L29237-LCD

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Local Coverage Determination (LCD) for Noninvasive Physiologic Studies of

Upper or Lower Extremity Arteries (L29237)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29237

LCD Title

Noninvasive Physiologic Studies of Upper or Lower Extremity Arteries

Primary Geographic Jurisdiction opens in new window

Florida

Oversight Region Region IV

Contractor's Determination Number 93922

Original Determination Effective Date

For services performed on or after 02/02/2009

AMA CPT/ADA CDT Copyright Statement

CPT only copyright 2002-2011 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Ending Date

Revision Effective Date

For services performed on or after 01/31/2012

Revision Ending Date

CMS National Coverage Policy

Language quoted from CMS National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals are italicized throughout the Local Coverage Determination (LCD). NCDs and coverage provisions in interpretive manuals are not subject to the LCD Review Process

(42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See §1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources: CMS Manual System, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15, Section 80

CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Section(s) 20.14, 20.29, 220.5

MS Manual System. Pub, 100-08, Medicare Program Integrity Manual, Chapter 3, Section 3.2.3 and Chapter 13, Section 13.5.1 42 CFR 410.32

42 CFR 410.33

Indications and Limitations of Coverage and/or Medical Necessity

Noninvasive peripheral arterial studies include two types of testing, noninvasive physiologic studies and duplex scans.Non-invasive physiologic studies are functional measurement procedures that include Doppler ultrasound studies, blood pressure measurements, transcutaneous oxygen tension measurements, or plethysmography. A complete extremity physiologic study includes pressure measurements and an additional physiologic technique, e.g., Doppler ultrasound study or plethysmography.

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.

Noninvasive physiologic studies are performed using equipment separate and distinct from the duplex scanner. Duplex scanning combines the information provided by two-dimensional imaging with pulsed-wave doppler techniques which allows analysis of the blood flow velocity.

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.

Indications

In general, noninvasive arterial studies are indicated when endovascular or other invasive correction is contemplated, but not to follow noninvasive medical treatment regimens or to monitor unchanged symptomatology. The latter may be followed with physical findings, including Ankle/Brachial Indices (ABIs), and/or progression or relief of signs and/or symptoms.

Noninvasive physiologic studies of the upper or lower extremity arteries performed to establish the level and/or degree of arterial occlusive disease, will be considered medically necessary if a) significant signs and/or symptoms indicate a high likelihood of limb ischemia, and b) the patient is a candidate for invasive therapeutic procedures under any of the following circumstances:

• Claudication of less than one block or of such severity that it interferes significantly with the patient's occupation or lifestyle.

• Rest pain of ischemic origin(typically including the forefoot), associated with absent pulses, which becomes increasingly severe with elevation and diminishes with placement of the leg in a dependent position.

• Tissue loss defined as gangrene or pre-gangrenous changes of the extremity, or ischemic ulceration of the extremity occurring in the absence of pulses.

• Aneurysmal disease of the extremity.

• Evidence of thromboembolic events in an extremity.

• Evidence of compression/occlusion of the vascular structures supplying the upper or lower extremities.

• Blunt or penetrating trauma of the extremities (including complications of diagnostic and/or therapeutic procedures of an extremity).

• Follow-up studies post-operative conditions:

• In the immediate post-operative period if re-established pulses are lost, become equivocal, or if the patient develops related signs and/or symptoms of ischemia with impending repeat intervention.

• Following bypass surgery or post-angioplasty with or without stent placement at three months, six months and one year when clinically indicated.

• Subsequent studies may be allowed if there is clinical evidence of recurrent vascular disease evidenced by signs (i.e. decreased ABI from previous exam) or symptoms (i.e., recurrence of claudication symptoms that interfere significantly with the patient’s occupation or lifestyle). For postoperative surveillance, either a limited Duplex or multi-level Doppler with pressures is usually sufficient, but it is not considered necessary to do both.

Transcutaneous oxygen tension measurements (Tp02) are utilized in conditions for which hyperbaric oxygen therapy (HBO) is being considered, as well as for monitoring the course of HBO therapy. The following conditions are considered medically indicated uses for Tp02 testing prior to, and during the course of HBO therapy:

• Acute traumatic peripheral ischemia

• Crush injuries and suturing of severed limbs

• Progressive necrotizing infections (necrotizing fasciitis)

• Acute peripheral arterial insufficiency

• Preparation and preservation of compromised skin grafts (not for primary management of wounds)

• Soft tissue radionecrosis as an adjunct to conventional treatment

• Tp02 used to determine a line of demarcation between viable and non-viable tissue when surgery or amputation is anticipated

Limitations

A routine history and physical examination, which includes Ankle/Brachial Indices (ABIs), can readily document the presence or absence of ischemic disease in a majority of cases. It is not medically necessary to proceed beyond the physical examination for minor signs and symptoms such as hair loss, absence of a single pulse, relative coolness of a foot, shiny thin skin, or lack of toe nail growth unless related signs and/or symptoms are present which are severe enough to require possible invasive intervention.

An ABI is not a separately reimbursable procedure when performed by itself and would be considered part of the physical examination. When the ABI is abnormal (i.e., <0.9 at rest), it must be accompanied by another appropriate indication before proceeding to more sophisticated or complete studies, except in patients with severely elevated ankle blood pressure.

Examples of additional signs and symptoms that donot indicate medical necessity include:

• Continuous burning of the feet is considered to be a neurologic symptom.

• "Leg pain, nonspecific" or "Pain in limb" as single diagnoses are too general to warrant further investigation unless they can be related to other signs and symptoms.

• Edema rarely occurs with arterial occlusive disease unless it is in the immediate postoperative period, in association with another inflammatory process or in association with rest pain.

• Absence of relatively minor pulses (eg, dorsalis pedis or posterior tibial) in the absence of ischemic symptoms. The absence of pulses is not an indication to proceed beyond the physical examination unless related signs and/or symptoms are present which are severe enough to require possible invasive intervention.

• Screening of an asymptomatic patient is not covered by Medicare.

In general, non-invasive studies of the arterial system are to be utilized when invasive correction is contemplated, but not to follow non-invasive medical treatment regimens (eg, to evaluate pharmacologic intervention) or to monitor unchanged symptomatology. The latter may be followed with physical findings including ABIs and/or progression or relief of signs and/or symptoms.

Noninvasive vascular testing studies are medically necessary only if the outcome will potentially impact the clinical management 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. It is also expected that the studies are not redundant of other diagnostic procedures that must be performed.

When an uninterpretable study (i.e., poor quality or not in accordance with regulatory standards)results in performing another type of study, only the successful study should be billed. For example, when an uninterpretable non- invasive physiologic study (CPT code 93922, 93923 or 93924) is performed which results in performing a duplex scan (CPT codes 93925 or 93926), only the duplex scan should be billed.

Noninvasive vascular procedures will not be covered when performed based on internal protocols of the testing facility; a referral for one noninvasive study is not a blanket referral for all studies. Each procedure must be specifically ordered by the physician/nonphysician practitioner treating the patient and the medical necessity criteria specified in this LCD must be met.

Typically, it is appropriate for follow-up studies post-angioplasty, with or without stent placement to be performed at three months, six months and one year. Subsequent studies may be allowed if there is clinical evidence of recurrent vascular disease evidenced by signs (i.e. decreased ABI from previous exam) or symptoms (i.e. recurrence of claudication). For postoperative surveillance, either a limited Duplex or multi-level Doppler with pressures is usually sufficient, but it is not considered necessary to do both.

Performance of both a physiological test (CPT codes 93922, 93923, 93924) and duplex scanning (CPT codes 93925, 93926) of extremity arteries during the same encounter would not generally be expected. Consequently, documentation must clearly support the medical necessity if both procedures are performed during the same encounter, and be available to Medicare upon request. Note: Reimbursement of physiologic testing will not be allowed after a duplex scanning has been performed.

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.

Performance of both non-invasive extracranial arterial studies (CPT code 93880 or 93881) and non-invasive evaluation of extremity arteries (CPT codes 93922, 93923, 93924) during the same encounter is not appropriate as a general practice or standing protocol, and therefore, would not generally be expected. Consequently, documentation must clearly support the medical necessity if both procedures are performed during the same encounter, and be available to Medicare upon request.

Methods Not Acceptable for Reimbursement

The following methods are not covered per CMS Manual System, Pub 100-3, Medicare National Coverage Determinations, Chapter 1, Section 20.14 as these methods have not yet reached a level of development such as to allow their routine use in the evaluation of suspected peripheral vascular disease:

• Inductance Plethysmography

• Capacitance Plethysmography

• Mechanical Oscillometry

• Photoelectric Plethysmography

Also, 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 2010, page 471). 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. Doppler procedures performed with zero-crossers (e.g., analog [strip chart recorder] analysis) are also considered to be part of the evaluation and management service and should not be reported separately.

TRAINING REQUIREMENTS

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.

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

• Registered Vascular Technologist (RVT) credential

• Registered Vascular Specialist (RVS) credential

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 credential

Appropriate nationally recognized laboratory accreditation bodies include:

• Intersocietal Commission for the Accreditation of Vascular Laboratories (ICAVL)

• American College of Radiology (ACR)

Additionally, the transcutaneous oxygen tension measurements (Tp02) may be performed by personnel credentialed as a certified hyperbaric registered nurse (CHRN) or certified hyperbaric technologist (CHT) by the National Board of Diving and Hyperbaric Medical Technology (NBDHMT).

General Supervision means the procedure is furnished under the physician’s overall direction and control, but the physician’s presence is not required during the performance of the procedure. Under general supervision, the training of the nonphysician personnel who actually performs the diagnostic procedure and the maintenance of the necessary equipment and supplies are the continuing responsibility of the physician.

Note: In accordance with 42 CFR 410.33, noninvasive vascular studies performed in an Independent Diagnostic Testing Facility (IDTF) include credentialing requirements that supersede those above. Noninvasive vascular studies performed in an IDTF must follow the supervision and credentialing guidelines set forth in the LCD for Independent Diagnostic Testing Facility (IDTF).

Notice: This LCD imposes diagnosis limitations that support diagnosis to procedure code automated denials. However, 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.

As published in the CMS online manual publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1: In order 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 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 which meet the requirements of the Clinical Trials NCD are considered reasonable and necessary); and

• 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 need; and

• At least as beneficial as an existing and available medically appropriate alternative.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

CPT/HCPCS Codes

93922 LIMITED BILATERAL NONINVASIVE PHYSIOLOGIC STUDIES OF UPPER OR LOWER EXTREMITY ARTERIES, (EG, FOR LOWER EXTREMITY: ANKLE/ BRACHIAL INDICES AT DISTAL POSTERIOR TIBIAL AND ANTERIOR TIBIAL/ DORSALIS PEDIS ARTERIES PLUS BIDIRECTIONAL, DOPPLER WAVEFORM RECORDING AND ANALYSIS AT 1-2 LEVELS, OR ANKLE/BRACHIAL INDICES AT DISTAL POSTERIOR TIBIAL AND ANTERIOR TIBIAL/DORSALIS PEDIS ARTERIES PLUS VOLUME PLETHYSMOGRAPHY AT 1-2 LEVELS, OR ANKLE/ BRACHIAL INDICES AT DISTAL POSTERIOR TIBIAL AND ANTERIOR TIBIAL/ DORSALIS PEDIS ARTERIES WITH, TRANSCUTANEOUS OXYGEN TENSION MEASUREMENT AT 1-2 LEVELS)

COMPLETE BILATERAL NONINVASIVE PHYSIOLOGIC STUDIES OF UPPER OR LOWER EXTREMITY ARTERIES, 3 OR MORE LEVELS (EG, FOR LOWER EXTREMITY: ANKLE/BRACHIAL INDICES AT DISTAL POSTERIOR TIBIAL AND ANTERIOR TIBIAL/DORSALIS PEDIS ARTERIES PLUS SEGMENTAL BLOOD PRESSURE MEASUREMENTS WITH BIDIRECTIONAL DOPPLER WAVEFORM RECORDING AND ANALYSIS, AT 3 OR MORE LEVELS, OR ANKLE/BRACHIAL

93923 INDICES AT DISTAL POSTERIOR TIBIAL AND ANTERIOR TIBIAL/DORSALIS PEDIS ARTERIES PLUS SEGMENTAL VOLUME PLETHYSMOGRAPHY AT 3 OR MORE LEVELS, OR ANKLE/BRACHIAL INDICES AT DISTAL POSTERIOR TIBIAL AND ANTERIOR TIBIAL/DORSALIS PEDIS ARTERIES PLUS SEGMENTAL TRANSCUTANEOUS OXYGEN TENSION MEASUREMENTS AT 3 OR MORE LEVELS), OR SINGLE LEVEL STUDY WITH PROVOCATIVE FUNCTIONAL MANEUVERS (EG, MEASUREMENTS WITH POSTURAL PROVOCATIVE TESTS, OR MEASUREMENTS WITH REACTIVE HYPEREMIA)

NONINVASIVE PHYSIOLOGIC STUDIES OF LOWER EXTREMITY ARTERIES, AT REST AND FOLLOWING TREADMILL STRESS TESTING, (IE, BIDIRECTIONAL DOPPLER WAVEFORM OR VOLUME PLETHYSMOGRAPHY RECORDING AND 93924 ANALYSIS AT REST WITH ANKLE/BRACHIAL INDICES IMMEDIATELY AFTER AND AT TIMED INTERVALS FOLLOWING PERFORMANCE OF A STANDARDIZED PROTOCOL ON A MOTORIZED TREADMILL PLUS RECORDING OF TIME OF

ONSET OF CLAUDICATION OR OTHER SYMPTOMS, MAXIMAL WALKING TIME, AND TIME TO RECOVERY) COMPLETE BILATERAL STUDY

ICD-9 Codes that Support Medical Necessity

440.0 ATHEROSCLEROSIS OF AORTA

440.20-440.24opensinnewwindow ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES UNSPECIFIED - ATHEROSCLEROSIS OF NATIVE ARTERIES OF THE EXTREMITIES WITH GANGRENE

440.30-440.32opensinnewwindow ATHEROSCLEROSIS OF UNSPECIFIED BYPASS GRAFT OF THE EXTREMITIES - ATHEROSCLEROSIS OF NONAUTOLOGOUS BIOLOGICAL BYPASS GRAFT OF THE EXTREMITIES

440.4 CHRONIC TOTAL OCCLUSION OF ARTERY OF THE EXTREMITIES

441.00-441.03opensinnewwindow DISSECTION OF AORTA ANEURYSM UNSPECIFIED SITE - DISSECTION OF AORTA THORACOABDOMINAL

442.0 ANEURYSM OF ARTERY OF UPPER EXTREMITY

442.3 ANEURYSM OF ARTERY OF LOWER EXTREMITY

443.1 RAYNAUD'S SYNDROME

443.2 THROMBOANGIITIS OBLITERANS (BUERGER'S DISEASE)

443.81 PERIPHERAL ANGIOPATHY IN DISEASES CLASSIFIED ELSEWHERE

443.9 PERIPHERAL VASCULAR DISEASE UNSPECIFIED

444.01-444.09opensinnewwindow SADDLE EMBOLUS OF ABDOMINAL AORTA - OTHER ARTERIAL EMBOLISM AND THROMBOSIS OF ABDOMINAL AORTA

444.1 EMBOLISM AND THROMBOSIS OF THORACIC AORTA

444.21-444.22opensinnewwindow ARTERIAL EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY - ARTERIAL EMBOLISM AND THROMBOSIS OF LOWER EXTREMITY

444.81-444.89opensinnewwindow EMBOLISM AND THROMBOSIS OF ILIAC ARTERY - EMBOLISM AND THROMBOSIS OF OTHER ARTERY

447.1 ARTERIOVENOUS FISTULA ACQUIRED

447.2 STRICTURE OF ARTERY

447.3 RUPTURE OF ARTERY

447.5 NECROSIS OF ARTERY

449 SEPTIC ARTERIAL EMBOLISM

707.10-707.19opensinnewwindow UNSPECIFIED ULCER OF LOWER LIMB - ULCER OF OTHER PART OF LOWER LIMB

707.8 CHRONIC ULCER OF OTHER SPECIFIED SITES

785.4 GANGRENE

903.00 INJURY TO AXILLARY VESSEL(S) UNSPECIFIED

903.02 INJURY TO AXILLARY VEIN

903.1 INJURY TO BRACHIAL BLOOD VESSELS

903.2 INJURY TO RADIAL BLOOD VESSELS

903.3 INJURY TO ULNAR BLOOD VESSELS

903.4 INJURY TO PALMAR ARTERY

903.5 INJURY TO DIGITAL BLOOD VESSELS

903.8 INJURY TO OTHER SPECIFIED BLOOD VESSELS OF UPPER EXTREMITY

904.1 INJURY TO COMMON FEMORAL ARTERY

904.2 INJURY TO SUPERFICIAL FEMORAL ARTERY

904.41 INJURY TO POPLITEAL ARTERY

904.51 INJURY TO ANTERIOR TIBIAL ARTERY

904.53 INJURY TO POSTERIOR TIBIAL ARTERY

904.6 INJURY TO DEEP PLANTAR BLOOD VESSELS

904.7 INJURY TO OTHER SPECIFIED BLOOD VESSELS OF LOWER EXTREMITY

996.1 MECHANICAL COMPLICATION OF OTHER VASCULAR DEVICE IMPLANT AND GRAFT

996.70-996.79opensinnewwindow OTHER COMPLICATIONS DUE TO UNSPECIFIED DEVICE IMPLANT AND GRAFT - OTHER COMPLICATIONS DUE TO OTHER INTERNAL PROSTHETIC DEVICE IMPLANT AND GRAFT

998.11-998.13opensinnewwindow HEMORRHAGE COMPLICATING A PROCEDURE - SEROMA COMPLICATING A PROCEDURE

998.2 ACCIDENTAL PUNCTURE OR LACERATION DURING A PROCEDURE NOT ELSEWHERE CLASSIFIED

Covered conditions for HBO therapy with associated transcutaneous oxygen tension measurements (Tp02) are limited to the following:

444.21-444.22opensinnewwindow ARTERIAL EMBOLISM AND THROMBOSIS OF UPPER EXTREMITY - ARTERIAL EMBOLISM AND THROMBOSIS OF LOWER EXTREMITY

444.81 EMBOLISM AND THROMBOSIS OF ILIAC ARTERY

728.86 NECROTIZING FASCIITIS

902.53 INJURY TO ILIAC ARTERY

903.01 INJURY TO AXILLARY ARTERY

903.1 INJURY TO BRACHIAL BLOOD VESSELS

904.0 INJURY TO COMMON FEMORAL ARTERY

904.41 INJURY TO POPLITEAL ARTERY

927.00-927.09opensinnewwindow CRUSHING INJURY OF SHOULDER REGION - CRUSHING INJURY OF MULTIPLE SITES OF UPPER ARM

927.10-927.11opensinnewwindow CRUSHING INJURY OF FOREARM - CRUSHING INJURY OF ELBOW

927.20-927.21opensinnewwindow CRUSHING INJURY OF HAND(S) - CRUSHING INJURY OF WRIST

927.8 CRUSHING INJURY OF MULTIPLE SITES OF UPPER LIMB

927.9 CRUSHING INJURY OF UNSPECIFIED SITE OF UPPER LIMB

928.00-928.01opensinnewwindow CRUSHING INJURY OF THIGH - CRUSHING INJURY OF HIP

928.10-928.11opensinnewwindow CRUSHING INJURY OF LOWER LEG - CRUSHING INJURY OF KNEE

928.20-928.21opensinnewwindow CRUSHING INJURY OF FOOT - CRUSHING INJURY OF ANKLE

928.3 CRUSHING INJURY OF TOE(S)

928.8 CRUSHING INJURY OF MULTIPLE SITES OF LOWER LIMB

928.9 CRUSHING INJURY OF UNSPECIFIED SITE OF LOWER LIMB

929.0-929.9opensinnewwindow CRUSHING INJURY OF MULTIPLE SITES NOT ELSEWHERE CLASSIFIED - CRUSHING INJURY OF UNSPECIFIED SITE

990 EFFECTS OF RADIATION UNSPECIFIED

996.52 MECHANICAL COMPLICATION OF PROSTHETIC GRAFT OF OTHER TISSUE NOT ELSEWHERE CLASSIFIED

996.90-996.99opensinnewwindow COMPLICATIONS OF UNSPECIFIED REATTACHED EXTREMITY - COMPLICATION OF OTHER SPECIFIED REATTACHED BODY PART

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation maintained by the ordering/referring physician/nonphysician practitioner must clearly indicate the medical necessity of non-invasive physiologic studies of the upper or lower extremity arteries i.e., signs and symptoms, relevant history (including known diagnoses, and/or prior imaging). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures. Also, the results of arterial studies must be included in the patient's medical record. A hard copy or soft copy convertible to a hard copy provides a permanent record of the study performed and must be of a quality that meets accepted medical standards. If performing procedure code 93924, documentation must include results of resting studies and after treadmill stress testing studies. This information is normally found in the office/progress notes and test results.

If the provider of non-invasive physiologic studies of arteries of the upper or lower extremity is other than the ordering/referring physician/nonphysician practitioner, the provider of the service must maintain a copy of the test results and interpretation, along with copies of the ordering/referring physician/nonphysician practitioner’s order for the studies. When ordering arterial studies from another provider, the ordering/referring physician/nonphysician practitioner must state the reason for the studies in his/her order for the test.

The provider is responsible for ensuring the medical necessity of procedures and maintaining the medical record, which must be available to MAC J9 upon request. Non-invasive vascular studies are medically reasonable and necessary only if the outcome will potentially impact the diagnosis or clinical course of the patient. Providers billing Medicare are encouraged to obtain additional information from referring providers and/or patients or medical records to determine the medical necessity of studies performed. Referring physicians are required to provide appropriate diagnostic information to the performing provider.

Noninvasive vascular procedures will not be covered when performed based on internal protocols of the testing facility; a referral for one non-invasive study is not a blanket referral for all studies. The provider treating the patient must specifically order the procedures in writing; an order must be on record for each non-invasive study performed.

When an uninterpretable study (i.e., poor quality or not in accordance with regulatory standards) results in performing another type of study, only the successful study should be billed. For example, when an uninterpretable non- invasive physiologic study (CPT code 93922, 93923 or 93924) is performed which results in performing a duplex scan (CPT codes 93925 or 93926), only the duplex scan should be billed.

Documentation must support the criteria for coverage as set forth in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of this LCD and should reflect how the results of this test will be used in the patient’s plan of care.

The medical necessity for performing repeat extremity arterial studies must be clearly documented in the medical record.

Per 42 CFR §410.32, all diagnostic tests must be ordered by the physician/nonphysician practitioner who is treating the patient, that is, the physician/nonphysician practitioner who furnishes a consultation or treats a patient for a specific medical problem and who uses the results in the management of the patient’s specific medical problem. Tests not ordered by the physician/nonphysician practitioner who is treating the patient are not reasonable and

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Customarily, transcutaneous oxygen tension measurements (TpO2) are acceptable for evaluating healing potential in non-healing or difficult-to-heal wounds at a frequency of no more than twice in any 60-day period. Generally, it is not expected that these services would be performed more than once a year, excluding inpatient hospital (21) and emergency room (23) places of service.

Note: This LCD imposes utilization guideline limitations. Each patient’s condition and response to treatment must medically warrant the number of services reported for payment. Medicare requires the medical necessity for each service reported to be clearly demonstrated in the patient’s medical record. It is expected that patients will not routinely require the maximum allowable number of services.

Sources of Information and Basis for Decision

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. (2007). ACR-AIUM-SIR practice guideline for the performance of physiologic evaluation of extremity arteries. Retrieved from http://www.acr.org/secondarymainmenucategories/quality_safety/guidelines.aspx

American College of Radiology. (2009). ACR appropriateness criteria: Follow-up of lower-extremity arterial bypass surgery. Retrieved from http://www.acr.org/ac American College of Radiology. (2009). ACR appropriateness criteria: Recurrent symptoms following lower-extremity angioplasty. Retrieved from http://www.acr.org/ac

Davies, A., Hawdon, A., Sydes, M., Thompson, S. (2005). Is duplex surveillance of value after leg vein bypass grafting? Circulation, 112, 1985-1991. doi:10.1161/CIRCULATIONAHA.104.518738. Retrieved from http://circ.ahajournals.org/content/112/13/1985.full.pdf+html

Hirsch, A., Haskal, Z., Hertzer, N., Bakal, C., Creager, M., Halperin, J., Hiratzka, L., Murphy, W., Olin, J., Puschett, J., Rosenfield, K., Sacks, D., Stanley, J., Taylor Jr., L. White, C., White, J., & White, R. (2006). ACC/AHA Guidelines for the Management of Patients with Peripheral Arterial Disease (Lower Extremity, Renal, Mesenteric, and Abdominal Aortic): A Collaborative Report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society for Vascular Medicine and Biology, and the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease). Journal of the American College of Cardiology, 47, e1-e192. doi:10.1016/j.jacc.2006.02.024. Retrieved from http://circ.ahajournals.org/cgi/reprint/113/11/e463.

Olin, J., Allie, D., Belkin, M., Bonow, R., Casey Jr., D., Creager, M., Gerber, T., Hirsch, A., Jaff, M., Kaufman, J., Lewis, C., Martin, E., Martin, L., Sheehan, P., Stewart, K., Treat-Jacobson, D., White, C., & Zheng, Z. (2010). ACCF/AHA/ACR/SCAI/SIR/SVM/SVN/SVS 2010 Performance Measures for Adults with Peripheral Artery Disease: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Performance Measures, the American College of Radiology, the Society for Cardiac Angiography and Interventions, the Society for Interventional Radiology, the Society for Vascular Medicine, the Society for Vascular Nursing, and the Society for Vascular Surgery (Writing Committee to Develop Clinical Performance Measures for Peripheral Artery Disease). Circulation, 122, 2583-2618. doi:10.1161/CIR.0b013e3182031a3c. Retrieved from http://circ.ahajournals.org/cgi/reprint/122/24/2583?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=ACR+Guidelines+peripheral+arterial+disease&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT

Other Contractor’s LCDs.

Society for Vascular Ultrasound–Professional performance guidelines. (2004). Upper extremity arterial segmental physiologic evaluation. (2003). Lower extremity arterial segmental physiologic evaluation. Retrieved July 8, 2005, from http://www.svunet.org/about/positions.

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.

United States Government Accountability Office. (2007). Report to congressional committees: Medicare ultrasound procedures-Consideration of payment reforms and technician qualification requirements, GAO-07-734. Retrieved from http://www.gao.gov/new.items/d07734.pdf

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was developed in cooperation with the advisory groups, which includes representatives from numerous societies.

Florida Contractor Advisory Committee Meeting held on October 15, 2011.

Puerto Rico/U.S. Virgin Islands Contractor Advisory Meeting held on October 20, 2011.

Start Date of Comment Period 10/07/2011

End Date of Comment Period 11/21/2011

Start Date of Notice Period 12/16/2011

Revision History Number 4

Revision History Explanation Revision Number:4 Start Date of Comment Period:10/07/2011

Start Date of Notice Period:12/16/2011 Revised Effective Date:01/31/2012

LCR B2011-119

December 2011 Connection

Explanation of Revision: LCD revised in the ‘Indications and Limitations of Coverage and/or Medical Necessity’ section to update language, add indications for follow-up studies post-operative conditions, and to add a ‘Limitations’ section. The ‘Training Requirements’ section of the LCD has been revised to add language to indicate noninvasive vascular studies performed in an IDTF include credentialing requirements that supersede those in this LCD in accordance with 42 CFR 410.33. The ‘Utilization Guidelines’ and the ‘Sources of Information and Basis for Decision’ sections of the LCD have also been updated. The effective date of this revision is based on date of service.

Revision Number:3

Start Date of Comment Period:N/A Start Date of Notice Period:10/01/2011 Revised Effective Date 10/01/2011

LCR B2011-101

September 2011 Connection

Explanation of Revision: Annual 2012 ICD-9-CM Update. Deleted diagnosis code 444.0 and replaced it with diagnosis code range 444.01-444.09. The effective date of this revision is based on date of service. Revision Number:2

Start Date of Comment Period:N/A Start Date of Notice Period:10/01/2011 Revised Effective Date 08/23/2011

LCR B2011-099

September 2011 Connection

Explanation of Revision: The ‘Indications and Limitations of Coverage and/or Medical Necessity’ section of the LCD has been revised to add language to indicate that the transcutaneous oxygen tension measurements (Tp02) may be performed by personnel credentialed as a certified hyperbaric registered nurse (CHRN) or certified hyperbaric technologist (CHT) by the National Board of Diving and Hyperbaric Medical Technology (NBDHMT). The effective date of this revision is based on date of service.

Revision Number:1

Start Date of Comment Period:N/A Start Date of Notice Period:01/01/2011

Revision Effective Date 01/01/2011

LCR B2011-018

December 2010 Update

Explanation of Revision: Annual 2011 HCPCS Update. Descriptors revised for CPT codes 93922, 93923 and 93924. The effective date of this revision is based on date of service. Revision Number:Original

Start Date of Comment Period:N/A

Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO). For Florida (00590) this LCD (L29237) replaces LCD L6001 as the policy in notice. This document (L29237) is effective on 02/02/2009.

"Indications and Limitations of Coverage and/or Medical Necessity" and "CPT/HCPCS Codes" sections of LCD revised to align with CMS Manual System, Pub. 100-03, Medicare National Coverage Determinations, Chapter 1, Section 20.29.

11/21/2010 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

93922 descriptor was changed in Group 1 93923 descriptor was changed in Group 1 93924 descriptor was changed in Group 1

08/27/2011 - This policy was updated by the ICD-9 2011-2012 Annual Update.

11/21/2011 - For the following CPT/HCPCS codes either the short description and/or the long description was changed. Depending on which description is used in this LCD, there may not be any change in how the code displays in the document:

93922 descriptor was changed in Group 1 93923 descriptor was changed in Group 1

Reason for Change