Indications and Limitations of Coverage and/or Medical Necessity
Notice: It is not appropriate to bill Medicare for services that are not covered (as described by this entire LCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.
In keeping with the CMS' national initiative, Fistula First project, Medicare would expect that wherever an AV fistula (native arteriovenous fistula) is feasible, the AV fistula will be used. The objective is to restore appropriate flow, preserve the fistula's functional integrity and avoid the need to create a new fistula. In order to increase the appropriate use of AV fistulae for hemodialysis access, Preoperative Venous Mapping (93970 and 93971) is considered medically indicated in patients with ESRD.
Percutaneous interventions to enhance or re-establish patency of a hemodialysis fistula have proven useful in extending the life of the fistula and reducing the need for open repair. Percutaneous fistula declotting for the re-establishment of appropriate and adequate flow may encompass the following procedures. They need not all be performed on every dysfunctional fistula.
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)
36870© - Thrombectomy including mechanical extraction and intra-graft thrombolysis.
These procedures may be necessary if, after removal of thrombotic material, blood flow remains inadequate and examination and/or vascular imaging demonstrate residual hemodynamically significant impairment to flow.
The following codes for diagnostic angiography would be expected to image flow prior to intervention when medically indicated:
75710© - Angiography, extremity, unilateral, radiological supervision and interpretation.
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
Typically, the physician's clinical examination may provide adequate findings to suggest impairment of flow. The clinical findings listed below may be appropriate indications for either direct therapeutic intervention or confirmatory imaging studies such as ultrasonography or angiography. When physical findings are clearly confirmatory of obstruction to flow, it is preferable to proceed to fistulography directly, as there is little derived value from performing ultrasonography. Further testing is also appropriate when the indirect measurements of Urea Reduction Ratio of the Dialysis Flow Rate X Time/Volume (KT/V) indicate the quality of dialysis has fallen.
- Absence of palpable flow in the fistula.
- Appearance of a visible aneurysm/pseudoaneurysm.
- Sudden onset of pain and clinical signs of ischemia of the hand.
- Swelling of the extremity.
- Large collateral venous channels.
- Abnormal thrill ("water hammer") felt during palpation.
- Distal tissue ischemia related to AV shunt.
- Clinical evidence of graft infection.
- Congestive heart failure due to shunt.
- Reduced intra-access flow.
- Elevated static venous pressures.
- Elevated dynamic venous pressures.
- Elevated recirculation.
- Unexplained decrease in U, Kt/V.
- Prolonged bleeding after needle removal.
- Elevated negative arterial pre-pump pressures.
- Ischemic changes of the extremity (steal syndrome).
- Inefficient dialysis.
Percutaneous angioplasty may be necessary if, after removal of thrombotic material, blood flow remains inadequate and examination and/or angiography demonstrate residual hemodynamically significant impediment to flow that is caused by other than thrombotic material (residual hemodynamically significant flow impairment may be demonstrated within the fistula at either anastomotic junction or more remotely in the artery or vein providing the fistula's inflow and outflow).
35475© - Percutaneous balloon angioplasty (arterial).
35476© - Percutaneous balloon angioplasty (venous).
Coverage of
CPT 36561 (insertion of tunneled central venous access device, with subcutaneous port) as it relates to this LCD is
specific only to vascular access for hemodialysis. Non-Invasive Vascular Studies Used to Monitor the Access Site of End Stage Renal Disease (ESRD) Patients This clarifies the application of a long-standing Medicare policy regarding services included in the composite rate for ESRD patients. Medicare pays for outpatient maintenance dialysis services furnished by ESRD facilities based on a composite payment rate. This rate is a comprehensive payment and includes all services, equipment, supplies and certain laboratory tests and drugs necessary to furnish a dialysis treatment.
For dialysis to take place, there must be a means of access so that the exchange of waste products may occur. As part of the dialysis treatment, ESRD facilities are responsible for monitoring access and when occlusions occur, either declotting the access or referring the patient for appropriate treatment. Procedures associated with monitoring access involve taking venous pressure, aspirating thrombus, observing elevated recirculation time, reduced urea reduction ratios or collapsed shunt, etc.
A number of ESRD facilities are monitoring access through non-invasive vascular studies such as duplex and Doppler flow scans and billing separately for these procedures.
Non-invasive vascular studies are not covered as a separately billable service if used to monitor a patient's vascular access site. Medicare pays for the
technical component of the procedure in the composite payment rate.
An ESRD facility must furnish all necessary services, equipment and supplies associated with a dialysis treatment either directly or under arrangements that make the facility financially responsible for the service. If an ESRD facility or a renal physician decides to monitor the patient's access site with a non-invasive vascular study and does not have the equipment to perform the procedure, the facility or physician may arrange for the service to be furnished by another source. The alternative source, such as an independent diagnostic testing facility, must look to the ESRD facility for payment. No separate payment for non-invasive vascular studies for monitoring the access site of an ESRD patient, whether coded as the access site or peripheral site, is permitted to any entity.
When there are signs and symptoms of vascular access problems, Doppler flow studies may be used as a means to obtain diagnostic information to permit medical intervention to address the problem. Doppler flow studies may be considered medically necessary in the presence of signs or symptoms of possible failure of the ESRD patient's vascular access site, and when the results are used to determine the clinical course of the treatment for the patient. The only CPT billing code for non-invasive vascular testing of a hemodialysis access site is 93990. When a dialysis patient exhibits signs and symptoms of compromise to the vascular access site, Doppler flow studies may provide diagnostic information that will determine the appropriate medical intervention. Medicare considers a Doppler flow study medically necessary when the beneficiary's dialysis access site manifests signs or symptoms associated with vascular compromise and when the results of this test are necessary to determine the clinical course of treatment. Examples supporting the medical necessity for Doppler flow studies include:
Venous Outflow Impediment
- Elevated dynamic venous pressure > 200 mm HG when measured during dialysis with the blood pump set on 200 cc/min.
- Access recirculation of 12 percent or greater.
- An otherwise unexplained urea reduction ratio < 60 percent.
- An access with a palpable "water hammer" pulse on examination (which implies venous outflow obstruction).
Unless the documentation is provided supporting the necessity of more than one study, Medicare will limit payment to either a Doppler flow study or an arteriogram (fistulogram, venogram) but not both. An example of when both studies may be clinically necessary is when a Doppler flow study demonstrates reduced flow (blood flow rate less than 800 cc/min. or a decreased flow of 25 percent or greater from the previous study) and the physician requires an arteriogram to further define the extent of the problem.
Arterial Inflow Impediment
- Access flow is equal to or less than 600-700 cc/min. or if access flow decreases 20 percent from baseline.
- Static venous pressure is less than 0.3 (bridge), less than 0.15 (direct), or decreases 0.25 from baseline.
The patient's medical record(s) must provide documentation supporting the need for more than one imaging study.
This LCD is applicable to claims from ESRD facilities and all other sources such as independent diagnostic testing facilities and hospital outpatient departments.
When a Doppler flow study is used to diagnose probable vascular access problems, Medicare would expect to see most of such patients referred to a radiologist or surgeon for further intervention. In these cases, the professional component of procedure 93990 is payable; when the study is done as routine screening without clear documentation of need as documented above, the professional component is included in the Monthly Capitation Payment (MCP) and may not be billed to Medicare.
Notice: Services performed for any given diagnosis must meet 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.
As published in CMS IOM 100-08, Section
13.5.1, to be covered under Medicare, a service shall be reasonable and necessary. When appropriate, contractors shall describe the circumstances under which the proposed LCD for the service is considered reasonable and necessary under Section 1862(a)(1)(A). Contractors shall consider a service to be reasonable and necessary if the contractor determines that the service is:
- Safe and effective.
- Not experimental or investigational (exception: routine costs of qualifying clinical trial services with dates of service on or after September 19, 2000, that meet the requirements of the clinical trials NCD are considered reasonable and necessary).
- Appropriate, including the duration and frequency that is considered appropriate for the service, in terms of whether it is:
- 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.
- Furnished in a setting appropriate to the patient's medical needs
and condition.
- Ordered and furnished by qualified personnel.
- One that meets, but does not exceed, the patient's medical needs.
- At least as beneficial as an existing and available medically
appropriate alternative.
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 Vascular Access for Hemodialysis. 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 Vascular Access for Hemodialysis 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 regarding Vascular Access for Hemodialysis are found in the following Internet-Only Manuals (IOMs) published on the CMS Web site:
- Medicare Benefit Policy Manual - Pub. 100-02, Chapter 11 ESRD.
- Medicare National Coverage Determinations Manual - Pub. 100-03, Chapter 1, Sections 110.15, 230.
- Correct Coding Initiative - Medicare Contractor Beneficiary and Provider Communications Manual - Pub. 100-09, Chapter 5.
- Social Security Act (Title XVIII) Standard References, Sections:
- 1862(a)(1)(A) Medically Reasonable & Necessary.
- 1862(a)(1)(D) Investigational or Experimental.
- 1862(a)(7) Screening (Routine Physical Checkups).
- 1833(e) Incomplete Claim.
Jurisdiction "H" Notice:
Jurisdiction "H" comprises the states of Arkansas, Louisiana, Mississippi, Colorado, New Mexico, Oklahoma, and Texas. Novitas is responsible for claims payment and Local Coverage Determination (LCD) development for this jurisdiction. This LCD was created as a part of the legacy transition (8/13/2012 - 11/19/2012); and, is a consolidation of the previous legacy contractors' policies. Coverage of each LCD begins when the state/contract number combination officially is integrated into the Jurisdiction. On the CMS MCD, this date is known as either the Original Effective Date or the Revision Effective Date. The following table details the official effective dates for each state/contract number combination.
| ST | Legacy A
Contractor
&
Contract Number | Legacy B
Contractor
&
Contract Number | J "H" MAC A
Contractor
&
Contract Number | J "H" MAC B
Contractor
&
Contract Number | J "H"
Effective
Date |
|---|
| AR | | PBSI: 00520 (J7) | | Novitas: 07102 | 08/13/12 |
| LA | | PBSI: 00528 (J7) | | Novitas: 07202 | 08/13/12 |
| AR | PBSI: 00020 (J7) | | Novitas: 07101 | | 08/20/12 |
| LA | PBSI: 00233 (J7) | | Novitas: 07201 | | 08/20/12 |
| MS | PBSI: 00233 (J7) | | Novitas: 07301 | | 08/20/12 |
| MS | | Cahaba: 00512 (J7) | | Novitas: 07302 | 10/22/12 |
J 4
States | Trailblazer: 04901 | | Novitas: 04911 | | 10/29/12 |
| CO | Trailblazer: 04101 | | Novitas: 04111 | | 10/29/12 |
| NM | Trailblazer: 04201 | | Novitas: 04211 | | 10/29/12 |
| OK | Trailblazer: 04301 | | Novitas: 04311 | | 10/29/12 |
| TX | Trailblazer: 04401 | | Novitas: 04411 | | 10/29/12 |
| CO | | Trailblazer: 04102 | | Novitas: 04112 | 11/19/12 |
| NM | | Trailblazer: 04202 | | Novitas: 04212 | 11/19/12 |
| OK | | Trailblazer: 04302 | | Novitas: 04312 | 11/19/12 |
| TX | | Trailblazer: 04402 | | Novitas: 04412 | 11/19/12 |
Documentation supporting medical necessity should be legible, maintained in the patient's medical record and made available to Medicare upon request.
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