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October 5, 2012Updated: 04.18.13

OVA1 or ROMA for Ovarian Cancer Screening

OVA1 has been FDA cleared for use in women who meet the following criteria:

  • Over 18 years of age
  • Have an ovarian adnexal mass
  • Have surgery planned
  • Have not yet been referred to a gynecologic oncologist; and
  • Have not had cancer in the past five years

OVA1 is not intended to be a screening test or to determine whether a patient should proceed to surgery. It can, however, be used as a tool by the patient's primary physician to decide if the referral for treatment of a mass should go to a gynecologist or a gyn-oncologist.

OVA1 will not be approved in conjunction with other screening testing for ovarian cancer, including the following CPT codes:

  • 86304: CA- 125
  • 80418, 80426, 83001: Follicle Stimulating Hormone (FSH)
  • 80418, 80426, 83002: Luteinizing Hormone (LH)

For dates of service prior to January 1, 2013, submit CPT code 84999 for OVA 1 and ROMA testing for ovarian cancer. CGS will review the supporting documentation for individual claims to determine if the medical need is established.

For dates of service on or after January 1, 2013, submit these services using the established CPT codes for OVA1 and ROMA testing (CPT codes 81500 and 81503). CMS has established that these codes are not payable by Medicare, effective for dates of service on or after January 1, 2013. As of this date of service, CGS will no longer review for medical necessity and follow CMS guidelines.


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