At long last, the Drug Enforcement Administration (DEA) has signaled its consideration of a separate Special Registration for telemedicine prescribing for patients without requiring an in-person examination.
On August 4, 2023, DEA filed a pre-publication Notice of Meeting (published in
Health Care Law Today
Health Care Law Today, published by Foley & Lardner LLP, focuses on legal developments and regulatory issues affecting the healthcare industry. The blog covers topics such as digital health investment trends, telehealth privacy and security best practices, Medicare policy changes including behavioral health service expansions, remote patient monitoring regulations, and compliance with state vaccination requirements for healthcare facilities. It addresses the intersection of healthcare delivery, technology, and law, providing updates on federal and state regulations, reimbursement policies, and risk management strategies relevant to healthcare providers, payers, and investors.
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Regulatory Alert: DEA’s New Controlled Substance Theft or Loss Rule Includes a New Deadline and May Require Changes to Corporate Compliance Systems
On July 24, 2023, a new final rule from the Drug Enforcement Administration (DEA) became effective, with important consequences for companies and individuals registered to manufacture, distribute, or dispense controlled substances. Specifically, DEA will now require that registrants submit DEA’s…
Episode 27: Subsidy Arrangements Between Hospitals and Physician Practices: What You Should Know
In this episode, partner Jana Kolarik of Foley’s Health Care Practice Group, and Angie Caldwell, Consulting Principal and Tampa’s Office Managing Principal of PYA, discuss subsidy arrangements between hospitals, health care systems, and physician practices.
We encourage you to…
Decentralized Clinical Trials: Investigator Responsibilities
In the second edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administrations’ (FDA) expectations of investigators articulated in the recently released draft guidance. Investigators continue to be responsible for overseeing the…
CMS Proposes Remedy for 340B-Acquired Drug Payment Policy for CY 2018-2022
Along with its calendar year (CY) 2024 Medicare Outpatient Prospective Payment System (OPPS) proposed rule, the Centers for Medicare & Medicaid Services (CMS) have also published the long-awaited proposal to remediate the violations that arose from Medicare’s rate cuts…
HRSA Uninsured Program Covid-19 Services: OIG Audit Finds HRSA Paid for Claims that did not Comply with Federal Requirements
On July 13, 2023 the Office of Audit Services of the Department of Health & Human Services Office of Inspector General (OIG) released the long-awaited audit (A-02-21-01013) of the Health Resources and Services Administration (HRSA) Uninsured Program (UIP) (Audit…
Changing Landscape: Federal and State Regulators Focus on Protecting Consumer Health Data
Recent developments at the federal and state level demonstrate that regulators are focused on protecting consumer health data. Specifically, state and federal regulators want to close the gap between HIPAA-protected data and other consumer health data. HIPAA only regulates protected…
IP Toolbox Is Crucial In AI-Powered Drug Discovery
This article was originally published in Law360 on July 12, 2023 and is republished here with permission.
Navigating the complex landscape of drug discovery requires innovative strategies and interdisciplinary collaborations spanning biotechnology, pharmacology, medicine and engineering.
As the cost of…
Complex Healthcare Litigation Toolkit: The Use of Plaintiff Fact Sheets and Summary Jury Trials
On May 15 and 30, 2023, the Northern District of California conducted two “summary jury trials in a pharmaceutical lawsuit brought by patients who claimed that taking the U.S. Food and Drug Administration (FDA)-approved HIV/AIDS medication developed and manufactured by…
Medicare Revocations and Enrollment Denials: Proposed Rule Adds False Claims Act Judgments and Misdemeanors; Creates New “Stay of Enrollment”
Continuing a now annual tradition, the Centers for Medicare & Medicaid Services (CMS) has included expansions and enhancements to its authorities to deny enrollment or revoke a provider’s Medicare billing privileges (currently listed in 22 different categories) in Section III.K…