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
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