Journal of health & life sciences law
Current impact factor: 0.00
Impact Factor Rankings
|Other titles||Journal of health & life sciences law, Journal of health and life sciences law|
|Document type||Journal / Magazine / Newspaper|
Publications in this journal
- [Show abstract] [Hide abstract] ABSTRACT: E-prescribing--the electronic transmission of prescriptions or prescription-related information--has been touted as an effective way to reduce adverse drug events and improve the efficiency and effectiveness of healthcare. The Centers for Medicare and Medicaid Services (CMS) and the Drug Enforcement Administration (DEA) have introduced measures designed to encourage e-prescribing. As a result of the agencies' dissimilar missions, the structure and substance of the two initiatives sharply contrast, and ultimately may prove incompatible. This article provides an overview of these two initiatives, their associated criticisms, and the obstacles preventing the widespread adoption of e-prescribing. Most importantly, it examines the conundrum posed by the competing interests of the two agencies and the extent to which DEA's responsibility to prevent unlawful activity will prevent generally law-abiding citizens from receiving safer and more efficient healthcare.
- [Show abstract] [Hide abstract] ABSTRACT: Healthcare providers, attorneys, and others working in the healthcare industry in the United States are well aware of the widespread concerns among federal and state policymakers (among others) about the growing cost and variability of care among different segments of the population. To address these concerns, many policymakers have begun supporting pay-for-performance and other quality-focused initiatives. This article examines the legal barriers to successful implementation of such initiatives, focusing specifically on payment changes in the Medicare program, and on the federal fraud and abuse laws (namely, the Anti-Kickback Statute, the Civil Monetary Penalty Law, and the Physician Self-Referral Law). As part of this examination, the article highlights several central statutory developments and federal agency initiatives that have begun exploring quality-based payment in the Medicare program, as well as some important initiatives likely to receive attention in the current political environment. The article also proposes congressional and regulatory actions that could help remove or reduce the legal impediments these initiatives will face. Finally, the article provides suggestions to help providers (especially hospitals) prepare for quality-based payment reforms.
- [Show abstract] [Hide abstract] ABSTRACT: Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in overseeing quality of care. Recent developments--the availability of comparative quality data, public reporting, and financial incentives for higher quality--have transformed expectations for board oversight. Enforcement of fraud and abuse laws based on poor quality of care, as well as federal standards for board oversight of healthcare quality and compliance, have set higher standards for board conduct. This article examines the emerging paradigm for board oversight of healthcare quality, and recommends how boards should proceed to meet their responsibilities in an era of comparative quality measures and transparency.
- [Show abstract] [Hide abstract] ABSTRACT: The Food and Drug Administration (FDA) is embarking on the "Sentinel Initiative" to create an electronic network operating across provider electronic health records, health plan claims databases, Medicare databases, and other data sources to monitor FDA-approved medical products. Many private research collaborations also are working to improve our "early warning" system for drugs, such as the eHealth Initiative Foundation (eHI) Connecting Communities for Drug Safety Collaboration, a public-private sector effort. In this article, the author examines a variety of legal issues from the compliance perspective of the private data sources participating in these drug safety programs. These legal issues include: the Food and Drug Act Administration Amendments Act of 2007; privacy laws, including the Health Insurance Portability and Accountability Act, federal alcohol and drug abuse treatment regulations, and state health information confidentiality laws; human subject research compliance; and tort liability.
- [Show abstract] [Hide abstract] ABSTRACT: State and local legislatures in more than twenty states have considered enacting fair share laws. Fair share laws typically require employers of a certain size either to spend a designated percentage of their total payroll costs on health insurance for their employees or pay into a state fund for uninsured individuals. Such laws have been challenged in the federal courts, ultimately resulting in differing decisions. In 2007, the Fourth Circuit Court of Appeals affirmed the lower court's decision to strike down the Maryland Fair Share Act, holding it was preempted by the Employee Retirement Income Security Act (ERISA). The Fair Share for Health Care Act in Suffolk County, NewYork succumbed to a similar fate. However, in the Ninth Circuit, San Francisco's Health Care Security Ordinance survived ERISA preemption. This article analyzes the Fourth and Ninth Circuit decisions and explores the potential effects of the differing outcomes on healthcare reform.
- [Show abstract] [Hide abstract] ABSTRACT: As growing numbers of Americans try complementary and alternative medicine, or CAM, treatments, such as acupuncture, chiropractic, and herbal remedies, the healthcare legal and regulatory structures face changes, particularly relating to the concept of medical integration, or using CAM therapies in conjunction with conventional medicine. First, this article examines the desirability of medical integration, documenting the popularity and growth of CAM. Second, the article discusses the legal barriers to CAM integration, ranging from professional discipline by state medical boards for unauthorized practice of medicine to liability risks and the need for third-party coverage of CAM treatments. Finally, the article concludes that although medical integration is a desirable goal, many changes in the healthcare legal and regulatory system will need to occur to facilitate that transition.
- [Show abstract] [Hide abstract] ABSTRACT: Employers in the healthcare industry face unique challenges regarding compliance with the Americans with Disabilities Act (ADA). Healthcare employers must reasonably accommodate employees in complex and often physically challenging positions, while ensuring safe and effective patient care. These challenges have become even more difficult with the recent passage of the ADA Amendments Act of 2008 (ADAAA), which significantly expands the definition and scope of "disability" under the ADA, and legislatively reverses several key Supreme Court decisions favorable to employers. Although the ultimate impact of the ADAAA remains to be determined, this article will help employers and their counsel understand how federal disability discrimination laws may affect their businesses going forward, with an analysis of the language of the ADAAA, case law under the ADA, and guidance from the Equal Employment Opportunity Commission (EEOC).
- [Show abstract] [Hide abstract] ABSTRACT: Healthcare costs continue to rise. Employers struggle to provide health insurance for their employees. Wellness programs continue to gain popularity as a method of cost-control, but implicate a variety of federal and state laws, including privacy laws, discrimination prohibitions, laws governing health plans, tax laws, and more. Additionally, employers must consider the practical concerns of promoting employee participation and benefits to workers in wellness programs. Wellness programs are not difficult to form, but do require consideration of all of these issues. This article identifies and explains the legal and practical issues of which the employer considering implementing a new wellness program must be aware, and makes some suggestions on how to address those issues when forming a program.
- [Show abstract] [Hide abstract] ABSTRACT: Many sellers in the United States offer bundled discounts, or package deals. Consumers generally welcome the ability to get more for less in return for purchasing multiple goods or services together. In the healthcare industry, payors and providers commonly negotiate such arrangements. Although bundled discounts often create a win-win for buyers and sellers, they can be anticompetitive when used by a monopolist to exclude a smaller competitor. In recent years, several antitrust lawsuits have addressed the legality of particular bundled discount arrangements. Two federal circuit courts of appeal have established divergent, and somewhat elusive, standards for evaluating the arrangements under the antitrust laws--and the law likely will remain in a state of flux until the Supreme Court steps in to hear the issue. This article explains the underlying economic rationale for antitrust concerns with bundled discounts, and surveys various standards that courts have applied to such arrangements as well as proposed standards that have not yet been adopted. It also discusses the practical implications of these standards for sophisticated healthcare entities that may seek to bundle a range of products or services. The article concludes with a checklist of questions that sellers should ask in conducting a preliminary evaluation of potential antitrust risk associated with a particular discount arrangement.
- [Show abstract] [Hide abstract] ABSTRACT: This article discusses the conflicting requirements of and assertions made to the Food and DrugAdministration 510(k) approval process and the United States Patent and Trademark Office patent application process for a medical device. Generally, in a 510(k) submission, a company asserts that its device is a substantial equivalent of a predicate device. Conversely, in a patent application, a company asserts that its device is new and nonobvious over all prior art devices. This article explores the risks that arise for a company, whether as a patent holder or an accused patent infringer, because of assertions made as part of a 510(k) submission. The authors look at the possibility of using a 510(k) submission against a company to invalidate that company's patent, then examine the possibility of using a company's 510(k) submission to show infringement of another company's patent. They discuss how regulatory and patent counsel can work together to navigate both regulatory schemes to minimize associated risks-requiring credible arguments of substantial equivalence simultaneous with arguments of novelty and nonobviousness.
- [Show abstract] [Hide abstract] ABSTRACT: In Part One, the authors addressed the relevance of genetic information, and how race and genetics have affected and may impact the development of medicines, pharmacogenomics, and personalized medicine in the United States. Part Two examines current and proposed federal and state laws and regulations intended to protect individuals from the misuse of genetic information, including uses that discriminate based on genetic predispositions. This Part next explores the potential for litigation against both manufacturers and providers,as well as potential defenses. The authors also discuss legal issues relating to research that relies on the use of genetic information.
- [Show abstract] [Hide abstract] ABSTRACT: Off-label drug or medical device "use" is the practice of prescribing drugs or medical devices to patients for a purpose not included on the federally approved label. Off-label "marketing" is the practice of attempting to influence physicians to prescribe drugs or devices for off-label purposes. The federal Food and Drug Administration (FDA) maintains regulatory authority over the proper labeling of drugs and medical devices. Although not illegal, off-label use of certain drugs has led to controversy in recent years, especially in light of alleged behind-the-scenes marketing practices intended to increase off-label prescribing. Off-label marketing practices are prohibited and could result in criminal charges against a manufacturer, depending upon the circumstances. Yet a vast gray area exists for subtle marketing practices, such as circulating published medical studies about off-label uses to physicians. This article summarizes the legal and medical standards associated with off-label use and marketing of drugs, provides summaries of recent enforcement activities regarding off-label marketing, and explains the current federal regulatory issues surrounding off-label marketing practices. The authors provide practical pointers on regulatory compliance and the risks associated with fraud and abuse laws for drug companies and practitioners.
- [Show abstract] [Hide abstract] ABSTRACT: The increase of physician ownership and use of in-office advanced diagnostic imaging equipment (magnetic resonance imaging, positron emission tomography, and computed axial tomography) has led to concerns about overuse, quality, and increased costs. The requirement that a physician or non-physician practitioner furnishing diagnostic testing services (1) enroll as an independent diagnostic testing facility (IDTF) for each practice location furnishing these services and (2) comply with the performance standards of 42 C.F.R. section 410.33 would represent a major step toward curbing potential advanced diagnostic imaging self-referral overutilization, improving quality, and lowering costs.
- [Show abstract] [Hide abstract] ABSTRACT: In 2007, the United States Court of Appeals for the District of Columbia rejected a claim that terminally ill patients have a constitutionally protected right to access experimental drugs that have passed Phase I testing, but have not yet received FDA approval. Since that case was decided, patients and patients' rights groups have continued to advance both constitutional and common law claims in an effort to compel FDA and manufacturers to grant access to unapproved therapies. Congress and FDA have also advanced proposals that would expand patient access to drugs that have not yet passed through Phase III trials. Whether patients with serious and life-threatening illnesses should be allowed to obtain experimental therapies before FDA approval is an issue that is poised to shape the practice of both law and medicine in the United States for some time to come.
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