Milestone Scientific Announces Medicare Price Assignment for the CompuFlo® Epidural System in Texas, Pennsylvania, New Jersey, Maryland, Colorado, Oklahoma, Louisiana, Arkansas, Mississippi, New Mexico, District of Columbia, and Delaware
Milestone Scientific (NYSE: MLSS) has secured Medicare price assignment for its CompuFlo® Epidural System in 12 states through Novitas Solutions. This covers Medicare regions Jurisdiction L and H, following a recent approval in Florida. The decision applies to the AMA's Category III CPT® code CPT0777T for real-time pressure-sensing epidural guidance systems.
This expansion represents a significant market opportunity, with an estimated 3.0 million epidural steroid injection procedures performed annually in these jurisdictions, accounting for about one-third of total U.S. procedures. The initial addressable market among Medicare patients in these regions is approximately $250 million. The CompuFlo® system uses Dynamic Pressure Sensing® technology to enhance patient safety and outcomes in epidural procedures.
Milestone Scientific (NYSE: MLSS) ha ottenuto l'assegnazione del prezzo Medicare per il suo Sistema Epidurale CompuFlo® in 12 stati attraverso Novitas Solutions. Ciò copre le regioni Medicare Giurisdizione L e H, a seguito di un recente approvazione in Florida. La decisione si applica al codice CPT® di Categoria III CPT0777T dell'AMA per i sistemi di guida epidurale con rilevamento della pressione in tempo reale.
Questa espansione rappresenta un'opportunità di mercato significativa, con un stimato 3,0 milioni di procedure di iniezione di steroidi epidurali eseguite annualmente in queste giurisdizioni, che rappresentano circa un terzo delle procedure totali negli Stati Uniti. Il mercato potenziale iniziale tra i pazienti Medicare in queste regioni è di circa 250 milioni di dollari. Il sistema CompuFlo® utilizza la tecnologia Dynamic Pressure Sensing® per migliorare la sicurezza dei pazienti e i risultati nelle procedure epidurali.
Milestone Scientific (NYSE: MLSS) ha conseguido la asignación de precios de Medicare para su Sistema Epidural CompuFlo® en 12 estados a través de Novitas Solutions. Esto abarca las regiones de Medicare Jurisdicción L y H, tras una reciente aprobación en Florida. La decisión se aplica al código CPT® de Categoría III CPT0777T de la AMA para sistemas de guía epidural con sensor de presión en tiempo real.
Esta expansión representa una oportunidad de mercado significativa, con un estimado de 3,0 millones de procedimientos de inyección de esteroides epidurales realizados anualmente en estas jurisdicciones, lo que representa alrededor de un tercio de los procedimientos totales en EE. UU. El mercado dirigible inicial entre los pacientes de Medicare en estas regiones es de aproximadamente 250 millones de dólares. El sistema CompuFlo® utiliza la tecnología Dynamic Pressure Sensing® para mejorar la seguridad del paciente y los resultados en los procedimientos epidurales.
밀스톤 사이언티픽(Milestone Scientific) (NYSE: MLSS)가 Novitas Solutions를 통해 12개 주에서 컴퓨플로®(CompuFlo®) 경막외 시스템의 Medicare 가격 책정을 확보했습니다. 이는 최근 플로리다에서 승인된 Medicare 지역 관할권 L 및 H를 포함합니다. 이 결정은 실시간 압력 감지 경막외 유도 시스템에 대한 AMA의 카테고리 III CPT® 코드 CPT0777T에 적용됩니다.
이번 확장은 중대한 시장 기회를 이루며, 이 지역에서는 매년 약 300만 건의 경막외 스테로이드 주사 시술이 이루어져 전체 미국 시술의 약 3분의 1을 차지합니다. 이 지역 Medicare 환자들 사이에서 초기 목표 시장은 약 2억 5천만 달러입니다. CompuFlo® 시스템은 Dynamic Pressure Sensing® 기술을 사용하여 경막외 시술에서 환자의 안전성과 결과를 향상시킵니다.
Milestone Scientific (NYSE: MLSS) a obtenu l'attribution des prix Medicare pour son Système Épidural CompuFlo® dans 12 États par l'intermédiaire de Novitas Solutions. Cela couvre les régions Medicare Juridiction L et H, suite à une récente approbation en Floride. La décision s'applique au code CPT® de Catégorie III CPT0777T de l'AMA pour les systèmes de guidage épidural avec détection de pression en temps réel.
Cette expansion représente une opportunité de marché significative, avec environ 3,0 millions de procédures d'injection de stéroïdes épiduraux effectuées chaque année dans ces juridictions, ce qui représente environ un tiers des procédures totales aux États-Unis. Le marché initial adressable parmi les patients Medicare dans ces régions est d'environ 250 millions de dollars. Le système CompuFlo® utilise la technologie Dynamic Pressure Sensing® pour améliorer la sécurité des patients et les résultats dans les procédures épidurales.
Milestone Scientific (NYSE: MLSS) hat über Novitas Solutions für sein CompuFlo® Epidural System in 12 Bundesstaaten die Medicare-Preiszuweisung erhalten. Dies betrifft die Medicare-Regionen Jurisdiktion L und H, nach einer kürzlichen Genehmigung in Florida. Die Entscheidung gilt für den CPT®-Code CPT0777T der Kategorie III der AMA für Echtzeit-Druckmesssysteme zur epiduralen Führung.
Diese Expansion stellt eine bedeutende Marktchance dar, mit geschätzten 3,0 Millionen Epidural-Steroideinjektionsverfahren, die jährlich in diesen Jurisdiktionen durchgeführt werden und etwa ein Drittel der gesamten Verfahren in den USA ausmachen. Der anfänglich adressierbare Markt unter den Medicare-Patienten in diesen Regionen wird auf etwa 250 Millionen Dollar geschätzt. Das CompuFlo®-System nutzt die Dynamic Pressure Sensing®-Technologie, um die Patientensicherheit und die Ergebnisse bei epiduralen Verfahren zu verbessern.
- Medicare price assignment secured for CompuFlo® Epidural System in 12 additional states
- Expands addressable market to approximately one-third of total U.S. epidural steroid injection procedures
- Initial addressable market among Medicare patients in these regions estimated at $250 million
- Medicare reimbursement expected to increase accessibility and support healthcare providers
- None.
Insights
The Medicare price assignment for the CompuFlo® Epidural System significantly enhances Milestone Scientific's market potential. By securing reimbursement in key states, the company can now target a broader segment of Medicare beneficiaries, which is particularly notable given that Medicare accounts for up to
The clinical value of the CompuFlo® Epidural System lies in its patented Dynamic Pressure Sensing® technology, which enhances the precision of epidural injections. This directly translates to reduced morbidity and increased patient safety. Such improvements are critical in chronic pain management and the Medicare reimbursement will likely accelerate its adoption in clinical settings. Furthermore, with an estimated 3.0 million ESI procedures annually in the covered jurisdictions, the potential impact on patient outcomes is considerable. This reimbursement could catalyze further clinical research and endorsements, solidifying the technology's role in modern medical practices.
This pricing assignment by Novitas is a strategic win for Milestone Scientific. It not only validates the clinical efficacy of the CompuFlo® Epidural System but also sets a precedent for future coverage in additional Medicare regions. The company's expansion strategy appears robust, focusing on both national and international markets. The acknowledgment from Medicare also increases the system's credibility, making it more appealing to private insurers and healthcare providers. This is likely to drive higher market penetration and long-term growth, positioning Milestone Scientific favorably against competitors in the pain management sector.
ROSELAND, N.J., July 23, 2024 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide painless and precise injections, today announced that Novitas Solutions, Inc. (Novitas), a Jurisdictional Medicare Administrative Contractor (JMAC), has granted a Medicare Part B Physician payment rate for the Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure).
This new price assignment applies to two Medicare regions: Jurisdiction L (JL) and Jurisdiction H (JH). JL includes Delaware, District of Columbia, Maryland, New Jersey, and Pennsylvania. JH includes Arkansas, Colorado, Louisiana, Mississippi, New Mexico, Oklahoma, and Texas.
The pricing assignment by Novitas represents a significant step forward in Milestone Scientific’s strategy to ensure broad coverage and appropriate payment for the CompuFlo® technology when deemed medically necessary and clinically appropriate for Medicare beneficiaries. This decision follows the recently announced Medicare Jurisdiction N (JN) pricing assignment in Florida by First Coast Service Options Inc. (FCSO), marking another milestone in the Company's ongoing efforts to expand access to this advanced technology.
Arjan Haverhals, CEO and President of Milestone Scientific, commented, “Securing Medicare price assignment for the CompuFlo® Epidural System in these additional states is a testament to the clinical value and safety of our technology. This approval by Novitas significantly expands our addressable market and enhances our ability to provide patients with safer, more comfortable epidural procedures. We remain committed to pursuing reimbursement in other Medicare jurisdictions across the country and are confident in our strategic approach to gain nationwide coverage. We also look forward to leveraging this momentum into new international markets.”
An estimated 3.0 million epidural steroid injection (ESI) procedures are performed each year in these three jurisdictions (JL, JH, JN), which represent approximately one-third of the total ESI procedures for the treatment of chronic back pain in the United States. Additionally, it is believed Medicare accounts for up to
The CompuFlo® Epidural System uses Milestone Scientific’s patented Dynamic Pressure Sensing® technology, which provides real-time feedback to ensure accurate needle placement during epidural procedures. This technology is designed to reduce the morbidity, pain, and discomfort associated with traditional epidural techniques, enhancing patient safety and outcomes.
Medicare reimbursement for the CompuFlo® Epidural System is expected to provide several key benefits:
- Increased Accessibility: Medicare reimbursement will make this advanced technology more accessible to a broader patient population, ensuring more Medicare beneficiaries can benefit from safer and more comfortable epidural procedures.
- Enhanced Patient Outcomes: By ensuring accurate needle placement, the CompuFlo® technology reduces the risk of complications, leading to better patient outcomes and higher satisfaction.
- Support for Healthcare Providers: The availability of reimbursement will support healthcare providers by allowing them to offer advanced pain management solutions without financial barriers, improving the overall quality of care.
Milestone Scientific is dedicated to expanding its reimbursement strategy across additional JMAC regions, with the goal of establishing the CompuFlo® technology as a standard of care in epidural procedures nationwide.
About Milestone Scientific Inc.
Milestone Scientific Inc. (MLSS) is a technology-focused medical research and development company that patents, designs and develops innovative injection technologies and instruments for medical and dental applications. Milestone Scientific’s computer-controlled systems are designed to make injections precise and efficient, as well as increase overall patient comfort and safety. The Company’s proprietary DPS Dynamic Pressure Sensing Technology® provides a platform to advance the development of next-generation devices, regulating flow rate and monitoring pressure from the tip of the needle, through platform extensions involving subcutaneous drug delivery of local anesthetic. To learn more, view the MLSS brand video or visit milestonescientific.com.
Safe Harbor Statement
This press release contains forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues, timing of regulatory approvals and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions, future business decisions and regulatory developments, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including without limitation, Milestone's Annual Report for the year ended December 31, 2022. The forward-looking statements in this press release are based upon management's reasonable belief as of the date hereof. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
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FAQ
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