Treatment Delays Associated With Prior Authorization for Infusible Medications: A Cohort Study.
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ABSTRACT: Objective
Prior authorizations (PAs) are commonly used by health payers as cost-containment strategies for expensive medications, including infused biologics. There is scarce data about the effect of PA requirements on patient-oriented outcomes.Methods
We included patients for whom an infusible medication was prescribed for a rheumatologic condition. The exposures of interest were a PA requirement and whether or not the PA was denied. The primary outcome was the difference in days from medication request to infusion. Secondary outcomes included the proportion of denied PAs and differences in glucocorticoid exposure following a PA request.Results
Of the 225 patients, the infusible medications of 160 (71%) required a PA. PAs were associated with a greater number of days to infusion compared to cases in which no authorization was required (median 31 days [interquartile range (IQR) 15-60 days] versus median 27 days [IQR 13-41 days]; P = 0.045), especially among the 33 patients (21%) whose PA was denied initially (median 50 days [IQR 31-76 days] versus median 27 days [IQR 13-41 days]; P < 0.001). PA denials were associated with greater prednisone-equivalent glucocorticoid exposure in the 3 months following the request than when a PA was not required (median 605 mg [IQR 0-1,575] versus median 160 mg [IQR 0-675]; P = 0.01). Twenty-seven of the 33 PA requests that were initially denied (82%) were eventually approved. Thus, 96% of all PAs were ultimately approved.Conclusion
PA requirements are associated with treatment delays and denials are associated with greater glucocorticoid exposure. Because the great majority of PA requests are ultimately approved, the value of PA requirements and their impact on patient safety should be reevaluated.
SUBMITTER: Wallace ZS
PROVIDER: S-EPMC7062557 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundDelays in advancing to biologic therapies are associated with adverse outcomes in inflammatory bowel disease (IBD). Insurer-mandated prior authorizations have been linked to prolonged medication initiation times. We hypothesized that prior authorizations are associated with prolonged biologic initiation time and increased IBD-related healthcare utilization among children with IBD.MethodsWe performed a retrospective cohort study of 190 pediatric patients with IBD initiating biologics at a tertiary care hospital to measure the association between prior authorization, biologic initiation time (physician recommendation to first dose), and healthcare utilization (hospitalization, surgery, or emergency department visit). Demographic, insurance, and disease severity-related covariables were collected. Multivariable linear regression was used to measure the association between prior authorization and biologic initiation time. Propensity score methods were used to measure the associations between prior authorization and IBD-related healthcare utilization within 180 days and corticosteroid dependence at 90 days, with adjustment for insurance type, demographics, and disease severity-related characteristics.ResultsMedian biologic initiation time was 21 days. Prior authorization and complicated prior authorizations (requiring appeal, step therapy, or peer-to-peer review) were associated with 10.2-day (95% confidence interval [CI] 8.2 to 12.3) and 24.6-day (95% CI 16.4 to 32.8) increases in biologic initiation time, respectively. Prior authorizations increased the likelihood of IBD-related healthcare utilization within 180 days by 12.9% (95% CI 2.5 to 23.4) and corticosteroid dependence at 90 days by 14.1% (95% CI 3.3 to 24.8).ConclusionsPrior authorizations are associated with prolonged biologic initiation time and increased IBD-related healthcare utilization. Minimizing prior authorization-related delays may expedite biologic delivery and reduce the risk of IBD-related healthcare utilization.
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Project description:Research objectiveMedications for opioid use disorder (MOUDs) - including methadone, buprenorphine, and naltrexone - are the most effective treatments for opioid use disorder (OUD). Historically, insurers have required prior authorization for MOUD, but prior authorization is often reported as a key barrier to MOUD prescribing. Some states have passed laws prohibiting MOUD prior authorization requirements. We sought to identify the frequency of MOUD prior authorization prohibitions in state laws and to categorize types of prohibitions.MethodsWe searched for regulations and statutes present in all U.S. states and Washington DC between 2005 and 2019 using MOUD-related terms in Westlaw legal software. In qualitative software, we coded laws discussing MOUD prior authorization using template analysis - a mixed deductive/inductive approach. Finally, we used coded laws to identify frequencies of states with prior authorization prohibitions, including changes over time.ResultsNo states had laws prohibiting MOUD prior authorization between 2005 and 2015, with the first prohibition appearing in 2016. By 2019, fifteen states had MOUD prior authorization prohibitions. States varied significantly in their approach to prohibiting MOUD prior authorization. In 2019, it was more common for states to have MOUD prior authorization prohibitions applying to all insurers (n = 10 states) than to only Medicaid (n = 7 states) or only non-Medicaid insurers (n = 1 state). In 2019, general prior authorization prohibitions (n = 10 states) were more common than prohibitions only applicable to medications on the formulary, prohibitions only applicable to medications on the preferred drug list, prohibitions only applicable during the first 5 days of treatment, and prohibitions only applicable during the first 30 days of treatment.ConclusionsThe number of states with an MOUD prior authorization law prohibition increased in recent years. Such laws could help expand access to life-saving OUD treatments by making it easier for clinicians to prescribe MOUD.KEY MESSAGESNo states had MOUD prior authorization prohibitions between 2005 and 2015 in state statutes or regulations, and only one state had such a prohibition in 2016.By 2019, fifteen states had an MOUD prior authorization prohibition law.States varied significantly in their approach to prohibiting MOUD prior authorization, including with respect to the insurer type, duration of the prohibition, and applicable medication.
| S-EPMC9897778 | biostudies-literature
Project description:BackgroundMany patients with major depressive disorder (MDD) who begin antidepressant treatment discontinue use before for six months, the recommended minimum treatment length. This study sought to identify predictors of six-month antidepressant persistence including predictors utilizing patients' electronic prescription records.MethodsCommercially insured children (3-17 years) and adults (18-64 years) with MDD who initiated antidepressant treatment, 1/1/2003-2/28/2010, were assessed for six-month persistence (based on prescriptions' days supply, allowing a 30-day grace period). Antidepressant persistence prediction models were developed separately for children and adults. Two additional measures, days without medication between the first and second antidepressant fill (children and adults) and prior persistence on other medications (adults only), were added to the models, concordance (c) statistics were compared and risk reclassification evaluated.ResultsAmong children (n=8837 children) and adults (n=47,495) with MDD, six-month antidepressant persistence was low and varied by age (37%, 18-24 years to 52%, 3-12 and 50-64 years). Independent baseline predictors of persistence were identified, with model c-statistics: children=0.582, adults=0.584. Patients with more days without medication between fills were less likely to be persistent (10-30 vs. 0 days, children: RR=0.72, adults: RR=0.74), as were adults not previously persistent to other medications (RR=0.73).LimitationsThe definition of six-month persistence is dependent on correct days supply values and the grace period utilized; potential predictors were limited to measures available in claims data.ConclusionsSix-month antidepressant persistence was low and overall prediction of persistence was poor; however, days without medication between fills and prior persistence on other medications marginally improved the ability to predict antidepressant persistence.
| S-EPMC5033109 | 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:OBJECTIVES:The US opioid medication epidemic has resulted in serious health consequences for patients. Formulary management tools adopted by payers, specifically prior authorization (PA) policies, may lower the rates of opioid medication abuse and overdose. We compared rates of opioid abuse and overdose among enrollees in plans that varied in their use of PA from "High PA" (ie, required PA for 17 to 74 opioids), with "Low PA" (ie, required PA for 1 opioid), and "No PA" policies for opioid medications. STUDY DESIGN:Retrospective cohort study of patients initiating opioid treatment in Pennsylvania Medicaid from 2010 to 2012. METHODS:Generalized linear models with generalized estimating equations were employed to assess the relationships between the presence of PA policies and opioid medication abuse and overdose, as measured in Medicaid claims data, adjusting for demographics, comorbid health conditions, benzodiazepine/muscle relaxant use, and emergency department use. RESULTS:The study cohort included 297,634 enrollees with a total of 382,828 opioid treatment episodes. Compared with plans with No PA, enrollees in High PA (adjusted rate ratio [ARR], 0.89; 95% confidence interval [CI], 0.85-0.93; P <.001) and Low PA plans (ARR, 0.93; 95% CI, 0.87-1.00; P = .04) had lower rates of abuse. Enrollees in the Low PA plan had a lower rate of overdose than those within plans with No PA (ARR, 0.75; 95% CI, 0.59-0.95; P = .02). High PA plan enrollees were also less likely than No PA enrollees to experience an overdose, but this association was not statistically significant (ARR, 0.88; 95% CI, 0.76-1.02; P = .08). CONCLUSIONS:Enrollees within Medicaid plans that utilize PA policies appear to have lower rates of abuse and overdose following initiation of opioid medication treatment.
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Project description:ImportancePrior authorization (PA) requires clinicians and patients to navigate a complex approval pathway. Resultant delays and denials can be particularly problematic for patients with cancer, who often need urgent treatment or symptom management.ObjectiveTo investigate the patient perspective of PA for cancer-related care, including perceptions about the process, outcomes (including delays and denials), and patient administrative burden.Design, setting, and participantsThis cross-sectional, anonymous survey used a convenience sample of patients with PA experience. Participants were recruited using social media and email lists of US-based cancer advocacy organizations from July 1 to October 6, 2022.ExposurePrior authorization for any cancer-related service.Main outcomes and measuresDelays to care, outcome of PA, communication, and changes in anxiety (measured on a scale of 0-100, with 0 indicating no anxiety and higher scores indicating higher levels of anxiety) and trust.ResultsOf 178 respondents (158 women [88%], 151 non-Hispanic White respondents [84%], 164 respondents [92%] <65 years), 112 (63%) reported that their cancer care was approved and given as recommended, and 39 (22%) did not receive recommended care due to delays or denials. Most respondents (123 [69%]) reported a PA-related delay in care; of those with delayed care, 90 (73%) reported a delay of 2 or more weeks. Most respondents (119 [67%]) had to personally become involved in the PA process; 35 (20%) spent 11 or more hours dealing with PA issues. Overall, the PA experience was rated as bad (70 [40%]) or horrible (55 of 174 [32%]); ratings were associated with the length of delay (ρ = 0.36; P < .001) and the time spent on PA (ρ = 0.42; P < .001). Self-reported PA-related anxiety was higher than usual anxiety (mean [SD] score, 74.7 [20.2] vs 37.5 [22.6]; P < .001) and was correlated with delay length (ρ = 0.16; P = .04), time spent on PA (ρ = 0.27; P < .001), and overall PA experience (ρ = 0.34; P < .001). After PA, 159 respondents (89%) trusted their insurance company less, and 148 respondents (83%) trusted the health care system less. Patient involvement in the PA process was associated with increased odds of distrusting their insurance company (β = 6.0; 95% CI, 1.9-19.2) and the health care system (β = 3.3; 95% CI, 1.4-8.1) and of having a negative experience (β = 6.6; 95% CI, 3.1-14.3).Conclusions and relevanceThis survey-based cross-sectional study of the patient experience with PA highlights an adverse outcome of PA: 22% of patients did not receive the care recommended by their treatment team because of PA. Most respondents experienced a delay in recommended oncology care, and delays were associated with increased anxiety, a negative perception of the PA process, and patient administrative burden.
| S-EPMC10585404 | biostudies-literature
Project description:ImportanceSome Medicare-reimbursed services are overused or improperly used, resulting in payments for unnecessary services.ObjectiveTo determine if prior authorization of services vulnerable to improper use is associated with reduced use and costs without changing patient access or health outcomes.Design setting and participantsThis study involved repeated cross-sectional evaluation with a state-level matched control group construction and inverse propensity score weighting at the Medicare beneficiary level. Eight states plus the District of Columbia requiring prior authorization were compared with 13 matched comparison group states not subject to prior authorization. Observations on approximately 1.7 million Medicare beneficiaries spanned January 2012 through December 2019. Depending on their state of residence, this included 3 or 4 preintervention years and 4 or 5 postintervention years. Data analysis was performed from September 2020 to July 2021.InterventionAmbulance suppliers were directed to request prior authorization for Repetitive, Scheduled, Non-Emergent Ambulance Transport (RSNAT) services; failure to do so resulted in prepayment claim review. The goal of prior authorization is to reduce use of nonemergency ambulance transports that do not meet Medicare coverage criteria.Main outcomes and measuresPrimary outcomes included total cost of care, RSNAT use rates and expenditures, unplanned hospital admission, emergency department admission, and emergency ambulance use per beneficiary-year. All measures were constructed from Medicare claims.ResultsApproximately 1.7 million Medicare beneficiaries were observed in the study (mean [SD] age, 71 [15] years; 50% female beneficiaries; 30% Black beneficiaries, 64% White beneficiaries; 20% rural residence; 35% dually eligible for Medicare and Medicaid; 58% with end-stage renal disease; and 44% with severe [stage 3 or 4] pressure ulcers). After controlling for covariates, the results showed that prior authorization was associated with a 2.4% reduction in total annual expenditures for a total of $1530 per beneficiary-year (95% CI, -$1775 to -$1285; P < .001); a 61% reduction in the probability of RSNAT use for a total of 4.1 percentage points per beneficiary-year (95% CI, -4.26 to -3.94; P < .001); a 77% reduction in RSNAT expenditures for a total of $1136 per beneficiary-year (95% CI, -$1179 to -$1093; P < .001); a 1.4% reduction in the probability of emergency department use by 0.99 percentage points per beneficiary-year (95% CI, -1.17 to -0.81; P < .001); no change in the probability of emergency ambulance use (0.07 percentage points, 95% CI, -0.15 to 0.29; P = .50); a 2.6% reduction in the probability of unplanned hospital admission for a total of 1.53 percentage points per beneficiary-year (95% CI, -1.71 to -1.35; P < .001); and a 19% annual increase in the probability of emergency dialysis use for a total of 1.4 percentage points per beneficiary with end-stage renal disease (95% CI, 1.28 to 1.60; P < .001).Conclusions and relevanceIn this difference-in-differences analysis of Medicare beneficiaries, the results suggest that the RSNAT Prior Authorization Model was associated with reduced costs with little or no change in the quality or access indicators examined. Targeted approaches to prior authorization may be an appropriate control measure for Medicare services vulnerable to improper use.
| S-EPMC9287758 | biostudies-literature
Project description:Several highly effective but costly therapies for hepatitis C virus (HCV) are available. As a consequence of their high price, 36 state Medicaid programs limited treatment coverage to patients with more advanced HCV stages. States have only limited information available to predict the long-term impact of these decisions.We adapted a validated hepatitis C microsimulation model to the Pennsylvania Medicaid population to estimate the existing HCV prevalence in Pennsylvania Medicaid and estimate the impact of various HCV drug coverage policies on disease outcomes and costs. Outcome measures included rates of advanced-stage HCV outcomes and treatment and disease costs in both Medicaid and Medicare.We estimated that 46,700 individuals in Pennsylvania Medicaid were infected with HCV in 2015, 33% of whom were still undiagnosed. By expanding treatment to include mild fibrosis stage (Metavir F2), Pennsylvania Medicaid will spend an additional $273 million on medications in the next decade with no substantial reduction in the incidence of liver cancer or liver-related death. Medicaid patients who are not eligible for treatment under restricted policies would get treatment once they transition to the Medicare program, which would incur 10% reduction in HCV-related costs due to early treatment in Medicaid. Further expanding treatment to patients with early fibrosis stages (F0 or F1) would cost Medicaid an additional $693 million during the next decade but would reduce the number of individuals in need of treatment in Medicare by 46% and decrease Medicare treatment costs by 23%. In some scenarios, outcomes could worsen with eligibility expansion if there is inadequate capacity to treat all patients.Expansion of HCV treatment coverage to less severe stages of liver disease may not substantially improve liver related outcomes for patients in Pennsylvania Medicaid in scenarios in which coverage through Medicare is widely available.
| S-EPMC5459672 | 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:While prior authorization aims to reduce unnecessary care, it may limit or delay medically necessary care. Delays in cancer care can impact survival and are more common in historically-marginalized populations. Our objective was to examine to what extent disparities occurred in prior authorizations for gynecologic oncology. Using electronic medical records, we performed a retrospective review of prior authorization occurrence during gynecologic oncology care and analyzed the association with patient race and insurance in a multivariate regression model. In this cohort of 1,406 patients treated at an academic gynecologic oncology practice, patients with Medicare Advantage and patients of Asian descent were more likely to experience prior authorization. Addressing insurance-mediate disparities, such as in the occurrence of prior authorization, may help reduce disparities in gynecologic cancer care.
| S-EPMC10024078 | biostudies-literature