Doctor Holding Cell Phone. Cell phones and other kinds of mobile devices and communications technologies are of increasing importance in the delivery of health care. Photographer Daniel Sone.

Clash of Titans? A Brewing Dispute between Telehealth Giants

By Vrushab Gowda

Competition between rival telehealth providers spilled into open conflict last month, as incumbent Teladoc Health, Inc. (Teladoc) filed a patent infringement suit against relative upstart American Well Corporation (Amwell).

This development marks a significant escalation in what has been a lengthy arms race between the two publicly traded entities. Both having witnessed skyrocketing sales in recent months, aided by a shift to virtual care and a host of regulatory flexibilities, although neither has turned a profit to date.

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A calculator, a stethoscope, and a stack of money rest on a table.

Telemedicine is No Cure for Fraud and Abuse

By Vrushab Gowda

The exponential growth of telehealth in recent years has revolutionized the delivery, access, and cost of care. Unfortunately, it is not immune to the fraud and abuse that divert nearly $70 billion from the health care system annually.

A rise in suspect practices has been accompanied by a concomitant escalation of Department of Justice (DOJ) enforcement, sending a clear signal to would-be fraudulent actors.

The ongoing Operation Rubber Stamp is one such enforcement thrust. A joint initiative of the of the Federal Bureau of Investigation (FBI) and the Department of Health and Human Services (HHS), it targeted an extensive network of telemedicine fraud totaling over $4.5 billion in false claims and yielding thirty guilty pleas to date.

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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