62506 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 

Dated: October 9, 2013. 

Thomas M. Harrigan, 

Deputy Administrator. 

[FR Doc. 2013–24600 Filed 10–21–13; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2013–HA–0164] 

RIN 0720–AB61 

TRICARE; Coverage of Care Related to 

Non-Covered Initial Surgery or 

Treatment 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense 

(DoD) is publishing this proposed rule 

to allow coverage for otherwise covered 

services and supplies required in the 

treatment of complications (unfortunate 

sequelae), as well as medically 

necessary and appropriate follow-on 

care, resulting from a non-covered 

incident of treatment provided pursuant 

to a properly granted Supplemental 

Health Care Program waiver. This 

proposed rule is necessary to protect 

TRICARE beneficiaries from incurring 

financial hardships due to the current 

regulatory restrictions that prohibit 

TRICARE coverage of the treatment of 

complications resulting from noncovered medical procedures, even when 

those procedures were provided while 

the beneficiary was an active duty 

member and were authorized by the 

Director, TRICARE Management 

Activity (TMA), based on a 

determination that a waiver authorizing 

the original non-covered surgery or 

treatment was necessary to assure 

adequate availability of health care to 

the Active Duty member. Additionally, 

with respect to care that is related to a 

non-covered initial surgery or treatment, 

the proposed rule seeks to eliminate any 

confusion regarding what services and 

supplies will be covered by TRICARE 

and under what circumstances they will 

be covered. 

DATES: Comments must be received on 

or before December 23, 2013. Do not 

submit comments directly to the point 

of contact or mail your comments to any 

address other than what is shown 

below. Doing so will delay the posting 

of the submission. 

ADDRESSES: You may submit comments, 

identified by docket number and/or 

Regulatory Identification Number (RIN) 

and title, by any of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 4800 Mark Center Drive, 

East Tower, Suite 02G09, Alexandria, 

VA 22350–3100. 

Instructions: All submissions received 

must include the agency name and 

docket number or RIN for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http://

regulations.gov as they are received 

without change, including any personal 

identifiers or contact information. 

FOR FURTHER INFORMATION CONTACT: 

Thomas Doss (703) 681–7512. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary 

1. Purpose of Regulatory Actions 

a. Need for Regulatory Actions 

Under the TRICARE private sector 

health care program, certain conditions 

and treatments are excluded from 

coverage. For example, any drug, 

device, medical treatment, or procedure 

whose safety and efficacy has not been 

established by reliable evidence is 

considered unproven and excluded 

from coverage. This exclusion includes 

all services directly related to the 

unproven drug, device, medical 

treatment or procedure. Specifically, 

benefits for otherwise covered services 

and supplies that are required in the 

treatment of complications (unfortunate 

sequelae) resulting from a non-covered 

incident of treatment, are generally 

excluded from TRICARE coverage 

pursuant to title 32 of the Code of 

Federal Regulation (CFR) section 

199.4(e)(9), unless the complication 

represents a separate medical condition 

such as a systemic infection, cardiac 

arrest, and acute drug reaction. 

TRICARE also excludes any needed 

follow-on care resulting from a noncovered condition or initial surgery or 

treatment pursuant to § 199.4(g)(63). 

There is currently one exception to 

this general exclusion, published in the 

Federal Register [76 FR 57642] on 

September 16, 2011, to allow coverage 

of otherwise covered services and 

supplies required in the treatment of 

complications (unfortunate sequelae) 

resulting from a non-covered incident of 

treatment provided in a Military 

Treatment Facility (MTF), when the 

initial non-covered service has been 

authorized by the MTF Commander and 

the MTF is unable to provide the 

necessary treatment of the 

complications. This current exception 

recognizes that in order to support 

Graduate Medical Education and 

maintain provider skill levels, MTF 

providers are required to perform 

medical procedures that may be 

excluded from coverage under the 

TRICARE private sector program. The 

final rule at 32 CFR199.4(e)(9)(ii) was 

viewed as necessary to protect TRICARE 

beneficiaries from incurring financial 

hardships in such cases. 

Currently, Active Duty Service 

members (ADSMs) may receive noncovered TRICARE private sector health 

care services under the Supplemental 

Health Care Program (SHCP) if a waiver 

is submitted through the Service and 

approved by the Director, TMA, or 

designee, in accordance with § 199.6(f). 

While the Department wants to ensure 

that Service members have access to the 

latest, promising medical technologies 

and procedures, there must be assurance 

that the care is safe and effective, and 

that members are not subjected to undue 

risk, or rendered unfit for continued 

service, due to complications suffered as 

a result of unproven medical care. 

Consequently, requests for non-covered 

procedures and treatments, including 

unproven care, are carefully reviewed in 

conjunction with other available, 

proven treatments, if any exist, to 

determine whether or not approval of 

the requested care is necessary to assure 

the adequate availability of health care 

to the member. Currently, Service 

members are counseled that the 

treatment remains a non-covered 

TRICARE benefit, and that any followon care, including care for 

complications, will not be covered by 

TRICARE once the member separates or 

retires. Members are left to make a 

difficult choice between pursuing a 

SHCP waiver in an effort to remain fit 

for full duty while assuming the 

financial risk of any necessary follow-on 

care after discharge, or, electing not to 

receive the care and risk separation from 

the Service. 

Like the existing exception at 32 

CFR199.4(e)(9)(ii) for non-covered care 

provided in a MTF, this proposed 

exception is narrowly tailored to serve 

a similar government interest; namely, 

protecting former active duty members 

who have received private sector care 

pursuant to a SHCP waiver in an effort 

to ensure their fitness for duty and 

continued service. 

Additionally, some confusion has 

arisen regarding the terms 

‘complication’’ and ‘‘unfortunate 

sequelae’’ as these terms are not 


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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 62507 

currently defined in regulation. 

Questions have arisen with respect to 

whether necessary follow-on care 

resulting from a non-covered procedure 

or treatment in an MTF is covered in 

situations where the MTF is unable to 

provide the necessary treatment. The 

intent of the original September 16, 

2011, final rule, as well as the current 

proposal, is to protect TRICARE 

beneficiaries from incurring financial 

hardships in limited circumstances, 

which serve valid governmental 

purposes. Absent an exception to the 

general exclusion from coverage, 

treatment of adverse outcomes, both 

expected and unexpected, as well as any 

necessary follow-on care that is a direct 

result of the initial non-covered 

treatment, are excluded and could result 

in less than optimal care (e.g., not 

receiving necessary physical therapy 

following surgery) and/or a significant 

financial hardship for the beneficiary. 

The Agency did not intend to prevent 

coverage of necessary follow-on private 

sector care in situations where an MTF 

is unable to provide that care but the 

current regulatory language is subject to 

such a narrow interpretation absent 

additional clarification. This proposal 

would permit coverage of necessary 

continued treatment, such as physical 

therapy following a non-covered 

surgical procedure in an MTF. It would 

also cover medically necessary followon care, including, for example, antirejection medications for former 

members who have received face and 

hand transplants. This proposal will 

eliminate the need to try to determine 

whether the medically necessary and 

appropriate care the patient is seeking 

from the private sector is considered to 

be treatment of an expected 

complication, an unexpected 

complication or routine follow-on care, 

because it will be clearly covered. 

b. Legal Authority for the Regulatory 

Action 

This regulation is proposed under the 

authority of 10 U.S.C. section 1073, 

which authorizes the Secretary of 

Defense to administer the medical and 

dental benefits provided in chapter 55 

of title 10, United States Code. The 

Department is authorized to provide 

medically necessary and appropriate 

treatment for mental and physical 

illnesses, injuries and bodily 

malfunctions, including hospitalization, 

outpatient care, drugs, treatment of 

medical and surgical conditions and 

other types of health care outlined in 10 

U.S.C. 1077(a). Although section 1077 

defines benefits to be provided in the 

MTFs, these benefits are incorporated 

by reference for the benefits provided in 

the civilian health care sector to active 

duty family members and retirees and 

their dependents through section 1079 

and 1086 respectively. 

2. Summary of Major Provisions of the 

Regulatory Action 

The proposed rule amends the 

existing special benefit provision 

regarding complications (unfortunate 

sequelae) resulting from non-covered 

initial surgery, to more clearly address 

what services and supplies will be 

covered by TRICARE and under what 

circumstances they will be covered. The 

provision itself is relabeled ‘‘Care 

related to non-covered initial surgery or 

treatment’’ to eliminate any confusion 

regarding what constitutes a 

complication or unfortunate sequelae 

and how broadly or narrowly the 

exclusion and exceptions to the 

exclusion should be applied. As 

amended, the regulatory section will 

specifically address coverage of 

otherwise covered medically necessary 

treatment, to include (i) coverage of 

complications that represent a separate 

medical condition; (ii) treatment of 

complications and necessary follow-on 

care resulting from a non-covered 

incident of treatment provided in an 

MTF; and (iii) treatment of 

complications and necessary follow-on 

care resulting from a non-covered 

incident of treatment provided pursuant 

to an approved SHCP waiver. Inclusion 

of the third prong will support the 

provision of care necessary to allow 

members to return to full duty and/or 

reach their maximum rehabilitative 

potential without requiring the member 

to bear the sole financial risk for 

unfortunate sequelae once they are no 

longer on active duty. This amendment 

provides consistent treatment of 

unfortunate sequelae and necessary 

follow-on care when an original episode 

of non-covered care is provided for a 

valid governmental purpose, whether to 

support Graduate Medical Education 

(GME) and maintain provider skill 

levels within an MTF or an ADSM’s 

fitness for duty through authorization of 

the purchase of otherwise non-covered 

care via an SHCP waiver. Additionally, 

the regulatory exclusion at 32 CFR 

199.4(g)(63) is amended to clearly state 

that all services and supplies related to 

a non-covered condition or treatment, 

including any necessary follow-on care 

and treatment of complications, are 

excluded from coverage except as 

provided in 32 CFR 199.4(e)(9). 

3. Summary of Costs and Benefits 

This proposed rule is not anticipated 

to have an annual effect on the economy 

of $100 million or more; therefore, it is 

not an economically significant rule 

under Executive Order 12866 and the 

Congressional Review Act. All services 

and supplies authorized under the 

TRICARE Basic Program must be 

determined to be medically necessary in 

the treatment of an illness, injury or 

bodily malfunction before the care can 

be cost shared by TRICARE. For this 

reason, DoD anticipates that TRICARE 

will have a marginal increase in cost 

associated with the inclusion of 

coverage for treatment of complications 

and necessary follow-on care for 

TRICARE beneficiaries who received 

previously authorized non-covered 

treatment pursuant to a SHCP waiver 

while on active duty. 

II. Background 

Members of the uniformed services on 

active duty are entitled to medical and 

dental care pursuant to 10 U.S.C. 1074, 

including the provision of such care in 

private facilities. 32 CFR199.16 

implements, with respect to the 

purchase of private sector health care 

services for ADSMs under the SCHP, the 

statutory authority at 10 U.S.C. 1074(c). 

As a general rule, the same rules that 

govern payment and administration of 

private sector health care claims under 

TRICARE apply to the SHCP and the 

care that members receive in private 

facilities is comparable to coverage for 

medical care under the TRICARE Prime 

program. 32 CFR 199.16(f) authorizes 

the Director of TRICARE Management 

Activity (TMA) discretionary authority 

to waive any requirements of TRICARE 

regulations, including any restrictions 

or limitations under the TRICARE Basic 

Program benefits, except those 

specifically set forth in statute, based on 

‘‘a determination that such waiver is 

necessary to assure adequate availability 

of health care to Active Duty members.’’ 

ADSMs have access to non-covered care 

including experimental or unproven 

medical care and treatments in the 

purchased care sector on a case-by-case 

basis using the SHCP waiver process. 

These case-by-case treatment decisions 

are specifically approved by the Director 

or Deputy Director of the TRICARE 

Management Activity, resulting in a 

number of ADSMs receiving otherwise 

non-covered private sector care while 

serving. 

If an ADSM is granted a waiver under 

the SCHP to receive an otherwise noncovered incident of treatment by a 

private sector provider, rather than in an 

MTF, and suffers complications from 

the care, SHCP funds can be used to 

cover necessary follow-on care and 

treatment of complications in the 

purchased care system as long as the 

member remains on active duty. Once 


tkelley on DSK3SPTVN1PROD with PROPOSALS
62508 Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Proposed Rules 

the member retires, however, SHCP 

coverage no longer exists and TRICARE 

does not cover unfortunate sequelae of 

non-covered care done in the purchased 

care sector except in limited 

circumstances (e.g. later complications 

that represent a separate medical 

condition separate from the condition 

that the non-covered treatment or 

surgery was directed toward, and the 

treatment of the complication is not 

essentially similar to the covered 

procedures. This may include a 

systemic infection, cardiac arrest, or 

acute drug reaction). Additionally, once 

retired, existing regulations would not 

allow the continuation of any needed 

follow-on care such as rehabilitative 

care or drug therapy. When these 

beneficiaries require such treatment, 

they are responsible for the payment for 

this necessary treatment resulting in 

significant financial hardship. This rule 

will address that unfortunate situation 

by allowing coverage of treatment for 

necessary follow-on care, including 

complications, resulting from the noncovered treatment provided to 

beneficiaries pursuant to a SHCP waiver 

while they were on active duty. The 

specific procedures for approval of this 

treatment will be addressed in the 

TRICARE Policy Manual rather than in 

the regulation to ensure that this 

information is current and easily 

accessible. TRICARE manuals may be 

accessed at http://www.tricare.mil. 

III. Regulatory Procedure 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ and E.O. 13563, 

‘‘Improving Regulation and Regulatory 

Review’’ 

It has been determined that this 

proposed rule is not a significant 

regulatory action. This rule does not: 

(1) Have an annual effect on the 

economy of $100 million or more or 

adversely affect in a material way the 

economy; a section of the economy; 

productivity; competition; jobs; the 

environment; public health or safety; or 

State, local, or tribunal governments or 

communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another Agency; 

(3) Materially alter the budgetary 

impact of entitlements, grants, user fees, 

or loan programs, or the rights and 

obligations of recipients thereof; or 

(4) Raise novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in these Executive Orders. 

Unfunded Mandates Reform Act (Sec. 

202, Pub. L. 104–4) 

It has been certified that this proposed 

rule does not contain a Federal mandate 

that may result in the expenditure by 

State, local and tribal governments, in 

aggregate, or by the private sector, of 

$100 million or more in any one year. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. 601) 

It has been certified that this proposed 

rule is not subject to the Regulatory 

Flexibility Act (5 U.S.C. 601) because it 

would not, if promulgated, have a 

significant economic impact on a 

substantial number of small entities. Set 

forth in the proposed rule are minor 

revisions to the existing regulation. The 

DoD does not anticipate a significant 

impact on the Program. 

Public Law 96–511, ‘‘Paperwork 

Reduction Act’’ (44 U.S.C. Chapter 35) 

It has been certified that this proposed 

rule does not impose reporting or 

recordkeeping requirements under the 

Paperwork Act of 1995. 

Executive Order 13132, Federalism 

It has been certified that this proposed 

rule does not have federalism 

implications, as set forth in Executive 

Order 13132. This rule does not have 

substantial direct effects on: 

(1) The States; 

(2) The relationship between the 

National Government and the States; or 

(3) The distribution of power and 

responsibilities among the various 

levels of Government. 

List of Subjects in 32 CFR Part 199 

Claims, Dental health, Health care, 

Health insurance, Individuals with 

disabilities, and Military personnel. 

Accordingly, 32 CFR part 199 is 

proposed to be amended to read as 

follows: 

PART 199— [AMENDED] 

■ 1. The authority citation for part 199 

continues to read as follows: 

Authority: 5 U.S.C. 301; 10 U.S.C. chapter 

55. 

■ 2. Amend § 199.4 by revising 

paragraphs (e)(9) and (g)(63) to read as 

follows: 

§ 199.4 Basic Program Benefits. 

* * * * * 

(e) * * * 

(9) Care related to non-covered initial 

surgery or treatment. (i) Benefits are 

available for otherwise covered services 

and supplies required in the treatment 

of complications resulting from a noncovered incident of treatment (such as 

nonadjunctive dental care or cosmetic 

surgery) but only if, the later 

complication represents a separate 

medical condition such as a systemic 

infection, cardiac arrest, and acute drug 

reaction. Benefits may not be extended 

for any later care or a procedure related 

to the complication that essentially is 

similar to the initial non-covered care. 

Examples of complications similar to 

the initial episode of care (and thus not 

covered) would be repair of facial 

scarring resulting from dermabrasion for 

acne. 

(ii) Benefits are available for 

otherwise covered services and supplies 

required in the treatment of 

complications (unfortunate sequelae) 

and any necessary follow-on care 

resulting from a non-covered incident of 

treatment provided in an MTF, when 

the initial non-covered service has been 

authorized by the MTF Commander and 

the MTF is unable to provide the 

necessary treatment of the 

complications or required follow-on 

care, according to the guidelines 

adopted by the Director, TMA, or a 

designee. 

(iii) Benefits are available for 

otherwise covered services and supplies 

required in the treatment of 

complications (unfortunate sequelae) 

and any necessary follow-on care 

resulting from a non-covered incident of 

treatment provided in the private sector 

pursuant to a properly granted waiver 

under § 199.16(f) of this chapter. The 

Director, TMA, or designee, shall issue 

guidelines for implementing this 

provision. 

* * * * * 

(g) * * * 

(63) Non-covered condition/

treatment, unauthorized provider. All 

services and supplies (including 

inpatient institutional costs) related to a 

non-covered condition or treatment, 

including any necessary follow-on care 

or the treatment of complications, are 

excluded from coverage except as 

provided in under paragraph (e)(9) of 

this section. In addition, all services and 

supplies provided by an unauthorized 

provider are excluded. 

* * * * * 

Dated: September 26, 2013. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2013–24233 Filed 10–21–13; 8:45 am] 

BILLING CODE 5001–06–P 


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