LCD for Extracorporeal Shock-Wave Therapy for Musculoskeletal Problems (L13281)

 

Contractor Information

Contractor Name 

BlueCross BlueShield of Tennessee (Riverbend Government Benefits Administrator) 

Contractor Number 

00390 

Contractor Type 

FI 

 

LCD Information

LCD ID Number 

L13281 

 

LCD Title 

Extracorporeal Shock-Wave Therapy for Musculoskeletal Problems 

 

Contractor's Determination Number 

L13281 

 

AMA CPT / ADA CDT Copyright Statement 

CPT codes, descriptions and other data only are copyright 2007 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 National Coverage Policy 

Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). This section excludes coverage of items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, Section 1862 (a)(7). This section prohibits Medicare payment for any expenses on items and services incurred for routine physical examinations.

Title XVIII of the Social Security Act, Section 1833 (e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.
 

 

Primary Geographic Jurisdiction 

New Jersey
Tennessee
 

 

Secondary Geographic Jurisdiction 

Alaska
Alabama
Arkansas
Arizona
California
Colorado
Connecticut
Florida
Georgia
Hawaii
Iowa
Idaho
Illinois
Indiana
Kansas
Kentucky
Louisiana
Massachusetts
Maryland
Maine
Michigan
Minnesota
Missouri
Mississippi
North Carolina
North Dakota
Nebraska
New Jersey
New Mexico
Nevada
New York
Ohio
Oklahoma
Oregon
Pennsylvania
Rhode Island
South Carolina
Tennessee
Texas
Utah
Virginia
Vermont
Washington
Wisconsin
West Virginia
Wyoming
 

 

Oversight Region 

Region IV
 

 

 

Original Determination Effective Date 

For services performed on or after 09/30/2003  

 

Original Determination Ending Date 

 

 

Revision Effective Date 

For services performed on or after 12/17/2005  

 

Revision Ending Date 

 

 

Indications and Limitations of Coverage and/or Medical Necessity 

CMS National Coverage Policy References

Title XVIII of the Social Security Act, Section 1862 (a)(1)(A). This section excludes coverage of items or services that are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Title XVIII of the Social Security Act, Section 1862 (a)(7). This section prohibits Medicare payment for any expenses on items and services incurred for routine physical examinations.

Title XVIII of the Social Security Act, Section 1833 (e). This section prohibits Medicare payment for any claim that lacks the necessary information to process the claim.



Indications Summary

Extracorporeal Shock-Wave Therapy (ESWT) devices generate pulses of high-pressure sound that travel through the skin. ESWT devices evolved from lithotripter devices used to send pressure pulses through the body to disintegrate kidney stones.

The FDA has approved the use of some ESWT machines for plantar fasciitis and lateral epicondylitis. RGBA will consider ESWT potentially medically reasonable and necessary for the FDA approved device to treat Plantar Fasciitis alone, due to insufficient evidence of effectiveness of ESWT for any other indications in the medical literatures at the time of the inception of this policy. Any other indications will be considered by RGBA to be investigational.


Plantar Fasciitis is the most common diagnosis for pain in the inferior aspect of the heel involving inflammation and degeneration of the plantar fascia origin from the medical tubercle of the calcaneal tuberosity. It is characterized by poor healing and the formation of scar tissue after an acute or overuse injury. The scar tissue, which has extremely poor blood supply, inhibits the entry of tissue healing cells (fibroblasts and osteoblasts) into the pathologic site. The delivery of shock waves to this scar tissue is thought to cause microscopic injury with associated deposit of endothelial cells, resulting in re-engineering of the scar tissues. A process of neovascularization (growth of new blood vessels) in the small cavities that are created by the pulses is triggered and new blood vessels to an area of tissue would promote the healing. Full benefit of an ESWT treatment may take as long as 12 weeks.

Indications:

1. ESWT will be covered when done with FDA approved devices, and these approved devices are used only for their FDA approved indications.

2. At present, only plantar fasciitis is a potentially covered indication for use of this modality. All other conditions are considered investigational and not covered.

3. ESWT for plantar fasciitis is still considered E&I as a separate procedure in the hospital outpatient environment as long as it is deferred only by a CPT tracking code(nnnnT).

4. ESWT may be medically indicated for treatment of plantar fasciitis when all of the following criteria are met:

 

  • The patient has been symptomatic (severe, chronic pain) for at least six (6) months
  • There has been a lack of response for at least the last two months to at least three conservative measures, including:

 

    • Rest
    • Physical therapy
    • Anti-inflammatory medications
    • Local corticosteroid injections
    • Heel orthotics

 

  • The patient would otherwise be considered a candidate for surgical treatment.




Limitations:

ESWT is contraindicated for children and in the presence of the following:

 

  • Blood coagulation disorders
  • Medications that may prolong bleeding or interfere with blood clotting
  • Polyneuropathy
  • Inflammatory systemic disorders
  • Cancer
  • Pregnancy


In addition, its safety and effectiveness have not been established for those with:

 

  • Nerve damage
  • Osteoporosis
  • Rheumatoid arthritis
  • Diabetic neuropathy
  • Severe peripheral vascular disease
  • Metabolic disorders
  • Infections



Repeat treatments may be medically necessary and covered if the following conditions are met:

 

  • Previous treatment resulted in significant improvement in symptoms and function
  • The criteria for initial treatment are met
  • For repeat treatment, documentation must be submitted with each claim to support medical necessity


Reasons for Denial:

ESWT is not covered when the above criteria and conditions are not met.

ESWT is not covered if there is active infection or an open wound at the treatment site.

ESWT is not covered if there is evidence of blood dyscrasia or bleeding disorder

ESWT will be denied if there is insufficient documentation to support its use/medical necessity.

ESWT is covered only if the device used in delivery of ESWT is FDA approved for use in treating the specific condition undergoing treatment. Non-FDA approved devices cannot be covered, and use of an FDA approved device for a condition other than a condition for which it has FDA approval will not be covered.

 

 

Coverage Topic 

Outpatient Hospital Services
 

 

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.

 

042X

Physical therapy-general classification

043X

Occupational therapy-general classification

 

 

CPT/HCPCS Codes 

CPT/HCPCS code 0020T effective until 01/01/2006
CPT/HCPCS code 0019T effective after 01/01/2006

0019T

EXTRACORPOREAL SHOCK WAVE INVOLVING MUSCULOSKELETAL SYSTEM, NOT OTHERWISE SPECIFIED, LOW ENERGY

 

 

ICD-9 Codes that Support Medical Necessity 

 

728.71

PLANTAR FASCIAL FIBROMATOSIS

 

 

Diagnoses that Support Medical Necessity 

 

 

ICD-9 Codes that DO NOT Support Medical Necessity 

 

 

 

 

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

 

 

Diagnoses that DO NOT Support Medical Necessity 

 

 

General Information

Documentation Requirements 

Documentation supporting the medical necessity and criteria specified above should be legible, maintained in the patient's medical record, and available to Medicare upon request, which should include but not limited to:

 

  • History and Physical
  • Diagnostic Tests Reports
  • MD Orders
  • Medical Necessity
  • Prior conservative treatments and patient response
  • Response to ESWT therapy and total number of therapies received



 

 

Appendices 

LINK TO QUESTIONS AND ANSWERS (COMMENTS) ABOUT THIS
POLICY:
Frequently Asked Questions


 

 

Utilization Guidelines 

No more than three (3) treatments will be covered for a single site during a 90-day period.

No more than six (6) treatments will be covered in a calendar year per anatomic site.

ESWT is currently not used as a first line treatment. 

 

Sources of Information and Basis for Decision 

Other contractor’s policy (Cigna Medicare)

Schroeder, Barrett. American College of Foot and Ankle Surgeons: Diagnosis and Treatment of Heel Pain. American Academy of Family Physicians. Vol 65. No. 8. April 15, 2002.

Rompe, JD, et al, Evaluation of Low-Energy Extracorporeal Shock-Wave Application for Treatment of Chronic Plantar Fasciitis. www.eswt.bayshore.ca/eswtbackground.htm.

Extracorporeal Shock Wave Therapy/ http://heelspurs.com/eswt/index.html.

Buchbinder, Rachelle, MBBS, MSc; Ptasznik, Ronnie, MBBS. “Ultrasound-Guided Extracorporeal Shock Wave Therapy for Plantar Fasciitis”. Journal of American Medical Association. Vol.288 No.11, September 18, 2002.

Wheelock, Argil MD; Theodore, George MD; Steven, Miller DPM; “Shock Wave Therapy for Treatment of Plantar Fasciitis”. Journal of American Medical Association”. Vol 289, No 2, January 2003.

Ogden, JA. “Shock Wave Therapy for Chronic Proximal Plantar Fasciitis”. Clin Orthop. May 2002, (398):267-8.

Hammer, Dietrich MD; Rupp, Stefan MD; Kreutz, Andreas MD. Sonographic Evaluation of Plantar Fasciitis after ESWT Therapy 6 month follow-up”. American Academy of Orthopaedic Surgeons. February 2003. www:aaos.org.

“Dornier MedTech Responds to Flawed Australian Study involving ESWT for the Treatment of Plantar Fasciitis” September 2002. www.dornier.com.

FDA New Device Approval documents

 

 

Advisory Committee Meeting Notes 

This policy does not reflect the sole opinion of the contractor or contractor medical director. Although the final decision rests with the contractor, this policy was developed in cooperation with advisory groups, which includes representatives from appropriate specialties as well as provider (facility) representatives. 

 

Start Date of Comment Period 

06/25/2003 

 

End Date of Comment Period 

08/08/2003 

 

Start Date of Notice Period 

08/14/2003 

 

Revision History Number 

097-03b 

 

Revision History Explanation 

11/07/2004 - The description for CPT/HCPCS code 0020T was changed in group 1

11/26/2005 - CPT/HCPCS code 0020T was deleted from group 1

This LCD was converted from an LMRP on 12/16/2005

10/04/2007 - Frequently Asked Questions restored to Appendices. 

 

Reason for Change 

Other
 

Last Reviewed On Date 

10/05/2007 

 

Related Documents 

Article(s)
A38097 - Extracorporeal Shock-Wave Therapy for Musculoskeletal Problems

 

LCD Attachments 

FAQ (5,386 bytes)

 

Other Versions 

Updated on 05/25/2007 with effective dates 12/17/2005 - N/A

Updated on 09/01/2006 with effective dates 12/17/2005 - N/A

Updated on 12/16/2005 with effective dates 12/17/2005 - N/A

Updated on 12/16/2005 with effective dates 11/07/2004 - 12/16/2005

Updated on 09/30/2003 with effective dates 09/30/2003 - 11/06/2004

Updated on 08/12/2003 with effective dates 09/28/2003 - N/A