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”
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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
Health System and Care Providers Settle FCA Allegations for $70.7M
Ventura County’s organized health system and three medical care providers were accused of falsely billing Medi-Cal.
New Test May Make It Faster, Cheaper, and Easier to Detect Aneuploidy
New Short-read Transpore Rapid Karyotyping test can identify fetal chromosomal abnormalities in a variety of samples.
Can You Increase Your Bottom Line While Putting Patients First?
Technology can make it possible for labs and other healthcare providers to boost revenue while still providing a positive patient experience.
SNAP Diagnostics Pays $3.9M to Settle Sleep Testing False Claims Charges
Federal enforcers and whistleblowers home in on billing of medically unnecessary sleep tests.
Cases of Undiagnosed Diabetes Are Declining in the US
A recent study shows that the proportion of undiagnosed diabetes has dropped over the past three decades, but certain groups are more affected.
CMS Proposes 20 Percent Increase to CLIA Lab User Fees
A new rule proposed by the agency would also mean new fees for follow-up and complaint surveys.
Home Healthcare Business Owner to See Prison Time for $10M Fraud
In key enforcement actions announced over the last week, a Texas-based owner faces 60 months behind bars for defrauding Medicare.
Don’t Trust a Negative At-Home COVID-19 Test Result, FDA Warns
The agency is recommending repeat testing with at home COVID-19 antigen tests, regardless of actual symptoms.
LDTs Legislation Inches Closer to Passage, but Major Hurdles Remain
The VALID Act for FDA regulation of laboratory developed tests is working its way through the final stages of the legislative process, but not everyone is loving it.
OIG and CMS Clash on Medicare Overpayment Recoveries
OIG says the agency is leaving millions of dollars on the table, but CMS doesn’t want to hear it.
