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.