CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look back at other important federal laws and regulations that triggered […]
Several Times, Feds Tried to ‘Redirect’ Lab Activities
During the past five decades, federal regulators attempted several times to recast how labs operated
- By Robert Michel
- > From the Volume XXXI, No. 8 - June 10, 2024 Issue
- Tags: Centers for Medicare and Medicaid Services, clfs, clia, CLIA ’67, Clinical Laboratory Fee Schedule, Clinical Laboratory Improvement Act of 1967, Clinical Laboratory Improvement Amendments of 1988, CMS, Congress, cytotech, cytotechnologist, FDA, Food and Drug Administration, HCFA, Health Care Financing Administration, lab risk & compliance, laboratory-developed test, ldt, Medicaid, Medicare, Medicare Part B, PAMA, Pap Mill, Pap smear, Pap test, Protecting Access to Medicare Act of 2014, The Wall Street Journal, Walt Bogdanich
