The Strengthen Opioid Misuse Prevention ("STOP") Act of 2017
THURSDAY, DECEMBER 19, 2019 STOP ACT'S ELECTRONIC PRESCRIBING FOR TARGETED CONTROLLED SUBSTANCES MANDATE EFFECTIVE JANUARY 1, 2020. As pharmacists know, the STOP Act of 2017 put into place a number of statutory requirements concerning targeted controlled substances that have phased in over the past couple of years. The final phase-in is effective January 1, 2020. Prescriptions for targeted controlled substances (which are opioid products in Schedules II and III of the North Carolina Controlled Substances Act, as well as buprenorphine) must be transmitted electronically unless an exception applies. Board staff encourage pharmacists to re-review the STOP Act FAQ, found here: http://www.ncbop.org/PDF/GuidanceImplementationSTOPACTJuly2017.pdf) for more detail about this requirement, as well as all other requirements of the STOP Act. Question #7 specifically addresses the electronic prescribing requirement, as well as pharmacist responsibility under that provision.
WEDNESDAY, JANUARY 3, 2018 BOARD OF PHARMACY ISSUES GUIDANCE TO PHARMACISTS ON IMPLEMENTATION OF THE STRENGTHEN OPIOID MISUSE PREVENTION (“STOP”) ACT. The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act. The STOP Act is an effort to combat the opioid abuse and misuse epidemic. The STOP Act makes changes to the laws governing controlled substance prescribing, controlled substance dispensing, and the North Carolina Controlled Substance Reporting System (“CSRS”). Please refer to this FAQ Guidance for more information.
WEDNESDAY, JANUARY 3, 2018 NORTH CAROLINA DIVISION OF MEDICAL ASSISTANCE STATEMENT ON DISPENSING OPIOIDS TO MEDICAID BENEFICIARIES WHEN THE PRESCRIBER HAS NOT OBTAINED A REQUIRED PRIOR AUTHORIZATION. Due to decades of increased prescribing of opioids, North Carolina is experiencing an opioid epidemic. NC Medicaid worked closely with prescribing physicians and pharmacists to develop the best approach to reduce the oversupply of prescription opioids available for diversion and misuse, promote safe opioid prescribing for patients, and encourage alternative pain management, while minimizing administrative requirements as much as possible. Modifying clinical coverage criteria to promote safe opioid prescribing was identified as an essential and significant step to realize the vision of the North Carolina Opioid Action Plan to reduce opioid deaths by 20 percent by 2021. On Aug. 27, 2017, NC Medicaid began requiring prior approval (PA) for opioid prescribed analgesic doses that exceed 120 mg of morphine equivalents per day; are greater than a 14-day supply of any opioid; or are non-preferred opioid products on the NC Medicaid Preferred Drug List (PDL). Effective Jan. 2, 2018, the clinical coverage criteria for opioid analgesics was updated to comply with the quantity limits mandated by the Strengthen Opioid Misuse Prevention (STOP) Act, S.L. 2017-74. Prior approval is now required for short-acting opioids for greater than a five-day supply for acute pain and seven-day supply for post-operative acute pain. Prior approval is also required for long-acting opioids for greater than a seven-day supply. Beneficiaries with diagnosis of pain secondary to cancer will continue to be exempt from prior approval requirements. Soon after implementation of these changes, NC Medicaid began receiving reports from pharmacists that some prescribers were prescribing a 30-day supply of an opioid, but refusing to request prior authorization (PA). This situation has resulted in Medicaid beneficiaries asking the pharmacist to partial fill the opioid prescription with concurrent allowed day supplies or asking to pay cash for the quantity exceeding the quantity paid for by Medicaid. NC Medicaid is aware that pharmacists may provide a partial fill of a Schedule II controlled substance prescription when the prescription is written and filled in compliance with federal and state law and the partial fill is requested by the patient or the prescriber. However, the intent of our clinical coverage criteria changes were to encourage prescribers to evaluate the medical necessity of an opioid to treat a patient’s chronic pain not related to cancer or end of life care and, when appropriate, request PA for those patients. NC Medicaid has no authority to prohibit beneficiaries from paying cash for any of their medications and the intent of our clinical coverage criteria changes were not intended to require Medicaid beneficiaries to pay out of pocket for opioids determined to be medically necessary and appropriate to treat their chronic pain. Understanding the intent of our changes to opioid clinical coverage criteria, NC Medicaid encourages pharmacists to use their professional judgement when a Medicaid beneficiary requests to pay cash for their prescribed opioids. Prescribers and pharmacists are also reminded that the Controlled Substance Reporting System (CSRS) collects data on all cash transactions for controlled substances, and this data can be reported to the medical and pharmacy boards for their review and investigation of any suspected inappropriate prescribing or dispensing of controlled substances. NC Medicaid also encourages pharmacists to contact prescribers who refuse to request PA for an opioid prescription that exceeds criteria to determine the medical necessity for the prescribed opioid and remind the prescriber of the PA requirement. While a pharmacist should not consider failure to follow NC Medicaid PA protocols, by itself, suspicious or inappropriate prescribing, the NC Medical Board continues to encourage pharmacists to report any prescriber they reasonably believe is engaged in suspicious or inappropriate prescribing of any medication. NC Medicaid appreciates the partnership of all medical and pharmacy providers to combat the opioid crisis in North Carolina and to keep our fellow North Carolinians safe. We realize the impact of these changes to all providers and beneficiaries, but equally realize that these changes were necessary to address this crisis and to promote appropriate opioid prescribing. Pharmacists with questions about North Carolina Medicaid’s prior authorization program should contact John Stancil at NC DMA: (919) 855-4305; john.stancil@dhhs.nc.gov.
TUESDAY, SEPTEMBER 26, 2017 Pharmacists Should Act **NOW** To Register for Access to the North Carolina Controlled Substance Reporting System The North Carolina General Assembly has passed, and the Governor has signed into law, the Strengthen Opioid Misuse Prevention (“STOP”) Act. Among other things, the STOP Act requires all pharmacists to register for access to the North Carolina Controlled Substance Reporting System (“CSRS”), with a narrow exemption. As a condition of renewing a pharmacist license for 2018, a pharmacist must attest either: (a) he/she has registered, or applied, for CSRS access; or (b) he/she is not employed in a pharmacy practice setting where Schedule II, III, or IV controlled substances are dispensed from a North Carolina-based facility or to North Carolina patients. Any pharmacist who does not already have a CSRS access registration should immediately apply for one. Pharmacists can access a simple, on-line application here: https://www.ncdhhs.gov/divisions/mhddsas/ncdcu/csrs#csrs4 Note: Pharmacists should register for a “master” account (not a “delegate” account); The STOP Act requires an individual registration – your pharmacy’s registration for purposes of uploading data to CSRS is not sufficient.
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