New Federal Guidance Makes It Harder for Patients With Cancer to Access Drugs.

A recent interpretation of the Stark Law limits cancer practices from delivering drugs to their patients by mail or courier-a perverse interpretation of a law meant to curb physician self-referrals and one that has led to patient harm.

Use of Tokens to Unlock Greater Data Sharing in Health Care.

This Viewpoint discusses the use of privacy-preserving record linkage, a token-based record linkage system, as a promising avenue for building a data infrastructure system that bridges isolated data.

The Inflation Reduction Act and Community Oncology Practices.

This Viewpoint explains how the Inflation Reduction Act negatively affects reimbursement and may undermine the solvency of community oncology practices and care.

Association Between Oncology Clinical Pathway Utilization and Toxicity and Cost Outcomes in Patients With Metastatic Solid Tumors.

PURPOSE: This retrospective observational study compared cancer care toxicity and cost outcomes for patients with metastatic cancer with nine different cancer types prescribed on- versus off-pathway regimens. METHODS: This study used claims and authorization data from a national insurer between January 1, 2018, and October 31, 2021. Participants included adults with metastatic breast, lung, colorectal, pancreatic, melanoma, kidney, bladder, gastric, or uterine cancer, who were prescribed first-line anticancer regimens. Multivariable regressions were used to assess outcomes including counts of emergency room visits or hospitalizations, use of supportive care medications, immune-related adverse events (IRAEs), and health care costs. RESULTS: Of the 8,357 patients in the study, 5,453 (65.3%) were prescribed on-pathway regimens. The on-pathway proportion trended downward, from 74.3% in 2018 to 59.8% in 2021. The on- and off-pathway groups had a similar proportion of patients with treatment-related hospitalization (adjusted odds ratio [aOR], 1.080; P = .201) and IRAEs (aOR, 0.961; P = .497). More all-cause hospitalizations (aOR, 1.679; P = .013) were observed among patients with melanoma treated on-pathway. The on-pathway group had higher use of supportive care drugs in bladder cancer (aOR, 4.602; P < .001) and colorectal cancer (aOR, 4.465; P < .001), and lower use in breast (aOR, 0.668; P = .001) and lung cancer (aOR, 0.550; P < .001). On average, on-pathway patients incurred $17,589 less total health care cost (P < .001), and $22,543 lower chemotherapy cost (P < .001) than those from the off-pathway group. CONCLUSION: Our findings suggest that use of on-pathway regimens was associated with significant cost savings. Toxicity outcomes were variable by disease, but overall, there were similar numbers of treatment-related hospitalizations and IRAEs compared to off-pathway regimens. This cross-institutional study provides evidence to support the use of clinical pathway regimens for patients with metastatic cancer.

Association of Patient, Physician, and Practice-Level Factors with Uptake of Payer-Led Oncology Clinical Pathways.

Importance: Payers use oncology clinical pathways programs to increase evidence-based drug prescribing and control drug spending. However, compliance with these programs has been low, which may decrease their efficacy, and factors associated with pathway compliance are unknown. Objective: To determine extent of pathway compliance and identify factors associated with pathway compliance using characteristics of patients, practices, and the companies that develop cancer treatment pathways. Design, Setting, and Participants: This cohort study comprised patients with claims and administrative data from a national insurer and a pathways health care professional between July 1, 2018, and October 31, 2021. Adult patients with metastatic breast, lung, colorectal, pancreatic, melanoma, kidney, bladder, gastric, and uterine cancer being treated in the first line were included. Six months of continuous insurance coverage prior to the date of treatment initiation was required for determination of baseline characteristics. Stepwise logistic regression was used to identify factors associated with pathway compliance. Main Outcomes and Measures: Use of a pathway program-endorsed treatment regimen in the first-line setting for metastatic cancer. Results: Among 17 293 patients (mean [SD] age, 60.7 [11.2] years; 9183 [53.1%] women; mean [SD] Black patients per census block, 0.10 [0.20]), 11 071 patients (64.0%) were on-pathway, and 6222 (36.0%) were off-pathway. Factors associated with increased pathway compliance were higher health care utilization during the 6-month baseline period (measured in inpatient visits and emergency department visits) (5220 on-pathway inpatient visits [47.2%] vs 2797 off-pathway [45.0%]; emergency department visits, 3304 [27.1%] vs 1503 [24.2%]; adjusted odds ratio [aOR] for inpatient visits, 1.32; 95% CI, 1.22-1.43; P < .001), volume of patients with this insurance provider per physician (mean [SD] visits: on-pathway, 128.0 [258.3] vs off-pathway, 121.8 [161.4]; aOR, 1.12; 95% CI, 1.04-1.20; P = .002), and practice participation in the Oncology Care Model (on-pathway participation, 2601 [23.5%] vs 1305 [21.0%]; aOR, 1.13; 95% CI, 1.04-1.23; P = .004). Higher total medical cost during the 6-month baseline period were associated with decreased pathway compliance (mean [SD] costs: on-pathway, $55 990 [$69 706] vs $65 955 [$74 678]; aOR, 0.86; 95% CI, 0.83-0.88; P < .001). There was heterogeneity in odds of pathway compliance between different malignancies. Pathway compliance rates trended down from the reference year of 2018. Conclusions and Relevance: In this cohort study, despite generous financial incentives, compliance with payer-led pathways remained at historically reported low rates. Factors such as increasing exposure to the program due to the number of patients impacted and participation in other value-based payment programs, such as the Oncology Care Model, were positively associated with compliance; factors such as the type of cancer and patient complexity may have played a role, but the directionality of potential effects was unclear.

Incorporating Cost Measures Into the Merit-Based Incentive Payment System: Implications for Oncologists.

PURPOSE: The Merit-Based Incentive Payment System (MIPS) is currently the only federally mandated value-based payment model for oncologists. The weight of cost measures in MIPS has increased from 0% in 2017 to 30% in 2022. Given that cost measures are specialty-agnostic, specialties with greater costs of care such as oncology may be unfairly affected. We investigated the implications of incorporating cost measures into MIPS on physician reimbursements for oncologists and other physicians. METHODS: We evaluated physicians scored on cost and quality in the 2018 MIPS using the Doctors and Clinicians database. We used multivariable Tobit regression to identify physician-level factors associated with cost and quality scores. We simulated composite MIPS scores and payment adjustments by applying the 2022 cost-quality weights to the 2018 category scores and compared changes across specialties. RESULTS: Of 168,098 identified MIPS-participating physicians, 5,942 (3.5%) were oncologists. Oncologists had the lowest cost scores compared with other specialties (adjusted mean score, 58.4 for oncologists v 71.0 for nononcologists; difference, -12.66 [95% CI, -13.34 to -11.99]), while quality scores were similar (82.9 v 84.2; difference, -1.31 [95% CI, -2.65 to 0.03]). After the 2022 cost-quality reweighting, oncologists would receive a 4.3-point (95% CI, 4.58 to 4.04) reduction in composite MIPS scores, corresponding to a four-fold increase in magnitude of physician penalties ($4,233.41 US dollars [USD] in 2018 v $18,531.06 USD in 2022) and greater reduction in exceptional payment bonuses compared with physicians in other specialties (-42.8% [95% CI, -44.1 to -41.5] for oncologists v -23.6% [95% CI, -23.8 to -23.4] for others). CONCLUSION: Oncologists will likely be disproportionally penalized after the incorporation of cost measures into MIPS. Specialty-specific recalibration of cost measures is needed to ensure that policy efforts to promote value-based care do not compromise health care quality and outcomes.

Tenets for Implementing Electronic Patient-Reported Outcomes for Remote Symptom Monitoring During Cancer Treatment.

PURPOSE: Symptoms are common in patients receiving systemic treatment for metastatic cancer. Monitoring patients with electronic patient-reported outcomes (ePROs) detects severe and worsening symptoms early, enabling care teams to intervene and prevent downstream complications and thereby improving outcomes. The Centers for Medicare & Medicaid Services will require patient-reported outcome (PRO) monitoring in the upcoming Enhancing Oncology Model, and many practices will likely attempt to implement PROs in patient care for the first time. METHODS: To assist practices with the design and implementation of ePRO remote symptom monitoring programs, tenets were drawn from prior ePRO program experiences and research. RESULTS: Successful implementation requires a quality improvement approach to change management with attention to software functionality, measured outcomes, personnel deployment, leadership and culture, workflow, equity, and patient engagement. Specific approaches in each of these areas can optimize program participation and effectiveness. Continuous program monitoring to identify and address barriers is essential to success. Initial challenges with personnel acceptance and patient participation are common and can be overcome by using these tenets. CONCLUSION: Remote symptom monitoring with ePROs is a key component of quality cancer care and population health management that requires organizational commitment and a deliberate approach by practices using established tenets to assure successful implementation.

Oncologist Participation and Performance in the Merit-Based Incentive Payment System.

The merit-based incentive payment system (MIPS) is a value-based payment model created by the Centers for Medicare & Medicaid Services (CMS) to promote high-value care through performance-based adjustments of Medicare reimbursements. In this cross-sectional study, we examined the participation and performance of oncologists in the 2019 MIPS. Oncologist participation was low (86%) compared to all-specialty participation (97%). After adjusting for practice characteristics, higher MIPS scores were observed among oncologists with alternative payment models (APMs) as their filing source (mean score, 91 for APMs vs. 77.6 for individuals; difference, 13.41 [95% CI, 12.21, 14.6]), indicating the importance of greater organizational resources for participants. Lower scores were associated with greater patient complexity (mean score, 83.4 for highest quintile vs. 84.9 for lowest quintile, difference, -1.43 [95% CI, -2.48, -0.37]), suggesting the need for better risk-adjustment by CMS. Our findings may guide future efforts to improve oncologist engagement in MIPS.

Next-Generation Alternative Payment Models in Oncology-Will Precision Preclude Participation?

This Viewpoint proposes 3 changes to the Enhancing Oncology Model of the US Centers for Medicare & Medicaid Services.

Reexamining Social Determinants of Health Data Collection in the COVID-19 Era.

This Viewpoint describes the association of various factors, including demographic factors, disease-related factors, and social determinants of health, with cancer treatment delays among a cohort of patients across multiple sites who had all tested positive for SARS-CoV-2.

Factors Associated With Cancer Treatment Delay Among Patients Diagnosed With COVID-19.

Importance: The COVID-19 pandemic led to disruptions in delivery of cancer treatments; factors associated with treatment delay among patients with cancer who contract COVID-19 need further characterization. Objective: To assess the associations of patient factors, social determinants of health, severity of COVID-19, and timing of COVID-19 diagnosis with the risk of treatment delay. Design, Setting, and Participants: This prospective cohort study was conducted from March 2020 through July 2021 at 60 academic and community medical practices in the United States. Participants included patients with any cancer diagnosis who were scheduled for treatment and contracted COVID-19. Data were analyzed in February 2022. Exposure: Positive test result for SARS-CoV-2. Main Outcomes and Measures: The main outcomes were treatment delay, defined as more than 14 days between the date originally planned for treatment and the date of initiation of therapy, or discontinuation of therapy. Multivariable analyses were used to assess outcomes. Results: A total of 3028 patients (1470 patients [49%] aged ≥65 years; 1741 [58%] women) were included in the registry. With 962 of 2103 patients (46%) experiencing anticancer drug delay or discontinuation, delays were higher among Black patients compared with White patients (odds ratio [OR], 1.87; 95% CI, 1.40-2.51), Hispanic or Latino patients compared with non-Hispanic or Latino patients (OR, 1.91; 95% CI, 1.34-2.72), patients with 2 or more comorbidities compared with patients with 0 to 1 (OR, 1.23; 95% CI, 1.00-1.53), patients with metastatic disease rather than locoregional disease (OR, 1.63; 95% CI, 1.29-2.05), and patients who experienced COVID-19 complications compared with those who did not (OR, 1.52; 95% CI, 1.24-1.86). Residing in an area with a higher proportion of residents reporting Hispanic or Latino ethnicity (OR, 0.76; 95% CI, 0.60-0.95) and contracting COVID-19 later in the pandemic, compared with those who were infected in March to June 2020, (eg, January to March 2021: OR, 0.38; 95% CI, 0.26-0.53) were associated with lower likelihood of drug therapy delay. A total of 95 of 202 patients (47%) experienced delay or discontinuation of radiation treatment, with having 2 or more comorbidities associated with delay (OR, 2.69; 95% CI, 1.20-6.20). Higher local-area median household income was associated with lower likelihood of radiation treatment delay (OR, 0.41; 95% CI, 0.17-0.94). There were 89 of 125 patients (71%) who experienced surgical treatment delay, and delays were higher among patients in the South compared with those in the Midwest (OR, 9.66; 95% CI, 2.14-52.3). Interestingly, patients with 2 or more comorbidities, compared with those with 0 to 1, experienced lower likelihoods of surgical treatment delay (OR, 0.26; 95% CI, 0.07-0.88). Conclusions and Relevance: Our findings suggest that individual patient factors, social determinants of health, and COVID-19 severity and diagnosis date were associated with exacerbated health disparities during the pandemic in regards to cancer treatment delay.

Genomic Characterization of De Novo Metastatic Breast Cancer.

De novo metastatic breast cancer (dnMBC) represents a minority of MBC cases, and as such, its genomics are poorly understood. Characterizing the genomics of dnMBC represents an opportunity to delineate metastatic drivers in the absence of treatment selection. In this review, we first summarize the literature of the genomics of MBC which showed that MBCs have greater mutational burden than early stage, treatment naïve breast cancers. We then turn to recent studies that have sought to focus on dnMBC. We propose that understanding genomic differences between dnMBC and relapsed MBC can inform treatment choices. Finally, we discuss translational strategies to better dissect the genomics of dnMBC.

Bridging the divide between physicians and administrators during COVID-19.

This article describes the tension that the coronavirus disease 2019 (COVID-19) pandemic brought up between administrators and physicians and offers a potential set of solutions to deal with it.