News
TELCOR is excited to share industry news and updates with our stakeholders across the country.
Congressional Leaders Express Disappointment With FDA Final Rule on LDTs, Call for Passage of VALID Act
Congressional leaders are disappointed with the U.S. Food and Drug Administration final rule on the regulation of in vitro diagnostic tests (IVDs), including laboratory-developed tests (LDTs). The final rule amends [...]
FDA Releases Final Rule Regarding Regulation of LDTs as Medical Devices
The U.S. Food and Drug Administration released a final rule on April 29 regarding the regulation of laboratory-developed tests (LDTs). The final rule amends existing regulations regarding LDTs -- defined [...]
CAP Responds to Senate HELP Committee Request for Information on Clinical Test Regulation
The College of American Pathologists (CAP) responded to a request for information from Senate leadership regarding how to improve regulation of clinical tests in the United States. Senator Bill Cassidy, [...]
OIG Issues Report Recommending Improvements to CMS CDLT Rate Setting During Future Public Health Emergencies
The U.S. Department of Health and Human Services Office of the Inspector General (OIG) issued an April report recommending improvements the Centers for Medicare & Medicaid Services (CMS) could make [...]
CMS Announces Updates to NCD Codes and Electronic Funds Transfer Application
The Centers for Medicare & Medicaid Services announced changes to the electronic funds transfer application for Medicare payments and the laboratory national coverage determination (NCD) edit software. Effective May 1, [...]
HHS, Labor, and Treasury Publish Short-Term, Limited-Duration Insurance Final Rule
The Departments of Health and Human Services, Labor, and the Treasury released a final rule on March 28 regarding short-term, limited-duration insurance (STLDI) and fixed indemnity insurance. The final rule [...]
Congressional Hearing Expounds Need for Legislative Action on LDT Regulation
The House Energy and Commerce Subcommittee on Health held a hearing on Thursday, March 21, to evaluate approaches to diagnostic test regulations and the recently proposed rule from the U.S. [...]
House Energy and Commerce to Hold Subcommittee Hearing on Diagnostic Test Regulation
The House Energy and Commerce Subcommittee on Health will convene a hearing on March 21 on diagnostic test regulation and the impact of the U.S. Food and Drug Administration proposed [...]
CAP Calls on CMS to Revise Local Coverage Determination Process
The College of American Pathologists (CAP) sent a letter to the Centers for Medicare & Medicaid Services (CMS) on Feb. 23 urging a revision of the local coverage determination (LCD) [...]
UnitedHealthcare Stresses Compliance With Z-Code Requirements Ahead of Deadline
UnitedHealthcare (UHC) will enforce compliance with new DEX Z-code requirements for molecular diagnostic testing on April 1. The DEX Z-code submission process for claims will take place in phases, with [...]