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
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.
Advance Beneficiary Notice of Noncoverage (ABN) Form (Spanish Version)
Here’s the Advance Beneficiary Notice of Non-Coverage that you should present to patients who speak Spanish, starting August 31, 2022.
Advance Beneficiary Notice of Noncoverage (ABN) Form (English Version)
Here’s the Advance Beneficiary Notice of Non-Coverage that you should present to patients, starting August 31, 2022.
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.
Federal Enforcers Crack Down on Telehealth Genetic Testing Scams
After the DOJ announced a massive National Health Care Fraud Enforcement Action on July 20 targeting telehealth and telemarketing scams, labs need to be extremely wary, especially if they provide genetic testing.
