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Healthcare New Guidance

Mitchell, Williams, Selig, Gates & Woodyard,...

Transportation/Hazardous Materials: Pipeline and Hazardous Materials Safety Administration Interpretive Letter Clarifying the...

The United States Pipeline and Hazardous Materials Safety Administration (“PHMSA”) addressed in an August 7th Interpretive Letter the application of the federal Hazardous Materials Regulations (“HMR”) to the transportation of...more

Alston & Bird

Health Care Week in Review | CMS Announces Oversight Initiative to Increase Medicaid and CHIP Citizenship Enforcement; HHS...

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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

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program (Updated)

As previously discussed in our prior blog post, on August 1, 2025, the Department of Health and Human Services (HHS) issued a Notice announcing a much-anticipated 340B Rebate Model Pilot Program (Pilot Program). Subsequently,...more

McDermott Will & Schulte

HRSA issues 340B rebate model pilot program guidance, requests comments

The Health Resources and Services Administration (HRSA) issued a notice announcing the application process for the 340B rebate model pilot program and requesting public comment. The notice sets the parameters of 340B rebate...more

Stoel Rives - Health Law Insider®

Oregon Staffing Plans Must Cover All Licensed Hospital Space

Oregon’s Hospital Staffing Law has enjoyed no lack of coverage (and commentary) in the last year.  The Oregon Health Authority (OHA) has posted numerous guidance documents, FAQs, video shorts, and recorded webinars to bring...more

Alston & Bird

Health Care Week in Review | HHS Cancels mRNA Vaccine Development Projects Under BARDA; President Trump Signs EO to Increase...

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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

Quarles & Brady LLP

Manufacturer Rebate Models: The Next 340B Program Battleground

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The 340B Drug Pricing Program (“340B Program”) space continues to be a hive of activity. While 340B stakeholders continue to litigate ongoing manufacturer contract pharmacy restrictions, states legislatures are enacting...more

Alston & Bird

Health Care Week in Review | CMS Finalizes FY 2026 Medicare Payment Rules, Senate Appropriations Committee Advances Labor-HHS...

Alston & Bird on

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

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Proskauer - The Patent Playbook

Discretionary Denials in Action: iRhythm Technologies Inc. v. Welch Allyn Inc.

The U.S. Patent and Trademark Office (“USPTO”) Acting Director’s recent decision to deny institution of inter partes review (“IPR”) in iRhythm Technologies Inc. v. Welch Allyn Inc. offers valuable lessons for both patent...more

Rivkin Radler LLP

CMS Rescinds EMTALA Abortion Guidance Amid Ongoing Legal Conflicts

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The Centers for Medicare & Medicaid Services (CMS) recently published a press release rescinding its June 2022 guidance concerning hospitals’ obligations to pregnant women under the Emergency Medical Treatment & Labor Act...more

McDermott Will & Schulte

CMS Requires Hospitals to Publish More Pricing Information, Signals Focus on Enforcement

On May 22, 2025, the Centers for Medicare & Medicaid Services (CMS) released new guidance for compliance with the hospital price transparency rule and published a request for information (RFI) seeking ways to bolster hospital...more

Stevens & Lee

CMS Issues Updated Hospital Price Transparency Guidance and Related RFI

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The Centers for Medicare & Medicaid Services (CMS) released new Updated Hospital Price Transparency Guidance (Guidance) to “strengthen the Hospital Price Transparency requirements, requiring hospitals to post the actual...more

King & Spalding

CMS Issues New Guidance and Request for Information on Hospital Price Transparency Regulations

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Last week, CMS published new guidance and issued a Request for Information on the Hospital Price Transparency Rule in response to President Trump’s February 25, 2025 Executive Order titled, “Making America Healthy Again by...more

Stevens & Lee

NY Department of Health Provides Guidance Regarding Material Transactions Law

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Under the Material Transactions Law, certain health care entities involved in a transaction that increases gross, in-state revenue to at least $25 million must provide written notice of the transaction to the New York State...more

Pullman & Comley, LLC

IRS Announces HSA and HDHP Dollar Limits for 2026

Pullman & Comley, LLC on

The IRS has announced the 2026 cost-of-living adjustments to the applicable dollar limits for health savings accounts (HSAs), high-deductible health plans (HDHPs), and excepted benefit health reimbursement arrangements...more

Epstein Becker & Green

Attorney General Issues Guidance to U.S. Department of Justice Regarding Transgender Healthcare for Children

On April 22, 2025, U.S. Attorney General Pam Bondi issued a memorandum entitled “Preventing the Mutilation of American Children” (“the AG Memorandum”)....more

McDermott Will & Schulte

CMS Updates SNF Attachment Guidance Ahead of May 1 Enrollment Deadline

Skilled nursing facilities (SNFs) historically have been required to disclose ownership and managerial control information as part of their Medicare enrollment. However, these requirements were significantly expanded to...more

Proskauer - Health Care Law Brief

DOH Issues Guidance on New York’s Material Health Care Transaction Law

Nearly two years ago, and as previously discussed in a Proskauer alert, New York enacted Public Health Law Article 45-A (the “Material Transactions Law”), which requires reporting of certain material health care transactions....more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

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In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Rivkin Radler LLP

NYS Reinforces Its Scrutiny Over Healthcare Transactions

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We recently discussed increasing state regulation of healthcare mergers and acquisitions in the face of the current Administration’s clear policy of federal deregulation. We noted that 15 states had implemented oversight laws...more

King & Spalding

NY Department of Health Issues Clarifying FAQs on Healthcare Transaction Notice Law

King & Spalding on

Earlier this month, the New York State Department of Health (DOH) released its first formal guidance under Public Health Law (PHL) Article 45-A, the state’s recently enacted healthcare transaction notice law. Issued in the...more

Holland & Knight LLP

New York State Department of Health Issues Long-Awaited Guidance on Material Transactions Law

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The New York State Department of Health (DOH) has published a set of Frequently Asked Questions (FAQs) to provide guidance on the "Disclosure of Material Transactions" law that took effect on Aug. 1, 2023. Pursuant to Article...more

Sheppard Mullin Richter & Hampton LLP

New Ohio Transparency Pricing Rules for Hospitals Comes with Limits to Targeted Advertising

Starting April 3, Ohio hospitals will have to navigate new requirements under House Bill 173. This law mandates greater transparency in healthcare pricing. It also includes rules for selling or targeted advertising related to...more

Arnall Golden Gregory LLP

AGG Talks: Cross-Border Business Podcast - Episode 27: U.S. Healthcare Reimbursement Guidance for Foreign Life Sciences Companies

In this episode, Mike Burke, AGG Corporate partner and co-chair of the firm’s International practice, is joined by Andrew Tsui, AGG Healthcare Litigation partner, to explore the intricacies of reimbursement in the U.S....more

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