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2 CHANGE M NOVEMBER 1, 2017 REMOVE PAGE(S) INSERT PAGE(S) CHAPTER 1 Section 12.1, pages 1 and 2 Section 12.1, pages 1 and 2 CHAPTER 4 Section 6.1, pages 1 and 2 Section 6.1, pages 1 and 2 Section 9.1, pages 1, 2, and 7 Section 9.1, pages 1, 2, and 7 CHAPTER 7 Section 3.8, pages 1 through 5 Section 3.8, pages 1 through 5 CHAPTER 8 Section 5.3, pages 1 and 2 Section 5.3, pages 1 and 2 2

3 Administration Chapter 1 Section 12.1 Category III Codes Issue Date: March 6, 2002 Authority: 32 CFR 199.2(b) and 32 CFR 199.4(g)(15) 1.0 CPT 1 PROCEDURE CODES 0073T, 0075T, 0076T, 0099T, 0184T, 0308T, 0446T-0448T, 0451T-0463T, 0466T-0468T 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 Division (MB&RD) 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 Category III code 0184T is a covered service as listed in Chapter 4, Section Category III code 0249T is a covered service as listed in Chapter 4, Section CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 1

4 Chapter 1, Section 12.1 Category III Codes 4.7 Category III code 0346T is a covered service as listed in Chapter 5, Section Category III codes 0446T-0448T are covered services as listed in Chapter 8, Section Category III codes 0451T-0463T and 0466T-0468T are covered services as listed in Chapter 4, 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 2 procedure code 0071T) in the treatment of uterine leiomyomata is unproven. 5.3 Computer-Aided Detection (CAD) with breast MRI (CPT 2 procedure code 0159T) is unproven. 5.4 XSTOP Interspinous Process Decompression System (CPT 2 procedure codes 0171T and 0172T, HCPCS code C1821) is unproven. 5.5 Ultrasound-guided facet joint injection (CPT 2 procedure codes 0216T and 0217T) is unproven. - END - 2 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 2

5 Surgery Chapter 4 Section 6.1 Musculoskeletal System Issue Date: August 26, 1985 Authority: 32 CFR 199.4(c)(2) and (c)(3) 1.0 CPT 1 PROCEDURE CODES , , , , 22858, 22859, 22861, , , , , HCPCS CODES S2118, S DESCRIPTION The musculoskeletal system pertains to or comprises the skeleton and the muscles. 4.0 POLICY 4.1 Services and supplies required in the diagnosis and treatment of illness or injury involving the musculoskeletal system are covered. U.S. Food and Drug Administration (FDA) approved surgically implanted devices are also covered. 4.2 Effective August 25, 1997, Autologous Chondrocyte Implantation (ACI) surgery for the repair of clinically significant, symptomatic, cartilaginous defects of the femoral condyle (medial, lateral or trochlear) caused by acute or repetitive trauma is a covered procedure. The autologous cultured chondrocytes must be approved by the FDA. 4.3 Single or multilevel anterior cervical microdiskectomy with allogeneic or autogeneic iliac crest grafting and anterior plating is covered for the treatment of cervical spondylosis. 4.4 Percutaneous vertebroplasty (CPT 1 procedure codes ) and balloon kyphoplasty (CPT 1 procedure codes ) are covered for the treatment of painful osteolytic lesions and osteoporotic compression fractures refractory to conservative medical treatment. 4.5 Total Ankle Replacement (TAR) (CPT 1 procedure codes and 27703) surgery is covered if the device is FDA approved and the use is for an FDA approved indication. However, a medical necessity review is required in case of marked varus or valgus deformity. 1 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 1

6 Chapter 4, Section 6.1 Musculoskeletal System 4.6 Core decompression of the femoral head (hip) for early (precollapse stage I or II) avascular necrosis may be considered for cost-sharing (Healthcare Common Procedure Coding System (HCPCS) code S2325). 4.7 Single-level, cervical Total Disc Replacement (ctdr) (CPT 2 procedure code 22856) and twolevel ctdr (CPT 2 procedure code 22858) using an FDA approved cervical artificial intervertebral disc for the treatment of cervical DDD, intractable radiculopathy, and/or myelopathy is covered if the disc is used in accordance with its FDA labeled indications. 4.8 High Energy Extracorporeal Shock Wave Therapy (HE ESWT) for the treatment of plantar fasciitis is covered when all of the following conditions are met: Patients have chronic plantar fasciitis of at least six months duration; Patients have undergone and failed six months of appropriate conservative therapy; and HE ESWT is defined as Energy Flux Density (EFD) greater than 0.12 millijoules per square millimeter (mj/mm2). 4.9 Meniscal allograft transplant of the knee is covered Hip resurfacing (CPT 2 procedure codes and 27130, and HCPCS S2118) with an FDA approved device is proven for the treatment of Degenerative Joint Disease (DJD) of the hip in patients who are less than 65 years old and who meet all of the following criteria: Have chronic, persistent pain and/or disability; Are otherwise healthy and active; Have normal proximal femoral bone geometry and bone quality; and Would otherwise receive a conventional Total Hip Replacement (THR), but are likely to outlive a conventional THR implant system s expected life Minimally Invasive Surgery (CPT 2 procedure code 27279) for treatment of sacroiliac joint pain is proven. 5.0 EXCLUSIONS 5.1 Ligament replacement with absorbable copolymer carbon fiber scaffold is unproven. 5.2 Prolotherapy, joint sclerotherapy and ligamentous injections with sclerosing agents (HCPCS procedure code M0076) are unproven. 5.3 Trigger point injection (CPT 2 procedure codes and 20553) for migraine headaches. 2 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 2 C-180, February 17, 2017

7 Surgery Chapter 4 Section 9.1 Cardiovascular System Issue Date: August 26, 1985 Authority: 32 CFR 199.4(c)(2) and (c)(3) 1.0 CPT 1 PROCEDURE CODES , 33140, 33141, , , , , , , 93770, , 0075T, 0076T, 0451T-0463T, 0466T-0468T 2.0 DESCRIPTION The cardiovascular system involves the heart and blood vessels, by which blood is pumped and circulated through the body. 3.0 POLICY 3.1 Medically necessary services and supplies required in the diagnosis and treatment of illness or injury involving the cardiovascular system are covered. 3.2 Ventricular Assist Devices (VADs) VADs (external and implantable) are covered if the device is U.S. Food and Drug Administration (FDA) approved and used in accordance with FDA approved indications VADs as destination therapy (CPT 1 procedure codes 33979, 0451T-0463T, 0466T-0468T) are covered if they have received approval from the FDA for that purpose and are used according to the FDA approved labeling instructions. Benefits are authorized when the procedure is performed at a TRICARE-certified heart transplantation center, a TRICARE-certified pediatric consortium heart transplantation center, or a Medicare facility which is approved for VAD implantation as destination therapy, for patients who meet all of the following conditions: The patient has chronic end-stage heart failure (New York Heart Association Class IV endstage left ventricular failure for at least 90 days with a life expectancy of less than two years) The patient is not a candidate for heart transplantation The patient s Class IV heart failure symptoms have failed to respond to optimal medical management, including a dietary salt restriction, diuretics, digitalis, beta-blockers, and ACE inhibitors (if tolerated) for at least 60 of the last 90 days. 1 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 1

8 Chapter 4, Section 9.1 Cardiovascular System The patient has Left Ventricular Ejection Fraction (LVEF) less than 25% The patient has demonstrated functional limitation with a peak oxygen consumption of less than 12 ml/kg/min; or the patient has a continued need for intravenous inotropic therapy owing to symptomatic hypotension, decreasing renal function, or worsening pulmonary congestion The patient has the appropriate body size (by device per FDA labeling) to support the VAD implantation. 3.3 Gamma and beta intracoronary radiotherapy (brachytherapy) is covered for the treatment of in-stent restenosis in native coronary arteries. 3.4 Transmyocardial Revascularization (TMR) (CPT 2 procedures codes and 33141) Coverage is available for patients with stable class III or IV angina which has been found refractory to standard medical therapy, including drug therapy at the maximum tolerated or maximum safe dosages. In addition, the angina symptoms must be caused by areas of the heart not amenable to surgical therapies such as percutaneous transluminal coronary angioplasty, stenting, coronary atherectomy or coronary bypass Coverage is limited to those uses of the laser used in performing the procedure which have been approved by the FDA for the purpose for which they are being used. 3.5 TMR as an adjunct to Coronary Artery Bypass Graft (CABG) is covered for patients with documented areas of the myocardium that are not amenable to surgical revascularization due to unsuitable anatomy. 3.6 FDA approved IDE clinical trials. See Chapter 8, Section 5.1, paragraphs 2.5 and 2.6 for policy. 3.7 Endovenous Radiofrequency Ablation (RFA)/obliteration (CPT 2 procedure codes and 36476) and endovenous laser ablation/therapy (CPT 2 procedure codes and 36479) for the treatment of saphenous venous reflux of named saphenous veins (which include greater, small, anterior accessory and posterior accessory) with symptomatic varicose veins and/or incompetent perforator veins is covered when: One of the following indications is present: Persistent symptoms interfering with activities of daily living in spite of conservative/ non-surgical management. Symptoms include aching, cramping, burning, itching and/or swelling during activity or after prolonged standing Significant recurrent attacks of superficial phlebitis Hemorrhage from a ruptured varix Ulceration from venous stasis where incompetent varices are a contributing factor. 2 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 2 C-181, March 9, 2017

9 Chapter 4, Section 9.1 Cardiovascular System 5.15 November 30, 2014, for continuous ambulatory Electrocardiogram (ECG) recording greater than 48 hours January 7, 2015, for percutaneous transluminal mechanical thrombectomy with stent retrievers July 2, 2015, for LAA closure for the prevention of embolism in patients with non-valvular atrial fibrillation January 1, 2017, for VADs (CPT 6 procedure codes 0451T-0463T and 0466T-0468T). - END - 6 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 7

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11 Medicine Chapter 7 Section 3.8 Treatment Of Mental Disorders - General Issue Date: December 5, 1984 Authority: 32 CFR 199.4(c)(3)(ix) 1.0 CPT 1 PROCEDURE CODE RANGES , , for care provided through December 31, , , for care provided on or after January 1, HCPCS CODES G0502-G0504 and G0507 for care provided on or after January 1, POLICY Benefits are payable for services and supplies that are medically or psychologically necessary for the treatment of mental disorders when: 3.1 The services are rendered by persons who meet the criteria of 32 CFR for their respective disciplines (whether the person is an individual professional provider or is employed by another authorized provider), and 3.2 A mental disorder is a nervous or mental condition that involves a clinically significant behavioral or psychological syndrome or pattern that is associated with a painful symptom, such as distress, and that impairs a patient's ability to function in one or more major life activities. A Substance Use Disorder (SUD) is a mental condition that involves a maladaptive pattern of substance use leading to clinically significant impairment or distress; impaired control over substance use; social impairment; and risky use of a substance(s). Additionally, the mental disorder must be one of those conditions listed in the current edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM). Conditions Not Attributable to a Mental Disorder, or V codes (Z codes in the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10- CM)), are not considered diagnosable mental disorders. Co-occurring mental and SUDs are common and assessment should proceed as soon as it is possible to distinguish the substance related symptoms from other independent conditions. 1 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 1

12 4.0 POLICY CONSIDERATIONS Chapter 7, Section 3.8 Treatment Of Mental Disorders - General 4.1 Professional and Institutional Providers of Mental Health Services List of authorized independent professional providers. Only the types of providers listed below are considered qualified providers of mental health services. The person providing the care must meet the criteria of 32 CFR 199.6, whether that person is an individual, professional provider or is employed by another authorized provider. Psychiatrists and other physicians; Clinical psychologists; Certified Psychiatric Nurse Specialists (CPNSs); Certified Clinical Social Workers (CCSWs); TRICARE Certified Mental Health Counselors (TCMHCs); Certified marriage and family therapists; Pastoral counselors; and Supervised Mental Health Counselors (SMHCs) List of institutional providers. Only the types of institutional providers listed below are considered qualified institutional providers of mental health services. The care must meet the criteria of 32 CFR Acute Hospital Psychiatric Care; Residential Treatment Centers (RTCs); Psychiatric Partial Hospitalization Programs (PHPs); and Intensive Outpatient Programs (IOPs). Note: Professional staff of institutions providing mental health services. For professional services billed by institutional providers that are authorized by the Defense Health Agency (DHA), reviewers may assume that all professional staff meet regulatory criteria. Any evidence to the contrary is to be brought to the attention of the TRICARE Regional Office (TRO), immediately. Contractors shall notify institutional providers within their jurisdictions that payment is authorized only for professional services provided by employees meeting the program requirements. In any situation where the contractor obtains evidence that an institution is billing for professional services of unqualified staff, the case is to be submitted to the DHA Office of Program Integrity (PI). 5.0 COVERED SERVICES AND TREATMENTS All claims for treatment of mental disorders are subject to review in accordance with claims processing procedures contained in the TRICARE Operations Manual (TOM). The following services and supplies are covered: 5.1 Institutional Benefits Medically or psychologically necessary acute hospital psychiatric care (see Section 3.1); Medically or psychologically necessary psychiatric RTC care for children and adolescents, up to age 21 (see Section 3.2); 2

13 Chapter 7, Section 3.8 Treatment Of Mental Disorders - General Medically or psychologically necessary psychiatric PHP care (see Section 3.4); Medically or psychologically necessary psychiatric IOP care (see Section 3.18). Note: Institutional benefits for SUDs are covered in Section 3.5, paragraph Professional Services Individual psychotherapy, adult or child (see Section 3.11); Group psychotherapy (see Section 3.11); Family or conjoint psychotherapy (see Section 3.12); Psychoanalysis (see Section 3.11, paragraph 4.3.3); Psychological testing and assessment (see Section 3.10); Specific mental health coverage descriptions are outlined in eating disorder treatment (see Section 3.15), specific learning disorder (see Section 3.6), Attention Deficit Hyperactivity Disorder (see Section 3.7), and Gender Dysphoria (see Section 1.2); Administration of psychotropic drugs. All patients receiving psychotropic drugs must be under the care of a qualified mental health provider authorized by state licensure to prescribe drugs (see Section 3.13); Electroconvulsive treatment (CPT 2 procedure codes and 90871). Electroconvulsive treatment is covered when medically or psychologically appropriate and when rendered by qualified providers. However, the use of electric shock as negative reinforcement (aversion therapy) is excluded; Collateral visits (see Section 3.14); Medication Assisted Treatment (MAT) (see Section 3.20); Ancillary therapies (no code, as separate reimbursement is not permitted). Includes art, music, dance, occupational, and other ancillary therapies, when included by the attending provider in an approved inpatient treatment plan and under the clinical supervision of a licensed doctoral level mental health professional. These ancillary therapies are not separately reimbursed professional services but are included within the institutional reimbursement; All providers are expected to consult with, or refer patients to, a physician for evaluation and treatment of physical conditions that may co-exist with or contribute to a mental disorder Transcranial Magnetic Stimulation (TMS) (also referred to as repetitive TMS (rtms)) for the treatment of major depressive disorder (CPT 2 procedure codes 90867, 90868, and 90869), is proven. 2 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 3

14 Chapter 7, Section 3.8 Treatment Of Mental Disorders - General 6.0 REFERRAL AND PREAUTHORIZATION REQUIREMENT Normal TRICARE Prime referral requirements shall apply. 6.1 Medically or psychologically necessary outpatient mental health (PHP, IOP, or office) visits do not require preauthorization. Exceptions include: Psychoanalysis requires preauthorization (see Chapter 1, Section 7.1, paragraph 1.5). Electroconvulsive treatment requires preauthorization to ensure the beneficiary has failed to respond to a less intensive form of treatment or that less intensive intervention is not more appropriate. TMS requires preauthorization to ensure the beneficiary has failed to respond to a less intensive form of treatment or that a less intensive intervention is not more appropriate. 6.2 Preauthorization is required for all non-emergency inpatient and residential levels of care. Contractors may establish additional preauthorization requirements in accordance with the TOM, Chapter 8, Section 5, paragraph Inpatient hospital services are considered medically necessary only when the patient s condition is such that the personnel and facilities of a hospital are required. Preauthorization is not required for emergency admissions, but authorization for a continuation of services must be obtained promptly (see Section 3.1, paragraph 3.4.2). 7.0 EXCLUSIONS 7.1 Sexual dysfunctions and paraphilic disorders (see Section 1.1). 7.2 Drug maintenance programs when one addictive drug is substituted for another on a maintenance basis, except as otherwise authorized in Sections 3.5 and Specific developmental disorders. 7.4 Microcurrent Electrical Therapy (MET), Cranial Electrotherapy Stimulation (CES), or any therapy that uses the non-invasive application of low levels of microcurrent stimulation to the head by means of external electrodes for the treatment of anxiety, depression or insomnia, and electrical stimulation devices used to apply this therapy (see Section 15.1). 8.0 EFFECTIVE DATES 8.1 November 13, May 31, 2014, TMS (also referred to as rtms) for the treatment of major depressive disorder, is proven. 8.3 Removal of day limits in any fiscal year for TRICARE beneficiaries of all ages for the provision of inpatient (including residential) mental health services on or after December 19,

15 Chapter 7, Section 3.8 Treatment Of Mental Disorders - General 8.4 Removal of all remaining quantitative treatment limitations on mental health care, and inclusion of IOPs, October 3, END - 5

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17 Other Services Chapter 8 Section 5.3 Continuous Glucose Monitoring System (CGMS) Devices Issue Date: December 15, 2009 Authority: 32 CFR CPT 1 PROCEDURE CODES 95250, 95251, 0446T-0448T 2.0 HCPCS CODES A A9278, S1030, S DESCRIPTION A Continuous Glucose Monitoring System (CGMS) is a medical device used to monitor patients with diabetes mellitus. These devices, which consist of an external receiver, external transmitter, and a subcutaneously placed sensor, monitor diabetic patients by providing the physician and/or patient with periodic measurements of glucose levels in interstitial fluid. CGMS devices are usually prescribed to diabetic patients whose diabetes is not sufficiently controlled with standard diabetic medical regimens. These devices are intended only to supplement, not replace, blood glucose readings obtained from standard fingerstick glucose meters and test strips. 4.0 POLICY U.S. Food and Drug Administration (FDA) approved CGMS devices (i.e., MiniMed CGMS System Gold, MiniMed Guardian Real Time System) (CPT 1 procedure codes 95250, 95251, 0446T- 0448T) may be cost-shared ONLY when it is documented that the recipient of the device is required to perform at least four self-monitoring blood glucose checks daily and is compliant with recommended medical regimens. 4.1 Short-term (up to 72-hour), intermittent (up to six times per year) use of a CGMS device may be covered for type I diabetic beneficiaries age seven years and over (or consistent with device labeling) when the beneficiary has completed a comprehensive diabetic education program, there is documentation of appropriate modification in insulin regimen, and the physician documents any one of the following: Glycosylated hemoglobin level (HBA1c) is greater than 9.0% or less than 4.0%; History of unexplained large fluctuations in daily glucose values before meals (greater than 150 mg/dl); 1 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 1

18 Chapter 8, Section 5.3 Continuous Glucose Monitoring System (CGMS) Devices History of early morning fasting hyperglycemia ( dawn phenomenon ); History of severe glycemic excursions; or Hypoglycemic unawareness. 4.2 Long-term (greater than 72-hour, continuous or periodic) use of a CGMS device (includes transmitter, receiver, and sensors), may be covered for beneficiaries who meet the criteria for shortterm use and the ordering physician documents any one or more of the following: History of recurrent, unexplained, severe hypoglycemic events or hypoglycemic unawareness (i.e., blood glucose less than 50 mg/dl); History of recurrent episodes of ketoacidosis; Hospitalizations for uncontrolled glucose levels; Frequent nocturnal hypoglycemia; or The beneficiary is pregnant and has poorly controlled type I diabetes or gestational diabetes. 5.0 EXCLUSIONS 5.1 Use of a CGMS device for any condition or indication NOT included above. 5.2 Use of a CGMS device that is NOT FDA approved. 6.0 EFFECTIVE DATES 6.1 December 1, January 1, 2017, for CGMS (CPT 2 codes 0446T-0448T). - END - 2 CPT only 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved. 2

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