Welcome to lesson number one of this learning activity titled Understanding the LAAO Registries Follow-up Process. The content in this lesson was developed and narrated by myself, Fernando Garcia Barbón. The objectives for lesson number one of Understanding the LAAO Registry Follow-up Process include to identify the registry's requirement, rationale, and purpose for follow-up, and to describe follow-up intervals and the different date ranges. What are the follow-up requirements from the Center for Medicare and Medicaid Services National Coverage Determination and the LAAO Registry? Follow-up and longitudinal patient outcome tracking is required by the CMS National Coverage Determination. The follow-up intervals required for the purpose of the LAAO Registry are 45-day, 6-month, 1, 2, 3, and 4 years. Hospitals will only be responsible for submitting follow-up data for the 45-day, 6-month, 1-year, and 2-year intervals. The 3rd and 4th year follow-up data will be the responsibility of the registry and CMS and gather through Medicare claims. What is required during each follow-up assessment? The LAAO Registry does not require labs or diagnostic studies to be performed for any given follow-up assessment. The assessments, labs, and diagnostic studies performed during a follow-up will be at the discretion of the provider or the facility protocol. Individual providers or facilities may have their own protocols of what is evaluated at each follow-up, based on device selection and directions for use. All elements are provided in the data collection tool for the convenience of the practitioner to identify which labs or imaging studies were performed. If an assessment listed in the data collection tool was not performed, it may be coded as not drawn, no, or not administered. What assessments can be used to code a patient's follow-up? In the absence of a follow-up assessment performed by the implanting physician, information for coding a follow-up can be obtained in many ways. You can use any visit to another provider, including an electrophysiologist, cardiologist, or a primary care physician, a hospitalization, a visit to the emergency department, a diagnostic procedure including a TEE or TTE, a phone call, or a video chat assessment. The method in which the follow-up information was gathered will be captured in Sequence 13005 to 13011, Methods to Determine Status. The element is all that apply and multiple methods can be chosen. Some important follow-up reminders are cancelled and aborted procedures will only require a 45-day follow-up. The data collection follow-up form is the same for all follow-ups. Only one follow-up record should be entered per patient for each specific time frame on each procedure. And the follow-up intervals that facilities will be responsible for are 45-day, 6-month, 1-year, and 2-year follow-ups. As discussed in the previous slides, the follow-up period consists of four follow-up intervals. The first follow-up interval is the 45-day follow-up. For the 45-day follow-up, the system allows a window from day 1 to day 91 from the date of the procedure to perform a 45-day follow-up. Within the registry's 45-day follow-up complete date range, the registry's recommended time window for a 45-day follow-up is 45 days plus and minus 14 days, which will give us a range from day 31 to day 59 post-procedure. Follow-ups that fall outside of the recommended time window, but inside of the total follow-up window, which is from day 1 to day 91 post-procedure, will be able to be submitted, but will receive an outlier warning once submitted. An outlier warning will not prevent submission of the follow-up, and if the date of assessment coded is the correct date, changes will have to be made. The system only allows for one follow-up submission per time period. If the 45-day follow-up window is missed, any follow-up performed after 91 days post-procedure will be considered a 6-month follow-up by the system, and a 45-day follow-up submission will not be able to be added. For the 6-month follow-up, the system allows a window from day 92 to day 256 from the date of the procedure to perform a 6-month follow-up. In the registry's 6-month follow-up complete date range, the registry's recommended time window for a 6-month follow-up is 180 days plus 60 days and minus 30 days, which gives us a time window from day 150 to day 240 post-procedure. Follow-ups that fall outside of the registry's recommended time window, but inside of the total follow-up window, will receive an outlier warning when submitted. An outlier warning will not prevent submission of the follow-up, and if the date of assessment coded is the correct date, no changes will have to be made. The system only allows for one follow-up submission per time period. If the 6-month follow-up window is missed, any follow-up performed after 256 days post-procedure will be considered as a 1-year follow-up by the system, and a 6-month follow-up submission will not be able to be added. For the 1-year follow-up, the system allows a window from day 257 to day 548 from the date of the procedure to perform a 1-year follow-up. Within the registry's 1-year follow-up complete date range, the registry's recommended time window for a 1-year follow-up is 365 days plus and minus 60 days, which gives us a time window from day 305 to day 425 post-procedure. Follow-ups that fall outside of the recommended time window, but inside of the total follow-up date range, which is from day 257 to day 548 post-procedure, will receive an outlier warning when submitted. An outlier warning will not prevent submission of the follow-up, and if the date of assessment coded is the correct date, no changes will have to be made. The system only allows for one follow-up submission per time period. If the 1-year follow-up window is missed, any follow-up performed after 548 days post-procedure will be considered as a 2-year follow-up by the system. Any 1-year follow-up submission will not be able to be added. For the 2-year follow-up, the system allows a window from day 549 to day 913 from the date of the procedure to perform a 2-year follow-up. Within the 2-year follow-up complete date range, the registry's recommended time window for a 2-year follow-up is 730 days plus and minus 60 days, which will give us a range from day 670 to day 790 post-procedure. Follow-ups that fall outside of the recommended time window, but inside of the total follow-up window, will receive an outlier warning when submitted. An outlier warning will not prevent submission of the follow-up, and if the date of assessment coded is the correct date, no changes will have to be made. The system only allows for one follow-up submission per time period. If the 2-year follow-up window is missed, any follow-up performed after 913 days post-procedure will not be able to be added. Not following the follow-up date ranges can result in errors and warnings that may affect the submission of follow-up data. The following slides are going over errors and outlier warnings that are generated by the system when the error is related to follow-up date ranges. The first is Selection Error 6620. This error will also cause a system alert and prevent submission. Error 6620 is assigned by the system when the assessment date coded is not within the complete date range nor the registry recommended time window of the interval coded in Sequence 13001. For example, in the slide we have a base procedure that took place on September 30, 2019. The follow-up being entered is coded as being performed on January 5, 2020, and the follow-up interval is coded as the 45-day follow-up. When performing a quality check, the system will alert the abstractor of the error with an explanation of what has caused it. The explanation will alert the abstractor that the assessment date entered as January 5, 2020, for a procedure which took place on September 30, 2019, is 97 days post-procedure, which is completely outside of the date range allowed for a 45-day follow-up, which is from day 1 to day number 91 post-procedure. The other is Outlier Warning 6185. This warning will not cause a system alert and will not prevent submission. Outlier Warning 6185 is assigned by the system when the assessment date coded is not within the registry recommended time window, but is within the complete follow-up date range of the interval coded in Sequence 13001. For example, in the slide we have a base procedure that took place on September 30, 2019. The follow-up being entered is coded as being performed on December 21, 2019, and the follow-up interval is coded as the 45-day follow-up. When performing a quality check, the system will alert the abstractor of the warning with an explanation of what has caused it. The explanation will alert the abstractor that the assessment date entered as December 21, 2019 is outside of the registry recommended or usual 45-day follow-up time window for a procedure which took place on September 30, 2019. It would also remind the abstractor of the registry recommended time window of 45 days plus and minus 14 days, which is from day 31 to day 59 post-procedure. This concludes Part 1 of 3 of Understanding the LAAO Registry Follow-up Process. Thank you for your participation.

LAAO Registry

Follow-up Process

Intervals

CMS National Coverage Determination

Patient Outcome Tracking