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Prolotherapy describes a procedure intended for healing and strengthening ligaments and tendons by injecting an agent that induces inflammation and stimulates endogenous repair mechanisms. Prolotherapy may also be referred to as proliferant injection, prolo, joint sclerotherapy, regenerative injection therapy, growth factor stimulation injection, or nonsurgical tendon, ligament, and joint reconstruction.
The goal of prolotherapy is to promote tissue repair or growth by prompting release of growth factors, such as cytokines, or increasing the effectiveness of existing circulating growth factors. The mechanism of action is not well understood, but may involve local irritation and/or cell lysis. Agents used with prolotherapy have included zinc sulfate, psyllium seed oil, combinations of dextrose, glycerine, and phenol, or dextrose alone, often combined with a local anesthetic. Polidocanol and sodium morrhuate, vascular sclerosants, have also been used to sclerose areas of high intratendinous blood flow associated with tendinopathies. Prolotherapy typically involves multiple injections per session conducted over a series of treatment sessions.
A similar approach involves the injection of autologous platelet-rich plasma (PRP), which contains a high concentration of platelet-derived growth factors. Treatment of musculoskeletal pain conditions (eg, tendinopathies) with PRP is discussed in Recombinant and Autologous Platelet-Derived Growth Factors as a Treatment of Wound Healing and Other Non‒Orthopedic Conditions medical policy.
The U.S. Food and Drug Administration has approved sclerosing agents for use in treating spider/varicose veins. These sclerosing agents include Asclera® (polidocanol), Varithena® (an injectable polidocanol foam), Sotradecol® (sodium tetradecyl sulfate), Ethamolin® (ethanolamine oleate), and Scleromate® (sodium morrhuate). These agents are not currently approved as joint and ligamentous sclerosing agents.
POLICYProlotherapy is considered investigational as a treatment of musculoskeletal pain.
Sarapin, an herbal extract, that has been used as a sclerosant in prolotherapy, is considered investigational.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
POLICY HISTORY6/1997: Approved by Medical Policy Advisory Committee (MPAC)
1/24/2001: Non-covered codes table added, HCPCS M0076 added non-covered codes
2/2001: Reviewed by MPAC; investigational status maintained
3/1/2001: Source(s) section updated
5/22/2001: ICD-9 procedure code 99.29 added non-covered codes
2/11/2002: Investigational definition added
5/2/2002: Type of Service and Place of Service deleted
5/29/2002: Code Reference section updated, ICD-9 procedure code 81.92 added non-covered codes
11/18/2004: Reviewed by MPAC, Prolotherapy remains investigational, sarapin, an herbal extract, that has been used as a sclerosant in prolotherapy, is considered investigational.
7/19/2005: Code Reference section reviewed, no changes
8/14/2009: Policy reviewed, no changes
09/09/2010: Policy description updated regarding treatment approaches. Policy statement unchanged.
09/23/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
10/22/2013: Policy reviewed; no changes.
09/29/2014: Policy reviewed; no changes.
08/14/2015: Code Reference section updated for ICD-10. Removed ICD-9 procedure codes 81.92 and 99.29 from the Code Reference section.
10/20/2015: Policy description updated regarding sclerosing agents. Policy statements unchanged. Investigative definition updated in policy guidelines section.
06/01/2016: Policy number A.2.01.26 added.
SOURCE(S)Blue Cross & Blue Shield Association policy #2.01.26
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
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