CurrentCignaPolicy N/A

Opioids - Long-Acting Products (Oral) Drug Quantity Management Policy - Per Days

Defines quantity limits and prior authorization rules for long-acting oral opioid products for Cigna-administered health benefit plans; applies to prescribing providers, pharmacies, and utilization management staff.

Policy Summary

PayerCigna

PolicyOpioids - Long-Acting Products (Oral) Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 23, 2024

Key ActionRequests exceeding the listed quantity limits (30 days retail / 90 days home delivery) require prior authorization; approvals are provided for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

30/90default maximum quantity covered without prior authorization

6 monthsapproval duration when criteria met

90 / 270Zohydro ER retail / home

1,600Morphine (Avinza) max daily mg

500Nucynta ER max daily mg

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288Xtampza ER max daily mg

Coverage Criteria for Long-Acting Oral Opioids

Initial coverage for specified products (morphine and hydrocodone long-acting products)

Covered when ALL of the following are met

Intractable pain from chronic condition: Request is for management of intractable pain from a chronic condition (examples: cancer, low back pain, musculoskeletal pain, sickle cell pain)

If met, approve quantity requested for a 30-day retail supply and a 90-day home delivery supply for duration of 6 months

Initial/Quantity Approval Criteria

Covered when ALL of the following are met

Chronic intractable pain indication: Request is for management of intractable pain from a chronic condition (examples: cancer, low back pain, musculoskeletal pain, sickle cell pain)

Supply limits and duration: Approve quantity requested for a 30-day retail supply and a 90-day home delivery supply for a duration of 6 months

Product-specific maximum daily dose limits: Approved quantities must not exceed the product-specific maximum daily doses (examples: morphine ER capsules (Avinza) ≤ 1,600 mg/day; Nucynta ER ≤ 500 mg/day; Xtampza ER ≤ 288 mg/day)

Any use of the listed long-acting oral opioid products that does not meet the policy exceptions described in this document is considered not medically necessary. The policy explicitly states: Any other exception is considered not medically necessary for the covered long-acting oral opioid products.

Long-acting oral opioids are not recommended for approval for the treatment of acute pain, including surgery/post-surgery, trauma/post-trauma, or acute medical illness (for example, acute abdominal pain, pelvic pain, or muscle spasm). The policy clarifies that these products are intended for pain severe enough to require daily, around-the-clock, long-term opioid treatment and are not indicated for acute pain management.

Any use of long-acting oral opioids that does not meet the stated coverage criteria is considered not medically necessary. Per policy, covered use is limited to management of intractable pain from a chronic condition (see definition in criteria); uses outside that indication should be denied as not medically necessary.

The use of long-acting oral opioids for acute pain or for as-needed (PRN) analgesia is considered not medically necessary. The policy states these agents are intended for patients requiring daily, around-the-clock, long-term opioid therapy and therefore are not appropriate for intermittent or PRN use.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required for Quantities Beyond Program Limits

A quantity of each medication listed in the Drug Quantity Limits table is limited to a 30-day retail supply or a 90-day home delivery supply and will be covered without prior authorization. For coverage of additional quantities beyond these program limits, prior authorization is required.

Limits accumulate for interchangeable products that share the same active ingredient (for example, morphine sulfate CR/ER/SR products; hydrocodone ER tablet and capsule products; oxycodone CR and Xtampza ER).
All approvals are provided for 6 months in duration (1 month = 30 days).

Step Therapy

Step/Initiating Therapy Guidance

When evaluating requests, follow the CDC 2022 opioid prescribing guidance: do not initiate opioid treatment with long-acting opioids in opioid-naïve patients; do not prescribe long-acting opioids for intermittent (as-needed) use; reserve long-acting opioids for severe, continuous pain. When initiating therapy, prescribe the lowest effective dosage of immediate-release opioids for the shortest duration needed and reassess risks/benefits during ongoing therapy.

Initiation and Initial Quantity Criteria

Initiation guidance — Initiation considerations per CDC guidance

Covered when ALL of the following are met

Initiation guidance: Do not initiate long-acting opioids in opioid‑naïve patients; long‑acting opioids should not be used for intermittent/as‑needed use and should be reserved for severe, continuous pain

Per CDC guidance referenced in policy

Initial Quantity Rules — Initial quantity approvals for chronic intractable pain

Covered when ALL of the following are met

Approval duration and permitted supply: Approve requested quantity for a 30-day retail supply and a 90-day home delivery supply for a duration of 6 months when criteria met

Approvals subject to product-specific maximum daily dose limits

Product-Specific Quantity Limits and Accumulation Rules

inv-21: Multiple long-acting oral opioids (product-specific) — retail/home delivery limits (30/90)

Default quantity limits30 days at retail / 90 days at home delivery (per product) — covered without prior authorization up to these limits

Accumulation ruleLimits accumulate across interchangeable products within the same active ingredient groups (morphine, oxycodone, hydrocodone)

Prior authorization for additional quantitiesCoverage of quantities beyond the 30/90 limits requires prior authorization

inv-22: MS Contin / morphine SR / Arymo ER group — accumulated across interchangeable morphine products

Accumulation across morphine productsLimits for MS Contin (morphine sulfate CR), morphine sulfate SR (Oramorph), and Arymo ER (morphine sulfate ER) accumulate across these interchangeable morphine products

Retail/ home delivery units

Product Coding and Dose Limits

inv-07: Product Maximum Daily Dose — morphine ER (Avinza) <=1,600 mg/day; Nucynta ER <=500 mg/day; Xtampza ER <=288 mg/day

Morphine ER (Avinza) maximum<= 1,600 mg/day

Nucynta ER maximum<= 500 mg/day

Xtampza ER maximum<= 288 mg/day

Key Definitions

inv-17: Intractable pain defined — pain that is difficult to manage, sustained and persistent rather than brief and intermittent, and interferes with activities of daily living

Definition (focused)Intractable pain: pain that is difficult to manage, sustained and persistent rather than brief and intermittent, and interferes with activities of daily living

Clinical contextApplies to chronic conditions such as cancer, low back pain, musculoskeletal pain, and sickle cell pain when approving long-acting opioids

Coverage implicationRequests for management of intractable chronic pain may be approved for a 30-day retail and 90-day home delivery supply for 6 months when criteria met

inv-18: Intractable pain — pain that is difficult to manage, alleviate, remedy, or cure; sustained and persistent rather than brief and intermittent

Expanded definitionIntractable pain — pain that is difficult to manage, alleviate, remedy, or cure; sustained and persistent rather than brief and intermittent; interferes with activities of daily living

Background

Long-acting opioid analgesics are indicated to manage severe, persistent pain requiring daily opioid therapy when alternative treatments are inadequate. These products act primarily at central nervous system opioid receptors and are reserved for patients who need around-the-clock, long-term opioid treatment rather than intermittent or short-term analgesia. Manufacturer REMS programs and labeling describe risks of misuse and overdose and include requirements for education and counseling to mitigate those risks.

Policy Summary

PayerCigna

PolicyOpioids - Long-Acting Products (Oral) Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateOct 23, 2024

Key ActionRequests exceeding the listed quantity limits (30 days retail / 90 days home delivery) require prior authorization; approvals are provided for 6 months.

SourceLink

On This Page

Documentation Required

Documentation and Review Framework

Coverage determinations require review of the applicable benefit plan terms and consideration of relevant laws/regulations and collateral materials. Medical directors should exercise clinical judgment and document the specific facts supporting the request. Ensure the medical record includes diagnosis, rationale for long-acting therapy, prior treatment history, and rationale for requested quantity/duration.

Document diagnosis and evidence the pain is chronic and intractable (see Definition of intractable pain).
Include prior therapies tried and failed, rationale for long-acting formulation, and monitoring plan.

Documentation Required

Documentation for Chronic Intractable Pain and Quantity Approval Requirement

For requests specifically for chronic intractable pain (pain that is sustained, persistent, interferes with activities of daily living, and is difficult to manage), approve the quantity requested up to the program limits: a 30-day retail supply and a 90-day home delivery supply for a duration of 6 months. For certain products, additional maximum daily limits apply (e.g., Morphine sulfate ER capsules [Avinza] — approve not to exceed 1,600 mg/day; Nucynta ER — approve not to exceed 500 mg/day; Xtampza ER — approve not to exceed 288 mg/day).

Approvals for intractable pain are for 6 months (1 month = 30 days).
Document that the condition is chronic and intractable and include rationale for requested quantity.

Denial Risk

Conditions Not Recommended for Approval

Overrides for long-acting oral opioids are not recommended for acute pain or for as-needed (intermittent) analgesia. Long-acting oral opioids are intended for daily, around-the-clock management of severe, persistent pain and are not indicated for acute or PRN use.

Examples of acute pain: surgery/post-surgery, trauma/post-trauma, acute medical illness (e.g., acute abdominal pain, pelvic pain, muscle spasm).
Requests for long-acting opioids for intermittent/as-needed use should generally be denied/not overridden.

Prior Authorization

Failure to Meet Quantity Limits Triggers Prior Authorization/Criteria Review

If the requested quantity exceeds the Drug Quantity Management program limits, the request will be reviewed against the clinical criteria. Failure to meet quantity limits at point of service triggers prior authorization and criteria-based review.

All approvals provided following criteria are for a 6-month duration.
Providers should supply comprehensive documentation to support exceptions to quantity limits.

Note

Provider Alert — Documentation Required

Provider-facing alert: when submitting a request for a long-acting opioid, ensure the record clearly documents opioid-naïve status, reason for long-acting agent, prior treatment attempts, intended duration, and monitoring plan. Incomplete documentation may result in denial.

Retail maximums expressed per 30 days and home delivery per 90 days (product-dependent tablet/capsule counts)

Covered without prior authorizationQuantities within the accumulated limits are covered without prior authorization

inv-23: OxyContin and Xtampza ER — limits accumulate across these oxycodone formulations

OxyContin + Xtampza accumulationLimits for OxyContin (oxycodone CR) and Xtampza ER accumulate across oxycodone controlled-release formulations

Retail/home delivery limitsApply the standard 30-day retail / 90-day home delivery quantity limits across these products

Example countsPolicy lists per-product maximums (e.g., up to 90 capsules/tablets per 30 days depending on product strength)

inv-24: Hysingla ER and Zohydro ER — limits accumulate across hydrocodone ER tablet and capsule products

Hysingla ER + Zohydro ER accumulationLimits for Hysingla ER (hydrocodone ER tablets) and Zohydro ER (hydrocodone ER capsules) accumulate across hydrocodone ER tablet and capsule products

Retail/home delivery applicationApply the 30-day retail and 90-day home delivery maximums across the accumulated hydrocodone group

Practical exampleIf patient already filled 60 Hysingla tablets in 30 days, only 30 Zohydro capsules would be available to meet the 90-per-30-day cap

inv-25: Zohydro ER (hydrocodone bitartrate ER) — retail maximum quantity per 30 days

Retail maximum per 30 daysZohydro ER retail maximum quantity per 30 days = 90 capsules

Dosing noteZohydro ER is dosed Q12H; single doses of 40–50 mg or total daily dose >80 mg are for opioid-tolerant patients only

Administration warningCapsules to be swallowed whole — chewing/crushing can lead to uncontrolled delivery and overdose

inv-26: Zohydro ER (hydrocodone bitartrate ER) — home delivery maximum quantity per 90 days

Home delivery maximum per 90 daysZohydro ER home delivery maximum quantity per 90 days = 270 capsules

AccumulationHome delivery limit accumulates with Hysingla ER (hydrocodone) within the same accumulation group

Safety noteCapsules to be swallowed whole; misuse risks include overdose if crushed or dissolved

inv-27: Morphine sulfate extended-release capsules (Avinza) — maximum daily limit (mg/day)

Maximum daily dose (mg/day)Morphine sulfate extended-release capsules (Avinza) maximum = 1,600 mg/day

Approval contextApproved quantities must not exceed this maximum when authorizing a 30-day retail or 90-day home delivery supply for intractable pain

Safety noteDoses above this maximum may carry risk (e.g., fumaric acid exposure, renal toxicity concerns noted)

inv-28: Nucynta ER (50/100/150 mg strengths) — maximum daily limit (mg/day)

Maximum daily dose (mg/day)Nucynta ER (50/100/150 mg strengths) maximum = 500 mg/day

Approval contextApproved quantities must not exceed 500 mg/day when authorizing a 30-day retail or 90-day home delivery supply for intractable pain

Strength availabilityAvailable strengths include 50 mg, 100 mg, 150 mg (also 200 mg and 250 mg formulations noted separately)

inv-29: Xtampza ER — maximum daily limit (mg/day)

Maximum daily dose (mg/day)Xtampza ER maximum = 288 mg/day

Approval contextApproved quantities must not exceed 288 mg/day when authorizing a 30-day retail or 90-day home delivery supply for intractable pain

Dosing detailsAdministered Q12H; initial dose 9 mg Q12H; single doses >36 mg or total daily >72 mg require opioid tolerance per prescribing info

Not for acute painLong-acting oral opioids are not indicated for acute pain or as-needed analgesia (overrides not recommended)

Use in authorizationThis definition is used as the required indication when granting quantity approvals under this policy