2023 Compliance and Policy Report

March 2023

Medicare MolDX Working to Streamline Policies, Speed Assessments

Top Compliance Challenges for Clinical Laboratories

Payment Coverage Key Policy Concerns for MAWD Pathology

April 2023

FDA to Move Forward on LDT Rulemaking

OIG Targets Drug Testing Overpayments for G0483

EKRA Rulings Cause Confusion, Clarification Needed

May 2023

CMS Says Its Policy Already Allows Nurses to Perform Moderate and High-Complexity Testing

 Tips on Assessing, Mitigating Compliance Risk Under EKRA

OIG Clarifies Use of Gift Cards to Encourage Screening Tests

June 2023

How to Ace Your Lab’s Competency Assessments

Top Five Lab Billing and Coding Changes

National Diagnostics Action Plan Proposes Solution for Future Pandemics

July 2023

FDA Preparing to Issue Proposed Rule on LDT Oversight

Key Legal Hotspots for Laboratory Sales Reps: Tips on What NOT to Do

Q&A With Gregg Brandush, CMS Division of Clinical Laboratory Improvement and Quality

August 2023

FTC Takes First-of-Its-Kind Action Against Genetic Testing Company

Labs, Path Groups Should Review Restrictive Covenants in Anticipation of Non-compete Ban

Pathologists Face Medicare Cuts in 2024 Under Proposed Rule

September 2023

Warren Investigating Google Efforts to Monetize Military Tissue Samples

Navigating New CMS Billing Edits for Drug Testing

Pathologists Call for Changes to Palmetto Special Stains Policy

October 2023

Some MACs Changing Coding on STI Testing in Conflict

MolDX to Cover Molecular Biomaker Testing for RA Targeted Therapy Selection

Labor Departments Sues United Subsidiary Over Denied Drug Screening Claims


November 2023

HHS OIG Nixes AP Purchased Services Agreement

 FDA Tries Once Again to Regulate LDTs, Lab Groups Push Back

PathAI Announces 13 Lab Contracts for Its AI Tools

December 2023

New OIG Compliance Guidance Places Emphasis on Individual Risk Assessment

Best Practices for Specialty Labs Contracting for Specimen Collection

What’s on the Government’s Radar for Labs in 2024?