No Appeal of LDT/FDA Lawsuit
The FDA had until May 30 to appeal U.S. District Court Judge Sean D. Jordan's decision to vacate the agency's Final...
Industry (4)
CMS Announces New FDA-Approved Waived Tests
In a change request (CR 14025) released on May 9, the Centers for Medicare & Medicaid Services (CMS) announced six new...
HHS Urged to Reinstate Clinical Laboratory Improvements Advisory Committee
The Association for Diagnostics & Laboratory Medicine (ADLM) urged the Department of Health and Human Service (HHS) to...
Medicare Administrative Contractor Expands Coverage of Special Histochemical, Immunohistochemical Stains
A revised local coverage determination, effective June 7, 2025, expands coverage for special histochemical stains and...
CMS Publishes Updates to the Clinical Laboratory Fee Schedule
The Centers for Medicare and Medicaid Services (CMS) announced the following updates to the Clinical Laboratory Fee...
Supreme Court Hears Arguments in Case Challenging ACA Mandate for Free Preventive Care Services
A recent Supreme Court case is challenging access to free preventive care screenings for millions of Americans under...
Congressional Working Group Seeks Input From Stakeholders on National Standard for Data Privacy
A congressional data privacy working group is exploring federal data privacy and security framework parameters.
Primary Source Verification to Be Used for Verifying Personnel Qualifications Under CLIA
Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), surveyors may now accept Primary Source...
CMS Issues Final Rule Closing Medicare Advantage Loopholes
On April 4, the Centers for Medicare and Medicaid Services issued a final rule making policy and technical changes to...
Federal Court Final Ruling on FDA Regulation of LDTs
Regarding the ongoing lawsuit challenging the U.S. Food and Drug Administration (FDA) regulation of...
CMS Releases Updates to CPT and HCPCS Codes
On March 13, the Centers for Medicare and Medicaid Services released updates for CPT and Healthcare Common Procedure...