Welcome, and thank you for viewing this on-demand session of the 2020 ACC Quality Summit. In this presentation, we will be discussing the LAAO Registry follow-up process. My name is Fernando Garcia Barbón. I am a Clinical Quality Advisor for the Registry. The objectives for this session include to identify the Registry's requirement, rationale, and purpose for follow-up, describe follow-up intervals and the different date ranges, identify one resource tool available to assist with tracking patients due for follow-up, and to select one practice process utilized for improving follow-up data capture. What are the follow-up requirements from the Center of Medicare & 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-year, 2-year, 3-year, and 4-year. 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 will be gathered 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 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 I use 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 from any visit to another provider, including electrophysiologist, cardiologist, primary care provider, or gastroenterologist, a hospitalization, a visit to the emergency department, a diagnostic procedure, a phone call, or video chat. 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 Canceled and aborted procedures only require a 45-day follow-up. The data collection 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. The follow-up intervals that facilities will be responsible for are 45-day, 6-month, 1-year, and 2-years. 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 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 from day 1 to day 91 will be submitted but will receive an outlier error when submitted. An outlier error 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 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. Within 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 minus 30 days, which gives us a time window from day 150 to day 240 post-procedure. The follow-ups that fall outside of the registry's recommended time window but inside of the total follow-up window will receive an outlier error when submitted. An outlier error will not prevent submission of the follow-up and if the date 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 the 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 will receive an outlier error when submitted. An outlier error will not prevent submission of the follow-up and if the date assessment coded is the correct date, no changes will have to be made. The system 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, and a 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 error when submitted. An outlier error 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 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 the follow-up date range. 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 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 when the assessment date coded is within the follow-up interval's date range, but outside of the registry recommended time window. 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 will also remind the abstractor of the registry recommended time window of 45 days plus and minus 14 days. We will now move on to coding the patient's follow-up status. Follow-up status is found in sequence 13015. The choices in this element are alive, deceased, or lost to follow-up. The first choice of the element is coding the patient as alive. The patient will be coded as alive if the patient was alive at the time of the follow-up assessment being captured. The second choice of the element is coding the patient as deceased. The patient will be coded as deceased if the patient expired after hospital discharge from the index LAAO procedure or at any time within the follow-up period. But when do we capture a deceased patient? If the patient expires after hospital discharge or after any follow-up assessment that has already been performed, the patient will be coded as deceased on the next follow-up interval. For example, if the patient expires between the time of hospital discharge and the 45-day follow-up, the patient's death will be captured on the 45-day follow-up. For example, if the patient expires between the time of the 45-day follow-up assessment and the 6-month follow-up, the patient's death will be captured on the 6-month follow-up. Let's go through the most common error generated when coding a patient as deceased, which is system alert and selection error 6625. This error will be assigned when the follow-up assessment date coded is not within the follow-up date range of the interval selected. We will discuss this error using a case scenario. We have documentation of a 65-year-old female patient who underwent a successful LAAO procedure in which a Watchman device was implanted on September 30, 2019. The patient had their 45-day follow-up at the clinician's office on November 19, 2019, which fell at day 50 post-procedure. The patient was readmitted to the hospital with pneumonia 30 days after their 45-day follow-up. The patient expired while in the hospital 87 days post-procedure due to complications from the pneumonia. The patient's date of death was December 26, 2019. Let's keep in mind that the patient's 45-day follow-up was already captured in the data collection tool, and the patient's death will be coded on the 6-month follow-up. When coding the patient's 6-month follow-up, what date should be coded as the assessment date? Our choices are 1. The actual date of death, which is December 26, 2019 2. The planned date for a 6-month follow-up, which is February 27, 2020 3. Any date within the 6-month follow-up date range, which for the sake of this scenario will use February 10, 2020 And the answer is both, 2 and 3. They are both correct choices based on the fact that they are both within the 6-month follow-up date range. February 27 falls 150 days post-procedure and February 10, 2020 falls 133 days post-procedure. If the actual date of death is used as the 6-month follow-up assessment date, the system will generate error 6625 as the date coded is still within the 45-day follow-up date range, specifically 87 days post-procedure, and not within the 6-month follow-up date range. The third choice of the element is coding the patient as lost to follow-up. The patient will be coded as lost to follow-up if the patient could not be reached for a follow-up or refuses to take part of the follow-up process. A quick reminder, in order to code a patient as lost to follow-up, there must be at least one documented attempt to reach the patient. If the patient is being coded as lost to follow-up based on their refusal to be part of the follow-up process, there must be also documentation of the patient's refusal. Let's now go through the coding of medications during the follow-up period. Follow-up medications are captured in sequence 13.1.10 to 13.1.17, and medication changes are captured in sequence 13.1.20 to 13.4.15. Sequence 13.1.10 to 13.1.17 will be coded based on the medications the patient was actively taken at the time of the follow-up assessment. In this case, a 6-month follow-up is being captured, and the patient was taken aspirin 325 mg as well as Plavix 75 mg daily at the time of the assessment. Sequence 13.1.20 to 13.4.15 will be used to capture any anticoagulation or antiplatelet medication changes that took place since the last follow-up. In this case, a 6-month follow-up is being captured. The patient's warfarin was discontinued and changed for Plavix during the patient's 45-day follow-up, which took place on February 20, 2020. Therefore, the medication change taking place during the 45-day follow-up will be captured on the 6-month follow-up. To better understand the coding of medication changes during the follow-up period, we will go through a couple of case scenarios. In our first case scenario, we have documentation on Mrs. Smith. Mrs. Smith had a successful LAAO Watchman procedure on December 20, 2019. She was discharged home from the hospital on warfarin and aspirin 81 mg daily. Mrs. Smith had a follow-up TEE performed on February 5, 2020, which showed a good seal with no device margin residual leak. She was seen by the implanting physician for her 45-day follow-up on February 10, 2020. During Mrs. Smith's follow-up assessment, warfarin was discontinued. Her aspirin dosage was increased to 325 mg and Plavix 75 mg was started. When coding Mrs. Smith's 45-day follow-up, the assessment date will be coded as February 10, 2020, and the follow-up interval will be coded as the 45-day follow-up. When coding the follow-up medications, we have to remember we are capturing the medications which the patient was actively taken at the time of the assessment. In the case of Mrs. Smith, she was taken aspirin 81 mg and warfarin. When coding the follow-up anticoagulation therapy section, we are capturing any change that might have taken place from the time of the last follow-up or hospital discharge to the follow-up being coded. In this case, based on the documentation, nor warfarin nor aspirin were discontinued or held between the time of the hospital discharge and the 45-day follow-up assessment. Based on this fact, we will code warfarin discontinued and resumed as no. We will also code aspirin discontinued and resumed also as no. The rest of the medications will also be coded as no as they were not started or discontinued during this time window. Mrs. Smith continues to have a great recovery from her LAAO procedure. She is seen by her cardiologist in his office for her 6-month follow-up on June 10, 2020. Based on documentation, Mrs. Smith has had no adverse events or readmissions since her 45-day follow-up. During the assessment, Plavix is discontinued, but aspirin is continued with no changes to dosage. When coding Mrs. Smith's 6-month follow-up, the assessment date will be coded as June 10, 2020, and the follow-up interval will be coded as the 6-month follow-up. When coding the follow-up medications, we have to remember we are capturing the medications which the patient was actively taking at the time of the assessment. In the case of Mrs. Smith, she was taking aspirin 325 mg and Plavix. When coding the follow-up anticoagulation therapy section, we are capturing any change that might have taken place from the time of the last follow-up, which was the 45-day follow-up, to the follow-up being coded. In this case, based on the documentation, warfarin was discontinued during the 45-day follow-up, which will be captured by coding Yes to warfarin discontinued with the date of the 45-day follow-up, which is the date in which warfarin was really discontinued. Warfarin resumed will be coded as No, as based on documentation, warfarin was never resumed after being discontinued. We will also code aspirin discontinued and resumed as No. Since aspirin was never discontinued, the dosage was just changed. The rest of the medications will also be coded as No, as they were not started or discontinued during this time window. For those of us wondering when the discontinuation of Plavix will be captured, it will be captured on Mrs. Smith's 1-year follow-up. When coding the follow-up anticoagulation therapy section, the discontinuation of Plavix will be coded by coding Yes to P2Y12 discontinued with the date of the 6-month follow-up. If the Plavix or any other P2Y12 was not restarted, P2Y12 resumed will be coded as No. Let's look at another case scenario. In our second case scenario, we have documentation of Mr. Sanders. Mr. Sanders had a successful LAAO Watchman procedure on November 15, 2019. He was discharged home from the hospital on apixaban and aspirin 81 mg daily. Two weeks post-procedure, Mr. Sanders had to be readmitted with an episode of GI bleeding. His readmission date was November 28, 2019. During the hospitalization, Mr. Sanders received 2 units of PacRev blood cells and his apixaban was held from November 28 to December 2, 2019. He was seen by his implanting physician for his 45-day follow-up on December 21, 2019. During Mr. Sanders' follow-up assessment, apixaban was discontinued. His aspirin dosage was increased to 325 mg and Plavix 75 mg was started. When coding Mr. Sanders' 45-day follow-up, the assessment date will be coded as December 21, 2019 and the follow-up interval will be coded as 45-day follow-up. When coding the follow-up medications, we have to remember we are capturing the medications which the patient was actively taken at the time of the assessment. In the case of Mr. Sanders, he was taken aspirin 81 mg and apixaban. When coding the follow-up anticoagulation therapy section, we are capturing any change that might have taken place from the time of the last follow-up or hospital discharge to the follow-up being coded. In this case, based on the documentation and the patient's GI bleeding event, apixaban, which is a DOAC medication, was discontinued on November 28 and restarted on December 2, 2019. Based on this knowledge, we will code DOAC discontinued as yes with the date in which it was stopped and DOAC resumed as yes also with the date in which it was resumed or restarted. Just a little note, if the medication was never restarted, this will be coded as no. We will code aspirin discontinued and resumed as no since based on the documentation, aspirin was never discontinued or held. The rest of the medications will also be coded as no as they were not started or discontinued during this time window. Follow-ups are also measured in metrics. The follow-up metrics provided to participating hospitals based on their submitted data are divided into quality and informational data metrics. The timing when the follow-up data were submitted may impact a metric depending on what the unique metric is reporting. As you review your metrics, note some of the metrics will only include patients who had their follow-up assessments performed within the registry recommended time window. Other metrics will include patients who had their follow-up assessment performed at any point outside of the recommended time window. And others will include performance based on follow-up data captured at any time during the entire follow-up window. This includes the registry recommended time window as well as anything outside of that window. When reviewing your follow-up metrics, it is good to note that reading the metric description will indicate which follow-ups are included in the metric. For example, metric 211 will include all procedures in the denominator that were illegible for a follow-up. Metric 200, as described, will include only procedures where the patient had a 45-day follow-up performed within the registry recommended time window. And metric 202, 203, and 204 will include procedures where the patient had an event from the procedure date through the follow-up insight window. In this case, since these are 45-day follow-up metrics, it's day 59 post-procedure. Please take advantage of the resources available in the registry's homepage. For detailed information of all follow-up timeframes and date ranges, please download the follow-up timeframe and guide document. The document is located under the Resources tab, Documents, and is part of the Version 1.3 data collection documents. This presentation, as well as many others, will also be available to review at your convenience on the Quality Improvement for Institutions or QII Learning Center, which is located under the Resources tab and Learning Center. There are also tools and ways to track patients during the follow-up period. The first are ways to confirm if a patient has had a follow-up entered in the system. To use this functionality, we must access the data collection tool, which is located under the Data tab. Once in the data collection tool, we must choose Follow-up Search and Edit from the menu. Once in the follow-up management page, you may search for a specific patient by entering any of their identifiers and clicking on the Search tab. The system also allows to search using date ranges. You may use the procedure date as well as follow-up date ranges. When a date range has been entered, the system will display the patients who had a procedure or a follow-up entered within the range. You may also enter a range and search which patients do not have a follow-up entered by selecting No Follow-up. Follow-ups within a specific quarter can be searched by clicking on the Follow-up Timeframe drop-down menu and selecting a specific quarter. Several participants have shared tracking tools that have been successful in keeping track of their patients during the follow-up process. These tools are available to all participants on the Participant Resource Sharing functionality. The Participant Sharing functionality is located under the Resources tab and Participants Resource Sharing. Here are several tips to have a successful follow-up process. If there is an LAO coordinator in your facility, ensure collaboration to align pre-procedure and follow-up processes. Communication and follow-up process with clinicians and their representatives is very important. Utilize a tracker-type document such as the one under Participants Resource Sharing and share in a location where the whole team can access. Review the follow-up plan with the patient as part of their discharge instructions. Set up a 45-day TEE and office visit as part of the patient's discharge and explore utilizing phone call for follow-up information as applicable based on clinician and patient agreement. That concludes this ACC Quality Summit On-Demand session on understanding the LAO Registry follow-up process. This presentation will also be housed in the QII Learning Center and will be accessible to all our participants in the near future. Thank you for your participation.

LAAO Registry

follow-up process

CMS

intervals

coding patient status

tracking patients