CurrentUnitedHealthcarePolicy N/A

Medicare Part D opioid safety edits and drug management programs

Guidance on Medicare Part D pharmacy-level opioid safety edits, override procedures, exemptions, and drug management programs that limit opioid/benzodiazepine access; intended for pharmacists dispensing Part D medications.

Policy Summary

PayerUnitedHealthcare

PolicyMedicare Part D opioid safety edits and drug management programs

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPharmacists should document and, when appropriate, request an override or coverage determination to allow higher MME or longer days' supply.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 MMEcare coordination edit threshold

200 MMEoptional hard edit threshold

7 daysopioid-naive supply limit

60-90dplan review window

nationalapplicability

Medicare Part D Opioid Safety Edits — Coverage & Exemptions

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Medicare Part D opioid coverage/edit criteria

Coverage and edit behavior under Medicare Part D for opioids and benzodiazepines:

Standard edits and exemptions: All Part D plans must implement mechanisms for opioid safety alerts; certain populations are exempt (residents of long-term care facilities, hospice, palliative/end-of-life care, cancer-related pain, sickle cell disease). MOUD access must not be impacted.

MME-based edits: Care coordination edit at >=90 MME (soft/consultation) and optional hard edit at >=200 MME; some plans apply alerts only for multiple prescribers/pharmacies.

Opioid-naive supply limit: Opioid-naive enrollees limited to a 7-day supply (hard edit); subsequent prescriptions during plan review window (generally 60-90 days) are not subject to the 7-day limit.

Concurrent therapy alerts: Soft edits trigger for concurrent opioid and benzodiazepine use or duplicative long-acting opioid therapy prompting additional safety review.

Drug Management Programs (DMP): Plans must have a DMP for enrollees at risk, which may limit prescribers/pharmacies and implement enrollee-specific POS edits after notice and opportunity to respond; appeals available to enrollee/prescriber.

Coverage under Medicare Part D includes pharmacy-level opioid safety edits and Drug Management Programs (DMPs). Certain populations are exempt from these safety edits and DMP restrictions: residents of long-term care facilities, enrollees in hospice care, those receiving palliative or end-of-life care, and enrollees being treated for cancer-related pain or sickle cell disease. In addition, access to medications for opioid use disorder (MOUD, also called MAT) such as buprenorphine must not be restricted by these edits.

Thresholds, Limits, and Key Coding Values

inv-03: Care coordination edit threshold (>= 90 MME)

Care coordination edit threshold>= 90 MME (cumulative daily MME triggers consult)

Trigger behaviorWhen cumulative MME across opioid prescriptions reaches or exceeds 90 MME, a care coordination edit triggers and the pharmacist should consult the prescriber unless recent consultation or up-to-date clinical info is available.

Override/documentationOverrides may be communicated at point of sale; document date, time, prescriber name and brief note (e.g., prescriber confirmed intent or provided exclusion).

inv-04: Optional hard edit threshold (>= 200 MME)

Optional hard edit threshold>= 200 MME (some plans)

Plan variabilitySome plans implement a hard edit at 200 MME or more; others apply only when multiple prescribers or pharmacies are involved.

Override mechanismOverrides for exemptions may be communicated at POS with a transaction code or by contacting the plan directly.

inv-05: Opioid-naive supply limit (7 days)

Opioid‑naive supply limit7 days (hard edit)

Subsequent fillsSubsequent prescriptions filled during the plan's review window (generally 60–90 days) are not subject to the 7‑day limit.

Override/processOverrides may be communicated at POS with a transaction code or by contacting the plan; enrollees may request a coverage determination for the full days' supply.

inv-18: Opioids (general) — quantity limit (7)

Quantity limit (Opioids, general)7 (days supply limit for opioid‑naive enrollees)

ApplicabilityApplies to Medicare Part D enrollees who have not filled an opioid prescription recently (opioid‑naive).

Notification if not filledIf prescription cannot be filled as written due to the edit, provide the standardized CMS pharmacy notice to the enrollee.

Pharmacist and Prescriber Actions, Overrides, and DMPs

Prior Authorization

Coverage determination for higher MME or days' supply — expedited/standard request procedures

CMS requires Part D sponsors to allow all opioid safety alerts, including hard edits, to be overridden at the point of sale (POS) when the pharmacist has information from the prescriber or otherwise knows the enrollee is exempt. MME thresholds and days-supply limits are not prescribing limits. Enrollees or prescribers may request an expedited or standard coverage determination from the plan for approval of higher MME or a longer days supply; this can be done in advance of the prescription.

Enrollee or prescriber may request an expedited or standard coverage determination for higher MME or longer days supply.
POS overrides must be permitted when prescriber information or other exemption evidence is known to the pharmacy.

Denial Risk

200 MME optional hard edit — potential denial at POS without override

When an enrollee's cumulative opioid daily dosage reaches 200 MME or more, some plans may implement an optional hard edit that can deny a claim at POS unless overridden. If the pharmacist knows the enrollee has an exemption or has up-to-date clinical information from the prescriber, an override may be communicated at POS via transaction code or by contacting the plan directly. If unresolved at POS and the prescription cannot be filled as written, provide the standardized CMS pharmacy notice to the enrollee.

Optional hard edit may apply at >= 200 MME (some plans only when multiple prescribers/dispensing pharmacies are involved).
Overrides at POS: transaction code or contact plan; provide CMS pharmacy notice if not resolved.

Denial Risk

7-day supply hard edit — opioid-naive enrollee limit and POS denial risk

Medicare Part D enrollees who are opioid-naive (no recent opioid fill) are typically limited to a 7-day supply (hard edit). If the pharmacist knows the enrollee has an exemption or is already taking opioids, the pharmacist may communicate an override at POS via transaction code or by contacting the plan. If no override is granted, the enrollee may receive up to a 7-day supply or may request a coverage determination for the full days supply as written. Subsequent prescriptions filled during the plan's review window (generally 60–90 days) will not be subject to the 7-day limit. If unresolved at POS and the prescription cannot be filled as written, provide the standardized CMS pharmacy notice to the enrollee.

7-day supply hard edit applies to opioid-naive enrollees (plans may not apply to enrollees already taking opioids or when plan has existing prescription data).
If no override, enrollee may receive up to a 7-day supply or request a coverage determination; subsequent fills during review window are not subject to 7-day limit.
Provide CMS pharmacy notice if issue not resolved at POS.

Documentation Required

Override documentation — what pharmacist should document when overriding edits

Document pharmacist-prescriber interactions and any POS override activity. Documentation should include date, time, prescriber name, brief note of the prescriber's confirmation (e.g., confirmed intent, did not confirm intent, provided information about an enrollee exclusion, or could not be reached after attempts), and the override transaction code submitted. When the pharmacist has up-to-date clinical information (PDMP or other records) and has already consulted the prescriber, additional consultation is not expected but should still be documented. If the issue cannot be resolved at POS and the prescription cannot be filled as written, distribute the standardized CMS pharmacy notice to the enrollee.

Include date/time, prescriber name, summary of prescriber response or lack of contact, and override transaction code.
If pharmacist recently consulted prescriber and has current clinical information (e.g., PDMP), note that in documentation.
Provide CMS pharmacy notice when prescription cannot be filled as written.

Documentation Required

90 MME care coordination edit — claims trigger and need for override/documentation

When the 90 MME care coordination edit triggers (cumulative MME ≥ 90), consult the enrollee's prescriber to confirm intent unless the pharmacist already has up-to-date clinical information or knows the enrollee is exempt. Overrides may be communicated at POS and should be accompanied by documentation of the consultation and submission of the appropriate override code. If unresolved at POS and the prescription cannot be filled as written, provide the standardized CMS pharmacy notice to the enrollee.

Edit triggers at cumulative MME ≥ 90.
Some plans trigger only when multiple opioid prescribers or dispensing pharmacies are involved.
Document date/time, prescriber name, prescriber confirmation status, and submit appropriate override code.

Note

DMP limitations — requiring specified prescribers or pharmacies, enrollee restrictions

Drug Management Programs (DMPs) may impose enrollee-specific limitations (e.g., requiring a specified prescriber or pharmacy or implementing POS edits limiting quantities). Before implementing DMP limitations, the plan must give written notice and allow the enrollee to provide preferred prescribers/pharmacies or other relevant information. Enrollees, their representatives, or prescribers have the right to appeal a DMP limitation; pharmacies should direct the enrollee or prescriber to the plan for appeals and are not expected to provide the CMS pharmacy notice for DMP-related rejections.

DMPs target enrollees at risk (multiple doctors/pharmacies or recent opioid-related overdose) and include case management with prescribers.
DMP limitations can require specific prescribers/pharmacies or enforce enrollee-specific POS quantity limits.
Plan must provide written notice before limitations and allow enrollee input; appeals rights available to enrollee/representative/prescriber.

OpenPayer

Medicare Part D opioid safety edits and drug management programs

Medicare Part D Opioid Safety Edits — Coverage & Exemptions

Thresholds, Limits, and Key Coding Values

Pharmacist and Prescriber Actions, Overrides, and DMPs

Initial Dispensing Rules for Opioid-Naive Enrollees

Drug Management Programs (DMP) Conditions

Policy Background and Purpose

Key Terms and Abbreviations