1. 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

2. CMS reimbursement decision for ICDs
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3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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

22. 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