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Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
Hogan Lovells

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

Hogan Lovells on

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

Maynard Nexsen on

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

Troutman Pepper Locke on

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

Benesch on

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

Gardner Law on

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

Cozen O'Connor on

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?

Ropes & Gray LLP on

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

A&O Shearman on

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

McDermott Will & Emery on

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

Harris Beach Murtha PLLC

Changed Laws and Regulations Impact Reproductive Health Care Providers

Within the past few months, the legal landscape for reproductive health care law has changed on both the federal and state levels. The Trump Administration has changed its approach, revising positions in administrative...more

Foley & Lardner LLP

Episode 36: Let’s Talk Compliance: The Risks and Pitfalls of Health Care Supply Chain Compliance

Foley & Lardner LLP on

In this episode, Monica Chmielewski, vice chair of Foley’s Health Care Practice Group and Shannon Sumner, Chief Compliance Officer and Nashville’s Office Managing Principal of PYA explore how supply chain compliance is...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Epstein Becker & Green

Shielding Reproductive Freedom: Uncovering New York’s Law Protecting Providers from Civil and Criminal Liability

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In the wake of the Dobbs decision, which eliminated the constitutional right to abortion, individual states were left to regulate or ban the procedure....more

Littler

Senate HELP Committee Hearing: Key Takeaways for Employers from the July 16, 2025 Nomination Review

Littler on

On July 16, 2025, the Senate Health, Education, Labor, and Pensions (HELP) Committee convened to review the nominations of three individuals whose roles could significantly shape the future of federal labor and employment...more

DLA Piper

China Releases First-of-its-kind Compliance Case Handbook for Life Sciences Companies

DLA Piper on

The Shanghai Administration for Market Regulation (AMR) has released a set of illustrative sample cases under the Compliance Guidelines for Pharmaceutical Companies to Prevent Commercial Bribery Risks (《医药企业防范商业贿赂风险合规指引》)...more

Polsinelli

HCBS Update: Indiana Implements Home-Grown 70/30 Direct Caregiver Compensation Requirement

Polsinelli on

Executive Summary: On July 10, 2025, Indiana Medicaid issued guidance to providers of attendant care and structured family caregiver services requiring providers to pass through a specific percentage of their Medicaid...more

DLA Piper

States Move Ahead With MAHA Agenda for Ultra-processed Food

DLA Piper on

As the Trump Administration considers what actions to take in response to its May 22, 2025 Make Our Children Healthy Again (MAHA) Assessment, state legislatures are taking action to regulate what they consider...more

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