Effectiveness and Cost-Effectiveness of Colorectal Cancer Screening With a Blood Test That Meets the Centers for Medicare & Medicaid Services Coverage Decision.

BACKGROUND & AIMS: A blood-based colorectal cancer (CRC) screening test may increase screening participation. However, blood tests may be less effective than current guideline-endorsed options. The Centers for Medicare & Medicaid Services (CMS) covers blood tests with sensitivity of at least 74% for detection of CRC and specificity of at least 90%. In this study, we investigate whether a blood test that meets these criteria is cost-effective. METHODS: Three microsimulation models for CRC (MISCAN-Colon, CRC-SPIN, and SimCRC) were used to estimate the effectiveness and cost-effectiveness of triennial blood-based screening (from ages 45 to 75 years) compared to no screening, annual fecal immunochemical testing (FIT), triennial stool DNA testing combined with an FIT assay, and colonoscopy screening every 10 years. The CMS coverage criteria were used as performance characteristics of the hypothetical blood test. We varied screening ages, test performance characteristics, and screening uptake in a sensitivity analysis. RESULTS: Without screening, the models predicted 77-88 CRC cases and 32-36 CRC deaths per 1000 individuals, costing $5.3-$5.8 million. Compared to no screening, blood-based screening was cost-effective, with an additional cost of $25,600-$43,700 per quality-adjusted life-year gained (QALYG). However, compared to FIT, triennial stool DNA testing combined with FIT, and colonoscopy, blood-based screening was not cost-effective, with both a decrease in QALYG and an increase in costs. FIT remained more effective (+5-24 QALYG) and less costly (-$3.2 to -$3.5 million) than blood-based screening even when uptake of blood-based screening was 20 percentage points higher than uptake of FIT. CONCLUSION: Even with higher screening uptake, triennial blood-based screening, with the CMS-specified minimum performance sensitivity of 74% and specificity of 90%, was not projected to be cost-effective compared with established strategies for colorectal cancer screening.

Adjusting for race in metrics of organ procurement organization performance.

The Scientific Registry of Transplant Recipients has previously reported the effects of adjusting for demographic variables, including race, in the Centers for Medicare & Medicaid Services (CMS) organ procurement organization (OPO) performance metrics: donation rate and transplant rate. CMS chose not to adjust for most demographic variables other than age (for the transplant rate), arguing that there is no biological reason that these variables would affect the organ donation/utilization decision. However, organ donation is a process based on altruism and trust, not a simple biological phenomenon. Focusing only on biological impacts on health ignores other pathways through which demographic factors can influence OPO outcomes. In this study, we update analyses of demographic adjustment on the OPO metrics for 2020 with a specific focus on adjusting for race. We find that adjusting for race would lead to 8 OPOs changing their CMS tier rankings, including 2 OPOs that actually overperform the national rate among non-White donors improving from a tier 3 ranking (facing decertification without possibility of recompeting) to a tier 2 ranking (allowing the possibility of recompeting). Incorporation of stratified and risk-adjusted metrics in public reporting of OPO performance could help OPOs identify areas for improvement within specific demographic categories.

Central Line-Associated Bloodstream Infection Misclassifications-Rethinking the Centers for Disease Control and Prevention's Central Line-Associated Bloodstream Infection Definition and Its Implications.

Centers for Medicare and Medicaid Services imparts financial penalties for central line-associated bloodstream infections (CLABSIs) and other healthcare-acquired infections. Data for this purpose is obtained from the Centers for Disease Control and Prevention (CDC)'s National Health Safety Network. We present examples of misclassification of bloodstream infections into CLABSI by the CDC's definition and present the financial implications of such misclassification and potential long-term implications.

Implications of the Centers for Medicare and Medicaid Services decision to expand indications for carotid artery stenting.

OBJECTIVE: On October 11, 2023, the Centers for Medicare and Medicaid Services (CMS) expanded the indications for carotid artery stenting (CAS) to include patients with ≥50% symptomatic or ≥70% asymptomatic carotid stenosis. The aim of this article was to investigate the implications of this decision. METHODS: The reasons behind the increased coverage for CAS are analyzed and discussed, as well as the various Societies supporting or opposing the expansion of indications for CAS. RESULTS: The benefits associated with expanding CAS indications include providing an additional therapeutic option to patients and enabling individualization of treatment according to patient-specific characteristics. The drawbacks of expanding CAS indications include a possible bias in decision-making and an increase in inappropriate CAS procedures. CONCLUSIONS: The purpose of the CMS recommendation to expand indications for CAS is to improve the available therapeutic options for patients. Hopefully this decision will not be misinterpreted and will be used to improve patient options and patient outcomes.

Individualized empirical null estimation for exact tests of healthcare quality.

United States federal agencies evaluate healthcare providers to identify, flag, and potentially penalize those that deliver low-quality care compared to national expectations. In practice, evaluation metrics are inevitably impacted by unobserved confounding factors, which reduce flagging accuracy and cause the statistics to be overdispersed relative to the theoretical null distributions. In response to this issue, several authors have proposed individualized empirical null (IEN) methods to estimate an appropriate null distribution for each provider's evaluation statistic while taking into account the provider's effective size. However, existing IEN methods require that the statistics asymptotically follow normal distributions, which often does not hold in applications with small providers or misspecified models. In this article, we develop an IEN framework for exact hypothesis tests that accounts for the impact of unobserved confounding without making any asymptotic assumptions. Simulations show that the proposed IEN method has greater flagging accuracy compared to conventional approaches. We apply these methods to evaluate dialysis facilities and transplant centers that are monitored by the Centers for Medicare and Medicaid Services.

Uptake and outcomes of supervised exercise therapy for peripheral artery disease: The importance of vascular medicine specialists at a large midwestern health care system during the first 5 years of CMS reimbursement.

BACKGROUND: Supervised exercise therapy (SET) is the cornerstone of medical therapy for symptomatic peripheral artery disease (PAD). Despite the efficacy of SET, initial reports following the 2017 Centers for Medicare and Medicaid Services (CMS) reimbursement decision indicate low SET uptake, referral, and completion. Vascular medicine specialists are key to the success of such programs. We examined rates of SET referral, completion, and outcomes in a health system with a robust SET program during the first 5 years of CMS reimbursement. METHODS: A retrospective chart review of patients with PAD referred to SET between October 1, 2017 and December 31, 2022 was conducted. Patient demographic and medical characteristics, SET indication, referring provider specialty, SET participation (e.g., exercise modality, number of sessions, treadmill prescription), and outcomes were abstracted. Descriptive statistics, t-tests, and multiple linear regression were used to examine the sample, evaluate outcomes, and explore outcomes by relevant covariates (i.e., age, sex, referring provider specialty). RESULTS: Of 5320 patients with PAD, N = 773 were referred to SET; N = 415 enrolled and were included in the present study. Vascular medicine and vascular surgery specialists were the two primary sources of referrals (30.6% and 51.6%, respectively). A total of 207 patients (49.9%) completed SET. Statistically significant and clinically meaningful improvements were observed in all outcomes. CONCLUSION: SET referral and completion rates are low in the 5 years following CMS reimbursement, despite the advocacy of vascular medicine specialists. SET is effective in improving patient functional capacity and quality of life. Additional efforts are needed to increase both SET availability and referrals as part of comprehensive treatment of PAD.

Comparing the Centers for Medicare and Medicaid Services (CMS) enrollment data death dates to the National Death Index (NDI).

PURPOSE: In the United States, the National Death Index (NDI) is the most complete source of death information, while epidemiologic studies with mortality outcomes often rely on U.S. Medicare data for outcome ascertainment. The purpose of this study was to assess the agreement of death information between the Centers for Medicare & Medicaid Services (CMS) Medicare enrolment data and NDI. METHODS: Using Medicare and NDI data from 1999 through 2016, we identified Medicare beneficiaries who were reported dead in the CMS Medicare enrolment database (EDB) and Common Medicare Environment (CME), linked these beneficiaries to the NDI using CMS Health Insurance Claim number, and compared death dates between the two data sources. To assess agreement between our data sources, we calculated kappa scores; where a kappa of 1 indicates perfect agreement and a kappa of 0 indicates agreement equivalent to chance. We also examined CMS to NDI linkage and death date matching for stability over time. RESULTS: Of the 36 785 640, Medicare beneficiaries reported dead in CMS enrollment data from 1999 to 2016, 97.5% were linked to the NDI. A kappa score of 0.98 showed a near perfect agreement between NDI and CMS reported deaths. The percentage of linked cases exactly matching on death dates increased from 94.8% in 1999 to 99.4% in 2016. CONCLUSIONS: Our findings suggest strong concordance between death dates as recorded by CMS enrollment data and the NDI in the entire Medicare population.

Are Quality Scores in the Centers for Medicaid and Medicare Services Merit-based Incentive Payment System Associated With Outcomes After Outpatient Orthopaedic Surgery?

BACKGROUND: The Medicare Merit-based Incentive Payment System (MIPS) ties reimbursement incentives to clinician performance to improve healthcare quality. It is unclear whether the MIPS quality score can accurately distinguish between high-performing and low-performing clinicians. QUESTIONS/PURPOSES: (1) What were the rates of unplanned hospital visits (emergency department visits, observation stays, or unplanned admissions) within 7, 30, and 90 days of outpatient orthopaedic surgery among Medicare beneficiaries? (2) Was there any association of MIPS quality scores with the risk of an unplanned hospital visit (emergency department visits, observation stays, or unplanned admissions)? METHODS: Between January 2018 and December 2019, a total of 605,946 outpatient orthopaedic surgeries were performed in New York State according to the New York Statewide Planning and Research Cooperative System database. Of those, 56,772 patients were identified as Medicare beneficiaries and were therefore potentially eligible. A further 34% (19,037) were excluded because of missing surgeon identifier, age younger than 65 years, residency outside New York State, emergency department visit on the same day as outpatient surgery, observation stay on the same claim as outpatient surgery, and concomitant high-risk or eye procedures, leaving 37,735 patients for analysis. The database does not include a list of all state residents and thus does not allow for censoring of patients who move out of state. We chose this dataset because it includes nearly all hospitals and ambulatory surgery centers in a large geographic area (New York State) and hence is not limited by sampling bias. We included 37,735 outpatient orthopaedic surgical encounters among Medicare beneficiaries in New York State from 2018 to 2019. For the 37,735 outpatient orthopaedic surgical procedures included in our study, the mean ± standard deviation age of patients was 73 ± 7 years, 84% (31,550) were White, and 59% (22,071) were women. Our key independent variable was the MIPS quality score percentile (0 to 19th, 20th to 39th, 40th to 59th, or 60th to 100th) for orthopaedic surgeons. Clinicians in the MIPS program may receive a bonus or penalty based on the overall MIPS score, which ranges from 0 to 100 and is a weighted score based on four subscores: quality, promoting interoperability, improvement activities, and cost. The MIPS quality score, which attempts to reward clinicians providing superior quality of care, accounted for 50% and 45% of the overall MIPS score in 2018 and 2019, respectively. Our main outcome measures were 7-day, 30-day, and 90-day unplanned hospital visits after outpatient orthopaedic surgery. To determine the association between MIPS quality scores and unplanned hospital visits, we estimated multivariable hierarchical logistic regression models controlling for MIPS quality scores; patient-level (age, race and ethnicity, gender, and comorbidities), facility-level (such as bed size and teaching status), surgery and surgeon-level (such as surgical procedure and surgeon volume) covariates; and facility-level random effects. We then used these models to estimate the adjusted rates of unplanned hospital visits across MIPS quality score percentiles after adjusting for covariates in the multivariable models. RESULTS: In total, 2% (606 of 37,735), 2% (783 of 37,735), and 3% (1013 of 37,735) of encounters had an unplanned hospital visit within 7, 30, or 90 days of outpatient orthopaedic surgery, respectively. Most hospital visits within 7 days (95% [576 of 606]), 30 days (94% [733 of 783]), or 90 days (91% [924 of 1013]) were because of emergency department visits. We found very small differences in unplanned hospital visits by MIPS quality scores, with the 20th to 39th percentile of MIPS quality scores having 0.71% points (95% CI -1.19% to -0.22%; p = 0.004), 0.68% points (95% CI -1.26% to -0.11%; p = 0.02), and 0.75% points (95% CI -1.42% to -0.08%; p = 0.03) lower than the 0 to 19th percentile at 7, 30, and 90 days, respectively. There was no difference in adjusted rates of unplanned hospital visits between patients undergoing surgery with a surgeon in the 0 to 19th, 40th to 59th, or 60th to 100th percentiles at 7, 30, or 90 days. CONCLUSION: We found that the rates of unplanned hospital visits after outpatient orthopaedic surgery among Medicare beneficiaries were low and primarily driven by emergency department visits. We additionally found only a small association between MIPS quality scores for individual physicians and the risk of an unplanned hospital visit after outpatient orthopaedic surgery. These findings suggest that policies aimed at reducing postoperative emergency department visits may be the best target to reduce overall postoperative unplanned hospital visits and that the MIPS program should be eliminated or modified to more strongly link reimbursement to risk-adjusted patient outcomes, thereby better aligning incentives among patients, surgeons, and the Centers for Medicare ad Medicaid Services. Future work could seek to evaluate the association between MIPS scores and other surgical outcomes and evaluate whether annual changes in MIPS score weighting are independently associated with clinician performance in the MIPS and regarding clinical outcomes. LEVEL OF EVIDENCE: Level III, therapeutic study.

Research and Nonresearch Industry Payments to Nephrologists in the United States between 2014 and 2021.

SIGNIFICANCE STATEMENT: Concerns about the financial relationships between nephrologists and the health care industry have been reported in the United States over the past decade. However, since the 2014 launch of the federal transparency database, Open Payments, few documents have explored the whole picture of research and nonresearch payments to US nephrologists from industry sources. In this study, the authors found that 87% of nephrologists have received nonresearch payments, and the aggregate amount of these payments has been increasing since 2014. Only 12% of nephrologists received research payments; these recipients were disproportionately male. In addition, the top 5% of nephrologists receiving nonresearch funds received 81% of all such payments. Nonresearch payments were larger among male nephrologists than among female nephrologists and increased by 8% annually among male nephrologists between 2014 and 2019. BACKGROUND: Financial relationships between nephrologists and the health care industry have been a concern in the United States over the past decade. METHODS: To evaluate industry payments to nephrologists, we conducted a cross-sectional study examining nonresearch and research payments to all US nephrologists registered in the National Plan and Provider Enumeration System between 2014 and 2021, using the Open Payments database. Payment data were descriptively analyzed on the basis of monetary value, and payment trends were evaluated by using a generalized estimating equations model. RESULTS: From 2014 through 2021, 10,463 of 12,059 nephrologists (87%) received at least one payment from the US health care industry, totaling $778 million. The proportion of nephrologists who did not receive nonresearch payments varied each year, ranging from 38% to 51%. Nonresearch payments comprised 22% ($168 million) of overall industry payments in monetary value but 87% in the number of payments. Among those receiving payments, the median per-physician 8-year aggregated payment values were $999 in nonresearch payments and $102,329 in associated research payments. Male nephrologists were more likely than female nephrologists to receive research payments, but the per-physician amount did not differ. However, nonresearch payments were three times larger for male nephrologists and increased by 8% annually between 2014 and 2019 among male nephrologists but remained stable among female nephrologists. The top 5% of nephrologists receiving nonresearch payments received 81% of all such payments. CONCLUSIONS: Between 2014 and 2021, 87% of US nephrologists received at least one payment from the health care industry. Notably, nonresearch payments to nephrologists have been increasing since the Open Payments database's 2014 launch. Male nephrologists were more likely than female nephrologists to receive research payments.

Continuity Matters: Financial Impact of the G2211 Code in Primary Care.

Family medicine is financially undervalued compared with other medical specialties, and reimbursement fails to recognize the valuable longitudinal care provided to patients. According to one estimate, a primary care physician earns approximately $80,000 less than a subspecialist peer in Medicare reimbursement over a one-year period.1 This gap persists despite primary care physicians addressing higher numbers of medical concerns during office visits. To address continuity, the Centers for Medicare and Medicaid Services created the G2211 code in 2019 to compensate for the "visit complexity inherent to evaluation and management associated with medical care services."2 The G2211 code was implemented in January 2024.

Trends and outcomes of outpatient total shoulder arthroplasty after its removal from CMS's inpatient-only list.

BACKGROUND: In January 2021, the US Medicare program approved reimbursement of outpatient total shoulder arthroplasties (TSA), including anatomic and reverse TSAs. It remains unclear whether shifting TSAs from the inpatient to outpatient setting has affected clinical outcomes. Herein, we describe the rate of outpatient TSA growth and compare inpatient and outpatient TSA complications, readmissions, and mortality. METHODS: Medicare fee-for-service claims for 2019-2022Q1 were analyzed to identify the trends in outpatient TSAs and to compare 90-day postoperative complications, all-cause hospital readmissions, and mortality between outpatients and inpatients. Outpatient cases were defined as those discharged on the same day of the surgery. To reduce the COVID-19 pandemic's impact and selection bias, we excluded 2020Q2-Q4 data and used propensity scores to match 2021-2022Q1 outpatients with inpatients from the same period (the primary analysis) and from 2019-2020Q1 (the secondary analysis), respectively. We performed both propensity score-matched and -weighted multivariate analyses to compare outcomes between the two groups. Covariates included sociodemographics, preoperative diagnosis, comorbid conditions, the Hierarchical Condition Category risk score, prior year hospital/skilled nursing home admissions, annual surgeon volume, and hospital characteristics. RESULTS: Nationally, the proportion of outpatient TSAs increased from 3% (619) in 2019Q1 to 22% (3456) in 2021Q1 and 38% (6778) in 2022Q1. A total of 55,166 cases were identified for the primary analysis (14,540 outpatients and 40,576 inpatients). Overall, glenohumeral osteoarthritis was the most common indication for surgery (70.8%), followed by rotator cuff pathology (14.6%). The unadjusted rates of complications (1.3 vs 2.4%, P < .001), readmissions (3.7 vs 6.1%, P < .001), and mortality (0.2 vs 0.4%, P = .024) were significantly lower among outpatient TSAs than inpatient TSAs. Using 1:1 nearest matching, 12,703 patient pairs were identified. Propensity score-matched multivariate analyses showed similar rates of postoperative complications, hospital readmissions, and mortality between outpatients and inpatients. Propensity score-weighted multivariate analyses resulted in similar conclusions. The secondary analysis showed a lower hospital readmission rate in outpatients (odds ratio: 0.8, P < .001). CONCLUSIONS: There has been accelerated growth in outpatient TSAs since 2019. Outpatient and inpatient TSAs have similar rates of postoperative complication, hospital readmission, and mortality.

New CMS Merit-Based Incentive Payment System Value Pathway After Total Knee and Hip Arthroplasty: Preparing for Mandatory Reporting.

This article discusses the implementation of a new Merit-Based Incentive Payment System Value Pathway (MVPs) applicable to elective total hip and total knee arthroplasty as created by Medicare and Medicaid Services (CMS) - the Improving Care for Lower Extremity Joint Repair MVP (MVP ID: G0058). We describe specific quality measures, surgeon-hospital collaborations, future developments with Quality Payment Program, and how lessons from early implementation will empower clinicians to participate in the refining of this MVP. The CMS has designed MVPs as a subset of measures relevant to a specialty or medical condition, in an effort to reduce the burden of reporting and improve assessment of care quality. Physicians and payors must be mindful of detrimental effects these measures in their current form may have on surgeons, institutions, and patients, including disincentivizing care for sicker or more vulnerable populations, and increased administrative costs. Early voluntary participation is crucial to gain valuable experience for the orthopedic community and in an effort to work alongside CMS to maximize care while minimizing cost for patients and burden for providers.

The relationship between hospital patient safety culture and performance on Centers for Medicare & Medicaid Services value-based purchasing metrics.

BACKGROUND: Despite the intense policy focus on reducing health-care-associated conditions, adverse events in health care settings persist. Therefore, evaluating patient safety efforts and related health policy initiatives remains critical. PURPOSE: The aim of this study was to explore the relationship between hospital patient safety culture and hospital performance on Centers for Medicare & Medicaid Services (CMS) Hospital Value-Based Purchasing (HVBP) metrics. METHODOLOGY/APPROACH: A pooled cross-sectional study design was used utilizing three secondary datasets from 2018 and 2021: the Hospital Survey on Patient Safety Culture, the American Hospital Association annual survey, and the Hospital Compare data from CMS. We used two multivariable linear regression models to examine the relationship between organizational patient safety culture and hospital performance. The dependent variables included the overall CMS total performance score (TPS) and the four individual TPS domain scores. Hospital patient safety culture, the independent variable, was operationalized using two measures from the Hospital Survey on Patient Safety Culture: (a) the domain score of overall perceptions of patient safety and (b) the patient safety grade. RESULTS: We observed positive and significant associations between hospital patient safety culture and a hospital's overall TPS and the "patient and community engagement" and "safety" domains. CONCLUSION: Findings suggest that building a strong patient safety culture has the potential to lead health care organizations to achieve high performance on HVBP metrics. PRACTICE IMPLICATIONS: Our findings have important policy implications for both the future of CMS HVBP as a motivator of patient safety and how health care managers integrate culture change into programs to meet external quality metrics.

Controlled CMS Data Demonstrates a Cost and Clinical Advantage for Hyperbaric Oxygen for Radiation Cystitis.

Introduction: Increasing cancer survivorship, in part due to new radiation treatments, has created a larger population at risk for delayed complications of treatment. Radiation cystitis continues to occur despite targeted radiation techniques. Materials and Methods: To investigate value-based care applying hyperbaric oxygen (HBO2) to treat delayed radiation cystitis, we reviewed public-access Medicare data from 3,309 patients from Oct 1, 2014, through Dec 31, 2019. Using novel statistical modeling, we compared cost and clinical effectiveness in a hyperbaric oxygen group to a control group receiving conventional therapies. Results: Treatment in the hyperbaric group provided a 36% reduction in urinary bleeding, a 78% reduced frequency of blood transfusion for hematuria, a 31% reduction in endoscopic procedures, and fewer hospitalizations when study patients were compared to control. There was a 53% reduction in mortality and reduced unadjusted Medicare costs of $5,059 per patient within the first year after completion of HBO2 treatment per patient. When at least 40 treatments were provided, cost savings per patient increased to $11,548 for the HBO2 study group compared to the control group. This represents a 37% reduction in Medicare spending for the HBO2-treated group. We also validate a dose-response curve effect with a complete course of 40 or more HBO2 treatments having better clinical outcomes than those treated with fewer treatments. Conclusion: These data support previous studies that demonstrate clinical benefits now with cost- effectiveness when adjunctive HBO2 treatments are added to routine interventions. The methodology provides a comparative group selected without bias. It also provides validation of statistical modeling techniques that may be valuable in future analysis, complementary to more traditional methods.

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

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

Assessing the impact of enforcement and compliance with minimum staffing standards on the quality of care in nursing homes: Evidence from the Centers for Medicare and Medicaid Services' staff star rating downgrade policy.

Policymakers have historically attempted to influence quality in nursing homes through the imposition of minimum staffing standards and through the public dissemination of quality on websites like Care Compare. One current Federal standard necessitates a registered nurse (RN) on duty for at least eight consecutive hours each day. In 2018, the Centers for Medicare and Medicaid Services announced that they would incentivize compliance with this requirement by downgrading nursing homes with 7+ days without an RN present during the quarter by one star on their Care Compare staffing domain quality rating. This study evaluates the impact of this new enforcement mechanism. Using an intent-to-treat sample of nursing homes at risk for downgrade with difference-in-differences and event study models, it finds that the policy increased compliance and staffing levels. Using the policy to instrument for full compliance, it finds that the daily presence of an RN causally improves several quality dimensions.

Using pooled electronic health records data to conduct pharmacoepidemiology safety studies: Challenges and lessons learned.

PURPOSE: We assessed the suitability of pooled electronic health record (EHR) data from clinical research networks (CRNs) of the patient-centered outcomes research network to conduct studies of the association between tumor necrosis factor inhibitors (TNFi) and infections. METHODS: EHR data from patients with one of seven autoimmune diseases were obtained from three CRNs and pooled. Person-level linkage of CRN data and Centers for Medicare and Medicaid Services (CMS) fee-for-service claims data was performed where possible. Using filled prescriptions from CMS claims data as the gold standard, we assessed the misclassification of EHR-based new (incident) user definitions. Among new users of TNFi, we assessed subsequent rates of hospitalized infection in EHR and CMS data. RESULTS: The study included 45 483 new users of TNFi, of whom 1416 were successfully linked to their CMS claims. Overall, 44% of new EHR TNFi prescriptions were not associated with medication claims. Our most specific new user definition had a misclassification rate of 3.5%-16.4% for prevalent use, depending on the medication. Greater than 80% of CRN prescriptions had either zero refills or missing refill data. Compared to using EHR data alone, there was a 2- to 8-fold increase in hospitalized infection rates when CMS claims data were added to the analysis. CONCLUSIONS: EHR data substantially misclassified TNFi exposure and underestimated the incidence of hospitalized infections compared to claims data. EHR-based new user definitions were reasonably accurate. Overall, using CRN data for pharmacoepidemiology studies is challenging, especially for biologics, and would benefit from supplementation by other sources.

Do prehospital sepsis alerts decrease time to complete CMS sepsis measures?

INTRODUCTION: In an effort to improve sepsis outcomes the Centers for Medicare and Medicaid Services (CMS) established a time sensitive sepsis management bundle as a core quality measure that includes blood culture collection, serum lactate collection, initiation of intravenous fluid administration, and initiation of broad-spectrum antibiotics. Few studies examine the effects of a prehospital sepsis alert protocol on decreasing time to complete CMS sepsis core measures. METHODS: This study was a retrospective cohort study of patients transported via EMS from December 1, 2018 to December 1, 2019 who met the criteria of the Maryland Statewide EMS sepsis protocol and compared outcomes between patients who activated a prehospital sepsis alert and patients who did not activate a prehospital sepsis alert. The Maryland Institute for Emergency Medical Services Systems developed a sepsis protocol that instructs EMS providers to notify the nearest appropriate facility with a sepsis alert if a patient 18 years of age and older is suspected of having an infection and also presents with at least two of the following: temperature >38 °C or <35.5 °C, a heart rate >100 beats per minute, a respiratory rate >25 breaths per minute or end-tidal carbon dioxide less than or equal to 32 mmHg, a systolic blood pressure <90 mmHg, or a point of care lactate reading greater than or equal to 4 mmol/L. RESULTS: Median time to achieve all four studied CMS sepsis core measures was 103 min [IQR 61-153] for patients who received a prehospital sepsis alert and 106.5 min [IQR 75-189] for patients who did not receive a prehospital sepsis alert (p-value 0.105). Median time to completion was shorter for serum lactate collection (28 min. vs 35 min., p-value 0.019), blood culture collection (28 min. vs 38 min., p-value <0.01), and intravenous fluid administration (54 min. vs 61 min., p-value 0.025) but was not significantly different for antibiotic administration (94 min. vs 103 min., p-value 0.12) among patients who triggered a sepsis alert. CONCLUSION: This study questions the effectiveness of prehospital sepsis alert protocols on decreasing time to complete CMS sepsis core measures. Future studies should address if these times can be impacted by having EMS providers independently administer antibiotics.

Industry Payments Comparison Between Female and Male Mohs Surgeons From 2015 to 2021.

BACKGROUND: There are limited data on female Mohs surgeon industry relationships. OBJECTIVE: To evaluate industry payment activity between female and male Mohs surgeons. MATERIALS AND METHODS: A retrospective review of the U.S. Centers for Medicare and Medicaid Services open payments data was performed between 2015 and 2021 for Mohs surgeons in the United States. Gender, academic affiliation, practice region, annual total payment, cumulative payment, and industry payment type was collected. RESULTS: Male Mohs surgeons received higher mean total payments than female Mohs surgeons ( p = .04), which persisted when data were stratified based on industry payment type and practice region. Both genders had similar median total payments ( p = .4). Females in academic practice received higher mean total payments than those in private practice. Females experienced a significant lower mean total payment compared with males in the South ( p = .03). CONCLUSION: High total payments received by male Mohs surgeons skewed the data, which is supported by a significant mean total payment difference despite a similar median total payment distribution. Female Mohs surgeons receiving the top payments may address this mean payment difference. Females seem to have higher payments if they practice in the Northeast and are in academics. Further studies are needed to evaluate this payment gap.

Addressing non-response data for standardized post-acute functional items.

BACKGROUND: The post-acute patient standardized functional items (Section GG) include non-response options such as refuse, not attempt and not applicable. We examined non-response patterns and compared four methods to address non-response functional data in Section GG at nation-wide inpatient rehabilitation facilities (IRF). METHODS: We characterized non-response patterns using 100% Medicare 2018 data. We applied four methods to generate imputed values for each non-response functional item of each patient: Monte Carlo Markov Chains multiple imputations (MCMC), Fully Conditional Specification multiple imputations (FCS), Pattern-mixture model (PMM) multiple imputations and the Centers for Medicare and Medicaid Services (CMS) approach. We compared changes of Spearman correlations and weighted kappa between Section GG and the site-specific functional items across impairments before and after applying four methods. RESULTS: One hundred fifty-nine thousand six hundred ninety-one Medicare fee-for-services beneficiaries admitted to IRFs with stroke, brain dysfunction, neurologic condition, orthopedic disorders, and debility. At discharge, 3.9% (self-care) and 61.6% (mobility) of IRF patients had at least one non-response answer in Section GG. Patients tended to have non-response data due to refused at discharge than at admission. Patients with non-response data tended to have worse function, especially in mobility; also improved less functionally compared to patients without non-response data. Overall, patients coded as 'refused' were more functionally independent in self-care and patients coded as 'not applicable' were more functionally independent in transfer and mobility, compared to other non-response answers. Four methods showed similar changes in correlations and agreements between Section GG and the site-specific functional items, but variations exist across impairments between multiple imputations and the CMS approach. CONCLUSIONS: The different reasons for non-response answers are correlated with varied functional status. The high proportion of patients with non-response data for mobility items raised a concern of biased IRF quality reporting. Our findings have potential implications for improving patient care, outcomes, quality reporting, and payment across post-acute settings.