Medicare-mandated shared decision making for left atrial appendage closure in clinical practice.

INTRODUCTION: The Centers for Medicare & Medicaid Services (CMS) required a shared decision-making (SDM) interaction, with an "independent" physician, before left atrial appendage closure (LAAC). The purpose of this study is to better understand how this requirement is implemented in clinical practice. METHODS: We surveyed LAAC-performing centers. The characteristics of respondent and nonrespondent hospitals were compared using the CMS Provider of Services File for 2017. RESULTS: We received 86 responses out of 269 surveys mailed (32%). Respondent and nonrespondent hospital affiliations were similar: mean hospital size 525 beds, 15% for-profit, and 34% teaching hospitals. Thirty-four respondents (39.5%) stated that the implanting physician conducts some or all of the SDM interactions. The percentage of patients who decide not to undergo LAAC after the SDM interaction was estimated at 8.1%. Out of 72 responses to an open-ended question about the benefit of the SDM interaction, 44 (61%) described the requirement in negative terms, of which most felt the requirement was burdensome for patients and providers. Only 28 respondents (39%) described the requirement in positive or mixed terms. CONCLUSION: In violation of the letter of the CMS policy for LAAC, implanting physicians perform the SDM interaction at nearly 40% of responding hospitals. Most respondents felt the SDM requirement was burdensome for patients. More detailed guidance from CMS on how to comply with the policy may result in better alignment between the intent of the policy and how it is implemented.

The cost burden of metastatic prostate cancer in the US populations covered by employer-sponsored health insurance.

BACKGROUND: Recent advancements in the clinical management of metastatic prostate cancer include several costly therapies and diagnostic tests. The objective of this study was to provide updated information on the cost to payers attributable to metastatic prostate cancer among men aged 18 to 64 years with employer-sponsored health plans and men aged 18 years or older covered by employer-sponsored Medicare supplement insurance. METHODS: By using Merative MarketScan commercial and Medicare supplemental data for 2009-2019, the authors calculated differences in spending between men with metastatic prostate cancer and their matched, prostate cancer-free controls, adjusting for age, enrollment length, comorbidities, and inflation to 2019 US dollars. RESULTS: The authors compared 9011 patients who had metastatic prostate cancer and were covered by commercial insurance plans with a group of 44,934 matched controls and also compared 17,899 patients who had metastatic prostate cancer and were covered by employer-sponsored Medicare supplement plans with a group of 87,884 matched controls. The mean age of patients with metastatic prostate cancer was 58.5 years in the commercial samples and 77.8 years in the Medicare supplement samples. Annual spending attributable to metastatic prostate cancer was $55,949 per person-year (95% confidence interval [CI], $54,074-$57,825 per person-year) in the commercial population and $43,682 per person-year (95% CI, $42,022-$45,342 per person-year) in the population covered by Medicare supplement plans, both in 2019 US dollars. CONCLUSIONS: The cost burden attributable to metastatic prostate cancer exceeds $55,000 per person-year among men with employer-sponsored health insurance and $43,000 among those covered by employer-sponsored Medicare supplement plans. These estimates can improve the precision of value assessments of clinical and policy approaches to the prevention, screening, and treatment of prostate cancer in the United States.

The impact of government-mandated shared decision-making for implantable defibrillators: A natural experiment.

BACKGROUND: In 2018, the Centers for Medicare and Medicaid Services (CMS) mandated that patients considering implantation of an implantable cardioverter-defibrillator (ICD) for primary prevention of sudden cardiac death undergo shared decision-making (SDM) using a decision-aid. OBJECTIVE: To observe the impact of the CMS's mandate on core measures of SDM using a natural experiment. RESEARCH DESIGN, SUBJECTS, AND MEASURES: Patients who underwent implantation of a primary prevention ICD within the Emory Healthcare system between 2017-2019 (pre and post SDM mandate) were surveyed. Survey domains included knowledge about the ICD, decisional conflict, values-choice concordance, and engagement in decision-making. Patients who had an ICD implant after the mandate were also asked about their views of the decision aid (DA). Responses of patients who had ICD implanted prior to the mandate were compared to those after the mandate using either Student t test or Chi-Squared tests. RESULTS: Of 101 patients who completed the survey, 45 had an ICD placed before the mandate and 56 had an ICD placed after. There were no major differences between knowledge, decisional conflict, values choice concordance, or patient engagement. Compared to patients with ICDs placed before the mandate, patients with ICDs after the mandate were more likely to subjectively feel more informed about the benefits of the procedure but were less likely to be able to correctly identify the frequency of complications. CONCLUSIONS: Policy effects to promote SDM that solely focus on a decision-aid may not substantively impact patient centered care.

Disparities in magnetic resonance imaging of the prostate for traditionally underserved patients with prostate cancer.

BACKGROUND: Prebiopsy magnetic resonance imaging (MRI) of the prostate improves detection of significant tumors, while decreasing detection of less-aggressive tumors. Therefore, its use has been increasing over time. In this study, the use of prebiopsy MRI among Medicare beneficiaries with prostate cancer was examined. It was hypothesized that patients of color and those in isolated areas would be less likely to undergo this approach for cancer detection. METHODS: Using cancer registry data from the Surveillance, Epidemiology, and End Results (SEER) program linked to billing claims for fee-for-service Medicare beneficiaries, men with nonmetastatic prostate cancer were identified from 2010 through 2015 with prostate-specific antigen (PSA) <30 ng/mL. Outcome was prebiopsy MRI of the prostate performed within 6 months before diagnosis (ie, Current Procedural Terminology 72197). Exposures were patient race/ethnicity and rural/urban status. Multivariable regression estimated the odds of prebiopsy prostate MRI. Post hoc analyses examined associations with the registry-level proportion of non-Hispanic Black patients and MRI use, as well as disparities in MRI use in registries with data on more frequent use of prostate MRI. RESULTS: There were 50,719 men identified with prostate cancer (mean age, 72.1 years). Overall, 964 men (1.9% of cohort) had a prebiopsy MRI. Eighty percent of patients with prebiopsy MRI lived in California, New Jersey, or Connecticut. Non-Hispanic Black men (0.6% vs 2.1% non-Hispanic White; odds ratio [OR], 0.28; 95% CI, 0.19-0.40) and men in less urban areas (1.1% vs 2.2% large metro; OR, 0.65; 95% CI, 0.44-0.97) were less likely to have prebiopsy MRI of the prostate. CONCLUSIONS: Non-Hispanic Black patients with prostate cancer and those in less urban areas were less likely to have prebiopsy MRI of the prostate during its initial adoption as a tool for improving prostate cancer detection.

The value of new drugs for advanced prostate cancer.

BACKGROUND: The US Food and Drug Administration has recently approved a number of new cancer drugs. The clinical trials that serve as the basis for new cancer drug approvals may not reflect how the drugs will perform in routine practice and do not measure the impact of the drugs on spending. The authors sought to evaluate the real-world effectiveness and value of drugs recently approved for advanced prostate cancer. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare data, the authors identified fee-for-service Medicare beneficiaries aged 65 years or older who began treatment with a drug approved for metastatic castration-resistant prostate cancer in 2007-2009, when only 1 drug was approved for metastatic castration-resistant prostate cancer, and in 2014-2016, when 5 additional drugs were approved. They calculated life expectancy and lifetime medical costs (ie, Medicare reimbursements) for each group. RESULTS: Between 2007-2009 and 2014-2016, life expectancy increased by 12.6 months. Lifetime medical costs increased by $87,000. The incremental cost per life-year gained was $83,000. CONCLUSION: The release of 5 new drugs coincided with increases in survival rates and spending. This study's estimates indicate that the new drugs collectively were cost-effective.

The eligibility and reach of the national breast and cervical cancer early detection program after implementation of the affordable care act.

INTRODUCTION: The uninsured rate declined following passage of the Affordable Care Act in 2010. It is unclear how this decrease affected the size of the population eligible for existing safety net programs. We evaluated trends in the number of women eligible for breast and cervical cancer screening and diagnostic services under the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) and the reach of the program. METHODS: Using the Census Bureau's Small Area Health Insurance Estimates data, we calculated the number of women who met the NBCCEDP eligibility criteria based on age, income, and insurance status. We used these data in conjunction with program to estimate the proportion of eligible women served by the NBCCEDP. RESULTS: The number of women eligible for breast cancer screening and diagnostic services under the program declined from 5.4 (90% CI 5.2-5.6) to 2.8 (90% CI 2.6-3.0) million from 2011 to 2017. The number of women eligible for cervical cancer screening and diagnostic services declined from 10.3 (90% CI 10.0-10.6) to 5.3 (90% CI 5.1-5.6) million. The share of eligible women served by the program was 15.0% (90% CI 14.8-15.1%) for breast services in 2016-2017 and 6.8% (90% CI 6.7-6.8%) for cervical services in 2015-2017. CONCLUSION: Insurance coverage expansions may have contributed to a decrease in the number of program-eligible women. There are many more women eligible for the program than are served.

Relationship Between Adherence to Antihypertensive Medication Regimen and Out-of-Pocket Costs Among People Aged 35 to 64 With Employer-Sponsored Health Insurance.

We used administrative claims data from 2014 on people with employer-sponsored health insurance to assess the proportion of patients taking antihypertensive medications, rates of nonadherence to these medication regimens, and out-of-pocket costs paid by patients. We performed multivariate logistic regression analysis to examine the association between out-of-pocket costs and nonadherence. Results indicated that patients filled the equivalent of 13 monthly prescriptions and paid $76 out of pocket over the calendar year; the likelihood of nonadherence increased as out-of-pocket costs increased (adjusted odds ratios ranged from 1.04 to 1.78; P < .001). These findings suggest a need for improvement in adherence among patients with employer-sponsored insurance.

Racial/ethnic disparities in waitlisting for deceased donor kidney transplantation 1 year after implementation of the new national kidney allocation system.

The impact of a new national kidney allocation system (KAS) on access to the national deceased-donor waiting list (waitlisting) and racial/ethnic disparities in waitlisting among US end-stage renal disease (ESRD) patients is unknown. We examined waitlisting pre- and post-KAS among incident (N = 1 253 100) and prevalent (N = 1 556 954) ESRD patients from the United States Renal Data System database (2005-2015) using multivariable time-dependent Cox and interrupted time-series models. The adjusted waitlisting rate among incident patients was 9% lower post-KAS (hazard ratio [HR]: 0.91; 95% confidence interval [CI], 0.90-0.93), although preemptive waitlisting increased from 30.2% to 35.1% (P < .0001). The waitlisting decrease is largely due to a decline in inactively waitlisted patients. Pre-KAS, blacks had a 19% lower waitlisting rate vs whites (HR: 0.81; 95% CI, 0.80-0.82); following KAS, disparity declined to 12% (HR: 0.88; 95% CI, 0.85-0.90). In adjusted time-series analyses of prevalent patients, waitlisting rates declined by 3.45/10 000 per month post-KAS (P < .001), resulting in ≈146 fewer waitlisting events/month. Shorter dialysis vintage was associated with greater decreases in waitlisting post-KAS (P < .001). Racial disparity reduction was due in part to a steeper decline in inactive waitlisting among minorities and a greater proportion of actively waitlisted minority patients. Waitlisting and racial disparity in waitlisting declined post-KAS; however, disparity remains.

Implementation of Florida Long Term Care Emergency Preparedness Portal Web Site, 2015-2017.

We built an online emergency preparedness Web site for Florida nursing homes after an earlier study revealed gaps in information and a lack of available preparedness resources for long-term care providers. The Long Term Care Emergency Preparedness Portal ( www.ltcprepare.org ) was launched in January 2015. We assessed its use and sought suggestions for improvement. Findings indicate that long-term care providers in Florida regularly use the Web site, and they welcome the opportunity to further leverage technology to aid their disaster planning.

Adverse effects of prohibiting narrow provider networks.

Many insurers participating in the new insurance exchanges are controlling costs by offering plans with narrow provider networks. Proposed regulations would promote network adequacy, but a pro-provider stance may not be inherently pro-consumer or even pro-patient.

Mammography rates after the 2009 revision to the United States Preventive Services Task Force breast cancer screening recommendation.

BACKGROUND: In 2009, the United States Preventive Services Task Force (USPSTF) recommended against routine mammography screening for women aged 40-49 years. This revised recommendation was widely criticized and has sparked off intense debate. The objectives of this study are to examine the impact of the revised recommendation on the proportion of women receiving mammograms and how the effect varied by age. METHODS: We identified women who had continuous health insurance coverage and who did not have breast cancer between 2008 and 2011 in the Truven Health MarketScan Commercial Claims Databases using mammogram procedure codes. Using women aged 50-59 years as a control group, we used a differences-in-differences approach to estimate the impact of the revised recommendation on the proportion of women ages 40-49 years who received at least one mammogram. We also compared the age-specific changes in the proportion of women ages 35-59 years who were screened before and after the release of the revised recommendation. RESULTS: The proportion of women screened among the 40-49 and 50-59 age groups were 58.5 and 62.5%, respectively, between 2008 and 2009, and 56.9 and 62.0%, respectively, between 2010 and 2011. After 2009, the proportion of women screened declined by 1.2 percentage point among women aged 40-49 years (P < 0.01). The proportion of women screened decreased for all ages, and decreases were larger among women closer to the 40-year threshold. CONCLUSIONS: The 2009 USPSTF breast cancer recommendation was followed by a small reduction in the proportion of insured women aged 40-49 years who were screened. Reductions were larger among women at the younger end of the age range, who presumably had less prior experience with mammography than women nearing 50.

Variation in Use of Prostate Biopsy Following Changes in Prostate Cancer Screening Guidelines.

PURPOSE: Prostate biopsy rates have paralleled decreasing prostate specific antigen screening rates since 2012. We hypothesized that biopsy rates and the change in rates since 2012 would vary considerably across hospital referral regions. MATERIALS AND METHODS: Using Medicare data from 2012 through 2014 we identified prostate biopsies performed by physicians who performed 11 or more biopsies annually. We calculated annual biopsy rates and changes in rates from 2012 to 2014 across 306 hospital referral regions. We performed multivariable regression adjusting for factors associated with annual biopsy rates (eg percent of patients older than 75 who were screened with prostate specific antigen and percent of the population that was African American). We also estimated adjusted prostate biopsy rates and changes with time across regions. RESULTS: We identified 395,993 biopsies. The overall rates decreased from 11.68 biopsies per 1,000 men in 2012 to 10.23 per 1,000 in 2014 (-12.4%, p = 0.11). Biopsy rates were higher in regions in which a greater percentage of the population was African American (ß = 0.810, 95% CI 0.235-1.384, p = 0.006), ambulatory surgical centers were available where biopsy could be performed (ß = 0.892, 95% CI 0.108-1.676, p = 0.026) and prostate specific antigen testing occurred more frequently (ß = 2.462, 95% CI 1.153-3.771, p <0.001). There was marked geographic variation in the adjusted average biopsy rate (median adjusted rate 9.08 biopsies per 1,000 men, IQR 7.65-10.76) and in the change in biopsy rates with time (median adjusted rate change -1.49 biopsies per 1,000 men, IQR -1.94--1.22 per 1,000). CONCLUSIONS: Since 2012 there has been considerable geographic variation in the performance of prostate biopsies as well as changes with time after prostate specific antigen recommendations changed. Characterizing the role of unmeasured patient and physician level factors is crucial to optimize the use and minimize the harms of prostate biopsy.

Cancer-directed therapy and potential impact on survivals in nonresected hepatocellular carcinoma: SEER-Medicare population study.

AIM: To investigate determinants of receiving cancer-directed therapies and their potential survival impact in nonresected hepatocellular carcinoma (HCC) Materials & methods: Nonsurgically resected HCC patients between 2000 and 2010 were stratified by American Joint Committee on Cancer staging and the type of therapy. Predictors of receiving therapy were identified and implication on survival was evaluated. RESULTS: Out of 9239 patients included, those receiving any therapy demonstrated prolonged overall survival with following median overall survival (months): ablation (30.8), Yttrium-90 (15.6), transcatheter arterial chemoembolization (15.5), Sorafenib (5.6), versus no cancer-directed therapy (3.7; p-values <0.001). Overall, 36% of patients received cancer-directed therapy including 47% with stage I/II. Favorable sociodemographic factors predicted receipt of percutaneous locoregional therapies (p-values <0.05). DISCUSSION & CONCLUSION: There appears to be significant disparity in care of nonresected HCC patients with significant underutilization of cancer-directed therapies.

Outcomes and Cost Analysis of Surveillance Strategies After Initial Treatment for Women With Recurrent Ovarian Cancer.

OBJECTIVE: The aim of this study was to determine whether there is a survival or cost benefit dependent on detection strategy of recurrent ovarian cancer (ie, imaging, physical examination findings, report of symptoms, or rising cancer antigen 125 [CA-125] levels). METHODS/MATERIALS: A retrospective chart review of 112 ovarian cancer patients was conducted, and method of detection of recurrent disease was determined from medical records. The following primary outcomes were determined using Cox proportional hazards regression model: progression-free survival (PFS) after diagnosis of recurrence and time to death after diagnosis of recurrence (overall survival [OS]). Several approaches to disease surveillance were proposed, and a cost model was applied. RESULTS: Median time to recurrence was 13.5 months. Overall, 6.3% presented with only physical examination findings; 24.1%, with elevating CA-125 levels; 34.8%, with imaging; and 32.1%, with symptoms. Most patients presenting with recurrent disease diagnosed by rising CA-125 were white (62.9%); those with imaging and symptomatic recurrences were blacks (56.4% and 57.1%, respectively). There was a small but not statistically significant OS benefit for recurrence detected via CA-125 (P = 0.85; OS per detection method: PE, 20.7 months; CA-125, 26.8 months; imaging, 17.8 months; and symptoms, 6.6 months). We modeled costs of surveillance in our patient cohort; up to 40.8% of cases of ovarian cancer recurrences would have been missed if no imaging were obtained during surveillance. CONCLUSIONS: Results indicate minimal differences in PFS and statistically insignificant differences in OS, depending on detection method. Notably, black patients with Medicaid presented most often with symptomatic recurrences, which surprisingly did not affect patient OS and PFS; and interestingly, pr\ivate or self-pay insurance was associated with decreased OS among black patients. From our cost analysis, we estimate that the most cost-effective surveillance strategy for the first year costs $9.2 million annually and includes office visit biannually, biannual CA-125 levels, and annual asymptomatic imaging.

Impact of a Sequential Intervention on Albumin Utilization in Critical Care.

OBJECTIVES: Literature generally finds no advantages in mortality risk for albumin over cheaper alternatives in many settings. Few studies have combined financial and nonfinancial strategies to reduce albumin overuse. We evaluated the effect of a sequential multifaceted intervention on decreasing albumin use in ICU and explore the effects of different strategies. DESIGN: Prospective prepost cohort study. SETTING: Eight ICUs at two hospitals in an academic healthcare system. PATIENTS: Adult patients admitted to study ICUs from September 2011 to August 2014 (n = 22,004). INTERVENTIONS: Over 2 years, providers in study ICUs participated in an intervention to reduce albumin use involving monthly feedback and explicit financial incentives in the first year and internal guidelines and order process changes in the second year. MEASUREMENTS AND MAIN RESULTS: Outcomes measured were albumin orders per ICU admission, direct albumin costs, and mortality. Mean (SD) utilization decreased 37% from 2.7 orders (6.8) per admission during the baseline to 1.7 orders (4.6) during the intervention (p < 0.001). Regression analysis revealed that the intervention was independently associated with 0.9 fewer orders per admission, a 42% relative decrease. This adjusted effect consisted of an 18% reduction in the probability of using any albumin (p < 0.001) and a 29% reduction in the number of orders per admission among patients receiving any (p < 0.001). Secondary analysis revealed that probability reductions were concurrent with internal guidelines and order process modification while reductions in quantity occurred largely during the financial incentives and feedback period. Estimated cost savings totaled $2.5M during the 2-year intervention. There was no significant difference in ICU or hospital mortality between baseline and intervention. CONCLUSIONS: A sequential intervention achieved significant reductions in ICU albumin use and cost savings without changes in patient outcomes, supporting the combination of financial and nonfinancial strategies to align providers with evidence-based practices.

Association of Antihypertensive Medication Adherence With Healthcare Use and Medicaid Expenditures for Acute Cardiovascular Events.

OBJECTIVES: We assessed the impact of antihypertensive medication (AHM) adherence on the incidence and associated Medicaid costs of acute cardiovascular disease (CVD) events among Medicaid beneficiaries. METHODS: The study cohort (n=59,037) consists of nonelderly adults continuously enrolled (36 mo and above) in a Medicaid fee-for-service program. AHM adherence was calculated using the medication possession ratio (MPR) and stratified to low (MPR<60%), moderate (60%≤MPR<80%), and high (MPR≥80%) levels. We used a proportional hazard model to estimate risk for acute CVD events and generalized linear models to estimate Medicaid per-patient-per-year costs. RESULTS: Low and moderate adherence subgroups had about 1.8 and 1.4 times higher risk of acute CVD events, compared with high adherence subgroup. By adherence level, Medicaid per-patient per-year costs for (1) CVD-related emergency department visits and hospitalizations were $661 (low), $479 (moderate), and $343 (high) and (2) AHMs were $430 (low), $604 (moderate), and $664 (high). Costs for CVD events and AHMs combined were similar across adherence subgroups. CONCLUSIONS: Lower adherence to AHM was associated with progressively higher CVD risk. The increase in medication cost from higher AHM adherence was offset solely by reduced Medicaid spending on acute CVD events.

Sociodemographic impact on survival in unresectable hepatocellular carcinoma: a survival epidemiology and end results study.

AIM: To investigate outcomes in unresectable hepatocellular carcinoma (HCC) patients stratified by sociodemographic and clinical factors in a population study. MATERIALS & METHODS: Surveillance, Epidemiology and End Results (SEER) database was used to identify patients diagnosed in 2000-2011. Overall survival (OS) was stratified using patient sociodemographic characteristics and American Joint Commission on Cancer (AJCC) staging. Log-rank test and Cox proportional hazard models were used to identify prognostic factors of OS. RESULTS: In patients with AJCC stage I and II unresectable HCC, prolonged OS was correlated with being married, younger age, ethnicity, geographic location, living in large urban areas, being insured and higher income and education levels. CONCLUSION: In AJCC stage I and II unresectable HCC patients with favorable sociodemographic factors, prolonged OS maybe in part related to better access to cancer-directed therapy.

Absenteeism and Employer Costs Associated With Chronic Diseases and Health Risk Factors in the US Workforce.

INTRODUCTION: Employers may incur costs related to absenteeism among employees who have chronic diseases or unhealthy behaviors. We examined the association between employee absenteeism and 5 conditions: 3 risk factors (smoking, physical inactivity, and obesity) and 2 chronic diseases (hypertension and diabetes). METHODS: We identified 5 chronic diseases or risk factors from 2 data sources: MarketScan Health Risk Assessment and the Medical Expenditure Panel Survey (MEPS). Absenteeism was measured as the number of workdays missed because of sickness or injury. We used zero-inflated Poisson regression to estimate excess absenteeism as the difference in the number of days missed from work by those who reported having a risk factor or chronic disease and those who did not. Covariates included demographics (eg, age, education, sex) and employment variables (eg, industry, union membership). We quantified absenteeism costs in 2011 and adjusted them to reflect growth in employment costs to 2015 dollars. Finally, we estimated absenteeism costs for a hypothetical small employer (100 employees) and a hypothetical large employer (1,000 employees). RESULTS: Absenteeism estimates ranged from 1 to 2 days per individual per year depending on the risk factor or chronic disease. Except for the physical inactivity and obesity estimates, disease- and risk-factor-specific estimates were similar in MEPS and MarketScan. Absenteeism increased with the number of risk factors or diseases reported. Nationally, each risk factor or disease was associated with annual absenteeism costs greater than $2 billion. Absenteeism costs ranged from $16 to $81 (small employer) and $17 to $286 (large employer) per employee per year. CONCLUSION: Absenteeism costs associated with chronic diseases and health risk factors can be substantial. Employers may incur these costs through lower productivity, and employees could incur costs through lower wages.