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National Coverage Determination (NCD) for Percutaneous Transluminal Angioplasty (PTA) (20.7)

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Publication Number

100-3

Manual Section Number

20.7

Manual Section Title

Percutaneous Transluminal Angioplasty (PTA)


Version Number

1

Effective Date of this Version

7/1/2001

Ending Effective Date of this Version

10/12/2004


Implementation Date

7/1/2001


Benefit Category
Inpatient Hospital Services
Physicians' Services
Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

This procedure involves inserting a balloon catheter into a narrow or occluded blood vessel to recanalize and dilate the vessel by inflating the balloon.


Indications and Limitations of Coverage

A - PTA is covered to treat the following indications:

  • Atherosclerotic obstructive lesions:
    • In the lower extremities, i.e., the iliac, femoral, and popliteal arteries, or in the upper extremities, i.e., the innominate, subclavian, axillary, and brachial arteries. The upper extremities do not include head or neck vessels.
    • Of a single coronary artery for patients for whom the likely alternative treatment is coronary bypass surgery and who exhibit the following characteristics:
      • Angina refractory to optimal medical management;
      • Objective evidence of myocardial ischemia; and
      • Lesions amenable to angioplasty;
    • Of the renal arteries for patients in whom there is inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. PTA for this group of patients is an alternative to surgery, not simply an addition to medical management.
  • Obstructive lesions of arteriovenous dialysis fistulas and grafts when performed through either a venous or arterial approach.

B - PTA is not covered to treat obstructive lesions of the carotid artery except in the following circumstance:

  • Effective July 1, 2001, Medicare will cover PTA of the carotid artery concurrent with carotid stent placement when furnished in accordance with the Food and Drug Administration (FDA) approved protocols governing Category B Investigational Device Exemption (IDE) clinical trials. PTA of the carotid artery, when provided solely for the purpose of carotid artery dilation concurrent with carotid stent placement, is considered to be a reasonable and necessary service only when provided in the context of such a clinical trial, and therefore is considered a covered service for the purposes of these trials. Performance of PTA in the carotid artery when used to treat obstructive lesions outside of approved protocols governing Category B IDE clinical trials remains a noncovered service.

PTA is not covered to treat obstructive lesions of the vertebral and cerebral arteries. The safety and efficacy of these procedures have not been established.


Transmittal Number

137

Coverage Transmittal Link

http://www.cms.gov/transmittals/downloads/R137CIM.pdf

Revision History

11/1985 - Provided for less than restrictive guidelines associated with patient selection criteria. Effective date 11/22/1985. (TN 1)

07/1991 - Provided coverage in treatment of obstructive lesions of arteriovenous dialysis fistulas and included appropriate ICD-9-CM and HCPCS codes. Effective date 07/29/1991. (TN 49)

03/1994 - Expanded coverage to include treatment of atherosclerotic obstructions of vessels in upper extremities.  (Upper extremities does not include head or neck vessels.) Also clarified that PTA covered in treatment of obstructive lesions of arteriovenous dialysis fistulas through either an arterial or venous approach. Effective date 03/17/1994. (TN 68)

05/2001 - Provided coverage of carotid artery only when concurrent with carotid stent placement when furnished in accordance with FDA approved protocols governing Category B IDE clinical trials. Effective and implementation dates 7/1/2001.  (TN 137) (CR 1660)


National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Other Versions
4