Medicare Coverage Research Articles

Out-of-Pocket Cost Modeling of Adjuvant Radiation Therapy Duration in Standard-of-Care Early Stage Breast Cancer Treatment Across Medicaid and Medicare Plans

For early-stage breast cancer (BC), the choice of radiotherapy duration (1- versus 3-weeks) is highly debated. Cost and financial toxicity are major concerns that BC patients face. Nonetheless, there remain limited discussions providing granular details of the role of insurance in the aggregate cost of 1 week versus 3 weeks of radiotherapy for patients. This project aims to disaggregate costs by plan to increase transparency of out-of-pocket (OOP) cost estimates in radiotherapy. Treatment procedures were determined through the National Comprehensive Cancer Network guidelines. OOP treatment costs, deductibles, and copays/coinsurance were calculated by utilizing Medicaid, Original Medicare, Medigap Plan G and Medicare Part D Rx plans. The medicare.gov, medicaid.oh.gov, aarpmedicareplans.com, and the physician fee schedule from cms.gov were used to determine costs by treatment. Price estimates reflect actual costs per insurance plan rather than costs estimated from claims data. All procedures were considered to be performed in an Ohio hospital setting. One-week radiotherapy was defined as 5 fractions without boost, and 3-week radiotherapy was defined as 15 fractions without boost. Medicare beneficiaries with Original Medicare coverage face an OOP treatment charge of $649.24 for one-week radiotherapy and $1006.20 for three-weeks of radiotherapy. Assuming the deductible is met post-lumpectomy, Medigap Plan G beneficiaries are faced with no additional charges for both lengths of radiotherapy. Similarly, for Medicaid beneficiaries (assuming treatment is approved by Medicaid), all expenses are covered without limit, resulting in no OOP expense. Considerations of one- and three-weeks of radiotherapy for post-lumpectomy early-stage BC are often dependent on cancer characteristics and patient preferences. This model (based on actual cost estimates per insurance plan rather than claims data) compares OOP costs across Medicaid and Medicare plans, which more holistically informs providers and patients in radiotherapy duration decision-making.

Comparative Safety of Robotic-Assisted vs Laparoscopic Cholecystectomy

Robotic-assisted cholecystectomy is rapidly being adopted into practice, partly based on the belief that it offers specific technical and safety advantages over traditional laparoscopic surgery. Whether robotic-assisted cholecystectomy is safer than laparoscopic cholecystectomy remains unclear. To determine the uptake of robotic-assisted cholecystectomy and to analyze its comparative safety vs laparoscopic cholecystectomy. This retrospective cohort study used Medicare administrative claims data for nonfederal acute care hospitals from January 1, 2010, to December 31, 2019. Participants included 1 026 088 fee-for-service Medicare beneficiaries 66 to 99 years of age who underwent cholecystectomy with continuous Medicare coverage for 3 months before and 12 months after surgery. Data were analyzed August 17, 2022, to June 1, 2023. Surgical technique used to perform cholecystectomy: robotic-assisted vs laparoscopic approaches. The primary outcome was rate of bile duct injury requiring definitive surgical reconstruction within 1 year after cholecystectomy. Secondary outcomes were composite outcome of bile duct injury requiring less-invasive postoperative surgical or endoscopic biliary interventions, and overall incidence of 30-day complications. Multivariable logistic analysis was performed adjusting for patient factors and clustered within hospital referral regions. An instrumental variable analysis was performed, leveraging regional variation in the adoption of robotic-assisted cholecystectomy within hospital referral regions over time, to account for potential confounding from unmeasured differences between treatment groups. A total of 1 026 088 patients (mean [SD] age, 72 [12.0] years; 53.3% women) were included in the study. The use of robotic-assisted cholecystectomy increased 37-fold from 211 of 147 341 patients (0.1%) in 2010 to 6507 of 125 211 patients (5.2%) in 2019. Compared with laparoscopic cholecystectomy, robotic-assisted cholecystectomy was associated with a higher rate of bile duct injury necessitating a definitive operative repair within 1 year (0.7% vs 0.2%; relative risk [RR], 3.16 [95% CI, 2.57-3.75]). Robotic-assisted cholecystectomy was also associated with a higher rate of postoperative biliary interventions, such as endoscopic stenting (7.4% vs 6.0%; RR, 1.25 [95% CI, 1.16-1.33]). There was no significant difference in overall 30-day complication rates between the 2 procedures. The instrumental variable analysis, which was designed to account for potential unmeasured differences in treatment groups, also showed that robotic-assisted cholecystectomy was associated with a higher rate of bile duct injury (0.4% vs 0.2%; RR, 1.88 [95% CI, 1.14-2.63]). This cohort study's finding of significantly higher rates of bile duct injury with robotic-assisted cholecystectomy compared with laparoscopic cholecystectomy suggests that the utility of robotic-assisted cholecystectomy should be reconsidered, given the existence of an already minimally invasive, predictably safe laparoscopic approach.

Impact of delayed intervention following admission for small bowel obstruction: A contemporary analysis

BackgroundThe optimal timing of surgical intervention for small bowel obstruction (SBO) remains debated. MethodsAll adults admitted for SBO were identified in the 2018–2019 National Inpatient Sample. Patients undergoing small bowel resection or lysis of adhesion after three days were considered part of the Delayed cohort. All others were classified as Early. Multivariable regressions were used to assess independent predictors of delayed surgical intervention as well as associations between delayed management and in-hospital mortality, major adverse events (MAE), perioperative complications, postoperative length of stay (LOS), hospitalization costs and non-home discharge. ResultsAmong 28,440 patients who met study criteria, 52.0 % underwent delayed intervention. Black race (AOR 1.19, 95 % CI 1.03–1.36, ref.: White) and Medicare coverage (AOR 1.16, 95 % CI 1.01–1.33, ref.: private payer) were associated with increased odds of delayed surgical management. While delayed intervention was not significantly associated with death (AOR 1.27, 95 % CI 0.97–1.68), it was linked to greater odds of MAE (AOR 1.30, 95 % CI 1.16–1.45) and several perioperative complications. The Delayed cohort also faced an incremental increase in postoperative LOS (+1.29 days, 95 % CI 0.89–1.70) and hospitalization costs (+$11,000, 95 % CI 10,000-12,000). Moreover, delayed intervention was linked to increased odds of non-home discharge (AOR 1.64, 95 % CI 1.47–1.84). ConclusionsDelay in surgical management following SBO is linked to inferior clinical outcomes and increased resource use. Our findings highlight the need to ensure proper timing of surgery for SBO as well as efforts to standardize these practices across all demographics of patients.

Access to effective smoking cessation medications in patients with medicare, medicaid and private insurance

ObjectivesCompare financial barriers to the most effective smoking cessation medications - varenicline and combination nicotine replacement therapy (CNRT) across major insurance categories and determine whether these financial barriers impact smoking cessation outcomes. Study designLongitudinal retrospective observational cohort study. MethodsPatients seen at Duke Smoking Cessation Program 05/2016 through 07/2021 were studied. Those prescribed varenicline or CNRT were determined to have financial barriers to access if they could not purchase the medication using insurance or their own funds. Outcomes were compared between Medicare, Medicaid, and private insurers. Abstinence was defined as self-reported 7-day smoking abstinence. ResultsPatients with Medicare were 5.08 times more likely to face a financial barrier to highly effective smoking cessation medications compared to patients with private insurance (p<0.00001) and 2.81 times more likely compared to Medicaid (p<0.00001). Patients able to access these highly effective medications achieved a smoking abstinence rate that was 1.58 times higher than those who could not (p = 0.01) ConclusionsFindings suggest Medicare coverage of the most effective smoking cessation medications is considerably worse than Medicaid or private insurance; inability to access these medications may lead to lower rates of smoking abstinence.

Improving Food and Drug Administration-Centers for Medicare and Medicaid Services Coordination for Drugs Granted Accelerated Approval.

The Food and Drug Administration (FDA)'s accelerated-approval pathway expedites patient access to promising treatments. However, increasing use of this pathway has challenged the Medicare program, which often pays for expensive therapies despite substantial uncertainty about benefits and risks to Medicare beneficiaries. We examined approaches to improve coordination between the FDA and Centers for Medicare and Medicaid Services (CMS) for drugs granted accelerated approval. We argue that policymakers have focused on expedited pathways at the FDA without sufficient attention to complementary policies at the CMS. Although differences between the FDA and CMS decisions are to be expected given the agencies' different missions and statutory obligations, procedural improvements can ensure that Medicare beneficiaries have timely access to novel therapies that are likely to improve health outcomes. To inform policy options and recommendations, we conducted semistructured interviews with stakeholders to capture diverse perspectives on the topic. We recommend ten areas for consideration: clarifying the FDA's evidentiary standards; strengthening FDA authorities; promoting earlier discussions among the FDA, the CMS, and drug companies; improving Medicare's coverage with evidence development program; tying Medicare payment for accelerated-approval drugs to evidence generation milestones; issuing CMS guidance on real-world evidence; clarifying Medicare's "reasonable and necessary" criteria; adopting lessons from international regulatory-reimbursement harmonization efforts; ensuring that the CMS has adequate staffing and expertise; and emphasizing equity. Better coordination between the FDA and CMS could improve the transparency and predictability of drug approval and coverage around accelerated-approval drugs, with important implications for patient outcomes, health spending, and evidence generation processes. Improved coordination will require reforms at both the FDA and CMS, with special attention to honoring the agencies' distinct authorities. It will require administrative and legislative actions, new resources, and strong leadership at both agencies.

Factors associated with adherence to provider referrals for lung cancer screening with low dose computed tomography before and during COVID-19 pandemic

BackgroundLung cancer has been the leading cause of American deaths from cancer. Although Medicare started covering lung cancer screening (LCS) with low-dose computed tomography (LDCT) in 2015, the uptake of LDCT-LCS remains low. This study examines the changes in adherence to provider referrals for LDCT-LCS and the factors at patient, provider, and health system levels that influence the completion rate of LDCT-LCS orders before and during the COVID-19 pandemic.MethodsOur study examined electronic health record data (December 2013 - December 2020) from a large, community-based clinical healthcare delivery system in California. We plotted monthly trends in the frequency of LDCT-LCS orders and completion rate and compared the annual LDCT-LCS completion rate between LCS-eligible, LCS-ineligible, and unknown eligibility groups. We then explored multilevel factors associated with the completion of LDCT-LCS orders using hierarchical generalized linear models.ResultsThere was an increase in LDCT-LCS orders (N = 12,469) from 2013 to 2019, followed by a sharp decline in March 2020 due to the onset of the COVID-19 pandemic. Thereafter, LDCT-LCS orders slowly increased again in June 2020. The completion rate of LDCT-LCS increased from 0% in December 2013 to approximately 70% in 2018–2019 but declined to 50–60% in 2020 during the pandemic. Ineligible patients had lower completion rates of LDCT-LCS. Patients who were new to the healthcare system, Black, received the LDCT-LCS order in the first few years after Medicare coverage (2016 or 2017), during the pandemic, had major comorbidities, and smoked less than 30 pack-years were less likely to complete an order. Patients were more likely to complete LDCT-LCS orders if they were younger, received the LDCT-LCS order from a physician (vs. nonphysician provider), from family medicine or other specialties (vs. internal medicine), or saw a provider with more experience in LDCT-LCS.ConclusionsThe beginning of the COVID-19 pandemic largely decreased the volume of LDCT-LCS orders, but rates have since been slowing recovering. Future interventions to improve lung cancer screening should consider doing more targeted outreach to new patients and Black patients as well as providing additional education to nonphysician practitioners and those providers with lower rates of LDCT-LCS referral orders.

Assessment of Socio-Economic Adaptability to Ageing in Resource-Based Cities and Its Obstacle Factor

The resource-based city is a type of city with pronounced ageing problems. Correctly grasping the socio-economic adaptability to ageing in resource-based cities can help actively guide the direction of urban development and build a new socio-economic order for the elderly. This paper first selects 125 resource-based cities in China from 2000 to 2020 for characteristic analysis, and finds that resource-based cities are characterized by fast growth rate and a large proportion of ageing population, deep ageing, large regional differences and uncoordinated ageing development with regional socio-economic development levels. The research objective of this article is to explore the temporal evolution characteristics, spatial patterns, agglomeration characteristics, and factors hindering the socio-economic adaptability to ageing in resource-based cities in China from 2000 to 2020. Therefore, an indicator system for assessing the socio-economic adaptability to ageing was constructed, and the improved entropy-weighted TOPSIS model was used to measure the socio-economic adaptability to ageing in 113 resource-based cities in China from 2000 to 2020. The spatio-temporal variation characteristics of the socio-economic adaptability to ageing in resource-based cities were analyzed by descriptive analysis and Moran’s index, and the main obstacle dimensions and obstacle indicators were clarified by the obstacle factor model. The findings can be summarized as follows: Temporal Analysis: Over the timeframe assessed, the socio-economic adaptability of ageing in resource cities demonstrates a consistent year-on-year improvement. The spatial clustering pattern exhibits a noteworthy trend of “significant-significant-insignificant”. Spatial Pattern: Examining the spatial arrangement from 2000 to 2020, areas with medium-low and low adaptability are prominently concentrated in Eastern China and Northeastern China, while regions with medium-high and high adaptability are focal in Northern China and Eastern China. Hebei Province and its neighboring provinces consistently display H-H clustering, contrasting with the Southwestern regions that persistently exhibit L-L clustering. Obstacle Degree Analysis: Across the 2000 to 2020 period, dimensions related to economic development, social participation, and social security consistently emerge as the primary obstacles. Notably, the top 12 average annual obstacle indicators are selected, and within economic development dimension all 4 indicators predominate as the key obstacles. Within the social participation dimension, tertiary sector value added and total retail sales of consumer goods per capita feature as primary obstacles. Regarding social security, impediments are primarily associated with the ratio of Medicare coverage, the ratio of pension coverage, alongside the development level of the social security sector. In the domain of service provision, key obstacle indicators include park area per capita, number of books in public libraries per 100 inhabitants, and public trams and buses per 10,000 inhabitants.

Medicare coverage of buprenorphine-naloxone film surrounding generic entry.

To investigate trends in Medicare coverage of buprenorphine-naloxone film before and after the FDA approval of its first generic versions. This study used data from the Part D Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from 2015 to 2022, which provide information on all stand-alone Medicare/Medicare Advantage Prescription Drug Plans. We examined the percentage of plans that provided coverage of brand-name and generic buprenorphine-naloxone films with strength 8 mg/2 mg during 2015-2022. Median out-of-pocket (OOP) cost for a 30-day supply was estimated among all plans that provided coverage. Generic buprenorphine-naloxone film was covered by 82% of Medicare Part D plans in 2020, 2 years after market entry. Coverage of brand-name Suboxone film decreased from 76% in 2019 to 42% in 2020. The median OOP cost of buprenorphine-naloxone films faced by Medicare enrollees decreased from $99 in 2019 to $42 in 2020, driven by the lower price of generic films. In contrast, the OOP cost for brand-name buprenorphine-naloxone film increased gradually from $85 in 2015 to $100 in 2022. Medicare Part D plan formularies replaced brand-name buprenorphine-naloxone films with the newly approved generic versions. This was accompanied by a substantial decrease in estimated OOP cost faced by Part D enrollees. These changes could potentially increase access to buprenorphine among Medicare enrollees with opioid use disorder.

Racial and ethnic disparities in telehealth use before and after California's stay-at-home order.

Telehealth can potentially improve the quality of healthcare through increased access to primary care. While telehealth use increased during the COVID-19 pandemic, racial/ethnic disparities in the use of telemedicine persisted during this period. Little is known about the relationship between health coverage and patient race/ethnicity after the onset of the COVID-19 pandemic. This study examines how differences in patient race/ethnicity and health coverage are associated with the number of in-person vs. telehealth visits among patients with chronic conditions before and after California's stay-at-home order (SAHO) was issued on 19 March 2020. We used weekly patient visit data (in-person (N = 63, 491) and telehealth visits (N = 55, 472)) from seven primary care sites of an integrated, multi-specialty medical group in Los Angeles County that served a diverse patient population between January 2020 and December 2020 to examine differences in telehealth visits reported for Latino and non-Latino Asian, Black, and white patients with chronic conditions (type 2 diabetes, pre-diabetes, and hypertension). After adjusting for age and sex, we estimate differences by race/ethnicity and the type of insurance using an interrupted time series with a multivariate logistic regression model to study telehealth use by race/ethnicity and type of health coverage before and after the SAHO. A limitation of our research is the analysis of aggregated patient data, which limited the number of individual-level confounders in the regression analyses. Our descriptive analysis shows that telehealth visits increased immediately after the SAHO for all race/ethnicity groups. Our adjusted analysis shows that the likelihood of having a telehealth visit was lower among uninsured patients and those with Medicaid or Medicare coverage compared to patients with private insurance. Latino and Asian patients had a lower probability of telehealth use compared with white patients. To address access to chronic care management through telehealth, we suggest targeting efforts on uninsured adults and those with Medicare or Medicaid coverage, who may benefit from increased telehealth use to manage their chronic care.

Comparing COVID-19 Response Behaviors between a Cancer Patient Sample and a Population-Based Cancer-Free Sample in a Rural Midwestern State

Introduction: The COVID-19 pandemic caused an increase in fear, anxiety, and depressive symptoms globally. For populations at increased risk for adverse outcomes due to illness, such as cancer patients, these worries may have been exacerbated. Understanding how the pandemic impacted cancer patients will inform better preparation for future events that cause disturbances to cancer care delivery. Methods: This study analyzed data from two surveys to determine whether cancer patients’ responses differed from a cancer-free population-based sample in terms of concerns, preventive behaviors, and thoughts on their healthcare provider’s communication regarding COVID-19 in a US Midwestern state. In August 2020, a survey was sent to 10,009 Iowans aged 18 and older, randomly selected from the 2018 Iowa voter registration file. In September 2020, a survey was emailed to 2,954 cancer patients aged 18 and older who opted into the University of Iowa Holden Comprehensive Cancer Center’s Patients Enhancing Research Collaborations at Holden program. Previously validated and pretested Likert-type and multiple-choice items assessed concern regarding COVID-19, social distancing perception and behaviors, and demographic characteristics of respondents. We used χ2 tests and logistic regression to examine differences between the cancer patient and general population survey responses. Results: We included 3,622 responses from the general population survey and 780 responses from the cancer patient survey in this analysis. Cancer patient survey respondents were more frequently older, lived in urban areas, had Medicare insurance coverage, had a college degree or higher, and were married. Cancer patients were more likely to report engaging in social distancing behaviors and greater concern regarding the pandemic. Conclusion: This study suggests differences in the impact of the COVID-19 pandemic on cancer patients compared to cancer-free members of the general population. These results indicate the need for consideration of cancer patients’ physical and mental health during large-scale disruptions to cancer care.

Unintended Consequences of Increased Out-of-Pocket Costs During Medicare Coverage Gap on Anticoagulant Discontinuation and Stroke.

This study aims to assess the risk of direct oral anticoagulant (DOAC) discontinuation among Medicare beneficiaries with non-valvular atrial fibrillation (NVAF) who reach the Medicare coverage gap stratified by low-income subsidy (LIS) status and the impact of DOAC discontinuation on rates of stroke and systemic embolism (SE) among beneficiaries with increased out-of-pocket (OOP) costs due to not receiving LIS. In this retrospective cohort study, Medicare claims data (2015-2020) were used to identify beneficiaries with NVAF who initiated rivaroxaban or apixaban and entered the coverage gap during ≥ 1year. DOAC discontinuation rates during the coverage gap were stratified by receipt of Medicare Part D Low-Income Subsidy (LIS), a proxy for not experiencing increased OOP costs. Among non-LIS beneficiaries, incidence rates of stroke and SE during the subsequent 12months were compared between beneficiaries who did and did not discontinue DOAC in the coverage gap. Among 303,695 beneficiaries, mean age was 77.3years, and 28% received LIS. After adjusting for baseline differences, non-LIS beneficiaries (N = 218,838) had 78% higher risk of discontinuing DOAC during the coverage gap vs. LIS recipients (adjusted hazard ratio [aHR], 1.78; 95% CI [1.73, 1.82]). Among non-LIS beneficiaries, DOAC discontinuation during coverage gap (N = 91,397; 34%) was associated with 14% higher risk of experiencing stroke and SE during the subsequent 12months (aHR, 1.14; 95% CI [1.08, 1.20]). Increased OOP costs during Medicare coverage gap were associated with higher risk of DOAC discontinuation, which in turn was associated with higher risk of stroke and SE among beneficiaries with NVAF.

Time From Authorization by the US Food and Drug Administration to Medicare Coverage for Novel Technologies

A wide variety of novel medical diagnostics and devices are determined safe and effective by the US Food and Drug Administration (FDA) each year, but to our knowledge the literature lacks evidence documenting how long it takes to establish new Medicare coverage for these technologies. To measure time from FDA authorization to at least nominal Medicare coverage for technologies requiring a new reimbursement pathway. In this cross-sectional study, public databases were used to associate each technology to billing codes, determine the effective date of each code and Medicare coverage decisions, and stratify by the maturity of the Medicare coverage. At least nominal coverage was defined as achievement of explicit coverage milestones through a national coverage determination, local coverage determinations by Medicare administrative contractors, or by implicit coverage aligned to a new billing code. Characterization by product type (acute treatment, chronic or ongoing treatment, diagnostic assay, and diagnostic device), manufacturer size, and evidence level were assessed for association with coverage achievement. The study included new product applications authorized by the FDA through the premarket approval pathway, the de novo pathway, or with breakthrough designation in the 510(k) pathway from January 1, 2016, to December 31, 2019. Data analysis took place between May 1, 2022, and December 31, 2022. Time from FDA authorization to the first coverage milestone. Among 281 identified technologies in the total sample, 64 (23%) were deemed novel technologies based on the absence of coverage determinations and/or the use of temporary or miscellaneous billing codes. Twenty-eight of 64 technologies (44%) successfully achieved explicit or implicit coverage following FDA authorization. The median time to at least nominal coverage for the analysis cohort was 5.7 years (90% CI, 4.4-NA years). Analysis of time-to-coverage data highlighted company size (log-rank P<.001) and product type (log-rank P = .01) as significant covariates associated with coverage achievement. No association was observed for technologies with level 1 evidence at FDA authorization and subsequent coverage milestone achievement (log-rank P = .40). In this cross-sectional study of 64 novel technologies, only 28 (44%) achieved coverage milestones over the study timeline. The several-year period observed to establish at least nominal coverage suggests existing coverage processes may affect timely reimbursement of new technologies.

Statutory Authority for Medicare Coverage Decisions—CMS Is an Independent Federal Agency

Statutory Authority for Medicare Coverage Decisions—CMS Is an Independent Federal Agency

Examining the &amp;ldquo;Medicare Effect&amp;rdquo; on Distant-Stage Cancer Diagnoses by Site, Gender, and Rurality

Background: Compared to cancers detected early, distant stage cancers are associated with lower survival, diminished quality of life, and higher costs. Evidence suggests that greater access to comprehensive health insurance (i.e., Medicare) improved early detection. Yet, few studies have evaluated the effect of Medicare coverage across cancers or factors influencing healthcare use. Methods: This study analyzed 35 years of population-based cancer registry data from the Surveillance Epidemiology and End Results program for eight common cancers: Oral, Digestive, Respiratory, Skin, Genital, Urinary, Endocrine, and Breast. Leveraging the subjective threshold determining Medicare’s eligibility at age 65, Medicare’s effect on the probability of a distant diagnosis was estimated using Robust Non-Parametric Regression Discontinuity models. Results: Medicare was associated with reduced proportion of distant diagnoses for five common cancers. The proportion of distant cancers declined by 1.7-percentage points for digestive cancers (p &lt; 0.01), 1.6-percentage points for respiratory cancers (p &lt; 0.01), 0.5-percentage points for genital cancers (p &lt; 0.05), 1.4-percentage points for urinary cancers (p &lt; 0.01), and 0.8-percentage points for female breast cancers (p &lt; 0.01). The relative difference from average distant stage rates for these significant estimates range from 3% (Respiratory) to 15% (Genital). Most estimates were consistent across gender, but Medicare was only associated with declined distant-stage diagnoses for patients in urban and metro regions. Conclusions: This study reaffirms that Medicare coverage is associated with earlier diagnoses for patients in urban and metro regions for digestive, respiratory, genital, urinary, and female breast cancers. These results stress the importance of healthcare insurance, but also reveal the limitations of insurance expansion policies for patients in rural areas and for cancers without standard screening protocols.

Integrating Medicare and Medicaid Coverage for Dual Eligibles—Recommendations for Reform

This Viewpoint highlights costly inefficiencies in delivery of care to patients who qualify to receive both Medicare and Medicaid and proposes more effective care models.

Changes In County-Level Access To Medications For Opioid Use Disorder After Medicare Coverage Of Methadone Treatment Began.

In 2020 Medicare began reimbursing for opioid treatment program (OTP) services, including methadone maintenance treatment for opioid use disorder (OUD), for the first time. Methadone is highly effective for OUD, yet its availability is restricted to OTPs. We used 2021 data from the National Directory of Drug and Alcohol Abuse Treatment Facilities to examine county-level factors associated with OTPs accepting Medicare. In 2021, 16.3percent of counties had at least one OTP that accepted Medicare. In 124 counties the OTP was the only specialty treatment facility offering any form of medication for opioid use disorder (MOUD). Regression results showed that the odds of a county having an OTP that accepted Medicare were lower for counties with higher versus lower percentages of rural residents and lower for counties located in the Midwest, South, and West compared with the Northeast. The new OTP benefit improved the availability of MOUD treatment for beneficiaries, although geographic gaps in access remain.

The Value of Medicare Coverage on Depressive Symptoms Among Older Immigrants.

The immigrant population, the primary driver of U.S. population growth, is aging and many immigrants remain uninsured. Lack of health insurance limits access to care, aggravating the already high level of depression for older immigrants. However, there is scarce evidence on how health insurance, particularly Medicare, affects their mental health. Using the Health and Retirement Study, this study examines the effect of Medicare coverage on depressive symptoms of older immigrants in the United States. Exploiting the fact that many immigrants are not covered by Medicare after passing age 65, we use a difference-in-difference model with propensity score weighting to compare differences in depressive symptoms pre- and post-age-65. We further stratify the sample by socioeconomic status and by race/ethnicity. Medicare coverage was significantly associated with a reduction in the probability of reporting depressive symptoms for immigrants with low socioeconomic status, especially for those below median wealth levels. The beneficial effect of Medicare coverage was also statistically significant for non-White immigrants-Black, Hispanic, and Asian/Pacific Islander-even when holding socioeconomic status constant. Our findings imply that immigration policies that expand health care protection to older immigrants can lead to further health benefits and reduce existing disparities for the aging population. Policy reforms such as providing limited Medicare access to immigrants who paid sufficient taxes but are still awaiting permanent residency status could increase coverage for the uninsured and improve participation of immigrants in the payroll system.

#5749 RATES OF SELECTED CARDIOVASCULAR AND NON-CARDIOVASCULAR EVENTS AMONG DIALYSIS PATIENTS WITH ANEMIA IN THE US MEDICARE POPULATION

Abstract Background and Aims The safety and efficacy of daprodustat in patients on dialysis were reported in ASCEND-D/ID trials [1,2]. Trials impose strict criteria for enrollment, making participants more narrowly selected than a broader population with disease who might benefit from treatment. We describe events, of which most were noted as safety events in ASCEND-D/ID trials, among general anemia “treatment eligible” (TE) patients on dialysis and patients similar to those in ASCEND-D/ID trials (“clinical trial-like” [CTL]) in the US. Method Using United States Renal Data System data, we conducted a retrospective cohort study of incident dialysis-dependent (IDD) patients from 2017–2019 and, separately, point prevalent dialysis-dependent (PDD) patients as of Jan 1 2018. Dialysis initiation date was the index date for IDD patients and Jan 1 2018 for PDD patients. We also required patients to have ≥6 months of continuous Medicare coverage before, and be aged ≥18 years on, index date. Patients with a history of kidney transplant or who had cancer during the year prior, and those who had a hospitalization for heart failure (HF), myocardial infarction (MI), or stroke in the 4 weeks before, the index date were excluded. For IDD patients, we required use of ESAs at the index date to support comparability to the PDD patients. The CTL cohort was a subset of the TE cohort, approximating eligibility in the ASCEND-D/ID trials. Patients were followed from index date to the earliest date of death, loss of Medicare coverage, kidney transplantation, or Dec 31 2019. We assessed cardiovascular (CV: all-cause death, HF, MI, stroke, thromboembolic events [TEEs], major cardiovascular events [MACE: death, MI, stroke] and MACE+HF) and non-CV (cancer, gastric erosions, ocular events, seizures, serious infections) events, derived from medical claims in the follow-up period using ICD-10 diagnosis, Healthcare Common Procedure Coding System, and Current Procedural Terminology codes. HF, MI, stroke, and serious infections were defined as inpatient events. First event rates for TE and CTL cohorts were calculated separately for IDD and PDD patients and expressed as number of events per 100 patient-years (PYs). Results Of IDD patients, 23,909 were in the TE and 6,962 in the CTL cohorts; corresponding numbers were 230,055 and 41,980 for PDD patients. Median follow-up was 12.6 and 13.8 months for the TE and CTL cohorts, respectively, in IDD patients; and 24 months for both TE and CTL cohorts in PDD patients. Mean ages were 70.3 and 71.0 years for the TE and CTL cohorts in IDD patients; and 63.3 and 64.1 years for the TE and CTL cohorts in PDD patients. For both IDD and PDD patients, the TE and CTL cohorts had similar demographics, but the TE cohorts had a slightly higher proportion of patients with comorbidities. First event rates are shown in the Table. TE cohorts had higher rates than CTL cohorts for most CV events (mortality, 17.3 vs 14.0 per 100 PYs in IDD and 16.8 vs 15.1 in PDD; MACE; 20.9 vs 17.5 in IDD and 20.3 vs 18.6 in PDD; MACE+HF, 25.6 vs 21.8 in IDD, 26.9 vs 25.1 in PDD). In IDD patients, HF was more common in the TE than the CTL cohort (7.1 vs 6.1) but was similar in PDD patients. MI, stroke, and TEEs (vascular access thrombosis [in hemodialysis patients only], deep venous thrombosis, and pulmonary embolism) had similar rates in the TE and CTL cohorts for both IDD and PDD patients. Serious infections were higher in the TE than the CTL cohort in both IDD and PDD patients. In PDD patients, gastric erosions were higher in the TE than the CTL cohort (40.0 vs 38.5) while ocular events and retinal hemorrhage were lower in the TE cohort. Conclusion Rates for most CV events were higher in TE cohorts, comprised of patients eligible for anemia treatment, compared with CTL cohorts mimicking trial participants. Rates of non-CV events did not show a consistent pattern. As expected, rates of VAT were higher in IDD than PDD patients. These findings further contextualize real-world event rates of interest in dialysis populations. Reported rates were crude (unadjusted) and should be interpreted with caution. Funding: GSK (study 217316).

#5810 SELECTED CARDIOVASCULAR (CV)/NON-CV EVENT RATES IN NON-DIALYSIS-DEPENDENT PATIENTS TREATED WITH ESAS IN US MEDICARE (2017–2019), BY CKD STAGE

Abstract Background and Aims The safety and efficacy of daprodustat in non-dialysis-dependent chronic kidney disease (CKD) patients have been reported in the ASCEND-ND trial [1]. However, CKD stage may affect both the need for anemia treatment as well as outcomes, including potential safety events for anemia treatment. This study describes cardiovascular (CV) and non-CV event rates by CKD stage among patients treated with erythropoietin-stimulating agents (ESAs) in the US Medicare population. Method Using Medicare data for all fee-for-service enrollees, we conducted a retrospective cohort study of patients who had diagnosis of CKD stages 3, 4, or 5 and a first use of ESA in 2017–2019. CKD stage was identified by ICD-10 codes; ESA use was derived using Healthcare Common Procedure Coding System (HCPCS) codes. The date of first ESA use was the index date and CKD stage was defined as the most recent diagnosis on or before index date. We further required patients to have at least 12 continuous months of Medicare Parts A and B coverage (also used as a washout period to identify new ESA users) prior to, and be aged ≥66 years on, the index date. Patients with a history of kidney transplant or who had cancer during the year prior, and those who had a hospitalization for heart failure (HF), myocardial infarction (MI), or stroke in the 4 weeks before, the index date were excluded. Patients were followed from index date to the earliest date of death, loss of Medicare coverage, kidney transplantation or dialysis, or December 31, 2019. Both CV (all-cause death, HF, MI, stroke, thromboembolic events [TEEs], MACE [death, stroke, MI], and MACE+HF) and non-CV (cancer, gastric erosions, ocular events, seizures, and serious infections) events were ascertained, derived from Medical claims using ICD-10 diagnosis, HCPCS, and Current Procedural Terminology codes in the follow-up period. HF, MI, stroke, and serious infection were defined as inpatient events. First event rates were calculated separately by CKD stage, expressed as number of events per 100 patient-years during the follow-up period. Results This study cohort included 50,206 patients; 22,332 had stage 3, 19,177 stage 4, and 8,697 stage 5 CKD at the index date. Median follow-up time was 11.5 months for patients with CKD stage 3, 8.9 months for patients with stage 4, and 3.7 months for patients with stage 5 CKD. Patients with higher (worse) CKD stages were slightly younger (mean ages for stages 3, 4, and 5 were 79.7, 79.1, and 76.8 years); with increasingly more males (42.9%, 45.1%, and 48.5%), increasingly more individuals of non-Hispanic Black race (14.2%, 15.7%, and 19.6%), with lower income (indicated by Medicare/Medicaid dual enrolment and Medicare Part D low-income subsidy), and lower proportion of comorbidities. Rates were higher for most CV events in patients with higher (worse) CKD stages (Table): death rates were 19.5, 22.1, and 28.1 per 100 patient-years for stages 3, 4, and 5, respectively; MI rates were 2.2, 2.9, and 3.2; HF rates were 12.5, 17.2, and 19.0; MACE rates were 22.0, 25.4, and 31.8; and MACE+HF rates were 31.0, 38.7 and 47.8, respectively. Rates of stroke were similar across CKD stages; but no pattern for TEE. For non-CV events, higher (worse) CKD stage had higher rates of first ocular events (17.2, 23.3, and 27.1) and seizures (2.3, 2.7, and 3.4), but lower rates of cancer (21.8, 14.2, and 10.2) and, within this, hematological malignancies (10.4, 4.11 and 2.3). Conclusion Medicare-covered ESA-treated patients with higher CKD stage had higher rates for most events assessed, while malignancy rates were lower. These findings may provide important context when assessing US event rates in non-dialysis-dependent CKD patients. Further investigation could clarify some of the differences between stages, such as rates of malignancy. Rates were reported as crude (unadjusted) and so should be interpreted with caution. Limiting the analysis to ESA-treated patients may have resulted in different event rates than would be expected to occur in the general CKD population. Funding: GSK (study 217316).

#5644 SELECTED CARDIOVASCULAR AND NON-CARDIOVASCULAR EVENTS IN INCIDENT AND PREVALENT DIALYSIS PATIENTS IN THE US MEDICARE POPULATION

Abstract Background and Aims The ASCEND-D/ID trial reported safety and efficacy of daprodustat in patients receiving dialysis [1,2]. Rates and types of clinical outcomes vary between incident and prevalent dialysis patients. This study assessed events, of which most were described as safety events in ASCEND-D/ID trial, among incident dialysis patients on erythropoiesis-stimulating agents (ESAs) and prevalent dialysis patients in the US Medicare population. Method This is a retrospective, observational cohort study using United States Renal Data System data. The study included incident dialysis-dependent (IDD) patients from 2017–2019 and, separately, prevalent dialysis-dependent (PDD) patients as of January 1, 2018. For IDD patients, the index date was the dialysis initiation date; for PDD patients, the index date was January 1, 2018. To establish the cohorts, we further required patients to have at least 6 continuous months of Medicare Parts A and B coverage prior to, and be aged ≥18 years on, the index date. For IDD patients, we also required ESA use on the index date to better support comparability to the PDD patients. Patients with a history of kidney transplant or who had cancer during the year prior to, or who had a hospitalization for heart failure (HF), myocardial infarction (MI), or a stroke in the 4 weeks before, the index date were excluded. Patients were followed from index date (for IDD patients, follow-up started from index date plus 60 days to ascertain dialysis modality stability) to the earliest date of death, loss of Medicare coverage, kidney transplantation, or December 31, 2019. Events assessed were cardiovascular (CV: all-cause death, HF, MI, stroke, thromboembolic events [TEE], major adverse CV events [MACE: composite of death, MI, stroke], and MACE+HF) and non-CV (cancer, gastric erosions, ocular events, seizures, serious infection) events, derived from medical claims in the follow-up period using ICD-10 diagnosis, Healthcare Common Procedure Coding System, and Current Procedural Terminology codes in the follow-up period. HF, MI, stroke, and serious infection events were defined as inpatient events. TEEs included vascular access thrombosis (VAT), deep venous thrombosis (DVT), and pulmonary embolism (PE). First event rates were calculated separately for IDD and PDD cohorts and expressed as number of events per 100 patient-years. Results The IDD cohort contained 23,909 patients; the PDD cohort, 230,055. Median follow-up time was 12.6 months for the IDD cohort and 24.0 months for PDD cohort. Mean ages of the IDD and PDD cohorts were 70.3 and 63.3 years, respectively. Compared with the PDD cohort, patients in the IDD cohort were more likely to be female (48.2% vs 43.7%), of non-Hispanic White race (61.6% vs 40.4%), less likely be of lower-income status (33.0% vs 47.4% for Medicare/Medicaid dual enrollment and 38.6% vs 57.0% for Part D low-income subsidy) and with higher proportion of comorbidities. First event rates are shown in the Table for the IDD and PDD cohorts. Compared with the PDD cohort, patients in the IDD cohort had higher rates of all-cause mortality (17.3 vs 16.8 per 100 patient-years), stroke (1.8 vs 1.4), VAT (109.4. vs 67.2, hemodialysis patients only), and MACE (20.9 vs 20.3); however, they had lower rates of MI (3.1 vs 3.5), HF (7.1 vs 8.9), DVT (3.2 vs 4.0), and MACE+HF (25.6 vs 26.9). For non-CV events, patients in the IDD cohort had lower event rates for nearly all events except malignancies. Conclusion ESA-treated IDD patients had higher event rates for some CV events but lower rates for most non-CV events compared with PDD patients. As expected, however, rates of VAT were higher in IDD patients than PDD patients. These background event rates in real-world populations with wide ESA use provide context when considering potential alternative treatments for anemia. Limitation of this descriptive study includes the reporting of crude (unadjusted) rates, and therefore should be interpreted with caution. Funding: GSK (study 217316).