CareDx Announces Transplant Community Secures Win Reaffirming Longstanding Medicare Coverage for AlloSure and AlloMap Testing
CareDx, Inc. (Nasdaq: CDNA) announced that the Centers for Medicare and Medicaid Services (CMS) plans to retire a draft LCD that would have restricted coverage for non-invasive blood-based surveillance testing for allograft rejection. This decision, along with the February 2024 removal of restrictive language in the accompanying Billing Article, effectively restores longstanding coverage for AlloSure®, AlloMap®, and HeartCare®.
The company's President and CEO, John W. Hanna, expressed appreciation for CMS listening to patients and clinicians who advocated for access to these tests. The restored coverage includes surveillance monitoring of organ transplant rejection without requiring ties to invasive biopsies. CareDx has been a proponent for improving access to transplantation innovations and supported efforts to restore Medicare coverage for non-invasive surveillance testing.
CareDx, Inc. (Nasdaq: CDNA) ha annunciato che i Centers for Medicare and Medicaid Services (CMS) pianificano di ritirare un progetto di LCD che avrebbe limitato la copertura per test di sorveglianza ematica non invasivi per il rigetto dell'innesto. Questa decisione, insieme alla rimozione nel febbraio 2024 del linguaggio restrittivo nell'articolo di fatturazione associato, ripristina effettivamente la copertura di lunga data per AlloSure®, AlloMap® e HeartCare®.
Il presidente e CEO dell'azienda, John W. Hanna, ha espresso gratitudine per il fatto che il CMS abbia ascoltato pazienti e medici che hanno fatto appello per l'accesso a questi test. La copertura ripristinata include il monitoraggio della sorveglianza del rigetto degli innesti d'organo senza richiedere legami con biopsie invasive. CareDx è stata sostenitrice del miglioramento dell'accesso alle innovazioni nel trapianto e ha supportato gli sforzi per ripristinare la copertura Medicare per i test di sorveglianza non invasivi.
CareDx, Inc. (Nasdaq: CDNA) anunció que los Centros de Servicios de Medicare y Medicaid (CMS) planean retirar un borrador de LCD que limitaría la cobertura para pruebas de vigilancia no invasivas basadas en sangre para el rechazo de injertos. Esta decisión, junto con la eliminación en febrero de 2024 del lenguaje restrictivo en el artículo de facturación asociado, restaura efectivamente la cobertura de largo plazo para AlloSure®, AlloMap® y HeartCare®.
El presidente y CEO de la empresa, John W. Hanna, expresó su agradecimiento por la escucha del CMS a pacientes y clínicos que abogaron por el acceso a estas pruebas. La cobertura restaurada incluye monitoreo de la vigilancia del rechazo de trasplantes de órganos sin requerir biopsias invasivas. CareDx ha sido un defensor de mejorar el acceso a innovaciones en trasplante y ha apoyado los esfuerzos para restaurar la cobertura de Medicare para pruebas de vigilancia no invasivas.
CareDx, Inc. (Nasdaq: CDNA)는 메디케어 및 메디케이드 서비스 센터(CMS)가 이식 거부 반응에 대한 비침습적 혈액 기반 감시 검사의 적용 범위를 제한하는 초안 LCD를 철회할 계획이라고 발표했습니다. 이 결정과 함께 2024년 2월에 동반된 청구 기사에서 제한적 언어가 제거됨으로써 AlloSure®, AlloMap® 및 HeartCare®에 대한 오랜 커버리지가 효과적으로 복원됩니다.
회사의 사장 겸 CEO인 John W. Hanna는 환자와 임상의들이 이 테스트에 대한 접근을 옹호한 것을 CMS가 경청한 것에 감사를 표했습니다. 복원된 커버리지에는 침습적인 조직검사와 연결하지 않고 장기 이식 거부 반응에 대한 감시 모니터링이 포함됩니다. CareDx는 이식 혁신 접근성을 개선하기 위한 주창자였으며 비침습적 감시 검사에 대한 메디케어 커버리지를 복원하기 위한 노력을 지원해 왔습니다.
CareDx, Inc. (Nasdaq: CDNA) a annoncé que les Centers for Medicare and Medicaid Services (CMS) prévoient de retirer un projet de LCD qui aurait restreint la couverture pour les tests de surveillance non invasifs basés sur le sang pour le rejet de greffe. Cette décision, ainsi que la suppression en février 2024 d'un langage restrictif dans l'article de facturation associé, restaure effectivement la couverture de longue date pour AlloSure®, AlloMap® et HeartCare®.
Le président et directeur général de l'entreprise, John W. Hanna, a exprimé sa gratitude pour le fait que le CMS a écouté les patients et les cliniciens qui ont plaidé pour l'accès à ces tests. La couverture restaurée comprend la surveillance du rejet de greffe d'organe sans nécessiter de biopsies invasives. CareDx a été un ardent défenseur de l'amélioration de l'accès aux innovations en matière de transplantation et a soutenu les efforts visant à rétablir la couverture Medicare pour les tests de surveillance non invasifs.
CareDx, Inc. (Nasdaq: CDNA) gab bekannt, dass die Centers for Medicare and Medicaid Services (CMS) planen, einen Entwurf für ein LCD zurückzuziehen, der die Deckung für nicht-invasive blutbasierte Überwachungsuntersuchungen zur Ablehnung von Transplantaten eingeschränkt hätte. Diese Entscheidung, zusammen mit der Streichung einschränkender Formulierungen im Begleitartikel zur Abrechnung im Februar 2024, stellt die langjährige Deckung für AlloSure®, AlloMap® und HeartCare® effektiv wieder her.
Der Präsident und CEO des Unternehmens, John W. Hanna, äußerte Dankbarkeit dafür, dass CMS den Patienten und Klinikern zugehört hat, die sich für den Zugang zu diesen Tests eingesetzt haben. Die wiederhergestellte Deckung umfasst die Überwachungsüberprüfung der Organtransplantat-Ablehnung ohne die Notwendigkeit invasiver Biopsien. CareDx war ein Befürworter der Verbesserung des Zugangs zu Transplantationsinnovationen und unterstützte die Bemühungen, die Medicare-Abdeckung für nicht-invasive Überwachungstests wiederherzustellen.
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CMS Recognizes the Importance of Surveillance Testing for Early Detection of Allograft Rejection
CMS to Retire Proposed Draft Policy that Would Have Restricted Coverage
“We appreciate the Agency and its local contractors for listening to the voices of thousands of patients and clinicians who tirelessly advocated for access to non-invasive surveillance testing based on its clinical utility in detecting early signs of rejection. We believe their efforts were instrumental in restoring longstanding Medicare coverage,” said John W. Hanna, CareDx President and CEO.
The longstanding Medicare coverage for AlloSure and AlloMap testing includes surveillance monitoring of organ transplant rejection, without requiring ties to invasive biopsies. In March 2023, Medicare issued a Billing Article that, among other restrictions, required clinicians to indicate that the surveillance testing was being performed instead of a surveillance biopsy. This resulted in a decrease in testing as not all transplant centers perform surveillance biopsies, particularly for kidney transplant monitoring.
AlloSure donor-derived cell-free DNA (dd-cfDNA) and AlloMap gene-expression profiling (GEP) are non-invasive blood tests that assess allograft injury and immune quiescence respectively, both important indicators of transplanted organ health. The clinical utility of AlloSure Kidney, AlloSure Heart, AlloSure Lung, AlloMap Heart and HeartCare have been widely demonstrated in peer-reviewed clinical studies.
CareDx has been a longstanding proponent for improving access to the latest transplantation innovations and supported the Honor the Gift and Health Equity in Transplantation coalitions in their recent efforts to restore Medicare coverage for non-invasive surveillance testing. CareDx has historically supported important transplant legislative policies, including the 21st Century Cures Act to help bring new innovations to patients who need them faster, the Living Donor Protection Act to promote live organ donations and protect donors from discrimination, and through the Honor the Gift Coalition, the passage of the Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2019 (Immuno Bill).
About CareDx – The Transplant Company
CareDx, Inc., headquartered in
Forward-Looking Statements
This press release includes forward-looking statements related to CareDx, Inc. including statements regarding the potential benefits and results that may be achieved with AlloSure®, AlloMap® and HeartCare®. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to risks and uncertainties that could cause actual results to differ materially from those projected, including general economic and market factors; and other risks discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
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CareDx, Inc.
Media Relations
Anna Czene
818-731-2203
aczene@caredx.com
Investor Relations
Greg Chodaczek
investor@caredx.com
Source: CareDx, Inc.
FAQ
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