Medicare Population Research Articles

National variation in the delivery of radiation oncology procedures in the non-facility-based setting.

PurposeThough utilization of medical procedures has been shown to vary considerably across the United States, similar efforts to characterize variation in the delivery of radiation therapy (RT) procedures have not been forthcoming. Our aim was to characterize variation in the delivery of common RT procedures in the Medicare population. We hypothesized that delivery would vary significantly based on provider characteristics.MethodsThe Centers for Medicare and Medicaid Services (CMS) Physician and Other Supplier Public Use File was linked to the CMS Physician Compare (PC) database by physician NPI to identify and sum all treatment delivery charges submitted by individual radiation oncologists in the non‐facility‐based (NFB) setting in 2016. Multivariable logistic regression analysis was carried out to determine provider characteristics (gender, practice rurality, practice region, and years since graduation) that predicted for the delivery of 3D conformal RT (3DCRT), intensity modulated RT (IMRT), stereotactic body RT (SBRT), stereotactic radiosurgery (SRS), low dose rate (LDR) brachytherapy, and high dose rate (HDR) brachytherapy delivery in the Medicare patient population. The overall significance of categorical variables in the multivariable logistic regression model was assessed by the likelihood ratio test (LRT).ResultsIn total, 1,802 physicians from the NFB practice setting were analyzed. Male gender predicted for greater LDR brachytherapy delivery (OR 8.19, 95% CI 2.58–26.05, p < 0.001), but not greater delivery of other technologies. Metropolitan practice was the only predictor for greater HDR brachytherapy utilization (OR 12.95, 95% CI 1.81–92.60, p = 0.01). Practice region was predictive of the delivery of 3DCRT, SRS and SBRT (p < 0.01, p < 0.001, and p < 0.001, respectively). With the Northeast as the reference region, 3DCRT was more likely to be delivered by providers in the South (OR 1.33, 95% CI 1.09–1.62, p < 0.01) and the West (OR 1.38, 95% CI 1.11–1.71, p < 0.01). At the same time, SRS use was less likely in the Midwest (OR 0.71, 95% CI 0.55–0.91, p < 0.01), South (OR 0.49, 95% CI 0.40–0.61, p < 0.001), and West (OR 0.43, 95% CI 0.34–0.55, p < 0.001). SBRT, on the other hand, was more commonly utilized in the Midwest (OR 2.63, 95% CI 1.13–6.13, p = 0.03), South (OR 3.44, 95% CI 1.58–7.49, p < 0.01), and West (OR 4.87, 95% CI 2.21–10.72, p < 0.001). HDR brachytherapy use was also more likely in the Midwest (OR 1.97, 95% CI 1.11–3.49, p = 0.02) and West (OR 1.87, 95% CI 1.08–3.24, p = 0.03). While the degree held by the billing physician did not predict for delivery of a given procedure, greater years since graduation was related to decreased likelihood of SBRT use (OR 0.98, 95% CI 0.96–0.99, p < 0.001) and increased likelihood of LDR brachytherapy use (OR 1.02, 95% CI 1.00–1.04, p = 0.02).ConclusionsSubstantial geographic variation in the use of specific RT technologies was identified. The degree to which this variation reflects effective care, preference‐sensitive care, or supply‐sensitive care warrants further investigation.

Trends in utilization of reflectance confocal microscopy in the United States, 2017-2019

Trends in utilization of reflectance confocal microscopy in the United States, 2017-2019

Trends in Endoscopic Sinonasal Debridement in the Medicare Population.

Nasal/sinus endoscopy with biopsy/polypectomy/debridement, or Current Procedure Terminology code 31237, is one of the top 10 most frequent and highest billed otolaryngology procedures among Medicare patients. We analyzed temporal and geographic trends in endoscopic debridement, and correlated them with sinus surgery and balloon sinuplasty trends. Medicare Part-B National Summary Data Files were analyzed from 2000 to 2016 for temporal trends of endoscopic debridement. Medicare Physician and Other Supplier Public Use Files detailing provider information were collected and analyzed from 2012 to 2016. Individual providers performing a reportable number of procedures were included. Linear regression was used to correlate endoscopic debridement, sinus surgery, and balloon sinuplasty procedures. Between 2000 and 2016, the number of endoscopic debridement procedures increased from 31,579 to 79,762 (6.0% average annual growth). The annual total payments increased from $5,944,582 to $19,438,956 (8.4% average annual growth), with average allowed charge per procedure increasing from $188.24 to $243.71. The greatest and least number of debridement procedures occurred in the Southeast (12,703) and New England (1810) regions, respectively. There was a positive correlation between providers (n = 752) performing endoscopic debridement and sinus surgery (r = 0.31, p < 0.001), which was similar to providers performing endoscopic debridement and balloon sinuplasty (r = 0.29, P < 0.001). Otolaryngologists continue to perform increasing numbers of endoscopic debridements and receive increasing payments. There is some geographic variation in these trends. Among individual providers, there was a positive correlation between the number of endoscopic debridement procedures and both the number of balloon sinuplasty and sinus surgery procedures.

PRS23 Outpatient Transfusions and Occurrence of Transfusion-Associated Circulatory Overload (TACO) Among U.S. Medicare Beneficiaries Ages 65 and Older, During 2011-2018

Transfusion-associated circulatory overload (TACO) is a leading cause of transfusion-related fatalities. The study aimed to assess TACO occurrence and potential risk factors among the U.S. Medicare population aged 65 and older transfused in the institutional outpatient setting.

PSS13 Evaluation of Sociodemographic Characteristics, Perceived Vision Impairment, and Functional Status in Patients With Retinal Disease: Analysis of the Medicare Current Beneficiary Survey (MCBS) Data

To characterize sociodemographic characteristics and overall functional status of community-dwelling patients with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) using data from a nationally representative survey of Medicare beneficiaries. A descriptive analysis was conducted using pooled cross-sectional data from the MCBS linked with Medicare fee-for-service (FFS) claims in 2006–2013 and 2015–2018. Community-dwelling beneficiaries (aged ≥18 years) diagnosed with nAMD or DME and with full-year Medicare Part A and B enrollment were identified separately from Medicare FFS claims. Those with other vision-threatening diseases were excluded. Sociodemographic characteristics, perceived vision, and overall functioning measured by activities of daily living (ADL) and instrumental ADL (IADL) were described for each disease cohort. Of 1228 nAMD beneficiaries (mean [SE] age, 83 [0.4] years; 62% female; 96% non-Hispanic White) and 101 DME beneficiaries (mean [SE] age, 72 [1.5] years; 50% female; 80% non-Hispanic White) identified, the majority resided in metropolitan areas (nAMD, 72%; DME, 66%) and lived above 200% of the federal poverty line (nAMD, 60%; DME, 55%); 59% and 66% of the nAMD and DME cohorts, respectively, received no more than high school education. During the survey years, in the nAMD and DME cohorts, respectively, 26% and 17% reported visual impairment/blindness; 37% and 47% reported difficulty in ≥1 ADL, with the most common ADL being walking (nAMD, 33%; DME, 39%); 52% and 53% reported difficulty in ≥1 IADL, with the most common IADL being heavy housework, such as scrubbing floors (44% for both cohorts); and 30% and 39% reported experiencing falls. About 1/3 patients with nAMD or DME in the Medicare population reported difficulty in walking and experiencing falls. Difficulty with heavy housework was the most commonly reported IADL. Further analyses of the MCBS data linked with claims could highlight the burden of nAMD, DME, and other retinal diseases.

265-OR: Black Race, Rurality, and Neighborhood Disadvantage in Major Amputations: A Medicare Cohort Study

Background: Black, rural, and disadvantaged neighborhood populations are at increased risk of major amputations due to diabetic foot ulcers (DFU). We aimed to determine how the intersection of these health disparity factors is tied to outcomes.Methods: We built a retrospective cohort of 124,487 patients hospitalized with DFU in 2014 with the 100% national Original Medicare population. We used logistic regression and marginal modeling to estimate 30-day composite major amputation/death rates, controlling for other sociodemographics and comorbidities, with interaction terms between the three disparity factors of focus.Results: The predicted rate of major amputation or death for black patients was 19.6% (95% CI 19.0-20.2), compared to 17.3% (17.1-17.6) for white patients, and 17.6% overall. Those living in a disadvantaged neighborhood had a predicated rate of 18.6% (18.1-19.1), compared to 17.4% (17.1-17.6) for those living in a non-disadvantaged neighborhood. Small town residence predicted a 20.2% (19.2-21.1) rate, compared to 16.9% (16.7-17.2) for urban residence. The predicted rate for black patients living in disadvantaged, small towns was 24.2% (20.6-27.8, Figure), with a significant interaction between black race and small town (OR 1.59, p<0.001).Conclusion: Black patients in small towns face high risk of major amputation or death. Such disparities call for new intervention strategies.View largeDownload slideView largeDownload slide DisclosureM. Brennan: None. J. Kramer: None. W. Powell: None. A. J. H. Kind: None. C. M. Bartels: Research Support; Self; Pfizer Foundation.FundingAgency for Healthcare Research and Quality (K08HS02679); National Institute of Diabetes and Digestive and Kidney Diseases; National Institute on Aging (RF1AG057784); National Institute on Minority Health and Health Disparities (R01MD010243)

Association Between First-Line Immune Checkpoint Inhibition and Survival for Medicare-Insured Patients With Advanced Non–Small Cell Lung Cancer

Immunotherapy is now a cornerstone of treatment for advanced non-small cell lung cancer (NSCLC), but its uptake and effectiveness among older patients outside clinical trials remain poorly understood. To understand treatment patterns and evaluate the overall survival associated with checkpoint inhibitor immunotherapy, cytotoxic chemotherapy, and combined chemoimmunotherapy for older patients who have advanced NSCLC and Medicare coverage. This retrospective cohort study included Medicare-insured patients in the US aged 66 to 89 years who initiated first palliative-intent systemic therapy for lung cancer between January 1, 2016, and December 31, 2018. Survival follow-up continued through March 31, 2020. A total of 19 529 patients who had advanced lung cancer and were insured by a Medicare fee-for-service plan were included in the analysis. Regimens included pembrolizumab monotherapy (n = 3079), combined platinum-based drug (ie, cisplatin or carboplatin [hereinafter, platinum]) and pemetrexed disodium (n = 5159), combined platinum and a taxane (ie, paclitaxel, nab-paclitaxel, or docetaxel) (n = 9866), and combined platinum, pemetrexed, and pembrolizumab (n = 1425), as ascertained using Medicare claims from the Centers for Medicare & Medicaid Services. The primary outcome was overall survival, which was measured using the restricted mean survival time (RMST) with propensity score adjustment for clinical and sociodemographic characteristics. Median survival was also reported for comparison with outcomes from registrational trials. A total of 19 529 patients (54% male, 46% female; median age, 73.8 [interquartile range, 69.9-78.4] years) were identified for analysis. The uptake of pembrolizumab-containing regimens in the Medicare population was rapid, increasing from 0.7% of first-line treatments in the second quarter of 2016 to 42.4% in the third quarter of 2018. Patients who were older (≥70 years, 2484 [81%]), were female (1577 [51%]), and/or had higher Risk Stratification Index scores (highest quintile, 922 [30%]) were more likely to receive single-agent pembrolizumab than chemotherapy. After propensity score adjustment, pembrolizumab was associated with survival similar to platinum/pemetrexed (RMST difference, -0.2 [95% CI, -0.5 to 0.2] months) or platinum/taxane (RMST difference, -0.7 [95% CI, -1.0 to -0.4] months). Patients receiving platinum/pemetrexed/pembrolizumab chemoimmunotherapy also had adjusted survival similar to those receiving platinum/pemetrexed chemotherapy (RMST difference, 0.5 [95% CI, 0.1-0.9] months). The unadjusted median survival was 11.4 (95% CI, 10.5-12.3) months among patients receiving single-agent pembrolizumab, approximately 15 months shorter than observed among pembrolizumab-treated participants in the KEYNOTE-024 trial. The unadjusted median survival was 12.9 (95% CI, 11.8-14.0) months among patients receiving platinum/pemetrexed/pembrolizumab chemoimmunotherapy, approximately 10 months shorter than observed among platinum/pemetrexed/pembrolizumab-treated participants in the KEYNOTE-189 trial. Immunotherapy has been incorporated rapidly into treatment for patients with advanced NSCLC. However, survival estimates in the Medicare population are much shorter than those reported in registrational trials. These results provide contemporary estimates of survival for older patients with advanced NSCLC treated in routine practice, facilitating patient-centered decision-making.

Evaluating differential cost growth across individual cancers: Insights from Oncology Care Model data.

e18853 Background: Analyzing cost growth in oncology often faces significant challenges, including fragmentation of data for infused vs. oral agents and ascertaining the cost of inpatient care. How differential cost growth at the individual cancer level contributes to aggregate cost growth in oncology is often opaque. We leverage the integrated claims data provided by Medicare for its Oncology Care Model (OCM) pilot to analyze variations across individual cancers with respect to cost growth. Methods: OCM’s innovative methodology creates a natural experiment where costs are compared against a counterfactual comprised of Medicare patients seen in non-OCM practices. Leveraging this differential counterfactual provides an opportunity to gain insight into cost growth for individual cancers compared to oncology as a whole. Specifically, cost growth is measured each Performance Period (PP) with respect to the Baseline Period, from 2012 to 2015. We analytically decomposed and remodeled key quantitative factors in OCM associated with cost dynamics in oncology, including the Trend Factor (TF), which represents non-OCM cost growth. From 124,896 episodes, we sampled with replacement 19,191 episodes from 17 practices between PP1 and PP6 using empirical data distributions. We assumed neutral novel therapy and experience adjustments and then compared the overall TF to the remodeled cancer-level TF, reaggregated from the individual episodes. Results: Reallocating the TF reveals that cost growth among cancer types is highly variable in the broader Medicare population. Cost growth at the individual cancer level varied from +99.3% to -14.3%. Of the 21 OCM cancers, 18 have TFs greater than zero, indicating cost growth in the non-OCM Medicare population since the Baseline Period. Four have a TF greater than 50%. Three cancer types show decreasing costs relative to the baseline period: intestinal cancer, MDS, and CNS tumor. Conclusions: Significant variation exists across individual cancer subtypes in terms of cost growth. Aggregate analyses of cancer at large have insufficient specificity to rationalize payment mechanisms. Payment reform efforts within cancer care should directly address dynamics at the individual cancer or cancer subtype level in order to provide more valid considerations for expected resource utilization, including in future payment policies. [Table: see text]

Disparities in adjuvant treatment of high-grade endometrial cancer.

e17572 Background: To examine surgical outcomes, patterns of adjuvant therapy, and survival for non-Hispanic Black (NHB) women compared to non-Hispanic White (NHW) and Hispanic (HS) women who have undergone surgery for high grade endometrial cancer in the Medicare population. Methods: We utilized the SEER-Medicare linked database to identify women who underwent surgery as a primary treatment for uterine grade 3 endometrioid adenocarcinoma, carcinosarcoma, clear cell carcinoma, or serous carcinoma between the years 2000 and 2015. Multinomial logistic regression was used to estimate odds ratios (OR) and 95% confidence intervals (95% CI) for receiving a treatment delay or not receiving adjuvant treatment (compared to those who received adjuvant treatment within 12 weeks) adjusted for clinical and demographic characteristics. Overall survival (OS) stratified by race/ethnicity, route of surgery, operative complications, and type and timing of adjuvant therapy were analyzed using the Kaplan-Meier method. Cox Proportional hazards regression was used to estimate hazard of death by race/ethnicity adjusted for known predictors, as well as surgical outcomes and adjuvant therapy patterns. Results: 12, 201 women met study inclusion criteria. NHB patients had a significantly worse five-year overall survival (OS) than HS and NHW patients (30.9 months vs 51.0 months vs 53.6 months, respectively). Approximately 8.6% of patients who received adjuvant treatment experienced a treatment delay (632/7, 282). Delay in treatment of greater than or equal to 12 weeks was significantly different by race/ethnicity (p=0.034), with 12% of HS, 9% of NHB, and 8% of NHW women experiencing a delay. After adjustment for number of complications, age, histology (endometrioid v. non-endometroid), FIGO stage, marital status, comorbidity count, surgical approach, lymph node dissection, and urban-rural code, HS had a 71% increased risk of treatment delay (OR 1.71, CI 1.23-2.38) for all stages of disease. In the same model, NHB race was independently predictive of decreased use of adjuvant treatment for FIGO stage II and higher (OR 1.32, CI 1.04-1.68). NHB race, number of perioperative complications, and non-endometrioid histology were predictive of worse OS in univariate models. Treatment delay was not independently predictive of worse 1- or 5-year survival at any stage. Conclusions: NHB race is predictive of worse 5-year survival across all stages and is also associated with omission of adjuvant treatment in ≥FIGO Stage II high grade endometrial cancers. HS ethnicity was associated with treatment delay across all stages. In unadjusted analyses, patients who experience treatment omission or delay experienced poorer OS, but these factors were not independently associated in multivariate analyses.

U.S. budget impact analysis of an intravenousrituximab biosimilar versus subcutaneous rituximab for the treatment of non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL).

e18821 Background: Rituximab-abbs is a CD20-directed monoclonal antibody and the first rituximab biosimilar approved in the US, expected to significantly reduce drug acquisition costs. This budget impact model (BIM) estimated budgetary impact of replacing a proportion of rituximab/hyaluronidase human subcutaneous injection (SC-R) utilization for NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL with rituximab-abbs (IV-R-BIOSIM). The objective was to project incremental cost differences between IV-R-BIOSIM and SC-R over one year for a hypothetical 5-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM was developed to estimate 1-year drug and administration costs for a one-quarter shift in SC-R market utilization to IV-R-BIOSIM, with equal efficacy and safety assumed. Values for epidemiology, market share, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Infused rituximab (IV-R) dosing assumed a mean body surface area (BSA) of 1.8m2. Annual dose counts of IV-R-BIOSIM or SC-R per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL. IV-R infusion duration was 3 hours. Drug acquisition and infusion/subcutaneous administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. SC-R costs included an initial IV-R originator dose. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drugs. Univariate sensitivity analyses were conducted. A scenario analysis used 2-year dosing to estimate costs for further FL maintenance treatment. Results: For a 5-million-member insured population, an estimated 972 patients would receive rituximab for NHL or CLL; 49 would receive SC-R. Estimated total incremental savings for one year for a 13-patient shift from SC-R to IV-R-BIOSIM were $57,864, equating to $0.02 per enrolled member per year (PMPY). Per-patient incremental annual savings with IV-R-BIOSIM for one year ranged between $2,359–$8,186 (Table). The model was most sensitive to low or high BSA dosing and proportion of patients with CLL. Conclusions: This BIM estimated annual savings of over $57,000 ($0.02 PMPY) for a 5-million-member US payer following a 25% shift of current SC-R use to IV-R-BIOSIM. These findings demonstrate the potential economic benefits of IV-R-BIOSIM vs SC-R that may result in expanded access to rituximab therapy.[Table: see text]

U.S. budget impact analysis of biosimilar versus originator intravenous rituximab for the treatment of non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

e18820 Background: Rituximab-abbs is an anti-CD20 monoclonal antibody and an important immuno-oncology agent for the treatment of B-cell malignancies NHL (diffuse large B-cell lymphoma [DLBCL] and follicular lymphoma [FL]) and CLL. It is also indicated for patients with RA, GPA, and MPA. Rituximab-abbs was the first rituximab biosimilar approved in the US and is expected to reduce drug acquisition costs. This budget impact model (BIM) estimated the impact of replacing a share of originator rituximab (IV-R-REF) use with rituximab-abbs (IV-R-BIOSIM) for NHL (DLBCL and FL), CLL, RA, GPA, and MPA. The objective was to project incremental annual cost differences between IV-R-BIOSIM and IV-R-REF for a hypothetical 1-million-member US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated changes in 1-year drug and administration costs for an increased IV-R-BIOSIM uptake from 17.5% to 22.0%. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Dosing was based on a mean patient body surface area of 1.8 m2. Annual dose counts per patient were: 10 untreated FL with maintenance; 8 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 6 CLL, and 4 for RA, GPA, or MPA. All treatments were assumed to infuse over 3 hours. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was based on 2020 Medicare Part B 20% cost-share for office visits and drug products. Univariate sensitivity analyses were conducted. A scenario analysis was performed to project 2-year costs for extended FL maintenance treatment. Results: Estimated total annual plan incremental savings for a 1-million-member payer after the utilization shift were $312,379, equating to $0.31 per enrolled member per year (PMPY). Per-patient incremental drug cost savings with IV-R-BIOSIM for 1-year were $5,474–$12,924 (Table). The model was most sensitive to IV-R-REF cost and proportion of patients with RA. Conclusions: This analysis estimated annual savings of over $310,000 ($0.31 PMPY) for a 1-million-member US payer following a 4.5% utilization shift from IV-R-REF to IV-R-BIOSIM, demonstrating that IV-R-BIOSIM may confer considerable economic benefits vs originator rituximab.[Table: see text]

U.S. budget impactanalysis of body surface area (BSA)dosing for a rituximab biosimilar vsflat-fixed-dosing for subcutaneous rituximab in non-Hodgkin lymphoma (NHL)and chronic lymphocytic leukemia (CLL).

e18822 Background: The first rituximab biosimilar approved in the US, rituximab-abbs, is a CD20-directed monoclonal antibody that is expected to significantly reduce drug acquisition costs. This economic analysis evaluated budgetary impact of BSA-based rituximab-abbs (IV-R-BIOSIM) vs flat-fixed rituximab/hyaluronidase human subcutaneous injection (SC-R) dosing in NHL (diffuse large B-cell lymphoma [DLBCL], follicular lymphoma [FL]) and CLL. The objective was to project incremental cost differences per patient between IV-R-BIOSIM and SC-R from a US healthcare insured (Medicare) population. Methods: An illustrative BIM estimated 1-year costs for IV-R-BIOSIM and SC-R. The model assumed equal efficacy and safety between products. Values for epidemiology, market share distribution, drug dosing, administration, and costs were derived from scientific literature, product labels, and publicly available cost resources. Costs for the first infused rituximab (IV-R) dose were excluded for appropriate comparison. IV-R-BIOSIM doses used BSAs of 1.6 m2, 1.8 m2, infusion duration was 3 hours. Annual dose counts of IV-R-BIOSIM or SC-R were: 9 untreated FL with maintenance; 7 untreated FL (without maintenance), relapsed/refractory FL, or untreated DLBCL; 5 CLL. Drug acquisition and administration costs were from 2020 Average Sales Price pricing file and Centers for Medicare and Medicaid Services Physician Fee Schedule. Patient cost share was 2020 Medicare Part B 20% cost-share for office visits and drugs. A scenario analysis was also performed to estimate FL maintenance costs for 2-year dosing. Results: Estimated 1-year savings with IV-R-BIOSIM for 1.8 m2 BSA dosing were $1,067–$6,893 with variability between indications (Table). For 1.6 m2 BSA dosing, estimated 1-year savings with IV-R-BIOSIM were $3,819–$10,856. Estimated 2-year savings with IV-R-BIOSIM for FL maintenance dosing were $9,191 for 1.8 m2 BSA dosing and $14,475 for 1.6 m2 BSA dosing. Savings of up to $1,900 were seen for higher-than-average BSA dosing, regardless of regimen. Conclusions: These findings demonstrate the potential economic benefits of replacing a proportion of SC-R use with BSA-based IV-R-BIOSIM from a US payer perspective, especially when lower BSA dosing is used. Savings are driven by drug costs and may increase with IV-R-BIOSIM as patient BSA decreases due to static costs with SC-R doses. These data also suggest that drug wastage may occur with SC-R in lower BSA patients.[Table: see text]

Emulating causal dose-response relations between air pollutants and mortality in the Medicare population

BackgroundFine particulate matter (PM2.5), ozone (O3), and nitrogen dioxide (NO2) are major air pollutants that pose considerable threats to human health. However, what has been mostly missing in air pollution epidemiology is causal dose-response (D-R) relations between those exposures and mortality. Such causal D-R relations can provide profound implications in predicting health impact at a target level of air pollution concentration.MethodsUsing national Medicare cohort during 2000–2016, we simultaneously emulated causal D-R relations between chronic exposures to fine particulate matter (PM2.5), ozone (O3), and nitrogen dioxide (NO2) and all-cause mortality. To relax the contentious assumptions of inverse probability weighting for continuous exposures, including distributional form of the exposure and heteroscedasticity, we proposed a decile binning approach which divided each exposure into ten equal-sized groups by deciles, treated the lowest decile group as reference, and estimated the effects for the other groups. Binning continuous exposures also makes the inverse probability weights robust against outliers.ResultsAssuming the causal framework was valid, we found that higher levels of PM2.5, O3, and NO2 were causally associated with greater risk of mortality and that PM2.5 posed the greatest risk. For PM2.5, the relative risk (RR) of mortality monotonically increased from the 2nd (RR, 1.022; 95% confidence interval [CI], 1.018–1.025) to the 10th decile group (RR, 1.207; 95% CI, 1.203–1.210); for O3, the RR increased from the 2nd (RR, 1.050; 95% CI, 1.047–1.053) to the 9th decile group (RR, 1.107; 95% CI, 1.104–1.110); for NO2, the DR curve wiggled at low levels and started rising from the 6th (RR, 1.005; 95% CI, 1.002–1.018) till the highest decile group (RR, 1.024; 95% CI, 1.021–1.027).ConclusionsThis study provided more robust evidence of the causal relations between air pollution exposures and mortality. The emulated causal D-R relations provided significant implications for reviewing the national air quality standards, as they inferred the number of potential early deaths prevented if air pollutants were reduced to specific levels; for example, lowering each air pollutant concentration from the 70th to 60th percentiles would prevent 65,935 early deaths per year.

453 Cost-Effectiveness of Requalifying for Positive Airway Pressure Treatment After Initial Nonadherence

Abstract Introduction Obstructive sleep apnea (OSA) is effectively treated with continuous positive airway pressure (CPAP). However, many people are not able to become adherent in the initial 90-day trial window for this therapy. Medicare requires a polysomnography and repeat trial documenting adherence before continuing payment for these services. Oral appliance therapy (OAT) is also an OSA first-line therapy but is less effective than CPAP. Methods We created a decision tree to model 4 strategies over a 5-year time horizon: (1) current policy, (2) direct referral for CPAP equipment, (3) OAT followed by CPAP under current policy, and (4) OAT followed by direct CPAP referral in a the Medicare population with mild-moderate OSA and nonadherence to a first attempt at CPAP therapy. Medicare fee schedules in 2020 defined costs. Incremental cost-effectiveness (ICER) was used to identify the supreme strategy Results The current policy was the most expensive. Both the current policy and direct DME referral were dominated by starting with OAT. OAT followed by titration was the most cost-effective strategy with an ICER of $42,586.47. The ICER was sensitive to adherence in the direct CPAP strategy and probability of getting CPAP equipment (vs. lost to follow-up). Conclusion Starting with OAT therapy in those that were CPAP nonadherent on first attempt is cost-effective. Despite decreased effectiveness, the increase adherence to OAT make it an attractive option for retrial of OSA therapy. If OAT therapy fails, the current policy is more cost-effective than direct CPAP referral. Support (if any) This study was supported Career Development Award IK2CX001882 from the United States (U.S.) Department of Veterans Affairs Clinical Sciences Research and Development Service. The contents of this work do not represent the views of the Department of Veterans Affairs or the United States government.

Uptake and cost of biosimilar filgrastim among Medicare and Medicaid populations in 2015-2018.

BACKGROUND: The first biosimilar product filgrastim-sndz was approved by the FDA in 2015, but real-world evaluations of its uptake and cost in nationally representative populations are limited. OBJECTIVE: To evaluate the uptake and cost of filgrastim-sndz, relative to its originator filgrastim and alternative biologic tbofilgrastim, among Medicare and Medicaid populations. METHODS: Using the annually aggregated, product-level utilization and cost data of biologic and biosimilar filgrastim products in 2015-2018 from CMS drug spending data, total number of claims and costs for all 3 filgrastim products were identified and extracted for Medicare Part B, Part D, and Medicaid reimbursement. Annual average cost per claim and per beneficiary of individual filgrastim products were also extracted, and their annual growth rates were calculated. RESULTS: Three years after entering the US market, use of filgrastim-sndz increased to 49.1% and 46.0% of all filgrastim claims paid by Medicare Parts B and D, respectively, and to 38.7% of filgrastim Medicaid claims in 2018. Total cost for filgrastim-sndz also reached 42.8%, 41.8%, and 26.9% of all filgrastim products paid by Medicare Parts B and D and Medicaid, respectively. Significant reductions in average cost per claim for filgrastim-sndz in 2017 and 2018 were observed in Medicare Part B and Medicaid. CONCLUSIONS: Significant uptake of biosimilar filgrastim in Medicare and Medicaid programs occurred during the first 3 years of marketing. Policymakers may use the evidence to evaluate existing barriers and policies regarding biosimilar adoption. DISCLOSURES: No outside funding supported this work. The author has no conflicts of interest to disclose.

Removal of prior authorization for medication-assisted treatment: impact on opioid use and policy implications in a Medicare Advantage population.

BACKGROUND: More than 30% of Medicare beneficiaries and 40% of patients dually eligible for Medicare and Medicaid use opioids. With an estimated 8%-12% of patients developing an opioid use disorder (OUD) after initiating opioids, opioid misuse is a significant public health challenge, especially among high-risk Medicare populations. Medication-assisted treatment (MAT) is the use of medications for the treatment of OUD and to prevent relapse to opioid use. MAT is the most effective treatment for OUD. There are a variety of barriers to MAT therapy that may delay access to treatment. OBJECTIVE: To study the impact of the removal of prior authorization requirements for MAT medications on MAT utilization, opioid utilization, and clinical outcomes, including emergency department visits, inpatient admission, relapse rates, behavioral health services, and nonopioid pain medication utilization, among opioid-using individuals with Medicare Advantage Prescription Drug (MAPD) coverage. METHODS: This retrospective, cross-sectional study used administrative medical, pharmacy, and enrollment data to identify chronic opioid users and a subset cohort initiating MAT use in 2017, when prior authorization requirements were in effect, and 2018 after removal of prior authorization requirements. Opioid and MAT utilization and clinical outcomes from emergency department visits were also examined before and after prior authorization requirements. A logistic regression analysis was conducted to examine the impact of the policy change on relapse rates, comparing relapse rates in 2017 and 2018, after controlling for potentially confounding demographic and clinical factors. RESULTS: This policy change was followed by a decrease in opioid utilization, an increase in MAT initiation, and a 4% decline in relapse rates. Patients initiating MAT after removal of prior authorizations had a 19% decrease in likelihood of relapse, and those with an OUD diagnosis were 47% less likely to relapse. The majority of MAT recipients were aged younger than 65 years, had a mental or behavioral health disorder diagnosis, and initially used relatively low doses (< 90 MME) of prescription opioids. There were no statistically significant differences in the use of behavioral health services or the use of nonopioid medications from 2017 to 2018. CONCLUSIONS: Utilization management policies should ensure appropriate MAT use, while minimizing impediments to access. Providing patients with evidence-based therapy effective for the treatment of OUD is essential to patient recovery and combating the consequences of the opioid epidemic. Further strides are needed to eliminate additional obstacles to OUD care. DISCLOSURES: No outside funding supported this study. All authors are or were employees of Humana, Inc., at the time of the study and have no other potential conflicts of interest to disclose.

Abstract No. 498 Trends in utilization and Medicare reimbursement for TIPS and open surgical portal decompression

To analyze trends in the number of minimally invasive TIPS (transjugular intrahepatic portosystemic shunt) vs. open surgical procedures performed for portal decompression in the Medicare population between 2009 and 2018 as well as the reimbursement rates for these procedures. Using the CPT Professional 2019 guidebook, 6 portosystemic decompression codes were identified: 1 for TIPS and 5 for open procedures. Medicare payments as well as the number of reimbursed procedures (allowed services) were selected for each code from the Centers for Medicare and Medicaid Services Part B National Summary Data Files between 2009 and 2018. All payments were adjusted for inflation to their respective 2018 prices. Four of the five open surgical codes were excluded from our analysis as they were performed < 10 times/year and were accordingly censored on the database. The total number of allowed services as well as payments per procedure were analyzed over time using linear regression. They were then compared between procedure types using tests for equality of slopes. Finally, TIPS cases as a proportion of total portosystemic decompressions were analyzed longitudinally via a chi-square test for trend. Significance in all analyses was defined as a 2-sided test with P < 0.05. The number of allowed TIPS procedures increased at a rate of 38.6 procedures/year between 2009 and 2018 (r2 = 0.67) while open procedures decreased at a rate of 2.8 procedures/year (r2 = 0.30) (P = 0.047). The reimbursements for TIPS decreased at a rate of $8.58 per year (r2 = 0.44) while the reimbursements for open procedures increased at a rate of $39.91 per year (r2 = 0.25) (P = 0.01). The number of TIPS cases as a proportion of total portosystemic decompressions increased from 95.0% in 2009 to 98.6% in 2018 (P < 0.001). In the Medicare population between 2009 and 2018, the number of TIPS procedures performed per year showed a positive trend while the number of open surgical procedures for portosystemic decompression demonstrated a slight negative trend. Payments for TIPS decreased while payments for the same open surgical procedures increased. Overall, TIPS was used at an increasing proportion of total portal decompression procedures over this time period, suggesting an increase in its availability or preference by physicians.

Abstract No. 104 National trends in inferior vena cava filter placement and retrieval: how are we doing?

Prior studies demonstrate a marked increase and subsequent decrease in the number of inferior vena cava (IVC) filters placed over the last several decades. The aim of this analysis was to evaluate national recent trends in placement and removal of IVC filters in the Medicare population using the most recent data available.

Abstract No. 195 National trends in transjugular intrahepatic portosystemic shunt placement, revision, and trainee procedure involvement

To evaluate national trends in transjugular intrahepatic portosystemic shunt (TIPS) creation and revision rates and evaluate trainee exposure to TIPS placement and revision Medicare Physician/Supplier Summary Files were evaluated from 2010 to 2018. TIPS shunt creation and revision procedures were aggregated. Procedures involving a trainee were identified. The rate of TIPS placement, revision, and trainee involvement were evaluated in the context of Medicare enrollment and number of diagnostic and interventional radiology residents as well as interventional radiology fellows using Accreditation of Graduate Medical Education (ACGME) data. From 2010 to 2018, annual claims for de novo TIPS placement increased from 1,725 procedures to 1,947 procedures (+12.8%). When controlled for number of Medicare enrollees, this resulted in an increase of 4.8 to 5.0 (+4.0%) TIPS procedures per 100,000 beneficiaries. TIPS revisions increased from 645 procedures in 2010 to 932 (+45%) procedures in 2018. When controlled for Medicare enrollment, this represented an increase from 1.8 to 2.4 (+33%) TIPS revisions per 100,000 Medicare enrollees. Over time, the ratio of TIPS placements to TIPS revisions decreased from 2.7 to 2.1 (-29%), driven by a relatively higher increase of revisions compared to de novo placements. The number of TIPS placements involving a trainee increased from 17% to 26%. Similarly, the rate of trainee involvement in revisions increased from 18% to 29%. Ratio of TIPS placements and revisions per one thousand trainees increased 55% and 111%, respectively. The rate of TIPS placement and revisions continues to increase in the Medicare population, with a disproportionate increase in TIPS revisions compared to placements. Trainee involvement in these procedures has increased nationally from 2010 to 2018. Further research is needed to evaluate the disproportionate increase in TIPS revisions to placements in this population.

The Increasing Economic Burden with Additional Steps of Pharmacotherapy in Major Depressive Disorder.

ObjectivesMajor depressive disorder (MDD) is a common and serious disorder with significant impact on patients and families. The goal of this retrospective cohort study was to determine the economic burden among patients with MDD stratified by number of treatment lines needed for episode resolution.MethodsTruven Health Analytics MarketScan® claims data were used to identify US patients (≥ 18 years) who were diagnosed with MDD and started on an antidepressant between 2013 and 2017. A generalized linear model estimated direct and employment-related costs for the first 12 months following initiation of treatment across cohorts with increasing number of lines of MDD pharmacotherapy. Analyses were adjusted for demographics and clinical factors.ResultsA total of 73,597 patients with MDD comprising the commercial (n = 66,459) and Medicare (n = 7138) populations met selection criteria. Patients who completed treatment for their episode with a single line of antidepressant had the lowest total adjusted direct costs (commercial $9975; Medicare $14,628) followed by those who completed with two lines (commercial $11,723; Medicare $15,526) and those treated with three or more lines of antidepressant regimens (commercial $21,259; Medicare $20,964). Patients who completed treatment with two lines as opposed to one incurred significantly higher direct costs (commercial +$1748, p < 0.0001; Medicare +$898, p = 0.0092). Patients who completed treatment with one line had the lowest employment-related costs compared to other groups.ConclusionsThere was an increased economic burden associated with delay of episode resolution as early as the second line compared to the first line in MDD.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40273-021-01021-w.