A Look at How CLIA-Exempt States Operate and Why This Setup Exists
Washington State’s Department of Health details how its medical testing site program meets federal standards
National Lab Reporter
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Articles and Reports
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Expanding Test Menus: A Compliance Roadmap for FDA-Regulated Labs
Two OIG advisory opinions guide laboratories that want to work with pharma or medical device companies on expanded testing
Staffing Special Report: CMS Proposes Changes to CLIA Laboratory Personnel Requirements
An overview and analysis of the recently proposed changes and how they could affect your medical laboratory.
Reimbursement: ABN’s Failure to Include List Prices for Denied Lab Tests Is Not Consumer Fraud
Recent case shows why failing to disclose to individuals the lab test list prices they may need to pay doesn’t count as consumer fraud.
Medicaid Fraud Recoveries Drop Significantly in 2022
At $1.1 billion, total recoveries in 2022 did exceed $1 billion for the fourth year in a row, but dropped from $1.7 billion in FY 2021
Congress Offers New Hopes of PAMA Reform
On March 28, the 118th Congress raised lab industry hopes once more by reintroducing the Saving Access to Laboratory Services Act (SALSA).
OIG OKs Offering Patients Gift Cards for Returning At-Home Test Kits
A new OIG Advisory Opinion sheds some light on when it’s permissible for a lab to offer customers a gift card for returning their at-home testing kit.
SCOTUS to Decide Monumental Question Affecting Providers’ FCA Liability
It’s not just billions of dollars on the line, but the very future of whistleblower lawsuits and FCA enforcement.
FCA Enforcement Activity Is Up but Recovery Dollars Are Down
The DOJ’s recent report on FCA enforcement statistics for FY 2022 shows that while actions are dramatically up, recoveries are way down.
No Surprises Act Controversy Takes Surprising Twist
Resolution process put on hold after federal court again strikes down parts of the regulation as being unfairly weighted in favor of insurers.
LDT Reform: If Congress Won’t Do It, We Will, Says FDA
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.
CMS Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
