MolDX: Molecular Test for Solid Organ Allograft Rejection (L38671) (2023)

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MolDX: Molecular tests for solid organ allograft rejection

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Title XVIII of the Social Security Act (SSA), §1862(a)(1)(A), states that Medicare payments will not be made for items or services that are “inappropriate and necessary for the diagnosis or treatment of a disease or injury or to improve the function of a malformed part of the body”.

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coverage guide

Indications of coverage, limitations and/or medical necessity

This Medicare contractor offers limited coverage for molecular diagnostic tests used in the evaluation and treatment of patients who have undergone solid organ transplants. These tests, along with standard clinical evaluations, can aid in decision making when evaluating organ damage due to active rejection (AR).

These tests can be ordered by qualified physicians who consider the diagnosis of RA affiliated with a transplant center and help rule in or rule out this condition when evaluating the need for or results of a diagnostic biopsy. They should be considered in conjunction with other clinical findings and evaluations and may be particularly helpful in patients with significant contraindications to invasive procedures.

Molecular diagnostic testing, which assesses the rejection status of a transplanted allograft, is covered when ALL of the following criteria are met:

  • The test must provide information on at least one of the following two determinations of clinical status:
    • AR-State
    • State of cellular or antibody-mediated rejection (ACR or AMR).
  • The intended use of the test should be:
    • To help assess the appropriateness of immunosuppression, where a non-invasive or minimally invasive test may be used instead of a tissue biopsy in a patient for whom information from a tissue biopsy would be used to make a management decision regarding to immunosuppression, OR
    • As an exclusion test for RA in validated populations of patients with clinical suspicion of rejection using a noninvasive or minimally invasive test to make a clinical decision about obtaining a biopsy, OR
    • To further assess the status of the allograft in terms of the likelihood of allograft rejection after pretesting as assessed by a physician, OR
    • Assess rejection status in patients who have received a biopsy but the biopsy results are inconclusive or limited by insufficient material.
  • The test demonstrates analytical validity (VA), including analytical and clinical validation for any analyte measured, and has equivalent or greater (depending on its intended use) sensitivity or specificity for detecting allograft rejection than other tests previously accepted for the same use intended tested for measuring the same or directly comparable analytes.
  • The clinical validity (CV) of any measured analyte (or expression profile) must be demonstrated by a study published in the peer-reviewed literature for the intended use of the test in the intended population. The level of validity must be similar to or better than the established and covered tests (see related articles on coverage). When consistent with the histological evaluation of the tissue, the Banff classification for allogeneic kidney transplants or other recognized criteria (if available) for other organs should be used.
  • The test is used in a patient who is part of the population in which the test has been analytically validated and has demonstrated CV.
  • Only one molecular test to assess allograft status should be performed for any patient contact, UNLESS a second test that meets all of the criteria set forth in this document is useful and necessary as an adjunct to the first test.
  • For minimal or non-invasive tests, the prescribing physician considers the risk-benefit profile of molecular testing to be more favorable than the risk-benefit profile of a tissue biopsy, or a tissue biopsy cannot be performed. This may be the case, for example, when a biopsy is considered clinically contraindicated in a patient.
  • The trial successfully completes a technical evaluation ensuring that the VA, CV, and clinical utility criteria set out in this policy are met to classify the trial as appropriate and necessary.

Coverage may be revoked for VA-covered tests significantly below similar services.

evidence summary

Solid organ allograft transplantation has become a standard of care for patients with end-stage organ disease. For some patients, these treatments, along with other advances in care, have turned a life-threatening disease into a treatable and preventable condition.1-3After transplantation, patients receive immunosuppressive drug therapy and are routinely monitored to prolong the survival of the donor allograft. The cost of treating a failed allograft can be 500% higher than treating a patient with a functional graft.4Early detection of RA resulted in a significant improvement in allograft survival in the first 12 months after transplantation.5

The importance of transplant rejection and immunosuppression was discovered soon after the development of transplantation, a challenge that could be met with the availability of immunosuppressive drugs, although with the current standard of care for the treatment of solid organ transplant patients, the rejection is still a common problem. with a high frequency of graft failure at 5 and 10 years.4,6-8Acute rejection occurs as cellular rejection (ACR) or antibody-mediated rejection (AMR).9

Graft assessment is used clinically to aid in the management of immunosuppression; The clinical value it provides is that it allows modification of immunosuppressive therapy to maximize graft longevity, which is the focus of post-transplant care. Histology has traditionally been used, possibly in conjunction with serologic markers, as a common tool for evaluating transplants.8,10-15While histology is considered the diagnostic gold standard at this time, it requires a biopsy, which is invasive and can present significant risks and barriers to accessing care.

Molecular diagnostic methods have emerged in an attempt to overcome the limitations of current diagnostics, including the measurement of donor-derived cell-free DNA (here cfDNA) and gene expression profiling (GEP) assays that have been developed in a variety of ways. of organ allografts, including kidneys, heart, liver, and lungs.16-24The principle behind cfDNA assays for evaluating rejection is that transplanting a new organ involves transplanting new genetic material, and the genetic material is released into the bloodstream as part of the rejection.25The fraction of donor-derived cell-free DNA in the bloodstream can serve as a marker of rejection.18-21Although this is a simple principle, the concentration of DNA in the bloodstream is quite low and therefore assays that are based on cell-free DNA require sophisticated methods to accurately detect and quantify the presence of allograft-specific cfDNA. .18,21,25The GEP test tends to quantify the expression of various genes in the allograft recipient and uses this data in algorithms developed using sophisticated modeling or machine learning to determine if rejection is occurring.22,24,26These tests not only provide information on graft status in a minimally invasive manner, but may also be sensitive enough to detect RA before it is histologically evident.27

However, these molecular tests have different strengths and weaknesses and can be used for different populations. For example, some PEG tests have a high negative predictive value for the probability of RA, but may have limited ability as a positive predictor of ACR or even to detect AMR, which may still be useful in a stable patient at low risk of rejection.28Other tests may have higher sensitivity or positive predictive value and may be appropriate for high-risk patients.18,21

Although these technologies are new, large multicenter studies have supported their use in kidney and heart transplantation as minimally noninvasive methods to assess allograft status, modify immunosuppression regimens, and avoid unnecessary biopsies.18,19,29-31Evidence for other graft allograft organs and other analytes continues to develop.16,17,32-35Furthermore, there is evidence that while some cfDNA and GEP tests may have different uses, the combination of the two may further improve determination of transplant rejection.36

Analysis of evidence (reason for discovery)

Numerous previous Medicare coverage decisions have considered evidence in the Fryback and Thornbury hierarchical structure.37where Level 2 addresses diagnostic accuracy, sensitivity, and specificity of the test; Level 3 focuses on whether the information causes a change in the physician's diagnostic thinking; Level 4 addresses the impact on the patient's treatment plan and Level 5 measures the impact of diagnostic information on patient outcomes. To apply the same hierarchical structure to the analysis of an in vitro diagnostic test, we use the ACCE model process to evaluate genetic tests.37The practical value of a diagnostic test can only be assessed by considering the subsequent health consequences. If a proven and well-established link or pathway is available, intermediate health outcomes may also be considered. For example, if a particular diagnostic test result can be shown to change patient management and other evidence shows that these changes in patient management improve health outcomes, these separate sources of evidence may be sufficient to demonstrate the results. .

Graft evaluation is an accepted part of solid organ transplant management. There is clear evidence that patients are living with transplanted organs from immunologically and genetically diverse individuals using current transplant management techniques, which may show significant heterogeneity between centers or even between individual clinicians.

It is also recognized in the transplant community that management of immunosuppression is an important component of post-transplant follow-up to optimize graft longevity and avoid side effects and toxicity of immunosuppressive therapies. Graft assessment is an important decision-making tool that helps clinicians optimize immunosuppressive therapy. The gold standard for evaluating rejection or injury has been, and historically has been, biopsy along with serological criteria. However, given the invasive nature and risks associated with biopsy, there is value and need for tests that can reduce the need for a biopsy and still provide clinicians with actionable information that can be used to optimize immunosuppressive therapy. Furthermore, ongoing studies have confirmed that cfDNA and GEP can accurately determine allograft status in multiple organ types and that molecular characterization can precede and enhance histological findings. As such, these approaches are useful as a type of service and necessary for graft evaluation.

Non-invasive graft evaluation remains an actively developing area of ​​medicine, as does histological evaluation of transplant rejection. Therefore, this contractor will continue to monitor the evidence and new developments may affect this coverage decision.


What is the gold standard for diagnosis of allograft rejection? ›

For diagnosis of rejection, invasive core needle biopsy of the graft is currently considered as the “gold-standard”.

Is it possible to have organ rejection even with a perfect match? ›

Regardless of how well-matched a donor and recipient are, the recipient's body will still try to reject the new organ since it is made completely of foreign cells. Fortunately, there are ways for patients and doctors to work together to prevent rejection or infection.

How long does organ rejection take? ›

The type of organ rejection you experience depends on its timing after transplant: Acute rejection: occurs within the first few months. Chronic rejection: happens after a year or at any time beyond.

Can your body reject allograft? ›

There are three major types of allograft rejection: Hyperacute, acute, and chronic rejection. [1] Hyperacute rejection occurs within minutes and hours after transplantation and is caused by the presence of preexisting antidonor antibodies in the recipient blood.

What causes allograft rejection? ›

Chronic allograft rejection can be caused by antibody-dependent complement activation lesions as well as cell arteritis leading to the development of interstitial fibrosis/tubular atrophy (IF/TA). [3] This injury can appear early after transplantation.

What two main things are usually done to limit organ rejection? ›

To reduce the chances of transplant rejection and loss of a transplant, the following steps are taken before transplantation occurs: Ensure recipient and donor have compatible blood types. Perform genetic testing to ensure compatible recipient and donor matches.

What is the most common type of graft rejection? ›

Endothelial graft rejection is the most common, whereas isolated stromal rejection is rare. In general, stromal involvement indicates a strong immune response; if it is not treated at an early stage, this can result in severe rejection episodes and graft loss caused by stromal necrosis.

How common is organ rejection? ›

Even with the use of immunosuppressants, your body can at times recognize your transplanted organ as a foreign object and attempt to protect you by attacking it. Despite immunosuppression medications, 10-20% of patients will experience at least one episode of rejection.

What is the most rejected organ transplant? ›

In heart transplants, the rate of organ rejection and patient mortality are the highest, even though the transplants are monitored by regular biopsies. Specifically, some 40% of heart recipients experience some type of severe rejection within one year of their transplant.

What is considered a perfect match for organ transplant? ›

Blood type O is considered the universal donor. People with blood type O can give to any other blood type. Blood type AB is called the universal recipient because they can receive an organ or blood from people with any blood type.

What is the most successful organ transplant? ›

More than 50% of liver transplant recipients survive for 7 years, in comparison with approximately 25% of patients on the waiting list. Adult cadaveric liver transplantation nearly quadruples the median survival time, from 3.1 to 11.1 years.

What organ takes longest to transplant? ›

Each organ has a specific timeframe in which it must be transplanted after it has been recovered:
  • Heart: 4 – 6 hours.
  • Lungs: 4 – 8 hours.
  • Liver: 8 – 12 hours.
  • Pancreas: 12 – 18 hours.
  • Intestines: 8 – 16 hours.
  • Kidneys: 24 – 36 hours.
Apr 7, 2022

Do transplant patients take anti rejection meds forever? ›

Patients must also take immunosuppressive drugs for the rest of their lives to keep the immune system from attacking transplanted organs. But these drugs can make it hard to fight off infections. The drugs may also boost the risk for diabetes, cancer and other conditions.

How often do transplant patients need to take medication to avoid organ rejection? ›

To maintain the health of your transplanted organ, it is important that you take your immunosuppressant (anti-rejection) medications, but also at the same times each day.

What are the stages of allograft rejection? ›

The process of graft rejection can be divided into two phases: (1) a sensitization phase in which antigen reactive lymphocytes in the recipient's lymph node proliferate in response to the donor's alloantigens and (2) an effector phase in which the recipient's sensitized effector cells mediate immune destruction of the ...

How successful is allograft surgery? ›

One study that was carried out on 33 patients (33 knees) who had undergone revision OCA transplantation, with an average follow-up of 10 years, found a graft survivorship of 79% at 5 years and 61% at 10 years.

What are signs of organ rejection? ›

Signs of Organ Rejection
  • Fever.
  • Decreased urine output.
  • Blood in urine.
  • Sudden weight gain.
  • Ankle swelling.
  • Pain, swelling, or pus near your surgery incision.
  • Aching all over.
  • Increase in creatinine levels, as shown on blood test.

Can you reverse transplant rejection? ›

Treating rejection

Most rejection episodes can be reversed if detected and treated early. Treatment for rejection is determined by severity. The treatment may include giving you high doses of intravenous steroids called Solumedrol, changing the dosages of your anti-rejection medications, or adding new medications.

How do doctors stop transplant rejection? ›

In order to control rejection, you'll be given a combination of medicines to suppress your immune system and stop your body from attacking its new organ. These medicines are called immunosuppresants or anti-rejection drugs and must be taken for the entire life of your graft.

How often do organ transplants fail? ›

One third of organ transplants are lost to transplant rejection. Although acute transplant rejection responds relatively well to steroids, chronic rejection (which is mainly mediated by antibodies) has no effective treatment.

Do all organ transplants eventually fail? ›

While transplanted organs can last the rest of your life, many don't. Some of the reasons may be beyond your control: low-grade inflammation from the transplant could wear on the organ, or a persisting disease or condition could do to the new organ what it did to the previous one.

How can you reduce the risk of transplant rejection? ›

To avoid rejection, participants must take medications called immunosuppressants or anti-rejection drugs. It is believed that by transplanting bone marrow at the same time as a solid organ such as a kidney, a state of "mixed chimerism" (a mixing of the donor and recipient's immune system) can be achieved.

Which organ helps in graft rejection? ›

The immune response to a transplanted organ consists of both cellular (lymphocyte mediated) and humoral (antibody mediated) mechanisms. Although other cell types are also involved, the T cells are central in the rejection of grafts. The rejection reaction consists of the sensitization stage and the effector stage.

What immunity causes graft rejection? ›

Rejection is caused by immune responses to alloantigens on the graft, which are proteins that vary from individual to individual within a species, and are thus perceived as foreign by the recipient.

Which immune is responsible for graft rejection? ›

T cell activation is central to graft rejection. Tissue destruction occurs due to direct T cell-mediated lysis of graft cells, T cell activation of accessory cells, alloantibody production, and/or complement activation.

What is the main cause of organ rejection? ›

Rejection is caused by the immune system identifying the transplant as foreign, triggering a response that will ultimately destroy the transplanted organ or tissue. Long term survival of the transplant can be maintained by manipulating the immune system to reduce the risk of rejection.

How long after transplant does rejection occur? ›

Acute rejection can occur at any time, but it is most common from one week to three months after transplant surgery. Fifteen percent or less of patients who receive a deceased donor kidney transplant will have an episode of acute rejection.

What organs Cannot be transplanted? ›

Organs are usually transplanted because the recipient's original organs are damaged and cannot function. The brain is the only organ in the human body that cannot be transplanted.

Can stress cause a transplant rejection? ›

However, we have now seen 11 patients in whom an acute rejection occurred just after emotional stress. There appears to be a clear relationship between psychological stress and rejection.

Which organ is the easiest to transplant? ›

Kidney transplantation surgery is relatively noninvasive with the organ being placed on the inguinal fossa without the need to breech the peritoneal cavity. If all goes smoothly, the kidney recipient can expect to be discharged from the hospital in excellent condition after five days.

Who is most likely to be a match for a kidney transplant? ›

The best donor is an identical twin, as the tissue type is identical. Unfortunately, most people do not have an identical twin waiting to give them a kidney! However, a kidney from another relative/friend may be suitable.

Who is the best match for a liver transplant? ›

You're a Family Member or Friend

If you're a blood relative, it's more likely that your blood type will be a good match for the person getting part of your liver. Some transplant centers, though, let you donate part of your liver to someone you don't know who's on the organ transplant waiting list.

Who gets priority for liver transplant? ›

Who gets priority for a liver transplant? Throughout the United States, patients waiting for liver transplants are prioritized based on the severity of their illness, as measured by what's called the Model for End-Stage Liver Disease (MELD) score.

What organ is in the highest demand? ›

Kidneys: Kidneys are the most needed and most commonly transplanted organ. Kidneys are responsible for filtering waste and excess water from the blood and balancing the body's fluids.

Which organ has the longest waiting list? ›

Waiting lists

As of 2022, the organ with the most patients waiting for transplants in the U.S. was kidneys, followed by livers.

What is the 20 year survival rate for liver transplant? ›

The 20-year survival rate for liver transplant patients is more than 50%, offering many people a longer life as well as much improved quality of life.

What blood type is hardest for transplant? ›

People with Group O blood wait longer for a heart transplant than those with other blood groups.
Patients with certain bloods group wait much longer for heart transplants
  • Group O – 479 days.
  • Group B – 150 days.
  • Group A – 87 days.
  • Group AB – 24 days.
Sep 28, 2018

Which organ is alive after death? ›

The brain and nerve cells require a constant supply of oxygen and will die within a few minutes, once you stop breathing. The next to go will be the heart, followed by the liver, then the kidneys and pancreas, which can last for about an hour. Skin, tendons, heart valves and corneas will still be alive after a day.

What is the fastest repairing organ? ›

Answer and Explanation: The mouth is the fastest healing organ, according to Brand et al. (2014). This is due to the presence of saliva, that moisturizes the wound, improves immune response to wound healing, and contains other wound-healing promoting factors.

Which drug is the best option to treat transplant rejection? ›

Cyclosporine (Neoral) Neoral is a drug that suppresses the immune system and is used to prevent rejection after transplant. It will be taken every day in the morning and at night.

What happens if you don't take anti-rejection drugs? ›

Unfortunately, these missed doses or forgotten medications can lead to serious problems in transplant patients including acute rejection, chronic transplant damage and ultimately the failure of a transplant.

Can anti-rejection drugs be stopped? ›

Study: Transplant Patients Stop Rejection Drugs Transplants are one of modern medicine's biggest victories. But patients have had to endure a lifetime of toxic drugs to prevent the body from rejecting an organ. New studies are showing it may be possible for some people to stop the drugs and live a better life.

Which is the most popular medication used to prevent transplant rejection? ›

Preventing Rejection

After your transplant surgery you will be prescribed medications that may include: Tacrolimus (Prograf) or cyclosporine (Neoral, Gengraf) Prednisone. Mycophenolate (CellCept, Myfortic) or azathioprine (Imuran)

Can you drink while taking anti rejection meds? ›

Take the capsule every morning, preferably on an empty stomach, at least 1 hour before or at least 2 hours after a meal. Do not drink alcohol with the capsule.

What medications increase tacrolimus levels? ›

Clotrimazole increases tacrolimus blood levels: a drug interaction in kidney transplant patients. Clin Transplant.

What diagnostic test is considered the gold standard for identifying the rejection of a kidney transplant? ›

The current gold standard for the rejection diagnosis is an allograft biopsy which is usually performed upon an unexplained decline in allograft function.

Which test is considered the gold standard diagnostic test? ›

Since the advancements of magnetic resonance imaging, the magnetic resonance angiogram (MRA) has become the new gold standard test for aortic dissection, with a sensitivity of 95% and a specificity of 92%. Before widespread acceptance of any new test, the former test retains its status as the "gold standard".

What is gold standard method of diagnosis? ›

A gold standard study may refer to an experimental model that has been thoroughly tested and has a reputation in the field as a reliable method. The correct interpretation of a diagnostic test demands one to master specific concepts such as sensitivity, specificity, prevalence, positive and negative predictive values.

What is the gold standard for diagnosing? ›

The gold standard (occasionally, erroneously, called the golden standard) is the term used in medicine for the test (imaging, blood test, biopsy, etc.) that is felt to be the current best for diagnosis of a particular condition. The gold standard for any specific disease is not set in stone and can change over time.

Which diagnostic test is the most accurate in testing overall kidney function? ›

Urine tests

A 24-hour urine test shows how much urine your kidneys produce, can give an more accurate measurement of how well your kidney are working and how much protein leaks from the kidney into the urine in one day. Urinalysis: Includes microscopic examination of a urine sample as well as a dipstick test.

What labs indicate kidney rejection? ›

TRAC is a dd-cfDNA test that determines the percentage of cell-free DNA from your transplanted kidney circulating in your bloodstream. A higher percentage of circulating cell-free DNA may indicate active rejection.

What determines a good match for kidney transplant? ›

There are three main blood tests that will determine if a patient and a potential donor are a kidney match. They are blood typing, tissue typing and cross-matching. A free self-paced online guide to transplant evaluation and getting on the waitlist.

What is the most accurate test for gold? ›

Scratch Test

One of the most foolproof methods for testing your gold jewelry is the ceramic scratch test. For this method, get an unglazed ceramic plate or piece of tiles and scrape a piece of gold across the surface. Real gold will leave a gold-colored marking, which other metals will just leave a black streak.

How accurate is the gold standard test? ›

An ideal gold standard test has a sensitivity of 100% (it identifies all individuals with the disease) and a specificity of 100% (it does not falsely identify someone with a condition that does not have the condition).

What diagnostic test confirms all? ›

If the CBC findings suggest leukemia, a diagnosis of ALL can sometimes be confirmed with additional testing of the blood sample. Sometimes, however, an ALL diagnosis can be made only after the examination of a sample of bone marrow cells. Bone Marrow Aspiration and Biopsy.

What are three tests for gold? ›

There are over seven tests you can choose from when testing gold at home. These include the magnifying glass test, hallmark test, skin test, float test, the magnet test, and acid test.

What is the gold standard test that must be ordered immediately to make the diagnosis of malaria? ›

Microscopic examination remains the “gold standard” for laboratory confirmation of malaria. These tests should be performed immediately when ordered by a health-care provider.

Which of the following is the gold standard method for drug testing? ›

The most sophisticated drug-testing approach is gas chromatography coupled with mass spectrometry (GC/MS), which is regarded as a "gold standard"; it is used in confirmatory testing.

What is considered the gold standard when determining the effectiveness of a medication? ›

Randomized controlled trials (RCT) are prospective studies that measure the effectiveness of a new intervention or treatment. Although no study is likely on its own to prove causality, randomization reduces bias and provides a rigorous tool to examine cause-effect relationships between an intervention and outcome.

Which of the following is considered to be the gold standard test for the diagnosis of scrub typhus? ›

Indirect immunofluorescence assay (IFA) is considered to be the gold standard test for the diagnosis of scrub typhus [16], in which the patients serum containing the antibodies to Orientia tsutsugamushi are mixed to antigen on a slide, then detected using a fluorescently labeled anti-human antibody.

What is a gold standard patient? ›

Many GP practices, hospitals, care homes or wider areas use GSF to mean 'gold standard care' and have adopted the term 'Gold patients', signifying the increased level of support they need, and the priority treatment they are given.


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