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Healthcare Reform Regulatory Agenda

McDermott+

McDermott+ Check-Up – July 25, 2025

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CBO releases final scores for OBBBA. The Congressional Budget Office (CBO) estimates that the One Big Beautiful Bill Act (OBBBA) will increase the uninsurance rate by 10 million individuals over 10 years. House Energy and...more

McDermott+

Site neutrality is on the menu in the CY 2026 Medicare Outpatient Prospective Payment System proposed rule

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Last week, the Centers for Medicare & Medicaid Services (CMS) issued two major regs: the calendar year (CY) 2026 Medicare Physician Fee Schedule (PFS) proposed rule and the CY 2026 Outpatient Prospective Payment System (OPPS)...more

White & Case LLP

DOJ and HHS Relaunch False Claims Act Working Group, Sharpen Healthcare Enforcement Priorities

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On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the reestablishment of the DOJ-HHS False Claims Act (FCA) Working Group. While the two agencies...more

McDermott+

CMS releases CY 2026 Physician Fee Schedule Proposed Rule

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On July 14, 2025, the Centers for Medicare & Medicaid Services (CMS) released the Calendar Year (CY) 2026 Revisions to Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Medicare Part B [CMS-13271]...more

McDermott+

Healthcare Preview for the Week of: July 14, 2025

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Rescissions rescissions - Congressional focus this week is on the rescissions package and appropriations. The rescissions bill has a July 18 deadline to reach the president’s desk for signature. The bill is pending in the...more

McDermott+

Healthcare Preview for the Week of: July 7, 2025

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Reconciliation aftermath - Last week, President Trump signed H.R. 1, the One Big Beautiful Bill Act, into law after months of work on the reconciliation package. This week, things will slightly cool down in Washington, DC....more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

McDermott+

Healthcare Preview for the Week of: June 16, 2025

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The House is out this week for the Juneteenth holiday, but the Senate will be in town through Wednesday. We expect these three days to be significant because the Senate Finance Committee has announced that it intends to...more

McDermott Will & Emery

GLP-1 Update: Court Backs FDA in Tirzepatide Compounding Case

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On May 7, 2025, the US District Court for the Northern District of Texas upheld the US Food and Drug Administration’s (FDA’s) decision to remove two tirzepatide injection medications from the FDA’s drug shortage list. This...more

Pullman & Comley - Connecticut Health Law

Three Bills Affecting Health Care Transactions That Will Not Be Signed into Law This Year

Members of the health care community may recall that the 2025 legislative session of the Connecticut General Assembly started out with Governor Lamont signing into law an emergency certificate of need (CON) process for...more

McDermott+

Healthcare Preview for the Week of: May 27, 2025

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Short Congressional Recess, Short Preview - While Congress is in recess this week, we are still on reconciliation watch as consideration of the One Big Beautiful Bill Act moves to the Senate. We are on the lookout for a...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Skadden, Arps, Slate, Meagher & Flom LLP

Trump Attempts To Rein In Drug Prices With Most-Favored-Nation Approach

On May 12, 2025, President Donald Trump signed the executive order (EO) “Delivering Most-Favored-Nation Prescription Drug Pricing To American Patients.” The EO sets forth policy positions that attempt to further rein in drug...more

Bass, Berry & Sims PLC

CMMI Announces New Strategy

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After months of signaling that a new strategy was in the works, on May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) released a new strategic direction for the CMS Center for Medicare and Medicaid Innovation...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | March 2025 Recap

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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

Bass, Berry & Sims PLC

Washington Enacts “Mini-HSR” Law, Expanding State-Level Premerger Filing Requirements

Bass, Berry & Sims PLC on

On April 4, Washington became the first state to adopt the Uniform Premerger Notification Act (Act) when Washington Governor Jay Inslee signed the bill into law. The new statute imposes state-level premerger filing...more

Health Care Compliance Association (HCCA)

Advancing shared accountability to reduce regulatory burden, promote well-being

Introduction: A different perspective - Within the compliance profession, Cecilia Fellouse has noted, “Under the weight of incessant regulatory demands, individuals and teams often fall prey to compliance fatigue. This...more

Bradley Arant Boult Cummings LLP

Alabama CON Report - April 2025

I. II. Certificate of Need Program - A. AL2024-025, 211-213 Ana Drive Operations, LLC d/b/a Hilltop at Glenwood II, Lauderdale County, AL: Proposes to convert sixteen (16) existing assisted living facility (ALF) beds into...more

McDermott Will & Emery

Special Report: Examining Group Health Coverage Alternatives for Small Employers - Update

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Originally published in February 2025, this updated report provides new material on physician practice management (PPM) arrangements, reference-based pricing arrangements, minimum essential coverage (MEC) and MEC+ plans, and...more

Maynard Nexsen

NAIC Spring Meeting Update Part Two

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As discussed in last week’s article, along with almost 3,000 regulators and insurance industry leaders, the Maynard Nexsen Insurance Regulatory team of attorneys attended the National Association of Insurance Commissioners...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | February 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for February 2025, including long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability Act...more

McDermott+

Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off

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Game On! 2026 Medicare Fee-for-Service Rulemaking Is About to Tip Off - It’s March, which means one thing for sports fans: the madness of the NCAA men’s and women’s basketball tournaments. However, to folks in the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Makary Is Confirmed as Commissioner of an FDA in Transition

Dr. Martin Makary has been confirmed by the Senate as the next commissioner of the Food and Drug Administration (FDA). Dr. Makary is taking the helm at FDA during an unprecedented time for the agency, which has been subject...more

Zuckerman Spaeder LLP

What to Expect in Consumer Protection in the New Administration

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At the 2025 American Bar Association (“ABA”) White Collar Crime Institute in Miami, industry veterans forecasted the new Trump Administration’s white collar objectives by examining trends during the first Trump presidency. In...more

Holland & Knight LLP

Holland & Knight Health Dose: March 25, 2025

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

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