Fostering rational regulation of patient safety

After decades of inattention to the problem of medical injuries, patient safety is now occupying a prominent place on the health policy agenda and garnering renewed regulatory interest. Health care providers' behavior, with respect to patient safety and health care quality improvement, is now being shaped by top-down regulation through statutes and administrative agency oversight, as well as bottom-up drivers such as tort litigation and the forces of the consumer-driven health care market. Patient safety today exemplifies that eclectic mix of regulation that can occur when a new problem is exposed to the general public; it also demonstrates the difficulties of coordinating regulatory signals from multiple sources and regulating incomplete information. This article reviews the evolution of the regulatory environment for patient safety, examines some of the tensions and challenges that currently define patient safety oversight, and suggests strategies for more rational and responsive regulation.     

The Medicare Cost Report and the limits of hospital accountability: improving financial accounting data

Health policy makers, legislators, providers, payers, and a broad range of other players in the health care market routinely seek information on hospital financial performance. Yet the data at their disposal are limited, especially since hospitals' audited financial statements--the "gold standard" in hospital financial reporting--are not publicly available in many states. As a result, the Medicare Cost Report (MCR), filed annually by most U.S. hospitals in order to receive payment for treating Medicare patients, has become the primary public source of hospital financial information. However, financial accounting elements in the MCR are unreliable, poorly defined, and lacking in critical detail. Comparative analyses of MCRs and matched, audited financial statements reveal long-standing problems with the MCR's data, including major differences in reported profits; variations in the reporting of both revenues and expenses; an absence of relevant details, such as charity care, bad debt, operating versus nonoperating income, and affiliate transactions; an inconsistent classification of changes in net assets; and a failure to provide cash flow statements. Because of these problems, MCR financial data give only a limited and often inaccurate picture of the financial position of hospitals. Audited financial statements provide a more complete perspective, enabling analysts to address important questions left unanswered by the MCR data. Regulatory action is needed to create a national database of financial information based upon audited statements.     

The hospital board at risk and the need to restructure the relationship with the medical staff: bylaws,peer review and related solutions

This article argues that the current structure of the hospital governing board and medical staff relationship does not support and promote quality and patient-centered care. The fundamental flaw in the current structure is the interdependent, yet independent and discordant relationships between hospital governing boards and medical staffs. These relationships are described as cultures and fit into three types of "silos": organizational (the "structural silo"); professional (the "professional silo", including the "culture of blame"); and the fragmented quality information silo (the "informational silo"). While case law, statutory requirements and regulatory expectations clearly state that governing boards are ultimately responsible for quality of patient care, governing boards delegate these functions to medical staff without having sufficient information to measure and monitor quality. As a result, problems manifest because of these failures of oversight and compliance. Dramatic lapses in quality occur due to overuse, underuse, and misuse of healthcare services. Furthermore, the challenges and opportunities from improved quality and patient safety, as a strategic business driver, cannot be seized until the underlying structural flaws are understood and addressed. This article proposes that solutions become apparent when the various health care constituencies are educated about these cultural impacts and when multidisciplinary bodies, with board leadership and direct authority, integrate and consider quality information.     

Private credentialing of health care personnel: an antitrust perspective. Part One

This Article explores the antitrust and other implications of private credentialing and accrediting programs in the health care industry. Although such programs are usually sponsored by powerful competitor groups, they serve the procompetitive purpose of providing useful information and authoritative advice to independent decision makers. Part One examines the risk that credentialing will sometimes be unfair to competitors and deceive consumers. Its survey of common-law, antitrust, and regulatory interventions to correct such unfairness and deception seeks to determine the degree of oversight to which credentialing and similar activities have been and should be subjected. In recommending that judicial or regulatory scrutiny should be limited to discovering whether standards and practices have a rational relation to a procompetitive purpose, the Article argues that greater intrusion into credentialing schemes would be inconsistent with market theory and first amendment values and would discourage line-drawing efforts that stimulate competition and facilitate consumer choice. By emphasizing throughout that personnel certification and institutional accreditation embody ideology and opinion as well as factual information, Part One sets the stage for the argument in Part Two that antitrust law can and should be used to contest the dominance of a single ideology of health care and to facilitate the development of alternative sources of consumer information. The Article's overall thesis is that, whereas the quality of advice given to the public about health care personnel and similar matters should not be closely regulated, neither should the supply of competing information and opinion be artificially curtailed.     

Waiting for Godot: wishes and worries in managed care

Managed care has done a better job at reducing expenditure growth than it has in improving quality. Although reduced expenditure growth is not appreciated by many, it has real benefits. For the majority of Americans who are privately insured, it results in greater disposable income for goods and services other than health care (although the illusion of employer-paid health insurance obscures this reality for many). For Medicaid programs, slower growth of expenditures facilitates efforts at expanding coverage. For low-income workers, slower expenditure growth results in larger numbers of people retaining insurance coverage than would have been the case if premiums rose more quickly. While there are some victories to which managed care organizations can point, we cannot credibly argue that overall levels of quality and health outcomes are improving as the health care system is massively disrupted by changes in health care finance and delivery. The disruptions create real hardships for some physicians and other health care workers, and worries for many consumers. These worries fuel the managed care backlash. The danger is that politicians will respond to these worries with policies that inhibit the development of high-quality delivery systems. The opportunity is for relatively modest public policy changes--external review organizations, better public-sector purchasing capabilities, public investment in producing and publicizing information on health plan and medical group performance, and establishment of a public ombudsperson--to respond to consumer worries and lead to improvements in health care quality and outcomes. Finally, I would be remiss without a reminder that the single most effective action politicians could take to improve health care quality and outcomes would be to change the rules of health care financing to assure that all Americans are covered by managed care. Even with all of its inadequacies, managed care is much superior to the patchwork care available to the 43 million Americans who are uninsured. The managed care backlash is concerned with protecting patients who are insured (and their providers). Far more valuable would be to protect those without insurance. Sadly, no politician has yet figured out how to do this. Still waiting.     

Is a public reporting approach appropriate for nursing home care?

Publicizing quality information has been used as a quality improvement strategy in the acute care sector for more than a decade. Despite research showing mixed results of these efforts, publicly reporting quality measures is currently being pursued as a quality improvement strategy for nursing homes. Designed to empower consumers to make informed choices and to stimulate provider competition on quality, nursing home public reporting began in 1998 with the Nursing Home Compare Web site and has received greater emphasis in the 2002 Nursing Home Quality Initiative, both directed by the federal government. Focusing on the response of three key stakeholder groups across settings of care-consumers, providers, and purchasers-I identify several challenges that nursing home reporting must overcome to be successful. I conclude that publicly reporting quality measures for nursing homes will have a harder time promoting quality improvement than for acute care settings, where results have been disappointing thus far. In addition to the conceptual analysis, I evaluate whether the quality information reported on Nursing Home Compare had any impact on nursing home occupancy rates following its release. Using a pre/post-release design, I find that the effect of public reporting on nursing home occupancy rates has been minimal thus far. Although some estimates of effect are statistically significant and in the hypothesized direction, they all suggest very small effect sizes. It is unclear whether the absence of a larger reporting effect to date is specific to Nursing Home Compare or whether it inheres to the broader task of using quality information to promote change in the nursing home care sector.     

Medicare and Medicaid program; regulatory provisions to promote program efficiency, transparency, and burden reduction. Final rule

This final rule identifies reforms in Medicare and Medicaid regulations that CMS has identified as unnecessary, obsolete, or excessively burdensome on health care providers and beneficiaries. This rule increases the ability of health care professionals to devote resources to improving patient care, by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care. This is one of several rules that we are finalizing to achieve regulatory reforms under Executive Order 13563 on Improving Regulation and Regulatory Review and the Department's Plan for Retrospective Review of Existing Rules.     

The FDA and genetic testing: improper tools for a difficult problem

The US Food and Drug Administration (FDA) has recently issued draft guidance on how it intends to regulate laboratory-developed tests, including genetic tests. This article argues that genetic tests differ from traditional targets of FDA regulation in both product as well as industry landscape, and that the FDA''s traditional tools are ill-suited for regulating this space. While existing regulatory gaps do create risks in genetic testing, the regulatory burden of the FDA''s proposal introduces new risks for both test providers and patients that may offset the benefits. Incremental expansion of current oversight outside of the FDA can mitigate many of the risks necessitating increased oversight while avoiding the creation of new ones that could undermine this industry.     

作为规制与治理工具的行政许可

源于私人生活中财产权人授权他人分享自己财产权实践的行政许可,正成为一种引人注目的政府规制与治理工具。作为治理工具,行政许可承载了一系列不同的社会目标,规制有时只是其中一个主要目标。当行政许可被限定为规制工具时,可以假定其核心是实现对特定行为的控制,具体机制包括信息收集、准入控制、行为监管以及许可的执行。尽管许可制度具有筛选市场主体并对他们进行识别和规制等积极作用,但同时也存在巨大的负面作用,如限制和阻碍竞争、可能导致权力滥用,而且许可制度是有成本的。政府在采取许可制度过程中,应考虑其他能够达成相同制度目标的替代性工具。     

The Journalist in the Courtroom

"Proceedings in all courts shall be open to the public." Such is the content of Article 157 of the Constitution of the USSR. The principle that judicial proceedings are to be open to the public—a principle that is contained in the nation's highest legislative act—is of enormous practical significance. The fact that judicial proceedings are open to the public is a guarantee that procedural norms are scrupulously observed in the process of examining the materials of a case, thereby substantially reducing the probability of judicial error. It goes without saying that the further improvement of social oversight over the work of law enforcement agencies is a necessary condition to the democratization of public life. What is more, the openness of judicial proceedings to public scrutiny is a powerful means for the legal education of citizens and of forming a truly socialist legal conscience.     

Standards for privacy of individually identifiable health information. Office of the Assistant Secretary for Planning and Evaluation, DHHS. Proposed rule

This rule proposes standards to protect the privacy of individually identifiable health information maintained or transmitted in connection with certain administrative and financial transactions. The rules proposed below, which would apply to health plans, health care clearinghouses, and certain health care providers, propose standards with respect to the rights individuals who are the subject of this information should have, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards would improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections would begin to address growing public concerns that advances in electronic technology in the health care industry are resulting, or may result, in a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule would implement the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.     

HMO promotion and the privatization of health care in Chile

Since 1973 the Chilean junta has privatized sectors of the national economy. This paper analyzes the country's policy process of promoting private medical programs through HMO-like plans (ISAPREs, or Institutes of Provisional Health). These plans have captured less than half of their originally anticipated market share. It is argued that the future performance of ISAPREs will be undermined by their limited maternal benefits, their targeting to a small upper-income group which cannot sustain many private medical programs, and competition with less expensive yet equally competent public medical programs. The paper briefly compares privatization in Chile with the experiences of other countries, and specifically contrasts the restructuring of health services under military rule in Chile with those of Argentina and Uruguay. The paper concludes that the Chilean experience with HMOs epitomizes the perils of planning health care during short-term periods of economic prosperity as well as failing to consult medical care providers and consumers.     

Organ Procurement and Transplantation Network--HRSA. Final rule with comment period

This document sets forth the final rule governing the operation of the Organ Procurement and Transplantation Network (OPTN), which performs a variety of functions related to organ transplantation under contract with HHS. The document also offers a 60 day period for additional public comment. The rule will become effective 30 days following the close of the comment period. If the Department believes that additional time is required to review the comments, we will consider delaying the effective date. In combination with a new National Organ and Tissue Donation Initiative, this rule is intended to improve the effectiveness and equity of the Nation's transplantation system and to further the purposes of the National Organ Transplant Act of 1984, as amended. These purposes include: encouraging organ donation; developing an organ allocation system that functions as much as technologically feasible on a nationwide basis; providing the bases for effective Federal oversight of the OPTN (as well as for implementing related provisions in the Social Security Act); and, providing better information about transplantation to patients, families and health care providers.     

Definition of primary mode of action of a combination product. Final rule

The Food and Drug Administration (FDA) is amending its combination product regulations to define "mode of action' (MOA) and "primary mode of action" (PMOA). Along with these definitions, the final rule sets forth an algorithm the agency will use to assign combination products to an agency component for regulatory oversight when the agency cannot determine with reasonable certainty which mode of action provides the most important therapeutic action of the combination product. Finally, the final rule will require a sponsor to base its recommendation of the agency component with primary jurisdiction for regulatory oversight of its combination product by using the PMOA definition and, if appropriate, the assignment algorithm. The final rule is intended to promote the public health by codifying the agency's criteria for the assignment of combination products in transparent, consistent, and predictable terms.     

Inching toward incrementalism: federalism, devolution, and health policy in the United States and the United Kingdom

In the United States, the recently enacted Patient Protection and Affordable Care Act of 2010 envisions a significant increase in federal oversight over the nation's health care system. At the same time, however, the legislation requires the states to play key roles in every aspect of the reform agenda (such as expanding Medicaid programs, creating insurance exchanges, and working with providers on delivery system reforms). The complicated intergovernmental partnerships that govern the nation's fragmented and decentralized system are likely to continue, albeit with greater federal oversight and control. But what about intergovernmental relations in the United Kingdom? What impact did the formal devolution of power in 1999 to Scotland, Wales, and Northern Ireland have on health policy in those nations, and in the United Kingdom more generally? Has devolution begun a political process in which health policy in the United Kingdom will, over time, become increasingly decentralized and fragmented, or will this "state of unions" retain its long-standing reputation as perhaps the most centralized of the European nations? In this article, we explore the federalist and intergovernmental implications of recent reforms in the United States and the United Kingdom, and we put forward the argument that political fragmentation (long-standing in the United States and just emerging in the United Kingdom) produces new intergovernmental partnerships that, in turn, produce incremental growth in overall government involvement in the health care arena. This is the impact of what can be called catalytic federalism.     

Give me shelter: the state of animal sheltering in Kentucky’s county shelter system

Abstract

The Commonwealth of Kentucky Animal Control and Advisory Board estimates that in 2012, approximately 285,000 dogs and cats entered the shelter system, but only 15% were retrieved by owners or adopted to a new home. While some shelters incorporate adoption, fostering, and low-cost spay and neuter programs, many shelters euthanize the majority of the animals that enter the shelter system. In an effort to address severe deficiencies within the shelter system, Kentucky passed the Humane Shelter Law which defined minimum care and facility standards for animals held in shelters, along with required data collection. The law also placed responsibility with the individual county governments for oversight and implementation of these requirements. This paper presents the background and history of the state policy regarding animal shelters followed by results from a study of the county animal shelters in Kentucky. Results from the study suggest that numerous problems with data collection and maintenance exist throughout Kentucky and that levels of care vary widely for animals in the system. We discuss these issues before making recommendations for improvement to this system and its oversight. Our research suggests that with proper funding and oversight, Kentucky’s statute could become a model for humane animal sheltering.     

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.     

The conflict between the ethics of th individual and the ethics governing public health: practical sustainability of health care in jeopardy?

The "health rights movement" has reconstructed the clinical relationship between health care workers and patients by simultaneously demanding more from traditional medical care and challenging the perceived power differential between doctors and patients by rejecting the paternalistic medical model in favour of an individual patients' rights model. However, the growth in individual expectations of a right to health care creates a potential conflict with the ethics that prioritise public health and guide the rationing of its limited financial and human capital resources. This, in turn, creates a practical dilemma which requires public health institutions to become service orientated while sacrificing their integral role in training and educating the medical workforce and potentially compromising the practical sustainable delivery of public health in Australia. However, the law can play a role in resolving this conflict through legislation, regulations, codes, administrative law and common law in an effort to ensure the quality and future sustainability of public health in Australia.     

Will pay for performance be worth the price to medical providers? A look at pay for performance and its legal implications for providers

This article explores the legal implications of pay for performance programs from the perspective of healthcare providers. The author provides an informative background on the emergence of pay for performance programs and examines the structure and operation of these programs. She then explores the liability issues of health plans and managed care organizations and delves into evidentiary issues related to pay for performance information. Her article concludes with some practical suggestions for providers in preparing for an expansion of these quality initiatives.     

Standards for privacy of individually identifiable health information. Office of the Assistant Secretary for Planning and Evaluation, DHHS. Final rule

This rule includes standards to protect the privacy of individually identifiable health information. The rules below, which apply to health plans, health care clearinghouses, and certain health care providers, present standards with respect to the rights of individuals who are the subjects of this information, procedures for the exercise of those rights, and the authorized and required uses and disclosures of this information. The use of these standards will improve the efficiency and effectiveness of public and private health programs and health care services by providing enhanced protections for individually identifiable health information. These protections will begin to address growing public concerns that advances in electronic technology and evolution in the health care industry are resulting, or may result in, a substantial erosion of the privacy surrounding individually identifiable health information maintained by health care providers, health plans and their administrative contractors. This rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996.