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Association of Formulary Exclusions and Restrictions for Opioid Alternatives With Opioid Prescribing Among Medicare Beneficiaries.

ABSTRACT: Importance:Although there are many pharmacologic alternatives to opioids, it is unclear whether the structure of Medicare Part D formularies discourages use of the alternatives. Objectives:To quantify the coverage of opioid alternatives and prevalence of prior authorization, step therapy, quantity limits, and tier placement for these drugs, and test whether these formulary exclusions and restrictions are associated with increased opioid prescribing to older adults at the county level. Design, Setting, and Participants:County fixed-effect models were estimated using a panel of counties across the 50 US states and the District of Columbia over calendar years 2015 and 2016. Data analysis was conducted from July 1 to September 23, 2019. The sample included 2721 counties in 2015 and 2671 counties in 2016 with sufficient data on Medicare Part D formulary design and opioid prescribing. Main Outcomes and Measures:County-level opioid prescribing rate (number of opioid claims divided by the number of overall claims) and counts of excluded opioid alternatives and opioid alternatives with prior authorization, step therapy, quantity limits, and high-tier placements. Results:A total of 30 nonopioid analgesics were examined across 28 997 Medicare plans in 2015 and 30 390 plans in 2016. Medicare plans did not cover a mean of 7% of these drugs (interquartile range, 10%; lower to upper limit, 0%-23%). Among covered nonopioids, prior authorization and step therapy were uncommon, with fewer than 5% affected by prior authorization and 0% by step therapy. However, 13% of covered nonopioids had quantity limits (interquartile range, 10%; lower to upper limit, 0%-31%) and 22% were in high-cost tiers (interquartile range, 38%; lower to upper limit, 0%-50%). Increases in the number of nonopioids excluded on Medicare plans in a county were associated with increased opioid prescribing (effect size relative to mean, 2.2%-3.7%; P = .004). Conversely, increases in the number of opioids not covered on Medicare plans in a county was found to be associated with decreased opioid prescribing (effect size relative to mean, 0.8%-1.5%; P = .02). None of the utilization management strategies (prior authorization, step therapy, and quantity limits) examined or high-cost tier placements of nonopioids were associated with increased opioid prescribing. Conclusions and Relevance:Lack of Medicare coverage for pharmacologic alternatives to opioids may be associated with increased opioid prescribing.

SUBMITTER: Rao T

PROVIDER: S-EPMC7052746 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Use of opioids during and shortly after an acute hospitalization is warranted in some clinical settings. However, given the potential of opioids for short-term adverse events and long-term physiologic tolerance, it is important to understand the frequency of opioid prescribing at hospital discharge, hospital variation, and patient and hospital factors associated with opioid prescribing, which is currently unknown in the United States.To estimate the frequency of opioid prescribing at hospital discharge among Medicare beneficiaries without an opioid prescription claim 60 days prior to hospitalization; to document hospital variation in prescribing; and to analyze patient and hospital factors associated with prescribing, including hospital average performance on pain-related Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) measures.Analysis of pharmacy claims of a 20% random sample of Medicare beneficiaries hospitalized in 2011 without an opioid prescription claim in the 60 days before hospitalization.Our main outcome was a new opioid claim within 7 days of hospital discharge. We estimated a multivariable linear probability model of patient factors associated with new opioid use and described hospital variation in adjusted rates of new opioid use. In multivariable linear regression analysis, we also analyzed hospital factors associated with average adjusted new opioid use at the hospital level, including the percentage of each hospital's patients who reported that their pain during hospitalization was always well controlled in the 2011 HCAHPS surveys.Among 623?957 hospitalizations, 92?882 (14.9%) were associated with a new opioid claim. Among those hospitalizations with an associated opioid claim within 7 days of hospital discharge, 32?731 (42.5%) of 77?092 were associated with an opioid claim after 90 days postdischarge. Across 2512 hospitals, the average adjusted rate of new opioid use within 7 days of hospitalization was 15.1% (interquartile range, 12.3%-17.4%; interdecile range, 10.5%-20.0%). A hospital's adjusted rate of new opioid use was modestly positively associated with the percentage of its inpatients reporting that their pain was always well managed (increase from 25th to the 75th percentile in the HCAHPS measure was associated with an absolute increase in new opioid use of 0.89 percentage points or a relative increase of 6.0%; P?<?.001).New opioid use after hospitalization is common among Medicare beneficiaries, with substantial variation across hospitals and a large proportion of patients using a prescription opioid 90 days after hospitalization. The degree to which observed hospital variation in short- and longer-term opioid use reflects variation in inappropriate prescribing at hospital discharge is unknown.

Project description:BackgroundBetween August 2016 and July 2018, three states classified gabapentin as a Schedule V drug and nine states implemented prescription drug monitoring program (PDMP) regulation for gabapentin. It is highly unusual for states to take drug regulation into their own hands. The impact of these changes on gabapentin prescribing is unclear.ObjectiveTo determine the effect of state-imposed regulation on gabapentin prescribing for Medicare Part D enrollees from 2013 to 2018.DesignPopulation-based difference-in-difference(DID) analysis study utilizing the Medicare Part D Prescriber Public Use File.ParticipantsAll eligible Medicare Part D prescribers excluding those outside of the fifty states and the District of Columbia were included in our analysis. Prescriber data and key sociodemographic variables were organized by state and year. States with a gabapentin schedule change or PDMP regulation enacted before 2019 were included in the intervention group. For the Schedule V DID analysis, a control group of the ten highest opioid-prescribing states was used.InterventionsStates with gabapentin schedule changes or PDMP regulation before January 1, 2019, were included and compared to control states that did not implement these policies.Main measuresTotal days' supply of gabapentin per enrollee per year was the primary outcome variable.Key resultsThe mean total days' supply of gabapentin per enrollee increased 41% from 19.71 to 27.81 total days' supply per enrollee per year between 2013 and 2018. After adjustment, Schedule V gabapentin regulation resulted in a reduction of 8.37 total days of gabapentin prescribed per enrollee (95% confidence interval of - 10.34 to - 6.39). In contrast, PDMP regulation resulted in a reduction of 1.01 total days of gabapentin prescribed per enrollee (95% confidence interval of - 1.74 to - 0.29).ConclusionsClassifying gabapentin as a Schedule V drug results in substantial reduction in total days prescribed whereas PDMP regulation results in modest reduction.

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.

Project description:ImportanceIn response to the opioid epidemic, policies aiming to reduce opioid prescribing, misuse, and abuse may have the unintended consequence of restricting access to necessary opioid therapy for cancer-related pain. It is unknown how opioid prescribing patterns have changed among generalists and oncologists during this era.ObjectiveTo examine trends in opioid prescription rates for Medicare Part D beneficiaries from 2013 to 2017 among oncologists and generalists.Design, setting, and participantsThis repeated cross-sectional study of generalist physicians (internal medicine, family medicine, geriatric medicine, general practice) and oncology specialists (medical oncology, hematology-oncology, and radiation oncology) analyzed the Medicare Provider Utilization and Payment Data: Part D prescriber files from 2013 to 2017.ExposuresGeneralist vs oncology specialty.Main outcomes and measuresOutcomes included physician-level rates of both opioid and long-acting opioid prescriptions per 100 Medicare Part D beneficiaries. Poisson regression was used to estimate annual predicted outcome rates and incidence rate ratios, adjusting for prescriber characteristics and state fixed effects.ResultsWe analyzed the prescribing patterns of 251 820 generalists and 14 210 oncologists. From 2013 to 2017, the annual adjusted predicted mean rate of opioid prescriptions per 100 Medicare beneficiaries decreased from 68.2 to 49.7 among generalists (adjusted incidence rate ratio [aIRR] = 0.73; 95% CI, 0.73-0.73) and from 77.8 to 58.8 among oncologists (aIRR = 0.76; 95% CI, 0.74-0.77). The rate of long-acting opioid prescriptions per 100 Medicare beneficiaries also decreased from 8.0 to 5.4 for generalists (aIRR = 0.67; 95% CI, 0.66-0.68) and from 18.6 to 13.3 for oncologists (aIRR = 0.72; 95% CI, 0.69-0.74).Conclusions and relevanceWe found large declines in opioid prescription rates for Medicare beneficiaries by generalists and oncologists from 2013 to 2017. Opioid policy and advocacy appear to have been effective in reducing the extent of opioid prescribing in the Medicare population. Similar declines between generalists and oncologists raise concern that access to cancer pain management may have been inadvertently restricted. How much of the decrease in prescribing by oncologists is appropriate vs inappropriate deserves further investigation.

Project description:ImportanceNonadherence to buprenorphine may increase patient risk of opioid overdose and increase health care spending. Quantifying the impacts of nonadherence can help inform clinician practice and policy.ObjectiveTo estimate the association between buprenorphine treatment gaps, opioid overdose, and health care spending.Design, setting, and participantsThis longitudinal case-control study compared patient opioid overdose and health care spending in buprenorphine-treated months with treatment gap months. Individuals who were US Medicare fee-for-service beneficiaries diagnosed with opioid use disorder who received at least 1 two-week period of continuous buprenorphine treatment between 2010 and 2017 were included. Analysis took place between January 2010 and December 2017.InterventionsA gap in buprenorphine treatment in a month lasting more than 15 consecutive days.Main outcomes and measuresOpioid overdose and total, medical, and drug spending (combined patient out-of-pocket and Medicare spending).ResultsOf 34 505 Medicare beneficiaries (17 927 [520%] male; 16 578 [48.1%] female; mean [SD] age, 49.5 [12.7] years; 168 [0.5%] Asian; 2949 [8.5%] Black; 2089 [6.0%] Hispanic; 266 [0.8%] Native American; 28 525 [82.7%] White; 508 [1.5%] other race), 11 524 beneficiaries (33.4%) experienced 1 or more buprenorphine treatment gaps. Treatment gap beneficiaries, compared with nontreatment gap beneficiaries, were more likely to be younger, be male, have a disability, and be Medicaid dual-eligible while less likely to be White, close to a buprenorphine prescriber, and treated with buprenorphine monotherapy (ie, buprenorphine hydrochloride). Beneficiaries were 2.89 (95% CI, 2.20-3.79) times more likely to experience an opioid overdose during buprenorphine treatment gap months compared with treated months. During treatment gap months, spending was $196.41 (95% CI, $110.53-$282.30) more than in treated months. Patients who continued to take buprenorphine dosages of greater than 8 mg/d and 16 mg/d were 2.61 and 2.84 times more likely to overdose in a treatment gap month, respectively, while patients taking buprenorphine dosages of 8 mg/d or less were 3.62 times more likely to overdose in a treatment gap month (maintenance of >16 mg/d: hazard ratio (HR), 2.64 [95% CI, 1.80-3.87]; maintenance of >8 mg/d: HR, 2.84 [95% CI, 2.13-3.78]; maintenance of ≤8 mg/d: HR, 3.62 [95% CI, 1.54-8.50]). Buprenorphine monotherapy was associated with greater risk of overdose and higher spending during treatment gaps months than buprenorphine/naloxone.Conclusions and relevanceMedicare patients treated with buprenorphine between 2010 and 2017 had a lower associated opioid overdose risk and spending during treatment months than treatment gap months.

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Association of Formulary Exclusions and Restrictions for Opioid Alternatives With Opioid Prescribing Among Medicare Beneficiaries.

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