Tag: nevin manimala

Cancer Med. 2025 Apr;14(8):e70811. doi: 10.1002/cam4.70811.

ABSTRACT

INTRODUCTION: With the reduction in human immunodeficiency virus (HIV)-related mortality secondary to antiretroviral therapy, chronic medical conditions and age-related cancers account for a larger proportion of mortality among those with HIV. Cancer risk overall remains elevated in HIV patients, and cancer screening data in this population is limited. The primary study aim was to determine whether screening colonoscopy findings differed between HIV and non-HIV patients.

METHODS: A retrospective review of adults with/without HIV undergoing screening colonoscopy between February 2015 and September 2022 was performed. HIV patients were matched with non-HIV patients by sex, race, and age, undergoing screening colonoscopy within six business days of their matched patients. Demographic data included age, race, sex, family history of colorectal cancer (CRC), smoking status, alcohol use, along with endoscopic and histologic findings that were compared between the matched pairs.

RESULTS: Ninety matched pairs of HIV and non-HIV patients undergoing screening colonoscopy comprised the study population. The study group was 78.9% African American, 55.6% male, with a mean age of 59.0 years in HIV patients and 54.9 years in non-HIV patients. Procedure indication was average risk screening in 91.1% of patients. No statistically significant differences in screening colonoscopy findings or polyp histology were observed between HIV and non-HIV patients.

DISCUSSION: Similar rates of polyps were found at screening colonoscopy regardless of HIV status. CRC screening recommendations are appropriate for the HIV patient population without limitation.

PMID:40249627 | DOI:10.1002/cam4.70811

Cancer Med. 2025 Apr;14(8):e70866. doi: 10.1002/cam4.70866.

ABSTRACT

BACKGROUND: We examined the association between academic center status and neurosurgical resection volume with surgical procedures performed and subsequent survival.

METHODS: In a population-based study using the Surveillance, Epidemiology, and End Results (SEER)-Medicare-linked databases, we identified patients > 65 years diagnosed with primary WHO grade III-IV glioma from 2008 to 2017. Surgical procedures were identified through Medicare claims from 2007 to 2019. Associations between center type (academic vs. not) and center volume (top 10% of distribution of resections during the study period vs. the bottom 90%) were estimated with upfront surgery procedure (resection vs. biopsy vs. none) and survival by estimating hazard ratios (HRs) and 95% confidence intervals (CIs) from multivariable regression models accounting for within-center provider cluster correlation.

RESULTS: We identified 8592 patients, of whom 8128 could both be attributed to a provider and received neurosurgical intervention attributed to resection or biopsy. When considered together, center volume, not center academic status, drove surgical decisions for first procedure type such that patients treated by a top 10% volume center were 23% more likely to receive resection (95% CI: 14%-34%, p < 0.0001). When considered together, resection, not center volume, drove improvement in overall survival such that patients who received resection, regardless of center volume, were 22% less likely to die during the study period (95% CI: 17%-27%, p < 0.0001).

CONCLUSIONS: We provide the first population-based evidence that older patients diagnosed with grade III-IV glioma who seek treatment from higher-volume centers are more likely to receive aggressive neurosurgical care. Aggressive neurosurgical care, even if received from low-volume centers, improves survival.

PMID:40249626 | DOI:10.1002/cam4.70866

JAMA Netw Open. 2025 Apr 1;8(4):e254483. doi: 10.1001/jamanetworkopen.2025.4483.

ABSTRACT

IMPORTANCE: Singapore is considering subsidizing left ventricular assist devices (LVADs) for end-stage heart failure (ESHF) and uses cost-effectiveness evidence to inform the determination. Yet, no economic evaluation has thus far been conducted.

OBJECTIVE: To estimate the lifetime cost-effectiveness of LVAD compared with optimal medical management for transplant-ineligible patients.

DESIGN, SETTING, AND PARTICIPANTS: This economic evaluation used a Markov model to simulate survival, stroke incidence, other adverse events, and heart failure hospitalizations for a cohort of adult patients in Singapore with transplant-ineligible ESHF, most of whom were inotrope dependent. Latest LVAD mortality data from a randomized clinical trial were age-adjusted, and an indirect comparison of prior trial results was performed to estimate survival for inotrope-dependent and inotrope-independent patients. Costs were estimated (in 2023 Singapore dollars [SGD]) using cohort billing data from 2017 to 2022 and National Heart Centre Singapore LVAD charges. Statistical analysis was performed from December 2023 to July 2024.

EXPOSURE: HeartMate 3 LVAD (Abbott).

MAIN OUTCOMES AND MEASURES: Health care costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER) evaluated against a threshold of SGD 114 000 (US $85 075) per QALY gained.

RESULTS: At model initiation, the cohort had a mean (SD) age of 64 (12) years, and 78% (range, 68%-86%) of patients were inotrope dependent. In the base case analysis, LVAD yielded an additional 3.45 QALYs at an incremental cost of SGD 404 678 (US $301 999), producing an ICER of SGD 117 370 (US $87 590) per QALY gained for the transplant-ineligible population. The ICER differed for inotrope-use subgroups at SGD 106 458 (US $79 446) per QALY gained for inotrope-dependent patients and SGD 174 798 (US $130 446) per QALY gained for inotrope-independent patients (with 59% and 19% probabilities, respectively, of attaining high value). The inotrope-dependent ICER was sensitive to model input changes and structural assumptions, whereas the inotrope-independent ICER consistently exceeded the high-value threshold in scenario analyses. In threshold analyses, a 44% reduction in the total implantation price or a 54% reduction in the all-cause mortality hazard were required for LVAD to be high value for inotrope-independent patients. Confidence that the inotrope-dependent ICER is high value increased to 75% and 85% with respective 20% and 33% reductions in total implantation price.

CONCLUSIONS AND RELEVANCE: In this economic evaluation comparing LVAD with optimal medical management, LVAD was potentially high value for most transplant-ineligible patients who are inotrope dependent. Confidence in this result was improved with plausible price reductions, yet only extreme changes rendered LVAD high value for inotrope-independent patients.

PMID:40249620 | DOI:10.1001/jamanetworkopen.2025.4483

JAMA Netw Open. 2025 Apr 1;8(4):e254708. doi: 10.1001/jamanetworkopen.2025.4708.

ABSTRACT

IMPORTANCE: There is an urgent need for a validated gender-affirming care-specific patient-reported outcome measure (PROM).

OBJECTIVE: To field test the GENDER-Q, a new PROM for gender-affirming care, in a large, international sample of transgender and gender diverse (TGD) adults and evaluate its psychometric properties.

DESIGN, SETTING, AND PARTICIPANTS: This international cross-sectional study was conducted among TGD adults aged 18 years and older who were seeking or had received gender-affirming care within the past 5 years at 21 clinical sites across Canada, the United States, the Netherlands, and Spain; participants were also recruited through community groups (eg, crowdsourcing platform, social media). The study was conducted between February 2022 and March 2024. Participants had to be capable of completing the instrument in English, Danish, Dutch, or French-Canadian. Eligible participants accessed an online REDCap survey to complete sociodemographic questions and questions about gender-affirming care they had received or sought (ie, to look, function, or feel masculine, feminine, gender fluid, or another way).

MAIN OUTCOME AND MEASURES: Branching logic was used to assign relevant instrument scales. Rasch measurement theory (RMT) analysis was used to examine the fit of the observed data to the Rasch model for each scale. Test-retest reliability and hypothesis-based construct validity of instrument scales were examined. The hypothesis was that instrument scale scores would increase with better outcomes on corresponding categorical questions.

RESULTS: A total of 5497 participants (mean [SD] age, 32.8 [12.3] years; 1837 [33.4%] men; 1307 [23.8%] nonbinary individuals; and 2036 [37.0%] women) completed the field test survey. Participants sought or had the following types of gender-affirming care: 2674 (48.6%) masculinizing, 2271 (41.3%) femininizing, and 552 (10.0%) other. RMT analysis led to the development of 54 unidimensional scales and 2 checklists covering domains of health-related quality of life, sexual, urination, gender practices, voice, hair, face and neck, body, breasts, genital feminization, chest, genital masculinization, and experience of care. Test-retest reliability of the scales (intraclass correlation coefficient [average] >0.70) was demonstrated. Only 1 item (phalloplasty donor flap) had an ICC less than 0.70. As hypothesized, scores increased incrementally with better associated self-reported categorical responses. For example, among 661 participants who reported poor psychological well-being, the mean (SD) scale score was 45 (18) points; for those who reported excellent psychological well-being, the mean (SD) scale score was 85 (16) points (P < .001).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of 5497 TGD adults, the instrument demonstrated reliability and validity. The instrument was validated in an international sample and is designed to collect and compare evidence-based outcome data for gender-affirming care from the patients’ perspective.

PMID:40249619 | DOI:10.1001/jamanetworkopen.2025.4708

JAMA Netw Open. 2025 Apr 1;8(4):e255768. doi: 10.1001/jamanetworkopen.2025.5768.

ABSTRACT

IMPORTANCE: The Rohingya displaced population in Bangladesh is the largest stateless population in the world. Infectious diseases, such as gastroenteritis, respiratory infections, and fever, are among the major health problems the Rohingya population has faced. Although associations between gastroenteritis and air temperature have been reported in various regions, no study has yet been carried out among the displaced populations.

OBJECTIVES: To evaluate the association between air temperature and risk of gastroenteritis among the forcibly displaced Rohingya population in refugee camps in Bangladesh.

DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional study, daily time series data derived from facility-based case reports were collected in 2 clinics organized by the UNHCR (United Nations High Commissioner for Refugees) in Kutupalong and Nayapara registered camps from January 1, 2019, to December 31, 2021. Statistical analysis was conducted from April 2023 to September 2024.

EXPOSURE: Hourly 2-m air temperature from ERA5-Land by the European Centre for Medium-Range Weather Forecasts.

MAIN OUTCOMES AND MEASURES: The daily number of gastroenteritis cases recorded in the camp clinics was the main outcome measure. Nonlinear lagged associations between daily temperature and gastroenteritis cases were modeled using a quasi-Poisson generalized linear model to account for overdispersion coupled with a distributed lag nonlinear model including a maximum 21-day lag. Covariates from the literature were adjusted in the model.

RESULTS: A total of 33 280 gastroenteritis cases (95% among individuals aged ≥5 years; 71% female) were recorded in Kutupalong and 31 165 gastroenteritis cases (99% among individuals aged ≥5 years; 67% female) were recorded in Nayapara. Further examination revealed a potential U-shaped curve in Kutupalong with minimum risk temperature (MRT) set at 26 °C. Cumulative relative risk (RR) at the 10th percentile temperature (21.1 °C) was 2.31 (95% CI, 1.18-4.65), while RR at 90th percentile temperature (28.5 °C) was 1.78 (95% CI, 1.24-2.56) relative to MRT. In Nayapara, a nearly linear risk increase was observed with decreasing temperature. Cumulative RR at the 10th percentile temperature (21 °C) was 1.32 (95% CI, 0.78-2.24), while the RR at the 90th percentile temperature (28.3 °C) was 0.75 (95% CI, 0.56-0.99). Lagged effects were delayed in nature. In Kutupalong, cold temperatures (10th percentile) were associated with statistically significant gastroenteritis risks at approximately 15 to 20 days (range: RR, 1.06 [95% CI, 1.00-1.13] to RR, 1.10 [95% CI, 1.00-1.21]). In Nayapara, gastroenteritis risks were correspondingly higher at longer lags (lag, 18 days; RR, 1.05 [95% CI, 1.00-1.10]).

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of the Rohingya displaced population in Bangladesh, cold temperatures were associated with an increase in the risk of gastroenteritis. It is important to understand the association of climatic factors with the health of displaced communities, whose population is expected to grow in the future.

PMID:40249618 | DOI:10.1001/jamanetworkopen.2025.5768

JAMA Netw Open. 2025 Apr 1;8(4):e255785. doi: 10.1001/jamanetworkopen.2025.5785.

ABSTRACT

IMPORTANCE: The Centers for Medicare & Medicaid Services implemented a National Coverage Determination (NCD) for genetic testing using next-generation sequencing (NGS) in March 2018 and amended it in January 2020. Little is known about how often NGS insurance claims are denied and what factors are associated with these denials.

OBJECTIVE: To examine the prevalence of and factors associated with claim denials for NGS testing among Medicare enrollees.

DESIGN, SETTING, AND PARTICIPANTS: This cohort study used a 20% random sample of Medicare claims data from January 1, 2016, to December 31, 2021. Statistical analysis took place from June to October 2024.

MAIN OUTCOMES AND MEASURES: Claim denials were measured based on payment and denial data. Multivariable logistic regression models were estimated with patient and claim characteristics, including testing type, testing site, and time period indicators reflecting the presence and scope of the NCD: no NCD (period 1), first NCD (period 2), and amended NCD (period 3).

RESULTS: The study sample included 29 919 cancer-related NGS claims among 24 443 unique Medicare beneficiaries (51.8% males; 44.7% aged >75 years). The number of cancer-related NGS testing claims increased from 1912 in 2016 to 9177 in 2021. Claim denial occurred among 23.3% of the NGS claims in the sample. The claim denial rate was 16.8% before the NCD, 20.3% after the implementation of the NCD in 2018, and 27.4% after the amended NCD in 2020. Claims for NGS testing were more likely to be denied if they were performed in independent laboratories (odds ratio [OR], 2.76 [95% CI, 2.58-2.95]; P < .001) or other nonhospital sites (OR, 2.55 [95% CI, 2.12-3.07]; P < .001) vs a hospital or if they were for 50 or more genes vs 50 or fewer genes for solid tumors (OR, 1.32 [95% CI, 1.23-1.43]; P < .001). The likelihood of a claim denial was higher in both time periods after the original 2018 NCD compared with before the NCD (period 2: OR, 1.23 [95% CI, 1.10-1.36]; P < .001; period 3: OR, 1.64 [95% CI, 1.49-1.80]; P < .001). The claim denial likelihood for period 3 was significantly higher than period 2 (OR, 1.34 [95% CI, 1.24-1.44]; P < .001).

CONCLUSIONS AND RELEVANCE: In this cohort study of cancer-related NGS testing claims among Medicare enrollees, denial rates varied by testing type and testing site and increased over time. The findings suggest the continued existence of uncertainty regarding coverage for NGS, despite the NCD. Policy approaches to further reduce uncertainty regarding NGS coverage and raise awareness of potential financial liability warrant consideration.

PMID:40249617 | DOI:10.1001/jamanetworkopen.2025.5785

JAMA Netw Open. 2025 Apr 1;8(4):e255791. doi: 10.1001/jamanetworkopen.2025.5791.

ABSTRACT

IMPORTANCE: A growing proportion of full-benefit dual-eligible Medicare and Medicaid beneficiaries (ie, individuals receiving Medicare and full Medicaid) are enrolled in Medicare Advantage (MA). MA plans vary in capacity and incentives to coordinate Medicare and Medicaid services, but little is known about the characteristics of dual-eligible beneficiaries across plan types.

OBJECTIVES: To compare the health and demographic characteristics of full-benefit dual-eligible beneficiaries across 4 MA plan types varying in Medicare-Medicaid service coordination and spending requirements.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study analyzed Medicare Health Outcomes Survey (HOS) data from 2017 to 2019, including 147 923 full-benefit dual-eligible beneficiaries (mean response rate, 29%) enrolled in MA in January of the survey year. Analyses were conducted from January 2024 to January 2025.

EXPOSURE: Enrollment in different MA plans.

MAIN MEASURES AND OUTCOMES: This study examined beneficiary characteristics and enrollment across 4 MA plan types: standard MA plans serving dual and nondual beneficiaries; coordination-only dual-eligible Special Needs Plans (D-SNPs) with Medicaid contracts and care coordination requirements serving dual-eligibles; D-SNP look-alikes, marketed to dual-eligible beneficiaries but exempt from D-SNP regulations; and fully integrated D-SNPs (FIDE-SNPs), which integrate Medicare and Medicaid services and spending. Beneficiary characteristics included demographics, self-reported comorbidities, functional status, living arrangements, and community-level factors, like the Area Deprivation Index (ADI).

RESULTS: The study included 147 923 dual-eligible beneficiaries with full Medicaid (mean (SD) age, 67.7 [13.9] years; 93 803 [63.4%] female), distributed across FIDE-SNPs (25 755 beneficiaries), coordination-only D-SNPs (65 220 beneficiaries), D-SNP look-alike plans (5193 beneficiaries), and standard MA plans (51 755 beneficiaries). Overall, 14 215 respondents (9.6%) were aged 85 years or older, and 9618 respondents (6.5%) lived with a caregiver. Respondents had a mean (SD) of 4.2 (2.7) comorbidities and 2.3 (2.8) difficulties with activities of daily living (measured on a 0-12 scale). FIDE-SNPs enrolled more beneficiaries aged 85 years or older (eg, FIDE-SNP: 59.0% [95% CI, 58.0%-59.9%]; coordination-only D-SNP: 16.1% [95% CI, 15.3%-16.8%]), living with a caregiver (eg, FIDE-SNP: 56.6% [95% CI, 55.3%-58.0%]; coordination-only SNP: 15.3% [95% CI, 14.3%-16.2%]), and FIDE-SNP beneficiaries had more comorbidities (mean [SD], FIDE-SNP: 4.6 [2.7]; coordination-only SNP: 4.1 [2.7]) and higher scores of difficulties with activities of daily living (mean [SD], FIDE-SNP: 3.1 [3.1]; coordination-only SNP: 2.1 [2.6]) vs beneficiaries with other plan types. In counties offering FIDE-SNPs, 38.4% (95% CI, 37.5%-39.3%) of individuals in areas with the greatest socioeconomic disadvantage were enrolled in coordination-only D-SNPs and 41.3% (95% CI, 40.2-42.4) were enrolled in FIDE-SNPs. In areas with the least socioeconomic disadvantage, 32.0% (95% CI, 31.3%-32.8%) of respondents were enrolled in coordination-only D-SNPs and 43.2% (95% CI, 42.4%-43.9%) respondents were enrolled in FIDE-SNPs. Most differences remained in multivariate analyses.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of full-benefit dual-eligible beneficiaries, substantial health burdens were reported, with notable differences across plan types. These findings highlight the need for tailored interventions to improve care and further research to understand MA plan selection in this population.

PMID:40249616 | DOI:10.1001/jamanetworkopen.2025.5791

JAMA Netw Open. 2025 Apr 1;8(4):e255819. doi: 10.1001/jamanetworkopen.2025.5819.

ABSTRACT

IMPORTANCE: A year after dried cannabis was legalized across Canada in October 2018, Canadian provinces except Quebec legalized sales of cannabis edibles and extracts, including youth-friendly edibles such as cannabis chocolates, candies, and desserts and cannabis vaping products. Little is known about the association of this legalization with adolescent cannabis use.

OBJECTIVE: To investigate changes in adolescent cannabis use and cannabis harm perceptions associated with the legalization of youth-friendly cannabis edibles and extracts in Canada.

DESIGN, SETTING, AND PARTICIPANTS: This serial cross-sectional study analyzed data from students in grades 7 to 11 who participated in the nationally representative Canadian Student Tobacco Alcohol and Drugs Surveys in 2018 to 2019 and 2021 to 2022. A differences-in-differences design compared changes in outcomes in provinces that legalized cannabis edibles and extracts with changes in Quebec where youth-friendly cannabis edibles and cannabis vaping products were banned. Data were analyzed from June 2024 to January 2025.

EXPOSURE: Legalization of youth-friendly cannabis edibles and extracts across provinces in Canada (except Quebec) in October 2019.

MAIN OUTCOMES AND MEASURES: The primary outcomes were cannabis use in the past 12 months, past 12-month use of edible cannabis use, cannabis smoking, cannabis vaping, and co-use of alcohol and cannabis. Secondary outcomes were perception of harm from occasional and regular cannabis use.

RESULTS: In the study sample of 106 032 students in grades 7 to 11 (54 441 male [weighted percentage, 51.3%]), between 2018 to 2019 and 2021 to 2022, past 12-month cannabis use increased from 14.6% (6081 of 41 477 students) to 15.9% (6163 of 38 675 students) and use of edible cannabis increased from 7.9% (3268 of 41 373 students) to 9.5% (3678 of 38 556 students) in provinces that legalized youth-friendly cannabis edibles and extracts. Meanwhile, past 12-month cannabis use declined from 17.4% (2264 of 13 030 students) to 15.6% (1960 of 12 550 students) and use of edible cannabis declined from 7.3% (955 of 13 002 students) to 5.9% (739 of 12 533 students) in Quebec. Regression analyses indicated that the legalization was associated with a 3.8 percentage point (95% CI, 1.1 to 6.6 percentage points; P = .01) or 26% increase in past 12-month cannabis use and a 3.4 percentage point (95% CI, 1.9 to 4.9 percentage points; P = .001) or 43% increase in use of cannabis edibles among adolescents. While there was no statistically significant change in cannabis vaping associated with the legalization, cannabis smoking increased by 4.4 percentage points (95% CI, 1.8 to 7.0 percentage points; P = .004) or 34% and co-use of alcohol and cannabis increased by 2.4 percentage points (95% CI, 0.5 to 4.3 percentage points; P = .02) or 28%. The legalization was also associated with a lower perception of harm from occasional cannabis use.

CONCLUSIONS AND RELEVANCE: In this serial cross-sectional study of adolescents in grades 7 to 11, legalization of cannabis edibles and extracts was associated with an increase not only in edible cannabis use and cannabis smoking, but also in the overall prevalence of cannabis use and co-use of alcohol and cannabis, highlighting the need for stricter policy measures to curb adolescents’ access to cannabis edibles and extracts and greater awareness among adolescents about harms of cannabis use.

PMID:40249613 | DOI:10.1001/jamanetworkopen.2025.5819

JAMA Netw Open. 2025 Apr 1;8(4):e255941. doi: 10.1001/jamanetworkopen.2025.5941.

ABSTRACT

IMPORTANCE: Firearm suicide among females has increased in the past decade; routes for prevention remain unclear.

OBJECTIVE: To identify classes of firearm suicide decedents among females based on preceding mental and physical health-related risk factors for suicide.

DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional retrospective study of females who died by firearm suicide between January 2014 and December 2018 used state-based surveillance data from the National Violent Death Reporting System Restricted Access Database representing 1 or more years of data from all 50 US states, the District of Columbia, and Puerto Rico; data were analyzed from March 2022 to September 2023. A latent class analysis was used to identify and characterize categories of mental and physical health-related factors among females (ie, classes).

EXPOSURE: Known mental and physical health-related risk factors for suicide.

MAIN OUTCOME AND MEASURE: The numbers (percentages) of females who died by firearm suicide across various factors.

RESULTS: Of the 8318 female decedents in our sample (mean [SD] age, 47.2 [17.0] years), more than half (4816 of 8318 [57.9%]) had more than 1 risk factor endorsed. Among this subgroup, a 4-class model was identified: (1) alcohol use disorder or substance use disorder (1273 [26.4%]); (2) depression and suicidal thoughts (2289 [47.5%]); (3) physical health problems and pain (1054 [21.9%]); and (4) all conditions (multimorbid; 200 [4.2%]); 3502 (42.1%) could not be classified. Black females made up a higher proportion (244 of 3502 [7.0%]) of the females with a 0 or 1 risk factor endorsed than of the females with multiple risk factors (184 of 4816 [3.8%]). Mental health problems were apparent in 51.7% of the full sample (4303 of 8318), with 28.6% (n = 2376) demonstrating evidence of mental health treatment. More than one-fifth (1766 of 8318 [21.2%]) had physical health problems. More than one-fourth of the full sample (2239 of 8318 [26.9%]) and nearly 40% (505 of 1273 [39.7%]) in class 1 had intimate partner problems before their death.

CONCLUSIONS AND RELEVANCE: In this cross-sectional study of females who died by firearm suicide, meaningfully distinct groups of female firearm suicide decedents were identified. Given the high proportion of females without mental health and physical health problems, it is plausible that many female firearm suicide decedents did not frequently intersect with the health care system before their death. Results suggest opportunities for preventing firearm suicide among females through nonmedical care settings.

PMID:40249612 | DOI:10.1001/jamanetworkopen.2025.5941

JAMA Health Forum. 2025 Apr 4;6(4):e250452. doi: 10.1001/jamahealthforum.2025.0452.

ABSTRACT

IMPORTANCE: Calcimimetics are a mainstay of treatment for secondary hyperparathyroidism (sHPT), a ubiquitous condition in end-stage kidney disease (ESKD) associated with fractures, cardiovascular events, and mortality. In 2018, Medicare implemented the Transitional Drug Add-On Payment Adjustment (TDAPA), which shifted calcimimetic coverage from Part D prescription drug plans to Part B. Prior to TDAPA, Medicare beneficiaries with ESKD faced varying out-of-pocket costs for calcimimetics at the point of pharmacy depending on presence and magnitude of low-income subsidies (LISs). TDAPA differentially alleviated barriers to filling these costly medications.

OBJECTIVE: To assess whether calcimimetic prescriptions increased post-TDAPA among patients subject to high out-of-pocket costs prior to the policy change (patients with Part D coverage without LIS and those lacking Part D coverage).

DESIGN, SETTING, AND PARTICIPANTS: In this longitudinal cohort study, a difference-in-differences analysis was performed at the patient-quarter level. The sample included adult Medicare fee-for-service beneficiaries undergoing maintenance dialysis between July 1, 2016, and December 31, 2020, at US outpatient dialysis facilities. The US Renal Data System, a national registry of patients with ESKD, was used to collect patient, facility, and claims data. The data analysis occurred between May 2023 and October 2024.

EXPOSURES: LIS extent for patients with Part D coverage (fully subsidized, partially subsidized, not subsidized); presence of Medicare Part D coverage; and whether the patient-quarter was before/after TDAPA implementation.

MAIN OUTCOMES AND MEASURES: The main outcome was having 1 or more filled calcimimetic prescriptions per quarter of the study period. A linear regression model was estimated, adjusting for demographics, dialysis modality and access, comorbidities, and facility characteristics, with 2-way fixed effects at the patient and quarter level.

RESULTS: A total of 509 765 adult Medicare fee-for-service beneficiaries were included in the analysis. The cohort had a mean (SD) age of 64 (14) years, was 57% male, 4% Asian, 38% Black, 15% Hispanic, 41% non-Hispanic White, and 3% other race and ethnicity. In adjusted difference-in-differences models, TDAPA’s estimated effect was an absolute increase of 9.8 percentage points (pp) (95% CI, 9.3-10.2 pp) in calcimimetic prescriptions for patients with Part D but no subsidy and a 2.2 pp (95% CI, 1.8-2.6 pp) increase for patients with partial LIS compared to patients with full LIS.

CONCLUSIONS AND RELEVANCE: The results of this longitudinal cohort study showed that after transitioning calcimimetic coverage from Part D to Part B via TDAPA, calcimimetic prescriptions increased in a graded manner, with the largest increases experienced by patients previously subject to the highest out-of-pocket prescription drug costs. Medicare’s TDAPA policy has the potential to expand access to medications for patients.

PMID:40249608 | DOI:10.1001/jamahealthforum.2025.0452