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Regulatory Requirements Healthcare Department of Health and Human Services (HHS)

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Hogan Lovells

An evolving ‘nexus’: OIG approves sponsored testing program involving companion diagnostic

Hogan Lovells on

The U.S. Department of Health and Human Services Office of Inspector General (OIG) once again addressed an industry-sponsored genetic testing program, posting a favorable decision on July 2, 2025 in Advisory Opinion (AO)...more

Ropes & Gray LLP

U.S. District Court Ruling Vacates HIPAA Final Rule that Strengthened Privacy Protections for Reproductive Health Information

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On June 18, 2025, the United States District Court for the Northern District of Texas Amarillo Division issued an opinion, Purl v. Department of Health and Human Services, declaring the U.S. Department of Health and Human...more

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

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On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

McDermott+

Health Plans’ Commitment to Prior Authorization Improvements: What’s New Versus What’s Already Required

McDermott+ on

Health plan members of AHIP and the Blue Cross and Blue Shield Association made news earlier this week when they announced a series of steps that a broad swath of health insurers will take to improve the prior authorization...more

Quarles & Brady LLP

HIPAA Reproductive Health Rule Vacated Nationally

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A federal judge in Texas has vacated almost all of the 2024 HIPAA Rule to Support Reproductive Health Care Privacy that created special protections for reproductive health care information, finding that the U.S. Department of...more

Seyfarth Shaw LLP

Time to Revisit Your HIPAA Documents After Reproductive Health Privacy Rule Vacated

Seyfarth Shaw LLP on

In the wake of a recent federal District Court decision, the reproductive health care HIPAA Privacy rules finalized during the Biden Administration have been vacated and plan sponsors should re-evaluate the language included...more

McDermott+

Health Information Technology Policy Under the Trump Administration

McDermott+ on

Patient engagement. Information blocking. Interoperability. These buzz words are flying around the health information technology (HIT) world as the Trump administration starts to make its mark on the HIT policy landscape....more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

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

McDermott Will & Emery

CMS Requests Hospitals Submit Gender-Affirming Care Data

McDermott Will & Emery on

On May 28, 2025, the Centers for Medicare & Medicaid Services (CMS) sent a letter to “select hospitals” that provide gender-affirming care services, requesting information about how those hospitals adhere to quality standards...more

Quarles & Brady LLP

Departments Will Not Enforce 2024 Final Rule under MHPAEA

Quarles & Brady LLP on

The Trump Administration has just announced that it will pause enforcement of the September 2024 final rule (“Final Rule”) under the Mental Health Parity and Addiction Equity Act (“MHPAEA”)....more

Seyfarth Shaw LLP

Parity in Peril? Plan Sponsors Breathe Easier As Trump Administration Hits Pause on Enforcement of Mental Health Parity Final Rule

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On May 15, 2025 the Departments of Labor, Health and Human Services, and Treasury (the “Departments”) announced they will temporarily not enforce their new standards published under the mental health parity Final Rule last...more

Carlton Fields

Executive Order Seeks to Eliminate Discrepancies in Drug Pricing Between United States and Other Countries

Carlton Fields on

President Trump’s highly publicized executive order 14297, titled “Delivering Most-Favored-Nation Prescription Drug Pricing to American Patients,” targets the discrepancy in drug pricing in the United States compared with...more

Clark Hill PLC

Right To Know - May 2025, Vol. 29

Clark Hill PLC on

Welcome to your monthly rundown of all things cyber, privacy, and technology, where we highlight all the happenings you may have missed. State Action: Virginia Governor Signs Bill Restricting Minor’s Use of Social Media:...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

McDermott Will & Emery on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights key regulatory and enforcement activity for March 2025. This month features: - Noteworthy enforcement actions demonstrating that the Anti-Kickback Statute...more

Ballard Spahr LLP

Section 1557: Deadlines Approach, But Long-Term Prognosis Unclear Under Executive Orders

Ballard Spahr LLP on

Section 1557 of the Affordable Care Act mandates nondiscrimination in health care programs managed or funded by the Department of Health and Human Services (HHS), with upcoming deadlines for compliance set for May and July...more

Schwabe, Williamson & Wyatt PC

Regulatory Changes Address Surge of Food-As-Health Initiatives and Shift “Healthy” ‎Standard; Plus New Labeling Requirements

Food and beverage products that promote health and well-being have proliferated. Demand has surged for foods and drinks that are loaded with nutrients and offer health benefits. Their growth is partly driven by an increased...more

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...more

Holland & Knight LLP

Holland & Knight Health Dose: April 2, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

McDermott Will & Emery

This Week in 340B: March 18 – 24, 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

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Nelson Mullins Riley & Scarborough LLP

Senate Bill 316: An Overview for North Carolina Hospitals

Earlier this week, Senate Bill 316 (the “Bill”) was filed in the North Carolina state legislature. The Bill covers a large swathe of healthcare-related issues, and the additional regulatory elements of the Bill would likely...more

Holland & Knight LLP

Holland & Knight Health Dose: March 19, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Rivkin Radler LLP

The Status of Providing Gender-Affirming Care to Minors in NY

Rivkin Radler LLP on

In recent months, Executive Orders issued by the current Administration regarding gender-affirming care of minors have been the subject of much debate and litigation. The crux of these lawsuits is largely two Executive...more

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