Laws & Regulations

2026 Lab Compliance Guide: AKS, EKRA, Necessity, and Coding
Infrastructure & Management 2026 Lab Compliance Guide: AKS, EKRA, Necessity, and Coding

Record-setting health care fraud takedowns and lab-centered prosecutions have reset the compliance baseline, forcing diagnostics leaders to prove that every dollar paid and every test billed can withstand statutory, clinical, and coding scrutiny. Momentum from the Department of Justice’s 2025

Can RAPID Align FDA Approval With Timely Medicare Coverage?
Infrastructure & Management Can RAPID Align FDA Approval With Timely Medicare Coverage?

A device can clear the FDA and still spend years in limbo before Medicare agrees to pay for it, a gap that has drained momentum from breakthrough technologies and stranded value for patients, providers, and investors alike. The Regulatory Alignment for Predictable and Immediate Device (RAPID)

AI-Backed WISeR Pilot in Washington Delays Care, Draws Fire
Infrastructure & Management AI-Backed WISeR Pilot in Washington Delays Care, Draws Fire

Introduction Phone lines that once confirmed Medicare approvals in days now relay weekslong holds as an AI gatekeeper reroutes care through a new federal experiment in Washington. The WISeR model—short for Wasteful and Inappropriate Service Reduction—was designed to slow unnecessary spending, yet

Can the FTC’s USAP Deal Rein in Private Equity Roll-Ups?
Regulatory & Compliance Can the FTC’s USAP Deal Rein in Private Equity Roll-Ups?

James Maitland has spent years in the trenches of healthcare antitrust and physician-practice M&A, advising on how roll-ups change bargaining dynamics, how remedies land in the real world, and how to translate legal settlements into better patient access and sustainable hospital operations. In this

No Surprises Act Arbitration Is Driving Up Healthcare Costs
Imaging & Diagnostics No Surprises Act Arbitration Is Driving Up Healthcare Costs

While patients are no longer receiving terrifying medical bills for thousands of dollars after an emergency, the hidden machinery of federal arbitration is quietly pushing the entire nation’s insurance premiums into a new and dangerous stratosphere. The No Surprises Act (NSA) was heralded as a

How Will the Star Rating Overhaul Reshape Medicare Advantage?
Infrastructure & Management How Will the Star Rating Overhaul Reshape Medicare Advantage?

The federal government’s decision to prioritize clinical results over administrative responsiveness marks a seismic departure from decades of established Medicare oversight and will permanently alter the financial trajectory of private insurance markets. What happens when the federal government

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