Humana Code Compendium (Obstetrics -Gynecology) Form

. Table of Contents Provider Claim Codes 37241, 75894 57465, 58999 0546T, 0694T 0567T, 0568T 0732T Section Title Ovarian Vein and/or Internal Iliac Vein Embolization Adjunctive Colposcopy Technologies Novel Methods for Intraoperative Margin Assessment During Lumpectomy or Mastectomy Permanent Fallopian Tube Occlusion Via Biodegradable Implant Immunotherapy Vaccine Administration with Electroporation for Cervical Lesions Ovarian Vein and/or Internal Iliac Vein Embolization Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 2 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Description 37241 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation Not Covered if used to report treatment of pelvic congestion by embolization of the ovarian vein or internal iliac veins Not Covered if used to report treatment of pelvic congestion by embolization of the ovarian vein or internal iliac veins Pelvic congestion syndrome (PCS), also called pelvic venous incompetence (PVI), may be a potential cause of chronic pelvic pain. Chronic pelvic pain is described as continuous or intermittent noncyclic pain, localized to the pelvic region, which lasts for 6 or more months. PCS may occur when valves within the pelvic veins weaken and cause blood to flow backward and pool, similar to varicose veins in the legs. Blood pooling in pelvic or ovarian veins may result in engorgement or thrombosis, causing pain and discomfort. Ovarian vein and/or internal iliac vein embolization, performed by interventional radiologists, is a procedure proposed to treat these varicosities. During the embolization procedure, fluoroscopy (which converts X-rays into video images) is used to guide a catheter to the affected vein and an embolic agent is inserted to close off the vein. In theory, the embolic agent may be permanent or temporary, rerouting blood flow and thereby reducing the pressure in the veins. Examples of embolic agents include, but may not be limited to, gelatin sponges, liquid glue, metal coils, particulate solutions and sclerosing agents. Sclerosing agents may be used alone or in combination with the coils. Coverage Determination Humana members may NOT be eligible under the Plan for ovarian vein and/or internal iliac vein embolization for pelvic congestion syndrome. This is considered experimental/investigational as it is not identified as widely used and generally See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 3 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. References accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. Note: The criteria for ovarian vein and/or internal iliac vein embolization are not consistent with the Medicare National Coverage Policy and therefore may not be applicable to Medicare members. Refer to the CMS website for additional information. 1. 2. 3. 4. 5. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin. Chronic pelvic pain. https://www.acog.org. Published March 2020. Accessed December 13, 2022. Centers for Medicare & Medicaid Services (CMS). National Coverage Determination (NCD). Therapeutic embolization (20.28). https://www.cms.gov. Published December 15, 1978. Accessed December 13, 2022. ECRI Institute. Hotline Response (ARCHIVED). Ovarian vein embolization for treating pelvic congestion syndrome. https://www.ecri.org. Published April 7, 2004. Updated December 29, 2014. Accessed November 29, 2022. Hayes, Inc. Health Technology Assessment. Ovarian or internal iliac vein embolization for the treatment of pelvic congestion syndrome. https://evidence.hayesinc.com. Published March 27, 2020. Updated March 17, 2022. Accessed November 29, 2022. Hayes, Inc. Health Technology Brief (ARCHIVED). Percutaneous transcatheter coil embolization for pelvic congestion syndrome (PCS). https://evidence.hayesinc.com. Published October 11, 2011. Updated October 18, 2013. Accessed November 29, 2022. 6. MCG Health. Ovarian and internal iliac vein embolization. 26th edition. https://www.mcg.com. Accessed November 29, 2022. 7. Society for Vascular Surgery (SVS). The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum (ARCHIVED). https://www.vascular.org. Published May 1, 2011. Accessed December 13, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 4 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 8. 9. Society of Interventional Radiology (SIR). Quality improvement standards for percutaneous transcatheter embolization. https://www.sirweb.org. Published March 1, 2021. Accessed December 13, 2022. UpToDate, Inc. Vulvovaginal varicosities and pelvic congestion syndrome. https://www.uptodate.com. Updated November 2022. Accessed December 13, 2022. Adjunctive Colposcopy Technologies Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated Description, References Description 57465 Computer-aided mapping of cervix uteri during colposcopy, including optical dynamic spectral imaging and algorithmic quantification of the acetowhitening effect (List separately in addition to code for primary procedure) 58999 Unlisted procedure, female genital system (nonobstetrical) Not Covered Not Covered if used to report adjunctive colposcopy technologies A colposcopy is a test which closely examines the cervix, vagina and vulva for signs of abnormal or cancerous cells. A magnifying device called a colposcope shines a light into the vagina and onto the cervix, which greatly enhances the normal view. An acetic solution (eg, vinegar) is often applied to help highlight any areas of suspicious cells. If abnormal areas are noted, a biopsy may be performed. Adjuncts to standard colposcopy have been developed to purportedly aid in efforts for more precise and targeted biopsy. Some examples of these technologies include, but may not be limited to: • Cervicography or video colpography – Visual screening methods where a specially designed camera captures images of the cervix after the application of See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 5 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. the acetic solution. The digital imaging with this technique allows for further evaluation. • Computer Aided Cervical Mapping – The DySIS Colposcope (Dynamic Spectral Imaging System) is a digital colposcope that is intended to provide computer- aided cervical mapping. DySIS acquires, displays and documents high resolution still or sequentially captured images and videos. This purportedly offers color- coded mapping that depicts the duration, extent and intensity of the aceto- whitening effect.5 • Enhanced Visual Assessment System – The EVA COLPO is an example of a handheld, internet connected, digital colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. It allows the physician to capture and annotate images which may be directly incorporated into an individual’s electronic medical record. • Spectroscopy – An exam method in which a probe emits light onto the cervix; this device measures diffuse reflectance of visible light along with fluorescence excited by the ultraviolet light. Based on previously determined differences in the light scattering and fluorescent properties of normal versus unhealthy tissues, a computer program calculates an abnormality score for each area scanned.3 An example of such a device is the LUMA Cervical Imaging System. • Speculoscopy – Technique which includes the same principle used in standard colposcopy but utilizes magnified vision and blue-white chemiluminescent light attached to the speculum to detect abnormalities. Coverage Determination Humana members may NOT be eligible under the Plan for adjunctive colposcopy technologies. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. American Society of Colposcopy and Cervical Pathology (ASCCP). Evidence- based consensus recommendations for colposcopy practice for cervical cancer prevention in the United States. https://www.asccp.org. Published October 2017. Accessed December 15, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 6 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 2. 3. 4. 5. Booth BB, Petersen LJ, Blaakaer J. Dynamic spectral imaging colposcopy versus regular colposcopy in women referred with high-grade cytology: a nonrandomized prospective study. J Low Genit Tract Dis. 2021;25(2)113-116. Hayes, Inc. Health Technology Brief (ARCHIVED). Luma Cervical Imaging System (MediSpectra Inc.) for detection of cervical intraepithelial neoplasia. https://evidence.hayesinc.com. Published October 7, 2006. Updated October 1, 2008. Accessed November 29, 2022. UpToDate, Inc. Colposcopy. https://www.uptodate.com. Updated November 2022. Accessed December 15, 2022. US Food & Drug Administration (FDA). 510(k) summary: DySIS. https://www.fda.gov. Published March 10, 2011. Accessed December 18, 2020. Novel Methods for Intraoperative Margin Assessment During Lumpectomy or Mastectomy Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description 0546T 0694T Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report 3-dimensional volumetric imaging and reconstruction of breast or axillary lymph node tissue, each excised specimen, 3-dimensional automatic specimen reorientation, interpretation and report, real-time intraoperative Not Covered Not Covered Intraoperative three-dimensional (3D) volumetric imaging is a technology that provides 3D digital X-ray images of harvested specimens during a lumpectomy or mastectomy to purportedly provide rapid verification that the correct tissue has been excised for appropriate surgical margins. The goal of this imaging is to potentially reduce the need for re-excision. Examples of such US Food & Drug Administration (FDA) approved cabinet X-ray systems include, but may not be limited to, the MOZART Supra or VSI-360. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 7 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. Radiofrequency (RF) spectroscopy has been suggested as an adjunctive tool to identify cancerous tissue intraoperatively at the surgical margins during a partial mastectomy, including lumpectomy. By subjecting tissue to a RF electric field and measuring the tissue response, the device purports to detect differences in tissues that contain cancer cells from tissues that do not. If cancer is identified on the surface of the removed breast tissue, the surgeon removes additional tissue while the individual is still in surgery. Identification of cancer-free margins is intended to reduce the need for re-excision (additional surgery). MarginProbe is an example of an FDA-approved system for intraoperative margin assessment, using RF spectroscopy. Coverage Determination Humana members may NOT be eligible under the Plan for intraoperative 3D volumetric imaging or radiofrequency spectroscopy during lumpectomy or mastectomy. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. American Society of Breast Surgeons (ASBrS). Official Statement. Consensus guideline on breast cancer lumpectomy margins. https://www.breastsurgeons.org. Published December 20, 2017. Accessed December 19, 2022. 2. 3. 4. ClinicalKey. Cartagena LC, McGuire K, Zot P, Pillappa R, Idowu M, Robila V. Breast-conserving surgeries with and without cavity shave margins have different re-excision rates and associated overall cost: institutional and patient-driven decisions for its utilization. Clin Breast Cancer. 2021;21(5):e594- e601. https://www.clinicalkey.com. Accessed December 19, 2022. ECRI Institute. Product Brief (ARCHIVED). MarginProbe System (Dune Medical Devices, Inc.) for margin assessment during lumpectomy. https://www.ecri.org. Published December 5, 2018. Accessed November 29, 2022. Hayes, Inc. Evidence Analysis Research Brief. MarginProbe (Dilon Technologies Inc.) for intraoperative assessment of surgical margins in patients with breast cancer. https://evidence.hayesinc.com. Published December 19, 2022. Accessed December 19, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 8 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 5. 6. 7. 8. Hayes, Inc. Health Technology Brief (ARCHIVED). MarginProbe System (Dune Medical Devices) for intraoperative assessment of surgical margins in patients with breast cancer. https://evidence.hayesinc.com. Published June 9, 2016. Updated May 29, 2018. Accessed November 29, 2022. UpToDate, Inc. Techniques to reduce positive margins in breast-conserving surgery. https://www.uptodate.com. Updated November 2022. Accessed December 19, 2022. US Food & Drug Administration (FDA). 510(k) summary: Volumetric Specimen Imager. https://www.fda.gov. Published December 27, 2019. Accessed October 21, 2021. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: MarginProbe System. https://www.fda.gov. Published June 21, 2012. Accessed June 2, 2019. Permanent Fallopian Tube Occlusion Via Biodegradable Implant Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description 0567T 0568T Permanent fallopian tube occlusion with degradable biopolymer implant, transcervical approach, including transvaginal ultrasound Introduction of mixture of saline and air for sonosalpingography to confirm occlusion of fallopian tubes, transcervical approach, including transvaginal ultrasound and pelvic ultrasound Not Covered Not Covered A method for occluding the fallopian tubes has been proposed as an alternative, less invasive form of permanent contraception in females. The FemBloc Permanent Contraception System involves a biodegradable, biopolymer material inserted through the cervix and then into the fallopian tubes. The temporary implant is purported to initiate a wound healing response as it deteriorates within the fallopian tubes, subsequently causing the individual’s own scar tissue to permanently occlude the tubes. This process is expected to be complete See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 9 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. approximately 30 days following insertion, therefore preventing pregnancy. FemBloc is undergoing clinical trials to demonstrate potential efficacy, safety and desired outcomes. The same company who developed FemBloc also created the FemVue Saline Air Device which is a dual-barrel syringe that can be connected to an intrauterine catheter to instill saline and air (bubbles) that are detectable with ultrasound. This type of sonosalpingography would be performed to purportedly confirm the presence of occlusion within the fallopian tubes. While sonosalpingography is a commonly performed procedure, this particular device is not one which is routinely utilized in practice to date. Coverage Determination Humana members may NOT be eligible under the Plan for permanent fallopian tube occlusion via biodegradable implant (eg, FemBloc) or sonosalpingography utilizing the FemVue device. These are considered experimental/investigational as they are not identified as widely used and generally accepted for the proposed uses as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. American College of Obstetricians and Gynecologists (ACOG). Practice Bulletin. Benefits and risks of sterilization. https://www.acog.org. Published March 2019. Updated 2021. Accessed December 12, 2022. 2. 3. 4. 5. ClinicalKey. Winikoff B, Grossman D. Contraception. In: Goldman L, Schafer AI. Goldman-Cecil Medicine. 26th ed. Elsevier; 2020:1568-1575.e2. https://www.clinicalkey.com. Accessed December 12, 2022. Divakar P, Caruso I, Moodie KL, Theiler RN, Hoopes PJ, Wegst UGK. Design, manufacture, and in vivo testing of a tissue scaffold for permanent female sterilization by tubal occlusion. MRS Adv. 2018;3(30):1685-1690. UpToDate, Inc. Female interval permanent contraception: procedures. https://www.uptodate.com. Updated November 2022. Accessed December 6, 2022. UpToDate, Inc. Hysteroscopic female permanent contraception. https://www.uptodate.com. Updated November 18, 2022. Accessed December 6, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 10 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 6. UpToDate, Inc. Overview of female permanent contraception. https://www.uptodate.com. Updated November 2022. Accessed December 6, 2022. Immunotherapy Vaccine Administration with Electroporation for Cervical Lesions Section Effective Date: 02/02/2023 Section Revision Date: 02/02/2023 Section Review Date: 02/02/2023 Change Summary: Updated References Description 0732T Immunotherapy administration with electroporation, intramuscular Not Covered A novel, DNA-based immunotherapy vaccine administered by electroporation, VGX-3100, is currently undergoing clinical trials as a nonsurgical treatment for adults with precancerous, cervical high-grade squamous intraepithelial lesions (HSIL) and confirmed infection with human papillomavirus (HPV) type 16 and/or 18. VGX-3100 is an intramuscular injection that includes DNA plasmids targeting the E6 and E7 proteins of HPV to act as antigens to purportedly induce antibody responses. The injection is followed by electroporation which is intended to increase cell membrane permeability by the application of electrical pulses. Coverage Determination Humana members may NOT be eligible under the Plan for immunotherapy vaccine administration by electroporation for precancerous cervical lesions (eg, VGX- 3100). This is considered experimental/investigational as it is not identified as widely used and generally accepted for the proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. 2. ClinicalKey. Lee MY, Allen CT. Immunotherapy for HPV malignancies. Semin Radiat Oncol. 2021;31(4):361-370. https://www.clinicalkey.com. Accessed December 5, 2022. ECRI Institute. Horizon scanning status report June 2021. https://www.ecri.org. Published June 30, 2021. Accessed November 29, 2022. See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 11 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 3. 4. Tang J, Li M, Zhao C, et al. Therapeutic DNA vaccines against HPV-related malignancies: promising leads from clinical trials. Viruses. 2022;14(2):239. UpToDate, Inc. Cervical intraepithelial neoplasia: management. https://www.uptodate.com. Updated November 8, 2022. Accessed December 5, 2022. Provider Claims Codes Any CPT, HCPCS or ICD codes listed on this medical coverage policy are for informational purposes only. Do not rely on the accuracy and inclusion of specific codes. Inclusion of a code does not guarantee coverage and or reimbursement for a service or procedure. Description Comments CPT® Code(s) 37241 57465 Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; venous, other than hemorrhage (eg, congenital or acquired venous malformations, venous and capillary hemangiomas, varices, varicoceles) Computer-aided mapping of cervix uteri during colposcopy, including optical dynamic spectral imaging and algorithmic quantification of the acetowhitening effect (List separately in addition to code for primary procedure) 58999 Unlisted procedure, female genital system (nonobstetrical) 75894 Transcatheter therapy, embolization, any method, radiological supervision and interpretation Not Covered if used to report treatment of pelvic congestion by embolization of the ovarian vein or internal iliac veins Not Covered Not Covered if used to report adjunctive colposcopy technologies Not Covered if used to report treatment of pelvic congestion by embolization of the ovarian vein or internal iliac veins CPT® Category III Code(s) Description Comments See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only. Code Compendium (Obstetrics/Gynecology) Policy Number: HUM-0608-002 Page: 12 of 12 Humana's documents are updated regularly online. When printed, the version of this document becomes uncontrolled. Do not rely on printed copies for the most up-to-date version. Refer to Medical and Pharmacy Coverage Policies to verify that this is the current version before utilizing. 0546T 0567T 0568T 0694T Radiofrequency spectroscopy, real time, intraoperative margin assessment, at the time of partial mastectomy, with report Permanent fallopian tube occlusion with degradable biopolymer implant, transcervical approach, including transvaginal ultrasound Introduction of mixture of saline and air for sonosalpingography to confirm occlusion of fallopian tubes, transcervical approach, including transvaginal ultrasound and pelvic ultrasound 3-dimensional volumetric imaging and reconstruction of breast or axillary lymph node tissue, each excised specimen, 3- dimensional automatic specimen reorientation, interpretation and report, real-time intraoperative 0732T Immunotherapy administration with electroporation, intramuscular HCPCS Code(s) No code(s) identified Description Not Covered Not Covered Not Covered Not Covered Not Covered New Code Effective 07/01/2022 Comments See the DISCLAIMER. All Humana member health plan contracts are NOT the same. All legislation/regulations on this subject may not be included. This document is for informational purposes only.