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Regulatory Requirements Enforcement Actions Health Care Providers

Hinshaw & Culbertson - Health Care

Emergency Alert! HHS Restricts Care for Immigrants—Health Centers Must Act Now

Overview of Key Changes and Immediate Impacts - Key Policy Shift: Section 330 Grants now treated as a “Federal Public Benefit” - The U.S. Department of Health and Human Services (HHS) now classifies the Health Center Program...more

Hendershot Cowart P.C.

Qlarant, Novitas Audits Escalate as Medicare Skin Substitutes Spending Hits $1.6 Billion, CMS Seeks Evidence of Clinical...

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The wound care industry faces unprecedented scrutiny as Medicare Part B expenditures for skin substitutes exceeded $1.6 billion in the fourth quarter of 2023 alone. The spending surge has triggered a wave of skin substitute...more

Morgan Lewis

AI in Healthcare: Opportunities, Enforcement Risks and False Claims, and the Need for AI-Specific Compliance

Morgan Lewis on

The risks associated with the growth of AI in the healthcare and life sciences industries, as well as recent federal and state activity and enforcement actions, emphasize the importance of understanding and implementing a...more

Bodman

DOJ Data Security Program – Another Privacy and Security Law that Impacts the Health Care Industry

Bodman on

The Department of Justice (“DOJ”) implemented the Data Security Program (“DSP”) intending to prevent access to Americans’ bulk sensitive personal data and government-related data by Countries of Concern. The DSP is aimed at...more

Ropes & Gray LLP

Navigating TRAIGA: Texas’s New AI Compliance Framework

Ropes & Gray LLP on

On June 22, 2025, Texas enacted the Texas Responsible Artificial Intelligence Governance Act (“TRAIGA”), putting it at the forefront of state-level AI regulation in the United States. TRAIGA becomes effective January 1, 2026....more

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

Jackson Lewis P.C. on

In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more

Foley & Lardner LLP

GLP-1 Compounded Medications Targeted by Connecticut Attorney General

Foley & Lardner LLP on

On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more

Wiley Rein LLP

FTC Sends Warning Letters to 37 Eyeglass and Contact Lens Prescribers Over Possible Rule Violations

Wiley Rein LLP on

On June 3, 2025, the Federal Trade Commission (FTC) announced its staff had sent warning letters to 37 contact lens prescribers that, according to the FTC, were the subject of consumer complaints concerning possible...more

Greenbaum, Rowe, Smith & Davis LLP

Legal Risks and Challenges for Private Equity in Healthcare Acquisitions

Private Equity (PE) firms continue to be significant players in U.S. healthcare, acquiring assets across various sectors such as physician practices, home health, behavioral health, and urgent care. However, recent legal...more

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

Gardner Law on

FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Roetzel & Andress

ADA Compliance for Medical and Dental Practices: Responding to Inquiries and Investigations

Roetzel & Andress on

Join us on the HealthLawHotSpot as host Ericka Adler and Michael Brohman, shareholder and member of Roetzel’s Employment Litigation Group, discuss ADA compliance for medical and dental practices. In this episode, you'll learn...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

McDermott Will & Emery

CMS Poised for Medicare, Medicaid Integrity Enforcement Actions

McDermott Will & Emery on

The Trump administration and 119th Congress are preparing to reduce federal expenditures by targeting Medicare and Medicaid fraud, waste, and abuse. Medicare enrollment revocations, Medicaid enrollment terminations, and...more

Health Care Compliance Association (HCCA)

OCR Loses Staff, Faces Move to New ‘Enforcement’ Office; Will HIPAA Focus, Independence Suffer?

Today, the HHS Office for Civil Rights (OCR) stands shoulder-to-shoulder with the likes of the Office of Inspector General and Office of General Counsel, one of just a dozen or so agencies reporting directly to the secretary....more

Saul Ewing LLP

New Executive Order and the Risks of Non-Compliance with Healthcare Price Transparency Rules

Saul Ewing LLP on

On February 25, 2025, President Trump issued an Executive Order titled “Making America Healthy Again by Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information” (the 2025 Order). This directive...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

States Follow Federal Lawmakers in Bipartisan Focus on Private Equity

For at least five years, under both Republican and Democrat administrations, there has been a focus on private equity actors in the healthcare space. Since at least 2020, the Department of Justice (DOJ) has focused on private...more

Baker Donelson

Looking Back at 2024: Key Health Care Regulatory Legal Developments in Fraud and Abuse, Compliance, and Enforcement

Baker Donelson on

The health care regulatory space realized significant regulatory and enforcement developments in 2024 that are influencing how providers and industry stakeholders approach various compliance measures and enforcement...more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Shumaker, Loop & Kendrick, LLP

Client Alert: The Agency for Health Care Administration Updates Background Screening Regulation

The Agency for Health Care Administration (AHCA) has updated Florida Administrative Rule 59A-35.090 for background screening. This update is to align with 2024 legislation, which added additional disqualifying offenses to the...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...more

Alston & Bird

FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers

Alston & Bird on

Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

Bass, Berry & Sims PLC

13th Annual Healthcare Fraud & Abuse Review - 2024

Bass, Berry & Sims is pleased to announce the release of the 13th annual Healthcare Fraud & Abuse Review examining important healthcare fraud developments in 2024. Compiled by the firm's Healthcare Fraud & Abuse Task Force,...more

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