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Medicare-certified ASCs must comply with the Conditions for Coverage set forth at 42 C

Independent clinical laboratory services are a distinct product market from ASC services and PPM services: • Regulatory framework: Clinical laboratories are regulated under the Clinical Laboratory Improvement Amendments ("CLIA") of 1988 and must obtain CLIA certification

Both conditions must be satisfied for the presumption to apply

New ASCs must obtain Medicare and Medicaid certification in order to participate in the federal healthcare programs and serve Medicare and Medicaid beneficiaries

The certification process typically takes several months and must be completed before the facility can bill Medicare for services rendered