From the President’s Desk

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In contrast, the bipartisan authors of VALID worked to develop a framework that establishes guardrails around the FDA role in the oversight of LDTs, including prohibitions against the infringement on the practice of medicine, duplication of CLIA requirements, or insertion into laboratory operations.

While it may have felt more gratifying to merely oppose this legislation, I think the most responsible way to represent pathologists—whose laboratories may soon need to coexist with the FDA—is to engage actively in influencing the terms of this relationship.

Based on the latest version of the VALID Act, the CAP’s efforts have gotten results. This is the third major version of the bill, and each revision has included positive steps that reflect feedback from the CAP. We have lobbied for very specific provisions to increase flexibility and lessen the burden on laboratories while still maintaining protections for patients. At every step, our goal has been to strike the right balance so that laboratories may continue to foster innovation as they ensure patient safety.

The current bill includes many provisions the CAP supports, such as:

• a three-tiered, risk-based system.
• a five-year delay to allow for rulemaking, public hearings, and study after the bill becomes law.
• a grandfather clause to protect all currently available LDTs in any given laboratory.
• a stipulation that there should be no duplication of current CLIA regulations.
• specific language prohibiting infringement on pathologists’ practice of medicine.
• allowance for modifications of LDTs in cases where performance characteristics are not significantly changed.
• exemptions for low-volume testing and humanitarian testing.

Based on this bill, new LDTs would be assessed individually, and the level of regulatory oversight would depend on the risk classification of that specific test. We believe the FDA’s focus will be on the highest-risk testing—testing that runs the risk of doing irreparable harm to a patient. CLIA regulations do not require establishing clinical validity for high-risk, “black box” LDTs; there are no reporting requirements for high-risk LDTs that may not work as expected and might have led to patient harm. Allowing focused regulatory oversight of these tests through the FDA fits into the overall movement of health care to a more transparent, patient-centric delivery model and away from the traditional paternalistic model of medicine. This is a direction the CAP fundamentally supports.

I understand that this change seems daunting for many in our community. But it is coming. There will be many opportunities for the pathology and laboratory community to engage in shaping how this legislation becomes operationalized through rulemaking, and I strongly encourage everyone to engage with a solution-based mindset. It is so important for us to have a seat at that table and to bring our expertise to influence those discussions.

Of course, the CAP will continue to lobby on behalf of our profession. It has lobbied elected officials for years to lessen the regulatory burden on laboratories and will continue to do so long after the VALID Act gets its vote. I believe this is core to the CAP’s mission of fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide.

Dr. Volk welcomes communication from CAP members. Write to her at president@cap.org.