News
TELCOR is excited to share industry news and updates with our stakeholders across the country.
FDA Webinar Covers Establishment Registration and Listing Requirements for LDTs
The U.S. Food and Drug Administration held a webinar on Dec. 3 to detail the registration and listing requirements for in vitro diagnostics (IVDs), including laboratory-developed tests (LDTs). Within the [...]
FDA Offers Guidance for Understanding LDT Regulatory Obligations
The U.S. Food and Drug Administration recently explained the regulatory obligations of laboratories for laboratory-developed tests (LDTs) under new regulations set to take effect May 6, 2025. The College of [...]
Plaintiffs File Closing Briefs in Lawsuit Against FDA Regulation of Laboratory-Developed Tests
The American Clinical Laboratory Association (ACLA) and Association for Molecular Pathology (AMP) each filed closing briefs on Nov. 25 in the lawsuit against the U.S. Food and Drug Administration oversight [...]
UHC Will No Longer Cover Pharmacogenetic Panel Tests for Commercial and Individual Exchange Plans
Effective Jan. 1, 2025, UnitedHealthcare (UHC) will no longer provide coverage for multigene panel pharmacogenetic tests. According to a policy bulletin issued by UHC on Nov. 1, “The use of [...]
Prior Authorization Issues and Laboratory Date of Service Rule Among Topics Discussed at AMA House of Delegates Meeting
During the 2024 American Medical Association (AMA) Interim Meeting from Nov. 8 to 12 in Orlando, Florida, the AMA House of Delegates addressed prior authorization requirements and the Medicare 14-Day [...]
Several Organizations File Briefs in Support of the FDA in LDT Lawsuit
Several organizations representing physician and patient interests filed amicus briefs in support of the U.S. Food and Drug Administration defense of its final rule on laboratory-developed test (LDT) regulation. The [...]
FDA Files Brief in Defense of LDT Final Rule
The U.S. Food and Drug Administration defended its regulation of laboratory-developed tests (LDTs) as medical devices in a legal brief filed on Oct. 25. Both the American Clinical Laboratory Association [...]
CMS-Mandated Changes to Laboratory Director Qualifications Effective in December
Changes to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations related to laboratory director qualifications are set to take effect soon. A final rule published by the Centers for [...]
CAP Files Amicus Brief Challenging FDA Final Rule on Laboratory-Developed Tests
The College of American Pathologists (CAP) filed an amicus brief in the U.S. District Court on Oct. 7, challenging the U.S. Food and Drug Administration regulation of laboratory-developed tests (LDTs). [...]
Association for Molecular Pathology Comments on Proposed MAC Consolidation
On Oct. 3, the Association for Molecular Pathology (AMP) submitted comments to the Centers for Medicare & Medicaid Services (CMS) regarding consolidation of certain Medicare Administrative Contractors (MACs). The comments [...]