Mar 6, 2023 | Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing
Novel scheme by medical laboratory company to induce patients to collect and return their own specimen for testing is central to a federal whistleblower case alleging violations of the Anti-Kickback Statute Handing out gift cards only to patients who return a specimen to a clinical laboratory company for colorectal cancer screening is a unique approach that is now at the center of a federal qui tamcase filed by a retired Indiana pathologist. The defendant in this whistleblower lawsuit is Exact...
Feb 27, 2023 | Compliance, Legal, and Malpractice, Laboratory Pathology, Laboratory Resources, Laboratory Sales and Marketing, Laboratory Testing
Supporters of the VALID Act say lobbying blitz by academic medical centers prevented its passage In 2022, a bill before Congress titled the Verifying Accurate Leading-Edge IVCT Development Act (VALID Act) sought to change the current regulatory scheme for clinical laboratory-developed tests (LDTs) and in vitro clinical tests (IVCTs). But even though the College of American Pathologists (CAP) and nine other organizations signed a December 12 stakeholder letter to leaders of key House and Senate...
Feb 3, 2023 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory News, Laboratory Testing, Pathology and Clinical Laboratory Conferences
Healthcare attorneys advise medical laboratory leaders to ensure staff understand difference between EKRA and other federal fraud laws, such as the Anti-kickback Statute More than four years have passed since Congress passed the law and yet the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) continues to cause anxiety and confusion. In particular are the differences in the safe harbors between the federal Anti-Kickback Statute (AKS) and Stark Law versus EKRA. This creates uncertainty...
Jan 25, 2023 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Testing
But insurers are complying under the Transparency in Coverage regulations and that is where discrepancies in the disclosure of prices to the public have been found Despite federal regulations requiring hospitals to publicly post their prices in advance of patient services, some large health systems still do not follow the law. That’s according to a new Transparency in Coverage Report from PatientRightsAdvocate.org (PRA), which found that some hospitals are “flouting” the federal Hospital Price...
Nov 21, 2022 | Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Resources, Laboratory Testing
Judge will decide the restitution Holmes must pay to defrauded Theranos investors at future court date; Ex-COO Ramesh “Sunny” Balwani to be sentenced next month Clinical laboratory leaders and anatomic pathologists who closely followed the fraud trial of Elizabeth Holmes may have wondered how the Theranos founder and ex-CEO would be punished for her crimes. Now we know. On Friday, a federal court judge sentenced Holmes to 135 months—11.25 years—in prison in the culmination of her conviction on...
Nov 7, 2022 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Testing
Organizations representing clinical laboratories and other critical healthcare providers urged Congress to pass the Saving Access to Laboratory Services Act by January 1, 2023, to prevent deep cuts in reimbursements Lessons about the essential role of clinical laboratories during a pandemic was the central theme in a significant publication released recently. The authors were the presidents of two of the nation’s largest healthcare companies and their goal was to connect the value clinical...
