Non-Vascular Extremity Ultrasound

This LCD supplements but does not replace, modify or supersede existing Medicare applicable National Coverage Determinations (NCDs) or payment policy rules and regulations for non-vascular extremity ultrasound services. 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 non-vascular extremity ultrasound services 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 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1, Section 220.5 Ultrasound Diagnostic Procedures
• CMS IOM Publication 100-04, Medicare Claims Processing Manual,
  
  • Chapter 1, Section 30.2.9 Payment to Physician or Other Supplier for Purchased Diagnostic Tests Subject to the Anti-Markup Payment Limitation-Claims Submitted to A/B MACs (B)
  • Chapter 13, Sections 10.1 Billing Part B Radiology Services and Other Diagnostic Procedures, 20 Payment Conditions for Radiology Services, and 150 Place of Service (POS) Instructions for the Professional Component (PC or Interpretation) and the Technical Component (TC) of Diagnostic Tests
  • Chapter 16, Section 40.2 Payment Limit for Purchased Services
• CMS IOM Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD

Social Security Act (Title XVIII) Standard References:

• Title XVIII of the Social Security Act, Section 1833(e) states that no payment shall be made to any provider for any claim that lacks the necessary information to process the claim.
• Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall 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.

Federal Register References:

• Title 42 Code of Federal Regulations (CFR) section 410.32(d)(3) Diagnositic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions, Diagnostic laboratory tests - Claims review.

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.

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

History/Background and/or General Information

Ultrasound of the extremity is a non-invasive imaging technique that uses high-frequency sound waves to evaluate the extremities (arms and legs including shoulders, hips, hands and feet), providing real-time, two-dimensional images. Longitudinal, transverse and oblique images of the area of interest are obtained. Musculoskeletal Ultrasound (MSK US) is highly operator dependent, making proper equipment and technique critical to obtaining an accurate examination. Basic knowledge of ultrasound physics and proper use of the controls are needed to produce adequate images.

Ultrasound, echography and sonography are all terms that may be used interchangeably to describe this particular imaging technique. This LCD identifies the indications and limitations of Medicare coverage and reimbursement for these services.

Medical record documentation must support the need for a complete examination and must include a report of the study findings that indicates all of the structures examined and the findings for each. 

Covered Indications

1. Non-Vascular extremity ultrasound examination (complete and limited) may be medically reasonable and necessary for the following conditions:
• To detect cysts, abscesses and effusions;
• To distinguish solid tumors from fluid-filled cysts;
• To evaluate muscles, tendons (including tears, especially those that are partial, tendonitis and tenosynovitis), joints, ligaments, soft tissue masses, nerve compression and stress fractures;
• To aid in the diagnosis of and surgical removal of foreign bodies;
• To evaluate plantar fasciitis unrelated to spondyloarthropathy when all of the following are met:
  
  • When only used once; AND
  • Only after a failed course of at least 6 months of conservative treatment; AND
  • Only when the medical records indicate that another disease process or pathology is indicated.

Please see the documentation requirements of this LCD below for information regarding proper documentation required to submit for an ultrasound, complete joint (i.e., joint space and peri-articular soft-tissue structures), real-time with image documentation and ultrasound, limited, joint or other nonvascular extremity structure(s), (e.g., joint space, peri-articular tendon[s], muscles[s], nerve[s], other soft-tissue structure[s], or soft tissue mass[es], real-time with image documentation. This documentation must be maintained in the medical record and made available to the contractor upon request. Please refer to Local Coverage Article A55037, Non-Vascular Extremity Ultrasound, for billing and coding information.

Limitations
Extremity ultrasound must be performed by individuals who possess the knowledge and skill required for the proper performance of this test. This includes, but is not limited to, physicians, Nurse Practitioners (NPs), Physician Assistants (PAs), or qualified technicians (sonographers). Sonographers, NPs or PAs must be under the general supervision of a physician. Documentation of training or qualifications must be kept on file and be made available to the contractor upon request.

Extremity ultrasound is limited to studies of the arms and legs. The upper extremity includes any part of the arm from the shoulder joint through the fingers including the clavicular and the scapular portions of the upper appendage but excluding the sternoclavicular joint. The lower extremity includes any part of the leg inferior to or below the inguinal ligament.

1. Extremity ultrasound including but not limited to the following conditions is considered not medically reasonable and necessary and therefore non-covered:
   • Avascular necrosis
   • Bunions
   • Chondromalacia patella
   • Cruciate ligament disorder
   • Hoffa’s fat pad
   • Intra articular loose bodies
   • Labrum disorders of the hip or shoulder
   • Marrow disorders
   • Meniscal disorders
   • Neuromas
   • Os trigonum syndrome
   • Osteochondritis dissecans or osteochondral defect
   • Osteomyelitis
   • Paronychia
   • Peripheral nerve injections
   • Plantar plate injuries
   • Plantar warts
   • Sesamoid complex disorders
   • Shoulder dislocation
   • Spurs (including shoulder spurs)
   • Superficial abscesses
   • Superficial ganglia
2. Bilateral studies are allowed only if there is pathology of both extremities dictating medical necessity for two distinct examinations. It is not reasonable and necessary to perform the contralateral extremity as a "control" or for comparison with normal.
3. In the case of plantar fasciitis unrelated to spondyloarthropathy, diagnostic ultrasound is NOT to be used in making an initial determination (diagnosis).
4. More than one complete ultrasound per joint, per extremity, in a 12 month period will be considered not medically necessary.
5. More than four extremity ultrasounds total in a 12 month period, complete or limited, will be considered not medically necessary.

It is not expected that there will be routine cascading of tests from ultrasound to MRI and vice versa when imaging of extremities is medically necessary.

Provider Training/Qualifications

Physicians who perform or interpret diagnostic musculoskeletal (MSK) ultrasound (US) examinations must be licensed medical practitioners who have a thorough understanding of the indications and guidelines for MSK US examinations as well as a familiarity with the basic physical principles and limitations of the technology of US imaging. They must be familiar with the best method of imaging for extremity abnormalities. They must have an understanding of US technology, instrumentation, power output, equipment calibration, and safety. Physicians responsible for diagnostic MSK US examinations must be able to demonstrate familiarity with the anatomy, physiology, and pathophysiology of the anatomic areas that are being examined. These physicians must provide evidence of the training and competence needed to perform or interpret diagnostic MSK US examinations successfully, upon request. The training should also include methods of documentation and reporting of US studies.

The diagnostic medical sonographer must be qualified, by appropriate training, to perform diagnostic US. This qualification can be demonstrated by certification for same by a nationally recognized certifying body.

This LCD imposes frequency limitations. For frequency limitations please refer to the Utilization Guidelines section below.

Notice: Services performed for any given diagnosis must meet all of the indications and limitations stated in this policy, 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. Refer to Billing and Coding: Non-Vascular Extremity Ultrasound, A55037, for applicable CPT/HCPCS codes and diagnosis codes.

The redetermination process may be utilized for consideration of services performed outside of the reasonable and necessary requirements of this LCD.

N/A

N/A

Refer to Local Coverage Article: Billing and Coding: Non-Vascular Extremity Ultrasound, A55037, for all coding information.

Documentation Requirements

1. All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
2. 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.
3. Documentation must support the right (RT), left (LT), or digit modifiers, as reported.
4. The medical necessity for the study must be documented in the patient's medical record including a permanent record of the ultrasound and its interpretation. The ultrasound report must include all of the following:
   • images of all appropriate areas, labeled with exam date, patient identification, and image orientation
   • documentation of the variations from normal, accompanied by measurements
   • formal interpretation
   • results of all testing must be shared with the referring physician
5. The AMA has established documentation guidelines for ultrasound, complete joint (i.e., joint space and peri-articular soft-tissue structures), real-time with image documentation and ultrasound, limited, joint or other nonvascular extremity structure(s) (e.g., joint space, peri-articular tendon[s], muscle[s]. nerve[s], other soft-tissue structure[s], or soft-tissue mass[es]), real-time with image documentation. AMA CPT Changes 2011 documents the criteria that must be met in order to bill for a complete examination of a joint or extremity. It is expected that providers will only bill an ultrasound, complete joint (i.e., joint space and peri-articular soft-tissue structures), real time with image documentation when the medical record documentation (as established by the AMA) supports that level of service. Please refer to Local Coverage Article (A55037), Non-Vascular Extremity Ultrasound, for billing information.
6. The medical record for complete ultrasound studies must include the following:
   
   • Indication for the complete study
   • Report of findings
   • Supporting information that all structures, as defined for the CPT code in the body of this LCD, were examined

Utilization Guidelines

In accordance with CMS Ruling 95-1 (V), utilization of these services should be consistent with locally acceptable standards of practice.

More than one complete ultrasound per joint, per extremity, in a 12 month period will be considered not medically necessary.

Following diagnosis, repetitive studies on the same extremity should be coupled with evidence of the need for a treatment decision.

More than four extremity ultrasounds total in a 12 month period, complete or limited, will be considered not medically necessary.

Notice: This LCD imposes utilization guideline limitations. Despite Medicare allowing up to these maximums, 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. Medicare expects that patients will not routinely require the maximum allowable number of services.

Contractor is not responsible for the continued viability of websites listed.

L30271, Non-Vascular Extremity Ultrasound, Novitas Solutions Jurisdiction L Local Coverage Determination

Other Contractor Policies
UPMC Health Plan Policy Number PAY.092 Accessed online on October 21, 2015

Contractor Medical Directors

1. Abdel-Wahab N, Fathi S, Al-Emadi S, Mahdi S. High-resolution ultrasonographic diagnosis of plantar fasciitis: a correlation of ultrasound and magnetic resonance imaging. International Journal of Rheumatic Diseases. 2008; 11: 279-286.
2. Alvarez S, Anorbe E, Alcorta P, et al. Role of Sonography in the Diagnosis of Axillary Lymph Node Metastases in Breast Cancer: A Systematic Review. AJR Am J Roentgenol. 2006 May;186(5):1342-8.
3. Bisicchia S, Savarese E. Infra-patellar fat pad cysts: a case report and review of the literature. Muscles, Ligaments and Tendons Journal. 2012; 2(4): 305-308.
4. Deslandes M, Guillin R, Cardinal E, Hobden R, Bureau NJ. The Snapping Iliopsoas Tendon: New Mechanisms Using Dynamic Sonography. American Journal of Roentgenology. 2008; 190(3): 576-581. doi: 10.2214/AJR.07.2375.
5. Gomez D, Jha KK, Jepson K. Case report: Ultrasound scan for the diagnosis of interdigital neuroma. Foot and Ankle Surgery. 2005; 11: 175-177. DOI: http://dx.doi.org/10.1016/j.fas.2005.04.001.
6. Hamilton GA, Mullins S, Schuberth JM, Rush SM, Ford L. Revision Lapidus Arthrodesis: Rate of Union in 17 cases. The Journal of Foot and Ankle Surgery. 2007; 46(6): 447-450.
7. Kane D, Greaney T, Shanahan M, Duffy G, Bresnihan B, Gigney R, et al. The role of ultrasonography in the diagnosis and management of idiopathic plantar fasciitis. Rheumatology. 2001; 40(9): 1002-1008.
8. Kasem MAO, Rezk MMA, El-Azizi HM. The potential role of high resolution ultrasound in evaluation of ankle sports injuries; a comparative study with high field MRI. European Society of Radiology. Poster Presentation at ECR 2015; C-0324. Doi 10.1594/ecr2015/C-0324.
9. Mahadevan D, Venkatesan M, Bhatt R, Bhatia M. Diagnostic Accuracy of Clinical Tests for Morton’s Neuroma Compared with Ultrasonography. The Journal of Foot & Ankle Surgery. 2015; 54(4): 549-553.
10. Mahowald S, Legge BS, Grady JF. The Correlation Between Plantar Fascia Thickness and Symptoms of Plantar Fasciitis. Journal of the American Podiatric Medical Association. 2011; 101(5): 385-389.
11. McAlindon T, Kissin E, Nazarian L, Ranganath V, Prakash S, Taylor M, et al. American College of Rheumatology Report on Reasonable Use of Musculoskeletal Ultrasonography in Rheumatology Clinical Practice. Arthritis Care & Research. 2012; 64(11): 1625-1640. DOI 10.1002/acr.21836.
12. McMillan AM, Landorf KB, Barrett JT, Menz HB, Bird AR. Diagnostic imaging for chronic plantar heel pain: a systemic review and meta-analysis. Journal of Foot and Ankle Research. 2009; 2:32. DOI: 10.1186/1757-1146-2-32.
13. Mohseni-Bandpei MA, Nakhaee M, Mousavi ME, Shakourirad A, Safari MR, Vahab Kashani R. Application of Ultrasound in the Assessment of Plantar Fascia in Patients with Plantar Fasciitis: A Systemic Review. Ultrasound in Medicine & Biology. 2014; 40(8): 1737-1754. doi: 10.1016/j.ultrasmedbio.2014.03.001.
14. Neustadter J, Raikin SM, Nazarian LN. Dynamic Sonographic Evaluation of Peroneal Tendon Subluxation. American Journal of Roentgenology. 2004; 183(4): 985-988. Doi: 10.2214/ajr.183.4.1830985.
15. Pastides P, El-Sallakh S, Charalambides C. Morton’s neuroma: A clinical versus radiological diagnosis. Foot and Ankle Surgery. 2012; 18(1): 22-24. doi: 10.1016/j.fas.2011.01.007.
16. Thomas JL, Christensen JC, Kravitz SR, Mendicino RW, Schuberth JM, Vanore JV, et al. The Diagnosis and Treatment of Heel Pain: A Clinical Practice Guideline-Revision 2010. The Journal of Foot & Ankle Surgery. 2010; 49: S1-S19. doi: 10.1053/j.jfas.2010.01.001.
17. Tsai W-C, Chiu M, Wang C, Tang F, Wong M. Ultrasound evaluation of plantar fasciitis. Scand J Rheumatol. 2000; 29(4): 255-259.
18. Xu Z, Duan X, Yu X, Wang H, Dong X, Xiang Z. The accuracy of ultrasonography and magnetic resonance imaging for the diagnosis of Morton’s neuroma: a systemic review. Clinical Radiology. 2015; 70(4): 351-358. DOI: http://dx.doi.org/10.1016/j.crad.2014.10.017.