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National Coverage Analysis (NCA) Tracking Sheet

Cardiac Pacemakers

CAG-00063N

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Issue

Medicare limits the number of conditions under which we will pay for treatment by a cardiac pacemaker (Section 65-6, Coverage Issues Manual). Since the initial formulation of this policy, more recent technological advancements may provide cause to alter the current coverage status.

There is evidence to suggest that beta blockers are beneficial in treating patients post myocardial infarction. However, it is alleged that this treatment increases the risk of AV Block, which impedes effective mechanical and physiological function of the heart. Currently, pacemaker insertion for sinus bradycardia, without significant symptoms, is not a covered service. Requestor has asked HCFA to review the current cardiac pacemaker policy to cover the use of cardiac pacemakers to treat asymptomatic bradycardia, post MI, for patients about to initiate long term beta blocker drug therapy.

National Coverage Determinations

Benefit Category

Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Medtronic, Inc. N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
06/07/2000
Expected NCA Completion Date
02/20/2001
Public Comment Period
07/07/2000 - 08/07/2000
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
03/20/2001

Contacts

Lead Analysts
Perry Bridger, MHS
Lead Medical Officers

Medicare Benefit Category Determination Date

Actions Taken

June 7, 2000

HCFA received Medtronic's request for reconsideration.

July 10, 2000

Letter sent to Medtronic officially accepting the request.

August 9, 2000

After careful review of Medtronic's request, we have come to the conclusion that additional information would be helpful in our analysis. To assist us in this process, we are seeking answers to the questions listed below.

All submissions must be received by August 23, 2000.
Please send information to Jennifer Doherty at:

e-mail:     Jdoherty@cms.hhs.gov
fax:     410 786 9286
address:
Office of Clinical Standards and Quality
Coverage and Analysis Group
MS C1-09-06
7500 Security Boulevard
Baltimore, MD 21244-1855

1. The ACC recommendation is for symptomatic, iatrogenic bradycardia. What is the rationale for use in asymptomatic patients who may begin beta blocker therapy?

2. What is the evidence that post MI patients with bradycardia benefit from beta blocker therapy?

3. One proposed definition of asymptomatic bradycardia includes post MI patients with one of the following documented conditions:

a. Resting (awake) heart rate less than or equal to 50 beats per minute on 2 consecutive days in the absence of treatment with rate-slowing medications (i.e., diltiazem, verapamil)
b. Sinus pauses (greater than 2 seconds) during the day
c. PR interval greater than or equal to 280 msec in the absence of medications that prolong AV nodal conduction time (digoxin, diltiazem, verapamil)
d. Second-degree AV block, type I at rest (and awake)

Is this a reasonable definition?

August 30, 2000

We received only two responses to questions posted above. Due to the low response rate to these important questions, we have decided to extend the deadline to October 5, 2000 to provide us with additional time to review this issue.

November 7, 2000

We've been notified by the requestor of plans to submit additional information. For this reason, a new deadline for the decision will be determined once more information is received.

December 9, 2000

Additional information has been provided by the requestor. We have therefore extended the due date in order to review this material.

March 20, 2001
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