A call for balancing of agency sentinel priorities

Currently, a plethora of enforcement initiatives are directed at the healthcare industry. This Article suggests that budget and time allocations for issuing regulations and guidelines to interpret the law in this area have been disproportionately set when compared to the budget and time allocations set to support these enforcement initiatives. As a result, HCFA and OIG have been seriously delinquent in providing the industry with needed regulatory guidance and workable instructions. The use of enforcement initiatives in lieu of formal rulemaking to regulate the industry accords little respect to the legitimate healthcare providers who constitute the vast majority of the industry. This Article calls for a reexamination of enforcement agencies' priorities to provide regulatory guidance through formal rulemaking, rather than through use of coercive enforcement initiatives.     

Biological monitoring: the employer's dilemma

The industrial workplace contains many potential health hazards that not only can cause great harm to workers, but also can destroy the employers' economic stability. Often these hazards are documented and dealth with, but frequently they are unknown. When health-conscious employers monitor the physical well-being of their employees in an effort to avoid the terrible personal and economic costs these hazards can produce, they may be supplying their employees with the documentation necessary to recover financially for their industrial illnesses. This Article analyzes this dilemma confronting employers. It describes the many factors employers must consider when deciding whether to institute a monitoring process that takes full advantage of technological developments in medical care. The Article suggests an approach employers may take until some of the disincentives surrounding the implementation of monitoring are removed.     

American Health Lawyers Association: the year in review 2002-2003

Every year, the Practice Groups of the American Health Lawyers Association assemble a Year in Review summary of the leading developments in case law, legislation, and administrative actions affecting healthcare. This Article provides a comprehensive overview of these developments. The introduction presents a "Top Ten" list of the year's most noteworthy developments. The remainder of the Article is divided into fourteen topical areas, and offers a brief overview of issues in those areas. Overall, these various developments demonstrate society's efforts to balance accountability, efficiency, and affordability in the delivery of healthcare.     

HIPAA privacy: the compliance challenges ahead

This Article reviews the HIPAA Privacy Standards' impact on healthcare organizations. It discusses whether a healthcare organization is a "Covered Entity" under the regulations, what information the Privacy Standards protect, what restrictions the regulations place on the use and disclosure of protected health information, what individual rights the Privacy Standards create, and what agreements they require between healthcare organizations and their business associates. The author provides relatively extensive guidance to organizations that are embarking upon their voyage of compliance with these broadly applicable regulations, but notes that the full extent of necessary compliance remains unclear, pending DHHS issuance of the next iteration of the rulemaking in this area. The Article was finalized in January 2002, before HHS issued any modifications to the Privacy Standards.     

The doctor-patient relationship as the business case for quality: doing well by doing right

The idea that healthcare quality in America has lagged behind optimal levels has been a central national policy issue since at least 1998. Reform efforts, however, have failed to acknowledge the critical and unique role physicians play in making quality initiatives real. This Article argues physicians are at the core of any effort to propel quality forward in a significant way and, therefore, must be taken into account directly and without apology. The Article examines the quality-accountability context present in this country. It addresses why the physician nexus on these issues is vital for real change to take place and sets forth a clear statement of what is essential to support the doctor-patient relationship in any quality agenda. Finally, it reiterates the author's previously proposed five principles for quality, as well as her unified field theory of quality, all of which are designed to advance quality in a very different way.     

Comparative effectiveness research under the Patient Protection and Affordable Care Act: can new bottles accommodate old wine?

The Patient Protection and Affordable Care Act (PPACA), as amended by the Health Care and Education Reconciliation Act of 2010, initiated comprehensive health reform for the healthcare sector of the United States. PPACA includes strategies to make the American healthcare sector more efficient and effective. PPACA's comparative effectiveness research initiative and the establishment of the Patient-Centered Outcomes Research Institute are major strategies in this regard. PPACA's comparative effectiveness research initiative is one in a long line of federal initiatives to address the rising costs of healthcare as well as to obtain better value for healthcare expenditures. The key question is whether the governance and design features of the institute that will oversee the initiative will enable it to succeed where other federal efforts have faltered. This Article analyzes the federal government's quest to ensure value for money expended in publically funded healthcare programs and the health sector generally. This Article will also analyze what factors contribute to the possible success or failure of the comparative effectiveness research initiative. Success can be defined as the use of the findings of comparative effectiveness to make medical practice less costly, more efficient and effective, and ultimately, to bend the cost curve.     

Private nurses and playboy bunnies: explaining permissible sex discrimination

Discrimination on the basis of sex in employment is illegal--usually. In cases in which employers contend that sex-based hiring is necessary to protect the privacy interests of their customer, however, and in cases in which employers contend that sex-based hiring is necessary to provide a particular type of sexual titillation for their customers, courts sometimes do allow employers to discriminate. Courts say that they allow sex discrimination in employment when it is necessary to preserve the "essence of the business." This Article shows, however, that there is no plausible conception of business "essence" that can explain and make sense of the existing case law. The Article therefore looks beyond the courts' rhetoric to explain and defend why courts distinguish in the ways they do between permissible and impermissible sex discrimination in employment.     

雇主不当劳动行为的民事救济——基于我国和美国不当劳动行为救济制度之比较

我国《工会法》第52条规定的责令雇主承担不当劳动行为的民事责任,与美国《国家劳资关系法》第10(c)条的规定看起来很相似,相比之下,这一规范在美国劳动法的实践中很有效,在我国却极少被适用,解释方面也存在较大的分歧。美国是世界上最早创设不当劳动行为救济制度的国家,从《瓦格纳法》规定的雇主不当劳动行为的禁止规范及救济措施,到《塔夫托—哈特莱法》将适用对象扩大到工会和雇员,在雇用自由原则和劳资自治模式的背景下,其演变始终以保护雇员团结权的松紧程度和收放态度为线索。我国《工会法》现正处于第三次修改阶段,适时检讨第52条的解释和适用的障碍,还可以解决其与《劳动合同法》规范的竞合问题。     

Understanding the physician-owned specialty hospital phenomenon: the confluence of DRG payment methodology and physician self-referral laws

Physician-owned specialty hospitals have flourished in today's healthcare arena, but also have been the subject of a great deal of controversy. The author argues that the rise of specialty hospitals has been the result of a confluence of two healthcare policies: (1) skewed DRG payment methodologies and (2) the misapplication of exemptions to the Stark Law's ban on physician self-referral. This Article examines the aspects of these healthcare policies that have allowed for the explosion of specialty hospitals, as well as the arguments for and against the creation and need for specialty hospitals. The Article also analyzes the reform proposals to correct the Stark and DRG methodologies and how those proposals will affect both specialty and general hospitals.     

The Labor Reform Act of 1977: a detailed analysis.

As a former General Counsel of the NLRB, Peter Nash enjoyed a vantage point from which to observe the procedures of the Board and evaluate how the provisions of the NLRA itself operated. Nou in private practice, he has made a detailed analysis of the labor reform legislation pending in Congress and strongly supported by organized labor. Writing from management's point of view, Mr. Nash concludes that the bills now pending are designed solely to assist unions in their organizing efforts; will not expedite the processing of Board cases; and contain harsh, unfair, and unnecessary deterrent remedies against employers.     

A proposal for a nonreinstatement rule in unfair labor practice cases involving patient abuse

Nursing home discharges of employees based on patient abuse raise a difficult issue when the motivating factor for the disciplinary action is union activism. A tension is created between the rights of employees to engage in protected concerted activity and the rights of patients to quality care. In 1974, Congress passed the Health Care Institutions Amendments, which granted to non-profit health care workers collective organizing and bargaining rights substantially similar to those which workers in other industries had enjoyed for decades under the National Labor Relations Act. Congress intended to give health care workers only that degree of parity, however, which is compatible with the provision of high quality patient care. The agency charged with enforcing the Act, the National Labor Relations Board (NLRB), has failed to distinguish employee misconduct in industrial settings from patient abuse in health care institutions when fashioning remedies for discriminatorily discharged union activists. The NLRB typically has ordered the reinstatement, with back pay, of the patient abuser as the patient's primary care-giver. This Article suggests that a front pay remedy is more appropriate to these cases because it protects the patient's right to be free from abuse without sacrificing employee unionization rights.     

Special report on labor and employment. Supreme Court upholds NLRB bargaining units rule

Providers should expect the number of union organizing campaigns to rise quickly in the wake of the Supreme Court's decision in AHA v. NLRB. Despite this increased activity, providers that offer good working conditions and maintain open lines of communication between employees and management, and that understand their legal rights in connection with such situations, will be much more likely to be effective in responding to union organizing activities.     

Union organizing drives dealt a blow by Supreme Court

The Lechmere case is important because it reaffirms that employers' property rights take precedence over the rights of nonemployees to engage in union organizing on employers' property. This is particularly important for hospitals and health care institutions because of their heightened exposure to union organizing activity after American Hospital Association v. National Labor Relations Board, discussed above. Providers should, however, remember two points. First, the principal focus of Lechmere was on union organizing by nonemployees; nothing in Lechmere limited the basic right of employees to form and join labor unions as guaranteed by Section 7 of the NLRA. Additionally, Lechmere notwithstanding, providers must be careful not to discriminate in their approach to union organizing activities--even by nonemployees. Thus, if a provider allows nonemployee groups other than unions to enter upon its property for purposes of soliciting employees and/or distributing literature, any attempt to bar nonemployee union organizers from the property would probably be deemed discriminatory and could indeed be an unfair labor practice. (In Lechmere, the employer consistently enforced a ban against all such nonemployee groups.)     

HIPAA privacy: "individual rights" and the "minimum necessary" requirements

This Article focuses on two key aspects of the proposed regulations related to health information privacy published by the Department of Health and Human Services ("DHHS") pursuant to the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"). These two aspects, the provisions regarding individual rights and the provisions requiring use of the minimum amount of information necessary to accomplish a given purpose, will be particularly burdensome for the healthcare industry. Furthermore, they are likely to generate a significant number of complaints to the DHHS Secretary relating to alleged violations of the regulations. This Article analyzes the proposed regulations governing these two issues and offers practical advice regarding steps that entities should take in anticipation of the final regulations.     

The money blind: how to stop industry bias in biomedical science, without violating the First Amendment

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions--the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals fail to mandate that industry funders utilize such a solution, the federal government has several regulatory levers available, including conditioning federal funding and direct regulation, both of which could be done without violating the First Amendment.     

Section 525(a) of the bankruptcy code plainly does not apply to Medicare provider agreements

Section 525(a) of the Bankruptcy Code prevents government entities from discriminating against debtors based on the debtor's bankruptcy filing. This Article analyzes how this provision is applied to healthcare providers who file for bankruptcy. Some commentators have expressed concerns that because of Section 525, the federal government is unable to deny a bankrupt provider a new Medicare provider agreement due to the debtor's failure to pay debts discharged during bankruptcy. This Article, however, argues that Section 525 does not apply to a provider agreements because it is not a "license, permit, charter, franchise, or other similar grant" as defined by the statute. Therefore, the author concludes that debtor healthcare providers should not be allowed back into the Medicare program without first paying their statutorily required debts.     

Smoking in the work place: a management perspective.

In the past, smoking in the private work place has been a matter left largely to the discretion of individual employees and employers. A recent poll of the nation's largest service and industrial companies indicates a strong employer preference for this noninterventionist approach by which employees work out smoking-related problems among themselves. Nonetheless, approximately eight states and four dozen localities have passed legislation regulating smoking in the private work place, apparently in response to the courts' reluctance to order such restrictions where the employer has undertaken reasonable efforts to accommodate smokers and nonsmokers. While these laws vary widely in their language and specifics, they may pose significant practical and compliance problems for employers. In the following article, the authors examine judicial, legislative, and employer responses to work-place smoking issues and discuss the options of private employers for coping with this problem.     

Hospitals’ Liabilities in Times of Pandemic: Recalibrating the Legal Obligation to Provide Personal Protective Equipment to Healthcare Workers

The Covid-19 pandemic has precipitated the global race for essential personal protective equipment in delivering critical patient care. This has created a dearth of personal protective equipment availability in some countries, which posed particular harm to frontline healthcare workers’ health and safety, with undesirable consequences to public health. Substantial discussions have been devoted to the imperative of providing adequate personal protective equipment to frontline healthcare workers. The specific legal obligations of hospitals towards healthcare workers in the pandemic context have so far escaped important scrutiny. This paper endeavours to examine this overlooked aspect in the light of legal actions brought by frontline healthcare workers against their employers arising from a shortage of personal protective equipment. By analysing the potential legal liabilities of hospitals, the paper sheds light on the interlinked attributes and factors in understanding hospitals’ obligations towards healthcare workers and how such duty can be justifiably recalibrated in times of pandemic.

     

Healthcare fraud and quality of care: a patient-centered approach

This Article explores the intersection between quality of care and healthcare fraud by examining the extent to which quality-related fraud settlements benefit patients. The author argues that, although the protection of beneficiary health and welfare often is invoked by the federal government as one of the reasons for undertaking anti-fraud efforts, such considerations do not appear to play a large role in many of the settlements that are negotiated. While returning funds to the federal Treasury helps to ensure that the federal healthcare programs remain solvent and continue to serve beneficiaries in the aggregate, it may not adequately address harm to individual patients. Thus, the author concludes it may be time to explore new models of fraud settlements that can provide adequate compensation to the patients who may have suffered harm.