FDA’s LDT Proposal Raises Questions About Clinical Validity
Debate is underway on whether current CLIA review of LDTs properly assesses a test’s likelihood to detect diseases.
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Using the IQCP Process to Improve CLIA Compliance and Lab Testing System Quality
Individualized quality control plans offer flexibility and the capacity to seamlessly adopt new nonwaived tests, practices, and technologies.
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CMS Provides New Guidance on When International Labs Must Seek CLIA Certification
Recently released Centers for Medicare and Medicaid Services guidance shares when CLIA regulations apply to international labs.
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Brief Your Billing & Coding Staff on New Medicare HCPCS & CLIA Code Changes
To avoid claims denials and improper billings, ensure billing and coding staff is aware of, and has adjusted to, all recent coding changes.
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Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel
While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.