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Regulatory Requirements Appeals Healthcare

Buchalter

9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

Buchalter on

The Eliminating Kickbacks in Recovery Act, enacted in 2018, was a bombshell for the addiction treatment and diagnostic laboratory industries. For the first time, paying commissions for sales and marketing services was...more

BakerHostetler

In Case of First Impression, Looking to AKS Precedent, Ninth Circuit Affirms EKRA Conviction for Improper Payments to Marketers

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In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...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

Troutman Pepper Locke

Federal Ruling on CMS Staffing Mandate Offers Relief for Long-Term Care Facilities

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Long-term care facilities, embattled by rising costs and potential Medicaid cuts, are seeing some relief on the horizon following a recent federal court ruling that struck down portions of the Centers for Medicare & Medicaid...more

Hanson Bridgett

Federal Judge Vacates Key Provisions of CMS’s Nursing Home Staffing Mandate

Hanson Bridgett on

Earlier last week, Hon. Matthew J. Kacsmaryk of the U.S. District Court for the Northern District of Texas vacated two key provisions of CMS’s 2024 nationwide staffing mandate, the requirements that skilled nursing facilities...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

Akin Gump Strauss Hauer & Feld LLP

District Court Vacates FDA LDT Rule; What’s Next for Regulation of Lab Testing?

On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA. Judge Jordan’s decision vacates and sets...more

McDermott Will & Emery

This Week in 340B: March 25 – 31, 2025

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

Littler

New York Court Issues Decision and Order Declaring the DOH’s August 2024 Reimbursement Rate Adjustment for Fiscal Intermediaries...

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On March 20, 2025, a New York Supreme Court Justice in Albany County issued a decision and order declaring the New York State Department of Health (NY DOH)’s August 2024 implementation of an administrative rate reimbursement...more

McDermott Will & Emery

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

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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

Stotler Hayes Group, LLC

Medicare Advantage Plans Onerous Prior Authorizations Requirements & Negative Impacts on Skilled Nursing Facilities

Traditional Medicare (Parts A and B) and Medicare Advantage (Part C, including additional vision, dental, and hearing benefits) plans aim to provide comprehensive medical benefits to American Seniors and adults with...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

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ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

Seyfarth Shaw LLP

The Health Care Provider Exemption to Emergency Paid Sick Leave in the Families First Coronavirus Act - Are you Covered?

Seyfarth Shaw LLP on

Yesterday, the Department of Labor issued temporary regulations regarding the “health care provider” exemption to employer-provided paid time off and paid leave under the Families First Coronavirus Response Act (“FFCRA”)....more

Littler

NY Court of Appeals Decision Saves the NY Home Care Industry – What’s Next for Home Care Providers?

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New York’s vast home care industry and those who rely on their services breathed a sigh of relief on March 26, 2019, when the New York Court of Appeals gave providers the green light to continue to pay home care aides for 13...more

Littler

A Paramount Reversal Just Saved the NY Home Care Industry

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The day most anxiously anticipated (or dreaded) by the vast home care industry in New York has arrived, and a huge sigh of relief from home care agencies and New Yorkers who rely on their services can be heard across the...more

FordHarrison

NY Court of Appeals Upholds 13 Hours Pay for 24-Hour Shift Home Health Aides

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Yesterday the New York Court of Appeals issued its long-awaited decision on 24-hour shift home health aides who work as “sleep-in” workers....more

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