Humana Code Compendium (Miscellaneous) Form

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Provider Claim Codes 36836, 36837, G2170, G2171 76499, C9733, C9776 76981, 76982, 76983 0358T 0485T, 0486T 0559T, 0560T, 0561T, 0562T 0583T 0602T, 0603T 0647T 0689T, 0690T, 0697T, 0698T, 0723T, 0724T, 0865T, 0866T 0744T 0777T 0781T, 0782T 0807T, 0808T 0820T, 0821T, 0822T A9156 Section Title Percutaneous Arteriovenous Fistula (pAVF) Creation Intraoperative Fluorescent Angiography Ultrasound Elastography Bioelectrical Impedance Analysis for Body Composition Optical Coherence Tomography (Middle Ear) Anatomic Three-Dimensional (3D) Printing Automated Tympanostomy Tube Placement System with Iontophoresis Transdermal Glomerular Filtration Rate Measurement Percutaneous Ultrasound Gastrostomy Tube Insertion Artificial Intelligence Applications in Quantitative Imaging Bioprosthetic Valve for the Treatment of Deep Vein Reflux Pressure Waveform Analysis for Aiding Epidural Catheter Placement Targeted Lung Denervation Pulmonary Tissue Ventilation Analysis Continuous Monitoring During Psychedelic Therapy Mucoadhesive for the Treatment of Oral Wounds Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 2 of 43 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. A9268, A9269 C9791 Ingestible Devices for Treatment of Chronic Idiopathic Constipation Pulmonary Hyperpolarized Xenon-129 Magnetic Resonance Imaging For information about other Code Compendium topics, please refer to the following Medical Coverage Policies: Code Compendium (Cardiovascular) Code Compendium (Laboratory) Code Compendium (Musculoskeletal and Neurologic) Code Compendium (Ophthalmology) Code Compendium (Obstetrics/Gynecology) Code Compendium (Wound Care) Percutaneous Arteriovenous Fistula (pAVF) Creation Section Effective Date: 07/27/2023 Section Revision Date: 07/27/2023 Section Review Date: 07/27/2023 Change Summary: Updated References Description 36836 36837 G2170 Percutaneous arteriovenous fistula creation, upper extremity, single access of both the peripheral artery and peripheral vein, including fistula maturation procedures (eg, transluminal balloon angioplasty, coil embolization) when performed, including all vascular access, imaging guidance and radiologic supervision and interpretation Percutaneous arteriovenous fistula creation, upper extremity, separate access sites of the peripheral artery and peripheral vein, including fistula maturation procedures (eg, transluminal balloon angioplasty, coil embolization) when performed, including all vascular access, imaging guidance and radiologic supervision and interpretation Percutaneous arteriovenous fistula creation (avf), direct, any site, by tissue approximation using thermal resistance energy, and secondary procedures to redirect blood flow (e.g., transluminal balloon angioplasty, coil Not Covered Not Covered Not Covered Deleted Code Effective 12/31/2022 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 3 of 43 embolization) when performed, and includes all imaging and radiologic guidance, supervision and interpretation, when performed Percutaneous arteriovenous fistula creation (avf), direct, any site, using magnetic-guided arterial and venous catheters and radiofrequency energy, including flow-directing procedures (e.g., vascular coil embolization with radiologic supervision and interpretation, when performed) and fistulogram(s), angiography, enography, and/or ultrasound, with radiologic supervision and interpretation, when performed G2171 Not Covered Deleted Code Effective 12/31/2022 Chronic kidney disease (CKD) can often lead to end stage renal disease (ESRD). Once an individual reaches ESRD, dialysis will likely be required. Vascular access to the bloodstream is required to administer dialysis treatment. An arteriovenous fistula (AVF) creates a direct connection between a vein and an artery in an individual’s arm. This results in a closed circuit that provides adequate blood flow for dialysis. Surgery is the traditional method of creating this AVF. Recent developments have introduced the concept of being able to create this percutaneously (pAVF). Currently, there are two devices with US Food & Drug Administration (FDA) approval for percutaneous creation. The Ellipsys Vascular Access System purportedly enables physicians to percutaneously access the proximal radial artery in the forearm to create an AV fistula. Under high frequency ultrasound guidance, the system uses an outer access cannula, guidewire and vessel capture construct that creates a connection of the vein to the artery using an intravascular approach. A low power thermal energy is used to cut the walls of the vessels and fuse the tissue, creating an anastomosis without leaving any foreign material (including sutures) in the resulting AV fistula. The WavelinQ EndoAVF System, formerly known as the everlinQ endoAVF System, is designed to create an endovascular AV fistula with catheters that are each inserted into an artery (brachial) and a vein (brachial, ulnar or radial) in the arm through a small puncture or incision. Using fluoroscopy, the catheters are both advanced to the appropriate location for endovascular AV fistula creation. The magnets in the catheters allow them to be precisely aligned while pulling the two adjacent vessels closer together. The venous catheter, which contains the electrode, delivers a burst of radiofrequency energy to create a connection between the artery and the vein. 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 4 of 43 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. Coverage Determination Humana members may NOT be eligible under the Plan for percutaneous arteriovenous fistula (pAVF) creation. This technology 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. ECRI Institute. Clinical Evidence Assessment. Ellipsys Vascular Access System (Avenu Medical, Inc.) for creating hemodialysis arteriovenous fistulas. https://www.ecri.org. Published March 18, 2019. Updated August 27, 2021. Accessed June 20, 2023. 2. 3. 4. 5. 6. 7. ECRI Institute. Clinical Evidence Assessment. Endovascular Systems for creating hemodialysis arteriovenous fistulas. https://www.ecri.org. Published September 13, 2021. Accessed June 20, 2023. ECRI Institute. Clinical Evidence Assessment. WavelinQ EndoAVF System (BD) for creating hemodialysis arteriovenous fistulas. https://www.ecri.org. Published February 28, 2019. Updated April 29, 2022. Accessed June 20, 2023. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Ellipsys Vascular Access System in patients with end stage renal disease. https://evidence.hayesinc.com. Published March 8, 2021. Accessed June 20, 2023. Hayes, Inc. Evolving Evidence Review. Ellipsys Vascular Access System (Avenu Medical) in patients with end-stage renal disease. https://evidence.hayesinc.com. Published August 4, 2021. Updated February 2, 2023. Accessed June 20, 2023. Hayes, Inc. Evolving Evidence Review. WavelinQ (formerly EverlinQ) EndoAVF System. https://evidence.hayesinc.com. Published July 23, 2021. Updated March 28, 2023. Accessed June 20, 2023. National Kidney Foundation (NKF). Kidney Disease Outcomes Quality Initiative (KDOQI) clinical practice guideline for vascular access: 2019 update. https://www.kidney.org. Published 1996. Updated April 2020. Accessed June 21, 2023. 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 5 of 43 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. UpToDate, Inc. Percutaneous hemodialysis arteriovenous fistula. https://www.uptodate.com. Updated May 2023. Accessed June 20, 2023. Intraoperative Fluorescent Angiography Section Effective Date: 03/23/2023 Section Revision Date: 03/23/2023 Section Review Date: 03/23/2023 Change Summary: Updated Description, References Description 76499 Unlisted diagnostic radiographic procedure C9733 Nonophthalmic fluorescent vascular angiography C9776 Intraoperative near-infrared fluorescence imaging of major extra-hepatic bile duct(s) (e.g., cystic duct, common bile duct and common hepatic duct) with intravenous administration of indocyanine green (ICG) (list separately in addition to code for primary procedure) Intraoperative fluorescent angiography is Not Covered as outlined in Coverage Determination section Refer to Breast Reconstruction Medical Coverage Policy Not Covered as outlined in Coverage Determination section Refer to Breast Reconstruction Medical Coverage Policy Not Covered 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 6 of 43 Intraoperative fluorescent angiography, also referred to as indocyanine green (ICG) fluorescence angiography, is a real-time assessment method that has been developed to assist surgeons in evaluating tissue perfusion and blood flow during surgery. This tool is frequently used in reconstructive breast surgery but is also being explored for a multitude of other procedure types (eg, cardiovascular, gastrointestinal, microsurgical, neurosurgical, organ transplant, reconstructive, tumor resection). Intraoperative fluorescent angiography involves intravenous injection of ICG dye during surgery. The ICG dye binds to proteins in the blood and emits light when stimulated by a low energy laser or near infrared light. The emitted light facilitates visualization of blood flow through the operative tissue, thus determining tissue perfusion and viability. Examples of US Food & Drug Administration (FDA)-approved imaging devices or systems used to capture fluorescent images for this purpose include, but may not be limited to, ActivSight, Firefly, Fluobeam, PDE-Neo II and SPY Fluorescent Imaging Systems (PINPOINT, SPY Elite, SPY-PHI). For information regarding fluorescent angiography of the breast during reconstructive surgery, please refer to Breast Reconstruction Medical Coverage Policy. Coverage Determination Humana members may NOT be eligible under the Plan for intraoperative fluorescent angiography. 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. American Heart Association (AHA). Perfusion assessment in critical limb ischemia: principles for understanding and the development of evidence and evaluation of devices: a scientific statement from the American Heart Association. https://www.heart.org. Published September 17, 2019. Accessed February 17, 2023. 2. ECRI Institute. Clinical Evidence Assessment. ActivSight intraoperative imaging module (Activ Surgical) for real-time blood flow and perfusion visualization during laparoscopic surgery. https://www.ecri.org. Published September 9, 2021. Accessed February 14, 2023. 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 7 of 43 3. 4. 5. 6. 7. 8. 9. ECRI Institute. Clinical Evidence Assessment. ICG fluorescence imaging for aiding thyroid and parathyroid surgery. https://www.ecri.org. Published June 2, 2022. Accessed February 14, 2023. ECRI Institute. Clinical Evidence Assessment. PDE-Neo II Indocyanine Green Imaging System (Hamamatsu Photonics K.K.) for blood and lymphatic labeling during colorectal surgery. https://www.ecri.org. Published August 5, 2020. Accessed February 14, 2023. ECRI Institute. Product Brief. Spy Portable Handheld Imager (SPY-PHI) (Stryker Endoscopy) for assessing tissue perfusion during surgery. https://www.ecri.org. Published July 1, 2019. Accessed February 14, 2023. ECRI Institute. Product Brief (ARCHIVED). Pinpoint Intraoperative Endoscopic Fluorescence Imaging System (Novadaq Technologies, Inc.) for assessing tissue perfusion during laparoscopic surgery. https://www.ecri.org. Published April 26, 2015. Updated May 5, 2017. Accessed February 14, 2023. Hayes, Inc. Clinical Research Response (ARCHIVED). SPY Portable Handheld Imaging System (SPY-PHI) (Stryker). https://evidence.hayesinc.com. Published January 30, 2019. Accessed November 24, 2020. Hayes, Inc. Health Technology Brief (ARCHIVED). SPY Fluorescent Imaging System (Novadaq Technologies Inc.) for intraoperative evaluation of graft patency during coronary artery bypass surgery (CABG). https://evidence.hayesinc.com. Published December 3, 2008. Updated January 5, 2010. Accessed February 14, 2023. UpToDate, Inc. Advanced vascular imaging for lower extremity peripheral artery disease. https://www.uptodate.com. Updated January 2023. Accessed February 15, 2023. 10. UpToDate, Inc. Early noncardiac complications of coronary artery bypass graft surgery. https://www.uptodate.com. Updated January 2023. Accessed February 15, 2023. 11. UpToDate, Inc. Instruments and devices used in laparoscopic surgery. https://www.uptodate.com. Updated January 2023. Accessed February 15, 2023. 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 8 of 43 12. UpToDate, Inc. Laparoscopic cholecystectomy. https://www.uptodate.com. Updated January 2023. Accessed February 15, 2023. 13. UpToDate, Inc. Managing the difficult gallbladder. https://www.uptodate.com. Updated January 2023. Accessed February 15, 2023. 14. UpToDate, Inc. Overview of colon resection. https://www.uptodate.com. Updated January 2023. Accessed February 15, 2023. Ultrasound Elastography Section Effective Date: 03/23/2023 Section Revision Date: 03/23/2023 Section Review Date: 03/23/2023 Change Summary: Updated References, Description Description 76981 Ultrasound, elastography; parenchyma (eg, organ) 76982 Ultrasound, elastography; first target lesion 76983 Ultrasound, elastography; each additional target lesion (List separately in addition to code for primary procedure) Not Covered Not Covered Not Covered Ultrasound elastography (UES) is a noninvasive medical imaging modality that measures the stiffness of soft tissues (eg, fat, muscles, organs, skin). This technology uses high frequency sound waves to purportedly determine whether a tissue is hard or soft which will possibly provide diagnostic information about the presence or status of a disease. Elastography techniques have received substantial attention in recent years for the noninvasive assessment of tissues. Ultrasound-based methods are also of particular interest due to its many inherent advantages, such as wide availability. This technology is being explored for multiple body systems and organs including, but may not be limited to, breast, cardiovascular, ophthalmological, gastrointestinal, musculoskeletal, neurological, thyroid and urinary. Ultrasound elastography has shown promising results for noninvasive assessment of liver fibrosis. For information regarding elastography for diagnostic ultrasound 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 9 of 43 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. imaging of the liver, please refer to Noninvasive Tests for Hepatic Fibrosis Medical Coverage Policy. Coverage Determination Humana members may NOT be eligible under the Plan for ultrasound elastography of any organ or body system (other than the liver) for any indication. This technology 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. 3. 4. 5. 6. 7. American Association of Clinical Endocrinologists (AACE). American Association of Clinical Endocrinologists, American College of Endocrinology, and Associazione Medici Endocrinologi medical guidelines for clinical practice for the diagnosis and management of thyroid nodules – 2016 update. Published May 2016. Accessed February 20, 2023. American College of Radiology (ACR). ACR Appropriateness Criteria. Abnormal uterine bleeding. https://www.acr.org. Published 2020. Accessed February 20, 2023. American College of Radiology (ACR). ACR Appropriateness Criteria. Assessment of gravid cervix. https://www.acr.org. Published 2019. Accessed February 20, 2023. American College of Radiology (ACR). ACR Appropriateness Criteria. Imaging of the axilla. https://www.acr.org. Published 2021. Accessed February 20, 2023. American College of Radiology (ACR). ACR Appropriateness Criteria. Neck mass/adenopathy. https://www.acr.org. Published 2018. Accessed February 20, 2023. American College of Radiology (ACR). ACR-SRU practice parameter for the performance of ultrasound elastography. https://www.acr.org. Published 2019. Accessed February 20, 2023. American Thyroid Association (ATA). 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 10 of 43 differentiated thyroid cancer. https://www.thyroid.org. Published January 12, 2016. Accessed February 20, 2023. 8. 9. ECRI Institute. Clinical Evidence Assessment. Shear-wave elastography for diagnosing interstitial lung disease. https://www.ecri.org. Published January 18, 2022. Accessed February 17, 2023. ECRI Institute. Clinical Evidence Assessment. Shear-wave ultrasound elastography for aiding breast cancer diagnosis. https://www.ecri.org. Published January 30, 2014. Updated January 7, 2022. Accessed February 17, 2023. 10. ECRI Institute. Hotline Response (ARCHIVED). Shear-wave elastography for diagnostic ultrasound imaging. https://www.ecri.org. Published January 30, 2014. Accessed December 7, 2021. 11. Sigrist RMS, Liau J, El Kaffas A, et al. Ultrasound elastography: review of techniques and clinical applications. Theranostics. 2017;7(5):1303-1329. https://www.thno.org. Accessed December 7, 2021. 12. UpToDate, Inc. Musculoskeletal ultrasonography: nomenclature, technical considerations, validation, and standardization. https://www.uptodate.com. Updated January 2023. Accessed February 17, 2023. 13. UpToDate, Inc. Technical aspects of thyroid ultrasound. https://www.uptodate.com. Updated January 2023. Accessed February 17, 2023. 14. UpToDate, Inc. Transabdominal ultrasonography of the small and large intestine. https://www.uptodate.com. Updated January 2023. Accessed February 17, 2023. 15. UpToDate, Inc. Ultrasound for peripheral nerve blocks. https://www.uptodate.com. Updated January 2023. Accessed February 17, 2023. Bioelectrical Impedance Analysis for Body Composition Section Effective Date: 03/23/2023 Section Revision Date: 03/23/2023 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 11 of 43 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. Section Review Date: 03/23/2023 Change Summary: Updated References Description 0358T Bioelectrical impedance analysis whole body composition assessment, with interpretation and report Not Covered Bioelectrical impedance analysis (BIA) is a noninvasive test that has been proposed as a method for whole body composition assessment (percentage of bone, fat, muscle and water) or body fat composition assessment (proportion of fat and fat free mass). This test may be performed in conjunction with annual wellness examinations, nutritional evaluations or weight management consultations with an individual’s health care provider. Variables such as testing methods, types of equipment and health factors of the individual being tested are known to affect results. During BIA, electrodes are attached to the hands and feet of the individual being evaluated. Certain electrodes apply a low level, imperceptible electrical current while others detect and measure the output. BIA determines the resistance to flow of the current as it passes through the body and provides estimates of body water from which body fat is calculated using selected equations. Muscle, having higher water content than adipose tissue (fat), should have lower resistance. For information regarding bioelectrical impedance spectroscopy (BIS) for lymphedema, please refer to Lymphedema – Diagnosis and Treatment Medical Coverage Policy. Coverage Determination Humana members may NOT be eligible under the Plan for the use of bioelectrical impedance analysis (BIA) for whole body composition assessment, body fat composition or any other indication. 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. American Academy of Pediatrics (AAP). Clinical practice guideline for the evaluation and treatment of children and adolescents with obesity. https://www.aap.org. Published January 9, 2023. Accessed February 21, 2023. 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 12 of 43 2. 3. American Society for Parenteral and Enteral Nutrition (ASPEN). Clinical Guidelines. The validity of body composition assessment in clinical populations. https://www.nutritioncare.org. Published June 19, 2019. Accessed February 22, 2023. ECRI Institute. Hotline Response. Body composition analyzers for diagnosis and management of obesity. https://www.ecri.org. Published July 10, 2019. Accessed February 21, 2023. 4. MCG Health. Bioimpedance spectroscopy. 26th edition. https://www.mcg.com. Accessed February 15, 2023. 5. 6. 7. 8. UpToDate, Inc. Determining body composition in adults. https://www.uptodate.com. Updated January 2023. Accessed February 21, 2023. UpToDate, Inc. Geriatric nutrition: nutritional issues in older adults. https://www.uptodate.com. Updated January 2023. Accessed February 21, 2023. UpToDate, Inc. Measurement of body composition in children. https://www.uptodate.com. Updated January 2023. Accessed February 21, 2023. US Department of Veterans Affairs (VA). VA/DoD Clinical Practice Guideline. The management of adult overweight and obesity. https://www.va.gov. Published July 2020. Accessed February 21, 2023. Optical Coherence Tomography (Middle Ear) Section Effective Date: 03/23/2023 Section Revision Date: 03/23/2023 Section Review Date: 03/23/2023 Change Summary: Updated Description, References Description 0485T 0486T Optical coherence tomography (OCT) of middle ear, with interpretation and report; unilateral Optical coherence tomography (OCT) of middle ear, with interpretation and report; bilateral Not Covered Not Covered 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 13 of 43 Optical coherence tomography (OCT) is a noninvasive imaging technology that uses near-infrared light to produce real-time, high-resolution, cross-sectional images of body tissues. Originally developed for retinal imaging, OCT is now being explored for examination of other tissues including, but not limited to, the ear, gastrointestinal tract, skin, urogenital tract and vascular endothelium.1 For the middle ear, it is intended as an alternative or complement to visual exam and tympanometry to aid in the diagnosis of middle ear conditions, by providing three dimensional (3D) images of the tympanic membrane, middle ear bones and their vibrations. For information regarding optical coherence tomography for retinal imaging, please refer to Scanning Computerized Ophthalmic Diagnostic Imaging Medical Coverage Policy. For information regarding remote optical coherence tomography, please refer to Code Compendium (Ophthalmology) Medical Coverage Policy. Coverage Determination Humana members may NOT be eligible under the Plan for optical coherence tomography (OCT) of the middle ear. 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. ECRI Institute. Hotline Response (ARCHIVED). Optical coherence tomography for aiding diagnosis of middle ear abnormalities. https://www.ecri.org. Published April 27, 2018. Accessed February 22, 2023. Hubler Z, Shemonski ND, Shelton RL, Monroy GL, Nolan RM, Boppart SA. Real- time automated thickness measurement of the in vivo human tympanic membrane using optical coherence tomography. Quant Imaging Med Surg. 2015;5(1):69-77. https://www.ncbi.nlm.nih.gov/pmc. Accessed December 7, 2021. 3. Monroy GL, Shelton RL, Nolan RM, et al. Noninvasive depth-resolved optical measurements of the tympanic membrane and middle ear for differentiating otitis media. Laryngoscope. Aug 2015;125(8):e276-282. https://www.ncbi.nlm.nih.gov/pmc. Accessed December 7, 2021. 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 14 of 43 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. 4. 5. Preciado D, Nolan RM, Joshi R, et al. Otitis media middle ear effusion identification and characterization using an optical coherence tomography otoscope. Otolaryngol Head Neck Surg. 2020;162(3):367-374. https://journals.sagepub.com/doi/full/10.1177/0194599819900762. Accessed December 7, 2021. UpToDate, Inc. Otitis media with effusion (serious otitis media) in children: clinical features and diagnosis. https://www.uptodate.com. Updated January 2023. Accessed February 22, 2023. Anatomic Three-Dimensional (3D) Printing Section Effective Date: 07/27/2023 Section Revision Date: 07/27/2023 Section Review Date: 07/27/2023 Change Summary: Updated References Description 0559T 0560T 0561T 0562T Anatomic model 3D-printed from image data set(s); first individually prepared and processed component of an anatomic structure Anatomic model 3D-printed from image data set(s); each additional individually prepared and processed component of an anatomic structure (List separately in addition to code for primary procedure) Anatomic guide 3D-printed and designed from image data set(s); first anatomic guide Anatomic guide 3D-printed and designed from image data set(s); each additional anatomic guide (List separately in addition to code for primary procedure) Not Covered Not Covered Not Covered Not Covered Three-dimensional (3D) printing technology creates 3D objects from plastic, metal, nylon or other source material by building the object layer upon successive layer until complete.3,6 Uses for anatomic 3D printing are actively being explored for multiple clinical applications and body systems including, but not limited to, preoperative surgical models for planning/rehearsal, tailored bone implants, prosthetic devices, operative templates/guides and bioprinting. 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 15 of 43 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. Coverage Determination Humana members may NOT be eligible under the Plan for anatomic 3D printing. This technology 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. Chepelev L, Wake N, Ryan J, et al. Radiological Society of North America (RSNA) 3D printing special interest group (SIG): guidelines for medical 3D printing and appropriateness for clinical scenarios. 3D Print Med. 2018;4(11):1-38. 2. 3. 4. 5. 6. 7. 8. ECRI Institute. Clinical Evidence Assessment. MySpine Patient-Specific Guide (Medacta International) for placing pedicle screws during spinal surgery. https://www.ecri.org. Published July 1, 2019. Updated March 25, 2021. Accessed June 21, 2023. ECRI Institute. Clinical Evidence Assessment. Use of three-dimensional printed anatomic models for cardiovascular surgical planning. https://www.ecri.org. Published July 25, 2018. Updated July 9, 2021. Accessed June 21, 2023. ECRI Institute. Clinical Evidence Assessment. Use of three-dimensional printed anatomic models for neurologic surgical planning. https://www.ecri.org. Published July 26, 2021. Accessed June 21, 2023. ECRI Institute. Clinical Evidence Assessment. Use of three-dimensional printed anatomic models for orthopedic surgical planning. https://www.ecri.org. Published July 8, 2021. Accessed June 21, 2023. ECRI Institute. Hotline Response (ARCHIVED). Clinical applications for three- dimensional printing technology. https://www.ecri.org. Published January 7, 2014. Updated September 15, 2015. Accessed June 21, 2023. Hayes, Inc. Clinical Research Response. Custom implants (restor3d) for ankle arthroplasty. https://evidence.hayesinc.com. Published March 10, 2023. Accessed June 21, 2023. Hayes, Inc. Clinical Research Response. My3D personalized pelvic reconstruction (Onkos Surgical). https://evidence.hayesinc.com. Published November 3, 2022. Accessed June 21, 2023. 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. 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. Code Compendium (Miscellaneous) Policy Number: HUM-0562-016 Page: 16 of 43 9. Hayes, Inc. Clinical Research Response (ARCHIVED). 3D printed porous titanium interbody cages for spinal fusion. https://evidence.hayesinc.com. Published February 25, 2021. Accessed June 21, 2023. 10. Hayes, Inc. Evidence Analysis Research Brief. Custom 3D printed prostheses for temporomandibular joint disorders. https://evidence.hayesinc.com. Published October 27, 2022. Accessed June 21, 2023. 11. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Custom 3D printed implants for complex lower extremity reconstruction. https://evidence.hayesinc.com. Published May 18, 2021. Accessed June 21, 2023. 12. Hayes, Inc. Health Technology Assessment. 3D-printed orthopedic implants. https://evidence.hayesinc.com. Published September 25, 2019. Updated October 19, 2022. Accessed June 21, 2023. Automated Tympanostomy Tube Placement System with Iontophoresis Section Effective Date: 07/27/2023 Section Revision Date: 07/27/2023 Section Review Date: 07/27/2023 Change Summary: Updated References Description 0583T Tympanostomy (requiring insertion of ventilating tube), using an automated tube delivery system, iontophoresis local anesthesia Not Covered Surgical placement of a tympanostomy tube via a myringotomy is a common ambulatory surgery performed on children in the United States. Tympanostomy tubes are most often inserted because of persistent middle ear fluid, frequent ear infections or ear infections that persist after antibiotic therapy.1 Occasionally, adults also may require tubes for the same reasons or for Eustachian tube dysfunction. An automated tube delivery system has been introduced to potentially allow for the procedure to be performed in a healthcare provider’s office or clinic without the need for general anesthesia. The Tula System is a device that creates a myringotomy in the eardrum and inserts a tympanostomy tube in one single pass. It is intended for use in pediatric (children six months and older) and adult individuals indicated to receive tympanostomy tubes. The Tula Iontophoresis System is designed to deliver 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 17 of 43 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. Tymbion (a drug combination consisting of a local anesthetic and an adrenergic agonist) to the tympanic membrane prior to tube placement. Coverage Determination Humana members may NOT be eligible under the Plan for automated tympanostomy tube placement systems utilizing iontophoresis. This technology 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. American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS). Clinical Practice Guideline. Tympanostomy tubes in children (update). https://www.entnet.org. Published 2013. Updated February 9, 2022. Accessed June 28, 2023. 2. 3. 4. 5. 6. American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS). Position Statement. In-office placement of tubes in pediatric patients while awake. https://www.entnet.org. Published July 9, 2019. Accessed June 28, 2023. ClinicalKey. Zeiders JW, Syms CA, Mitskavich MT, et al. Tympanostomy tube placement in awake, unrestrained pediatric patients: a prospective multicenter study. Int J Pediatr Otorhinolaryngol. 2015;79(12):2416-2423. https://www.clinicalkey.com. Accessed June 27, 2023. Hayes, Inc. Evidence Analysis Research Brief (ARCHIVED). Automated tympanostomy tube placement systems for pediatric patients. https://evidence.hayesinc.com. Published May 12, 2022. Accessed June 27, 2023. UpToDate, Inc. Overview of tympanostomy tube placement, postoperative care, and complications in children. https://www.uptodate.com. Updated May 2023. Accessed June 27, 2023. US Food & Drug Administration (FDA). Summary of safety and effectiveness data: Tula System. https://www.fda.gov. Published November 25, 2019. Accessed January 7, 2020. 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 18 of 43 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. 7. Waldman E, Ingram A, Vidrine D, et al. Two-year outcomes after pediatric in- office tympanostomy using lidocaine/epinephrine iontophoresis and an automated tube delivery system. Otolaryngol Head Neck Surg. 2023;00(00):1- 9. https://aao-hnsfjournals.onlinelibrary.wiley.com. Accessed June 28, 2023. Transdermal Glomerular Filtration Rate Measurement Section Effective Date: 07/27/2023 Section Revision Date: 07/27/2023 Section Review Date: 07/27/2023 Change Summary: Updated References Description 0602T 0603T Glomerular filtration rate (GFR) measurement(s), transdermal, including sensor placement and administration of a single dose of fluorescent pyrazine agent Glomerular filtration rate (GFR) monitoring, transdermal, including sensor placement and administration of more than one dose of fluorescent pyrazine agent, each 24 hours Not Covered Not Covered The glomerular filtration rate (GFR) is a measurement that provides information about kidney function. Measuring GFR directly is considered the most accurate way to detect changes in kidney status, but it is a complex procedure and generally not routinely performed.3 Because of this, an estimated GFR calculated from formulas based on results of blood and urine tests are more commonly used. A novel device, called the Transdermal GFR Measurement System (TGFR), is currently being trialed that would purportedly provide clinicians with continuous, real-time measurement of GFR at the point of care with no need for blood sampling or urine collection. The US Food & Drug Administration (FDA) has granted a Breakthrough Device designation for this product. It includes a skin sensor, monitor and a proprietary fluorescent tracer agent (MB-102) that glows in the presence of light and is filtered from the blood exclusively by the GFR mechanism of the kidneys. Coverage Determination Humana members may NOT be eligible under the Plan for transdermal glomerular filtration rate measurement. This technology is considered experimental/ investigational as it is not identified as widely used and generally accepted for the 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 19 of 43 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. proposed use as reported in nationally recognized peer-reviewed medical literature published in the English language. References 1. National Library of Medicine (NLM). Tolerability and background fluorescence of the MediBeacon Transdermal GFR Measurement System. https://www.clinicatrials.gov. Published January 22, 2019. Updated January 10, 2020. Accessed June 28, 2023. 2. 3. 4. Solomon R, Goldstein S. Real-time measurement of glomerular filtration rate. Curr Opin Crit Care. 2017;23(6):470-474. Testing.com: for health professionals. Estimated glomerular filtration rate (eGFR). https://www.testing.com. Published July 22, 2016. Updated December 6, 2022. Accessed June 29, 2023. UpToDate, Inc. Assessment of kidney function. https://www.uptodate.com. Updated May 2023. Accessed June 28, 2023. Percutaneous Ultrasound Gastrostomy Tube Insertion Section Effective Date: 07/27/2023 Section Revision Date: 07/27/2023 Section Review Date: 07/27/2023 Change Summary: Updated References Description 0647T Insertion of gastrostomy tube, percutaneous with magnetic gastropexy, under ultrasound guidance, image documentation and report Not Covered A gastrostomy tube is a device which provides enteral feedings when an individual has a functioning gastrointestinal tract but is unable to eat or swallow for an extended period of time. Gastrostomy tubes have traditionally been placed endoscopically, radiologically or surgically depending on the individual’s anatomy or condition and available resources. The percutaneous endoscopic gastrostomy (PEG) has now become the most common method for insertion.2 Percutaneous ultrasound gastrostomy (PUG) is a novel procedure for gastrostomy tube placement to purportedly become an alternative means of placement, 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 (Miscellaneous) Policy Number: HUM-0562-016 Page: 20 of 43 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. specifically proposed to be performed for those in critical care at the bedside. The Point of Care Ultrasound Magnet Aligned-Gastrostomy (PUMA-G) System is the first US Food & Drug Administration (FDA)-approved, ultrasound-based solution for feeding tube placement. The PUMA-G consists of a balloon catheter which is placed orogastrically. An external magnet pulls the balloon to the anterior stomach to create a temporary gastropexy. After a safe tract is identified via ultrasound, a needle and guidewire are inserted. The balloon catheter catches the guidewire, and the two components are removed to create complete orogastric access. Following that, a standard technique is utilized for over-the-wire gastrostomy tube placement. Coverage Determination Humana members may NOT be eligible under the Plan for percutaneous ultrasound gastrostomy tube insertion. This technology 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. 3. ECRI Institute. Clinical Evidence Assessment. PUMA-G System (Coap Tech) for gastrostomy tube placement. https://www.ecri.org. Published November 4, 2021. Accessed June 29, 2023. Olivieri PP, Abdulmahdi M, Heavner JJ. Bedside percutaneous ultrasound gastrostomy tube placement by critical care physicians. J Clin Ultrasound. 2021;49(1):28-32. UpToDate, Inc. Gastrostomy tubes: placement and routine care. https://www.uptodate.com. Updated May 2023. Accessed June 29, 2023. 4. Wilkerson RG, Pustavoitau A, Carolan H, et al. Percutaneous ultrasound gastrostomy: a novel device and bedside procedure for gastrostomy tube insertion using magnetic and ultrasound guidance. J Med Devices. 2019;13(2). Artificial Intelligence Applications in Quantitative Imaging Section Effective Date: 11/02/2023 Section Revision Date: 11/02/2023 Section Review Date: 03/23/2023 Change Summary: Updated Description, Coverage Determination,