Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills

Dec 14, 2022 | Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Resources, Laboratory Testing, News From Dark Daily

Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’ Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through. The Verifying Accurate Leading-edge IVCT Development (VALID) Act and Saving Access to Laboratory Services Act (SALSA) could be added to a year-end spending package that will fund...

Four Regulatory Developments Coming This Fall That Are Relevant for Clinical Laboratory Leaders and Pathology Group Managers

Oct 31, 2022 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Laboratory Testing, Molecular Diagnostics, Genetic Testing, Whole Gene Sequencing

Regulators and lawmakers are considering proposed changes to CLIA and PAMA involving medical laboratory services Clinical laboratories and pathology groups should monitor a series of federal regulatory developments underway this fall. The proposals and documents will potentially affect how lab managers and staff do their jobs and how much Medicare reimbursement medical laboratories receive for certain diagnostic tests next year. Among the initiatives under consideration are the following:...

Federal Regulators Issue Notice to DTC Test Company Orig3n That Its Purchase of Interleukin Genetics Could Involve CLIA Compliance Issues

Jan 10, 2018 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, Laboratory Testing

CMS sends letter to Orig3n notifying the genetic test company that it may not have the required certifications to market its genetic tests Orig3n’s recent ill-fated “DNA Day” promotion to offer free genetic tests during an NFL football game this past fall pushed Orig3n into the media spotlight. The Massachusetts-based biotech company—which sells 18 different DNA tests on its website—suspended the promotion due to questions from the Centers for Medicare and Medicaid Services (CMS) and the...

State and Federal Agencies Throw Yellow Flag Delaying Free Genetic Tests at NFL Games in Baltimore—Are Clinical Laboratories on Notice about Free Testing?

Oct 13, 2017 | Uncategorized

Media coverage of a recent Orig3n promotion-and intervention from state and federal officials-reveals the level of discomfort public and policymakers have for handling the publics’ protected health information, including genetic test data Is it appropriate to offer free genetic tests to 70,000 fans attending a professional football game? Apparently not, say federal and state healthcare regulators who took steps to block a planned free genetic test giveaway that the Baltimore Ravens and...

Recent Study Confirms that Clinical Laboratories and Pathologists Have an Opportunity to Help Educate Consumers in Key Health Information, such as Cholesterol, and Blood Glucose Levels

Mar 11, 2016 | Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations

Reviewing medical laboratory test results online is a popular resource among consumers, says a different study by Kaiser Permanente More than half of patients and consumers have trouble understanding their health information, along with the steps needed to further improve their health, according to a recent study conducted by HealthMine. This gap in consumer understanding represents a great opportunity for clinical laboratories and pathology groups that want to forge stronger bonds with...