Humana Erectile Dysfunction and Peyronie's Disease Treatments - Medicare Advantage Form
Procedure is not covered
Please refer to CMS website for the most current applicable CMS Online Manual System (IOMs)/National Coverage Determination (NCD)/ Local Coverage Determination (LCD)/Local Coverage Article (LCA)/ Transmittals.
Erectile Dysfunction and Peyronie’s Disease Treatments
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- NCD
- Diagnosis and Treatment of Impotence
- ID Number: 230.4 —
- LCD
- Vacuum Erection Devices (VED) © ©
- ID Number: 134824
- Medicare Administrative Contractors (MACs): Noridian Healthcare Solutions, LLC (DME MAC), CGS Administrators, LLC (DME MAC)
- Applicable States/Territories: CT, DE, DC, ME, MD, MA, NH, NJ, NY, PA, RI, VT, IL, IN, KY, MI, MN, OH, WI
- LCA
- Vacuum Erection Devices (VED) - Policy Article
- ID Number: AS52712
- Medicare Administrative Contractors (MACs): Noridian Healthcare Solutions, LLC (DME MAC), DME D
- Applicable States/Territories: AL, AR, CO, FL, GA, LA, MS, NM, NC, OK, SC, TN, TX, VA, WV, PR, U.S. VI, AK, AZ, CA, HI, ID, IA, KS, MO, MT, NE, NV, ND, OR, SD, UT, WA, WY, American Samoa, Guam, Northern Mariana Islands
- Inflatable penile prostheses are designed to approximate the rigidity and flaccidity of the normally functioning penis and are available as two-piece or three-piece components. Inflation occurs by manually squeezing a pump.
- Semi-rigid (noninflatable) penile implants are made of firm yet malleable material so that the resulting permanent erection can be manually positioned downward close to the body unnoticeably.
Description
Erectile Dysfunction
Erectile dysfunction (ED) is the chronic inability to achieve or maintain an erection of sufficient duration and firmness to complete satisfactory intercourse. Causes may be psychological or organic (physical). Treatment options generally include devices, medications or surgical procedures.
Penile implants are prosthetic devices surgically inserted into the corpus cavernosum. Two types of penile implants are available; inflatable and semi rigid (noninflatable).
Penile arterial revascularization is a surgical procedure to improve blood flow to the corpora cavernosa. The most commonly performed technique for penile revascularization involves anastomosis of the inferior epigastric artery to the dorsal penile artery (dorsal artery arterialization).
Nerve graft (eg, sural nerve graft) is a procedure that purportedly restores erectile function in an individual who has undergone deliberate excision of one or both neurovascular bundles during radical prostatectomy. An autologous sural nerve graft is interposed between the divided ends of the cavernous nerves.
Penile venous reconstructive or veno-occlusive surgery is a surgical procedure that purportedly improves blood flow to the corpora cavernosa, prevents the pathologic blood egress from the penis and corrects veno-occlusive ED.
Platelet-rich plasma (PRP) therapy is an adaptation of autologous whole blood injections. Whole blood is centrifuged to a concentrated state and is injected into penile erection tissue to purportedly assist in repairing and regenerating the tissue.
Shockwave therapy, also referred to as low-intensity extracorporeal shockwave therapy (LI-ESWT), is a noninvasive procedure that uses acoustic waves to purportedly induce neovascularization to improve erectile tissue function.
Stem cell therapy is an injection of stem cells into penile erection tissue that purportedly assists in replenishing, repairing or regenerating the tissue.
Vacuum erection devices (VEDs) offer a mechanical nonsurgical method of filling the penis with blood and creating an erection. VEDs are usually comprised of an airtight tube, a handheld or battery operated pump and a ring.
Erectile Dysfunction and Peyronie’s Disease Treatments
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Air is removed from the cylinder by the pump; thereby creating a vacuum and drawing blood into the penis. The erection is maintained by trapping the blood in the penis with a tight elastic band around its base.
Peyronie’s Disease
Peyronie’s disease (PD) is an acquired, localized fibrotic disorder of the tunica albuginea, which can cause significant penile deformity and lead to sexual dysfunction and psychological trauma. The exact cause of PD has not yet been defined, although most would agree that some injurious stimulus is necessary to trigger the cascade of events that leads to PD in the susceptible individual. Trauma may be perceived as a single event experienced by the individual or may take the form of repetitive microtrauma to the penis. The nature and extent of Peyronie's plaque, and therefore severity or complexity of penile deformity, varies widely. The most frequent presenting symptoms of an individual with PD include penile pain, erect deformity and palpable plaque, as well as ED.
There are two phases. The first is the acute (active) phase, which is commonly associated with painful erections and changing deformity of the penis. This is followed by a chronic (stable) phase, which is characterized by stabilization of the deformity and disappearance of painful erections. Complete spontaneous resolution of PD is a rare occurrence.
Nonsurgical treatment for PD may include oral medications, injections, traction, vacuum therapy or a combination. Additional nonsurgical treatments such as electromotive drug administration have limited evidence of efficacy while treatments such as extracorporeal shockwave therapy (ESWT) and radiation therapy are not recommended for the treatment of PD.
Surgical management of PD includes plication, plaque excision and grafting or placement of a penile prosthesis. Important factors to consider in determining the best surgical approach include the length of the penis, configuration (eg, hourglass, curved) and severity of the deformity, erectile capacity and individual expectations.
Tunica plication is a surgical procedure to straighten the penis where plication is accomplished by shortening the convex side of the penis (opposite the plaque). All plication procedures result in loss of penile length as the tunica albuginea is shortened on the longer side to match the shorter side. Since the stretched penile length is determined by the shorter, less elastic side, the objective loss of penile length after plication is often less than what is perceived by the individual. The most common plication techniques are the Lue, Nesbit and Yachia procedure.
Tunical lengthening procedure (plaque excision or partial excision and grafting) is a surgical procedure to improve plaque-induced penile deformities associated with PD. Following management or removal of the plaque, a graft is placed. Grafting the concave side of the penis serves to lengthen that side and, therefore, straighten the penis. For curvature associated with significant ED, a penile prosthesis can be placed, and additional corrective procedures (plication or grafting) may be performed if the prosthesis does not provide adequate straightening.
Coverage Determination
Humana follows the CMS requirements that only allows coverage and payment for services that are reasonable and necessary for the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member except as specifically allowed by Medicare.
Please refer to the above CMS guidance for erectile dysfunction and Peyronie’s disease treatments.
In interpreting or supplementing the criteria above and in order to determine medical necessity consistently, Humana may consider the following criteria:
Erectile Dysfunction and Peyronie’s Disease Treatments
The use of the criteria in this Medicare Advantage Medical Coverage Policy provides clinical benefits highly likely to outweigh any clinical harms.
Services that do not meet the criteria above are not medically necessary and thus do not provide a clinical benefit. Medically unnecessary services carry risks of adverse outcomes and may interfere with the pursuit of other treatments which have demonstrated efficacy.
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Coverage Limitations
US Government Publishing Office. Electronic code of federal regulations: part 411 – 42 CFR § 411.15 - Particular services excluded from coverage