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

On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed Rule covers an array of regulatory topics including the Star Ratings program, marketing and communications, agent and broker compensation, health equity, dual eligible special needs plans (“D-SNPs”), utilization management, network adequacy, and access to biosimilars.Continue Reading CMS Promotes Competition, Transparency, Health Equity and More in the CY2025 Medicare Advantage and Part D Proposed Rule

On November 2, 2023, the American Hospital Association and Texas Hospital Association, in conjunction with the Texas Health Resources and United Regional Health Care System, filed suit against the Secretary of the Department of Health and Human Services (“HHS”) and the Director of the HHS Office for Civil Rights (“OCR”) regarding OCR’s guidance on the use of online tracking technologies by HIPAA entities.[i] This action and its results will impact how healthcare entities must protect and may use certain information collected on their digital sites.Continue Reading Caught in the Web: Hospital Associations Sue OCR on Third-Party Web Tracking Guidance

This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”) from November 11, 2023 until December 31, 2024. Under the Second Temporary Rule, practitioners may continue to prescribe schedule II-V controlled medications via telemedicine for new and existing patients without conducting a prior in-person medical evaluation through 2024. Continue Reading Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule

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