National Coverage Determination (NCD)

Percutaneous Transluminal Angioplasty (PTA)

20.7

Expand All | Collapse All

Tracking Information

Publication Number
100-3
Manual Section Number
20.7
Manual Section Title
Percutaneous Transluminal Angioplasty (PTA)
Version Number
4
Effective Date of this Version
11/06/2006
Ending Effective Date of this Version
04/30/2007
Implementation Date
02/05/2007
Implementation QR Modifier Date

Description Information

Benefit Category
Inpatient Hospital Services
Physicians' Services


Please 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.

4. Effective March 17, 2005, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent with embolic protection for the following:

  • Patients who are at high risk for carotid endarterectomy (CEA) and who also have symptomatic carotid artery stenosis ≥ 70%. Coverage is limited to procedures performed using FDA-approved carotid artery stenting systems and embolic protection devices;
  • Patients who are at high risk for CEA and have symptomatic carotid artery stenosis between 50% and 70%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare National Coverage Determinations Manual (NCD), 310.1), or in accordance with the NCD on carotid artery stenting (CAS) post-approval studies (Medicare NCD Manual 20.7);
  • Patients who are at high risk for CEA and have asymptomatic carotid artery stenosis ≥ 80%, in accordance with the Category B IDE clinical trials regulation (42 CFR 405.201), as a routine cost under the clinical trials policy (Medicare NCD Manual 310.1), or in accordance with the NCD on CAS post- approval studies (Medicare NCD Manual 20.7).

Patients at high risk for CEA are defined as having significant comorbidities and/or anatomic risk factors (i.e., recurrent stenosis and/or previous radical neck dissection), and would be poor candidates for CEA in the opinion of a surgeon.

Significant comorbid conditions include but are not limited to:

  • congestive heart failure (CHF) class III/IV;
  • left ventricular ejection fraction (LVEF) <30%;
  • unstable angina;
  • contralateral carotid occlusion;
  • recent myocardial infarction (MI);
  • previous CEA with recurrent stenosis;
  • prior radiation treatment to the neck; and
  • other conditions that were used to determine patients at high risk for CEA in the prior CAS trials and studies, such as ARCHER, CABERNET, SAPPHIRE, BEACH, and MAVERIC II.

Symptoms of carotid artery stenosis include carotid transient ischemic attack (distinct focal neurologic dysfunction persisting less than 24 hours), focal cerebral ischemia producing a nondisabling stroke (modified Rankin scale <3 with symptoms for 24 hours or more),1 and transient monocular blindness (amaurosis fugax). Patients who have had a disabling stroke (modified Rankin scale ≥ 3) would be excluded from coverage.

The determination that a patient is at high risk for CEA and the patient’s symptoms of carotid artery stenosis should be available in the patient medical records prior to performing any procedure.

The degree of carotid artery stenosis should be measured by duplex Doppler ultrasound or carotid artery angiography and recorded in the patient medical records. If the stenosis is measured by ultrasound prior to the procedure, then the degree of stenosis must be confirmed by angiography at the start of the procedure. If the stenosis is determined to be less than 70% by angiography, then CAS should not proceed.

In addition, CMS determines that CAS with embolic protection is reasonable and necessary only if performed in facilities that have been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes. Standards to determine competency will include specific physician training standards, facility support requirements, and data collection to evaluate outcomes during a required reevaluation.

The CMS created a list of minimum standards modeled in part on professional society statements on competency. All facilities must at least meet CMS’s standards in order to receive coverage for CAS for high risk patients.

  • Facilities must have necessary imaging equipment, device inventory, staffing, and infrastructure to support a dedicated carotid stent program. Specifically, high-quality X-ray imaging equipment is a critical component of any carotid interventional suite, such as high resolution digital imaging systems with the capability of subtraction, magnification, road mapping, and orthogonal angulation.
  • Advanced physiologic monitoring must be available in the interventional suite. This includes real time and archived physiologic, hemodynamic, and cardiac rhythm monitoring equipment, as well as support staff who are capable of interpreting the findings and responding appropriately.
  • Emergency management equipment and systems must be readily available in the interventional suite such as resuscitation equipment, a defibrillator, vasoactive and antiarrhythmic drugs, endotracheal intubation capability, and anesthesia support.
  • Each institution should have a clearly delineated program for granting carotid stent privileges and for monitoring the quality of the individual interventionalists and the program as a whole. The oversight committee for this program should be empowered to identify the minimum case volume for an operator to maintain privileges, as well as the (risk-adjusted) threshold for complications that the institution will allow before suspending privileges or instituting measures for remediation. Committees are encouraged to apply published standards from national specialty societies recognized by the American Board of Medical Specialties to determine appropriate physician qualifications. Examples of standards and clinical competence guidelines include those published in the December 2004 edition of the American Journal of Neuroradiology, and those published in the August 18, 2004, Journal of the American College of Cardiology.
  • To continue to receive Medicare payment for CAS under this decision, the facility or a contractor to the facility must collect data on all CAS procedures done at that particular facility. This data must be analyzed routinely to ensure patient safety, and will also be used in the process of re-credentialing the facility. This data must be made available to CMS upon request. The interval for data analysis will be determined by the facility but should not be less frequent than every 6 months.

Since there currently is no recognized entity that evaluates CAS facilities, CMS established a mechanism for evaluating facilities. Facilities must provide written documentation to CMS that the facility meets one of the following:

  1. The facility was an FDA-approved site that enrolled patients in prior CAS IDE trials, such as SAPPHIRE, and ARCHER;
  2. The facility is an FDA-approved site that is participating and enrolling patients in ongoing CAS IDE trials, such as CREST;
  3. The facility is an FDA-approved site for one or more FDA post-approval studies; or,
  4. The facility has provided a written affidavit to CMS attesting that the facility has met the minimum facility standards. This should be sent to:
    Director, Coverage and Analysis Group
    7500 Security Boulevard, Mailstop C1-09-06
    Baltimore, MD 21244.

The letter must include the following information:
Facility's name and complete address;
Facility's Medicare provider number;
Point-of-contact for questions with telephone number;
Mechanism of data collection of CAS procedures; and,
Signature of a senior facility administrative official.

A list of approved facilities will be made available and viewable at http://www.cms.gov/MedicareApprovedFacilitie/CASF/list.asp. In addition, CMS will publish a list of approved facilities in the "Federal Register". A new affidavit is required every two years to ensure that facilities maintain high standards.

5. Effective November 6, 2006, Medicare covers PTA and stenting of intracranial arteries for the treatment of cerebral artery stenosis ≥50% in patients with intracranial atherosclerotic disease when furnished in accordance with the Food and Drug Administration (FDA)-approved protocols governing Category B Investigational Device Exemption (IDE) clinical trials. CMS determines that coverage of intracranial PTA and stenting is reasonable and necessary under these circumstances.

C. Nationally Noncovered Indications

All other indications for PTA with or without stenting 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 November 2006.)

Cross Reference

Transmittal Information

Transmittal Number
64
Revision History

01/2007 - CMS has determined that PTA and stenting of intracranial arteries is reasonable and necessary for treatment of cerebral artery stenosis greater than or equal to 50% in patients with intracranial atherosclerotic disease when furnished in accordance with FDA-approved protocols governing Category B IDE clinical trials. Effective date: 11/06/2006. Implementation date: 02/05/2007. (TN 64) (CR5432)

04/2006 - Updated broken link to approved facilities. Effective and implementation dates NA.  (TN 53) (CR 5022)

04/2005 - Covered PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent with embolic protection. Effective date 03/17/2005. Implementation date 07/05/2005. (TN 33) (CR 3811)

10/2004 - Covered 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)

05/2001 - Covered 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)

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

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

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

Other

Coding Analyses for Labs (CALs)

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

Additional Information

Other Versions
Title Version Effective Between
Percutaneous Transluminal Angioplasty (PTA) 11 10/11/2023 - N/A View
Percutaneous Transluminal Angioplasty (PTA) 10 01/01/2013 - 10/11/2023 View
Percutaneous Transluminal Angioplasty (PTA) 9 12/09/2009 - 01/01/2013 View
Percutaneous Transluminal Angioplasty (PTA) 8 10/14/2008 - 12/09/2009 View
Percutaneous Transluminal Angioplasty (PTA) 7 05/12/2008 - 10/14/2008 View
Percutaneous Transluminal Angioplasty (PTA) 6 02/14/2008 - 05/12/2008 View
Percutaneous Transluminal Angioplasty (PTA) 5 04/30/2007 - 02/14/2008 View
Percutaneous Transluminal Angioplasty (PTA) 4 11/06/2006 - 04/30/2007 You are here
Percutaneous Transluminal Angioplasty (PTA) 3 03/17/2005 - 11/06/2006 View
Percutaneous Transluminal Angioplasty (PTA) 2 10/12/2004 - 03/17/2005 View
Percutaneous Transluminal Angioplasty (PTA) 1 07/01/2001 - 10/12/2004 View
CPT Copyright Statement
CPT only copyright 2002-2011 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.
Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.