NCD 20.7

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 percutaneous transluminal angioplasty (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 when used under the following conditions:

1. Treatment of 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. 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. Concurrent with Carotid Stent Placement in Food and Drug Administration (FDA)-Approved Category B Investigational Device Exemption (IDE) Clinical Trials

Effective July 1, 2001, Medicare covers PTA of the carotid artery concurrent with carotid stent placement when furnished in accordance with the FDA-approved protocols governing Category B 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 when provided in the context of such a clinical trial.

3. Concurrent with Carotid Stent Placement in FDA-Approved Post-Approval Studies

Effective October 12, 2004, Medicare covers PTA of the carotid artery concurrent with the placement of an FDA-approved carotid stent and an FDA-approved or –cleared embolic protection device (effective December 9, 2009) for an FDA-approved indication when furnished in accordance with FDA-approved protocols governing post-approval studies. The Centers for Medicare & Medicaid Services (CMS) determines that coverage of PTA of the carotid artery is reasonable and necessary in these circumstances.

4. Concurrent with Carotid Stent Placement

Effective October 11, 2023, CMS covers PTA of the carotid artery concurrent with stenting with the placement of an FDA-approved carotid stent with an FDA-approved or cleared embolic protection device, for Medicare beneficiaries under the following conditions:

A. Patients with symptomatic carotid artery stenosis ≥50%; and,

B. Patients with asymptomatic carotid artery stenosis ≥70%.

For both A and B above:

1. Neurological assessment by a neurologist or NIH stroke scale (NIHSS) certified health professional before and after CAS must be performed.

2. First-line evaluation of carotid artery stenosis must use duplex ultrasound.

3. Computed tomography angiography or magnetic resonance angiography, if not contraindicated, must be used to confirm the degree of stenosis and provide additional information about the aortic arch, and extra- and intra-cranial circulation.

4. Intra-arterial digital subtraction (catheter) angiography may be used only when there is significant

discrepancy between non-invasive imaging results, or in lieu of computed tomography angiography or magnetic resonance angiography if these are contraindicated.

Prior to furnishing CAS, the practitioner must engage in a formal shared decision-making interaction with the beneficiary. The shared decision-making interaction must include:

• Discussion of all treatment options including carotid endarterectomy (CEA), CAS (which includes transcarotid artery revascularization (TCAR), and optimal medical therapy (OMT)).

• Explanation of risks and benefits for each option specific to the beneficiary’s clinical situation.

• Integration of clinical guidelines (e.g., patient comorbidities and concomitant treatments).

• Discussion and incorporation of beneficiary’s personal preferences and priorities in choosing a treatment plan.

Facilities must establish and maintain institutional and physician standards to support a dedicated carotid stent program. These standards must at least include and ensure the following:

• Facilities have a clearly delineated program for granting carotid stent privileges and for monitoring patient outcomes for individual physicians and the program as a whole.

• The oversight committee for this program shall be empowered to identify the minimum case volume for a physician 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 specialty societies and widely-used, published professional society guidelines to determine appropriate physician qualifications.

• Facilities have appropriately trained staff capable of fulfilling roles and responsibilities as delineated under the dedicated carotid stent program.

• Facilities have appropriate supporting personnel and equipment for imaging, emergency management, advanced physiologic monitoring, and other ancillary care.

• Facilities must ensure continuous quality improvement by assessing procedural outcomes and making necessary programmatic adjustments to assure patient safety.

5. Concurrent with Intracranial Stent Placement in FDA-Approved Category B IDE Clinical Trials

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 FDA-approved protocols governing Category B IDE clinical trials. CMS determines that coverage of intracranial PTA and stenting is reasonable and necessary under these circumstances.

C. Nationally Non-Covered Indications

All other indications for PTA with or without stenting to treat obstructive lesions of the vertebral and cerebral arteries remain non-covered.

All other indications for PTA without stenting for which CMS has not specifically indicated coverage remain non-covered.

D. Other

In addition to the national coverage described above, Medicare Administrative Contractors (MACs) may make reasonable and necessary determinations under section 1862(a)(1)(A) of the Social Security Act for any other beneficiary seeking coverage for PTA of the carotid artery concurrent with stenting.

Coverage of PTA with stenting not specifically addressed or discussed in this NCD is at the discretion of the MACs.

(This NCD last reviewed October 2023)

Revision History

04/2024 - Transmittal 12571 issued April 11, 2024, The purpose of this Change Request (CR) is to make contractors aware of policy updates for Percutaneous Transluminal Angioplasty (PTA) of the Carotid Artery Concurrent with

Stenting sections B4 and D of NCD 20.7. (TN 12571) (CR13512)

04/2023 - Transmittal 11884 issued March 01, 2023, is being rescinded and replaced by Transmittal 11952, dated, April 12, 2023, to remove the A/B MACs (Part A) and FISS from BR 13070.1 and to revise the NCD 20.4 Implantable Automatic Defibrillators (ICDs) spreadsheet. All other information remains the same. (TN 11952) (CR13070)

02/2023 - The purpose of the Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 11832) (CR13070)

09/2019 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 2362) (CR11392)

01/2019 - This Change Request (CR) contains language-only changes for updating the New Medicare Card Project-related language in Pub 100-03. There are no new coverage policies, payment policies, or codes introduced in this transmittal. Specific policy changes and related business requirements have been announced previously in various communications. (TN 212) (CR11118)

11/2018 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html, along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process.(TN 2202) (CR11005)

11/2016 - This change request (CR) is the 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, and CR9631. Some are the result of revisions required to other NCD-related CRs released separately.

Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1753) (CR9751)

08/2016 - This change request (CR) is the 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, and CR9631. Some are the result of revisions required to other NCD-related CRs released separately.

Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1708) (CR9751)

06/2016 - Transmittal 1665, dated May 13, 2016, is being rescinded and replaced by Transmittal 1672 to: (1) 9631.1: Remove FISS responsibility and 1st sentence; (2) 9631.2: Remove additional procedure codes, including 0075T, 0076T; (3) 9631.4: Revise descriptor of dx L59.8; (4) 9631.6: Add deletion of dx C49.10, C65.9, remove deletion of dx C54.9, remove deletion of invalid dx C47.90; (5) 9631.8: Remove deletion of invalid dx C51.29, replace with deletion of dx C50.029; (6) 9631.9: Add deletion of 0V504ZZ, 0V500ZZ, override capability, and contractor discretion verbiage. All other information remains the same. (TN 1672) (CR9631)

05/2016 - This change request (CR) is the 7th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, and CR9540. Some are the result of revisions required to other NCD-related CRs released separately.

Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1665) (CR9631)

12/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1580 ) (CR9252)

08/2015 - This change request (CR) is the 3rd maintenance update of ICD-10 conversions/updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, & CR9087. Some are the result of revisions required to other NCD-related CRs released separately that included ICD-10 coding.

These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 01/04/2016 Effective date: 10/1/2015. (TN 1537) (CR 9252)

05/2014 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/06/2014 Effective date: 10/1/2015. (TN 1388) (TN 1388) (CR 8691)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)

02/2013 - This change request serves to update the address identified in the NCD to which the approval request letters and recertification letters must be sent. Effective date: 01/01/2013. Implementation date: 03/11/2013. (TN 151) (CR8199)

03/2010 - Contractors shall be aware that percutaneous transluminal angioplasty (PTA) concurrent with carotid artery stenting (CAS) system placement in Food and Drug Administration-Approved post-approval studies, and PTA Concurrent with CAS system placement in patients at high risk for carotid endarterectomy includes revised language specific to embolic protection devices. Effective date: 12/09/2009. Implementation date: 04/05/2010. (TN 115) (CR6839)

12/2008 - CMS has decided to make no changes to the national coverage determination (NCD) for percutaneous transluminal angioplasty (PTA) of the carotid artery concurrent with stenting. Effective date: 10/14/2008. Implementation date: 01/26/2009. (TN 98) (CR6301)

07/2008 - CMS reaffirmed its existing National Coverage Decision for PTA with Intracranial Stenting. Effective date: 05/12/2008. Implementation date: 08/11/2008. (TN 87) (CR6137)

04/2008 - CMS has reviewed the evidence and determined that Medicare coverage of PTA of the renal arteries and PTA concurrent with renal artery stent placement should not be changed. Therefore, coverage remains as described in section 20.7 and at the discretion of local Medicare contractors, respectively. Effective date: 02/14/2008. Implementation date: 05/05/2008. (TN 81) (CR5984)

09/2007 - Transmittal 71, Change Request 5660, Dated June 29, 2007 is RECINDED AND REPLACED WITH THIS TRANSMITTAL (TN 77).

06/2007 - CMS clarifies use of PTA concurrent with carotid stent placement for patients at high risk for carotid endarterectomy and process facilities must follow for certification and recertification. Effective date: 04/30/2007. Implementation date: 07/30/2007. (TN 71) (CR5660)

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)