A Telehealth Explosion: Using Lessons from the Pandemic to Shape the Future of Telehealth Regulation

From board rooms, to classrooms, to Saturday Night Live skits, the video conferencing app Zoom became a seemingly overnight sensation as a way to connect while businesses were shuttered and individuals were forced to stay at home when the coronavirus pandemic erupted in the United States in March 2020. From 10 million daily users in December 2019 to over 200 million daily users by March 2020, the company founded in 2011 became a market leader as the country tried to figure out how to continue business as usual—to the extent possible—during the global pandemic. While hospitals prepared for the onslaught of patients suffering from COVID–19, many physicians and physician offices around the country not tasked with treating patients suffering from COVID–19 shuttered their doors along with other businesses and contemplated ways in which they could still render necessary care to their patients.4 How could physicians advise or diagnose patients who exhibited coronavirus symptoms without exposing other patients to coronavirus? How could physicians who were themselves immunocompromised or at special risk if they were to contract COVID–19 continue to treat their patients? How could patients feel comfortable seeking care for non-COVID–19 related conditions without feeling like seeking such care could expose them to the virus? In short, providers were facing many of the same dilemmas that other businesses have been facing during the global pandemic, and just like the 200 million fellow Americans who turned to Zoom, the health care industry likewise looked to technology

Medicaid Expansion Expectations

Although financial stability in rural hospitals has been a relatively long-standing national problem, in the last decade, hospital closures and the incidence of highly distressed hospitals in rural areas have disproportionately impacted certain states. States that have not expanded their Medicaid programs under the Affordable Care Act, which implemented a program to extend additional federal support to cover adults living below 138% of the federal poverty line (referred to herein as “Medicaid Expansion”), are bearing the brunt of this crisis. Although the reason for hospital closures is multi-faceted and complex, health policy experts have consistently identified the lack of Medicaid Expansion as a key driver for hospital closures and consider future adoption of expansion as an imperative. To that end, there have been several initiatives within the last year to promote and incentivize the remaining twelve states that have not expanded their Medicaid programs to do so. Thus far, no states have opted for expansion based on these incentives—although Medicaid Expansion remains an option. Several other bills have been proposed in Congress to close the so-called “coverage gap,” which range from a federal public option for those in the gap to additional state incentives. This Article will argue that current federal initiatives attempting to incentivize states to expand Medicaid, while well-intentioned, are politically challenging and unlikely to be successful with the present state leadership. Regardless, the adoption of Medicaid Expansion will remain a key component to maintaining stability in rural health markets and continued federal efforts to narrow the coverage gap should continue.This Article will explore both current and proposed legal approaches aimed at closing the Medicaid coverage gap to determine whether such efforts will be successful in creating greater financial stability for rural health care providers and the communities they serve. In Part II, it will examine the existing research and literature regarding rural hospital closures since 2010 and how a state’s decision to adopt Medicaid Expansion impacts closures and economic stability for the entire community. It will further outline the efforts to incentivize Medicaid Expansion through the American Rescue Plan of 2021, and survey other proposals at federal and state levels aimed at creating greater sustainability for hospital providers in rural markets. In Part III, the Article will compare rural hospitals in expansion states to those in non-expansion states to ascertain whether the expectations for Medicaid Expansion will meet reality. This Part will also analyze the legislative climate in those states that have yet to expand their Medicaid coverage for purposes of understanding the likelihood of success in current efforts. In Part IV, this Article will argue that current incentive-based efforts to close the Medicaid coverage gap in the twelve remaining states that have not yet adopted Medicaid Expansion are unlikely to be successful due to political barriers in those states, both actual and perceived. It will further argue that narrowing or closing the coverage gap nevertheless remains a vital aspect of stabilizing health access and resources in rural communities and that federal efforts to continue to narrow or close that gap should continue. Even if these efforts will not save all hospitals, increasing health access through other forms of providers such as emergency-only services will still require a largely insured population for long-term stability. Part V will then conclude by offering a few suggestions regarding where federal regulators and legislators should focus their efforts to stem the tide of rural hospital closure and instability and further endeavor to suggest ways in which current proposed bills might better target specific issues that will bolster the health care infrastructure of rural communities. This issue needs to be addressed with great urgency to prevent further gaps in the urban-rural health care divide

KEEPING OUR EYES ON THE PRIZE: EXAMINING MINNESOTA AS A MEANS FOR ASSURING ACHIEVEMENT OF THE “TRIPLE AIM” UNDER THE ACA

KEEPING OUR EYES ON THE PRIZE: EXAMINING MINNESOTA AS A MEANS FOR ASSURING ACHIEVEMENT OF THE “TRIPLE AIM” UNDER THE AC

The New Face of Creationism: The Establishment Clause and the Latest Efforts to Suppress Evolution in Public Schools

If America wants to stay at the forefront of scientific study and remain competitive with other nations, its students must be taught scientific principles that are generally applied in the global scientific community. Thus, the implications involved in the latest battles over God and science extend beyond whether to teach controversial subjects, and could have a significant effect on the future of American schools. These problems warrant the development of a new test, or new legal analysis, that will enable the Court to deal with this latest chapter in the heated evolution and creationism debate. This Note examines the evidentiary factors that will be necessary to preserve First Amendment ideals and the consequences that may follow from adopting a more narrow, textualist approach when analyzing the Establishment Clause

Send Us the Bitcoin or Patients Will Die: Addressing the Risks of Ransomware Attacks on Hospitals

“You just have 10 days to send us the Bitcoin. After 10 days we will remove your private key and it\u27s impossible to recover your files.” Message to Medstar employees. Within a span of just a few months in the spring of 2016, fourteen hospitals (four hospital systems) experienced ransomware attacks resulting in an inability for the hospitals to access any of their electronic medical records, including necessary patient data. Knowing that hospitals must have access to this data in order to appropriately treat and monitor patients, those responsible for the attacks requested a bitcoin payment as ransom for the ability to regain access to the data. At least one hospital, Hollywood Presbyterian Medical Center in Los Angeles, California, publicly acknowledging to paying the asking price of 40 bitcoin, which is equivalent to about $17,000. While these hospitals are not the only ones experiencing these ransomware attacks, the potential consequences of such attacks in the health care context are severe. With the enactment of the Health Insurance and Portability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (“HITECH”) Act, hospitals and other health care providers are required to adopt and meaningful use electronic health records. Thus, in order to comply with federal law, all patient health records and all patient health information that might be necessary to treat, monitor, or even admit and triage patients is tied to an electronic record keeping system. While the ultimate goals of better efficiency and better coordination (and, thus, better patient care) demonstrate the need for this push towards electronic health records, the manner in which these laws have been implemented has left hospitals and other health care providers with some challenges that were never faced in a system of paper records. This article examines recent attacks and addresses why hospitals and health care providers might be especially vulnerable to these sorts of attacks. It further surveys the various hospital responses and analyzes whether such responses may be helpful or hurtful for avoiding future attacks. This article concludes that the fractured approach to data exchange in the healthcare industry leaves hospitals and other providers open to attack, and thus, hospitals and providers need to move quickly towards a more coordinated and uniform approach to electronic health records. This can be accomplished either through federal regulations that will obligate a movement towards more coordinated systems or a grass roots movement of providers themselves in an effort to stave off these attacks, which can be devastating to providers, both operationally and financially

From Guns that Do Not Shoot to Foreign Staplers: Has the Supreme Court’s Materiality Standard Under Escobar Provided Clarity for the Health Care Industry About Fraud under the False Claims Act?

In June of 2016, the U.S. Supreme Court issued an opinion in the case of Universal Health Services, Inc. v. United States ex rel. Escobar, in order to resolve a circuit split regarding the viability of the “implied false certification” theory of liability under the False Claims Act (FCA). This article examines what has happened in the twelve months since the Escobar opinion by observing the reaction and subsequent arguments arising out of the Department of Justice and exploring the analyses of district courts and courts of appeals in trying to apply a new and more demanding materiality standard as set forth in Escobar. While lower courts seem to be taking Escobar to heart and applying this more rigorous materiality standard for implied false certification claims, there remains a great deal of variability in the lower courts about what may or may not be actionable under the FCA. With nearly 60 percent of recoveries from the FCA since 1986 attributable to the healthcare industry, this article examines Escobar through the unique lens of the healthcare industry. While Escobar does seem to be motivating lower courts to apply a rigorous and demanding materiality standard, the back-to-basics approach to examining materiality for fraud seems to be providing little consistency regarding what type of evidence would need to be proffered to satisfy such materiality standard. To the extent such lack of consistency remains, providers, suppliers, manufacturers, and other parties potentially subject to application of the FCA in the healthcare setting will continue to struggle to determine how to consider Escobar for purposes of assessing and prioritizing compliance risk

Keeping Our Eyes on the Prize: Examining Minnesota as a Means for Assuring Achievement of the \u27Triple Aim\u27 Under the ACA

A little more than four years after enactment of the Patient Protection and Affordable Care Act of 2010 (“ACA”), daily headlines still abound on newspapers and websites across the country highlighting both successes and failures of the ACA. In analyzing those successes and failures, especially in the context of care delivery, it is important to take a step back to consider the stated goals of the ACA, which goals have their origins in a premise first proposed by Dr. Donald M. Berwick and the Institute for Healthcare Improvement (“IHI”) in 2006 referred to as the “Triple Aim.” The Triple Aim is a framework for healthcare that, at its origin, was intended to “optimize population health, care experience, and cost.” It was with this Triple Aim in mind that legislators and policy makers established the framework for accountable care organizations (“ACOs”) and the Medicare Shared Savings Program (“MSSP”). This article examines the origins of the Triple Aim and its impact on the development of ACOs under the ACA. It then analyzes why academic medical centers and other integrated delivery systems such as the Mayo Clinic, which entities are leaders in research, innovation, and quality care, are opting out of a model of care in the ACO structure that was designed with the goal of functioning more like these entities. With that in mind, it examines the potential risks of maintaining an ACO structure that is not open, available, and accessible to academic medical centers such as the Mayo Clinic, suggesting that such a structure that does not encourage participation by entities such as the Mayo Clinic will be unable to achieve the goals of the Triple Aim that the ACA set out to accomplish. Finally, the article will offer some suggestions for amendments to the ACO model that might make ACO participation possible for the Mayo Clinic and entities like the Mayo Clinic and move the U.S. healthcare delivery system closer to its goals of achieving the Triple Aim

From Guns That Do Not Shoot to Foreign Staplers: Has the Supreme Court\u27s Materiality Standard Under Escobar Provided Clarity for the Health Care Industry About Fraud Under the False Claims Act?

As federal district courts and courts of appeals attempt to apply the Supreme Court’s dictates in Universal Health Services, Inc. v. U.S. ex rel. Escobar, it is necessary to ask whether the Court succeeded in easing the complexity of this aspect of the Federal Claims Act (FCA). Have lower courts been able to consistently apply the new standards to assess materiality? Or, has the opinion, which arguably both broadened and narrowed application of the implied false certificate theory and when liability might attach, further muddied the waters for courts and parties attempting to determine whether behavior is of the sort that qualifies as “fraud”? Most importantly, what impact has the Escobar opinion had on providers and other government contractors for purposes of trying to determine whether noncompliance with a regulation of any sort constitutes fraud for purposes of the FCA? In reviewing lower court opinions analyzing FCA claims in accordance with the dictates of Escobar, this article argues that while Escobar does seem to be motivating lower courts to apply a rigorous and demanding materiality standard, the Court’s “back-to-basics” approach in determining materiality seems to be providing little consistency regarding what type of evidence would need to be proffered to satisfy the new materiality standard. To the extent such lack of consistency endures, providers, suppliers, manufacturers, and other parties potentially subject to application of the FCA in the health care setting will continue to struggle to determine how to consider Escobar for purposes of assessing and prioritizing compliance risk. Part I of this article briefly examines the history of the FCA and explores how the FCA has evolved as the primary enforcement tool for health care fraud and abuse. This Part further examines the origins of the implied false certification theory and the various splits and issues among the circuit courts that prompted the Supreme Court to review this issue in Escobar. In Part II, this article examines the details of the Escobar case and outlines the specific findings of the Supreme Court as well as how the DOJ, federal district courts, and federal courts of appeals have interpreted the Escobar opinion. Then, Part II analyzes the approaches of various courts in applying the new materiality standard to examine the impact the standard will have on future FCA cases relying on the implied false certification theory. It further highlights consistent themes, open questions, or distinctions that have emerged since the issuance of the Escobar opinion. Part III argues that while Escobar may succeed in ensuring a more exacting and demanding standard for claims relying on an implied false certification theory, and thus a broader number of defenses available to defendants involved in FCA cases, the lack of consistency for specific types of proof that constitute materiality will have a detrimental effect on ongoing compliance efforts by those entities subject to the FCA. These challenges will be particularly acute for health care entities, including providers and suppliers, in trying to prioritize and assess risk and in operation of effective compliance programs under the countless regulations to which such entities are subject. Finally, this article concludes by offering some suggestions for potentially mitigating or lessening some of the confusion that might arise through the Centers for Medicare and Medicaid Services and other state regulatory agencies by issuing clear and precise communication about what types of fraud those agencies believe should be actionable under the FCA

Everything Old is New Again: Will Narrow Networks Succeed Where HMOs Failed?

As health insurers try to navigate the new limitations set forth under the ACA, including prohibitions on denying individuals with pre-existing conditions and limitations on the rating of patients, insurers are looking towards models that will enable them to control costs without access to their usual tools. What they have developed is not so much a new insurance model, but actually a concept that first arose during the rise of managed care; that is, limited provider networks utilized within health maintenance organizations (“HMOs”). These “new” insurance products, often referred to as narrow networks or high-performance networks, offer beneficiaries a more limited network of physicians typically in exchange for lower premiums. These insurance plans are becoming increasingly common both on the federal and state health insurance exchanges as well as in insurance product offerings outside the exchanges. As these limited provider networks become more prevalent, there is evidence of a number of similarities between the narrow networks of today and the HMOs that increased in popularity during the 1980s and 1990s. But, if narrow networks are in fact simply a redux of HMOs, can it be surmised that narrow networks are likely be a short-lived trend? Will narrow networks fall into disfavor and suffer the same consumer backlash and financial challenges as the HMOs of twenty-plus years ago? Or, is there something unique and distinct about the narrow networks arising in the current health insurance market that will create greater longevity for these insurance products that was not achievable with HMOs, despite their similarities? This article argues that the narrow networks that have emerged in the current healthcare marketplace are indeed unique and distinct from their HMO predecessors and, because of such distinctions, appear poised to experience greater success and longevity than HMOs. Part II of this article will examine the history of limited provider organizations, specifically HMOs, including their rapid rise and then subsequent descent into disfavor with consumers and providers alike. It will then review the movement back towards limited provider networks, defining what constitutes a narrow network and highlighting current prevalence of these products on the insurance market. Part III will then review the existing legal structure (much of which arose during the time of HMOs) surrounding narrow networks, including examination of a few recent lawsuits against insurers under both federal and state law and the state and federal statutes designed to protect both providers and consumers. This Part will identify some of the challenges for providers and consumers with the existing legal structure in connection with taking action against limited provider networks. Next, Part IV will consider the advantages and disadvantages of narrow networks and forecast the potential outlook for narrow networks based on such factors. Part IV will also examine the current activities of certain “high-cost providers,” such as academic medical centers, to create their own alternative networks or alternative product offerings, and what impact such activities might have on the sustainability of narrow networks. Finally, in Part V, this article will conclude that narrow networks are likely to realize more sustained longevity and success than their HMO predecessors because of the following three distinctions between narrow networks and HMOs: (a) unlike HMOs, narrow networks, especially those offered on federal and state health insurance exchanges, are consumer-driven products, responding to a specific need for insurance offerings at a lower cost; (b) existing laws in place to protect against potential ills of limited provider networks are either too narrowly focused on HMOs or too discretionary for consistent application and enforcement against modern narrow network products; and (c) so long as large and influential high-cost providers continue to create alternative structures rather than fight exclusion from narrow networks, there is a greater likelihood of a co-existence of both narrow networks and alternative networks (which cater to different segments of the population) and thus greater longevity of narrow networks

Cybersecurity Report Identifies Unique Challenges to Tackling Cybersecurity in Health Care

A discussion of the Health Care Industry Cybersecurity Task Force report regarding the preparedness of the health care industry to respond to ever increasing cybersecurity threats