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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
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.
OCR Doles Out Record Fine for Right of Access Violation
On July 15, the Department of Health & Human Services Office for Civil Rights announced 11 new enforcement actions, including the biggest penalty doled out since the agency began the right of access program back in April 2019—$240,000 against Texas nonprofit Memorial Hermann Health System.
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.
Be Sure to Use New ABN Form, Starting August 31
As of August 31, 2022, labs and other providers must use the new ABN labeled with the appropriate federal OMB Number (0938-0566) and CMS-R-131 to ensure they can bill Medicare beneficiaries for any lab tests or other services that Medicare doesn’t cover.