Medicare Coverage of Organ-Rejection Blood Tests

The relevant tests are non-invasive blood tests to detect the rejection of transplanted kidneys or hearts. The issue for Medicare coverage is whether they can be performed more frequently than a biopsy (i.e., used broadly for “surveillance” purposes to detect rejection problems early, before clinical symptoms develop). The Centers for Medicare & Medicaid Services (CMS) now says no. That position, however, contradicts the actual coverage policies that have been in effect since 2017 and continue to be in effect today.

Regarding surveillance use, see the written statements below from the official public record concerning the creation of the Medicare coverage policies.

Note that this is not about constant screenings to determine whether people have a disease or condition. This is about patients who do have a disease or condition. Every day they face the possibility of rejection of the transplanted organ, and so the patients must be monitored to detect rejection problems. Monitoring is the issue, not screenings.

The relevant coverage polices were set by Medicare administrative contractors (MACs). Noridian is the MAC with direct jurisdiction over these CareDx blood tests (known as “AlloSure” tests). Noridian works with the Palmetto MAC as part of the “MolDX program”, which concerns molecular diagnostic tests. The MolDX program is primarily housed within the Palmetto MAC, but Noridian and Palmetto reach agreement on all coverage decisions concerning such tests.

The MACs are private companies that have contracts with CMS. Noridian is owned by a holding company that also owns Blue Cross Blue Shield of North Dakota (https://www.bcbsnd.com/our-company/about/company-facts; click on “Affiliates”). Palmetto is owned by Blue Cross Blue Shield of South Carolina (https://corporate.palmettogba.com/partnering/oasis-program/; “Palmetto GBA, a Celerian Group company, is an organization within BlueCross BlueShield of South Carolina companies”).

[“LCD” refers to a MAC “local coverage determination”. LCDs set coverage policies.]

2017 Noridian LCD for AlloSure Kidney

Follow the link here to see the full LCD.

In the links on the left of the page, scroll down to “Associated Documents” and click on it. One of these is the official “Response to Comments” on the proposed LCD. In that document, you will find a response to a public comment that includes the following:

“Since a biopsy is not frequently performed for surveillance due to its invasive nature, the use of AlloSure may be performed at a frequency established for other non-invasive tests such as viral testing and donor-specific antibody testing (4-6x during the first year; 2-4x in subsequent years).   AlloSure testing may also be performed to assess the probability of rejection prior to deciding on an unscheduled (non-protocol) biopsy.”

2021 Noridian “Umbrella” LCD

[Applies to both kidney and heart blood tests; replaced earlier LCDs.]

Follow the link here to see the full LCD.

Again, in the links on the left of the page, scroll down to “Associated Documents” and click on it. One of these is the official “Response to Comments” on the proposed LCD. In that document, you will find responses to public comments that include the following:

“The final draft of this policy has been amended to allow for a broader range of considerations consistent with prior coverage determinations. It now additionally contains two use cases consistent with the above, not tying its need to a biopsy.”

“This policy was not intended to rescind coverage for tests used for low-risk patients using such tests for surveillance, and the coverage criteria, and evidentiary review, has been altered to reflect this.”

Noridian March 2023 Billing Article

Follow the link here to see the full billing article.

The billing article includes the following:

“In all scenarios presented the patients must be in consideration for a tissue biopsy or additional biopsy (such that the test prevents this when the biopsy won't likely be of benefit) OR require allograft evaluation because of a priori concern for rejection or rejection risk due to clinical or biological factors (pre-test). No other intended uses are allowed by the policy.”

The point is that, in direct contradiction of the prior coverage rules,  this language does tie the use of the test to a biopsy. In other words, the test must be in lieu of a biopsy that otherwise would have been performed. This drastically narrows the use of the test for surveillance. Performing the test more frequently than biopsies would have been performed is a key feature of the blood tests—it allows rejection issues to be detected early.

The language “due to clinical or biological factors” refers to for-cause testing, meaning that there are clinical symptoms of rejection, so a biopsy would have been performed in the past but now the blood test can be used in lieu of the biopsy. The issue is that symptoms are already occurring. Surveillance use of the test could have detected the problems before they reached the symptoms stage.

Under section 1834A(g)(1)  of the Social Security Act (42 U.S.C. 1395m-1(g)(1)), a billing article may not be used to establish or change coverage policies. Only an LCD can do that. This requirement was added by the Protecting Access to Medicare Act of 2014 (PL 113-93).

Under section 1862(l)(5)(D) of that Act (42 U.S.C. 1395y(l)(5)(D)), a public process is required for a MAC to issue an LCD. This process is parallel to the notice-and-comment process for agency rulemaking. This requirement was added in 2016 by the 21st Century Cures Act (PL 114-255).

Noridian Proposed LCD of August 10

Follow the link here to see the full proposed LCD.

In the links on the left of the page, scroll down to “Proposed Process Information” and click on it.

“Revision for clarity of coverage criteria section and CAC session held on November 16th and 17th, 2022. There is no change in coverage from the current Policy. Only comments pertaining to the changes made for clarity will be considered.”

The “current Policy” is the 2021 Noridian umbrella LCD discussed above. The “only comments pertaining” statement meant that the MACs would not consider public comments that addressed the overall scope of coverage.

The proposed LCD has the same coverage policies as the billing article of March 2 (frequency of using the blood test must be the same as what would have been the frequency of biopsies).

CMS Statement of September 25

Follow the link here to see the full Sept. 25 CMS statement.

CMS says there have been no changes in coverage policies that were established by the 2021 umbrella LCD.

The statement begins with:

“The Centers for Medicare & Medicaid Services (CMS) confirms that neither CMS nor the Medicare Administrative Contractors (MACs) have made changes that affect patients’ ability to have blood tests used to monitor for organ transplantation rejection covered when ordered by their physicians in medically appropriate circumstances.”

The Honor the Gift issued a press release on September 27, which responded to the CMS statement on September 25 asserting that there have been no coverage changes (discussed below). Compare the above MAC statement about the frequency of tests with the statement in the press release by Dr. Melancon of GWU School of Medicine, which concerns the frequency of tests now allowed under the billing article of March 2 (discussed below).

Dr. Melancon: “"Before the Medicare coverage guidance [i.e., the March 2023 billing article], my center was giving kidney recipients seven surveillance tests in the first year following their transplant and then three to four tests per year in the following years. But after the change, we drastically cut down on the number of surveillance tests to just two in the first year and none in the following years, to match the number of surveillance biopsies we had been conducting before the coverage change."