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
- 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
LDT Reform: If Congress Won’t Do It, We Will, Says FDA
Hopes are high that something will finally be done to resolve the LDTs situation this year, however that action may not come from Congress.
CMS Clarifies Rules for IDTF Medicare Billing of Diagnostic Tests
The agency recently issued new guidance exempting indirect independent diagnostic testing facilities from some requirements.
Labs Should Be Wary of Improper Billing of G0483 Testing
Recent OIG report says Medicare could have saved up to $215.8 million on at-risk payments for G0483 definitive drug tests.
Proposed Rule Puts Labs at Greater Risk of FCA Liability
CMS recently proposed a rule that would make the False Claims Act rule the standard for overpayments under the Affordable Care Act regulations.
New PLA Codes Billable Under the Medicare CLFS to Be Aware Of
Here’s a quick briefing of the new codes that come into effect on April 1 that your billing staff should know about.
Federal Court Strikes Down No Surprises Act Dispute Resolution Rules
The rules unfairly favor insurers in out-of-network payment disputes, court says.
Recent Blood-Based Tests May Help Increase Colorectal Cancer Screening
Though not yet recommended for screening by the ACS or other medical groups, recently developed blood-based tests show promise.
Weekly Enforcement Report: Medical Centers Pay Big
Recently announced enforcement actions saw three big settlements, with two of those coming from medical centers.
OIG Sounds the Warning on Overbilling of G0483 Definitive Drug Tests
Labs may be billing Medicare for high-reimbursing and medically unnecessary drug tests, according to the OIG.
Amazon Makes Bold Move into DTC Healthcare Services
Though the e-commerce giant recently closed its acquisition of One Medical, FTC antitrust intervention could disrupt Amazon’s plans.