Health Law and Policy Commons^™

The Promise And Failures Of Children's Medicaid And The Role Of Medical-Legal Partnerships As Monitors And Advocates, L. Kate Mitchell

Health Matrix: The Journal of Law-Medicine

For decades we have known that access to early and preventive diagnosis and treatment can dramatically alter the course of a child’s life. Because of this knowledge, immediately after Congress enacted Medicaid, it created the Early and Periodic Screening, Diagnostic and Treatment, or EPSDT, program. EPSDT requires broad, holistic, and preventive care to correct or ameliorate health defects identified in Medicaid-eligible children. This coverage currently extends to 2 out of 5 children in the United States, and 47 percent of children with special health care needs. Because of the broad parameters of coverage mandated by EPSDT, Medicaid-eligible children should receive …

The Off-Label Loophole In The Psychopharmacologic Setting: Prescription Of Antipsychotic Drugs In The Nonpsychotic Patient Population, Lisa E. Smilan

Health Matrix: The Journal of Law-Medicine

U.S. physicians have wide discretion in treating patients with off-label medications. Many consider off-label prescription essential in our country’s health care system, and it is wholly supported by FDA and federal courts. Assumptions about physicians’ expertise, judgments, and commitments to beneficence and nonmaleficence undergird laissez-faire policies that allow and support physicians’ novel and innovate uses of FDA-approved drugs for purposes and populations not studied in original, strictly regulated clinical trials. Though sometimes beneficial, off-label prescribing, which flourishes in privatepractice psychiatry, often harms scores of psychiatric patients. Frequently, potential harms are insufficiently disclosed to patients. In the public health sector, officials …

Why The United States Is Failing New Mothers And How It Can Counteract Its Rapidly Climbing Maternal Mortality Rate, Khouloude Abboud

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Where No One Can Hear You Scream: Regulating The Commercial Space Industry To Ensure Human Safety, Kurt Harris

Health Matrix: The Journal of Law-Medicine

Outstanding Note of the Year (2019)

Hipaa's Privacy Rule And State Privacy Laws: Roadblocks To Medical Organizations' Self-Policing Expert Medical Testimony, Miles J. Zaremski, Douglas M. Belofsky

Alumni Publications

As part of the wave of medical malpractice reforms over the last several decades, efforts were initiated to ensure the reliability and credibility of expert witness opinion and testimony, which is the sine qua non of necessary proof for any such claim or lawsuit. Governing bodies of professional medical organizations and societies have crafted rules and regulations for their members that wish to provide expert medical witness testimony. Where such testimony does not conform to these organizations’ standards, sanctions can be levied, including membership expulsion. Such self-policing has found favor with courts.

Before sanctions are imposed, however, necessary administrative investigations …

Portable Medical Order Sets (Polst®): Ethical And Legal Landscape, Sharona Hoffman

Faculty Publications

Anyone who has observed the dying of a loved one or who has thought about medical care in the final months of life may be concerned about end-of-life care. How can individuals ensure that their care fits their needs and preferences if they cannot express these because of dementia, confusion, or other frailties? Some worry that they will receive care that is painful and aggressive in the last stages of disease even though they would prefer comfort care only. By contrast, others worry that physicians will withhold therapeutic care because they assume that such care is unwanted by patients who …

Healing The Healers: Legal Remedies For Physician Burnout, Sharona Hoffman

Faculty Publications

A career as a doctor was long considered to be among the best professional paths that one could pursue. But medicine may no longer be the sought-after career that it once was. All too often, doctors, struggling with the demands of electronic health record systems and a myriad of administrative and regulatory responsibilities, find that they fail to derive much joy from their work and become victims of burnout. Physician burnout is an acute concern in the medical community, with over half of doctors reporting that they suffer from it. Physician burnout is a public health threat. Doctors who are …

What Genetic Testing Teaches About Long-Term Predictive Health Analytics Regulation, Sharona Hoffman

Faculty Publications

The ever-growing phenomenon of predictive health analytics is generating significant excitement, hope for improved health outcomes, and potential for new revenues. Researchers are developing algorithms to predict suicide, heart disease, stroke, diabetes, cognitive decline, future opioid abuse, and other ailments. The researchers include not only medical experts, but also commercial enterprises such as Facebook and LexisNexis, who may profit from the work considerably. This Article focuses on long-term disease predictions (predictions regarding future illnesses), which have received surprisingly little attention in the legal and ethical literature. It compares the robust academic and policy debates and legal interventions that followed the …

Masthead, Volume 29 (2019)

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Liability (And) Rules For Health Information, Jorge L. Contreras, Francisca Nordfalk

Health Matrix: The Journal of Law-Medicine

The recent trend toward propertization of health data could pose significant challenges to biomedical research and public health. Property rule systems can result in sizable up-front costs in the acquisition of consent from individual data subjects, as well as the ongoing risk that data subjects will retract consent or object to unanticipated data uses, thus compromising existing data resources and analyses. Instead, we propose that research using individual health data should be subject to a regulatory regime, enforceable by government/public repositories, while at the same time permitting private enforcement actions to address particularized individual injury. Thus, while the physical collection …

How Failure To Protect Laws Punish The Vulnerable, Amanda Mahoney

Health Matrix: The Journal of Law-Medicine

No abstract provided.

50 Shades Of Data Sharing: How A Uniform Fifty-State Prescription Drug Monitoring Program Can Restore Discretion To Opioid Prescribers And Autonomy To Chronic Pain Patients, Allyson Cady

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Volume 29 (2019), Health Matrix

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Invented Purposes And Blue Sky Predictions: Why The Trump Administration Cannot Win The Medicaid Work Experiment Cases, Sara Rosenbaum

Health Matrix: The Journal of Law-Medicine

No abstract provided.

The Web Of Legal Protections For Participants In Genomic Research, Leslie E. Wolf, Erin Fuse Brown, Ryan Kerr, Genevieve Razick, Gregory Tanner, Brett Duvall, Sakinah Jones, Jack Brackney, Tatiana Posada

Health Matrix: The Journal of Law-Medicine

The identification and arrest of the Golden State Killer using DNA uploaded to an ancestry database occurred shortly before recruitment for the National Institutes of Health’s (NIH) All of Us Study commenced, with a goal of enrolling and collecting DNA, health, and lifestyle information from one million Americans. It also highlighted the need to ensure prospective research participants that their confidentiality will be protected and their materials used appropriately. But there are questions about how well current law protects against these privacy risks. This article is the first to consider comprehensively and simultaneously all the federal and state laws offering …

The Last Hope: How Starting Over Could Save Private Long-Term Care Insurance, Jalayne J. Arias

Health Matrix: The Journal of Law-Medicine

No abstract provided.

High Times Ahead: Products Liability In Medical Marijuana, Steven B. Perlmutter

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Unlocking Access To Health Care: A Federalist Approach To Reforming Occupational Licensing, Gabriel Scheffler

Health Matrix: The Journal of Law-Medicine

Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons.

Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing …

Experience Is Treacherous: An Intimate View Of The Physician's Experience Of Adverse Patient Outcomes And Malpractice Litigation, M. Stacia Dearmin

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Robbing The Grave: Amending The Uniform Anatomical Gift Act To Curtail Abuses Within The Whole-Body Donation Industry, Andrew Y. Schiefer

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Solving The Uncertainty: Why The Hipaa Privacy Rule Fails To Appropriately Address Disclosures Of Psychotherapy Notes Of Deceased Patients, Elizabeth Burnett

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Our Students Explore, Experience And Excel, Case Western Reserve University School Of Law, Law-Medicine Center

Case Law-Med

• Alison Smith’s passion for helping vulnerable populations to access healthcare drove her to Case Western Reserve University’s health law program
• Case Western Reserve University’s Law-Medicine Director awarded federal NIH grant and presented at Harvard conference
• Law Professor Jonathan Adler elected to prestigious American Law Institute
• Katharine Van Tassel joins CWRU Law as Visiting Professor 
• Health law students excel in writing
• Opioid Epidemic: Case Western Reserve law grads play central roles in unprecedented opioid litigation
• Health law faculty publications
• The Law-Medicine Center’s 2018-18 events
• Faculty in the news: What we’re saying about Obamacare, abortion, opioids and genetically engineered babies
• Gerber Fellows …

Step Therapy: Legal And Ethical Implications Of A Cost-Cutting Measure, Sharona Hoffman

Faculty Publications

The very high and ever-increasing costs of medical care in the United States are well-recognized and much discussed. Health insurers have employed a variety of strategies in an effort to control their expenditures, including one that is common but has received relatively little attention: step therapy. Step therapy programs require patients to try less expensive treatments and find them to be ineffective or otherwise problematic before the insurer will approve a more high-priced option. This Article is the first law journal piece dedicated to analyzing this important cost control measure.

The Article explores the strengths and weaknesses of step therapy …

Make America Discriminate Again? Why Hobby Lobby's Expansion Of Rfra Is Bad Medicine For Transgender Health Care, Alexis M. Florczak

Health Matrix: The Journal of Law-Medicine

The article highlights the implications of the U.S. Supreme Court's decision in "Burwell v. Hobby Lobby Stores, Inc." which held for-profit corporations could be exempt from the Affordable Care Act's (ACA)contraceptive mandate because of their sincerely held religious beliefs. Topics discussed include ACA Nondiscrimination or Civil Rights provision provides valuable protections to transgender individuals; and Department of Health and Human Services' further guidance on the ACA's provision.

Personal Health Records As A Tool For Transparency In Health Care (Draft), Sharona Hoffman

Faculty Publications

This chapter explores the benefits and limitations of personal health records (PHRs) as a tool to promote transparency in health care. A PHR can be defined as “an electronic application through which individuals can access, manage and share their health information . . . in a private, secure, and confidential environment.” PHRs can enhance efficiency, communication, data accuracy, and health outcomes. At the same time, they can disrupt the physician-patient relationship and raise liability concerns. For example, PHRs may induce patients and physicians to rely on electronic communication when office visits would be far more appropriate. The chapter analyzes the …

Big Data Analytics: What Can Go Wrong, Sharona Hoffman

Faculty Publications

It is not uncommon to read that long-held beliefs about medical treatments have been dislodged by new studies. For example, there is now doubt as to whether women should undergo annual mammograms, previously a cornerstone of cancer screening. Hormone replacement therapy for menopausal women, once considered highly suspect in light of worrisome research findings, is now being reconsidered as a beneficial therapy. These reversals trouble and confuse many Americans.

This Article explores why medical research findings can be erroneous and what can go wrong in the process of designing and conducting research studies. It provides readers with essential analytical tools …

Law Students Represent Victims Of The Largest Social Security Disability Fraud Case In History, Case Western Reserve University School Of Law, Law-Medicine Center

Case Law-Med

• Welcome from our Law-Medicine Center leaders
• Cleveland: A top city for health care
• Cover Story: Seeking justice for victims of Social Security disabilities fraud
• Helping clients live their lives to the fullest
• Scott Schweikart: reporting on legal issues at the AMA
• Hilary Leeds: promoting clinical trials transparency
• National Jurist recognizes Alison Epperson as a “law student of the year”
• CWRU law student wins second place in national health law writing competition
• CWRU hosts the 41st annual Health Law Professors Conference
• The Law-Medicine Center’s 2017-18 events take on malpractice litigation, patient trust, opioid crisis, contraception and more
• Iowa Supreme Court adopts …

Masthead, Volume 28 (2018)

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Health Care Held Ransom: Modifications To Data Breach Security & The Future Of Health Care Privacy Protection, Ryan M. Krisby

Health Matrix: The Journal of Law-Medicine

The article highlights the need of modification in the U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA), as the federal data breach security regulation fails to adequately protect patient data. Topics discussed include data breach security under HIPAA; need of modifications that address these inadequacies concerning ransomware; and actions by the U.S. Federal Trade Commission to provide an impetus for healthcare organizations to carry out data security modifications.

Needles, Haystacks, And Next-Generation Genetic Sequencing, Teneille R. Brown

Health Matrix: The Journal of Law-Medicine

Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as "incidental" or "secondary" findings. In 2013, the American College of Medical Genetics ("ACMG") recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG's recommendations galvanized critical responses by the genetics and ethics …