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
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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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
AI Algorithm Gets FDA Breakthrough Device Designation
The algorithm, designed to help diagnose pulmonary hypertension earlier, aims to ensure patients get treatment sooner.
What Happens to COVID Tests After Public Health Emergency Ends?
The FDA will almost certainly keep EUA tests on the market after the PHE expires.
Labs in Court Weekly Roundup
Settlements for False Claims Act allegations the theme in recent enforcement actions involving the healthcare industry.
Should Certain Racial Groups be Screened for Diabetes at Lower BMIs?
Recent study shows that different diabetes screening guidelines are required to produce equal benefits for certain racial groups.
Labs in Court Weekly Roundup
Recent health care industry-related cases involved a variety of fraud types, including kickbacks and fake vaccine card distribution.
World Leaders Promise More Funds to Fight Pandemic at COVID-19 Summit
Meeting for the second Global COVID-19 Summit, leaders from around the world made additional financial commitments to fighting the disease
Lab Compliance Will Change When the Public Health Emergency Ends
The relaxed regulatory environment labs have provided during the COVID-19 pandemic is set to come to and end soon.
Millions Will Lose Medicaid Coverage When the PHE Ends: Report
New report says between 5.3 and 14.2 million people will lose their Medicaid coverage when the COVID-19 public health emergency ends.
New Resource Aims to Improve Diagnosis of Patients with Hearing Loss
Guidance from the American College of Medical Genetics and Genomics shares the importance of a genetic evaluation for hearing loss.
FDA Recalls More COVID-19 Tests
Recall of Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test the latest in string of recent Class I events.
