CAP Comments on CMS Antifraud Efforts, Urges Reevaluation of MolDX Program
The College of American Pathologists (CAP) submitted comments in response to a request for information on the Centers for Medicare & Medicaid...
1 min read
brandon.rakes Sep 9, 2025
The College of American Pathologists (CAP) is urging the U.S. Department of Health and Human Services (HHS) to make improvements to data interoperability, information blocking, and artificial intelligence.
“As the Trump administration looks to reduce regulatory burden, create efficiencies with the federal government, and improve our nation’s health, the CAP has expertise and resources to help the government achieve these goals,” CAP President Donald S. Karcher, M.D., wrote to Thomas Keane, M.D., assistant secretary for technology policy and national coordinator for health information technology at the HHS, in an Aug. 26 letter.
CAP promoted initiatives such as the FDA Systemic Harmonization and Interoperability Enhancement of Laboratory Data (SHIELD) and the integration of CAP electronic Cancer Protocols into laboratory information systems (LISs) in concert with industry partners.
CAP called for a blanket exception to the Information Blocking Rule, established by the 21st Century Cures Act, to allow for an integrated response from clinicians before engaging in communication with patients. “Immediate release without medical context can hinder care coordination and cause undue confusion and distress,” Keane wrote.
CAP also expressed support for data integration between LISs, hospitals, and other stakeholders, suggesting increased incentives for hospitals to share data.
Finally, CAP noted that the expansion of artificial intelligence in clinical laboratories should be addressed through federal regulations that are not overly burdensome or duplicative of existing regulations.
Sources:
https://documents.cap.org/documents/CAP-Letter-to-Keane-Final.pdf

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