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Arushi Pandya is an associate in the Corporate Practice Group in the firm's Washington, D.C. office.

This blog is the second installment of our Digital Health Trends series.

Overview

Digital health services have exploded since the onset of the COVID-19 pandemic, and behavioral health services have seen large increases in utilization. Prior to the pandemic, telehealth visits for mental health or substance use disorder represented less than 1% of outpatient visits, but by mid-2020 nearly 40% of telehealth outpatient visits were for mental health or substance use.[i] Behavioral health is the highest-funded clinical indication within digital health, and digital behavioral health companies raised $1.7 billion in the first three quarters of 2022.[ii] Investments in behavioral digital health services have the potential to transform the healthcare system in several key areas.

Continue Reading The Transformation in Behavioral Digital Health Services

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

This blog is the first in our Digital Health Trends series.

Digital health’s explosion in the last few years has led to the proliferation of new technologies and novel solutions to long-standing health problems. FemTech, in particular, has become a major movement in women’s healthcare, and the market appears ready to support this rapid growth. A recent report projects FemTech to grow by approximately 17% over the next five years with a market value over $60 billion.[1] Despite FemTech’s initial focus on access to reproductive health services, the FemTech market has evolved to encompass a broad range of women’s health issues from fertility to cardiovascular disease while increasing access to traditionally stigmatized or ignored health conditions such as menopause, mental health, and sexual health.

Continue Reading The FemTech Revolution

The Emergency Medical Treatment and Labor Act (EMTALA) requires hospitals with emergency departments and participating in Centers for Medicare and Medicaid Services (CMS) programs to provide medical screening, treatment and transfer for patients with emergency medical conditions (EMCs) or women in labor.[1] EMTALA, which was enacted in 1986 to address concerns about patient dumping, went unnoticed for many years, but has garnered heightened attention as a result of the COVID-19 pandemic, and more recently, the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (Dobbs).[2]

Continue Reading EMTALA in the Post-Dobbs World

The Office of the Inspector General (“OIG”) recently issued Advisory Opinion 22-08 (the “Advisory Opinion”), concluding that the provision of limited use smartphones by a federally qualified health center (“FQHC”) to existing, low-income patients (the “Arrangement”) lacked the intent required to violate the federal Anti-Kickback Statute (“AKS”)[1] and was not likely to generate remuneration prohibited under the federal Civil Monetary Penalties Law prohibiting inducements to health care program beneficiaries (“Beneficiary Inducement CMP”)[2].

Continue Reading OIG Issues Favorable Advisory Opinion For Federally Qualified Health Center’s Smartphone Loan Program

On June 21, 2022 the Supreme Court granted certiorari in Polansky v. Exec. Health Res., 17 F.4th 376 (3d Cir. 2021), allowing the Court to review the Department of Justice’s (“DOJ”) authority to dismiss qui tam suits brought under the False Claims Act (“FCA”), over objections by the relators. The case invites the high Court to decide two key issues: (1) whether the DOJ has the authority to dismiss qui tam suits where it declined to intervene, and (2) what standard of review applies to such requests for dismissal. 

Continue Reading Supreme Court To Review DOJ’s Authority to Dismiss Qui Tam FCA Suits Over Objections From Relators

On April 25, 2022, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 22-07 which evaluated the risk of fraud and abuse under the federal anti-kickback statute (“AKS”) posed by an arrangement involving physician-ownership of a medical device company. The opinion identified six characteristics of the arrangement which greatly reduced the risk of fraud and abuse.

Continue Reading OIG Issues Favorable Advisory Opinion for Physician-Owned Medical Device Company

The metaverse has been described as the “next frontier” and the “new era” of healthcare. Although still a loosely defined and relatively broad term, the “metaverse” generally refers to a shared virtual environment accessed by individuals via the Internet. Individuals generally enter the metaverse through the following four technologies: virtual reality, augmented reality, mixed reality and extended reality.  

Continue Reading Digital Health in the Metaverse: Three Legal Considerations

Last month, the U.S. Department of Health and Human Services Office of Inspector (“OIG”) released a report that studied prior authorization denials and payment denials by Medicare Advantage Organizations (“MAOs”) (the “Report”). While the Report found that the “vast majority” of prior authorizations and payment requests were approved, the Report focused on the finding that MAOs “sometimes” denied prior authorization and payment requests that met Medicare coverage rules claiming that the denials delayed or denied beneficiaries’ access to medically necessary services.
Continue Reading HHS OIG Report On Prior Authorizations Under Medicare Advantage

On April 1, 2022, the Centers for Medicare & Medicaid Services (“CMS”) announced states may seek to extend Medicaid postpartum coverage from 60 days to one year through a new state plan option offered by the American Rescue Plan Act (“ARPA”). The new state plan option allows state Medicaid and Children’s Health Insurance Program (“CHIP”) agencies to provide 12 months of continuous postpartum coverage, regardless of any changes in circumstances, through a state plan amendment (“SPA”). This option is available for five years and ends on March 31, 2027.
Continue Reading CMS Begins Option to Extend Medicaid Postpartum Coverage