LDT Regulation: New Survey Asks Readers for Their Views About Two Bills Before Congress

Survey respondents can give their opinions about the proposed VALID and VITAL acts Two bills are pending in Congress, and each is written to change the current regulatory scheme for laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). The bills go by the acronyms of the VALID Act and VITAL Act. Many clinical laboratories offering LDTs today may be unaware of the details within each bill as currently written. An LDT is a proprietary diagnostic test developed and performed by...

Multiple Pathology and Other Healthcare Organizations Request CDC Include Clinical Laboratory Personnel in First Round of COVID-19 Vaccinations

CAP president maintains medical laboratory staff are ‘indispensable’ in pandemic fight and should be in ‘top tier’ for vaccination As COVID-19 vaccinations continue to roll out, the College of American Pathologists (CAP) is lobbying for clinical pathologists and medical laboratory staff to be moved up the priority list for vaccinations, stating they are “indispensable” in the pandemic fight. In a news release, CAP’s President Patrick Godbey, MD, FCAP argued for the early vaccination of...

PwC Predicts Forces Shaping Healthcare in 2018; Some Could Impact Clinical Laboratories and Anatomic Pathology Groups

PwC’s list of 12 factors that will shape the healthcare landscape in 2018 calls attention to many new innovations Dark Daily has reported on that will impact how medical laboratories perform their tests PwC’s Health Research Institute (HRI) issued its annual report, detailing the 12 factors expected to impact the healthcare industry the most in 2018. Dark Daily culled items from the list that will most likely impact clinical laboratories and anatomic pathology groups. They include: Artificial...

What Every Lab Needs to Know about the Medicare Part B Clinical Laboratory Price Cuts That Take Effect in Just 157 Days, on Jan. 1, 2018

Another big question is whether the lobbying of medical laboratory and pathology societies can educate and convince members of Congress to delay and reform the PAMA Final Rule that uses the market price study of what private payers pay for lab tests Coming in just five months are the deepest, most painful clinical laboratory test price cuts ever implemented by Medicare officials. During calendar 2018 alone, both the Centers for Medicare and Medicaid Services (CMS) and the Office of Inspector...

Nation’s Smaller Community Medical Laboratories Have Major Concerns about Financial Survival Once Medicare Officials Implement Deep Price Cuts to Lab Test Fees in 2018

In vitro diagnostic manufacturers and medical distributors share concerns, along with other types of medical labs in nation’s small cities and hinterlands that include rural hospital labs and physician office labs (POLs) because, along with financial erosion, there is the potential of reduced access by Medicare beneficiaries to clinical lab tests where they live SAN ANTONIO, TEXAS—Owners and managers of community and regional independent lab companies and community laboratories gathered here...
;