美国新冠检测收费标准及医保支付政策（全文译）

特别鸣谢：NACCCA候任主席、原CAP认证实验室临床实验室主任王永强博士对全文的审校，及WILEY旗下VIEW期刊助理编辑Becky的翻译。

Centers for Medicare &Medicaid Services

Ruling No.: [CMS-2020-01-R]

Date: April 14, 2020

CMS Rulings are decisions of the Administrator that serve as precedent final opinions and orders and statements of policy and interpretation. They provide clarification and interpretation of complex or ambiguous statutory or regulatory provisions relating to Medicare, Medicaid, Utilization and Quality Control Peer Review, private health insurance, and related matters. They are published under the authority of the Administrator of the Centers for Medicare & Medicaid Services (CMS).

CMS裁决是行政官的决定，作为先例、最终意见、命令、政策声明和解释。它们对与医疗保险、医疗补助、使用和质量控制同行评审、私人健康保险和相关事项有关的复杂或含糊不清的法律或监管规定进行了澄清和解释。它们在医疗保险和医疗补助服务中心（CMS）的管理者的授权下发布。

CMS Rulings are binding on all CMS components, on all Department of Health and Human Services components that adjudicate matters under the jurisdiction of CMS, and on the Social Security Administration (SSA) to the extent that components of the SSA adjudicate matters under the jurisdiction of CMS.

CMS裁决对所有CMS组成部分、裁定CMS管辖范围内事项的所有卫生和公共服务部组成部分以及社会保障管理局（SSA）具有约束力，只要SSA组成部分裁定CMS管辖范围内的事项。

This Ruling articulates CMS policy concerning the designation and payment of certain clinical diagnostic laboratory tests related to COVID-19 under the Medicare Part B Clinical Laboratory Fee Schedule.

本裁决阐明了CMS政策，涉及根据医疗保险B部分临床实验室费用表指定和支付与COVID-19相关的某些临床诊断实验室测试。

MEDICARE PROGRAM

Payment under Medicare Supplementary Medical Insurance (Part B) for clinical diagnostic laboratory tests for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19 making use of high throughput technologies.

医疗保险计划

医疗保险补充医疗保险（B部分）项下的付款，用于检测SARS-CoV-2或利用高通量技术诊断导至COVID-19的病毒的临床诊断实验室测试.

CITATIONS: Section 1833(h) of the Social Security Act (42 U.S.C. 1395l(h)), Section 1834A of the Social Security Act (42 U.S.C. 1395m-1), and 42 CFR Part 414, Subpart G. 2 CMS-Ruling 2020-1-R.

BACKGROUND

Medicare Part B items and services that are clinical diagnostic laboratory tests (CDLTs) are paid for on the Clinical Laboratory Fee Schedule in accordance with section 1833(h) and section 1834A of the Social Security Act (the Act). CMS and the Medicare Administrative Contractors (MACs) that process Medicare claims for payment make payment based on the Act, regulations, and CMS instructions or guidance. Sections 1833(h) and section 1834A of the Act contain provisions outlining the process for determining payment amounts for CDLTs. CDLTs are currently being used to detect SARS–CoV–2 or for the diagnosis of the virus that causes COVID–19 in many settings, including nursing homes and other sites where Medicare beneficiaries obtain care or reside.

背景

根据《社会保障法》第1833（h）节和第1834A节的规定，医疗保险B部分的临床诊断实验室检查（CDLTs）项目和服务按照临床实验室费用表支付。CMS和医疗保险管理承包商（MAC）根据法案、法规和CMS指示或指导处理医疗保险付款索赔。该法第1833（h）条和第1834A条载有规定，概述了确定信用违约贷款支付金额的程序。CDLTs目前正被用于检测SARS-CoV-2或诊断导至COVID-19的病毒，在许多环境中，包括养老院和其他医疗保险受益人获得护理或居住的场所。

PAYMENT FOR LABORATORY TESTS FOR THE DETECTION OF SARS–COV–2 OR THE DIAGNOSIS OF THE VIRUS THAT CAUSES COVID–19 MAKING USE OF HIGH THROUGHPUT TECHNOLOGIES.

使用高通量技术检测SARS-COV-2或诊断导至COVID-19的病毒的实验室测试费用。

CDLTs making use of high throughput technologies (as defined in this Ruling) and administered during the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Act beginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, are new and involve high throughput machines (which are highly sophisticated equipment) which require more intensive technician training (to ensure the role of extremely skilled personnel) and more time intensive processes (to assure quality). A high throughput technology uses a platform that employs automated processing of more than two hundred specimens a day. Examples of high throughput technology as of April 14, 2020 include but are not limited to technologies marketed on that date as the Roche cobas 6800 System, Roche cobas 8800 System, Abbott m2000 System, Hologic Panther Fusion System, GeneXpert Infinity System, and NeuMoDx 288 Molecular. This training and these processes represent an increase in resources, bringing the total resources required for these tests to $100 (a more accurate payment than the one CMS-Ruling 2020-1-R.currently in use via contractor pricing). These tests are a type of CDLT currently paid for under Medicare Part B.

CDLTs利用高通量技术（定义见本裁定），并在2020年3月18日或之后开始的法案第1135（g）节第（1）（B）段规定的持续紧急时期内进行管理，用于检测SARS-CoV-2或诊断导至COVID-19的病毒，是新的，涉及高吞吐量的机器（它们是高度精密的设备），需要更密集的技术人员培训（以确保极熟练人员的作用）和更耗时的过程（以确保质量）。高吞吐量技术使用一个平台，每天自动处理200多个样本。截至2020年4月14日，高通量技术的例子包括但不限于罗氏cobas 6800系统、罗氏cobas 8800系统、雅培m2000系统、Hologic Panther聚变系统、GeneXpert Infinity系统和NeuMoDx 288分子。这一培训和这些过程意味着资源的增加，使这些测试所需的总资源达到100美元（比目前通过承包商定价使用的费用更准确）。这些测试是目前根据CMS规则2020-1-R支付的一种CDLT。

Specifically, the following codes would identify these tests:

U0003: Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (Coronavirus disease [COVID-19]), amplified probe technique, making use of high throughput technologies as described by CMS-2020-01-R.

U0004: 2019-nCoV Coronavirus, SARS-CoV-2/2019-nCoV (COVID-19), any technique, multiple types or subtypes (includes all targets), non-CDC, making use of high throughput technologies as described by CMS-2020-01-R.

具体而言，以下代码将确定这些测试：

U0003：用核酸（DNA或RNA）检测传染源；严重急性呼吸综合征冠状病毒2（SARS-CoV-2）（冠状病毒病[COVID-19]），扩增探针技术，利用CMS-2020-01-R描述的高通量技术。

U0004:2019 nCoV冠状病毒，SARS-CoV-2/2019 nCoV（COVID-19），任何技术，多种类型或亚型（包括所有目标），非CDC，利用CMS-2020-01-R所述的高通量技术。

It is noted that U0003 should identify tests that would otherwise be identified by CPT code 87635 but for being performed with these high throughput technologies. It is further noted that U0004 should identify tests that would otherwise be identified by U0002 but for being performed with these high throughput technologies. Finally, it is noted that neither U0003 nor U0004 should be used for tests that detect COVID-19 antibodies.

CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that make use of high throughput technologies developed after this issuance upon request for payment at an appropriate rate.

值得注意的是，U0003应该识别那些本来由CPT代码87635识别，但使用这些高吞吐量技术执行的测试。还应注意，U0004应识别由U0002识别但使用这些高吞吐量技术执行的测试。最后，值得注意的是，U0003和U0004都不应用于检测COVID-19抗体的试验。

CMS打算在收到付款请求后，立即评估使用本次发行后开发的高通量技术的COVID-19测试相关CDL的付款情况，并以适当的费率付款。

CONCLUSION

With regard to CDLTs that make use of high throughput technologies (as defined in this Ruling), are administered during the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Act beginning on or after March 18, 2020, for the detection of SARS–CoV–2 or the diagnosis of the virus that causes COVID–19, and are a type of CDLT currently paid for under Medicare Part B using CPT code 87635 or U0002, such tests, as identified using U0003 or U0004 as appropriate, shall be paid for at the rate of $100. Payment for all other CDLTs remains at the current level. CMS intends to promptly evaluate payment for relevant CDLTs for COVID-19 testing that make use of high throughput technologies developed after this issuance upon request for payment at an appropriate rate.

结论

对于使用高通量技术（定义见本裁定）的CDL，从2020年3月18日或之后开始在法案第1135（g）节第（1）（B）段规定的持续紧急时期内进行管理，以检测SARS-CoV-2或诊断导至COVID-19的病毒，并且是一种目前根据医疗保险B部分使用CPT代码87635或U0002支付的CDLT中，使用U0003或U0004确定的测试（视情况而定）应按100美元的费率支付。所有其他CDL的付款仍保持在当前水平。CMS打算在收到付款请求后，立即评估使用本次发行后开发的高通量技术的COVID-19测试相关CDL的付款情况，并以适当的费率付款。

CMS-Ruling 2020-1-R4

MACs are hereby directed to engage in whatever processes are necessary to make determinations orpolicies to process claims in accordance with this Ruling, including implementing any additional Agency instructions which refer to effectuating this Ruling. This Ruling expires upon the expirationof the ongoing emergency period defined in paragraph (1)(B) of section 1135(g) of the Actbeginning on or after March 18, 2020.

CMS裁定2020-1-R 4

特此指示MACs从事任何必要的程序，以作出决定或根据本裁定处理索赔的政策，包括实施指执行本裁决的机构指令。本裁定自期满之日起失效法案第1135（g）条第（1）（B）款规定的持续紧急期从2020年3月18日或之后开始。

CMS-Ruling 2020-1-R 

EFFECTIVE DATE

This Ruling is effective April 14, 2020.

Dated: April 14, 2020

CMS裁定2020-1-R

生效日期

本裁定自2020年4月14日起生效。

日期：2020年4月14日

Seema Verma

Administrator

Centers for Medicare & Medicaid Services