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National Coverage Analysis (NCA) Tracking Sheet

Cardiac Pacemakers

CAG-00063R

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Issue

On March 20, 2001, CMS posted a decision memorandum maintaining the current non-coverage policy that Medicare will not cover pacemaker implantation for either post-myocardial infarction (MI) patients with asymptomatic bradycardia who otherwise would be precluded from beta-blocker long-term drug therapy, or post-MI patients who are treated with beta-blockers and later develop asymptomatic bradycardia as a result of the treatment. We will be reviewing new clinical evidence only regarding pacemaker implantation for post-MI patients with asymptomatic bradycardia.

National Coverage Determinations

Benefit Category

Prosthetic Devices

Requestor Information

Requestor Name Requestor Letter
Medtronic, Inc., Jeffrey Goldberger, MD, MBA N/A
N/A

Important Dates

Formal Request Accepted and Review Initiated
04/24/2001
Expected NCA Completion Date
10/01/2001
Public Comment Period
05/24/2001 - 06/22/2001
Proposed Decision Memo Due Date
Proposed Decision Memo Released
Proposed Decision Memo Public Comment Period
Decision Memo Released
10/01/2001

Contacts

Lead Analysts
Perry Bridger, MHS
Lead Medical Officers
Michael Londner, MD, MPH

Medicare Benefit Category Determination Date

Actions Taken

April 3, 2001

CMS receives Medtronic's request for reconsideration.

April 4, 2001

CMS receives Dr. Goldberger's request for reconsideration.

April 12, 2001

Because new scientific evidence was submitted, CMS decides to reconsider this issue. The Medtronic request and Dr. Goldberger's request are combined into a single reconsideration.

April 24, 2001

CMS receives additional information from Dr. Goldberger, including clinical evidence.

July 10, 2001

CMS meets with Medtronic and Dr. Goldberger to discuss the reconsideration. The Requestors agree to provide CMS the following three pieces of information:
  1. Additional data on how pacemaker patients tolerate beta-blockers.

  2. Medtronic claims the following conditions can be used to define the asymptomatically, bradycardic post-MI population. This definition includes patients with one of the following:

    1. 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)
    2. Sinus pauses (greater than 2 seconds) during the day
    3. PR interval greater than or equal to 280 msec in the absence of medications that prolong AV nodal conduction time (digoxin, diltiazem, verapamil)
    4. Second-degree AV block, type I at rest (and awake)

      Is there scientific evidence to demonstrate that these conditions accurately define asymptomatic, bradycardic post-MI patients who will become symptomatic?

  3. Provide additional information concerning the pacemaker patients in the Rathore study.

Requestor was asked to submit additional material by August 10, 2001. We therefore extended the due date of the decision memorandum to September 11, 2001 in order to review any submitted information.

August 24, 2001

CMS received additional material from Requestor on August 10th. We will continue our analysis and issue a decision by the due date stated above.

September 17, 2001

CMS requires additional time to review this issue. Therefore, the due date is further extended to October 1, 2001.

October 1, 2001
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