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Centers for Medicare & Medicaid Services (CMS) Department of Justice (DOJ) Food and Drug Administration (FDA)

Holland & Knight LLP

What's Next for the Regulatory Landscape Post-Chevron?

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For nearly 40 years and in more than 18,000 judicial opinions, federal courts have used the Chevron doctrine to defer to an agency's reasonable interpretation of an ambiguous statute. On June 28, 2024, the U.S. Supreme Court...more

Holland & Knight LLP

Holland & Knight Health Dose: June 11, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include:...more

Holland & Knight LLP

Holland & Knight Health Dose: May 14, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Gardner Law

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

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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

Manatt, Phelps & Phillips, LLP

Access to Care for Justice-Involved Pregnant People With a Substance Use Disorder

There is a critical need to increase access to evidence-based care for justice-involved pregnant people with a substance use disorder (SUD)—and connect them to continued coverage and care upon release—according to national...more

Paul Hastings LLP

Finance in Five Minutes: Healthcare Finance Checkup

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While mergers and acquisitions, and attendant financings may not be at a blistering pace globally, the prognosis for deal activity in the healthcare sector remains healthy, in particular as the consolidation of providers, the...more

ArentFox Schiff

Kitchen Sink MDRP Proposed Rule Radically Changes Best Price Determination Resulting in Financial and Operational Challenges for...

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On May 26, 2023, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule titled: “Medicaid Program: Misclassification of Drugs, Program Administration and Program Integrity Updates Under the Medicaid Drug...more

Foley Hoag LLP

United States v. Elizabeth Holmes and Ramesh Balwani

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I. WHY THIS CASE MADE THE LIST - A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more

ArentFox Schiff

Pharmacy Benefit Manager Reform Remains Legislative Priority

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The 2022 midterms have concluded, but the Republican underperformance is not expected to dampen Congressional enthusiasm for Pharmacy Benefit Manager (PBM) reform. The issue remains at the forefront of the healthcare pricing...more

Benesch

Dialysis & Nephrology Digest - August 2022

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DOJ files civil complaint alleging Fresenius performed unnecessary procedures on dialysis patients - In June, it was revealed that DOJ would partially join a whistleblower lawsuit against the dialysis provider. In a civil...more

King & Spalding

DOJ and HHS Issue Healthcare Fraud and Abuse Control Program Fiscal Year 2021 Report

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Last week, DOJ and HHS-OIG published its annual report regarding the Healthcare Fraud and Abuse Control (HFAC) Program (the Report). The Report summarizes the enforcement activity of DOJ and HHS and states that during Fiscal...more

Mintz - Health Care Viewpoints

DOJ Announces Another Wide-Ranging COVID-19 Fraud Enforcement Action

For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more

Oberheiden P.C.

6 Frequently Asked Questions with Lab Defense Attorney Nick Oberheiden

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Clinical laboratories have come under increased scrutiny in the past few years, especially those that deal with COVID-19 testing or drug testing. These federal investigations can be surprising and confusing for lab...more

McGuireWoods Consulting

Washington Healthcare Update - July 2021 #3

This week in Washington: Infrastructure talks continue, Labor HHS Appropriations bill clears House Committee and is on the way to the floor....more

MoFo Life Sciences

Biden Administration Executive Order On Promoting Competition In The American Economy: Drug Pricing And Healthcare Industry...

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On July 9, 2021, President Biden enacted a sweeping executive order creating a “whole‑of-government competition policy.” Morrison & Foerster outlined the administration’s policy in a recent client alert that provides a...more

Benesch

Dialysis & Nephrology Digest - January 2021 #2

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CMS to reprocess excepted off-campus provider-based outpatient claims following court ruling - CMS says it’ll begin reprocessing claims for outpatient clinic visit services provided at excepted off-campus provider-based...more

McGuireWoods Consulting

Washington Healthcare Update - October 2020 #1

This week in Washington: The Continuing Resolution (CR) to fund the government until Dec. 11 was signed by President Trump; House passes COVID-19 stimulus bill....more

ArentFox Schiff

HHS Proposes New Practices for Issuance of Guidance Documents

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In a move with far reaching implications for the health care industry, the Department of Health and Human Services (HHS) recently released a proposed rule that would codify into regulation specific requirements that it and...more

McGuireWoods Consulting

Washington Healthcare Update - August 2020 #4

This week in Washington: Congress remains in a district work period, while COVID-19 legislative talks continue....more

McGuireWoods Consulting

Washington Healthcare Update - May 2020 #3

This week in Washington: House hearing on the response to COVID-19 by the Department of Veterans Affairs; Senate hearing on caring for seniors amid the COVID-19 crisis....more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - May 2019

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

McGuireWoods Consulting

Washington Healthcare Update April 2019

Upcoming Hearings - Tuesday, April 2, 2019 - House Committee on Energy and Commerce: “Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs” - The Subcommittee on Oversight and Investigations of the...more

Saul Ewing LLP

2019 Health Care Predictions

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INTRODUCTION - The Saul Ewing Arnstein & Lehr, LLP health care practice group includes attorneys that handle regulatory, compliance, transactional and litigation needs for clients across the entire health care delivery...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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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

Holland & Knight LLP

Healthcare Law Update: February 2018

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Antitrust - FTC Announces Revised Hart-Scott-Rodino Thresholds for Acquisitions and Exclusive Licenses - The Federal Trade Commission (FTC) has announced this year's revisions to the thresholds under the...more

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