Natural Settings Trials — Improving the Introduction of Clinical Genetic Tests

Approaches to genetic testing differ in the research setting and the clinical setting. More data are needed to develop approaches that will best facilitate the use of new genetic tests in the clinical setting, especially settings where genetic testing has not been widely used, such as in primary care. Furthermore, data are needed to establish the clinical utility of new genetic tests in the general practice setting. Natural setting trials are proposed as a strategy to develop this information. While natural setting trials are clinical research studies and will expose participants to some degree of risk, the risks are different, and arguably less than the risks those same individuals would otherwise face if the test went directly into clinical practice. Ultimately, clinical practice and safety of new genetic tests can be improved by adding the evaluation provided by natural setting trials.     

Legislative responses to managed care pressures

Changes brought about by the increasing presence of managed care have sparked responses in a number of states. While proponents of managed care contend that it fosters competition and allows the market to influence its nature and functioning, the legislators' responses call into question the notion that managed care will bring greater freedom to insurers and providers and, at the same time, will benefit health care consumers.     

Managed care liability today: laws, cases, theories, and current issues

Managed care entities face numerous liability issues in today's changing healthcare environment. This Article provides the plaintiff with a comprehensive road map for navigating the many avenues of managed care liability. The author describes ERISA pre-emption provisions and suggests ways plaintiffs' attorneys can strive to narrow the pre-emption. The Article also provides in-depth analysis of each theory of managed care liability that has been litigated against managed care entities to date, and then goes on to explore state laws imposing liability on managed care entities, and how HMO liability is being reformed through legislative action. For plaintiffs' attorneys seeking the full spectrum of theories of managed care liability, or for defendants' attorneys wanting to remain updated on all potential claims to defend, this Article constitutes an extensive primer on the current issues.     

State Medicaid reform under Section 1115 demonstration authority

Given the complexity of federal Medicaid law and the limitations it imposes on state flexibility, it is likely that states will continue to ask the Secretary to grant waivers under Section 1115 to allow them to pursue new approaches to health care reform. The results of currently operational Section 1115 projects involving statewide managed care systems will be useful in evaluating the Medicaid reform measures currently under discussion in other states and at the federal level. In particular, the ability of the states to control Medicaid and indigent care costs and to utilize federal dollars more efficiently should prove important in evaluating a block grant approach to federal Medicaid funding. Moreover, Section 1115 project results that bear on the sufficiency of various Medicaid capitation rate methodologies will also be of value as more states expand the use of managed care arrangements for their Medicaid populations.     

Underwhelmed: hyperbole,regulatory policy,and the genetic revolution

Rapid advances in the field of genetics in recent years have caused some commentators to suggest the emergence of a "genetic revolution." Such advances have been both praised as the "future of medicine" and condemned for encouraging the acceptance in society of laissez-faire eugenics. Yet the effect of technological advances flowing from the science of genetics appear somewhat overstated as few products of the genetic revolution, particularly in the areas of gene therapy and genetic testing, have managed to satisfy scientists' expectations to date. Furthermore, misdirected regulation of such advances can exacerbate the social, legal, and ethical problems associated with genetics, particularly in the context of health care, where issues of human cloning and the use of premature genetic testing technologies dominate current public debate. In this article, the author criticizes the hyperbolic rhetoric surrounding the genetic revolution and calls for a more balanced and informed approach to the development of genetic policies and regulations. Such an approach should include substantial interdisciplinary debate and an active role on the part of government in the identification and communication of accurate information relating to the effects of recent technological advances in the field of genetics.     

Obesity, courts, and the new politics of public health

Health care politics are changing. They increasingly focus not on avowedly public projects (such as building the health care infrastructure) but on regulating private behavior. Examples include tobacco, obesity, abortion, drug abuse, the right to die, and even a patient's relationship with his or her managed care organization. Regulating private behavior introduces a distinctive policy process; it alters the way we introduce (or frame) political issues and shifts many important decisions from the legislatures to the courts. In this article, we illustrate the politics of private regulation by following a dramatic case, obesity, through the political process. We describe how obesity evolved from a private matter to a political issue. We then assess how different political institutions have responded and conclude that courts will continue to take the leading role.     

Medicare prospective payment: anticipated effect on hospitals, other community agencies, and families

The switch to prospective payment for hospitals under Medicare is expected to have ramifications in a number of different areas. This paper addresses a select number of those areas: hospital organization and management, other community agencies, and families. Questions are raised as to the capacity to provide adequate care in response to the increased demand for care outside the hospital setting that will result from the new payment system.     

Race, Money and Medicines

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. Attention to race can make a therapeutic difference, to the point of saving lives. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. I argue in this essay that we should start with a presumption against racial categories in medicine, but permit their use when it might prolong lives or meaningfully improve health. Use of racial categories should be understood as an interim step; follow-up inquiry into the factors that underlie race-correlated clinical differences is important both to improve the efficacy of clinical care and to prevent race in itself from being misunderstood as a biological determinant. If we pursue such inquiry with vigor, the pernicious effects of racial categories on public understanding can be managed. But perverse market and regulatory incentives create the danger that use of race will be "locked-in," once drugs or other therapies are approved. These incentives should be revisited.     

Any-Willing-Provider laws: their financial effect on HMOs

Any-Willing-Provider (AWP) legislation requires that health plans accept any health care provider who agrees to conform to the plan's conditions, terms, and reimbursement rates. Many states have adopted such legislation, raising questions about its effect on the managed care market. Those favoring this legislation argue that it will reduce restrictions on choice of provider, while opponents argue that it will reduce competition by increasing administrative and medical costs for managed care plans. Using cross-sectional time-series data for the period 1992-1995 (the period during which many of these laws were enacted), this study investigates the effect that these laws have on HMO financial performance. Our results show that "all-provider" AWP laws have a very limited effect on the financial performance measures we examine. "Pharmacy" AWP laws have a more significant effect, but neither type of law appears to affect the overall profitability of HMOs.     

Medicaid program and State Children's Health Insurance Program (SCHIP) payment error rate measurement. Interim final rule with comment period

This interim final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and the State Children's Health Insurance Program (SCHIP), as required under the Improper Payments Information Act (IPIA) of 2002. The IPIA requires heads of Federal agencies to annually estimate and report to the Congress these estimates of improper payments for the programs they oversee and, submit a report on actions the agency is taking to reduce erroneous payments. We published a proposed rule on August 27, 2004 to propose that States measure improper payments in Medicaid and SCHIP and report the State-specific error rates to us for purposes of computing the improper payment estimates for these programs. After extensive analysis of the issues related to having States measure improper payments in Medicaid and SCHIP, including public comments on the provisions in the proposed rule, we are revising our proposed approach. Our new approach incorporates commenters' suggestions to engage a Federal contractor by contracting with that entity to complete the data processing and medical reviews and calculate the State-specific error rates. Based on the States' error rates, the contractor also will calculate the improper payment estimates for these programs which will be reported by the Department of Health and Human Services as required by the IPIA. This interim final rule sets out the types of information that States would need to submit to allow CMS to conduct medical and data processing reviews on claims made in the fee-for-service (FFS) setting. CMS will address estimating improper payments for Medicaid managed care and eligibility and SCHIP FFS, managed care and eligibility at a later time. This rule responds to the public comments on the proposed rule, sets forth the requirements for States to assist us and the contractor to produce State-specific error rates in Medicaid and SCHIP which will be used as the basis for a national error rate, and outlines future plans for measuring eligibility, which may include greater State involvement than the level required for the medical and data processing reviews.     

Ethical issues in managed care: can the traditional physician-patient relationship be preserved in the era of managed care or should it be replaced by a group ethic?

Over the last decade managed care has become the dominant form of health care delivery, because it has reduced the cost of health care; however, it has also created serious conflicts of interest for physicians and has threatened the integrity of the traditional physician-patient relationship. In this Article, Dr. Grochowski argues that the efficiencies created by managed care are one time savings and will not in the long run reduce the rate of rise of health care expenditures without a concomitant plan to ration health care. He explores the traditional physician-patient relationship and concludes: a) that while rationing of health care is inevitable, physicians must not ration care at the bedside; b) that physicians must be advocates for their patients; c) that physicians must avoid conflicts of interest whenever possible; d) that physicians must put the needs of the patient before their own self-interests; and e) that physicians must act in ways to promote trust in their relationship with patients.     

Cost-effectiveness analysis in the courts: recent trends and future prospects

This article provides an initial look at how managed care organizations (MCOs) might incorporate cost-effectiveness analysis (CEA) into their decision-making process and how the courts might respond. Because so few medical liability cases directly involve CEA, we must look at other areas of the law to assess potential MCO liability for applying CEA. In general negligence cases, courts rely on a risk-benefit test to determine customary practice. Likewise, in product liability cases, courts use a risk-utility calculus to determine liability for product design defects. And in challenges to government regulation, courts examine how agencies use CEA to set regulatory policy. The results have been mixed. In product liability cases, CEA has led to some punitive damage awards against automobile manufacturers. But courts have integrated it in negligence cases without generating juror antipathy, and generally defer to agency expertise in how to incorporate CEA. The article discusses the implications of these cases for MCO use of CEA and outlines various options for setting the standard of care in the managed care era.     

Extending due process protections in managed care credentialling to hospital privileges

The Article analyzes two recent state court decisions granting due process rights to physicians deselected from managed care networks. The author applauds these decisions and argues that managed care organizations wishing to deselect a physician should be required to demonstrate (1) that they have a legitimate reason for doing so relating to quality of care, economic factors, or administrative considerations, and (2) that the deselection will not unduly affect the quality of healthcare available in the network. In addition, the author contends that these same due process requirements may be applied to the closely analogous area of hospital staff privileges in situations in which the privileges of hospital-based practitioners are tied to employment, or the grant or termination of exclusive contracts.     

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.     

明清州县监狱的督查制度

明清州县监狱有多种形式,依其设立是否有典章制度为依据,可粗略划分为正规监狱和非正规监狱两大类。前者由于有章可循、有典可据,所以在设置、设施、管理等方面都比较规范。后者则没有明确的法律依据,是因为某些特殊需要或缘由而设,多是本做它用的场所、设施用于监禁,具有临时性。这些临时性的监狱处于法律和监管的盲区,无论在设立、废止、运行、管理、条件上都有较大的随意性、不确定性。虽然在监管上,无论是正规,还是非正规的监狱都纳入正规管理的范畴,在加强考核、监督的前提下,重视对监狱官吏责任的追究和处罚,但是制度的局限性和弊端也是明显的,不但狱囚生存状况恶化,而且狱政的腐败犹如挥之不去的恶魔,缠绕在州县监狱内外。     

Physician collective bargaining: all eyes are on Texas

In June of 1999, Texas became the first state to pass a law allowing physicians to collectively bargain with managed care plans for fee-related activities. Whether this law will give physicians renewed control over patient care remains to be seen. Notwithstanding the intention of its drafters, it is likely that the law and its proposed regulations may only provide physicians with costly and time-consuming procedures that present multiple risks instead of renewed power.     

Pegram v. Herdrich: On peritonitis, preemption, and the elusive goal of managed care accountability

Managed care presents the paradox of organizations having real power over people's lives without there being clear or consistent means of ensuring accountability. In Pegram v. Herdrich, the United States Supreme Court struggled with whether "fiduciary duties" under the federal Employee Retirement Income Security Act (ERISA) could be used to counterbalance the incentives that HMOs have to deny necessary care. Given press coverage of the case, however, it was easy to get the impression that the managed care industry itself was on trial in Pegram. This report examines the political and legal forces underlying the dispute and analyzes the Supreme Court's unanimous rejection of the notion of federally imposed duties for HMOs. In the absence of ERISA fiduciary obligations, attention must now shift to developments in state tort law, the scope of federal ERISA preemption, and the prospect of legislative reform. The report concludes with an exploration of how the elusive goal of managed care accountability might be pursued in the wake of Pegram.     

State Medicaid managed care enrollment: understanding the political calculus that drives Medicaid managed care reforms

The objective of this article is to understand the political motivations underlying Medicaid managed care reforms by examining the determinants of enrollment of beneficiaries in managed care plans in the fifty states. To highlight the role of the model variables, including measures of the political environment, public interest, and special interests, a distinction is made between capitated and fee-for-service managed care enrollment. The results show that cost containment within the context of the Medicaid program is perceived as strongly favored by voters. Accordingly, the relative cost and tax price of providing Medicaid services are important factors in states' decision to enroll Medicaid beneficiaries in managed care plans, particularly capitated ones. The results also indicate a surprisingly significant influence by labor unions that generally oppose managed care enrollment for fears of lost jobs. The recipient population and provider groups also play an important role in shaping the Medicaid managed care landscape. The influence of variables measuring states' ability and willingness to pay and median voter preferences suggest that, within the context of Medicaid managed care enrollment, the public's interests are being served; however, the results also point toward inequities within the program and implications concerning financing arrangements between states and the federal government.     

TRICARE senior demonstration of military managed care--DOD. Notice of demonstration project

This notice is to advise interested parties of a demonstration project in which the Department of Defense (DoD) will provide health care services to Medicare-eligible military retirees in a managed care program, called TRICARE Senior, and receive reimbursement for such care from the Medicare Trust Fund. The program is authorized by section 1896 of the Social Security Act, amended by section 4015 of the Balanced Budget Act of 1997 (P.L. 105-33). The statue authorizes DoD and the Department of Health and Human Services (HHS) to conduct at six sites during January 1998 through December 2000, a three-year demonstration under which dual-eligible beneficiaries will be offered enrollment in a DoD-operated managed care plan, called TRICARE Senior Prime. The legislation also authorizes Medicare HMOs to make payments to DoD for care provided to HMO enrollees by military treatment facilities (MTFs) participating in the demonstration. This part of the demonstration, to be called Medicare Partners, will allow DoD to enter into contracts with Medicare HMOs to provide specialty and impatient care to dual-eligible beneficiaries currently provided on a space-available basis. Additional legal authority pertinent to this demonstration project is 10 U.S.C. section 1092. Under TRICARE Senior Prime, Medicare-eligible military retirees who enroll in the program will be assigned primary care manager (PCMs) at the MTF. Enrollees will be referred to specialty care providers at the MTF and to participating members of the existing TRICARE Prime network. TRICARE Senior Prime enrollees will be afforded the same priority access to MTF care as military retiree and retiree family member enrollees in TRICARE Prime. DoD will receive reimbursement from HCFA on a capitated basis at a rate which is 95 percent of the rate HCFA currently pays to Medicare-risk HMOs, less costs such as capital and graduate medical education, disproportionate share hospital payments, and some capital costs, which are already covered by DoD's annual appropriation. However, under the authorizing statute, DoD must meet its current level of effort for its Medicare-eligible beneficiaries before receiving payments from the Medicare Trust Fund. That is, DoD must continue to fund health care at a certain expenditure level for its Medicare-eligible population before it may be reimbursed by HCFA for care provided to TRICARE Senior Prime enrollees. The Balanced Budget Act of 1997 required DoD and HHS to complete a memorandum of agreement (MOA) specifying the operational requirements of the demonstration project. That MOA was completed on February 13, 1998, and is published below. Except as provided in the MOA, TRICARE Senior Prime will be implemented consistent with applicable provisions of the CHAMPUS/TRICARE regulation, particularly 32 CFR sections 199.17 and 199.18.