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。

• Coverage Analysis tab lists out all services and procedures that are detailed in the study protocol and notes

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

If yes-

1. Should it be billed to the patient/patient insurance?

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

进行覆盖分析,全面审查of all study documents, clinic procedures, and national billing guidelines must be performed. At UTHealth, this starts with the billing risk review by the Clinical Research Finance and Administration (CRFA) team. Each week, the CRFA team reviews all protocols submitted to the Institutional Review Board from the prior week. While reviewing the protocol, CRFA analyzes the schedule of activities to determine if any activity could generate a charge in the clinical billing system. If a study has an activity that could generate a bill, it is designated as a billing risk.

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” under located Tools& Resources/Forms &Tools - CRF section

护理标准与beplay苹果手机能用吗研究成本

In the terms of the UTHealth Coverage Analysis, standard of care activities are those which the patient would receive regardless of their participation in the study, while research costs are those that being performed outside of this. Another way to think about the difference, is whether or not your normal clinic practice is changing to accommodate the service or procedure. In addition, any activities which are promised as free of charge in the Informed Consent Form automatically become research costs.

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. Submit study to IRB (This initiates the CA process)

2.审查最终CA由SPA的CRFA团队上传到一开始

• Contact CRFA team via email tocrf@uth.tmc.eduif any discrepancies are noted.

3.Complete internal budget tabs

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

4. Negotiate budget with sponsor AFTER the internal budget tabs have been completed

• 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. Upload the final completed CAIB tool under the Proposal Record

• See START guidance document “Clinical Trials- PD”

SPA TASKS/RESPONSIBILITIES

1. Review IRB application for potential billing risk

2. Send study documents to Huron Research Group to build out the Coverage Analysis

3. Upload completed Coverage Analysis into START

• START will send automatic notification to the department.

4. Send a copy of final Coverage Analysis to CPHS to upload into IRIS

5. Maintain all records