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TRICARE Policy Manual 6010.60-M, April 1, 2015

D R A F T

Revision:

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

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)

Index

D R A F T

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 - CQSS 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

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

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

Administration

D R A F T

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. TRICARE is a blend of the military’s Direct Care (DC) system of hospitals and clinics and the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). A key feature of the DoD’s managed care implementation is the creation within the United States of three Health Services Regions. Within each region, a Director, TRICARE Regional Offices is responsible for managing health care services in the region.

2.0 OFFICE OF RECORD

The Medical Benefits and Reimbursement Office (MB&RO) 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 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

D R A F T

3.1.1.2 Reduced cost. Prime enrollees’ cost-share for civilian services is substantially reduced from that which is applicable under TRICARE Extra and TRICARE Standard. In addition, when a TRICARE Prime enrollee is referred to a non-participating provider, the enrollee is only responsible for the copayment amount, but not for any balance billing amount by the non-participating provider.

3.1.2 TRICARE Extra Plan

Beneficiaries who do not enroll in Prime may still benefit from using the providers in the contractor’s network where possible. On a case by case basis, beneficiaries may participate in TRICARE Extra by receiving care from a network provider. The beneficiary will take advantage of the reduced charges under Extra and a reduction in cost-shares. Covered services are the same as under TRICARE Standard.

3.1.3 TRICARE Standard Plan

The TRICARE Standard plan is identical to the CHAMPUS fee for service program. Its benefits and costs are unchanged from the CHAMPUS program.

3.2 Eligibility for TRICARE

3.2.1 Active Duty Eligibility

All active duty members are considered TRICARE Prime. They must, however, take action to be enrolled in Prime, and be assigned to a PCM (see the TRICARE Operations Manual (TOM) for PCM provisions under the TRICARE Prime Remote (TPR) program).

3.2.2 Non-Active Duty Eligibility

All individuals entitled to civilian health care under Sections 1079 or 1086 or Title 10, Chapter 55, United States Code, are eligible for TRICARE. These non-active duty individuals, commonly referred to as “TRICARE eligibles”, include the spouse and children of active duty personnel, retirees and their spouses and children, and survivors.

Note: This group also includes former spouses as defined in Section 1072(2), of Title 10, Chapter 55, United States Code (USC). Not included are those individuals who are entitled to care in the DC system but ordinarily are not entitled to civilian care, such as family member parents and parents-in-law.

3.2.3 TRICARE For Life (TFL)

Pursuant to Section 712 of the National Defense Authorization Act for FY 2001, Medicare eligible beneficiaries based on age, whose TRICARE eligibility is determined by 10 USC Section 1086, are eligible for Medicare Part A, and those who are enrolled in Medicare Part B, are eligible for the TRICARE benefit effective October 1, 2001. These beneficiaries are not eligible to enroll in TRICARE Prime.

3.2.4 Supplemental Health Care Program (SHCP) and TPR Program

See the TOM, Chapters 16 and 17.

General Policy And Responsibilities

D R A F T

3.2.5 Non-DoD TRICARE Eligibles

TRICARE eligibles sponsored by non-DoD uniformed services (the Public Health Service (PHS), the United States 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 is required to describe in writing and submit to the Chief, MB&RO, TRICARE Management Activity (TMA), 16401 East Centretech Parkway, Aurora, CO 80011-9066.

General Policy And Responsibilities

D R A F T

3.3.4 Reimbursement Policy

3.3.4.1 Reimbursement policy sets forth the payment procedures used for reimbursing TRICARE claims. The related implementation instructions for these payment procedures are found in the TSM and the TOM.

3.3.4.2 The TRM provides the methodology for pricing allowable services and items and for payment to specific categories and types of authorized allowable services and items and for payment to specific categories and types of authorized providers. These methods allow the contractor to price and render payment for specific examples of services or items which are not explicitly addressed in the Manual but which belong to a general category or type which is addressed in the Manual.

3.4 Administrative and Effective Dates

3.4.1 Issuance Date

The date located on the first page of each separate policy issuance. This is the date that the issuance was initially issued by TMA.

3.4.2 Revision Date

The revision date is at the bottom of each page that has been revised along with the change number. This is the date that TMA changed the issuance in any way. Each time an issuance is changed, the revised page and/or issuance is given a change number. The revision date and the change number together identify a unique version of the issuance on a specific subject.

3.4.3 Effective Date

A date within the body of the text of an issuance which establishes the specific date that a policy is to be applied to benefit adjudication or in program administration. An effective date may be earlier than the issuance or revision date. This date is explicit (e.g., Effective Date: January 1, 1998). The policy effective date takes precedence over the issuance date and the revision date. In the absence of an effective date the policy or instruction is considered to have always been applicable because the newly published policy or instruction confirms the application of existing published program requirements.

3.4.4 Implementation Date

The implementation date of a policy or instruction is not noted in the issuance as this date is determined by the terms of the contract modification between TMA and the contractor. Unless otherwise directed by TMA, contractors are not to identify finalized claims for readjudication under revised or new policy. However, the contractor shall readjudicate any denied claim affected by the policy that is brought to the contractor’s attention by any source. Pending claims and denied claims in reconsideration shall be adjudicated using the current applicable policy.

General Policy And Responsibilities

D R A F T

4.0 GENERAL RESPONSIBILITIES

4.1 Director, TRICARE Regional Offices

The Director, TRICARE Regional Offices, working with all the MTFs/eMSMs within the region, is responsible for organizing and managing health care delivery for all TRICARE and the Military Health System (MHS) beneficiaries in the region. Supporting the Director, TRICARE Regional Offices is a contractor with responsibility for establishing a network of health care providers to supplement the care available at the MTFs/eMSMs and for performing a variety of health care administrative services on behalf of the Director, TRICARE Regional Offices. The Director, TRICARE Regional Offices are also responsible for planning and delivering services to meet the health needs of the beneficiaries in the region, whether through the MTFs/eMSMs or the contractor. The Director, TRICARE Regional Offices is primarily responsible for oversight and administration of those tasks in the MCS contract that relate to the delivery and management of care.

4.2 Military Treatment Facility (MTF)/Enhanced Multi-Service Market (eMSM) Commanders

MTF/eMSM Commanders are responsible for managing health care delivery for the active duty personnel and TRICARE eligibles who are enrolled in Prime with MTF/eMSM PCMs, as well as for providing care to other TRICARE and the MHS beneficiaries who are eligible for care in MTFs/eMSMs.

The MTF Commander/eMSM Manager sets priorities for assignment of MTF/eMSM PCMs and works directly with the contractor in network development, resource sharing arrangements and similar local initiatives (see the TOM, Chapter 17 for SHCP).

4.3 Contractor

The contractor is responsible for establishing provider networks in those Prime Service Areas (PSAs) and BRAC sites designated by the Director, TRICARE Regional Offices. The provider networks must include both primary care providers and specialists. The contractor shall ensure that first priority for referral of Prime enrollees for specialty care or inpatient care is the MTF/eMSM. The contractor processes all Prime, Extra, and Standard claims for all beneficiaries, except for TRICARE for Life (TFL), who reside in the Region and performs other tasks specified in the contracts and the manuals. The contractor has a number of responsibilities for support of the Director, TRICARE Regional Offices as well as the MTF/eMSM.

4.4 TRICARE Dual Eligible Fiscal Intermediary Contractor (TDEFIC)

The TDEFIC is responsible for processing all TRICARE claims for services rendered within the fifty United States and the District of Columbia, as well as Puerto Rico, Guam, the U.S. Virgin Islands, American Samoa, and the Northern Mariana Islands, to individuals who have dual eligibility under both TRICARE and Medicare.

4.5 Administrative Personnel

The Procurement Contracting Officer (PCO) and the Contracting Officer’s Representative (COR) are TMA personnel who oversee the functions of the MCS contract, with special emphasis in areas such as claims processing, and who coordinate contract oversight and administration among the variety of TRICARE Regional Office staff. The PCO is the sole authority for directing the contractor or modifying provisions of the contract (some of this authority may be delegated to the ACO at the Office of the

General Policy And Responsibilities

D R A F T

Director, TRICARE Regional Offices).

4.6 Assistant Secretary of Defense (Health Affairs) (ASD(HA))

Overall policy for TRICARE is established by the ASD(HA).

5.0 GEOGRAPHIC AVAILABILITY

5.1 TRICARE is effective throughout the United States. TRICARE Overseas Program (TOP) Regions are established but operate under different procedures than TRICARE in the United States.

5.2 Within a region, the contractor is required to create a provider network to support PSAs.

5.3 The contractor is encouraged to establish a provider network sufficient to support offering TRICARE Extra in as many non-PSAs as patient population (including enrollees in the TPR Program) and provider availability make cost effective.

- END -

Administration

D R A F T

Chapter 1 Section 1.2

Exclusions

Issue Date: June 1, 1999 Authority: 32 CFR 199.4(g) Revision:

1.0 POLICY

1.1 In addition to any definitions, requirements, conditions, or limitations enumerated and described in other sections of this manual, the following specifically are excluded:

1.1.1 Services and supplies that are not medically or psychologically necessary for the diagnosis or treatment of a covered illness (including mental disorder) or injury or for the diagnosis and treatment of pregnancy or well-baby care.

1.1.2 X-ray, laboratory, and pathological services and machine diagnostic tests not related to a specific illness or injury or a definitive set of symptoms except for cancer screening allowed under the Preventive Services policy. (See Chapter 7, Sections 2.1 and 2.2; and TRICARE Operations Manual (TOM) Chapter 24, Section 6.)

1.1.3 Services and supplies related to inpatient stays in hospitals or other authorized institutions above the appropriate level required to provide necessary medical care.

1.1.4 Services and supplies related to an inpatient admission primarily to perform diagnostic tests, examinations, and procedures that could have been and are performed routinely on an outpatient basis.

Note: If it is determined that the diagnostic x-ray, laboratory, and pathological services and machine tests performed during such admission were medically necessary and would have been covered if performed on an outpatient basis, benefits may be extended for such diagnostic procedures only, but cost-sharing will be computed as if performed on an outpatient basis.

1.1.5 Postpartum inpatient stay of a mother for purposes of staying with the newborn infant (usually primarily for the purpose of breast feeding the infant) when the infant (but not the mother) requires the extended stay; or continued inpatient stay of a newborn infant primarily for purposes of remaining with the mother when the mother (but not the newborn infant) requires extended postpartum inpatient stay.

1.1.6 Therapeutic absences from an inpatient facility, except when such absences are specifically included in a treatment plan approved by TRICARE.

Chapter 1, Section 1.2

Exclusions

D R A F T

1.1.7 Custodial care. The term “custodial care”, as defined in 32 CFR 199.2, means treatment or services, regardless of who recommends such treatment or services or where such treatment or services are provided, that (a) can be rendered safely and reasonably by a person who is not medically skilled; or (b) is or are designed mainly to help the patient with the Activities of Daily Living (ADL). These are also known as “essentials of daily living” as defined in 32 CFR 199.2.

1.1.8 Domiciliary care. The term “domiciliary care”, as defined in 32 CFR 199.2, means care provided to a patient in an institution or homelike environment because

• Providing support for the activities of daily living in the home is not available or is unsuitable; or

• Members of the patient’s family are unwilling to provide the care.

1.1.9 Inpatient stays primarily for rest or rest cures.

1.1.10 Costs of services and supplies to the extent amounts billed are over the allowed cost or charge.

1.1.11 Services or supplies for which the beneficiary or sponsor has no legal obligation to pay; or for which no charge would be made if the beneficiary or sponsor was not eligible under TRICARE; or whenever TRICARE is a secondary payer for claims subject to the Diagnosis Related Group (DRG) based payment system, amounts, when combined with the primary payment, which would be in excess of charges (or the amount the provider is obligated to accept as payment in full, if it is less than the charges).

1.1.12 Services or supplies furnished without charge.

1.1.13 Services and supplies paid for, or eligible for payment, directly or indirectly by a local, state, or Federal Government, except as provided under TRICARE, or by government hospitals serving the general public, or medical care provided by a Uniformed Service medical care facility, or benefits provided under title XIX of the Social Security Act (Medicaid).

Note: This exclusion applies to services and items provided in accordance with beneficiary’s Individualized Family Service Plan (IFSP) as required by Part C of the Individuals with Disabilities Education Act (IDEA), and which are otherwise eligible under the TRICARE Basic Program or the Extended Care Health Option (ECHO) but determined not to be “medically or psychologically necessary” as that term is defined within 32 CFR 199.2.

1.1.14 Services and supplies provided as a part of or under a scientific or medical study, grant, or research program.

1.1.15 Unproven drugs, devices, and medical treatments or procedures (see Section 2.1).

1.1.16 Services or supplies provided or prescribed by a sponsor or beneficiary, member of the beneficiary’s or sponsor’s immediate family, or person living in the beneficiary’s or sponsor’s household.

1.1.17 Services and supplies that are (or are eligible to be) payable under another medical insurance or program, either private or governmental, such as coverage through employment or Medicare.

Exclusions

D R A F T

1.1.18 Services or supplies which require preauthorization if preauthorization was not obtained.

Services and supplies which were not provided according to the terms of the preauthorization. An exception to the requirement for preauthorization may be granted if the services otherwise would be payable except for the failure to obtain preauthorization.

1.1.19 Psychoanalysis or psychotherapy provided to a beneficiary or any member of the immediate family that is credited towards earning a degree or furtherance of the education or training of a beneficiary or sponsor, regardless of diagnosis or symptoms that may be present.

1.1.20 Inpatient stays primarily to control or detain a runaway child, whether or not admission is to an authorized institution.

1.1.21 Services or supplies, including inpatient stays, directed or agreed to by a court or other governmental agency. However, those services and supplies (including inpatient stays) that otherwise are medically or psychologically necessary for the diagnosis or treatment of a covered condition and that otherwise meet all TRICARE requirements for coverage are not excluded.

1.1.22 Services and supplies required as a result of occupational disease or injury for which any benefits are payable under a worker’s compensation or similar law, whether or not such benefits have been applied for or paid; except if benefits provided under such laws are exhausted.

1.1.23 Services and supplies in connection with cosmetic, reconstructive, or plastic surgery except as specifically provided in 32 CFR 199.4(e)(8) (see Chapter 4, Section 2.1).

1.1.24 Surgery performed primarily for psychological reasons (such as psychogenic) (see Chapter 4, Section 2.1).

1.1.25 Electrolysis (see Chapter 4, Section 2.1).

1.1.26 Dental care or oral surgery, except as specifically provided in 32 CFR 199.4(e)(10) (see Chapter 4, Section 7.1 and Chapter 8, Section 13.1).

1.1.27 Services and supplies related to obesity or weight reduction whether surgical or nonsurgical;

wiring of the jaw or any procedure of similar purposes; regardless of the circumstances under which performed; except that benefits may be provided for the gastric bypass, gastric stapling, or gastroplasty procedures in connection with morbid obesity as provided in 32 CFR 199.4(e)(15) (see Chapter 4, Section 13.2 and Chapter 8, Section 7.2).

1.1.28 Services and supplies related to transsexualism or such other conditions as gender dysphoria (including, but not limited, to intersex surgery, psychotherapy, and prescription drugs), except as specifically provided in 32 CFR 199.4(e)(7) (see Chapter 4, Sections 15.1, 16.1, 17.1, and Chapter 7, Section 1.1).

1.1.29 Sex therapy, sexual advice, sexual counseling, sex behavior modification, psychotherapy for mental disorders involving sexual deviations (i.e., transvestic fetishism), or other similar services, and any supplies provided in connection with therapy for sexual dysfunctions or inadequacies (see Chapter 4, Section 15.1 and Chapter 7, Section 1.1).

Exclusions

D R A F T

1.1.30 Removal of corns or calluses or trimming of toenails and other routine podiatry services, except those required as a result of a diagnosed systemic medical disease affecting the lower limbs, such as severe diabetes (see Chapter 8, Section 1.1).

1.1.31 Treatment of dyslexia.

1.1.32 Surgery to reverse surgical sterilization procedures (see Chapter 4, Sections 15.1 and 17.1 and Chapter 7, Section 2.3).

1.1.33 Noncoital reproductive procedures including artificial insemination, In Vitro Fertilization (IVF), gamete intrafallopian transfer and all other such assistive reproductive technologies. Services and supplies related to artificial insemination (including semen donors and semen banks), IVF, gamete intrafallopian transfer and all other noncoital reproductive technologies (see Chapter 4, Sections 17.1,

18.1 and Chapter 7, Section 2.3).

1.1.34 Nonprescription contraceptives (see Chapter 4, Section 17.1 and Chapter 7, Section 2.3).

1.1.35 Diagnostic tests to establish paternity of a child; or tests to determine sex of an unborn child (see Chapter 4, Section 18.2 and Chapter 5, Section 2.1).

1.1.36 Preventive care, such as routine annual, or employment-requested physical examinations;

routine screening procedures; immunizations; except as provided in the Clinical Preventive Services policy (see Chapter 7, Sections 2.1, 2.2, 2.5, and 2.6).

1.1.37 Services of chiropractors and naturopaths whether or not such services would be eligible for benefits if rendered by an authorized provider (see Chapter 7, Section 18.5).

1.1.38 Counseling services that are not medically necessary in the treatment of a diagnosed medical condition. For example, educational counseling, vocational counseling, and counseling for socioeconomic purposes, stress management, lifestyle modification, etc. Services provided by a certified marriage and family therapist, pastoral counselor or Supervised Mental Health Counselor (SMHC) in the treatment of a mental disorder are covered only as specifically provided in 32 CFR 199.6.

Services provided by alcoholism rehabilitation counselors are covered only when rendered in a TRICARE-authorized treatment setting and only when the cost of those services is included in the facility’s TRICARE-determined allowable cost rate.

Note: See Chapter 8, Section 7.1 for policy on Nutritional Therapy. Diabetes Self-Management Training (DSMT) is covered (see Chapter 8, Section 8.1).

1.1.39 Acupuncture, whether used as a therapeutic agent or as an anesthetic.

1.1.40 Hair transplants, wigs (also referred to as cranial prosthesis), or hairpieces, except as allowed in accordance with section 744 of the DoD Appropriations Act for 1981 (see Chapter 4, Section 2.1 and Chapter 8, Section 12.1).

1.1.41 Self-help, academic education or vocational training services and supplies, unless the provisions of 32 CFR 199.4(b)(1)(v) relating to general or special education, apply.

Note: See 32 CFR 199.5 and Chapter 9, Section 8.1, for training benefits under ECHO.

Exclusions

D R A F T

1.1.42 Exercise equipment, spas, whirlpools, hot tubs, swimming pools, health club membership or other such charges or items (see Chapter 8, Section 2.1).

1.1.43 General exercise programs, even if recommended by a physician and regardless of whether or not rendered by an authorized provider. In addition, passive exercises and range of motion exercises also are excluded, except when prescribed by a physician and rendered by a physical therapist concurrent to, and as an integral part of a comprehensive program of physical therapy (see Chapter 7, Sections 18.2 and 18.3).

1.1.44 Services of an audiologist or speech therapist, except when prescribed by a physician and rendered as a part of an otherwise covered benefit or treatment addressed to the physical defect itself and not to any educational or occupational defect (see Chapter 7, Sections 7.1 and 8.1).

1.1.45 Eye exercises or visual training (orthoptics) (see Chapter 4, Section 21.1 and Chapter 7, Section 6.1).

1.1.46 Eye and hearing examinations except as specifically provided in 32 CFR 199.4(b)(2)(xvi), (b)(3)(xi), and (e)(24) or except when rendered in connection with medical or surgical treatment of a covered illness or injury. Vision and hearing screening in connection with well-child care is not excluded (see Chapter 4, Section 21.1 and Chapter 7, Sections 2.1, 2.2, 2.5, 6.1 and 8.1).

1.1.47 Prostheses, other than those determined to be necessary because of significant conditions resulting from trauma, congenital anomalies, or disease. All dental prostheses are excluded, except for those specifically required in connection with otherwise covered orthodontia directly related to the surgical correction of a cleft palate anomaly (see Chapter 8, Section 4.1).

1.1.48 Orthopedic shoes, arch supports, shoe inserts, and other supportive devices for the feet, including special-ordered, custom-made built-up shoes, or regular shoes later built up (see Chapter 8, Sections 3.1 and 11.1).

1.1.49 Eyeglasses, spectacles, contact lenses, or other optical devices, except as specifically provided under 32 CFR 199.4(e)(6) (see Chapter 7, Section 6.2).

1.1.50 Hearing aids or other auditory sensory enhancing devices except as specifically provided in 32 CFR 199.4(e)(24).

1.1.51 Services or advice rendered by telephone are excluded, except that a diagnostic or monitoring procedure which incorporates electronic transmission of data or remote detection and measurement of a condition, activity, or function (biotelemetry) is not excluded when:

1.1.51.1 The procedure without electronic transmission of data or biotelemetry is otherwise an explicit or derived benefit; and

1.1.51.2 The addition of electronic transmission of data or biotelemetry to the procedure is found to be medically necessary and appropriate medical care which usually improves the efficiency of the management of a clinical condition in defined circumstances; and

1.1.51.3 That each data transmission or biotelemetry device incorporated into a procedure that is otherwise an explicit or derived benefit of this section, has been classified by the U.S. Food and Drug

Exclusions

D R A F T

Administration (FDA), either separately or as a part of a system, for use consistent with the defined circumstances in 32 CFR 199.4(g)(52)(ii).

Note: See Chapter 7, Section 22.1 for policy on Telemental Health (TMH)/Telemedicine.

1.1.52 Air conditioners, humidifiers, dehumidifiers, and purifiers.

1.1.53 Elevators or chair lifts.

1.1.54 Alterations to living spaces or permanent features attached thereto, even when necessary to accommodate installation of covered durable medical equipment or to facilitate entrance or exit.

1.1.55 Items of clothing or shoes, even if required by virtue of an allergy.

1.1.56 Food, food substitutes, vitamins, or other nutritional supplements, including those related to prenatal care, except as specifically covered (see Chapter 8, Sections 7.1 and 7.2).

1.1.57 Enuretic conditioning programs.

1.1.58 Autopsy and postmortem (see Chapter 6, Section 1.1).

1.1.59 All camping even though organized for a specific therapeutic purpose, and even though offered as a part of an otherwise covered treatment plan or offered through an approved facility.

1.1.60 Housekeeping, homemaker, or attendant services, sitter or companion (for exceptions, see 32 CFR 199.4(e)(19) regarding hospice care) (see the TRICARE Reimbursement Manual (TRM), Chapter 11, Sections 1 and 4).

1.1.61 All services and supplies (including inpatient institutional costs) related to a noncovered condition or treatment, or provided by an unauthorized provider.

1.1.62 Personal, comfort, or convenience items, such as beauty and barber services, radio, television, and telephone (for exceptions, see 32 CFR 199.4(e)(19) regarding hospice care).

Note: Admission kits are covered.

1.1.63 Megavitamin psychiatric therapy, orthomolecular psychiatric therapy.

1.1.64 All transportation except by ambulance, as specifically provided under 32 CFR 199.4(d) and (e)(5).

Note: Transportation of an institutionalized ECHO beneficiary to or from a facility or institution to receive authorized ECHO services or items may be cost-shared under 32 CFR 199.5(c)(6). Transportation of an accompanying medical attendant to ensure the safe transport of the ECHO beneficiary may also be cost-shared (see Chapter 9, Section 11.1).

1.1.65 All travel even though prescribed by a physician and even if its purpose is to obtain medical care, except as specified in 32 CFR 199.4(a)(6).

Exclusions

D R A F T

Note: For the exception for certain Prime travel expenses and non-medical attendants, see 32 CFR 199.17(n)(2)(vi) and the TRM, Chapter 1, Section 30.

1.1.66 Services and supplies provided by other than a hospital, unless the institution has been approved specifically by TRICARE. Nursing homes, intermediate care facilities, halfway houses, homes for the aged, or institutions of similar purpose are excluded from consideration as approved facilities.

1.1.67 Service animals (Seeing Eye dogs, hearing/handicap assistance dogs, seizure and other detection animals, service monkeys, etc.) are excluded from coverage under the Basic or ECHO programs.

Administration

D R A F T

Chapter 1 Section 1.3

Court-Ordered Care

Issue Date: December 5, 1984 Authority: 32 CFR 199.4(g)(22) Revision:

1.0 DESCRIPTION

Court-ordered care is medical service, including inpatient admissions, that a court of law orders or directs a party in a legal proceeding to obtain.

2.0 POLICY

The fact that medical services are ordered by a court does not determine the coverage of those medical services. Benefits will be paid only if the service is to diagnose or treat a covered condition, if the service is at the appropriate level of care to treat the condition, and if the beneficiary (or the beneficiary’s family) has a legal obligation to pay for the service.

Administration

D R A F T

Chapter 1 Section 2.1

Unproven Drugs, Devices, Medical Treatments, And Procedures

Issue Date: November 1, 1983 Authority: 32 CFR 199.2 and 32 CFR 199.4(g)(15) Revision:

1.0 POLICY

By law, TRICARE can only cost-share medically necessary supplies and services. TRICARE regulations and program policies restrict benefits to those drugs, devices, treatments, or procedures for which the safety and efficacy have been proven to be comparable or superior to conventional therapies. Any drug, device, medical treatment, or procedure whose safety and efficacy has not been established is unproven and is excluded from coverage.

2.0 A drug, device, medical treatment, or procedure is unproven:

2.1 If the drug or device cannot be lawfully marketed without the approval or clearance of the U.S.

Food and Drug Administration (FDA) and approval or clearance for marketing has not been given at the time the drug or device is furnished to the patient.

2.2 If a medical device with an Investigational Device Exemption (IDE) approved by the FDA is categorized by the FDA as experimental/investigational (FDA Category A).

2.3 Unless reliable evidence shows that any medical treatment or procedure has been the subject of well-controlled studies of clinically meaningful endpoints, which have determined its maximum tolerated dose, its toxicity, its safety, and its efficacy as compared with standard means of treatment or diagnosis.

2.4 If the reliable evidence shows that the consensus among experts regarding the medical treatment or procedure is that further studies or clinical trials are necessary to determine its maximum tolerated dose, its toxicity, its safety, or its effectiveness as compared with the standard means of treatment or diagnosis.

3.0 This exclusion includes all services directly related to the unproven drug, device, medical treatment or procedure.

4.0 Cost-sharing may be allowed for services or supplies when there is no logical or causal relationship between the unproven drug, device, treatment, or procedure and the treatment at issue or where such a logical or causal relationship cannot be established with a sufficient degree of certainty.

This cost-sharing is authorized in the following circumstances:

Chapter 1, Section 2.1

Unproven Drugs, Devices, Medical Treatments, And Procedures

D R A F T

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 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 bring to TRICARE Management Activity’s (TMA) attention drugs, devices, medical treatments, or procedures that they believe have moved from unproven to proven. TMA will apply the standards and procedures in TRICARE regulation and policy and if determined by TMA 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 2.1

Unproven Drugs, Devices, Medical Treatments, And Procedures

D R A F T established as the date of publication of a well-controlled study of clinically meaningful endpoints published in refereed medical literature, or the publication date of a formal technology assessment.

Note: See Section 3.1 for policy on Rare Diseases.

Note: See Chapter 7, Section 24.1 for policy on cancer clinical trials.

Note: See Chapter 8, Section 5.1 for policy on medical devices, including coverage of off-label uses of medical devices, Humanitarian Use Devices and a FDA-approved IDE categorized by the FDA as non-experimental/investigational (FDA Category B).

Note: See Chapter 8, Section 9.1 for policy on off-label use of drugs.

Administration

D R A F T

Chapter 1 Section 3.1

Rare Diseases

Issue Date: May 18, 1994 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 DESCRIPTION

TRICARE defines a rare disease as any disease or condition that affects less than 200,000 persons in the United States.

2.0 POLICY

2.1 Coverage for treatment of rare diseases may be considered on a case-by-case basis. Case-by-case review is not required for drugs, devices, medical treatments, and procedures that have already been established as safe and effective for treatment of rare diseases.

2.1.1 In reviewing the case, any or all of the following sources may be used to determine if the proposed benefit is considered safe and effective.

2.1.2 Trials published in refereed medical literature.

2.1.3 Formal technology assessments.

2.1.4 National medical policy organization positions.

2.1.5 National professional associations.

2.1.6 National expert opinion organizations.

2.2 If case review indicates that the proposed benefit for a rare disease is safe and effective for that disease, benefits may be allowed. If benefits are denied, an appropriate appealing party may request an appeal.

2.3 Off-label use of rituximab may be considered for cost-sharing for the treatment of recurrent nodular CD20 positive lymphocyte predominant Hodgkin’s disease. The effective date is January 1, 2003.

Chapter 1, Section 3.1

Rare Diseases

D R A F T

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 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.

2.6 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.

2.7 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.

2.8 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.

2.9 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.

2.10 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.

2.11 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

D R A F T

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.

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

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

Administration

D R A F T

Chapter 1 Section 4.1

Waiver Of Liability

Issue Date: April 8, 1989 Authority: 32 CFR 199.4 Revision:

1.0 ISSUE

Payment and liability for services or supplies retrospectively excluded by a Peer Review Organization (PRO) by reason of being not medically necessary, at an inappropriate level, custodial care, or other reason relative to reasonableness, necessity or appropriateness.

2.0 POLICY

2.1 General Applicability

2.1.1 Summary

Subject to application of other TRICARE definitions and criteria, the principle of waiver of liability is summarized as follows: If the beneficiary did not know, or could not reasonably be expected to know, that certain services were potentially excludable from the TRICARE Basic Program by reason of being not medically necessary, not provided at an appropriate level, custodial care, or other reason relative to reasonableness, necessity or appropriateness (hereafter, all such services will be referred to as not medically necessary), then the beneficiary will not be held liable for such services and, under certain circumstances, payment may be made for the excludable services as if the exclusion for such services did not apply.

Note: The word service(s), as used in this section, will be understood to include services and supplies.

2.1.2 Peer Review Organizations

PROs make waiver of liability determinations. For purposes of this section, PROs include the contractors, the Clinical Quality Support Services (CQSS), the pharmacy contractors, and dual eligible contractor.

2.1.3 Non-Network Providers

Waiver of liability applies only to services rendered by non-network providers.

Chapter 1, Section 4.1

Waiver Of Liability

D R A F T

2.1.4 Retrospective Determinations

Waiver of liability applies only to retrospective determinations that services are not medically necessary.

2.1.4.1 A determination is retrospective if the Notice of Denial is received after the excludable services were provided.

Example: Provider requests preauthorization for certain services, but the Notice of Denial is received after the services are provided. The determination that the services are not medically necessary is retrospective because the services were rendered before the Notice of Denial was received.

Example: Provider requests a concurrent review of ongoing inpatient care which had been authorized prior to the beneficiary’s admission. If the PRO determines that continued care is not medically necessary, such determination is retrospective as to inpatient services rendered prior to the date the Notice of Denial was received.

2.1.4.2 A retrospective determination that services are not medically necessary includes denials of cost-sharing for related services provided during the same Episode Of Care (EOC). EOC includes not only the services excluded as not medically necessary, but includes other services related to the excluded services.

2.1.5 Applicability to all TRICARE Beneficiaries

Waiver of liability applies to retrospective determinations that services are not medically necessary (with the exception of services provided by network providers) regardless of whether the beneficiary is a Prime enrollee, Extra, or Standard beneficiary.

Example: A TRICARE Prime enrollee obtains services under the point-of-service option. Cost-sharing is denied because a retrospective review determines that the services were not medically necessary. Waiver of liability applies to this retrospective denial. If it is determined that neither the beneficiary nor the provider knew, or could not reasonably be expected to know, that the services were not medically necessary, then cost-sharing will be provided in accordance with the applicable point-of-service deductibles and reimbursement rate.

2.2 Waiver of Liability Not Applicable

2.2.1 Factual Determinations

Waiver of liability does not apply to denials based on factual determinations, which include coverage limitations under 32 CFR 199.4, the TRICARE Policy Manual (TPM), or TRICARE guidelines and other factual determinations as described in the TRICARE Operations Manual (TOM), Chapter 12, Section 5. The following are examples of denials based on factual determinations:

Example: Payment is denied for treatment for dyslexia because such services are specifically excluded under 32 CFR 199.4(g)(32).

Waiver Of Liability

D R A F T

Example: Payment is denied for surgical extraction of hematomas after removal of the beneficiary’s breast prostheses. The surgical implantation of the prostheses was a noncovered procedure (benefit) (augmentation mammoplasty). This denial is based upon a determination that the hematomas do not constitute separate medical conditions as required by 32 CFR 199.4(e)(9). Therefore, treatment of the hematomas is excluded from the Basic Program. Although medical judgment may be required to determine if extraction of the hematomas represents a separate medical condition, this denial is based on a coverage limitation. The denied procedure is excluded from the Basic Program regardless of whether it was medically necessary.

Example: Payment is denied because the provider did not comply with medical records requirements as set forth in 32 CFR 199.2 and 32 CFR 199.7. This denial is not based on a determination that the services are not medically necessary, but is based on the factual determination that the provider did not document services in accordance the TRICARE regulatory requirements.

2.2.2 Network Providers

Waiver of liability does not apply to services provided by network providers.