Health Care Lobbying and Oncology.

BACKGROUND: The health care industry spends more on lobbying than any other industry, with more than $700 million spent in 2022. However, health care lobbying related to cancer has not been characterized. In this study, we sought to describe overall health sector lobbying spending and oncology-related lobbying spending across patient and clinician organizations. METHODS: We obtained lobbying data from OpenSecrets.org and the Federal Election Commission. Overall health sector lobbying spending was categorized by OpenSecrets into 4 groups: pharmaceuticals/health products, health services/health maintenance organizations (HMOs), hospitals/nursing homes, and health professionals. We then identified and categorized 4 oncology-related lobbying groups: oncology physician professional organizations (OPPOs), prospective payment system (PPS)-exempt cancer hospitals, patient advocacy organizations, and provider networks (eg, US Oncology Network). We described temporal trends in lobbying spending from 2014 to 2022, in both overall dollar value (inflation-adjusted 2023 dollars) and in per-physician spending (using American Association of Medical Colleges [AAMC] data for number of hematologists/oncologists) using a Mann-Kendall trend test. RESULTS: Among the overall health sector lobbying, pharmaceuticals/health products had the greatest increase in lobbying spending, with an increase from $294 million in 2014 to >$376 million in 2022 (P=.0006). In contrast, lobbying spending by health professionals did not change, remaining at $96 million (P=.35). Regarding oncology-related lobbying, OPPOs and PPS-exempt cancer hospitals had a significant increase of 170% (P=.016) and 62% (P=.009), respectively. Per-physician spending also demonstrated an increase from $60 to $134 for OPPOs and from $168 to $226 for PPS-exempt cancer hospitals. Overall, OPPO lobbying increased as a percentage of overall physician lobbying from 1.16% in 2014 to 3.76% in 2022. CONCLUSIONS: Although overall health sector lobbying has increased, physician/health professional lobbying has remained relatively stable in recent years, spending for lobbying by OPPOs has increased. Continued efforts to understand the utility and value of lobbying in health care and across oncology are needed as the costs of care continue to increase.

Increasing diversity in clinical trials: demographic trends at the National Cancer Institute, 2005-2020.

BACKGROUND: We described participant demographics for National Cancer Institute (NCI) clinical trials at the clinical center (NCI-CC participants) of the National Institutes of Health to identify enrollment disparities. METHODS: We analyzed NCI-CC data from 2005 to 2020, calculated enrollment fractions, compared with the US cancer population represented by the Surveillance, Epidemiology, and End Results cancer incidence data (2018) and the Cancer in North America database (2018), and compared further with clinical trial disparities data from the NCI Community Oncology Research Program and National Clinical Trials Network (2005-2019), and from ClinicalTrials.gov (2003-2016). RESULTS: NCI-CC (38 531 participants) had higher enrollment fractions for older adults (8.5%), male (5.6%), non-Hispanic (5.1%), and Black or African American (5.3%) participants; lower women proportion across race and ethnicity; and fewer female sex-specific cancer (6.8%) than male sex-specific cancer (11.7%) participants. NCI-CC had lower median age than Surveillance, Epidemiology, and End Results (54.0 vs 65.4); more Black or African American participants (12.0% vs 11.1%); and fewer women (41.7% vs 49.5%), White (76.1% vs 80.5%), Asian or Pacific Islander (4.6% vs 6.0%), American Indian or Alaska Native (0.3% vs 0.5%), and Hispanic participants (7.1% vs 13%). NCI-CC had more Black or African American and Asian or Pacific Islander participants; fewer Hispanic participants than the NCI Community Oncology Research Program and National Clinical Trials Network; more Black or African American and Hispanic participants; fewer Asian or Pacific Islander participants than ClinicalTrials.gov data. Improvement was noted for NCI-CC (older adults, Black or African American, Asian or Pacific Islander, Hispanic participants). CONCLUSION: We found lower representation of older adults, women, Asian or Pacific Islander, American Indian or Alaska Native, and Hispanic participants vs the US cancer population and higher representation of Black or African American vs US cancer population and oncology clinical trials. Multifaceted efforts are underway to reduce disparities in cancer clinical trials at the NCI-CC.

Cataract Surgery in the Medicare Merit-Based Incentive Payment System: Episode-Based Cost Measure Development and Evaluation.

Objective: To characterize the development and performance of a cataract surgery episode-based cost measure for the Medicare Quality Payment Program. Design: Claims-based analysis. Participants: Medicare clinicians with cataract surgery claims between June 1, 2016, and May 31, 2017. Methods: We limited the analysis to claims with procedure code 66984 (routine cataract surgery), excluding cases with relevant ocular comorbidities. We divided episodes into subgroups by surgery location (Ambulatory Surgery Center [ASC] or Hospital Outpatient Department [HOPD]) and laterality (bilateral when surgeries were within 30 days apart). For the episode-based cost measure, we calculated costs occurring between 60 days before surgery and 90 days after surgery, limited to services identified by an expert committee as related to cataract surgery and under the influence of the cataract surgeon. We attributed costs to the clinician submitting the cataract surgery claim, categorized costs into clinical themes, and calculated episode cost distribution, reliability in detecting clinician-dependent cost variation, and costs with versus without complications. We compared episode-based cost scores with hypothetical "nonselective" cost scores (total Medicare beneficiary costs between 60 days before surgery and 90 days after surgery). Main Outcome Measures: Episode costs with and without complications, clinician-dependent variation (proportion of total cost variance), and proportion of costs from cataract surgery-related clinical themes. Results: We identified 583 356 cataract surgery episodes attributed to 10 790 clinicians and 8189 with ≥ 10 episodes during the measurement period. Most surgeries were performed in an ASC (71%) and unilateral (66%). The mean episode cost was $2876. The HOPD surgeries had higher costs; geography and episodes per clinician did not substantially affect costs. The proportion of cost variation from clinician-dependent factors was higher in episode-based compared with nonselective cost measures (94% vs. 39%), and cataract surgery-related clinical themes represented a higher proportion of total costs for episode-based measures. Episodes with complications had higher costs than episodes without complications ($3738 vs. $2276). Conclusions: The cataract surgery episode-based cost measure performs better than a comparable nonselective measure based on cost distribution, clinician-dependent variance, association with cataract surgery-related clinical themes, and quality alignment (higher costs in episodes with complications). Cost measure maintenance and refinement will be important to maintain clinical validity and reliability. Financial Disclosures: Proprietary or commercial disclosure may be found after the references.

Development of a Knee Arthroplasty Episode-Based Cost Measure for Evaluating Cost in the Merit-Based Incentive Payment System.

BACKGROUND: Under the Merit-based Incentive Payment System (MIPS), the U.S. Centers for Medicare and Medicaid Services (CMS) evaluate clinicians who manage Medicare patients on the basis of cost and quality outcomes. CMS contractor Acumen, LLC, convened an expert panel to develop a knee arthroplasty episode-based cost measure (EBCM) for use in the MIPS. METHODS: A Clinical Subcommittee of 28 clinician experts affiliated with 27 specialty societies provided guidance in developing the knee arthroplasty EBCM. The Clinical Subcommittee specified all aspects of the EBCM including triggering of the episode, services within the episode, risk adjustment, subgrouping, and exclusions. Services were counted only if the Clinical Subcommittee deemed them under the influence of the clinician assigned to the EBCM (selective service assignment; SSA). We assessed the reliability of the EBCM and compared it with an alternative population-based cost measure constructed without SSA. RESULTS: We identified 249,301 knee arthroplasty episodes from June 1, 2016, to May 31, 2017, with 10,681 clinicians having at least 10 attributed episodes. The mean episode cost was $19,321 with a standard deviation of $1,816. SSA increased the reliability score from 0.71 to 0.81 relative to an alternative measure that counted all patient costs. SSA also led to reclassification of 41.8% of clinicians into different quintiles of performance. CONCLUSIONS: We found that the use of SSA in the creation of the EBCM substantially reduces random noise (i.e., unrelated medical procedures or costs) and offers a tool for assessing clinicians' costs of management that is focused on care directly related to knee arthroplasty.

Development of Episode-Based Cost Measures for the US Medicare Merit-based Incentive Payment System.

Importance: The Merit-based Incentive Payment System (MIPS), established as part of the Quality Payment Program, is a Medicare value-based payment program that evaluates clinicians' performance across 4 categories: quality, cost, promoting interoperability, and improvement activities. The cost category includes novel episode-based measures designed for targeted evaluation of the resource use of specific conditions. This report describes the development of episode-based cost measures and their role in the shift from volume-based to value-based purchasing. Objectives: Episode-based cost measures focus on resource use related to the treatment of a specific condition or procedure. The measures exclude health care costs unrelated to the condition or procedure of focus. The episode-based cost measures provide a nuanced examination of resource use that can be used alongside quality metrics to identify opportunities to improve the value by capturing costs that are clinically related to the care being delivered within a given patient-clinician relationship of care delivered to patients. These measures were developed with the input of clinical committees composed of over 320 clinicians from 127 specialty societies and stakeholder organizations. The MIPS program currently evaluates clinician cost category performance based on 2 population-based cost measures (Medicare spending per beneficiary and total per capita costs) in addition to 18 episode-based cost measures. Additional episode-based cost measures are currently under development. Conclusions and Relevance: The transition to value-based payment requires an accurate assessment of clinician effect on health care quality and cost. The use of episode-based cost measures to assess clinician influence on health care costs for high-priority conditions and procedures is an important step. The Centers for Medicare & Medicaid Services is introducing MIPS Value Pathways that will align episode-based cost measures with related quality measures to further incentivize the transition from fee-for-service to value-based care.

Adjustment For Social Risk Factors Does Not Meaningfully Affect Performance On Medicare's MIPS Clinician Cost Measures.

Medicare's Merit-based Incentive Payment System (MIPS) includes episode-based cost measures that evaluate Medicare expenditures for specific conditions and procedures. These measures compare clinicians' cost performance and, along with other MIPS category scores, determine Medicare Part B clinician payment adjustments. The measures do not include risk adjustment for social risk factors. We found that adjusting for individual and community social risk did not have a meaningful impact on clinicians' cost measure performance. Across eight cost measures, 1.4 percent of clinician groups, on average, had an absolute change in their cost measure performance percentile of 10 percent or more (range, 0.4-3.4 percent). Prior analyses have generally found higher health care costs for patients with increased social risk. MIPS episode-based cost measures are distinct from previous cost measures because they only include costs related to the specific condition being evaluated. This unique approach may explain why costs were similar for patients with high and low social risk before any risk adjustment. MIPS episode-based cost measures do not appear to penalize clinicians who primarily care for patients with increased social risk.

Correction to: Treatment duration with immune-based therapies in Cancer: an enigma.

Following publication of the original article [1], the authors reported an error in the typesetting of their article. The first section of the main text was mistakenly included in the abstract.

Treatment duration with immune-based therapies in Cancer: an enigma.

Unlike chemotherapy treatments that target the tumor itself (rather nonspecifically), immune-based therapies attempt to harness the power of an individual patient's immune system to combat cancer. Similar to chemotherapeutic agents, the dosage and Administration section of labeling for all five currently approved PD-1/PD-L1 inhibitors (immunotherapy) recommends duration of treatment until disease progression or unacceptable toxicity. Overactivation or constitutive activation of the immune system with immune based therapies can lead to T-cell exhaustion and activation induced cell death (AICD) in T- and B-cells. Examples of immune exhaustion and T-cell depletion is noted in preclinical and clinical studies. Overactivation or constitutive activation leading to Immune exhaustion is a real phenomenon and of profound concern as immune cells are the true arsenal for control of the tumor growth. Designing trials rigorously to address the optimum treatment duration with immune based therapies is critical. By addressing this concern now, not only we may improve patient outcomes, but also gather a deeper understanding of the role and mechanisms of the immune system in the control of tumor growth.Chemotherapy and immune-based therapies provide antitumor effects through completely different mechanisms. Chemotherapeutic agents are cytotoxic in that they directly inhibit basic cellular mechanisms, killing both malignant and nonmalignant cells (hopefully with a preference for malignant cells), while immune based therapies wake-up the host immune system to recognize malignant cells and eliminate them.While there is a burgeoning excitement surrounding development of immune based therapies for the treatment of cancer, the optimal duration for these therapies need to be explored with equal fervor. Dosing for chemotherapy has been determined over years through large-scale prospective randomized trials to pinpoint the dose which maximizes therapeutic effect while minimizing side effects. Also, due to the mechanism of chemotherapeutic action, the duration of treatment with these agents is generally until disease progression or patient intolerance. However, experience with immune based therapies is limited, with current dosing and duration guidelines based primarily on initial trials required for approval of the agents. Since immune based therapies work by activating the body's own immune system, there is concern that overactivation or constitutive activation of the immune system may lead to immune exhaustion and depletion of effector T-cells thereby causing decreased anti-tumor effects and possible allowing for tumor progression.Similar to chemotherapeutic agents, the Dosage and Administration section of labeling for all five currently approved PD-1/PD-L1 inhibitors recommends duration of treatment until disease progression or unacceptable toxicity. However, since immune based therapies work with a completely different mechanism compared to chemotherapy, using the same therapy duration may not be the optimal approach.In exploring treatment duration with immune based therapies, we need to answer the following: (1) does indefinite treatment with immune based therapies exhaust the immune system counteracting its own mechanism of action leading to tumor progression and (2) how can clinical trials be designed to identify the optimal duration of immune-based therapy that prevents immune cell exhaustion but supports anti-tumor immunity.

Understanding the impact of 'cost' under MACRA: a neurointerventional imperative!

The cost of providing healthcare in the United States continues to rise. The Affordable Care Act created systems to test value-based alternative payments models. Traditionally, procedure-based specialists such as neurointerventionalists have largely functioned in, and are thus familiar with, the traditional Fee for Service system. Administrative charge data would suggest that neurointerventional surgery is an expensive specialty. The Medicare Access and CHIP Reauthorization Act consolidated pre-existing federal performance programs in the Merit-based Incentive Payments System (MIPS), including a performance category called 'cost'. Understanding cost as a dimension that contributes to the value of care delivered is critical for succeeding in MIPS and offers a meaningful route for favorably bending the cost curve.

Kinomic exploration of temozolomide and radiation resistance in Glioblastoma multiforme xenolines.

BACKGROUND AND PURPOSE: Glioblastoma multiforme (GBM) represents the most common and deadly primary brain malignancy, particularly due to temozolomide (TMZ) and radiation (RT) resistance. To better understand resistance mechanisms, we examined global kinase activity (kinomic profiling) in both treatment sensitive and resistant human GBM patient-derived xenografts (PDX or "xenolines"). MATERIALS AND METHODS: Thirteen orthotopically-implanted xenolines were examined including 8 with known RT sensitivity/resistance, while 5 TMZ resistant xenolines were generated through serial TMZ treatment in vivo. Tumors were harvested, prepared as total protein lysates, and kinomically analyzed on a PamStation®12 high-throughput microarray platform with subsequent upstream kinase prediction and network modeling. RESULTS: Kinomic profiles indicated elevated tyrosine kinase activity associated with the radiation resistance phenotype, including FAK and FGFR1. Furthermore, network modeling showed VEGFR1/2 and c-Raf hubs could be involved. Analysis of acquired TMZ resistance revealed more kinomic variability among TMZ resistant tumors. Two of the five tumors displayed significantly altered kinase activity in the TMZ resistant xenolines and network modeling indicated PKC, JAK1, PI3K, CDK2, and VEGFR as potential mediators of this resistance. CONCLUSION: GBM xenolines provide a phenotypic model for GBM drug response and resistance that when paired with kinomic profiling identified targetable pathways to inherent (radiation) or acquired (TMZ) resistance.