Last updated: July 2007
Effective date of this version: April 30, 2004 / Implementation date: April 30, 2004
Prosthetic Devices
(Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.)
Prosthetic Devices
Cardiac pacemakers are self-contained, battery-operated units that send electrical stimulation to the heart. They are generally implanted to alleviate symptoms of decreased cardiac output related to abnormal heart rate and/or rhythm. Pacemakers are generally used for persistent, symptomatic second- or third-degree atrioventricular (AV) block and symptomatic sinus bradycardia.
Cardiac pacemakers are covered as prosthetic devices under the Medicare program, subject to the following conditions and limitations. While cardiac pacemakers have been covered under Medicare for many years, there were no specific guidelines for their use other than the general Medicare requirement that covered services be reasonable and necessary for the treatment of the condition. Services rendered for cardiac pacing on or after the effective dates of this instruction are subject to these guidelines, which are based on certain assumptions regarding the clinical goals of cardiac pacing. While some uses of pacemakers are relatively certain or unambiguous, many other uses require considerable expertise and judgment.
Consequently, the medical necessity for permanent cardiac pacing must be viewed in the context of overall patient management. The appropriateness of such pacing may be conditional on other diagnostic or therapeutic modalities having been undertaken. Although significant complications and adverse side effects of pacemaker use are relatively rare, they cannot be ignored when considering the use of pacemakers for dubious medical conditions, or marginal clinical benefit.
These guidelines represent current concepts regarding medical circumstances in which permanent cardiac pacing may be appropriate or necessary. As with other areas of medicine, advances in knowledge and techniques in cardiology are expected. Consequently, judgments about the medical necessity and acceptability of new uses for cardiac pacing in new classes of patients may change as more conclusive evidence becomes available. This instruction applies only to permanent cardiac pacemakers, and does not address the use of temporary, non-implanted pacemakers.
The two groups of conditions outlined below deal with the necessity for cardiac pacing for patients in general. These are intended as guidelines in assessing the medical necessity for pacing therapies, taking into account the particular circumstances in each case. However, as a general rule, the two groups of current medical concepts may be viewed as representing:
CMS opened the NCD on Cardiac Pacemakers to afford the public an opportunity to comment on the proposal to revise the language contained in the instruction. The revisions transfer the focus of the NCD from the actual pacemaker implantation procedure itself to the reasonable and necessary medical indications that justify cardiac pacing. This is consistent with our findings that pacemaker implantation is no longer considered routinely harmful or an experimental procedure.
Note: Effective March 16, 1983.
Conditions under which cardiac pacing is generally considered acceptable or necessary, provided that the conditions are chronic or recurrent and not due to transient causes such as acute myocardial infarction, drug toxicity, or electrolyte imbalance. (In cases where there is a rhythm disturbance, if the rhythm disturbance is chronic or recurrent, a single episode of a symptom such as syncope or seizure is adequate to establish medical necessity.)
Note: Effective May 9, 1985.
Conditions which, although used by some physicians as a basis for permanent cardiac pacing, are considered unsupported by adequate evidence of benefit and therefore should not generally be considered appropriate uses for single-chamber pacemakers in the absence of the above indications. Contractors should review claims for pacemakers with these indications to determine the need for further claims development prior to denying the claim, since additional claims development may be required. The object of such further development is to establish whether the particular claim actually meets the conditions in A above. In claims where this is not the case or where such an event appears unlikely, the contractor may deny the claim.
Note: Effective October 1, 2001
Note: Effective May 9, 1985.
Conditions under dual-chamber cardiac pacing are considered acceptable or necessary in the general medical community unless conditions 1 and 2 under Group II. B., are present:
Dual-chamber pacemakers may also be covered for the conditions, as listed in Group I. A., if the medical necessity is sufficiently justified through adequate claims development. Expert physicians differ in their judgments about what constitutes appropriate criteria for dual-chamber pacemaker use. The judgment that such a pacemaker is warranted in the patient meeting accepted criteria must be based upon the individual needs and characteristics of that patient, weighing the magnitude and likelihood of anticipated benefits against the magnitude and likelihood of disadvantages to the patient.
Whenever the following conditions (which represent overriding contraindications) are present, dual-chamber pacemakers are not covered:
All other indications for dual-chamber cardiac pacing for which CMS has not specifically indicated coverage remain nationally noncovered, except for Category B IDE clinical trials, or as routine costs of dual-chamber cardiac pacing associated with clinical trials, in accordance with section 310.1 of the NCD Manual.
(This NCD last reviewed June 2004)
Payer policies will vary and should be verified prior to treatment for limitations on diagnosis, coding or site of service requirements. Medicare does not preauthorize services, however, coverage policies and criteria may be found on contractor web sites or by contacting your local Medicare carrier/fiscal intermediary. The coding options listed within this guide are commonly used codes and are not intended to be an all-inclusive list. We recommend consulting your ICD-9-CM and AMA CPT manuals for appropriate coding options. When performing multiple procedures, review current correct coding guidelines carefully. Services that are considered a component of another procedure cannot always be coded and billed separately. Medicare's Correct Coding Initiative is reviewed and updated several times a year. Commercial (non-Medicare) payer policies vary and should be carefully reviewed.
C5-133-0106
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