Description:
Erectile dysfunction (ED), or impotence, is defined as the inability to achieve or maintain an erection of sufficient rigidity to enable penetration and completion of the sexual act.

Policy:

1. The following procedures are considered MEDICALLY NECESSARY in the diagnosis of erectile dysfunction:
   • Comprehensive history and physical examination;
   • Nocturnal penile tumescence (NPT) test and rigidity monitoring when psychogenic etiology is suspected;
   • Duplex scan (Doppler and ultrasound) in conjunction with intracorporeal papaverine;
   • Dynamic infusion cavernosogram and cavernosometry;
   • Lab tests:
     • Blood glucose (fasting/HbA1c)
     • Complete blood count
     • Creatinine and Blood Urea Nitrogen
     • Hepatic panel
     • Lipid profile
     • Prostate specific antigen
     • Serum testosterone (Total/Free or Bioavailable)*  (See Note 1)
     • Thyroid function studies
     • Urinalysis
   • Pudendal arteriography.
2. The following test for the diagnosis of erectile dysfunction investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY. because their effectiveness has not been established
   • Angiotensin-converting enzyme insertion/deletion polymorphism testing
   • Endothelial nitric oxide synthase polymorphism (4 VNTR, G894T, T786C) testing for estimating risk of erectile dysfunction
   • Iron binding capacity
   • Prostatic acid phosphatase

NOTE 1: Due to considerable variability in serum total testosterone testing, the Centers for Disease Control and Prevention (CDC) developed a standardization program for total testosterone assays (Hormone Standardization [HoSt]/Testosterone). An assay certified by the CDC’s HoSt/Testosterone program is standardized to within ±6.4% of the CDC total testosterone reference standard. It is STRONGLY RECOMMENDED that serum total testosterone testing be performed on an assay that has been certified by the CDC HoSt/Testosterone program. A list of CDC-certified assays is available on the HoSt website.

Policy Guidelines:
Lab tests that may be indicated in selected patients are:

• Morning serum testosterone. If the testosterone level is low, the lab test may be repeated once along with tests for luteinizing hormone (LH), follicle-stimulating hormone (FSH), and prolactin levels to diagnose a pituitary disorder;
• Complete blood count (CBC);
• Urinalysis;
• Creatinine;
• Lipid profile;
• Fasting blood sugar (FBS); and
• Thyroid function studies.

Intracavernous injection therapy is administered via a small, thin needle that is injected into an area along the shaft of the penis known as the corpus cavernosum. The smooth muscle is relaxed, enhancing blood flow and causing erection in 5 to 20 minutes and lasting approximately one hour. It is recommended that the first injection be administered in the physician’s office. Several test injections may be required to establish proper drug dosage.

The NPT test should be administered in a sleep lab.

Cavernosography may be used to indicate arterial and veno-occlusive function abnormality or to differentiate between vascular, neuropathic, or psychogenic etiology. More extensive vascular testing may be indicated in young men with a history of pelvic or perineal trauma and who may have anatomic arterial blockage.

Rationale
It has been projected that approximately 150 million men in the world suffer from erectile dysfunction (ED) and the worldwide prevalence is expected to increase to 322 million men by 2025, making it one of the most frequent chronic health problems in men over 40 years of age and a common reason for consultation of family physicians and specialists. Najari and Kashanian (2016) report that ED is present in 1 of 2 men over the age of 40. However, men younger than 40 also seek medical help for new-onset ED. One study reports that one in four patients younger than 40 experience ED, with almost 50% of the young men complaining of severe ED (Capogrosso et al., 2013). ED may be an indicator for other underlying diseases, such as diabetes, hypertension, or atherosclerosis, and thus merits investigation. Men with ED experience twice as many heart attacks and strokes (6.3%) in comparison to men who do not have ED (2.6%).

The development of an erection is a complex process that involves the brain, hormones, emotions, nerves, muscles, and blood vessels. A problem with any of these components (endocrine, cardiovascular, neurological, and so on) can result in ED. For example, low intracavernosal nitric oxide synthase, which is necessary for nitric oxide to maximize blood flow to the penis, is often found in low levels in diabetic patients or patients with low testosterone. Any disruption of blood flow or nitric oxide synthesis may prevent intracavernosal blood pressure from rising enough to maintain acceptable rigidity for an erection. Other causes of erectile dysfunction may be penile trauma, spinal cord injuries, abnormalities of the penis (e.g., penile fibrosis and Peyronie’s disease), veno-occlusive dysfunction or as a result of a radical pelvic surgery (e.g., radical prostatectomy or cystectomy). Regardless of the cause, ED has a negative impact on the quality of life of both the patient and partner.

ED may be cured or improved simply by implementing lifestyle changes. Diet and weight loss plans may improve ED symptoms significantly. Patients are also recommended to reduce alcohol intake, avoid smoking, and eliminate illicit drug use (Najari & Kashanian, 2016). Further, if side effects from medication are the cause of ED, physicians may work with the patient to prescribe alternative medications. Psychotherapy may also be recommended if ED is caused by psychological factors.

Proprietary tests exist for the assessment of risk factors for ED. For example, Walk-In Lab offers an ED panel consisting of several biomarkers (thyroid stimulating hormone [TSH], complete blood count [CBC], luteinizing hormone [LH], and so on). Genova offers a similar panel, which evaluates hormones, including free testosterone, estradiol, PSA (prostate specific antigen), DHEA-S (dehydroepiandrosterone), Dihydrotestosterone (DHT), Insulin-Like Growth Factor 1 (IGF-1), and Sex Hormone Binding Globulin (SHBG). Finally, GX Sciences offers a genetic “Men’s Health Panel” that evaluates 15 gene variants proposed to play a significant role in “Testosterone conversion and breakdown, estrogen formation, risk of metabolic weakness, and risk of hypertension.” Besides low sex drive and testicular atrophy, GX Sciences states that their genetic test can also be used to address “carbohydrate cravings,” “slow recovery,” and male pattern baldness. AccesaLabs has also developed an ED test panel which measures FSH, LH, prolactin, total testosterone and free testosterone levels.

Clinical Utility and Validity
The evaluation of male sexual dysfunction may include sexual history and physical examination, which have been reported to have a 95 percent sensitivity but only a 50 percent specificity in determining the cause of ED. Additional diagnostic tests include fasting glucose or glycated hemoglobin (A1C) to examine for diabetes or level of glucose control, complete blood count (CBC), comprehensive metabolic profile to assess liver and kidney function, thyroid-stimulating hormone (TSH) to rule out thyroid disease, lipid profile to assess cardiac risk factors, and serum total testosterone to assess gonadal function.

Lane-Cordova, Kershaw, Liu, Herrington, and Lloyd-Jones (2017) performed a study assessing cardiovascular health with ED. The study included 1,136 men who were divided into three categories of cardiovascular health (CVH, low, medium, high) and were assessed for ED. The researchers concluded that 58% of men with low CVH were found to have ED (233/387), 41% with moderate CVH (277/670), and 33% (26/79) with CVH. ED was also found to have a prevalence ratio of 0.75 with moderate CVH and 0.68 with high CVH.

Brooke et al. (2014) conducted a study examining the association between testosterone levels in ED patients with type 2 diabetes. A total of 355 diabetic patients were evaluated, and on average, patients with ED were found to have 9.1% lower SF-36 health questionnaire score, which correlated with lower total, bioavailable, and free testosterone.

Kizilay, Kalemci, Simsir, and Altay (2020) researched predisposing factors for ED and response to treatment in young versus old men. Patients were divided in to two groups: <40 years (n=58, group I) and ≥40 years (n=73, group II). Participants completed both the International Index of Erectile Function‐5 (IIEF‐5) questionnaire, and Beck's Depression Inventory (BDI) questionnaire. Results seem to be typical. The researchers report higher morning rigidity and libido in group I. Further, “In multivariate analysis, the factors predicting the low IIEF‐Erectile Function domain score in young men were testosterone level and BDI score (p = .026 and p = .034). Although psychogenic factors contribute significantly to the aetiology of ED, hormone profile is more preserved in young men than in older men.”

Huntingdon, Muscat, de Wit, Duracinsky, and Juraskova (2020) completed a systematic review for ED in men with and without HIV. Fourteen studies from 1997 to 2019 met the inclusion criteria. The researchers found that both age and depression were significantly associated with ED. Also, “Importantly, factors unique to HIV emerged as consistently significant across studies, including time on antiretroviral medication and protease inhibitor medication use.” The authors concluded by suggesting that psychological factors such as fear of transmission or rejection by a sexual partner should be considered in future ED/HIV research.

Yilmaz et al. (2021) completed a cross-sectional study to define the relationship between triglyceride-glucose index (TyG) and erectile dysfunction (ED). TyG is an inexpensive insulin resistance marker that is calculated using serum glucose and triglyceride values. Out of 142 patients included in the study, 91 patients (64.1%) had ED according to the International Index of Erectile Function survey. "BMI, fasting insulin level, fasting glucose level, IR, GGT, HDL, HbA1c, Triglyceride, TyG, DM, HT, and MetS status of the patients in ED group were statistically significantly higher compared to non‐ED group." The cutoff value of TyG index for ED was found to be 8.88 and any value above the cut off is deemed to be an independent predictor of ED. The authors conclude that TyG index may be useful in the diagnosis and follow up of erectile dysfunction.

American College of Physicians (ACP)
The ACP concluded that the evidence for the utility of hormonal blood tests in identifying and affecting therapeutic outcomes for treatable causes of ED is inconclusive. The ACP makes no recommendations either for or against routine use of hormonal blood tests or hormonal treatment in the management of patients with ED. Clinicians should make decisions to measure hormone levels on a case-by-case basis, in accordance with the patient’s clinical presentation.

In 2020, the ACP published guidelines for testosterone treatment in adult men with age-related low testosterone levels. These guidelines mention that the “ACP suggests that clinicians discuss whether to initiate testosterone treatment in men with age-related low testosterone with sexual dysfunction who want to improve sexual function (conditional recommendation; low-certainty evidence).” However, these guidelines do not give specific examples of recommended testing methods for men experiencing sexual dysfunction.

European Association of Urology (EAU)
In 2016, EAU published revised guidelines for the diagnosis and treatment of patients suffering from erectile dysfunction. It recommended that laboratory testing must be ordered based on the patient’s complaints and risk factors. It recommended that “patients may need a fasting blood glucose or HbA1C and lipid profile if not recently assessed. Hormonal tests include an early morning total testosterone. If indicated, bioavailable or calculated-free testosterone may be needed to corroborate total testosterone measurements.” It further recommended that additional laboratory testing may be considered in some patients (for example, prostate-specific antigen, prolactin and luteinizing hormone).

American Urological Association (AUA)
The AUA recommends measuring morning serum total testosterone in men with ED. The AUA also states that “with the possible exception of serum testosterone, glucose/hemoglobin A1c, and in some cases serum lipids, no routine serum study is likely to alter ED management”, but list “serum BUN/Cr, fasting lipids, fasting glucose or hemoglobin A1c, morning testosterone, thyroid function studies (i.e., thyroid-stimulating hormone, free T4) and PSA” as potentially appropriate tests for men with ED.

American Association of Clinical Endocrinologists (AACE)
The AACE guidelines state that “chemistry testing should evaluate for anemia, increased plasma glucose levels, or impaired renal function. Thyroid testing should be done if clinically indicated. Other hormone screening should include serum testosterone and prolactin levels”. The AACE concluded that free or bioavailable testosterone assays were preferred over measurement of the total testosterone level. AACE further recommended that “if the testosterone level is low, or even borderline, a serum LH level should be obtained to distinguish primary from secondary hypogonadism.”

American Society of Clinical Oncology (ASCO)
The ASCO published guidelines which state that “Clinicians should check testosterone levels, even if the patient has a cancer that is not typically associated with hormone changes in men reporting decreased sexual functioning and satisfaction.”

ASCO recommends discussing sexual health and dysfunction due to cancer or treatment with the patient. Psychosocial and/or psychosexual counseling should be offered to all male patients with cancer. The first step should be to identify medical and treatable contributing factors and address those issues first.

British Society for Sexual Medicine (BSSM)
The BSSM recommends the following lab testing for ED: “fasting glucose and/or glycated hemoglobin, lipid profile, and fasting testosterone level in all cases.” Serum PSA may also be considered if “clinically indicated.” The BSSM also notes that if serum testosterone is borderline or low, the test should be repeated together with serum LH and prolactin.

References:

1. AccesaLabs. (2020). Erectile Dysfunction Test Panel. Retrieved from https://www.accesalabs.com/Erectile-Dysfunction-Test
2. AHA. (2018). Erectile dysfunction may be warning sign for more serious health problems. Retrieved from https://www.heart.org/en/news/2018/07/11/erectile-dysfunction-may-be-warning-sign-for-more-serious-health-problems#:~:text=Men%20with%20ED%20experienced%20more,the%20study's%20senior%20author%2C%20Dr.
3. Althof, S. E. (2002). Quality of life and erectile dysfunction. Urology, 59(6), 803-810. Retrieved from https://www.goldjournal.net/article/S0090-4295(02)01606-0/fulltext
4. Bhasin, S., Brito, J. P., Cunningham, G. R., Hayes, F. J., Hodis, H. N., Matsumoto, A. M., . . . Yialamas, M. A. (2018). Testosterone Therapy in Men With Hypogonadism: An Endocrine Society* Clinical Practice Guideline. The Journal of Clinical Endocrinology & Metabolism, 103(5), 1715-1744. doi:10.1210/jc.2018-00229
5. Brooke, J. C., Walter, D. J., Kapoor, D., Marsh, H., Muraleedharan, V., & Jones, T. H. (2014). Testosterone deficiency and severity of erectile dysfunction are independently associated with reduced quality of life in men with type 2 diabetes. Andrology, 2(2), 205-211. doi:10.1111/j.2047-2927.2013.00177.x
6. Brotons, F. B., Campos, J. C., Gonzalez-Correales, R., Martín-Morales, A., Moncada, I., & Pomerol, J. M. (2004). Core document on erectile dysfunction: key aspects in the care of a patient with erectile dysfunction. International Journal of Impotence Research, 16. doi:doi:10.1038/sj.ijir.3901240
7. Burnett, A. L., Nehra, A., Breau, R. H., Culkin, D. J., Faraday, M. M., Hakim, L. S., . . . Shindel, A. W. (2018). Erectile Dysfunction: AUA Guideline. J Urol, 200(3), 633-641. doi:10.1016/j.juro.2018.05.004
8. Capogrosso, P., Colicchia, M., Ventimiglia, E., Castagna, G., Clementi, M. C., Suardi, N., . . . Salonia, A. (2013). One Patient Out of Four with Newly Diagnosed Erectile Dysfunction Is a Young Man&#x2014;Worrisome Picture from the Everyday Clinical Practice. The Journal of Sexual Medicine, 10(7), 1833-1841. doi:10.1111/jsm.12179
9. Carter, J., Lacchetti, C., Andersen, B. L., Barton, D. L., Bolte, S., Damast, S., . . . Rowland, J. H. (2018). Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. J Clin Oncol, 36(5), 492-511. doi:10.1200/jco.2017.75.8995
10. Carter, J., Lacchetti, C., Andersen, B. L., Barton, D. L., Bolte, S., Damast, S., . . . Rowland, J. H. (2018). Interventions to Address Sexual Problems in People With Cancer: American Society of Clinical Oncology Clinical Practice Guideline Adaptation of Cancer Care Ontario Guideline. Journal of Clinical Oncology, 36(5), 492-511. doi:10.1200/jco.2017.75.8995
11. CDC. (2020, 09/28/2020). HoSt/VDSCP: Certified Participants. Retrieved from https://www.cdc.gov/labstandards/hs_certified_participants.html
12. Cunningham, G., & Khera, M. (2020). Evaluation of male sexual dysfunction - UpToDate. In K. Martin (Ed.), UpToDate. Retrieved from https://www.uptodate.com/contents/evaluation-of-male-sexual-dysfunction?source=search_result&search=erectile%20dysfunction&selectedTitle=3~150
13. Davis-Joseph, B., Tiefer, L., & Melman, A. (1995). Accuracy of the initial history and physical examination to establish the etiology of erectile dysfunction. Urology, 45(3), 498-502. Retrieved from https://www.goldjournal.net/article/S0090-4295(99)80022-3/abstract
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19. Hatzimouratidis, K. (2016). EAU Guidelines on Erectile Dysfunction, Premature Ejaculation, Penile Curvature and Priapism. Retrieved from https://uroweb.org/wp-content/uploads/EAU-Guidelines-Male-Sexual-Dysfunction-2016-3.pdf
20. Hatzimouratidis, K., Amar, E., Eardley, I., Giuliano, F., Hatzichristou, D., Montorsi, F., . . . Wespes, E. (2010). Guidelines on male sexual dysfunction: erectile dysfunction and premature ejaculation. Eur Urol, 57(5), 804-814. doi:10.1016/j.eururo.2010.02.020
21. Huntingdon, B., Muscat, D. M., de Wit, J., Duracinsky, M., & Juraskova, I. (2020). Factors associated with erectile dysfunction among men living with HIV: a systematic review. AIDS Care, 32(3), 275-285. doi:10.1080/09540121.2019.1653443
22. Kizilay, F., Kalemci, S., Simsir, A., & Altay, B. (2020). Predisposing factors for erectile dysfunction and response to treatment in younger males: Are they different from those of older men? An observational-comparative study. Andrologia, 52(2), e13495. doi:10.1111/and.13495
23. Lane-Cordova, A. D., Kershaw, K., Liu, K., Herrington, D., & Lloyd-Jones, D. M. (2017). Association Between Cardiovascular Health and Endothelial Function With Future Erectile Dysfunction: The Multi-Ethnic Study of Atherosclerosis. Am J Hypertens, 30(8), 815-821. doi:10.1093/ajh/hpx060
24. McKinlay, J. B. (2000). The worldwide prevalence and epidemiology of erectile dysfunction. Int J Impot Res, 12 Suppl 4, S6-s11. doi:10.1038/sj.ijir.3900567
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26. Qaseem, A., Horwitch, C. A., Vijan, S., Etxeandia-Ikobaltzeta, I., & Kansagara, D. (2020). Testosterone Treatment in Adult Men With Age-Related Low Testosterone: A Clinical Guideline From the American College of Physicians. Ann Intern Med. doi:10.7326/m19-0882
27. Qaseem, A., Snow, V., Denberg, T. D., Casey, D. E., Jr., Forciea, M. A., Owens, D. K., & Shekelle, P. (2009). Hormonal testing and pharmacologic treatment of erectile dysfunction: a clinical practice guideline from the American College of Physicians. Ann Intern Med, 151(9), 639-649. doi:10.7326/0003-4819-151-9-200911030-00151
28. Shindel, A., Brant, W. O., Bochinski, D., Bella, A. J., & Lue, T. F. (2014). Medical and Surgical Therapy of Erectile Dysfunction. doi:https://www.ncbi.nlm.nih.gov/books/NBK278925/
29. Walk-In. (2017). ERECTILE DYSFUNCTION. Retrieved from https://www.walkinlab.com/men-s-wellness-tests/erectile-dysfunction.html
30. Yilmaz, M., Karaaslan, M., Tonyali, S., Celik, M., Toprak, T., & Odabas, O. (2021). Triglyceride-Glucose Index (TyG) is associated with erectile dysfunction: A cross-sectional study. Andrology, 9(1), 238-244. doi:https://doi.org/10.1111/andr.12904
31. Yoshimura, N., Kato, R., Chencellor, M. B., Nelson, J. B., & Glorioso, J. C. (2010). Gene therapy as future treatment of erectile dysfunction. Expert Opin Biol Ther, 10(9), 1305-1314. doi:10.1517/14712598.2010.510510

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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