Medical Policy: 02.01.18
Original Effective Date: November 1996
Reviewed: October 2020
Revised: October 2019
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.
This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Prolotherapy, also referred to as regenerative injection therapy, joint sclerotherapy, and proliferation therapy, as well as a therapy called prolozone, refers to a procedure performed to strengthen the lax or injured ligaments by injecting proliferating agents/sclerosing solutions directly into torn or stretched ligaments. The mild inflammatory response that is created by the injection promotes growth of new ligament or tendon fibers, resulting in a tightening of the weakened area. The goal of prolotherapy is to promote tissue repair or growth by prompting the release of growth factors, such as cytokines, or by 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. It is proposed that additional treatments of prolotherapy, over a period of a few weeks, allow a gradual buildup of tissue to restore the original strength to the area and may relieve pain.
Prolotherapy may involve a single or a series of injections of the proliferating agent, which are often diluted with a local anesthetic. Agents used for prolotherapy include zinc sulfate, psyllium seed oil, combinations of dextrose; glycerin; and phenol or dextrose alone. Polidocanol and sodium morrhuate, vascular sclerosants, have also been used to sclerose areas of high intratendinous blood flow associated with tendinopathies.
The relevant populations of interest are individuals who suffer from musculoskeletal pain, osteoarthritic pain, or upper- or lower-limb tendinopathies.
The therapy being considered is prolotherapy.
Injections are administered in an outpatient setting.
The following therapies and practices are currently being used to treat musculoskeletal pain, osteoarthritic pain, and upper- or lower-limb tendinopathies: observation and other conservative therapies.
The general outcomes of interest are reductions in pain and medication use, improvements in function, and treatment-related adverse events (mostly mild but in rare instances serious).
Varying by condition, injections are administered over a series of sessions, which can last from several weeks to months.
Guidelines on low back pain have concluded that the use of prolotherapy for acute, subacute, chronic or radicular pain syndromes is not recommended.
Guidelines on hand, wrist, and forearm disorders were unable to make a recommendation about the use of prolotherapy because of insufficient evidence.
A practice guideline from the American Pain Society on low LBP (Chou et al, 2009) stated that prolotherapy is not recommended for persistent non-radicular LBP.
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."
Prolotherapy is a procedure and, therefore, not subject to FDA regulation. 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). The agents used in the historic studies, (dextrose, lidocaine, and approved sclerotherapy agents for varicose veins) are approved for injection by the FDA but are not specifically approved for prolotherapy as joint and ligament injections and these agents are not currently approved as joint and ligamenous sclerosing agents. The use for prolotherapy is considered off-label.
Prolotherapy is considered investigational for all applications, including but not limited to:
Prolotherapy as a part of another procedure is considered investigational.
The literature consists of small randomized trials on a variety of pain syndromes with inconsistent results. The body of scientific evidence does not permit conclusions concerning the effect of prolotherapy on health outcomes for chronic neck or back pain, tendinopathies of the upper or lower limbs, osteoarthritic pain, or other musculoskeletal pain conditions. For individuals who have musculoskeletal pain (eg, chronic neck, back pain), osteoarthritic pain, or tendinopathies of the upper or lower limbs who receive prolotherapy, the evidence includes small 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.
To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.
Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc. They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.
*CPT® is a registered trademark of the American Medical Association.