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Health Environmental

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
McDonnell Boehnen Hulbert & Berghoff LLP

Shockwave Medical, Inc. v. Cardiovascular Systems, Inc. (Fed. Cir. 2025)

Received wisdom is that inter partes review proceedings are limited to prior art as defined by patents and printed publications.  But in recently decided Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., another prior...more

McDermott Will & Emery

Motivation, expectation of success negate obviousness presumption in overlapping range case

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit affirmed (on its second review) a district court’s ruling upholding the validity of patent claims related to a long-acting injectable dosing regimen, finding that the...more

Sheppard Mullin Richter & Hampton LLP

Policy Brief: Aligning Nursing Home Bed Planning with New York’s Certificate of Need Reform Goals

Last month, New York State began a formal review of its Certificate of Need (CON) process for nursing homes, launching a timely conversation about how best to align regulatory oversight with evolving system needs. A new...more

Keating Muething & Klekamp PLL

Benefits Monthly Minute - July 2025

The July Monthly Minute highlights several benefits provisions under the One Big Beautiful Bill Act and offers reminders about upcoming PCORI and Form 5500 deadlines. Many Benefits, One Big Beautiful Bill On July 4, 2025,...more

Ballard Spahr LLP

Courts Split on Enforcement of No Surprises Rules

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The Fifth Circuit and the Federal District Court of Connecticut have issued conflicting decisions on whether service providers may sue to enforce arbitration awards under the No Surprises Rules in the Consolidated...more

Holland & Knight LLP

Healthcare Coalition Sues HHS Secretary Kennedy Over Vaccine Policy Changes

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On July 7, 2025, a coalition of healthcare organizations – including the American Academy of Pediatrics, American College of Physicians and Infectious Diseases Society of America, along with a pregnant Massachusetts physician...more

Akin Gump Strauss Hauer & Feld LLP

FDA Green Lights Another Natural Food Color

This week, the U.S. Food and Drug Administration (FDA) granted another color additive petition, approving the use of Gardenia (Genipin) in various food and beverage products. This marks the fourth naturally-derived color...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces AI Councils Amid Calls for Greater Agency Transparency

Recently, it was reported that the U.S. Food and Drug Administration (FDA) is launching two cross-agency artificial intelligence (AI) councils. One AI council will be tasked with addressing how the agency uses AI internally...more

Hogan Lovells

FDA issues letter to industry on recall communications for infant and baby foods

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On July 9, 2025, the U.S. Food and Drug Administration (FDA) issued a letter from Commissioner for Human Foods Martin Makary and Deputy Commissioner for Human Foods Kyle Diamantas to industry members involved in the...more

Maynard Nexsen

Understanding CMS’ Proposed Physician Payment Rule for 2026

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On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) unveiled its proposed rule for the 2026 Medicare Physician Fee Schedule (PFS), aiming to enhance the quality of care for Medicare beneficiaries while...more

Troutman Pepper Locke

Strategic Alignment With Collaboration Partners Is Essential to a Successful Life Sciences M&A Exit

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In the midst of shifting political headwinds and a tight funding market, many life sciences companies are considering their M&A exit. Potential acquirers (both strategic and private equity) have plenty of dry powder and are...more

Kilpatrick

Healthcare Fraud in the False Claims Act Enforcement Crosshairs: Why Now is the Time to Strengthen Compliance Efforts

Kilpatrick on

The U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) have announced that they are revitalizing the DOJ-HHS False Claims Act Working Group. The primary focus of the working group will be...more

Benesch

Dialysis & Nephrology Digest - July 2025

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CMS Releases Proposed Rule for 2026 ESRD PPS - As the nephrology organization representing the specialty on socioeconomic and physician practice issues, the Renal Physicians Association analyzes and disseminates...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Cozen O'Connor

FDA Transparency Push: CRLs Released

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On July 10, 2025, citing a drive to increase transparency, the Food and Drug Administration (“FDA”) published more than 200 complete response letters (CRLs) previously issued to companies that had submitted new drug...more

Kelley Drye & Warren LLP

The FTC Takes a ShOt at Telehealth Program for Allegedly Deceptive Pricing, Consumer Reviews, and Weight Loss Claims

In an enforcement action akin to an advertising law issue spotting exam, the FTC announced this week a settlement with a telemedicine company and its principals for allegedly using misleading pricing claims that failed to...more

Jackson Lewis P.C.

OSHA’s 2025 Amputations NEP: Key Changes Manufacturers Should Know

Jackson Lewis P.C. on

The Occupational Safety and Health Administration (OSHA) has issued its 2025 update to the National Emphasis Program on Amputations in Manufacturing Industries (Amputations NEP), renewing the program and introducing several...more

Ropes & Gray LLP

FDA Commissioner Makary Promises “Real Time” Release of Complete Response Letters: Can FDA Really Do That?

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On July 10, 2025, in the name of embracing “radical transparency,” the U.S. Food and Drug Administration (“FDA”) announced that it was publishing more than 200 complete response letters (“CRLs”) issued in response to drug and...more

McDermott+

CMS releases CY 2026 Physician Fee Schedule Proposed Rule

McDermott+ on

On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-13271]...more

A&O Shearman

A new European strategy to foster life sciences innovation and market access

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On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

McDermott Will & Emery

This Week in 340B: July 8 – 14, 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

McDermott+

Digesting a giant reg: the CY 2026 Medicare Physician Fee Schedule proposed rule

McDermott+ on

Earlier this week, the Centers for Medicare & Medicaid Services (CMS) issued the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed reg. Stakeholders have highly anticipated the release of this reg, as it...more

Mintz - Health Care Viewpoints

California’s Office of Health Care Affordability – First Ever Cost and Market Impact Review and Potential Expansion of Office’s...

Since April 2024, the California Department of Health Care Access and Information (HCAI), Office of Health Care Affordability (OHCA) has received twenty-six Material Change Transaction Notices (Notices) as part of its...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Biosimilars Boom: 2025’s Fast Track Approvals Look to Reshape Healthcare

With healthcare costs rising and biologics driving a large portion of drug spend, the next wave of biosimilar launches promises to reshape the U.S. pharmaceutical market in profound ways, including reduced prices for close...more

Proskauer - Law and the Workplace

New York State COVID-19 Sick Time Requirement to Sunset on July 31, 2025

New York State employers are reminded that, beginning July 31, 2025, they will no longer be required to provide COVID-specific sick time to employees. Since March 2020, New York employers have been required to provide...more

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