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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, 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 lung transplant recipients and imposes unrealistic testing restrictions for my center and my patients.

The policy’s changes to the frequency of molecular surveillance testing based on center-specific biopsy protocols as well as the exclusion of concurrent biopsy will impact our ability to improve care of lung transplant recipients. These restrictions will stifle innovation that is so desperately needed to improve patient care and outcomes in lung transplantation. 

• Limiting the frequency of testing to center-specific protocol biopsies is flawed given the fundamentally disparate risk profile of a non-invasive blood test from an invasive procedure with known risks of complication. 
I request MolDX to strongly reconsider implementing this proposed LCD which would be vastly detrimental to my care of transplant recipients.   

• ​Center-specific surveillance biopsy schedules represent a desire to balance the utility of surveillance against the risks of an invasive procedure and logistic considerations such as travel time to a transplant center. Surveillance biopsy schedules, limited as described, should not be conflated with evidence-based surveillance interval of a noninvasive test. 

My center currently uses ** [DD-CFDNA TEST]** on a **[FREQUENCY] ** basis to assess for **[ACUTE REJECTION AS WELL AS CLINICALLY SIGNIFICANT INFECTIONS].** With the changes imposed 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 patients.

Sincerely, 
 
**[SIGNATURE/NAME]**