Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices.

This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

A Qualitative Study of the Views of Individuals With Type 1 Diabetes on the Ethical Considerations Raised by the Artificial Pancreas.

Type 1 diabetes management requires regular blood glucose measurements and tailored insulin administration to prevent its complications. An artificial pancreas is developed to automate insulin therapy, thereby improving its safety and effectiveness. Despite its benefits compared to conventional approaches, the artificial pancreas raises ethical considerations which could impact its uptake and user satisfaction. The objective of this qualitative study was to understand the ethical considerations associated with the artificial pancreas of significance to individuals with type 1 diabetes. Sixteen interviews were conducted with these stakeholders. Qualitative content analysis was conducted on interview transcriptions. Five categories of ethical considerations were identified: (1) contextualized autonomy and control in diabetes management; (2) relational autonomy, identity, and relationships; (3) safety, privacy, and confidentiality; (4) public and private coverage; and (5) justice and patient selection criteria. These issues need to be addressed in the development of the artificial pancreas, clinical practice, and coverage policies.

Equity in healthcare financing: a case of Iran.

BACKGROUND: Fair financial contribution in healthcare financing is one of the main goals and challengeable subjects in the evaluation of world health system functions. This study aimed to investigate the equity in healthcare financing in Shiraz, Iran in 2018. MATERIALS AND METHODS: This was a cross- sectional survey conducted on the Shiraz, Iran households. A sample of 740 households (2357 persons) was selected from 11 municipal districts using the multi-stage sampling method (stratified sampling method proportional to size, cluster sampling and systematic random sampling methods). The required data were collected using the Persian format of "World Health Survey" questionnaire. The collected data were analyzed using Stata14.0 and Excel 2007. The Gini coefficient and concentration and Kakwani indices were calculated for health insurance premiums (basic and complementary), inpatient and outpatient services costs, out of pocket payments and, totally, health expenses. RESULTS: The Gini coefficient was obtained based on the studied population incomes equal to 0.297. Also, the results revealed that the concentration index and Kakwani index were, respectively, 0.171 and - 0.125 for basic health insurance premiums, 0.259 and - 0.038 for health insurance complementary premiums, 0.198 and - 0.099 for total health insurance premiums, 0.126 and - 0.170 for outpatient services costs, 0.236 and - 0.061 for inpatient services costs, 0.174 and - 0.123 for out of pocket payments (including the sum of costs related to the inpatient and outpatient services) and 0.185 and - 0.112 for the health expenses (including the sum of out of pocket payments and health insurance premiums). CONCLUSION: The results showed that the healthcare financing in Shiraz, Iran was regressive and there was vertical inequity and, accordingly, it is essential to making more efforts in order to implement universal insurance coverage, redistribute incomes in the health sector to support low-income people, strengthening the health insurance schemes, etc.

Clinical Ethicists Awakened: Addressing Two Generations of Clinical Ethics Issues Involving Undocumented Patients.

Because the United States has failed to provide a pathway to citizenship for its long-term undocumented population, clinical ethicists have more than 20 years of addressing issues that arise in caring for this population. I illustrate that these challenges fall into two sets of issues. First-generation issues involve finding ethical ways to treat and discharge patients who are uninsured and ineligible for safety-net resources. More recently, ethicists have been invited to help address second-generation issues that involve facilitating the presentation for care of undocumented patients. In the current environment of widespread fear of deportation in the immigrant community, ethicists are working with health care providers to address patient concerns that prevent them from seeking care. I illustrate that in both generations of issues, values implicit within health care, namely, caring, efficiency, and promotion of public health, guide the strategies that are acceptable and recommended.

Infertility, Inequality, and How Lack of Insurance Coverage Compromises Reproductive Autonomy.

Disparities in access to infertility care and insurance coverage of infertility treatment represent marked injustices in US health care. The World Health Organization defines infertility as a disease. Infertility has multiple associated billing codes in use, as determined by the International Statistical Classification of Diseases and Related Health Problems. However, the often-prohibitive costs associated with infertility treatment, coupled with the lack of universal insurance coverage mandates, contribute to health care inequity, particularly along racial and socioeconomic lines.

When Societal Structural Issues Become Patient Problems: The Role of Clinical Ethics Consultation.

The debate about health insurance coverage and the related issue of unequal access to health care turn on fundamental questions of justice, but for an individual patient like DM, the abstract question about who is deserving of health insurance becomes a very concrete problem that has a profound impact on care and livelihood. DM's circumstances left him stuck in the hospital. A satisfactory discharge plan remained elusive; his insurance coverage severely limited the number and type of facilities that would accept him; and his inadequate engagement in his own rehabilitation process limited discharge options even further. Despite extensive involvement with the psychiatry, social work, physical therapy, and occupational therapy teams, DM consistently made "bad" decisions. He repeatedly refused antibiotics and did not consistently work with rehab services to improve his strength and mobility. Although the clinicians wanted to provide him with the best care possible, he often seemed unwilling to do the things necessary to achieve this care-or perhaps his depression rendered him unable to do so. He also tended to take out his frustration on staff members caring for him. All of this was, in turn, very frustrating for the staff. It may be easy, however, to make too much of DM's role, to see his choices as more important than his circumstances. A major goal of the ethics consultants was to reframe DM's predicament for the staff members involved in his care.

Autonomy-Centered Healthcare.

In this paper, I aim to demonstrate that the consequences of the current United States health insurance scheme on both physician and patient autonomy is dire. So dire, in fact, that the only moral solution is something other than what we have now. The United States healthcare system faces much criticism at present. But my focus is particular: I am interested in the ways in which insurance interferes with physician and patient autonomy. (I do not consider The Affordable Care Act much of a change in this aspect of the system, for it still relies heavily on private insurance, albeit often subsidized.) I will argue in favor of an expansion of the traditional conception of what I call "medical autonomy" or "healthcare autonomy" and the usual role it plays in bioethical discussions. More generally, I show that in morally designing or evaluating any healthcare system, serious attention should be paid to how this system helps foster what I call active autonomy.

Moral Distress with Obstacles to Hepatitis C Treatment: A Council of Academic Family Medicine Educational Research Alliance (CERA) Study of Family Medicine Program Directors.

BACKGROUND AND OBJECTIVE: To determine whether family medicine program directors (PDs) experienced moral distress due to obstacles to Hepatitis C virus (HCV) treatment, and to explore whether they found those obstacles to be unethical. DESIGN: An omnibus survey by the Council of Academic Family Medicine's Educational Research Alliance was administered to 452 and completed by 273 US-based PDs. The survey gauged attitudes and opinions regarding ethical dilemmas in patient access to HCV treatment. RESULTS: Most of the respondents were male. Sixty-four percent of respondents believed that treatment should be an option for all patients regardless of cost. Forty-one percent believed that it was unethical to deny treatment based on past or current substance use, and 38% believed treatment should be offered to patients who were substance abusers. Moral distress was reported by 61% (score >3) of participants when they were unable to offer treatment to patients due to the patient's failure to meet eligibility criteria. In addition, PDs reporting moderate-to-high levels of moral distress were also likely to report the following opinions: 1) treatment should be offered regardless of cost, 2) it is unethical to deny treatment based on past behavior, 3) substance abusers should be offered treatment, 4) it is unethical for medicine to be prohibitively expensive, and 5) Medicaid policy that limits treatment will worsen racial and ethnic disparities. CONCLUSIONS: Currently, important ethical dilemmas exist in the access and delivery of HCV therapy. Although a diversity of opinions is noted, a significant proportion of PDs are concerned about patients' inability to avail equitable care and experience distress. In some cases, this moral distress is in response to, and in conflict with, current guidelines.

"Without bodily autonomy we are not free": exploring women's concerns about future access to contraception following the 2016 US presidential election.

OBJECTIVE: Following the 2016US presidential election, social media posts and news stories amplified concerns about the potential for reduced access to contraception under the incoming administration and urged women to seek long-acting reversible contraception. We aimed to describe women's concerns about future access to contraception, in their own words. STUDY DESIGN: A social-media-based, anonymous online survey assessing thoughts and concerns about future access to contraception was distributed to reproductive-aged US women for 1 week in mid-January 2017. Participants who were concerned about future access to contraception could share their thoughts and feelings in an open-ended comments box. We qualitatively analyzed 449 written responses for content and themes, with the goal of characterizing key concerns. RESULTS: Women who provided written comments had a mean age of 28years; 85% were white, 88% had at least a college degree, and 93% identified as Democratic or Democratic-leaning. Women were highly concerned about future affordability of contraceptive methods due to potential loss of insurance, reduced insurance coverage for contraceptive methods and reduced access to low-cost care at Planned Parenthood. Many also worried about increased restrictions on abortion. Participants' concerns regarding access to contraception and abortion centered around themes of reproductive and bodily autonomy, which women described as fundamental rights. CONCLUSIONS: Women in this study expressed considerable fear and uncertainty regarding their future access to contraception and abortion following the 2016US presidential election. The potential for restricted access to affordable contraception and abortion was viewed as an unacceptable limitation on bodily autonomy. IMPLICATIONS: As the future of US health care policy is debated, many women are concerned about the impact of policy changes on their ability to access affordable contraception and abortion, which many view as essential to the preservation of bodily and reproductive autonomy.

Restrictions of Hepatitis C Treatment for Substance-Using Medicaid Patients: Cost Versus Ethics.

Medicaid programs provide health insurance coverage for many patients with hepatitis C, a public health problem for which effective but very expensive treatments are now available. Facing constrained budgets, most states adopted prior authorization criteria for sofosbuvir, the first of these agents. Using fee-for-service utilization data from 42 Medicaid programs in 2014, we found that strict behavioral criteria-those that limited coverage on the basis of drug or alcohol use and included specific abstinence or treatment requirements-were associated with significantly less spending on sofosbuvir. Despite the potential cost savings, such criteria raise troubling questions in terms of public health as well as medical ethics, clinical evidence, and potentially federal law. Decision-makers should reject these requirements in Medicaid coverage policy and pursue national and state policy strategies to balance short-term budgetary realities with long-term public health benefits.

Effective cataract surgical coverage: An indicator for measuring quality-of-care in the context of Universal Health Coverage.

OBJECTIVE: To define and demonstrate effective cataract surgical coverage (eCSC), a candidate UHC indicator that combines a coverage measure (cataract surgical coverage, CSC) with quality (post-operative visual outcome). METHODS: All Rapid Assessment of Avoidable Blindness (RAAB) surveys with datasets on the online RAAB Repository on April 1 2016 were downloaded. The most recent study from each country was included. By country, cataract surgical outcome (CSOGood, 6/18 or better; CSOPoor, worse than 6/60), CSC (operated cataract as a proportion of operable plus operated cataract) and eCSC (operated cataract and a good outcome as a proportion of operable plus operated cataract) were calculated. The association between CSC and CSO was assessed by linear regression. Gender inequality in CSC and eCSC was calculated. FINDINGS: Datasets from 20 countries were included (2005-2013; 67,337 participants; 5,474 cataract surgeries). Median CSC was 53.7% (inter-quartile range[IQR] 46.1-66.6%), CSOGood was 58.9% (IQR 53.7-67.6%) and CSOPoor was 17.7% (IQR 11.3-21.1%). Coverage and quality of cataract surgery were moderately associated-every 1% CSC increase was associated with a 0.46% CSOGood increase and 0.28% CSOPoor decrease. Median eCSC was 36.7% (IQR 30.2-50.6%), approximately one-third lower than the median CSC. Women tended to fare worse than men, and gender inequality was slightly higher for eCSC (4.6% IQR 0.5-7.1%) than for CSC (median 2.3% IQR -1.5-11.6%). CONCLUSION: eCSC allows monitoring of quality in conjunction with coverage of cataract surgery. In the surveys analysed, on average 36.7% of people who could benefit from cataract surgery had undergone surgery and obtained a good visual outcome.

Is It Desirable that I Must Disclose My Genetic Data to Swiss Private Medical Insurances?

Genetic testing has far-reaching consequences, not only in terms of immediate patient management and the wider implications for the patient and their families, but also with respect to disclosure to insurance companies. The focus of this review is the controversial but important topic of the use of genetic data in private medical insurance. We discuss the current legal regulation of genetic data in the context of Swiss insurance, what type(s) of information is relevant to insurance companies, and why 'genetic exceptionalism' (the notion that genetic data has special status) persists. Furthermore, we discuss the sensitive area of handling genetic data from children. The consequences of legal regulation of disclosure of genetic information are considered, particularly from the economic perspective. Finally, we examine how legal conditions correspond to current insurance practice and contrast the Swiss system with the handling of genetic data in other countries in the context of private insurance. Switzerland has adopted fairly 'laissez-faire' regulations compared to other countries, and the public need education on the potential effects of genetic testing on their insurance, especially with respect to direct-to-consumer genetic testing, where there is no consultation from a qualified doctor, or when minors are involved.

Which moral hazard? Health care reform under the Affordable Care Act of 2010.

Purpose - Moral hazard is a concept that is central to risk and insurance management. It refers to change in economic behavior when individuals are protected or insured against certain risks and losses whose costs are borne by another party. It asserts that the presence of an insurance contract increases the probability of a claim and the size of a claim. Through the US Affordable Care Act (ACA) of 2010, this study seeks to examine the validity and relevance of moral hazard in health care reform and determine how welfare losses or inefficiencies could be mitigated. Design/methodology/approach - This study is divided into three sections. The first contrasts conventional moral hazard from an emerging or alternative theory. The second analyzes moral hazard in terms of the evolution, organization, management, and marketing of health insurance in the USA. The third explains why and how salient reform measures under the ACA might induce health care consumption and production in ways that could either promote or restrict personal health and safety as well as social welfare maximization. Findings - Insurance generally induces health care (over) consumption. However, not every additional consumption, with or without adverse selection, can be considered wasteful or risky, even if it might cost insurers more in the short run. Moral hazard can generate welfare and equity gains. These gains might vary depending on which ACA provisions, insured population, covered illnesses, treatments, and services, as well as health outcomes are taken into account, and because of the relative ambiguities surrounding definitions of "health." Actuarial risk models can nonetheless benefit from incorporating welfare and equity gains into their basic assumptions and estimations. Originality/value - This is the first study which examines the ACA in the context of the new or alternative theory of moral hazard. It suggests that containing inefficient moral hazard, and encouraging its desirable counterpart, are prime challenges in any health care reform initiative, especially as it adapts to the changing demographic and socio-economic characteristics of the insured population and regulatory landscape of health insurance in the USA.

The ethics of insurance limiting institutional medical care: It's all about the money.

Dr F. Inest practices surgery at a renowned medical center but is concerned because increasing numbers of medical insurers are excluding his institution from coverage. Many of his former referring physicians are beginning to send their patients elsewhere for this reason. The marketing people have been busy increasing their advertising buys and exploring new business models. There is even talk about reducing expensive clinical trials. However, regardless of his affiliation, he has little control over these and other organizational decisions that directly impact his practice clinically and fiscally. What should he do?