NEW YORK — The US Centers for Medicare and Medicaid Services said on Friday that Medicare administrative contractors have backed off finalizing a proposed local coverage determination issued a year ago covering non-invasive blood-based surveillance testing for solid organ allograft rejection.

纽约——美国医疗保险和医疗补助服务中心周五表示，医疗保险管理承包商已放弃敲定一年前发布的拟议的当地覆盖率确定，该确定涵盖了实体器官同种异体移植排斥反应的无创血液监测测试。

In a statement, CMS said the decision was based on 'response to public comments and upon further review of the evidence' and in the coming months, the MACs will issue a new LCD with a chance for the public to comment on the new proposal.

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As a result, coverage of blood tests for monitoring organ transplantation rejection when ordered by physicians will not change. Patients with transplanted hearts, lungs, or kidneys who meet Medicare's current LCD criteria can continue to access tests such as CareDx's AlloSure, AlloMap, and Heartcare tests if there are signs or symptoms of transplant rejection and following a physician-assessed pretest, including for surveillance testing, CMS said..

因此，当医生下令进行器官移植排斥反应监测时，血液检测的覆盖范围不会改变。CMS表示，如果有移植排斥的迹象或症状，并且经过医生评估的预测试（包括监测测试），符合Medicare当前LCD标准的心脏，肺或肾脏移植患者可以继续接受CareDx的AlloSure，AlloMap和Heartcare测试。。

Additionally, the blood-based testing must follow an indeterminate biopsy or be used as a replacement for biopsy as determined to be appropriate by a physician, or it is being used to evaluate the adequacy of immunosuppression.

此外，基于血液的检测必须遵循不确定的活检，或者由医生确定为合适的替代活检，或者用于评估免疫抑制的充分性。

While the LCD that the MACs are backing away from was proposed in August 2023, the transplantation field began signaling its disapproval of the forthcoming LCD months earlier when Palmetto MolDx updated a reimbursement guidance for molecular tests assessing rejection risk in solid organs. Among other things, the billing article aimed to reimburse only one test per patient encounter, provide new coding to define surveillance and for-cause testing, and redefine acceptable surveillance testing as compliant only for patients enrolled in centers that use surveillance protocols and would otherwise receive such testing..

虽然MACs正在退出的LCD是在2023年8月提出的，但移植领域在几个月前开始表示不赞成即将推出的LCD，当时Palmetto MolDx更新了评估实体器官排斥风险的分子测试报销指南。除其他外，计费文章的目的是只报销每个患者遇到的一次测试，提供新的编码来定义监测和原因检测，并将可接受的监测检测重新定义为仅适用于使用监测协议并将接受此类检测的中心登记的患者。。

Also, unless the tests were used in place of a biopsy or to confirm a biopsy result, the test would no longer be reimbursed.

此外，除非测试用于替代活检或确认活检结果，否则测试将不再报销。

While revisions were made to MolDx's guidance when the updated proposed LCD hit a year ago, some still were troubled by MolDx's plan.

一年前，当更新后的液晶显示器上市时，MolDx的指导方针进行了修订，但仍有一些人对MolDx的计划感到困惑。

CareDx in May 2023 said MolDx's reimbursement guidance caused the firm to miss its first quarter 2023 revenue targets and to withdraw its financial guidance for 2023.

CareDx在2023年5月表示，MolDx的报销指导导致该公司未能实现2023年第一季度的收入目标，并撤回了2023年的财务指导。

On Friday, the Brisbane, California-based developer of organ transplant tests cheered the new decision by the MACs.

周五，这位总部位于加利福尼亚州布里斯班的器官移植测试开发商对MACs的新决定表示欢迎。

'We appreciate the [CMS] 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,' CareDx President and CEO John Hanna said in a statement.

CareDx总裁兼首席执行官约翰·汉纳（JohnHanna）在一份声明中说：“我们感谢（CMS）及其当地承包商倾听了数千名患者和临床医生的声音，他们不知疲倦地倡导基于其在检测早期排斥迹象方面的临床效用进行非侵入性监测测试。”。

'We believe their efforts were instrumental in restoring longstanding Medicare coverage.'.

“我们相信他们的努力有助于恢复长期的医疗保险覆盖率。”。