Knowledge Base Article

On November 21, 2018, CMS issued Transmittal 211 regarding revisions made to the Implantable Cardiac Defibrillator (ICD) National Coverage Determination (NCD 20.4) through a February 15, 2018 Final Decision Memo. Transmittal 211 indicated the revisions effective date was February 15, 2018 and the implementation date was to be February 26, 2019.

New Implementation Date: March 26, 2019

Almost two weeks ago on February 15th, CMS rescinded Transmitted 211 and replaced it with Transmittal 213. The only change made in the Transmittal was to change the implementation date from February 26, 2019 to March 26, 2019 (for MAC local edits). All other information remained the same.

Summary of Significant NCD Revisions

The delay in implementation affords providers an opportunity to make last minute adjustments to their systems and/or provide additional education to key stakeholders to ensure compliance with the NCD revisions. Following is a summary review of the significant changes in the NCD revision:

• MRI has been added to the list of imaging studies that can be performed to evaluate left ventricular ejection fraction (LVEF);
• At least three months of Optimal Medical Therapy (OMT) is a new requirement for patients who have severe non-ischemic dilated cardiomyopathy and no personal history of sustained ventricular tachyarrhythmia or cardiac arrest due to ventricular fibrillation;
• A Shared Decision Making (SDM) interaction must happen prior to ICD implantation for certain patients. (Note: This includes all patients receiving an ICD for primary prevention);
• The Class IV heart failure requirement for cardiac resynchronization therapy (CRT) has been removed,
• An exception to the waiting period has been added for patients meeting CMS coverage requirements for cardiac pacemakers, and who meet the criteria for an ICD;
• An exception to the waiting period has also been added for patients with an existing ICD and qualifying replacement; and
• There is no longer a data collection requirement (e.g. a registry).

Additional information about the NCD Revisions and Effective and Implementation dates can be found in related Wednesday@One articles (http://mmplusinc.com/news-articles/item/ncd-20-4-implantable-cardiac-defibrillators-icds and http://mmplusinc.com/news-articles/item/effective-dates-of-new-icd-ncd-rules).

Implantable Automatic Defibrillator – Coding and Billing Local Coverage Article

CMS A/B MACs have been instructed to implement the NCD at the local level. At the time information for this article was compiled, all but two MACs (WPS and CGS) had posted or announced their plan to post an Implantable Automatic Defibrillator – Coding and Billing Local Coverage Article. The following table provides links to the currently available Future Articles.

The Articles provide coding and billing instructions for the implementation of NCD 20.4, including the ICD-10-CM codes that must be billed for the now six covered indications. In addition to meeting one of the covered indications, there are additional criteria that must be met. The first one being, “patients must be clinically stable (e.g., not in shock, from any etiology).” Indications 2, 3 and 4 are for patients with a low LVEF (≤ 30 or ≤ 35%). Per the Coverage Articles, one of the heart failure codes in the following table must be billed.

Note this list of heart failure ICD-10-CM codes does not include I50.9 Heart failure, unspecified. From auditing records, physicians still have a tendency to document congestive heart failure without further clarification and CDI Professionals in turn continue to query to clarify the type of congestive heart failure. Without the clarification, unspecified heart failure would not meet the coding requirement outlined in the coverage article.

The next issue that raised a question for me was the “patients must be clinically stable” requirement. While ICD’s are not an inpatient only procedure and are in general performed as an outpatient, there are instances where an ICD is implanted during an inpatient admission. Can an inpatient undergoing ICD placement due in part to a low LVEF be in acute heart failure and clinically stable at the same time? Or, could the acute systolic heart failure inpatient admission be long enough for the patient to stabilize and be clinically stable at the time of ICD implant? At this time I have questions with no answers and a plan to seek clarification from Palmetto. Stay tuned for an answer……