Health Equity Adjustment and Hospital Performance in the Medicare Value-Based Purchasing Program.

Importance: Medicare's Hospital Value-Based Purchasing (HVBP) program will provide a health equity adjustment (HEA) to hospitals that have greater proportions of patients dually eligible for Medicare and Medicaid and that offer high-quality care beginning in fiscal year 2026. However, which hospitals will benefit most from this policy change and to what extent are unknown. Objective: To estimate potential changes in hospital performance after HEA and examine hospital patient mix, structural, and geographic characteristics associated with receipt of increased payments. Design, Setting, and Participants: This cross-sectional study analyzed all 2676 hospitals participating in the HVBP program in fiscal year 2021. Publicly available data on program performance and hospital characteristics were linked to Medicare claims data on all inpatient stays for dual-eligible beneficiaries at each hospital to calculate HEA points and HVBP payment adjustments. Exposures: Hospital Value-Based Purchasing program HEA. Main Outcomes and Measures: Reclassification of HVBP bonus or penalty status and changes in payment adjustments across hospital characteristics. Results: Of 2676 hospitals participating in the HVBP program in fiscal year 2021, 1470 (54.9%) received bonuses and 1206 (45.1%) received penalties. After HEA, 102 hospitals (6.9%) were reclassified from bonus to penalty status, whereas 119 (9.9%) were reclassified from penalty to bonus status. At the hospital level, mean (SD) HVBP payment adjustments decreased by $4534 ($90 033) after HEA, ranging from a maximum reduction of $1 014 276 to a maximum increase of $1 523 765. At the aggregate level, net-positive changes in payment adjustments were largest among safety net hospitals ($28 971 708) and those caring for a higher proportion of Black patients ($15 468 445). The likelihood of experiencing increases in payment adjustments was significantly higher among safety net compared with non-safety net hospitals (574 of 683 [84.0%] vs 709 of 1993 [35.6%]; adjusted rate ratio [ARR], 2.04 [95% CI, 1.89-2.20]) and high-proportion Black hospitals compared with non-high-proportion Black hospitals (396 of 523 [75.7%] vs 887 of 2153 [41.2%]; ARR, 1.40 [95% CI, 1.29-1.51]). Rural hospitals (374 of 612 [61.1%] vs 909 of 2064 [44.0%]; ARR, 1.44 [95% CI, 1.30-1.58]), as well as those located in the South (598 of 1040 [57.5%] vs 192 of 439 [43.7%]; ARR, 1.25 [95% CI, 1.10-1.42]) and in Medicaid expansion states (801 of 1651 [48.5%] vs 482 of 1025 [47.0%]; ARR, 1.16 [95% CI, 1.06-1.28]), were also more likely to experience increased payment adjustments after HEA compared with their urban, Northeastern, and Medicaid nonexpansion state counterparts, respectively. Conclusions and Relevance: Medicare's implementation of HEA in the HVBP program will significantly reclassify hospital performance and redistribute program payments, with safety net and high-proportion Black hospitals benefiting most from this policy change. These findings suggest that HEA is an important strategy to ensure that value-based payment programs are more equitable.

Budget Impact of Introducing Fixed-Duration Mosunetuzumab for the Treatment of Relapsed or Refractory Follicular Lymphoma After Two or More Lines of Systemic Therapy in the USA.

OBJECTIVE: This study aimed to assess the budget impact of introducing fixed-duration mosunetuzumab as a treatment option for adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies and to estimate the total cumulative costs per patient in the USA. METHODS: A 3-year budget impact model was developed for a hypothetical 1-million-member cohort enrolled in a mixed commercial/Medicare health plan. Comparators were: axicabtagene ciloleucel, tisagenlecleucel, tazemetostat, rituximab plus lenalidomide, copanlisib, and older therapies (rituximab or obinutuzumab ± chemotherapy). Costs per patient comprised treatment-associated costs including the drug, its administration, adverse events, and routine care. Dosing and safety data were ascertained from respective package inserts and clinical trial data. Drug costs (March 2023) were estimated based on the average wholesale acquisition cost reported in AnalySource®, and all other costs were based on published sources and inflated to 2022 US dollars. Market shares were obtained from Genentech internal projections and expert opinion. Budget impact outcomes were presented on a per-member per-month basis. RESULTS: Compared with a scenario without mosunetuzumab, its introduction over 3 years resulted in a budget increase of $69,812 (1% increase) and an average per-member per-month budget impact of $0.0019. Among the newer therapies, mosunetuzumab had the second-lowest cumulative per patient cost (mosunetuzumab = $202,039; axicabtagene ciloleucel = $505,845; tisagenlecleucel = $476,293; rituximab plus lenalidomide = $263,520; tazemetostat = $250,665; copanlisib = $127,293) and drug costs, and its introduction only increased total drug costs by 0.1%. By year 3, the cumulative difference in the per patient cost with mosunetuzumab was -$303,805 versus axicabtagene ciloleucel, -$274,254 versus tisagenlecleucel, -$61,481 versus rituximab plus lenalidomide, -$48,625 versus tazemetostat, and $74,747 versus copanlisib. Older therapies were less costly with 3-year cumulative costs that ranged from $36,512 to $147,885. CONCLUSIONS: Over 3 years, the estimated cumulative per patient cost of mosunetuzumab is lower than most available newer therapies, resulting in a small increase in the budget after its formulary adoption for the treatment of relapsed or refractory follicular lymphoma.

Prices for Common Services at Quaternary vs Nonquaternary Hospitals.

This study uses commercial claims data to assess whether quaternary hospitals charge higher prices for common, unspecialized services also offered by nonquaternary hospitals.

Effects of the Million Hearts Model on Myocardial Infarctions, Strokes, and Medicare Spending: A Randomized Clinical Trial.

Importance: The Million Hearts Model paid health care organizations to assess and reduce cardiovascular disease (CVD) risk. Model effects on long-term outcomes are unknown. Objective: To estimate model effects on first-time myocardial infarctions (MIs) and strokes and Medicare spending over a period up to 5 years. Design, Setting, and Participants: This pragmatic cluster-randomized trial ran from 2017 to 2021, with organizations assigned to a model intervention group or standard care control group. Randomized organizations included 516 US-based primary care and specialty practices, health centers, and hospital-based outpatient clinics participating voluntarily. Of these organizations, 342 entered patients into the study population, which included Medicare fee-for-service beneficiaries aged 40 to 79 years with no previous MI or stroke and with high or medium CVD risk (a 10-year predicted probability of MI or stroke [ie, CVD risk score] ≥15%) in 2017-2018. Intervention: Organizations agreed to perform guideline-concordant care, including routine CVD risk assessment and cardiovascular care management for high-risk patients. The Centers for Medicare & Medicaid Services paid organizations to calculate CVD risk scores for Medicare fee-for-service beneficiaries. CMS further rewarded organizations for reducing risk among high-risk beneficiaries (CVD risk score ≥30%). Main Outcomes and Measures: Outcomes included first-time CVD events (MIs, strokes, and transient ischemic attacks) identified in Medicare claims, combined first-time CVD events from claims and CVD deaths (coronary heart disease or cerebrovascular disease deaths) identified using the National Death Index, and Medicare Parts A and B spending for CVD events and overall. Outcomes were measured through 2021. Results: High- and medium-risk model intervention beneficiaries (n = 130 578) and standard care control beneficiaries (n = 88 286) were similar in age (median age, 72-73 y), sex (58%-59% men), race (7%-8% Black), and baseline CVD risk score (median, 24%). The probability of a first-time CVD event within 5 years was 0.3 percentage points lower for intervention beneficiaries than control beneficiaries (3.3% relative effect; adjusted hazard ratio [HR], 0.97 [90% CI, 0.93-1.00]; P = .09). The 5-year probability of combined first-time CVD events and CVD deaths was 0.4 percentage points lower in the intervention group (4.2% relative effect; HR, 0.96 [90% CI, 0.93-0.99]; P = .02). Medicare spending for CVD events was similar between the groups (effect estimate, -$1.83 per beneficiary per month [90% CI, -$3.97 to -$0.30]; P = .16), as was overall Medicare spending including model payments (effect estimate, $2.11 per beneficiary per month [90% CI, -$16.66 to $20.89]; P = .85). Conclusions and Relevance: The Million Hearts Model, which encouraged and paid for CVD risk assessment and reduction, reduced first-time MIs and strokes. Results support guidelines to use risk scores for CVD primary prevention. Trial Registration: ClinicalTrials.gov Identifier: NCT04047147.

Protecting Medicare's Discretion to Say No to Unproven Therapies.

In this Viewpoint, Kesselheim and coauthors discuss 2 bills in Congress that would curtail Medicare's ability to decline, limit, or conditionally cover medical products that lack robust evidence and argue that officials should distinguish between better and worse therapies when determining reimbursement.

The Problem of Limited-Supply Agreements for Medicare Price Negotiation.

This Viewpoint discusses how limited-supply agreements (introduction of generic products in reduced volumes) might thwart efforts to negotiate lower prices on prescription drugs in the US.

Medicare's Historic Prescription Drug Price Negotiations.

This Viewpoint evaluates the legal claims and policy implications of historic drug price negotiations possible with the Inflation Reduction Act of 2022.

Cardiovascular Disease Burden and Outcomes Among American Indian and Alaska Native Medicare Beneficiaries.

Importance: American Indian and Alaska Native persons face significant health disparities; however, data regarding the burden of cardiovascular disease in the current era is limited. Objective: To determine the incidence and prevalence of cardiovascular disease, the burden of comorbid conditions, including cardiovascular disease risk factors, and associated mortality among American Indian and Alaska Native patients with Medicare insurance. Design, Setting, and Participants: This was a population-based cohort study conducted from January 2015 to December 2019 using Medicare administrative data. Participants included American Indian and Alaska Native Medicare beneficiaries 65 years and older enrolled in both Medicare part A and B fee-for-service Medicare. Statistical analyses were performed from November 2022 to April 2023. Main Outcomes and Measures: The annual incidence, prevalence, and mortality associated with coronary artery disease (CAD), heart failure (HF), atrial fibrillation/flutter (AF), and cerebrovascular disease (stroke or transient ischemic attack [TIA]). Results: Among 220 598 American Indian and Alaska Native Medicare beneficiaries, the median (IQR) age was 72.5 (68.5-79.0) years, 127 402 were female (57.8%), 78 438 (38.8%) came from communities in the most economically distressed quintile in the Distressed Communities Index. In the cohort, 44.8% of patients (98 833) were diagnosed with diabetes, 61.3% (135 124) were diagnosed with hyperlipidemia, and 72.2% (159 365) were diagnosed with hypertension during the study period. The prevalence of CAD was 38.6% (61 125 patients) in 2015 and 36.7% (68 130 patients) in 2019 (P < .001). The incidence of acute myocardial infarction increased from 6.9 per 1000 person-years in 2015 to 7.7 per 1000 patient-years in 2019 (percentage change, 4.79%; P < .001). The prevalence of HF was 22.9% (36 288 patients) in 2015 and 21.4% (39 857 patients) in 2019 (P < .001). The incidence of HF increased from 26.1 per 1000 person-years in 2015 to 27.0 per 1000 person-years in 2019 (percentage change, 4.08%; P < .001). AF had a stable prevalence of 9% during the study period (2015: 9.4% [14 899 patients] vs 2019: 9.3% [25 175 patients]). The incidence of stroke or TIA decreased slightly throughout the study period (12.7 per 1000 person-years in 2015 and 12.1 per 1000 person-years in 2019; percentage change, 5.08; P = .004). Fifty percent of patients (110 244) had at least 1 severe cardiovascular condition (CAD, HF, AF, or cerebrovascular disease), and the overall mortality rate for the cohort was 19.8% (43 589 patients). Conclusions and Relevance: In this large cohort study of American Indian and Alaska Native patients with Medicare insurance in the US, results suggest a significant burden of cardiovascular disease and cardiometabolic risk factors. These results highlight the critical need for future efforts to prioritize the cardiovascular health of this population.

Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

Use and Cost of Sustained-Release Corticosteroids for Cataract Surgery Under the Medicare Pass-Through Program.

Importance: Sustained-release corticosteroids offer the potential of improved compliance and greater patient convenience for anti-inflammatory treatment after cataract surgery. However, they are substantially more expensive than postoperative corticosteroid eye drops, which have historically been standard care. Objective: To examine the use and cost of sustained-release corticosteroids in patients with Medicare who underwent cataract surgery in the US during the temporary pass-through reimbursement program period. Design, Setting, and Participants: This cross-sectional study examined Medicare fee-for-service (FFS) claims from beneficiaries with at least 12 continuous months of Medicare enrollment who underwent at least 1 cataract surgery from March 2019 through December 2021. Patients younger than 65 years, those with missing demographic information, those who had more than 1 cataract surgery on each eye, and those who received more than 1 corticosteroid on the day of surgery were excluded. Cataract surgeries with concurrent use of dexamethasone intraocular suspension 9% or dexamethasone ophthalmic insert were identified. Information on surgeon demographic characteristics and costs of surgery and drugs were extracted. Data were analyzed from June 15 to December 4, 2022. Exposure: Use of dexamethasone intraocular suspension 9% or dexamethasone ophthalmic insert during cataract surgery. Main Outcome Measures: Utilization rate and cost of dexamethasone intraocular suspension 9% and dexamethasone ophthalmic insert among Medicare FFS beneficiaries who underwent cataract surgery. Results: A total of 4 252 532 cataract surgeries in Medicare FFS beneficiaries (mean [SD] age, 74.8 [5.8] years; 1 730 811 male [40.7%] and 2 521 721 female [59.3%]) were performed by 12 284 ophthalmologists (8876 male [72.3%], 2877 female [23.4%], and 531 sex unknown [4.3%]). In all, 34 627 beneficiaries (0.8%) received dexamethasone intraocular suspension 9% and 73 430 (1.7%) received a dexamethasone ophthalmic insert; the use of both drugs increased over the study period. The mean (SD) Medicare allowed charges for dexamethasone intraocular suspension 9% and dexamethasone ophthalmic insert were $531.47 ($141.52) and $538.49 ($63.79), respectively. Conclusions and Relevance: Despite offering the potential of improved compliance and greater patient convenience, findings of this study suggest that sustained-release corticosteroid use during cataract surgery was low and associated with cost increases to the health care system vs conventional postoperative eye drops. As these new products must be priced high enough to qualify for the Medicare pass-through program, unreasonable cost may have been a deterrent to their use, suggesting that the current Medicare reimbursement rules may not be appropriate for sustained-release postoperative corticosteroids in cataract surgery.