The context of opioid analgesics in the United States
Prescription opioid analgesics rose in popularity in the 1990s to treat chronic pain. However, opioid medications can have adverse effects ranging from chemical dependency to death. The CDC refers to the waves of opioid overdose deaths that occurred between 1999-2019 as the opioid epidemic.
In an attempt to reduce opioid misuse and insurance fraud, many states have enacted policies restricting access to opioid medications. But are these policies effective when it comes to reducing harm and preventing waste?
I contributed to research with a Federal Health client to do a deep dive into how states monitor opioid utilization and how these programs do(n't) communicate with Medicaid agencies.
How do states monitor opioid usage?
Opioid Lock-In Programs
As of 2019, 46 states in the U.S. had opioid lock-in programs. These programs restrict how a beneficiary (or patient) can receive prescription opioids. Depending on the state, these restrictions can be a mixture of seeing only a single provider, using a single pharmacy, and/or a limit on how many controlled substances can be dispensed for them.
States with lock-in programs are required to report their criteria (among other data related to their programs) annually in the National Medicaid Drug Utilization Review. For example, the following map (created in R with data from the 2019 fiscal year Drug Utilization Review) shows the variation in how states restrict a beneficiary in a lock-in program.
Most states use 3 criteria to ID beneficiaries for lock-in: # of Rx, Clinicians, and Pharmacies
Prescription Drug Monitoring Programs
In addition to Lock-In Programs, 49 states also have a Prescription Drug Monitoring Program (PDMP). These programs are electronic databases that track controlled substances. Similar to Lock-In Programs, there is also a wide variation in how states track information related to controlled substances, including whether or not state Medicaid agencies have access to this data when identifying candidates for Lock-In Programs. The 2018 National Medicaid Drug Utilization Review reported that of the 32 states (see adjacent map, created in R with data from the 2019 fiscal year Drug Utilization Review) whose Medicaid agencies can access PDMP data, only 14 use this data to determine Lock-In Program eligibility.
Most states' Medicaid agencies can see their PDMP, but do not use it to make decisions for opioid lock-in eligibility
Unintended Consequences of Lock-In Programs: An evaluation
Circumventing state restrictions
Research on controlled substance dispensing data showed that many states cannot track cash purchases; that is, a locked-in beneficiary can still obtain a controlled substance by paying the full cash price for the prescription without generating a Medicaid claim.
Additionally, beneficiaries who enroll in a managed care organization are removed from a lock-in program.
Inadvertent beneficiary risk
Lock-In Program criteria may incorrectly identify candidates as at-risk who have medical conditions necessitating the use of opioids (such as late-stage cancer patients) or individuals using buprenorphine to treat an opioid use disorder.
Overall health benefits are unclear
While cost-savings for Lock-In Programs are reported in annual Drug Utilization Reports, there is little to no established evidence that Lock-In Programs prevent overdose deaths or substance misuse (ASAM 2016).
This study showed that people in North Carolina can purchase opioid prescriptions with cash and it is not recorded in the state's system
Proposed changes to drug utilization programs
Proposed Rule CMS-2020-0072 (June 2020)
The Centers for Medicare and Medicaid Services proposed the following changes to state drug monitoring programs:
Minimum standards for reporting controlled substance usage by all states
Stricter quantity limits for opioid-naive beneficiaries to mitigate adverse effects
Opioid quantity limits should be informed by clinical recommendations and dosing schedules
Automated claims reviews and retrospectives for states which hit a specified threshold of opioid prescription fills
Physician alerts when beneficiaries have concurrent controlled substances which increase the risk of adverse effects (such as opioids and benzodiazepines)
Minimum standards to identify beneficiaries who are at-risk for opioid misuse for treatment with naloxone
