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Date Printed: August 21, 2017: 07:44 PM

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This medical policy (medical coverage guideline) is Copyright 2017, Blue Cross and Blue Shield of Florida (BCBSF). All Rights Reserved. You may not copy or use this document or disclose its contents without the express written permission of BCBSF. The medical codes referenced in this document may be proprietary and owned by others. BCBSF makes no claim of ownership of such codes. Our use of such codes in this document is for explanation and guidance and should not be construed as a license for their use by you. Before utilizing the codes, please be sure that to the extent required, you have secured any appropriate licenses for such use. Current Procedural Terminology (CPT) is copyright 2017 American Medical Association. All Rights Reserved. No fee schedules, basic units, relative values, or related listings are included in CPT. The AMA assumes no liability for the data contained herein. Applicable FARS/DFARS restrictions apply to government use. CPT® is a trademark of the American Medical Association. The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

02-20000-24

Original Effective Date: 09/27/01

Reviewed: 09/22/11

Revised: 01/01/17

Subject: Extracorporeal Shock Wave (ESW) for Treatment of Plantar Fasciitis and Other Musculoskeletal Conditions

THIS MEDICAL COVERAGE GUIDELINE IS NOT AN AUTHORIZATION, CERTIFICATION, EXPLANATION OF BENEFITS, OR A GUARANTEE OF PAYMENT, NOR DOES IT SUBSTITUTE FOR OR CONSTITUTE MEDICAL ADVICE. ALL MEDICAL DECISIONS ARE SOLELY THE RESPONSIBILITY OF THE PATIENT AND PHYSICIAN. BENEFITS ARE DETERMINED BY THE GROUP CONTRACT, MEMBER BENEFIT BOOKLET, AND/OR INDIVIDUAL SUBSCRIBER CERTIFICATE IN EFFECT AT THE TIME SERVICES WERE RENDERED. THIS MEDICAL COVERAGE GUIDELINE APPLIES TO ALL LINES OF BUSINESS UNLESS OTHERWISE NOTED IN THE PROGRAM EXCEPTIONS SECTION.

           
Position Statement Billing/Coding Reimbursement Program Exceptions Definitions Related Guidelines
           
Other References Updates    
           

DESCRIPTION:

Extracorporeal shock wave (ESW/ESWT) treatment is also known as orthotripsy. ESW has been available since the early 1980s for the treatment of renal stones. The mechanism by which ESWT might have an effect on musculoskeletal conditions is not well defined. Chronic musculoskeletal conditions, such as (tendinitis), can be associated with a substantial degree of scarring and calcium deposition. Calcium deposits may restrict motion and encroach on other structures such as nerves and blood vessels, causing pain and decreased function. One hypothesis is that disruption of these calcific deposits by shock waves may loosen adjacent structures and promote resorption of calcium, thereby decreasing pain and improving function.

Currently a number of ESWT devices are approved for marketing by the U.S. Food and Drug Administration (FDA). The OssaTron® device (HealthTronics, Marietta, GA), an electrohydraulic delivery system was approved by the FDA on July 20, 2000. The Epos™ Ultra (Dornier, Germering, Germany), an electromagnetic delivery system, was approved by the FDA on January 15, 2002, for plantar fasciitis. The SONOCUR® Basic (Seimans, Erlangen, Germany) also uses an electromagnetic delivery system and was approved by the FDA on July 19, 2002 for use in chronic lateral epicondylitis (symptoms unresponsive to conservative therapy for more than 6 months). In 2005, the Orthospec™ Orthopedic ESWT (Medispec Ltd, Germantown, MD), an electrohydraulic spark-gap device, and the Orbasone™ Pain Relief System (Orthometrix, White Plains, NY), a high-energy sonic wave system received FDA approval.

Both high-dose and low-dose protocols have been investigated. A high-dose protocol consists of a single treatment of high energy shock waves (1300mJ/mm-2). This painful procedure requires anesthesia. A low-dose protocol consists of multiple treatments, spaced 1 week to 1 month apart, in which a lower dose of shock waves is applied. This protocol does not require anesthesia. The FDA-labeled indication for the OssaTron® and Epos™ Ultra device specifically describes a high-dose protocol, while the labeled indication for the SONOCUR® device describes a low-dose protocol.

Plantar Fasciitis

Plantar fasciitis is a very common ailment characterized by deep pain in the plantar aspect of the heel, particularly on arising from bed. While the pain may subside with activity, in some patients the pain may persist, interrupting activities of daily living. On physical examination, firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology of plantar fasciitis is unclear, although repetitive injury is suspected. Heel spurs are a common associated finding, although it has never been proven that heel spurs cause the pain. It should be noted that asymptomatic heel spurs can be found in up to 10% of the population.

Conservative therapy of plantar fasciitis is successful in the vast majority of cases. Rest or minimization of running or jumping is the cornerstone of therapy. Heel cups are sometimes helpful in alleviating symptoms, presumably by padding the heel and absorbing the impact of walking. Nonsteroidal anti-inflammatory drugs are also helpful in acute cases. If these measures are ineffective, a local injection of steroids may be effective. Improvement is frustratingly slow and gradual, taking up to a year in some cases.

Tendinitis of the Elbow (Lateral Epicondylitis)

Lateral epicondylitis is the most common form of tendonitis (tendinitis) of the elbow, and results in lateral elbow pain and functional limitations. The disorder is caused by overuse or injury of the tendons that attach the arm muscles to the elbow, such as commonly occurs from playing tennis (“tennis elbow”). Only a minority of cases are caused by playing tennis, the majority occur from other activities that involve repetitive extension of the wrist. Overuse of the extensor muscles lead to microtears at their insertion point, which incites an inflammatory response. Repetitive cycles of injury and inflammation lead to tendinosis, degeneration of the tendon structures, and disorganized healing.

Conservative treatment consists of rest, activity modification, anti-inflammatory medications, and/or physical therapy. Corticosteroid injections and orthotic devices can also be tried as adjuncts to conservative measures. A number of surgical treatments are available for patients who do not respond to conservative treatment; approximately 5% – 10% of patients with tendinitis of the elbow require surgery. Surgery may be performed as open or laparoscopic procedures. The general approach is to debride any degenerative or nonviable tissue and to repair tears or other structural abnormalities.

Nonunion and Delayed Union

The definition of a fracture nonunion has remained controversial, particularly in the necessary duration to define a condition of nonunion. Complicated variables are present in fractures, i.e., degree of soft tissue damage, alignment of the bone fragments, vascularity, and quality of the underlying bone stock. The time period has been variously described as lack of visible signs of healing within 3 months, 6 months, or 9 months. The significance of disagreement on the clinical definition of nonunion is that study populations have been heterogeneous and comparisons between studies are difficult. The nonunion fracture can be further defined as atrophic, in which no callus formation occurs, or hypertrophic, with callus formation at both sides of the fracture, but without fusion. Delayed union refers to a decelerating bone healing process, as identified in serial x-rays. (In contrast, nonunion serial x-rays show no evidence of healing.) When grouped together, delayed union and nonunion are sometimes referred to as ununited fractures.

POSITION STATEMENT:

Extracorporeal shock wave therapy (ESWT), using either a high- or low-dose protocol, is considered experimental or investigational, as there is insufficient clinical evidence to support the use of ESWT as a treatment of musculoskeletal conditions, and specifically for the following conditions:

There is a lack of scientific evidence to permit conclusions on efficacy and net health outcomes.

BILLING/CODING INFORMATION:

CPT Coding:

0101T

Extracorporeal shock wave involving musculoskeletal system, not otherwise specified; high energy (Investigational)

0102T

Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle (Investigational)

28890

Extracorporeal shock wave, high energy, performed by a physician or other qualified health care professional, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia (Investigational)

REIMBURSEMENT INFORMATION:

Refer to section entitled POSITION STATEMENT.

PROGRAM EXCEPTIONS:

Federal Employee Program (FEP): Follow FEP guidelines.

State Account Organization (SAO): Follow SAO guidelines.

Medicare Advantage products:

The following Local Coverage Determination (LCD) was reviewed on the last guideline reviewed date: Noncovered Services (L29288) located at fcso.com.

DEFINITIONS:

Delayed union: a fracture that fails to consolidate (unite) within normal limits, less than 9 months (i.e., healing has slowed with no indications that union will fail).

Nonunion: fracture site that shows no visibly progressive signs of healing after 3 months or more, as confirmed by serial radiographs (i.e., bone healing has ceased).

Tendonitis, Tendinitis: an inflammation of a tendon.

RELATED GUIDELINES:

None applicable.

OTHER:

Other terms used to describe Extracorporeal shock wave treatment for musculoskeletal conditions:

Note: The use of specific product names is illustrative only. It is not intended to be a recommendation of
one product over another, and is not intended to represent a complete listing of all products available.

Epos™ Ultra
Extracorporeal Shock Wave Treatment (ESWT)
Orthotripsy
Orbasone™
Orthospec™
Ossa Tron Device®
SONOCUR®.

REFERENCES:

  1. AHRQ/National Guideline Clearinghouse. NGC-8320, Shoulder (acute & chronic). Work Loss Data Institute; 2011. Encinitas, CA. Accessed 08/31/11.
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual. 2.01.40 Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions 02/11.
  3. Blue Cross Blue Shield TEC Assessment “Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciitis”. Volume 19, No. 18, (03/05).
  4. Blue Cross Blue Shield TEC Assessment. “Extracorporeal Shock Wave Treatment for Chronic Tendinitis of the Elbow (Lateral Epicondylitis)”. Volume 19, No. 16, (02/05).
  5. Buchbinder R, Green SE, Youd JM, Assendelft WJJ, Barnsley L, Smidt N. Shock wave therapy for lateral elbow pain. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD003524. DOI: 10.1002/14651858.CD003524.pub2.
  6. Buchbinder R, Ptasznik R, Gordon J, Buchanan J, Prabaharan V, Forbes A. Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial. JAMA. 2002 Sep 18; 288(11): 1364-72.
  7. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal Shock-Wave Therapy Compared with Surgery for Hypertrophic Long-Bone Nonunions. J Bone Joint Surg Am. 2009;91:25 89-97.
  8. California Technology Assessment Forum (CTAF). Extracorporeal Shock Wave Therapy (ESWT) For Plantar Fasciitis Not Responding to Conservative Therapy. (06/20/07).
  9. Canadian Agency for Drugs and Technologies in Health. Issues in Emerging Technologies. Extracorporeal shock wave treatment for Chronic plantar fasciitis (heel pain). Issue 96. Part 1. January 2007.
  10. Canadian Agency for Drugs and Technologies in Health. Issues in Emerging Technologies. Extracorporeal shock wave treatment for lateral epicondylitis (elbow pain). Issue 96. Part 2. January 2007.
  11. Canadian Agency for Drugs and Technologies in Health. Issues in Emerging Technologies. Extracorporeal shock wave treatment for rotator cuff tendonitis (shoulder pain). Issue 96. Part 3. January 2007.
  12. Chung B, Wiley JP. Effectiveness of extracorporeal shock wave therapy in the treatment of previously untreated lateral epicondylitis: a randomized controlled trial. Am J Sports Med. 2004 Oct-Nov; 32(7): 660-7.
  13. ClinicalTrials.gov NCT00653081. Supervised Exercises Compared with Radial Extracorporal Shock Wave Therapy (rESWT) in Patients with SIS. Verified on January 2007 by Ullevaal University Hospital. Last Updated on April 3, 2008. Accessed 09/01/11.
  14. ClinicalTrials.gov NCT00958620. Shockwave Therapy of Chronic Achilles Tendinopathy. Verified August 12, 2009 by Aalborg Hospital - Aarhus University Hospital, Denmark. Accessed 08/31/11.
  15. Crawford F, Thomson C. Interventions for treating plantar heel pain. Cochrane Database of Systematic Reviews 2003, Issue 3. Art. No.: CD000416. DOI: 10.1002/14651858. CD000416.
  16. ECRI Health Technology Assessment Information Services. Custom Hotline Response. Extracorporeal Shockwave Therapy for Epicondylitis. Updated 07/17/06.
  17. ECRI Health Technology Assessment Information Services. Custom Hotline Response. Extracorporeal Shockwave Therapy for Shoulder Tendonitis. Updated 07/17/06.
  18. ECRI Institute, Extracorporeal Shock Wave Therapy for the Treatment of Plantar Fasciitis, 11/06. Updated 08/17/07.
  19. ECRI Windows on Medical Technology. Extracorporeal Shockwave Therapy for Epicondylitis, (10/02).
  20. Florida Medicare Part B Local Coverage Determination. L5780 NCSVCS The List of Medicare Noncovered Services, (08/07/06).
  21. Florida Medicare Part B local Coverage Determination. List of Medicare Noncovered Services. (L5780) 10/20/1997, Revised 07/01/08. Accessed 08/15/08.
  22. Florida Medicare Part B local Coverage Determination. List of Medicare Noncovered Services. (L29288). Revised 08/11/09. Accessed 09/01/11.
  23. Hayes Inc. Medical Technology Directory: “Extracorporeal Shock Wave Therapy for Chronic Lateral Epicondylitis of the Elbow.” Lansdale, PA: Hayes, Inc. 08/22/05; update performed 09/02/07.
  24. Hayes Inc. Medical Technology Directory: “Extracorporeal Shock Wave Therapy for Chronic Plantar Fasciitis” Lansdale, PA: Hayes, Inc. 08/22/05; update performed 02/13/08.
  25. Hayes Inc. Medical Technology Directory: “Extracorporeal Shock Wave Therapy for Tendonitis of the Rotator Cuff.” Lansdale, PA: Hayes, Inc. 08/22/05; update performed 09/01/07.
  26. Hayes, Inc., Extracorporeal Shock Wave Therapy for Tendonitis of the Rotator Cuff, 08/06.
  27. Institute for Clinical Systems Improvement (ICSI). Extracorporeal Shock Wave Therapy for Plantar Fasciitis. ICSI Technology Assessment Report # 86. Bloomington, MN: ICSI; November 2004.
  28. InterQual® 2011. CP:Procedures Adult. Plantar Fasciitis, Extracorporeal Shock Wave Therapy (ESWT).
  29. Johnson GW, Cadwallader K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. Am Fam Physician. 2007 Sep 15; 76(6):843-8.
  30. Pettrone FA, McCall BR. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. J Bone Joint Surg Am. 2005 Jun; 87(6): 1297-304.
  31. Rompe JD, Cacchio A, Weil Jr. L, Furia JP, Haist J, Reiners V, Schmitz C, Maffulli N. Plantar Fascia-Specific Stretching Versus Radial Shock-Wave Therapy as Initial Treatment of Plantar Fasciopathy. J Bone Joint Surg Am. 2010;92:2514-22.
  32. Rompe JD, Meurer A, Nafe B, Hofmann A, Gerdesmeyer L. Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. J Orthop Res. 2005 Jul; 23(4): 931-41.
  33. Thomson CE, Crawford F, Murray GD. The effectiveness of extra corporeal shock wave therapy for plantar heel pain: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2005 Apr 22; 6: 19.
  34. U. S. Food and Drug Administration (FDA). Notice of Approval #P000048 Dornier Epos™, 01/15/02.
  35. U. S. Food and Drug Administration (FDA). Notice of Approval #P010039 Siemens SONOCUR® Basic System, 07/19/02.
  36. U. S. Food and Drug Administration (FDA). Notice of Approval #P990086 Health Tronics Ossa Tron, 10/12/00.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 09/22/11.

GUIDELINE UPDATE INFORMATION:

09/27/01

New Medical Coverage Guideline.

04/25/02

Annual review.

01/01/03

HCPCS coding update.

04/15/03

Reviewed; no changes.

01/01/04

HCPCS coding update. Changed the policy number from 09-E0000-39 to 02-20000-24.

04/15/04

Scheduled review and revision to guideline; consisting of updated references.

07/01/05

3rd quarter HCPCS coding update; consisting of revision of code 0019T and addition of code 0101T and 0102T.

10/15/05

Scheduled review and revision of guideline; consisting of updated references.

01/01/06

Annual HCPCS coding update consisting of the deletion of codes G0279 – G0280 and the addition of code 28890.

10/15/06

Scheduled review and revision of guideline consisting of updated references and maintaining investigational statement.

07/15/07

Annual review; investigational status maintained, guideline reformatted, references updated.

10/15/08

Scheduled review; no change in position statement. Update references.

10/15/09

Scheduled review; no change in position statement. Update description section and references.

10/15/11

Scheduled review; no change in position statement. Updated description section and references.

01/01/13

Annual CPT coding update. Revised code descriptor for 28890.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

01/01/17

Annual CPT/HCPCS update. Deleted 0019T.

Date Printed: August 21, 2017: 07:44 PM