RealClearPolitics: Medicare Restricts Coverage for Vital Transplant Tests
By: Ken Sutha
The road to an organ transplant can be a long and painful process, from getting on the transplant waiting list to finally receiving a new organ. But the difficult journey doesn’t stop there. Once someone is given a second chance at life through organ donation, the focus of their care pivots toward ensuring the ongoing health of the transplant to avoid rejection.
Patients require anti-rejection medication and must undergo frequent testing and invasive biopsies to monitor for organ injury. However, these decades-old methods may detect organ rejection after it’s too late to intervene. It is estimated that within the first year post-transplant, one in three lung transplants will fail. Within five years, one in three hearts and one in five kidneys will fail.
As a pediatric nephrologist and two-time kidney transplant recipient myself, I know this perilous journey firsthand. I had my first kidney transplant at age 24, a gift from my father. Unfortunately, my first transplant ultimately failed, and I had to go on grueling dialysis for several years. However, a revolutionary advancement in post-transplant care that became available in 2017 could have potentially saved my first kidney.
Non-invasive diagnostic testing, performed through a simple blood test, has offered a much-needed tool for transplant patients to detect organ injury or rejection earlier – so that doctors can intervene at the earliest stages of damage to the organ. These molecular tests, including gene expression profiling (GEP) and donor-derived cell-free DNA (dd-cfDNA), can also help avoid traditional biopsies, a process that can be physically painful, harmful to the organ, and disruptive to patients’ daily lives.
In my case, routine screening with less invasive and earlier indicators of damage might have allowed for earlier detection of rejection before there was a persistent decline in my kidney health, and allowed for intervention sooner. With my second transplant, I am grateful to have these tests as a part of my routine care. They give me peace of mind that my doctors have the real-time information they need to intervene and ensure the long-term health of my kidney.
That is why I am deeply concerned about a new policy change that has already impacted access to these tests for Medicare patients.
In March 2023, MolDX, a program administered by Medicare contractors to determine coverage for molecular transplant diagnostic tests, issued a billing article (Medicare’s coverage guidance) that makes significant changes to how tests like dd-cfDNA are covered. In accordance with federal legislation, any significant coverage changes should be put through public comment where patient advocates, clinicians, and other experts can weigh in on the potential impact of proposed policy changes. However, in this case, clinicians and patients like me were not able to voice our concerns.
One of the changes imposed includes a new restriction on the use of molecular tests for monitoring the health of transplants or for surveillance purposes, a move that will greatly reduce the ability to detect subclinical or early signs of rejection.
Additionally, the billing article limits Medicare reimbursement to one molecular test per visit. This is especially troublesome for heart transplant patients where the combination of GEP and dd-cfDNA molecular tests most effectively monitors for potential rejection. For kidney patients, dual testing was just starting to gain traction, but now that progress has been halted, with one company removing their dual test product from the market immediately following the effective date of the billing article.
These restrictions are already hindering innovation in the transplant field and will impact all patients, but especially those in rural, marginalized, and under-resourced communities, who confront significant barriers to healthcare access and are disproportionately impacted by chronic conditions like kidney disease.
For example, patients being treated by providers in their local community where resources for biopsies may not be available will no longer have access to molecular diagnostics for surveillance because the new restrictions require tests to be used in lieu of a biopsy. This means they’ll need to travel to the nearest transplant center more frequently – a center that may be hours away.
Restricting access to technology that can save people from going through organ rejection is unacceptable. That is why the transplant community is mobilizing to protect healthcare coverage for those lucky enough to be given the gift of life. Several medical societies have written letters to MolDX raising concerns, including the American Society of Transplant Surgeons and the International Society for Heart and Lung Transplantation. Additionally, a coalition of more than a dozen patient advocacy groups has banded together to fight for access and coverage for post-transplant care. This Honor the Gift coalition was originally established in 2019 and successfully advocated to extend Medicare’s immunosuppressive medication coverage for kidney transplants.
The transplant community is resilient and will continue to fight for equitable and optimal care for all patients. To start, we must urge policymakers to take a closer look at the misuse of the MolDX billing article to restrict access to critical and innovative care.
Dr. Ken Sutha is a pediatric nephrologist at Stanford Medicine Children’s Health and a two-time recipient of a kidney transplant.