User fee policies and women's empowerment: a systematic scoping review.

BACKGROUND: Over the past decade, an increasing number of low- and middle-income countries have reduced or removed user fees for pregnant women and/or children under five as a strategy to achieve universal health coverage. Despite the large number of studies (including meta-analyses and systematic reviews) that have shown this strategy's positive effects impact on health-related indicators, the repercussions on women's empowerment or gender equality has been overlooked in the literature. The aim of this study is to systematically review the evidence on the association between user fee policies in low- and middle-income countries and women's empowerment. METHODS: A systematic scoping review was conducted. Two reviewers conducted the database search in six health-focused databases (Pubmed, CAB Abstracts, Embase, Medline, Global Health, EBM Reviews) using English key words. The database search was conducted on February 20, 2020, with no publication date limitation. Qualitative analysis of the included articles was conducted using a thematic analysis approach. The material was organized based on the Gender at Work analytical framework. RESULTS: Out of the 206 initial records, nine articles were included in the review. The study settings include three low-income countries (Burkina Faso, Mali, Sierra Leone) and two lower-middle countries (Kenya, India). Four of them examine a direct association between user fee policies and women's empowerment, while the others address this issue indirectly -mostly by examining gender equality or women's decision-making in the context of free healthcare. The evidence suggests that user fee removal contributes to improving women's capability to make health decisions through different mechanisms, but that the impact is limited. In the context of free healthcare, women's healthcare decision-making power remains undermined because of social norms that are prevalent in the household, the community and the healthcare centers. In addition, women continue to endure limited access to and control over resources (mainly education, information and economic resources). CONCLUSION: User fee removal policies alone are not enough to improve women's healthcare decision-making power. Comprehensive and multi-sectoral approaches are needed to bring sustainable change regarding women's empowerment. A focus on "gender equitable access to healthcare" is needed to reconcile women's empowerment and the efforts to achieve universal health coverage.

Pay to Play? State Laws Related to High School Sports Participation Fees.

CONTEXT: Participation in high school sports can impact the physical and mental health of students and influence other positive social and economic outcomes. To maintain sports programs amidst school budget deficits, many districts are implementing sports participation fee policies. Although locally implemented, these district policies can be guided by state law. OBJECTIVE: The main objective of this study was to assess state laws and regulations related to high school sports participation fees. DESIGN: Codified statutes and administrative regulations were compiled for all 50 states and the District of Columbia using subscription-based services from LexisNexis and WestlawNext. A content assessment tool was developed to identify key components of school sports participation fee laws and used for summarization. Key components identified included legislation summarization, years in effect, whether it allows fees, whether there is any fee waiver, qualifications needed for fee waiver, whether there is a tax credit, and whether there is disclosure of implementation. State information was aggregated and doubled-coded to ensure reliability. RESULTS: As of December 31, 2016, 18 states had laws governing sports participation fees; 17 of these states' laws allowed for such fees, whereas 1 state prohibited them. Most laws give authority to local school boards to set and collect fees. The laws in 9 states have provisions for a waiver program for students who cannot pay the fees, although they do not all mandate the existence of these waivers. Other content within laws included tax credits and disclosure. CONCLUSION: This analysis shows that states with laws related to school sports participation fees varied in scope and content. Little is known about the implementation or impact of these laws at the local level and the effect of fees on different student population groups. This warrants future investigation.

Economic Impacts of the Generic Drug User Fee Act Fee Structure.

BACKGROUND: A Food and Drug Administration (FDA) Generic Drug User system, Generic Drug User Fee Amendment of 2012 (GDUFA), started October 1, 2012, and has been in place for over 3 years. There is controversy about the GDUFA fee structure but no analysis of GDUFA data that we could find. OBJECTIVE: To look at the economic impact of the GDUFA fee structure. METHODS: We compared the structure of GDUFA with that of other FDA Human Drug User fees. We then, using FDA-published information, analyzed where GDUFA facility and Drug Master File fees are coming from. We used the Orange Book to identify the sponsors of all approved Abbreviated New Drug Applications (ANDAs) and the S&P Capital IQ database to find the ultimate parent companies of sponsors of approved ANDAs. RESULTS: The key differences between the previous structure for Human Drug User fees and the GDUFA are as follows: GDUFA has no approved product fee and no first-time or small business fee exemptions and GDUFA charges facility fees from the time of filing and charges a foreign facility levy. Most GDUFA fees are paid by or on behalf of foreign entities. The top 10 companies hold nearly 50% of all approved ANDAs but pay about 14% of GDUFA facility fees. CONCLUSIONS: We conclude that the regressive nature of the GDUFA fee structure penalizes small, new, and foreign firms while benefiting the large established firms. A progressive fee structure in line with other human drug user fees is needed to ensure a healthy generic drug industry.

Code Red: The Essential Yet Neglected Role of Emergency Care in Health Law Reform.

The United States' health care system is mired in uncertainty. Public opinion on the Patient Protection and Affordable Care Act ("ACA") is undeniably mixed and politicized. The individual mandate, tax subsidies, and Medicaid expansion dominate the discussion. This Article argues that the ACA and reform discourse have given short shrift to a more static problem: the law of emergency care. The Emergency Medical Treatment and Active Labor Act of 1986 ("EMTALA") requires most hospitals to screen patients for emergency medical conditions and provide stabilizing treatment regardless of patients' insurance status or ability to pay. Remarkably, this law strengthened the health safety net in a country that has no universal health care. But it is an unfunded mandate that responded to the problem of emergency care in a flawed fashion and contributed to the supposed "free rider" problem that the ACA attempted to cure. But the ACA has also not been effective at addressing the issue of emergency care. The ACA's architects reduced funding for hospitals that serve a disproportionate percentage of the medically indigent but did not anticipate the Supreme Court's ruling in NFIB v. Sebelius, which made Medicaid expansion optional. Public and non-profit hospitals now face a scenario of less funding and potentially higher emergency room utilization due to continued uninsurance or underinsurance. Alternatives to the ACA have been insufficiently attentive to the importance of emergency care in our health system. This Article contends that any proposal that does not seriously consider EMTALA is incomplete and bound to produce some of the same problems that have dogged the American health care system for the past few decades. Moreover, the Article shows how notions of race, citizenship, and deservingness have filtered into this health care trajectory, and in the context of reform, have the potential to exacerbate existing health inequality. The paper concludes with normative suggestions on how to the mitigate EMTALA's problems in ways that might improve population health.

Balance Billing by Health Care Providers: Assessing Consumer Protections Across States.

ISSUE: Privately insured consumers expect that if they pay premiums and use in-network providers, their insurer will cover the cost of medically necessary care beyond their cost-sharing. However, when obtaining care at emergency departments and in-network hospitals, patients treated by an out-of-network provider may receive an unexpected "balance bill" for an amount beyond what the insurer paid. With no explicit federal protections against balance billing, some states have stepped in to protect consumers from this costly and confusing practice. GOAL: To better understand the scope of state laws to protect consumers from balance billing. METHODS: Analysis of laws in all 50 states and the District of Columbia and interviews with officials in eight states. FINDINGS AND CONCLUSIONS: Most states do not have laws that directly protect consumers from balance billing by an out-of-network provider for care delivered in an emergency department or in-network hospital. Of the 21 states offering protections, only six have a comprehensive approach to safeguarding consumers in both settings, and gaps remain even in these states. Because a federal policy solution might prove difficult, states may be better positioned in the short term to protect consumers.

Use of Fees to Discourage Nonmedical Exemptions to School Immunization Laws in US States.

Recent outbreaks of vaccine-preventable diseases in the United States have renewed public discourse about state vaccine mandates for children entering schools. With acknowledgment of the challenge of eliminating religious and philosophical exemptions in most states, some have proposed instead to impose additional administrative burdens for parents seeking such exemptions. We review the use of taxes, fines, and fees as financial disincentives in public health. We argue that adding processing fees to a comprehensive set of administrative requirements for obtaining exemptions will avoid the use of taxpayer funding for exemption processing and will help tilt the balance of convenience in favor of vaccination.

Amendments to Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications To Provide for the User Fee Program. Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is amending its regulations on accreditation of third-party certification bodies to conduct food safety audits and to issue certifications to provide for a reimbursement (user fee) program to assess fees for the work FDA performs to establish and administer the third-party certification program under the FDA Food Safety Modernization Act (FSMA).

Reconciling Estimates of the Value to Firms of Reduced Regulatory Delay in the Marketing of Their New Drugs.

The prescription drug user fee program provides additional resources to the U.S. Food and Drug Administration at the expense of regulated firms. Those resources accelerate the review of new drugs. Faster approvals allow firms to realize profits sooner, and the program is supported politically by industry. However, published estimates of the value to firms of reduced regulatory delay vary dramatically. It is shown here that this variation is driven largely by differences in methods that correspond to differences in implicit assumptions about the effects of reduced delay. Theoretical modeling is used to derive an equation describing the relationship between estimates generated using different methods. The method likely to yield the most accurate results is identified. A reconciliation of published estimates yields a value to a firm for a one-year reduction in regulatory delay at the time of approval of about $60 million for a typical drug. Published 2015. This article is a U.S. Government work and is in the public domain in the U.S.A.

The role of policy actors and contextual factors in policy agenda setting and formulation: maternal fee exemption policies in Ghana over four and a half decades.

BACKGROUND: Development of health policy is a complex process that does not necessarily follow a particular format and a predictable trajectory. Therefore, agenda setting and selecting of alternatives are critical processes of policy development and can give insights into how and why policies are made. Understanding why some policy issues remain and are maintained whiles others drop off the agenda is an important enquiry. This paper aims to advance understanding of health policy agenda setting and formulation in Ghana, a lower middle-income country, by exploring how and why the maternal (antenatal, delivery and postnatal) fee exemption policy agenda in the health sector has been maintained over the four and half decades since a 'free antenatal care in government facilities' policy was first introduced in October 1963. METHODS: A mix of historical and contemporary qualitative case studies of nine policy agenda setting and formulation processes was used. Data collection methods involved reviews of archival materials, contemporary records, media content, in-depth interviews, and participant observation. Data was analysed drawing on a combination of policy analysis theories and frameworks. RESULTS: Contextual factors, acting in an interrelating manner, shaped how policy actors acted in a timely manner and closely linked policy content to the intended agenda. Contextual factors that served as bases for the policymaking process were: political ideology, economic crisis, data about health outcomes, historical events, social unrest, change in government, election year, austerity measures, and international agendas. Nkrumah's socialist ideology first set the agenda for free antenatal service in 1963. This policy trajectory taken in 1963 was not reversed by subsequent policy actors because contextual factors and policy actors created a network of influence to maintain this issue on the agenda. Politicians over the years participated in the process to direct and approve the agenda. Donors increasingly gained agenda access within the Ghanaian health sector as they used financial support as leverage. CONCLUSION: Influencers of policy agenda setting must recognise that the process is complex and intertwined with a mix of political, evidence-based, finance-based, path-dependent, and donor-driven processes. Therefore, influencers need to pay attention to context and policy actors in any strategy.

A delayed inheritance: the Medical Board of Victoria's 75-year wait to find doctors guilty of "infamous conduct in a professional respect".

The Medical Board of Victoria (Board) was created in 1844 to register "legally qualified medical practitioners". It was not until 1933, however, that the Board attained the power to remove from its register a doctor who had engaged in "infamous conduct in a professional respect" (the power), even though the General Council of Medical Education and Registration of the United Kingdom on which the Board was modelled had been granted the power 75 years earlier. This article argues that the delay in the Board's inheritance was attributable to successive Victorian Parliaments' distrust of the Board and that this attitude was unwarranted, at least from early in the 20th century. The article maintains that the granting of the power to the Board was a crucial event in the history of the regulation of the Victorian medical profession. This is illustrated both by the difficulty encountered by the medical profession in dealing with doctors' unethical conduct before 1933, and the Board's concern to use its new authority responsibly and appropriately to protect the public and the profession in the three years after it attained the power.