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.

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.

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.

Government regulation of private health insurance.

BACKGROUND: The strain on public resources to meet the healthcare needs of populations through publicly-provided health insurance programmes is increasing and many governments turn to private health insurance (PHI) to ease the pressure on government budgets. With the goal of improving access to basic health care for citizens through PHI programmes, several high-income countries have developed strong regulations for PHI schemes. Low- and middle-income countries have the opportunity to learn from this experience to optimise PHI. If poorly regulated, PHI can hardly achieve an adequate quantity or quality of population coverage, as can be seen in the USA where a third of adults younger than 65 years of age have no insurance, sporadic coverage or coverage that exposes them to high out-of-pocket healthcare costs. OBJECTIVES: To assess the effects of policies that regulate private health insurance on utilisation, quality, and cost of health care provided. SEARCH METHODS: In November 2019 we searched CENTRAL; MEDLINE; Embase; Sociological Abstracts and Social Services Abstracts; ICTRP; ClinicalTrials.gov; and Web of Science Core Collection for papers that have cited the included studies. This complemented the search conducted in February 2017 in IBSS; EconLit; and Global Health. We also searched selected grey literature databases and web-sites.  SELECTION CRITERIA: Randomised trials, non-randomised trials, interrupted time series (ITS) studies, and controlled before-after (CBA) studies conducted in any population or setting that assessed one or more of the following interventions that governments use to regulate private health insurance: legislation and licensing, monitoring, auditing, and intelligence. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed study eligibility, extracted data, and assessed risk of bias and certainty of the evidence resolving discrepancies by consensus. We planned to summarise the results (using random-effects or fixed-effect meta-analysis) to produce an overall summary if an average intervention effect across studies was considered meaningful, and we would have discussed the implications of any differences in intervention effects across studies. However, due to the nature of the data obtained, we have provided a narrative synthesis of the findings. MAIN RESULTS: We included seven CBA studies, conducted in the USA, and that directly assessed state laws on cancer screening. Only for-profit PHI schemes were addressed in the included studies and no study addressed other types of PHI (community and not for-profit). The seven studies were assessed as having 'unclear risk' of bias. All seven studies reported on utilisation of healthcare services, and one study reported on costs. None of the included studies reported on quality of health care and patient health outcomes. We assessed the certainty of evidence for patient health outcomes, and utilisation and costs of healthcare services as very low. Therefore, we are uncertain of the effects of government mandates on for-profit PHI schemes. AUTHORS' CONCLUSIONS: Our review suggests that, from currently available evidence, it is uncertain whether policies that regulate private health insurance have an effect on utilisation of healthcare services, costs, quality of care, or patient health outcomes. The findings come from studies conducted in the USA and might therefore not be applicable to other countries; since the regulatory environment could be different. Studies are required in countries at different income levels because the effects of government regulation of PHI are likely to differ across these income and health system settings. Further studies should assess the different types of regulation (including regulation and licensing, monitoring, auditing, and intelligence). While regulatory research on PHI remains relatively scanty, future research can draw on the rich body of research on the regulation of other health financing interventions such as user fees and results-based provider payments.

The Complex Cancer Care Coverage Environment - What is the Role of Legislation? A Case Study from Massachusetts.

Over the past decades, anti-cancer treatments have evolved rapidly from cytotoxic chemotherapies to targeted therapies including oral targeted medications and injectable immuno-oncology and cell therapies. New anti-cancer medications come to markets at increasingly high prices, and health insurance coverage is crucial for patient access to these therapies. State laws are intended to facilitate insurance coverage of anti-cancer therapies.Using Massachusetts as a case study, we identified five current cancer coverage state laws and interviewed experts on their perceptions of the relevance of the laws and how well they meet the current needs of cancer care given rapid changes in therapies. Interviewees emphasized that cancer therapies, as compared to many other therapeutic areas, are unique because insurance legislation targets their coverage. They identified the oral chemotherapy parity law as contributing to increasing treatment costs in commercial insurance. For commercial insurers, coverage mandates combined with the realities of new cancer medications - including high prices and often limited evidence of efficacy at approval - compound a difficult situation. Respondents recommended policy approaches to address this challenging coverage environment, including the implementation of closed formularies, the use of cost-effectiveness studies to guide coverage decisions, and the application of value-based pricing concepts. Given the evolution of cancer therapeutics, it may be time to evaluate the benefits and challenges of cancer coverage mandates.

Associations Between Transgender Exclusion Prohibitions and Insurance Coverage of Gender-Affirming Surgery.

Purpose: This investigation examined how coverage of gender-affirming surgery differs between states that do and do not have prohibitions against explicit transgender exclusions in private insurance. Methods: Insurance policies for gender-affirming surgery were obtained from the three largest insurers, by market share, in each state. Policies were reviewed manually between May and August of 2019. The number of major gender-affirming surgical services covered by each policy was recorded. This investigation examined coverage of facial feminization/masculinization, augmentation mammoplasty, mastectomy, phalloplasty, vaginoplasty, thyroid chondroplasty, and hair removal. Descriptive statistics were calculated to compare the number of services covered in states that do and do not prohibit transgender exclusions in private insurance. Results: The total number of gender-affirming surgical services covered by insurance policies ranged from zero to seven. The mean number of services covered in states prohibiting transgender exclusions in private insurance was 4.52, whereas the mean in states without prohibitions against transgender exclusions was 3.83. The mean difference was 0.69 (95% confidence interval = 0.17-1.21, p = 0.004). Although almost all policies covered phalloplasty, vaginoplasty, and mastectomy, the policies of the top insurers in states without prohibitions against transgender exclusions were significantly less likely to cover hair removal (p = 0.03), thyroid chondroplasty (p = 0.0008), and facial feminization/masculinization (p = 0.01). Conclusion: Insurers in states prohibiting transgender exclusions in private insurance offered coverage of a small but significant number of additional gender-affirming surgical services compared with states allowing transgender exclusions. Although a core group of services was covered almost universally, insurers based in states allowing transgender exclusions were much less likely to cover services that are sometimes thought of as less central to transgender care.

The Affordable Care Act improved health insurance coverage and cardiovascular-related screening rates for cancer survivors seen in community health centers.

BACKGROUND: This study assessed the impact of Affordable Care Act (ACA) Medicaid expansion on health insurance rates and receipt of cardiovascular-related preventive screenings (body mass index, glycated hemoglobin [HbA1c], low-density lipoproteins, and blood pressure) for cancer survivors seen in community health centers (CHCs). METHODS: This study identified cancer survivors aged 19 to 64 years with at least 3 CHC visits in 13 states from the Accelerating Data Value Across a National Community Health Center Network (ADVANCE). Via inverse probability of treatment weighting multilevel multinomial modeling, insurance rates before and after the ACA were estimated by whether a patient lived in a state that expanded Medicaid, and changes between a pre-ACA time period and 2 post-ACA time periods were assessed. RESULTS: The weighted estimated sample size included 409 cancer survivors in nonexpansion states and 2650 in expansion states. In expansion states, the proportion of uninsured cancer survivors decreased significantly from 20.3% in 2012-2013 to 4.5%in 2016-2017, and the proportion of those with Medicaid coverage increased significantly from 38.8% to 55.6%. In nonexpansion states, there was a small decrease in uninsurance rates (from 33.6% in 2012-2013 to 22.5% in 2016-2017). Cardiovascular-related preventive screening rates increased over time in both expansion and nonexpansion states: HbA1c rates nearly doubled from the pre-ACA period (2012-2013) to the post-ACA period (2016-2017) in expansion states (from 7.2% to 12.8%) and nonexpansion states (from 9.3% to 16.8%). CONCLUSIONS: This study found a substantial decline in uninsured visits among cancer survivors in Medicaid expansion states. Yet, 1 in 5 cancer survivors living in a state that did not expand Medicaid remained uninsured. Several ACA provisions likely worked together to increase cardiovascular-related preventive screening rates for cancer survivors seen in CHCs.

Health Insurance Coverage of Permanent Hair Removal in Transgender and Gender-Minority Patients.

Importance: Hair removal can be an essential component of the gender affirmation process for gender-minority (GM) patients whose outward appearance does not align with their gender identity. Objective: To examine the health insurance policies in the Affordable Care Act (ACA) marketplace and Medicaid policies for coverage of permanent hair removal for transgender and GM patients and to correlate the policies in each state with statewide protections of coverage for gender-affirming care. Design and Setting: Private health insurance policies available on the ACA marketplace and statewide Medicaid policies were examined in a cross-sectional study from September 1 to October 31, 2019, and January 17 to 30, 2020. Policies were assessed for coverage of permanent hair removal. Language concerning hair removal was found in each policy's medical or clinical coverage guidelines and separated into general categories. Main Outcomes and Measures: Logistic regression analyses were performed to compare Medicaid policies and ACA policies in states with and without transgender protections. Results: A total of 174 policies were analyzed, including 123 private insurance policies and 51 statewide Medicaid policies. Of these policies, 8 (4.6%) permitted the coverage of permanent hair removal without explicit restrictions. The remaining 166 policies (95.4%) broadly excluded or did not mention gender-affirming care; prohibited coverage of hair removal or did not mention it; or only permitted coverage of hair removal preoperatively for genital surgery. The ACA marketplace policies in states without transgender care protections were less likely to cover hair removal without restrictions than ACA policies in states with protections (2 of 85 policies [2.4%] in states without transgender care protections vs 5 of 38 policies [13.2%] in states with transgender care protections), and Medicaid policies were less likely to cover preoperative or nonsurgical hair removal compared with ACA policies (6 of 51 Medicaid policies [11.8%] vs 47 of 123 ACA policies [38.2%]). Conclusions and Relevance: Despite adoption of statewide restrictions on GM health care exclusions by several states, most Medicaid and ACA policies examined in this study did not cover permanent hair removal for transgender patients. Many GM patients seeking hair removal may be required to pay out-of-pocket costs, which could be a barrier for gender-affirming care.

Questions regarding 'epistemic injustice' in knowledge-intensive policymaking: Two examples from Dutch health insurance policy.

In contemporary healthcare policies the logic of Evidence-based Medicine (EBM) is typically proposed as a way of addressing a demand to explicitly justify policy decisions. Policymakers' use of 'evidence' is presumed to pertain to ideals of justice in decision-making. However, according to some, EBM is liable to generate 'epistemic injustice' because it prefers quantitative types of evidence and - as a result of that - potentially undervalues the qualitative testimonies of doctors and patients. Miranda Fricker's concept of 'epistemic injustice' refers to a wrong done to a person in their capacity as a knower. This paper explores the usefulness and limits of this concept in the context of public decision-making. How is evidence-based policymaking intertwined with questions of 'epistemic injustice'? Drawing from ethnographic research conducted at the National Health Care Institute, we analyze two cases of EBM-inspired policy practices in Dutch social health insurance: 1) the use of the principles of EBM in making a public reimbursement decision, and 2) private insurers' use of quantitative performance indicators for the practice of selective contracting on the Dutch healthcare market. While the concept of 'epistemic injustice' misses some key processes involved in understanding how 'knowing gets done' in public policy, it does shed new light on priority-setting processes. Patients or medical professionals who are not duly recognized as credible and intelligible epistemic agents, subsequently, lack the social power to influence priority-setting practices. They are thus not merely frustrated in their capacity to be heard and make themselves understood, they are potentially deprived of a fair share in collective financial and medical resources. If we fail to recognize inequalities in credibility and intelligibility between diverse groups of knowers, there is a chance that these epistemic inequalities are being reproduced in our system of health insurance and our ways of distributing healthcare provisions.

Socioeconomic and Demographic Variation in Insurance Coverage Among Patients With Head and Neck Cancer After the Affordable Care Act.

Importance: Health insurance status has a significant association with early diagnosis and stage at presentation, which are the most important predictors of survival among patients with head and neck cancer (HNC). Literature on the association of the Patient Protection and Affordable Care Act (ACA) with changes in insurance status among patients with HNC remains limited. To our knowledge, no studies have evaluated changes in insurance rates across sociodemographic subgroups of patients with HNC. Objective: To assess the association of the implementation of the ACA with insurance status across socioeconomic and demographic subpopulations of patients with HNC. Design, Setting, and Participants: A retrospective cohort study using data from the National Cancer Database (NCDB), a hospital-based cancer registry (2011-2015) for adults diagnosed with a malignant primary HNC was carried out. The analyses were conducted from November 2018 through December 2018. Main Outcomes and Measures: Changes in the percentage of patients with insurance. Results: A total of 131 779 patients with HNC were identified in the pre-ACA (77 071) and post-ACA (54 708) periods. Overall, 98 207 (74.5%) participants were men and 33 572 (25.5) were women, with 73 124 (55.5%) being aged between 50 to 64 years. There was a 2.68 percentage point decrease (PPD) (95% CI, 2.93-2.42) in the percentage of patients with HNC without insurance from the pre-ACA to the post-ACA period. Changes in the percentage of uninsured patients varied significantly by age, with the largest reduction in uninsured status among patients with HNC aged 18 to 34 years (5.12 PPD; 95% CI, 3.18-7.06) and the smallest reduction in uninsured among those aged 65 to 74 years (0.24 PPD; 95% CI, 0.03-0.45). There was a significantly greater reduction in uninsured status in low-income zip codes (3.45 PPD; 95% CI, 2.76-4.14) than in high-income zip codes (1.99 PPD; 95% CI, 1.63-2.36). Conclusions and Relevance: There was a significant association between ACA implementation and percentage decrease in uninsured patients. Young adults and those residing in low-income zip codes experienced a significantly higher rate of insurance uptake compared with older adults and residents of high-income areas. This suggests that coverage expansions enacted through the ACA are not only associated with increased access to care among the broader HNC population, but that they may also yield a greater benefit among subpopulations with historically limited insurance coverage.

The Effect of the Breast Cancer Provider Discussion Law on Breast Reconstruction Rates in New York State.

BACKGROUND: New York State passed the Breast Cancer Provider Discussion Law in 2010, mandating discussion of insurance coverage for reconstruction and expedient plastic surgical referral, two significant factors found to affect reconstruction rates. This study examines the impact of this law. METHODS: A retrospective cohort study of the New York State Planning and Research Cooperative System database to examine breast reconstruction rates 3 years before and 3 years after law enactment was performed. Difference-interrupted time series models were used to compare trends in the reconstruction rates by sociodemographic factors and provider types. RESULTS: The study included 32,452 patients. The number of mastectomies decreased from 6479 in 2008 to 5235 in 2013; the rate of reconstruction increased from 49 percent in 2008 to 62 percent in 2013. This rise was seen across all median income brackets, races, and age groups. When comparing before to after law enactment, the increase in risk-adjusted reconstruction rates was significantly higher for African Americans and elderly patients, but the disparity in reconstruction rates did not change for other races, different income levels, or insurance types. Reconstruction rates were also not significantly different between those treated in various hospital settings. CONCLUSIONS: The aim of the Breast Cancer Provider Discussion Law is to improve reconstruction rates through provider-driven patient education. The authors' data show significant change following law passage in African American and elderly populations, suggesting effectiveness of the law. The New York State Provider Discussion Law may provide a template for other states to model legislation geared toward patient-centered improvement of health outcomes.

Agreeing on the minimum: An 11-year review of Prescribed Minimum Benefits appeals.

BACKGROUND: Prescribed Minimum Benefits (PMBs) in South Africa (SA) are a set of minimum health services that all members of medical aid schemes have access to regardless of their benefit options or depleted funds. Medical aid schemes are liable to pay for these services. However, ~40% of all complaints received by the Council for Medical Schemes (CMS) are in relation to PMBs. Individuals/stakeholders who are unsatisfied with judgments on their complaints are allowed to appeal. OBJECTIVES: To determine and describe the pattern of PMB appeals from 1 January 2006 to 31 December 2016. METHODS: This was a descriptive cross-sectional study that utilised the CMS Judgments on Appeals database. Data for PMBs, levels of appeal, judgments, appellants, respondents and medical scheme types were extracted. The CMS's lists of chronic conditions, PMBs and registered schemes were used to confirm PMBs and to categorise schemes as either open (i.e. to all South Africans) or restricted (i.e. only open to members of specific organisations). Data were extracted and frequencies were calculated using Stata software, version 14. RESULTS: All eligible appeal reports (N=340) were retrieved and 123 PMB appeals were included in the study (36.2%). The median number of PMB appeals per year was 11 (interquartile range 9 - 27). Open schemes accounted for 82.1% of all the PMB appeals. Half of the total appeals (50.4%, 62/123) were by medical aid schemes appealing their liability to pay for PMBs, and of these 69.4% (43/62) were found in favour of members. The remaining half (49.6%, 61/123) were appeals by members appealing that schemes were liable to pay, and of these 80.3% (49/61) were found in favour of the medical aid schemes. Treatment options that were scheme exclusions constituted 34.4% (21/61) of reasons why schemes were found not liable to pay. Various types of cancers and emergency conditions constituted one-quarter of all PMB appeals. CONCLUSIONS: While the pattern is unclear and the extent of the problem is masked, this study shows that a quarter of the conflict resulting in PMB appeals was due to various types of cancers and emergency conditions. Medical schemes should revise their guidelines, policies and criteria for payment of these two services and improve their communication with healthcare providers and members.