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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

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