Local Coverage Determination (LCD)

Non-Coronary Vascular Stents

L35998

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L35998
Original ICD-9 LCD ID
Not Applicable
LCD Title
Non-Coronary Vascular Stents
Proposed LCD in Comment Period
N/A
Source Proposed LCD
DL35998
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 01/01/2023
Revision Ending Date
N/A
Retirement Date
N/A
Notice Period Start Date
08/01/2015
Notice Period End Date
09/15/2015

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Issue

Issue Description

Review completed with no changes in coverage.

Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

CMS Pub. 100-03 Medicare National Coverage Determination (NCD) Manual, Chapter 1-Coverage Determinations, Part 1, Section 20.7-Percutaneous Transluminal Angioplasty
National Coverage Analysis (NCA) for Percutaneous Transluminal Angioplasty (PTA) and Stenting of the Renal Arteries (CAG-00085R4)
CMS Pub. 100-08 Medicare Program Integrity Manual, Chapter 13- Local Coverage Determinations, Section 13.5 - Content of an LCD and Section 13.5.1-Reasonable and Necessary Provisions in LCDs

Social Security Act (Title XVIII) Sections:
1862 (a)(1)(A) Medically Reasonable & Necessary
1862 (a)(1)(D) Investigational or Experimental
1862 (a)(7) Screening (Routine Physical Checkups)

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Vascular stents are used to enhance primary patency in arteries and veins, usually at the site of stenotic or occlusive lesions. Stents also may be used as an adjunct to technically inadequate Percutaneous Transluminal Angioplasty (PTA) or in cases where PTA alone will not be expected to provide a durable result. Peripheral vascular stenting may be indicated for patients with symptomatic arterial and venous disease resulting from an occlusive process. This LCD does not address carotid artery stenting, which is subject to National Coverage Determination 20.7.

PTA and stenting of vessels is covered only when all of the following conditions are met:

  • The patient has undergone prior thorough medical evaluation and management of symptoms. See below under specific categories for guidelines on medical evaluation and management recommendations.
  • Surgical intervention would otherwise be considered as an alternative treatment for the patient.
  • A stent may be placed as a planned adjunct to PTA rather than in response to a suboptimal or failed PTA (so-called primary stent deployment). Primary stenting is justified for situations where PTA alone is not expected to provide a durable result, such as arterial or venous occlusions that carry a high risk for distal embolization or rapid recurrence OR occlusive lesions known to be unfavorable for PTA alone such as significantly calcified lesions, eccentric lesions, lesions related to external compression (e.g., May-Thurner syndrome and malignant compression of the superior vena cava), or ostial renal artery stenosis.

Coverage for non-coronary vascular stents depends on the use of an FDA-approved stent. Several different stents are currently used in the medical community. Each device has specific indications described by the FDA for approved market uses. Stent placement is covered by Medicare only when an FDA-approved stent is:

  • Used for the FDA-approved indications, OR
  • Used for the above indications supported by the peer medical literature.

Specific Arterial Indications for PTA and Stenting

  • Brachiocephalic arteries: PTA and stenting may be indicated for treatment of flow-limiting stenosis resulting in conditions such as subclavian steal syndrome, upper extremity claudication, ischemic rest pain of the arm and hand, non-healing tissue ulceration and focal gangrene. Stenting of the inflow arteries, such as the innominate or subclavian when they are the inflow vessels of an arteriovenous fistula for chronic hemodialysis and are significantly stenotic, is often useful.
  • Pulmonary artery: PTA and stenting may be indicated for certain people with congenital pulmonary artery stenosis.
  • Renal artery: PTA and stenting may be indicated for renal artery stenosis. The following guidelines should be followed when making determination for RAS:

    Renal artery stenting is considered appropriate for renal artery dissection; renal artery aneurysm and renal artery atherosclerosis greater than 50% in a transplanted kidney. 

    Renal artery stenting is considered appropriate under the following conditions:
    Flash pulmonary edema or acute coronary syndrome (ACS) with severe hypertension;
    Resistant HTN (Uncontrolled hypertension with failure of maximally tolerated doses of at least three antihypertensive agents, one of which is a diuretic, or intolerance to medications); or
    Ischemic nephropathy with chronic kidney disease (CKD) with eGFR < 45 cc/min and global renal ischemia (unilateral significant renal artery stenosis with a solitary kidney or bilateral significant renal artery stenosis ) without other explanation.

    Renal artery stenting may be considered appropriate under the following conditions:
    Unilateral renal artery stenosis with CKD (eGFR < 45cc/min).
    Unilateral renal artery stenosis with prior episodes of congestive heart failure (Stage C).
    Anatomically challenging or high-risk lesion (early bifurcation, small vessel, severe concentric calcification, and severe aortic atheroma or mural thrombus).

    Renal artery stenting is rarely considered appropriate under the following conditions:
    Unilateral, solitary, or bilateral renal artery stenosis with controlled BP and normal renal function.
    Unilateral, solitary, or bilateral renal artery stenosis with kidney size < 7cm in pole-to-pole length.
    Unilateral, solitary, or bilateral renal artery stenosis with chronic end stage renal disease on hemodialysis > 3 months.
    Unilateral, solitary, or bilateral renal artery chronic total occlusion.
  • Lower extremity arteries (aorto-iliac, superficial femoral and infra-popliteal arteries): PTA and stent placement in infra-popliteal vessels is not expected to be often indicated and in those cases the rationale for stent placement must be thoroughly explained in the record.

    PTA and stenting for critical limb ischemia is considered appropriate under the following conditions: Limb threatening lower extremity ischemia.

    PTA and stenting for claudication may be appropriate under the following conditions: Individuals who have failed medical management and home exercise program and continue to have significant activity limiting disease, with an anatomically suitable lesion for intervention. Medical management of peripheral artery disease (PAD) should include Class I recommendations for antiplatelet therapy, statins, home exercise program, smoking cessation including planning, counseling or behavior modification and pharmacotherapy if needed.
  • Mesenteric vessels: This includes acute mesenteric ischemia, chronic mesenteric ischemia, mesenteric thrombosis, dissection, or any other vascular insufficiency resulting in gastrointestinal symptoms. Stenting of the mesenteric vessels is covered only when angioplasty of the vessels would not suffice and after the patient has had a thorough medical evaluation and management of symptoms, and for whom surgical intervention is the likely alternative. The eligible patients will be required to have multiple comorbidities documented making them poor candidates for open surgical procedures. In these situations, PTA and stent placement should be considered an alternative to surgery and not an addition to medical management.
  • Hemodialysis access graft/fistula: This includes stenosis, restenosis, occlusion and pseudoaneurysm.

Specific Venous Stents

  • Superior vena cava and subclavian/innominate veins stents: PTA and stenting are covered for superior vena cava syndrome, post-radiation venous stenosis, congenital stenosis, and thrombosis and embolism, including acute thrombophlebitis. Stenting of the veins, such as the innominate, subclavian, or superior vena cava when they are the outflow vessels of an arteriovenous fistula for chronic hemodialysis and are significantly stenotic, is often useful.
  • Inferior vena cava and iliofemoral veins: This includes vena caval and iliofemoral venous occlusions and stenosis due to the following: post-radiation venous stenosis, congenital stenosis or webs, extrinsic venous compression (May-Thurner syndrome), thrombophlebitis, and symptomatic post-traumatic venous stenosis.

Sequential Procedures
Vascular obstructions may be caused by thrombosis, embolism, atherosclerosis, or other conditions and may be multifocal in a single vascular family or in multiple vascular families. Management options to maintain or re-establish the patency of a vessel in a particular vascular family include surgery, thrombectomy, embolectomy, endarterectomy, thrombolysis, atherectomy, angioplasty, and stent placement. These procedures may be performed alone or in sequence. The subsequent procedure(s) is necessary because the initial approach was unsuccessful or only partially successful in accomplishing the intended goal (that is, to maintain or re-establish the patency of a vessel). An example of this situation is when an atherectomy is followed by an angioplasty and the angioplasty followed by the placement of a stent.
Limitations

  1. The placement of a stent in a vessel for which there is no objective-related symptom or limitation of function is considered to be preventive, and therefore, not covered by Medicare.
  2. Use of non-coronary vascular stents is covered only after the patient has had a thorough evaluation and treatment of symptoms and when PTA of the vessel alone has not, or is not expected to sufficiently resolve the symptoms making surgery the likely alternative.
  3. A non-coronary intravascular stent(s) that carries an Investigational Device Exemption (IDE) may be covered under Medicare. Medicare coverage of IDE devices is predicated, in part, upon their status with the FDA. Payment will cease in the event a manufacturer loses (or violates relevant IDE requirements necessitating FDA’s withdrawal of) IDE approval. The FDA issues a special identifier number that corresponds to each device or stent(s) granted an IDE.

Training and Competency Requirements

Physicians who perform vascular stent procedures must possess the knowledge, skills, training, and experience necessary to properly select suitable patients who will benefit from and not be harmed by stent therapy as opposed to other intervention, perform the procedures safely, and recognize and handle complications of stent placement. Practitioners who perform and report these services for Medicare payment must have satisfied training and competency guidelines in peripheral vascular medicine and intervention as part of a formal postgraduate training program in radiology, cardiology, or general/vascular surgery. Alternatively, physicians must have completed supervised training in vascular medicine and intervention as published by a recognized specialty organization of the same stature as the American College of Radiology, American College of Cardiology or American College of Surgery.

Medicare expects that any provider who seeks and receives payment for these services is prepared to substantiate his training and experience if asked to do so by Medicare.

Notice: As published in CMS IOM Pub.100-08, Section 13.5.1, in order to be covered under Medicare, a service shall be reasonable and necessary. The service provided should have an appropriate duration and frequency in terms of whether it is:

  1. Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the patient's condition or to improve the function of a malformed body member.
  2. Furnished in a setting appropriate to the patient's medical needs and condition.
  3. Ordered and furnished by qualified personnel.
  4. One that meets but does not exceed, the patient's medical needs and at least as beneficial as an existing and available medically appropriate alternative.
Summary of Evidence

NA

Analysis of Evidence (Rationale for Determination)

NA

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
N/A
Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
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N/A
Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

Code Description

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

Group 1

Group 1 Paragraph:

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Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

Group 1

Group 1 Paragraph:

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Group 1 Codes:

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Additional ICD-10 Information

General Information

Associated Information
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Sources of Information
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Bibliography
  1. Anderson JL, Halperin JL, Albert N, et al. Management of patients with peripheral artery disease (compilation of 2005 and 2011 ACCF/AHA guideline recommendations). Journal of the American College of Cardiology. 2013;61(14):1555-1570. doi:10.1016/j.jacc.2013.01.004
  2. Armstrong EJ, Chen DC, Westin GG, et al. Adherence to guideline-recommended therapy is associated with decreased major adverse cardiovascular events and major adverse limb events among patients with peripheral arterial disease. Journal of the American Heart Association. 2014;3(2). doi:10.1161/jaha.113.000697
  3. Berger JS, Hiatt WR. Medical therapy in peripheral artery disease. Circulation. 2012;126(4):491-500. doi:10.1161/circulationaha.111.033886
  4. Cooper CJ, Murphy TP, Cutlip DE, et al. Stenting and medical therapy for atherosclerotic renal-artery stenosis. New England Journal of Medicine. 2014;370(1):13-22. doi:10.1056/nejmoa1310753
  5. Klein AJ, Feldman DN, Aronow HD, et al. SCAI expert consensus statement for aorto-iliac arterial intervention appropriate use. Catheterization and Cardiovascular Interventions. 2014;84(4):520-528. doi:10.1002/ccd.25505
  6. Murphy TP, Hirsch AT, Ricotta JJ, et al. The claudication: Exercise vs. Endoluminal Revascularization (clever) study: Rationale and methods. Journal of Vascular Surgery. 2008;47(6):1356-1363. doi:10.1016/j.jvs.2007.12.048
  7. Murphy TP, Cutlip DE, Regensteiner JG, et al. Supervised exercise versus primary stenting for Claudication resulting from AORTOILIAC peripheral artery disease. Circulation. 2012;125(1):130-139. doi:10.1161/circulationaha.111.075770
  8. Parikh SA, Shishehbor MH, Gray BH, White CJ, Jaff MR. SCAI expert consensus statement for renal artery stenting appropriate use. Catheterization and Cardiovascular Interventions. 2014;84(7):1163-1171. doi:10.1002/ccd.25559
  9. Rooke TW, Hirsch AT, Misra S, et al. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (updating the 2005 guideline). Journal of the American College of Cardiology. 2011;58(19):2020-2045. doi:10.1016/j.jacc.2011.08.023

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
01/01/2023 R14

Posted 08/31/2023 Review completed with no changes in coverage 07/18/2023.

  • Other
10/28/2021 R13

10/28/2021 Sources of Information updated to AMA format and moved under Bibliography. Review completed 10/04/2021.

  • Other
08/27/2020 R12

08/27/2020 Review completed 08/05/2020 with no change in coverage. Formatting changes made to spell out RAS to either renal artery stenting or renal artery stenosis.

  • Other
11/01/2019 R11

Change Request 10901 Local Coverage Determinations (LCDs): it will no longer be appropriate to include Current Procedure Terminology (CPT)/Health Care Procedure Coding System (HCPCS) codes or International Classification of Diseases Tenth Revision-Clinical Modification (ICD-10-CM) codes in the LCDs. All CPT/HCPCS, ICD-10 codes, and Billing and Coding Guidelines have been removed from this LCD and placed in the Billing and Coding Article related to this LCD. Consistent with Change Request 10901, if any language from IOMs and/or regulations was present in the LCD, it has been removed and the applicable manual/regulation has been referenced.

  • Revisions Due To Code Removal
10/01/2019 R10

09/26/2019 ICD-010 code update: Description change in Group 9: I70.238, I70.248.

  • Revisions Due To ICD-10-CM Code Changes
10/01/2018 R9

10/01/2018 Annual review done 08/31/2018. Formatting changes made to CMS National Coverage Policy section. Typographical error corrected.

  • Other (Annual Review)
10/01/2017 R8

10/01/2017 Annual review done 09/01/2017. No change in coverage. At this time 21st Centruy Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Other (Annual Review)
04/01/2017 R7 04/01/2017 Added diagnosis codes I82.411, I82.412, I82.413, I82.421, I82.422 and I82.423 to Group 5 venous CPT codes 37238 and 37239.
  • Reconsideration Request
02/01/2017 R6 02/01/2017 Added diagnosis codes T82.858A, T82.858D and T82.858S to Group 9 codes for lower extremity arteries, effective 02/01/2017.
  • Reconsideration Request
10/01/2016 R5 10/01/2016 Annual review done. Formatting changes made. Clarified the wording for the conditions considered appropriate for renal arterial stenosis (RAS) by adding the word “or”. Per ICD-10 Code updates: in Group 3 description code changes made to codes T82.818A, T82.828A, T82.838A, T82.848A, T82.858A, and T82.868A; in Group 4 deleted code K55.0 and added codes K55.011, K55.012, K55.019, K55.021, K55.022, K55.029, K55.031, K55.032, K55.039, K55.041, K55.042, K55.049, K55.051, K55.052, K55.059, K55.061, K55.062, and K55.069; and in Group 9 deleted code Q25.2 and added codes Q25.21 and Q25.29, effective 10/01/2016.

  • Other (Annual Review )
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R4 05/01/2016: Group 9 Paragraph CPT/HCPCS added 37236 and 37237 for non-occlusive disease of lower extremities-effective 10/01/2015.
  • Revisions Due To CPT/HCPCS Code Changes
  • Other (CPT/HCPCS code addition )
10/01/2015 R3 01/01/2016: Effective for 10/01/2015: Added I72.1 to Group 1 ICD-10 codes and I71.3, I71.4, I72.3, I72.4 to Group 9 ICD-10 codes. Added verbiage under Specific Venous Stents to include stenting of veins (innominate, subclavian or superior vena cava) when outflow vessels of AV fistula and are significantly stenotic.
  • Other (ICD 10 code additions)
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R2 12/01/2015: Effective for 10/01/2015-added the following ICD 10 codes to Group 9: I70.231-I70.238, I70.241-I70.248, I70.301-I70.303, I70.311-I70.313, I70.321-I70.323, I70.331-I70.338, I70.341-I70.348, I70.361-I70.363, I70.401-I70.403, I70.411-I70.413, I70.421-I70.423, I70.431-I70.438, I70.441-I70.448, I70.461-I70.463, I70.491-I70.493, I70.501-I70.503, I70.511-I70.513, I70.521-I70.523, I70.531-I70.538, I70.541-I70.548, I70.561-I70.563, I70.591-I70.593, I70.601-I70.603, I70.611-I70.613, I70.621-I70.623, I70.631-I70.638, I70.641-I70.648, I70.661-I70.663,I70.691-I70.693, I70.701-I70.703, I70.711-I70.713, I70.721-I70.723, I70.731-I70.738, I70.741-I70.748, I70.761-I70.763, I70.791-I70.793 Added I70.218 to Group 1. Added stenting of inflow arteries of an AV fistula if significantly stenotic as an indication under Brachiocephalic arteries section. Added pseudoaneurysm as an indication under Hemodialysis access graft/fistula section. Removed CAC information per CMS guidance.
  • Revisions Due To ICD-10-CM Code Changes
10/01/2015 R1 09/01/2015: Added 7th digit instructions to group 3 and 5 codes. Updated J5 National list.
  • Other
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Associated Documents

Attachments
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Related National Coverage Documents
NCDs
20.7 - Percutaneous Transluminal Angioplasty (PTA)
Public Versions
Updated On Effective Dates Status
08/23/2023 01/01/2023 - N/A Currently in Effect You are here
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