Press Releases
CMS Statement on Current Status of Blood Tests for Organ Transplant Rejection
Statement:
Patients with transplanted hearts, lungs, or kidneys who meet Medicare’s local coverage criteria can continue to access blood tests used to monitor for organ transplantation when ordered by their doctors. In March 2023, the Centers for Medicare & Medicaid Services’ (CMS), through its local contractors (known as Medicare Administrative Contractors or MACs) issued revised billing instructions for these tests in response to improper billing and overutilization. Billing instructions help health care providers understand when and how to bill Medicare for a covered service. Today, the MACs updated these instructions to clarify that these tests remain available to patients when medically necessary and ordered by a physician.
Additional Background:
The Centers for Medicare & Medicaid Services (CMS) is reaffirming that neither CMS nor the Medicare Administrative Contractors (MACs) have changed patients’ access to blood tests that monitor for organ transplantation rejection, covered when ordered by their physicians in medically appropriate circumstances. Patients with transplanted hearts, lungs, or kidneys who meet the coverage criteria for these tests, as laid out in the Local Coverage Determination (LCD), can continue to access these tests in place of a more invasive biopsy or other clinically appropriate indications.
CMS’s Medicare Administrative Contractors (MACs) have removed and replaced the March 31, 2023, billing article. The new article restores the table of solid organ allograft rejection tests for indications that meet the coverage criteria, as requested by interested parties, and removes explanatory language that may have confused physicians and patients.
Under the Medicare statute, the MACs develop LCDs for their jurisdiction in the absence of national coverage policy or so long as the LCD doesn’t conflict with a national coverage policy. CMS requires that the MACs follow the LCD development process, including providing opportunities for public comment and input from the local medical community. As part of an effort to share information and improve consistency between the MACs on review of Medicare coverage for complex molecular diagnostics, one MAC, Palmetto GBA, developed the Molecular Diagnostic Services Program (MolDX) to identify and establish coverage and payment for molecular diagnostic tests. Review of molecular diagnostics and technology is technical and involves both laboratory medicine and genomics. Other MACs have implemented Palmetto’s MolDX program as part of their operations. In the MolDX program, the MACs review all evidence that a manufacturer produces and public comments to determine whether an item or service meets the standards for Medicare coverage under the “reasonable and necessary” standard.
In response to improper billing and overutilization that the MACs were observing, the MACs issued a revised billing and coding article on March 31, 2023. Billing and coding articles are intended only to provide additional educational content to help providers, suppliers, and other interested parties better understand the intent of the existing LCD criteria language. The MACs determined that the coding for the test needed to be revised to indicate when a test is a surveillance (per a protocol) test versus a for-cause (when the patient has symptoms of rejection) test. This new coding clarification was intended to help the labs comply with the billing requirements. The MACs also attempted to clarify when the overutilization of the tests did not align with the coverage guidelines in the LCD.
As a result of feedback from interested parties, the MACs have updated this article, adding a table listing the solid organ allograft rejection tests covered when used for indications included in the LCD. This table had been present in a previous billing and coding article.
In addition, to give an opportunity for interested parties to provide further feedback, on August 10, 2023, the MACs released a new proposed LCD, seeking comment and evidence from the public pertaining to proposed changes intended to better explain the existing coverage policy. In this proposed LCD, the coverage criteria remained intact. The comment period on this proposed LCD closed on September 23, 2023, and the MACs are reviewing the comments, including any clinical evidence received, to inform future decisions about coverage criteria for these tests.
With the issuance of the revised billing article and the MACs considering the public comment on the proposed LCD, CMS expects that physicians will continue to prescribe post-transplant testing for patients with transplanted hearts, lungs, and kidneys who meet the coverage criteria. In the event the proposed LCD is finalized, the MACs would issue a final LCD summarizing the rationale for the LCD as informed by public comment as well as a new billing and coding article, consistent with the final LCD, to provide additional education and guidance about coding and billing for these tests.
Under the existing coverage policies, patients with Medicare can continue to access blood tests for organ transplantation rejection when medically appropriate and ordered by their physicians. CMS remains committed to ensuring transplant patients with Medicare can access the coverage, care, and services they need.
For reference:
MolDx: Molecular Testing for Solid Organ Allograft Rejection: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38680&ver=5
Billing and Coding Article: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=58019&ver=30&bc=0
###
Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSgov