CMS WISeR documentation checklist · §6.2.8
Operational Guide v7.0, last updated July 24, 2026 · retrieved 2026-09-14
Diagnosis and Treatment of Impotence (NCD 230.4)
CMS: “To meet coverage criteria, the patient’s medical record must contain documentation that fully supports the medical necessity of services. Subsections 6.2.1 to 6.2.13 list the documentation requirements for example services. For detailed documentation requirements, providers who choose to submit a prior authorization request for a WISeR Select Item or Service should refer to the relevant NCDs and/or their MAC jurisdiction’s LCDs and Local Coverage Articles (LCAs), if available, for guidance. They can be found on the Medicare Coverage Database website.”
NCD 230.4 provides Medicare coverage and payment criteria for the diagnosis and treatment of impotence. WISeR initially will implement prior authorization for the insertion of penile prostheses (CPT codes 54400, 54401, and 54405). General documentation requirements are as follows:
- Documentation of evaluation and diagnosis of erectile dysfunction (e.g., testosterone level if a patient has signs or symptoms concerning for hypogonadism)
- Treatments tried and failed (or contraindicated), such as but not limited to addressing reversible etiologies: a) Oral medications, e.g., phosphodiesterase-5 (PDE-5) inhibitors b) Intracavernosal injection c) Vacuum-assisted erection device d) Psychotherapy (for psychogenic erectile dysfunction) e) Testosterone replacement therapy (for patients with testosterone deficiency)
- Absence of systemic infection, active urogenital infection, and/or active skin infection in the region of surgery