News
TELCOR is excited to share industry news and updates with our stakeholders across the country.
House Hearing Examines Shortcomings and Successes of CMS Innovation Center
The House Energy & Commerce Committee held a Health Subcommittee hearing on Thursday, June 13, regarding the Centers for Medicare & Medicaid Innovation (CMMI). CMMI, also known as the Centers [...]
House Energy & Commerce Health Subcommittee to Hold Hearing About the State of CMMI
The House Energy & Commerce Committee will hold a Health Subcommittee hearing on Thursday, June 13, regarding the Centers for Medicare & Medicaid Innovation (CMMI). The CMMI, also known as [...]
ACLA Sues FDA Over Final Rule Regulating LDTs as Medical Devices
The American Clinical Laboratory Association (ACLA), along with its member company HealthTrackRx, filed a lawsuit against the U.S. Food and Drug Administration as a challenge to the May 6 final [...]
FDA to Host Webinar on In Vitro Diagnostic Devices Draft Guidance
The U.S. Food and Drug Administration will host a webinar on June 5, 2024, to provide an overview of draft guidance documents concerning the regulation of in vitro diagnostic devices [...]
HHS Announces New Resubmission Process for NSA Independent Dispute Resolution
On May 1, the U.S. Departments of Health and Human Services, Labor, and the Treasury announced the release of a new process for resubmitting improperly batched or bundled Independent Dispute [...]
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, [...]