CHAPTER 1 Section 11.1, pages 1 and 2 Section 11.1, pages 1 and 2

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2 CHANGE M OCTOBER 27, 2017 REMOVE PAGE(S) INSERT PAGE(S) CHAPTER 1 Section 11.1, pages 1 and 2 Section 11.1, pages 1 and 2 CHAPTER 4 Section 20.1, pages 3 through 5 Section 20.1, pages 3 through 5 Section 21.1, pages 1 through 3 Section 21.1, pages 1 through 3 CHAPTER 5 Section 1.1, pages 3 through 8 Section 1.1, pages 3 through 8 2

3 CHANGE M OCTOBER 27, 2017 SUMMARY OF CHANGES CHAPTER 1 1. Section This change adds new codes to OPPS. EFFECTIVE DATE: 08/01/2017. CHAPTER 4 2. Section This change updates language. EFFECTIVE DATE: 08/09/ Section This change adds new codes to OPPS. EFFECTIVE DATE: 08/01/2017. CHAPTER 5 4. Section 1.1. This change revises language and removes outdated/deleted codes. EFFECTIVE DATE: 08/15/

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5 Administration Chapter 1 Section 11.1 Category III Codes - Temporary Codes For Emerging Technology, Services And Procedures Issue Date: March 6, 2002 Authority: 32 CFR 199.2(b) and 32 CFR 199.4(g)(15) Copyright: CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Revision: 1.0 CPT PROCEDURE CODES 0073T, 0075T, 0076T, 0099T, 0184T, 0308T 2.0 DESCRIPTION Category III codes are a set of temporary codes for emerging technology, services, and procedures. These codes are used to track new and emerging technology to determine applicability to clinical practice. When a Category III code receives a Category I code from the American Medical Association (AMA) it does not automatically become a benefit under TRICARE. However, the codes that may have moved from unproven to proven must be forwarded to the Office of Medical Benefits and Reimbursement Section (MB&RS) for coverage determination/policy clarification. 3.0 POLICY 3.1 Category III codes are to be used instead of unlisted codes to allow the collection of specific data. TRICARE has not opted to track Category III codes at this time. 3.2 Category III codes are excluded from coverage since clinical safety and efficacy or applicability to clinical practice has not been established. 4.0 EXCEPTIONS 4.1 U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) (Category B) clinical trial. See Chapter 8, Section Category III code 0073T is a covered service as listed in Chapter 5, Section Category III codes 0075T and 0076T are covered codes as outlined in Chapter 4, Section Category III codes 0099T and 0308T are covered codes as outlined in Chapter 4, Section

6 Chapter 1, Section 11.1 Category III Codes - Temporary Codes For Emerging Technology, Services And Procedures 4.5 Category III codes 0184T and 0249T are covered services as listed in Chapter 4, Section Category III code 0346T is a covered service as listed in Chapter 5, Section Category III code 0474T is a covered service as listed in Chapter 4, Section Category III codes 0472T and 0473T are a covered service as listed in Chapter 4, Section EXCLUSIONS 5.1 Unlisted codes for Category III codes. Effective January 1, Ultrasound ablation (destruction of uterine fibroids) with Magnetic Resonance Imaging (MRI) guidance (CPT procedure code 0071T) in the treatment of uterine leiomyomata is unproven. 5.3 Computer-Aided Detection (CAD) with breast MRI (CPT procedure code 0159T) is unproven. 5.4 XSTOP Interspinous Process Decompression System (CPT procedure codes 0171T and 0172T, HCPCS code C1821) is unproven. 5.5 Ultrasound-guided facet joint injection (CPT procedure codes 0216T and 0217T) is unproven. - END - 2

7 Chapter 4, Section 20.1 Nervous System 2.9 Sacral Nerve Stimulation (SNS) for the treatment of chronic fecal incontinence is covered for patients who have failed or are not candidates for more conservative treatment, and who have a weak but structurally intact anal sphincter refractory to conservative measures. See Section 14.1 for coverage policy for the urinary system and the Sacral Nerve Root Stimulation (SNS) Intracranial angioplasty (CPT procedure code 61630) may be covered when medically necessary and appropriate. 3.0 EXCLUSIONS 3.1 N-butyl-2-cyanoacrylate (Histacryl Bleu ), iodinated poppy seed oils (e.g., Ethiodol ), and absorbable gelatin sponges are not FDA approved. 3.2 Transcutaneous, percutaneous, functional dorsal column electrical stimulation in the treatment of multiple sclerosis or other motor function disorders is unproven. 3.3 Deep brain neurostimulation in the treatment of insomnia, depression, anxiety, and substance abuse is unproven. 3.4 Psychosurgery is not in accordance with accepted professional medical standards and is not covered. 3.5 Endovascular GDC treatment of wide-necked aneurysms and rupture is unproven. 3.6 Cerebellar stimulators/pacemakers for the treatment of neurological disorders are unproven. 3.7 Dorsal Root Entry Zone (DREZ) thermocoagulation or microcoagulation neurosurgical procedure is unproven. 3.8 Extraoperative electrocortiography for stimulation and recording in order to determine electrical thresholds of neurons as an indicator of seizure focus is unproven. 3.9 Neuromuscular Electrical Stimulation (NMES) for the treatment of denervated muscles is unproven Stereotactic cingulotomy is unproven Laminoplasty, cervical with decompression of the spinal cord, two or more vertebral segments with reconstruction of the posterior bony elements (CPT procedure codes and 63051) Transcatheter placement of intravascular stent(s) intracranial (e.g., atherosclerotic or venous sinus stenosis) including angioplasty, if performed (CPT procedure code 61635) is unproven. See Chapter 1, Section 3.1 for coverage policy regarding treatment of pseudotumor cerebri Balloon dilation of intracranial vasospasm, initial vessel (CPT procedure code 61640) each additional vessel in same family (CPT procedure code 61641) or different vascular family (CPT procedure code 61642) is unproven Endoscopic thoracic sympathectomy. 3

8 Chapter 4, Section 20.1 Nervous System 3.15 Trigger point injection for migraine headaches Sphenopalatine ganglion block (CPT procedure code 64505) for the treatment of chronic migraine headaches and neck pain is unproven RF denervation (CPT procedure codes 64633, 64634) for the treatment of thoracic facet pain is unproven. Pulsed Radiofrequency Ablation (RFA) for spinal pain is unproven Implantation of Occipital Nerve Stimulator for the treatment of chronic intractable migraine headache is unproven Cryoablation of Occipital Nerve (CPT procedure code 64640) for the treatment of chronic intractable headache is unproven Spinal cord and deep brain neurostimulation in the treatment of chronic intractable headache or migraine pain is unproven Thermal Intradiscal Procedures (TIPs) (CPT procedure codes 22526, 22527, 62287, and Healthcare Common Procedure Coding System (HCPCS) code S2348) are unproven. TIPs are also known as: Intradiscal Electrothermal Annuloplasty (IEA), Intradiscal Electrothermal Therapy (IDET), Intradiscal Thermal Annuloplasty (IDTA), Percutaneous Intradiscal Radiofrequency Thermocoagulation (PIRFT), Coblation Percutaneous Disc Decompression, Nucleoplasty (also known as Percutaneous RF thermomodulation or Percutaneous Plasma Diskectomy), Radiofrequency Annuloplasty (RA), Intradiscal Biacuplasty (IDB), Percutaneous (or Plasma) Disc Decompression (PDD), Targeted Disc Decompression (TDD), Cervical Intradiscal RF Lesioning Laser ablation of paravertebral facet joint nerves (CPT procedure codes and 64623) is unproven. (This applies only to laser ablation and should not be applied to RFA.) 3.23 Minimally Invasive Lumbar Decompression (mild ) for the treatment of Degenerative Disc Disease (DDD) and/or spinal stenosis is unproven. 4.0 EFFECTIVE DATES 4.1 January 1, 1989, for PAVM. 4.2 April 1, 1994, for therapeutic embolization for treatment of meningioma. 4.3 July 14, 1997, for GDC. 4.4 The date of FDA approval of the embolization device for all other embolization procedures. 4.5 June 1, 2004, for Magnetoencephalography. 4.6 June 10, 2008, for thoracic epidural steroid injections. 4.7 January 1, 2009, for non-pulsed RF denervation for the treatment of chronic cervical and lumbar facet pain. 4

9 Chapter 4, Section 20.1 Nervous System 4.8 January 1, 2009, for endoscopic laminotomy for the treatment of lumbar spinal stenosis. 4.9 October 1, 2011, for vagus nerve stimulator for treatment of LGS in children 12 years of age or younger March 14, 2011, for SNS for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatment, and who have a weak but structurally intact anal sphincter refractory to conservative measures Effective July 27, 2012, for implantation of a U.S. Food and Drug Administration (FDA) approved vagus nerve stimulator, and battery replacement as adjunctive therapy in reducing the frequency of seizures that are refractory to anti-epileptic medications in beneficiaries under the age of August 9, 2012, for intracranial angioplasty. - END - 5

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11 Surgery Chapter 4 Section 21.1 Eye And Ocular Adnexa Issue Date: August 26, 1985 Authority: 32 CFR 199.4(c)(2), (c)(3) and (g)(46) Copyright: CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Revision: 1.0 CPT PROCEDURE CODES 0191T, 0253T, 0308T, 0376T, 0402T, 0472T T, , , , HCPCS PROCEDURE CODES C1783, L DESCRIPTION The eye is the organ of vision and the ocular adnexa are the appendages or adjunct parts; i.e., eyelids, lacrimal apparatus. 4.0 POLICY 4.1 Services and supplies required in the diagnosis and treatment of illness or injury involving the eye or ocular adnexa are covered. 4.2 Phototherapeutic Keratectomy (PTK) is covered for corneal dystrophies. 4.3 Strabismus. Surgical procedures and eye examinations to correct, treat, or diagnose strabismus are covered. 4.4 Corneal transplants. A corneal transplant (keratoplasty) is a covered surgical procedure. Relaxing keratotomy to relieve astigmatism following a corneal transplant is covered. 4.5 Transpupillary thermotherapy (laser hyperthermia, Current Procedural Terminology (CPT) procedure codes ), with chemotherapy, is covered for the treatment of retinoblastoma. See also Chapter 5, Section Intrastromal Corneal Ring Segments (Intacs ) is covered for U.S. Food and Drug Administration (FDA) approved indications for beneficiaries with keratoconus who meet all of the following criteria: 1

12 Chapter 4, Section 21.1 Eye And Ocular Adnexa Are unable to achieve adequate vision using lenses or spectacles; and For whom corneal transplant is the only remaining option. Coverage allowed effective July 17, The Ex-PRESS Mini Glaucoma Shunt (CPT procedure code 66183) and other FDA approved aqueous shuts or stents may be considered for cost-sharing when they are used to reduce Intraocular Pressure (IOP) in the treatment of glaucoma, that cannot be controlled effectively with medications. 4.8 Off-label use of Photodynamic Therapy (CPT procedure code 67221) with Visudyne (HCPCS J3396) may be considered for cost-sharing for the treatment of retinal astrocytic hamartoma in Tuberous Sclerosis. The effective date is February 1, Transpupillary thermotherapy (CPT procedure code 67299) with Plaque Radiotherapy (Brachytherapy) is covered for the treatment of choroidal melanoma. See also Chapter 5, Section Photodynamic Therapy for the treatment of Central Serous Chorioretinopathy in accordance with the TRICARE provisions for the treatment of rare diseases Implantable Miniature Telescope (IMT) is covered for FDA approved indications for beneficiaries with end-stage-related macular degeneration Canaloplasty for the treatment of primary open angle glaucoma (CPT procedure codes and 66175) is covered Insertion of aqueous drainage device (istent, CyPass ) during cataract surgery to reduce IOP in the treatment of glaucoma, initial insertion (CPT procedure codes 0191T, 0474T, C1783, and L8612), and each additional insertion (CPT procedure code 0376T) Collagen Cross-linking for the treatment of corneal ectasia due to the rare disease Keratoconus is safe and effective and may be considered for cost-sharing Programing of retinal prosthesis (CPT procedure codes 0472T and 0473T) is covered for use with Argus II Retinal Prosthesis System. 5.0 EXCLUSIONS 5.1 Refractive corneal surgery except as noted in paragraph 4.4 (CPT procedure codes 65760, 65765, 65767, 65770, 65771). 5.2 Eyeglasses, and contact lenses except as noted in Chapter 7, Section Orthokeratology. 5.4 Orthoptics, also known as visual training, vision therapy, eye exercises, eye therapy, is excluded by 32 CFR 199.4(g)(46) (CPT procedure code 92065). 5.5 Epikeratophakia for treatment of aphakia and myopia is unproven. 2

13 Chapter 4, Section 21.1 Eye And Ocular Adnexa 5.6 Transpupillary thermotherapy (CPT procedure code 67299) as primary treatment of choroidal melanoma is unproven. 5.7 Autologous serum eye drops for the treatment of dry eye syndrome, keratitis, or ocular hypertension is unproven. 6.0 EFFECTIVE DATES 6.1 April 1, 2011, coverage for Ex-PRESS Mini Glaucoma Shunt. 6.2 July 17, 2005 coverage for Intrastromal Corneal Ring Segments (Intacs ). 6.3 December 1, 2014, coverage for Photodynamic Therapy for Central Serous Chorioretinopathy. 6.4 February 14, 2015, coverage for Canaloplasty for the treatment of glaucoma. 6.5 June 17, 2015, coverage date for IMT. 6.6 October 7, 2015, coverage date for istent. 6.7 April 15, 2016, for Collagen Cross-linking for corneal ectasia due to the rare disease Keratoconus. 6.8 July 29, 2016, for CyPass. 6.9 August 1, 2017, for programming of retinal prosthesis. - END - 3

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15 4.4.2 Detection of CAD: TRICARE Policy Manual M, April 1, 2015 Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging) Symptomatic--evaluation of intracardiac structures (use of Magnetic Resonance (MR) coronary angiography). Evaluation of suspected coronary anomalies Risk assessment with prior test results (use of vasolidator perfusion CMR or dobutamine stress function CMR). Coronary angiography (catheterization or CT). Stenosis of unclear significance Structure and Function. Evaluation of ventricular and valvular function. Procedures may include Left Ventricular (LV)/Right Ventricular (RV) mass and volumes, MRA, quantification of valvular disease, and delayed contrast enhancement Assessment of complex congenital heart disease including anomalies of coronary circulation, great vessels, and cardiac chambers and valves Evaluation of LV function following Myocardial Infarction (MI) OR in heart failure patients. Patients with technically limited images from echocardiogram Quantification of LV function. Discordant information that is clinically significant from prior tests Evaluation of specific cardiomyopathies (infiltrative [amyloid, sarcoid], Hypertrophic Cardiomyopathy (HCM), or due to cardiotoxic therapies Characterization of native and prosthetic cardiac valves--including planimetry of stenotic disease and quantification of regurgitant disease. Patients with technically limited images from echocardiogram or Transesophageal Echocardiography (TEE) Evaluation for Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC). Patients presenting with syncope or ventricular arrhythmia Evaluation of myocarditis or MI with normal coronary arteries. Positive cardiac enzymes without obstructive atherosclerosis on angiography Structure and Function. Evaluation of intracardiac and extracardiac structures Evaluation of cardiac mass (suspected tumor or thrombus). Use of contrast for perfusion and enhancement Evaluation of pericardial conditions (pericardial mass, constrictive pericarditis) Evaluation for aortic dissection. 3

16 Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging) Evaluation of pulmonary veins prior to radiofrequency ablation for atrial fibrillation. Left atrial and pulmonary venous anatomy including dimensions of veins for mapping purposes Detection of Myocardial Scar and Viability. Evaluation of myocardial scar (use of late gadolinium enhancement) To determine the location and extent of myocardial necrosis including no reflow regions. Post acute MI To determine viability prior to revascularization. Establish likelihood of recovery of function with revascularization (Percutaneous Coronary Intervention [PCI] or Coronary Artery Bypass Graft [CABG]) or medical therapy To determine viability prior to revascularization. Viability assessment by Single Photon Emission Tomography (SPECT) or dobutamine echo has provided equivocal or indeterminate results. 4.5 MRA is covered when medically necessary, appropriate and the standard of care. (CPT procedure codes , 71555, 72159, 72198, 73225, 73725, and ) 4.6 CT scans are covered when medically necessary, appropriate and the standard of care and all criteria stipulated in 32 CFR 199.4(e) are met. (CPT procedure codes , , , , , , , 75635, and ) 4.7 TRICARE considers three-dimensional (3D) rendering (CPT procedure codes and 76377) medically necessary under certain circumstances (see Section 2.1), for exclusion with maternity ultrasound. 4.8 Helical (spiral) CT scans, with or without contrast enhancement, are covered when medically necessary, appropriate and the standard of care. 4.9 Chest x-rays (CPT procedure codes ) are covered Diagnostic mammography (CPT procedure codes /HCPCS codes G G0207) to further define breast abnormalities or other problems is covered Portable X-ray services are covered. The suppliers must meet the conditions of coverage of the Medicare program, set forth in the Medicare regulations, or the Medicaid program in that state in which the covered service is provided. In addition to the specific radiology services, reasonable transportation and set-up charges are covered and separately reimbursable Bone density studies (CPT procedure codes ) are covered for the following: The diagnosis and monitoring of osteoporosis The diagnosis and monitoring of osteopenia When medically necessary and appropriate. 4

17 Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging) Patients must present with signs and symptoms of bone disease or be considered at highrisk for developing osteoporosis. High-risk factors for osteoporosis are those identified as the standard of care by the American College of Obstetricians and Gynecologists (ACOG) Radiological supervision and interpretation, percutaneous vertebroplasty or vertebral augmentation including cavity creation, per vertebral body; under fluoroscopic guidance (CPT procedure code 72291) or under CT guidance (CPT procedure code 72292) is covered Multislice or multidetector row CT angiography (CT, heart) (CPT codes ) is covered for the following indications: Evaluation of heart failure of unknown origin when invasive coronary angiography +/- Percutaneous Coronary Intervention (PCI) is not planned, unable to be performed or is equivocal In an Emergency Department (ED) for patients with acute chest pain, but no other evidence of cardiac disease (low-pretest probability), when results would be used to determine the need for further testing or observation Acute chest pain or unstable angina when invasive coronary angiography or a PCI cannot be performed or is equivocal Chronic stable angina and chest pain of uncertain etiology or other cardiac findings prompting evaluation for CAD (for example: new or unexplained heart failure or new bundle branch block) When invasive coronary angiography or PCI is not planned, unable to be performed, or is equivocal; AND Exercise stress test is unable to be performed or is equivocal; AND At least one of the following non-invasive tests were attempted and results could not be interpreted or where equivocal or none of the following tests could be performed: Exercise stress echocardiography Exercise stress echo with dobutamine Exercise myocardial perfusion (SPECT) Pharmacologic myocardial perfusion (SPECT) Evaluation of anomalous native coronary arteries in symptomatic patients when conventional angiography is unsuccessful or equivocal and when results would impact treatment Evaluation of complex congenital anomaly of coronary circulation or of the great vessels Presurgical evaluation prior to biventricular pacemaker placement. 5

18 Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging) Presurgical evaluation of coronary anatomy prior to non-coronary surgery (valve placement or repair; repair of aortic aneurysm or dissection) Presurgical cardiovascular evaluation for patients with equivocal stress study prior to kidney or liver transplantation Presurgical evaluation prior to electrophysiologic procedure to isolate pulmonary veins for radiofrequency ablation of arrhythmia focus CT angiography for acute ischemic stroke (CPT codes and 70498) are proven when medically necessary and appropriate CT angiography for intracerebral aneurysm and subarachnoid hemorrhage (CPT codes and 70498) are proven when medically necessary and appropriate Transient elastography (TE) (ultrasound-based transient elastography or FibroScan ) (CPT procedure codes 0346T and 91200) for the detection and monitoring of hepatic cirrhosis in patients with chronic hepatitis C is covered. 5.0 EXCLUSIONS 5.1 Bone density studies for the routine screening of osteoporosis. 5.2 Ultrafast CT (electron beam CT (HCPCS code S8092)) to predict asymptomatic heart disease is preventive. Ultrafast CT (electron beam CT) is excluded for symptomatic patients and for screening asymptomatic patients for CAD. 5.3 MRIs (CPT procedure codes and 77059) to screen for breast cancer in asymptomatic women considered to be at low or average risk of developing breast cancer; for diagnosis of suspicious lesions to avoid biopsy, to evaluate response to neoadjuvant chemotherapy, to differentiate cysts from solid lesions. 5.4 MRIs (CPT procedure codes and 77059) to assess implant integrity or confirm implant rupture, if implants were not originally covered or coverable D rendering (CPT procedure codes and 76377) for monitoring coronary artery stenosis activity in patients with angiographically confirmed CAD is unproven D rendering (CPT procedure codes and 76377) for evaluating graft patency in individuals who have undergone revascularization procedures is unproven D rendering (CPT procedure codes and 76377) for use as a screening test for CAD in healthy individuals or in asymptomatic patients who have one or more traditional risk factors for CAD is unproven. 5.8 CT, heart, without contrast material, with quantitative evaluation of coronary calcium (CPT procedure code 75571) is excluded for patients with typical anginal chest pain with high suspicion of CAD; patients with acute MI; and for screening asymptomatic patients for CAD. 6

19 Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging) 5.9 CT, heart, without contrast material, for evaluation of cardiac structure and morphology (including 3D image postprocessing, assessment of cardiac function, and evaluation of venous structures, if performed) (CPT procedure code 75572) is excluded for patients with typical anginal chest pain with high suspicion for CAD; patients with acute MI; and for screening asymptomatic patients for CAD CT, heart, with contrast material, for evaluation of cardiac structure and morphology in the setting of congenital heart disease (including 3D image postprocessing, assessment of LV cardiac function, RV structure and function and evaluation of venous structures, if performed) (CPT procedure code 75573) is excluded for patients with typical anginal chest pain with high suspicion for CAD; patients with acute MI; and for screening asymptomatic patients for CAD CT angiography heart, coronary arteries and bypass (when present), with contrast material, including 3D image postprocessing (including evaluation of cardiac structure and morphology, assessment of cardiac function, and evaluation of venous structures, if performed) (CPT procedure code 75574) is excluded for patients with typical anginal chest pain with high suspicion for CAD; patients with acute MI; and for screening asymptomatic patients for CAD Multislice or multidetector row CT angiography of less than 16 slices per sec and 1mm or less resolution is excluded Radiological supervision and interpretation of percutaneous vertebroplasty (CPT procedure codes and 72292) Computer-Aided Detection with breast MRI (CPT 0159T) is unproven Magnetic Resonance Spectroscopy (MRS), also known as NMR spectroscopy, of the brain is unproven Digital Breast Tomosynthesis (DBT) (CPT procedure codes and 77062) is unproven. 6.0 EFFECTIVE DATES 6.1 The effective date for MRIs with contrast media is dependent on the U.S. Food and Drug Administration (FDA) approval of the contrast media and a determination by the contractor of whether the labeled or unlabeled use of the contrast media is medically necessary and a proven indication. 6.2 March 31, 2006, for breast MRI. 6.3 March 31, 2006, for coverage of multislice or multidetector row CT angiography. 6.4 January 1, 2007, for CPT procedure codes and January 1, 2007, for coverage of multislice of multidetector row CT angiography performed for presurgical evaluation prior to electrophysiological procedure to isolate pulmonary veins for radiofrequency ablation of arrhythmia focus. 7

20 Chapter 5, Section 1.1 Diagnostic Radiology (Diagnostic Imaging) 6.6 October 1, 2008, for breast MRI for guidance of interventional procedures such as vacuum assisted biopsy and preoperative wire localization for lesions that are occult on mammography or sonography and are demonstrable only with MRI. 6.7 October 3, 2006, for CMR. 6.8 December 9, 2014, for TE. - END - 8