Introduction

On December 29, 2022, President Biden signed the Consolidated Appropriations Act, 2023 (the “Act”). The Act provides for nearly $1.7 trillion in funding across a range of domestic

Continue Reading Key Healthcare Provisions of the Consolidated Appropriations Act, 2023

The COVID-19 Public Health Emergency (“PHE”) led to a rapid expansion in the utilization of telehealth. Now, almost three years later, governmental entities have focused their attention on telehealth services and the potential for fraud and abuse. In July 2022, the Department of Health and Human Services Office of Inspector General (“OIG”) issue a Special Fraud Alert alerting practitioners to exercise caution when entering into arrangements with telemedicine companies. The issuance of this report is a significant step and reinforces the government’s interest in scrutinizing telehealth arrangements. The Department of Justice (“DOJ”) and the Drug Enforcement Agency (“DEA”) have also launched several high-profile investigations that the industry is monitoring closely. Telehealth providers should carefully review and update their practices given the heightened enforcement climate.

Continue Reading Recent Developments in Telehealth Enforcement

During the COVID-19 pandemic, Medicare coverage expanded to include a vast arsenal of tools that help patients access medical services while keeping patients and practitioners safe. Many of these tools involve telehealth services and were made possible by the COVID-19 emergency blanket waivers, which went into effect when the U.S. Department of Health & Human Services (“HHS”) declared a Public Health Emergency (the “PHE”). Some of these tools:

Continue Reading Finding Our Way Out of the Pandemic Haze: What Telehealth Tools Are Medicare Providers Allowed to Keep, and Which Must They Leave Behind?

On July 20, 2022, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert warning physicians and other practitioners to exercise caution when entering into telemedicine arrangements that have certain suspect characteristics.

Continue Reading OIG Warns Physicians About Entering into Arrangements with Telemedicine Companies

As telehealth services surged in response to the COVID-19 pandemic, unique compliance challenges likewise developed in unexpected ways. Recognizing these challenges, the Office of Civil Rights (“OCR”) indicated that it would exercise its enforcement discretion by declining to impose penalties against covered health care providers for instances of good faith noncompliance with the requirements of the Health Insurance Portability and Accountability Act (“HIPAA”) in connection with the provision of telehealth services. In effect, a covered health care provider seeking to use audio or video communication technology to provide telehealth services during the public health emergency could do so with greater flexibility.

Continue Reading Office of Civil Rights Publishes Guidance on Use of Audio-Only Telehealth Services

The digital health sector has seen tremendous growth and innovation over the past few years. This momentum introduces new complexities within the legal and regulatory landscape that is trying to
Continue Reading Top 5 Legal Issues in Digital Health to Watch for in 2022

The United States Department of Health and Human Services Office of Inspector General (“OIG”) recently issued a report concerning the use of telehealth to render behavioral health services to Medicaid enrollees, calling for greater evaluation and oversight in the hopes of encouraging states to implement changes to improve how their Medicaid programs use telehealth for behavioral health services, including mental health assessments, individual therapy, and medication management.

Continue Reading HHS OIG Studies State Medicaid Programs’ Use of Telehealth

On November 2, 2021, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will be taking actions to advance its strategic commitment to drive innovation to support health equity and high quality, person centered care. CMS’ 2022 Physician Fee Schedule final rule (the “Final Rule”), will focus on, amongst other things:

Continue Reading Health Equity Remains a Priority for the Center for Medicare and Medicaid Services in 2022

As the world continues to shift and adapt to the ongoing COVID-19 pandemic, the digital health sector has experienced tremendous growth and the momentum has only accelerated in 2021.

Continue Reading Trends in Digital Health Funding and Transactions: A Tremendous Year So Far

On July 13, 2021, the Centers for Medicare & Medicaid Services (“CMS”) unveiled a proposal to temporarily extend Medicare coverage for particular telehealth services granted during the COVID-19 public health emergency (the “Pandemic”), in order to evaluate which services should be covered permanently. Through the 2022 Physician Fee Schedule (“PFS”), CMS is allowing certain services to remain on the telehealth list until the end of December 31, 2023.

Continue Reading CMS’ Proposal to Expand Telehealth Coverage

The public health crisis (the “Pandemic”) brought more attention, and more money, to the use of digital technologies to provide remote services to millions of individuals affected by the Pandemic. The use of digital technologies to provide medical services otherwise known as “telehealth”, exploded during the Pandemic but has since then made a steady growth across the healthcare industry, with many realizing the value of using digital technology to supplement, and in some cases, replace traditional methods of medical care. While many expected the value and investment in telehealth to decline with Pandemic restrictions being lifted, a recent report from venture firm Rock Health (the “Report”), shows that digital health funding continues to break records as venture-backed companies raised $14.7 billion in the first half of the year. Rock Health’s CEO Bill Evans notes that while even he was a bit surprised by the increase, the fundamentals checked out, “we saw pace increase and size per round increase,” noted Evans.

Continue Reading Telehealth Investment and Telehealth Utilization: Let’s Look at the Numbers