ePolicy News—June 2025

The LDT Final Rule is Officially Dead: FDA Has No Jurisdiction 

On May 30, the FDA chose not to appeal a court decision that vacated its attempt to regulate laboratory developed tests (LDTs), marking a major win for patient care and ending a decades-long dispute over regulatory authority. The court affirmed that oversight of LDTs belongs to CMS under the CLIA framework, not the FDA, aligning with the position of ASCP. ASCP now plans to support CMS in its regulatory role and continue opposing legislation like the VALID Act, which could impose burdensome requirements on clinical laboratories. Read more.  

Federal Workforce Programs, Medicare Payment Impacted by Congressional Reconciliation Bill 

Congressional Republicans passed a budget reconciliation bill which extends $4.5 trillion in tax cuts while cutting $1.7 trillion in federal spending, and a potential $500 billion in Medicare cuts. While the bill includes a modest inflationary update to Medicare’s physician fee schedule and provisions from the Tomorrow’s Workforce Act to support lab training programs, it also makes significant cuts to student loan and workforce development programs. ASCP is actively lobbying against Medicare and education funding reductions and urging the Senate to mitigate their impact on healthcare professionals. Read more.  

ASCP Urges Trump Administration to Reinstate CLIAC 

ASCP is urging the Trump Administration to reinstate the Clinical Laboratory Improvement Advisory Committee (CLIAC), which was terminated following Executive Order 14217 aimed at reducing federal bureaucracy. CLIAC, a key advisory body on laboratory testing and patient care, officially shut down on March 31. ASCP and allied organizations are calling for the restoration of CLIAC and its website, emphasizing the critical value of its guidance and resources. Read more. 

ASCP Opposes Legislation to Allow Gene Patents 

ASCP, alongside more than 20 medical and patient advocacy groups, is opposing the Patent Eligibility Restoration Act, which would allow companies to patent human genes and other natural phenomena. ASCP argues that such patents could hinder clinical care, research, and patient access to vital genetic information. ASCP was a key plaintiff in the 2013 landmark case where the Supreme Court ruled that genes like BRCA1 and BRCA2 are not patentable, and which upheld that naturally occurring genes are not eligible for patents under the Patent Act. Read more.