New Medicare Part D Opioid Prescribing Guidelines for 2019—What You Need to Know

November 16, 2018

Effective January 1, 2019, Medicare is instituting new opioid prescribing policies that will impact Medicare Part D beneficiaries with a prescription drug benefit and their prescribers. Major changes are summarized below; for additional information please see the full Medicare Learning Network article.

Real-Time Safety Alerts at the Time of Pharmacy Dispensing

7 day supply limit for opioid naïve patients:  Part D plans are expected to limit initial opioid dispensing to a 7-day supply or less. This policy will affect Medicare patients who have not filled an opioid prescription recently. If a prescriber believes that an opioid naïve patient will need more than a 7-day supply initially, the provider can proactively request a coverage determination on behalf of the patient attesting to the medical need for a supply greater than 7 days.

Opioid care coordination alert:  This policy will affect Medicare patients when they present an opioid prescription at the pharmacy and their cumulative morphine milligram equivalent (MME) per day across all of their opioid prescription(s) reaches or exceeds 90 MME. The fill of a prescription that brings a patient to the cumulative threshold of 90 MME or greater will trigger an alert to the prescriber, who who will be contacted by the pharmacy.

This is not a prescribing limit. In reviewing the alert, the pharmacist may consult with the prescriber to confirm medical need for the higher MME. The pharmacist can then indicate that the prescriber was consulted so the prescription claim can pay. Once a pharmacist consults with a prescriber on a patient’s prescription for a plan year, the pharmacist does not have to consult with the prescriber on every opioid prescription written for the same patient after that unless the plan implements further restrictions.

Drug Management Programs

If a provider prescribes opioids or benzodiazepines for a patient who is identified as a potential at-risk patient, the Part D plan will contact the provider to review the patient’s total utilization pattern of frequently abused drugs. The plan will ask the prescriber:

• Are the prescription opioid medications appropriate, medically necessary, and safe for the patient’s medical condition and treatment;

• Is the patient at-risk for misusing or abusing opioids and benzodiazepines; and

• Would one of the drug management program tools help the prescriber better manage their patient’s prescription drug use?

Potential tools for Part D plans include:

1. Patient-specific point of sale (POS) claim edit: This limits the amount of frequently abused drugs that may be dispensed to a specific patient. This limitation could be a restriction on all frequently abused drugs or limitations to specific drugs and/or specific amounts, which the plan will determine on a case by case basis as a result of their review. The plan will make every effort to obtain a prescriber’s agreement for this limitation, but it is authorized to implement if no prescriber responds to the plan’s attempts at contacting the prescriber.

2. Pharmacy limitation (also known as “pharmacy lock-in”): This limitation will require a patient to obtain prescriptions for frequently abused drugs at a certain pharmacy(ies). Before implementing this limitation, the plan must verify with a prescriber that the patient is at-risk, but the plan is not required to obtain a prescriber’s agreement to the limitation. Patients can choose which pharmacy(ies) they prefer to use and may update those preferences as needed.

3. Prescriber limitation (also known as “prescriber lock-in”): A limitation that will require a patient to obtain their prescriptions for frequently abused drugs from a certain prescriber(s). The plan must obtain the prescriber’s agreement to be a prescriber and confirm the prescriber’s selection for this limitation. Patients can choose which prescribers(s) they prefer to use and may update those preferences as needed.

Patient Care Under the New Policies

Residents of long-term care facilities, those in hospice care, patients receiving palliative or end-of-life care, and patients being treated for active cancer-related pain are exempt from these interventions.

As new opioid safety alerts are implemented in 2019, on-going communication between pharmacists, Part D plans, and prescribers will be critical. Physicians and other prescribers can protect their patients’ access to medically necessary drugs by responding to pharmacists’ or plan sponsors’ telephone calls or case management notices. Providers will also want to initiate coverage determinations or exceptions, when clinically appropriate. To resolve opioid safety alerts expeditiously and avoid withdrawal or disruption of therapy, the Centers for Medicare & Medicaid Services encourages prescribers to respond to pharmacists’ outreach in a timely manner and give appropriate training to on-call prescribers when necessary.

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