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
Labs in Court Weekly Roundup
Settlements for False Claims Act allegations the theme in recent enforcement actions involving the healthcare industry.
False Billing of UDTs Remains a Prime Target for Enforcement
UDT false billing cases seem to be on the rise again, accounting for a trio of recent multimillion dollar settlements.
OIG Issues First Positive Advisory Opinion for Free Genetic Testing
On April 11, the OIG approved a proposed arrangement involving the offering of free genetic tests and counseling services.
FDA Sounds the Alarm on Counterfeit OTC COVID-19 Tests
Counterfeit COVID-19 tests are being illegally imported into the US and being distributed to unsuspecting consumers across the country.
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.
How the End of the COVID-19 PHE Will Impact Lab Compliance
A briefing on how labs should prepare for the inevitable end of the PHE after more than two years of unprecedented relief.
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.
