LCD/NCD Portal

L32828

 

DIALYSIS (AV FISTULA AND GRAFT) VASCULAR ACCESS MAINTENANCE

 

10/09/2012

 

Indications and Limitations of Coverage and/or Medical Necessity

• Arteriovenous (AV) dialysis access (AV fistula, AV dialysis graft) interventions are intended to restore and/or maintain functional patency of the AV dialysis access.

o These procedures encompass a number of percutaneous or open surgical procedures.

o This Local Coverage Determination (LCD) is not intended to limit access revision of the neck, trunk or lower extremities.

o The LCD is intended to address access maintenance of the upper extremities.

o For procedures performed on the neck, trunk or the lower extremities, it will be expected that they are performed following the standards of practice and applicable guidelines (e.g. KDOQI).

o Indications for interventions on an AV dialysis access include compromised flow with threatened occlusion, recent thrombosis of AV dialysis access, and management of structural abnormalities such as pseudoaneurysms.

o Interventions are performed on AV dialysis fistulas and grafts in order to restore adequate flow, to preserve the access' function, and avoid the need to create a new AV access.

o Fistulae which are not maturing as expected may also be evaluated and treated with percutaneous interventions.

• Percutaneous interventions to enhance or re-establish patency of a hemodialysis AV access have proven useful in extending the life of the access, reducing the need for open repair, reconstruction or replacement.

o This LCD documents acceptable indications for coverage, the limitations of coverage, and other requirements for dialysis access maintenance services.

o Also, at various points within this LCD, attention is directed to Current Procedural Terminology (CPT) 2012, Special instructions on Diagnostic studies of Arteriovenous (AV) Shunts for Dialysis and Interventions for Arteriovenous (AV) Shunts created for Dialysis (AV Grafts and AV Fistulae).

 

• Covered Indications:

o Change in physical examination characteristics of the thrill.

o Elevated venous pressures recorded during hemodialysis (static and dynamic pressures) or measured within the vascular access during a diagnostic study (static pressures).

o Detection of decreased intra-access blood flow at dialysis.

o Swollen extremity

o Unexplained reduction in dialysis kinetics.

o Clinical parameters such as prolonged bleeding after needle withdrawal, altered physical examination characteristics of vascular access, or thrombosis.

o Elevated negative arterial prepump pressures that prevent increasing to acceptable blood flow.

o Inability to puncture to perform hemodialysis.

o Abnormal recirculation values.

o Stenosis associated with thrombosis.

o Autogenous fistulae that have failed to mature after 4 to 6 weeks.

o Inefficient dialysis and access dysfunction; (Urea Reduction Ratio below 60%. see KDOQI guidelines).

o Recirculation percentage greater than 10-15%.

o Development of pseudoaneurysm(s).

o Superficial collateral venous channels.

o Evidence for in- flow obstruction.

o Distal steal syndrome.

 

 

Diagnostic Studies of AV shunts for dialysis:

• If a stenosis is suspected clinically, typically a diagnostic study is required to determine the level(s) of disease and to formulate a plan for treatment.

o This is most commonly accomplished with a fistulagram (CPT code 36147).

o Diagnostic fistulagram – with puncture of the AV dialysis access with needle or catheter placement, and diagnostic angiography of the entire AV dialysis access circuit, from the arterial anastomosis through the central vena cava, which is performed to identify the area or areas of narrowing or occlusion that are creating flow problems for the AV dialysis access (CPT code 36147).

o This includes visualization and examination of the vena cava.

• Diagnostic fistulagram - without directly puncturing and/or catheterizing the AV dialysis access.

o For instance, a fistulagram may be performed through an existing needle or sheath or via an injection of a vessel other than direct puncture of the AV dialysis access (e.g., injection of the subclavian artery through a femoral arterial puncture) (CPT code 75791).

• Diagnostic non-invasive vascular studies (CPT code 93990), such as Duplex scanning, may be considered reasonable and necessary when performed for a patient with signs or symptoms of compromise or failure of the vascular access site, and when the results are used to determine the clinical course of the treatment/intervention for the patient.

 

 

Percutaneous AV Dialysis Access Maintenance and Interventions

• Percutaneous AV dialysis access declotting, maintenance, or re-establishment of appropriate and adequate flow may encompass any of the procedures listed below.

o These need not all be performed on every dysfunctional access, but each may, under unique circumstances, be considered reasonable and medically necessary.

• Venous Percutaneous Transluminal Angioplasy: PTA is typically necessary to treat stenoses.

o PTA is commonly needed after the acute thrombus has been removed.

o Per CPT 2012 special instructions (Interventions for Arteriovenous (AV) Shunts Created for Dialysis (AV Grafts and AV Fistulae) and noted in the attached coding guideline:

 For the purposes of coding interventional procedures in arteriovenous (AV) shunts created for dialysis (both arteriovenous fistulae [AVF] and arteriovenous grafts [AVG]), the AV shunt is artificially divided into two vessel segments.

• The first segment is peripheral and extends from the peri-arterial anastomosis through the axillary vein (or entire cephalic vein in the case of cephalic venous outflow).

• The second segment includes the veins central to the axillary and cephalic veins, including the subclavian and innominate veins through the vena cava.

• Interventions performed in a single segment, regardless of the number of lesions treated, are coded as a single intervention.

• The AV shunt is considered to be venous and most interventions are coded with the venous intervention codes (i.e., angioplasty is reported with venous angioplasty [CPT codes 35476, 75978]).

• Arterial Percutaneous transluminal angioplasty (PTA): PTA of the AV dialysis access vessel(s) is not necessary for all poorly functioning AV dialysis accesses.

o There must be clear documentation of the site and extent of any hemodynamically significant stenosis. This documentation may be subjected to medical necessity review.

o Per CPT 2012 special instruction and noted in the attached coding guideline:

o There is an exception to the use of venous interventional codes.

o When there is a stenosis at the arterial anastomosis, it typically extends across the anastomosis and involves the artery just proximal to and at the anastomosis as well as the outflow vessel or graft.

o This segment is called the peri-anastomotic (or juxta-anastomotic) region, and even though the stenosis can involve multiple vessels, it is typically a single lesion with a single etiology crossing the anastomosis, and treatment to open this lesion crosses from the artery into the vein or venous graft.

o An intervention treated in this peri-anastomotic segment is coded as an arterial intervention (CPT codes 35475, 75962).

o Since the entire segment of the AV shunt from the peri-arterial anastomosis through the axillary vein is considered a single vessel for coding of interventions, the arterial angioplasty codes include the work of opening the peri-anastomotic stenosis, as well as all other stenoses treated within this segment of the vessel.

o CPT codes 35475 and 75962 are reported once to describe all work done to angioplasty any lesion from the peri-arterial anastomosis through the axillary vein in procedures that involve angioplasty of the peri-arterial anastomosis of the AV shunt.

o In these special instances, venous angioplasty codes would not be reported additionally for this first or most peripheral shunt segment, even if balloon angioplasty is performed on segments of the AV dialysis shunt that are purely venous anatomy within this specific vessel segment.

• Mechanical and/or pharmacologic maneuvers to promote dissolution, fragmentation and/or removal of obstructing thrombotic materials (CPT code 36870) - includes all work necessary to remove thrombus from the AV dialysis access, including mechanical thrombolysis, mechanical removal of thrombus, as well as all pharmacological means of removing thrombus from the dialysis access (including bolus, infusion, pulse-spray etc.). As noted in CPT 2012 and in the LCD “Coding Guidelines” attachment.

o It is never appropriate to report removal of the arterial plug during a declot/thrombectomy procedure as an arterial or venous angioplasty (CPT codes 35475, 35476).

o Removal of the arterial plug is included in the work of a fistula thrombectomy (CPT code 36870), even if a balloon catheter is used to mechanically dislodge the resistant thrombus.

 

 

Open Dialysis Access Revision:

• Stents - Subject to Food and Drug Administration (FDA) approval of specific devices, stents are covered if used to salvage a graft or fistula after all other conservative measures to re-establish patency have failed.

o If conservative treatment has failed, placement of an intravascular stent (e.g. CPT codes 37205-37206) and the associated supervision and interpretation (CPT code 75960) is appropriate.

• Surgical therapy for thromboses or impaired AV dialysis access utilizes direct open access to the conduit and contiguous vessels.

o Mechanical fragmentation and surgical removal of occlusive thrombotic material is effected under direct visualization.

o Adjunctive thrombolytic pharmacotherapy may be employed.

o Residual vascular stenosis or obstructive lesions are removed and corrected using standard vascular surgical techniques (e.g., CPT codes 36831, 36832, 36833).

o Angiography is adjunctively employed, when appropriate and medically necessary, to assess the functional integrity of afferent and efferent vessels remote from the surgical field.

 

 

Limitations of Coverage:

• No separate payment for non-invasive vascular studies for monitoring the access site of an end stage renal disease (ESRD) patient, whether coded as the access site or peripheral site, is permitted to any entity.

o Medicare does not pay for services that are screening in nature or that do not provide clinically relevant information that is used in the medical management of the patient.

• Duplex scanning will be considered medically necessary only in the presence of signs and symptoms of possible failure of the access site, and when the results of the procedures will permit medical or surgical intervention to address the problem.

• Based on the outcome of a Duplex scan study, contrast studies (i.e. fistulagram, venogram), could be considered as a definitive diagnostic tool guiding surgical revision.

o The documentation must support the need for the additional imaging study.

• Use of a device that is not FDA approved for the indication will be considered investigational and not medically necessary.

• Services will be considered reasonable and necessary only if documentation in the medical record (e.g., procedure report) verifies that the services described by the submitted CPT codes were provided and were medically necessary.

• Limitation of liability and refund requirements apply when denials are likely, whether based on medical necessity or other coverage reasons.

o The provider/supplier must notify the beneficiary in writing, prior to rendering the service, if the provider/supplier is aware that the test, item or procedure may not be covered by Medicare.

o The limitation of liability and refund requirements do not apply when the test, item or procedure is statutorily excluded, has no Medicare benefit category or is rendered for screening purposes.

 

 

CPT/HCPCS Codes

 

35475 TRANSLUMINAL BALLOON ANGIOPLASTY, PERCUTANEOUS; BRACHIOCEPHALIC TRUNK OR BRANCHES, EACH VESSEL

35476 TRANSLUMINAL BALLOON ANGIOPLASTY, PERCUTANEOUS; VENOUS

36147 INTRODUCTION OF NEEDLE AND/OR CATHETER, ARTERIOVENOUS SHUNT CREATED FOR DIALYSIS (GRAFT/FISTULA); INITIAL ACCESS WITH COMPLETE RADIOLOGICAL EVALUATION OF DIALYSIS ACCESS, INCLUDING FLUOROSCOPY, IMAGE DOCUMENTATION AND REPORT (INCLUDES ACCESS OF SHUNT, INJECTION[S] OF CONTRAST, AND ALL NECESSARY IMAGING FROM THE ARTERIAL ANASTOMOSIS AND ADJACENT ARTERY THROUGH ENTIRE VENOUS OUTFLOW INCLUDING THE INFERIOR OR SUPERIOR VENA CAVA)

36148 INTRODUCTION OF NEEDLE AND/OR CATHETER, ARTERIOVENOUS SHUNT CREATED FOR DIALYSIS (GRAFT/FISTULA); ADDITIONAL ACCESS FOR THERAPEUTIC INTERVENTION (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

36215 SELECTIVE CATHETER PLACEMENT, ARTERIAL SYSTEM; EACH FIRST ORDER THORACIC OR BRACHIOCEPHALIC BRANCH, WITHIN A VASCULAR FAMILY

36831 THROMBECTOMY, OPEN, ARTERIOVENOUS FISTULA WITHOUT REVISION, AUTOGENOUS OR NONAUTOGENOUS DIALYSIS GRAFT (SEPARATE PROCEDURE)

36832 REVISION, OPEN, ARTERIOVENOUS FISTULA; WITHOUT THROMBECTOMY, AUTOGENOUS OR NONAUTOGENOUS DIALYSIS GRAFT (SEPARATE PROCEDURE)

36833 REVISION, OPEN, ARTERIOVENOUS FISTULA; WITH THROMBECTOMY, AUTOGENOUS OR NONAUTOGENOUS DIALYSIS GRAFT (SEPARATE PROCEDURE)

36838 DISTAL REVASCULARIZATION AND INTERVAL LIGATION (DRIL), UPPER EXTREMITY HEMODIALYSIS ACCESS (STEAL SYNDROME)

36870 THROMBECTOMY, PERCUTANEOUS, ARTERIOVENOUS FISTULA, AUTOGENOUS OR NONAUTOGENOUS GRAFT (INCLUDES MECHANICAL THROMBUS EXTRACTION AND INTRA-GRAFT THROMBOLYSIS)

37205 TRANSCATHETER PLACEMENT OF AN INTRAVASCULAR STENT(S) (EXCEPT CORONARY, CAROTID, VERTEBRAL, ILIAC, AND LOWER EXTREMITY ARTERIES), PERCUTANEOUS; INITIAL VESSEL

37206 TRANSCATHETER PLACEMENT OF AN INTRAVASCULAR STENT(S) (EXCEPT CORONARY, CAROTID, VERTEBRAL, ILIAC, AND LOWER EXTREMITY ARTERIES), PERCUTANEOUS; EACH ADDITIONAL VESSEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

37207 TRANSCATHETER PLACEMENT OF AN INTRAVASCULAR STENT(S) (EXCEPT CORONARY, CAROTID, VERTEBRAL, ILIAC AND LOWER EXTREMITY ARTERIES), OPEN; INITIAL VESSEL

75791 ANGIOGRAPHY, ARTERIOVENOUS SHUNT (EG, DIALYSIS PATIENT FISTULA/ GRAFT), COMPLETE EVALUATION OF DIALYSIS ACCESS, INCLUDING FLUOROSCOPY, IMAGE DOCUMENTATION AND REPORT (INCLUDES INJECTIONS OF CONTRAST AND ALL NECESSARY IMAGING FROM THE ARTERIAL ANASTOMOSIS AND ADJACENT ARTERY THROUGH ENTIRE VENOUS OUTFLOW INCLUDING THE INFERIOR OR SUPERIOR VENA CAVA), RADIOLOGICAL SUPERVISION AND INTERPRETATION

75960 TRANSCATHETER INTRODUCTION OF INTRAVASCULAR STENT(S) (EXCEPT CORONARY, CAROTID, VERTEBRAL, ILIAC, AND LOWER EXTREMITY ARTERY), PERCUTANEOUS AND/OR OPEN, RADIOLOGICAL SUPERVISION AND INTERPRETATION, EACH VESSEL

75978 TRANSLUMINAL BALLOON ANGIOPLASTY, VENOUS (EG, SUBCLAVIAN STENOSIS), RADIOLOGICAL SUPERVISION AND INTERPRETATION

93990 DUPLEX SCAN OF HEMODIALYSIS ACCESS (INCLUDING ARTERIAL INFLOW, BODY OF ACCESS AND VENOUS OUTFLOW)

 

 

Documentation Requirements

• All documentation must be maintained in the patient’s medical record and available to the contractor upon request.

• The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD. (See the "Indications and Limitations of Coverage and/or Medical Necessity" section of the LCD.)

• This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

• The applicable CPT code from the table above should be selected if a true arterial anastomotic stenosis is present.

• Angiographic and ultrasound report studies may be required to document the need for angioplasty of arterial and venous vessels at the same setting.

• Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service(s)).

• The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.

• The submitted medical record must support the use of the selected ICD-9-CM code(s).

• The description of the submitted CPT/HCPCS code must evident within the documentation of the service performed.

 

 

Utilization Guidelines

• The AV shunt is considered venous and most interventions are coded with the venous intervention codes.

o CPT codes 35475 (arterial) and 35476 (venous) performed on the same day will be developed for documentation (records requested for prepayment review) since this should be a rare occurrence.

o If stenosis is present at the arterial anastomosis and treated in addition to angioplasty of a venous anastomotic stenosis, only one angioplasty is reported.

o CPT code 35475 may be reported for angioplasty of an inflow lesion that is proximal to the graft or at the arterial anastomosis while CPT code 35476 may be reported for PTA of the venous anastomosis and/or venous outflow.

o CPT codes 35475 and 35476 should never be reported on the same day for the graft alone since it is considered a single vessel.

• Services performed at a frequency not typically encountered in an ESRD population may be reviewed for documentation (i.e., access dysfunction).

• Repair of both in-flow and out-flow lesions at the same access site on the same date of service shall be considered a single revision.

• Compliance with the provisions in this LCD may be monitored and addressed through post payment data analysis and subsequent medical review audits.

 

 

Treatment Logic

• Arteriovenous (AV) dialysis access (AV fistula, AV dialysis graft) interventions are intended to restore and/or maintain functional patency of the AV dialysis access.

• These procedures encompass a number of percutaneous or open surgical procedures

• DEFINITIONS:

o AV dialysis access: A surgically-created communication between an artery and a vein used for vascular access for hemodialysis.

 The communication may be a direct fistula (AV fistula) (e.g. Brescia Cimino fistula), brachiocephalic fistula or an interposed conduit (AV graft) (e.g. brachiocephalic loop graft).

 The conduit may be an autogenous vessel or synthetic material.

o Percutaneous transluminal angioplasty (PTA): An invasive procedure which, when successful, enlarges a narrowed vascular lumen.

 Typically, a balloon-tipped catheter is introduced percutaneously into the narrowed vessel.

 The balloon is inflated at the site of vascular stenosis, stretching the vessel and opening the lumen to restore adequate flow through the vessel.

 The balloon is removed after angioplasty.

o Thrombolysis: Pharmacologic and/or mechanical dissolution of a thrombus or blood clot.

o Mechanical Thrombectomy: Mechanical methods to remove thrombus.

o Dysfunctional hemodialysis access: A patent autogenous fistula or prosthetic graft with impaired function that limits the ability to complete the prescribed hemodialysis treatment.

 Evidence of impaired function includes; suboptimal rate of intra access blood flow, elevated intra access venous pressures, inability to cannulate the access, prolonged bleeding after removal of the hemodialysis needles, venous hypertension ipsilateral to the hemodialysis access.

o Infusion: Continuous intravascular administration of a medication containing solution. Bolus injections are not considered infusions, regardless of the time required to inject the solution.

 

 

Sources of Information and Basis for Decision

 

American College of Radiology (2011). Practice Guideline for Endovascular Management of the Thrombosed or Dysfunctional Dialysis Access. http://www.acr.org

 

American College of Radiology (2011). Practice Guideline for the Performance of Diagnostic Arteriography in Adults. http://www.acr.org

 

American College of Radiology (2011). Practice Guideline for the Performance of Physiologic Evaluation of Extremity Arteries. http://www.acr.org

 

American College of Radiology (2008). Practice Guideline for the Performance of Diagnostic Infusion Venography. http://www.acr.org

 

Kidney Disease Outcomes Quality Initiative (KDOQI), Clinical practice guidelines for vascular access, update 2006, National Kidney Foundation (http://www.kidney.org/professionals/KDOQI/guideline_upHD_PD_VA/index.htm)

 

 

Other Contractors Local Coverage Determinations

 

10/09/2012

The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

 

AMA CPT / ADA CDT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply. Current Dental Terminology, (CDT) (including procedure codes, nomenclature, descriptors and other data contained therein) is copyright by the American Dental Association. © 2002, 2004 American Dental Association. All rights reserved. Applicable FARS/DFARS apply.

 

 

CMS LCD DIALYSIS (AV FISTULA AND GRAFT) VASCULAR ACCESS MAINTENANCE