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Morgan Lewis

Does GLP-1 Compounding Foretell Patent Enforcement Outside the Hatch-Waxman Framework?

Morgan Lewis on

Recent developments involving compounded GLP-1 products have renewed questions about compounded drugs as a potential quasi-generic competitor. This LawFlash examines the regulatory limits on drug compounding and highlights...more

Sheppard Mullin Richter & Hampton LLP

The Fix Is In: New Jersey Tweaks Its Privacy Law

New Jersey’s existing, comprehensive privacy law was amended at the end of last month, with some tweaks that mirror changes seen in other privacy laws. (For example, changes that went into place for the Connecticut law last...more

Sheppard Mullin Richter & Hampton LLP

Governor Hochul’s 2026 State of the State: What the Executive Budget Really Tells Us About Healthcare and Medicaid

Governor Hochul’s 2026 State of the State Agenda, released in January, and the FY 2027 Executive Budget are best understood as two parts of a single healthcare strategy. The Agenda sets the direction; the Budget supplies the...more

Mintz - Health Care Viewpoints

What PBMs and Group Health Plans Need to Know About the Department of Labor’s Proposed PBM Fee Disclosure Rule

On January 30, 2026, the Department of Labor released a proposed rule (Proposed Rule) that would end long‑running confusion about how ERISA disclosure obligations apply to PBMs under the Consolidated Appropriations Act, 2021,...more

Holland & Hart - Health Law Blog

Do the New Substance Use Disorder Record Rules Apply to You?

The revised federal rules for substance use disorder (“SUD”) records will be enforced effective February 16, 2026. (42 CFR part 2, hereafter “Part 2”). Failure to comply with the new Part 2 rules may subject healthcare...more

Foley & Lardner LLP

Single‑Reference Disclosures and the Motivation‑to‑Combine Requirement

Foley & Lardner LLP on

In January 2026, the Federal Circuit issued a nonprecedential opinion in Guardant Health, Inc. v. University of Washington (Slip Op. 2024-1129, Jan. 23, 2026) that, while not binding precedent, is nevertheless highly relevant...more

King & Spalding

CMS Announces Changes to CY 2027 Medicare Advantage Capitation Rates and Part D Payment Policies

King & Spalding on

On January 26, 2026, CMS released 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 (Advance Notice). The Advance...more

King & Spalding

FTC’s “Landmark” Settlement with Pharmacy Benefit Manager Express Scripts: Impact on Pharma

King & Spalding on

On February 4, 2026, the Federal Trade Commission (FTC) announced what it called a “landmark” settlement with Express Scripts, Inc. (ESI) in its enforcement action alleging anticompetitive practices under Section 5 of the FTC...more

Brownstein Hyatt Farber Schreck

A Closer Look at FDA Policies Included in the Consolidated Appropriations Act

The recently enacted Consolidated Appropriations Act (H.R. 7148) includes several Food and Drug Administration (FDA) policies that were repeatedly considered in the House and Senate but were stalled for years before finally...more

Polsinelli

OIG’s New Medicare Advantage Program Compliance Guidance: What Providers Need to Know

Polsinelli on

Key Takeaways - OIG’s new Medicare Advantage Industry Segment-Specific Compliance Program Guidance (MA ICPG) highlights major compliance risk areas and provides practical guidance for MA plans and other parties....more

Baker Donelson

Department of Justice Reports Record-Breaking $6.8 Billion Year in False Claims Act Recoveries

Baker Donelson on

When the second Trump administration took office, many legal commentators anticipated major changes to the Department of Justice's (DOJ) enforcement efforts. Some declared federal white-collar enforcement dead as the...more

Haynes Boone

FDA Takes Steps to Ease Path for Non-Petroleum Food Colors

Haynes Boone on

After years of maintaining a policy that any added color in food is “artificial color,” the U.S. Food and Drug Administration (FDA) issued a letter to industry announcing that it will exercise enforcement discretion as to the...more

Akerman LLP - Health Law Rx

The No Surprises Act: Key Developments to Watch in 2026

As the No Surprises Act (NSA) enters 2026, federal agencies are expected to focus on three key issues: finalizing delayed rulemaking, issuing guidance to address operational challenges in the Independent Dispute Resolution...more

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

McDermott+ on

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...

DLA Piper on

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

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