News & Analysis as of

Healthcare

Manatt, Phelps & Phillips, LLP

CMS Releases Proposed Forms to Effectuate Medicare MFP Under the IRA of IPAY 2026 and IPAY 2027

On October 28, CMS requested public comment​ on four proposed information collections (ICRs) it intends to impose on drug manufacturers and pharmacies in order to effectuate maximum fair prices (MFP) under the Inflation...more

Nelson Mullins Riley & Scarborough LLP

Federal Regulatory Update: CMS Medicare Payment Changes & Congressional Next Steps

The Centers for Medicare & Medicaid Services (CMS) have released significant updates affecting Medicare payments for 2025. The changes, outlined in two final rules, will impact both physicians and hospitals, eliciting strong...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Hetero USA Inc. - Entresto® (sacubitril/valsartan)

Robins Kaplan LLP on

Case Name: Novartis Pharms. Corp. v. Hetero USA Inc., Civ. No. 20-md-2930-RGA, 2024 WL 3757086 (D. Del. Aug. 12, 2024)....more

Akin Gump Strauss Hauer & Feld LLP

FDA Approves the First Flu Vaccine for At Home Use, Providing a Needle Free Option Outside of Traditional Health Care Settings

On September 20, 2024, the U.S. Food and Drug Administration (FDA) approved the first influenza (flu) vaccine for at‑home use. The vaccine, FluMist, is administered by nasal spray and prevents the flu by using a weakened...more

Foley Hoag LLP

What President-Elect Trump’s Victory Means for Healthcare in 2025

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Donald Trump will be the 47th President of the U.S. Not since 1892 has a President been elected to two non-consecutive terms, and his victory has helped Republicans pick up several critical seats in Congress. Senate...more

Sheppard Mullin Richter & Hampton LLP

California Limits Health Plan Use of AI in Utilization Management

California Governor Newsom signed Senate Bill 1120 into law, which is known as the Physicians Make Decisions Act. At a high level, the Act aims to safeguard patient access to treatments by mandating a certain level of health...more

Paul Hastings LLP

Paid Prenatal Personal Leave Goes Into Effect for Pregnant New Yorkers in 2025

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In April 2024, the New York State Legislature passed Governor Hochul’s 2025 Executive Budget that expands the statewide Paid Family Leave (PFL) policy to provide 20 hours of paid prenatal personal leave per 52-week period for...more

Harris Beach PLLC

“No Surprises Act” Ruling Favors Regulators, Insurers

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Share Federal regulators recently won a large legal victory when the Fifth Circuit Court of Appeals upheld several provisions of the rule regulating Qualified Payment Amount (“QPA”) calculations under the No Surprises Act...more

Manatt, Phelps & Phillips, LLP

CMS and CFPB Issue Joint Statement on Federal Efforts to Protect Low-Income Medicare Enrollees

On October 31, the Centers for Medicare & Medicaid Services (CMS) and the Consumer Financial Protection Bureau (CFPB) released a joint statement reiterating federal requirements aimed to “protect Qualified Medicare...more

Polsinelli

Calling All SNFs… and All of Your Operational Associates – Get Ready Now: Sweeping New Disclosure Requirements Under The Updated...

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Skilled Nursing Facilities and their operational associates need to prepare themselves now for new disclosure requirements that require much greater disclosure of ownership as well as disclosure from a much broader class of...more

McDermott+

Digesting the Huge Buffet of CMS Regs: Highlights from the CY 2025 PFS Final Reg

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While we all are focused on the election results, let’s take a quick break to digest some regs and eggs. The Centers for Medicare & Medicaid Services (CMS) “spoiled” all of us in the health policy world with a huge buffet of...more

Robins Kaplan LLP

Novartis Pharms. Corp. v. Becerra - Entresto® (sacubitril/valsartan)

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Case Name: Novartis Pharms. Corp. v. Becerra, No. 24-CV-02234 (DLF), 2024 WL 3823270 (D.D.C. Aug. 13, 2024) (Friedrich, J.)....more

Brownstein Hyatt Farber Schreck

Trump’s Alliance with RFK Jr. Indicates Realignment of Priorities for HHS in Second Term

As former President Donald Trump has clinched a second term with a victory, his health care priorities will differ somewhat from his first term, which focused heavily on repealing and replacing the Affordable Care Act (ACA)....more

BakerHostetler

What Washington is Thinking About This Morning…

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In a nation divided down the middle over politics, and in a handful of states where those divisions are concentrated, Americans narrowly but collectively voted in one direction, returning Donald Trump to the White House....more

McDermott Will & Emery

This Week in 340B: October 29 – November 4, 2024

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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

McDermott+

CMS Releases CY 2025 Hospital Outpatient Prospective Payment and ASC Payment Systems Final Rule

McDermott+ on

On November 1, 2024, the Centers for Medicare & Medicaid Services (CMS) released the calendar year (CY) 2025 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems Final Rule [CMS-1809-F],...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S. - ProAir® HFA (albuterol sulfate)

Robins Kaplan LLP on

Case Name: Teva Branded Pharm. Products R&D, Inc. v. Deva Holding A.S., Civ. No. 24-4404 (SRC), 2024 WL 3966314 (D.N.J. Aug. 28, 2024) (Chesler, J.)....more

Goldberg Segalla

Healthcare Insurers Take Note: New Federal Whistleblower Program is Coming for You

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Late this past summer, the Department of Justice (DOJ) launched a new initiative to crackdown on corporate misconduct. Beginning August 1, whistleblowers can submit original information to the DOJ regarding various types of...more

Oberheiden P.C.

Insulin Overpricing Lawsuits: 6 Things to Know

Oberheiden P.C. on

Anyone who needs insulin to treat diabetes knows that the cost of the drug has skyrocketed in the last few years. The reason for the sharp increase seems to be simple: corporate greed. Recently, though, the high price of...more

Epstein Becker & Green

Unpacking Averages: CDRH Recognition of Consensus Standards Appears to Overlook Software

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For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions....more

Foley & Lardner LLP

Quantum Computing’s Transcendence: Impacts on Industry

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In previous articles we addressed quantum computing’s expected impact on the foundational technologies underpinning today’s computing ecosystem. But entire industries stand to be radically transformed by its advent – from...more

Ropes & Gray LLP

Hospital and Health Systems Reimbursement Check - NOVEMBER 2024

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Ropes & Gray attorneys share their analysis of administrative and court litigation, regulatory developments, key developments affecting federal program payments to hospitals and health systems, and other reimbursement-related...more

Sheppard Mullin Richter & Hampton LLP

CMS Continues to Plan AHEAD Amid Rising Healthcare Costs

On October 28, 2024, the Centers for Medicare & Medicaid Services (“CMS”) announced the latest states to participate in the voluntary state total cost of care (“TCOC”) model: the All-Payer Health Equity Approaches and...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - October 2024 #5

News Briefs - 20 AGs Seek Immediate Injunction Over Nursing Home Staffing Rule - A group of 20 attorneys general asking a federal court to strike down the nursing home staffing rule also has now asked the court for an...more

Alston & Bird

Health Care Week in Review: CMS Releases PFS, OPPS, ESRD, and Home Health Final Rules; Senators Cassidy and Hassan Release a...

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

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