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Arushi Pandya

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

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On May 1, 2023, the Centers for Medicare and Medicaid Services (“CMS”) announced two investigations of hospitals that failed to offer necessary stabilizing care to a pregnant individual experiencing an emergency medical condition (“EMC”), in violation of the Emergency Medical Treatment and Labor Act (“EMTALA”). The U.S. Department of Health and Human Services (“HHS”) released a public statement and a letter to hospitals and provider associations, emphasizing the obligations of Medicare-participating hospitals’ under EMTALA, including stabilizing treatment, like abortion care, or an appropriate transfer. These investigations represent the first EMTALA enforcement action related to abortion emergency care since the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization (“Dobbs”).…

Continue Reading EMTALA and Pregnancy Care Remains a Federal Enforcement Priority

This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”). This is notable as access to care, including mental health and substance abuse treatment, remains a crucial industry focus, especially as the transition to the post-PHE has begun.…

Continue Reading DEA and SAMHSA Extend Tele-Prescribing Flexibilities

This blog is the third installment of our Digital Health Trends Series, see previous blog posts here and here.

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008 (“RHA”) after the COVID-19 Public Health Emergency (“PHE”) terminates on May 11, 2023. The proposed rule extends certain flexibilities beyond the PHE and proposes to make permanent certain scenarios, in which a practitioner may prescribe controlled substances without a prior in-person medical evaluation.…

Continue Reading DEA Proposes Rule for Post-PHE Telemedicine

The once-novel medium of telehealth surged onto the stage as a common sense solution to the COVID-19 pandemic. This surge was facilitated, in part, by certain flexibilities authorized by the Centers for Medicare & Medicaid Services in its response to the public health emergency (“PHE”) declared in March of 2020 and which was repeatedly renewed until now. On January 30, 2023, President Joe Biden announced that the PHE would end on May 11, 2023. As the curtains are drawn on the PHE, there can be no doubt that telehealth is here to stay. In light of that reality, it is essential that participants in the telehealth space understand what flexibilities will remain in play.…

Continue Reading Telehealth in a Post-PHE World

On February 13, 2023, the Centers for Medicare and Medicaid Services (CMS) published the revised List of Telehealth Services for Calendar Year (CY) 2023 (List). The List includes the services that are payable under the Medicare Physician Fee Schedule when furnished via telehealth.…

Continue Reading CMS Updates List of Telehealth Services for CY 2023

Regulatory enforcement and large litigation relating to the use of third party trackers on companies’ websites and applications have been on the rise. Tracking often occurs without the companies’ knowledge or consent. Third party tracking on hospital and provider websites has specifically garnered notable media attention. Recently, there has been significant activity by the Federal Trade Commission (“FTC”) under the Health Breach Notification Rule for unauthorized sharing of personal information. It has begun to penalize and impose steep corrective actions, including long-impacting future restrictions, for such violations.…

Continue Reading Web Tracking Creates a Web of Data Privacy Risks

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