FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
National Lab Reporter
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
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Articles and Reports
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
White House Unveils New “Bill of Rights” for Responsible Use of AI
The US has taken its first steps to establish legal limits over AI use by publishing a voluntary code to ensure responsible corporate use of AI.
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.
