Medicare Issues Final Coverage Determination for kidneyintelX.dkd
Renalytix announced that on June 13, 2024, Medicare issued a final Local Coverage Determination (LCD) for its kidneyintelX.dkd test, effective from August 1, 2024. The Medicare price for the test is set at $950 per test, and specific CPT codes have been established. The LCD covers tests for patients with Type 2 diabetes and Stage 1-3b Chronic Kidney Disease, aligning with the FDA label. This LCD comes after key milestones such as FDA authorization, clinical outcomes data, and inclusion in clinical guidelines, positioning kidneyintelX.dkd as a preventative standard for 14 million Americans. The company expects this Medicare coverage to drive further adoption and coverage decisions, leading to incremental sales growth in targeted US regions with lower operational costs.
- Medicare final Local Coverage Determination (LCD) issued for kidneyintelX.dkd.
- Effective date for Medicare coverage is August 1, 2024.
- Medicare price set at $950 per test.
- Specific CPT codes established and published in CMS' 2024 Clinical Lab Fee Schedule.
- Coverage targets patients with Type 2 diabetes and Stage 1-3b Chronic Kidney Disease.
- LCD aligns with FDA label for kidneyintelX.dkd.
- Positioned as a preventative standard for 14 million Americans with diabetes and kidney disease.
- Anticipated prompt of additional major coverage decisions.
- Expected to accelerate testing adoption.
- Focus on incremental sales growth in targeted US regions.
- Significantly lower cost of operations expected.
- No specific revenue figures or sales projections provided.
- The final LCD issuance may not guarantee immediate or widespread adoption.
- Dependence on additional major coverage decisions for broader market penetration.
- Potential financial strain until adoption and incremental sales growth materialize.
Insights
The announcement of Medicare issuing a final Local Coverage Determination (LCD) for Renalytix's kidneyintelX.dkd testing is a significant milestone for the company. The established Medicare price of
From a financial perspective, this development has the potential to substantially increase Renalytix's revenue streams. With Medicare's backing, other insurance companies might follow suit, leading to broader coverage and an increase in the number of tests administered. This can drive a significant rise in sales volumes, which will positively impact the company's top line.
Moreover, the inclusion in the CMS' 2024 Clinical Lab Fee Schedule and the establishment of distinct CPT codes simplify the billing process, offering a streamlined approach for healthcare providers. This can lead to a more predictable revenue model for Renalytix.
However, investors should be mindful of the operational costs associated with scaling up, including potential increases in staffing and laboratory capacities to meet the likely surge in demand. While the CEO mentions a lower cost of operations, it remains to be seen how well the company manages these growth-related expenses.
The issuance of the final LCD for kidneyintelX.dkd by Medicare is a groundbreaking advancement in the field of predictive diagnostics for chronic kidney disease (CKD), especially among patients with Type 2 diabetes. The endorsement from Medicare, along with previous FDA authorization and inclusion in international clinical guidelines, underscores the clinical credibility and utility of this test.
From a medical perspective, this test becoming reimbursable by Medicare means that a larger patient population can benefit from early detection and intervention strategies. The inclusion in clinical guidelines suggests that kidneyintelX.dkd is expected to be integrated into the standard of care, which can improve patient outcomes by enabling earlier and more accurate intervention for CKD.
Furthermore, the test's specific approval for patients with diabetes and Stage 1-3b CKD aligns well with the current clinical approach to managing these patient groups, ensuring that it will be used precisely where it is needed the most.
One potential challenge could be the test's adoption rate among clinicians, which can vary based on their familiarity with the test and its perceived utility in practice. Continuous education and robust clinical data will be essential to drive widespread use.
Renalytix's achievement of securing Medicare coverage for kidneyintelX.dkd holds considerable market implications. This development positions the company strongly within the diagnostic testing market, particularly for chronic conditions like diabetes and kidney disease, which affect a significant portion of the population.
In terms of market potential, the addressable market for kidneyintelX.dkd is substantial. The estimated 14 million individuals in the U.S. who could benefit from this test represent a significant market opportunity. Medicare's coverage is likely to serve as a catalyst, encouraging other insurers to also provide coverage, thus expanding the market reach further.
Strategically, this move is likely to enhance Renalytix’s competitive positioning. The combination of FDA approval, clinical guideline inclusion and now Medicare coverage creates a robust framework for the company to market its product aggressively and capture market share from competitors.
However, market dynamics such as competition from other diagnostic tests and the pace at which healthcare providers adopt the new test will influence the overall impact. Renalytix must continue to demonstrate the test’s clinical benefits and cost-effectiveness to maintain its competitive edge.
Company has Achieved Prerequisites for Growing Test Adoption with FDA Authorization, Clinical Outcomes Data, Inclusion in Clinical Guidelines, and Broad Insurance Coverage
LONDON and NEW YORK, June 14, 2024 (GLOBE NEWSWIRE) -- Renalytix plc (NASDAQ: RNLX) (LSE: RENX) announces that on June 13, 2024 Medicare issued a final Local Coverage Determination ("LCD") for the Company's kidneyintelX.dkd testing. The final LCD can be accessed at LCD - KidneyIntelX and KidneyIntelX.dkd Testing (L39726) (cms.gov), and is effective for dates of service on or after August 1, 2024. The established Medicare price for kidneyintelX.dkd is
The LCD specifies coverage for use of kidneyintelX.dkd for patients with diagnosed Type 2 diabetes and Stage 1-3b Chronic Kidney Disease is reasonable and necessary. Any specified limitations for use conform to the U.S. Food and Drug Administration ("FDA") label for kidneyintelX.dkd. The LCD was issued by National Government Services ("NGS"). NGS is a subsidiary of Elevance Health, Inc. (previously Anthem, Inc.), a Medicare Administrative Contractor responsible for claims processing for testing performed in the Company's New York City laboratory.
“With final Medicare Coverage, an FDA authorization, and an April recommendation in the international clinical guidelines, kidneyintelX.dkd is poised to be a preventative medicine standard for 14 million people in the United States living with diabetes and kidney disease. We expect this Medicare coverage will prompt additional major coverage decisions and help accelerate testing adoption,” said James McCullough CEO of Renalytix. “We remain focused on incremental sales growth in targeted US regions with a now significantly lower cost of operations.”
For further information, please contact:
| Renalytix plc | www.renalytix.com |
| James McCullough, CEO | Via Walbrook PR |
| Stifel (Nominated Adviser, Joint Broker) | Tel: 020 7710 7600 |
| Alex Price / Nicholas Moore / Nick Harland / Samira Essebiyea | |
| Investec Bank plc (Joint Broker) | Tel: 020 7597 4000 |
| Gary Clarence / Shalin Bhamra | |
| Walbrook PR Limited Paul McManus / Alice Woodings / Charlotte Edgar | Tel: 020 7933 8780 or renalytix@walbrookpr.com Mob: 07980 541 893 / 07407 804 654 / 07884 664 686 |
| CapComm Partners | |
| Peter DeNardo | Tel: 415-389-6400 or investors@renalytix.com |
About Renalytix
Renalytix (NASDAQ: RNLX) (LSE: RENX) is an artificial intelligence enabled in-vitro diagnostics and laboratory services company that is the global founder and leader in the field of bioprognosis™ for kidney health. In late 2023, our kidneyintelX.dkd test was recognized as the first and only FDA-authorized prognostic test to enable early-stage CKD (stages 1-3b) risk assessment for progressive decline in kidney function in T2D patients. By understanding how disease will progress, patients and clinicians can take action earlier to improve outcomes and reduce overall health system costs. For more information, visit www.renalytix.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Examples of these forward-looking statements include statements concerning: timing and outcome of LCD determination, and the commercial prospects of KidneyIntelX. Words such as "anticipates," "believes," "estimates," "expects," "intends," "plans," "seeks," and similar expressions are intended to identify forward-looking statements. The Company may not actually achieve the plans and objectives disclosed in the forward-looking statements, and you should not place undue reliance on the Company's forward-looking statements. Any forward-looking statements are based on management's current views and assumptions and involve risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. These risks and uncertainties include, among others: that KidneyIntelX is based on novel artificial intelligence technologies that are rapidly evolving and potential acceptance, utility and clinical practice remains uncertain; and that the Company has only recently commercially launched KidneyIntelX. These and other risks are described more fully in the Company's filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of its annual report on Form 10-K filed with the SEC on September 28, 2023, and any risks that may be contained in any subsequent filings that the Company makes with the SEC . All information in this press release is as of the date of the release, and the Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required by law.
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