NEW YORK – Medicare administrative contractors released final local coverage determinations (LCDs) for a number of molecular diagnostics this week.

纽约——医疗保险管理承包商本周发布了一些分子诊断的最终本地覆盖率测定（LCD）。

Below is a list and brief description for each of the LCDs. Each listing starts with the Medicare contractor that made the decision.

下面是每个LCD的列表和简要说明。每个清单都从做出决定的医疗保险承包商开始。

Final LCDs:

LCD端：

Although the below tests were mentioned in each of the LCDs, the MAC noted that those tests are not automatically covered under the final LCD.

尽管在每个LCD中都提到了以下测试，但MAC指出，这些测试不会自动包含在最终的LCD中。

CGS Administrators: Veracyte's Afirma, Sonic Healthcare USA's ThyroSeq

CGS管理员：Veracyte的Afirma，Sonic Healthcare USA的ThyroSeq

CGS Administrators released a final LCD aligning its coverage with Palmetto for molecular tests for patients with an indeterminate or suspicious thyroid nodule under certain conditions, referencing Veracyte's Afirma Genomic Sequencing Classifier and Sonic Healthcare USA's ThyroSeq test in its decision.

CGS管理人员发布了最终的LCD，将其覆盖范围与Palmetto对齐，用于在某些条件下对不确定或可疑甲状腺结节患者进行分子检测，在其决定中参考了Veracyte的Afirma基因组测序分类器和Sonic Healthcare USA的ThyroSeq测试。

For these kinds of tests to be covered, the patient must not have been tested with the same or a similar assay for the same clinical indication and must have either an indeterminate thyroid nodule as defined by Bethesda categories III or IV or a Bethesda category V nodule for which molecular testing can help further stratify the type of malignancy. .

对于要覆盖的这些类型的测试，患者不得使用相同或类似的检测方法进行相同的临床指征测试，并且必须具有Bethesda III或IV类定义的不确定甲状腺结节或Bethesda V类结节，分子检测可以帮助进一步分析恶性肿瘤的类型。。

If a patient has multiple nodules, concurrent or reflex testing may be medically necessary as long as the criteria are met, CGS said.

如果患者有多个结节，只要符合标准，同时或反射测试可能在医学上是必要的，CGS说。

The test results must be used to help with surgical decision-making after clinical, radiographic, and cytologic features are considered. The patient must also be within the population and indication for which the test was developed.

在考虑临床，放射学和细胞学特征后，测试结果必须用于帮助手术决策。患者也必须在测试开发的人群和适应症范围内。

The MAC also noted that these tests may safely preclude unnecessary surgical procedures and better select patients who could benefit from surgery.

MAC还指出，这些测试可以安全地排除不必要的外科手术，并更好地选择可能从手术中受益的患者。

CGS added that next-generation sequencing tests used to identify genetic variants in malignant samples aren't within the scope of the LCD but may be covered under other existing policies.

CGS补充说，用于识别恶性样本中遗传变异的下一代测序测试不在LCD的范围内，但可能会被其他现有政策所涵盖。

The LCD will go into effect on Oct. 13, 2024.

LCD将于2024年10月13日生效。

CGS Administrators: Veracyte's Percepta Genomic Sequencing Classifier

CGS管理员：Veracyte的Percepta基因组测序分类器

CGS also released a final LCD aligning its coverage with Palmetto for molecular assays to help diagnose or rule out lung cancer in patients with an indeterminate pulmonary nodule (IPN) after a non-diagnostic bronchoscopy in some circumstances. The MAC mentioned Veracyte's Percepta Genomic Sequencing Classifier as an example but noted that the policy includes all molecular analytes that are within the scope of the MolDX program and is not limited to a single analyte, such as RNA..

CGS还发布了最终的LCD，将其覆盖范围与Palmetto进行分子检测，以帮助在某些情况下进行非诊断性支气管镜检查后诊断或排除不确定肺结节（IPN）患者的肺癌。MAC以Veracyte的Percepta基因组测序分类器为例，但指出该政策包括MolDX程序范围内的所有分子分析物，并且不限于单个分析物，例如RNA。。

To be covered, a patient must have undergone a non-diagnostic bronchoscopy for an IPN, and the test results must be used to meaningfully inform patient management within the framework of nationally recognized consensus guidelines. The nodule can't be evaluated by an alternate methodology for a specific diagnosis before receiving the molecular test results..

要覆盖这一范围，患者必须接受IPN的非诊断性支气管镜检查，并且必须在国家公认的共识指南的框架内使用测试结果为患者管理提供有意义的信息。在收到分子检测结果之前，无法通过替代方法对结节进行特定诊断。。

The test is not covered if a patient has a personal history of lung cancer or a current cancer diagnosis, or if the patient has an overall high-enough or low-enough risk for pulmonary malignancy that the test results wouldn't meaningfully affect patient management and significantly improve patient outcomes. .

如果患者有肺癌的个人病史或目前的癌症诊断，或者患者的肺部恶性肿瘤总体风险足够高或足够低，测试结果不会有意义地影响患者管理并显着改善患者预后，则不包括测试。。

The patient also cannot have been tested with the same or a similar assay for the same clinical indication and must be within the population and indication for which the test was developed and is covered.

对于相同的临床适应症，患者也不能使用相同或类似的检测方法进行检测，并且必须在开发和涵盖检测的人群和适应症范围内。

CGS noted that next-generation sequencing-based tests to identify genetic variants in malignant samples are not covered in the scope of this policy.

CGS指出，该政策的范围不包括用于鉴定恶性样本中遗传变异的基于下一代测序的测试。

The services will be covered starting Oct. 13, 2024.

这些服务将于2024年10月13日开始。

**Palmetto administers the MolDx program, in which three other Medicare administrative contractors (MACs) participate, including Noridian, CGS, and Wisconsin Physicians Service Insurance Corporation. Each MAC issues its own draft and final policy to align with Palmetto’s coverage terms for a specific test. .

**Palmetto管理MolDx计划，其他三家医疗保险管理承包商（MAC）也参与了该计划，包括Noridian、CGS和威斯康星州医生服务保险公司。每个MAC都会发布自己的草案和最终政策，以符合Palmetto针对特定测试的覆盖条款。。