November 6, 2006

Leslie Norwalk
Interim Administrator
Centers for Medicare and Medicaid Services
Department of Health and Human Services
Hubert H. Humphrey Building, Room 445-G
200 Independence Avenue, SW
Washington, DC 20201

Dear Administrator Norwalk:

The Heart Rhythm Society (the Society) welcomes the opportunity to comment on proposed rule CMS 1506-P entitled Ambulatory Surgical Center Payment System and CY 2008 Payment Rates published in the August 23, 2006 Federal Register that would revise payment policies for ambulatory surgical centers (ASCs) beginning January 1, 2008.

HRS is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Founded in 1979, HRS is the preeminent professional group representing more than 4,000 specialists in cardiac pacing and electrophysiology, known as electrophysiologists or heart rhythm specialists. HRS members perform electrophysiology (EP) studies and curative catheter ablations to diagnose, treat and prevent cardiac arrhythmias. Electrophysiologists also implant pacemakers and implantable cardioverter defibrillators (ICDs) in patients who have indications for these life-saving devices. After device implantation, heart rhythm specialists then monitor these patients and their implanted devices.

ASC Payable Procedures

The Society appreciates CMS’s efforts to implement a new ASC payment system to maintain Medicare beneficiaries’ access to surgical care. However, we are concerned about CMS’s proposal to add the following electrophysiology codes to the list of procedures payable in an ASC.

33224: Insertion of LV pacing electrode, with attachment to previously placed device
33225: Insertion of LV pacing electrode, at time of insertion of device
33226: Repositioning of LV electrode
33234: Removal of single lead system electrode
33240: Insertion of pulse generator
33241: Removal of pulse generator

Based on the criteria outlined in the proposed rule, the Society believes that performance of these procedures in an ASC could pose a significant risk to patient safety. Insertion, repositioning, and extraction of electrodes as well as insertion and removal of a pulse generator are complex procedures that have a significant risk of complications. The Society does not believe that the appropriate personnel and equipment are available in ASCs to respond to complications that may occur during or after these procedures.

In particular, extractions of electrodes and pulse generators are high-risk procedures that require close and continual observation during the post-operative period. The Society is concerned that the appropriate level of observation care is not available in ASCs. Additionally, removal of a single lead system electrode (code 33234) is a complex procedure that if improperly performed, could result in the need for emergency cardiovascular surgery. During a lead extraction, there is the risk that a vital part of the heart can be torn with resultant rapid hemorrhage. When this occurs, a cardiovascular surgeon must perform either a full or limited sternotomy, which could not be performed safely in an ASC. Furthermore, an additional potential complication of a lead removal is that the lead can degenerate and require a complete device extraction using a powered sheath. As with a sternotomy, a complete device extraction could not be performed safely in the ASC setting.

The Society agrees that many procedures, including numerous electrophysiology procedures, can be safely performed in ASCs. We commend CMS for expanding the list of procedures covered in ASCs as it provides physicians and patients with more options for deciding on the safest and most appropriate site of service for surgical procedures. However, for the procedures addressed above, the Society does not agree that an ASC is the proper site of service due to the potential patient safety risks.

The Society appreciates the opportunity to provide input on Medicare payment policy and thanks CMS for your consideration of our comments. We look forward to continuing to work together to maintain access to medical services for Medicare beneficiaries. If you have any questions about the Society’s comments, please contact Amy Melnick, Vice-President, Health Policy, at amelnick@hrsonline.org or 202.464.3434.

Sincerely,

Dwight Reynolds, MD, FHRS
President
Heart Rhythm Society