Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
OIG Work Plan Monthly Review: July 2018
From - G2 Compliance Advisor
None of the six new items that OIG added to its Work Plan last month directly impact labs…
Whole-Genome Sequencing Adds Value to Cardiomyopathy Workup
From - Diagnostic Testing & Emerging Technologies
Whole-genome sequencing (WGS) identifies additional genetic causes of hypertrophic cardiomyopathy (HCM) beyond those identified through targeted…
CMS Takes 3 New Measures to Bolster Medicaid Program Integrity
From - National Intelligence Report
With Medicaid spending on the rapid ascent, CMS unveiled a trio of new initiatives to bolster program integrity and make states more accountable for…
How to Avoid a Laboratory Audit
By Sean McSweeney bio
Laboratory audits have a much harder impact on your lab than intended. As detailed by the NCBI, the audit's intent is to review and…
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…