Volume 20 (2010-2011)
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 20 (2010-2011)
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Editor-in-Chief: |
Publications Editor: |
Technical Publications Editor: |
|
Marketing & Coordinating Editor: |
Symposium Editor: |
Advance Directive Editor: |
|
Senior Editors: Advance Directive Senior Editor: |
|
Research Coordinator: |
|
Members:
|
|
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Issue 1, Winter 2011
Articles
Lebron v. Gottlieb Memorial Hospital: Capping Medical Practice Reform in Illinois
Authors: Leonard Nelson, Amanda Swanson, and Marianne Buckley
On February 4, 2010 the Illinois Supreme Court struck down Illinois’ medical practice reform bill, P.A. 94-677, when it decided Lebron v. Gottlieb Memorial Hospital. Although the court only considered the unconstitutionality of the cap on non-economic damages contained in that bill, an inseverability provision resulted in the invalidation of all of its provisions. The end result of the Lebron decision extends much further than the striking of the cap on non-economic damages. It affects such areas as medical liability insurance law, physician discipline, public disclosure of information, the admissibility of physician statements into evidence, and expert witness standards. The Lebron holding has raised a significant obstacle to the implementation of a wide range of legislative measures intended to improve both the delivery and quality of healthcare services in Illinois. This article explains the impact of Lebron in these collateral, but important, areas of the law.
The Stark Law in Retrospect
Author: Patrick A. Sutton
Considering the ultimate goals of preventing the over-utilization of medical services and protecting the Medicare program, are the numerous phases of the Stark Law and their concomitant regulations effective; or, conversely, has the legislation served to impede entrepreneurialism among physicians to the detriment of innovations and better integration in the delivery of medical treatment? This article endeavors to answer the above question through an analysis of the policy goals behind the legislation; the evolution of its regulations; its effect on competitiveness in the field of medicine; and the ethical considerations implicated by the issue of physician self-referral. It further offers some proposals which attempt to address the problem of physician self-referral abuse while at the same time reducing the complexity and breadth of the Stark law and its regulations. The article concludes by noting that to truly change the practice of inappropriate self-referral as well as the culture of over-utilization, it is necessary not only to target specific relationships and practices prone to abuse, but to realign the financial incentives created by our current payment mechanisms as well.
The False Claims Act and the Eroding Scienter in Healthcare Fraud Litigation
Author: Richard Doan
This article addresses the federal government’s expansive methods in tackling healthcare fraud, particularly in misapplying the False Claims Act. Although tasked with the obligation to curtail the fraudulent submission of Medicare & Medicaid claims, the U.S. government must rein in the current trend to utilize the False Claims Act against smaller medical providers. As the Act’s original focus has ebbed in significance, the government has increasingly applied the False Claims Act to circumstances that do not evince actual fraud. In doing so, federal courts have effectively eroded the statute’s critical scienter requirement. The federal common-law doctrines of “payment by mistake” and “unjust enrichment” adequately address the payment of non-fraudulent, albeit false, Medicare & Medicaid claims. Yet the federal government pursues these appropriate remedies only rarely and in the alternative, essentially when the government fails under the False Claims Act. Thus, this article argues for reform, calling for a clearer delineation between remedial and punitive measures. In cases involving smaller medical providers, courts should strictly limit the False Claims Act to those instances where fraud is clearly manifest.
Squeezing the Middleman: Ending Underhanded Dealing in the Pharmacy Benefit Management Industry Through Regulation
Author: Mark Meador
Pharmacy benefit management (PBM) companies are the middlemen of the pharmaceutical industry, designing plans for sponsors and insurers and pushing the products of manufacturers. Their unique position can often create conflicts of interest, which has been the basis of much litigation. This article reviews the structure of the PBM industry and analyzes concerns arising from its handling of prescription drug pricing, manufacturer rebates and discounts, and mail order pharmacies. After surveying several legislative proposals, it concludes with a comprehensive outline for legislation to eliminate underhanded dealing in the industry and lower the cost of prescription drugs.
Is State Power to Protect Health Compatible With Substantive Due Process Rights?
Author: Allan J. Jacobs
Public health laws may mandate drastic limitations on individual liberty, such as forced medication and quarantine. This results in a tension between public health laws and guarantees of liberty such as the Due Process Clauses of the Fifth and Fourteenth Amendments to the United States Constitution. The Supreme Court has resolved this tension in favor of one or the other of these legal principles, depending on the facts and issues involved. Nevertheless, Supreme Court jurisprudence is internally consistent. The Court has applied a level of scrutiny that, while rigorous, is more flexible than strict scrutiny. I denote this as “enhanced public health scrutiny.” Applying this scrutiny, the Court will uphold public health legislation if it protects an inchoate class of people who may not yet be identifiable, who will incur a specific disease or injury absent the law, but who will not experience this disease or injury if the law is enforced. If this doctrine were explicit, it would constitute a clear guideline to courts seeking to balance health and liberty concerns. This guideline would be consistent with current case law, and would not impact on law affecting reproductive liberty.
Issue 2, Summer 2011
Articles
From Clinical Integration to Accountable Care
Author: Mark Shields
Four key challenges to reforming health care organizations can be addressed by a clinical integration model patterned after Advocate Physician Partners (APP). These challenges are: predominance of small group practices, dominant fee-for-service reimbursement methods, weaknesses of the traditional hospital medical staff structure and a need to partner with commercial insurance companies. APP has demonstrated teamwork between 3800 physicians and hospitals to improve quality, patient safety and cost-effectiveness. Building on this model, an innovative contract with Blue Cross Blue Shield of Illinois serves as a prototype for a commercial Accountable Care Organization. For this contract to succeed, APP must outperform the market competition. To accomplish this, APP has implemented strategies to reduce readmissions, avoid unnecessary admissions and emergency room visits, expand primary care access, and enhance quality and patient safety.
Between the Scylla and Charybdis: Physicians and the Clash of Liability Standards and Cost Cutting Goals within Accountable Care Organizations
Author: Christopher Smith
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.
The Schizophrenia of Physician Extender Utilization
Author: Thomas McLean
The Patient Protection and Affordable Care Act of 2010 provides incentives for healthcare to be delivered by Affordable Care Organizations (ACOs). The public face of many, if not most, ACOs is likely to be the Patient Centered Medical Home (PCMHs), a business structure that evolved from Retail Medical Clinics, which made greater use of physician extenders (PAs). Accordingly, this paper examines the evolution and structure of PCMHs as well as how the PCMH is regulated. As neither legal or market regulatory mechanisms are ideal for policing business structures that employ PAs, this paper concludes that the tort reform most appropriate for PCMHs is the introduction of either no-fault or enterprise liability coverage.
Using Law to Fight a Silent Epidemic:The Role of Health Literacy in Health Care Access, Quality, & Cost
Author: Brietta Clark
The dominant rhetoric in the health care policy debate about cost has assumed an inherent tension between access and quality on the one hand, and cost effectiveness on the other; but an emerging discourse has challenged this narrative by presenting a more nuanced relationship between access, quality, and cost. This is reflected in the discourse surrounding health literacy, which is viewed as an important tool for achieving all three goals. Health literacy refers to one’s ability to obtain, understand and use health information to make appropriate health decisions. Research shows that improving patients’ health literacy can help overcome access barriers and empower patients to be better health care partners, which should lead to better health outcomes. Promoting health literacy can also reduce expenditures for unnecessary or inappropriate treatment. This explains why, as a policy matter, improving health literacy is an objective that has been embraced by almost every sector of the health care system.
As a legal matter, however, the role of health literacy in ensuring quality and access is not as prominent. Although the health literacy movement is relatively young, it has roots in longstanding bioethical principles of patient autonomy, beneficence, and justice as well as the corresponding legal principles of informed consent, the right to quality care, and antidiscrimination. Assumptions and concerns about health literacy seem to do important, yet subtle work in these legal doctrines — influencing conclusions about patient understanding in informed consent cases, animating decisions about patient responsibility in malpractice cases, and underlying regulatory guidance concerning the quality of language assistance services that are necessary for meaningful access to care. Nonetheless, health literacy is not explicitly treated as a legally relevant factor in these doctrines. Moreover, there is no coherent legal framework for incorporating health literacy research that challenges traditional assumptions about patient comprehension and decision-making, and that emphasizes the need for providers to improve communication and take affirmative steps to assess patient understanding.
The absence of a clear and robust consideration of health literacy in these doctrines undermines core access and quality aims, and it means that such laws are of limited efficacy in promoting health literacy. Returning to the theme that the health literacy problem reflects a complementary view of access, quality and cost, it is likely that the cost implications of this problem (and not concerns about quality and access) will motivate the kind of health literacy reform that may ultimately strengthen existing quality and access standards. One recent example of this can be seen in reforms linked to government, insurer and provider attempts to reduce costly medication errors.
Annals of Health Law
The Health Policy and Law Review of Loyola University Chicago School of Law
Volume 20 (2010-2011)
|
Editor-in-Chief: |
Publications Editor: |
Technical Publications Editor: |
|
Marketing & Coordinating Editor: |
Symposium Editor: |
Advance Directive Editor: |
|
Senior Editors: Advance Directive Senior Editor: |
|
Research Coordinator: |
|
Members:
|
|
|
Issue 1, Winter 2011
Articles
Lebron v. Gottlieb Memorial Hospital: Capping Medical Practice Reform in Illinois
Authors: Leonard Nelson, Amanda Swanson, and Marianne Buckley
On February 4, 2010 the Illinois Supreme Court struck down Illinois’ medical practice reform bill, P.A. 94-677, when it decided Lebron v. Gottlieb Memorial Hospital. Although the court only considered the unconstitutionality of the cap on non-economic damages contained in that bill, an inseverability provision resulted in the invalidation of all of its provisions. The end result of the Lebron decision extends much further than the striking of the cap on non-economic damages. It affects such areas as medical liability insurance law, physician discipline, public disclosure of information, the admissibility of physician statements into evidence, and expert witness standards. The Lebron holding has raised a significant obstacle to the implementation of a wide range of legislative measures intended to improve both the delivery and quality of healthcare services in Illinois. This article explains the impact of Lebron in these collateral, but important, areas of the law.
The Stark Law in Retrospect
Author: Patrick A. Sutton
Considering the ultimate goals of preventing the over-utilization of medical services and protecting the Medicare program, are the numerous phases of the Stark Law and their concomitant regulations effective; or, conversely, has the legislation served to impede entrepreneurialism among physicians to the detriment of innovations and better integration in the delivery of medical treatment? This article endeavors to answer the above question through an analysis of the policy goals behind the legislation; the evolution of its regulations; its effect on competitiveness in the field of medicine; and the ethical considerations implicated by the issue of physician self-referral. It further offers some proposals which attempt to address the problem of physician self-referral abuse while at the same time reducing the complexity and breadth of the Stark law and its regulations. The article concludes by noting that to truly change the practice of inappropriate self-referral as well as the culture of over-utilization, it is necessary not only to target specific relationships and practices prone to abuse, but to realign the financial incentives created by our current payment mechanisms as well.
The False Claims Act and the Eroding Scienter in Healthcare Fraud Litigation
Author: Richard Doan
This article addresses the federal government’s expansive methods in tackling healthcare fraud, particularly in misapplying the False Claims Act. Although tasked with the obligation to curtail the fraudulent submission of Medicare & Medicaid claims, the U.S. government must rein in the current trend to utilize the False Claims Act against smaller medical providers. As the Act’s original focus has ebbed in significance, the government has increasingly applied the False Claims Act to circumstances that do not evince actual fraud. In doing so, federal courts have effectively eroded the statute’s critical scienter requirement. The federal common-law doctrines of “payment by mistake” and “unjust enrichment” adequately address the payment of non-fraudulent, albeit false, Medicare & Medicaid claims. Yet the federal government pursues these appropriate remedies only rarely and in the alternative, essentially when the government fails under the False Claims Act. Thus, this article argues for reform, calling for a clearer delineation between remedial and punitive measures. In cases involving smaller medical providers, courts should strictly limit the False Claims Act to those instances where fraud is clearly manifest.
Squeezing the Middleman: Ending Underhanded Dealing in the Pharmacy Benefit Management Industry Through Regulation
Author: Mark Meador
Pharmacy benefit management (PBM) companies are the middlemen of the pharmaceutical industry, designing plans for sponsors and insurers and pushing the products of manufacturers. Their unique position can often create conflicts of interest, which has been the basis of much litigation. This article reviews the structure of the PBM industry and analyzes concerns arising from its handling of prescription drug pricing, manufacturer rebates and discounts, and mail order pharmacies. After surveying several legislative proposals, it concludes with a comprehensive outline for legislation to eliminate underhanded dealing in the industry and lower the cost of prescription drugs.
Is State Power to Protect Health Compatible With Substantive Due Process Rights?
Author: Allan J. Jacobs
Public health laws may mandate drastic limitations on individual liberty, such as forced medication and quarantine. This results in a tension between public health laws and guarantees of liberty such as the Due Process Clauses of the Fifth and Fourteenth Amendments to the United States Constitution. The Supreme Court has resolved this tension in favor of one or the other of these legal principles, depending on the facts and issues involved. Nevertheless, Supreme Court jurisprudence is internally consistent. The Court has applied a level of scrutiny that, while rigorous, is more flexible than strict scrutiny. I denote this as “enhanced public health scrutiny.” Applying this scrutiny, the Court will uphold public health legislation if it protects an inchoate class of people who may not yet be identifiable, who will incur a specific disease or injury absent the law, but who will not experience this disease or injury if the law is enforced. If this doctrine were explicit, it would constitute a clear guideline to courts seeking to balance health and liberty concerns. This guideline would be consistent with current case law, and would not impact on law affecting reproductive liberty.
Issue 2, Summer 2011
Articles
From Clinical Integration to Accountable Care
Author: Mark Shields
Four key challenges to reforming health care organizations can be addressed by a clinical integration model patterned after Advocate Physician Partners (APP). These challenges are: predominance of small group practices, dominant fee-for-service reimbursement methods, weaknesses of the traditional hospital medical staff structure and a need to partner with commercial insurance companies. APP has demonstrated teamwork between 3800 physicians and hospitals to improve quality, patient safety and cost-effectiveness. Building on this model, an innovative contract with Blue Cross Blue Shield of Illinois serves as a prototype for a commercial Accountable Care Organization. For this contract to succeed, APP must outperform the market competition. To accomplish this, APP has implemented strategies to reduce readmissions, avoid unnecessary admissions and emergency room visits, expand primary care access, and enhance quality and patient safety.
Between the Scylla and Charybdis: Physicians and the Clash of Liability Standards and Cost Cutting Goals within Accountable Care Organizations
Author: Christopher Smith
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.
The Schizophrenia of Physician Extender Utilization
Author: Thomas McLean
The Patient Protection and Affordable Care Act of 2010 provides incentives for healthcare to be delivered by Affordable Care Organizations (ACOs). The public face of many, if not most, ACOs is likely to be the Patient Centered Medical Home (PCMHs), a business structure that evolved from Retail Medical Clinics, which made greater use of physician extenders (PAs). Accordingly, this paper examines the evolution and structure of PCMHs as well as how the PCMH is regulated. As neither legal or market regulatory mechanisms are ideal for policing business structures that employ PAs, this paper concludes that the tort reform most appropriate for PCMHs is the introduction of either no-fault or enterprise liability coverage.
Using Law to Fight a Silent Epidemic:The Role of Health Literacy in Health Care Access, Quality, & Cost
Author: Brietta Clark
The dominant rhetoric in the health care policy debate about cost has assumed an inherent tension between access and quality on the one hand, and cost effectiveness on the other; but an emerging discourse has challenged this narrative by presenting a more nuanced relationship between access, quality, and cost. This is reflected in the discourse surrounding health literacy, which is viewed as an important tool for achieving all three goals. Health literacy refers to one’s ability to obtain, understand and use health information to make appropriate health decisions. Research shows that improving patients’ health literacy can help overcome access barriers and empower patients to be better health care partners, which should lead to better health outcomes. Promoting health literacy can also reduce expenditures for unnecessary or inappropriate treatment. This explains why, as a policy matter, improving health literacy is an objective that has been embraced by almost every sector of the health care system.
As a legal matter, however, the role of health literacy in ensuring quality and access is not as prominent. Although the health literacy movement is relatively young, it has roots in longstanding bioethical principles of patient autonomy, beneficence, and justice as well as the corresponding legal principles of informed consent, the right to quality care, and antidiscrimination. Assumptions and concerns about health literacy seem to do important, yet subtle work in these legal doctrines — influencing conclusions about patient understanding in informed consent cases, animating decisions about patient responsibility in malpractice cases, and underlying regulatory guidance concerning the quality of language assistance services that are necessary for meaningful access to care. Nonetheless, health literacy is not explicitly treated as a legally relevant factor in these doctrines. Moreover, there is no coherent legal framework for incorporating health literacy research that challenges traditional assumptions about patient comprehension and decision-making, and that emphasizes the need for providers to improve communication and take affirmative steps to assess patient understanding.
The absence of a clear and robust consideration of health literacy in these doctrines undermines core access and quality aims, and it means that such laws are of limited efficacy in promoting health literacy. Returning to the theme that the health literacy problem reflects a complementary view of access, quality and cost, it is likely that the cost implications of this problem (and not concerns about quality and access) will motivate the kind of health literacy reform that may ultimately strengthen existing quality and access standards. One recent example of this can be seen in reforms linked to government, insurer and provider attempts to reduce costly medication errors.