AJRR s Level II Data Collection: Comorbidities Complications Risk Variables

AJRR s Level II Data Collection: Comorbidities Complications Risk Variables September 2017 9400 West Higgins Road, Suite 210 Rosemont, IL 60018-4975 p: 847-292-0530 f: 847-292-0531 www.ajrr.net

AJRR Level II Data Collection 2 Overview Since its inception, AJRR has outlined a process for capture of various levels of data. The first (Level I) includes procedural data (patient demographics, surgeon and hospital identifiers, procedure and diagnosis codes, and detailed implant information). The second (Level II) is designed to capture items such as patient comorbidities which will be used to risk-adjust data such as revision rates, and other surgical complications. Patient-reported outcomes (PROs) are Level III data. With the introduction of the Comprehensive Care for Joint Replacement (CJR) model in November 2015, it is clear that the Centers for Medicare & Medicaid Services (CMS) has identified risk variables and outcomes after total joint replacement as key priorities. It is imperative to have a clear understanding of those risk factors that influence postoperative outcomes. AJRR Data Elements Overview LEVEL I Patient Hospital Surgeon Name (Last, First) Date of Birth Social Security Number Diagnosis (ICD-9 and 10) Gender Ethnicity Address Name and Address Name (National Provider Identifier) Procedure Type (ICD-9 and 10) Date of Surgery Laterality Implants LEVEL II Expanded Procedural Data Patient Risk Factors/Comorbidities (ICD-9 and 10) Operative and Post-operative Complications LEVEL III Recommended measures: VR-12 PROMIS-10 Global Health HOOS, JR. and KOOS, JR. We also accept: SF-36 HOOS and KOOS Oxford Hip and Knee Scores Knee Society Knee Scoring System Harris Hip Score SF-12, EQ-5D, WOMAC (only accepting final scores)

AJRR Level II Data Collection 3 Background on Level II Risk Variables AJRR is collecting Level II data (comorbidities, risk variables, and surgical complications) in order to provide valid comparative information to hospital and surgeon participants in the Registry. Various Level I and post-operative complication data is adjusted for certain characteristics which already exist within patients prior to their joint replacement surgery. Variation in patient characteristics can substantially affect the outcomes of total joint replacement. Risk adjustment is a statistical technique used to level the playing field regarding the reporting of patient outcomes by adjusting for the differences in risk among specific patients. Risk adjustment also makes it possible to compare hospital and surgeon performance fairly. Comparing unadjusted event rates for different hospitals and surgeons would unfairly penalize those performing operations on higher risk patients (those who are sicker or have more comorbidities). In 2014, AJRR conducted a pilot program assessing participating hospitals ability to capture and submit proposed Level II data (comorbidities, lab values, prophylaxis, ASA scores, and others) to the Registry. Among a sample of 20 hospitals, lab values, prophylaxis, and beta blockers were not consistently submitted or even available in the hospital electronic health record (EHR). However, comorbidities and complications were readily submitted as those items had an associated ICD-9 code. The next step for AJRR was to take the findings from the Level II pilot program and develop a list of candidate risk variables to begin developing a risk adjustment model. Risk adjustment is a statistical technique that is used to overcome the differences between health care organizations that can influence indicator rates and distort comparisons. In the summer of 2015, AJRR convened a Risk Adjustment Task Force to identify candidate risk variables and subsequently develop a risk adjustment model examining post-operative complications. Members of this task force included those from the AJRR Data Management Committee, individuals who worked on the California Joint Replacement Registry (CJRR), and others with relevant experience. The task force identified a set of 20 must-have items for a risk model, along with 21 items to be considered at a later date. Similarly, the American Academy of Orthopaedic Surgeons (AAOS), AJRR, The Hip Society, The Knee Society, and the American Association of Hip and Knee Surgeons (AAHKS) convened a Patient-reported Outcomes Summit for Total Joint Arthroplasty on August 31, 2015. One of the Summit s main goals was to obtain consensus regarding risk variables appropriate for total joint arthroplasty performance measures. The group identified a list of must-have variables, future variables, and variables that should not be included. In some instances, the variables proposed at the Summit overlapped with AJRR s candidate risk variables (i.e., age, sex, race, ethnicity, BMI, nicotine dependence) while others such as ASA score were not included. AJRR will continue to suggest entities submit ASA scores, as its Level II pilot program found this was regularly included in the hospital s EHR and easily submitted.

AJRR Level II Data Collection 4 On November 16, 2015, CMS finalized the CJR model, set to begin on April 1, 2016. Included in the model s Final Rule was a list of candidate risk variables. The list included many of the variables already discussed by AJRR, and variables covered at the AAHKS Summit. Some variables mentioned at the Summit and in the CJR Proposed Rule were eventually removed from the Final Rule. Included variables can be found in our Required table on page 5. Submission of risk variables is a key part of the composite quality score used by CMS to link quality outcomes to payment. The composite quality score for a participant hospital is determined by performance and improvement on two quality measures as well as submission of voluntary reporting of the PRO and limited risk variable data. More information on the scoring methodology can be found on CMS.gov, and you can view any of the documents posted under the Additional Information section. Complications AJRR will be collecting complications data in order to provide valid comparative information to hospital and surgeon participants in the Registry. Complications data will allow the AJRR to provide additional metrics on the frequency of complications at the national, network, hospital, and surgeon level. We anticipate that the metrics will also allow participants to identify root causes of complications that are part of the quality initiatives of patient care and overall costs. The Hip Society and The Knee Society are the leading orthopaedic specialty organizations in the United States, and they established standardized lists of complications following THA and TKA. Whereas, the standardized list and definitions of THA complications were published in Clinical Orthopaedics and Related Research in 2015 and can be found here. The standardized list and definitions of the TKA complications were published in Clinical Orthopaedics and Related Research in 2013 and can be found here. These two publications informed the development of the AJRR Level II complications list for THA and TKA. List of Level II Data Elements to Be Collected The list of comorbidity data elements is substantial due to the comorbidities included in the Elixhauser Comorbidity Index (32 total variables) and Charlson Comorbidity Index (17 total variables). In the table on the following page, variables included in these indices are indicated with a *. While neither of these indices was included in the CJR Final Rule, AJRR felt these indices could prove beneficial for future risk adjustment efforts undertaken on behalf of the Registry. Additionally, even though the variable list is large, no additional burden should be placed on submitting institutions as AJRR is modifying the Registry technology to accept all comorbidity codes included in administrative claim forms, such as UB-04. Removing the burden to filter comorbidity codes on the AJRR requirements list eliminates a large software effort to electronically submit AJRR Level II comorbidity data.

AJRR Level II Data Collection 5 Required CMS or AJRR Pre-operative Comorbidity Data Elements and Risk Variables Required Either by CMS (for CJR) or by AJRR Admission/discharge date or length of stay Height + weight and/or body mass index (BMI) American Society of Anesthesiologists (ASA) score Pain in non-operative lower extremity joint Elixhauser and Charlson comorbidity indices Quantified spinal pain (via Oswestry Disability Index) Charnley classification Race and ethnicity Date of birth Sex Single item health literacy screening questionnaire General comorbidities Acquired immune deficiency syndrome/human Hemiplegia paralysis other paralysis* immunodeficiency virus (AIDS/HIV)* Blood loss anemia and deficiency anemia* Hyperthyroidism* Cancer, metastatic, solid tumor and lymphoma* Immunocompromised Chronic kidney disease/renal failure* Mild, moderate, and severe liver disease* Chronic pulmonary/lung disease* Obesity* Connective tissue or rheumatologic disease* Other neurological disorders* Diabetes with sequelae, diabetes uncomplicated* Peptic ulcer disease* Fluid and electrolyte disorders* Weight loss* Addictions and other mental health comorbidities Alcohol abuse* Psychoses* Dementia* Smoking status/nicotine dependence Depression/psychiatric disease* Use of chronic ( 90 day) narcotics Drug abuse (incl. opioids, hallucinogens, inhalants)* Cardiac-related comorbidities Cardiac arrhythmias * Myocardial infarction/previous cardiac condition Congestive heart failure* Valvular disease* Circulatory vascular comorbidities Cerebrovascular disease Peripheral artery and vascular disease* Coagulopathy* Pulmonary circulation disorders* Coronary artery disease Venous thromboembolism (VTE)/deep vein thrombosis (DVT) Hypertension (complicated + uncomplicated)* Variables required for Elixhauser and Charlson are indicated with a *. Data elements in yellow are required as risk variables by AJRR and/or CMS that may not be readily available in some EHR systems. As such, it will be up to each institution to determine the best method for data capture and submission to AJRR. AJRR will develop custom forms for collection of these elements as a method of manual capture if these elements are not available in the institution s EHR.

AJRR Level II Data Collection 6 Operative and Post-operative Complication Data Elements HIP and/or KNEE complications Bleeding postoperative requiring surgical treatment Wound complication Thromboembolic disease Neural deficit Vascular injury Deep periprosthetic joint infection Bearing surface wear Implant fracture Osteolysis Reoperation Implant loosening Revision Death Readmission HIP complications Dislocation/Instability Heterotopic ossification Periprosthetic fracture of the proximal femur or the acetabulum Abductor muscle disruption Cup-liner dissociation KNEE complications Instability Medial collateral ligament injury Stiffness Extensor mechanism disruption Periprosthetic fracture distal femur, proximal tibia, or patella Patellofemoral dislocation Tibiofemoral dislocation Malalignment Tibial insert dissociation Pre-operative Data Elements Not Required by CMS or AJRR Not required Variables under consideration for future editions of Level II elements Antibiotic prophylaxis + type Long term use of anticoagulants Antithrombolytics + type Marital status Beta blocker administration Presence of retained hardware Burden of arthritis on the body Presence of live-in home support, including spouse Creatinine Previous intra-articular infection HgA1c value and date Serum albumin Hemoglobin Total lymphocyte Joint range of motion in degrees Use of gait aids Kellgren-Lawrence scale Workers compensation/adverse effects of work environment For TKA patients only Anatomic angle (femorotibial angle) in degrees with varus/valgus Knee extensor strength Angular knee deformity >15 degrees/other acquired deformity of knee Previous open reduction internal fixation (ORIF) knee For THA patients only Abductor muscle strength Presence of Trendelenburg gait History of congenital hip dysplasia or other congenital hip disease Presence of angular, translational, or rotational deformities of proximal femur Previous ORIF hip

AJRR Level II Data Collection 7 Level II Data Submission Comorbidities The Level II data acquisition pilot study required that participating institutions submit patient comorbidity data based on a list of comorbidities identified by a CJRR workgroup in 2012. As such, hospital clinicians and IT staff were required to match all patient comorbidities reported in their EHR or administrative claims to the list provided by AJRR. The complexity involved in the matching required additional hospital staff and IT time to complete the report and submit the data. Based on the pilot program learnings, AJRR staff has modified the hospital specifications and Registry technology tools to accept all ICD-10-CM comorbidities reported on the administrative claims data. This both simplifies the hospitals efforts and allows AJRR to collect additional comorbidities that may impact the implants survivorship. AJRR has modified the Registry software to categorize and aggregate the reported comorbidities into groupings for reporting. In addition, the Registry s reporting and dashboard technology has been modified to utilize the grouping categories as filters allowing participants to view procedure metrics based on comorbidities. Due to the CJR Final Rule, new forms have been created allowing subscribing Registry users to manually enter data for literacy, pain in the non-operative lower extremity joint, and spinal pain. Complications The complications data fall into two groups: 1) Those that occur during the inpatient surgical encounter and 2) those that occur after discharge. AJRR anticipates that acquiring the inpatient complication data would be a low complexity workflow task since hospitals are already extracting information from the patient EHR which typically contains the complication data. Please note that sites will need to be more precise about recording this type of information as well as designating when diagnoses are present on admission. Acquiring the post-operative discharge complication data may be a complex workflow issue, similar to collecting patient reported outcomes once the patient leaves the hospital. The sources of data include the hospital and practice groups. Therefore: For acquisition of complication data from surgeons employed by and utilizing the hospital EHR system, AJRR expects that submitting complication data will be similar to submission of procedural data through the existing hospital EHR interfaces. For acquisition of complication data from private practice groups, AJRR expects that this may take one of two possible pathways: 1. Practice groups must be participants of AJRR and utilize the registry data entry forms to manually enter the complication data. 2. Development of electronic data transfer to AJRR by the practice group. Since practice groups may not have the same level of IT support afforded to hospitals, there may be few practice groups that have the capability to submit data electronically. As with post-operative outcome reporting, it is envisioned that all post-discharge complication submissions will be the responsibility of the hospital or practice group.

AJRR Level II Data Collection 8 Risk Adjustments The goal of comorbidity data collection is to ultimately risk adjust AJRR national, hospital, and surgeon reporting metrics. How Do I Learn More? For more information on AJRR s Level II comorbidity/risk adjustment analysis and data collection requirements, please contact us at (847)-292-0530 or info@ajrr.net. www.ajrr.net (847) 292-0530 info@ajrr.net 1/6/2016. Revised 9/29/2017. American Joint Replacement Registry. 9400 W. Higgins Rd., Suite 210 Rosemont, IL 60018