Composición de Comités y órganos de control

We intended to use the ADOPT model to evaluate the costs and outcomes (in terms of health impact and return on investment) of patient review and restriction (PRR) programs in different states. However, we were unable to obtain state-specific model inputs, such as state-specific opioid user demographics, state-specific opioid reimbursement rates, and state PRR program spending. Due to the lack of state-specific data, we used values derived from the MarketScan® database, to analyze and compare different program eligibility criteria adopted by several representative states. Because we used a hypothetical population derived from a database combining multiple, unknown states, our analytic output is exploratory rather than deterministic or predictive. Although the lack of state-specific inputs prohibits us from carrying out state- specific analysis at this stage, more relevant analyses can be conducted by users, especially state officials, who have better access to and knowledge of state-specific data.

Patient Review and Restriction Program Policies

Although the patient review and restriction (PRR) programs exist in many states, the enrollment criteria vary across states. Based on a brief review of accessible sources of the state PRR

program criteria, we selected 6 representative states and modeled 5 different scenarios of program eligibility criteria (the criteria in West Virginia and North Carolina are similar and, therefore, modeled as one) (Table 10). It is noteworthy that some state PRR program eligibility criteria involve non-quantifiable items, such as “referral by provider,” “excessive emergency room use,” “noncompliance with narcotics contract,” or “demonstrated inappropriate utilization.” These situations cannot be modeled using the ADOPT model. Additionally, the current version of the ADOPT model does not simulate frequent use of emergency departments or office visits

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can render a patient eligible for the PRR program, nor does it simulate misuse of other

prescription drugs including stimulants, and carisoprodol (however, these can be added to the model when/if supporting data becomes available).

The modeled eligibility criteria used combinations of the number of prescribers seen, the number of pharmacies visited, and the number of prescriptions filled over a given time span.

Washington, West Virginia, and North Carolina specify the number of PRR eligibility criteria a patient has to meet, while the other three states (Kentucky, Idaho, and Michigan) do not mention a required number of criteria. For example, upon referral to the Idaho program, patients may be restricted based on an analysis of potential overuse of targeted medications including opioids, tramadol and benzodiazepines, as well as the number of prescribers and pharmacies used, excessive ER use and history of drug abuse. However, the program does not specify a cutoff number of pharmacies/prescribers or require meeting a specific number of criteria (Table 3-11). In these cases, we modeled similar eligibility criteria based on our interpretation.

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Table 3-11. Representative State Patient Review and Restriction Program Policies

Scenario #

State Current Eligibility Criteria for State Patient Review and Restriction Programs Modeled Eligibility Criteria

1 Washington12 Two or more of the following conditions occurred in a period of ninety consecutive

calendar days in the previous twelve months.

Received services from four or more different providers, including physicians, advanced registered nurse practitioners (ARNPs), and physician assistants (PAs); Had prescriptions filled by four or more different pharmacies;

Received ten or more (opioid) prescriptions;

Had prescriptions written by four or more different prescribers; Received similar services from two or more providers in the same day; Had ten or more office visits.

Two or more of the following conditions in a

period of ninety consecutive calendar days: Visited >4 prescribers

Used >4 pharmacies

Received >10 opioid prescriptions

2 West Virginia13 Any of the following conditions (note: the program is not limited to the listed criteria):

Overutilization: ≥ 6 claims for ≥ 3 different agents (listed below) in the past 60 days o Opiates

o Benzodiazepines o Stimulants o Tramadol o Carisoprodol

Multiple Prescribers: ≥ 3 prescribers for the agents, or combinations of the agents, listed below in the past 60 days

o Opiates

o Benzodiazepines o Stimulants o Tramadol o Carisoprodol

Any of the following conditions in any 60

days:

Visited >3 prescribers

Received > 6 opioid prescriptions

North Carolina14 One or more of the following criteria:

Filled > 6 prescriptions for either opioid pain relievers or anti-anxiety (benzodiazepine) medications within a two month period

Prescribed opioid pain relievers and/or benzodiazepine medications by >3 prescribers within a two month period

Referral from a provider, DMA or CCNC.

3 Kentucky15 The recipient has the following conditions in consecutive 180 calendar day periods: Received services from > 5different providers

Received >10 different (opioid) prescription drugs

Received (opioid) prescriptions from >3different pharmacies

All of the following conditions in any 180-

day period:

Visited >5 providers Used >3 pharmacies

Received >10 opioid prescriptions

Meet above conditions in two consecutive 180-day periods.

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Scenario #

State Current Eligibility Criteria for State Patient Review and Restriction Programs Modeled Eligibility Criteria

4 Idaho16 Upon referral, the following are analyzed:

Medication profile for the potential overuse of target medications o ≥ 6 Benzodiazepines claims in last 60 days

o ≥ 8 opiate claims within last 60 days

o ≥ 3 Tramadol claims or 480 tablets within last 60 days o Continuous use of skeletal muscle relaxants for > 6 months Multiple providers

Multiple pharmacies

Excessive emergency room use

Screening of health conditions for a history of drug dependence or abuse

All of the following conditions in any 60-day

period:

Prescription overuse:

o Received >8 opioid prescriptions, OR o 3 tramadol claims or 480 tablets in any

60 days;

Visited >2 or more pharmacies Visited >2 or more prescribers

(The number of pharmacies and prescribers are not specified in the state criteria. The numbers used in the modeled criteria are assumed.)

5 Michigan17 Any of the following conditions:

Visited >3 different physicians in one quarter

Visited >2 different physicians to obtain duplicate services for the same health condition or prescriptions the following drug categories:

o Narcotic Analgesics o Barbiturates

o Sedative-Hypnotic, Non-Barbiturates

o Central Nervous System Stimulants/Anti-Narcoleptics o Anti-Anxieties

o Amphetamines

o Skeletal Muscle Relaxants

Visited multiple physicians for vague diagnosis (e.g., myalgia, myositis, sinusitis, lumbago, migraine) to obtain any of the drugs listed above

Used >3 different pharmacies in one quarter

Received > 11 prescriptions in the listed categories in one quarter

Other criteria includes convicted fraud and inappropriate use of ED services (content not shown here)

Any of the following conditions in any 90

days:

Visited >3 prescribers Used > 3 pharmacies

Received >11 opioid prescriptions

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Impact on Prescription Opioid Use

After the simulation is completed, users will be directed to the output screen where the impact of the patient review and restriction (PRR) program on prescription opioid use, overdose-related events, and cost (including prescription reimbursement, overdose-related medical services and PRR program cost) is summarized. Figure 3-4 shows a screenshot of the model output using criteria from Scenario #1 (i.e., based on the Washington program). The tables shown hereinafter are based on a summary of the output after 10 simulation rounds. The population characteristics are set to be the same as those used in the model calibration (as shown in Table 3-3).

Figure 3-4. ADOPT Output: Program Summary

Table 3-12 summarizes the demographics and the opioid use pattern of the eligible cohort under the five scenarios of eligibility criteria. The size of the eligible cohort varies substantially among the different scenarios. Scenario #3 (based on the Kentucky program) uses the most stringent criteria, with only 82 (95% CI: 61-103) out of 10,000 simulated patients eligible for the program. Scenarios #4 and #5 are less stringent, with over a quarter of the simulated population (2,775 [95% CI: 2,241-3,309] and 2,865 [95% CI: 2,317-3,413] patients for scenarios 4 and 5, respectively) eligible for the program. Under all five simulated scenarios, the PRR program eligible cohorts are younger than the entire simulated population, with a mean age of 47.9 (95% CI: 47.4 – 48.4). Similarly, all scenarios show that the proportion of males in the eligible cohort is slightly, but statistically significantly higher than the entire population (29.7% [95% CI: 29.6%-29.8%] male).

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Table 3-12. Demographic and Drug Use Patterns of PRR Program Enrollees in a Simulated Population of 10,000 Long-Term Users under Different Eligibility Scenarios (with 95% confidence interval in parentheses)

Scenario 1 Scenario 2 Scenario 3 Scenario 4 Scenario 5