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Renalytix AI gets preliminary Medicare pricing for 'KidneyIntelX'

By Josh White

Date: Monday 30 Sep 2019

Renalytix AI gets preliminary Medicare pricing for 'KidneyIntelX'

(Sharecast News) - Artificial intelligence-enabled kidney disease clinical diagnostics developer Renalytix AI announced on Monday that Centers for Medicare & Medicaid Services (CMS) has published its preliminary determination for national Medicare pricing for its 'KidneyIntelX' test, to be included in the national 2020 Clinical Laboratory Fee Schedule in the United States.
The AIM-traded firm said the preliminary determination set a price of $950 for each test, after CMS considered recommendations received through an open meeting and brief comment period, along with the consensus of an independent advisory panel.

It explained that a public comment period followed the publication of the preliminary determinations, with comments accepted by CMS up until 27 October.

Final pricing determinations were expected to be published in November, and would become effective on 1 January.

The price set for KidneyIntelX would be effective for a three-year period, ending on 31 December 2022.

Renalytix AI said it intended to pursue coverage determinations from both Medicare and private insurance payers at that pricing level, beginning in 2019, for patients with kidney disease and type-2 diabetes.

Its board said one of the greatest drivers of healthcare costs was patients with rapidly-progressing diabetic kidney disease, who were not identified in time and who faced progressive kidney failure and unplanned transition to dialysis.

Around 12 million people had diabetic kidney disease in the US, and each year kidney disease resulted in the death of more people than breast and prostate cancer.

"KidneyIntelX is designed to predict progression of kidney disease and ultimately improve outcomes and health care system economics in patients with type-2 diabetes and existing kidney disease," the board explained in its statement.

"KidneyIntelX uses machine-learning algorithms to assess a combination of predictive blood-based biomarkers and features from a patient's electronic health record to generate a prognostic risk score for rapid-progression of kidney disease."

The company said that in a recent study published online on 1 April, the rate of rapid progression of kidney disease for patients identified as high-risk by KidneyIntelX was shown to be around 10 times greater than patients identified in the low risk group.

"For patients experiencing rapid progression of kidney disease, and therefore most likely to advance toward end-stage renal disease and dialysis, there are several clinical management strategies and proven therapeutic options to slow the rate of disease progression and/or halt its progress.

"This announcement follows confirmation of the vote in favour of recommending 'crosswalk' pricing for KidneyIntelX by the independent Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests as referenced in the company's results release dated 3 September."

Renalytix AI said a further announcement was expected in November, following confirmation of the final pricing determination for KidneyIntelX from Medicare.

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