Young male doctor in telehealth concept

COVID-19’s Impact on Clinical Trials: Meeting Participants Where They Are

By Sarah V. Ferranti and Shine Chen Schattgen

“Decentralized” clinical trials (referred to as “DCTs”) are not novel, but nevertheless failed to gain real momentum given the regulatory and operational complexities involved. In light of COVID-19, however, it seems almost certain that the remote and virtual study activities that characterize DCTs, and a site and sponsor’s ability to flex to “meet the participant where they are” will be critical to the conduct of clinical trials going forward.

In the first half of 2020, as health care facilities prepared for capacity-exceeding patient volumes and equipment shortages, non-essential clinical care and non-COVID-related clinical trials came to a screeching halt. According to ClinicalTrials.gov, 1473 clinical trials were suspended, terminated, or withdrawn between December 1, 2019 and July 1, 2020, with a reported reason that explicitly mentioned COVID-19.

At the same time, initiation of clinical trials for COVID-19 vaccines and treatments exploded at speeds previously considered unachievable within the clinical trial industry. As of October 13, 2020, 811 COVID-19-related clinical trials had been initiated in the United States. To enable COVID-19 trials and, more recently, to restart previously paused non-COVID trials, clinical trial sponsors and sites have been forced to quickly adapt to protect participants and preserve the integrity of clinical trial data and results.

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computer and stethoscope

How Telehealth Could Improve — or Worsen — Racial Disparities

By Craig Konnoth, JD, M.Phil., Wendy Netter Epstein, JD, and Max Helveston, JD

Despite upping the stakes of America’s partisan divide, the pandemic has prompted bipartisan support for at least one cause — the rapid rollout of telehealth, which allows people to see their doctors by videoconference or telephone.

In last week’s executive order, the Trump Administration reaffirmed its commitment to the use of telehealth. While telehealth may be, in many ways, a panacea for access to healthcare, particularly in COVID times, we should be concerned that patients of color may be left behind.

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Person typing on computer.

Telehealth Policy Brought to the Fore in the COVID-19 Pandemic

By Vrushab Gowda

The COVID-19 pandemic has highlighted the value of telehealth as both a tool of necessity (e.g., minimizing infection risk, conserving thinly stretched healthcare resources, reducing cost) as well as of innovation.

Telehealth services have surged in recent months; in April alone, they constituted over 40 percent of primary care visits nationwide and over 73 percent of those in Boston. “Increasing Access to Care: Telehealth during COVID-19,” a recent publication in the Journal of Law and the Biosciences, dissects the issues that have accompanied the growth of telehealth and identifies further areas of potential reform.

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Photograph of a doctor holding a headset sitting in front of a laptop

How Telehealth Can Reduce Disparities

By Jenna Becker

Telehealth can and should be used in an intentional effort to reduce health disparities.

Increased COVID-19 mortality rates in communities of color have been a constant, tragic reminder of the ways in which systemic racism causes poor health outcomes in the United States. Immigrants are facing an increased risk of illness and limited access to care. Rural Americans may face an increased risk of serious illness.

Telehealth can reduce barriers to care that these groups face, such as lack of access to transportation, culturally-competent providers, and childcare.

The last six months have seen rapid growth in the use of telemedicine in response to the COVID-19 pandemic. In response to urgent need, regulatory agencies and private insurance companies have loosened requirements that previously inhibited the use of telehealth.

The expansion of telehealth and removal of traditional barriers to care may lead to more equitable health outcomes.

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Person typing on computer.

Substantial Obstacles after June Medical Services: ACOG v. FDA

By Rachel Rebouché

In June Medical Services v. Russo, the Supreme Court held that a Louisiana law requiring that physicians obtain admitting privileges at a nearby hospital was unconstitutional. Had the law taken effect, all but one provider would have lost the ability to deliver abortion care in the state. Despite the result, a number of commentators have expressed concern about the future of abortion rights. The source of their concerns is the Chief Justice’s application of the undue burden test—the standard for judging the constitutionality of an abortion restriction—established in Planned Parenthood v. Casey.

Justice Breyer, who wrote the judgment of the Court in June Medical Services, balanced the benefits and burdens conferred by the law, finding that the statute offered no benefit for people’s health and created significant burdens on the delivery of abortion. The admitting-privileges requirement does not protect patients’ safety because complications from abortion are rare and thus rarely will a patient need admission to a hospital. Moreover, admitting privileges, which the district court found each provider had pursued in good faith, do not determine a physician’s competency or credentials.

Although Chief Justice Roberts’s concurrence provided the fifth vote to strike down the law, Roberts wrote separately to emphasize that whether the Louisiana law had any identifiable benefit for patients was immaterial. The Court need only address what burdens the law imposed—if a law establishes “significant obstacles” to abortion. Roberts’s concurrence clearly departs from Breyer’s approach of weighing the law’s benefits against its burdens. Breyer’s formulation would render a law unconstitutional if it had no health benefits but erected a minimal obstacle to abortion care. Roberts’s approach would not: a law only fails the undue burden test—no matter how unsuccessful legislation is in achieving its purported goals—if the restriction renders abortion access substantially more difficult.

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Young male doctor in telehealth concept

Telehealth amid COVID-19: What Health Care Providers Should Know

By Adriana Krasniansky

COVID-19 stands to be a watershed moment for telehealth adoption within the U.S. healthcare system.

In response to the COVID-19 pandemic, the Trump administration and the Centers for Medicare & Medicaid Services (CMS) (part of the Department of Health and Human Services, or HHS) announced expanded Medicare telehealth coverage for over 80 health services, to be delivered over video or audio channels. Additionally, the HHS Office for Civil Rights (OCR) announced it would waive potential Health Insurance Portability and Accountability Act (HIPAA) penalties for good faith use of telehealth during the emergency. Both measures are designed to enable patients to receive a wider range of health care services remotely, reducing clinical congestion and limiting transmission of the virus. 

In the midst of this emergency situation, health care providers can take measures to consider the ethical and legal aspects of tele-practice as they get started. This article is a short primer to help medical professionals understand telehealth in this moment, navigate regulations and technology practice standards, and choose technologies to support quality patient care. Read More

pill bottle - buprenorphine / naloxone

Protecting the Vulnerable Substance Use Disorder Population During COVID-19

By Brandon George and Nicolas P. Terry

Introduction

Earlier this month, Dr. Nora Volkow, director of the National Institute on Drug Abuse identified those with substance use disorder (SUD) as a particularly vulnerable population during the COVID-19 pandemic. She highlighted the negative effects of opioid or methamphetamine use on respiratory and pulmonary health in addition to the disproportionate number of those with SUD who are homeless or incarcerated.

We detail the additional challenges faced by the SUD population and, specifically, the opioid use disorder (OUD) sub-group at this time, identify positive ameliorative steps taken by federal, state, and local governments, and recommend additional steps.

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TeleSitters are entering hospital rooms. How will they change patient care?

By Adriana Krasniansky

In many medical circumstances, clinicians and caregivers may choose not to leave a patient alone. For example, a patient may present a fall risk, experience confusion and agitation, or be at risk of self-harm.  Traditionally, in such situations, a hospital assigns the patient a sitter, or a caregiver who provides patients patient supervision and companionship. 

The need for sitters in hospital settings is rising, as patient loads increase and fewer patients have family members who are able to stay with them for long periods of time. Sitters are also a considerable investment for hospitals; one community hospital reported employing 14 sitters a day, totaling $425,000 in costs annually. Many healthcare networks are exploring the possibility of TeleSitters, or virtual monitoring systems to support patient care. In this article, we review the national adoption of TeleSitters and point out benefits and considerations to their implementation.  Read More

Illustration of cell phones and prescription pill bottles

Access as Equity: Efforts to Use Telemedicine to Expand Abortion Access

By Oliver Kim

I’ve written here before about areas where technology could play a role in providing access to complicated, controversial healthcare services. Earlier this year, I presented a forthcoming paper co-authored with a colleague on how technology can be used to provide greater equity in women’s health and how the law is being used to encourage such advances or block them. Given the political battles over women’s health, it should be no surprise that technology’s role in abortion access is under increasing scrutiny from lawmakers.

A medication abortion involves a two-step regimen: the woman first takes mifepristone, generally in a clinical setting, and 24 to 48 hours later, she takes misoprostol, generally in the privacy of her home. Recent research, though, suggests that women may not need to take mifepristone in a clinical setting: the World Health Organization revised its guidelines on whether the medications require “close medical supervision,” and a recent op-ed in the New England Journal of Medicine called on the Food and Drug Administration to revise its restrictions on mifepristone.

Given these findings, abortion providers have recognized that telemedicine could be utilized to expand access into areas where abortion services are limited due to geography, legal restrictions, or both. Since 2008, Planned Parenthood in Iowa has used telemedicine to overcome both provider shortages and geographic challenges: a physician can use video conferencing services to appear virtually at health centers across the state, reviewing a patient’s ultrasound and medical history remotely and providing counseling over a secure, private system. The majority of the medical literature finds that using telemedicine to provide medication abortions is just as safe and effective as if a woman met with a clinician in person.

As we discuss in our paper, when technology expands access to care that is politically controversial, policymakers may use the law to restrict such technological advances. In response to this use of telemedicine, states hostile to abortion began passing bans. When Iowa’s medical board attempted to restrict such a use of telemedicine, the Iowa Supreme Court struck down the board’s regulation, holding that it would be an undue burden on a woman’s right to an abortion. Some hailed the Iowa decision as groundbreaking and hopefully influential on other state supreme courts. (Later that same year, the U.S. Supreme Court in Whole Woman’s Health would strike down two Texas statutory restrictions on abortion providers as undue burdens on a woman’s right to an abortion.)

What I find interesting—and what came out after we submitted our paper—is how telemedicine and abortion are being treated in neighboring Kansas and how it reflects the larger legal debate over these issues. In 2011, Kansas first attempted to ban telemedicine abortions by requiring a physician to be physically present when administering mifepristone, thus eliminating the value of telemedicine. Subsequently, the Kansas state legislature modified the ban in 2015 by clarifying that a physician would not need to be physically present in a medical emergency; in 2018, the legislature passed explicit language in the Kansas Telemedicine Act that nothing in this new telemedicine legislation authorized the use of telemedicine for abortion. However, a Kansas court enjoined the Kansas attorney general, the only defendant in this line of cases, from enforcing this provision or the in-person requirements under the court’s prior 2011 decision.

Even more remarkable, in the same state that elected Sam Brownback governor twice, the Kansas Supreme Court recently held in Hodes & Nauser v. Schmidt that the Kansas constitution provided a fundamental right to an abortion.

Thus, it may seem surprising that in a subsequent decision, a district court refused to grant a preliminary injunction for Trust Women, a Wichita-based abortion provider, to prohibit the state from enforcing the telemedicine abortion restrictions. Part of this new case turns on standing as well as recognizing that the prior line of telemedicine-abortion cases only enjoined the state attorney general and was silent on whether the state health department or county attorneys were similarly enjoined from enforcing the telemedicine-abortion bans.

Further, the court also turned part of its decision on whether Trust Women would suffer an irreparable injury: the court found that there was insufficient evidence of an injury because Trust Women still required patients to be present physically at its Wichita clinic in its telemedicine pilot, and Trust Women had taken no preliminary steps to open clinics in remote rural parts of the state. Indeed, the court decried the prior telemedicine-abortion rulings as “a growing procedural backwater” and suggested that the court needs to be able “to resolve the underlying merits of the telemedicine abortion issue,” necessitating that “the parties… present additional evidence and more probing legal analysis than has occurred at this early stage.”

While the district court has significant discretion in considering a request for a preliminary injunction, it does feel troubling that the court suggests that Trust Women should have invested time and resources into a telemedicine strategy that might be illegal before seeking relief. In light of the bans and the legislature’s hostility, it seems unlikely that Trust Women could have raised the funds necessary to create a telemedicine infrastructure and build clinics in remote rural areas. After all, although the Kansas Supreme Court’s decision was not on the telemedicine restrictions, it seems unlikely that they would survive a strict scrutiny review under Hodes since the state will bear the burden of justifying the law. Moreover, it’s also likely that the restrictions might not survive review under Whole Woman’s Health given the weight of medical evidence that suggests singling out abortion from all other services provided by telemedicine, is suspect.

This is also playing out on the national stage as the Fifth Circuit in June Medical v. Gee seemingly sent a direct challenge to Whole Woman’s Health where the Fifth Circuit upheld Louisiana abortion restrictions that were basically identical to the Texas restrictions that were struck down. How June Medical is ultimately resolved will have ramifications for telemedicine in this particular context.

While medical evidence demonstrates that telemedicine is a safe means of providing medication abortion (as well as providing other benefits for women such as privacy), there are of course those that dispute this notion. One could see a conservative court finding that a telemedicine ban is not an undue burden: under the Trust Women preliminary injunction ruling, women in rural areas are no worse off than they were before since they never had access to abortion via telemedicine to begin with. Further, if waiting periods and similar barriers are upheld post-Whole Woman’s Health, this could put rural access even further at risk. In other words, a woman still has access to abortion, just not via telemedicine. Of course many such arguments could be applied to any telemedicine application, so the question turns back again: Why place restrictions just on abortion services?

In so many areas, though, telemedicine has been hailed as a way to increase access for all patients. The issues arise in the same areas where there have always been strong opinions, but the evidence and the trend lines are overwhelmingly in favor of expanded telemedicine access. The law should follow.

Image of a surgery room with a robot whose screen has a doctor with a stethoscope

The Problem With Doctors Communicating via Robot is Attitudes About Technology, Not Poorly Communicating Doctors

By Evan Selinger and Arthur Caplan

Perhaps you’ve seen the debate? A physician used video chat technology to inform a hospitalized Ernest Quintana and his family that he would be dying sooner than they expected. After he passed away, they objected to how the news was delivered. Over at Slate, Joel Zivot an anesthesiologist and ICU physician, responded to the uproar with an essay titled, “In Defense of Telling Patients They’re Dying Via Robot.” Read More