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Date Printed: August 18, 2017: 07:59 PM

Private Property of Blue Cross and Blue Shield of Florida.
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.

02-20000-08

Original Effective Date: 01/01/93

Reviewed: 04/30/09

Revised: 11/01/15

Subject: Prolotherapy

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:

Prolotherapy describes a procedure for strengthening lax ligaments by injecting proliferating agents/sclerosing solutions directly into torn or stretched ligaments, joint or adjacent structures to create scar tissue in an effort to stabilize a joint. Agents used with prolotherapy have included zinc sulfate, psyllium seed oil, combinations of dextrose, glycerine, and phenol, or dextrose alone (D50). “Proliferatives” act to promote tissue repair or growth by prompting release of growth factors, such as cytokines, or increasing the effectiveness of existing circulating growth factors. Prolotherapy may involve a single injection or a series of injections, often diluted with a local anesthetic.

POSITION STATEMENT:

Prolotherapy is considered experimental or investigational for all applications. As with any therapy for pain, a placebo effect is anticipated, and thus randomized placebo-controlled trials are necessary to investigate the extent of the placebo effect and to determine whether any improvement with prolotherapy exceeds that associated with a placebo. Although there is extensive literature regarding prolotherapy, the scientific data does not demonstrate prolotherapy injections to be more effective than placebo injections.

BILLING/CODING INFORMATION:

The following codes may be used to describe prolotherapy:

HCPCS Coding:

M0076

Prolotherapy (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 National Coverage Determination (NCD) was reviewed on the last guideline reviewed date: PROLOTHERAPY, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents (150.7) located at cms.gov.

DEFINITIONS:

No guideline specific definitions apply.

RELATED GUIDELINES:

Tendon Sheath, Ligament, and Trigger Point Injections, 02-20000-28

OTHER:

Other names used to report Prolotherapy:

Joint Sclerotherapy
Ligament strengthening injections
Ligamentous injections with sclerosing agents
Proliferative therapy
Sclerotherapy

REFERENCES:

  1. American Academy of Pain Medicine. Chronic Pain Medical Treatment Guidelines. Prolotherapy. (Draft, 08/20/07).
  2. Blue Cross Blue Shield Association Medical Policy Reference Manual. 2.01.26 Prolotherapy, 07/10/08.
  3. California Technology Assessment Forum (CTAF). Prolotherapy for the Treatment of Chronic Low Back Pain. (06/09/04).
  4. Centers for Medicare and Medicaid Services (CMS) Manual System, Pub. 100-3, Medicare National Coverage, Chapter 1, Part 2, Section 150.7. Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents, 09/27/99.
  5. Clinical Trials.gov: Efficacy of Prolotherapy vs. Corticosteroid for tennis Elbow. Identifier NCT000160303, Verified by Spaulding Rehabilitation Hospital. (09/05).
  6. Clinical Trials.gov: Joint Injections for Osteoarthritic Knee Pain. Identifier NCT00085722. Verified by National Center for Complementary and Alternative Medicine. (09/07).
  7. Dagenais S, Yelland MJ, Del Mar C, Schoene ML. Prolotherapy injections for chronic low back pain. Cochrane Database of Systemic Reviews 2007, Issue 2. Art. No.: CD004059. DOI: 10.1002/14651858. CD004059.pub3.
  8. Feldman M. Prolotherapy for the treatment of chronic low back pain. Technology Assessment. San Francisco, CA: California Technology Assessment Forum; June 09, 2004.
  9. Hayes Alert. Technology Brief, Prolotherapy for Orthopedic Indications. March 2006.
  10. Hayes, Inc. HAYES Medical Technology Directory. Sclerotherapy, Joint and Ligamentous Injections. Lansdale, PA: Hayes, Inc.; May 2000. Updated 07/08/06.
  11. The Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Prolotherapy for the treatment of chronic musculoskeletal pain. Ottawa, ON: CCOHTA, March 2004.
  12. Yelland MJ, Del Mar C, Pirozzo S, Schoene ML, Vercoe P. Prolotherapy injections for chronic low-back pain. The Cochrane Database of Systematic Reviews 2004, Issue 2. Art. No.: CD004059.pub2. DOI: 10.1002/14651858.CD004059.pub2.
  13. Yelland MJ, Schluter PJ. Defining worthwhile and desired responses to treatment of chronic low back pain. Pain Med. 2006 Jan-Feb; 7 (1): 38-45.

COMMITTEE APPROVAL:

This Medical Coverage Guideline (MCG) was approved by the BCBSF Medical Policy & Coverage Committee on 04/30/09.

GUIDELINE UPDATE INFORMATION:

01/01/93

New Medical Coverage Guideline; investigational

08/15/02

Reformatted and reviewed; investigational

08/15/03

Annual review; description updated; investigational.

07/15/04

Scheduled review and revision; consisting of updating references and maintain investigational status.

07/15/05

Review and revision; consisting of updating references.

06/15/06

Review and revision; consisting of updating references.

05/15/07

Review and revision; consisting of updated references and reformatted guideline.

05/15/08

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

05/15/09

Scheduled review; no change in position statement.

05/11/14

Revision: Program Exceptions section updated.

11/01/15

Revision: ICD-9 Codes deleted.

Date Printed: August 18, 2017: 07:59 PM