Medicare program; Medicare appeals of individual claims--HCFA. Final rule with comment period

Under section 1869 of the Social Security Act, Medicare beneficiaries and, under certain circumstances, providers or suppliers of health care services may appeal adverse determinations regarding claims for benefits under Medicare Part A or Part B. This rule expands our regulations to recognize the right of Part B appellants to a hearing before an administrative law judge (ALJ) for claims if at least $500 remains in dispute and the right to judicial review of an adverse ALJ decision if at least $1,000 remains in controversy. Also, this rule codifies in regulations: Limitations on the review by ALJs and the courts of certain national coverage determinations, and the statutory authority for an expedited appeals process under Part A and Part B.     

Medical Error and Patient Safety: Understanding Cultures in Conflict

Evidence documenting the high rate of medical errors to patients has taken a prominent place on the health care radar screen. The injuries and deaths associated with medical errors represent a major public health problem with significant economic costs and erosion of trust in the health care system. Between 44,000 and 98,000 deaths due to preventable medical errors are estimated to occur each year, making medical errors the eighth leading cause of death in the United States. However, the recent prominence of the issue of safety or error does not reflect a new phenomenon or sudden rift in the quality of health care (although it is a system fraying at the edges). Rather, the prominence of the issue reflects a radical change in the culture of health care, and in how relationships within the health care system are structured and perceived. In this paper, I discuss the multiple factors responsible for the change in the culture of health care. First, the culture has shifted from a clinician cantered system, in which decision making is one–sided, to a shared system of negotiated care between clinician and patient, and, often, between administrator or payer. Second, the nature of quality in health care has changed due to the geometric increase in the availability of technological and pharmaceutical enhancements to patient care. Third, the health care culture continues to rely on outdated models of conflict resolution. Finally, the regulatory structure of health system oversight was set in place when fee–for–service care governed physician–patient relationships and where few external technologies were available. In the current health care culture, that structure seems inadequate and diffuse, with multiple and overlapping federal and state regulatory structures that make implementation of patient safety systems difficult.     

Balancing public health and practitioner accountability in cases of medical manslaughter: reconsidering the tests for criminal negligence-related offences in Australia after R v Patel

In 2010 Dr Jayant Patel was convicted of several offences on the basis of criminal negligence. Following the Queensland Court of Appeal's 2011 endorsement of the trial judge's decision, the case provides a timely opportunity to review prosecutions for medical negligence criminal offences throughout Australia and to critically examine the tests in assessing whether the balance has been correctly struck. The author argues that the thresholds required for prosecutions for criminal negligence for medical manslaughter are problematic and unduly onerous, and do not adequately strike the balance between the utilitarian value in health care and patient safety, on the one hand, and practitioner accountability and deterrence, on the other. This article considers reforms to remedy the imbalance, including a reformulation of the Criminal Code (Qld) and common law thresholds, proposals for the enactment of a separate offence of criminally negligent manslaughter and the utilisation of corporate prosecutions for manslaughter liability to broaden accountability in health care and promote patient safety on a systemic level.     

Avoiding HMO liability for utilization review

In this article, the author describes the potential liability of Health Maintenance Organizations for utilization review programs. Utilization review is used to determine whether certain medical treatment is necessary according to the standards of the HMO, and the HMO may decline to pay for treatments it deems unnecessary. If a doctor abstains from treatment because of this decision and the patient is harmed, the HMO may become the target of litigation. The author analyzes several recent cases and offers practical ideas for preventing and defending suits brought against HMO's for utilization review decisions.     

The Health Care Quality Improvement Act of 1986: its history, provisions, applications and implications

Congress granted qualified immunity from liability for peer review participation to physicians, osteopaths and dentists, created a national practitioner data bank to track inept, incompetent or unprofessional physicians, and enacted procedural rules for due process, privilege restrictions, and reporting and disbursement of information. The Health Care Quality Improvement Act of 1986 is now in full force, and peer review participants are anxious to cloak themselves with immunity from actions brought by health care professionals. Although its goals are worthy, HCQIA's effects remain to be seen. Serious loopholes appear to exist, warranting close monitoring and possibly early amendment of the Act. Cautious judicial assessment is needed, in order to prevent not only circumvention of the Act's requirements by artful litigants, but also use of the national data bank by health care entities as a pretext for denying privileges and escaping antitrust liability.     

Preferred provider organization liability for physician malpractice

The preferred provider organization (PPO) is a recent innovation in the health care industry, designed to reduce costs through selective contracting and utilization controls. This Note examines malpractice liability theories potentially applicable to PPOs. The Note compares PPOs to other health care institutions, including hospitals and HMOs, and concludes that PPOs are at minimal risk of incurring liability for physician negligence.     

Medical liability and health care reform

We examine the impact of the Affordable Care Act (ACA) on medical liability and the controversy over whether federal medical reform including a damages cap could make a useful contribution to health care reform. By providing guaranteed access to health care insurance at community rates, the ACA could reduce the problem of under-compensation resulting from damages caps. However, it may also exacerbate the problem of under-claiming in the malpractice system, thereby reducing incentives to invest in loss prevention activities. Shifting losses from liability insurers to health insurers could further undermine the already weak deterrent effect of the medical liability system. Republicans in Congress and physician groups both pushed for the adoption of a federal damages cap as part of health care reform. Physician support for damages caps could be explained by concerns about the insurance cycle and the consequent instability of the market. Our own study presented here suggests that there is greater insurance market stability in states with caps on non-economic damages. Republicans in Congress argued that the enactment of damages caps would reduce aggregate health care costs. The Congressional Budget Office included savings from reduced health care utilization in its estimates of cost savings that would result from the enactment of a federal damages cap. But notwithstanding recent opinions offered by the CBO, it is not clear that caps will significantly reduce health care costs or that any savings will be passed on to consumers. The ACA included funding for state level demonstration projects for promising reforms such as offer and disclosure and health courts, but at this time the benefits of these reforms are also uncertain. There is a need for further studies on these issues.     

Managed care liability and the capitated provider

While there have been no reported cases as yet on the subject of ERISA preemption of claims arising from utilization review decisions by providers, it will unquestionably be a significant issue facing providers that participate in capitated arrangements. If preemption is determined not to be available, providers will be exposed to risks from which health plans are currently shielded. Providers conducting utilization review should be following this issue as it develops, but should also be obtaining insurance for this risk to the extent it is available (e.g., it will not be available for punitive damages). Providers should also consider negotiating provisions in their contracts with health plans to the effect that any utilization review conducted by the provider is on behalf of the health plan and that the provider's utilization review activities will be covered under the health plan's liability insurance.     

Patient dumping in the hospital emergency department: renewed interest in an old problem

Alarm about the adverse effects of transferring emergency patients for economic reasons has resulted in federal legislation aimed at curbing the practice. We review the history of common law hospital liability for denial of emergency care and analyze the federal legislation designed to restrict the transfer of medically indigent patients with emergency problems. We conclude that the currently proposed solutions to patient dumping will have limited effectiveness without more specific incentives for the provision of health care to the medically indigent.     

What is an employee benefit plan?: ERISA preemption of "any willing provider" laws after Pegram

This note considers the implications of a recent Supreme Court decision, Pegram v. Herdrich, for preemption of state laws under the Employee Retirement Income Security Act (ERISA). Though Pegram dealt with a fiduciary liability question, and not preemption specifically, the Court in arriving at its decision laid out a definition of the word "loan"--a word that is used in both the fiduciary liability section of ERISA and the preemption section. The Court's definition focuses upon the relationship between the managed care organization and the employer that hires it. The definition, however, excludes from the meaning of "plan" the relationship between the managed care organization and the health care providers it hires. Thus, this Note argues that according to Pegram, state laws that regulate the relationship between managed care organizations and health care providers, such as "any willing provider" laws, should not be preempted by ERISA.     

Between the Scylla and Charybdis: physicians and the clash of liability standards and cost cutting goals within accountable care organizations

This article seeks to examine the conflict between non-cost-conscious medical malpractice liability standards and health care cost cutting measures within the context of Accountable Care Organizations ("ACOs") under the new health care reform law. This article begins by providing an overview of the high level of health care spending within the United States health care system in order to provide a context for better understanding policymakers' push for cost cutting measures, including ACOs. This article then examines the tension between cost containment efforts and medical liability standards through an examination of the "stuck in the middle" mentality that physicians face when they are forced to meet both liability standards that do not take into account cost concerns and cost cutting standards imposed by or through managed care organizations, pay-for-performance programs and consumer-driven healthcare. This article then introduces the concept of the ACO and describes elements of the ACOs envisioned under the new health care reform legislation. This article concludes by examining and analyzing whether and how ACOs will exacerbate the cost containment/liability standard tension, and how that tension may impact the effectiveness of ACOs.     

Injuries and Health Care Use in Women with Partners in Batterer Intervention Programs

Objective:To characterize injury frequency, injury patterns, and health care seeking behavior in women with intimate partners enrolled in batterer intervention programs. Methods: A standardized telephone interview was conducted on a sample of women with male partners enrolled in batterer intervention programs in four U.S. cities. Information on prior injuries and the utilization of health care services was sought. Results: Four hundred and eighty eight of the 648 women (75.3%) reported a history of prior injury as a result of abuse. Contusions were the most common injury. Of the women reporting contusions, 233 (51.4%) reported contusions as their only injuries. Another 220 women (48.6%) reported other injuries in addition to contusions. In the majority of cases (63.2%) the contusions were to multiple body parts. When the contusion involved only one anatomical region, it was mostly to the face. A total of 192 of the 488 injured women (39.3%) reported ever seeking medical care for injuries caused by their intimate partner. Twenty-three women (4.7% of the injured cohort or 3.5% of the total cohort) reported having ever been hospitalized for injuries sustained from abuse.     

The importance of national laws in the implementation of European legislation of biomedical research

The industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation.     

A hospital's non-delegable duty of care

Visiting, honorary and staff medical practitioners, to name but a few, provide medical treatment and services to a variety of "patients", including private, public, in-patients and out-patients. The legal implications arising from the often complex fact situations created by the interactions of these participants and the relationship between hospitals and these participants can lead to hospitals both incurring and avoiding liability for injuries sustained by patients from negligent medical treatment. This article discusses the legal principles governing hospitals' liabilities in this context on the more onerous non-delegable duty of care ground.     

Public expectations of health professionals when patients telephone for medical advice

This article focuses on the ethical, social and liability implications of patients obtaining unsolicited medical advice over the phone. The ethical discussion centres on the demise of paternalism and the increase in patient autonomy and individualism and the growing public expectations of health professionals. The article then discusses the advantages and disadvantages of telephone consultations from a social and policy perspective. In light of these considerations it considers what the liability implications are for phone consultations. It argues that the ethic of individualism, coupled with recent Australian tort reforms, suggests that only in limited circumstances would a doctor be found liable for negligence in relation to telephone consultations. However, the increasing expectations being placed on medical personnel, as evidenced by the increase in unsolicited telephone consultations, if left untempered, may lead to a situation with which the health care system is ill equipped to deal.     

Medicare program; home health agencies: conditions of participation--HCFA. Final rule

This final rule responds to the major comments we received on an interim final rule that was published on August 14, 1989 (54 FR 33354). That interim final rule added requirements to the current conditions of participation for home health agencies (HHAs). Specifically, the rule specified requirements for protecting and promoting patient rights; training and competency evaluation of home health aides; notifying State entities responsible for the licensing or certification of HHAs of changes in ownership of the agency or management of the agency; including an individual's plan of care as part of the individual's clinical records; and operating and furnishing services in compliance with applicable Federal, State, and local laws and regulations and with accepted professional standards and principles that apply to professionals furnishing home health services. Most of the provisions of the rule implemented section 930 of the Omnibus Reconciliation Act of 1980 (Pub. L. 96-499), section 4021 of the Omnibus Budget Reconciliation Act of 1987 (Pub. L. 100-203), and section 411(d) of the Medicare Catastrophic Coverage Act of 1988 (Pub. L. 100-360). This final rule implements changes, based on our review and consideration of the public comments, concerning patient notification of changes in payment liability, requirements for evaluators and instructors of home health aides, in-service training, and supervisory visits, and clarifies other home health issues.     

The business judgment rule and other protections for the conduct of not-for-profit directors

The authors review the Business Judgment Rule as applied to a not-for-profit director's duty of care, with particular emphasis on the different forms of state statutory liability shields that serve to enhance the protections of the Rule. They also examine current trends in enforcement of breach of fiduciary duty of care standards, and provide a series of specific recommendations for not-for-profit boards to consider implementing as a means of increasing the likelihood of affording such protections to individuals serving as directors.     

Economic models of compensation for damage caused by nuclear accidents: Some lessons for the revision of the Paris and Vienna Conventions

In this paper the economic analysis of accident law is used to examine the liability for nuclear accidents. It is argued that the classic system of individual liability of a nuclear power plant operator with a financial cap on compensation and individual insurance by national pools is not effective. The current system leads to a too low compensation for victims and lacks an adequate internalization of the nuclear risk. Hence, it is argued that the economic analysis of law can provide useful insights for the revision of the Paris and Vienna Conventions on the liability for nuclear accidents. It is also argued that higher amounts of compensation can be generated only if the idea is accepted that all plants share the costs of an accident wherever it occurs. This could be realized through a mutual pooling system. Such a system could also be fitted into the revision of the Paris and Vienna Conventions.     

The Independent Medicare Advisory Committee: death panel or smart governing?

This comment explores whether health care reform legislation establishes an administrative body effectively charged with the rationing of health care resources; insofar as it establishes a presidentially appointed Independent Medicare Advisory Committee (IMAC). IMAC would be charged with "making two annual reports dictating updated rates for Medicare providers including physicians, hospitals, skilled nursing facilities, home health, and durable medical equipment." IMAC's recommendations would be implemented nationally, subject to a Congressional vote. Congress would be granted a thirty-day window to achieve a simple majority for or against the IMAC recommendations. Part I is an introduction. Part II of this article covers the history of American health care. It lays out the federal government's evolving role in the arena of public health and health care, starting in the mid-nineteenth century and continues up to the present day. Part III examines the existing process by which Medicare spending is controlled. This part focuses on the administrative procedures that control Medicare reimbursements. Part IV examines IMAC. This part discusses IMAC's statutory provisions and the administrative transparency laws IMAC would be bound to follow. The close of this part, draws on three analogies as a gauge for how IMAC will operate: Senator Tom Daschle's Federal Health Board (FHB) proposal; the administrative oversight of the Federal Reserve; and the United Kingdom's National Institute for Health and Clinical Excellence (NICE). Part V creates a snapshot of the U.S. health care system as it operates today. This part emphasizes cost, quality, and accessibility of health care, with comparisons to international and state-run health care systems. Throughout this article there are a number of words, phrases, and agencies that have been given acronyms. For convenience, an index of these acronyms is provided in an appendix following the article.     

Employer strategies for modifying or terminating retiree benefits in the 1990s

Over the past decade, access to health care coverage has become a crucial national concern. At the same time, the rising cost of health care, the aging of the population, and new accounting requirements for retiree medical benefits have caused employers to reevaluate their commitment to providing unrestricted health care benefits to the retirees. This article discusses the key federal appellate court decisions concerning an employer's decision to modify or terminate retiree medical benefits. It then explores alternatives for meeting the statutory, legal, and accounting challenges faced by employers who now offer retiree health care coverage.