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Government Agencies Regulatory Requirements Healthcare

A&O Shearman

Italian Medical Device Payback: Italy approves 75% reduction on medical device payback to end disputes

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Background: The Payback Mechanism and Its Impact - Italy’s payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring...more

McNees Wallace & Nurick LLC

Navigating Pa.’s unique IBHS licensing requirement for ABA therapy providers

Per Autism Speaks’ “Autism by the Numbers: 2025 Annual Report” (see autismspeaks.org/ABN, last visited July 20, 2025), currently one in 35 children in the United States has autism....more

McDermott Will & Schulte

A need for speed: FDA piloting voucher program to expedite drug review

On July 22, 2025, the US Food and Drug Administration (FDA) started accepting applications to participate in the Commissioner’s National Priority Voucher (CNPV) pilot. This one-year initiative – announced on June 17 – aims to...more

Health Care Compliance Association (HCCA)

Amid Seeming Error, HHS Finalizes Klote’s Termination As Director of Crippled OHRP; She Issues a Warning

In the end, the final termination letter arrived in the mail on July 18. For nearly three months—about half of the length of time she was director of the HHS Office for Human Research Protections (OHRP)—Molly Klote, M.D.,...more

Polsinelli

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

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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

King & Spalding

CMS Escalates Aggressive Rates Cut in Home Health Prospective Payment System Proposed Rule for CY 2026

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On June 30, 2025, CMS issued its annual Home Health Prospective Payment System Proposed Rule for Calendar Year (CY) 2026 (the Proposed Rule). The Proposed Rule continues the agency’s policy of using provisions of the...more

Stikeman Elliott LLP

Canada’s Drug Agency Launches Public Consultation on Proposed List of Essential Prescription Drugs and Related Products

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On June 19, 2025, Canada’s Drug Agency (“CDA”) opened a public consultation to gather input on a proposed list of essential prescription drugs and related products. This initiative is part of the agency’s responsibilities...more

Stevens & Lee

Pennsylvania to Join Three Interstate Health Care Licensure Compacts

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Pennsylvania Governor Josh Shapiro recently announced that, effective July 7, 2025, Pennsylvania will commence full participation in three interstate health care licensure compacts: the Interstate Medical Licensure Compact,...more

Quarles & Brady LLP

Puerto Rico Repeals Special Authorization Requirement for Nonresident Manufacturers and Distributors

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In July 2022, the agency formerly known as the Puerto Rico Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS), now the Auxiliary Secretariat for the Regulation of Public Health (SARSP),...more

Jackson Lewis P.C.

OFCCP Extends Enforcement Moratorium for VAHBP Providers Until 2027

Jackson Lewis P.C. on

In a move the Agency reported is designed to maintain healthcare access for active and retired service members and their families, the Office of Federal Contract Compliance Programs (OFCCP) has announced a two-year extension...more

Knobbe Martens

Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth

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The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent months combined with market...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

King & Spalding

OIG Releases Audit of Medicare Payments for Evaluation Management Services Billed on the Same Day as Eye Injections

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On May 27, 2025, HHS Office of Inspector General (OIG) issued a report outlining its finding that Medicare payments for evaluation management (E&M) services provided on the same day as eye injections were at risk for...more

McDermott Will & Schulte

CMS Requests Hospitals Submit Gender-Affirming Care Data

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

Hendershot Cowart P.C.

Texas HB 3749: What IV Hydration Clinic Owners Need to Know

Hendershot Cowart P.C. on

Texas House Bill 3749 (HB 3749), known as "Jenifer's Law," has undergone dramatic revisions since its introduction. What began as a bill that could have shuttered many IV hydration clinics has transformed into legislation...more

Whiteford

Client Alert: 2025 Legislative Changes for CCRCs

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House Bill 938 was passed in the Maryland legislature and signed by the Governor into law on May 6, 2025. This bill requires the appointment of an alternate subscriber (resident) to the governing body of a continuing care...more

Rivkin Radler LLP

NYS DOH Releases New Electronic Material Transaction Form

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Just last week, we reported that the 2025/26 NYS Budget Bill did not include a provision that would have increased the requirements for seeking Department of Health (DOH) approval of a material healthcare transaction (which...more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

King & Spalding

Texas Bills Introduce New Requirements for Healthcare Transactions

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On February 12, 2025, the Texas House of Representatives introduced Texas House Bill 2747 (H.B. 2747), which requires healthcare entities to submit written notice to the Texas attorney general ninety days prior to a material...more

Troutman Pepper Locke

Is Bayh-Dole the Next Lever in the Push to Onshore Pharma Manufacturing?

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The U.S. government is pushing to redomesticate the manufacturing of pharmaceutical, biotech, gene therapy, and medical device products, both to bolster U.S. manufacturing generally and to address continuing shortages of...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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

King & Spalding

Executive Order Continues Focuses on Anticompetitive Regulations

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On April 9, 2025, President Trump issued an executive order, titled “Reducing Anti-Competitive Regulatory Barriers” (the EO), directing federal agencies to identify and rescind or modify anticompetitive regulations. The EO...more

Quarles & Brady LLP

Alabama Bill Rewriting Pharmacy Practice Act Clears Senate Hurdle

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As detailed in our February 24, 2025 update, House Bill 123 continues the operations of the Alabama Board of Pharmacy (“the Board”) until October 1, 2026, with changes to the Board’s structure, operations, and practices....more

Chambliss, Bahner & Stophel, P.C.

How To Get a Disabled Parking Permit

Disabled parking permits enable individuals with mobility issues to access businesses and public spaces more easily. Different types of disabled parking permits include permanent and temporary placards, license plates,...more

McDermott Will & Schulte

This Week in 340B: March 11 – 17, 2025

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

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