Biomarker Testing, Medicare Billing, and CMS Laboratory Date of Service Policy (the “14-Day Rule”)
Centers for Medicare and Medicaid Services (CMS) Laboratory Date of Service Policy (sometimes referred to as the “14-day rule”) affects diagnostic tests ordered less than 14 days after an inpatient or outpatient discharge. The policy requires laboratories to bill the hospital for tests performed for Medicare patients within this 14-day window. The updated policy requires laboratories to bill Medicare directly for exempted tests performed within the 14-day window.
Addressing Challenges With Biomarker Testing During the COVID-19 Pandemic
Guidelines recommend limiting in-person contact to protect patients and health care workers. Liquid biopsy and germline testing using blood samples are less invasive options to assess for actionable biomarkers. The use of mobile phlebotomy may further reduce barriers to testing during the coronavirus disease 2019 (COVID-19) pandemic.
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BRCA, breast cancer susceptibility gene; EGFR, epidermal growth factor receptor; PD-L1, programmed death-ligand 1; NSCLC, non-small cell lung cancer; PCR, polymerase chain reaction.
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