A recap of how CMS’ CROWNWeb data-collection system will impact the renal community, and a look at the road ahead.
By Oniel Delva, BA
For over three years, the Centers for Medicare & Medicaid Services (CMS) has been dedicated to developing and implementing a next generation data-collection system that will help increase the efficiency of data collection for CMS and for Medicare-certified end stage renal disease (ESRD) dialysis facilities. In 2008, CMS began this initiative by announcing the development and release of CROWNWeb in an updated version of the Conditions for Coverage for ESRD facilities (CfCs). Since publishing the updated CfCs, CMS has continued to work closely with stakeholders in the ESRD community to ensure that CROWNWeb is a practical data-management system that meets the data submission needs of dialysis facilities, while adhering to requirements set for federal information systems, and supporting CMS goals. Currently, CROWNWeb is on track to be released for use by 100 percent of the 5,500+ dialysis facilities in the United States and U.S. territories in February 2012.
As the national release date grows closer, some of the system’s likely users may have limited knowledge of CROWNWeb’s purpose, access requirements, and impact on the renal community.
History Lesson: A Brief CROWNWeb Overview
Initially released to a select group of dialysis facilities in February of 2009, CROWNWeb is a Web-based data-compilation system that allows authorized users to securely submit and access patient-based data. The system is designed to allow dialysis facilities to comply with Section 494.180(h) of the April 2008 updated CfCs, which indicates that all Medicare-certified dialysis facilities must submit their patient and facility data to CMS via an electronic format.
Since CROWNWeb’s first installment, CMS has implemented two additional “phase-in” releases in which the agency has assessed participating facilities' use of CROWNWeb through monthly user group meetings, interactions with each of the 18 ESRD Networks, and data validation studies. These events have given CMS an opportunity to modify and enhance CROWNWeb based on study results and user feedback.
Once CROWNWeb is fully released in 2012, the system will allow for more timely, accurate, and efficient use of data to support administration of the ESRD program with an electronic process that considers the capabilities of providers.1 (See Fig. 1)
Fig. 1: CROWNWeb Release Timeline
Advancement in Data Reporting
The ability of facilities to electronically submit data to CMS using CROWNWeb will help usher the renal community into a new era of data management, on par with recent technological advances in computing and data collection. CROWNWeb will help transition information gathering efforts from the current paper-based process to an electronic “real-time” method.
Facilities using CROWNWeb will enter most of the information that has been historically mailed to their ESRD Networks directly into the system. Facilities will also have the ability to generate standardized facility and audit reports to help ensure their units continue to assist CMS with its quality improvement efforts.
CROWNWeb’s data elements include:
- Patient admission and discharge history
- CMS-2728 ESRD Medical Evidence Report: Medicare Entitlement and/or Patient Registration and CMS-2746 Death Notification forms
- CMS-2744 ESRD Facility Survey form
- Patient Attributes and Related Treatment (currently known as the monthly Patient Activity Reports)
- Hemodialysis (HD), peritoneal dialysis (PD), and vascular access clinical values
Additionally, most of the data entered into CROWNWeb will be used to support CMS’ quality improvement initiatives for ESRD beneficiaries. Traditionally, the data analyzed as part of this project came from a sample of five to eight percent of the ESRD total patient population. However, after CROWNWeb’s national release, the system will provide a more accurate reflection of the entire dialysis patient population by providing data for 100 percent of the ESRD population.
Due to the sensitivity of the data available via CROWNWeb, the system must adhere to information security and acceptable risk safeguard policies mandated by CMS and the National Institute of Standards and Technology (NIST). In order to meet these guidelines, CROWNWeb will feature a new account activation and verification process that will strengthen the system’s account management requirements.
CROWNWeb’s national release in 2012 will boast two new security protocols:
- QualityNet Identity Management System (QIMS)
- Two-factor authentication
QIMS is an identity management security service (IdM) that will capture the information collected during the registration process and provide each user with an identity credential and access to QualityNet applications, including CROWNWeb. This new IdM security service is scheduled to replace CROWNWeb’s current account activation process, known as the QualityNet Identity Provisioning System (QIPS).
QIMS will serve as a robust system that meets federal standards for identity credential and access management. Similar to QIPS, QIMS will be used to register and manage user accounts in a manner that minimizes the risk of security incidents, and it will incorporate additional features such as online registration, automated workflow for application approval, and two-factor authentication.
Two-factor authentication is an identity verification process in which more than one form of authentication is used to verify a user’s identity. This method, which is often used by banking organizations to allow customers to access their accounts, will give CROWNWeb an extra level of security by requiring a user to enter a one-time system-generated pass code in addition to his/her username and password.
When registering for a CROWNWeb account via QIMS, users will be able to select the method by which they would like to receive their system-generated pass codes (See Fig. 2 ). Delivery methods include:
- Text message
Fig. 2: Example of CROWNWeb's One-Time Pass Code (Text Message)
To minimize the burden of entering a one-time-use code at every log in, individual users will have the ability to have CROWNWeb store their pass codes on a single computer for up to 12 hours before a new pass code is required.
Down the Road
Since CROWNWeb’s initial release, CMS has been able to obtain assistance from three of the renal community’s large dialysis organizations (DaVita, Fresenius, and Dialysis Clinic Incorporated) to test the ability to transfer data directly into CROWNWeb by using an electronic data interchange (EDI) format. These facilities were selected to test this submission method, better known as CROWNWeb’s “batch” data submission process, because of the time and resources required to refine the procedure. While these organizations entered data into CROWNWeb via batch submission, CMS continued to explore how to make this process available for small and medium dialysis organizations (SDOs and MDOs).
In 2010, CMS partnered with the National Renal Administrators Association (NRAA) to develop an EDI solution that will help meet the electronic data submission needs of SDOs and MDOs. As part of this joint effort, both parties will work with a third-party Health Information Exchange (HIE) to use a secure health data infrastructure known as the Nationwide Heath Information Network (NwHIN) gateway for SDOs and MDOs. This project is slated to debut as a limited production pilot in which the HIE will submit organizations’ CROWNWeb data to CMS through the NwHIN.
CMS and NRAA have followed the initial steps required to develop this project, such as outlining system development requirements, reviewing all security documents, and signing a multi-party data exchange agreement. As the project progresses, CMS will continue to review its success and the possibility of making the NwHIN solution available nationally.
For more information on CROWNWeb, visit the Project CROWNWeb website at www.projectcrownweb.org, or go to www.qualitynet.org and click on the ESRD tab. Details regarding CROWNWeb and the NwHIN project are also available in CMS’ monthly CRAFT and CROWNWeb Newsletters. Interested individuals can sign up to receive both newsletters, or submit CROWNWeb-related questions to CRAFT@projectcrownweb.org.
The work on which this publication is based was performed under Contract Number HHSM-500-2010-00261G, titled “CROWNWeb Outreach, Communication, and Training,” funded by the Centers for Medicare & Medicaid Services, Department of Health and Human Services. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.
The author assumes full responsibility for the accuracy and completeness of the ideas presented. The author welcomes comments on the ideas presented; please send comments to CRAFT@projectcrownweb.org
Publication Number: FL-ESRD-2011OTCT2-9-12415
1. Centers for Medicare & Medicaid Services. Conditions for Coverage for End-Stage Renal Disease Facilities; Final Rule. www.cms.hhs.gov/CFCsAndCoPs/downloads/ESRDfinalrule0415.pdf. Apr. 15, 2008: p 74. Accessed Aug. 2, 2011.