Mark McClellan, MD, PhD
Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS-1501-P
P.O. Box 8016
Baltimore, MD 21244-8018

Dear Dr. McClellan:
 
Re: Medicare proposed device reimbursement in hospital outpatient payments for 2006.

The Heart Rhythm Society (HRS) appreciates the opportunity to comment on the Centers for Medicare and Medicaid Services (CMS) Proposed Rule on the Medicare Hospital Outpatient Prospective Payment System (OPPS) for FY 2006, published in the July 25 , 2005 Federal Register (CMS-1501-P).  The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients and the primary information resource on heart rhythm disorders.

“Device Related APCs”
The Heart Rhythm Society is very concerned with the proposed reductions for device related procedures, specifically for implantable cardioverter defibrillators (ICDs).  The Heart Rhythm Society believes it is a requirement of any payment system to appropriately pay for medical services so as not to limit access to care or diminish the quality of care.  The proposed reductions for ICDs are based on inaccurate and incomplete data. CMS acknowledged at the meeting of the Advisory Panel on APC Groups held August 17, 18, 2005 that the data used as a basis for this proposed rule “may not be accurate or complete”.

The 2006 OPPS proposed rule payment rates for ambulatory payment classification (APC) groups 0107 Implantation of Cardioverter-Defibrillator and 0108 Insertion/Replacement/Repair of Cardioverter Defibrillator Leads and Insertion of Cardioverter-Defibrillator, mark the second consecutive year of payment decreases amounting to -16.8%. The proposed rates will not cover the hospital’s cost of the ICD and additional procedural costs.

ICDs have been shown in many clinical trials to save lives and reduce the enormous loss of life due to sudden cardiac arrest. The impact of a payment decrease of this magnitude will affect patient access to care.  Given this unprecedented payment reduction, there will likely be no expansion of the availability of this life-saving clinical technology, as hospitals will not be able to absorb the losses associated with the implementation of a device implant program. As such, access to life-saving implantable defibrillation technology will become limited.

Recommendation
The CMS Advisory Panel recommended CMS create adequate payment levels for ICD procedures by using 100% of the 2005 payment rates plus the hospital update of 3.2% to create the 2006 final OPPS payment rates for APCs 0107 and 0108. The Heart Rhythm Society fully supports this recommendation and strongly encourages CMS to implement the 2006 final OPPS with this recommendation.

If CMS staff have questions please feel free to contact Lisa Miller, Manager of Regulatory and Reimbursement Affairs at lmiller@HRSonline.org or 202-464-3433.
 
Sincerely,

Anne B. Curtis, MD    
President, Heart Rhythm Society  

Mark D. Carlson, MD
Chair – Health Policy Committee