SLIDE 1 New ICD-10-PCS Codes for Minimally Invasive Cardiac Surgery Francis Duhay, MD, MBA Chief Medical Director & Vice President, Medical and Clinical Affairs Edwards Lifesciences ICD-10 Coordination & Maintenance Committee Meeting September 23, 2014 SLIDE 2 Clinical Background: Valvular Heart Disease * Background - Heart failure affects 5.7 million Americans, and is leading cause of death, disability and impaired quality of life (QOL)1 - Valve disease leads to heart failure * Aortic Valve Disease - Aortic valve disease classified as stenosis (AS) or regurgitation (AR) - Medicare Population Prevalence2 - AS: 1.3% to 2.8% - AR: 1.0% to 2.0% - AS and AR are insidious with prolonged latent periods - Onset of HF symptoms, however, heralds 50% mortality at 2 years3 * Mitral Valve Disease - Mitral valve disease classified as stenosis (MS) or regurgitation (MR) - Medicare Population Prevalence2 - MS: 0.2% - MR: 6.4% to 9.3% SLIDE 3 Traditional Heart Valve Surgery * Aortic Valve Replacement (AVR) 1. General anesthesia 2. Chest incision 3. Cross clamp 4. Heart-lung machine 5. Excise diseased valve 6. Implant prosthetic valve * Mitral Valve Replacement and Repair (MVR) - Surgical Mitral Valve Replacement - Similar to AVR, but valve is not excised; prosthetic valve sewn within diseased valve - Surgical Mitral Valve Repair - Similar to AVR, but valve is not excised; preserved using a variety of repair techniques Slide 4 Minimally Invasive Cardiac Valve Surgery Advances The Standard of Care * Traditional cardiac surgery involves a full sternotomy that requires an 8-10 inch incision to split the entire breastbone * Two primary minimally Invasive Cardiac Surgery (MICS) techniques: - Mini-Sternotomy - Right Thoracotomy *MICS techniques, use an incision of up to 6 inches. Only the mini-sternotomy requires a dissection of the breastbone Slide 5 Unlike Traditional Sternotomy, MICS Uses Smaller Incisions to Access Diseased Valves * Traditional Sternotomy - Sternum is divided with a 8 to 10 inch incision * Mini-Sternotomy4 - Aortic: Four to five inch J-shaped, partial division of the sternum that is extended to the 3rd or 4th right intercostal space (ICS). - Mitral: Four to five inch incision and division of the sternum from the xiphoid process to the 2nd left ICS. * Right Thoracotomy4 - Aortic: A four to six cm incision in the 3rd right ICS (location may vary by patient). - Mitral: A small incision in the 4th or 5th right ICS. - The sternum is not divided. - The operative field is smaller and typically requires the placement of cannulae outside of the operative field and use of long shafted surgical instruments. MICS = Minimally Invasive Cardiac Surgery Slide 6 MICS Offers Important Benefits Over Traditional Cardiac Surgery * Benefits of MICS include5,6: - Fewer peri-operative deaths - Reduced tissue trauma - Less blood loss - Shorter recovery time - Shorter hospital stays MICS = Minimally Invasive Cardiac Surgery Slide 7 Clinical Benefits: Open vs. Minimally Invasive * Cardiac Events - Atrial fibrillation (23.5% vs. 24.7%) – Equivalent - Pacemaker implant (3.3% vs. 4.0%) – Equivalent - Myocardial infarction (0.4% vs. 0.7%) – Equivalent - Pericardial effusions (7.0% vs. 2.6%) – Equivalent * Hematological transfusions (36.0% vs. 52.4%) – MICS Lower * ICU days (-0.60 days*) – MICS Lower * LOS (-1.34 days*) – MICS Lower * Neurological events (2.2% vs. 2.2%) – Equivalent * Peri-operative deaths (1.9% vs. 3.3%) – MICS Lower * Pulmonary events - Pneumonia (3.6% vs. 2.9%) – Equivalent - Pleural effusion (8.4% vs. 4.6%) – Equivalent - Sternal infection (0.9% vs. 1.5%) – Equivalent - Pneumothorax (4.7% vs. 2.2%) – Equivalent - Pain scores (-0.87 points**) – Equivalent * Renal failure (2.5% vs. 4.2%) – MICS Lower * Respiratory failure (3.6% vs. 5.3%) – MICS Lower * Reoperations for bleeding (4.7% vs. 4.9%) – Equivalent MICS = Minimally Invasive Cardiac Surgery ICU = Intensive Care Unit LOS = Length of Stay **Weighted Mean Difference Slide 8 MICS In the Medicare Population * Based on internal data sources, an estimated 20 to 25 percent of procedures are minimally invasive. * MICS procedure are complex, requiring additional training and experience. - MICS techniques require training to perform the valve surgery under decreased visualization. Fundamental MICS skills include using: - Specialized cannulation techniques - Neck lines - Long-shafted instruments - Not all surgeons are performing MICS, and those that do should have experience in traditional valve surgery * The inability to run claims-based analyses using International Classification of Diseases, Ninth Revisions, Clinical Modification (ICD-9-CM) procedure codes limits the ability to determine the number of MICS procedures. MICS = Minimally Invasive Cardiac Surgery Slide 9 Coding Rationale Slide 10 Current Coding Does Not Capture MICS Techniques * Current ICD-9-CM procedure codes only differentiate between open and closed procedures. - 35.22 (open and other replacement of aortic valve) - 35.24 (open and other replacement procedures of mitral valve) * Draft ICD-10-PCS codes only expand ICD-9-CM procedure codes by differentiating between valves and not approach. MICS = Minimally Invasive Cardiac Surgery ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification ICD-10-PCS = International Classification of Diseases, Tenth Revision, Procedure Code System Slide 11 A Lack of Unique Coding Complicates Tracking and Monitoring MICS Procedures * An estimated 20 to 25 percent of procedures are minimally invasive. - The lack of specific coding in ICD-9 for MICS makes it difficult to determine the precise volume of MICS procedures being performed. - Insufficient coding also prevents robust and health economic analysis of MICS. * MICS’ clinical and resource requirement differences from the traditional open sternotomy make the MICS distinct and unique procedures that should be uniquely identified and clearly reported. ICD-9 = International Classification of Diseases, Ninth Revision MICS = Minimally Invasive Cardiac Surgery Slide 12 Draft ICD-10-PCS Coding For Percutaneous Heart Valve Procedures Uses Qualifiers * Qualifiers are used to identify different techniques for an approach. - ICD-10-PCS uses a qualifier to identify transapical percutaneous procedures. Section: 0 Medical and Surgical Body System: 2 Heart and Great Vessels Operation: R Replacement: Putting in or on biological or synthetic material that physically takes the place of and/or functions of all or a portion of a body part Body System/Region: F Aortic Valve Approach: 3 Percutaneous Device: 7 Autologous Tissue Substitute, 8 Zooplastic Tissue, J Synthetic Substitute, K Nonautologous Tissue Substitute Qualifier: Z No qualifier, H Transapical ICD-10-PCS = International Classification of Diseases, Tenth Revision, Procedure Code System Slide 13 Qualifiers May Be Used To Identify MICS Techniques * Two new qualifiers could be established for use with open aortic and mitral valve replacement, repair, and removal MICS = Minimally Invasive Cardiac Surgery Slide 14 Unique Codes Necessary For MICS Techniques * MICS techniques are closely linked to the traditional open approach, but are unique procedures. * Draft ICD-10-PCS codes do not capture these distinct procedures because they maintain the pitfalls of current ICD-9-CM procedure codes. - Only differentiates between open and closed procedures. - Puts unique procedures into a catch-all bucket, which CMS has stated that it aims to reduce in ICD-10. * The differences in clinical and resource requirements from traditional open valve surgery make MICS techniques distinct and unique procedures that should be more easily identified and reported. MICS = Minimally Invasive Cardiac Surgery ICD-9-CM = International Classification of Diseases, Ninth Revision, Clinical Modification ICD-10-PCS = International Classification of Diseases, Tenth Revision, Procedure Code System Slide 15 References 1. American Heart Association. What is Heart Failure? Answers by heart. Online. Accessed Aug 11 2014. http://www.heart.org/idc/groups/heart-public/@wcm/@hcm/documents/downloadable/ucm_300315.pdf. 2. Nkomo, VT, et al. Burden of valvular heart diseases: a population-based study. Lancet 2006; 368: 1005-11. 3. Otto, CM. Timing of Aortic Valve Surgery. Heart 2000; 84(2):211-8. 4. Malaisrie, SC. Er al. Current era minimally invasive aortic valve replacement: Techniques and practice. J Thoac Cardiovasc Surg 2014; 147:6-14. 5. Phan. K. Et al. A Metal-Analysis of Minimally Invasive Versus Conventional Sternotomy for Aortic Valve Replacement. Ann Thorac Surg 2014;05.060. 6. Bonacchi M, et al. “Does Ministernotomy Improve Postoperative Outcomes in Aortic Valve Operation? A Prospective Randomized Study”. Ann Thorac Surg 2002;73:460-6.