Registry for Lung Screening Excellence
With the announcement of the National Coverage Determination (NCD) for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) the Centers for Medicare & Medicaid Services (CMS) will begin to provide coverage for eligible Medicare Beneficiaries effective February 5th, 2015.
There is an additional requirement that certain data be collected and submitted to a CMS approved registry. The Registry for Lung Screening Excellence (RLSE) is a web-based lung cancer screening registry that has been developed by the Early Diagnosis and Treatment Research Foundation which also hosts the International Early Lung Cancer Action Program (I-ELCAP) database (read more about I-ELCAP). RLSE collects data elements that capture the demographic, medical history, exam results, and follow-up information that we believe are necessary to monitor and improve the quality of lung cancer screening. The RLSE has worked closely with the American College of Radiology (ACR), and the data collected is intended to meet all requirements of CMS, as well support all of the additional data elements that are being collected by the ACR Lung Cancer Screening Registry (LCSR).
We are currently finalizing our agreement with the ACR so that data in the RSLE may be sent to their CMS-approved registry. All sites will be required to sign a business associate agreement with RLSE and ACR, and a participation agreement and data use agreement with RLSE to allow the transmission of the data to CMS through the ACR registry.
The RLSE is available to sites located in the United States of America and its territories.
How to enroll
- Contact us at email@example.com to let us know that you are interested in using the RLSE system. For those sites wanting to collect more comprehensive data, the current I-ELCAP Management System will continue to be available.
- Each site will need to provide the following information:
- Name and Address of the Screening Location
- Name and Contact Information for the Site Coordinator/Administrator
- The National Provider Identifier (NPI) for the location
- We also recommend providing a URL for the location's website
- All sites will need to complete the agreements with ACR and RLSE
- Sites should review the current posted I-ELCAP protocol and flowchart.
- Sites will be assigned an Institution Code for their location, and the site coordinator/administrator will receive a password for their location as well as a personal password.
Q. How much does it cost to join the RLSE?
A. Participation in the RLSE will be free (no-cost) to sites for the first year of the RLSE. There will be a charge in subsequent years to be determined.
Q. What agreements will be required to join the RLSE?
A. Each site will need to sign agreements with the RLSE and ACR.
- Participation agreement
- Business associate agreement
- Data use agreement
- business associate agreement
Q. Do I need to enter all CT screening exams, or only those that qualify for Medicare reimbursement?
A. To ensure that we have the best possible data to help advance lung cancer screening world-wide, we require sites to include all of the CT screening exams performed at their site, and as much data as possible.
Q. Do I need to use a specific protocol?
A. For Medicare reimbursement, the protocol that is used must be specified. We suggest the use of the I-ELCAP management protocol, but you may use any other protocol, such as the NCCN or Lung-RADS protocols.
Q. Is the system compatible with Lung-RADS?
A. RLSE suggests the use of the I-ELCAP management protocol and collects detailed information on any pulmonary nodules identified during screening. However, RLSE also records the Lung-RADS category for each exam.
Q. How will my institution’s data be used?
A. RLSE will provide each participating institution with reports on a regular basis that can be used to assess quality and performance. RLSE will aggregate data to generate comparison reports on regional, state, and national levels, as well as using the data to help guide advance in lung screening protocols.
About the Early Diagnosis and Treatment Research Foundation
The Early Diagnosis and Treatment Research Foundation (EarlyDxRx) is a 501.c3 corporation focused on researching new methods for the diagnosis and treatment of early stage diseases of the chest, including lung cancer and pleural disease. The EarlyDxRx Foundation currently hosts several studies on lung cancer screening, including I-ELCAP and FAMRI. Both studies have produced seminal papers in the area of lung cancer screening.