2019 Medicare Part D Rule Opioid-related Provisions Cynthia Reilly, MS, BS Pharm Senior Vice President, Academy of Managed Care Pharmacy

Opioid Use in the Medicare Population An evaluation of 2016 data by the Health & Human Services Office of the Inspector General found that: 1 in 3 Part D beneficiaries received a prescription opioid Almost 90,000 beneficiaries at serious risk of opioid misuse or overdose 70,000 received average MED of 240 mg/day for 12 months 22,000 were likely doctor shopping About 400 prescribers caring for those at serious risk had questionable opioid prescribing patterns Notable Stats: In total, 14.4 million of the 43.6 million beneficiaries enrolled in Medicare Part D received opioids. Medicare Part D paid almost $4.1 billion for 79.4 million opioid prescriptions for these beneficiaries. Each of the 501,008 beneficiaries received an average morphine equivalent dose (MED) of greater than 120 mg a day for at least 3 months Two groups of beneficiaries are at serious risk of opioid misuse or overdose: (1) beneficiaries who received extreme amounts of opioids and (2) beneficiaries who appeared to be doctor shopping. A total of 401 prescribers stand out as having questionable prescribing patters; these prescribers ordered opioids for the highest numbers of beneficiaries at serious risk https://www.oig.hhs.gov/oei/reports/oei-02-17-00250.pdf

Patient Review and Restriction Programs (PRRs) Use dispensing and other data to identify patients at risk of harm from opioids and other controlled substances # of prescriptions, prescribers, pharmacies Therapeutic duplication, MME thresholds, etc. At-risk beneficiaries assigned to a designated pharmacy, or a designated prescriber and pharmacy, to obtain these prescriptions Widely used in Medicaid and commercial health plans; previously not authorized for use in Medicare The Pew Charitable Trusts: http://www.pewtrusts.org/en/research-and-analysis/issue-briefs/ 2016/03/curbing-prescription-drug-abuse-with-patient-review-and-restriction-programs

“PRRs have the potential to reduce opioid usage to lower, safer levels, and thus save lives and lower health care costs.” --CDC Expert Panel Meeting Report 2012 https://www.cdc.gov/drugoverdose/pdf/pdo_patient_review_meeting-a.pdf 4

PRRs in Medicare Use of PRRs in Medicare authorized by the Comprehensive Addiction and Recovery Act (CARA) Draft regulations to guide use of PRRs issued in Nov. 2017 Potential areas of concern in proposed rule Criteria similar to existing Overutilization Management System Different timelines for use of pharmacy-only versus prescriber PRRs Prescribers must agree to the PRR Opioids only Beneficiaries automatically discharged from program after one year https://www.gpo.gov/fdsys/pkg/FR-2017-11-28/pdf/2017-25068.pdf

Medicare Part D 2019 Final Rule: Use of PRR Programs Effective January 1, 2019

Frequently Abused Drugs and Thresholds Opioid Use in Previous Six Months Average daily MME ≥ 90 mg AND 3 or more prescribers and 3 or more prescribers OR 5 more prescribers ≥ 7 prescribers or pharmacies regardless of MME https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

Frequently Abused Drugs and Thresholds (cont’d) Benzodiazepines also defined as frequently abused drugs Overuse/misuse alone doesn’t allow for use of a PRR Beneficiary must also meet opioid thresholds Guidelines, including designation of frequently abused drugs, to be reviewed/updated annually via Medicare Part D Call Letter https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

PRR Process Use of data to identify potentially at-risk beneficiaries Case management required for at-risk determination Notify prescriber(s) and request information for assessment of risk Plans must make “reasonable” attempt to contact prescriber, but response/approval not required for a pharmacy-only PRR Designated prescriber and pharmacy must be notified if a PRR is implemented https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

PRR Process (cont’d) Exempted beneficiaries Beneficiary notifications Hospice care; non-hospice palliative and end-of-life care Long-term care residents Those currently receiving treatment for active cancer-related pain Beneficiary notifications First: describe at-risk status, intent to implement a PRR, and provide information about resources Second: notice of PRR implementation, start and end date Timing: second notice must be at least 30 days and no more than 60 days after first notice https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

Provider Selection Provider selection Based on beneficiary input, unless provider contributing to fraud/abuse Beneficiary may submit unlimited requests for a change in providers Must be in-network and ensure reasonable access Provisions for multiple residences, disasters and emergencies For provider selection and potentially at-risk designation Prescribers with same tax identification number = single prescriber Multi-location pharmacies w/ real-time data sharing = single pharmacy https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

Other Provisions Duration: 12 months Can extend up to a total of 24 months based on reassessment If prescriber-based PRR, consent of prescriber needed for extension Utilizes existing Part D appeals process Integrated with existing Overutilization Monitoring System Requires reporting to CMS and information sharing between subsequent/former plans Prevents low-income subsidy beneficiaries from using special enrollment period to avoid PRR enrollment https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

2019 Projected Impact Beneficiaries Enrolled = 67,173 Medicare Savings = $19 million (reduced opioid prescriptions) Health Plan Costs = $2.8 million (administrative functions) https://www.gpo.gov/fdsys/pkg/FR-2018-04-16/pdf/2018-07179.pdf

Q&A Cynthia Reilly, MS, BS Pharm creilly@amcp.org