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Enforcement Actions Regulatory Requirements Centers for Medicare & Medicaid Services (CMS)

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

WilmerHale

2024 CMS Audit and Enforcement Report

WilmerHale on

On July 15, 2025, the Centers for Medicare & Medicaid Services (CMS) released an Audit and Enforcement Report summarizing its annual Medicare Advantage (Part C) and Prescription Drug (Part D) program audits and enforcement...more

Hendershot Cowart P.C.

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

Hendershot Cowart P.C. on

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

King & Spalding

CMS Announces Heightened Financial Oversight to Detect Misuse of Medicaid Funds Used for Immigrant Care

King & Spalding on

CMS announced in a letter released on Tuesday, May 27, 2025 (CMS Letter) that it will ramp up financial oversight of states to detect misuse of federal Medicaid funds “[t]o ensure that federal money is not used to pay for or...more

McDermott Will & Schulte

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

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

Proskauer - Health Care Law Brief

CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts

On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more

Epstein Becker & Green

Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®

On March 31, 2025, the U.S. District Court for the Eastern District of Texas ruled that the Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory-developed tests (LDTs). The court’s judgment...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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 & Schulte

CMS Poised for Medicare, Medicaid Integrity Enforcement Actions

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

Dickinson Wright

Federal Enforcement of Mental Health Parity: Key Updates and Challenges Ahead

Dickinson Wright on

On January 17, 2025, the U.S. Departments of Labor, Health and Human Services, and the Treasury (“the Departments”) issued their 2024 Report to Congress on the enforcement and implementation of the Mental Health Parity and...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

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

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

Wiley Rein LLP

Trump Prioritizes Health Care Pricing Transparency in New Executive Order

Wiley Rein LLP on

On Tuesday, February 25, 2025, President Trump issued an Executive Order (EO), “Making America Healthy Again By Empowering Patients with Clear, Accurate, and Actionable Healthcare Pricing Information.” The EO aims to improve...more

Goodell, DeVries, Leech & Dann, LLP

Understanding CMS “Immediate Jeopardy” Investigations in Healthcare Facilities

When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more

Baker Donelson

CMS Revises Immediate Jeopardy Guidance: Key Updates for Providers

Baker Donelson on

The federal Centers for Medicare and Medicaid Services (CMS) issued QSO-25-09-ALL on November 21, 2024, revising Core Appendix Q guidance to the State Operations Manual on Immediate Jeopardy. Immediate Jeopardy (IJ) is the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - November 1st, Scottsdale, AZ

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Gardner Law

[Hybrid Event] “Steer” Clear of Legal Lassos: Readiness Strategies for FDA-Regulated Companies - May 1st, Austin, TX

Gardner Law on

Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2023 Managed Care Compliance Conference - January 31st - February 2nd, 8:25 am - 3:15 pm CT

Join us for our annual event dedicated to compliance management for health plan providers. Learn the latest best practices and emerging trends from industry leaders while making connections with peers and mentors who...more

Health Care Compliance Association (HCCA)

[Virtual Event] Indianapolis & Pittsburgh Regional Healthcare Compliance Conference - October 7th, 8:25 am - 4:30 pm EDT

General and specialty compliance training from the comfort of your home or office! HCCA’s Regional Healthcare Compliance Conferences provide practitioners with virtual compliance training that includes updates on the...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

McDermott Will & Schulte

[Ongoing Program] On Location: New CMS Hospital Co-Location Guidance in the Spotlight - February 17th, 12:30 pm - 1:30 pm ET

Hospital and health systems rely on vendors and other partners to provide vital services that support patient care, efficient operations and smooth administrative functions. However, the regulations governing different types...more

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