News & Analysis as of

Final Rules Enforcement Actions Health Care Providers

Morgan Lewis - ML Benefits

Reproductive Healthcare Privacy Final Rule Vacated by Texas Court

The US District Court for the Northern District of Texas on June 18, 2025 vacated portions of the HIPAA Privacy Rule to Support Reproductive Health Care Privacy (2024 Final Rule) related to reproductive healthcare privacy....more

McDermott Will & Emery

FDA Relaxes Critical Positions on Use of Scientific Information in Off-Label Communications

McDermott Will & Emery on

On January 6, 2025, the US Food and Drug Administration (FDA) published final guidance titled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

Goodwin on

On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

HHS Finalizes Disincentives for Healthcare Providers That Have Committed Information Blocking

King & Spalding on

Last week, HHS published its final rule outlining disincentives for certain healthcare providers that have committed information blocking (the Final Rule). The Final Rule also provides information related to OIG’s...more

Mintz - Health Care Viewpoints

FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to Stakeholders

The Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs) in the Federal Register on May 6, marking a watershed moment in the agency’s arduous decade-plus-long journey toward winding...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

McDermott Will & Emery

[Webinar] How Not to Lose $1M: Preparing for HHS-OIG Info Blocking Enforcement - August 15th, 1:00 pm - 2:00 pm EDT

The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more

Health Care Compliance Association (HCCA)

[Event] Chicago Regional Healthcare Compliance Conference - October 22nd, Chicago, IL

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Health Care Compliance Association (HCCA)

[Event] Indianapolis Regional Healthcare Compliance Conference - September 24th, Indianapolis, IN

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more

Sheppard Mullin Richter & Hampton LLP

Secret Rules and Hidden Penalties: Biden Executive Order Takes Aim at the Trump Administration’s Efforts to Limit HHS’s Use of...

Executive Orders and the Biden Administration’s promises to postpone or withdraw certain last-minute, so-called “midnight rules” promulgated by the Trump Administration are currently grabbing everyone’s attention, especially...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Regional Healthcare Compliance Conference - Denver, CO - October 16th, 8:25 am - 5:00 pm MDT

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Akin Gump Strauss Hauer & Feld LLP

Interoperability and Information Blocking: What Providers, Payers and IT Developers Need to Know about New Enforcement Timelines

- On May 1, 2020, the ONC Interoperability, Information Blocking, and Health IT Certification Program Final Rule and the CMS Interoperability and Patient Access Final Rule were published in the Federal Register, marking the...more

Mintz - Health Care Viewpoints

Skeletons in the Closet? Beware of Potential Enforcement Actions

With Halloween looming, a discussion of skeletons that may be lurking in a health care provider’s closet is timely. Many of our previous posts, as well as the monthly Qui Tam Updates published by our Health Care Enforcement...more

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