CurrentUnitedHealthcarePolicy N/A

Medicare Part D Opioid Safety Edits and Drug Management Programs (pharmacy-facing)

Rules and pharmacy-facing procedures for opioid-related safety edits, hard edits, supply limits, concurrent opioid/benzodiazepine soft edits, and Drug Management Programs (DMPs) that apply to Medicare Part D enrollees and affect pharmacists at point of sale.

Policy Summary

PayerUnitedHealthcare

PolicyMedicare Part D Opioid Safety Edits and Drug Management Programs (pharmacy-facing)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2024

Next Review DateN/A

Key ActionIf a safety edit is triggered, consult the prescriber, document the interaction and submit the appropriate override code or initiate a coverage determination to approve 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-naïve supply limit

60-90 daysplan review window

All plansDMP requirement

Policy Summary

PayerUnitedHealthcare

PolicyMedicare Part D Opioid Safety Edits and Drug Management Programs (pharmacy-facing)

Policy CodePolicy N/A

Change TypeNo material change

Effective DateSep 1, 2024

Next Review DateN/A

SourceLink

On This Page

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Opioid care coordination edit at 90 morphine milligram equivalent (MME)

Care coordination edit at 90 morphine milligram equivalent (MME).

ALL of the following

This edit triggers when an enrollee's cumulative MME per day across their opioid prescription(s) reaches or exceeds 90 MME.
Some plans only trigger this alert when the enrollee uses multiple opioid prescribers and/or multiple dispensing pharmacies.
If the pharmacist has recently consulted with the prescriber and has up-to-date clinical information (e.g., Prescription Drug Monitoring Program (PDMP) records), additional consultation with the prescriber is not expected.
Provide information to the plan for override if the pharmacist knows the enrollee has an exemption (residents of long-term care facilities, hospice, palliative or end-of-life care, enrollees treated for cancer-related pain or sickle cell disease) or if the prescriber has recently been consulted and the pharmacist has up-to-date clinical information. Overrides may be communicated at point-of-sale (POS).
Operational: include exemption type when available.
Outside of a known exclusion, when the care coordination edit is triggered, consult with the enrollee's prescriber to confirm intent. The consultation should follow current pharmacy practice to verify the prescription and validate clinical appropriateness and is an opportunity to inform the prescriber of other opioid prescribers or increasing opioid amounts.
Document interaction per plan requirements.
Document the discussion and submit the appropriate override code. Documentation may include date, time, prescriber name, and a brief note indicating whether the prescriber confirmed intent, did not confirm intent, provided information on enrollee exclusion, or could not be reached after attempts.
If the issue is not resolved at POS and the prescription cannot be filled as written, distribute the standardized CMS pharmacy notice 'Medicare Prescription Drug Coverage and Your Rights' to the enrollee.

Optional Hard Edit at 200 MME or more

Optional hard edit at 200 MME or more.

ALL of the following

Some plans may implement a hard edit when an enrollee's cumulative opioid daily dosage reaches 200 MME or more.
Some plans only apply this alert when the enrollee has multiple opioid prescribers and/or multiple opioid dispensing pharmacies.
Provide information to the plan for override if the pharmacist knows the enrollee has an exemption (long-term care, hospice, palliative or end-of-life care, cancer-related pain, sickle cell disease). Overrides may be communicated at POS with a transaction code or by contacting the plan directly.
If the issue is not resolved at POS and the prescription cannot be filled as written, distribute the standardized CMS pharmacy notice 'Medicare Prescription Drug Coverage and Your Rights' to the enrollee.

Seven-day supply limit for opioid-naïve enrollees (hard edit)

Seven-day supply limit for opioid-naïve enrollees (hard edit) and soft edits for concurrent opioid/benzodiazepine or duplicative long-acting opioid therapy.

ALL of the following

Medicare Part D enrollees who have not filled an opioid prescription recently will be limited to a supply of 7 days or less (hard edit).
Subsequent prescriptions filled during the plan's review window (generally 60-90 days) will not be subject to the 7-day supply limit.
This edit should not impact enrollees who already take opioids, but may occur for enrollees who enroll in a new plan that does not have their current prescription information.
Provide information to the plan for override if the pharmacist knows the enrollee has an exemption or is currently taking opioids. Overrides may be communicated at POS with a transaction code or by contacting the plan directly.

Drug Management Programs (DMPs)

Drug Management Program (DMP) limitations and enrollee rights.

ALL of the following

All Medicare Part D plans must have a DMP that limits access to opioids and/or benzodiazepines for enrollees the plan considers at risk for prescription drug abuse or misuse.
Enrollees are identified by patterns such as opioid use involving multiple doctors and pharmacies or a recent history of opioid-related overdose and undergo case management with the plan and the enrollee's prescribers.
DMP limitations may require the enrollee to obtain medications from a specified prescriber and/or pharmacy or implement an enrollee-specific POS edit limiting covered amounts.
Before implementing a limitation, the plan must give written notice to the enrollee and an opportunity for the enrollee to state preferred prescribers or pharmacies or provide additional relevant information.

Residents of long-term care facilities, those in hospice care, enrollees receiving palliative or end-of-life care, and enrollees being treated for cancer-related pain or sickle cell disease are exempt from the safety edits, supply limits, and DMP interventions described above. Enrollee access to medications for opioid use disorder (MOUD), such as buprenorphine, must not be impacted by these safety programs.

Provider Actions, Overrides, and Documentation

Prior Authorization

Coverage determination option for overrides and longer supply

CMS expects Part D plan 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. Enrollees or their prescribers may request an expedited or standard coverage determination from the plan to approve higher MME thresholds or a longer days supply; this can be requested in advance of the prescription.

Enrollee or prescriber may request an expedited or standard coverage determination for higher MME or longer days supply (can be done in advance).
POS overrides must be available for safety alerts and hard edits when prescriber/pharmacy information supports an exemption.

Note

DMP prescriber/pharmacy restriction

Some plans may require enrollees enrolled in Drug Management Programs (DMPs) to obtain opioids and/or benzodiazepines from specified prescribers and/or pharmacies or impose enrollee-specific POS edits limiting covered amounts. Prior to imposing such limitations, plans must provide written notice and an opportunity for the enrollee to provide preferred prescribers/pharmacies or additional relevant information. Enrollees, representatives, or prescribers may appeal DMP limits through the plan; pharmacies are not expected to provide the CMS pharmacy notice in response to a DMP limitation denial.

DMPs identify at-risk enrollees (multiple prescribers/pharmacies, recent overdose) and may require designated prescriber/pharmacy.
Plan must give written notice before limitations and allow enrollee input on preferred providers.
Appeals of DMP limitations go through the plan; pharmacies should not distribute the standardized CMS pharmacy notice for DMP denials.

Documentation Required

Documentation of prescriber consultation for overrides

When an override is requested at POS based on a prescriber consultation, pharmacies should document the interaction and submit the appropriate override transaction code. Documentation should include the date/time of contact, prescriber name, and a brief note indicating whether the prescriber confirmed intent, did not confirm intent, provided information on an enrollee exclusion, or could not be reached after attempts.

Document date and time of prescriber consultation, prescriber name, and brief outcome note.
Submit the appropriate override code/transaction at POS to communicate the prescriber confirmation or enrollee exemption to the plan.

Billing Rule

Override mechanism at POS

Plans must allow safety alerts and hard edits to be overridden at the point of sale when the pharmacist has valid clinical information from the prescriber or other records indicating the enrollee is exempt. Overrides may be communicated at POS using designated transaction/override codes or by contacting the plan directly when necessary.

POS override allowed when pharmacist has up-to-date clinical information (e.g., PDMP or prescriber consultation).
Overrides may be transmitted via a transaction code or by contacting the plan if the POS transaction does not resolve the edit.

Denial Risk

90 MME care coordination edit

When an enrollee's cumulative opioid daily dosage reaches or exceeds 90 MME, a care-coordination edit may trigger. Pharmacists should consult the prescriber to confirm intent unless the pharmacist already has up-to-date clinical information. Document the consultation (date/time/prescriber and brief note) and submit the appropriate override code. If unresolved at POS and the prescription cannot be filled, provide the standardized CMS pharmacy notice to the enrollee.

Edit triggers at >= 90 MME/day (may be limited to cases with multiple prescribers/dispensing pharmacies).
If pharmacist has recent prescriber consultation or PDMP evidence, additional contact may not be required; otherwise consult prescriber and document.
If unresolved at POS, distribute the CMS pharmacy notice.

Denial Risk

Optional 200 MME hard edit

Some plans may implement an optional hard edit when cumulative opioid daily dosage reaches 200 MME or more. Pharmacists should provide information to the plan for an override if the enrollee is known to have an exemption; overrides may be communicated at POS via transaction code or by contacting the plan. If the issue is not resolved at POS and the prescription cannot be filled as written, provide the standardized CMS pharmacy notice to the enrollee.

Optional hard deny at >= 200 MME (may apply only when multiple prescribers/dispensing pharmacies are involved).
Overrides for exemptions may be communicated at POS with a transaction code or by contacting the plan directly.
If unresolved at POS, distribute the CMS pharmacy notice.

Denial Risk

7-day supply hard edit

Opioid-naïve Medicare Part D enrollees may be limited by a hard edit to a maximum 7-day supply. Subsequent prescriptions during the plan's review window (generally 60–90 days) are not subject to the 7-day limit. Provide information to the plan for an override if the pharmacist knows the enrollee is exempt or currently taking opioids; overrides may be communicated at POS via transaction code or by contacting the plan. If no override is granted, enrollee may receive up to a 7-day supply or may request a coverage determination for the full days supply. If unresolved at POS, distribute the CMS pharmacy notice.

7-day supply hard edit for opioid-naïve enrollees; subsequent fills during review window typically exempt.
Overrides may be communicated at POS with a transaction code or by contacting the plan.
If no override, dispense up to 7 days or advise enrollee/prescriber to request coverage determination.
If unresolved at POS, distribute the CMS pharmacy notice.

Key Definitions

inv-18: MME — Morphine Milligram Equivalent definition

MME definitionMorphine Milligram Equivalent (MME): a standardized daily opioid dose metric used to trigger safety edits

UseUsed to calculate cumulative daily opioid dosage across prescriptions

Trigger examplesCare coordination edit at >= 90 MME; optional hard edit at >= 200 MME

inv-19: DMP — Drug Management Program definition

DMP definitionDrug Management Program (DMP): plan-level program that limits access to opioids and/or benzodiazepines for enrollees considered at risk for misuse

ComponentsMay include case management, enrollee identification by multiple doctors/pharmacies or overdose history, and enrollee-specific POS edits

RightsPlan must give written notice before limitation; enrollee/prescriber may appeal plan decisions

inv-20: MOUD / MAT — Medication for Opioid Use Disorder should not be impacted by safety edits

MOUD/MAT protectionMedications for Opioid Use Disorder (MOUD), such as buprenorphine, should not be impacted by opioid safety edits

ExemptionsMOUD access is listed among exemptions from interventions (e.g., long-term care, hospice, cancer-related pain, sickle cell disease)

Pharmacy actionIf edits affect MOUD, pharmacist should provide information to plan for override or ensure exemption applies

OpenPayer

Medicare Part D Opioid Safety Edits and Drug Management Programs (pharmacy-facing)

Coverage Criteria — Opioid Safety Edits & Limits

Thresholds & Key Coding Values

Provider Actions, Overrides, and Documentation

Key Definitions

Background & Rationale

Step Therapy / Program Restrictions

Quantity Limits