Description:

A Coverage Analysis is a systematic review of all procedures detailed in the study protocol to determine how each service and/or procedure at each visit time point should be billed to ensure institutional billing compliance. Medicare billing guidelines are referred to during this determination process.

Uthealth创建了“覆盖范围分析/内部预算”（CAIB）工具，以记录该机构进行的所有临床研究的计费覆盖分析确定。

• 覆盖范围分析选项卡列出了研究协议和注释中详细介绍的所有服务和程序

- Will this service or procedure generate a bill in billing system?

If yes-

1.应该向患者/患者保险收费吗？

2.应该向研究帐户收费吗？

分析完成后，研究人员/研究团队将有一个特定于研究的计费摘要，可以指导研究团队进行研究访问的临床计费。beplay苹果手机能用吗

PROCESS

要进行覆盖分析，必须对所有研究文件，诊所程序和国家计费准则进行彻底审查。在Uthealth，这始于临床研究金融与管理（CRFA）团队的计费风险审查。beplay苹果手机能用吗每周，CRFA团队都会审查上一周从机构审查委员会提交的所有协议。在审查协议时，CRFA分析了活动时间表，以确定任何活动是否可以在临床计费系统中产生指控。如果一项研究的活动可以产生账单，则将其指定为计费风险。

After identifying a billing risk, the CRFA team then is responsible for ensuring a billing coverage analysis (CA) is built for the study. Effective 01/01/2022, UTHealth utilizes a third party who specializes in billing coverage analyses to build out CAs. This ensures unbiased billing assessments and condition/indication specific billing expertise. UTHealth has contracted with Huron Research Group to build out the coverage analysis which includes notating billing determinations for all services and procedures occurring at each study visit as described within the protocol and providing justification for all items notated as routine/standard care by referencing a national guideline or peer reviewed publication which indicates that the activity is adequate and necessary in the treatment of the patient’s condition.

Once CRFA team has received completed CA back from Huron, the CA is uploaded into START CA AGT record and the status is changed to “Approved”. START will send an automated notification to the Department that the CA is complete and ready for review. If the Department has any questions or comments, they should notify the CRFA team via email atcrf@uth.tmc.edu。CRFA团队将与部门和休伦合作进行更改（如果适用）。如果部门想对最终决定进行质疑，则可以将CA升级为Uthealth计费审计小组。

然后，CRFA团队将将最终覆盖范围分析发送给委员会，以保护人类受试者上传到IRIS，并在EPIC中创建研究行政记录（如果适用）

覆盖范围分析（CA）记录是由CRFA团队创建的。一旦您的项目的CA完成，您将通过自动电子邮件从Start开始通知您。

FEES FOR INDUSTRY SPONSORED CLINICAL TRAILS:

Industry Sponsored studies will be billed for CA build and CA amendment build. The Department must ensure that coverage analysis costs are included in startup fees when negotiating budgets with Industry/For profit sponsors (See “覆盖范围分析费 - 行业赞助的研究”定位工具和资源/表格和工具 - CRF部分

护理标准与beplay苹果手机能用吗研究成本

就UTHealth的覆盖范围分析而言，护理活动的标准是患者无论参与研究，而研究成本是在此工作之外进行的。beplay苹果手机能用吗考虑差异的另一种方法是，您的正常诊所实践是否正在改变以适应服务或程序。此外，在知情同意书中免费承诺的任何活动都会自动成为研究成本。beplay苹果手机能用吗

有用的护理标准网站与研究：beplay苹果手机能用吗

https://www.cms.gov/medicare/coverage/clinicaltrialpolicies/downloads/finalnationalcoverage.pdf

https://www.fda.gov/ForPatients/ClinicalTrials/ClinicalvsMedical/default.htm

DEPARTMENT TASKS/RESPONSIBILITIES

1.将研究提交给IRB（这启动了CA流程）

2.审查最终CA由SPA的CRFA团队上传到一开始

• 通过电子邮件联系CRFA团队crf@uth.tmc.eduif any discrepancies are noted.

3.完成内部预算选项卡

• See guidance document “CAIB Tool Guidance Document” located Tools& Resources/Forms &Tools - CRF section

4.内部预算选项卡完成后与赞助商协商预算

• 在您对进行研究的成本有清晰的了解之前，请勿与赞助商进行谈判

5.在提案记录下上传最终完成的CAIB工具

• See START guidance document “Clinical Trials- PD”

SPA TASKS/RESPONSIBILITIES

1.审查IRB申请潜在的计费风险

2.将研究文件发送给休伦研究小组以建立覆盖范围分析beplay苹果手机能用吗

3.将完成的覆盖分析上传到开始

• START will send automatic notification to the department.

4.将最终覆盖分析的副本发送到CPHS上传到IRIS

5.维护所有记录