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
The State of State Licensing Law Restrictions on Telehealth
With temporary waivers of restriction relating to telehealth likely to end soon, here’s a roundup of the current state of state telehealth licensing law.
Four Things You Need to Know About the 2023 OPPS Payments Rule
The final Outpatient Prospective Payment System Final Rule for 2023 provides for a rate increase of nearly four percent.
Court Nixes COVID-19 Lab Test Reimbursement Lawsuit Against Private Payor
Despite Congress’ clear policy on private insurer payment of COVID-19 tests, many labs have been struggling to get reimbursed.
Despite MDUFA Setback, VALID Act Is Back on Track for Passage
Though Congress didn’t pass VALID as part of the medical devices user fees bill, there’s still a good chance it will pass before year’s end.
Holmes May Get a New Trial on Basis of Witness Tampering
Sentencing has been postponed for one month to explore possible government mishandling of key witness testimony.
HHS’ Proposed New Anti-Discrimination Rule & What You Can Do to Comply with It
What you need to know about the 308-page proposed rule and its potential impact on your lab, along with a basic strategy to implement it.
Ambry Genetics Shells Out Millions to Settle Data Breach Class Action
The problems began in January 2020 when hackers got access to an employee’s email account, compromising clients’ personal data.
FDA Tightens the Screws on EUA Review of COVID-19 Tests
The agency recently announced subtle but significant changes to its policies governing review of new lab tests for COVID-19.
CMS Dishes Out First Penalties for Hospital Price Transparency Violations
After the price transparency rules took effect in January 2021, CMS finally issued the first penalties for violations.
Eight New CLIA-Waived Tests Your Lab Staff Need to Know About
CMS has instructed its MACs to recognize eight new CLIA-waived complexity tests for which labs will be allowed to bill, effective Oct. 1.
