Opioid Safety Edits

Medicare Part D patients who have not filled an opioid prescription recently (such as within the past 60 days) will be limited to a supply of 7 days or less. Limiting the amount dispensed with the first opioid prescription may reduce the risk of a future dependency or overuse of these drugs. Important: This alert will not impact patients who already take opioids.

Please note, there are specific dispensing laws by New York State that are required on prescriptions for opioids, hence pharmacists serving your patients may require new prescriptions to be written for the exact quantity for compliance purposes. For reference, these laws are available on the New York State Board of Pharmacy website.

If a member reaches a certain pain medication dose, some prescriptions may be stopped by our system, if it’s determined that the amount of medication being filled may be unsafe. Details are below:

• At the soft stop, known to be a care co-ordination edit, Morphine Milligram Equivalent (MME) dose per day equal to or exceeding the minimum threshold of 90 MME across a single or multiple opioid-containing claim(s), the pharmacists will reach out to prescribers to gather information on opioid utilization that was noted to document appropriate use and allow for claims to process upon seeking this information. You and your staff are encouraged to provide this information to the pharmacists when contacted so there is no interruption in necessary therapies for the beneficiary.
• At the hard stop, Morphine Milligram Equivalent (MME) dose per day equal to or exceeding a hard-stop threshold of 200 MME across a single or multiple opioid-containing claim(s), the claim will not process further until a prior authorization is requested from the health plan.
• If a patient has filled duplicative long-acting opioid therapies or demonstrated concurrent use of opioids along with benzodiazepines and/or buprenorphine, this can result in a soft stop in which case the Pharmacist may need to speak to you, and upon determining appropriate use, he/she may be able dispense the drug in question. You and your staff are encouraged to provide this information to the pharmacists when contacted so there is no interruption in necessary therapies for the beneficiary.

• We will review monthly Drug Utilization Evaluation reports that identify members who meet the minimum overutilization management criteria (as per CMS specifications) for ‘Frequently Abused Drugs’ (FAD) (CMS considers Opioids and benzodiazepines as FADs with the exception of buprenorphine for MAT and injectables) and will perform case management for those members.
• Case management will include written prescriber outreach advising the prescriber(s) of your patient’s potential at-risk status and requesting that you provide an attestation of appropriate opioid utilization or of concerns of overutilization.
• Three (3) telephone outreach calls will be made to follow-up with the prescriber if no response has been received. We encourage you and your staff to be responsive in a timely manner to these communications, so that we can minimize any disruptions in therapy.
  • Only if you are in agreement that the patient is at-risk, we will evaluate if placing a Point of Sale (POS) edit, pharmacy lock-in and/or prescriber lock-in is necessary for the patient’s safety.
  • If no response is received, the case will be evaluated further if implementing a POS edit or pharmacy lock-in needs to be pursued but we will not implement a prescriber lock-in.
  • Member/prescriber/pharmacy notifications will be provided prior to any edit/lock-in implementations.

• You may call 1-888-672-7205
• Faxes can be sent to 1-858-790-7100
• You may use the ‘opioid safety edit specific prior authorization request form’ that is available on our website.

We encourage you to use this form to make sure we receive all the information necessary to evaluate the case and provide an appropriate outcome. You and your patient will be notified once we have made a decision on the case.

• Opioid safety edits are being established based on guidance from CMS and are independent of the plan’s formulary and UM restrictions. Both are treated separately of each other.
• Known exceptions such as patients with Cancer diagnosis, residents in LTC facilities, or elected hospice status will not be subjected to these edits. Additionally, any beneficiaries who have existent prior authorizations with the plan that have demonstrated medical necessity will also be exempted from these requirements and their prior authorizations will be evaluated by plan (by contacting prescribing providers if necessary) for any extension of authorizations in order to minimize disruption in therapy. If your patients need to be exempted from these safety edits for any medical necessity, you may contact us through contact means provided below and request prior authorizations ahead of time.
• Opioid safety edits and the Drug Management Program are being established to provide collaborative care to beneficiaries keeping their safety in mind and are not intended as prescribing limits. Prescriber’s professional judgement and statements for medical necessity that are provided in any form of communications and methods by prescribers will be honored and considered on case management reviews and prior authorization case reviews to ensure beneficiaries’ access to necessary therapies is not limited in any way.

Please review this CMS Tip Sheet.

• On September 18, 2018, the Food and Drug Administration (FDA) approved the Opioid Analgesic REMS Program as one among the many strategies and efforts to reduce the risk of abuse, misuse, addiction, overdose, and deaths due to prescription opioid analgesics.
• The REMS program requires that training be made available to all health care providers (HCPs) who are involved in the management of patients with pain, including nurses and pharmacists. To meet this requirement, drug companies with approved opioid analgesics will provide unrestricted grants to accredited continuing education providers for the development of education courses for HCPs based on the FDA’s Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.

  We encourage you and your prescribing staff to visit this webpage for more information on how to access the continuing education trainings: https://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.