News
TELCOR is excited to share industry news and updates with our stakeholders across the country.
Oral Arguments Heard in Lawsuit Challenging FDA Regulation of LDTs
Oral arguments were heard on Feb. 19 in the ongoing lawsuit challenging the U.S. Food and Drug Administration regulation of laboratory-developed tests (LDTs) as medical devices. The plaintiffs in the [...]
Updates Announced for 2025 Specimen Collection Fees and Travel Allowance Payments
The Centers for Medicare & Medicaid Services made updates to specimen collection fees and travel allowance payments for 2025. Effective Jan. 1, the general specimen collection fee increased from $8.83 [...]
Medicare Administrative Contractors Update Genetic Testing Coverage for Oncology
Medicare Administrative Contractors (MACs) Novitas and FCSO released finalized local coverage determinations (LCDs) for genetic tests for oncology: L39365 and L39367, respectively. The change comes after the College of American [...]
Court Will Hear Oral Arguments in Lawsuit Against FDA Final Rule on LDTs
Oral arguments will be heard on Feb. 19 in the lawsuit concerning federal oversight of laboratory-developed tests (LDTs). On Jan. 23, the U.S. District Court in Eastern Texas granted a [...]
CMS Updates Provisions of the Clinical Laboratory Fee Schedule for 2025
The Centers for Medicare & Medicaid Services (CMS) has delayed the Clinical Laboratory Fee Schedule (CLFS) data reporting period and the phase-in of payment reductions for 2025 and made updates [...]
No Surprises Act IDR Entity Fees Updated for 2025
On Dec. 27, the Centers for Medicare & Medicaid Services (CMS) published updated independent dispute resolution (IDR) entity fees for 2025 on the No Surprises Act webpage. The IDR entity [...]
HHS Proposes Costly Updates to HIPAA to Address Cybersecurity Threats
The U.S. Department of Health and Human Services (HHS) issued a proposed rule to modify the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security Rule to improve cybersecurity. [...]
FDA Submits Closing Brief in Lawsuit Over Agency Oversight of LDTs
On Dec. 23, the U.S. Food and Drug Administration submitted its closing argument in defense of its regulation of laboratory-developed tests (LDTs) as medical devices. The plaintiffs, the American Clinical [...]
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 [...]