The EP Show: CMS reimbursement decision for ICDs Eric Prystowsky MD Director, Clinical Electrophysiology Laboratory St Vincent Hospital Indianapolis, IN Robert M Califf MD Professor of Medicine Associate Vice Chancellor for Clinical Research Director, Duke Clinical Research Institute Duke University Medical Center Durham, NC Stephen Hammill MD Professor of Medicine Director, Electrophysiology and Arrhythmia Ablation Laboratory Mayo Clinic College of Medicine Rochester, MN

CMS reimbursement decision for ICDs To our listeners: Due to recording difficulties, the audio portion of this file contains segments with poor sound quality. We apologize for any inconvenience this may cause.

Coding for new devices "Frustrating" delay between FDA approval and CMS reimbursement decision, despite efficacy data Process improved But may still take 18 months from the time of needing a new code until one is available for reimbursement FDA approval and CMS reimbursement not necessarily inclusive November 2004 Hammill

Subgroup analysis "The most reliable answer is the average answer in the trial." Subgroups are interesting but must be replicated in an independent study; until then, there is a need to be suspicious of subgroup analyses November 2004 Califf

Multicenter Automatic Defibrillator Implantation Trial (MADIT) II Significant mortality benefit for implantable cardiac defibrillator therapy in patients with MI and advanced left ventricular dysfunction Initial CMS decision expanded national coverage for the use of ICDs in patients with a previous MI, LVEF of <30%, and QRS duration >120 ms November 2004

Interpreting results Many considerations besides the general interpretation of a single trial's result "We'd be deceitful if we didn't say that cost is an issue that at least needs to be considered." November 2004 Califf

Interpreting results Not appropriate to exclude patients based on a subgroup analysis from one trial Conversely, however, to pay for a subgroup based on definitive data might be appropriate November 2004 Califf

Scientific statement EP community "thrown for a loop" when CMS used subgroup analyses to decide ICD payment issue Payment decision not based on a scientific statement Prystowsky November 2004

Defending the CMS Definitive data in a broad population finding benefit for the average patient, but really strong data in patients with wide QRS intervals November 2004 Califf

How is clinical practice affected? Physicians forced to inform patients of the ICD benefit but that the device is not covered by the CMS "That was a very awkward discussion that we had to have with patients, and it made patient care quite difficult this past year." - Hammill November 2004

New CMS data QRS-duration caveat scrapped Reimbursement criteria now include patients with nonischemic cardiomyopathy, as well as those with a history of MI, and an LVEF <30% "It is obvious from the data that you can risk-stratify in terms of the degree of benefit achieved." - Califf November 2004

LVEF criteria What happens to patients with LVEF >30% and <35%? Odds ratio for mortality is 1.0 from multiple trials Reimbursement decision not to save money, but based on data from a large number of pooled trials November 2004

National registry CMS and SCD-HeFT Sped up the review and coverage decision for patients with nonischemic cardiomyopathy CMS interested in registry to determine whether implanting criteria and the results seen in clinical trials are paralleled in real-world setting Registry will provide feedback to improve patient care

National registry Stepping away from the different specialties, most clinicians believe Medicare is wasting money on useless, or worse, treatments New therapies FDA approval does not mean Medicare should reimburse when better alternative therapies exist - Califf November 2004

Budget issues $400-billion federal deficit CMS using payment clout Helping clinicians make decisions that are difficult due to complex, self- interested practice situations - Califf November 2004

Getting paid Need to collect data about how ICDs are implanted, where it's done, and who the implanters are to improve how the procedure is done Inputting data When data are submitted to the federal government as a means of getting paid, the data get to be very good . . . - Califf November 2004

Lack of reconciliation Majority of patients who have a primary indication for an ICD will get one by the current data Clinicians put in difficult double bind where they can't apply a class 1 indication due to reimbursement issues - Prystowsky November 2004

The real world Clinicians need to grow up and act according to reality The bigger problem, however, is patients with an indication for an ICD who are not referred for treatment November 2004 Califf

Scientific statement Issue of payment is an evolving mark that will likely progress to other areas with "fuzzy" data Coated stents another huge payment issue Prystowsky November 2004

Spreading the word Need to offer consumers and doctors the best information to make choices ICD therapy "I think it is really exciting that the therapy has come this far and there will be a broad increase in payment. We need to proselytize to get people the treatment they need." - Califf November 2004

Heart Rhythm Society Challenges Instead of debating the CMS indication, focus should be on treating more patients who meet the LVEF <30% criteria November 2004

Spreading the word What we need to do now is educate the community, family physicians, and referring physicians, on all that we do to reduce the risk of sudden death - Hammill November 2004