California v. Texas: Avoiding an Antidemocratic Outcome.

The Affordable Care Act ("ACA") contains a section titled "Requirement to Maintain Essential Minimum Coverage." Colloquially known as the Individual Mandate, this section of the Act initially established a monetary penalty for anyone who did not maintain health insurance in a given tax year. But with the passage of the Tax Cuts and Jobs Act, the monetary penalty was reset to zero, inducing opponents of the ACA to mount a legal challenge over the Individual Mandate's constitutionality. As the third major legal challenge to the ACA, California v. Texas saw the Supreme Court punt on the merits and instead decide the case on grounds of Article III standing. But how would the ACA have fared if the Court had in fact reached the merits? Did resetting the Individual Mandate penalty to zero uncloak the provision from the saving construction of Nat'l Fed'n of Indep. Bus. v. Sebelius? This Note posits that, had the Court reached the merits, it would have found the Individual Mandate no longer met the requirements for classification as a tax under the rule relied on in NFIB. Moreover, it argues that the Court would have found the unconstitutional provision to be inseverable from the ACA insofar as it was integral to funding both the novel structure of the reformed healthcare system and the prohibition against insurance carriers denying coverage due to a pre-existing condition. This examination ultimately reveals that an outright repeal of the ACA would have been antidemocratic in the face of current consensus opinion that favors the reform and highlights the impact its abrogation would have had.

The State of State Biomarker Testing Insurance Coverage Laws.

This Viewpoint discusses laws mandating insurance coverage of biomarker testing to broaden access to care for patients with cancer.

Medicolegal and insurance issues regarding BRCA1 and BRCA2 gene tests in high income countries.

Hereditary breast and ovarian cancer syndrome is an autosomal dominant cancer susceptibility syndrome mainly due to variants in BRCA1 or BRCA2 genes. Patients presenting with BRCA1 or BRCA2 gene mutations have a lifetime risk of developing breast or ovarian cancer (80% and 40%, respectively). Genetic testing to explore the predisposition to develop cancer represents a pivotal factor in such cases, and this review wants to explore the main implications in terms of medicolegal liability and insurance issues. Medicolegal issues related to these diagnostic processes include: (a) failure to recommend the test; (b) failure to properly interpret the test; (c) failure to correctly translate results into clinical practice; (d) lack of informed consent; and (e) failure to refer patients to specialized genetic counseling. Such errors may lead to compensation since the legal burden inherent in the efficacy of prophylactic interventions is a proof that requires the so-called 'preponderance of the evidence'. Concerning insurance issues, the carriers of such alleles without cancer are healthy because the genetic predisposition is not a disease per se but represents a (relevant) health risk. However, disclosure of these conditions can be impelled by insurers. It can lead to so-called 'genetic discrimination' because insurance companies might use genetic information to limit insurance options or increase their costs. Many private and public healthcare funders do not cover risk reducing surgeries, even when recommended as part of a risk reduction management plan for BRCA gene mutation carriers. Here, positions on these matters from different high income countries are discussed, stressing the importance of a common supranational or international regulatory framework to reach a trade-off between the economic interests of insurers and the rights of carriers not to disclose extremely sensitive information.

State Public Insurance Coverage Policies and Postpartum Care Among Immigrants.

Importance: Professional medical organizations recommend that adults receive routine postpartum care. Yet, some states restrict public insurance coverage for undocumented immigrants and recently documented immigrants (those who received legal documentation status within the past 5 years). Objective: To examine the association between public insurance coverage and postpartum care among low-income immigrants and the difference in receipt of postpartum care among immigrants relative to nonimmigrants. Design, Setting, and Participants: A pooled, cross-sectional analysis was conducted using data from the Pregnancy Risk Assessment Monitoring System for 19 states and New York City including low-income adults with a live birth between 2012 and 2019. Exposure: Giving birth in a state that offered public insurance coverage for postpartum care to recently documented or undocumented immigrants. Main Outcomes and Measures: Self-reported receipt of postpartum care by the category of coverage offered (full coverage: states that offered publicly funded postpartum care regardless of immigration status; moderate coverage: states that offered publicly funded postpartum care to lawfully residing immigrants without a 5-year waiting period, but did not offer postpartum care to undocumented immigrants; no coverage: states that did not offer publicly funded postpartum care to lawfully present immigrants before 5 years of legal residence or to undocumented immigrants). Results: The study included 72 981 low-income adults (20 971 immigrants [29%] and 52 010 nonimmigrants [71%]). Of the 19 included states and New York City, 6 offered full coverage, 9 offered moderate coverage, and 4 offered no coverage; 1 state (Oregon) switched from offering moderate coverage to offering full coverage. Compared with the states that offered full coverage, receipt of postpartum care among immigrants was 7.0-percentage-points lower (95% CI, -10.6 to -3.4 percentage points) in the states that offered moderate coverage and 11.3-percentage-points lower (95% CI, -13.9 to -8.8 percentage points) in the states that offered no coverage. The differences in the receipt of postpartum care among immigrants relative to nonimmigrants were also associated with the coverage categories. Compared with the states that offered full coverage, there was a 3.3-percentage-point larger difference (95% CI, -5.3 to -1.4 percentage points) in the states that offered moderate coverage and a 7.7-percentage-point larger difference (95% CI, -10.3 to -5.0 percentage points) in the states that offered no coverage. Conclusions and Relevance: Compared with states without insurance restrictions, immigrants living in states with public insurance restrictions were less likely to receive postpartum care. Restricting public insurance coverage may be an important policy-driven barrier to receipt of recommended pregnancy care and improved maternal health among immigrants.

[The Continuing Training Courses of Medical Assessors and Legal Medical Advisors in Swiss Insurance Medicine (SIM)]. / Die Weiter- und Fortbildungskurse von medizinischen Gutachtern in der Swiss Insurance Medicine (SIM).

The Continuing Training Courses of Medical Assessors and Legal Medical Advisors in Swiss Insurance Medicine (SIM) Abstract. In the context of insurance medicine, the medical assessor has the task of clarifying the state of health in a professional manner and making a medical assessment. The medical appraisal is to be carried out in the context of the legal context based on legislation and case law. With the professional expert clarification of the state of health and the medical assessment, the medical expert places his knowledge in the service of the jurisdiction. Around the turn of the millennium, it became apparent that specialization and medical experience alone were not sufficient to meet the increasing requirements of a medical expert in a legal context. For this reason, Swiss Insurance Medicine (SIM), on behalf of the FMH, established and, over time, expanded a structured continuing education program for medical experts. In recent years, further training opportunities have been created for the early assessments and second opinions necessary for rapid and sustainable professional integration, as well as for continuing education.

Association Between California's State Insurance Gender Nondiscrimination Act and Utilization of Gender-Affirming Surgery.

Importance: Gender-affirming surgery is often beneficial for gender-diverse or -dysphoric patients. Access to gender-affirming surgery is often limited through restrictive legislation and insurance policies. Objective: To investigate the association between California's 2013 implementation of the Insurance Gender Nondiscrimination Act, which prohibits insurers and health plans from limiting benefits based on a patient's sex, gender, gender identity, or gender expression, and utilization of gender-affirming surgery among California residents. Design, Setting, and Participants: Population epidemiology study of transgender and gender-diverse patients undergoing gender-affirming surgery (facial, chest, and genital surgery) between 2005 and 2019. Utilization of gender-affirming surgery in California before and after implementation of the Insurance Gender Nondiscrimination Act in July 2013 was compared with utilization in Washington and Arizona, control states chosen because of geographic similarity and because they expanded Medicaid on the same date as California-January 1, 2014. The date of last follow-up was December 31, 2019. Exposures: California's Insurance Gender Nondiscrimination Act, implemented on July 9, 2013. Main Outcomes and Measures: Receipt of gender-affirming surgery, defined as undergoing at least 1 facial, chest, or genital procedure. Results: A total of 25 252 patients (California: n = 17 934 [71%]; control: n = 7328 [29%]) had a diagnosis of gender dysphoria. Median ages were 34.0 years in California (with or without gender-affirming surgery), 39 years (IQR, 28-49 years) among those undergoing gender-affirming surgery in control states, and 36 years (IQR, 22-56 years) among those not undergoing gender-affirming surgery in control states. Patients underwent at least 1 gender-affirming surgery within the study period in 2918 (11.6%) admissions-2715 (15.1%) in California vs 203 (2.8%) in control states. There was a statistically significant increase in gender-affirming surgery in the third quarter of July 2013 in California vs control states, coinciding with the timing of the Insurance Gender Nondiscrimination Act (P < .001). Implementation of the policy was associated with an absolute 12.1% (95% CI, 10.3%-13.9%; P < .001) increase in the probability of undergoing gender-affirming surgery in California vs control states observed in the subset of insured patients (13.4% [95% CI, 11.5%-15.4%]; P < .001) but not self-pay patients (-22.6% [95% CI, -32.8% to -12.5%]; P < .001). Conclusions and Relevance: Implementation in California of its Insurance Gender Nondiscrimination Act was associated with a significant increase in utilization of gender-affirming surgery in California compared with the control states Washington and Arizona. These data might inform state legislative efforts to craft policies preventing discrimination in health coverage for state residents, including transgender and gender-diverse patients.

State insurance mandates for in vitro fertilization are not associated with improving racial and ethnic disparities in utilization and treatment outcomes.

BACKGROUND: Racial and ethnic disparities in utilization and clinical outcomes following fertility care with in vitro fertilization in the United States are well-documented. Given the cost of fertility care, lack of insurance is a barrier to access across all races and ethnicities. OBJECTIVE: This study aimed to determine how state insurance mandates are associated with racial and ethnic disparities in in vitro fertilization utilization and clinical outcomes. STUDY DESIGN: This was a cohort study using data from the Society for Assisted Reproductive Technology Clinical Outcome Reporting System from 2014 to 2019 for autologous in vitro fertilization cycles. The primary outcomes were utilization-defined as the number of in vitro fertilization cycles per 10,000 reproductive-aged women-and cumulative live birth-defined as the delivery of at least 1 liveborn neonate resulting from a single stimulation cycle and its corresponding fresh or thawed transfers. RESULTS: Most (72.9%) of the 1,096,539 cycles from 487,191 women occurred in states without an insurance mandate. Although utilization was higher across all racial and ethnic groups in mandated states, the increase in utilization was greatest for non-Hispanic Asian and non-Hispanic White women. For instance, in the most recent study year (2019), the utilization rates for non-Hispanic White women compared with non-Hispanic Black/African American women were 23.5 cycles per 10,000 women higher in nonmandated states and 56.2 cycles per 10,000 women higher in mandated states. There was no significant interaction between race and ethnicity and insurance mandate status on any of the clinical outcomes (all P-values for interaction terms > .05). CONCLUSION: Racial and ethnic disparities in utilization of in vitro fertilization and clinical outcomes for autologous cycles persist regardless of state health insurance mandates.

The Importance of and Challenges with Adopting Life-Cycle Regulation and Reimbursement in Canada.

Regulatory and reimbursement decisions for drugs and vaccines are increasingly based on limited safety and efficacy evidence. In this environment, life-cycle approaches to evaluation are needed. A life-cycle approach grants market approval and/or positive reimbursement decisions based on an undertaking to conduct post-market clinical trials that address evidentiary uncertainties, relying on the collection and analysis of post-market data. In practice, however, both conditional regulatory and reimbursement decisions have proven problematic. Here we discuss some of the regulatory implications and unsettled ethical and pragmatic issues, taking lessons from the recent experiences of Israel in rapidly approving the Pfizer-BioNTech COVID-19 vaccine.

Association of Surprise-Billing Legislation with Prices Paid to In-Network and Out-of-Network Anesthesiologists in California, Florida, and New York: An Economic Analysis.

Importance: Several states have passed surprise-billing legislation to protect patients from unanticipated out-of-network medical bills, yet little is known about how state laws influence out-of-network prices and whether spillovers exist to in-network prices. Objective: To identify any changes in prices paid to out-of-network anesthesiologists at in-network facilities and to in-network anesthesiologists before and after states passed surprise-billing legislation. Design, Setting, and Participants: This retrospective economic analysis used difference-in-differences methods to compare price changes before and after the passage of legislation in California, Florida, and New York, which passed comprehensive surprise-billing legislation between January 1, 2014, and December 31, 2017, to 45 states that did not. Commercial claims data from the Health Care Cost Institute were used to identify prices paid to anesthesiologists in hospital outpatient departments and ambulatory surgery centers. The final analytic sample comprised 2 713 913 anesthesia claims across the 3 treated states and the 45 control states. Exposures: Temporal and state-level variation in exposure to surprise-billing legislation. Main Outcomes and Measures: The unit price (allowed amounts standardized per unit of service) paid to out-of-network anesthesiologists at in-network facilities and to in-network anesthesiologists. Results: This retrospective economic analysis of 2 713 913 anesthesia claims found that after surprise-billing laws were passed in 3 states, the unit price paid to out-of-network anesthesiologists at in-network facilities decreased significantly in 2 of them: California, -$12.71 (95% CI, -$25.70 to -$0.27; P = .05) and Florida, -$35.67 (95% CI, -$46.27 to -$25.07; P < .001). In New York, a decline in the overall out-of-network price was not statistically significant (-$7.91; 95% CI, -$17.48 to -$1.68; P = .10); however, by the fourth quarter of 2017, the decline was -$41.28 (95% CI, -$70.24 to -$12.33; P = .01). In-network prices decreased in California by -$10.68 (95% CI, -$12.70 to -$8.66; P < .001); in Florida, -$3.18 (95% CI, -$5.17 to -$1.19; P = .002); and in New York, -$8.05 (95% CI, -$11.46 to -$4.64; P < .001). Conclusions and Relevance: This retrospective study found that prices paid to in-network and out-of-network anesthesiologists in hospital outpatient departments and ambulatory surgery centers decreased after the introduction of surprise-billing legislation, providing early insights into how prices may change under the federal No Surprises Act and in states that have recently passed their own legislation.

Federal Out-of-Network Balance Billing Legislation: Context and Implications for Radiology Practices.

Out-of-network (OON) balance billing, commonly known as surprise billing but better described as a surprise gap in health insurance coverage, occurs when an individual with private health insurance (vs a public insurer such as Medicare) is administered unanticipated care from a physician who is not in their health plan's network. Such unexpected OON care may result in substantial out-of-pocket costs for patients. Although ending surprise billing is patient centric, patient protective, and noncontroversial, passing federal legislation was challenging given its ability to disrupt insurer-physician good-faith negotiations and thus impact in-network rates. Like past proposals, the recently passed No Surprises Act takes patients out of the middle of insurer-physician OON reimbursement disputes, limiting patients' expense to standard in-network cost-sharing amounts. The new law, based on arbitration, attempts to protect good-faith negotiations between physicians and insurance companies and encourages network contracting. Radiology practices, even those that are fully in network or that never practiced surprise billing, could nonetheless be affected. Ongoing rulemaking processes will have meaningful roles in determining how the law is made operational. Physician and stakeholder advocacy has been and will continue to be crucial to the ongoing evolution of this process. © RSNA, 2021.