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Katten Muchin Rosenman LLP

Pharmaceutical Direct to Consumer Programs: OIG's Low-Risk Roadmap for Drug Discounts & Congressional Concerns on TrumpRx...

On January 27, 2026, the Department of Health and Human Services, Office of Inspector General (“OIG”) published a Special Advisory Bulletin (the “SAB”) addressing key considerations for pharmaceutical manufacturers' offering...more

Pullman & Comley - Connecticut Health Law

Medicare Telehealth Flexibilities Extended Through December 2027

As a follow-up to our post earlier this week, President Trump has signed into law the Consolidated Appropriations Act, 2026 (CAA). The law extends key COVID-19 era Medicare telehealth flexibilities through December 31, 2027...more

McGuireWoods LLP

HHS OIG Issues Guidance on Anti-Kickback Statute Implications for Direct-to-Consumer Drug Sales Ahead of TrumpRx Launch

McGuireWoods LLP on

In advance of the anticipated rollout of the “TrumpRx” website, a platform promising lower-priced drugs sold directly to consumers, the Office of Inspector General of the Department of Health and Human Services (OIG) released...more

Cozen O'Connor

AG Coalition Reaches $17.85M Settlement in Generic Drug Pricing Antitrust Litigation

Cozen O'Connor on

A coalition of 48 AGs led by Connecticut AG William Tong reached separate settlements with Lannett Company, Inc. (“Lannett”) and Bausch Health US, LLC/Bausch Health Americas, Inc. (“Bausch”) in generic-drug antitrust...more

Venable LLP

Building on Recent Hemp Reforms, Congress Considers Further Federal Oversight of Cannabinoid Products

Venable LLP on

Recent congressional activity reflects a dual-track approach to hemp regulation: lawmakers are simultaneously seeking to delay the implementation of certain existing hemp provisions while advancing legislation that would...more

Mintz - Health Care Viewpoints

DOJ Criminal Fraud Section 2025 Year in Review – Health Care Fraud Is Front and Center

On January 22, 2026, the Department of Justice (DOJ or the Department) Criminal Fraud Section issued its 2025 Year in Review summary (YIR Summary). Our more detailed analysis of the full YIR Summary can be found here. DOJ’s...more

Shumaker, Loop & Kendrick, LLP

Client Alert: Centers for Medicare & Medicaid Services Proposes Sweeping Restrictions on "Sex-Rejecting Procedures" (aka...

The Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has issued two landmark proposed rules that would significantly restrict the delivery and funding of...more

Troutman Pepper Locke

CMS’s 2027 Medicare Advantage Proposal: “Flat” Rates with Tighter Risk Adjustment

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On January 26, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year 2027 Advance Notice of Methodological Changes for Medicare Advantage (MA) capitation rates and Medicare Part D payment policies. CMS...more

Cozen O'Connor

AG Bird Sues PBMs and Insulin Manufacturers over Alleged Pricing Scheme

Cozen O'Connor on

Iowa AG Brenna Bird filed a lawsuit against multiple pharmacy benefit managers (PBMs) and insulin manufacturers, alleging the companies violated Iowa’s Consumer Fraud Act by artificially inflating diabetes drug prices for...more

Stevens & Lee

Hospitals Beware – Mandatory Provider-Based Attestations Are Back

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On Feb. 3, 2026, President Trump signed into law the Consolidated Budget Act of 2026. One small but mighty provision included in the Act will create a compliance burden on hospitals that provide outpatient off-campus...more

Health Care Compliance Association (HCCA)

[Event] 30th Annual Compliance Institute - April 27th - 30th, Orlando, FL

Don’t miss game-changing compliance education, connections, and program solutions in Orlando - For three decades, the Compliance Institute® (CI) has been the ultimate go-to event for healthcare compliance professionals...more

Brownstein Hyatt Farber Schreck

Labor-HHS Fiscal Year 2026 Appropriations Bill and Health Care Extenders Overview

Congress enacted the fiscal year 2026 Labor, Health and Human Services, Education, and Related Agencies (LHHS) appropriations bill, providing roughly $221 billion in total funding across the subcommittee’s jurisdiction,...more

Mintz - Health Care Viewpoints

Telehealth Update: Partial Government Shutdown Ends With Extension of Medicare Telehealth Provisions

As the telehealth industry is acutely aware, Medicare’s telehealth flexibilities and the Acute Hospital Care at Home Program, both of which have been in place since 2020, expired on January 31, 2026. While on that day the...more

Davis Wright Tremaine LLP

Time for Hospitals to Get Their Provider-Based Compliance in Order

Medicare reimbursement for off-campus hospital outpatient departments is once again under attack....more

ArentFox Schiff

The Eyes Have It: FDA Approves Phase 1 Clinical Trial of Life Biosciences’ Reprogramming Therapy for Vision Loss

ArentFox Schiff on

The US Food and Drug Administration (FDA) has approved a Phase 1 clinical trial from Life Biosciences that aims to help certain eye cells act younger and improve vision in glaucoma and related conditions....more

King & Spalding

GAO Recommends Reforms to Organ Transplantation Oversight

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On Thursday, January 22, 2026, the U.S. Government Accountability Office (GAO) released a report containing three main recommendations for improving the oversight and operations of the Organ Procurement Transplant Network...more

Dentons

Ep. 95 – How Productive is Your Compliance Committee?

Dentons on

When was the last time you stopped to ask yourself: How effective is our compliance committee, really? For busy compliance officers – especially those juggling multiple roles – a well-functioning compliance committee isn’t a...more

Polsinelli

Mandatory Provider-Based Attestations Make a Comeback

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After a nearly 24-year hiatus from the mandatory provider-based attestation requirement, the Consolidated Appropriations Act of 2026 (Act, signed into law on Feb. 3, 2026), mandates (again) that hospitals file attestations of...more

Baker Donelson

Deadline to Apply for Final Round of Medicare-Funded GME Residency Positions

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Teaching hospitals training over their graduate medical education (GME) caps have limited opportunities to receive additional funding from Medicare. Therefore, it is important to note the upcoming March 31, 2026, deadline to...more

Arnall Golden Gregory LLP

HHS OIG Advisory Opinion 26-01: Commercial‑Only Cost‑Sharing Waivers for a New Colorectal Screening Test Do Not Trigger AKS or...

Key Takeaways - Coverage and beneficiary class drive the outcome. Because the manufacturer’s colorectal screening test currently has minimal federal program coverage and the waiver is limited to commercially insured patients,...more

Morgan Lewis

Recent EU Life Sciences Regulatory Changes – What You Need to Know

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At the end of 2025, the European Union advanced significant initiatives aimed at modernising and strengthening the regulatory framework for the life sciences sector. From the political agreement on the pharmaceutical package...more

Goodwin

European Biologic and Biosimilar Updates

Goodwin on

On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type 1 diabetes (“T1D”) in adults and children eight years and older who have stage 2...more

Skadden, Arps, Slate, Meagher & Flom LLP

State Compounding Legislation: Federal Preemption, State Limits and Patient Impact

Legislative sessions are underway in most states, and some have introduced novel legislation to regulate compounded medications, including those specific to weight loss....more

McDermott Will & Schulte

CMS indefinitely suspends submission of SNF Attachment for Medicare enrollment

Skilled nursing facilities (SNFs) have long been required to report ownership and managerial control information to Medicare. Those disclosure obligations have been substantially broadened with the introduction of the...more

McDermott Will & Schulte

This Week in 340B: January 20 – 27, 2026

Find the 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 summary...more

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