DESCRIPTION
Erectile dysfunction (ED) affects at least 12 million men in the United States and can be caused by vascular, neurologic, psychological or hormonal factors. Hypertension, diabetes, hyperlipidemia, obesity, testosterone deficiency and prostate cancer treatment are all common conditions related to ED. Common psychological issues are performance anxiety and relationship issues and can possibly be resolved with psychotherapy and/or behavioral therapy. Medication and substance use (i.e., antidepressants, tobacco use) can cause or exacerbate ED. Lifestyle changes, such as tobacco cessation, regular exercise, weight loss, improved control of diabetes, hyperlipidemia and hypertension are recommended as initial interventions. Men with ED should have a complete medical, sexual, and psychosocial history done along with a physical exam and any labs needed. The first line of treatment is oral phosphodiesterase-5 inhibitors. Second-line treatment includes vacuum devices and alprostadil. When these treatments are ineffective, penile prosthesis are then an option.
POLICY
Penile prosthesis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Removal of penile prosthesis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Treatment for erectile dysfunction with any of the following is considered investigational:
Extracorporeal shock wave therapy (ESWT)
Platelet-rich plasma therapy
Intracavernosal stem cell therapy
MEDICAL APPROPRIATENESS
Penile prosthesis is considered medically appropriate if ANY ONE of the following are met:
Penile prosthesis insertion if ALL of the following are met:
Lifestyle modifications (e.g., weight management, quit smoking, sedentary lifestyle) have been tried and failed
Medication changes if needed (e.g., antihypertensive drugs, antihistamines, antidepressants, tranquilizers, histamine-receptor antagonist)
Individual is able to cough or uses an assist device to clear secretions
Complete history/physical exam and ANY ONE of the following:
Systemic infection
Cutaneous infection
Infection
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes 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. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Restorative therapies have emerged as a less invasive treatment option for ED. More high-quality studies with long-term follow-up outcomes are needed to evaluate efficacy, reproducibility, and define evidenced-based protocols to standardize techniques.
SOURCES
American Academy of Family Physicians. (2016, November). Erectile Dysfunction. Retrieved June 3, 2025 from https://www.aafp.org/pubs/afp/issues/2016/1115/p820.html.
American Urological Association. (2018, May). Erectile Dysfunction: AUA Guideline. Retrieved June 3, 2025 from https://www.auanet.org/guidelines-and-quality/guidelines/erectile-dysfunction-(ed)-guideline.
Centers for Medicare & Medicaid Services. Palmetto GBA. CMS.gov. NCD for Diagnosis and Treatment of Impotence. (230.4). Retrieved May 29, 2025 from http://www.cms.gov.
Chung, D.Y., Ryu, J-K., & Yin, G.N. (2023). Regenerative therapies as a potential treatment of erectile dysfunction. Investigative and Clinical Urology, 64 (4), 312-324. (Level 3 evidence)
Iskakov, Y., Omarbayev, R., Nugumanov, R., Turgunbayev, T., & Yermaganbetov, Y. (2024). Treatment of erectile dysfunction by intracavernosal administration of mesenchymal stem cells in patients with diabetes mellitus. Official Journal of the Brazilian Society of Urology, 50 (4), 386-397. (Level 3 evidence)
Mesquita, F.C., Barros, R., Lima, T.F.N., Velasquez, D., Favorito, L.A., Pozzie, E., et al. (2024). Evidence of restorative therapies in the treatment of peyronie disease: a narrative review. Official Journal of the Brazilian Society of Urology, 50 (6), 703-713. (Level 4 evidence)
Mykoniatis, I., Pyrgidis, N., Sokolakis, I., Ouranidis, A., Sountoudlides, P., Haidich, A., et al. (2021). Assessment of combination therapies vs monotherapy for erectile dysfunction a systematic review and meta-analysis. JAMA Network Open, 4 (2), e2036337. Doi: 10.1001. (Level 1 evidence)
Porst, H. (2021). Review of the current status of low intensity extracorporeal shockwave therapy (Li-ESWT) in erectile dysfunction (ED), peyronie’s disease (PD), and sexual rehabilitation after radical prostatectomy with special focus on technical aspects of the different marketed eswt devices including personal experiences in 350 patients. Sexual Medicine Reviews, 9 (1), 93-122. (Level 4 evidence)
Wang, X., Liu, H., Tang, H., Wu, G., Chu, Y., Wu, J., et al. (2024). Updated recommendations on the therapeutic role of extracorporeal shock wave therapy for peyronie’s disease: systematic review and meta-analysis. BMC Urology, 23 (1), 145. (Level 1 evidence)
ORIGINAL EFFECTIVE DATE: 10/31/2025
MOST RECENT REVIEW DATE: 10/31/2025
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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