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  • Expanded ICD reimbursement-eligibility

    Sep 29, 2004

    CMS expands ICD reimbursement criteria, with conditions

    Baltimore, MD - The Centers for Medicare & Medicaid Services (CMS) has proposed a far-reaching expansion of reimbursement-eligibility criteria for patients receiving implantable cardioverter defibrillators as primary prevention, one that includes caveats but eliminates some prior restrictions that had rankled many in the cardiology community.


    It's a major step forward.



    The proposed criteria, which the CMS announced yesterday, for the first time include patients with nonischemic cardiomyopathy in addition to those with a history of MI. And gone is the requirement that patients have a QRS duration exceeding 120 ms, which had drawn fire for being an inaccurate way to single out those at highest risk for sudden death.



    Dr Eric N Prystowsky

    "I think it's a major step forward," Dr Eric N Prystowsky (St Vincent Hospital, Indianapolis, IN) told heartwire. "We have a paradigm change in the ischemic patients because they have taken away the QRS-duration issue that was initially given after MADIT-2 . . . and they also opened it up to the nonischemics," he said. "Those two issues open widely the patients who can be acceptable for an ICD."

    The proposals are far from a blank check, however. A statement from the Heart Rhythm Society, attributed to its president Dr Stephen C Hammill (Mayo Clinic, Rochester, MN), in general supported the CMS proposal while expressing concerns about some of its stated conditions for reimbursement eligibility. They include, notably, a requirement that patients benefiting from Medicare reimbursement have an LVEF <30%, not be in NYHA class 4, receive only a single-lead device unless a specific case is made for a more advanced model, and be enrolled in either a registry or clinical trial.


    We have a paradigm change in the ischemic patients because they have taken away the QRS duration issue.



    The HRS "strongly supports" the expanded eligibility criteria but "looks forward to submitting comments and working with the CMS to address these concerns," the statement said. After an initial 30-day public-comment period, the CMS has 60 days to address any feedback and issue its final policy statement.

    The SCD-HeFT factor
    The CMS credits the expanded criteria largely to the accumulation of evidence from a series of ICD trials, including MADIT-2 and the "well-designed" National Heart, Lung, and Blood Institute-sponsored SCD-HeFT, that the devices significantly improve survival. "The draft coverage decision recommends coverage for most of the population studied in the trial," according to a CMS statement that referred specifically to SCD-HeFT.


    We had a very long discussion about the QRS, and I think that they listened.



    "I'm very appreciative that CMS, in looking at SCD-HeFT, has also been willing to listen to our entire discussion concerning primary prevention of sudden death," Prystowsky said. "We had a very long discussion about the QRS, and I think that they listened."



    Dr Jeanne E Poole

    SCD-HeFT investigator Dr Jeanne E Poole (University of Washington, Seattle) noted that the new criteria in some ways more resemble those of an earlier trial, with the addition of nonischemic patients based on SCD-HeFT. "For the ischemic population, it's basically MADIT-2 without the QRS width requirement. They still require that [patients] have a prior myocardial infarction, which was not part of the SCD-HeFT enrollment criteria. And although most people [in SCD-HeFT] did have an EF less than 30%, [the proposal] still leaves out people with an EF between 30% and 35%, who by the SCD-HeFT data would be candidates for an ICD," Poole told heartwire. The CMS proposal, although an improvement, is therefore "not as comprehensive as it should have been." But the inclusion of nonischemic cardiomyopathy based on SCD-HeFT, she said, "is a great victory."

    The new restrictions


    Dr Douglas P Zipes

    The proposed criteria are "mostly positive," Dr Douglas P Zipes (Indiana University School of Medicine, Indianapolis) said to heartwire. "But obviously there are restrictions. . . . The biggest is the registry, which will be cumbersome, and I'm not certain who's going to pay for that. I suspect we'll have to go to industry. The second is restricting us to the type of [single-lead] ICD that was used in the SCD-HeFT trial and making us justify an ICD that has antitachycardia pacing and other features. That is going to be a drawback." Still, he said, "In the main, I think we've done okay."

    Poole also wondered about the limitation to single-lead ICDs. "For the majority of patients, that's probably all they truly need. But it does leave open the issue of sicker patients that maybe are class 3 who fall more under the indication for a dual-chamber device," she said. "That I think is going to be potentially problematic."

    The registry proposal, Poole said, "I think is a bigger hurdle. . . . I'm curious as to why they felt the need to do this, as it certainly will make it difficult to move forward with implants in patients who we think are candidates. We've already done the clinical trials."


    In the main, I think we've done okay.





    Dr Kim A Eagle

    Others see an advantage to requiring the registries. Dr Kim A Eagle (University of Michigan, Ann Arbor) said, "I'm pleased that this insurer is challenging caregivers to document long-term therapy and follow-up. And being involved in a registry also improves the chance that patients not only have their defibrillator tracked carefully for battery-life issues, but also that their medical therapy for cardiomyopathy is maximized. And that's great."

    Eagle added, "I and others have advocated that we need a stronger collaboration between those who insure for care, those who deliver care, and those who create new technology to create ongoing mechanisms for tracking outcomes, looking for both benefit and potential risk."

    Eagle says the proposed CMS criteria are "reasonable." Regarding the exclusion of patients with an LVEF of 31% to 35% and those in NYHA class 4, he said, "We're suffering from a dearth of science for some of these subgroups, and hopefully further studies will help us have a better sense of whether all of these exclusions are perfectly appropriate or not."


    It would have been nice if they just simply said, we're going to go by the trial, and leave it at that.



    Prystowsky said it may be defensible to exclude those with an LVEF of 31% to 35%, "but it would have been nice if they just simply said, we're going to go by the trial [SCD-HeFT], and leave it at that."

    Poole also saw some justification for not including patients in NYHA class 4 HF. "We don't have a lot of data on class-4 patients, and their life expectancy is presumably short. That's why I think they were excluded," she said. "But those are the patients who appear to be candidates for [cardiac resynchronization therapy]. The question is raised, 'Are you limited to just putting in a CRT device in those patients because they don't have reimbursement for a CRT-defibrillator?' I think most providers are uncomfortable implanting a CRT device now in a class-3 or class-4 patient and have it not be in combination with a defibrillator."




    Related links

    1. The explosion in HF devices, part 1: Culture, economics, and unresolved issues [HeartWire > Heart failure; Aug 20, 2004 ]
    2. The explosion in HF devices, part 2: What kind, in whom, and for how long? [HeartWire > Heart failure; Aug 20, 2004 ]
    3. CMS, clinical community face off on ICD reimbursement policies [HeartWire > Heart failure; Jun 7, 2004 ]
    4. SCD-HeFT subanalysis: ICD cuts mortality regardless of QRS duration [HeartWire > Heart failure; May 24, 2004 ]
    5. QRS duration appears worthless as risk stratifier in otherwise-qualified ICD candidates [HeartWire > Heart failure; Mar 16, 2004 ]
    6. The experts on SCD-HeFT: Implement now, but seek more discriminating ICD patient-selection criteria [HeartWire > Heart failure; Mar 10, 2004 ]
    7. SCD-HeFT: Experts look for closure on ICD reimbursement debate after MADIT-II [HeartWire > Heart failure; Mar 2, 2004 ]
    8. Reaction to Medicare ICD decision: Experts dismayed full MADIT II criteria not included in coverage [HeartWire > News; Jun 13, 2003 ]
    9. No decision on coverage for patients with MADIT II criteria leaves doctors in limbo [HeartWire > News; May 22, 2003 ]
    10. FDA announces approval of low-cost ICD: Scaled-down device half the cost of standard ICDs [HeartWire > News; May 19, 2003 ]
    11. DAVID trial: Dual-chamber pacing has no advantage over ventricular backup pacing with ICD [HeartWire > News; Dec 19, 2002 ]
    Knowledge is power ... Stay informed!
    YOU can make a difference - all you have to do is try!

    Dx age 12 current age 46 and counting!
    lost: 5 family members to HCM (SCD, Stroke, CHF)
    Others diagnosed living with HCM (or gene +) include - daughter, niece, nephew, cousin, sister and many many friends!
    Therapy - ICD (implanted 97, 01, 04 and 11, medication
    Currently not obstructed
    Complications - unnecessary pacemaker and stroke (unrelated to each other)

  • #2
    Aetna Clinical Policy Bulletin

    Aetna approves, too.

    As of March 15, 2005 (or possibly earlier -- that's the date of the most recent revision), Aetna also appears to include HCM as a condition that alone is sufficient for coverage for an ICD. See #8 in the bulletin.

    Amount of coverage still depends on the particular plan, but Aetna considers ICD's for HCM patients to be medically necessary -- at least the way I read it.

    http://www.aetna.com/cpb/data/CPBA0585.html

    ...and personal experience confirms this, as they did pre-approve the one that was installed in me a few weeks ago.

    --MET[/u]

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