The impact of external reference pricing on pharmaceutical costs and market dynamics.

Growth in the cost of prescription drugs in the US has generated significant interest in the use of external reference pricing (ERP) to tie prices paid for drugs to those in other countries. We used data from the Pricentric ONE™ database, an international drug pricing database, to examine product launch timing, launch price, and price changes from January 2010 - October 2021 in both ERP and non-ERP settings, with a focus on 100 high-priced drugs of interest to Medicare and Medicaid. We found that ERP policies were associated with a 73% reduction in the likelihood of drug launch within 9 months of regulatory approval relative to non-ERP settings. In addition, while ERP was associated with statistically significant reductions in annual drug price changes, such policies did not impact launch price. In addition, no single ERP feature (e.g., number of countries referenced, ERP calculation) was materially associated with the outcomes of interest. We conclude that ERP policies do not appear to impact drug launch price and may delay access to new therapies, raising questions about the utility of such policies in the US and potential consequences abroad.

Patient Outcomes After Delirium Screening and Incident Alzheimer's Disease or Related Dementias in Skilled Nursing Facilities.

BACKGROUND: The extent to which a positive delirium screening and new diagnosis of Alzheimer's disease or related dementias (ADRD) increases the risk for re-hospitalization, long-term nursing home placement, and death remains unknown. OBJECTIVE: To compare long-term outcomes among newly admitted skilled nursing facility (SNF) patients with delirium, incident ADRD, and both conditions. DESIGN, SETTING, AND PARTICIPANTS: A retrospective cohort study of Medicare beneficiaries who entered a SNF from hospital with a minimum 14-day stay (n = 100,832) from 2015 to 2016. MAIN MEASURES: Return to home, hospital readmission, admission to a long-term care facility, or death. KEY RESULTS: Patients with delirium were as likely to be discharged home as patients diagnosed with ADRD (HR: 0.63, 95% CI: 0.59, 0.67; HR: 0.65, 95% CI: 0.64, 0.67). Patients with both delirium and ADRD were less likely to be discharged home (HR: 0.49, 95% CI: 0.47, 0.52) and showed increased risk of death (HR: 1.30, 95% CI: 1.17, 1.45). Patients with ADRD, regardless of delirium screening status, had increased risk for long-term nursing home care transfer (HR: 1.66, 95% CI: 1.63, 1.70; HR: 1.76, 95% CI: 1.69, 1.82). Patients with delirium and no ADRD showed increased risk of transfer to long-term nursing home care (HR: 1.25, 95% CI: 1.18, 1.33). The rate of deaths was higher among patients who screened positive for delirium without ADRD compared to the no delirium and no ADRD groups (HR: 2.35, 95% CI: 2.11, 2.61). CONCLUSION: A positive delirium screening increased risk of death and transfer to long-term care in the first 100 days after admission regardless of incident ADRD diagnosis. Patients with delirium and/or ADRD also are less likely to be discharged home. Our study builds on the evidence base that delirium is important to address in older adults as it is associated with negative outcomes.

Low-Value Prostate-Specific Antigen Test for Prostate Cancer Screening and Subsequent Health Care Utilization and Spending.

Importance: Delivering low-value care can lead to unnecessary follow-up services and associated costs, and such care cascades have not been well examined in common clinical scenarios. Objective: To evaluate the utilization and costs of care cascades of prostate-specific antigen (PSA) tests for prostate cancer screening, as the routine use of which among asymptomatic men aged 70 years and older is discouraged by multiple guidelines. Design, Setting, and Participants: This cross-sectional study included men aged 70 years and older without preexisting prostate conditions enrolled in a Medicare Advantage plan during January 2016 to December 2018 with at least 1 outpatient visit. Medical billing claims data from the deidentified OptumLabs Data Warehouse were used. Data analysis was conducted from September 2020 to August 2021. Exposures: At least 1 claim for low-value PSA tests for prostate cancer screening during the observation period. Main Outcomes and Measures: Utilization of and spending on low-value PSA cancer screening and associated care cascades and the difference in overall health care utilization and spending among individuals receiving low-value PSA cancer screening vs those who did not, adjusting for observed characteristics using inverse probability of treatment weighting. Results: Of 995 442 men (mean [SD] age, 78.0 [5.6] years) aged 70 years or older in a Medicare Advantage plan included in this study, 384 058 (38.6%) received a low-value PSA cancer screening. Utilization increased for each subsequent cohort from 2016 to 2018 (49 802 of 168 951 [29.4%] to 134 404 of 349 228 [38.5%] to 199 852 of 477 203 [41.9%]). Among those receiving initial low-value PSA cancer screening, 241 188 of 384 058 (62.8%) received at least 1 follow-up service. Repeated PSA testing was the most common, and 27 268 (7.1%) incurred high-cost follow-up services, such as imaging, radiation therapy, and prostatectomy. Utilization and spending associated with care cascades also increased from 2016 to 2018. For every $1 spent on a low-value PSA cancer screening, an additional $6 was spent on care cascades. Despite avoidable care cascades, individuals who received low-value PSA cancer screening were not associated with increased overall health care utilization and spending during the 1-year follow-up period compared with an unscreened population. Conclusions and Relevance: In this cross-sectional study, low-value PSA tests for prostate cancer screening remained prevalent among Medicare Advantage plan enrollees and were associated with unnecessary expenditures due to avoidable care cascades. Innovative efforts from clinicians and policy makers, such as payment reforms, to reduce initial low-value care and avoidable care cascades are warranted to decrease harm, enhance equity, and improve health care efficiency.

State-Level Variation In Low-Value Care For Commercially Insured And Medicare Advantage Populations.

Low-value care is a major source of health care inefficiency in the US. Our analysis of 2009-19 administrative claims data from OptumLabs Data Warehouse found that low-value care and associated spending remain prevalent among commercially insured and Medicare Advantage enrollees. The aggregated prevalence of twenty-three low-value services was 1,920 per 100,000 eligible enrollees, which amounted to $3.7 billion in wasteful expenditures during the study period. State-level variation in spending was greater than variation in utilization, and much of the variation in spending was driven by differences in average procedure prices. If the average price for twenty-three low-value services among the top ten states in spending were set to the national average, their spending would decrease by 19.8 percent (from $735,000 to $590,000 per 100,000 eligible enrollees). State-level actions to improve the routine measurement and reporting of low-value care could identify sources of variation and help design state-specific policies that lead to better patient-centered outcomes, enhanced equity, and more efficient spending.

Effect of the 2012 US Preventive Services Task Force Recommendations on Prostate-Specific Antigen Screening in a Medicare Advantage Population.

BACKGROUND: In 2012, the US Preventive Service Task Force revised its recommendations for prostate-specific antigen (PSA) screening from "insufficient evidence" to "do not recommend" for men aged 70-74 while maintaining "do not recommend" for men aged 75+. METHODS: Using the difference-in-difference approach, we evaluated whether the rate of change in the use of low-value PSA screening differed between the control group (men aged 75+, N=7,856,204 person-years) and the intervention group (men aged 70-74, N=5,329,192 person-years) enrolling in the Medicare Advantage plan without a history of prostate cancer within the OptumLabs Data Warehouse claims data (2009-2019). A generalized estimating equation logistic model was specified with independent variables: an intervention group indicator, a pre- and post-period (after 2012 Q2) indicator, index time, and interaction terms. We assumed a 12-month dissemination period. RESULTS: Before the revised recommendation in 2012, the trends did not significantly differ between the 2 age groups with the odds of receiving PSA screening decreasing by 1.2% (95% confidence interval [1.0, 1.4%]) per quarter. However, the odds of receiving PSA screening increased by 3.0% [2.8, 3.2%] per quarter across both groups since the revision. There was no significant additional change in the trend for those aged 70-74 (0.1% [-0.2, 0.5%]). CONCLUSIONS: Although the 2012 US Preventive Service Task Force's recommendations were expected to only change behaviors among men aged 70-74, our analysis found that men aged 70-74 and aged 75+ exhibited similar trends from 2009 to 2019, including the increased use of low-value PSA screening since 2016. Multifaceted efforts to discourage low-value PSA screening would be important for a sustained impact.

Psychoactive medication therapy and delirium screening in skilled nursing facilities.

BACKGROUND: A positive delirium screen at skilled-nursing facility (SNF) admission can trigger a simultaneous diagnosis of Alzheimer's Disease or related dementia (AD/ADRD) and lead to psychoactive medication treatment despite a lack of evidence supporting use. METHODS: This was a nationwide historical cohort study of 849,086 Medicare enrollees from 2011-2013 who were admitted to the SNF from a hospital without a history of dementia. Delirium was determined through positive Confusion Assessment Method screen and incident AD/ADRD through active diagnosis or claims. Cox proportional hazard models predicted the risk of receiving one of three psychoactive medications (i.e., antipsychotics, benzodiazepines, antiepileptics) within 7 days of SNF admission and within the entire SNF stay. RESULTS: Of 849,086 newly-admitted SNF patients (62.6% female, mean age 78), 6.1% had delirium (of which 35.4% received an incident diagnosis of AD/ADRD); 12.6% received antipsychotics, 30.4% benzodiazepines, and 5.8% antiepileptics. Within 7 days of admission, patients with delirium and incident dementia were more likely to receive an antipsychotic (relative risk [RR] 3.09; 95% confidence interval [CI] 2.99 to 3.20), or a benzodiazepine (RR 1.23; 95% CI 1.19 to 1.27) than patients without either condition. By the end of the SNF stay, patients with both delirium and incident dementia were more likely to receive an antipsychotic (RR 3.04; 95% CI 2.95 to 3.14) and benzodiazepine (RR 1.32; 95% CI 1.29 to 1.36) than patients without either condition. CONCLUSION: In this historical cohort, a positive delirium screen was associated with a higher risk of receiving psychoactive medication within 7 days of SNF admission, particularly in patients with an incident AD/ADRD diagnosis. Future research should examine strategies to reduce inappropriate psychoactive medication prescribing in older adults admitted with delirium to SNFs.

Large-scale validation of the prediction model risk of bias assessment Tool (PROBAST) using a short form: high risk of bias models show poorer discrimination.

OBJECTIVE: To assess whether the Prediction model Risk Of Bias ASsessment Tool (PROBAST) and a shorter version of this tool can identify clinical prediction models (CPMs) that perform poorly at external validation. STUDY DESIGN AND SETTING: We evaluated risk of bias (ROB) on 102 CPMs from the Tufts CPM Registry, comparing PROBAST to a short form consisting of six PROBAST items anticipated to best identify high ROB. We then applied the short form to all CPMs in the Registry with at least 1 validation (n=556) and assessed the change in discrimination (dAUC) in external validation cohorts (n=1,147). RESULTS: PROBAST classified 98/102 CPMS as high ROB. The short form identified 96 of these 98 as high ROB (98% sensitivity), with perfect specificity. In the full CPM registry, 527 of 556 CPMs (95%) were classified as high ROB, 20 (3.6%) low ROB, and 9 (1.6%) unclear ROB. Only one model with unclear ROB was reclassified to high ROB after full PROBAST assessment of all low and unclear ROB models. Median change in discrimination was significantly smaller in low ROB models (dAUC -0.9%, IQR -6.2-4.2%) compared to high ROB models (dAUC -11.7%, IQR -33.3-2.6%; P<0.001). CONCLUSION: High ROB is pervasive among published CPMs. It is associated with poor discriminative performance at validation, supporting the application of PROBAST or a shorter version in CPM reviews.

Comorbidity Burden and Adverse Outcomes After Transcatheter Aortic Valve Replacement.

Background Transcatheter aortic valve replacement (TAVR) has become the preferred treatment for symptomatic patients with aortic stenosis and elevated procedural risk. Many deaths following TAVR are because of noncardiac causes and comorbid disease burden may be a major determinant of postprocedure outcomes. The prevalence of comorbid conditions and associations with outcomes after TAVR has not been studied. Methods and Results This was a retrospective single-center study of patients treated with TAVR from January 2015 to October 2018. The association between 21 chronic conditions and short- and medium-term outcomes was assessed. A total of 341 patients underwent TAVR and had 1-year follow-up. The mean age was 81.4 (SD 8.0) years with a mean Society of Thoracic Surgeons predicted risk of mortality score of 6.7% (SD 4.8). Two hundred twenty (65%) patients had ≥4 chronic conditions present at the time of TAVR. There was modest correlation between Society of Thoracic Surgeons predicted risk of mortality and comorbid disease burden (r=0.32, P<0.001). After adjusting for Society of Thoracic Surgeons predicted risk of mortality, age, and vascular access, each additional comorbid condition was associated with increased rates of 30-day rehospitalizations (odds ratio, 1.21; 95% CI, 1.02-1.44), a composite of 30-day rehospitalization and 30-day mortality (odds ratio, 1.20; 95% CI, 1.02-1.42), and 1-year mortality (odds ratio, 1.29; 95% CI, 1.05-1.59). Conclusions Comorbid disease burden is associated with worse clinical outcomes in high-risk patients treated with TAVR. The risks associated with comorbid disease burden are not adequately captured by standard risk assessment. A systematic assessment of comorbid conditions may improve risk stratification efforts.

Association of Positive Delirium Screening with Incident Dementia in Skilled Nursing Facilities.

BACKGROUND AND OBJECTIVE: Early detection of delirium in skilled nursing facilities (SNFs) is a priority. The extent to which delirium screening leads to a potentially inappropriate diagnosis of Alzheimer's disease and related dementia (ADRD) is unknown. DESIGN: Nationwide retrospective cohort study from 2011 to 2013. SETTING: An SNF. PARTICIPANTS: A total of 1,175,550 Medicare enrollees who entered the SNF from a hospital and had no prior diagnosis of dementia. EXPOSURE: A positive screen for delirium using the validated Confusion Assessment Method (CAM), performed as part of the federally mandated Minimum Data Set (MDS) assessment. MEASUREMENTS: Incident all-cause dementia, ascertained through International Classification of Diseases, Ninth Revision (ICD-9), diagnosis in Medicare claims or active diagnoses in MDS. RESULTS: Positive screening for delirium was identified in 7.7% of cases (n = 90,449), and most occurred within the first 7 days of SNF admission (62.5%). The overall incidence of ADRD was 6.3% (n = 73,542). Nearly all new diagnoses of ADRD (93.5%) occurred within the first 30 days of SNF admission. Patients who screened CAM positive for delirium had a nearly threefold increased risk of receiving an incident ADRD diagnosis on the same day (hazard ratio (HR) = 2.63; 95% confidence interval (CI) = 1.50-4.63). Among patients who screened CAM positive for delirium, those who were cognitively intact or had mild cognitive impairments were, on average, six times more likely to receive an incident ADRD diagnosis (HR = 6.64; 95% CI = 1.76-25.0) relative to those testing CAM negative. CONCLUSION AND RELEVANCE: Among older adults not previously diagnosed with dementia, a positive screen for delirium was significantly associated with higher risk of ADRD diagnosis after admission to a SNF. This risk was highest for patients in the first days of their stay and with the least cognitive impairment, suggesting that the ADRD diagnosis was potentially inappropriate.

Adequacy of Prescription Drug Coverage in Long-term Care.

RESEARCH OBJECTIVE: Affordable access to medications is important to Medicare enrollees in long-term care (LTC), yet, it is unknown if prescription drug coverage is universal and adequate to meet their high medication needs. STUDY DESIGN: We assessed enrollment in prescription drug coverage, out-of-pocket (OOP) payments and medication use in a nationwide LTC database of prescription-level, resident-level, and facility-level data for the period 2011-2013. Inadequate drug coverage was defined as ≥50% medications paid for OOP. Risk-adjusted generalized estimation equations models were estimated to identify predictors of inadequate drug coverage and total prescription fills. POPULATION STUDIED: A nationwide sample of 332,087 Medicare enrollees observed >100 days in LTC. PRINCIPAL FINDINGS: We found Medicare Part D was the main source of drug coverage (82.4%), followed by private insurance (8.5%), and Veterans Administration (0.2%). No drug coverage could be detected for 8.9% (n=29,378) who paid for all of their medications OOP or received only temporary drug payment assistance. Inadequate drug coverage was identified in another 2721 persons. LTC Medicare enrollees without drug coverage or who had private insurance received significantly fewer prescriptions than if they had been enrolled in Medicare Part D. CONCLUSION: A substantial proportion of Medicare enrollees in LTC have inadequate or no drug coverage and are receiving less medication than indicated by their health needs. POLICY IMPLICATIONS: Medicare Part D is an important policy for ensuring affordable access to medications in LTC. However, expansions are needed to increase enrollment and decrease inadequate drug coverage.

Economic Barriers to Antiretroviral Therapy in Nursing Homes.

OBJECTIVES: Our aim was to clarify if persons living with human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS) have adequate economic access to antiretroviral therapy (ART) when admitted to nursing homes (NHs). Medicare Part A pays NHs a bundled skilled nursing rate that includes prescription drugs for up to 100 days, after which individuals are responsible for the costs. DESIGN: A cross-sectional study. SETTING: NHs. PARTICIPANTS: A total of 694 newly admitted long-stay (>100 d) NH residents with HIV. MEASUREMENTS: We used Minimum Dataset v.3.0, pharmacy dispensing data, NH provider surveys, and Medicare claims from 2011 to 2013. We assessed receipt of any HIV antiretrovirals or recommended combinations (ART), as defined by national care guidelines, and the source of payment. We identified predictors of antiretroviral use with risk-adjusted generalized estimating equation logistic models. RESULTS: All study persons living with HIV/AIDS in NHs had prescription drug coverage through Medicare's Part D program, and ART was 100% covered. However, only 63.9% received recommended ART, and 15.2% never received any antiretrovirals during their NH stay. The strongest predictor of not receiving antiretrovirals was the first 100 days of a long NH stay (odds ratio [OR] = .44; 95% confidence interval [CI] = .24-.80). The strongest predictor of receiving recommended ART was health acuity (OR = 1.51; 95% CI = 1.20-1.88). CONCLUSION: People living with HIV in NHs do not always receive lifesaving ART, but the reasons are unclear and appear unrelated to economic barriers. J Am Geriatr Soc 68:777-782, 2020.

Nursing homes underreport antipsychotic prescribing.

Objective: Determine the accuracy of nursing home self-reported antipsychotic prescribing before and after implementation of a Medicare campaign to reduce use.Methods: Quasi-experimental study comparing trends in self-reported antipsychotic prescribing relative to claims-based prescribing. Setting is a nationwide sample of 11,912 facilities, 2011-2013. Participants are long-stay nursing home residents (n = 586,281) with prescribing data in Medicare Minimum Data Set 3.0 and Medicare Part D claims database. Verified with a pharmacy dispensing database. Main outcomes are the discrepancies in quarterly prevalence of antipsychotic prescribing between nursing home self-reports and claims data and the characteristics of facilities and residents where discrepancies were identified.Results: Nursing homes underreport their antipsychotic prescribing levels, on average, by 1 percentage point per quarter relative to Medicare Part D claims (0.013, 95% confidence interval (CI), 0.012-0.015; p<.001). After the Medicare campaign, the underreporting gap increased by another half a percentage point (0.004, 95% CI .003-.005; p = .012). Nursing home residents with dementia, Alzheimer's disease or bipolar disorders were at the highest risk for underreported antipsychotic prescribing before the campaign (Adjusted Odds ratio (AOR) 1.385, 95% CI: 1.330-1.444; AOR 1.234, 95% CI: 1.172-1.300; AOR 1.574, 95% CI: 1.444-1.716, respectively) and afterwards. After the launch of the Medicare campaign, underreported antipsychotic prescribing occurred most in for-profit nursing homes (AOR 1.088, 95% CI: 1.005-1.178) and facilities in the US South (AOR 1.262, 95% CI: 1.145-1.391). Agreement was high between claims and dispensing data (99.7%).Conclusion: Nursing homes did not identify up to 6,000 residents per calendar quarter as having received antipsychotics despite these prescriptions being paid by Medicare and dispensed by a pharmacy. Nursing home rates of antipsychotic prescribing from self-reported data may be biased.

Impact Of Health Care Delivery System Innovations On Total Cost Of Care.

Using delivery system innovations to advance health care reform continues to be of widespread interest. However, it is difficult to generalize about the success of specific types of innovations, since they have been examined in only a few studies. To gain a broader perspective, we analyzed the results of forty-three ambulatory care programs funded by the first round of the Center for Medicare and Medicaid Innovation's Health Care Innovations Awards. The innovations' impacts on total cost of care were estimated by independent evaluators using multivariable difference-in-differences models. Through the first two years, most of the innovations did not show a significant effect on total cost of care. Using meta-regression, we assessed the effects on costs of five common components of these innovations. Innovations that used health information technology or community health workers achieved the greatest cost savings. Savings were also relatively large in programs that targeted clinically fragile patients-clinically complex populations at risk for disease progression. While the magnitude of these effects was often substantial, none achieved conventional levels of significance in our analyses. Meta-analyses of a larger number of delivery system innovations are needed to more clearly establish their potential for patient care cost savings.