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Medicare

Alston & Bird

Health Care Week in Review | CMS Finalizes FY 2026 Medicare Payment Rules, Senate Appropriations Committee Advances Labor-HHS...

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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

Mintz - Health Care Viewpoints

CMMI Proposes Mandatory Ambulatory Specialty Model in 2026 PFS Proposed Rule: Key Considerations for Health Care Organizations...

In the CY 2026 Medicare Physician Fee Schedule proposed rule (PFS Proposed Rule), released on July 14, 2025, the Center for Medicare and Medicaid Innovation (CMMI) introduced the Ambulatory Specialty Model (ASM), a new...more

Venable LLP

EKRA Has Teeth: Ninth Circuit Upholds Lab Operator’s Criminal Conviction for Paying Marketers for Referrals

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In a matter of first impression, the Ninth Circuit Court of Appeals interpreted the scope of the 2018 Eliminating Kickbacks in Recovery Act (EKRA) in the context of a lab operator who allegedly paid marketers to induce...more

Rivkin Radler LLP

Expert Witness Report in FCA Case Afflicted with AI Hallucinations

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The epidemic of out-of-control generative artificial intelligence in litigation filings has metastasized to a False Claims Act (FCA) lawsuit against a group of Utah anesthesiologists. On July 25, Mountain West Anesthesia, LLC...more

Foley Hoag LLP

Sweeping Changes in Store for Federal Healthcare Programs After the Enactment of the "One Big Beautiful Bill Act"

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Key Takeaways: - The One Big Beautiful Bill Act will create a sea change in the healthcare landscape. - This law will make significant changes to federal healthcare programs, especially Medicaid’s financing and eligibility...more

Robinson+Cole Health Law Diagnosis

HHS Publishes 340B Guidance Proposing Rebate Pilot Program

On July 31, 2025, the Department of Health and Human Services (HHS) announced a much-anticipated 340B Rebate Model Pilot Program (Pilot Program) via guidance (Guidance) that will be formally published on August 1, 2025. The...more

Polsinelli

Virtual Oversight, Real Impacts: “Incident-To” and Beyond in CMS’s CY 2026 PFS Proposed Rule

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Key Takeaways - CMS proposes to significantly expand the use of virtual direct supervision for incident-to services, removing prior limitations based on Professional Component (PC)/Technical Component (TC) indicators and...more

Troutman Pepper Locke

HHS Sets Its Sights on $50B in Cost Savings: Medicare Payments to Nonhospice Providers Potentially Under Fire

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In May 2025, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) published a review, titled “Potential Cost Savings HHS Programs – HHS Actions,” which provided some insight into the OIG’s...more

Foley & Lardner LLP

Remote Patient Monitoring (RPM) and Remote Therapeutic Monitoring (RTM): What You Need to Know About CMS’ Proposed Changes

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On July 14, 2025, the Centers for Medicare and Medicaid Services (CMS) proposed key changes to remote patient monitoring (RPM) and remote therapeutic monitoring (RTM) services reimbursed under the Medicare program. The...more

Mintz - Health Care Viewpoints

CMS Proposes New Standards for Bona Fide Service Fees in Average Sales Price Calculations: What Plans, PBMs, and Other Recipients...

The CY 2026 Physician Fee Schedule Proposed Rule (PFS Proposed Rule) introduces significant changes to how drug manufacturers must treat Bona Fide Service Fees (BFSFs) when calculating Average Sales Price (ASP) for Medicare...more

Holland & Knight LLP

HHS and DOJ Revitalize False Claims Act Working Group

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The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more

Cooley LLP

‘Whole-of-Government Approach’ Targets Healthcare Fraud From Every Angle

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Just months after the US Department of Justice (DOJ) designated healthcare fraud as one of its key criminal enforcement priorities, two recent announcements underscore the federal government’s continued focus on combating...more

Blank Rome LLP

CMS Proposes New Rules for Calculating Average Sales Price for Medicare Part B Drug Reimbursement

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The Centers for Medicare & Medicaid Services (“CMS”) released the Calendar Year 2026 Medicare Physician Fee Schedule (“PFS”) proposed rule on July 16, 2025. (See...more

Morgan Lewis - As Prescribed

Orphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill Act'

The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease drugs and biologics to be...more

Tucker Arensberg, P.C.

CMS Unveils 2026 Physician Fee Schedule Proposal: Key Changes Ahead

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On July 14, the Centers for Medicare & Medicaid Services (CMS) released its proposed rule for the 2026 Physician Fee Schedule. As expected, there are several meaningful updates that providers, practices, and health systems...more

McDermott+

Back for seconds: digital health policies in the CY 2026 PFS proposed rule

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It’s been more than two weeks since the release of the CY 2026 Medicare Physician Fee Schedule (PFS) proposed rule. We’ve had a chance to digest our initial helping and now we’re ready for seconds. We thought we would see...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - July 2025

Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter,...more

DLA Piper

Keeping Watch on Medicare: Formulary Assessment Shows Large Declines in Access for Certain Rare Disease Treatments

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The Inflation Reduction Act (IRA) changed how drugs are covered and reimbursed in Medicare. It is anticipated that this may lead to more restrictive formularies in drug plans....more

Saul Ewing LLP

New DOJ Healthcare Working Group and Data Fusion Center Keep the Focus on Healthcare Fraud Enforcement

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Introduction - The U.S. Department of Justice (“DOJ”) has doubled down on eliminating healthcare fraud in government programs, including through the launch of new inter-agency groups in both the Civil and Criminal Divisions,...more

A&O Shearman

Pharma company challenges the US False Claims Act: what’s at stake for whistleblowers and government enforcement?

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A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the US False Claims Act (FCA) is unconstitutional. This case, now before the Court of Appeals for the...more

Sheppard Mullin Richter & Hampton LLP

Potential False Claims Act Liability for Providers of Gender-Affirming Care for Minors

On July 9, 2025, the U.S. Department of Justice (“DOJ”) announced it sent more than 20 subpoenas to physicians and clinics involved in providing gender-affirming care to minors, and that the subpoenas related to...more

Ropes & Gray LLP

Proposed Changes to Medicare Payment Rules: What Life Sciences Companies Need to Know

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The Centers for Medicare & Medicaid Services (“CMS”) recently released two proposed updates to Medicare payment rules that, if implemented, could have a significant impact on life sciences companies. The Medicare proposed...more

DLA Piper

CMS Proposes New Behavioral Health Integration Add-on Codes for APCM Services in CY 2026 MPFS

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The Centers for Medicare and Medicaid Services (CMS) issued the calendar year (CY) 2026 Medicare Physician Fee Schedule (MPFS) Proposed Rule (Proposed Rule) on July 14, 2025. The Proposed Rule includes important proposals to...more

Haynes Boone

False Claims Act - 2025 Mid-Year Review

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The False Claims Act continues to be one of the most commonly used weapons in the government’s enforcement arsenal to address various forms of fraud. In addition to our “Year in Review” publication providing an overview of...more

McDermott+

Healthcare Preview for the Week of: July 28, 2025

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Senate Steers Toward Summer Break - With the House already on August recess, the Senate will consider several of President Trump’s nominees, including Gustav Chiarello III to be an assistant secretary of the US Department of...more

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