Centers For Medicare Research Articles

Unintended Consequences of Data Sharing Under the Meaningful Use Program.

Interoperability has been designed to improve the quality and efficiency of health care. It allows the Centers for Medicare and Medicaid Services to collect data on quality measures as a part of the Meaningful Use program. Covered providers who fail to provide data have lower rates of reimbursement. Unintended consequences also arise at each step of the data collection process: (1) providers are not reimbursed for the extra time required to generate data; (2) patients do not have control over when and how their data are provided to or used by the government; and (3) large datasets increase the chances of an accidental data breach or intentional hacker attack. After detailing the issues, we describe several solutions, including an appropriate data use review board, which is designed to oversee certain aspects of the process and ensure accountability and transparency.

Representativeness of Studies Required Under Medicare's Coverage With Evidence Development Program.

This study evaluates representation of older adults, women, and people of Black race and Hispanic ethnicity in Centers for Medicare & Medicaid Services national coverage determination (NCD) and coverage with evidence development (CED)–approved studies.

Complexity and Variation in Infectious Disease Birth Cohorts: Findings from HIV+ Medicare and Medicaid Beneficiaries, 1999–2020

The impact of uncertainty in information systems is difficult to assess, especially when drawing conclusions from human observation records. In this study, we investigate survival variation in a population experiencing infectious disease as a proxy to investigate uncertainty problems. Using Centers for Medicare and Medicaid Services claims, we discovered 1,543,041 HIV+ persons, 363,425 of whom were observed dying from all-cause mortality. Once aggregated by HIV status, year of birth and year of death, Age-Period-Cohort disambiguation and regression models were constructed to produce explanations of variance in survival. We used Age-Period-Cohort as an alternative method to work around under-observed features of uncertainty like infection transmission, receiver host dynamics or comorbidity noise impacting survival variation. We detected ages that have a consistent, disproportionate share of deaths independent of study year or year of birth. Variation in seasonality of mortality appeared stable in regression models; in turn, HIV cases in the United States do not have a survival gain when uncertainty is uncontrolled for. Given the information complexity issues under observed exposure and transmission, studies of infectious diseases should either include robust decedent cases, observe transmission physics or avoid drawing conclusions about survival from human observation records.

Abstract 4131630: Comparative Outcomes of Left Atrial Appendage Occlusion Device Implantation in Atrial Fibrillation Patients with a Lower Stroke Risk

Introduction: Current guidelines recommend oral anticoagulation in atrial fibrillation (AF) patients with a CHA 2 DS 2 -VASc score ≥ 2 for stroke prevention. Left atrial appendage occlusion (LAAO) devices serve as alternatives to reduce stroke risk in select AF patients that are unable to tolerate long-term oral anticoagulation. However, Centers for Medicare&Medicaid Services reimburses left atrial appendage occlusion (LAAO) for patients with CHA 2 DS 2 -VASc score ≥ 3. Objective: To evaluate differences in outcomes and complications of LAAO therapy in AF patients with a CHA 2 DS 2 -VASc score of ≥ 3 versus < 3. Methods: National Inpatient Sample and International Classification of Diseases, 10th Revision codes were used to identify AF patients who underwent LAAO device implantation in the U.S. from 2016−2020. The study population was stratified by stroke risk into two groups, CHA 2 DS 2 -VASc ≥ 3 and < 3. Study endpoints assessed included procedural complications, inpatient outcomes and resource utilization. A multivariable logistic regression model was used to assess the independent association of CHA 2 DS 2 -VASc score with study outcomes. Results: A total of 73,795 and 15,500 LAAO devices were implanted in patients with CHA 2 DS 2 -VASc ≥ 3 and < 3, respectively. Compared to patients with CHA 2 DS 2 -VASc score of ≥ 3, patients with CHA 2 DS 2 -VASc < 3 had lower overall (6.9% vs 9.9%, P< 0.01) and major (4.5% vs 6.2%, P< 0.01) complications in the crude analysis. After multivariable adjustment for potential confounders, CHA 2 DS 2 -VASc < 3 was associated with lower overall complications (aOR 0.84, 95% CI 0.78 – 0.91), major complications (aOR 0.90, 95% CI 0.81-0.99) and cost of hospitalization (aOR 0.95, 95% CI 0.91-0.99). Conclusions: Patients with CHA 2 DS 2 -VASc < 3 had lower complications and hospitalization costs after LAAO device implantation than patients with CHA 2 DS 2 -VASc ≥ 3 . These data, if redemonstrated in a large randomized trial can have important clinical implications for stroke prevention in AF patients.

CMS's Drug Price Negotiation Program 2023 Patient-Focused Listening Sessions: A Descriptive Analysis of Speaker Remarks.

The US Centers for Medicare and Medicaid Services (CMS) held patient-focused listening sessions in Fall 2023 for each of the first ten drugs selected for the Inflation Reduction Act's (IRA) Drug Price Negotiation Program (DPNP). This study aimed to quantitatively describe speaker input at the sessions, including the absolute and relative time allocated to key areas of interest for the DPNP. In this descriptive analysis of speaker remarks from ten CMS-hosted patient-focused listening sessions, speaker demographics were examined using video streams, time-stamped transcripts, public data, contextual clues, validated tools, and visual assessment when necessary. Audio recordings were transcribed using a speech-to-text application programming interface, followed by human review for accuracy. Transcripts included speaker identification and sentence-level timestamping. Two researchers coded each sentence into predefined categories on the basis of CMS's optional discussion topics, DPNP goals, and potential unintended consequences of the IRA: speaker background, evidence about selected drugs or therapeutic alternatives, drug prices, patient access/benefit design, therapeutic advancements, and other. The total and proportion of time spent by category were calculated per speaker. Out of an anticipated 200 speaker slots, 106 total speakers (median per session: 10; range 5-17) and 70 unique speakers participated, most of whom were patients (n = 38, 54.2%), female (n = 40, 57.1%), and below Medicare age (n = 40, 57.1%). The most popular categories discussed included evidence about the selected drug or therapeutic alternatives (median per slot: 36.5% of time; range 0-93.0%) and patient access/benefit design (median per slot: 12.1%; range 0-75.5%). CMS received a median of 12.3 total minutes of evidence about selected drugs or therapeutic alternatives per listening session across all speakers (range per session 3.9-22.6 minutes). The first listening sessions provided an important, but limited, first step toward patient engagement with the DPNP. Speaker demographics suggest the sessions fell short of capturing the voices of diverse and Medicare-representative patient populations. While speakers often focused their time on patient experience and evidence, CMS received less than 15 minutes of patient-focused evidence about therapeutic alternatives for more than half of the drug listening sessions. CMS has indicated its intent to improve upon the design of the patient-focused listening sessions for drugs selected in the second round of the DPNP. Future iterations should prioritize robust, two-way dialogue, transparency surrounding the impact of patient input on CMS's price determination process, and improvements to event logistics and outreach that facilitate the participation of diverse patients and stakeholders.

Populationwide Screening for Chronic Kidney Disease

Sodium-glucose cotransporter-2 (SGLT2) inhibitors have changed clinical management of chronic kidney disease (CKD) and made populationwide screening for CKD a viable strategy. Optimal age of screening initiation has yet to be evaluated. To compare the clinical benefits, costs, and cost-effectiveness of population-wide CKD screening at different initiation ages and screening frequencies. This cost-effectiveness study used a previously published decision-analytic Markov cohort model that simulated progression of CKD among US adults from age 35 years and older and was calibrated to population-level data from the National Health and Nutrition Examination Survey (NHANES). Effectiveness of SGLT2 inhibitors was derived from the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial. Mortality, quality-of-life weights, and cost estimates were obtained from published cohort studies, randomized clinical trials, and US Centers for Medicare & Medicaid Services data. Analyses were performed from June 2023 through September 2024. One-time or periodic (every 10 or 5 years) screening for albuminuria, initiated at ages between 35 and 75 years, with and without addition of SGLT2 inhibitors to conventional CKD therapy (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers). Cumulative incidence of kidney failure requiring kidney replacement therapy (KRT); life years, quality-adjusted life years (QALYs), lifetime health care costs (2024 US currency), and incremental cost-effectiveness ratios discounted at 3% annually. For those aged 35 years, starting screening at age 55 years, and continuing every 5 years through age 75 years, combined with SGLT2 inhibitors, decreased the cumulative incidence of kidney failure requiring KRT from 2.4% to 1.9%, increased life expectancy by 0.13 years, and cost $128 400 per QALY gained. Although initiation of screening every 5 years at age 35 or 45 years yielded greater gains in population-wide health benefits, these strategies cost more than $200 000 per additional QALY gained. The comparative values of starting screening at different ages were sensitive to the cost and effectiveness of SGLT2 inhibitors; if SGLT2 inhibitor prices drop due to patent expirations, screening at age 55 years continued to be cost-effective even if SGLT2 inhibitor effectiveness were 30% lower than in the base case. This study found that, based on conventional benchmarks for cost-effectiveness in medicine, initiating population-wide CKD screening with SGLT2 inhibitors at age 55 years would be cost-effective.

Impact of the Inflation Reduction Act on Patient Access and Out-of-Pocket Costs

The Inflation Reduction Act (IRA) represents a recent policy enactment that will influence prescription drug pricing. This paper examines the IRA's elements and their impact on patients' access to medications, specifically around programs funded by the Centers for Medicare and Medicaid. This review analyzed grey literature on patient medication access concerning the IRA, along with the legislation itself. It finds that the IRA contains six key provisions with the potential to impact patients' access to medications and stakeholder business practices: insulin and vaccine cost share, OOP cost limits, premium stabilizations, drug negotiations, and low-income subsidy programs. Although the IRA presents cost-saving provisions, it may exert downstream effects on new drug innovation, increased medication utilization management by payers and pharmacy benefit managers (PBMs), and how healthcare providers, manufacturers, and payers/(PBMs) work together to balance patient well being with fair economic returns for all stakeholders.

Optimizing Hierarchical Condition Category-Risk Adjustment Factor Management in Population Health Using Rapid Process Improvement Methods.

Centers for Medicare & Medicaid Services provides reimbursement through Hierarchical Condition Category (HCC) coding. Medical systems strive toward risk adjustment optimization, often implementing costly chart review processes. Previously, our organization implementing countermeasures through workflows was complex and performed in silos. Our goal was to put in place HCC-Risk Adjustment Factor (RAF) improvement tools to optimize HCC-RAF management in Population Health using rapid process improvement methods. In this quality improvement analysis (IRB#806198), we used Lean methodology to develop tools and implement streamlined processes for providers to manage, document, and code high-risk HCC conditions. Rather than applying costly countermeasures, Transformational Healthcare conducted a Rapid Process Improvement Workshop (RPIW), with workgroups implementing proposed changes, to improve processes. Each of these tools was embedded in standard work, for teams to use in practice. Tools included the development of RPIW-inspired work groups, a Provider Education website, tip sheets, clinical champions, trainings, audits, practice alerts, smart phrases, schedule view tools, severity scores, reports, dashboards, on-screen decision-support tools, coding expertise, and HCC standard work. Quantitatively, Year 1 showed enterprise HCC-RAF scores improved by 4.1%. We were able to develop tools for providers and team members to allow for more optimized pathways. Although quantitatively we realized an improvement in enterprise HCC-RAF score, our overall aim was to improve process flow and limit waste. Leveraging Lean improvement methods for the collective design of tools has supported culture change. In the end, we found that providers are indeed willing to adopt these newly built tools. These tools have optimized operations, allowing providers to work smarter, not harder.

Trends in Medicare Utilization and Reimbursement of Tracheostomy From 2000 to 2022.

To analyze the utilization and reimbursement for tracheostomy. Retrospective Cross-Sectional Study. Centers for Medicare & Medicaid Services (CMS) Medicare Provider Utilization and Payment Data (2013 and 2021) and Part B Medicare Fee-For-Service National Summary Data (2000-2022). Utilization, payment, and specialty breakdown were analyzed for planned tracheostomy (Current Procedural Terminology [CPT] codes 31600, 31601, 31610) and emergency tracheostomy (CPT codes 31603, 31605). From 2000 to 2022, there was a 48.9% decrease (40,754-20,812) in number of planned tracheostomies and a 75.3% decrease (3277-811) in number of emergency tracheostomies, leading to an overall decrease of 51%. Similarly, there was a 59.3% inflation-adjusted decrease ($13.4-$5.5 million) in total reimbursement for planned tracheostomies and an 82.1% inflation-adjusted decrease ($1.1 million-$205 thousand) in total reimbursement for emergency tracheostomies. There was a 20.3% inflation-adjusted decrease ($329-$262) in reimbursement per planned tracheostomy and a 27.7% inflation-adjusted decrease ($349-$252) in reimbursement per emergency tracheostomy. In our sample of 280 high-volume tracheostomy providers in 2021 (28.2% otolaryngology, 28.2% general surgery, 14.6% thoracic surgery, 14.3% pulmonary disease, 6.4% critical care), the average provider performed 15.8 tracheostomies and was reimbursed $5362. Despite significant declines in tracheostomy utilization and reimbursement, understanding trends for these lifesaving procedures are critical for otolaryngologists and other providers in delivering high-quality care, and can be used by surgeons, hospital systems, and policymakers to guide future health care legislation.

Medicare Advantage Plans With High Numbers Of Veterans: Enrollment, Utilization, And Potential Wasteful Spending.

Medicare Advantage (MA) plans are increasingly enrolling veterans. Because MA plans receive full capitated payments regardless of whether or not veterans use Medicare services, the federal government can incur substantial duplicative, wasteful spending if veterans in MA plans predominantly seek care through the Veterans Health Administration (VHA) system. The recent growth of MA plans that disproportionately enroll veterans could further exacerbate such wasteful spending. Using national data, we found that veterans increasingly enrolled in MA between 2016 and 2022, including in a growing number of MA plans in which 20percent or more of the enrollees were veterans. Notably, about one in five VHA enrollees in these high-veteran MA plans did not incur any Medicare services paid by MA within a given year-a rate 2.5 times that of VHA enrollees in other MA plans and 5.7 times that of the general MA population. Meanwhile, VHA enrollees in high-veteran MA plans were significantly more likely to receive VHA-funded care. In 2020, the Centers for Medicare and Medicaid Services paid more than $1.32billion to MA plans for VHA enrollees who did not use any Medicare services, with 19.1percent going to high-veteran MA plans.

An Overview of Open Payments: Public Reporting of Pharmaceutical and Medical Device Industry Payments to Advanced Practice Registered Nurses

In 2021, United States federal law mandated greater public transparency around the relationships between pharmaceutical and medical device companies and advanced practice registered nurses (APRNs). Pharmaceutical and device companies must report all payments, gifts, and value of meals to APRNs in a searchable database called Open Payments, which is hosted by the Centers for Medicare and Medicaid Services. In this policy feature, we introduce Open Payments, provide an overview of recent changes, and discuss implications for APRNs. We aim to familiarize APRNs with Open Payments and current publicly reported practice patterns to catalyze conversations regarding ethical interactions between industry and APRNs.

Financial Impacts of Paying for Gene Therapy for Sickle Cell Disease Under Alternate Prices and Financing Mechanisms

To understand the role of alternative prices and financing mechanisms on a payer's budget impact and the manufacturers' risks and returns for gene therapies. This paper uses fundamental economic principles to interpret the implications of alternative pricing mechanisms in terms of the manufacturer's appropriation share of the value and how alternate financing mechanisms alter it. It demonstrates these concepts by studying the financial impacts for a payer and the manufacturer across alternative pricing and financing mechanisms that could be used by the US Centers for Medicare and Medicaid Services (CMS) to pay for gene therapy for sickle cell disease (SCD). Unlike value-based and manufacturer-set monopoly prices, an effective monopoly price can be derived to guarantee monopoly profits for manufacturers during their exclusivity period, thereby providing a high appropriation share and substantially lowering price and budget impact for a payer. For SCD gene therapy, the 10-year budget impact for CMS would range from $8.6 Billion-$12.8 Billion under a value-based price, $10.2 Billion-$15.2 Billion under a monopoly price, but reduce to $7.7 Billion under an effective monopoly price. The latter price would still fetch over 50% of the total surplus to the manufacturer while mitigating their risk of sales volume. I show that significant budget impacts for funding gene therapy are not mitigated across alternative financing mechanisms at any given price. The price determines most of the budget impact. The option of a patent buyout may help negotiate down prices to effective monopoly prices.

Click and learn: a longitudinal interprofessional case-based sepsis education curriculum

BackgroundSepsis is a global healthcare challenge and a leading cause of morbidity and mortality. In the USA, the Centers for Medicare & Medicaid Services has integrated the Severe Sepsis and...

The Veterans Affairs Rheumatoid Arthritis Registry: A Unique Population in Rheumatoid Arthritis Research

Background: As the largest integrated healthcare system in the U.S., the Veterans Affairs (VA) provides a unique context for the conduct of clinical and clinical-translational research in rheumatoid arthritis (RA). Objectives: To review attributes of the VA Rheumatoid Arthritis Registry (RA) and highlight its research contributions. Findings: With more than 3,600 participants enrolled from 19 VA medical centers across the U.S., VARA includes longitudinally collected clinical data and a central biorepository that includes serum, plasma, and DNA collected at enrollment. VARA research capacity is enhanced via active linkages with internal data including the VA's Corporate Data Warehouse and elements captured during oncology care. This capacity is further enabled via active linkages with the National Death Index and Centers for Medicare & Medicaid Services (CMS) data. Conclusion: As a highly unique study population with comprehensive data annotation available to researchers, VARA is poised to continue address impactful questions in RA for years to come.

Academic Productivity at Orthopedic Surgery Sports Medicine Fellowship Programs in the United States Has a Weak Positive Correlation with Non-Research Life-Time Industry Earnings

PurposeTo characterize the relationship between academic productivity, as defined by H-index, and industry payments for fellowship-trained sports medicine surgeons in faculty positions at sports medicine fellowships. MethodsThe American Orthopaedic Society for Sports Medicine (AOSSM) fellowship directory was used to create a comprehensive list of all fellowship programs nationwide. Fellowship websites were then reviewed to generate a list of the teaching faculty associated with each program. Total non-research life-time earnings was obtained from the Centers for Medicare and Medicaid Services website. Academic productivity of each fellowship faculty was assessed via H-index. Frequency counts and other descriptive statistic measures were used to describe the data for this study. Correlation was performed for continuous data using Spearman’s rho. Results90 orthopedic surgery sports medicine fellowships were identified with a combined total of 574 orthopedic surgery sports medicine fellowship faculty. There was a weak positive correlation between individual physician H-index and individual physician life-time earnings at orthopedic surgery sports medicine fellowships (p<0.001; Spearman’s rho = 0.329). There was a statistically significant difference between individual faculty H-index by quartile and individual faculty life-time earnings (test statistic: 47.3; p<0.001). There was no significant regional difference in payments but there is remarkable heterogeneity in the distribution of payments to individual physicians, with the top 10% of physicians receiving over 80% of industry dollars. ConclusionThere is a positive correlation between academic productivity and industry payments at both the individual and institutional level in orthopedic sports medicine departments, although this relationship was greater at the fellowship level. Furthermore, the majority of non-research industry funding goes to a minority of physicians. Clinical RelevanceEvaluating the impact that non-research industry payments have on a sports medicine orthopedic surgeon's research productivity can offer valuable insights into the relationship between industry compensation and scholarly output in this field.

Medical Devices Applying for Outpatient Medicare Supplemental Payments.

Medicare transitional pass-through payments (TPTPs) provide supplemental reimbursement that is intended to facilitate adoption of new devices in the outpatient setting. The US Centers for Medicare & Medicaid Services (CMS) have historically evaluated manufacturer applications for TPTPs based on newness, cost, and evidence of substantial clinical improvement, ie, the traditional pathway. In 2020, CMS introduced an alternative pathway to allow US Food and Drug Administration (FDA)-designated breakthrough devices to qualify for supplemental reimbursement without demonstrating substantial clinical improvement. To characterize CMS TPTP approval rates and the premarket evidence used by FDA to support authorization of new outpatient medical devices considered for CMS TPTP. This was a cross-sectional study of TPTP applications for new outpatient medical devices from 2017 to 2023. Using the Federal Register, CMS Outpatient Prospective Payment System final rules for fiscal years 2017 through 2023 were obtained, from which all manufacturer applications for TPTPs were identified. For each application, the CMS TPTP review pathway (traditional/alternative), CMS final decision (award/deny), and FDA authorization pathway were assessed. Characteristics of devices considered for CMS TPTPs and design, effectiveness end points, and patient demographic characteristics of premarket clinical studies used to support FDA authorization. CMS approved 17 of 43 (40%) applications for TPTPs, including all 8 (100%) alternative pathway applications for breakthrough devices and 9 of 35 applications (26%) using the traditional pathway. Devices approved for TPTPs were more likely to have been assessed in premarket clinical studies than devices denied TPTPs (12/17 [71%] vs 2/26 [8%]). Among the 14 premarket studies of TPTP-approved devices, 8 (57%) used surrogate markers as primary effectiveness end points and 5 (42%) did not meet all primary end points. The median (IQR) percentage of female, Black, and Hispanic patients among the trials that reported demographic data was 26% (17%-36%), 6% (2%-17%), and 4% (3%-5%), respectively. The findings of this cross-sectional analysis indicated that CMS more commonly awarded supplemental outpatient payment through TPTPs for devices assessed in premarket clinical studies to support FDA authorization. However, these studies often lacked generalizability to Medicare beneficiaries, used surrogate markers of effectiveness, or did not meet all primary end points. As more breakthrough devices receive FDA authorization and effectively qualify for automatic supplemental payments, strengthening premarket clinical evidence requirements for CMS TPTP approvals would provide better information to guide clinical decision-making and ensure that supplemental reimbursement enhances care for Medicare beneficiaries.

Market Factors, Not Quality, Influence Reimbursement for Pancreaticoduodenectomy in an Era of Price Transparency.

The Centers for Medicare and Medicaid Services (CMS) price transparency rule tries to facilitate cost-conscious decision-making. For surgical services, such as pancreaticoduodenectomy (PD), factors mediating transparency and real-world reimbursement are not well described. The Leapfrog Survey was used to identify United States hospitals performing PD. Financial and operational data were obtained from Turquoise Health and CMS Cost Reports. Chi-square tests and modified Poisson regression evaluated associations with reimbursement disclosure. Two-part logistic and gamma regression models estimated effects of hospital factors on commercial, Medicare, and self-pay reimbursements for PD. Of 452 Leapfrog hospitals, 295 (65%) disclosed PD hospital or procedure reimbursements. Disclosing hospitals were larger (beds >200: 81.0% vs. 71.3%, p = 0.04), reported higher net margins (0.7% vs. -2.1%, p = 0.04), more likely for-profit (26.1% vs. 6.4%, p < 0.001), and teaching-affiliated (82.0% vs. 65.6%, p < 0.001). Nonprofit status conferred hospitalization reimbursement increases of $8683-$12,329, while moderate market concentration predicted savings up to $5066. Teaching affiliation conferred reimbursement increases of $4589-$16,393 for hospitalizations and $644 for procedures. Top Leapfrog volume ratings predicted an increase of up to $7795 for only Medicare hospitalization reimbursement. Nondisclosure of hospital and procedural reimbursements for PD remains a major issue. Transparency was noted in hospitals with higher margins, size, and academic affiliation. Factors associated with higher reimbursement were non-profit status, academic affiliation, and more equitable market share. Reimbursement inconsistently tracked with PD quality or volume measures. Policy changes may be required to incentivize reimbursement disclosure and translate transparency into increased value for patients.

Participant Diversity in Stroke‐Related Medical Device Trials: Historical Context and Ongoing Challenges

Despite an acknowledgment of the ethical and clinical importance of recruiting diverse populations into clinical trials, there is a continued underenrollment of patients with diverse demographic characteristics within the field of neurology and more specifically, in stroke‐related device trials. Efforts on the part of the US Congress, the National Institutes of Health, the US Food and Drug Administration, and the Centers for Medicare &amp; Medicaid Services over the past several decades have attempted to increase trial participant diversity with varying success. This historical context provides an important lens for analyzing diversity proposals and their bearing on device trials in the field of stroke neurology. Despite economic and logistical challenges, recruitment of appropriately diverse clinical trial populations through policy change and community engagement is critical to continuing to advance health equity goals.

Home- and Community-Based Services: A Comparison of Brain Injury Waivers Across the United States.

Adults and children who experience brain injury may need services and support when they return to the community. Home- and community-based services waivers are one way to access those supports. Brain injury waivers do not exist in every state, and variations exist in current waivers. This article describes existing brain injury waivers and how they vary by state. States were included if their most recent waiver application was approved by the Centers for Medicare and Medicaid Services. States were excluded if waivers were terminated or expired. Data were collected by analyzing each state's waiver across the areas of diagnosis definition, ages served, self-direction, service setting, persons served, services offered, budget, and assistive technology. Statistical analysis included frequency and descriptive statistics due to the limited number of participants. Each state designs its own waivers. Differences exist in eligibility criteria, services provided, settings, and the rights of participants. Analysis of the waivers showcased differences in all areas. These factors determine which brain injury survivors can receive services from specialized waivers, what services are available to them, where they can receive services, and what rights they can exercise.

Trends in Pregnancy Outcomes in People with Sickle Cell Disease and Medicaid Insurance (2006-2018).

Background: Although the risk of pregnancy-related morbidity and mortality in people with sickle cell disease (SCD) is well established, limitations in data sources and heterogeneity in outcome reporting hinder the ability to make meaningful comparisons between historical and contemporary populations. This study used a national administrative claims database to compare pregnancy outcomes in people with SCD between 2006-2011 and 2012-2018. Materials and Methods: Pregnant females aged 16-44 years with SCD were identified from the Centers for Medicare and Medicaid Service Analytic eXtract, along with a control cohort of pregnant people. People were followed from first identified pregnancy until one year postpartum. Outcomes of interest were identified with ICD-9 or 10 codes. Results: We included 6,388 people with SCD and 17,278 controls in analyses. Preeclampsia/eclampsia, hypertension, thrombosis, poor fetal growth, preterm delivery, and postpartum hemorrhage were all more common in people with SCD compared with controls. Maternal death occurred in 0.5% of people with SCD versus <0.1% in those without SCD (p < 0.001). When comparing infant deliveries in 2006-2011 to those occurring in 2012-2018, all pregnancy-related complications except preterm delivery, including maternal death, occurred at similar or higher frequencies in more recent years. Conclusions: Between 2006 and 2018, maternal death occurred in approximately 1 out of every 200 publicly insured people with SCD in the year following infant delivery. Our work confirms, on a national-level, that pregnancy-related outcomes in people with SCD in the United States have not improved with time, and that some complications have in fact increased in frequency.