Lock-In Programs and the Opioid Epidemic: A Call for Evidence

In July 2016, the Comprehensive Addiction and Recovery Act (CARA) passed both houses of Congress with overwhelming bipartisan support and was signed into law by President Obama.¹ CARA contains sweeping initiatives addressing America’s opioid crisis. Among them is a provision implementing “drug management programs for at-risk beneficiaries,” commonly called lock-in programs (LIPs), in Medicare Part D prescription drug plans beginning in January 2019. Until CARA, LIPs garnered minimal attention in policy and academic communities in comparison with other opioid-centric policies (e.g., prescription drug monitoring programs), possibly because LIPs originated as insurance fraud and abuse prevention measures.

The emergence of LIPs into the national opioid policy discussion is notable for a pair of contrasting reasons: LIPs have existed for decades and are common across the managed care landscape, particularly in Medicaid, and yet the evidence base to support LIPs as public health interventions to combat opioid abuse and misuse is largely nonexistent. It is imperative that we give pause and carefully scrutinize the possible effects and numerous unknowns of this policy strategy as we prepare for LIPs to be deployed on a much larger scale.

WHAT ARE LOCK-IN PROGRAMS?

LIPs have operated since at least 1970² and are currently used in most Medicaid programs.³ LIPs identify beneficiaries exhibiting “high-risk” opioid use and restrict their access to, typically, one prescriber and pharmacy for opioid coverage. Predefined prescription claims thresholds are used to flag beneficiaries as high risk; for example, in the North Carolina Medicaid program, beneficiaries are eligible for the LIP if they have more than six opioid claims or use more than three unique opioid prescribers in two months. LIPs aim to decrease fraud, waste, and abuse of benefit resources; reduce unsafe opioid use behaviors; and improve quality of care for high-risk beneficiaries through enhanced care coordination and tighter access to these high-risk medications.

WHAT WE KNOW ABOUT LOCK-IN PROGRAMS

The LIP evidence base is sparse despite the current prevalence and historical tenure of these programs. Other than a handful of peer-reviewed LIP studies dating back to 1977, most LIP outcome evidence comes from the gray literature, including non–peer-reviewed Medicaid programmatic evaluations.³ These sources indicate three consensus LIP outcomes: opioid prescription claims decrease, medical service claims decrease, and insurance benefit expenditures decrease. LIPs are unequivocally beneficial to payers as fraud, waste, and abuse interventions.³ However, there is little evidence informing LIP design and operation standards, particularly in terms of how LIPs define their high-risk opioid use eligibility criteria. And there is little or no compelling evidence as to whether LIPs achieve meaningful patient and public health outcomes through improved quality of care for individuals at risk for opioid abuse, misuse, and overdose.

It is understandable why policymakers and payers would tap LIPs for broader implementation despite a dearth of outcome evidence. The opioid crisis in America has become an urgent, nonpartisan public health issue demanding top legislative priority at both the federal and state levels. LIPs are established, scalable programs that reduce opioid prescription and medical claims among patients using a high volume of opioid-related services.

Yet, as LIP momentum builds, it is incumbent on all stakeholders to proceed with a clear understanding of what we actually know about this policy. First, and most notably, discussions around the merits of LIPs inappropriately conflate health care use measures based on insurance claims with meaningful public health outcomes. Reductions in payer claims and expenditures for opioid prescriptions and physician and emergency department visits, which comprise the bulk of existing LIP evidence, are incomplete process measures. This narrow focus fails to capture opioid use occurring through out-of-pocket cash payments, other sources of insurance, or diversion. It also perpetuates an evidence base that reinforces LIPs as effective waste prevention tools, falling short of supporting LIPs as public health interventions. Successfully deploying LIPs to combat the opioid epidemic requires examining their effects on opioid overdose rates, diagnosis and treatment of opioid use disorders, patient care coordination, and relevant patient-reported outcomes.

Second, there is little consensus about which patients benefit most from LIP enrollment. Medicaid LIPs vary drastically in how they define “at-risk beneficiaries” with claims-based opioid use measures. Current LIP eligibility criteria are often intended to target the highest utilizers of payer resources and to maintain a limited program size. If the priority of LIPs is to transition from waste reduction to achievement of positive clinical outcomes, these programs must optimize their enrollment criteria to capture patients at greatest risk for preventable outcomes from opioid abuse and misuse and those with unnecessarily fractured or duplicative pain management care. This will likely require moving beyond flagging high-risk patients with simple opioid claims thresholds to using more nuanced approaches to measuring high-risk opioid use, such as evidence-based milligram morphine equivalent thresholds, and accounting for comprehensive opioid use with prescription drug monitoring program data.

Third, we know little about how LIPs’ opioid prescriber and pharmacy restrictions affect downstream use of health care services. There are well-documented concerns about LIPs inducing patients to obtain opioids through cash payments or diversion, resulting in programs being circumvented and undermined.^3–5 This circumvention behavior signals the limitations of LIPs in preventing provider shopping. It also may reflect LIP restrictions causing new barriers to necessary care for patients with legitimate medical needs. Furthermore, we don’t understand how LIPs affect patient–provider communication and trust, the burdens on prescribers and pharmacists to maintain LIP integrity, or the possible spillover effects of LIP restrictions on medication access for other comorbid conditions, particularly in populations with limited mobility and transportation.

Lastly, CARA’s focus on Medicare Part D highlights a large gap in knowledge around LIP effectiveness in varied patient populations. It makes sense from a public health perspective that, to date, LIPs have been most commonly applied and studied among Medicaid patients, who are known to be at greatest risk for opioid abuse, misuse, and overdose. However, Medicare-aged older adults, not dually enrolled in Medicaid, are a fundamentally different patient population not typically considered a high priority for opioid abuse interventions. Adults aged 65 years and older have the lowest opioid overdose rate of any age group.⁶ Therefore, what little LIP evidence we do have may lack generalizability to this large, complex older patient population.

THE FORESIGHT OF CARA

CARA shows a keen understanding of the many challenges we face when deploying LIPs as public health interventions that should be replicated in future LIP efforts. It directs Part D LIPs to mitigate barriers to necessary care and ensure “reasonable access” to necessary drugs for LIP enrollees by “taking into account geographic location, beneficiary preference, impact on cost-sharing, and reasonable travel time”; allowing selection of multiple lock-in providers for some; and reviewing LIP enrollee complaints about lack of access [Section 704(a)].¹ Part D LIPs are also required to deliver comprehensive educational materials to LIP enrollees and providers regarding the purpose of the program and additional resources available for substance use disorders and other mental health treatment. Many Medicaid LIPs fail to provide similarly comprehensive education or services aside from imposing provider restrictions. In addition, CARA commissions a wide-ranging evaluation of LIP implementation and clinical effectiveness [Section 704(f)].

CONCLUSIONS

Lock-in programs appear destined to assume a much larger role in national efforts to combat the opioid epidemic. The scant evidence on LIP outcomes—coupled with concerns over LIPs inadvertently imposing health care access barriers—requires payers, policymakers, and providers to collectively and concertedly work to ensure that LIPs are designed, implemented, and evaluated with a patient and public health focus.