News & Analysis as of August 18, 2025

Patient Protection and Affordable Care Act (PPACA)

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The Anti-Kickback Statute is a United States federal criminal statute that prohibits the exchange (or the promise to exchange) of anything of value for referrals of federal healthcare program business. The statute aims to prevent situations where government officials channel federal healthcare dollars towards particular providers, who have offered or given the official a personal benefit. Penalties for violation of the Anti-Kickback statute apply to both sides of a prohibited transaction and can include jail time and steep monetary fines. less -

Healthcare Regulatory Check-Up Newsletter | June 2025 Recap

McDermott Will & Schulte on 7/28/2025

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

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

McDermott Will & Schulte on 5/28/2025

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

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Schulte on 4/28/2025

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

Welcome to the Post-Chevron World: HHS on the Defensive

Stevens & Lee on 7/29/2024

The Supreme Court’s recent ruling in Loper Bright Enterprises v. Raimondo (and its companion case, Relentless v. Department of Commerce), in which it overruled the Chevron doctrine, has received a great deal of attention...more

Additional Disclosure Required: CMS Implements Substantial Changes to Reporting Skilled Nursing Facility Ownership Information

Goodwin on 12/1/2023

On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) issued a Final Rule that will require skilled nursing facilities (SNFs) to disclose an expanded array of ownership, managerial, and control information...more

Dialysis & Nephrology Digest - December 2022

Benesch on 12/7/2022

Benesch: AKS claims against Azura dropped; FCA allegations to continue with DOJ intervention - The DOJ filed an Amended Intervenor Complaint in Aug. alleging between 2012 and 2018, Fresenius Medical Care’s business unit,...more

Healthcare Regulatory Check-Up Newsletter | August 2022 Recap

McDermott Will & Schulte on 9/1/2022

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant enforcement activity between July 21 and August 20, 2022. Key updates include a case in which the US Court of Appeals for the Eighth Circuit...more

Latest Open Payments Data Released Under Heightened Government Scrutiny

Foley & Lardner LLP on 7/9/2021

On June 30, 2021, the Centers for Medicare & Medicaid (CMS) released Open Payments data for the past year, 2020. This new data publication comes amid heightened government scrutiny of payments by drug and medical device...more

New Opportunities in Value-Based Care Part 1: New Opportunities for Provider Collaboration

Nelson Mullins Riley & Scarborough LLP on 5/4/2021

This is the first in a five- part series discussing the new Value-Based Regulations adopted last year by the Centers for Medicare & Medicaid Services and the Office of Inspector General. At the end of 2020 the Centers for...more

He Actually Did It: Trump Administration Implements Medicare Part B “Most Favored Nation” Drug Pricing Reform

King & Spalding on 11/24/2020

On November 20, 2020, 60 days before the end of his Administration, President Trump announced a series of major drug pricing regulations. This Alert summarizes the Most Favored Nation Model (“MFN Model”) for Medicare Part B...more

Medtronic Settles Kickback And Open Payments Violations For $9.2M

Rivkin Radler LLP on 11/13/2020

The U.S. Department of Justice (DOJ) announced on October 29 that Medtronic USA Inc. agreed to pay $8.1 million to settle allegations that it violated the False Claims Act (FCA) and federal Anti-Kickback Statute by paying...more

New Risks, New Rewards, New Exposure

King & Spalding on 6/24/2020

Value-Based Purchasing, Multiple Best Prices, Expanded Alternative URA, and other MDRP Drug Pricing Changes in Proposed Rule - On June 17, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released a major...more

Healthcare Law Update: October 2019

Holland & Knight LLP on 10/15/2019

In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Healthcare Law Review: Overview of the U.S. Healthcare System

Foley & Lardner LLP on 10/11/2019

The U.S. healthcare industry remains at a crossroads. The healthcare reform legislation passed under President Barack Obama in 2010, officially called the Patient Protection and Affordable Care Act (ACA) but widely referred...more

Executive Order on Hospital Price Transparency May Prompt Disclosure of Negotiated Prices

McDermott Will & Schulte on 6/28/2019

President Trump has issued an Executive Order instructing several federal agencies to begin rulemaking processes intended to increase the transparency of hospital pricing. Among other measures, the Executive Order directs the...more

Health Care Weekly Preview from ML Strategies – September 2018 #2

Mintz - Health Care Viewpoints on 9/11/2018

With the first wave of Kavanaugh confirmation drama complete, the Senate is expected to vote on an opioid package this week. It’s a noteworthy step for the Senate although it’s still not entirely clear what a final package...more

Stark Under the Microscope: Congress and HHS Examine Reform of the Stark Law for a Value-Based System

Bass, Berry & Sims PLC on 7/19/2018

On July 17, 2018, the U.S. House of Representatives' Ways and Means Committee Subcommittee on Health ("Subcommittee") expressed its commitment to modernizing the Stark Law during a hearing in which industry and government...more

Healthcare Fraud & Abuse Review 2017

Bass, Berry & Sims PLC on 3/13/2018

A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Lifting the Limits on Physician-Owned Hospitals: Can Regulators Prevail Where Legislators Have Stalled?

Sheppard Mullin Richter & Hampton LLP on 3/5/2018

We reported, in early 2017, on what was then the latest legislative effort to repeal the Affordable Care Act’s amendment to the Stark Law’s whole hospital exception, which amendment has effectively prevented new...more

Health Law Insights: January Newsletter

Roetzel & Andress on 1/27/2017

ALERT: Health Reform Outlook for 2017: A Year of Major Uncertainty - Fulfilling their promises, Congressional Republicans moved to repeal the Affordable Care Act (ACA) on the first day of the new Congress when Senate...more

OIG Revises Safe Harbors under the Anti-Kickback Statute and Civil Monetary Penalty Rules Regarding Beneficiary Inducements

McDermott Will & Schulte on 12/14/2016

On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services published a final rule containing revisions to both the federal Anti-Kickback Statute safe harbors and the beneficiary...more

Health Law Insights Newsletter - Issue 13

McCarter & English, LLP on 10/17/2016

McCarter & English, LLP’s Health Care Group presents Issue 13 of the Health Law Insights, which discusses the latest legal issues in the health care industry. - Failure to Update Business Associate Agreement Results in...more

Health Law Pulse - January 2016

Robinson & Cole LLP on 1/6/2016

CHANGES TO STARK LAW, NEW ADVANCE CARE PAYMENTS INCLUDED IN 2016 PHYSICIAN FEE SCHEDULE - The Centers for Medicare & Medicaid Services (CMS) recently published a final rule (Final Rule) regarding physician payment...more

Skeletons in the Closet? Beware of Potential Enforcement Actions

Mintz - Health Care Viewpoints on 10/29/2015

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

Two More Hospitals Qualify for Exception to Exception to Grandfather Exception to Elimination of Whole Hospital Exception to Stark...

Faegre Drinker Biddle & Reath LLP on 9/18/2015

The Stark Law generally prohibits physicians from referring Medicare and Medicaid patients to facilities in which they have an ownership interest. There used to be a “whole hospital exception” excluding entire hospitals (as...more

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