SUPERSEDED Local Coverage Determination (LCD)

Non-Invasive Evaluation of Extremity Veins

L33693

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Proposed LCD
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Superseded
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Document Note

Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L33693
Original ICD-9 LCD ID
Not Applicable
LCD Title
Non-Invasive Evaluation of Extremity Veins
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 12/17/2020
Revision Ending Date
01/27/2024
Retirement Date
N/A
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for Non-Invasive Evaluation of Extremity Veins. Federal statute and subsequent Medicare regulations regarding provision and payment for medical services are lengthy. They are not repeated in this LCD. Neither Medicare payment policy rules nor this LCD replace, modify or supersede applicable state statutes regarding medical practice or other health practice professions acts, definitions and/or scopes of practice. All providers who report services for Medicare payment must fully understand and follow all existing laws, regulations and rules for Medicare payment for Non-Invasive Evaluation of Extremity Veins and must properly submit only valid claims for them. Please review and understand them and apply the medical necessity provisions in the policy within the context of the manual rules. Relevant CMS manual instructions and policies may be found in the following Internet-Only Manuals (IOMs) published on the CMS Web site.

Internet Only Manual (IOM) Citations:

  • CMS IOM Publication 100-02, Medicare Benefit Policy Manual,
    • Chapter 15, Section 80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests
  • CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual,
    • Chapter 1, Part 1, Section 20.14 Plethysmography and Section 20.29 Hyperbaric Oxygen Therapy
    • Chapter 1, Part 4, Section 220.5 Ultrasound Diagnostic Procedures (Effective May 22, 2007)
  • CMS IOM Publication 100-08, Medicare Program Integrity Manual,
    • Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD 

Social Security Act (Title XVIII) Standard References:  

  • Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury. 
  • Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations. 
  • Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim. 

Federal Register References:

  • Code of Federal Regulations (CFR), Title 42, Volume 2, Chapter IV, Part 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions and Part 410.33 Independent diagnostic testing facility.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

History/Background and/or General Information

Non-invasive vascular diagnostic studies utilize ultrasonic Doppler to assess irregularities in blood flow in the venous system. Vascular studies include patient care required to perform the studies, supervision of the studies and interpretation of study results with copies for patient records of hard copy output with analysis of all data, including bidirectional vascular flow or imaging when provided. The display may be a two-dimensional image with spectral analysis and color flow or a plethysmographic recording that allows for quantitative analysis.

The use of a simple hand-held or other Doppler device that does not produce hard copy output, or that produces a record that does not permit analysis of bidirectional vascular flow, is considered to be part of the physical examination of the vascular system and is not separately reported (CPT code book 2010). The appropriate assignment of a specific ultrasound CPT code is not solely determined by the weight, size, or portability of the equipment, but rather by the extent, quality, and documentation of the procedure. If an examination is performed with hand-carried equipment, the quality of the exam, printout, and report must be in keeping with accepted national standards.

Definitions

A duplex scan is an ultrasonic scanning procedure with display of both two-dimensional structure and motion with time and Doppler ultrasonic signal documentation with spectral analysis and/or color flow velocity mapping or imaging.

Plethysmography implies volume measurement procedures including air impedance or strain gauge methods. Plethysmography involves the measurement and recording (by one of several methods) of changes in the size of a body part as modified by the circulation of blood in that part.

Covered Indications

Non-invasive evaluation of extremity veins will be considered to be medically necessary under any of the following circumstances:

  • The patient has deep venous thrombophlebitis or has clinical findings (otherwise unexplained limb pain, swelling) which suggest the possibility of acute deep venous thrombophlebitis.
  • The patient presents with signs and symptoms of pulmonary embolism (PE) indicated by dyspnea, chest pain, and/or hemoptysis.
  • The patient has acute pulmonary embolism.
  • Evaluation of patient with symptomatic varicose veins such as stasis ulcer of the lower leg, significant pain and significant edema that interferes with activities of daily living that have not resolved following three months of conservative therapy, and symptoms are suspected to be secondary to venous insufficiency, and testing is performed to confirm this diagnosis by documenting venous valvular incompetence prior to an invasive therapeutic intervention, which meets criteria for medical necessity as outlined in the LCD L38720 for Treatment of Chronic Venous Insufficiency of the lower extremities.
  • The patient has chronic venous insufficiency, post phlebitic syndrome, or lymphedema.
  • The patient has sustained trauma and injury of the venous system is suspected, making evaluation of the venous system of extremities necessary.
  • Venous mapping for the selection of a vein suitable for creating a dialysis fistula or prior to revascularization.
  • Evaluation of possible venous obstruction or thrombosis in hospitalized patients who have recently undergone procedures, which predispose them to thrombosis and who would not have been therapeutically anti-coagulated otherwise (e.g., hip replacements, knee replacements).

Venous mapping is not always indicated as a routine pre-operative study. However, this procedure may be useful prior to surgical revascularization or creation of a dialysis fistula as part of the patient’s clinical evaluation in determination of an adequate venous conduit

Limitations

Since the signs and symptoms of arterial occlusive disease and venous disease are so divergent, the performance of simultaneous arterial and venous studies during the same encounter should be rare. Consequently, documentation must clearly support the medical necessity of both procedures if performed during the same encounter, and be available upon request.

Non-invasive vascular studies are considered medically necessary only if the outcome will potentially impact the clinical course of the patient. For example, if a patient is (or is not) proceeding on to other diagnostic and/or therapeutic procedures regardless of the outcome of non-invasive studies, and non-invasive vascular procedures will not provide any unique diagnostic information that would impact patient management, then the non-invasive procedures are not medically necessary. If it is obvious from the findings of the history and physical examination that the patient is going to proceed to angiography, then non-invasive vascular studies are not medically necessary.

Performance of both non-invasive extracranial arterial studies and non-invasive evaluation of extremity veins during the same encounter is not appropriate as a general practice or standing protocol, and therefore, would not generally be expected (American College of Radiology, 2010). Consequently, documentation must clearly support the medical necessity if both procedures are performed during the same encounter, and be available upon request.

It is not considered medically reasonable and necessary to study asymptomatic varicose veins.

Generally, it is not expected that these services would be performed more than once a year, excluding inpatient hospital and emergency room places of service.

Please refer to the CMS IOM Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Part 1, Section 20.14 Plethysmography for covered and noncovered procedures.

As published in the CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4, an item or service may be covered by a contractor LCD if it is reasonable and necessary under the Social Security Act Section 1862 (a)(1)(A). Contractors shall determine and describe the circumstances under which the item or service is considered reasonable and necessary.

Provider Qualifications

The accuracy of non-invasive vascular diagnostic studies depends on the knowledge, skill and experience of the technologist and the physician performing the interpretation of the study. Consequently, the technologist and the physician must maintain proof of training and experience.

All non-invasive vascular diagnostic studies must be: (1) performed by a qualified physician, or (2) performed under the general supervision of a qualified physician by a technologist who has demonstrated minimum entry level competency by being credentialed in vascular technology, and/or (3) performed in a laboratory accredited in vascular technology.

The CMS IOM, Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 outlines that “reasonable and necessary” services are “ordered and/or furnished by qualified personnel.” Services will be considered medically reasonable and necessary only if performed by appropriately trained providers.

A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare. B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

Examples of certification in vascular technology for non-physician personnel include:

  • Registered Vascular Technologist (RVT) credential
  • Registered Vascular Specialist (RVS) credential 
  • Registered Phlebology Sonographer (RPhS)
  • Registered Technologist in Vascular Sonography (R.T. [VS])

These credentials must be provided by nationally recognized credentialing organizations such as:

  • The American Registry of Diagnostic Medical Sonographers (ARDMS) which provides RDMS and RVT credentials 
  • The Cardiovascular Credentialing International (CCI) which provides RVS and RPhS credentials
  • The American Registry of Radiologic Technologists (ARRT)

Appropriate nationally recognized laboratory accreditation bodies include:

  • Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL)
  • American College of Radiology (ACR)

However, if the facility has a documented process for grand-fathering experienced technicians who have performed the services referenced in this LCD (a process addressing years of service and experience with number of supervised cases), this documentation should be available upon request; otherwise the provider must have documentation available upon request which indicates that the technician meets the credentialing requirements as stated above or is in the process of obtaining this credentialing.

Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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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
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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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
View Letter
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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

Documentation Requirements

Please refer to the Local Coverage Article: Billing and Coding: Non-Invasive Evaluation of Extremity Veins (A57125) for documentation requirements that apply to the reasonable and necessary provisions outlined in this LCD.

Utilization Guidelines

Please refer to the Local Coverage Article: Billing and Coding: Non-Invasive Evaluation of Extremity Veins (A57125) for utilization guidelines that apply to the reasonable and necessary provisions outlined in this LCD.

Sources of Information

First Coast Service Options, Inc. reference LCD number(s) – L28957, L29234, L29369

Abuhamad, A., Benacerraf, B., Woletz, P., Burke, B. (2004). The accreditation of ultrasound practices – Impact on compliance with minimum performance guidelines. J Ultrasound Med, 23, 1023-1029.

American College of Radiology Practice Guidelines. (2006). ACR Practice guidelines for the performance of peripheral venous ultrasound examination.

Other Contractor's Policies

Pellerito, J.S. (2001). Current approach to peripheral arterial sonography. Radiologic Clinics of North America. (39), 3. 553-567. This source was used to provide indications.

Society for Vascular Ultrasound–Professional performance guidelines. (2004). Lower extremity venous insufficiency evaluation. (2003). Upper extremity vein mapping.

Stanley, D. (2004). The importance of Intersocietal Commission for the accreditation of vascular laboratories (ICAVL) certification for noninvasive peripheral vascular tests: The Tennessee experience. The Journal for Vascular Ultrasound, 28(2), 65-69.

The complete ICAVL standards for accreditation in noninvasive vascular testing. Parts I through VII. (2010). ICAVL Standards.

Bibliography

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Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
12/17/2020 R6

LCD revised and published on 12/17/2020 to update the reference to the LCD for the treatment of varicose veins in the ‘Covered Indications’ section, Bullet #4 with the title of the new LCD ‘Treatment of Chronic Venous Insufficiency of the Lower Extremities’ (L38720) in response to the new LCD becoming effective 12/27/2020.
2020PITLAB017

  • Other (Non Substantive Change)
10/01/2019 R5

Revision Number: 5
Publication: September 2019 Connection
LCR A/B2019-058

Explanation of Revision: Based on Change Request (CR) 10901, the LCD was revised to remove all billing and coding and all language not related to reasonable and necessary provisions (“Bill Type Codes”, “Revenue Codes”, “CPT/HCPCS Codes”, “ICD-10 Codes that Support Medical Necessity”, “Documentation Requirements” and “Utilization Guidelines” sections of the LCD) and place them into a newly created billing and coding article. During the process of moving the ICD-10-CM diagnosis codes to the billing and coding article, the ICD-10-CM diagnosis code ranges were broken out and listed individually. In addition, the Social Security Act, Code of Federal Regulations, and IOM reference sections were updated. The effective date of this revision is for claims processed on or after January 8, 2019, for dates of service on or after October 3, 2018.

Based on CR 11322/CR 11333 (Annual 2020 ICD-10-CM Update) the newly created Billing and Coding Article was revised. Added ICD-10-CM diagnosis codes I26.93, I26.94, I48.20, I48.21, I80.241, I80.242, I80.243, I80.251, I80.252, I80.253, I82.451, I82.452, I82.453, I82.461, I82.462, I82.463, I82.551, I82.552, I82.553, I82.561, I82.562, and I82.563. Deleted ICD-10-CM diagnosis code I48.2. The effective date of this revision is for dates of service on or after 10/01/19.

10/01/2019:  At this time 21st Century 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 LCD.

  • Revisions Due To ICD-10-CM Code Changes
  • Other (Revisions based on CRs 10901, 11322, 11333)
10/01/2017 R4

Revision Number: 4

Publication: September 2017 Connection 

LCR A/B2017-038 

Explanation of Revision: Based on CR 10153 (Annual 2018 ICD-10-CM Update) the LCD was revised. Descriptor revised for ICD-10-CM diagnosis codes I82.819, I83.899. The effective date of this revision is based on date of service.

 

10/01/2017:  At this time 21st Century 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.

  • Revisions Due To ICD-10-CM Code Changes
01/01/2017 R3 Revision Number: 3
Publication: December 2016 Connection
LCR A/B2017-001

Explanation of Revision: Based on CR 9752 (Annual 2017 HCPCS Update), the LCD was revised. CPT code 93965 was deleted in the “CPT/HCPCS Codes” section of the LCD and all reference to CPT code 93965 was deleted in the “Documentation Requirements” and “Limitations” sections of the LCD. The effective date of this revision is based on date of service.
  • Revisions Due To CPT/HCPCS Code Changes
10/01/2016 R2 Revision Number: 2
Publication: October 2016 Connection
LCR A/B2016-097

Explanation of Revision: Based on CR 9677 (Annual 2017 ICD-10-CM Update) the LCD was revised for descriptor change to ICD-10-CM diagnosis code range T82.817A-T82.818S. The effective date of this revision is based on date of service.
  • Revisions Due To ICD-10-CM Code Changes
01/12/2016 R1 Revision Number: 1
Publication: January 2016 Connection
LCR A/B2016-025
Explanation of Revision: This LCD is being revised to replace CPT code 93881 with 93882 in the “Limitations” and “Documentation Requirements” sections of the LCD. The effective date of this revision is based on process date
  • Other
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Associated Documents

Attachments
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Related Local Coverage Documents
Articles
A57125 - Billing and Coding: Peripheral Venous Ultrasound
Related National Coverage Documents
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Public Versions
Updated On Effective Dates Status
12/08/2023 01/28/2024 - N/A Currently in Effect View
12/09/2020 12/17/2020 - 01/27/2024 Superseded You are here
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

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