Press Releases

The Food and Drug Administration (FDA) announced on April 29, 2024 that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices. C21 has long been concerned that applying FDA regulatory requirements designed for distributed medical devices to laboratory procedures will hinder patient access to critical LDTs that are the leading edge of advancing precision medicine in patient care.

The Food and Drug Administration (FDA) announced today that it intends to regulate Laboratory Developed Tests (LDTs) furnished by clinical laboratories as medical devices and outlined a plan to end enforcement discretion for all LDTs over the next 4 years. These proposed new FDA regulatory requirements would be in addition to the comprehensive regulations applicable to LDTs and laboratories under the Clinical Laboratory Improvement Amendments (CLIA).

On March 23, the Centers for Medicare & Medicaid Services (CMS) released the long awaited application and designation process for Advanced Diagnostic Laboratory Tests (ADLTs) as required by the market-based payment reforms enacted in Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). The Coalition for 21st Century Medicine (C21) strongly supported the enactment of these PAMA requirements to establish transparent, predictable and market-based pricing for new innovative clinical diagnostic laboratory tests.

On November 17, the Centers for Medicare & Medicaid Services (CMS) released the first Clinical Laboratory Fee Schedule (CLFS) reflecting private payor rate-based payment amounts as required by the market-based payment reforms enacted in Section 216 of the Protecting Access to Medicare Act of 2014 (PAMA). The Coalition for 21st Century Medicine (C21) strongly supported the enactment of these PAMA requirements to establish transparent, predictable, and market-based pricing for clinical diagnostic laboratory tests.

On November 1, 2017, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year 2018 Hospital Outpatient Prospective Payment System Final Rule, establishing a new policy for determining the billing rules (commonly referred to as the “date of service”) for precision medicine laboratory tests. The new policy will take effect January 1, 2018 and will enable laboratories to bill Medicare directly for many precision diagnostic tests performed on specimens collected from hospital outpatients. Current Medicare regulations frequently require hospitals to bill Medicare for tests that are performed separately by independent laboratories, creating unnecessary complexity and delayed patient access to test results and treatments.