Introduction

Prolotherapy therapy (proliferative therapy) is a method to try to heal joints and connective  tissue. A solution is injected in the area. The solution irritates the tissue, causing inflammation.  This inflammation is supposed to stimulate the body’s natural healing response. These injections  are repeated over time. The hope is to gradually build up new issue in the injured area and  restore strength. Prolotherapy is investigational (unproven). The studies that have been done are  small and don’t show substantial improvement. There’s not enough medical evidence to show if  this technique works.

Note: The Introduction section is for your general knowledge and is not to be  taken as policy coverage criteria . The  rest of the policy uses specific words and concepts familiar to medical professionals. It is intended for  providers. A provider can be a person, such as a doctor, nurse, psychologist, or dentist. A provider also can be a place where medical care is given, like a hospital, clinic, or lab. This policy  informs them about when a  service may be covered 

Coding Code Description

CPT 20999 Unlisted procedure,  musculoskeletal system, general

HCPCS  Description

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 M0076 Prolotherapy

Background

The goal of prolotherapy is to promote tissue repair or growth by prompting release of growth  factors, such as cytokines, or by increasing the effectiveness of existing circulating growth  factors due to injection of an irritant solution. 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 , glycerin , 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 treatment approach involves the injection of autologous platelet – rich plasma, which  contains a high concentration of platelet – derived growth factors.Treatment of musculoskeletal  pain conditions (eg, tendinopathies) with PRP is discussed in a sepa rate policy (see  Related  Policies ).

Summary of Evidence

For  individuals who have musculoskeletal pain (eg, chronic neck, back pain),  osteoarthritic pain,  or  tendinopathies of the upper or lower limbs includes ,the evidence includessmall randomized trials with inconsistent results. Relevant outcomes are symptoms, functional outcomes, and quality of life. The strongest evidence evaluates the use of prolotherapy for the treatment of  osteoarthritis, but the clinical significance of  the  therapeutic  results is  uncertain. The evidence is  insufficient to determine the effects of the technology on health outcomes

Practice Guidelines and Position Statements

American Association of Orthopaedic Medicine

The American Association of Orthopedic Medicine currently has a recommendation posted  online for the use of prolotherapy for back pain. The Association has indicated that “…prolotherapy should be considered a valid treatment option in a selected group of chronic low back pain patients.”Medicare National Coverage The Coverage Issues Manual #35 – 13 states that prolotherapy, joint sclerother apy, and  ligamentous injections with sclerosing agents are not covered, noting that the medical effectiveness of these therapies has not been verified by scientifically controlled studies. In 1999,  on request for reconsideration of coverage of prolotherapy for treatment for chronic low back pain, Medicare retained its noncoverage decision for prolotherapy, citing a lack of scientific  eviden ce on which to base a decision.

Regulatory Status

Sclerosing agents have been approved by the U.S. Food and Drug Administration for use in  treating spider and 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