Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
The Diagnostics Pipeline: First FDA Approval of CRISPR Therapy Possible This Year
The agency recently announced it will decide in December whether to grant clearance for a CRISPR therapy for treating sickle cell disease.
Making Complete Genome Sequencing Affordable, Accessible
Automation software uses advanced computational tools to generate gapless genome sequences in just a couple of days.
Emerging Polygenic Risk Score Tests Demonstrate Potential for Improving Cancer Screening
Although PRS technology and adoption still have a way to go, it is progressing quickly, especially in the cancer and oncology space.
4 Open-Source Diagnostic Software Projects to Explore
Free open-source software can be leveraged across diagnostic processes—how can your organization benefit from it?
OIG Semi-Annual Report Calls Out Drug, Genetic, and COVID-19 Testing Fraud
These three lab testing areas were the main sources of fraud and abuse revealed in the OIG’s latest Semi-Annual Report to Congress.
Could SALSA Pass This Year?
Lab industry insiders say they’re confident the Saving Access to Laboratory Services Act (SALSA) will pass in 2023.
Congress Moves to Permanently Restore Medicare Coverage of Pharmacy Lab Tests
Congress is renewing its previous efforts to make Medicare reimbursement of pharmacy testing permanent—here’s what that could mean for labs.
Compliance Alert: OIG Sounds the Alarm on Medicare Overpayments for Physician Services Provided to Inpatients
According to a recent report, Medicare overpaid for such services over a two-year period between 2019 and 2020.
Special Report: The Current State of Genetic Testing Fraud Enforcement
Current genetic testing enforcement trends and what you can do to minimize the liability risks of your lab.
Reproposed SALSA Offers Real Chance of Long-Term PAMA Relief
After it failed to pass at the end of 2022, lab leaders and other insiders say they’re optimistic SALSA will pass this year.
