2019 Medicare Part D Opioid Policies: Information for Pharmacies
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Describes CMS-required opioid safety edits, pharmacist responsibilities, and Drug Management Programs (DMPs) for Medicare Part D prescriptions beginning January 1, 2019; intended for pharmacies and pharmacists dispensing opioids to Medicare Part D patients.
No material clinical or coverage changes in this revision.
Opioid Safety Edits and Coverage Criteria
Opioid edits and safety checks
Coverage and edits applied to opioid prescriptions for Medicare Part D patients
Subsequent prescriptions during the plan review window (generally 60-90 days) are not subject to the 7-day limit.
Care coordination may be limited to cases involving multiple prescribers and/or pharmacies; pharmacist-prescriber consultation and documentation can allow override.
If issue is not resolved at point of sale and the prescription cannot be filled, provide the standardized CMS pharmacy notice and inform the plan for override.
These opioid safety edits do not apply to certain populations. Exclusions include residents of long-term care facilities, patients in hospice care, those receiving palliative or end-of-life care, and patients being treated for active cancer-related pain. The policy also must not restrict access to medication-assisted treatment (MAT), for example, buprenorphine.
Key Thresholds and Coding Metrics
Pharmacist and Prescriber Actions at Point of Sale
Request expedited or standard coverage determination for larger/longer fills
The patient or prescriber may request an expedited or standard coverage determination from the plan to approve higher opioid amounts or a longer days supply; requests can be made in advance of the prescription.
Follow DMP prescriber/pharmacy restrictions and appeal rights
Plans operating Drug Management Programs (DMPs) may require that patients obtain opioids and benzodiazepines from specified prescribers and/or pharmacies, and may implement individualized point-of-sale limits on covered amounts.
- Before limitations are implemented the plan must give written notice to the patient and allow the patient to identify preferred prescribers or pharmacies or provide additional information.
- Patients and prescribers have the right to appeal a DMP limitation; pharmacies are not expected to distribute the standardized CMS pharmacy notice for DMP-related rejected claims.
Document pharmacist–prescriber consultation and submit override code at POS
At point of sale, pharmacists must document the consultation and submit the appropriate override code; documentation may include date, time, prescriber name, and a brief note that the prescriber confirmed intent, did not confirm, provided exclusion information, or could not be reached after attempts.
- Include number of attempts to contact the prescriber when relevant.
- Submit the appropriate POS override transaction code when communicating an override at POS.
Give CMS pharmacy notice when fill cannot be completed at POS
If the prescription cannot be filled as written and the issue is not resolved at POS, distribute the standardized CMS pharmacy notice 'Medicare Prescription Drug Coverage and Your Rights' to the patient.
- Provide the notice when full days supply is not dispensed or the claim is rejected and unresolved at POS.
7‑day supply hard edit for opioid‑naïve patients
Claims for opioid prescriptions for opioid‑naïve Medicare Part D patients that exceed a 7‑day supply will be rejected by a hard edit unless the plan has approved an override or coverage determination.
- Subsequent prescriptions during the plan's review window (generally 60–90 days) are not subject to the 7‑day limit.
- Patient or prescriber may request a coverage determination to approve a longer days supply.
Optional 200 MME hard edit may reject fills at ≥200 MME/day
Some plans may implement an optional hard edit that rejects fills when a patient’s cumulative daily opioid dosage reaches 200 MME or more; pharmacists should provide information to the plan for override if the patient has a documented exclusion.
- Overrides for exclusions may be communicated at POS with a transaction code or by contacting the plan directly.
- If unresolved at POS, distribute the standardized CMS pharmacy notice to the patient.
Policy Background and Rationale
CMS implemented opioid safety edits for Medicare Part D plans effective January 1, 2019 to reduce misuse and improve care coordination. These measures include limits on initial opioid supplies, edits that flag high cumulative daily opioid dosages, and drug management programs for patients identified as at risk for misuse or abuse.
Key Definitions
Initial Opioid Therapy Rules
Initial opioid therapy
Initial opioid therapy rules for opioid-naïve Medicare Part D patients
Patient or prescriber may request an expedited or standard coverage determination; subsequent fills during the plan review window (generally 60‑90 days) are not subject to the 7‑day limit.
Drug Management Program (DMP) Step Requirements
| DMP Requirement | Details |
|---|---|
| Specified prescriber | Plan may require the patient to obtain opioids and benzodiazepines from a specified prescriber as part of a Drug Management Program (DMP). |
| Specified pharmacy | Plan may require the patient to obtain opioids and benzodiazepines from a specified pharmacy as part of a DMP. |
| Point-of-sale (POS) individualized limits | Plan may implement an individualized POS edit that limits the amount of these medications that will be covered for the patient. |
| Patient notice and preference | Before implementing a limitation, the plan must give written notice to the patient and allow the patient to state prescriber or pharmacy preferences or provide additional information. |
| Appeals rights | If the plan limits coverage under a DMP, the patient and their prescriber have the right to appeal the plan's decision; pharmacies should direct patients/prescribers to contact the plan for appeal information. |
Quantity Limits for Opioids
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