DAL 16-07: Cardiac Services EP Reminder

April 7, 2016

Dear Chief Executive Officer:

This letter serves as a reminder of New York State Department of Health (DOH) regulations that were published in 2009 regarding cardiac services, especially Electrophysiology (EP). Only those hospitals approved for EP may perform EP services. If a hospital wishes to perform those services, DOH approval is required through the Certificate of Need (CON) process.

Regulations at subsection (e) (5) of Section 10 NYCRR 405.29 address the requirements for Cardiac EP programs. The regulations provide for:

  1. Structure and service requirements
  2. Staffing; and
  3. Patient selection criteria

These regulations identify procedures which can only be performed if cardiac surgery services are available on site. A hospital with an approved Cardiac EP lab program and no cardiac surgery on site SHALL NOT admit patients under the age of 18, patients in need of chronic lead extractions, patients being treated for ventricular tachycardia ablations and patients being treated for atrial fibrillation ablations for Cardiac EP Lab Program services. The regulations did not identify which procedures were included in the term EP. In a June 2010 letter, DOH clarified what procedures are included in the term EP (see attached letter). EP is understood to include "EP studies, ICD implants, biventricular pacemakers or cardiac resynchronization therapy devices (CRT-D), and ablations," as described.

The Cardiac Services program has received a number of inquiries regarding where EP procedures may be performed. The regulation is clear that EP services can only be performed in a hospital that has a Cardiac EP Laboratory Services program.

Hospitals wishing to offer EP services and, which are not currently approved to do so, may submit a Certificate of Need application pursuant to 10 NYCRR section 709.14 of the DOH regulations. Information about submission may be found on the DOH website at: www.health.ny.gov/facilities/cons/

DOH will soon be performing a review to determine where EP services are being provided, and will conduct a focused review, if its initial analysis suggests that EP services are being provided in hospitals that do not have a Cardiac EP Laboratory Services program. If a specific hospital is determined to be noncompliant with regulations, DOH will cite the provider for violations and require corrective action as appropriate.

If you have any questions related to the EP program requirements, you may contact the Division of Hospitals and Diagnostic & Treatment Centers at 518-402-1004. If you have questions related to the certificate of need requirements, please contact the Center for Health Care Facilities Planning, Licensure, and Finance, Project Management Unit at 518-402-0911.

Thank you for your prompt attention to this important patient safety matter.

Ruth Leslie
Division of Hospitals and Diagnostic & Treatment Centers