1. 2019 Medicare Part D Rule Opioid-related Provisions
Cynthia Reilly, MS, BS Pharm
Senior Vice President, Academy of Managed Care Pharmacy

2. 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

3. 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:
2016/03/curbing-prescription-drug-abuse-with-patient-review-and-restriction-programs

4. “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 4

5. 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

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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 2019 Projected Impact Beneficiaries Enrolled = 67,173
Medicare Savings = $19 million
(reduced opioid prescriptions)
Health Plan Costs = $2.8 million
(administrative functions)

14. Q&A
Cynthia Reilly, MS, BS Pharm