Assessing mandatory HPV vaccination: who should call the shots?

In 2007, many legislatures considered, and two enacted, bills mandating HPV vaccination for young girls as a condition of school attendance. Such mandates raise significant legal, ethical, and social concerns. This paper argues that mandating HPV vaccination for minor females is premature since long-term safety and effectiveness of the vaccine has not been established, HPV does not pose imminent and significant risk of harm to others, a sex specific mandate raises constitutional concerns, and a mandate will burden financially existing government health programs and private physicians. Absent careful consideration and public conversation, HPV mandates may undermine coverage rates for other vaccines.     

The ghost that slayed the mandate

Virginia v. Sebelius is a federal lawsuit in which Virginia has challenged President Obama's signature legislative initiative of health care reform. Virginia has sought declaratory and injunctive relief to vindicate a state statute declaring that no Virginia resident shall be required to buy health insurance. To defend this state law from the preemptive effect of federal law, Virginia has contended that the federal legislation's individual mandate to buy health insurance is unconstitutional. Virginia's lawsuit has been one of the most closely followed and politically salient federal cases in recent times. Yet the very features of the case that have contributed to its political salience also require its dismissal for lack of statutory subject matter jurisdiction. The Supreme Court has placed limits on statutory subject matter jurisdiction over declaratory judgment actions in which a state seeks a declaration that a state statute is not preempted by federal law--precisely the relief sought in Virginia v. Sebelius. These statutory limits are a sea wall; they keep out, on statutory grounds, some suits that should otherwise be kept out on Article III grounds. The statutory and constitutional limits on federal jurisdiction over suits like Virginia v. Sebelius insulate federal courts from the strong political forces surrounding lawsuits that follow from state statutes designed to create federal jurisdiction over constitutional challenges by states to federal law. This Article identifies previously neglected jurisdictional limits, shows why they demand dismissal of Virginia v. Sebelius, and explains why it is appropriate for federal courts to be closed to suits of this type.     

Delegation and digital mandates: Legal requirements and security objectives

Now that more and more legal transactions are being performed online, it is increasingly necessary to enable integration of legal mandates within identity and information management systems. The purpose of this article is to outline the legal framework surrounding delegation and to identify basic requirements for any technical application which seeks to provide recognition to legal mandates and delegation processes. Special consideration is also given to the legal implications in situations where a (presumed) mandate holder acts without or outside his authority. Based on these considerations, this article attempts to outline an approach which can significantly reduce the potential risks for both mandate issuers and relying service providers.     

The Purchase of Insurance Across State Lines in the Individual Market

Proposals to allow the purchase of insurance across state lines (PASL) have gained some support in recent years. Health insurers have traditionally been allowed to sell a policy only within the state that approved and regulates that particular policy. PASL would allow insurers to sell a policy approved in one state to people residing in any state. Any federal legislation to enact PASL in an individual insurance market would have to address two main legal considerations: (1) the McCarran-Ferguson Act, which allows the states to retain their regulatory authority over insurance; and (2) a constitutional prohibition against the commandeering of state officials by the federal government. This paper outlines these obstacles and potential solutions, and concludes that as long as the legislation is thoughtfully drafted, there is no significant legal or constitutional barrier to enacting PASL. Additionally, the concepts discussed here may be relevant to any federal health reform legislation involving regulation of health insurance or the use of state officials.     

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.     

The role of Medicare reimbursement in contemporary hospital finance

A hospital, while performing its major function of providing health care, is also viewed as a business. It needs capital from a wide variety of sources, many of which are government regulated. Over the past few years, federal expenditures for Medicare have increased dramatically, as has regulation of hospital revenue sources. Congress enacted the Medicare Prospective Payment System (PPS) to curb hospital cost inflation. This Note examines historical trends in health care financing and analyzes the Medicare reimbursement system, with emphasis on PPS and its impact on hospital revenues. The Note suggests that hospitals, due to the effects of PPS, will be forced to reduce their levels of financial leverage and will have to look for corporate financial alternatives. PPS may signal a new era in hospital finance. Survival mandates an increased focus on efficient corporate, financial and managerial policies.     

Why requiring employers to provide health insurance is a bad idea

There is mounting pressure at the federal (and state) level to require employers to provide health insurance to their employees. However, two quite different groups of workers could be affected by such a mandate. In addition, there are at least five major problems with requiring employers to provide health insurance. Chief among these is the further fracturing of the insurance market, so that the spreading of risk will be reduced, and only the young and healthy will be offered insurance at relatively low premiums. We should be designing a health insurance system that has both universal coverage and a cost-containment structure. Toward this end, we need to tackle issues that transcend alternative methods of financing health care in the U.S.     

Prevention for those who can pay: insurance reimbursement of genetic-based preventive interventions in the liminal state between health and disease

Clinical use of genetic testing to predict adult onset conditions allows individuals to minimize or circumvent disease when preventive medical interventions are available. Recent policy recommendations and changes expand patient access to information about asymptomatic genetic conditions and create mechanisms for expanded insurance coverage for genetic tests. The American College of Medical Genetics and Genomics (ACMG) recommends that laboratories provide incidental findings of medically actionable genetic variants after whole genome sequencing. The Patient Protection and Affordable Care Act (ACA) established mechanisms to mandate coverage for genetic tests, such as BRCA. The ACA and ACMG, however, do not address insurance coverage for preventive interventions. These policies equate access to testing as access to prevention, without exploring the accessibility and affordability of interventions. In reality, insurance coverage for preventive interventions in asymptomatic adults is variable given the US health insurance system''s focus on treatment. Health disparities will be exacerbated if only privileged segments of society can access preventive interventions, such as prophylactic surgeries, screenings, or medication. To ensure equitable access to interventions, federal or state legislatures should mandate insurance coverage for both predictive genetic testing and recommended follow-up interventions included in a list established by an expert panel or regulatory body.     

Altered states: state health privacy laws and the impact of the Federal Health Privacy Rule

Although the Federal Health Privacy Rule has evened out some of the inconsistencies between states' health privacy laws, gaps in protection still remain. Furthermore, the Federal Rule contains some lax standards for the disclosure of health information. State laws can play a vital role in filling these gaps and strengthening the protections afforded health information. By enacting legislation that has higher privacy-protective standards than the Federal Health Privacy Rule, states can play three important roles. First, because they can directly regulate entities that are beyond HHS's mandate, states can afford their citizens a broader degree of privacy protection than the Federal Health Privacy Rule. Second, by having state health privacy laws, states can enforce privacy protections at the local level. Finally, action by the states can positively influence health privacy policies at the federal level by raising the standard as to what constitutes sufficient privacy protection. High privacy protections imposed by states may serve as the standard for comprehensive federal legislation, if and when Congress reconsiders the issue. So far, states' reactions to the Federal Privacy Rule have been mixed. Only time will tell whether states will assume the mantle of leadership on health privacy or relinquish their role as the primary protectors of health information.     

Insurance Discrimination on the Basis of Health Status: An Overview of Discrimination Practices, Federal Law, and Federal Reform Options

Actuarial underwriting, or discrimination based on an individual's health status, is a business feature of the voluntary private insurance market. The term "discrimination" in this paper is not intended to convey the concept of unfair treatment, but rather how the insurance industry differentiates among individuals in designing and administering health insurance and employee health benefit products. Discrimination can occur at the point of enrollment, coverage design, or decisions regarding scope of coverage. Several major federal laws aimed at regulating insurance discrimination based on health status focus at the point of enrollment. However, because of multiple exceptions and loopholes, these laws offer relatively limited protections. This paper provides a brief overview of discrimination practices, the federal law, and federal reform options to manage discriminatory practices in the insurance and employee health benefit markets.     

In the Best Interests of an Indian Child: The Indian Child Welfare Act

Before passage of the Indian Child Welfare Act in 1978, state, private, and federal agencies systematically removed Indian children from their families and tribal communities, placing them with non‐Indian families with little appreciation for the detrimental impact that cultural deprivation would have on these children. State courts often ignored the sovereign authority of tribal courts with regard to their children, and were, more often than not, unwilling to acknowledge the importance of the perspective of the child's tribe and/or extended family members. With passage of the Indian Child Welfare Act in 1978, Congress imposed upon state child welfare practices substantive and procedural requirements to which state courts must adhere, most notably the mandate that state courts must now give primary consideration to the placement of Indian children within their extended families and tribal communities. In addition, federal law requires state courts to recognize tribal court authority and jurisdiction over tribal children. This article reviews the history of federal, state, and private practices that propelled Congress to pass the ICWA, the changes that have resulted from this vital legislation, and the challenges that face courts in ensuring that state courts meet these requirements.     

Legal issues raised by private review activities of medical peer-review organizations

Increasingly, medical peer-review organizations are entering into contracts with insurance companies and self-insured employers to conduct utilization reviews and quality-of-care assessments. Such private review activities raise new legal issues, requiring analysis of state law as well as federal law. This paper analyzes several of the most important of these legal issues, and suggests some directions for peer-review organizations to take in order to avoid unnecessary legal problems.     

ALL CHILDREN ARE NOT CREATED EQUAL: PRWORA'S UNCONSTITUTIONAL RESTRICTION ON IMMIGRANT CHILDREN'S ACCESS TO FEDERAL HEALTH CARE PROGRAMS

The lack of health insurance for children is a serious problem in the United States, especially for those children in families that earn too little to get private health insurance and too much to qualify for Medicare. Even within this subclass of children, immigrant children are particularly vulnerable to the problems faced by lack of health care. Nevertheless, with the passage of the Personal Responsibility and Work Reconciliation Act (PRWORA) by Congress, equality interests of low‐income immigrant children are undermined when immigrant children are denied federal benefits for the first 5 years of residency in the United States. The first part of this Note examines the importance of child health care and the long‐term problems with uninsured children, especially with uninsured immigrant children and pregnant women. The next part introduces Medicaid as well as State Children's Health Insurance Program, a supplemental federal program designed to increase health care coverage to all children, while contrasting these programs in light of the restrictive anti‐immigrant PRWORA provisions. The third part explains the passage of PRWORA, its anti‐immigrant provisions, and how these provisions prevent needy immigrant children from receiving federally funded health care. Then, the fourth part uses both the Equal Protection Clause of the Fourteenth Amendment and the Due Process Clause of the Fifth Amendment to argue the unconstitutionality of the anti‐immigrant provisions. Finally, the last part lays out the recommendation to amend the Social Security Act so that the PRWORA barriers can be removed and recent immigrant children can receive federally funded health care.     

State legislative approaches to regulating coverage for experimental procedures

As addressed in past issues of the Newsletter, the Employment Retirement Income Security Act ("ERISA"), 29 U.S.C. sections 1001 et seq., limits the ability of states to regulate the terms and conditions of group health plans. See Newsletters, Vol. 8, No. 6, June 1993, at 6 and 23; Vol. 8, No. 1, January 1993, at 7; Vol. 7, No. 2, February 1992, at 13; Vol. 6, No. 11, November 1991, at 3. Under ERISA, states cannot mandate that self-insured group health plans or employers provide specific types of coverage. Metropolitan Life Ins. Co. v. Massachusetts, 471 U.S. 724, 105 S.Ct. 2380 (1985). Such mandates are enforceable only as to insurance companies and HMOs, and only to the extent that they are deemed to "regulate insurance." Id. As a result, state legislative attempts to regulate experimental treatment insurance coverage have largely been limited to health plans that are not self insured. Given the inconsistent handling of experimental treatment insurance coverage by both insurance companies and courts across the nation, state legislatures have demonstrated that they are ready to address this matter themselves. However, unless ERISA is amended to afford employees with self-insured plans the same protections as those with insured plans, such state efforts will not be able to resolve the problem for all citizens.     

Three meanings of capacity; or,why the federal government is most likely to lead on insurance access issues

This essay considers on what health policy issues the federal government is best able to lead. Positive leadership requires knowledge, power, and will. The federal government has different supplies of each for different aspects of quality of, cost of, and access to health care. Here I review technical capacity to attain desired ends, define the institutional strengths and weaknesses of the federal government, and outline current dynamics of the national political process. This analysis suggests both prospects for and some characteristics of successful policy. The federal government is more likely to lead on insurance than on other health policy issues because its supply of relevant knowledge and power is relatively high on insurance issues and the political barriers are lower than conventional wisdom suggests. But that leadership could take the form of either the expanding or contracting of access to insurance.     

Forgotten Children of Immigration and Family Law: How The Absence of Legal Aid Affects Children in the United States

The absence of government‐appointed legal counsel in immigration proceedings adversely affects large numbers of children in the United States. Children born in the United States to parents without citizenship status (U.S.‐born children of noncitizen parents or UCNP) are harmed by a parent's detention and removal. Unaccompanied alien children (UAC) who have entered the country without legal status are adversely affected by their own detention and removal. The possibility of obtaining relief from removal is drastically diminished by the lack of legal representation. Currently UAC and immigrant parents are not entitled to court‐appointed attorneys. Any meaningful change in immigration law, such as a federal statutory amendment to provide UAC and immigrant parents with government‐appointed counsel is unlikely due to the present political dissension in Congress regarding this issue. Because UAC and immigrant parents are not entitled to government‐funded legal representation, a pro bono legal service system has developed, but is unable to meet the present need adequately. For immigrant parents, this Note proposes the adoption of a statute to allow the appointment of court liaisons in family court proceedings. The court liaison is a nonattorney who is familiar with the processes of the family court and ensures that immigrant parents are fully informed regarding all pertinent family court proceedings. For UAC, this Note proposes an amendment to the William Wilberforce Trafficking Victims Protection Reauthorization Act to mandate the appointment of a child advocate to all UAC. The child advocate is not a lawyer, but works with the UAC's attorney to provide the child with legal representation and advocacy.

Key Points for the Family Court Community:
• UCNP confront the loss of parents to detention and removal. Children are condemned to limbo, torn between absent biological parents and placement in foster care.
• The recent surge in the number of UAC who enter the United States by crossing the border from Mexico has been described as a humanitarian crisis. These children often remain alone without legal protection, vulnerable to detention and removal.
• Ideally, UAC and the immigrant parents would be provided with government‐funded legal representation in immigration proceedings. In the absence of the federal statutory reform necessary to make that a reality, state statutory reform to allow for the provision of court liaison programs for immigrant parents and federal statutory reform to allow the appointment of child advocates for UAC can begin to offer children and families needed legal support and advocacy.

     

Health care financing among the elderly: who really pays the bills?

This paper investigates the issue of who pays the health care bills of the elderly by considering the types of subsidized health insurance protection enjoyed by the noninstitutionalized elderly and the way that increased Medicare cost-sharing efforts in the 1980s are affecting those without additional health insurance subsidies. In making this examination we estimate the out-of-pocket health care expenditures of the elderly either directly or as nonsubsidized medigap premiums by income level, taking into account four types of health insurance subsidies received by elderly persons: Medicare, Medicaid, Veterans Administration health care, and subsidized health insurance from either current or former employers. We find that increased cost sharing is likely to fall most heavily on those elderly least likely to afford it: the poor and near-poor elderly who have only Medicare as a health insurance subsidy, particularly those who are older and sicker and who use Medicare services more heavily. These persons are caught between well-intentioned federal cost-cutting efforts and the often confusing panoply of health insurance programs for the aged, and they will bear an inequitably large portion of any future Medicare cost-sharing initiatives.     

Entrepreneurial Regulatory Legal Strategy: The Case of Cannabis

This article develops the concepts of regulatory legal strategy, a resource-based view of government agencies, and regulatory entrepreneurship. These ideas are explored through a case study of the limited (if any) access that legal cannabis-related businesses have to the banking system due to the clash between federal law and laws in those states that have legalized some uses of cannabis. This article argues that regulators’ entrepreneurial regulatory legal strategies can have a material impact on regulated entities and give them a competitive advantage. To demonstrate, this article claims that regulators’ adoption of permissive regulatory legal strategies has facilitated access of some cannabis-related businesses to the banking system. Conversely, if regulators adopted obstructive regulatory strategies, this would act as a constraint on such access in the future, even if Congress resolves the federalism issue largely responsible for the current limitations these businesses face.     

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.     

A conversation with Donald Berwick on implementing national health reform

Michael Birnbaum interviews Donald Berwick shortly after his departure from the Centers for Medicare and Medicaid Services about the national health care landscape. Berwick discusses the strategic vision, policy levers, operational challenges, and political significance of federal health care reform. He rejects the notion that the Affordable Care Act represents a government takeover of health care financing or service delivery but says the law's Medicaid expansion and its creation of health benefit exchanges present a "watershed moment for American federalism." Berwick argues that the solution to Medicare's cost-containment challenge lies in quality improvement. He is optimistic that accountable care organizations can deliver savings and suggests that shifting risk downstream to providers throws the health insurance model into question. Finally, looking to the future, Berwick sees a race against time to make American health care more affordable.