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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

2

Effective Date of this Version

10/12/2004

Ending Effective Date of this Version

3/17/2005


Implementation Date

10/12/2004


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

A. General

This procedure involves inserting a balloon catheter into a narrow or occluded blood vessel to recanalize and dilate the vessel by inflating the balloon.  The objective of PTA is to improve the blood flow through the diseased segment of a vessel so that vessel patency is increased and embolization is decreased. With the development and use of balloon angioplasty for treatment of atherosclerotic and other vascular stenoses, PTA (with and without the placement of a stent) is a widely used technique for dilating lesions of peripheral, renal, and coronary arteries.


Indications and Limitations of Coverage

B. Nationally Covered Indications

The PTA is covered to treat the following indications:

  1. 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 an inadequate response to a thorough medical management of symptoms and for whom surgery is the likely alternative. The PTA for this group of patients is an alternative to surgery, not simply an addition to medical management.
    • Of arteriovenous dialysis fistulas and grafts when performed through either a venous or arterial approach.

  2. Effective July 1, 2001, Medicare covers 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. The 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.

  3. Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent for an FDA-approved indication when furnished in accordance with FDA-approved protocols governing post-approval studies. CMS determines that coverage of PTA of the carotid artery is reasonable and necessary under these circumstances.

C. Nationally Noncovered Indications

  1. Performance of PTA in the carotid artery when used to treat obstructive lesions outside of FDA-approved protocols governing Category B IDE clinical trials and outside of FDA-required post approval studies remains a noncovered service.

  2. Performance of PTA to treat obstructive lesions of the vertebral and cerebral arteries remains noncovered. The safety and efficacy of these procedures are not established.

D. Other

All other indications for PTA for which CMS has not specifically indicated coverage remain noncovered.

(This NCD last reviewed September 2004.)


Transmittal Number

25

Coverage Transmittal Link

http://www.cms.gov/transmittals/downloads/R25ncd.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)

10/2004 - Provided coverage for PTA of carotid artery concurrent with placement of FDA-approved carotid stent for FDA-approved indication when furnished in accordance with FDA-approved protocols governing post-approval studies. Performance of PTA of carotid artery concurrent with carotid stent placement when furnished outside FDA-approved protocols governing both FDA-required post-approval studies and FDA Category B IDE clinical trials remains noncovered. Effective and implementation dates 10/12/2004. (TN 25) (CR 3489)


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
25