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Health Elections & Politics

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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

Holland & Knight LLP

EPA Imposes More Stringent Lead Paint Dust Requirements

Holland & Knight LLP on

In response to a decision by the U.S. Court of Appeals for the Ninth Circuit finding that the U.S. Environmental Protection Agency's (EPA) updates to its lead paint hazard standards were deficient because they improperly took...more

Alston & Bird

When Disaster Strikes: Issues and Relief for Health Benefit Plans

Alston & Bird on

In the wake of a federally declared disaster, employees may face issues with their benefit plans. Our Employee Benefits & Executive Compensation Group discusses what plan administrators should know and the agency guidance...more

Robins Kaplan LLP

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

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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

Akin Gump Strauss Hauer & Feld LLP

FDA Authorizes Marketing for First Combination Flu and COVID-19 At-Home Test Outside of Emergency Use

On October 7, 2024, FDA granted marketing authorization for the over‑the‑counter combination flu and COVID-19 combination test, Healgen Rapid Check COVID-19/Flu A&B Antigen Test. Although other at‑home combination tests...more

Winstead PC

HIPAA Gets a Potential Counterpart in HISAA

Winstead PC on

Americans hear about cybersecurity incidents on a frequent basis. As the adage goes, it is not a matter of “if” a breach or security hack occurs; it is a matter of “when.”...more

Foley Hoag LLP

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

Foley Hoag LLP on

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

Fenwick & West LLP

California’s SB 1120 Regulates AI in Health Plan Utilization Review and Management Activities Starting in January

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On September 28, California Gov. Gavin Newsom signed Senate Bill 1120 Health Care Coverage: Utilization Review into law, amending § 1367.01 of the Health and Safety Code and § 10123.135 of the state’s Insurance Code....more

Hogan Lovells

Le durcissement économique progressif de l'industrie pharmaceutique en France

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Au travers de diverses évolutions récentes, la situation économique des entreprises pharmaceutiques opérant en France devient progressivement plus contraignante. ...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

Marshall Dennehey

Appellate Division Maintains Kind-for-Kind, Credential Equivalency Requirement Under Affidavit of Merit Statute

Marshall Dennehey on

Wiggins v. Hackensack Meridian Health, 478 N.J. Super. 355 (App. Div. 2024) - The plaintiffs alleged that the defendant, Dr. Goyal, prescribed tramadol to the decedent for pain associated with a medical condition. One month...more

Marshall Dennehey

Pennsylvania Superior Court Finds the Treatment of a Dog Bite Undeniably “Arises Out of” the Dog Bite and Medical Negligence...

Marshall Dennehey on

Early v. Patient First Medical Group, et al., 311 A.3d 608 (Pa. Super. Dec. 26, 2023) - The plaintiff was bitten by a dog and treated by the defendants. She later filed a medical malpractice action against the providers who...more

Hogan Lovells

Increasing financial regulation of the pharmaceutical sector by the French government

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Through various recent evolutions, the economic situation of the pharmaceutical companies operating in France become increasingly challenging. Various evolutions have recently occur in France: The Ministry of Health is...more

Fenwick & West LLP

California Governor calls Legislative Special Session Following Trump Election

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California Gov. Gavin Newsom has called a legislative special session “to safeguard California values and fundamental rights in the face of an incoming Trump administration,” his office announced today....more

Jones Day

FDA's New Human Foods Program: Enhancing Post-Market Safety Assessments of Chemicals in Food

Jones Day on

Food chemical safety is among Food and Drug Administration ("FDA") top priorities as it rolls out a new Human Foods Program, amid a flurry of federal and state legislation addressing food additive safety, resulting in a...more

Cozen O'Connor

Bipartisan AGs Reach $49 Million Settlement over Alleged Price-Fixing in Generic Drugs Market

Cozen O'Connor on

A bipartisan coalition of 50 states, D.C., and two territories reached settlements with Heritage Pharmaceuticals, Inc. and Apotex Corp. to resolve allegations of price fixing generic drugs in violation of the Sherman Act....more

Foster Swift Collins & Smith

IRS Announces 2025 Cost-of-Living Adjustments for Retirement Plans and for Health and Welfare Benefit Plans

The IRS has announced the 2025 cost-of-living adjustments for retirement plan and health and welfare benefit plan limitations. The charts below set forth the applicable limitations....more

Williams Mullen

Will 50 Enforcement Actions Be Sufficiently “Loud and Clear” that HIPAA’s Right of Access Must Be Honored?

Williams Mullen on

Because of pervasive misunderstanding of the Health Insurance Portability and Accountability Act (HIPAA), providers all too frequently create impermissible barriers to patient access to medical records. In many cases, such...more

Cozen O'Connor

Minnesota AG Settles with Blue Cross Blue Shield over Mental Health Parity

Cozen O'Connor on

Minnesota AG Keith Ellison has reached a settlement with BCBSM, Inc. d/b/a Blue Cross and Blue Shield of Minnesota, and HMO Minnesota d/b/a Blue Plus (collectively, “Blue Cross”) to resolve allegations that the insurer...more

Jackson Lewis P.C.

Marijuana Ballot Initiatives Approved in Nebraska, Defeated in Three Other States

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Nebraska voters approved medical cannabis measures, while voters in Florida, North Dakota, and South Dakota rejected ballot initiatives to legalize recreational cannabis on election day....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

K&L Gates LLP

Increasing Regulatory Scrutiny of Formaldehyde Under TSCA

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Companies using formaldehyde in their manufacturing processes and/or selling products incorporating formaldehyde-containing components from upstream suppliers face significant challenges in an evolving regulatory landscape....more

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