T-5 Draft TPM.pdf

TRICARE Policy Manual 6010.60-M, June 1, 2020 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

Chapter 1

Administration

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/Veterans Health Administration (DVA/VHA) And Department Of Defense/Defense Health Agency (DoD/DHA) 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

14.3 Advance Care Planning (ACP) Services

Chapter 1 Section 1.1

General Policy And Responsibilities

Issue Date:

Authority: 32 CFR 199

1.0 PROGRAM DESCRIPTION

TRICARE is the Department of Defense’s (DoD) program to deliver a comprehensive managed health care program which is closely integrated with the Military Medical Treatment Facilities (MTFs) of the DoD. The TRICARE program is established for the purpose of implementing a comprehensive managed health care program for the delivery and financing of health care services in the Military Health System.

2.0 OFFICE OF RECORD

The Medical Benefits and Reimbursement 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&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 Through December 31, 2017, 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. Market/MTF Directors have the authority and responsibility to set priorities for enrollment to Market/MTF PCMs. When a Market’s/MTF’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

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. This option is terminated as of December 31, 2017 and replaced by TRICARE Select.

3.1.3 TRICARE Standard Plan

The TRICARE Standard plan is a fee-for-service program. This option is terminated as of December 31, 2017 and replaced by TRICARE Select.

3.2 Beginning January 1, 2018, the TRICARE program consists of three options:

TRICARE Prime, TRICARE Select, and TRICARE For Life (TFL). See 10 United States Code (USC) 1072(7).

3.2.1 TRICARE Prime Plan

TRICARE Prime is a Health Maintenance Organization (HMO)-like program. It generally features use of MTFs and substantially reduced out-of-pocket costs for authorized care provided outside MTFs. Beneficiaries generally agree to use MTFs and designated civilian provider networks and to follow certain managed care rules and procedures. Beneficiaries who enroll in TRICARE Prime are assigned or select a PCM. A PCM is a provider of primary care, who furnishes or arranges for all health care services required by the Prime enrollee. Market/MTF Directors have the authority and responsibility to set priorities for enrollment to Market/MTF PCMs. When a Market’s/MTF’s primary care capacity is full, civilian PCMs, who are all part of the contractor’s network, are available to provide care to patients.

3.2.2 TRICARE Select Plan

TRICARE Select is a self-managed, Preferred Provider Organization (PPO) program.

It allows beneficiaries to use the TRICARE civilian provider network, with reduced out-of-pocket costs compared to care from non-network providers, as well as military facilities (where they exist and when space is available). Similar to the long-operating “TRICARE Extra” and “TRICARE Standard” plans, which this replaces, a major feature of TRICARE Select is that enrollees will not have restrictions on their freedom of choice with respect to health care providers. TRICARE Select is based primarily on 10 USC 1075 (as added by Section 701 of National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2017 and 10 USC 1097.

3.2.3 TFL Plan

TFL is the Medicare wraparound coverage plan under 10 USC 1086(d).

3.3 Eligibility for TRICARE

3.3.1 Active Duty Eligibility

All active duty members are considered TRICARE Prime. When qualified, active duty members may be eligible for enrollment in the TRICARE Prime Remote (TPR) program (see the TRICARE Operations Manual (TOM) for PCM provisions for TPR).

3.3.2 Non-Active Duty Eligibility

All individuals entitled to civilian health care under 10 USC Sections 1079 or 1086, are eligible for TRICARE. Beginning January 1, 2018, beneficiaries other than TFL beneficiaries must enroll in a TRICARE plan to receive care outside the Direct Care (DC) only system. 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 10 USC Section 1072(2). Not included are those individuals who are entitled to care in the DC system, on a space available basis, but ordinarily are not entitled to civilian care, such as family member parents and parents-in-law.

3.3.3 TFL and Medicare Wraparound Coverage

3.3.3.1 TFL

3.3.3.1.1 By law, 10 U.S.C. 1072(13), "The term 'TRICARE for Life' means the Medicare wraparound coverage option of the TRICARE program made available to the beneficiary by reason of section 1086(d) of this title." Section 1086(d) (i.e., TFL) only applies to those beneficiaries otherwise eligible under section 1086(c) who become eligible for Medicare Part A: specifically, Section 1086(c)(1) are members and former members entitled to retired or retainer pay (i.e., eligible under section 1074(b)) and their dependents other than parents/parents-in-law (i.e., eligible under section 1076(b)); 1086(c)(2) are surviving dependents; and 1086(c)(3) are certain former spouses.

3.3.3.1.2 Pursuant to Section 712 of the NDAA 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.

3.3.3.1.3 TFL beneficiaries older than age 65 cannot enroll in TRICARE Prime (exception for grandfathered Uniformed Services Family Health Plan (USFHP) enrollees).

3.3.3.1.4 Retirees and their family members under age 65 who have Medicare coverage due to disability or with end stage renal disease can enroll in TRICARE Prime if they have Medicare Part B. Their TRICARE Prime enrollment fees are waived if they have Part B coverage.

3.3.3.1.5 Retirees, dependents, and survivors who are not entitled to premium-free Medicare Part A on their own record, or the record of their current, former, or deceased spouse may enroll in TRICARE Prime or TRICARE Select. Enrollment fees are not waived.

3.3.3.1.6 Retirees, dependents, and survivors with any Medicare coverage at any age are not eligible to enroll in TRICARE Select because they are excluded from the “Retired Category” for TRICARE Select as defined in 10 USC 1075(b)(1)(B).

3.3.3.2 Other Medicare Wraparound Coverage:

3.3.3.2.1 Eligible beneficiaries other than those listed paragraph 3.3.3.1.1 who are eligible for Medicare A may qualify for Medicare wraparound coverage.

3.3.3.2.2 Active Duty Service Members (ADSMs): ADSMs with Medicare Part A qualify for Medicare wraparound coverage without enrolling in Medicare Part B. ADSMs may only enroll in in TRICARE Prime or TRICARE Prime Remote (when qualified).

3.3.3.2.3 Active Duty Family Members (ADFMs):

3.3.3.2.3.1 ADFMs with Medicare Part A and enrolled in Medicare Part qualify for Medicare wraparound coverage and are not required to enroll in either TRICARE Prime or TRICARE Select. Their claims are processed according to TFL claims rules.

3.3.3.2.3.2 ADFMs with Medicare Part A but not Medicare Part B must elect to enroll in either TRICARE Prime (where available) or TRICARE Select for their TRICARE coverage to qualify as Medicare wraparound coverage.

3.3.3.2.4 TRICARE Retired Reserve (TRR), TRICARE Reserve Select (TRS), and TRICARE Young Adult (TYA) Enrollees: Enrollees in these plans with Medicare Part A and/or Medicare Part B have their claims processed as Medicare wraparound coverage which is dependent whether they have Medicare A, Medicare B, or both.

3.3.4 Supplemental Health Care Program (SHCP) and TPR Program

See the TOM, Chapters 16 and 17.

3.3.5 Non-DoD TRICARE Eligibles

TRICARE eligibles sponsored by non-DoD uniformed services (the Public Health

Service (PHS), the U.S. Coast Guard (USCG), and the National Oceanic and Atmospheric Administration (NOAA)) are eligible for TRICARE and may enroll in TRICARE Prime or TRICARE Select (beginning January 1, 2018).

3.3.6 North Atlantic Treaty Organization (NATO) And Partnership For

Peace (PfP) Beneficiaries

The Department of Defense equates foreign military members and family members from PfP countries the same as those from NATO Status of Forces Agreement (SOFA) countries, in terms of access to outpatient medical and dental care from DoD medical and dental treatment facilities, and access to TRICARE Select (TRICARE Standard before January 1, 2018) civilian care. A current list of NATO SOFA countries is at: https://www.nato.int/cps/ie/natohq/topics_52044.htm. A current list of NATO PfP countries is at: https://www.nato.int/cps/en/natohq/51288.htm.

3.3.6.1 NATO or PfP ADSM

The contractor shall use only the DEERS claims eligibility response to determine eligibility for TRICARE-covered services for active duty members of the armed forces of NATO and PfP nations. As specified in applicable SOFAs, active duty members of the armed forces of NATO and PfP nations qualify for TRICARE outpatient services in similar fashion as their U.S.

Armed Forces active duty counterparts. However, there is no coverage for inpatient services under TRICARE. No enrollment in a TRICARE plan is required or authorized. See the TOM, Chapter 17, Section 3, and TRM, Chapter 4, Sections 2 and 4 for more information.

3.3.6.2 NATO or PfP Family Members

The contractor shall not use the Government furnished web-based enrollment system/application to determine eligibility Family members of active duty members of the armed forces of NATO and PfP nations are only eligible for outpatient care under TRICARE; there is no coverage for inpatient services under TRICARE. Effective January 1, 2018, TRICARE Select Group B cost-shares for Active Duty Family Members (ADFMs) apply. Prior to January 1, 2018, TRICARE Standard/Extra cost-shares for ADFMs apply. No enrollment in a TRICARE plan is required or authorized.. See TOM, Chapter 17, Section 3; TRM, Chapter 2, Section 2, and Chapter 4, Sections 2 and 4; and TRICARE Systems Manual (TSM), Chapter 2, Addendum L for more information.

3.3.7 Enrollment

Starting in calendar year 2018, beneficiaries other than active duty members and TFL beneficiaries need to elect to enroll in TRICARE Select or TRICARE Prime in order to be covered by the private sector care portion of TRICARE.

3.3.7.1. Open Season

3.3.7.1.1 TRICARE Select or TRICARE Prime: Enrollment will be done during an open season period prior to the beginning of each plan year, which operates with the calendar year.

An enrollment choice will be effective for the plan year. As an exception to the open season enrollment rule, enrollment changes can be made during the plan year for certain Qualifying Life Events (QLEs), such as a change in eligibility status, marriage, divorce, birth of a new family member, relocation, loss of Other Health Insurance (OHI), or other events. Beneficiaries eligible to enroll in TRICARE Prime or TRICARE Select plans who do not enroll or fail to qualify to maintain their TRICARE Prime or TRICARE Select enrollment status no longer have coverage under the TRICARE Program (including the TRICARE retail pharmacy and Mail Order Pharmacy (MOP) programs), and may not re-enroll until the following annual open season enrollment period or until the sponsor or an eligible family member experiences a QLE, whichever comes first.

3.3.7.1.2 Such beneficiaries eligible to enroll in TRICARE Prime or TRICARE Select do not lose any statutory entitlement to space-available care in Markets/MTFs.

3.3.7.2 Open Enrollment

https://www.nato.int/cps/ie/natohq/topics_52044.htm https://www.nato.int/cps/en/natohq/51288.htm

TRS, TRR and TYA have open enrollment, i.e., they may elect to enroll in coverage at any time when qualified and not subject to being locked out for failure to pay premiums. The plan effective date of coverage is the date the completed request is received by the contractor or a date up to 90 calendar days in the future as specified by the requestor as indicated on the request. (See the TOM, Chapter 22, Section 8.)

Note: Included in all of the TRICARE benefit packages is a retail pharmacy network and a mail service pharmacy program. Beneficiaries must be enrolled to a TRICARE private sector plan or to Continued Health Care Benefits Program (CHCBP) to receive pharmacy services outside the direct care system.

3.4 Administrative Policy

3.4.1 Benefit Policy

3.4.1.1 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.

3.4.1.2 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.

3.4.1.3 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.

3.4.2 Program Policy

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

3.4.2.1 The contractor shall ensure that, in cases where the TPM is silent regarding a specific drug, device, procedure, or service, or specific HCPCS, CPT, or other descriptor, care reimbursed is medically or psychologically necessary for the treatment of a covered condition, in accordance with statute, regulation, and TRICARE policy (including applicable general policy provisions).

3.4.2.2 The contractor shall, upon request, provide the utilization management (UM) criteria or clinical review utilized for services that: (1) exceed 1000 claims, annually; or (2) have an allowable charge for a claim line in excess of $1,000. The UM criteria or clinical review criteria shall be made available to the DHA within five business days of request.

3.4.2.3 The contractor shall make available on a public-facing website its medical coverage policies for drugs, devices, and procedures that meet the criteria in paragraph 3.4.2.2, and ensure that these policies comply with all the requirements in the TRICARE Policy Manual. The medical coverage policies shall include, but is not limited to, the procedure in question, whether the procedure in question is covered or not covered, any limitations on or requirements for coverage, and applicable HCPCS, CPT, and ICD-10 codes.

3.4.3 The contractor shall describe in writing and submit to the Government Designated Authority (GDA) 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,.

3.4.4 Reimbursement Policy

3.4.4.1 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.

3.4.4.2 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.

3.5 Administrative and Effective Dates

3.5.1 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 DHA.

3.5.2 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 DHA 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.

3.5.3 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, 2004). 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.

3.5.4 Implementation Date

The contractor shall readjudicate any denied claim affected by the policy that is brought to the contractor’s attention by any source. 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 DHA and the contractor. Unless otherwise directed by DHA, contractors are not to identify finalized claims for readjudication under revised or new policy.

The contractor shall adjudicate pending claims and denied claims in reconsideration using the current applicable policy.

4.0 GENERAL RESPONSIBILITIES

4.1 Regional, Government Designated Authority (GDA)

The Regional GDA, working with all the Markets/MTFs/ 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 Regional GDA is a contractor with responsibility for establishing a network of health care providers to supplement the care available at the Markets/MTFs and for performing a variety of health care administrative services on behalf of the

Regional GDAs. The Regional GDA are also responsible for planning and delivering services to meet the health needs of the beneficiaries in the region, whether through the Markets/MTFs or the contractor. The Regional GDA 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 Market/Military Medical Treatment Facility (MTF) Directors

Market Directors/MTF Directors are responsible for managing health care delivery for the active duty personnel and TRICARE eligibles who are enrolled in Prime with Market/MTF PCMs, as well as for providing care to other TRICARE and the MHS beneficiaries who are eligible for care in Markets/MTFs. The Market Director/MTF Director sets priorities for assignment of Market/MTF 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 Managed Care Support and TRICARE Overseas Contractor

The contractor (managed care support and TRICARE Overseas) shall be responsible for establishing provider networks in those Prime Service Areas (PSAs) and Base Realignment and Closure (BRAC) sites designated by the appropriate GDA.

4.3.1 The contractor shall establish provider networks, effective January 1, 2018, in non-PSAs accessible by at least 85% of TRICARE Select enrollees in the geographic area of responsibility and in overseas areas where a preferred network provider is determined by the Defense Health Agency to be economically in the best interest of the DoD.

4.3.2 The contractor shall establish provider networks that include both primary care providers and specialists.

4.3.3 The contractor shall ensure that first priority for referral of Prime enrollees for specialty care or inpatient care is the Market/MTF.

4.3.4 The contractor shall process all claims for all beneficiaries, except for TFL, who reside in the geographic area of responsibility and performs other tasks specified in the contracts and the manuals.

4.3.5 The TRICARE overseas contractor shall process all TFL claims when care is received overseas regardless of where the beneficiary lives.

4.4 TRICARE Medicare Eligible Program (TMEP) Contractor

The TMEP contractor shall process all TRICARE claims for services rendered within the 50 U.S. 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 Contracting Officer (CO) and the Contracting Officer’s Representative (COR) are

DHA 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 staff. The CO is the sole authority for directing the contractor or modifying provisions of the contract.

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 U.S. TRICARE Overseas Program (TOP) geographic areas of responsibility are established but operate under different procedures than TRICARE in the U.S.

5.2 The contractor shall create a provider network to support PSAs and BRAC sites, within a geographic area of responsibility.

5.3 The contractor shall provide a network, beginning January 1, 2018, to meet TRICARE Select standards.

5.4 The contractor shall establish a network as authorized by DHA to support a special Prime program; this network may be accessed by Select enrollees based on available resources, in overseas geographic areas of responsibility.

5.5 The contractor shall, in addition to support the TOP Prime program, establish a network for TOP Select enrollees only in geographical areas determined by DHA to be economically in the best interest of the DoD.

5.6 The contractor shall establish a provider network, on or before December 31, 2017, 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 -

Chapter 1 Section 1.2

Exclusions

Issue Date: June 1, 1999 Authority: 32 CFR 199.4(e)(8)(ii)(D) and (g)

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

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.

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 that are not medically necessary and appropriate for the treatment of obesity, or that are otherwise excluded from coverage (e.g., unproven or cosmetic procedures).

1.1.28 Services and supplies related to sex gender change, also referred to as sex reassignment surgery, are prohibited by Section 1079 of Title 10, United States Code (USC).

This exclusion does not apply to surgery and related medically necessary services performed to correct ambiguous genitalia which has been documented to have been present at birth (see Chapter 4, Sections 15.1, 16.1, 17.1, and Chapter 7, Sections 1.1 and 1.2).

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

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 11.1).

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, except as provided in the Clinical Preventive Services policy (see Chapter 7, Sections 2.1, 2.2, and 2.5).

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. 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.

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 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, 7.2, and 7.3).

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).

Note: For the exception for certain Prime travel expenses and non-medical attendants, see 32 CFR 199.17(n)(2)(vii) 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 (e.g., Seeing Eye dogs, hearing/handicap assistance dogs, seizure and other detection animals, service monkeys) are excluded from coverage under the Basic or ECHO programs.

Court-Ordered Care Section 1.3

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

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.

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)

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

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 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. (For reporting requirements, see Contract Data Requirements List, DD Form 1423, located in Section J of the applicable contract.) 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

Chapter 1, Section 2.1 Unproven Drugs, Devices, Medical Treatments, And Procedures example, the effective date may be 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.

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)(ii) Copyright: CPT only © 2006 American Medical Association (or such other date of publication of CPT). All Rights Reserved.

1.0 DESCRIPTION

TRICARE defines a rare disease as any disease…