The Centers for Medicare & Medicaid Services (CMS) understands the magnitude of the nation’s opioid epidemic and its impact on communities and recently published a roadmap with a three pronged approach to combating the opioid epidemic:
- Prevention of new cases of opioid use disorder (OUD)
- Treatment of patients who have already become dependent on or addicted to opioids
- Utilization of data from across the country to better target prevention and treatment activities.
The new policies include improved safety edits when opioid prescriptions are dispensed at the pharmacy and drug management programs for patients determined to be at-risk for misuse or abuse of opioids or other frequently abused drugs. CMS’s tailored approach is to help distinct populations of Medicare Part D opioid users, including new and chronic users, those with concurrent medication use and high-risk users.
Claim Level Edits
CMS’s new opioid policies for Medicare drug plans start on January 1, 2019. The new policies include improved safety edits when opioid prescriptions are dispensed at the pharmacy and drug management programs for patients determined to be at-risk. It is important to note that CMS’s final call letter does not limit the prescribing of opioids but does outline requirements for hard and soft edits during the claims adjudication process. Examples include:
- Seven-day supply limit for opioid naïve patients (hard edit)
- Opioid care coordination edit at 90 morphine milligram equivalent (MME)
- Optional hard edit at 200 MME or more
- Concurrent opioid and benzodiazepine use or duplicative long-acting opioid therapy (soft edits)
7-Day Supply Limit Edit
This edit is focused on opioid naïve Medicare Part D patients who have not filled an opioid prescription recently. They will be limited to a supply of 7 days or less and this edit should not impact patients who already take opioids. Subsequent prescriptions filled during the plan’s review window (generally 60-90 days) will not be subject to the 7 days supply limit.
Overrides may be communicated at point-of sale (POS) with a transaction code or by contacting the plan directly. Patient may receive up to a 7 days supply or request a coverage determination for full days supply as written. If the issue is not resolved at the POS and the prescription cannot be filled as written, including when the full days supply is not dispensed, distribute a copy of the standardized CMS pharmacy notice Medicare Prescription Drug Coverage and Your Rights to the patient.
Opioid Care Coordination at 90 MME Edit
This is a formulary level edit will trigger when a patient’s cumulative MME per day across his/her opioid prescription(s) reaches or exceeds 90 MME. Some plans use this alert only when the patient uses multiple opioid prescribers and/or opioid dispensing pharmacies. If the pharmacist recently consulted with the prescriber and has up to date clinical information (e.g., Prescription Drug Monitoring Program (PDMP) system or other records), additional consultation with the prescriber is not expected.
Provide information to the plan for override if known to the pharmacist that patient has an exclusion (discussed above) or if prescriber has recently been consulted and the pharmacist has up to date clinical information. Overrides may be communicated at POS.
Pharmacist should consult with the patient’s prescriber to confirm intent and be consistent with current pharmacy practice to verify the prescription and to validate its clinical appropriateness. This is an opportunity for pharmacists to inform the prescriber of other opioid prescribers or increasing amounts of opioids.
Optional Hard Edit at 200 MME or More Edit
Some plans may implement a hard edit when a patient’s cumulative opioid daily dosage reaches 200 MME or more. Some plans use this alert only when the patient has multiple opioid prescribers and/or opioid dispensing pharmacies.
Provide information to the plan for override if known to the pharmacist that patient has an exclusion (discussed above). Overrides for exclusions from the safety edit may be communicated at POS with a transaction code or by contacting the plan directly
Concurrent Opioid Use Edit
These soft edits will trigger when the patient is taking opioids and benzodiazepines concurrently or is taking multiple long-acting opioids. The pharmacist should conduct additional safety review to determine if the patient’s opioid use is safe and clinically appropriate.
As with all of the edits, record any documentation including the date, time, name of prescriber, and brief note that the prescriber confirmed intent, did not confirm intent, provided information on patient exclusion and override information at the point of sale. If the issue is not resolved at the POS and the prescription cannot be filled as written, distribute a copy of the standardized CMS pharmacy notice Medicare Prescription Drug Coverage and Your Rights to the patient.
For more information, Pharmacy First members can login to the Member Portal for plan specific requirements or go to CMS’s website: https://www.cms.gov/Medicare/Prescription-Drug-coverage/PrescriptionDrugCovContra/RxUtilization.html
About the Author
Todd Wormington is the Director, Pharmacy Programs for Pharmacy First and has over 25 years of pharmacy industry experience. His work as a practicing pharmacist helped frame a passion for direct patient care and led to a career focused on the clinical and operational resources required to deliver enhanced pharmacy services in a community-based setting.