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Clinical Policy Bulletin:
Scrotal Ultrasonography
Number: 0532


Policy

Aetna considers scrotal ultrasonography medically necessary for any of the following conditions:

  • Detection and characterization of scrotal mass lesions/tumors; or
  • Detection of undescended (cryptorchid) testes; or
  • Diagnosis of suspected testicular torsion; or
  • Evaluation of hydroceles; or
  • Evaluation of infertile men; or
  • Evaluation of scrotal pain and/or swelling (acute scrotal symptoms); or
  • Evaluation of scrotal trauma; or
  • Evaluation of varicoceles.

Aetna considers scrotal ultrasonography experimental and investigational for surveillance of testicular microlithiasis in the absence of additional risk factors (e.g., a history of cryptorchidism or testicular atrophy (less than 12 ml), previous testicular cancer).

Aetna considers scrotal ultrasonography experimental and investigational for all other indications because of insufficient evidence of its clinical value for other indications.



Background

Scrotal ultrasonography has been demonstrated to have a clinically significant impact on urologists’ diagnoses of scrotal abnormalities and disorders. Scrotal ultrasound is characterized by high sensitivity in the detection of intra-scrotal abnormalities and is a very good mode for differentiating testicular from para-testicular lesions.  The main indication for color Doppler ultrasound (which can reveal scrotal blood flow) is assessment of acute scrotal symptoms (pain or swelling), especially in the diagnosis of suspected testicular torsion.  The vast majority of boys who exhibit acute scrotal symptoms have non-surgical conditions, usually epididymitis or torsion of the appendix testis.  Since the clinical appearances of these conditions are often similar to that of testicular torsion, imaging is frequently performed to help with diagnosis.  In fact, color Doppler ultrasound is the method of choice for imaging scrotal organs, and allows more objective and precise assessment of varicoceles.  Varicoceles can be diagnosed by showing intra-scrotal veins larger than 2 mm.  It has also been shown that color Doppler ultrasound is more accurate and reliable than physical examination in conjunction with gray-scale ultrasound (which is non-specific and can’t be used to diagnose testicular torsion) in the differential diagnosis of acute scrotum.

Patients with hydroceles large enough to prevent adequate palpation of the testes should undergo scrotal ultrasound.  Sonographic identification of calculi in the hydroceles may prevent further imaging and unnecessary surgery.  Color Doppler ultrasound is also used in the evaluation of traumatized scrotum.  Testis rupture must be diagnosed rapidly and color Doppler ultrasound can be used to evaluate perfusion of the testis.  The prediction of testicular viability following trauma is essential for proper treatment.  Other indications for scrotal ultrasonography are detection of undescended (cryptorchid) testes, and evaluation of infertile men.  It should be noted that intra-abdominal testes can not be located with ultrasound.  Routine scrotal ultrasound has been reported to provide valuable information in the diagnostic evaluation of infertile men and substantially more pathological conditions are detected compared to clinical palpation.  The high prevalence of testicular malignancies underscores the importance of routine scrotal ultrasonography in infertile men.

Serter et al (2006) noted that testicular microlithiasis (TM) is a rare, usually asymptomatic finding of the testes associated with various genetic anomalies and infertility.  It is believed that TM is strongly associated with testicular tumor.  In a prospective study, these researchers determined the prevalence of TM in an asymptomatic population by means of ultrasound screening.  Healthy male volunteers (17 to 42 years old) were recruited from the annual Army Reserve Officer Training Corps training camp at Manisa, Turkey.  A screening genito-urinary history was obtained and a physical examination and screening scrotal ultrasound scan were performed.  All men diagnosed with TM underwent complete clinical evaluations, physical examinations and determination of tumor markers.  A total of 53 men with TM were identified from the 2,179 ultrasound scans, giving a prevalence of TM of 2.4 % in this asymptomatic population.  The age (mean ± SD) of subjects with TM was 23.9 ± 4.2 years (range of 20 to 31 years).  The authors concluded that these findings suggested that there is no significant association between TM and testicular cancer, although it is difficult to rule out such an association without further studies with a longer follow-up period.

DeCastro and colleagues (2007) stated that TM is an imaging entity of the testicle with questionable significance as a marker for testicular cancer.  In 2001 these investigators reported on a large prospective screening study establishing the prevalence of TM to be 5.6 % in a healthy asymptomatic population of Army volunteers 18 to 35 years old.  In contrast, testicular cancer develops in only 5 of 100,000 men.  Two-year follow-up of 63 of the 84 patients with TM showed that none of these men had testicular cancer or scrotal masses.  Here these researchers reported he 5-year follow-up in this cohort of men with TM at risk for testicular cancer.  According to the original parameters of the screening study these investigators performed a history, genito-urinary examination and scrotal ultrasound on 1,504 healthy army volunteers 18 to 35 years old.  Testicular microlithiasis was defined as greater than 6 echogenic signals found on ultrasound.  They identified 84 patients with TM (5.6 %).  These men were entered into the follow-up phase of the study and instructed regarding testicular self-examination and the need for follow-up.  They were told to report any changes in their examination or a finding of testicular mass or cancer.  Five years after the initial screening study, the authors attempted to contact all remaining 84 men by e-mail, standard mail and telephone.  Of the original 84 men with TM identified in the original screening study, 63 have been contacted via e-mail and by telephone (75 %).  Of the 63 subjects, a mixed germ cell tumor developed in 1 patient 64 months after the initial screening study.  Compared to the incidence of testicular cancer in the general population the odds ratio of developing testicular cancer in this study population was 317 (95 % confidence interval [CI]: 36 to 2,756).  The authors concluded that testicular cancer will not develop in the majority of men with TM (98.4 %) during a 5-year follow-up interval.  They believed that an intensive screening program for men with TM is not cost-effective and would do little to improve outcomes associated with testicular cancer.  These investigators continued to recommend testicular self-examination in men at risk.

In a retrospective study, Chen and colleagues (2010) determined the incidence of TM in Taiwanese males who were referred for scrotal sonography (US) and evaluated the association between TM and cancer, with state-of-the-art equipment.  A total of 513 males who underwent scrotal US in a period of 7 months were included in this study.  The US images and charts of each patient were reviewed to determine the presence of TM and note relevant clinical information.  The data for all 513 patients were analyzed.  Their age was 0 to 91 years (mean of 54.3 years).  The overall incidence of TM was 14.4 % (74/513); 6.2 % (32/513) had classic TM, and 8.2 % had limited TM.  The incidence of testicular cancer in this population was 1.6 % (8/513).  Six of 8 (75 %) patients who had testicular cancer at presentation had classic TM or limited TM.  There was a significant difference (p < 0.01) between the rate of malignancy in subjects with TM (6/74) and that in subjects without TM (2/439).  The authors concluded that the incidence of TM in Taiwanese people may be higher than previously reported, which may be due to the difference in methodology and increased awareness of the US findings.  Moreover, they stated that although there was a significant difference in the rate of malignancy in males with TM compared with those without TM, the question remains whether TM independently increases the risk of testicular malignancy.

Dutra et al (2011) evaluated the prevalence of TM among pediatric patients with inguino-scrotal affections.  Between January 2005 and January 2010, these investigators evaluated, prospectively 1,504 children ranging from 1 to 15 years with inguino-scrotal affections with a high-frequency ultrasound system, which employs a 10-MHz transducer.  Testicular microlithiasis was identified in 20 testes of 11 children (0.71 % of 1,504 patients evaluated), through an ultrasound scan.  Testicular microlithiasis was found in 5 children with cryptorchidism (3.93 % of 127 patients), 4 children with retractile testes (14.8 % of 27 patients), 1 child with a hypotrophic testis (100 % of 1 patient), and 1 child with inguinal hernia (0.07 % of 1,349 patients).  The children with TM were submitted to annual physical examinations and ultrasound evaluations.  The authors concluded that TM was a rare condition and occurred in 0.7 % of the subjects studied.  The association with cryptorchidism, retractile and hypotrophic testis was significant.

Richenberg et al (2012) stated that ultrasound surveillance of patients with TM has been advocated following the reported association with testicular cancer.  These researchers evaluated the evidence supporting such surveillance.  Formal literature review identified cohort studies comprising at least 15 patients followed-up for at least 24 months.  Combining an institutional audit with the identified studies in a pooled analysis the incidence of new cancers during the surveillance period was evaluated.  Literature review identified 8 studies.  The authors’ institutional audit comprised 2,656 men referred for scrotal ultrasound.  Fifty-one men (1.92 %) with TM were identified, none of whom developed testicular cancer (mean follow-up: 33.3 months).  In a combined population of 389 men testicular cancer developed in 4.  Excluding 3 who had additional risk factors, only 1 of 386 developed testicular cancer during follow-up (95 % confidence interval: 0.05 5 to 1.45 %).  The authors concluded that ultrasound surveillance is unlikely to benefit patients with TM in the absence of other risk factors.  In the presence of additional risk factors (a history of cryptorchidism or testicular atrophy, previous testicular cancer) patients are likely to be under surveillance; nonetheless monthly self-examination should be encouraged, and open access to ultrasound and formal annual surveillance should be offered.

An UpToDate review on “Screening for testicular cancer” (Lin, 2014) states that “Testicular microlithiasis is a common finding during infertility evaluations, but its association with testicular cancer is controversial.  Microlithiasis has been detected with scrotal ultrasonography in up to 5 percent of healthy adolescents and young men”.

Shetty et al (2014) examined if there is a consensus regarding the significance of TM and a strategy for managing patients with this condition, among ultrasound practitioners in the United Kingdom (U.K.).  An electronic questionnaire was distributed to 1,482 members of the British Medical Ultrasound Society (BMUS), requesting information from ultrasound practitioners involved in scrotal ultrasound about their interpretation of the risk associated with TM and their departmental or personal recommendations for managing patients with this condition.  Responses were obtained from 221 BMUS members.  Analysis demonstrated a wide variation in the significance attributed to the discovery of TM and the risk of subsequent development of testicular germ cell tumors.  There was also great variation in strategies for management of patients with TM, including the need for surveillance ultrasound, among ultrasound practitioners regardless of their job description.  The authors concluded that lack of consensus shown by this study highlights significant differences across the U.K. in managing patients with TM and validates the importance of guidance currently being formulated by the European Society of Urogenital Radiology.  These researchers believe that this is the first survey conducted among imaging specialists in the U.K. regarding TM and demonstrates that there is currently no uniform practice in managing patients with this condition.

Furthermore, the European Association of Urology’s clinical practice guidelines on “Testicular cancer” (Albers et al, 2011) stated that “In the absence of other risk factors (less than 12 ml (atrophy), maldescent testis), testicular microlithiasis is not an indication for biopsy or further (ultrasound) screening”.

 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes covered if selection criteria are met:
76870
ICD-9 codes covered if selection criteria are met:
187.7 Malignant neoplasm of scrotum
222.4 Benign neoplasm of scrotum
236.4 Neoplasm of uncertain behavior of testis
456.4 Scrotal varices
603.0 - 603.9 Hydrocele
604.0 - 604.99 Orchitis and epididymitis
606.0 - 606.9 Infertility, male
608.1 Spermatocele
608.20 - 608.24 Torsion of testis
608.3 Atrophy of testis
608.86 Edema, male genital organs [scrotum]
752.51 Undescended testis
752.52 Retractile testis
752.81 Scrotal transposition
778.6 Congenital hydrocele
959.14 Other injury of external genitals
ICD-9 codes not covered for indications listed in the CPB:
608.89 Other specified disorders of male genital organs [testicular microlithiasis, not covered for surveillance in absence of cryptorchochidism, testicular atrophy (less than 12 ml) or previous testicular cancer]
Other ICD-9 codes related to the CPB:
186.0 - 186.9 Malignant neoplasm of testis
V10.47 Personal history of malignant neoplasm of testis


The above policy is based on the following references:
  1. Older RA, Omary RA, Watson LR. The impact of sonography on the diagnosis of scrotal disorders. J Urol. 1997;158(2):479-480.
  2. Dewbury K. Scrotal ultrasound. Br J Hosp Med. 1997;57(1-2):10-14.
  3. Hamm B. Differential diagnosis of scrotal masses by ultrasound. Eur Radiol. 1997;7(5):668-679.
  4. Horstman WG. Scrotal imaging. Urol Clin North Am. 1997;24(3):653-671.
  5. Namjoshi SP. Calculi in hydroceles: Sonographic diagnosis and significance. J Clin Ultrasound. 1997;25(8):437-441.
  6. Suzer O, Ozcan H, Kupeli S, Gheiler EL. Color Doppler imaging in the diagnosis of the acute scrotum. Eur Urol. 1997;32(4):457-461.
  7. Dubinsky TJ, Chen P, Maklad N. Color-flow and power Doppler imaging of the testes. World J Urol. 1998;16(1):35-40.
  8. Geraghty MJ, Lee FT Jr, Bernsten SA, et al. Sonography of testicular tumors and tumor-like conditions: A radiologic-pathologic correlation. Crit Rev Diagn Imaging. 1998;39(1):1-63.
  9. Pierik FH, Dohle GR, van Muiswinkel JM, et al. Is routine scrotal ultrasound advantageous in infertile men? J Urol. 1999;162(5):1618-1620.
  10. Zahalsky M, Nagler HM. Ultrasound and infertility: Diagnostic and therapeutic uses. Curr Urol Rep. 2001;2(6):437-442.
  11. Pavlica P, Barozzi L. Imaging of the acute scrotum. Eur Radiol. 2001;11(2):220-228.
  12. Bushby LH, Miller FN, Rosairo S, et al. Scrotal calcification: Ultrasound appearances, distribution and aetiology. Br J Radiol. 2002;75(891):283-288.
  13. Dogra VS, Gottlieb RH, Oka M, et al. Sonography of the scrotum. Radiology. 2003;227(1):18-36.
  14. Tasu JP, Faye N, Eschwege P, et al. Imaging of burned-out testis tumor: Five new cases and review of the literature. J Ultrasound Med. 2003;22(5):515-521.
  15. American College of Radiology (ACR), Expert Panel on Urologic Imaging. Acute onset of scrotal pain (without trauma, without antecedent mass). ACR Appropriateness Criteria. Reston, VA: American College of Radiology (ACR); 2001.
  16. Akin EA, Khati NJ, Hill MC. Ultrasound of the scrotum. Ultrasound Q. 2004;20(4):181-200.
  17. Bhatt S, Rubens DJ, Dogra VS. Sonography of benign intrascrotal lesions. Ultrasound Q. 2006;22(2):121-136.
  18. Deurdulian C, Mittelstaedt CA, Chong WK, Fielding JR. US of acute scrotal trauma: Optimal technique, imaging findings, and management. Radiographics. 2007;27(2):357-369.
  19. Dagash H, Mackinnon EA. Testicular microlithiasis: What does it mean clinically? BJU Int. 2007;99(1):157-160.
  20. Lee JC, Bhatt S, Dogra VS. Imaging of the epididymis. Ultrasound Q. 2008;24(1):3-16.
  21. Huyghe E, Izard V, Rigot JM; les membres du Comité d'andrologie de l'association française d'urologie (CCAFU). Optimal evaluation of the infertile male. 2007 French urological association guidelines. Prog Urol. 2008;18(2):95-101.
  22. Bhatt S, Dogra VS. Role of US in testicular and scrotal trauma. Radiographics. 2008;28(6):1617-1629.
  23. Guichard G, El Ammari J, Del Coro C, et al. Accuracy of ultrasonography in diagnosis of testicular rupture after blunt scrotal trauma. Urology. 2008;71(1):52-56.
  24. Mihmanli I, Kantarci F. Sonography of scrotal abnormalities in adults: An update. Diagn Interv Radiol. 2009;15(1):64-73.
  25. Carkaci S, Ozkan E, Lane D, Yang WT. Scrotal sonography revisited. J Clin Ultrasound. 2010;38(1):21-37.
  26. Walker AR, Kogan BA. Cost-benefit analysis of scrotal ultrasound in treatment of adolescents with varicocele. J Urol. 2010;183(5):2008-2011.
  27. American College of Radiology (ACR), American Institute of Ultrasound in Medicine (AIUM), Society of Radiologists in Ultrasound (SRU). ACR-AIUM-SRU practice guideline for the performance of scrotal ultrasound examinations [online publication]. Reston, VA: American College of Radiology (ACR); 2010.
  28. American Institute of Ultrasound in Medicine; American College of Radiology; Society of Radiologists in Ultrasound. AIUM practice guideline for the performance of scrotal ultrasound examinations. J Ultrasound Med. 2011;30(1):151-155.
  29. Oto A, Yacoub JH, Casalino DD, et al; Expert Panel on Urologic Imaging. ACR Appropriateness Criteria® staging of testicular malignancy. [online publication]. Reston (VA): American College of Radiology (ACR); 2012. Available at: http://www.guideline.gov/content.aspx?id=37942&search=scrotal+ultrasonography+. Accessed May 31, 2013.
  30. Serter S, Gumus B, Unlu M, et al. Prevalence of testicular microlithiasis in an asymptomatic population. Scand J Urol Nephrol. 2006;40(3):212-214.
  31. DeCastro BJ, Peterson AC, Costabile RA. A 5-year followup study of asymptomatic men with testicular microlithiasis. J Urol. 2007;179(4):1420-1423; discussion 1423.
  32. Chen JL, Chou YH, Tiu CM, et al. Testicular microlithiasis: Analysis of prevalence and associated testicular cancer in Taiwanese men. J Clin Ultrasound. 2010;38(6):309-313.
  33. Dutra RA, Perez-Boscollo AC, Melo EC, Cruvinel JC. Clinical importance and prevalence of testicular microlithiasis in pediatric patients. Acta Cir Bras. 2011;26(5):387-390.
  34. Albers P, Albrecht W, Algaba F, et al; European Association of Urology. EAU guidelines on testicular cancer: 2011 update. Eur Urol. 2011;60(2):304-319.
  35. Richenberg J, Brejt N. Testicular microlithiasis: Is there a need for surveillance in the absence of other risk factors? Eur Radiol. 2012;22(11):2540-2546.
  36. Shetty D, Bailey AG, Freeman SJ. Testicular microlithiasis an ultrasound dilemma: Survey of opinions regarding significance and management amongst UK ultrasound practitioners. Br J Radiol. 2014;87(1034):20130603.
  37. Lin KW. Screening for testicular cancer. Last reviewed March 2014. UpToDate Inc., Waltham, MA.


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