Vision Session: PEW Foundation - One Patient, One Pharmacy, One Prescriber: How Patient Review and Restriction Programs Can Help Address Rx Drug Abuse

1. One Patient, One Pharmacy, One Prescriber
How Patient Review and Restriction Programs
Can Help Address Prescription Drug Abuse
Cynthia Reilly, B.S. Pharm.
Director, Prescription Drug Abuse Project
The Pew Charitable Trusts

2. Goals for Vision Session
1. Provide an overview of the role of patient review
and restriction programs (PRRs) in addressing
the prescription drug abuse epidemic
2. Describe models for effective PRRs in state
Medicaid fee-for-service, Medicaid managed care,
and private-payer plans
3. Provide a forum for stakeholders to ask questions
and discuss potential best practices

3. Pain Management and
Prescription Drug Abuse
CDC. MMWR. 2015;64(1):32.

4. Defining Risk for
Opioid Overdose
Yang Z, et al. Journal of Pain (2015), doi: 10.1016/j.jpain.2015.01.475

5. What is a Patient Review and Restriction
Program (PRR)?
• Programs that state Medicaid and private insurance plans
use to identify and manage patients at-risk for prescription
drug abuse
• Plan identifies a patient receiving large quantities or
duplicative opioids from multiple prescribers or pharmacies
• Patient is required to use a designated pharmacy and/or
prescriber to obtain controlled substance prescriptions
• PRRs can improve continuity of care
• Patient protections ensure access to pain medicine while
lowering the risk of overdose

6. “PRR programs 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

7. Federal Landscape
• Bipartisan legislation in
Congress authorizing PRRs in
Medicare
• President’s FY 2016 budget
request proposes authorization
to establish PRRs in Medicare
• Office of Inspector General
includes PRRs on its list of 25
recommendations that would
positively impact HHS programs
in terms of cost savings and/or
quality improvements and
should be prioritized for
implementation

8. Expert Panel
Melwyn Wendt, Pharmacy Director, Louisiana Medicaid
Sarah Kachur, Clinical Pharmacy Manager, Johns Hopkins
Healthcare
Jo-Ellen Abou Nader, Senior Director, Drug Waste Solutions,
Express Scripts

9. Thank You
Cynthia Reilly
Director, Prescription Drug Abuse
The Pew Charitable Trusts
creilly@pewtrusts.org
202-540-6916

10. Overview of the
Louisiana Medicaid Lock-in Program

11. 11
Background
The Bureau of Health Services Financing (Medicaid) developed the Lock-In
Program to educate recipients who may be unintentionally misusing program
benefits and to ensure funds are used to provide optimum health services.
The Louisiana Lock-In Program began in the 1970s.
Recipients who misuse pharmacy and physician benefits may be restricted to
one physician/one pharmacy (Physician-Pharmacy Lock-In) or one pharmacy
(Pharmacy-Only Lock-In).
Prior to move to managed care in 2012, approximately 75% of the Lock-In
recipients were in Physician-Pharmacy Lock-In and 25% in Pharmacy-Only
Lock-In.
Overview of the Louisiana Medicaid Lock-In Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

12. 12
Identification of Potential Lock-In Recipients
Include
 9 months of data,
 72 or more prescriptions,
 5 or more prescribers,
 3 or more pharmacies, and
 Utilization of narcotics, antianxiety agents, sedative
hypnotics, or muscle relaxants
Exclude
 Long-term care
Also consider prescription-related offenses, referrals
Generate claims-based profiles
Overview of the Louisiana Medicaid Lock-In Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA
Step 1—Claims Review

13. 13
Identification of Potential Lock-In Recipients
 Four regional Drug Utilization Review (DUR)
Committees managed by Fiscal Intermediary (Molina).
 Meet monthly.
 Composed of physicians and pharmacists.
 Review individual recipient profiles containing pharmacy and
medical care utilization data.
 May eliminate recipients with cancer, terminal prognosis,
serious illness such as ESRD, etc.
 Make recommendations but final decision made by the
Department.
Overview of the Louisiana Medicaid Lock-In Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA
Step 2—Clinical Review

14. 14
Notification Process
Recipients are notified by mail.
 Letter states recipient is being placed in special program to
use Medicaid in healthier way.
 Recipient chooses PCP, up to 3 specialists, pharmacy, and
specialty pharmacy, if warranted, all subject to Medicaid
approval.
 Recipient has 30 days to call with provider choices.
 Call used to reinforce positive benefits of coordinated care.
 Non-responsive recipients have benefit temporarily
suspended.
 Provider history drives acceptable provider choices.
 School of Pharmacy supports the Lock-In Program from
notification, provider choice and ongoing management.
Overview of the Louisiana Medicaid Lock-In Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

15. 15
Appeals
Initial letter also contains appeal rights and form to
register an appeal.
If recipient chooses to appeal, Lock-In process stops.
Administrative law judge handles appeals.
 This also applies to MCOs.
Recipient provider choices are subject to Medicaid
approval.
Overview of the Louisiana Medicaid Lock-In Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

16. 16
Lock-In Process for MCOs
In the Shared Plans, process is very similar, except:
 There is no Physician-Pharmacy Lock-In because the PCP has
the role of the Lock-In Physician.
 Plans are sent the PCP’s prescribing history (same profile
used by Regional DUR Committees).
 Case management is required.
Prepaid Plans (full-risk MCO):
 Plans have their own selection criteria.
 Plans opted to have no Physician-Pharmacy Lock-In.
 In Pharmacy-Only Lock-In, recipient is sent 3 acceptable
pharmacies from which to choose.
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

17. 17
Lessons Learned
Do
 Create educational/benefit focus.
 Discuss the benefits of a single provider.
 Share prescription and medical care utilization patterns
with providers.
 Encourage case management.
 Have emergency procedures in place.
Don’t
 Perceive Lock-In as punitive.
 Be too restrictive. Need recipient cooperation so offer
encouragement and assistance.
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

18. 18
Demographics
Lock-In type # of Members
Physician-Pharmacy 914 (79%)
Pharmacy-Only 250(21%)
Total 1,164
(Prior to Managed Care)
Gender # of Members
Female 857(74%)
Male 307(26%)
Total 1,164
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA
Age # of Members
19-39 324(28%)
40-59 734(63%)
60+ 106(9%)
Total 1,164
903 (78%) are Disabled (Aid Category).

19. 19
Results of Analyses
For both Lock-In groups, reductions were noted in:
Pharmacy expenditures.
 For the Physician Pharmacy Lock-In study group, average monthly
costs declined from $111,207 to $70,347.
 For the Pharmacy Only Lock-In study group, average monthly costs
declined from $108,798 to $95,953.
Outpatient office visits.
 For the Physician Pharmacy Lock-In study group, average monthly
number of visits declined from 136 to 91.
 For the Pharmacy Only Lock-In study group, average monthly
number of visits declined from 135 to 117.
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

20. 20
Results of Analyses-cont’d
Emergency Room admissions
 For the Physician Pharmacy Lock-In study group, average monthly
ER visits declined from 112 to 71 per month.
 For the Pharmacy-Only Lock-In study group, pre-lock-in the average
number of ER visits per month declined from 123 to 88.
Inpatient admissions
 Before lock-in, the Physician-Pharmacy Lock-In study group had an
average of 23 inpatient admissions per month, while, after lock-in,
this group had an average of 21 inpatient admissions per month.
 For the Pharmacy-Only Lock-In study group, pre-lock-in, the
average number inpatient admissions per month was 19, and after
lock-in, the average inpatient admissions per month declined to 14.
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 7, 2015 * Atlanta, GA

21. 21
Results of Analyses-cont’d
 The number of prescriptions per month for anxiolytics,
carisoprodol, and analgesic narcotics decreased post-lock-in.
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 7, 2015 * Atlanta, GA
Physician/Pharmacy Pharmacy Only
Drug Class
Pre-
Lock-In
Post-
Lock-In
Anxiolytics 198 81
Carisoprodol 156 53
Narcotic
Analgesics
416 151
Maintenance
Medications
227 186
Drug Class
Pre-
Lock-In
Post-
Lock-In
Anxiolytics 166 123
Carisoprodol 141 92
Narcotic
Analgesics
429 262
Maintenance
Medications
234 238

22. 22
Results of Analyses-cont’d
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 7, 2015 * Atlanta, GA
Usual Provider Consistency (UPC)
Physician/Pharmacy Pharmacy Only
UPC Type
Pre-
Lock-In
Post-
Lock-In
Prescriber 0.48 0.80
Pharmacy 0.60 0.91
Physician 0.65 0.77
UPC Type
Pre-
Lock-In
Post-
Lock-In
Prescriber 0.45 0.58
Pharmacy 0.57 0.92
Physician 0.63 0.68

23. 23
Contact Information
Melwyn Wendt, PharmD
Louisiana Medicaid Pharmacy Director
Pharmacy Benefits Management Section
melwyn.wendt@la.gov
Overview of the Louisiana Medicaid Lock-in Program * National Rx Drug Abuse Summit * April 6-9, 2015 * Atlanta, GA

24. JHHC Research & Development Unit 24
JHHC Research & Development Unit
Improving the health of populations by developing innovative healthcare solutions
based on rigorous research and evaluation
Impact of Provider/Pharmacy
Restrictions for Opiates in a Medicaid
Managed Care Population
April 7, 2015

25. JHHC Research & Development Unit 25
Program Description
• Maryland Medicaid Managed Care plan with
approx. 200,000 enrollees
• Opiate overuse led to quality and cost
concerns at plan level
• Program initiated in 2005, continuous
operation
• Plan members locked into one prescriber and
one pharmacy to fill prescription opioids

26. JHHC Research & Development Unit 26
CMC – Volume of Cases
(# of cases)
0
5
10
15
20
25
30
35
40
45
50
Sum of Reviewed
Sum of Locked In

27. JHHC Research & Development Unit 27
Program Staffing
• 2 FTE dedicated staff
– 1 RN case manager
– 1 MSW social worker
• Program support
– Pharmacy technician
– Clinical pharmacist
– Pharmacy director
– Compliance
– Chief Medical Officer (committee chair)

28. JHHC Research & Development Unit 28
Evaluation Overview
Study Design:
Pre-post design with retrospective difference-in-difference analysis

29. JHHC Research & Development Unit 29
Study Population
• Intervention Group =
– 111 plan members
– 18 years or older
– Initial enrollment in the lock-in program March 2008 –
February 2011
• Comparison Group =
– 2248 members from the same health plan
– Identified on a semi-annual screening report for opiate
overuse BUT were not evaluated for program.

30. JHHC Research & Development Unit 30
Primary Outcomes
1 Means reported as unadjusted model predicted means
2 Differences reported from both unadjusted model and risk adjusted model (in bold)
* p<0.05

31. JHHC Research & Development Unit 31
Key Secondary Outcomes
1 Means reported as unadjusted model predicted means
2 Differences reported from both unadjusted model and risk adjusted model (in bold)
* p<0.05

32. JHHC Research & Development Unit 32
Percent in Substance Abuse Treatment
0%
5%
10%
15%
20%
25%
-5 -4 -3 -2 -1 0 1 2 3 4 5 6
Buprenorphine Tx
IOP
Methadone

33. JHHC Research & Development Unit 33
Summary
• Lock-in program decreases opiate prescriptions and
opiate cost
• Program enrollment had a non-significant impact on
emergency department visits, specialist office visits,
and total costs.
• The lock-in program did not increase enrollment in
substance abuse treatment programs.
• Essential to coordinate with state DHMH and other
MCOs within Maryland
– Members changing plans
– Criteria harmonized between MCO programs

34. Curbing Opioid Abuse
PRR Options and Outcomes: A PBM
Perspective
Jo-Ellen Abou Nader, CFE, CIA, CRMA
Senior Director, Express Scripts - Drug Waste Solutions

35. 35
1. Restrict patient to one pharmacy and/or physician for all controlled
substances and muscle relaxers
2. Efficiently manages and reduces risk within population
3. Completed through communications to patient
Automatic Pharmacy Lock Client Choice
Pharmacy Lock | Physician Lock | Pharmacy & Physician Lock
• Express Scripts initiates
process once abuse
allegation is confirmed
• Letter notifies patient of
restriction
• Decision made by client on a case by case basis
• Client chooses to restrict patient to one pharmacy and/or
physician
• Letter notifies patient of pharmacy restriction
• Client must choose physician to be restricted
• Patient and physician notified of restriction
PRR Program

36. Uniquely Positioned to Address Rx Drug Abuse
83%REDUCTION IN DRUG SEEKING
CLAIMS
500+
PATIENTS IN PHARMACY
RESTRICTION
300+COMMERCIAL CLIENTS IN FWA
132AUTOMATIC LOCK CLIENTS
Express Scripts Internal Team to field pharmacy change requests
and appeals

37. • Total narcotic
prescriptions
received within
10 months
• Number of
unique
prescribers
utilized to
obtain
narcotics
• Number of
pharmacies
used to fill the
narcotic
prescriptions
90%OF NARCOTICS
PRESCRIBED
FOR ≤10 DAYS’
SUPPLY
141762
Lock-in implemented to restrict patient to one
pharmacy and one physician for controlled substances
Case Study: Restriction Program Benefits

38. PROBLEM > SOLUTION
Controlled Substance Claims
Reduction
83%Compared with before lock-in
Controlled Substance Spend
Decrease
81%Compared with period prior to lock-in
Total Drug Spend Decrease
72%Compared with period prior to lock-in
May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul Aug
Lock-in
implemented
Lock-in In Action
PRR Proves Savings

39. Confidential and Proprietary Information
© 2013 Express Scripts Holding Company. All Rights Reserved.
Patient Demographics in
PRR
Gender
60% Female vs. 40% Male
Average Age
57 years of age

40. Clients
• Ability to take
action on abuse
cases
• Improve patient
health outcomes
• Reduce future
costs
Physicians
• Physician chosen
for lock can manage
care of patient closer
• Full visibility into
patient’s drug profile
Patients
• Patient Safety
• Intervention to
reduce future risk
Value of a PRR Program

41. Questions