Medicaid Lock-In Programs 19

In addition to operating PDMPs, the vast majority of states (n=46) also operate controlled substance lock-in programs designed to identify, correct, and prevent high-risk nonmedical use behaviors in their Medicaid populations.15 _{(Medicaid was established in 1965 by Title XIX of the Social Security} Act as a joint state and federally funded health insurance program for the poor and disabled.101_{) This is} not surprising given Medicaid beneficiaries are particularly susceptible to nonmedical controlled substance use behaviors and its consequences.102 _{The rate of controlled substance prescribing among} Medicaid beneficiaries increased two- to three-fold over the past 15 years.19,22,48 In fact, literature has shown Medicaid beneficiaries are up to twice as likely to receive an opioid analgesic prescription than privately insured or uninsured populations, when controlling for demographic and clinical

characteristics.21,103 Notably, Washington Medicaid beneficiaries had a six-fold risk of opioid-related death, accounting for half of all such events despite making up only 22% of the state’s population.20

MLIPs—sometimes referred to as patient review and restriction programs—attempt to mitigate these trends by enrolling beneficiaries that exhibit controlled substance utilization patterns indicative of nonmedical use. Once identified, MLIP administrators restrict their access, or “lock” them in, to specific providers as a stipulation for Medicaid coverage of controlled substance-related services. The purpose of operating an MLIP is multifactorial.15 _{First, restricting beneficiaries, for example, to one prescriber and} one pharmacy for their opioid prescriptions allows those providers to establish heightened levels of care coordination, deliver higher quality care, and ultimately improve health outcomes. Also, MLIPs are intended to prevent doctor- and pharmacy-shopping behaviors, which would mitigate the diversion of Medicaid-covered controlled substance prescriptions to other parties for nonmedical use. Lastly, states

stand to enjoy substantial economic savings from a reduction in unnecessary controlled substance-related services and avoidance of downstream clinical outcomes from nonmedical controlled substance use. 15

The legal foundation for MLIPs was established in 42 CFR 431.54(e). These rules provide a general framework for MLIPs16_:

(e) If a Medicaid agency finds that a recipient has utilized Medicaid services at a frequency or amount that is not medically necessary, as determined in accordance with utilization guidelines established by the State, the agency may restrict that recipient for a reasonable period of time to obtain Medicaid services from designated providers only. The agency may impose these restrictions only if the following conditions are met:

(1) The agency gives the recipient notice and opportunity for a hearing (in accordance with procedures established by the agency) before imposing the restrictions.

(2) The agency ensures that the recipient has reasonable access (taking into account geographic location and reasonable travel time) to Medicaid services of adequate quality.

(3) The restrictions do not apply to emergency services furnished to the recipient.

The Federal rules only stipulate that MLIPs must inform candidates of the lock-in decision prior to their MLIP enrollment, must ensure reasonable access to quality Medicaid services, and must not impede access to emergency medical services. The rest of the program design decisions are left up to state Medicaid agencies. These decisions include the MLIP enrollment criteria, qualifying medication classes, which provider(s) MLIP enrollees get locked in to, and the duration of the lock-in period. Most MLIPs restrict enrollees to either one pharmacy or one pharmacy plus one prescriber. The lock-in period

typically lasts from 12 to 24 months, with some states employing longer subsequent lock-in periods if the nonmedical use behaviors do not resolve after the initial enrollment term. In addition, most states define their MLIP eligibility criteria using threshold measures of numbers of controlled substance prescription claims and number of controlled substance prescribers and pharmacies used. However, considerable variability exists in how state MLIP administrators utilize these measures to define their criteria for “excessive” use of controlled substance services (Table 2.3).15

21

Table 2.3: Enrollment criteria for states with publicly available Medicaid lock-in eligibility details (as of 2/22/14)a State

Assessment

periodb _{Prescription criteria Prescriber criteria} Pharmacy _{criteria Other criteria}

Alaska Monthly for 2

consecutive months

Receipt of prescriptions with frequency ≥2 standard deviations of mean;

Receipt of prescriptions from ≥1 prescribers in total average daily doses exceeding those recommended in Facts & Comparisons

Provider referral

Colorado 3 months ≥3 drugs in the same therapeutic category; ≥16 prescriptions

≥3 pharmacies Provider referral

Idaho 60 days ≥6 benzodiazepine claims;

≥8 opiate claims; ≥3 tramadol claims; ≥480 tramadol tablets;

≥6 months of continuous muscle relaxant use

Use of "multiple" prescribers Use of "multiple" pharmacies "Excessive" ED use; Drug dependence or abuse history;

Provider referral

Kentucky 2 consecutive

180-day periods

≥10 different prescription drugs; ≥5 prescribers ≥3 pharmacies ≥4 ED visits for non-emergency; ≥3 different EDs used for non-emergency

Massachusetts 3 months ≥11 Schedule II-IV prescription fills; AND ≥4 prescribers; OR ≥4 pharmacies Michigan 3 months ≥5 claims for CS or muscle relaxants;

"Aberrant" CS utilization patterns over 1 year

≥2 prescribers for duplicate services

≥3 pharmacies ≥3 ED visits;

Repeat ED use with no follow-up; Repeat ED use for non-

emergency

Nevada 60 days ≥9 CS claims

New Hampshire (any three criteria)

90 days ≥3 drugs in same drug class;

Same/similar drug received from different pharmacies within 2 days;

100 units per prescription per 7-day supply

≥3 prescribers ≥3 pharmacies ≥2 ED visits

New Jersey NR ≥2 prescription fills "in excess of what any one prescriber would intend"

Use of "multiple" prescribers

Use of "multiple" pharmacies

Presentation of forged or altered prescription

North Carolina 2 consecutive months

≥6 benzodiazepine claims; ≥6 opiate claims

≥3 prescribers Provider referral

Oregon 6 months “Exhibit patterns of drug misuse” Use of "multiple"

prescribers to obtain same/similar drugs

22

Utah 12 months ≥6 CS prescription fillsc _{≥3 prescribers ≥4 pharmacies ≥4 primary care providers visited;}

≥4 specialists visited;

≥5 ED visits for non-emergency

Virginia 3 months Exceed 200% max therapeutic dose of drug

class or 100% max therapeutic dose of drug class from ≥2 prescribers for period ≥4 weeks; Duplicate prescription fills within 2 days on two separate occasions;

≥2 CS prescriptions from ≥2 pharmacies or ≥2 prescribers for period ≥4 weeks;

≥24 prescriptions; ≥12 CS prescriptions

≥3 prescribers; ≥2 physician visits for similar diagnoses within 2 days

≥3 pharmacies ≥3 ED visits for non-emergency; Provider referral; Pattern of non-compliance Washington (any two criteria) 3 months ≥10 prescriptions;

CS prescriptions from ≥2 prescribers (automatic eligibility if this criterion met)

≥4 prescribers ≥4 pharmacies Similar services from ≥2 providers

on same day; ≥10 office visits;

≥2 ED visits (automatic eligibility); “At risk” fraudulent behavior (automatic eligibility) West Virginia 60 days Suboxone therapy in last 30 days;

≥6 claims within single class with abuse potential;

≥6 claims from ≥3 classes with abuse potential; ≥16 claims for all drugs with abuse potential; "Doctor shopping" involving ≥6 claims for drug

with abuse potential from ≥3 prescribers filled at ≥2 pharmacies

≥3 prescribers of drugs

with abuse potential

History of dependence; History of poisoning/overdose

Wyoming NR ≥2 prescribers ≥2 pharmacies

Note: CS=controlled substance; ED=emergency department; NR=not reported. Information in this table reflects evidence identified in published literature and publicly available sources online.

a. Eligibility for lock-in enrollment contingent on meeting one individual criterion listed within the state, except where noted as otherwise.

b. Assessment of individual lock-in enrollment criteria occurs over the designated time period in this column, except where noted with criterion as otherwise. c. CS utilization criteria for Utah Medicaid Restriction Program assessed over time period shorter than 12 months, but exact duration unavailable

Table from: Roberts AW, Skinner AC. Assessing the Present State and Potential of Medicaid Controlled Substance Lock-In Programs. J Manag Care Pharm. May 2014;20(5):439-446c.

Unlike the PDMP policy strategy, there is limited peer-reviewed evidence available to inform our current understanding of optimal MLIP design and the effectiveness of MLIPs in achieving positive effects on nonmedical controlled substance use. Available literature pertaining to MLIP-related outcomes and MLIP enrollment criteria design are discussed in Sections 2.2 and 2.3, respectively.

2.1.11.1 North Carolina Medicaid Recipient Management Lock-In Program

North Carolina Medicaid implemented their MLIP, the Recipient Management Lock-In Program, in October of 2010.17,104 _{North Carolina Medicaid beneficiaries are eligible for MLIP enrollment if they} meet at least one of the following criteria based on retrospective utilization review of NC Medicaid claims data and are not being treated for cancer:

• Fill ≥7 opioid analgesic prescriptions in a period of two consecutive months; • Fill ≥7 benzodiazepine prescriptions in a period of two consecutive months;

• Receive opioid or benzodiazepine prescriptions from four or more unique prescribers in a period of two consecutive months;

• Referred for enrollment from a provider or the North Carolina Division of Medical Assistance. The North Carolina Division of Medical Assistance (DMA) administers the NC MLIP but contracts with a third-party vendor, Affiliated Computer Services (ACS), to manage program enrollment. ACS retrospectively applies the NC MLIP enrollment criteria to the most recent 60 days of Medicaid claims data to identify beneficiaries eligible for lock-in. Roughly 3,000 to 4,000 Medicaid beneficiaries meet the inclusion criteria at any given time.105 They then rank those eligible for the MLIP by severity of controlled substance seeking-behavior, which is assessed through clinical pharmacist review and a proprietary algorithm that considers number of prescriptions received, providers used, and controlled substance costs incurred. ACS then provides DMA with the prioritized list of eligible Medicaid

beneficiaries, at which point DMA conducts another clinical drug utilization review and begins the MLIP enrollment process for the finalized list of eligible individuals.

MLIP enrollees are notified of their lock-in status through a mailed letter and have a 30-day period in which to designate one preferred lock-in pharmacy and one preferred lock-in prescriber. Once enrolled, individuals are locked in to their preferred prescriber and one pharmacy—or assigned a

prescriber and pharmacy if no preference is designated—for North Carolina Medicaid coverage of services involving benzodiazepine and opioid analgesic medications. The initial enrollment period lasts 12 months, at which point enrollees are evaluated for release from the MLIP or for re-enrollment.

DMA phased in NC MLIP implementation by enrolling roughly 200 eligible NC Medicaid beneficiaries into the MLIP each month beginning in October 2010. For example, in the first six months of MLIP implementation, the number of lock-in beneficiaries increased from 58 to 954.105

2.2 LITERATURE REVIEW—MLIP Outcomes and Evaluations