2021: The Allomap (Non) NCD

I had forgotten this minor NCD event in 2020/2021.  Access documents here:

https://www.cms.gov/medicare-coverage-database/view/ncacal-tracking-sheet.aspx?NCAId=302

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ALLOMAP was an early (2006) advanced molecular MAAA test of lymphocyte activation to predict cardiac transplant rejection.   The test got FDA approval (though as a sole source lab test, not a kit) in 2008.

In a January 2013 letter, a Johns Hopkins professor asked for a non coverage NCD on ALLOMAP.  The 84-page letter is clearly dated January 2013, but the Tracking Sheet shows all events being years later - request accepted 10/2020 (COVID year).

CMS issued a  proposed memo 10/2020 (thus opening the issue with proposed memo), and final memo 4/2021.

Note the seven year time span between the 2013 request letter and the 2020 activities at CMS.

The final decision was to leave ALLOMAP test as an LCD issue not an NCD issue.

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Quoting CMS:

We believe the decision to continue to allow MACs to determine coverage of ALLOMAP® Molecular Expression Testing for Detection of Rejection of Cardiac Allografts is clinically appropriate and in the best interest of beneficiaries.  Since 2013, when we received the request to open an NCD to non-cover ALLOMAP, there have been several new studies published in the peer-reviewed medical literature evaluating the test (e.g., Deng 2014, Kobashigawa 2015, Crespo-Leiro 2015 and 2016, Fujita 2017, Moyayedi 2019), focusing on predictive value and clinical utility.[1]  

While each study has limitations, collectively they demonstrate that use of the test may better allow physicians to select patients who should undergo post-transplant heart biopsy.  Specifically, the evidence indicates that the test may add value to selected patients, especially those for whom invasive biopsy poses greater risk due to poor venous access, scar tissue or other factors.  

Due to the very low volume of tests and affected beneficiaries, and the need for careful patient selection, CMS believes that coverage of ALLOMAP is an appropriate determination made by the Medicare Administrative Contractors (MACs).  The MACs are structured to be able to take into account local patient, clinician and institutional factors, which are important when the overall prevalence is low.

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It's code 81595. In CY2020, there were about 7000 uses in Part B for about $22M.

The company is increasingly using a different test, I believe, the ALLOSURE test, which detects donor DNA being leaked by a rejecting donor organ.  A similar test is also commercialized by Natera.

81595 was one of the first CPT MAAA codes, in about 2014.   As I recall, CMS proposed to price it at a very low rate, which was later raised to over $2000 as it was moved from a proposed to a final rate.   The current rate (set by PAMA in 2018) is around $3800.