Federal Statutes Research Articles

Financial Eligibility Criteria and Medication Coverage for Independent Charity Patient Assistance Programs

Although independent charity patient assistance programs improve patient access to costly prescription drugs, recent federal investigations have raised questions about their potential to increase pharmaceutical spending and to violate the federal Anti-Kickback Statute. Little is known about the design of the programs, patient eligibility, or drug coverage. To examine the eligibility criteria of the independent charity patient assistance programs and the drugs covered by them. Descriptive cross-sectional study of the 6 largest independent charities offering patient assistance programs for patients including, but not limited to, Medicare beneficiaries in 2018. These charities offered 274 different disease-specific patient assistance programs. Drugs were identified for subgroup analysis that had any use reported on the Medicare Part D spending dashboard and any off-patent brand-name drugs that incurred more than $10 000 in Medicare spending per beneficiary in 2016. Support by independent charity patient assistance programs. The primary outcomes were the characteristics of patient assistance programs, including assistance type, insurance coverage (vs uninsured), and income eligibility. The secondary outcomes were the cost of the drugs covered by the patient assistance programs and the coverage of expensive off-patent brand-name drugs vs substitutable generic drugs. Among the 6 independent charity foundations included in the analysis, their total revenue in 2017 ranged from $24 million to $532 million, and expenditures on patient assistance programs ranged from $24 million to $353 million, representing on average, 86% of their revenue. Of the 274 patient assistance programs offered by these organizations, 168 (61%) provided only co-payment assistance, and the most common therapeutic area covered was cancer or cancer treatment-related symptoms (113 patient assistance programs; 41%). A total of 267 programs (97%) required insurance coverage as an eligibility criterion (ie, excluded uninsured patients). The most common income eligibility limit was 500% of the federal poverty level. The median annual cost of the drugs per beneficiary covered by the programs was $1157 (interquartile range, $247-$5609) compared with $367 (interquartile range, $100-$1500) for the noncovered drugs. Off-patent brand-name drugs (cost: >$10 000) were covered by a mean of 3.1 (SD, 2.0) patient assistance programs, whereas their generic equivalents were covered by a mean of 1.2 (SD, 1.0) patient assistance programs. In 2018, among 274 patient assistance programs operated by the 6 independent charity foundations, the majority did not provide coverage for uninsured patients. Medications that were covered by the patient assistance programs were generally more expensive than those that were not covered.

The Emera Return on Equity Inquiry and Interstate Gas Pipelines

In June 2019, public comments were due to the Federal Energy Regulatory Commission (FERC) in response to a large list of fairly complicated questions the commission presented in a Notice of Inquiry (NOI) in Docket No. PL19‐4. The NOI represents a wide‐ranging reconsideration of how the commission arrives at allowed returns on equity (ROEs)—first for the electric public utilities where the current reexamination started and then—perhaps—for natural gas and liquids pipelines regulated under different federal statutes. We can assume by now the commission has received mountains of expertise‐laden discussions of related methodologies, data, investor expectations, and consumer interests.

Risk Management Practices to Strengthen Public Sector Accountability

Manuscript type: Research paper Research aims: Risks can challenge the public sector’s service delivery system and growth sustainability. While the notion of modern accountability demands some display of risk management (RM) initiatives, less attention has been given to the impact of RM practices on organisational accountability as well as the effect of performance measurement system (PMS) use on RM practices. Drawing from the resource-based view, this study attempts to investigate the predictive effect of RM practices and (PMS) use on accountability by using a mediation framework. Design/Methodology/Approach: Cross-sectional survey is applied to collect data from the top management of the Malaysian Federal Statutory Bodies (FSBs). The research framework is tested by analysing the data of 110 Malaysian FSBs through the structural equation modelling technique (PLS-SEM). Research findings: The result of the study demonstrates that PMS use for monitoring and PMS use for attention-focusing have a significant positive effect on RM practices. Additionally, RM practices mediate the relationship between PMS use and accountability. Theoretical contribution/Originality: This paper is among the few to assess the effect of PMS use on RM practices and to determine the mediation effect of RM practices on the relationship between PMS use and accountability. Practitioner/Policy implication: These findings provide valuable insights for authorities in the public sector on the ways to enhance public sector governance through new mechanisms of accountability such as RM practices. Research limitation/Implication: This study uses a non-probability sampling. Considering the difference in design and use of control systems among the different sectors or industries, the results may not be generalised to other populations. However, the outcome of this study suggests that RM practices do strengthen public sector accountability with the appropriate use of the PMS. Keywords: Risk Management, Performance Measurement System, Accountability, Public Sector JEL Classification: M41

Arriving Aliens, Custody, and Interagency Determinations Post Jennings

Currently, federal statutes and regulations give the Department of Homeland Security vast authority to detain noncitizens in a variety of categories. Immigration authorities have applied that detention authority to persons with a credible claim to U.S. citizenship, a practice that poses grave tensions to the U.S. rule of law because U.S. citizens are guaranteed constitutional and statutory protection from deportation, removal, and immigration detention. This essay argues briefly that the statutory mandatory detention provisions for arriving aliens do not apply to persons with a credible claim to U.S. citizenship. Further, this essay argues that regulations prohibiting or eliminating administrative judicial review of Department of Homeland Security detention decisions of arriving aliens who have a credible claim to U.S. citizenship are inconsistent with the reorganization of immigration functions in 2003 and must be revised to allow for administrative review of the decision whether to detain during the administrative process.

The President's Tax Returns

This Article examines whether congressional committees enjoy the unrestricted authority to demand a President’s tax returns. It concludes that they do not. Though a federal statute seemingly compels the IRS to furnish, on request, anyone’s tax returns to some congressional committees, a statute cannot transcend the constitutional limits on Congress’s investigative authority. Congress enjoys a near-automatic right to review a President’s tax returns only through a proper impeachment inquiry. After analyzing the general constitutional principles, the Article briefly examines the House Ways & Means Committee’s disputed request for President Trump’s tax return information. That controversy remains ongoing, and subsequent events may affect the legitimacy of any congressional request for that information. However, the Article expresses doubt that the Committee’s request satisfies the relevant constitutional standard.

“The War Power Is Not a Blank Check”: The Supreme Court and Conscientious Objection, 1917–1973

Abstract:This article examines the Supreme Court’s role in the development of federal conscientious objector policy in the twentieth century. Focusing on two key periods—the three years following the end of World War II, and the era of the Vietnam War—I argue that the policy’s evolution was more complex than previous studies have indicated, and that the Court’s changing attitudes toward conscientious objection can be traced to the justices’ increasing but irresolute concern for civil liberties. By the early 1970s, the Court was interpreting federal statutes much more broadly than Congress ever intended, but the justices remained divided over just how broad those interpretations should be. While the end of the draft rendered the question of compulsory military service moot, the Court’s failure to arrive at a clear position on conscientious objection has had lasting implications on other issues.

Teleprescribing Controlled Substances: Flowchart Analysis of the Ryan Haight Act and State Telemedicine Laws

Legal liability concerns rank among the top organizational barriers to telemedicine adoption. Such concerns extend to medication-assisted treatment for opioid use disorders and to clinical use of controlled substances in general. These concerns stem from the complex web of federal and state regulations that govern teleprescribing of controlled substances. Existing health law literature on this topic has in large measure summarized regulations and exceptions under the Ryan Haight Act Online Pharmacy Consumer Protection Act (Ryan Haight Act) or categorized state telemedicine laws by nature and breadth of requirement. However, flowcharts can aid in the cognition, understanding, and evaluation of complex legal knowledge. This study analyzed the Ryan Haight Act, state administrative code, and published telemedicine guidelines using a multimethod qualitative approach. Legal analysis identified the structure and key language of federal statute through examination of sentence structure, logical connectors, punctuation, and key terms and language. Subsequently, Ryan Haight Act and state regulatory compliance flowcharts were developed using an adapted version of the six-stage process described by the American Society for Quality (ASQ). The creation of flowcharts proceeded in an iterative manner, and an interdisciplinary workgroup of subject matter experts reviewed the results for logic, clarity, cohesion, completion, and accuracy. Regulatory compliance flowcharts for teleprescribing of controlled substances may provide practitioners, educators, and advocates a tool for telemedicine risk management, competency-based education, and policy development.

Comparing integration and inclusion between Canadians and Americans with disabilities: Evidence from national surveys of time use

As Canada moves toward the passage of a federal statute assuring access and inclusion for disabled persons, inevitable comparisons arise between the statutory environments for people with disabilities in Canada and the USA. In previous research, we have used daily time use as a macro indicator of the degree of integration of people with disabilities into the wider society. If statutory protection of disabled persons is effective, activity participation should be similar between persons with and without disabilities in jurisdictions that are favorable to full participation. This paper provides the analysis of national survey data on time use in the United States and Canada for 2010. It shows that the dissimilarity of time use by persons with and without disabilities is smaller for Canadians than for Americans. This finding shows that disabled Canadians are more integrated into their wider society than disabled Americans. Paid work is one activity where Canadians and Americans with and without disabilities are most dissimilar. Regression analysis of time spent in paid work indicates that, with demographic and economic descriptors held constant, the American residency does not promote an advantage in paid work which is a key indicator of integration. This casts doubt on the effectiveness of statutory protections for persons with disabilities.

Medicolegal Sidebar: Avoiding Gender-based Inequities During Orthopaedic Training.

Medicolegal Sidebar: Avoiding Gender-based Inequities During Orthopaedic Training.

The law of genetic privacy: applications, implications, and limitations.

Recent advances in technology have significantly improved the accuracy of genetic testing and analysis, and substantially reduced its cost, resulting in a dramatic increase in the amount of genetic information generated, analysed, shared, and stored by diverse individuals and entities. Given the diversity of actors and their interests, coupled with the wide variety of ways genetic data are held, it has been difficult to develop broadly applicable legal principles for genetic privacy. This article examines the current landscape of genetic privacy to identify the roles that the law does or should play, with a focus on federal statutes and regulations, including the Health Insurance Portability and Accountability Act (HIPAA) and the Genetic Information Nondiscrimination Act (GINA). After considering the many contexts in which issues of genetic privacy arise, the article concludes that few, if any, applicable legal doctrines or enactments provide adequate protection or meaningful control to individuals over disclosures that may affect them. The article describes why it may be time to shift attention from attempting to control access to genetic information to considering the more challenging question of how these data can be used and under what conditions, explicitly addressing trade-offs between individual and social goods in numerous applications.

Comment in Opposition to Proposed Revisions to National Historic Preservation Act, No. 1024-AE49 (U.S. Department of the Interior)

This public comment was submitted to the Department of the Interior in opposition to certain proposals to change aspects of the regulations for the National Register of Historic Places. The proposed regulatory revisions appear to aim to conform federal regulations with amendments to the National Historic Preservation Act, which were adopted in 2016. However, these revisions would undermine the federal statutory framework for preservation and would make it harder to preserve America’s great places for future generations in that they: (1) Unlawfully contradict federal statutes setting forth agency responsibilities, (2) Unlawfully misinterpret the federal statutory provision regarding owner objection, (3) Jeopardize full use of the federal rehabilitation tax credit, (4) Place undue and unfunded mandates on State Historic Preservation Offices, and (5) Are being proposed, unlawfully, without required tribal consultation.

Who is More Accountable? Federal or State Malaysian Statutory Bodies

The World Bank on Governance Indicators in the aspect of ‘Voice and Accountability’ reported accountability for Malaysia had declined to 34% in 2017 from 37% in 2013. Data from the International Country Risk Guide showed a decrease in accountability since 2011 from 4.46 to 4 points out of 6 points in the year 2012. Public sector organisations like statutory bodies might also face issues of accountability. This study aims to evaluate and compare the accountability outcomes of federal and state statutory bodies through a questionnaire. The measurement for accountability based on four dimensions, namely transparency, evaluation, stakeholders' participation and complaint and response. Based on 194 responses received from top management of Malaysian statutory bodies, the overall accountability outcome has shown an above-average score of 5.97 for both federal and state statutory bodies. This shows that Malaysian statutory bodies have delivered a high level of accountability. The test for the difference between the means scores of independent T-tests also shows that there is no significant difference between the accountability level of federal and state statutory bodies. Despite the different level of obligation and legislation, both types of statutory bodies seem to deliver an equally high level of accountability outcomes.

Protect Our Children: Vaccination Exemptions Can Establish Child Abuse and Neglect

The need to protect public health has increased as the anti‐vaccine movement is on the rise. Exemptions to vaccination requirements have become more lax, and parents find ways to avoid vaccinating their children, thereby exposing not only their children to the dangers of serious diseases, but other children as well. This Note proposes a federal statute mandating that parents subject their children between the ages of infancy and 6 to acquire vaccinations for all diseases recommended by the Centers for Disease Control and Prevention unless a licensed physician recommends otherwise.

Dual Illegality and Geoambiguous Law: A New Rule for Extraterritorial Application of U.S. Law

Scores of federal criminal and civil statutes are “geoambiguous” - they do not say whether they apply to conduct that takes place in foreign countries. This is a vital concern in an age of exploding globalization. The Supreme Court regularly recites a “presumption against extraterritoriality” but just as often overlooks it and opts to apply geoambiguous law abroad. The Court’s inconsistency bespeaks a deep divide among scholars. Judicial unilateralists favor liberally imposing U.S. law abroad to respond to unwanted effects from foreign conduct. Judicial territorialists favor restraint and a return to traditional territoriality to avoid international conflict. And judicial interests-balancers favor multi-factored, case-by-case consideration of whether it is “reasonable” to apply geoambiguous law abroad. This Article advances a new approach - a proposed rule of “dual illegality” to govern how courts apply geoambiguous laws. Under a dual illegality rule, U.S. courts should decline to apply geoambiguous laws to penalize or regulate conduct that occurs in the territory of a foreign state unless the same conduct is also illegal or similarly regulated by the law of the foreign territorial state. A similar rule of dual illegality has worked for many decades as a limitation in countless criminal extradition treaties. A dual illegality rule would revitalize traditional territoriality values as a limiting principle on U.S. assertion of its law abroad, while also allowing extraterritoriality when there is the least likelihood of provoking political dispute. The response to greater globalization should be less jurisdictional contestability and more reliance on rules that do not invite judges - as the rules wrongly do now - to engage in policy-like assessments of the needs or interests of the United States in having its law applied to activity abroad. Courts should apply a dual illegality rule to decide the scope of geoambiguous law.

Party Autonomy and the Presumption Against Extraterritoriality

What happens when contracting parties attempt to use a choice-of-law clause to bring about the extraterritorial application of statutes that would ordinarily be subject to the presumption against extraterritoriality? Should the choice-of-law clause trump the presumption? Or should the presumption take precedence over the clause? This symposium Essay aspires to answer these questions. It begins by surveying the ability of parties under existing doctrine to utilize choice-of-law clauses to bring about the extraterritorial application of state statutes. Next, it lays out a framework for thinking through the relationship between the presumption and the principle of party autonomy. It then utilizes this framework to determine how courts should resolve conflicts between the two doctrines in the context of state statutes that are silent or ambiguous as to their geographic scope. The Essay concludes by discussing the implications of this analysis for state common law and for federal statutes.

Identifying and critically examining government legislation relevant to children's dental caries in Calgary, Alberta, Canada: a health inequities lens.

ObjectivesChildren's dental caries is an important and urgent public health concern that is largely preventable. Using a social equity framework, our objectives were to identify and critically examine government legislation relevant to the issue of children's dental health in Calgary, Alberta, Canada.MethodsWe conducted a systematic, gray literature search of federal, provincial (Alberta), and municipal (Calgary) statutes and bylaws related to children's dental caries, through the relevant law databases. Eligibility criteria were applied for document screening and selection. Data extraction and synthesis pertained to objectives of the legislation (policy task), relevant agent or actor (level of government), and upstream or downstream focus, in terms of potential impact on social inequities in health.ResultsLegislation (n = 114) was retrieved and grouped into eight policy tasks. Most legislation fit under the policy tasks: protection of public safety and health promotion (n = 40) and benefits and compensation (n = 27). Federal and provincial governments have greater involvement in children's dental caries than municipal (Calgary) government. The majority of legislation was classified as upstream in orientation (e.g., improving living and working conditions; macro‐level policies).ConclusionsAnalysis of legislation relevant to children's dental caries reveals policies that are more often upstream in nature, and unsurprisingly are multijurisdictional. Despite this, there remains a high prevalence and inequitable distribution of children's dental caries in Canada. This suggests that the nature of upstream involvement and fragmented government involvement is ineffective in tackling this pervasive and urgent public health issue. Implications for children's dental health are discussed.

Comparative Discussion on the Arbitrability of Intellectual Property Disputes in India and the United States of America (USA)

This essay shall delve into the general meaning afforded to terms such as Arbitration, Intellectual Property and Arbitrability. It observes and elucidates upon the development and recent trends in intellectual property arbitration in India and USA. USA is a liberal jurisdiction for intellectual property arbitration and the same has found mention in the federal statute. In stark contrast, India recently opened its doors to intellectual property arbitration and is predominantly ambiguous due to the failure of a central national policy. The aim of the essay is to objectively compare and analyze the different arbitration regimes in the two countries, attaining the conclusion that intellectual property arbitration should proceed only inter partes. This approach finds balance and preserves the inviolability of both the courts and the arbitral tribunal.

Use technology to improve your compliance with regulations, statutes

Keeping your department and your institution compliant with state and federal statutes and standards is a necessary task, but that doesn't mean it's always easy. It's also not easy to ensure that everyone in your office has undergone proper training. “Part of my job is to verify that everyone's accountable for all required training,” said Cynthia Pugsley, accreditation manager for the University of Central Florida Police Department.

When courts refuse to play by the rules (of law): the failure of public administration theory in securing constitutional rights

If there is any area of government in which one would expect to locate the rule of law, it would be in the courts. And, if there is any group of people deserving the protections of the rule of law, it would be the accused unable to afford an attorney. In the United States of America, the Sixth Amendment to the Constitution provides a right to assistance of counsel, and both Supreme Court precedent and federal statute extend that right to indigent defendants in criminal cases while establishing that the representation provided is at least minimally effective. However, while these rights exist on paper, their protection has gone wanting in practice as the competing goals of federal judicial administration have starved indigent defense of sufficient funding and have failed to ensure that the attorneys and representation provided are adequate. Indeed, as federal judicial administration has become more ‘professionally’ focused – deferring to the administrative expertise of staff members and emphasizing cost-effective, results-oriented management – indigent criminal defendants have seen the adequacy of their representation fall, in turn threatening the rule of law. This paper tells that story by simultaneously explaining the growth of judicial administration at the federal level in the United States and showing how the federal courts’ increased focus on bureaucratic processes and staff expertise in cost containment have endangered the most vulnerable parties in the federal criminal cases. As such, the federal courts’ over-reliance on public administration theory and their failure to balance its implementation with other central goals threatens the rule of law in their very courtrooms. There is a way out of this morass, which a committee of the federal courts has even recommended: independence of the defense function from the courts’ administrative structures. Barring that change, a central constitutionally-protected right will remain at risk.

Workplace Bullying Among Surgeons-the Perfect Crime.

Workplace Bullying Among Surgeons-the Perfect Crime.