Proposed LCD - Peripheral Venous Ultrasound (DL35451)

CMS National Coverage PolicyThis LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for peripheral venous ultrasound. 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 peripheral venous ultrasound 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: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 TestsCMS IOM Publication 100-03,Medicare National Coverage Determinations (NCD)Manual, Chapter 1,Part 1, Section 20.14 PlethysmographyPart 4, Section 220.5 Ultrasound Diagnostic ProceduresCMS IOM Publication 100-04,Medicare Claims Processing Manual,Chapter 13, Radiology Services and Other Diagnostic Procedures, Section 10 ICD Coding for Diagnostic Tests and Section 20 Payment Conditions for Radiology ServicesCMS IOM Publication 100-08,Medicare Program Integrity Manual,Chapter 13, Section 13.5.4 Reasonable and Necessary Provisions in LCDsSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment may 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.Coverage Indications, Limitations, and/or Medical NecessityCompliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.History/Background and/or General InformationNon-invasive vascular diagnostic studies utilize ultrasonic Doppler and physiologic principles 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. (AMA 2023 CPT book, page 788)For the purpose of this LCD, we utilize the general term Venous Ultrasound which includes the following terminology: ultrasound doppler venous studies, compression ultrasound, whole leg ultrasound, limited ultrasound, two point ultrasound or two region ultrasound, and three point ultrasound or three region ultrasound.DefinitionsUltrasound doppler venous studies  Combines B-mode imaging of the deep and superficial veins with pulsed Doppler assessment of flow direction with provocative maneuvers.1Compression ultrasound  Venous compression is applied every two centimeters or less in the transverse (short-axis) plane with adequate pressure on the skin to completely obliterate the normal vein lumen. The fullest visible extent of the common femoral, femoral, popliteal, and posterior tibial and peroneal veins must be scanned by an optimal grayscale compression technique. The deep femoral vein should also be examined at the confluence with the femoral vein. The great saphenous vein is examined at the saphenofemoral junction.2Compression ultrasound (US) evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be limited to the proximal leg veins (usually popliteal-trifurcation and more proximally).3Whole leg ultrasound  Extended imaging including the calf veins.4Defined as an examination of both the proximal and distal deep venous system of the leg, including the femoral veins, the popliteal vein, the posterior and anterior tibial vein, and the peroneal vein. It may include the muscular veins (gastrocnemius or soleus).5Compression US evaluates the compressibility, or lack thereof, of a venous segment to diagnose thrombosis and is commonly coupled with a color Doppler to assess blood flow. Compression US may be performed on the entire leg (whole-leg US).3Whole-leg venous ultrasound or complete venous ultrasound is extended imaging of inferior vena cava, iliac and femoral veins, and calf veins.6Limited ultrasound  Defined as either a two-point or (extended) proximal approach. The two-point technique includes an examination of two venous segments, i.e. the common femoral vein at the level of the inguinal ligament and the popliteal in the popliteal fossa. The (extended) proximal strategy examines additional segments off the proximal venous system, and may include the common and superficial femoral veins, the popliteal vein, and sometimes includes the confluence of the deep calf veins (i.e. calf trifurcation). Limited compression ultrasonography (CUS) comprises either a single or a serial examination in which a second assessment is performed after 5 to 10 days.5Two point ultrasound or two region ultrasound is a limited protocol that has compression of the femoral and popliteal regions. It is sometimes described as 2-point ultrasound, but this term is misleading because the proper protocol is two areas rather than two compressions.7For two point compression ultrasound scanning the deep vein patency is only assessed in two venous territories (usually the common femoral vein and the popliteal vein).8Two-point/two region compression venous ultrasonography or limited compression venous ultrasonography examines the popliteal and common femoral veins only.6Three point ultrasound or three region ultrasound tests the compressibility of the common femoral vein (CFV), superficial femoral vein (SFV) and the popliteal vein (PV), as well as detects isolated SFV thrombosis of lower extremity deep vein thrombosis.9For three point compression ultrasound scanning the deep vein patency is only assessed in three venous territories (usually the common femoral vein, the popliteal vein, and the femoral vein).8Covered IndicationsDeep Vein Thrombosis (DVT)Due to the risk of DVT associated with pulmonary embolism (PE), objective testing of venous function is considered medically reasonable and necessary in any of the following situations:To evaluate clinical signs or symptoms suggestive of acute or new onset DVT such as extremity swelling, tenderness, or erythema. Both clinical evaluation and objective tests are required to make a diagnosis for venous thromboembolism (VTE). Wells score is a validated clinical decision rule to estimate the pretest probability for acute DVT in ambulatory settings.3,4,6,7,8,10,11,12,13ORInvestigation for DVT as the source of a suspected or confirmed PE.2,10,14ORTo follow-up patients with known venous thrombosis on therapy and who undergo a clinical change and where a change in the thrombus burden will alter treatment.2,14Chronic Venous InsufficiencyChronic venous insufficiency is impaired venous return which may cause lower extremity symptoms. Objective testing of venous function is considered medically reasonable and necessary in any one of the following situations:Evaluation of Postthrombotic (Postphlebitic) Syndrome (PTS) in patients with symptoms of PTS (e.g., chronic leg pain, leg heaviness, leg swelling, leg itching or ulcers on the leg).8,15OREvaluation of suspected valvular incompetence in patients with symptomatic chronic venous insufficiency or symptomatic varicose veins (e.g., significant pain or edema of the lower leg, ulceration, itching, aching, thickening and discoloration) suspected to be secondary to venous insufficiency in order to confirm this diagnosis prior to treatment.1,16,17,18ORPost-procedural assessment of venous ablation.2,14,19,20Note:Additional coverage information pertinent to the treatment of varicose veins and ablation therapy is located in JH/JL LCD L34924, Treatment of Chronic Venous Insufficiency of the Lower Extremities and JN LCD L38720 Treatment of Chronic Venous Insufficiency of the Lower Extremities.Preoperative ExaminationsVenous ultrasound studies are considered medically reasonable and necessary for select preoperative examinations that meet criteria for coverage as follows:Bypass surgeryVenous ultrasound of extremity veins including responses to compression and other maneuvers; unilateral or limited study is indicated for the preoperative examination of potential harvest vein grafts to be utilized during bypass surgery. This service is considered medically reasonable and necessary when the results of the study are needed to locate suitable graft vessels.14,21,22LimitationsThe following are considered not medically reasonable and necessary:Objective testing of peripheral venous function for any one of the following11,14:Asymptomatic varicose veinsRoutine screening testsVenous ultrasound performed when the results will have no impact on the decision for further diagnostic or therapeutic procedures or will not provide any unique diagnostic information that would impact patient management. For example, if it is evident from the findings of the history and physical examination that the patient is going to proceed to angiography, then venous ultrasounds are not reasonable and necessary.11,14Imaging while on adequate anticoagulation is unwarranted unless it will change the patients treatment.2,7,23Performance of multiple duplex scans and multiple duplex plus noninvasive physiologic studies of the upper and lower extremities on the same day. There may be rare occurrences where this may be appropriate. In such circumstances, individual consideration will be made on redetermination.In the outpatient setting in non-active cancer patients, if the clinical decision score (Wells score) is less than two, a positive D-dimer must be obtained prior to ordering an ultrasound.4,6,7,13Please refer to NCD 20.14, for a list of plethysmography methods that are not covered.Provider QualificationsServices will be considered medically reasonable and necessary when all aspects of care are within the scope of practice of the providers professional licensure, when performed according to the supervision requirements per state scope of practice laws, and when all procedures are performed by appropriately trained providers in the appropriate setting.Please see CMS IOM Publication 100-02,Medicare Benefit Policy Manual, Chapter 15, Section 80, for supervision definitions and requirements for diagnostic tests.Note:For services performed in an Independent Diagnostic Testing Facility (IDTF), please refer to LCD L35448, Independent Diagnostic Testing Facility (IDTF), and related Local Coverage Article A53252, Independent Diagnostic Testing Facility (IDTF), for additional information.Notice:Services performed for any given diagnosis must meet all of the indications and limitations stated in this LCD, the general requirements for medical necessity as stated in CMS payment policy manuals, any and all existing CMS national coverage determinations, and all Medicare payment rules.General InformationAssociated InformationRefer to the Local Coverage Article: Billing and Coding: Peripheral Venous Ultrasound, DA52993, for documentation requirements, utilization parameters and all coding information as applicable.Sources of InformationContractor Medical DirectorsBibliographyThis bibliography presents those sources that were obtained during the development of this policy. 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