DraftPremera BluecrossPolicy 5.01.529

Management of Opioid Therapy (Pharmacy Policy)

Pharmacy coverage and prior authorization rules for short-acting and long-acting opioid medications, including step therapy, quantity limits, and special rules for transmucosal fentanyl; applies to clinicians prescribing opioids and pharmacists dispensing them.

Policy Summary

PayerPremera Bluecross

PolicyManagement of Opioid Therapy (Pharmacy Policy)

Policy CodePolicy 5.01.529

Key ActionSubmit medical records and document a PDMP check when requesting quantities beyond the default supply.

Change TypeMultiple edits (step-therapy, quantity limits, product removals/additions)

Effective DateMay 1, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

Updated the short-acting opioid step-therapy requirement to limit to a 3-day supply for individuals < 18 years of age.

Removed OxyContin ER and Zohydro ER criteria and added them into the long-acting opioid step therapy criteria; added generic and brand entries for Hysingla ER and Zohydro ER.

Expanded criteria for specialist involvement to include providers supervised by or consulting regularly with an ABMS board-certified specialist for chronic pain and addiction-related reviews.

Added tapentadol HCL ER to the Long-Acting Opioid Quantity Limit table.

Removed Abstral (fentanyl) from the policy as it has been withdrawn from the market.

Removed Bunavail (buprenorphine/naloxone) and Morphabond ER (morphine sulfate ER) due to product discontinuation.

Non-formulary exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

Exception review authorizations for all drugs listed in this policy may be approved up to 12 months.

7-dayadult default supply

3 dayspediatric default limit

130 days

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opioid‑naïve window

3 monthsPDMP check timeframe

12 monthsmax exception auth

60common long-acting 30‑day limit

Coverage Criteria

Short-Acting Opioid Therapy — Adults

Covered when ALL of the following are met:

Adult short-acting opioid default coverage: A quantity sufficient for a 7-day supply will be covered for individuals aged 18 years or older without prior authorization.7-day

Opioid-naïve defined as no opioid in past 130 days; additional quantities require meeting further criteria

Criteria for >7-day supply for adults: At least one trial of a non-opioid medication (e.g., NSAIDs, acetaminophen) has provided inadequate response or non-opioid medications are inappropriate according to the prescribing clinician AND the individual's controlled substance prescription history has been checked within the last 3 months using the state PDMP (unless unavailable).

Exceptions may be medically necessary for certain clinical situations

Short-Acting Opioid Therapy — Children

Covered when ALL of the following are met:

Pediatric short-acting opioid default coverage: A quantity sufficient for a 3-day supply will be covered for individuals aged 17 years or younger without prior authorization.3-day

Additional quantities require coverage review for opioid-naïve individuals

Criteria for >3-day supply for children: At least one trial of a non-opioid medication (e.g., NSAIDs, acetaminophen) has provided inadequate response or non-opioid medications are inappropriate according to the prescribing clinician AND the individual's controlled substance prescription history has been checked within the last 3 months using the state PDMP (unless unavailable).

Exceptions may be medically necessary for certain clinical situations (e.g., traumatic injury, surgeries with extended recovery)

Long-Acting Opioid Therapy — Chronic Pain

Covered when ALL of the following are met:

Non-opioid-naïve requirement: Individual has chronic pain and is not opioid naïve (defined as no opioid history within the past 130 days).130 days

Short-acting opioid use requirement: Individual has a concurrent prescription or previous use of a short-acting opioid.

Optimization of non-opioid therapies: Non-opioid therapies (e.g., NSAIDs, SNRIs, tricyclics, anticonvulsants, exercise therapy) have been optimized and are being used in conjunction with opioid therapy, or have failed according to the prescribing clinician.

Treatment plan and reassessment: A treatment plan (including goals for pain and function) is in place and reassessments are scheduled at regular intervals per the prescribing clinician.

Long-Acting Opioid Quantity Limit — Exception Criteria

Exception approval requires ALL of the following:

Specialist involvement: Individual is being seen by a board-certified pain specialist (ABMS) or by a provider who is supervised by or consults regularly with a board-certified pain specialist.

For chronic pain quantity exceptions

Trials of non-pharmacologic therapies: Individual has had trials of 2 or more non-pharmacologic therapies (e.g., physical therapy, acupuncture, massage).2 therapies

Trials of non-opioid pharmacologic therapies: Individual has had trials of 3 or more non-opioid pharmacologic therapies (e.g., acetaminophen, NSAIDs, gabapentinoids, tricyclics, SNRIs).3 therapies

Transmucosal Fentanyl — Cancer indication

Covered when ALL of the following are met:

Breakthrough cancer pain indication: Transmucosal fentanyl citrate products may be considered medically necessary for treatment of breakthrough cancer pain in adult individuals with compromised oral intake or absorption.

Examples include Actiq, Lazanda, Subsys

Opioid tolerance requirement: Must be used only in opioid-treated and tolerant cancer individuals; contraindicated in opioid non-tolerant individuals and for acute/postoperative pain due to risk of life-threatening respiratory depression.

Coverage criteria (policy-level)

Covered when criteria for appropriate opioid use and quantity limits are met:

Pharmacy benefit management: Drugs listed are managed under the pharmacy benefit and are subject to prior authorization and product-specific quantity limits consistent with formulary status and FDA labeling.see quantity limits and step therapy

Initial short-acting opioid supply: Limit initial days' supply to 7 days for the general population; limit to 3 days for individuals under 18 per updated step-therapy.7 days (general); 3 days (<18)

Long-acting opioid use: Long-acting opioids are for daily, around-the-clock treatment when alternatives are inadequate; quantity limits and step-therapy criteria apply, and product-specific tablet/day guidance (e.g., OxyContin up to 3 tablets/day) is used where specified.product-specific

This policy does not apply to individuals with cancer, sickle cell disease, or those enrolled in a hospice program, receiving palliative or end-of-life care.

Short-acting opioid step therapy requirements do not apply when methadone (Dolophine, Methadose) is prescribed to treat opioid use disorder; these agents are exempt from the step therapy constraint in that clinical context.

Transmucosal fentanyl products are approved only for treatment of breakthrough pain in opioid-treated, opioid-tolerant cancer patients and are contraindicated for management of acute or postoperative pain and for use in opioid non‑tolerant individuals because of the risk of life‑threatening respiratory depression.

Policy tables were cleaned up to remove products no longer available or withdrawn from the market (examples: multiple short‑ and long‑acting products removed in prior updates; Abstral previously withdrawn; more recently Bunavail and Morphabond ER removed as discontinued). In addition, several long‑acting agents (including OxyContin ER and Zohydro ER) were moved into the long‑acting opioid step therapy criteria. Non‑formulary exception review authorizations have been clarified to allow approvals of up to 12 months where applicable.

There is no fully published randomized controlled evidence supporting the use of transmucosal fentanyl products for non‑cancer pain at this time; therefore their use outside the labeled breakthrough cancer pain indication in opioid‑tolerant cancer patients is not supported by available randomized controlled trial data.

Coding and Drug Lists

Codingneutral

No codes listed

Covered drug list (by generic/brand)mixedCovered

Morphine	Injection, oral solution, rectal suppository, tablet - Duramorph; Infumorph; Mitigo
Oxycodone	Capsule, injection, oral concentrate, oral solution, tablet - Oxaydo; Roxicodone; Roxybond
Oxycodone/acetaminophen	Tablet, solution - Endocet; Nalocet; Percocet; Primlev; Prolate
Oxymorphone	Tablet - Opana
Pentazocine lactate	Injection - Talwin; Pentazocine/naloxone: Tablet
Tapentadol	Tablet - Nucynta
Tramadol	Oral suspension, tablet - Qdolo; Ultram
Tramadol/acetaminophen	Tablet - Ultracet
Tramadol/celecoxib	Tablet - Seglentis
Buprenorphine	Buccal film, injection, intradermal implant, transdermal patch - Belbuca; Buprenex; Buprenorphine patch; Butrans

1–10 of 15

1/2

Opioid‑naïve definition window — 130 days

Opioid‑naïve definition windowOpioid‑naïve is defined as no history of any opioid within the past 130 days.

PDMP check timeframeControlled substance history must be checked within the last 3 months when requesting quantities beyond default for opioid‑naïve individuals.

Default adult initial supplyOpioid‑naïve adults default to a 7‑day supply without prior authorization (see initial therapy rules).

Quantity limits per drug — various drug/strength limits referenced

Range of quantity limitsQuantity limits vary by drug and strength (examples include 60 tablets/30 days, 90 tablets per 30 days, 120 tablets/30 days, and 181 tablets per fill).

Provider Actions and Requirements

Prior Authorization

Prior Authorization for Quantities Beyond Default

A prior authorization (coverage review) is required when dispensing quantities exceed the default supply limits: adults — any short‑acting opioid quantity greater than a 7‑day supply for opioid‑naïve individuals; children (<18 years) — any short‑acting opioid quantity greater than a 3‑day supply for opioid‑naïve individuals. Opioid‑naïve is defined as no history of any opioid within the past 130 days. Requests for quantities beyond the default may be approved only when the specific clinical criteria in the policy are met and appropriate documentation is provided.

Adults: ≤7‑day supply covered without prior authorization for short‑acting opioids; >7 days requires coverage review for opioid‑naïve members.
Children (≤17 years): ≤3‑day supply covered without prior authorization for short‑acting opioids; >3 days requires coverage review for opioid‑naïve members.
Long‑acting opioid quantity limits: see Long‑Acting Opioid Quantity Limits table; quantities exceeding listed limits require case‑by‑case review.

Prior Authorization

Pharmacy Benefit and Prior Authorization Required

This policy is managed through the pharmacy benefit and applies to all pharmacy benefit contracts that include pharmacy prior authorization edits. Drugs listed in this policy are therefore subject to pharmacy prior authorization and the non‑formulary exception process; failure to follow pharmacy prior authorization processes may result in denial of coverage.

Initial Therapy Criteria

Initial short-acting therapy — Initial short-acting therapy defaults

Initial short-acting therapy defaults:

Adult initial short-acting: Opioid-naïve adults may receive up to a 7-day supply of short-acting opioids without prior authorization.7-day

Opioid-naïve defined as no opioid in past 130 days

Pediatric initial short-acting: Opioid-naïve individuals aged 17 years or younger may receive up to a 3-day supply of short-acting opioids without prior authorization.3-day

Per 2022 update limiting pediatric initial supply

Initial therapy limits — Initial supply objective and pediatric-specific step-therapy

Initial therapy limits and pediatric-specific step-therapy:

Continuation and Reauthorization Criteria

Approval lengths — Lengths of approval and reauthorization notes present in policy

Approval lengths and reauthorization notes:

Short-acting approval length: Short-acting opioid drugs may be approved up to 3 months; approvals are provided one time only and on a case-by-case basis.3 months

Long-acting approval length: Long-acting opioid drugs may be approved up to 12 months; quantity limit exceptions for long-acting opioids may be approved on a case-by-case basis for a maximum of 3 months.12 months

Continuation/authorization duration — Non-formulary exception review authorizations duration

Authorization duration for exception reviews:

Step Therapy Requirements

Requirement	Details
PDMP check	Chart notes must document that the individual's controlled substance prescription history was checked within the last 3 months using the state PDMP (unless PDMP unavailable).
Opioid‑naïve assessment	Opioid‑naïve is defined as no history of any opioid within the past 130 days; initial default supply for opioid‑naïve adults is a 7‑day supply and for individuals ≤17 years is a 3‑day supply without prior authorization.
Prior/concurrent short‑acting opioid use (long‑acting only)	For long‑acting opioid step therapy, the individual must have a concurrent prescription or previous use of a short‑acting opioid.
Non‑opioid trial (short‑acting > default; long‑acting)	Requests for quantities greater than the default (>7 days adults; >3 days children) require documentation of at least one trial of a non‑opioid medication with inadequate response or that non‑opioid medications are inappropriate; long‑acting therapy requires optimization/failed non‑opioid therapies.
Documented treatment plan (long‑acting)	Long‑acting opioid criteria require a treatment plan with goals for pain and function and scheduled reassessments per the prescribing clinician.

Policy change / rule	Effect / detail
Pediatric short‑acting limit	Updated (2022) to limit initial short‑acting opioid supply for individuals <18 years to a 3‑day supply without prior authorization; additional days require coverage review.
Reclassification of certain agents	(2023) OxyContin ER and Zohydro ER were removed from short‑acting criteria lists and added into the long‑acting opioid step therapy/quantity limit criteria; generic and brand Hysingla ER and Zohydro ER entries were added to long‑acting criteria.

Aspect	Application / note
Different application: short‑acting vs long‑acting	Short‑acting opioids: default initial supply objective is limited (7 days adults; 3 days for <18) and extensions require a trial of non‑opioid and PDMP check. Long‑acting opioids: intended for daily, around‑the‑clock long‑term treatment and require the individual to be non‑opioid‑naïve, prior/concurrent short‑acting opioid use, optimization/failed non‑opioid therapies, a documented treatment plan, and PDMP check within last 3 months.
Additions to long‑acting criteria	Policy history documents reclassification and additions to long‑acting step therapy/quantity limits over time (examples: moving OxyContin ER and Zohydro ER into long‑acting criteria and removing discontinued products); quantity limits and step therapy for long‑acting agents are applied per product.

Aspect

Application / note

Different application: short‑acting vs long‑acting

Short‑acting opioids: default initial supply objective is limited (7 days adults; 3 days for <18) and extensions require a trial of non‑opioid and PDMP check. Long‑acting opioids: intended for daily, around‑the‑clock long‑term treatment and require the individual to be non‑opioid‑naïve, prior/concurrent short‑acting opioid use, optimization/failed non‑opioid therapies, a documented treatment plan, and PDMP check within last 3 months.

Additions to long‑acting criteria

Policy history documents reclassification and additions to long‑acting step therapy/quantity limits over time (examples: moving OxyContin ER and Zohydro ER into long‑acting criteria and removing discontinued products); quantity limits and step therapy for long‑acting agents are applied per product.

Quantity Limits

Long-acting opioids listed in policy — Product-specific quantity limits based on FDA dosing

Product‑specific limitsLong‑acting opioids listed in the policy have product‑specific quantity limits based on FDA‑approved maximum dosing; some ER products have combined 30‑day limits across strengths.

Examples of long‑acting classesLong‑acting opioids include buprenorphine, hydrocodone ER, hydromorphone ER, methadone, morphine sulfate ER, oxycodone ER, oxymorphone ER, tapentadol ER, and tramadol ER.

Documentation for exceptionsQuantity exceptions for chronic pain require specialist involvement, trials of non‑pharmacologic and non‑opioid therapies, a management contract, PDMP documentation, and urine drug screening per policy criteria.

Buprenorphine/naloxone (2 mg-0.5 mg; 4 mg-1 mg) — 90

Quantity limit90 tablets or films per fill.

Site of Care / Benefit

Note

Pharmacy benefit management — submit PA via pharmacy benefit processes

Managed through the pharmacy benefit; applies to pharmacy contracts that include pharmacy prior authorization edits — providers should submit PA requests through the pharmacy benefit processes.

Policy administration and PA edits are handled under the member's pharmacy benefit.

Note

Policy applies to medications dispensed through pharmacy benefit

Policy is managed through the pharmacy benefit and applies to medications dispensed via pharmacy; prescribers and pharmacies must follow pharmacy PA and quantity‑limit edits.

Dispensing and PA edits are enforced through the pharmacy benefit.

Note

Policy historically clarified as managed via the member's pharmacy benefit

Policy management occurs through the member's pharmacy benefit (statement historically added); providers should reference the pharmacy benefit's PA requirements when submitting requests.

Background

Opioid analgesics act at opioid receptors and are used for management of pain, but carry significant risk for dependence, misuse, and respiratory depression. The policy emphasizes limiting initial supplies and using step therapy and quantity limits to reduce exposure: the standard initial objective for short‑acting opioids is a 7‑day supply for adults and more conservative limits for children, with additional safety checks (PDMP review, trial of non‑opioid therapies) and specialist oversight for long‑acting therapy.

Definitions

opioid naïve — defined as not having history of any opioid within the past 130 days

Opioid‑naïve definitionOpioid‑naïve is defined as not having a history of any opioid within the past 130 days.

Use in step therapyOpioid‑naïve status is assessed when applying initial short‑acting and long‑acting step‑therapy rules and quantity limits.

Implication for prior authorizationOpioid‑naïve individuals requesting supplies beyond default limits require coverage review and supporting documentation.

Formulary — list of drugs approved by the P&T Committee for routine use

Formulary definitionFormulary: a list of drugs approved by the Pharmacy and Therapeutics (P&T) Committee for routine use.

Role

Revision History

2011-02-08created

Policy added to the Prescription Drug Section as a new policy.

2011-12-13revised

Policy replaced and updated with additional approval parameters and a dosing limitation for OxyContin.

2012-11-13reviewed

Policy replaced after literature search found no need for changes to criteria.

Policy Summary

PayerPremera Bluecross

PolicyManagement of Opioid Therapy (Pharmacy Policy)

Policy CodePolicy 5.01.529

Key ActionSubmit medical records and document a PDMP check when requesting quantities beyond the default supply.

Change TypeMultiple edits (step-therapy, quantity limits, product removals/additions)

Effective DateMay 1, 2026

Next Review DateN/A

SourceLink

On This Page

PDMP check: The individual's controlled substance prescription history has been checked within the last 3 months using the state PDMP, unless unavailable.3 months

Management contract: Individual and the prescribing clinician have a pain management contract/management contract in place.

Urine drug screening: Individual participates in urine drug screening per the frequency documented in the provider's chronic opioid therapy plan or has a urine drug screen documented within the last 6 months.6 months

PDMP documentation: Chart notes document that the state PDMP was checked within the last 3 months.3 months

Transmucosal fentanyl restrictions: Transmucosal fentanyl is indicated only for breakthrough pain in opioid-tolerant cancer patients and is contraindicated for opioid non-tolerant individuals and for acute/postoperative pain.opioid tolerance and cancer indication required

Specialist involvement for higher quantity/long-term use: For long-acting opioid quantity limit review for chronic pain or OUD, the individual must be seen by a board-certified specialist or by a provider supervised by or consulting regularly with an ABMS board-certified specialist; management contract requirements apply as specified.specialist or supervised provider involvement

Combined‑strength limits

Some ER opioids have combined 30‑day limits across all strengths (e.g., hydromorphone ER, morphine sulfate ER, Nucynta ER, oxymorphone ER).

FDA labeling basisDispensing quantity limits are based on the maximum dose recommendations in the product's FDA‑approved labeling.

Initial short-acting opioid days' supply — 7 days

Adult initial short‑acting supply objectiveA quantity sufficient for a 7‑day supply will be covered for individuals aged 18 years or older without prior authorization.

PurposeObjective is to restrict initial days' supply to seven days to align with guidelines and reduce misuse/stockpiling.

Exceptions require reviewAdditional quantities beyond 7 days for opioid‑naïve adults require coverage review and documentation (e.g., failed non‑opioid trial, PDMP check).

Initial short-acting opioid days' supply (individuals <18) — 3 days

Pediatric initial short‑acting supplyA quantity sufficient for a 3‑day supply will be covered for individuals aged 17 years or younger without prior authorization.

Updated ruleShort‑acting opioid step‑therapy requirement was updated (2022) to limit initial supply for individuals <18 to 3 days.

Coverage review for >3 daysRequests for more than 3 days for opioid‑naïve children require coverage review with documentation (e.g., failed non‑opioid trial, PDMP check).

Policy applies across all formulary types per member contract.
Non‑formulary exception reviews for drugs listed may be approved up to 12 months (see History updates).

Documentation Required

Medical Records and Documentation Required

Prior authorization requests must include supporting medical record documentation. A copy of the individual's medical records history is required when submitting prior authorization requests for drugs affected by this policy. Absence of adequate medical records or required documentation (including PDMP check and urine drug screening where applicable) may result in denial.

Include medical records demonstrating prior trials, treatment plan, and rationale for greater quantity.
Document state PDMP check within the last 3 months (unless PDMP unavailable in the state).
For long‑acting opioid chronic therapy: include pain management/therapy plan, evidence of urine drug screening participation or record within last 6 months as specified.

Denial Risk

Prior Authorization and Quantity‑Limit Coverage Review

Requests for quantities greater than policy quantity limits or for overrides of step‑therapy/formulary defaults will undergo individual case review and must provide clinical justification and documentation. Quantity limit requests that exceed the listed limits may be denied if criteria are not met.

Long‑acting opioid quantity limits (combined strengths over 30 days) are listed in the Long‑Acting Opioid Quantity Limits table; examples include hydromorphone ER, morphine ER, MS Contin, Nucynta ER, oxymorphone ER.
Some products have per‑fill limits (e.g., buprenorphine/naloxone formulations listed with 60–90 units per fill).
Dispensing quantity limits are based on FDA‑approved labeling; exceptions considered case‑by‑case for chronic pain or OUD with specialist oversight.

Documentation Required

Quantity Limit Documentation

Pharmacy or prescriber must provide documentation to support dispensing quantities larger than the policy limits. Documentation should directly address the policy criteria for the applicable override (e.g., trials of non‑opioid therapies, specialist involvement, treatment/management contract, pain/function goals, and monitoring plans).

For chronic pain overrides: documentation of trials of required number of non‑pharmacologic and non‑opioid therapies.
For long‑acting opioids: evidence patient is seen by an ABMS board‑certified specialist or supervised/consulted by one as specified.
Include monitoring documentation: PDMP check, urine drug screening frequency or recent results, and written treatment/management contract.

Step Therapy

Step‑Therapy Requirements (Short‑Acting and Long‑Acting)

Step‑therapy rules apply for both short‑acting and long‑acting opioids. Short‑acting step‑therapy: non‑opioid therapies should be tried and found inadequate or inappropriate prior to approval of quantities beyond the default (7 days adult; 3 days pediatric). Long‑acting step‑therapy: long‑acting opioids are appropriate only when specific criteria are met, including non‑opioid optimization, concurrent/previous short‑acting opioid use, and regular reassessment and monitoring.

Short‑acting step therapy: at least one trial of non‑opioid medication (e.g., NSAID, acetaminophen) required before > default supply for opioid‑naïve individuals.
Long‑acting step therapy: individual must not be opioid‑naïve, have trials/optimization of non‑opioid therapies, an established treatment plan with reassessments, PDMP check, and concurrent/previous short‑acting opioid use.
Pediatric change: short‑acting limit revised to 3‑day supply for individuals under 18 (2022 update).

Step Therapy

Opioid Step‑Therapy Rules and Recent Changes

Opioid step‑therapy and quantity rules include pediatric‑specific and long‑acting reclassification changes. Providers should note recent policy updates changing pediatric short‑acting limits to 3 days and reclassifying certain long‑acting agents into step‑therapy criteria; ensure prescriptions and prior authorization requests reflect these rules.

2022: short‑acting limit changed to 3 days for individuals <18 years.
2023: OxyContin ER and Zohydro ER moved into long‑acting opioid step‑therapy criteria; several generics added to quantity limits.
2025–2026: clarifications around exception durations (up to 12 months) and specialist supervision/consultation requirements for quantity limit overrides.

Initial supply objective: Objective to restrict initial days' supply of short-acting opioids to 7 days for the general population.7 days

Reduce risk of stockpiling and misuse

Pediatric step-therapy limit: For individuals under 18 years, short-acting opioid initial supply is limited to 3 days per the 2022 step-therapy update; supplies beyond this require coverage review.3 days

Non-formulary exception duration: Non-formulary exception review authorizations for all drugs listed in this policy may be approved for up to 12 months.12 months

Medications remain subject to FDA dosage and administration information

Strengths referenced

Applies to buprenorphine/naloxone strengths 2 mg‑0.5 mg and 4 mg‑1 mg as listed in the Long‑Acting Opioid Quantity Limits table.

FormulationsIncludes tablets or films (product/formulation dependent).

Buprenorphine/naloxone (12 mg-3 mg) — 60

Quantity limit60 tablets or films per fill.

Strength referencedApplies to buprenorphine/naloxone 12 mg‑3 mg per the quantity limit table.

FormulationsIncludes tablets or films (product/formulation dependent).

Hydrocodone ER (all strengths) — 60

Quantity limit60 tablets per 30 days for all strengths.

Product examplesIncludes hydrocodone ER formulations such as Hysingla ER (all strengths).

BasisLimit is applied per the Long‑Acting Opioid Quantity Limits table (30‑day basis).

Hydromorphone HCl ER (all strengths) — 60

Quantity limit60 tablets per 30 days for all strengths.

ScopeApplies to hydromorphone HCl ER across strengths (combined 30‑day limit).

Combined strengths noteSome ER opioids have limits that combine all strengths in a 30‑day period as noted in the policy.

Morphine sulfate ER (MS Contin / generics) — 60-120

Quantity range60–120 tablets per 30 days depending on product (examples: 60 for some generics, up to 120 for MS Contin).

Product‑specific capsMS Contin and certain morphine ER generics are listed with higher 30‑day tablet limits (e.g., MS Contin = 120 tablets/30 days; other generics 60–90 per 30 days).

Combined strengths noteSome morphine ER entries specify limits across all strengths combined in 30 days.

Nucynta (tapentadol HCl) — 181

Quantity limit181 tablets per fill (all strengths).

Product nameNucynta (tapentadol HCl) listed with 181 tablets per fill in the long‑acting quantity table.

Per‑fill basisLimit shown as 'per fill' in the quantity limits table rather than per 30 days for the immediate‑release product.

Oxycodone HCl ER (10-40 mg) — 90

Quantity limit90 tablets per 30 days for 10–40 mg strengths.

Strengths coveredApplies to oxycodone HCl ER 10 mg, 20 mg, and 40 mg strengths per the table.

Per‑30‑day basisLimit specified as per 30 days in the Long‑Acting Opioid Quantity Limits table.

Oxycodone HCl ER (80 mg) — 120

Quantity limit120 tablets per 30 days for the 80 mg strength.

High‑strength rationaleThe 80 mg tablet corresponds to 160 mg/day at two tablets; limit set to allow higher dosing per product labeling.

Per‑30‑day basisLimit specified as per 30 days in the Long‑Acting Opioid Quantity Limits table.

Suboxone (buprenorphine/naloxone) multiple strengths — 30-90

Quantity range30–90 films/tablets per fill depending on strength (strength‑dependent limits per table).

Product examplesSuboxone (buprenorphine/naloxone) is listed with multiple strength entries and corresponding 30–90 limits per fill.

Formulation noteLimits apply to films or tablets as specified by product and strength in the table.

Zubsolv (buprenorphine/naloxone) multiple strengths — 30-90

Quantity range30–90 tablets per fill depending on strength (strength‑dependent limits per table).

Product examplesZubsolv (buprenorphine/naloxone) entries show strength‑dependent limits of 30–90 tablets per fill.

Formulation noteLimits are listed per specific Zubsolv strengths in the quantity limits table.

Tapentadol HCl ER (all strengths) — 60

Quantity limit60 tablets per 30 days for tapentadol HCl ER (all strengths).

Addition to tableTapentadol HCl ER (tapentadol HCL ER) was added to the Long‑Acting Opioid Quantity Limit table in 2026 updates.

Per‑30‑day basisLimit specified as per 30 days in the Long‑Acting Opioid Quantity Limits table.

OxyContin (oxycodone ER) — up to 3 tablets/day generally; 4 tablets/day exception for cancer patients

OxyContin tablet/day guidanceOxyContin generally dosed every 12 hours; quantity guidance allows up to 3 tablets/day to provide prescriber flexibility in unusual clearance circumstances.

Cancer exceptionFor cancer patients, a 4 tablets/day allowance permits escalation up to higher daily dosing (e.g., 4 tablets/day reaches 320 mg/day at 80 mg tablets) before a quantity override is required.

Product strengthsOxyContin is available in tablet sizes 10, 15, 20, 30, 40, 60, and 80 mg; limits are strength‑specific in the quantity table.

Short-acting opioids (general) — initial supply objective 7 days

Initial supply objectiveStandard objective is to limit initial short‑acting opioid supply to 7 days for opioid‑naïve adults.

Step therapy roleShort‑acting step therapy limits initial supply and requires trials of non‑opioid medications before larger quantities are approved for opioid‑naïve individuals.

PDMP and documentationRequests for >7 days require PDMP check within 3 months and supporting documentation (medical records) per prior authorization rules.

all drugs listed in this policy — subject to FDA dosing and product-specific reviews

All drugs subject to FDA dosing guidanceAll drugs listed in this policy are subject to the product's FDA‑approved dosing and quantity limits; dispensing limits are based on FDA labeling and product‑specific reviews.

Quantity limit reviewsSome products have quantity limit reviews specific to chronic pain or opioid use disorder and may require additional documentation for exceptions.

Policy updatesThe policy history clarifies that medications are subject to FDA dosage and administration prescribing information; exception authorizations may be approved up to 12 months.

tapentadol HCL ER — added to long-acting opioid quantity limit table

Table additionTapentadol HCL ER was added to the Long‑Acting Opioid Quantity Limit table (2026 updates).

Quantity entryTapentadol HCl ER is listed with a 60 tablets per 30 days limit in the long‑acting quantity limits table.

ContextAddition reflects product availability updates and aligns tapentadol ER with other long‑acting opioid quantity limits.

Historical note: policy wording clarified that management is through the member's pharmacy benefit.

Formulary status influences routine coverage and whether exceptions or prior authorization are required.

Non‑formulary noteDrugs not on the formulary are considered non‑formulary and may require exception review for coverage.

Quantity limits — definition of maximum amount dispensed during a period

Quantity limits definitionA quantity limit is the maximum amount of a medication that may be dispensed during a given calendar period or at one prescription fill without an exception request.

Exception processDispensing of a larger quantity may be approved based on individual case review and supporting clinical documentation.

PurposeQuantity limits help align dispensing with FDA dosing recommendations and reduce unnecessary quantities that could be misused.

Formulary drug — definition

Formulary drugA formulary drug (preferred drug) is a medication that appears on the formulary list; drugs not on the list are considered non‑formulary.

Coverage implicationFormulary drugs are typically covered per the formulary rules; non‑formulary drugs require exception review for authorization.

P&T roleFormulary decisions are made by the Pharmacy and Therapeutics Committee to meet treatment needs of most individuals.

Formulary / Formulary drug — duplicate definition entry from policy

Formulary (duplicate entry)Formulary / Formulary drug: A formulary drug is on the P&T approved list for routine use; non‑formulary drugs require exceptions.

TerminologyThis entry reiterates the formulary definition used in the policy's Definitions section.

Practical noteRefer to plan‑specific formulary lists for routine coverage and prior authorization edits.

Quantity limits — duplicate definition entry for quantity limits

Quantity limits (duplicate)Quantity limit: maximum amount of a medication that may be dispensed during a given calendar period or at one prescription fill without an exception request.

Approval of larger quantitiesA specified larger quantity may be approved when individual‑specific circumstances require it or published clinical evidence supports it.

Documentation requirementDispensing larger quantities requires submission of medical records and other supporting documentation per the policy's exception criteria.

management contract — definition or term entry

Management contract termPolicy uses the term 'management contract' (updated from 'pain management contract') as part of long‑acting opioid exception criteria.

ContextA management contract is required documentation for some long‑acting opioid quantity exceptions (chronic pain or OUD reviews).

Related requirementsManagement contract is listed alongside requirements such as specialist involvement, PDMP checks, and urine drug screening.

board-certified specialist — defined per ABMS

ABMS‑defined specialistBoard‑certified specialist is defined per the American Board of Medical Specialties (ABMS) and is required for certain long‑acting opioid quantity exceptions.

Supervised/consulting provider allowancePolicy allows a provider supervised by or consulting regularly with an ABMS board‑certified specialist to meet the specialist requirement for chronic pain or OUD reviews.

DocumentationChart documentation must support specialist involvement or regular supervision/consultation as part of exception requests.

2013-07-08administrative_update

Clarified that the policy is managed through the member's pharmacy benefit (added to header and coding section).

2013-10-14revised

OxyContin medically necessary statement updated to reflect new FDA labeling and stricter FDA indication wording.

2014-04-14revised

Extended-release hydrocodone (Zohydro ER) added as medically necessary for its labeled indication for severe pain requiring around-the-clock treatment when alternatives are inadequate.

2016-05-01revised

Interim update added additional quantity limit criteria for OxyContin and Zohydro ER.

2017-06-01reviewed

Annual review completed (approved May 23, 2017) and policy moved into new format; introduction summary created.

2022revised

Updated short-acting opioid step-therapy to limit initial supply to a 3-day supply for individuals under 18 years of age.

2023revised

Moved OxyContin ER and Zohydro ER criteria into the long-acting opioid step therapy criteria and added generic/brand entries for Hysingla ER and Zohydro ER.

2025-11-01removed

Removed Abstral (fentanyl) from the policy as it was withdrawn from the market and clarified that non-formulary exception review authorizations may be approved up to 12 months.

2026revisedLatest

Removed Bunavail and Morphabond ER due to product discontinuation and updated specialist/management contract language and added tapentadol HCl ER to the long-acting quantity limit table.

Material changes include updating the pediatric short‑acting opioid step‑therapy limit to a 3‑day supply for individuals under 18 years (2022 update) and moving certain agents (for example, OxyContin ER and Zohydro ER) into the long‑acting opioid step therapy criteria (2023 update). These updates reflect an emphasis on minimizing initial opioid exposure in pediatric patients and reclassifying some products under long‑acting opioid controls.

Products withdrawn or discontinued have been removed from the policy lists (for example, Abstral was removed when withdrawn). Recent history entries document removal of additional discontinued products (Bunavail, Morphabond ER) and reiterate that non‑formulary exception authorizations for drugs in this policy may be approved for up to 12 months.