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Morgan Lewis - As Prescribed

New Year, New Guidance: FDA Revisits Wellness and CDS Boundaries

The FDA released updates to two guidance documents on January 6: General Wellness: Policy for Low Risk Devices (General Wellness) and Clinical Decision Support Software (CDS). FDA did not issue a traditional press release;...more

Sheppard Mullin Richter & Hampton LLP

Healthy AI: 2025 Year in Review

Artificial intelligence (AI) in healthcare may have reached an inflection point in 2025. After being defined by proofs of concept and isolated pilots for more than a decade, recent advances signal that AI is moving decisively...more

Morgan Lewis - Health Law Scan

Medicare Advantage Agent and Broker Agreements: 2025 in Review

2025 was an important year for Medicare Advantage (MA) plans that pay state-licensed agents and brokers to market their plans and engage in lead generation, subject to complex federal regulations. As we previously discussed...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - February 2026

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Our Drug Pricing and Market Access team tracks recent developments in healthcare reform, the Medicaid Drug Rebate Program, the 340B Program, Medicare, and state law....more

Hogan Lovells

FDA Notifies Industry of Enforcement Discretion Regarding “No Artificial Colors” Claims

Hogan Lovells on

On February 5, 2026, the U.S. Food and Drug Administration (FDA) issued a letter to the food industry announcing a new enforcement discretion policy for “no artificial colors” labeling claims. The agency states that it “does...more

Sheppard Mullin Richter & Hampton LLP

Provider Alert: ‘Voluntary’ Attestations to Provider-Based Status Are No Longer Voluntary for Off-Campus Hospital Outpatient...

The submission of an attestation to a hospital’s and its off-campus outpatient department’s compliance with Medicare’s provider-based rules has long been voluntary under the Centers for Medicare & Medicaid Services’ (“CMS’”)...more

McDermott+

McDermott+ Check-Up: February 6, 2026

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Congress passed a package that funds the US Department of Health and Human Services through fiscal year 2026 and includes health extenders and additional bipartisan health policies....more

Bass, Berry & Sims PLC

From 1999 to Prime Time: OIG Revamps Medicare Advantage Guidance for Today’s—and Tomorrow’s—Evolving Market

On February 3, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued new Medicare Advantage Industry Segment-Specific Compliance Program Guidance (MA ICPG) for the MA industry and...more

McDermott Will & Schulte

New York governor proposes changes to healthcare transaction rules

On January 20, 2026, New York Governor Kathy Hochul introduced legislation that would significantly modify New York’s material transaction notice requirements for certain healthcare transactions....more

DLA Piper

CMS proposes to exclude unlinked diagnoses from Medicare Advantage risk adjustment: An opportunity for plan-provider value-based...

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The Centers for Medicare & Medicaid Services (CMS) published its “Advance Notice of Methodological Changes for Calendar Year (CY) 2027 for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies” on...more

Axinn, Veltrop & Harkrider LLP

2025 Healthcare Antitrust Enforcement Wrap Up

Renewed Openness to Merger Settlements Creates Greater Deal Certainty. Unlike the Biden Administration, both the DOJ and FTC leadership under Trump have indicated a clear willingness to negotiate merger remedies to resolve...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

Laboratory Fraud: The Gift That Keeps On Giving

Every sector of the healthcare industry relies upon laboratory testing. Lab tests are used to diagnose virtually all illnesses and conditions ranging from the common flu to cancer. The average American receives their first...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - February 2026 #1

News Briefs - Physicians Seeing Major Benefits to Using Ambient AI Scribes - Ambient AI scribes are being hailed by physicians as a game changer that helps free them to focus on their patients rather than their computer...more

Akin Gump Strauss Hauer & Feld LLP

False Claims Act: Risks Increase for Wound Care Industry

During January 28, 2026, remarks at the American Conference Institute’s Advanced Forum on False Claims and Qui Tam Enforcement, Deputy Assistant Attorney General Brenna Jenny, the U.S. Department of Justice’s (DOJ) top civil...more

Epstein Becker & Green

OIG Greenlights Cost-Sharing Waiver for Commercially Insured Patients

On January 16, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 26-01, offering clarity as to whether a manufacturer may waive patient cost-sharing amounts for...more

Alston & Bird

Biological Products Regulation Part 5: Preparing for the FDA’s Pre-License Inspection

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Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number of questions drug developers may have about the regulation and regulatory pathway...more

Phelps Dunbar

2025 Was a Banner Year for False Claim Act Qui Tam Filings and DOJ Recoveries

Phelps Dunbar on

The Civil Division of the U.S. Department of Justice (DOJ) recently issued its annual statistics and press release on False Claims Act (FCA) settlements and judgments for fiscal year 2025 covering the period Oct. 1, 2024 to...more

BCLP

False Claims Act: Recent Updates - February 2026

BCLP on

On January 16, 2026, DOJ released its annual report on FCA enforcement statistics for the 2025 fiscal year. The report reveals over $6.8 billion in settlements and judgments—the highest single‑year total and over double the...more

Freeman Mathis & Gary

Eleventh Circuit tightens Rule 803(4) purpose requirement in recent case

Freeman Mathis & Gary on

In United States v. Keegan (Dec. 17, 2025), the Eleventh Circuit addressed a defense attempt to use Federal Rule of Evidence 803(4)—the hearsay exception for statements “made for—and … reasonably pertinent to—medical...more

Alston & Bird

President Signs 2026 Spending Package to End Brief Shutdown; Trump Administration Launches TrumpRX

Alston & Bird on

On February 2, 2026, the Health Resources and Services Administration (HRSA) released a request for public comment entitled, Request for Public Comment on the Updated Criteria for Determining Maternity Care Health...more

Husch Blackwell LLP

Major HIPAA Security Rule Changes on the Horizon: Is Your Healthcare Organization Ready?

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Why Now? The Rising Cyber Threats Driving HIPAA Reform- In December 2024, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) proposed the first significant update to the HIPAA Security Rule...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Home Care Agencies and Sign-On Bonuses: Understanding the Recent Advisory Opinion of HHS’s Office of Inspector General

On December 30, 2025, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published Advisory Opinion No. 25-12 (AO 25-12) concerning home care agencies’ proposal to market compensation...more

Holland & Knight LLP

Massachusetts Considers a Healthcare Preceptor Tax Credit

Holland & Knight LLP on

The Massachusetts Legislature is considering companion legislation, H.3218 and S.1960, in its attempt to 1) recognize and address healthcare workforce shortages throughout the Commonwealth and 2) encourage health...more

Dinsmore & Shohl LLP

Supreme Court to Clarify Liability Boundary for Induced Infringement

Dinsmore & Shohl LLP on

The Supreme Court of the United States has agreed to resolve a question of patent infringement liability: can advertising a product as a “generic”—without more details—give rise to liability for induced infringement? The...more

Holland & Knight LLP

Proposed Illinois Amendments Would Help Capture Healthcare Private Equity Investments

Holland & Knight LLP on

A legislator on February 4, 2026, introduced HB5000, an amendment to Illinois' healthcare reporting statute that would broaden the types of transactions subject to the existing 30-day reporting process and ensure that certain...more

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