CurrentUnitedHealthcarePolicy N/A

Medicare Part D opioid safety alerts and Drug Management Programs

Describes Medicare Part D requirements for opioid safety alerts (pharmacy claim edits), hard edit limits (including a 7-day supply for opioid-naïve enrollees), MME-based alerts, and Drug Management Programs that limit opioid/benzodiazepine access for enrollees at risk. Affects Part D plan sponsors, pharmacists, prescribers, and Medicare Part D enrollees.

Policy Summary

PayerUnitedHealthcare

PolicyMedicare Part D opioid safety alerts and Drug Management Programs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionPrescribers may request a coverage determination or attest to medical necessity to allow overrides when hard edits (for opioid‑naïve 7‑day supply or high cumulative MME) stop pharmacy adjudication.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7-daysupply limit for opioid-naïve enrollees (hard edit)

90 MMEopioid care coordination alert threshold

200 MMEsome plans' hard edit cumulative daily MME threshold

30 daysminimum notice before implementing DMP coverage limitations

Opioid Safety Alerts and Coverage Criteria

Policy Summary

PayerUnitedHealthcare

PolicyMedicare Part D opioid safety alerts and Drug Management Programs

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

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Opioid safety alerts and DMP criteria

Part D plan-required safety alerts and Drug Management Program (DMP) actions are covered when the conditions below are met or defined thresholds are reached.

Opioid-naive 7-day hard edit: Hard edit triggers when an enrollee who has not filled an opioid prescription recently (for example, within the past 60 days) attempts to fill an opioid prescription for more than a 7-day supply; the enrollee may receive up to a 7-day supply without action. Enrollee or prescriber can request a coverage determination for the full days' supply as written; the prescriber may attest that the days' supply is the intended and medically necessary amount to allow an override.>7 days for opioid-naive

Exemptions: residents of long-term care facilities; hospice, palliative, or end-of-life care; cancer-related pain treatment; sickle cell disease.

MME-based alerts: Alerts trigger based on cumulative opioid milligram morphine equivalent (MME) per day across all opioid prescriptions: care coordination alert at >= 90 MME; some plans may implement a hard edit at >= 200 MME that stops pharmacy processing until an override or coverage determination is completed.>=90 MME (care coordination); some plans >=200 MME (hard edit)

Resolving hard-edit MME alerts generally requires a coverage determination requested by the enrollee or prescriber; prescriber attestation that the cumulative MME is intended and medically necessary should allow approval.

Concurrent opioid and benzodiazepine or duplicative long-acting opioid therapy alerts: Soft edit alerts trigger when opioids are prescribed concurrently with benzodiazepines or when there is duplicative long-acting opioid therapy; pharmacists may perform a safety review and contact prescribers to confirm dose and medical need.N/A

Pharmacist may call prescriber even if dose is below 90 MME; prescriber may attest to medical necessity.

Drug Management Program limits: Plans must operate DMPs for enrollees identified as at risk (for example, opioid use involving multiple doctors/pharmacies or recent opioid-related overdose); DMPs may require enrollees to obtain opioids and/or benzodiazepines from a specified prescriber and/or pharmacy or implement individualized point-of-sale (POS) edits limiting covered amounts after case management.N/A

Plans must notify the enrollee in writing at least 30 days before implementing coverage limitations, make reasonable efforts to notify prescribers, and send a second written notice after 30 days; the enrollee, representative, or prescriber may appeal.

Residents of long-term care facilities, those receiving hospice, palliative, or end-of-life care, people being treated for cancer-related pain, and individuals with sickle cell disease are exempt from Part D opioid safety alert interventions. These exemptions also preserve access to medications for opioid use disorder (MOUD/MAT), such as buprenorphine.

Dosage and Supply Thresholds (Coding / Limits)

Opioid daily dosage thresholds

Care coordination alert thresholdAlert triggers when cumulative opioid daily dosage reaches or exceeds 90 MME/day across all opioid prescriptions

Some plans' hard edit thresholdSome plans may implement a hard edit when cumulative opioid daily dosage reaches 200 MME/day, which stops pharmacy processing until override or coverage determination

Scope of alertsSome plans apply MME-based alerts only when enrollee uses multiple opioid prescribers and/or dispensing pharmacies

Opioid-naïve supply threshold

Opioid-naïve supply hard editHard edit triggers when an enrollee who has not filled an opioid prescription recently (such as within the past 60 days) attempts to fill more than a 7-day supply

Automatic 7-day allowanceEnrollee may receive up to a 7-day supply without taking action

Override pathwayEnrollee or prescriber can request a coverage determination; prescriber may attest that the days supply is intended and medically necessary to allow override

Prescriber and Pharmacy Actions / Overrides

Prior Authorization

Coverage determination and DMP limits — overrides allowed only after coverage determination or prescriber attestation when cumulative MME thresholds exceeded

Coverage determinations (including expedited requests) may be submitted by the prescriber or enrollee when a safety edit or DMP limit would otherwise prevent dispensing. Plans are required to process coverage determination requests and may approve an override when the prescriber attests the prescribed days' supply or cumulative MME is medically necessary. Prescribers may request coverage determinations in advance of prescribing to avoid delays at the point of sale.

Prescriber or enrollee may request standard or expedited coverage determination
Plans should approve higher days' supply or MME after prescriber attestation of medical necessity

Note

DMP prescriber/pharmacy restriction — DMPs may require enrollees to use specific prescribers or pharmacies

Plans operate Drug Management Programs (DMPs) that may require enrollees to use specific prescribers and/or pharmacies or impose individualized point‑of‑sale coverage limits. Before implementing access restrictions, the plan must complete case management and send written notice to the enrollee at least 30 days prior, and a second notice confirming the limitation; prescribers and enrollees retain the right to appeal.

DMPs may restrict dispensing to a designated prescriber and/or pharmacy
Enrollees receive at least 30 days advance written notice and a second confirmation notice; appeals rights preserved

Documentation Required

Prescriber documentation and coverage determination — prescribers may be asked to provide information to allow pharmacist override at point of sale

Pharmacies may be required to collect or receive prescriber documentation at the point of sale to allow an override of opioid safety alerts (for example, attestation that a patient is exempt or that a higher days' supply/MME is medically necessary). CMS expects plans to allow hard edits and other safety alerts to be overridden at POS when the pharmacy has appropriate prescriber information.

Prescriber attestation or documentation can allow pharmacist override at POS
Documentation examples: statement that enrollee is exempt (hospice, cancer, palliative care, sickle cell) or that prescribed days' supply/MME is medically necessary

Denial Risk

Pharmacy hard edit stops adjudication — claims may be stopped at point of sale when hard edits trigger (e.g., >7-day supply for opioid‑naïve or cumulative MME thresholds)

Some safety alerts are implemented as hard edits that stop pharmacy adjudication (for example: >7‑day supply for opioid‑naïve patients or cumulative MME thresholds such as 90 MME care‑coordination and 200 MME stop edits). When a hard edit stops the claim, dispensing will not proceed until the plan processes an override via coverage determination or the pharmacy has required prescriber attestation/documentation.

7‑day supply hard edit for opioid‑naïve patients (exemptions apply)
Cumulative MME hard edits (e.g., alerts at 90 MME care‑coordination and potential hard stop at 200 MME)
Hard edits stop adjudication until override via coverage determination or prescriber attestation

Background and Intent

Medicare Part D safety edits and Drug Management Programs (DMPs) are intended to prevent unsafe opioid use, identify enrollees at risk for misuse (for example, those using multiple prescribers or pharmacies or with prior overdose), and promote care coordination. Safety edits include a 7-day supply hard edit for opioid‑naïve enrollees (an enrollee who has not filled an opioid prescription recently, e.g., within the past 60 days); an enrollee or prescriber may request a coverage determination or the prescriber may attest that a longer days’ supply is medically necessary to allow an override. DMPs limit access to opioids and/or benzodiazepines for enrollees deemed at risk and may include requirements such as designated prescribers or pharmacies and point‑of‑sale coverage edits after case management and notice.

Key Definitions

Drug Management Program (DMP) definition

DefinitionA Drug Management Program (DMP) is a plan-conducted case management program that limits access to opioids and/or benzodiazepines for enrollees deemed at risk for prescription drug misuse, with the goal of better care coordination for safer use

Typical enrollee identificationEnrollees identified by opioid use involving multiple doctors and pharmacies or recent history of opioid-related overdose

Possible DMP limitationsMay require enrollee to obtain medications from a specified prescriber and/or pharmacy or implement individualized POS coverage edits limiting covered amounts

Notification requirementPlan must notify the enrollee in writing at least 30 days before implementing coverage limitations and make reasonable efforts to notify prescribers; a second written notice must follow after 30 days

Opioid-naïve definition

Opioid-naïve definitionAn enrollee who has not filled an opioid prescription recently (such as within the past 60 days)

Relevance to limitsOpioid-naïve status is used to trigger the 7-day supply hard edit when filling an opioid prescription

Transition out of statusSubsequent prescriptions filled within the plan's look-back window remove opioid-naïve status so the 7-day limit no longer applies

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