A New Device Character for the S-ICD System Subcutaneous Defibrillator Lead

A new device character value for character 6, “F” for “subcutaneous defibrillator lead” (for the S-ICD system), was added to Tables 0JH (Insertion), 0JP (Removal) and 0JW (Revision), effective October 1, 2019.

Although the subcutaneous implantable defibrillator (S-ICD) system, manufactured by Boston Scientific, was approved by the FDA in 2012, a device character value for the subcutaneous defibrillator lead/electrode component of the S-ICD system was not previously available. Not having a distinct device character for the subcutaneous defibrillator lead made it impossible to distinguish a subcutaneous lead from a transvenous lead.

The EMBLEM MRI S-ICD System (as it is called by the manufacturer, Boston Scientific) “is the first and only subcutaneous implantable defibrillator that provides protection for patients at risk for sudden cardiac death while avoiding risks and complications associated with transvenous leads.”

The S-ICD system is similar in function to traditional transvenous implantable cardio-defibrillators in that they both sense and convert cardiac arrhythmia via an electrical shock.

Why is it better than a conventional transvenous lead or leads?

According to the manufacturer, “The EMBLEM S-ICD System is a proven treatment option for patients at risk of sudden cardiac arrest, that leaves the heart and vasculature untouched, thus reducing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillator leads.”

The S-ICD system is comprised of two components as depicted in the image below:

• The EMBLEM MRI S-ICD Pulse Generator, and
• The EMBLEM S-ICD-Electrode (defibrillator lead)

The two components are attached together at the end of the procedure.

The EMBLEM MRI S-ICD Pulse Generator is 83.1 x 69.1 x 12.7 mm (3.27 x 2.72 x 0.5 inches) and weighs 130 grams (about 4.6 ounces).

What does “MRI” in the S-ICD’s name mean?

Boston Scientific has long manufactured a range of cardiac devices, including EMBLEM S-ICD Systems. New for 2016, the EMBLEM MRI S-ICD System U.S. Food and Drug Administration (FDA) approval for the EMBLEM™ MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted EMBLEM S-ICD Systems.

The EMBLEM MRI S-ICD System is part of Boston Scientifics line of ImageReady™ MR-conditional devices. These devices allow patients to undergo magnetic resonance imaging (MRI) safely and still be protected from cardiac arrest.

• Note: “MRI” in the name does not mean the patient will have an MRI. It means that, if or when an MRI is needed, it can be done safely.

The six new codes pertain only to the defibrillator lead and are assigned for

Insertion of a subcutaneous defibrillator lead

• 0JH60FZ Insertion of Subcutaneous Defibrillator Lead into Chest Subcutaneous Tissue and Fascia, Open Approach
• 0JH63FZ Insertion of Subcutaneous Defibrillator Lead into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach

Removal of a subcutaneous defibrillator lead

• 0JPT0FZ Removal of Subcutaneous Defibrillator Lead from Trunk Subcutaneous Tissue and Fascia, Open Approach
• 0JPT3FZ Removal of Subcutaneous Defibrillator Lead from Trunk Subcutaneous Tissue and Fascia, Percutaneous Approach

Revision of a subcutaneous defibrillator lead

• 0JWT0FZ Revision of Subcutaneous Defibrillator Lead in Trunk Subcutaneous Tissue and Fascia, Open Approach
• 0JWT3FZ Revision of Subcutaneous Defibrillator Lead in Trunk Subcutaneous Tissue and Fascia, Percutaneous Approach

The S-ICD System vs a Traditional Transvenous ICD device system- What’s the Difference?

• Pulse generator location

S-ICD System – left side of the chest next to the rib cage

Transvenous ICD- the left shoulder area, near the clavicle

• Lead(s) location

S-ICD System – subcutaneous, near the heart

Transvenous ICD – in the atrium and/or ventricle

The image below is what the S-ICD System looks like after it has been inserted. Note that the lead is not implanted in the heart. This is the major difference between the S-ICD System and a transvenous ICD device in which one or more leads are implanted in the heart.

• Coding Note: PCS codes pertaining to the Body System “Heart and Great Vessels” are not used for the subcutaneous defibrillator lead because the subcutaneous lead resides near, but not in, the heart. Be mindful of this when using an Encoder.

See Table 0JH (Subcutaneous Tissue and Fascia) for Insertion of subcutaneous defibrillator lead

See Table 02H (Heart and Great Vessels) for Insertion of cardiac defibrillator lead

Compare the S- ICD System (image above) to what a traditional ICD system looks like (image below). Note the location of the pulse generator and two leads, one into the right ventricle and one into the right atrium.

Source: https://www.medtronic.com/us-en/patients/treatments-therapies/icd-devices/implant-procedure.html

Assigning the Procedure Code(s) for the S-ICD System

Codes pertaining to the pulse generator are not new codes and are assigned with the code for the lead, or alone, depending on the procedure performed.

These codes would likely be assigned with a related code for the defibrillator lead:

• 0JH638Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach
• 0JH608Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Open Approach

These codes would be assigned either with or without a related code for the defibrillator lead:

• 0JPT0PZ Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, Open Approach
• 0JPT3PZ Removal of Cardiac Rhythm Related Device from Trunk Subcutaneous Tissue and Fascia, Percutaneous Approach
• 0JWT0PZ Revision of Cardiac Rhythm Related Device in Trunk Subcutaneous Tissue and Fascia, Open Approach

Coding Example 1. A patient presents for an insertion of an S-ICD System. The approach for the pulse generator is “subcutaneous.” Assign these codes:

• 0JH638Z Insertion of Defibrillator Generator into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach
• 0JH63FZ Insertion of Subcutaneous Defibrillator Lead into Chest Subcutaneous Tissue and Fascia, Percutaneous Approach,

Coding Example 2. A patient’s subcutaneous lead has migrated out of position and needs to be repositioned. The approach is “subcutaneous.” Assign this code:

• 0JWT3FZ Revision of Subcutaneous Defibrillator Lead in Trunk Subcutaneous Tissue and Fascia, Percutaneous Approach

For this procedure, one code is assigned for the revision of the subcutaneous defibrillator lead. There is no mention of a procedure performed on the defibrillator generator.

MS-DRG Assignment

Note that in Coding Example 1, the code for the insertion of the defibrillator generator was sequenced first as the principal procedure, followed by the code for the insertion of the subcutaneous defibrillator lead.

Using the principal diagnosis code I42.1 Obstructive hypertrophic cardiomyopathy and the procedures listed above, the case groups to DRG 227 Cardiac defibrillator implant without cardiac catheterization without MCC.

• If the code for the defibrillator lead was assigned as the first-listed procedure, the case would still group to DRG 227
• The new device character “subcutaneous” does not affect or influence the DRG assignment

Indications for an S-ICD System

Hypertrophic cardiomyopathy (HCM)

Patients with hypertrophic cardiomyopathy (HCM) are candidates for cardiac defibrillators due to the risk of this condition leading to life-threatening ventricular tachyarrhythmia and sudden cardiac death. We sometimes hear about seemingly healthy adolescents and young adults succumbing to sudden cardiac death, later found to be due to HCM. HCM may be diagnosed on an echocardiogram with findings of left ventricular end diastolic wall thickness >13 mm. HCM affects people of any age and has no distinct pattern of sex or ethnicity.

Below is an image depicting a normal heart in comparison to a heart with non-obstructive HCM. Note the differences in the size and thickness of the left ventricle in the heart with HCM.

“Obstructive” HCM refers to HCM with left ventricular outflow obstruction. Patients with obstructive HCM may also have mitral valve stenosis – note the location of the mitral valve, between the left ventricle and left atrium and atrial fibrillation or other types of arrhythmias.

HCM Diagnosis Coding

All of the diagnosis codes in code category I42 Cardiomyopathy are Major Complication/Comorbidity codes (MCC’s). Let’s consider the codes for “cardiomyopathy” diagnoses (Dx), as assigned beginning with the Index:

• Dx “Congenital cardiomyopathy” is assigned to 4 Endocardial fibroelastosis (MCC). The term “obstructive” is not included in this diagnosis. This is a rare heart disorder affecting infants and children.
• Dx “Obstructive hypertrophic cardiomyopathy” is assigned to 1 Obstructive hypertrophic cardiomyopathy (MCC).
• Dx “Congenital obstructive hypertrophic cardiomyopathy” is assigned to 8 Other specified congenital malformations of heart (code Q24.8 is not an MCC or Comorbidity/Complication CC).

According to the American Heart Association, congenital obstructive hypertrophic cardiomyopathy is an inherited disorder caused by gene mutations in the heart muscle proteins. Non-congenital hypertrophic cardiomyopathy may be caused by hypertension, diabetes or thyroid disease.

• Coding Note: Review the documentation and query the provider if the diagnosis “obstructive hypertrophic cardiomyopathy” is not clearly and definitively documented as non-congenital or congenital to support either 1 Obstructive hypertrophic cardiomyopathy (MCC) or Q24.8 Other specified congenital malformations of heart (not an MCC or CC). Either code reported as a secondary diagnosis code may affect the MS-DRG assignment.
• Coding Note: If the provider documents “congenital cardiomyopathy,” a query is recommended to clarify and document whether the patient has “obstructive” congenital cardiomyopathy. As noted, congenital cardiomyopathy is a rare disorder affecting infants and children. Again, be mindful of the Encoder pathway when assigning these codes.

An S-ICD system may also be indicated for patients who have had

• an episode of or high risk of having sudden cardiac arrest or cardiac death,
• an episode of ventricular tachycardia,
• an episode of ventricular fibrillation, and/or
• a myocardial infarction

Cooper University Health Care, Camden NJ, was the first hospital in South Jersey to offer and perform the S-ICD System. This YouTube video (run time 4:20) provides a good overview of the patient/physician relationship and why the S-ICD System was selected for this particular patient who was diagnosed with hypertrophic cardiomyopathy.

Next, here is a YouTube video (run time 1:35) animation of an S-ICD System implant procedure provided by Boston Scientific:. In this animation, a “three incision technique” is used to implant the S-ICD defibrillator generator and the subcutaneous lead. Physicians are advised to start out with the three incision technique before performing the implant procedure using the “two incision” technique. The feasibility of using a “single incision” technique is under study.

• The number of incisions does not affect code assignment.

Much more information about the S-ICD System can be found on the Boston Scientific website, including PCS and CPT codes.

Summary

• A new device character value for character 6, “F” for “subcutaneous defibrillator lead” (for the S-ICD system), was added to Tables 0JH (Insertion), 0JP (Removal) and 0JW (Revision), effective October 1, 2019.
• According to the manufacturer, Boston Scientific, “The EMBLEM S-ICD System is a proven treatment option for patients at risk of sudden cardiac arrest, that leaves the heart and vasculature untouched, thus reducing the risk of complications associated with conventional transvenous implantable cardioverter-defibrillator leads.”
• The S-ICD system is similar in function to traditional transvenous implantable cardio-defibrillators in that they both sense and convert cardiac arrhythmia via an electrical shock.
• The S-ICD system is comprised of two components:
  • The EMBLEM MRI S-ICD Pulse Generator, and
  • The EMBLEM S-ICD-Electrode (defibrillator lead)
• Codes pertaining to the pulse generator are not new codes and are assigned with the code for the lead, or alone, depending on the procedure performed.
• “MRI” in the name does not mean the patient will have an MRI. It means that, if or when an MRI is needed, it can be done, and done safely.
• Patients with hypertrophic cardiomyopathy (HCM) are candidates for cardiac defibrillators due to the risk of this condition leading to life-threatening ventricular tachyarrhythmia and sudden cardiac death.
• Carefully review and query, if necessary, obstructive HCM documentation to clarify if the HCM is congenital or non-congenital.

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