News & Analysis as of

Healthcare Reform Enforcement Actions

Foley & Lardner LLP

CMS Finalizes Rule Change Applying Preponderance of the Evidence Standard to Agent, Broker, and Web-Broker Exchange Agreement...

Foley & Lardner LLP on

In its recently issued Final Rule (CMS-9884-F; 90 FR 27074-01; the Final Rule), the Centers for Medicare and Medicaid Services (CMS) finalized revisions to 45 C.F.R. § 155.220(g)(2) to specify a standard of proof for...more

Bradley Arant Boult Cummings LLP

New Healthcare Practitioner Non-Compete Provisions Effective September 1, 2025

On June 20, 2025, Texas enacted SB 1318, modifying the criteria for enforceable healthcare practitioner non-competes in the Texas Business and Commerce Code. The modifications (1) limit the scope of enforceable physician...more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for June 2025, including a new Centers for Medicare & Medicaid Services (CMS) innovation model; proposed rules with significant...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

White & Case LLP on

On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

Sheppard Mullin Richter & Hampton LLP

DOJ and HHS Announce Joint False Claims Act Working Group and Enforcement Priorities

On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter - May 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2025, including the rollout of a new Centers for Medicare & Medicaid Services (CMS) strategy to expand and enhance Medicare...more

Clark Hill PLC

Beyond HIPAA: How state laws are reshaping health data compliance

Clark Hill PLC on

We are in an era where smartphones track sleep patterns, fitness apps monitor heart rates, and online searches reveal sensitive medical inquiries. As a result, the notion of “health data” has expanded dramatically. This...more

Health Care Compliance Association (HCCA)

From $5,000 to $800,000: Days Apart, OCR Security Settlements Show Puzzling Math

A single incident that may have started as a personal vendetta or an extortion threat seven years ago has cost a Florida health care system $800,000, and comes on the heels of an unrelated breach suffered by a different...more

McDermott Will & Emery

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

McDermott Will & Emery on

On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

McDermott Will & Emery

CMS Requires Hospitals to Publish More Pricing Information, Signals Focus on Enforcement

McDermott Will & Emery on

On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released new guidance for compliance with the hospital price transparency rule and published a request for information (RFI) seeking ways to bolster hospital...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Perkins Coie

New Utah AI Laws Change Disclosure Requirements and Identity Protections, Target Mental Health Chatbots

Perkins Coie on

Key Takeaways - - Utah has introduced five new bills that further shape its existing Artificial Intelligence Policy Act and add new requirements. - Both the scope of disclosure requirements surrounding the use of AI...more

Arnall Golden Gregory LLP

Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more

McDermott Will & Emery

Enforcement of Mental Health Parity Regulations Suspended: Takeaways for Plan Sponsors and Health Insurance Issuers

McDermott Will & Emery on

In January 2025, The ERISA Industry Committee (ERIC) filed a complaint against the US Departments of Labor, Health and Human Services, and the Treasury (the departments) seeking to invalidate the 2024 final regulations under...more

Foley & Lardner LLP

California Agency Cracks Down on High-Cost Hospitals

Foley & Lardner LLP on

California’s Office of Health Care Affordability (OHCA) is moving beyond broader policy-setting and into direct intervention at the provider level — a shift all hospitals and health systems across the state should take...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Weintraub Tobin

CMS Ramps Up Enforcement of Hospital Price Transparency Rule

Weintraub Tobin on

The Hospital Price Transparency Law, codified at 45 CFR Part 180 and effective as of January 1, 2021, was implemented to provide the public with accessible hospital pricing information, aiming to eliminate hidden fees and...more

Warner Norcross + Judd

Executive Order Directs Enhanced Enforcement of Group Health Plan Transparency Rules

Among the many Executive Orders issued by President Donald Trump’s administration, Executive Order 14221 (the “Order”) reinforces and expands healthcare price transparency enforcement. This Order builds on Executive Order...more

Zuckerman Spaeder LLP

What to Expect in Consumer Protection in the New Administration

Zuckerman Spaeder LLP on

At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more

Sheppard Mullin Richter & Hampton LLP

Proving Fraud is and Should Be Hard: Lessons from a Recent Medicare Advantage False Claims Act Decision

The litigator’s adage “it’s easy to plead, it’s hard to prove” once again came true in the long-running False Claims Act (FCA) case targeting Medicare Advantage (“MA”) plans operated by UnitedHealth (United). Eight years...more

Skadden, Arps, Slate, Meagher & Flom LLP

Closing the GRAS Loophole: Secretary Kennedy’s Plan To Enhance FDA Food Safety Regulations

On March 10, 2025, Health Secretary Robert F. Kennedy Jr. initiated a significant shift in the regulation of ultra-processed foods by directing the Food and Drug Administration (FDA) to revise the GRAS (Generally Recognized...more

McDermott Will & Emery

HHS Signals Action on Gender-Affirming Care

On March 5, 2025, the Center for Clinical Standards and Quality (CCSQ) within the Centers for Medicare & Medicaid Services (CMS) released a Quality & Safety Special Alert Memo for hospitals related to President Trump’s...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

McDermott Will & Emery

This Week in 340B: February 18 – 24, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

58 Results
 / 
View per page
Page: of 3

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide