On Medicare's Wearable Cardiac Defibrillator "Reconsideration"

I know what you're thinking. "Did he fire six shots or only five?" Well, to tell you the truth, in all this excitement I kind of lost track myself. But being as this is a .44 Magnum, the most powerful handgun in the world, and would blow your head clean off, you've got to ask yourself one question: Do I feel lucky?

Well, do ya, punk?

Harry Callihan, from the movie Dirty Harry

It was a small article in the Wall Street Journal on 8 August 2011: "Zoll Medical Falls As LifeVest May Face Reimbursement Revisions." No doubt most doctors missed this, but the implications of this article for our patients discovered to have weak heart muscles and considered at high risk for sudden cardiac death could be profound.

That's because Medicare (CMS) is considering the requirement for the same waiting period after diagnosis of a cardiomyopathy or myocardial infarction as that for permanent implantable cardiac defibrillators (ICDs). To this end, they issued a draft document that contains the new proposal for their use.

By way of background, Zoll Medical makes the only wearable external cardiac defibrillator on the market, marketed as "LifeVest." The device is fairly simple: it consists of (1) a vest-like wearable garmet that contains EKG electrodes to sense a person's heart rhythm and and front and back electrode pads to deliver shock therapy and (2) a monitoring computer that can respond to the development of potentially left-threatening rhythm problems by automatically rupturing hidden gel-packs under the electrode pads before delivering a defibrillation shock to the patient to restore normal rhythm. Clinically, heart rhythm specialists have used these devices to assure our patients are protected from the development of life-threatening heart rhythm disorders as they begin medical therapy for their condition. After three months of medical therapy (according to our guidelines) if a person's heart muscle does not improve sufficiently, they are candidates for surgical implantation of a permanent (internal) cardiac defibrillator to protect against sudden cardiac arrest. For Medicare-eligible patients in need of these devices, they must pay a $200/month co-pay for their rental and the company receives approximately $2641 per month from Medicare. Certainly the use of these devices is not cheap, but they are much less expensive than the cost of an implantable defibrillator.

CMS justifies their need to "reconsider" their prior approval of wearable defibrillators on the basis of five documents that do not pertain to wearable cardiac defibrillators at all:

1.Epstein AE, et.al. ACC/AHA/HRS 2008 Guidelines for Device-based Therapy of Cardiac Rhythm Abnormalities: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J. Am. Coll. Cardiol. 2008;51(21);e-1-62

2.Hohnloser, SH, et.al. Prophylactic Use of an Implantable Cardioverter-Defibrillator after Acute Myocardial Infarction (DINAMIT-Defibrillator in Acute Myocardial Infarction Trial). N. Engl. J. Med. 2004;351:2481-88

3.Bigger JT, et.al. Prophylactic Use of Implanted Cardiac Defibrillators in Patients at High Risk for Ventricular Arrythmias after Coronary-Artery Bypass Graft Surgery. N. Engl. J. Med. 1997;337:1569-75

4.Bardy GH, et.al. Home Use of Automated External Defibrillators for Sudden Cardiac Arrest. N. Engl. J. Med. 2008;358 (online publication only at www.nejm.org)

5.Steinbeck G, et.al. Defibrillator Implantation Early after Myocardial Infarction. N. Engl. J. Med. 2009;361:1427-36

The use of the wearable cardiac defibrillator has dramatically increased after Department of Justice investigations surfaced regarding the appropriateness of defibrillator implantations being performed. Doctors looked to these devices as an acceptable compromise to the governmental and evidenced-based studies that suggested no signficant early mortality benefit with devices early after MI.

But clinically, doctors remained concerned about their patients after a severe heart attack or when a very weak heart muscle is discovered. When making prospective decisions about their patient's care, theydoctors do not have the benefit of retrospectively reviewing a patient's outcome in such a precarious situation. They only see the pleading eyes, the young physique, the patient's children and the desire to live to see another day.

And not unexpectedly, wearable cardiac defibrillators have been effective at saving lives in these high risk patient populations. If these wearable cardiac defibrillators aren't approved for early protection, what will doctors be forced to do? There are three possibilities: (1) treat them medically and wish them the best of luck for the next several months, (2) require they remain admitted for as long as three months to assure their safety, or (3) tell the patient they'll have to pay if they want the protection.

So how are these payement decisions made by our government officials? Who makes them? I realized while writing this post that I was not familiar how Medicare decides how and if they should pay for such a life-saving therapy.

The answer lies with the insurers contracted by Medicare called "Durable Medical Equipment (DME) Medicare Administrative Contractor (MAC)" or "DME MAC" for short. These are the same folks who decide if wheelchairs or home oxygen therapy is paid for. In the interest of transparency, I thought it would be interesting to expose exactly how, and by whom, the decision for wearable defibrillators will be made by currently. (It never hurts to keep the public informed who is deciding their fate clinically.)

First, it seems Medicare has contracted with four really important insurers which each manages a separate "region" of states called "jurisdictions:"

• Jurisdiction A - http://www.medicarenhic.com
• Jurisdiction B - http://www.ngsmedicare.com
• Jurisdiction C - http://www.cgsmedicare.com/jc
• Jurisdiction D - http://www.noridianmedicare.com/dme

Next, each of these jurisdictions has its own medical administrator with the insurance Medicare Administration Contractor. They are:

• Jurisdiction A: Paul Hughes, MD – FAMILY PRACTICE, with the National Heritage Insurance Co., Hingham, MA
• Jusrisdiction B: Stacey Brennan, MD – FAMILY PRACTICE with National Government Services, Indianapolis, IN
Jurisdiction C: Robert Hoover, Jr, MD, MPH, FACP – INTERNAL MEDICINE with CIGNA Government Services, Nashville TN
• Jusdiction D: Richard Whitten, MD, MBA, FACP – INTERNAL MEDICINE, CRITICAL CARE with Noridian Administrative Services, LLC, Fargo, ND

Now even though this "reconsideration" request has submitted to all four jurisdictions, only one jurisdiction typically reviews a particular issue and the others usually follow the first reviewer's lead.

As part of this "reconsideration," a public hearing occurs. In the case of wearable defibrillators (which will be reviewed with suction pumps and pneumatic compression devices), the meeting will occur at the Sheraton Baltimore North Hotel in Baltimore, MD. Then, after the public hearing, a three week "open comment period occurs" where the public can offer their agreement or disagreement (and why) to the proposed draft recommendation by submitting comments to a specific e-mail: nhicdmedraftLCDfeedback@hp.com . Comments must be recieved by 23 Sep 2011. After that time, a decision is rendered regarding the appropriate circumstances (if any) these "durable medical goods" will be paid for.

Doctors interested in contributing their thoughts are welcome to. Just be respectful and link to data or studies, if possible. Realize that the lucky individuals are not cardiologists nor cardiac electrophysiologists. They are physicians working for insurers. The draft proposal for wearable defibrillators is not a final document and is subject to change.

It is interesting to ponder why non-cardiologists from the insurance industry have proposed this restriction with little data to prove their harm to patients while significant data suggesting benefit exists to this therapy. I suspect that doctors who use sophisticated medical devices are more likely to see these "reconsiderations" for payment by CMS in the years ahead even though, by policy, cost is not supposed to be a consideration for approvals.

Staying aware of the payment system in place and who makes these decisions going forward might become our best way to effectively advocate for our patients in the coming years.

-Wes

PS: Reponsible corrections to my understanding of this process are welcomed. After all, I'm just a doctor.