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
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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
Watch Out for Fake COVID-19 Tests, FDA Warns
Agency warns the public to be on the lookout as counterfeit at-home OTC COVID-19 diagnostic tests appear on the US market.
OIG: Medicare Advantage Plans Are Stiffing Physicians on Reimbursement
New report shows a fair portion of prior authorization and physician reimbursement request denials actually met Medicare coverage rules.
Precision Oncology Company Nabs Coverage for Advanced Cancer Test
In this month’s Business Roundup, we cover key happenings including Medicare coverage and reimbursement, as well as the US surpassing Europe as medtech’s market of choice.
Labs in Court Weekly Roundup
In last week’s announced enforcement actions involving the healthcare industry, two defendants were sentenced, one was convicted, and two others were charged in various fraud-related schemes.
Florida Lab Owner Jailed for Telemedicine Genetic Test Ripoff
Case is part of a larger coordinated enforcement action targeting COVID-19-related fraud spanning seven judicial districts.
New Tech Could Make At-Home Disease Diagnosis More Feasible
A research team has developed a new, simpler microfluidic chip that could make at-home diagnosis of diseases faster and more affordable
PAMA Hasn’t Reduced Part B Lab Test Costs
For the third straight year since the PAMA pricing system has been in place, overall year-over-year spending on lab tests increased in FY 2020.
Healthcare M&A Deal Volume & Size Bottom Out in First Quarter
Healthcare M&A might have bottomed out in the first quarter of 2022 in terms of both deal volume and size, according to a new report.
FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
Onco Pharma Giants Team Up to Boost Access to Cancer Genomic Testing
The recently-formed Precision Cancer Consortium will make it easier for cancer patients around the world to get access to genomic testing.
