LCD Reference Article Response To Comments Article

Response to Comments: Treatment of Chronic Venous Insufficiency of the Lower Extremities

A58378

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Novitas Solutions, Inc.	A and B MAC	04111 - MAC A	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04112 - MAC B	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04211 - MAC A	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04212 - MAC B	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04311 - MAC A	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04312 - MAC B	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04411 - MAC A	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04412 - MAC B	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04911 - MAC A	J - H	Colorado New Mexico Oklahoma Texas
Novitas Solutions, Inc.	A and B MAC	07101 - MAC A	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07102 - MAC B	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07201 - MAC A	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07202 - MAC B	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07301 - MAC A	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	07302 - MAC B	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	12101 - MAC A	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12102 - MAC B	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12201 - MAC A	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12202 - MAC B	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12301 - MAC A	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12302 - MAC B	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12401 - MAC A	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12402 - MAC B	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12501 - MAC A	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12502 - MAC B	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12901 - MAC A	J - L	Delaware District of Columbia Maryland New Jersey Pennsylvania

Article Information

General Information

Article ID
A58378

Article Title
Response to Comments: Treatment of Chronic Venous Insufficiency of the Lower Extremities

Article Type
Response to Comments

Original Effective Date
11/12/2020

Retirement Date
N/A

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Article Guidance

Article Text

The following are the comment summaries and contractor responses for Novitas Solutions Proposed Local Coverage Determination (LCD) DL34924, Treatment of Chronic Venous Insufficiency of the Lower Extremities which was posted for comment on 6/25/2020, and presented at the July 2020 Open Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number	Comment	Response
1	A comment was received recommending some updates to the first paragraph of the "History/Background and/or General Information" section of the LCD to remove “Chronic Venous Insufficiency (CVI) from sentence 2 and include “and have reflux >500 milliseconds “ in sentence 3.	We appreciate your comments, after further consideration and review; the LCD is revised with the recommended changes. Thank you.
2	Multiple comments were received regarding the third paragraph of the "Terminology of veins discussed within this LCD" section of the LCD recommending to add verbiage for pathologic perforator veins, remove circumflex veins and include the terms Anterior Accessory Great Saphenous Vein (AAGSV)’ and “Posterior Accessory Great Saphenous Vein (PAGSV).	Thank you for the comments. Upon review, the LCD is revised with these recommendations.
3	Multiple comments were received recommending changes to the "Invasive Procedures for the management of chronic venous insufficiency" section of the LCD in regards to Foam Sclerosant: Ultrasound-Guided Foam Sclerotherapy (UGFS) to include the different types of foam: physician-compounded foam (PCF) and non-compounded foam (NCF) also referred to as (polidocanol endovenous microfoam - PEM). It was also recommended to correlate these changes to reflect in the “Covered Indications” section of the Proposed LCD and to differentiate the CPT codes in the related billing and coding article.	We would like to thank you for your comments. The LCD is revised to reflect the difference between the types of foam: physician-compounded foam (PCF) and non-compounded foam (NCF). The related billing and coding article was updated to differentiate the appropriate CPT codes (36465 & 36466 is used for NCF and 36470 & 36471 is used for PCF).
4	Multiple comments were received recommending some changes to the "Covered Indications" section of the LCD regarding duplex scan criteria; to reword the sentence that contains “spontaneous” and to remove the 1000 ms requirement.	We would like to thank you for your comments. After further review, the LCD is revised with the recommended verbiage to clarify the duplex scan covered indication.
5	Multiple comments were received recommending some changes to number 3 of the "Covered Indications" section of the LCD to clarify incompetent perforator vein management criteria for circumstances such as; An active venous ulcer is in close proximity to the IPV, OR The proximal significant reflux has been treated and an IPV persists under or adjacent to a healed venous ulcer, OR The proximal and regional venous reflux has been treated and there is persisting focal pain and tenderness or stasis dermatitis overlying an IPV, OR The incompetent perforator demonstrates reflux >500 ms and diameter > 3.5 mm.	We would like to thank you for your comments. After further review of the LCD, the incompetent perforator vein management covered indication is revised to reflect the following circumstances; An active venous ulcer is in close proximity to the IPV, OR The proximal significant reflux has been treated and an IPV persists under or adjacent to a healed venous ulcer, OR The proximal and regional venous reflux has been treated and there is persisting focal pain and tenderness or stasis dermatitis overlying an IPV, OR The incompetent perforator demonstrates reflux >500 ms and diameter > 3.5 mm.
6	Multiple comments were received recommending some changes to number 5 and 6 of the "Covered Indications" section of the LCD to remove “tributary veins” from thermal ablation and chemical adhesive treatment.	We appreciate your comments. The LCD is revised to remove “tributary veins” from thermal ablation and chemical adhesive treatment in the “Covered Indications” section of the LCD.
7	Multiple comments were received recommending revising the phlebectomy treatment covered indication. Suggestions received mention that treatment can be “after or at the same time as” treatment of the saphenous vein and to allow phlebectomy for any patient that has symptomatic bulbous varicosities greater than 3mm diameter regardless of their relationship to the saphenous vein.	We appreciate your comments. After further consideration and review, the LCD is revised to include that phlebectomy treatment may be staged or concomitant and the relationship to the saphenous vein was removed.
8	Multiple comments were received recommending some changes to the "Professional Societies” and “Consultation Summary" section of the LCD in reference to appropriately identifying the Societies attending the Consultation Summary meetings and to reword some of the verbiage to fully capture the content of the meetings.	Thank you for your comments. After further consideration and review, the LCD is revised to include the appropriate Societies and representatives for the Consultation Summary meetings. The LCD is also revised to include "chemical/cyanoacrylate adhesive" in the "Professional Societies: American College of Phlebology" and "Consultation Summary" sections of the LCD.
9	A commenter submitted a presentation and FDA article in regards to "Retrograde Administration of Ultrasound-Guided Microfoam Chemical Ablation vs Endovenous Laser Ablation for the Treatment of Superficial Venous Insufficiency."	The presentation and FDA article were reviewed and we would like to thank you for the submission of this information.
10	A comment was received to reconsider eliminating the conservative treatment period requirement in the "Conservative management for chronic venous insufficiency (Noninvasive procedures)" section of the Proposed LCD.	We appreciate your comments, after further review, the LCD is revised to include conservative treatment requirements in the covered indications section of the LCD and in the plan of care documentation requirements section of the billing and coding article.
11	A comment was received to clarify the purpose of Radiofrequency ablation in the "Invasive Procedures for the management of chronic venous insufficiency" section of the LCD.	Thank you for your comments. After further consideration and review, the LCD is revised to include the purpose of RFA is to damage the collagen of the vein wall resulting in fibrosis and occlusion of a vein segment to eliminate reflux.
12	A comment was received recommending revision to the "Invasive Procedures for the management of chronic venous insufficiency" section of the LCD for the chemical adhesive to clarify the purpose and process of this treatment.	Thank you for your comments. After further consideration and review, the LCD is revised with the recommendation and the section regarding chemical adhesive was updated accordingly.
13	Multiple comments were received recommending some changes to the "Invasive Procedures for the management of chronic venous insufficiency: Sclerotherapy: Liquid Sclerosant" and "Limitations" section of the LCD in regards to liquid sclerotherapy to remove the limitation and clarify that it can be used when addressing telangiectasia and their feeding reticular veins with spontaneous and/or traumatic venous hemorrhage or when unique patient features suggest liquid sclerotherapy may be the safer option.	Thank you for your comments. After further consideration and review, the LCD is revised to remove limitation number two for liquid sclerotherapy. The LCD is also revised to clarify that liquid sclerotherapy can be used when addressing telangiectasia and their feeding reticular veins with spontaneous and/or traumatic venous hemorrhage or when unique patient features suggest liquid sclerotherapy may be the safer option.
14	A comment was received to remove the statement "Agents must be used per the FDA approved label," from the "Covered Indications" section of the Proposed LCD due to product labeling being an issue between the FDA and the industry. Commenter also stated that it should not be a determinant in CMS coverage policy.	Thank you for your comments. After further consideration and review, the LCD is revised to remove the drug label and FDA approved indications statement and link.
15	A comment was received recommending some changes to the "Covered Indications" section of the LCD in regards to the fourth bullet under indication number 2. The commenter suggested adding limited coverage for C1 disease and language regarding conservative therapy.	We appreciate your comment. After further review, the LCD is revised with the recommended changes.
16	A comment was received to include provider qualifications within the proposed LCD for physicians who are board certified in vascular surgery, interventional radiology, or interventional cardiology.	Thank you for your comment. After further review, the LCD is not going to be revised to include any provider qualifications. It is the responsibility of the provider to comply with all applicable State and Federal laws related to the human use of agents.
17	A comment was received that recommended that no more than 3 ablations be approved for any one leg over the course of 1 year and a 90-day global period on a leg following an ablation.	Thank you for your comment. Medicare established a national definition of a global surgical package to ensure that Medicare Administrative Contractors (MACs) make payments for the same services consistently across all jurisdictions. At this time, the ablation procedure codes have not been assigned a global period. After further review, the LCD and the billing and coding article documentation requirements is revised to clarify that a plan of care is for a 90 day episode of care.
18	Multiple comments were received in support of the proposed LCD and related billing and coding article.	We would like to thank you for your comments.
19	Multiple comments received in regards to the title of the LCD and related billing and coding article to include “Surgical,” stating that the LCD addresses surgical treatments and not medical management.	We would like to thank you for your comment. After review of the LCD, the title of the LCD will not reflect a change to include “Surgical”. However, the LCD and billing and coding article is revised to clarify that the plan of care, covered indications and documentation requirements apply to invasive procedures.
20	A comment was received to add ICD-10 diagnosis codes in relation to the listed venous malformations or other complex malformations.	Thank you for your comment. After review of the Draft Local Coverage Article: Billing and Coding: Treatment of Chronic Venous Insufficiency of the Lower Extremities, the Local Coverage Article (LCA) is revised to include the following ICD-10-CM code; Q27.8, Other specified congenital malformations of peripheral vascular system.
21	A comment was received to include non-physician licensed independent providers (nurse practitioners and physician assistants) to those who are allowed to perform procedures covered within the LCD.	We appreciate your comment. Provider types and provider qualifications are not included within the LCD. It is the responsibility of the provider to comply with all applicable State and Federal laws related to the human use of agents.
22	A comment was received to exclude the requirement that a venous clinical severity score (VCSS) be recorded for every patient.	We appreciate your comment. After review of the LCD, the decision was made to not exclude the requirement for venous clinical severity score (VCSS) for each patient.
23	A comment was received that the LCD suggests that Medicare will cover ultrasound guided foam sclerotherapy for the first time. Will a new code be created for this procedure or will RVUs be assigned to S2202?	We appreciate your comment. Medicare and other federal payers do not recognize “S” codes; however, S codes may be useful for claims to some private insurers. For the purposes of this LCD/LCA, Physician-compounded foam (PCF) sclerotherapy is reported using CPT codes 36470 and 36471. Non-compounded foam (NCF) sclerotherapy is reported using CPT codes 36465 and 36466.

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ICD-10-CM Codes that Support Medical Necessity

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Non-Excluded CPT/HCPCS Ended Codes - Table Format

Code	Descriptor Generic Name	Descriptor Brand Name	Exclusion Effective Date	Exclusion End Date	Reason for Exclusion

Revision History Information

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Associated Documents

Related Local Coverage Documents
Articles
A55229 - Billing and Coding: Treatment of Chronic Venous Insufficiency of the Lower Extremities
LCDs
L34924 - Treatment of Chronic Venous Insufficiency of the Lower Extremities

Updated On	Effective Dates	Status
11/06/2020	11/12/2020 - N/A	Currently in Effect	You are here

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Response to Comments: Treatment of Chronic Venous Insufficiency of the Lower Extremities

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