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Letter

Subject:  Response to Proposed LCD for MolDX: Testing for Solid Organ Allograft Rejection

To Whom it May Concern,

My name is Dr. **[XX]**, I am a **[TITLE/SPECIALTY]** at **[INSTITUTION].** I have been caring for transplant patients for over **[XX]** years, and have been using molecular diagnostics for transplant recipients to care for determining rejection, avoiding biopsy, and titrating immunosuppression. My credentials include **[LIST ANY HONORS, MAJOR ACADEMIC APPOINTMENTS, OR SOCIETY APPOINTMENTS].**

The proposed LCD for MolDX: Molecular Testing for Solid Organ Allograft Rejection, released on August 10, 2023, effectively limits my ability to care for my center and my patients. Specifically, if the current draft LCD is finalized, we could see a rise in the number of unnecessary biopsies, rejections, and a decline in patient care.

The policy's change to surveillance, requirement for OPTN centers to have surveillance biopsy protocol, and limitations on multi-modality testing in the same visit will impact our ability to individualize immunosuppression and reduce toxicity and improve care of patients who have received a kidney transplant. The limitations will stifle the innovation that is so desperately needed to improve patient care and outcomes in kidney transplant.

My center currently uses molecular diagnostics for all patient types, for both surveillance and for-cause reasons to assess for rule out rejection, inform the need for a biopsy, and for borderline rejections. With the changes imposed in the above, we will no longer be able to provide the best transplant patient care.

I request MolDX to strongly reconsider implementing this proposed LCD which would be vastly detrimental to my care of transplant recipients.

Sincerely,

**[SIGNATURE/NAME]**