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2019 Medicare Part D Opioid Policies: Information for Prescribers

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Describes CMS-required Medicare Part D opioid safety alerts, supply limits for opioid-naïve patients, MME-based care coordination alerts, prescriber responsibilities, and drug management program (DMP) procedures affecting Medicare Part D beneficiaries and their prescribers.

Policy Summary

Payernetwork_health

Policy2019 Medicare Part D Opioid Policies: Information for Prescribers

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2019

Next Review DateN/A

Key ActionPrescribers may request a standard or expedited coverage determination to override edits or obtain the full days' supply as written.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

7 daysinitial supply limit (opioid-naïve)

90 MME/daycare coordination alert

200 MME/dayoptional hard edit

12 monthsDMP typical duration

LTC/hospice/cancerexemptions

Coverage & Utilization Management

Utilization management rules

Coverage and utilization management actions that Part D plans may apply

Initial opioid prescription for opioid-naïve patient: If patient is opioid-naïve (no opioid fill within ~60 days), the initial opioid prescription is limited to a supply of 7 days or less.opioid-naïve; <=7 days

MME-based pharmacy alerts: Pharmacy safety alerts trigger when a patient's cumulative opioid dose across prescriptions reaches or exceeds 90 MME/day (care coordination alert); some plans may implement an optional hard edit at 200 MME/day that blocks processing until overridden or authorized.>=90 MME/day (care coordination); optional >=200 MME/day (hard edit)

Drug Management Program (DMP) limits: Plans may identify patients at-risk (for example, use of multiple prescribers or pharmacies) and implement DMPs that limit coverage to specified prescribers and/or pharmacies or impose individualized point-of-sale edits for up to 12 months (extendable to 24) after case management and written notice; patients and prescribers may appeal these decisions.

Residents of long-term care facilities, patients in hospice, patients receiving palliative or end-of-life care, and patients being treated for active cancer-related pain are exempt from the Part D opioid safety interventions described in this policy. These exemptions mean that the utilization management rules (including initial supply limits, pharmacy safety alerts, and enrollment in Drug Management Programs) do not apply to those groups.

Plans must still ensure access to appropriate therapy for exempt patients; the policy does not change coverage for medically necessary opioid treatment in these circumstances and should not interfere with access to medication-assisted treatment (e.g., buprenorphine) where clinically indicated.

Thresholds, Limits, and Definitions

MME alert thresholds

Care coordination alert threshold90 MME per day — pharmacy safety alert triggers when a patient's cumulative daily opioid dose across all prescriptions reaches or exceeds 90 MME

Optional hard edit threshold200 MME per day — some plans may implement a hard safety alert that blocks processing until overridden or authorized

Use case for alertsAlerts may be used particularly when a patient uses multiple opioid prescribers and/or dispensing pharmacies

Initial supply limit

Initial supply limitLimit initial opioid dispense to 7 days or less for opioid‑naïve Medicare Part D patients

Trigger for limitApplies when the patient has not filled an opioid prescription recently (such as within the past 60 days)

PurposeIntended to reduce risk of future dependency or overuse by limiting the first opioid prescription

Initial Opioid Dispensing Rules

Initial opioid supply limits

Initial dispensing for opioid‑naïve patients

Opioid‑naïve initial fill: Limit initial dispense to 7 days or less for opioid‑naïve Medicare Part D patients (defined as no opioid fill within approximately the past 60 days).<=7 days

Implemented as a hard edit at dispensing in Part D plans.

Prescriber & Pharmacy Responsibilities

Prior Authorization

Prescriber may request standard or expedited coverage determination

On the patient’s behalf the prescriber has the right to request a coverage determination — either standard or expedited — to override dispensing edits or obtain the full days’ supply as written. The prescriber may request this determination in advance of prescribing an opioid.

Step Therapy

Directed prescriber and/or pharmacy requirement (DMP)

Plans may require patients identified as at‑risk to obtain opioids and benzodiazepines from a specified prescriber and/or a specified pharmacy as part of a Drug Management Program (DMP). These directed prescriber/pharmacy requirements can be implemented as coverage limitation tools or individualized point‑of‑sale edits.

Documentation Required

Prescriber attestation and pharmacist outreach

Prescribers must attest to the plan that the days’ supply (including the 7‑day initial supply for opioid‑naïve patients) is the intended and medically necessary amount; pharmacists and plans may contact the prescriber to resolve safety alerts and prescribers should respond in a timely manner.

Attestation is required for the identified cumulative MME level to allow dispensing.
Once a pharmacist consults with a prescriber for a plan year, the prescriber will generally not be contacted on every subsequent opioid prescription for that patient unless further restrictions are implemented.

Denial Risk

Drug Management Program coverage limitations and notification requirements

DMPs may limit coverage to specified prescribers/pharmacies or apply individualized POS edits for patients the plan identifies as at‑risk; plans will perform case management, notify the patient in writing (and make reasonable efforts to notify the prescriber) before imposing limits, and may impose limits for 12 months (extendable to 24).

Potentially at‑risk patients are identified by use involving multiple prescribers and/or pharmacies.
After case management and a 30‑day notification period, plans send a second written notice confirming the specific limitation and duration if a limitation is implemented.
Patients and prescribers retain the right to appeal DMP coverage limitation decisions.

Policy Background

CMS implemented new Medicare Part D opioid safety policies effective January 1, 2019 to reduce opioid overutilization. The policies require improved pharmacy safety alerts at dispensing and allow Part D plans to establish drug management programs for beneficiaries deemed at-risk for misuse or abuse.

The intent of these changes is to support prescribers and pharmacists in identifying potential safety issues at the point of dispensing and to provide care coordination tools for patients at higher risk, while preserving access to necessary treatments.

Key Terms

MME — definition and use

DefinitionMorphine milligram equivalent (MME) — a standardized measure used to calculate a patient’s cumulative daily opioid dose across all prescriptions

Use for alertsCumulative MME per day across all opioid prescriptions is compared to thresholds (e.g., 90 MME/day, optional 200 MME/day) to trigger pharmacy safety alerts

Calculation contextApplied at dispensing to evaluate total daily opioid exposure and inform care coordination or hard edits

Opioid‑naïve — definition

Definition of opioid‑naïveA Medicare Part D patient who has not filled an opioid prescription recently (such as within the past 60 days)

ImplicationPatients meeting this definition are subject to the initial 7‑day supply limit on their first opioid dispense

ExemptionsExemptions from these interventions include residents of long‑term care facilities, hospice patients, those receiving palliative or end‑of‑life care, and patients treated for active cancer‑related pain

Policy Summary

Payernetwork_health

Policy2019 Medicare Part D Opioid Policies: Information for Prescribers

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateJan 1, 2019

Next Review DateN/A

Key ActionPrescribers may request a standard or expedited coverage determination to override edits or obtain the full days' supply as written.

SourceLink

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2019 Medicare Part D Opioid Policies: Information for Prescribers

Customize your policy alerts

Sign up for all network_health policy alerts

Know when network_health releases new policies or updates existing guidance.

Monitor payer policy activity

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Coverage & Utilization Management

Utilization management rules

Coverage and utilization management actions that Part D plans may apply

Thresholds, Limits, and Definitions

MME alert thresholds

Care coordination alert threshold90 MME per day — pharmacy safety alert triggers when a patient's cumulative daily opioid dose across all prescriptions reaches or exceeds 90 MME

Optional hard edit threshold200 MME per day — some plans may implement a hard safety alert that blocks processing until overridden or authorized

Use case for alertsAlerts may be used particularly when a patient uses multiple opioid prescribers and/or dispensing pharmacies

Initial supply limit

Initial supply limitLimit initial opioid dispense to 7 days or less for opioid‑naïve Medicare Part D patients

Trigger for limitApplies when the patient has not filled an opioid prescription recently (such as within the past 60 days)

PurposeIntended to reduce risk of future dependency or overuse by limiting the first opioid prescription

Initial Opioid Dispensing Rules

Initial opioid supply limits

Initial dispensing for opioid‑naïve patients

Opioid‑naïve initial fill: Limit initial dispense to 7 days or less for opioid‑naïve Medicare Part D patients (defined as no opioid fill within approximately the past 60 days).<=7 days

Implemented as a hard edit at dispensing in Part D plans.

Prescriber & Pharmacy Responsibilities

Prior Authorization

Prescriber may request standard or expedited coverage determination

Step Therapy

Directed prescriber and/or pharmacy requirement (DMP)

Documentation Required

Prescriber attestation and pharmacist outreach

Attestation is required for the identified cumulative MME level to allow dispensing.
Once a pharmacist consults with a prescriber for a plan year, the prescriber will generally not be contacted on every subsequent opioid prescription for that patient unless further restrictions are implemented.

Denial Risk

Drug Management Program coverage limitations and notification requirements

Potentially at‑risk patients are identified by use involving multiple prescribers and/or pharmacies.
After case management and a 30‑day notification period, plans send a second written notice confirming the specific limitation and duration if a limitation is implemented.
Patients and prescribers retain the right to appeal DMP coverage limitation decisions.

Policy Background

Key Terms

MME — definition and use

DefinitionMorphine milligram equivalent (MME) — a standardized measure used to calculate a patient’s cumulative daily opioid dose across all prescriptions

Use for alertsCumulative MME per day across all opioid prescriptions is compared to thresholds (e.g., 90 MME/day, optional 200 MME/day) to trigger pharmacy safety alerts

Calculation contextApplied at dispensing to evaluate total daily opioid exposure and inform care coordination or hard edits

Opioid‑naïve — definition

Definition of opioid‑naïveA Medicare Part D patient who has not filled an opioid prescription recently (such as within the past 60 days)

ImplicationPatients meeting this definition are subject to the initial 7‑day supply limit on their first opioid dispense