Trends in Buprenorphine Coverage and Prior Authorization Requirements in US Commercial Formularies, 2017-2021.
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SUBMITTER: Nguyen TD
PROVIDER: S-EPMC9270692 | biostudies-literature | 2022 Jul
REPOSITORIES: biostudies-literature
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Trends in Buprenorphine Coverage and Prior Authorization Requirements in US Commercial Formularies, 2017-2021.
Nguyen Thuy D TD Chua Kao-Ping KP Andraka-Christou Barbara B Bradford W David WD Simon Kosali K
JAMA health forum 20220708 7
This cross-sectional study assesses buprenorphine coverage and prior authorization requirements in US commercial formulary data from 2017 to 2021. ...[more]
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Project description:ImportancePrior authorization (PA) requirements for buprenorphine are associated with lower provision of the medication for the treatment of opioid use disorder (OUD). While Medicare plans have eliminated PA requirements for buprenorphine, many Medicaid plans continue to require them.ObjectiveTo describe and classify buprenorphine coverage requirements based on thematic analysis of state Medicaid PA forms.Design, setting, and participantsThis qualitative study used a thematic analysis of 50 states' Medicaid PA forms for buprenorphine between November 2020 and March 2021. Forms were obtained from the jurisdiction's Medicaid websites and assessed for features suggesting barriers to buprenorphine access. A coding tool was developed based on a review of a sample of forms, including fields for behavioral health treatment recommendations or mandates, drug screening requirements, and dosage limitations.Main outcomes and measuresOutcomes included PA requirements for different buprenorphine formulations. Additionally, PA forms were evaluated for various criteria such as behavioral health, drug screenings, dose-related recommendations or mandates or patient education.ResultsAmong the total of 50 US states in the analysis, most states' Medicaid plans required PA for at least 1 formulation of buprenorphine. However, the majority did not require a PA for buprenorphine-naloxone. Four key themes of coverage requirements were identified: restrictive surveillance (eg, requirements for urine drug screenings, random drug screenings, pill counts), behavioral health treatment recommendations or mandates (eg, mandatory counseling or 12-step meeting attendance), interfering with or restricting medical decision-making (eg, maximum daily dosages of 16 mg, requiring additional steps for dosages higher than 16 mg), and patient education (eg, information about adverse effects and interactions with other medications). Eleven states (22%) required urine drug screenings, 6 states (12%) required random urine drug screenings, and 4 states (8%) required pill counts. Fourteen states' forms (28%) recommended therapy, and 7 (14%) required therapy, counseling, or participation in group sessions. Eighteen states (36%) specified dosage maximums; among them, 11 (22%) required additional steps for a daily dosage higher than 16 mg.ConclusionIn this qualitative study of state Medicaid PA requirements for buprenorphine, themes were identified that included patient surveillance with drug screenings and pill counts, behavioral health treatment recommendations or mandates, patient education, and dosing guidance. These results suggest that state Medicaid plans' buprenorphine PA requirements for OUD are in conflict with existing evidence and may negatively affect states' efforts to address the opioid overdose crisis.
| S-EPMC10273019 | biostudies-literature
Project description:ImportanceBuprenorphine treatment for opioid use disorder (OUD) is associated with decreased morbidity and mortality. Despite its effectiveness, buprenorphine uptake has been limited relative to the burden of OUD. Prior authorization (PA) policies may present a barrier to treatment, though research is limited, particularly in Medicaid populations.ObjectiveTo assess whether removal of Medicaid PAs for buprenorphine to treat OUD is associated with changes in buprenorphine prescriptions for Medicaid enrollees.Design, setting, and participantsThis state-level, serial cross-sectional study used quarterly data from 2015 through the first quarter (January-March) of 2019 to compare buprenorphine prescriptions in states that did and did not remove Medicaid PAs. Analyses were conducted between June 10, 2021, and August 15, 2023. The study included 23 states with active Medicaid PAs for buprenorphine in 2015 that required similar PA policies in fee-for-service and managed care plans and had at least 2 quarters of pre- and postperiod buprenorphine prescribing data.ExposuresRemoval of Medicaid PA for at least 1 formulation of buprenorphine for OUD.Main outcomes and measuresThe main outcome was number of quarterly buprenorphine prescriptions per 1000 Medicaid enrollees.ResultsBetween 2015 and the first quarter of 2019, 6 states in the sample removed Medicaid PAs for at least 1 formulation of buprenorphine and had at least 2 quarters of pre- and postpolicy change data. Seventeen states maintained buprenorphine PAs throughout the study period. At baseline, relative to states that repealed PAs, states that maintained PAs had lower buprenorphine prescribing per 1000 Medicaid enrollees (median, 6.6 [IQR, 2.6-13.9] vs 24.1 [IQR, 8.7-27.5] prescriptions) and lower Medicaid managed care penetration (median, 38.5% [IQR, 0.0%-74.1%] vs 79.5% [IQR, 78.1%-83.5%] of enrollees) but similar opioid overdose rates and X-waivered buprenorphine clinicians per 100 000 population. In fully adjusted difference-in-differences models, removal of Medicaid PAs for buprenorphine was not associated with buprenorphine prescribing (1.4% decrease; 95% CI, -31.2% to 41.4%). For states with below-median baseline buprenorphine prescribing, PA removal was associated with increased buprenorphine prescriptions per 1000 Medicaid enrollees (40.1%; 95% CI, 0.6% to 95.1%), while states with above-median prescribing showed no change (-20.7%; 95% CI, -41.0% to 6.6%).Conclusions and relevanceIn this serial cross-sectional study of Medicaid PA policies for buprenorphine for OUD, removal of PAs was not associated with overall changes in buprenorphine prescribing among Medicaid enrollees. Given the ongoing burden of opioid overdoses, continued multipronged efforts are needed to remove barriers to buprenorphine care and increase availability of this lifesaving treatment.
| S-EPMC10589810 | biostudies-literature
Project description:ImportanceHIV preexposure prophylaxis (PrEP) is a key component of the Ending the HIV Epidemic (EHE) Initiative to curb new HIV diagnoses. In October 2019, emtricitabine/tenofovir alafenamide was added as an approved formulation for PrEP in addition to emtricitabine/tenofovir disoproxil fumarate; despite availability of another formulation with a similar prevention indication, variations in coverage may limit access.ObjectiveTo assess qualified health plan (QHP) coverage, prior authorization (PA) requirements, and specialty tiering for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide following emtricitabine/tenofovir alafenamide approval as a PrEP treatment.Design, setting, and participantsThis cross-sectional study analyzed QHPs in the US that were compliant with the Patient Protection and Affordable Care Act from 2018 to 2020. QHPs were categorized by region and EHE priority jurisdictions. Data analysis occurred from March 2022 to March 2023.ExposuresEnrollment in a qualified health plan certified by the Patient Protection and Affordable Care Act.Main outcome and measuresAnnual variation in QHP coverage and PA requirement for emtricitabine/tenofovir disoproxil fumarate and/or emtricitabine/tenofovir alafenamide. Descriptive statistics were reported for all outcomes. A secondary outcome was whether the PrEP formulation was determined by the QHP to be placed on a specialty drug tier.ResultsA total of 58 087 QHPs (19 533 for 2018; 17 007 for 2019; and 21 547 for 2020) were analyzed. QHPs covered emtricitabine/tenofovir disoproxil fumarate (19 165 QHPs [98.1%] in 2018; 16 970 QHPs [99.8%] in 2019; 20 045 QHPs [94.8%] in 2020) at a higher rate than emtricitabine/tenofovir alafenamide (17 391 QHPs [91.9%] in 2018; 15 757 QHPs [92.7%] in 2019; 18 836 QHPs [87.4%] in 2020). QHPs in the South required exclusive PA (ie, PA for 1 of the formulations even if the QHP covered both) for emtricitabine/tenofovir disoproxil fumarate and emtricitabine/tenofovir alafenamide at the highest rates in all 3 years. In the South, the rate of PA for emtricitabine/tenofovir disoproxil fumarate increased from 806 of 8023 QHPs (10.0%) in 2018 to 3466 of 7401 QHPs (46.8%) in 2020. QHPs with exclusive PA requirement for emtricitabine/tenofovir disoproxil fumarate were higher in EHE jurisdictions than non-EHE jurisdictions (difference: 2018, 0.9 percentage points; 2019, 3.5 percentage points; 2020, 29.1 percentage points). QHPs were more likely to place emtricitabine/tenofovir disoproxil fumarate on a specialty tier compared with emtricitabine/tenofovir alafenamide (difference: 2018, 1.8 percentage points; 2019, 3.7 percentage points; 2020, 4.1 percentage points).Conclusions and relevanceIn this cross-sectional study, despite similar indications for biomedical prevention, QHPs were more likely to cover emtricitabine/tenofovir disoproxil fumarate than emtricitabine/tenofovir alafenamide, and QHPs were also more likely to subject emtricitabine/tenofovir disoproxil fumarate to PA or place it on a specialty tier despite the broader clinical indication. QHP PA requirements of emtricitabine/tenofovir disoproxil fumarate following emtricitabine/tenofovir alafenamide approval does not reflect clinical guidelines. The requirements could reflect differences in clinical indication, manufacturer discounts, or anticipation of a changing regulations and emerging generics. High rates of exclusive PA for emtricitabine/tenofovir disoproxil fumarate in areas where rates of HIV diagnoses are highest and PrEP is most needed (eg, the South and EHE priority jurisdictions) is concerning; policy solutions to address the growing PrEP health equity crisis could include regulator actions and a national PrEP program.
| S-EPMC10638648 | biostudies-literature
Project description:ObjectivesPrior authorization (PA) aims to promote the safe and effective use of medications and to control costs. However, PA-related administrative tasks can contribute to burden on health care providers. This study examines how such tasks affect treatment decisions.Study designCross-sectional, online survey.MethodsWe conducted an online survey of US medical providers in 2020 based on a convenience sample of 100,000 providers. Multivariate path analysis was used to examine associations among provider practice characteristics, step therapy and other health plan requirements, perceived burdens of PA, communication issues with insurers, and prescribing behaviors (prescribing a different medication than planned, avoiding prescribing of newer medications even if evidence-based guideline recommendations are met, and modifying a diagnosis). Weighted analyses were conducted to assess nonresponse bias.ResultsA total of 1173 respondents (1.2% response rate) provided 1147 usable surveys. Step therapy requirements had the largest effect on clinical decision-making. Other significant effects on clinical decision-making included perceived PA likelihood, communication issues, and health plan requirements (eg, clinical documentation). Weighted analyses showed that the study conclusions were unlikely to have been biased by nonresponse.ConclusionsRespondents report that they may alter clinical decisions to avoid PA requirements and related burdens, even in cases in which use of the PA medication was clinically appropriate. Processes that reduce the administrative burden of PA through improved communication and transparency as well as standardized documentation may help ensure that PA more seamlessly achieves its goals of safe and effective use of medications.
| S-EPMC10403277 | biostudies-literature
Project description:ImportanceState Medicaid programs have implemented initiatives to expand treatment coverage for opioid use disorder (OUD); however, some Medicaid programs still require prior authorizations (PAs) for filling buprenorphine prescriptions.ObjectiveTo evaluate the changes in buprenorphine use for OUD among Medicaid enrollees in states that completely removed buprenorphine PA requirements.Design setting and participantsThis retrospective cross-sectional study analyzed the immediate and trend changes on buprenorphine use during 2013 to 2020 associated with removal of PA requirements using a controlled interrupted time series analysis to account for autocorrelation. Data were collected from Medicaid State Drug Utilization Data for 2 states (California and Illinois) that completely removed a buprenorphine PA during the study period, and buprenorphine prescriptions for OUD treatment were identified among Medicaid enrollees.Main outcomes and measuresQuarterly total number of buprenorphine prescriptions for each state was calculated, and stratification analyses were conducted by dosage form (films and tablets).ResultsAmong the 2 state Medicaid programs (California and Illinois) that removed buprenorphine PAs, there was a total of 702 643 and 415 115 eligible buprenorphine prescription claims, respectively. After removing PA requirements for buprenorphine, there was an immediate increase that was not statistically significant (rate ratio [RR], 1.11; 95% CI, 0.76-1.61) in the number of all buprenorphine prescriptions in California and a statistically significant increase (RR, 6.99; 95% CI, 4.67-10.47) in the number of all buprenorphine prescriptions in Illinois relative to the change in the control states (Alabama, Florida, Idaho, Kansas, Mississippi, Nevada, South Dakota, and Wyoming). Additionally, there was a statistically significant decreasing trend in the number of all buprenorphine prescriptions in California (RR, 0.88; 95% CI, 0.82-0.94) and a statistically significant increasing trend in Illinois (RR, 1.11; 95% CI, 1.05-1.19) relative to the trend in control states.Conclusions and relevanceIn this cross-sectional study, removal of buprenorphine PA requirements was associated with a statistically significant increase in the number of buprenorphine prescription fills among Medicaid populations in 1 of the 2 included states.
| S-EPMC9233239 | biostudies-literature
Project description:IntroductionPrior authorizations (PAs) are intended to control prescription drug expenditures.MethodsOne hundred fifty-six physician and advanced practice provider members of the American College of Gastroenterology completed a national survey to assess PA burden and impact.ResultsOne-half of PA requests relate to prescription refills. Greater than 50% of the respondents choose inferior treatments at least weekly because of perceived PA burden for preferred agents. One-half of the respondents reported a patient who experienced serious adverse events due to PA-related care delays.DiscussionPA is an administrative burden that exhausts practice resources and may have a negative impact on patient care.
| S-EPMC9060934 | biostudies-literature
Project description:COVID-19 pandemic-related shifts in healthcare utilization, in combination with trends in non-COVID-19 disease transmission and non-pharmaceutical intervention use, had clear impacts on rates of hospitalization for infectious and chronic diseases. Using a U.S. national healthcare billing database, we estimated the monthly incidence rate ratio of hospitalizations between March 2020 and June 2021 according to 19 ICD-10 diagnostic chapters and 189 subchapters. The majority of primary diagnoses for hospitalization showed an immediate decline in incidence during March 2020. Hospitalizations for reproductive neoplasms, hypertension, and diabetes returned to pre-pandemic levels during late 2020 and early 2021, while others, like those for infectious respiratory disease, did not return to pre-pandemic levels during this period. Our assessment of subchapter-level primary hospitalization codes offers insight into trends among less frequent causes of hospitalization during the COVID-19 pandemic in the U.S. In this study, the authors investigate the impacts of the COVID-19 pandemic on healthcare utilisation in the US. They show that, following an immediate decline, hospitalisations for some conditions returned to pre-pandemic norms by the end of 2020, but for others, including respiratory conditions, this had not occurred by June 2021.
| S-EPMC9546751 | biostudies-literature
Project description:ObjectiveTo assess the impact of a 2008 dose-based prior authorization policy for Massachusetts Medicaid beneficiaries using buprenorphine + naloxone for opioid addiction treatment. Doses higher than 16 mg required progressively more frequent authorizations.Data sourcesMediciaid claims for 2007 and 2008 linked with Department of Public Health (DPH) service records.Study designWe conducted time series for all buprenorphine users and a longitudinal cohort analysis of 2,049 individuals who began buprenorphine treatment in 2007. Outcome measures included use of relapse-related services, health care expenditures per person, and buprenorphine expenditures.Data collection/extraction methodsWe used ICD-9 codes and National Drug Codes to identify individuals with opioid dependence who filled prescriptions for buprenorphine. Medicaid and DPH data were linked with individual identifiers.Principal findingsIndividuals using doses >24 mg decreased from 16.5 to 4.1 percent. Relapses increased temporarily for some users but returned to previous levels within 3 months. Buprenorphine expenditures decreased but total expenditures did not change significantly.ConclusionPrior authorization policies strategically targeted by dose level appear to successfully reduce use of higher than recommended buprenorphine doses. Savings from these policies are modest and may be accompanied by brief increases in relapse rates. Lower doses may decrease diversion of buprenorphine.
| S-EPMC4237648 | biostudies-literature
Project description:ImportancePrior authorization requirements may be a barrier to accessing medications for opioid use disorder treatment and may, therefore, be associated with poor health care outcomes.ObjectiveTo determine the association of prior authorization with use of buprenorphine-naloxone and health care outcomes.Design, setting, and participantsThis comparative interrupted time series analysis examined enrollment and insurance claims data from Medicare beneficiaries with an opioid use disorder diagnosis or who filled a prescription for an opioid use disorder medication between 2012 and 2017. Over this period, 775 874 members were in 1479 Part D plans that always required prior authorization, 113 286 members were in 206 plans that removed prior authorization, 189 461 members were in 489 plans that never required prior authorization, and 619 919 members were in 485 plans that added prior authorization. Data analysis was performed from April 2019 to February 2020.ExposuresRemoval or addition of prior authorization and new prescriptions filled for buprenorphine-naloxone.Main outcomes and measuresBuprenorphine-naloxone use, inpatient admissions, emergency department visits, and prescription drug and medical expenditures.ResultsThe study population in 2012 included 949 206 Medicare beneficiaries (mean [SD] age, 57 [15] years; 550 445 women [58%]). Removal of prior authorization was associated with an increase of 17.9 prescriptions (95% CI, 1.1 to 34.7 prescriptions) filled for buprenorphine-naloxone per plan per year, which is a doubling of the number of prescriptions, on average. Each prescription filled was associated with statistically significant decreases in adverse health care outcomes: substance use disorder-related inpatient admissions decreased by 0.1 admission per plan per year (95% CI, -0.2 to -0.1 admission per plan per year), and substance use disorder-related emergency department visits decreased by 0.1 visit per plan per year (95% CI, -0.13 to -0.03 visit per plan per year) (all P < .001). Combining these results, removal of prior authorization was associated with a reduction in substance use disorder-related inpatient admissions by 2.0 admissions per plan per year (95% CI, -4.3 to -0.1 admissions per plan per year) and substance use disorder-related emergency department visits by 1.4 visits per plan per year (95% CI, -3.2 to -0.1 visits per plan per year).Conclusions and relevanceRemoving prior authorization for buprenorphine-naloxone was associated with an increase in the medication use and decreases in health care utilization and expenditures.
| S-EPMC7171554 | biostudies-literature
Project description:COVID-19 pandemic-related shifts in healthcare utilization, in combination with trends in non-COVID-19 disease transmission and NPI use, had clear impacts on infectious and chronic disease hospitalization rates. Using a national healthcare billing database (C19RDB), we estimated the monthly incidence rate ratio of hospitalizations between March 2020 and June 2021 according to 19 ICD-10 diagnostic chapters and 189 subchapters. The majority of hospitalization causes showed an immediate decline in incidence during March 2020. Hospitalizations for diagnoses such as reproductive neoplasms, hypertension, and diabetes returned to pre-pandemic norms in incidence during late 2020 and early 2021, while others, like those for infectious respiratory disease, never returned to pre-pandemic norms. These results are crucial for contextualizing future research, particularly time series analyses, utilizing surveillance and hospitalization data for non-COVID-19 disease. Our assessment of subchapter level primary hospitalization codes offers new insight into trends among less frequent causes of hospitalization during the COVID-19 pandemic.
| S-EPMC9094108 | biostudies-literature