tp15_160106.pdf

TRICARE Policy Manual 6010.60-M, April 1, 2015

SUMMARY OF CHANGES

In addition to typographical and grammatical corrections, the following changes are included.

CHAPTER 1

1. Section 3.1.

a. Evolving Practices. Added coverage for the off-label use of rituximab for treatment of neuromyelitis optica.

b. Evolving Practices. Confirmed that off-label use of Photodynamic Therapy with Visudyne may be used in the treatment of retinal astrocytic hamartoma in Tuberous Sclerosis.

c. Evolving Practices. Allowed coverage for and removed the exclusion of, intracranial angioplasty with stenting of the venous sinuses for the treatment of pseudotumor cerebri.

d. Added coverage for treatment of Acute Intermittent Porphyria effective February 1, 2012.

e. Evolving Practices. Removed intracranial angioplasty with stenting of the venous sinuses for treatment of pseudotumor cerebri from the Exclusions.

CHAPTER 4

2. Section 6.1. Athletic pubalgia surgery was added as unproven.

3. Section 8.2.

a. LVRS facility certification requirements were updated.

b. LVRS diagnostic and therapeutic services were updated.

4. Section 9.1. Added intracranial angioplasty with stenting of the venous sinuses to be considered for cost-sharing for the treatment of pseudotumor cerebri. (Removed from the list of Exclusions.)

5. Section 15.1. Added Penile Vibratory Stimulation (PVS) devices as an exclusion.

6. Section 20.1. Added reference for transcatheter placement of intravascular stent(s) intracranial coverage policy regarding treatment of pseudotumor cerebri.

1 January 6, 2016

CHAPTER 4 (Continued)

7. Section 21.1.

a. Evolving Practices. Added off-label use of Photodynamic Therapy with Visudyne may be used in the treatment of retinal astrocytic hamartoma in Tuberous Sclerosis.

b. Added coverage of transpupillary thermotherapy as a treatment for choroidal melanoma, but excludes it as a primary treatment for this disease.

8. Section 22.2. Clarified coverage requirements concerning cochlear implantation and cochlear implants. Removed obsolete requirements.

9. Section 24.5. Added coverage of Orthotopic Liver Transplantation for treatment of Acute Intermittent Porphyria effective February 1, 2012 under the rare disease provisions.

CHAPTER 5

10. Section 3.1. Included image-guided robotic linear accelerator-based stereotactic body radiotherapy under extracranial stereotactic radiosurgery/radiotherapy for prostate cancer, effective October 24, 2014.

CHAPTER 6

11. Section 4.1. New section added to clarify TRICARE coverage of drug testing and provided guidance on the appropriate use and billing for those services, in accordance with TRICARE statute and regulation.

CHAPTER 8

12. Section 2.6. This section was updated and added Breast Pump Supplies and Breastfeeding Counseling requirements for coverage.

13. Section 9.1. The National Defense Authorization Act 2015, Section 702 terminated the TRICARE For Life Pilot Program, effective September 30, 2015. Beginning October 1, 2015, beneficiaries shall obtain select non-generic maintenance medications from the national mail order pharmacy or the military treatment facility pharmacy.

2 January 6, 2016

CHAPTER 8 (Continued)

14. Section 15.1.

a. Clarified authorized services for Custodial Care Transitional Policy (CCTP). Approved services should not change significantly without a reassessment of those medical needs.

b. Authorized, but not used care periods or portions thereof, cannot be saved or accumulated for future use.

c. Added a requirement to include projected costs as part of the annual eligibility review for custodial care.

d. Removed contractor responsibility for payment from administrative funds for all services provided by contractor custodial determination that are in conflict with prescribed limitation of the CCTP program or outside the DHA CSD concurrence, delivered by/through contractor.

e. Clarified the exclusion for custodial care.

CHAPTER 9

15. Section 2.3. Updated to reflect the Autism Spectrum Disorder (ASD), and the ICD-10-CM F84.0, (Autistic Disorder).

16. Section 13.1. Clarified personal incontinence supplies may be cost-shared as medical supplies for ECHO beneficiaries age three and older who meet all requirements, effective October 1, 2015. Some exclusions apply.

CHAPTER 10

17. Section 2.1. Clarified Prime enrollment/reenrollment for active duty members who retire.

18. Section 3.1.

a. Clarified requirements for continued Prime coverage for all Prime enrollees.

b. Clarified enrollment in Prime for newborns and adoptees.

19. Section 5.1. Clarified policy for covered groups under the Transitional Assistance Management Program (TAMP).

CHAPTER 12

20. Section 1.2. Updated coverage requirements for authorization of private room accommodations for the TOP effective September 1, 2016.

3 January 6, 2016

CHAPTER 13

21. New chapter added to provide provisional coverage for emerging healthcare services and supplies as mandated by the National Defense Authorization Act 2015, Section 704.

4 January 6, 2016

Revision:

For Definitions, see the TRICARE Operations Manual (TOM), Appendix A.

Foreword

Chapter 1 - Administration

Chapter 2 - Evaluation And Management

Chapter 3 - Anesthesia

Chapter 4 - Surgery

Chapter 5 - Radiology

Chapter 6 - Pathology And Laboratory

Chapter 7 - Medicine

Chapter 8 - Other Services

Chapter 9 - Extended Care Health Option (ECHO)

Chapter 10 - Eligibility And Enrollment

Chapter 11 - Providers

Chapter 12 - TRICARE Overseas Program (TOP)

Chapter 13 - Provisional Coverage For Emerging Services And Supplies

Index

HPOS HPOB April 1, 2015

Revision:

Foreword

The TRICARE Policy Manual (TPM) 6010.60-M, in conjunction with the TRICARE Reimbursement Manual (TRM), 6010.61-M, contains operational policy necessary to efficiently implement the Code of Federal Regulations at 32 CFR 199. This manual augments the 32 CFR 199 and must be used in conjunction for complete policy information, providing guidance, policy interpretation and decisions implementing TRICARE, including those policies and procedures applicable to the TRICARE Health Plan.

The Department of Defense (DoD) has a License Agreement with the American Medical Association (AMA) regarding the use of the Physician’s Current Procedural Terminology (CPT), a coding work of medical nomenclature developed by the AMA. In accordance with the terms of that Agreement, the DoD has agreed to:

1. Include a Copyright notice in every section that references CPT codes;

2. Specifically identify procedure codes as CPT procedure codes;

3. Use only short descriptions with CPT codes and delete all long descriptions; and

4. Italicize short descriptions wherever they are used and include a footnote stipulating that they are excerpted from the CPT.

The TRICARE Manuals provide instructions, guidance and responsibilities in addition to the requirements set forth in the incorporated federal statutes and the regulations and may not be interpreted in contradiction thereto.

John L. Arendale, Section Branch Chief Health Plan Operations Sections (HPOS) Branch

(HPOB)

Defense Health Agency (DHA)

Definitions are available in the Apr 2015 TRICARE Operations Manual (TOM), Appendix A.

Acronyms and Abbreviations are available at http://www._______________.

Chapter 1

Administration

Revision:

Section/Addendum Subject/Addendum Title

1.1 General Policy And Responsibilities

1.2 Exclusions

1.3 Court-Ordered Care

2.1 Unproven Drugs, Devices, Medical Treatments, And Procedures

3.1 Rare Diseases

4.1 Waiver Of Liability

Figure 1.4.1-1 Waiver Of Liability - Initial Denial Determinations Figure 1.4.1-2 Waiver Of Liability - Contractor Reconsideration Determinations Figure 1.4.1-3 Waiver Of Liability - TRICARE Quality Management Contract (TQMC)

Reconsideration Determinations

5.1 Requirements For Documentation Of Treatment In Medical Records

5.2 Medical Photography

6.1 Special Authorization Requirements

7.1 Primary Care Managers (PCMs)

8.1 Department Of Veterans Affairs (DVA) And Department Of Defense (DoD) Health Care Resources Sharing

9.1 Individual Case Management Program For Persons With Extraordinary Conditions

(ICMP-PEC)

10.1 Category II Codes - Performance Measurement

11.1 Category III Codes - Temporary Codes For Emerging Technology, Services And Procedures

12.1 Healthcare Common Procedure Coding System (HCPCS) “C” And “S” Codes

13.1 Relationship Between TRICARE And Employer-Sponsored Group Health Plans (GHPs)

14.1 Transitional Care Management Services

14.2 Chronic Care Management (CCM) Services

Administration Chapter 1 Section 1.1

General Policy And Responsibilities

Issue Date:

Authority: 32 CFR 199 Revision:

1.0 PROGRAM DESCRIPTION

TRICARE is the Department of Defense’s (DoD) managed health care program for Service members, service families, retirees and their families and survivors. A key feature of the DoD’s managed care implementation is the creation within the United States (U.S.) of two Health Services Regions.

Within each region, a Director, TRICARE Regional Offices (TROs) is responsible for managing health care services in the region.

2.0 OFFICE OF RECORD

The Medical Benefits and Reimbursement Office (MB&RO) Section (MB&RS) is the “office of record” for the TRICARE Policy Manual (TPM) and TRICARE Reimbursement Manual (TRM). In accordance with Federal Acquisition Regulations (FAR), Subpart 37.203, contractors cannot make policy decisions, as this is an inherent Government function. Consistent with Subpart 7.503, the Office of MB&RO MB&RS has the responsibility for ensuring that all medical benefits considered for cost-sharing under TRICARE are supported by scientific peer reviewed literature and within the constraints of the law and regulation. These responsibilities include promulgating policy interpretations and maintaining continuous regulatory and policy updates based on Congressional mandate and the current standards of medical care.

3.0 GENERAL POLICY

3.1 TRICARE offers beneficiaries three health care options:

3.1.1 TRICARE Prime Plan

Beneficiaries who enroll in TRICARE Prime are assigned or select a Primary Care Manager (PCM). A PCM is a provider of primary care, who furnishes or arranges for all health care services required by the Prime enrollee. Military Treatment Facility (MTF)/Enhanced Multi-Service Market (eMSM) Commanders have the authority and responsibility to set priorities for enrollment to MTF/ eMSM PCMs. When an MTF’s/eMSM’s primary care capacity is full, civilian PCMs, who are all part of the contractor’s network, are available to provide care to patients.

3.1.1.1 Expanded benefits. As enrollees of Prime, patients receive certain clinical preventive services that are provided without cost-share for the patient.

Chapter 1, Section 1.1

General Policy And Responsibilities

3.2.5 Non-DoD TRICARE Eligibles

TRICARE eligibles sponsored by non-DoD uniformed services (the Public Health Service (PHS), the U.S. Coast Guard, and the National Oceanic and Atmospheric Administration (NOAA)) are eligible for TRICARE and may enroll in TRICARE Prime.

3.2.6 North Atlantic Treaty Organization (NATO) Beneficiaries

Family members of active duty members of the armed forces of foreign NATO nations who are eligible for outpatient care under TRICARE may access care under TRICARE Extra and TRICARE Standard only. They are not eligible to enroll in TRICARE Prime.

3.2.7 Prime Enrollment

Eligible beneficiaries must enroll in Prime to receive the expanded benefits and special cost-sharing. All active duty and non-active duty individuals who wish to take advantage of the full benefits of the Prime program and have their claims adjudicated correctly must take specific action to enroll.

Note: Included in all of the TRICARE benefit packages is a retail pharmacy network and a mail service pharmacy program.

3.3 Administrative Policy

3.3.1 Benefit Policy

3.3.1.1 Benefit policy applies to the scope of services and items which may be considered for cost-sharing by the TRICARE within the intent of the 32 CFR 199.

3.3.1.2 The current edition of the American Medical Association’s (AMA’s) Physicians’ Current Procedural Terminology (CPT) is incorporated by reference into this Manual to describe the scope of services potentially allowable as a benefit, subject to explicit requirements, limitations, and exclusions, in this Manual or in the 32 CFR 199.

3.3.1.3 Procedures listed in the CPT and the Healthcare Common Procedure Coding System (HCPCS) may be cost-shared only when the procedure is “appropriate medical care” and is “medically or psychologically necessary” and is not “unproven” as defined in the 32 CFR 199.4(g)(15), and the procedure is not explicitly excluded in the TRICARE program.

3.3.2 Program Policy

Program Policy applies to beneficiary eligibility, provider eligibility, claims adjudication, and quality assurance. Program policy implementation instructions are found in the TRICARE Systems Manual (TSM) and the TOM.

3.3.3 Any benefit or program administration issue for which benefits or program operation policy guidance is required, or when TRICARE policy is silent on an issue, the contractor shall describe in writing and submit to the Team Chief, MB&RO MB&RS, Defense Health Agency (DHA).

Chapter 1, Section 2.1

Unproven Drugs, Devices, Medical Treatments, And Procedures

4.1 Treatment that is not related to the unproven drug, device, treatment, or procedure; e.g., medically necessary treatment the beneficiary would have received in the absence of the unproven drug, device, treatment, or procedure.

4.2 Treatment which is a necessary follow-up to the unproven drug, device, treatment, or procedure but which might have been necessary in the absence of the unproven treatment.

5.0 In making a determination that a drug, device, medical treatment, or procedure has moved from the status of unproven to the position of nationally accepted medical practice, TRICARE uses the following hierarchy of reliable evidence (see 32 CFR 199.2):

5.1 Well controlled studies of clinically meaningful endpoints, published in refereed medical literature.

5.2 Published formal technology assessments.

5.3 The published reports of national professional medical associations.

5.4 Published national medical policy organization positions.

5.5 The published reports of national expert opinion organizations.

6.0 The hierarchy of reliable evidence of proven medical effectiveness, established by paragraph

5.1 through 5.5, is the order of the relative weight to be given to any particular source. With respect to clinical studies, only those reports and articles containing scientifically valid data and published in the refereed medical and scientific literature shall be considered as meeting the requirements of reliable evidence. Specifically not included in the meaning of reliable evidence are reports, articles, or statements by providers or groups of providers containing only abstracts, anecdotal evidence or personal professional opinions. Also not included in the meaning of reliable evidence is the fact that a provider or a number of providers have elected to adopt a drug, device, medical treatment, or procedure as their personal treatment or procedure of choice or standard of practice.

7.0 TRICARE policy and benefit structure is never based solely on that of other Government medical programs, including Medicare, because each operates under its own statutes and regulations.

Furthermore, while TRICARE may examine the policies of private third party payers., TRICARE coverage may only be based on governing statutes and regulations.

8.0 The contractor(s) shall routinely review the hierarchy of reliable evidence, as defined in 32 CFR 199.2, and provide a report to the Defense Health Agency (DHA) when the contractor identifies drugs, devices, medical treatments, or procedures that they believe have moved from unproven to proven.

DHA will apply the standards and procedures in TRICARE regulation and policy and if determined by DHA to have moved to proven, will notify all contractors that the drug, device, medical treatment, or procedure is proven and a part of the TRICARE benefit.

9.0 For drugs, devices, medical treatments, and procedures that TRICARE has determined have moved from the status of unproven to the status of proven in accordance with the procedure established in paragraph 5.0, the effective date (or the date on which the particular drug, device, medical treatment, or procedure may be cost-shared) is the date published reliable evidence (as described in 32 CFR 199.2) shows proven medical effectiveness. For example, the effective date may be

Chapter 1, Section 3.1

Rare Diseases

2.4 Off-label use of rituximab may be considered for cost-sharing in reducing proteinuria for the treatment of Immunoglobulin A (IgA) nephropathy (proliferative glomerulonephritis). The effective date is May 1, 2007.

2.5 Off-label use of rituximab (HCPCS J9310) may be considered for cost-sharing for the treatment of neuromyelitis optica. The effective date is March 26, 2010.

2.6 Effective May 13, 2009, Intraperitoneal Hyperthermic Chemotherapy (IPHC) (Current Procedural Terminology (CPT) procedure codes 77600, 77605, and 96445) in conjunction with cytoreductive surgery or peritonectomy for treatment of pseudomyxoma peritonei resulting from appendiceal carcinoma may be covered on a case-by-case basis for adult patients when all of the following criteria are met:

• There is no evidence of distant metastasis.

• There is evidence of low histological aggressiveness of the disease.

• The patient has not undergone preoperative systemic chemotherapy.

• The patient’s condition does not preclude major surgery.

• The chemotherapeutic agents used are Mitomycin C, Cisplatin (also known as Cisplatinum), or Fluorouracil.

2.7 External Infusion Pumps (EIPs) for insulin may be considered for cost-sharing when the diagnosis is Cystic Fibrosis-Related Diabetes (CFRD) with fasting hyperglycemia. See Chapter 8, Section

2.3 for policy regarding EIPs. Effective January 21, 2009.

2.8 Post-operative proton beam radiosurgery/radiotherapy (CPT procedure codes 77520, 77522, 77523, and 77525) may be considered for cost-sharing when the diagnosis is sacral chordoma. See Chapter 5, Section 3.1 for policy regarding proton beam radiosurgery/radiotherapy.

2.9 Extracorporeal photopheresis (CPT procedure code 36522) may be considered for cost-sharing when the diagnosis is Bronchiolitis Obliterans Syndrome (BOS) that is refractory to immunosuppressive drug treatment. See Chapter 4, Section 9.2 for policy regarding photopheresis.

2.10 Off-label use of Selective Internal Radiation Therapy (SIRT) with yttrium-90 microspheres (resin or glass) may be considered for cost-sharing for the treatment of unresectable liver metastases from neuroendocrine tumors. The effective date is May 1, 2008. See Chapter 5, Section 3.2 for policy regarding brachytherapy/radiation therapy.

2.11 Radiofrequency Ablation (RFA), when performed using an U.S. Food and Drug Administration (FDA) approved electrosurgical cutting and coagulation device, may be considered for cost-sharing for the treatment of liver metastases from gastric cancer. The effective date is June 1, 2010.

2.12 Effective September 1, 2012, the NovoTTF-100A system (HCPCS A4555 and E0766) may be cost-shared for treatment of adult patients (22 years of age or older) with recurrent glioblastoma after surgical and radiation options have been exhausted.

Chapter 1, Section 3.1

Rare Diseases

2.13 Effective February 4, 2011, Radiesse® Voice laryngoplasty injections may be cost-shared for the treatment of type 1 laryngeal cleft (also described as supraglottic interarytenoid defects that extend no further than the true vocal folds).

2.14 Effective November 27, 1995, Orthotopic Liver Transplantation (OLT) may be cost-shared for the treatment of Crigler-Najjar Syndrome Type I. OLT may be performed both prior to the onset of neurological symptoms or after the onset of neurological symptoms.

2.15 Effective June 5, 2013, off-label use of intravenous immune globulin (CPT procedure code 90283) for the treatment of Hashimoto’s Encephalopathy, may be considered in exceptional circumstances where there is progressive neurologic decline despite appropriate steroid therapy or where steroid therapy is contraindicated.

2.16 Effective January 4, 2013, allogeneic hematopoietic cell transplant (CPT procedure code 38240) for the treatment of primary plasma cell leukemia.

2.17 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, 2008.

2.18 Effective June 25, 2014, intracranial angioplasty with stenting (CPT procedure code 61635) of the venous sinuses may be considered for cost-sharing for the treatment of pseudotumor cerebri (also known as idiopathic intracranial hypertension and benign intracranial hypertension).

2.19 Effective February 1, 2012, OLT (CPT procedure code 47135) for the treatment of Acute Intermittent Porphyria.

3.0 EXCLUSIONS

3.1 Intracranial angioplasty with stenting (CPT procedure code 61635) of the venous sinuses for treatment of pseudotumor cerebri (also known as idiopathic intracranial hypertension and benign intracranial hypertension) is unproven.

3.1 The off-label use of rituximab for the treatment of pediatric linear Immunoglobulin A (IgA) dermatosis is unproven.

3.2 Proton Beam Therapy (PBT)/radiosurgery/radiotherapy for the treatment of thymoma is unproven.

- END -

Chapter 1, Section 9.1

Individual Case Management Program For Persons With Extraordinary Conditions (ICMP-PEC)

2.5.5 Beneficiaries covered under paragraphs 2.1 or 2.2 must have a primary caregiver in the home.

2.5.6 Reassessment. Continuation of receipt of services requires reassessment on a regular basis.

The contractors will provide supporting clinical documentation of all authorized participant’s medically necessary skilled needs, to include a plan of care signed by the attending physician. Each letter of authorization for continued coverage issued by the DHA Clinical Operations, Chief Medical Officer, or designee, will include a statement regarding the frequency of a periodic reassessment of the beneficiary. Generally, periodic reassessment will occur annually, but will be based on the needs of the beneficiary. Contractors shall provide a complete clinical documentation update and recommendation for continuation of coverage at the same level or indicate if either an increase or decrease in services is indicated by the beneficiary’s current needs. DHA will provide a courtesy reminder when a periodic reassessment is due for a beneficiary. Once DHA reviews the reassessment and updated recommendations of the contractor, a revised or updated authorization letter will be issued to the contractor.

2.5.7 Revisions. If at any time a contractor determines a need for a change in authorized funding for a beneficiary (e.g., due to a change in CMAC rates, a change in patient condition, such as a need for more or fewer covered hours, change in HHA, etc.), then the contractor must submit a written request for such change to the DHA Clinical Operations, Chief Medical Officer, or designee, that includes a detailed explanation of why the change is required. The DHA Clinical Operations, Chief Medical Officer, or designee, will evaluate each request and provide a written decision to the contractor.

2.5.8 Cost-shares. Cost-shares shall not be applied to services authorized under the ICMP-PEC prior to December 28, 2001 nor to those services provided under this policy. Cost-shares will continue to apply to all other TRICARE benefits.

2.5.9 Appeals. Appeals should be made directly to the DHA Office of General Counsel (OGC).

There are three appealable issues related to the ICMP-PEC:

2.5.9.1 A custodial care determination;

2.5.9.2 A determination by the contractor that ICMP-PEC does not apply;

2.5.9.3 The types and extent of services authorized for a beneficiary by DHA. The following language is to be included in subsequent determination of custodial care letters and notification of benefits related to ICMP-PEC:

“Should you disagree with this initial determination, you have the right to appeal and request a formal review. Appealable issues include the types and extent of the services and supplies authorized under the ICMP-PEC and the determination that the care is custodial. The request must be in writing, be signed, and must be postmarked or received by DHA OGC, within 90 days from the date of this determination. For the purposes of TRICARE, a postmark is a cancellation mark issued by the United States Postal Service.

Additional documentation in support of the appeal may be submitted.

However, because a request for a formal review must be received within 90 days of the date of the initial determination, a request for formal review should

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

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 Office (MB&RO) 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 5.1.

4.2 Category III code 0073T is a covered service as listed in Chapter 5, Section 3.1.

4.3 Category III codes 0075T and 0076T are covered codes as outlined in Chapter 4, Section 9.1.

4.4 Category III code 0099T is a covered code as outlined in Chapter 4, Section 21.1.

Chapter 1 Section 14.2

Chronic Care Management (CCM) Services

Issue Date: August 19, 2015 Authority: 32 CFR 199.4(g)(1) Copyright: CPT only © 2006 American Medical Association (or such other date of publication of CPT).

All Rights Reserved.

Revision:

1.0 CPT PROCEDURE CODE

99490

2.0 DESCRIPTION

2.1 CCM services -- at least 20 minutes of clinical staff time directed by a physician or other qualified healthcare professional, per calendar month, with the following required elements:

• Multiple (two or more) chronic conditions expected to last at least 12 months or until death of the patient;

• Chronic conditions place the patient at significant risk of death, acute exacerbation/ decompensation, or functional decline; and

• Comprehensive care plan established, implemented, revised, or monitored.

2.2 CCM reflects services provided over a monthly period to specified patients with chronic health conditions who have consented to receipt of such services.

3.0 POLICY

CCM services are not covered by TRICARE because the services are not medically necessary as a separately itemized service.

4.0 EFFECTIVE DATE

January 1, 2015.

Chapter 4, Section 6.1

Musculoskeletal System

5.9 XSTOP Interspinous Process Decompression System (CPT procedure codes 0171T and 0172T, HCPCS code C1821) for the treatment of neurogenic intermittent claudication secondary to lumbar spinal stenosis is unproven.

5.10 Femoroacetabular Impingement (FAI) open surgery, surgical dislocation (CPT procedure codes 27140 and 27179), for the treatment of hip impingement syndrome or labral tear is unproven.

5.11 Hip arthroscopy with debridement of articular cartilage (CPT procedure code 29862) for the treatment of FAI is unproven.

5.12 Femoroplasty (CPT procedure code 29999) for the treatment of FAI syndrome is unproven.

5.13 Osteochondral allograft of the humeral head with meniscal transplant and glenoid microfracture in the treatment of shoulder pain and instability is unproven.

5.14 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 Radiofrequency (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.

5.15 Total hip resurfacing (HCPCS code S2118) for treatment of degenerative hip disease is unproven.

5.16 Spinal manipulation under anesthesia (CPT procedure codes 00640 and 22505) for the treatment of back pain is unproven.

5.17 Minimally Invasive Lumbar Decompression (mild®) for the treatment of Degenerative Disc Disease (DDD) and/or spinal stenosis is unproven.

5.18 ACI surgery for the repair of patellar cartilage lesions is unproven.

5.19 iFuse Implant System (CPT procedure code 27279) for treatment of sacroiliac joint pain is unproven.

5.20 Athletic pubalgia surgery is unproven.

6.0 EFFECTIVE DATES

6.1 February 6, 2006, for percutaneous vertebroplasty and balloon kyphoplasty.

6.2 May 1, 2008, for TAR.

6.3 May 1, 2008, for core decompression of the femoral head.

Chapter 4, Section 8.2

Lung Volume Reduction Surgery (LVRS)

4.3.2.3.6 Previous lobectomy.

4.3.2.3.7 Uncontrolled hypertension (systolic greater than 200 mm Hg or diastolic greater than 100 mm Hg).

4.3.2.3.8 Oxygen requirement greater than 6 liters per minute during resting to keep oxygen saturation greater than or equal to 90%.

4.3.2.3.9 History of recurrent infections with clinically significant production of sputum.

4.3.2.3.10 Unplanned weight loss greater than 10% within three months prior to consideration for surgery.

4.3.2.3.11 Pulmonary hypertension, defined as mean pulmonary artery pressure of 33 mm Hg or greater on right-heart catheterization or peak systolic pulmonary artery pressure of 44 mm Hg or greater.

4.3.2.3.12 Resting bradycardia (less than 50 beats per minute), frequent multifocal Premature Ventricular Contractions (PVCs) of complex ventricular arrhythmia or sustained Supraventricular Tachycardia (SVT).

4.3.2.3.13 Evidence of systemic disease or neoplasia that is expected to compromise survival.

4.4 LVRS must be preceded and followed by a program of diagnostic and therapeutic services consistent with those provided in the National Emphysema Treatment Trial (NETT) and designed to maximize the patient’s potential to successfully undergo and recover from surgery. The program must include a six to 10 week series of at least 16, and no more than 20 preoperative sessions, each lasting a minimum of two hours. It must also include at least six and no more than 10, postoperative sessions, each lasting a minimum of two hours, within eight to nine weeks of the LVRS.

4.5 LVRS must be performed at facilities that were identified by the National Heart, Lung and Blood Institute (NHLBI) to meet the threshold for participation in the NETT or at sites that have been approved by Medicare or TRICARE as lung transplant facilities.

4.5 LVRS must be performed at facilities that are:

4.5.1 Certified by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) under LVRS Disease Specific Care Certification Program (program standards and requirements as printed in the Joint Commission’s JCAHO October 25, 2004, Disease Specific Care Certification Program packet); or

4.5.2 Approved by Medicare or TRICARE as lung or heart-lung transplantation facilities.

4.5.3 In addition, LVRS performed between January 1, 2004 and May 17, 2007 may be covered in facilities that were approved by the NHLBI to participate in the NETT.

5.0 EXCLUSION

Thorascopic laser bullectomy.

Chapter 4, Section 9.1 Cardiovascular System

3.11.7 All procedures are performed in a Centers for Medicare and Medicaid Services (CMS) approved facility that has been determined to be competent in performing the evaluation, procedure, and follow-up necessary to ensure optimal patient outcomes.

3.12 Transcatheter Aortic Valve Replacement (TAVR) for the treatment of severe symptomatic aortic stenosis is proven safe and effective for patients who are not candidates for Surgical Aortic Valve Replacement (SAVR).

3.13 TAVR for the treatment of severe symptomatic aortic stenosis in high-risk operative patients is considered proven safe and effective.

3.14 Intracranial angioplasty with stenting (CPT procedure code 61635) of the venous sinuses may be considered for cost-sharing for the treatment of pseudotumor cerebri (also known as idiopathic intracranial hypertension and benign intracranial hypertension).

4.0 EXCLUSIONS

4.1 Thermogram; cephalic (CPT procedure code 93760); peripheral (CPT procedure code 93762) are unproven.

4.2 Percutaneous Myocardial Laser Revascularization (PMR) is unproven.

4.3 Cardiomyoplasty (Cardiac Wrap) for treatment of heart failure is unproven.

4.4 Minimally Invasive CABG surgery to include Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) and Port Access Coronary Artery Bypass (PACAB) are unproven.

4.5 Percutaneous Transluminal Angioplasty (PTA) in the treatment of obstructive lesions of the vertebral and cerebral arteries is unproven. PTA of the carotid artery without stenting is unproven. PTA of the carotid artery with stenting but without embolic protection (CPT procedure code 37216) is unproven.

4.6 Signal-Average Electrocardiography (CPT procedure code 93278) is unproven.

4.7 Percutaneous transluminal mechanical thrombectomy vein(s) including intraprocedural pharmacological thrombolytic injections and fluroscopic guidance (CPT procedure code 37187) is unproven.

4.8 Percutaneous transluminal mechanical thrombectomy, vein(s) including intraprocedural pharmacological thrombolytic injections and fluroscopic guidance, repeat treatment on subsequent day during course of thrombolytic therapy (CPT procedure code 37188) is unproven.

4.9 Intracranial angioplasty with stenting (CPT procedure code 61635) of the venous sinuses for treatment of pseudotumor cerebri (also known as idiopathic intracranial hypertension and benign intracranial hypertension) is unproven.

5.0 EFFECTIVE DATES

5.1 March 1, 2001, for gamma and beta intracoronary radiotherapy (brachytherapy).

Chapter 4, Section 9.1 Cardiovascular System

5.2 January 1, 2002, for TMR.

5.3 October 1, 2003, for VADs as destination therapy.

5.4 December 1, 2003, for endovenous RFA/obliteration.

5.5 January 1, 2005, for ABPM.

5.6 March 17, 2005, for PTA of the carotid artery with stenting in beneficiaries at high risk for CEA.

5.7 March 21, 2006, for percutaneous transluminal mechanical thrombectomy for acute limb ischemia.

5.8 January 1, 2007, for pulmonary vein isolation/ablation.

5.9 January 1, 2009, for endovenous laser ablation/therapy.

5.10 May 1, 2011, for endovenous RFA/obliteration for the treatment of incompetent perforator veins.

5.11 July 27, 2012, for endovenous laser ablation/therapy for the treatment of incompetent perforator veins.

5.12 February 8, 2012, for TAVR for the treatment of severe symptomatic aortic stenosis in patients who are not candidates for SAVR.

5.13 July 27, 2012, for TAVR, for treatment of severe symptomatic aortic stenosis in high-risk operative patients.

5.14 June 25, 2014, for intracranial angioplasty with stenting of the venous sinuses for the treatment of pseudotumor cerebri.

Chapter 4, Section 15.1

Male Genital System

4.4 Arterial revascularization for distal lesions and venous leakage when treatment is for organic impotency.

4.5 Intersex surgery, except when performed to correct ambiguous genitalia, which is documented to have been present at birth (CPT procedure code 55970).

4.6 Reversal of surgical sterilization (CPT procedure code 55400).

4.7 Cryosurgery for prostate metastases M or N is unproven.

4.8 Electroejaculation (CPT procedure code 55870).

4.9 Prophylactics (condoms).

4.10 Over-The-Counter (OTC) spemicidal products.

4.11 Prostate saturation biopsy (CPT procedure code 55706).

4.12 Penile Vibratory Stimulation (PVS) devices, such as Ferticare Personal 2 medical vibrator.

Chapter 4, Section 20.1

Nervous System

2.8 Endoscopic laminotomy (CPT procedure code 63030) is covered for the treatment of lumbar spinal stenosis. The endoscopic spinal system used in the procedure must be FDA approved.

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).

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.

3.10 Stereotactic cingulotomy is unproven.

3.11 Laminoplasty, cervical with decompression of the spinal cord, two or more vertebral segments with reconstruction of the posterior bony elements (CPT procedure codes 63050 and 63051).

3.12 Balloon angioplasty, intracranial, percutaneous (CPT procedure code 61630) is unproven.

3.13 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.

3.14 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.

Chapter 4, Section 21.1 Eye And Ocular Adnexa

3.7 Optonal ExPRESS Mini glaucoma Shunt (CPT procedure code 0192T) to reduce Intraocular Pressure (IOP) in the treatment of glaucoma, that cannot be controlled effectively with medications.

3.8 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, 2008.

3.9 Transpupillary thermotherapy (CPT procedure code 67299) with Plaque Radiotherapy (Brachytherapy) is covered for the treatment of choroidal melanoma. See also Chapter 5, Section 3.2.

4.0 EXCLUSIONS

4.1 Refractive corneal surgery except as noted in paragraph 3.4 (CPT procedure codes 65760, 65765, 65767, 65770, 65771).

4.2 Eyeglasses, and contact lenses except as noted in Chapter 7, Section 6.2.

4.3 Orthokeratology.

4.4 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).

4.5 Epikeratophakia for treatment of aphakia and myopia is unproven.

4.6 Transpupillary thermotherapy (CPT procedure code 67299) for as primary treatment of choroidal melanoma is unproven.

4.7 Canaloplasty for the treatment of glaucoma (CPT procedure codes 66174 and 66175).

4.8 Autologous serum eye drops for the treatment of dry eye syndrome, keratitis, or ocular hypertension is unproven.

4.9 Visudyne Photodynamic Therapy for Central Serous Retinopathy is considered unproven (CPT procedure code 67221 and HCPCS J3396).

5.0 EFFECTIVE DATES

5.1 April 1, 2011, coverage for Optonal ExPRESS Mini Glaucoma Shunt.

5.2 July 17, 2005 coverage for Inrastromal Corneal Ring Segments (Intacs®).

Surgery Chapter 4 Section 22.2

Cochlear Implantation

Issue Date: March 2, 1988 Authority: 32 CFR 199.4(c)(2), (c)(3), (d)(3), and 32 CFR 199.5(c)(2) Copyright: CPT only © 2006 American Medical Association (or such other date of publication of CPT).

All Rights Reserved.

Revision:

1.0 CPT PROCEDURE CODES

69930, 90669, 90732, 92601 - 92604, 92626, 92627

2.0 HCPCS PROCEDURE CODES

Level II Codes L8614 - L8624

3.0 DESCRIPTION

A cochlear implant device is an electronic instrument, part of which is implanted surgically to stimulate auditory nerve fibers, and part of which is worn or carried by the individual to capture and amplify sound. Cochlear implant devices are available in single channel and multi-channel models. The purpose of implanting the device is to provide an awareness and identification of sounds and to facilitate communication for persons who are profoundly hearing impaired.

4.0 POLICY

4.1 Cochlear implantation using a United States (U.S.) Food and Drug Administration (FDA) approved single or multichannel cochlear implants and when used according to approved labeling is a covered benefit. when all of the following criteria are met:

4.1.1 The cochlear implant is used in accordance with FDA approved labeling for the specific device prescribed; and

4.1.2 The individual has had an assessment by an audiologist and from an otolaryngologist experienced in this procedure indicating the likelihood of success with this device; and

4.1.3 The individual has the cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation. A post-cochlear implant rehabilitation program is necessary to achieve benefit from the cochlear implant. The rehabilitation program consists of six to 10 sessions that last approximately 2.5 hours each. The rehabilitation program includes development of skills in understanding running speech, recognition of consonants and vowels, and tests of speech perception ability. See Chapter 7, Sections 7.1 and 18.1.

Chapter 4, Section 22.2 Cochlear Implantation

4.1.4 In addition to the above, the recipient of a cochlear implant should be up-to-date on age appropriate pneumococcal vaccination at least two weeks prior to the implant, in accordance with the Centers for Disease Control and Prevention (CDC).

4.2 Simultaneous or sequential bilateral cochlear implantation is a covered benefit for:

4.2.1 Adults aged 18 years and older with bilateral, pre or post-linguistic, sensorineural, moderate to profound hearing impairment who meet both of the following criteria: have received limited benefit from appropriately fitted binaural hearing aids. Limited benefit from amplification is defined by test scores of 40% correct or less in best-aided listening condition on open-set sentence cognition (e.g., Central Institute for the Deaf (CID) sentences, Hearing in Noise Test (HINT) sentences).

4.2.1.1 Individual has bilateral severe to profound sensorineural hearing loss determined by a pure tone average of 70 dB or greater at 500 Hz, and 2000 Hz; and

4.2.1.2 Individual has limited benefit from appropriately fitted binaural hearing aids. Limited benefit from amplification is defined by test scores of 40% correct or less in best-aided listening condition on open-set sentence cognition (e.g., Central Institute for the Deaf (CID) sentences, Hearing in Noise Test (HINT) sentences).

4.2.2 Children with bilateral sensorineural hearing impairment who meet all both of the following criteria:

4.2.2.1 Child has profound, bilateral sensorineual hearing loss determined by a pure tone average of 90 dB or greater at 500, 1000 and 2000 Hz; and

4.2.2.1 Child has limited benefit from appropriately fitted binaural hearing aids. For children four years of age or younger, limited benefit is defined as failure to reach developmentally appropriate auditory milestones measured using the Infant-Toddler Meaningful Auditory Integration Scale, the Meaningful Auditory Integration Scale, or the Early Speech Perception test, or less than 20% correct on open-set word recognition test (Multisyllabic Lexical Neighborhood Test (MLNT)) in conjunction with appropriate amplification and participation in intensive aural habilitation over a three to six month period. For children older than four years of age, limited benefit is defined as less than 12% correct on the Phonetically Balanced-Kindergarten Test, or less than 30% correct on the Hearing in Noise Test HINT for children, the open-set MLNT or Lexical Neighborhood Text (LNT), depending on the child’s cognitive ability and linguistic skills; and

4.2.2.2 A three to six month hearing aid trial has been undertaken and failed by a child without previous experience with hearing aids.

4.2.3 The following additional criteria must also be met for unilateral (monaural) or bilateral (binaural) cochlear implantation in adults and children:

4.2.3.1 The individual must have had an assessment by an audiologist and from an otolaryngologist experienced in this procedure indicating the likelihood of success with this device;

and

4.2.3.2 The individual must have the cognitive ability to use auditory clues and a willingness to undergo an extended program of rehabilitation. A post-cochlear implant rehabilitation program is

Chapter 4, Section 22.2 Cochlear Implantation necessary to achieve benefit from the cochlear implant. The rehabilitation program consists of six to ten sessions that last approximately 2.5 hours each. The rehabilitation program includes development of skills in understanding running speech, recognition of consonants and vowels, and tests of speech perception ability. See Chapter 7, Sections 7.1 and 18.1; and

4.2.3.3 The individual should be up-to-date on age appropriate pneumococcal vaccination at least two weeks prior to the implant, in accordance with the Centers for Disease Control and Prevention

(CDC).

4.3 Replacement of the cochlear implant external speech processor device is covered.

5.0 EXCLUSIONS

5.1 Cochlear implantation is contraindicated when preoperative radiographic evidence indicates an underdeveloped internal auditory canal, the absence of cochlear development or a physical condition which precludes placement of the electrode array or receiver-stimulator (e.g., cochlear ossification that prevents electrode insertion).

5.2 Cochlear implantation is contraindicated when there is a middle ear infection, the cochlear lumen is structurally unsuited to implantation, or there is a lesion in the auditor nerve or acoustic area of the central nervous system.

5.3 Cochlear implantation may not be cost-shared when there is a contraindication to surgery and implantation, such as poor anesthetic risk, severe mental retardation, severe psychiatric disorders, and organic brain syndrome.

6.0 EFFECTIVE DATES

6.1 April 4, 2005.

6.2 July 27, 2012, for children under 12 months of age.

Chapter 4, Section 24.5

Liver Transplantation

2.4 Liver transplantation for severe classical Maple Syrup Urine Disease (MSUD) not controlled by dietary restriction may be considered on a case-by-case basis under the TRICARE provisions for the treatment of rare diseases.

2.5 Liver transplantation for the treatment of pediatric Ornithine Transcarbamylase Deficiency (OTCD) may be covered for this specific class of beneficiaries in accordance with the TRICARE provisions for the treatment of rare diseases.

2.6 Liver transplantation may be covered for the treatment of Citrullinemia Type 1 (CTLN1) in accordance with the TRICARE provisions for the treatment of rare diseases.

2.7 Services and supplies related to liver and LDLTs are covered for:

2.7.1 Evaluation of a potential candidate’s suitability for liver transplantation whether or not the patient is ultimately accepted as a candidate for transplantation.

2.7.2 Pre- and post-transplantation inpatient hospital and outpatient services.

2.7.3 Pre- and postoperative services of the transplantation team.

2.7.4 The donor acquisition team, including the costs of transportation to the location of the donor organ and transportation of the team and the donated organ to the location of the transplantation center.

2.7.5 The maintenance of the viability of the donor organ after all existing legal requirements for excision of the donor organ have been met.

2.7.6 Donor costs.

2.7.7 Blood and blood products.

2.7.8 U.S. Food and Drug Administration (FDA) approved immunosuppression drugs to include off-label uses when reliable evidence documents that the off-label use is safe, effective and in accordance with nationally accepted standards of practice in the medical community (proven).

(Chapter 8, Section 9.1)

2.7.9 Complications of the transplantation procedure, including inpatient care, management of infection and rejection episodes.

2.7.10 Periodic evaluation and assessment of the successfully transplanted patient.

2.7.11 Deoxyribonucleic Acid-Human Leucocyte Antigen (DNA-HLA) tissue typing determining histocompatibility.

2.7.12 Transportation of the patient by air ambulance and the services of a certified life support attendant.

2.8 Orthotopic Liver Transplantation (OLT) (CPT procedure code 47135) for the treatment of Acute Intermittent Porphyria in accordance with…