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
Former Patients Join the Legal Posse on the Trail of Theranos
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The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Thermo Fisher Scientific and Invitae were among the firms releasing multiple new products from the end of June through the third week of July. Here's a more…
Brief Your CEO: Real Stark Law Relief Might Actually Happen
From - G2 Compliance Advisor
Fool me once, shame on you; fool me twice, shame on me.
That may have been your reaction when you first heard about the new CMS Request for Information (RFI) seeking input on ways to…
Medicare Reimbursement: CMS Begins Implementing New HOPPS Date of Service Rules for ADLTs & Molecular Pathology Tests
From - National Intelligence Report
CMS has begun implementing the new rules that exempt advanced diagnostic laboratory tests (ADLTs) and molecular pathology tests from…
Noninvasive Gene Expression Test for Melanoma Cuts Costs
From - Diagnostic Testing & Emerging Technologies
The noninvasive pigmented lesion assay (PLA; DermTech) reduces costs compared to the current standard of care for diagnostic workup of pigmented skin lesions suggestive of…
Strategic Alliances, Partnerships & Collaborations Analysis – August 2018
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Ex-CEO of HDL Settles Bankruptcy Claims for $10 Million
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Next-Gen Sequencing Has Significant Utility for Drug-Resistant Epilepsy
From - Diagnostic Testing & Emerging Technologies
Next-generation sequencing improves definitive diagnoses for children with drug-resistant epilepsy, according to a pilot study published online…
Compliance Perspectives: Genetic Test Labs Face Growing Risk of Medical Malpractice Liability
From - G2 Compliance Advisor
Compliance managers of lab involved in the $3 billion consumer-based genetic testing business need to safeguard their flank against a growing legal risk…
FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From - National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
