/day tiers

MME/day tiers (examples)30, 45, 60, 90, 120, 180, 240, 300, 360, 480, 800 MME/day

UsageTiers correspond to daily-equivalent potency used to set per-product/monthly caps

Chart examplesMS Contin and Xtampza entries illustrate high-end tiers (e.g., MS Contin 200 mg mapped to 800 MME/day)

Daily MME groupings

Daily MME groupings (examples)30 MME/day; 45 MME/day; 60 MME/day — used to derive monthly and 3-month quantity limits

Role in limitsPer-day MME grouping is paired with per-strength dosing to produce monthly/3-month caps (e.g., 2 tabs/day → 60 caps/month)

Chart referenceXtampza and Zohydro entries demonstrate grouping-to-quantity mapping

Prescriptions and prior authorization requests must specify the exact product and strength. Review of quantity limits and initial step therapy status is performed at the product/strength level; requests that do not indicate product and strength or that seek quantities inconsistent with the listed product‑specific limits may be denied or require additional documentation.

Include product name and strength on all prescriptions and PA submissions.
PA reviewers will match requests to the Opioid Analgesics ER Quantity Limits Chart by product and strength; discrepancies may trigger denial or request for more information.

Step Therapy

Initial step: documentation of prior opioid exposure

Initial step therapy requires prior opioid exposure unless the patient is already stable on an ER opioid. Specifically, the patient must have claim history showing either: an ≥8‑day supply of an immediate‑release (IR) opioid in the past 90 days, or a ≥30‑day supply of an extended‑release (ER) opioid in the past 90 days. If neither condition is met, the claim will reject and a prior authorization is required for further review.

At least an 8‑day IR opioid fill within 90 days OR at least a 30‑day ER opioid supply within 90 days to meet initial step requirement.
Claims without required prior opioid exposure will reject with a PA requirement; PA criteria will then be applied.

Step Therapy

Step therapy referenced (details handled via PA)

The policy enforces step therapy at the class level for extended‑release opioids and references step therapy sequencing in the title and criteria, but detailed step sequences or alternative‑trial specifications beyond the initial exposure requirements are not fully enumerated in this section. Providers should follow the initial exposure rules above and submit a prior authorization when the initial step conditions are not met; PA reviewers will apply the full step therapy and medical necessity criteria.

Step therapy is applied to the ER opioid class; prescribers must show trial/failure or intolerance of alternatives when applicable.
When initial step criteria are not present on claim history, submit a PA for clinical review; PA criteria include safety, monitoring, and dosing considerations.

If neither condition is met the claim will reject and prior authorization is required.

MME mappingAssigned MME/day values shown in chart accompany the listed film limits

Belbuca 900 mcg

Belbuca 900 mcg tiers and caps60 films/month or 180 films/3 months (2 films/day) at the 60 MME/day tier; 90 films/month or 270 films/3 months (3 films/day) at the 120 MME/day tier

Label max per dosing intervalMaximum per 12-hour dosing referenced as 900 mcg/12 hrs in chart context

MME/day mappingChart pairs each films/day regimen with an equivalent daily MME value

Butrans (5, 7.5, 10, 15, 20 mcg/hr)

Butrans patches common capsTypically 4 patches/month (12 patches/3 months) at lower MME tiers and 8 patches/month (24 patches/3 months) at higher MME tiers; per-strength caps detailed in chart

Per-strength examplesButrans 5, 7.5, 10, 15, 20 mcg/hr entries list 4 patches/month at 60 MME/day and 8 patches/month at 120 MME/day with per-patch MME equivalents

Dosing frequencyPatch application interval documented as q7d for Butrans strengths

ConZip (100, 200, 300 mg)

ConZip 100 mg example limits30 caps/month or 90 caps/3 months (1 cap/day) at a 60 MME/day tier; 60 caps/month or 180 caps/3 months (2 caps/day) at a 120 MME/day tier

ConZip other strengths200 mg and 300 mg entries follow similar 1 or 2 caps/day monthly and 3-month caps tied to MME tiers

Maximum daily dosingChart notes qd maximum daily mg (e.g., MAX 300 mg/day for certain strengths)

Dolophine (methadone) 5 mg, 10 mg

Dolophine (methadone) 5 mg example90 tabs/month or 270 tabs/3 months (3 tabs/day) at lower MME/day tier; 120 tabs/month or 360 tabs/3 months (4 tabs/day) at higher MME/day tier

Dolophine 10 mg90 tabs/month or 270 tabs/3 months (3 tabs/day) at specified MME tiers; higher-tier monthly/3-month caps (120/360) at higher MME/day mapping

Dosing intervalq8-12h dosing frequency noted for Dolophine entries

Duragesic (various mcg/hr)

Duragesic common capsOften 10 patches/month (30 patches/3 months) at lower MME tiers and 20 patches/month (60 patches/3 months) at higher MME tiers; per-patch/day MME equivalencies provided

Per-strength examplesDuragesic entries list 12, 25, 37.5, 50, 62.5, 75, 87.5, 100 mcg/hr with corresponding 10 or 20 patches/month caps and MME/day mapping

Patch intervalPatch administration interval documented as q72h for Duragesic strengths

Exalgo, Hysingla ER, Kadian (various strengths)

Exalgo, Hysingla ER, Kadian patternPer-strength monthly and 3-month caps provided, commonly 30/month or 90/3 months at lower MME tiers and 60/month or 180/3 months at higher MME tiers

Exalgo examplesExalgo 8–32 mg entries show 30 tabs/month (1/day) or 60 tabs/month (2/day) depending on MME tier with 90/180 3-month equivalents

Hysingla & KadianMultiple strengths listed with 30/60 caps per month and 90/180 caps per 3 months tied to MME/day groupings

Kadian (10–200 mg) and Methadone (tablets, injection, solutions)

Kadian and Methadone entriesKadian strengths (10–200 mg) have per-strength caps with 60/180 or 90/270 monthly/3-month limits depending on MME tier; Methadone tablet and solution volumes listed with monthly and 3-month equivalents

Methadone solution exampleMethadone 5 mg/5 mL oral solution: 450 mL/month or 1350 mL/3 months at certain MME tiers (15 mL/day) per chart

Kadian high-dose capsHigher Kadian strengths mapped to larger monthly/3-month caps corresponding to higher daily MME equivalents

MorphaBond ER (15, 30, 60 mg)

MorphaBond ER 15 mg example90 tabs/month or 270 tabs/3 months (3 tabs/day) at an 80 MME/day tier; 120 tabs/month or 360 tabs/3 months (4 tabs/day) at a 160 MME/day tier

Other strengths30 mg and 60 mg strengths have corresponding monthly and 3-month caps mapped to higher MME/day tiers

Dosing intervalq8-12h dosing frequency cited in chart entries

Methadone Intensol 10 mg/mL

Methadone Intensol example90 mL/month (3 mL/day) at an 80 MME/day tier; 270 mL/3 months at same tier; higher tiers map to 120 mL/month (4 mL/day) and 360 mL/3 months

Per-day mL mappingChart shows mL/day equivalents (e.g., 1.334 mL/day or 3 mL/day) tied to MME/day tiers

ApplicationsIntensol soln entries provide tiered monthly and 3-month limits consistent with other methadone formulations

MorphaBond ER (various strengths) and MS Contin examples

MorphaBond ER multi-strength mappingChart provides tab/month and 3-month caps across strengths with explicit MME/day mapping (examples include 15 mg = 90/month at 45 MME/day; 100 mg = 90/month at 300 MME/day)

MS Contin examplesMS Contin entries show wide MME/day mapping (e.g., 15 mg = 90 tabs/month at 45 MME/day; 200 mg = 120 tabs/month at 800 MME/day)

3-month equivalentsMost per-strength entries include both 30-day and 90-day quantity limits

MS Contin and other ER product examples

MS Contin examplesExamples include 15 mg = 90 tabs/month (3/day, 45 MME/day) and 200 mg = 120 tabs/month (4/day, 800 MME/day) with 3-month equivalents listed

Nucynta ER / Tramadol ER / Troxyca ERChart lists product-specific monthly and 3-month caps mapped to per-day dosing and MME tiers (examples provided)

Role in chartThese entries illustrate how different ER opioids are paired to MME tiers to set quantity limits

Xtampza ER and Zohydro ER (examples)

Xtampza ER caps rangeMultiple strengths with examples: 60 caps/month; 90 caps/month; 120 caps/month; 240 caps/month; 270 caps/3 months; 360 caps/3 months; 720 caps/3 months for high-dose entries

Zohydro ER caps examplesPer-strength examples include 60 caps/month; 90 caps/month; 120 caps/month and 270 caps/3 months depending on strength and MME/day mapping

High-dose capacityXtampza high-dose entries illustrate very large 3-month caps (up to 720 caps/3 months) tied to high MME/day equivalents

Inpatient care for non‑addiction admitting diagnosis and brief emergency treatment (≤3 days) are narrow exceptions per 21 CFR 1306.07

Consequences of noncomplianceFailure to comply may result in criminal prosecution, seizure of drug supply, revocation of approval, and injunctions

Extended‑release (ER) opioid

Extended‑release (ER) opioid definitionOpioid agonist formulations indicated for management of pain severe enough to require daily, around‑the‑clock, long‑term opioid treatment and not indicated for as‑needed (prn) use

Clinical reserve useER opioids should be reserved for patients for whom non‑opioid analgesics or immediate‑release opioids are ineffective, not tolerated, or otherwise inadequate

ExamplesVantrela ER, Xtampza ER, Zohydro ER among listed ER opioid products

MME/day (chart usage)

MME/day — chart presentationMorphine milligram equivalents per day (MME/day) are presented alongside product strength and quantity limits in the Opioid Analgesics ER Quantity Limits Chart

Standardization purposeMME/day standardizes opioid potency across products and strengths to derive monthly/3-month caps

Applied examplesChart pairs specific tab/cap/patch regimens (e.g., 2 tabs/day) with an equivalent MME/day value used to set caps

MME/day (standardization)

MME/day — standardizationMorphine milligram equivalents per day used to standardize opioid potency across products and strengths as presented in the chart

Role in prior authorizationMME/day mapping informs which monthly/3-month caps apply and when PA is required for quantities above those caps

Examples in chartMultiple chart entries show MME/day alongside per-day dosing and monthly caps (e.g., Belbuca, Duragesic, Xtampza)

MME (daily groupings)

MME groupings useDaily MME groupings (e.g., 30 MME/day, 45 MME/day) are used to set product-specific quantity limits for ER opioid products

Chart reliancePolicy quantity limits and PA decisions reference these daily MME groupings to map dosing to monthly/3-month caps

Reference sourcesPackage inserts and clinical references cited support the MME mappings used in the chart