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question did the use of direct-acting hepatitis c antiviral (hcv) drugs change after these drugs were excluded from medicaid managed care organization (mco) coverage and Was fee-for-service funded in 4 state Medicaid programs?

Findings In this cross-sectional study, exclusions were associated with a median quarterly increase of 22.1 HCV prescription fills per 100,000 Medicaid enrollees compared with synthetic control states, which translates to a relative increase of 86%.

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what it means this study suggests that excluding hcv medications from medicaid mco coverage may increase access to these medications, which could improve the health of hvc members medicaid with hcv and reduce the economic burden of untreated hcv on patients. American health system.

importance Medicaid enrolls a disproportionate share of adults with the hepatitis C virus (HCV), and most receive Medicaid benefits through managed care organizations (MCOS). Medicaid MCOS often impose more stringent requirements for access to HCV medications than traditional fee-for-service Medicaid, which can inhibit use. While Medicaid MCOS generally cover prescription drugs, several states have excluded direct-acting HCV antiviral drugs from MCO coverage and opted to cover them on a fee-for-service basis. Whether these exclusions were associated with changes in medication use is unknown.

purpose to examine the association between medicaid covered hcv drug fills and the exclusion of these drugs from mco coverage.

Design, Setting, and Participants This cross-sectional study examined changes in the supply of Medicaid-covered HCV direct-acting antiviral medications in 4 states (Indiana, Michigan, New Hampshire, and West Virginia) that excluded these drugs from medicaid mcos between 2015 and 2017. a synthetic control approach was used to compare changes in vhc prescription fills between states that did and did not exclude these drugs from mco prescription drug coverage. Prescription data for HCV direct-acting antivirals were obtained from Medicaid State Drug Utilization Data Files from January 2015 to June 2020. Data analysis was performed from November 2020 to June 2020. 2021.

exposures exclude direct-acting hcv antiviral drugs from medicaid mco prescription drug coverage.

Key Outcomes and Measures HCV direct-acting antiviral prescriptions filled per 100,000 Medicaid enrollees.

Results In this cross-sectional study, exclusions were associated with a mean quarterly increase of 22.1 (95% CI, 12.7-34.1) HCV prescriptions per 100,000 enrolled in Medicaid, a relative increase of 86.3% compared to synthetic control states. Compared to each state’s respective synthetic control, hcv prescription fills were associated with an increase of 11.5 (95% CI, 5.1-19.0) hcv prescription fills per 100,000 enrollees in quarterly medicaid in indiana, 36.6 (95% CI, 23.5-53.9) in michigan, 20.7 (95% CI, 11.1-32.8) in west virginia, and 43.6 ( 95% CI, 25.9-68.4) in New Hampshire.

Conclusions and Relevance In this cross-sectional study of data from 39 states and the District of Columbia, direct-acting HCV antiviral drug exclusions from Medicaid MCO prescription drug coverage were associated with significant increases in the use of HCV medications. Given their clinical benefits, increased acceptance of HCV medications may help improve the health of Medicaid members with HCV and reduce the economic burden of untreated HCV on the US health care system. uu.

An estimated 4.1 million people are infected with the hepatitis C virus (HCV) in the United States, and the prevalence of HCV is disproportionately higher among people enrolled in Medicaid.1,2 Since the late As of 2013, the use of highly active direct medications active antivirals have revolutionized HCV treatment.3 In contrast to earlier HCV treatments, these newer medications are well tolerated and often curative after 1 course of treatment. for all patients with acute or chronic HCV infection, regardless of the stage of infection.5 Prompt treatment of HCV can prevent negative health consequences and reduce the economic burden of untreated HCV on the health care system of I know. uu. Programs often limit access to HCV medications due to their high cost, with list prices ranging from $25,000 to $95,000 for a single cycle of treatment.6,7 hi Historically, access to HCV treatment was limited through prior authorization requirements and restrictions requiring advanced liver damage and abstinence from substance use. % of recipes in 2017.9

Medicaid Managed Care Organizations (MCOS) provide insurance coverage to more than 70% of Medicaid enrollees in the United States through private health plans. ) (42 cfr § 438.210),11 MCOS often impose more stringent barriers to accessing HCV medications, including more stringent clinical requirements or narrower preferred drug lists.12,13 These restrictions may reflect the financial risk that faced by mcos, which receive capitation payments from states for a defined benefit package and provision of services to mco enrollees.14 Comprehensive mcos generally cover inpatient and outpatient services and include prescription drug benefits in most mcos. states.14,15 However, a growing number of states have begun to selectively remove direct-acting HCV antiviral drugs from MCO coverage and fund them under state Medicaid FFS programs.10,15,16 Given the differences in the usefulness of the automation management techniques used by Medicaid’s MCOS vs. FFS programs, the Exclusion of HCV medications from Medicaid’s MCO drug coverage can reduce barriers to access and subsequently increase use of these life-saving medications.17

To our knowledge, this is the first study to examine whether OC exclusions from direct-acting HCV antiviral medications are associated with changes in HCV medication use. We examined HCV medication use in 4 states (Indiana, Michigan, New Hampshire, and West Virginia) before and after these medications were removed from MCO coverage. We hypothesized that HCV drug use would increase among states transitioning from exclusive to exclusive coverage compared with a set of synthetic control states that experienced no change in their HCV drug coverage mechanism.

data on medicaid covered hcv prescriptions obtained from centers for medicare & Medicaid Services Medicaid State Drug Utilization Data Files from January 2015 through June 2020. 18 States are required to report Medicaid-covered prescription volume quarterly to Centers for Medicare & Medicaid services as a condition of your participation in the Medicaid drug reimbursement program. Direct-acting HCV antiviral drugs were identified using national drug codes according to methods used in previous research. Table 1 of the supplement lists national drug codes.4,19 State Medicaid drug utilization data includes prescriptions that are eligible for the Medicaid drug reimbursement program and therefore does not include prescriptions funded under the 340b drug pricing program.18

hcv medication exclusions were identified through kaiser family foundation reports.16 we confirmed the effective dates of the exclusions through state filings. We identified restrictions imposed by state Medicaid programs (FFS and MCO) on access to HCV medications from a collaboration between the Center for Health Law and Policy Innovation at Harvard Law School and the Roundtable We obtained data on HCV-related deaths from the Centers for Disease Control and Prevention’s Wonder Database.21 We identified HCV-related deaths using the International Statistical Classification of Diseases and related health problems, 10th revision (icd-10) codes 17.1 and 18.2 listed as underlying or additional cause of death. We obtained data on the incidence of acute HCV infections from the National Notifiable Disease Surveillance System of the Centers for Disease Control and Prevention.22

We included states in our analysis if they had at least 1 year of data before an HCV medicine was excluded, provided criteria for public access to HCV medicines, and did not implement subscription-based payment models during the study period.23 south carolina eliminated hcv drug coverage in 2015, but was excluded because we required at least 1 full year of data prior to the period. illinois was excluded because several of the state’s largest medicaid doctors do not provide public criteria for access to hcv medications. louisiana and washington were also excluded because they implemented subscription-based payment models for hcv drugs in july 2019. registries (state quarter national drug code) with fewer than 11 prescriptions are suppressed due to risk of identification of the patient, so we excluded 7 states in which more than 50% of observations were suppressed (alaska, delaware, iowa, nebraska, north dakota, south dakota, and wyoming). Five states were missing data for a single quarter (New Hampshire, West Virginia, South Carolina, Indiana, and Michigan), which we replaced using linear interpolation. our final sample included 39 states and the district of columbia, and our study period ran from the first quarter of 2015 to the second quarter of 2020. our unit of analysis was the state-quarter (880 state-quarters).

the boston university medical center institutional review board determined that the need for approval was waived because the study was not an investigation involving human participants. this study followed the strengthening of the reporting of observational studies in the epidemiology (stroboscopic) reporting guideline for cross-sectional studies. quarterly medicaid enrollment was obtained from cms.24 monthly enrollment reports

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our primary exposure was a binary indicator of whether hcv medications were excluded from state medicaid mco coverage. indiana, michigan, and new hampshire removed hcv medications from mco prescription drug coverage in 2016, and west virginia removed coverage of all prescription drugs from mco benefits in 2017. effective dates are shown on the table 2 of the supplement.

Our primary outcome was the use of Medicaid-covered direct-acting HCV antiviral prescriptions, expressed as the quarterly rate of HCV drug fills per 100,000 Medicaid enrollees.

State Medicaid programs often impose criteria that require members to have fibrosis (ie, liver damage) and/or sobriety to access HCV medications. we include these restrictions as covariates given their association with hcv drug use.25,26 we consider states that require any level of liver damage to access hcv drugs to have a fibrosis requirement. Similarly, we consider states that require any period of abstinence from substances to have a sobriety requirement. fibrosis and sobriety requirements were coded as binary variables that took the value 1 if a state had any restrictions during a trimester and 0 otherwise.20

we used synthetic control methods to estimate the association between exclusions and HCV drug use, comparing outcomes in a treated state with a weighted average of control states comparing pre-period trends and other covariates .27,28 Synthetic control methods are particularly useful in estimating how a policy change may affect a small number of treatment groups at different times,27-31 and are based on traditional difference-in-difference estimation but require fewer assumptions. .27,32 for example, differences-in-differences assumes that any differential change in outcomes between treated and control groups is attributable to the policy change. however, the treated and control groups are often not equivalent in terms of pretreatment outcome levels, trends in outcomes, and other important covariates. non-equivalence of treatment and control groups introduces potential selection problems, which can bias estimates of association. investigators using traditional regression approaches attempt to control for a wide range of potential confounders associated with treatment assignment or study outcomes. in contrast, synthetic control methods mitigate this limitation by constructing a synthetic control from a pool of donors from groups not exposed to the treatment of interest. Researchers may also include covariates in synthetic control methods, but they are often not necessary and may worsen preperiod matches between treated states and their respective synthetic control.27 The synthetic control state is constructed using a weighted average of untreated states for which the synthetic control is similar to the treated state in outcome trends and other specified covariates before treatment. In other words, instead of comparing New Hampshire (i.e., treated group) with New York, Texas, California, or a simple average of those states (i.e., untreated group), researchers can use synthetic control methods to construct a weighted average of these states, so the resulting synthetic control best matches the treated state with respect to pretreatment characteristics and outcome trends.27

Our analysis proceeded in 4 steps. First, we created individual synthetic control states for each treated state (i.e., synthetic Indiana, synthetic Michigan, synthetic New Hampshire, and synthetic West Virginia) from weighted averages of states in the donor pool (untreated states). data-driven approach to minimize pre-period differences between treated states and their respective synthetic control states on 3 variables. These variables included liver damage and sobriety criteria for access to Medicaid-covered HCV treatment, as well as supply of HCV medications per 100,000 Medicaid enrollees. table 3 of the supplement presents the actual weights used.

Second, we estimated the mean differences in quarterly HCV prescription fills per 100,000 Medicaid enrollees between treated states and synthetic control states during the 2 years after adoption of opt-out policies by part of the treaty states. this 2-year period was selected to provide adequate time for clinicians to respond to changes in coverage policies and to limit the risk that future health policy changes may confound our results.33 in sensitivity analyses. , we tested a later period of 1 year. We also visually assessed whether there were differences in trends in HCV-related mortality rates (expressed as number of deaths per 100,000 residents) or incidence of infections (expressed as number of acute infections per 100,000 residents). between the states treated during the previous period.

Third, we used Taylor series linearization to determine the 95% cis and performed permutation tests because synthetic control methods do not produce traditional measures of uncertainty.27,28 Permutation tests were performed by reassigning the treatment to each synthetic control state one by one. , rerunning our synthetic control models and estimating placebo effect sizes. if the observed effect sizes in the treated states exceed the placebo effect sizes in the synthetic control states during the permutation tests, this further indicates that our results are unlikely to have occurred by chance. the number of permutation tests varied by state; individual permutation tests that failed to achieve an adequate match during the previous period were eliminated when calculating the results. specifically, states were removed from the permutation tests if the mean square error between the treated state and its synthetic control was greater than 1. any limit on the mean square error is, by definition, arbitrary; therefore, we also tested thresholds of 0.5 and 1.5 and achieved similar results. note that, unlike traditional regression analyses, cis are not usually symmetric about the point estimate. we then used a two-sided t test to determine whether the observed effects in the treated states exceeded the placebo effects in the control states at the α = .05 level of significance. if so, this provided further support that the results were unlikely to have occurred by chance.

In addition, we created overall estimates of the association of exclusions with HCV prescription fills, achieved by weighting individual statewide results by their median Medicaid enrollment totals over the subsequent 2-year period. analyzes were performed with version 4.0.2 of r (r project for statistical computing), with synthetic control models estimated with the microsynth version package. Data analysis was performed between November 2020 and June 2021. Additional details are available in the methods in the supplement.

one state (new hampshire) removed coverage of direct-acting hcv antiviral drugs from mco prescription drug benefits in 2016, then reinstated these drugs during 2019. this situation allowed us to estimate changes in use of HCV drugs in a single state that went from treated (excluded) to untreated (excluded) during the study period. if our effect estimate is in the opposite direction to that found in the exclusion analyses, it lends more credibility to our results.

all states that gained hcv drug coverage enrolled the majority of medicaid enrollees in managed care plans during the study period. Before HCV drug coverage was established, 61% of members in Illinois, 66% of members in New Hampshire, 50% of members in Michigan, and 71% of members in West Virginia were enrolled in Medicaid managed care plans.24 Trends in HCV Medication use was generally stable in treated states and was very similar to those in synthetic control states before exclusions (figure). Hepatic and sobriety restrictions remained constant in all treated states during the 2-year period after the opt-out policies were adopted, except for New Hampshire, which removed both restrictions when it removed HCV medications from MCO coverage. . the incidence of acute hcv infections and hcv mortality rates remained relatively stable among states treated during the previous period (figure 1 in the supplement). Estimated differences in usage between each treated state and its synthetic control state are presented in the table, and HCV prescription fill trends across the treated states and their respective synthetic control states are presented in the figure.

HCV medication exclusions were associated with 22.1 additional quarterly prescription fills per 100,000 Medicaid enrollees in the 2 years following exclusions (95% CI, 12.7-34.1) , a relative increase of 86.3% (95% CI, 49.6%-133.2%). state-by-state estimates are provided below.

In the year prior to exclusion, the mean (sd) rate of hcv prescription fills in indiana was 26.5 (3.8) per 100,000 medicaid enrollees per quarter. the mean (sd) rate of hcv prescription fills increased to 43.6 (5.9) per 100,000 in the post-exclusion period. We estimated that exclusion was associated with an additional 11.5 (95% CI, 5.1-19.0) additional HCVs per 100,000 Medicaid enrollees compared with synthetic indiana, a relative increase of 35.7% (95% CI, 5.1-19.0). 95%, 15.9%-59.0%). ). however, findings of similar magnitude were observed in a small number of permutation tests (3 of 25 tests; p = .15).

In the year prior to exclusion, the mean (sd) rate of hcv prescription fills in michigan was 1.6 (0.6) per 100,000 medicaid enrollees per quarter. this increased to a mean (sd) of 53.0 (8.1) hcv prescriptions filled per 100,000 in the post-exclusion period. We estimated that exclusion was associated with 36.6 (95% CI, 23.5-53.9) additional HCV prescriptions per 100,000 Medicaid enrollees, a relative increase of 221.6% (95% CI, 142.2%-327.0%) compared to michigan synthetic medicine. no findings of similar magnitude were observed in permutation tests (0 of 28 tests; p = .03).

in new hampshire, the mean (sd) rate of hcv prescription fills per quarter was 16.0 (3.4) per 100,000 medicaid enrollees before exclusion, which increased to 60.6 ( 20.9) in the post-exclusion period. synthetic results from new hampshire suggest that exclusions were associated with 43.6 (95% CI, 25.9-68.4) additional hcv prescriptions per 100,000 medicaid enrollees, a relative increase of 256.2% (95% ci, 152.5%-402.4%). no findings of similar magnitude were observed in permutation tests (0 of 34 tests; p = .03).

the mean (sd) rate in west virginia of hcv prescription fills during the prior period was 30.3 (2.1) per 100,000 medicaid enrollees, which changed to 45.7 (18.0 ) refills of hcv prescriptions after the carve-out period. Exclusion was associated with 20.7 (95% CI, 11.1-32.8) additional quarterly HCV prescriptions per 100,000 Medicaid enrollees, a relative increase of 82.8% (95% CI, 44.5%-131.3%) compared to synthetic West Virginia. findings of similar magnitude were observed in a small number of permutation trials (3 of 32 trials; p = .12).

Synthetic control results show that hcv drug addition in new hampshire was associated with a decrease in hcv prescription fill rate compared to its synthetic control state (−22.0; ci 95%, -31.4 to -6.5), a relative percentage decrease of 30.7% (95% CI, -46.8% to -9.7%). no findings of similar magnitude were observed in permutation tests (0 of 22 tests; p = .045).

direct-acting hcv antiviral drug exclusions from medicaid mco drug coverage were associated with increased use of these drugs, which can lead to better health and quality of life for medicaid members with vhc. although states have largely transitioned from medicaid to mcos to reduce their financial risk and gain budget predictability, it is important to ensure that the transition from ffs to mco coverage does not diminish access to highly effective treatments but expensive. Because insurance churn frequently occurs among Medicaid enrollees, and MCOS assume the full financial risk for providing covered services, they are encouraged to limit their use of high-cost services, even if these treatments are high-cost. long-term value.35 We found evidence of this in the 4 states that changed from carved to carved status for HCV medications during our study period, with HCV prescriptions increasing from 35.7% (Indiana) to 256.2% (new hampshire) compared to their respective synthetic control states. Although permutation tests indicate that our results for Michigan and New Hampshire are unlikely to have occurred by chance, findings of similar magnitude were seen in some permutation tests for Indiana and West Virginia (Figure 2 in the Supplement). Differences in HCV drug use between treated states and synthetic control states also appeared to shrink over time, which may reflect a pent-up demand for HCV treatment that was not met by built-in benefits. Additionally, differences in contractual arrangements between MCOS and states may moderate the association between exceptions and usage. For example, mco contracts may limit medical profit and loss rates to specific parameters, which can determine the degree of financial risk mco’s face in covering high-cost medications.

thus, high-cost drug exclusions may represent an important strategy for states to increase access to these drugs, especially when combined with other approaches. Under a capitated payment model, Medicaid MCOS face financial risk in providing health care coverage to their enrollees and have a limited set of strategies to mitigate this risk.10 Alternative coverage policies may allow Medicaid MCOS to increase access to high-cost medicines. Co-payments, co-payments made by the state to cover specific services,16 can allow MCOs to reduce access restrictions by transferring the financial risk of covering HCV treatment back to the state. Although kick payments are most commonly used for maternity-related services, they have also been implemented for high-cost medications.16,36

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another strategy to reduce the restrictions imposed by medicaid mcos is for states to regulate and enforce coverage parity between mco and ffs plans.20 although several states require drug coverage parity between ffs and mco, many states allow mcos to impose more stringent clinical criteria or prior authorization requirements for access to HCV medications.20 Since 2014, 6 states have adopted uniform preferred drug formularies, which require that the same medications be covered without needing of obtaining prior authorization for people enrolled in Medicaid managed care and ffs.16 drug formularies can improve access to prescription drugs by standardizing the drugs MCO plans must cover to a state benchmark. Other strategies to enforce parity in drug coverage include policies that require MCOS to impose no more restrictive criteria for accessing prescription drugs than those imposed by Medicaid FFS.16 Many states that use MCOS to provide coverage have either implemented or plan to implement policies that encourage parity in drug coverage, but no research has evaluated how these policies affect access to prescription drugs.

Innovative payment models for high-cost medicines can offer a population health-focused solution that lowers prescription costs and increases access. Subscription-based payment models, in which states negotiate reduced prices with a single drug manufacturer in exchange for exclusive inclusion on drug formularies, can reduce per prescription spending and increase access.37 louisiana and Washington adopted subscription-based payment models for HCV medications in 2019. Prescription fills for HCV increased substantially in Louisiana, but did not change in Washington after the implementation of subscription-based payment models.38 As of To date, no research has evaluated the effect of subscription-based payment models on HCV drug spending.

Timely HCV treatment is critical to reducing the burden of HCV-related morbidity and mortality.3 Although short-term treatment costs are high, reductions in HCV-associated negative health outcomes may result in considerable long-term cost savings. term.2 furthermore, by restricting access to curative hcv treatment, mcos may be worsening long-term health outcomes among people with hcv.

This study has limitations. First, the suppression of Medicaid-covered HCV prescriptions in predominantly rural states may limit the generalizability of our results. however, we were able to achieve an acceptable match in preperiod results between our treated states and their respective synthetic control states. Second, state Medicaid drug utilization data does not include prescriptions funded under the 340b program, and our results may not generalize to prescriptions funded under this mechanism. Third, our data do not allow us to elucidate the potential mechanisms underlying the differential changes after exclusions in the treated states. For example, differences in HCV prevalence could affect demand for HCV medications at the state level. these data were not available; however, we found no evidence of differential trends prior to the period between treated and synthetic control states for which data on incidence or mortality of HCV infection were available. Fourth, we cannot unravel the removal of access restrictions and HCV medication exclusions, which occurred concomitantly in New Hampshire. In addition, the observational nature of our study design limits causal conclusions regarding the effects of OC exclusions on the use of HCV direct-acting antiviral medications.

In this cross-sectional study, exclusions of direct-acting HCV antiviral medications from Medicaid MCO coverage were associated with increased use of these medications. Medicaid MCOS may limit the use of life-saving HCV medications, which could negatively affect the health of Medicaid members with HCV. States and MCOS should explore alternative strategies to limit spending on high-cost medications while ensuring widespread access. As states implement policies that attempt to limit Medicaid spending on prescription drugs, lawmakers must consider potential unintended consequences for access.

Accepted for publication: June 28, 2021.

Published: August 27, 2021. doi:10.1001/jamahealthforum.2021.2285

open access: This is an open access article distributed under the terms of the cc-by license. © 2021 auty sg et al. jama health forum.

corresponding author: samantha g. auty, ms, department of health law, policy and management, boston university school of public health, 715 albany st, talbot bldg, boston, ma 02118 (sgauty@bu.edu).

Authors’ contributions: ms auty and dr griffith had full access to all study data and took responsibility for the completeness and accuracy of the data analysis.

concept and design: auty, shafer, griffith.

data acquisition, analysis or interpretation: all authors.

manuscript writing:auty, griffith.

critical review of the manuscript for important intellectual content: all authors.

statistical analysis: auty, griffith.

administrative, technical or material support: dusetzina.

supervision: shafer, griffith.

Conflict of Interest Disclosures: ms auty receives separate support from the national institute on drug abuse (t32-da041898-03) and dr griffith receives separate support from the agency for research and the quality of medical care (k12 -hs026395). The doctor. Shafer reported receiving research support for unrelated work from the Robert Wood Johnson Foundation, the Commonwealth Fund, Renova Health, and the Department of Veterans Affairs (through a contract with the Boston University School of Public Health), and who served as a consultant for the financing of non-related work alternatives patients. dr dusetzina reported grants from the robert wood johnson foundation, leukemia grants & lymphoma society, arnold ventures grants, west health personal fees, national academy of state health policy personal fees, and icer personal fees outside of featured work. no other disclosures were reported.

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