Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Rules and Regulations 12951 

§ 50.3 Definitions. 

* * * * * 

(n) Assent means a child’s affirmative 

agreement to participate in a clinical 

investigation. Mere failure to object 

should not, absent affirmative 

agreement, be construed as assent. 

* * * * * 

(r) Permission means the agreement of 

parent(s) or guardian to the 

participation of their child or ward in a 

clinical investigation. 

(s) Guardian means an individual 

who is authorized under applicable 

State or local law to consent on behalf 

of a child to general medical care. 

■ 3. Revise § 50.51 to read as follows: 

§ 50.51 Clinical investigations not 

involving greater than minimal risk. 

Any clinical investigation within the 

scope described in §§ 50.1 and 56.101 of 

this chapter in which no greater than 

minimal risk to children is presented 

may involve children as subjects only if 

the IRB finds that: 

(a) No greater than minimal risk to 

children is presented; and 

(b) Adequate provisions are made for 

soliciting the assent of the children and 

the permission of their parents or 

guardians as set forth in § 50.55. 

■ 4. Revise the introductory text of 

§ 50.52 to read as follows: 

§ 50.52 Clinical investigations involving 

greater than minimal risk but presenting the 

prospect of direct benefit to individual 

subjects. 

Any clinical investigation within the 

scope described in §§ 50.1 and 56.101 of 

this chapter in which more than 

minimal risk to children is presented by 

an intervention or procedure that holds 

out the prospect of direct benefit for the 

individual subject, or by a monitoring 

procedure that is likely to contribute to 

the subject’s well-being, may involve 

children as subjects only if the IRB finds 

that: 

* * * * * 

■ 5. Revise the introductory text of 

§ 50.53 to read as follows: 

§ 50.53 Clinical investigations involving 

greater than minimal risk and no prospect 

of direct benefit to individual subjects, but 

likely to yield generalizable knowledge 

about the subjects’ disorder or condition. 

Any clinical investigation within the 

scope described in §§ 50.1 and 56.101 of 

this chapter in which more than 

minimal risk to children is presented by 

an intervention or procedure that does 

not hold out the prospect of direct 

benefit for the individual subject, or by 

a monitoring procedure that is not likely 

to contribute to the well-being of the 

subject, may involve children as 

subjects only if the IRB finds that: 

* * * * * 

■ 6. Revise paragraph (a) of § 50.54 to 

read as follows: 

§ 50.54 Clinical investigations not 

otherwise approvable that present an 

opportunity to understand, prevent, or 

alleviate a serious problem affecting the 

health or welfare of children. 

* * * * * 

(a) The IRB finds that the clinical 

investigation presents a reasonable 

opportunity to further the 

understanding, prevention, or 

alleviation of a serious problem 

affecting the health or welfare of 

children; and 

* * * * * 

■ 7. Revise paragraph (e) of § 50.55 to 

read as follows: 

§ 50.55 Requirements for permission by 

parents or guardians and for assent by 

children. 

* * * * * 

(e) In addition to the determinations 

required under other applicable sections 

of this subpart D, the IRB must 

determine, in accordance with and to 

the extent that consent is required under 

part 50, that the permission of each 

child’s parents or guardian is granted. 

(1) Where parental permission is to be 

obtained, the IRB may find that the 

permission of one parent is sufficient for 

clinical investigations to be conducted 

under § 50.51 or § 50.52. 

(2) Where clinical investigations are 

covered by § 50.53 or § 50.54 and 

permission is to be obtained from 

parents, both parents must give their 

permission unless one parent is 

deceased, unknown, incompetent, or 

not reasonably available, or when only 

one parent has legal responsibility for 

the care and custody of the child. 

* * * * * 

PART 56—INSTITUTIONAL REVIEW 

BOARDS 

■ 8. The authority citation for 21 CFR 

part 56 continues to read as follows: 

Authority: 21 U.S.C. 321, 343, 346, 346a, 

348, 350a, 350b, 351, 352, 353, 355, 360, 

360c–360f, 360h–360j, 371, 379e, 381; 42 

U.S.C. 216, 241, 262, 263b–263n. 

■ 9. Revise in § 56.109 the second 

sentence of paragraph (h) to read as 

follows: 

§ 56.109 IRB review of research. 

* * * * * 

(h) * * * When some or all of the 

subjects in a study that was ongoing on 

April 30, 2001, are children, an IRB 

must conduct a review of the research 

to determine compliance with part 50, 

subpart D of this chapter, either at the 

time of continuing review or, at the 

discretion of the IRB, at an earlier date. 

Dated: February 21, 2013. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2013–04387 Filed 2–25–13; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[Docket ID: DOD–2011–HA–0059] 

RIN 0720–AB52 

TRICARE; Elimination of the NonAvailability Statement (NAS) 

Requirement for Non-Emergency 

Inpatient Mental Health Care 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Final rule. 

SUMMARY: This final rule eliminates the 

requirement that states a NAS is needed 

for non-emergency inpatient mental 

health care in order for a TRICARE 

Standard beneficiary’s claim to be paid. 

Currently, NAS are required for nonemergency inpatient mental health care 

for TRICARE Standard beneficiaries 

who live within a military treatment 

facility catchment area. At this time, the 

number of NASs issued is negligible as 

most mental health admissions are 

emergency admissions. Requiring a NAS 

for a relatively few non-emergency 

inpatient mental health admissions is 

disproportionate to the cost of 

maintaining the systems necessary to 

process and coordinate the NAS. 

DATES: Effective March 28, 2013. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Richard Hart, TRICARE Policy and 

Operations, TRICARE Management 

Activity, 5111 Leesburg Pike, Suite 810, 

Falls Church, VA 22041, 703–681–0047. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

I. Purpose of This Regulatory Action 

a. Currently, NAS are required for 

non-emergency inpatient mental health 

care for TRICARE Standard beneficiaries 

who live within a military treatment 

facility catchment area. Pursuant to 

section 1080(c)(2) of title 10, United 

States Code, the Secretary can waive the 

requirement to obtain NASs following 

an evaluation of the effectiveness of 

such statements in optimizing the use of 


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12952 Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Rules and Regulations 

facilities of the uniformed services. At 

this time, the number of NASs issued is 

negligible as most mental health 

admissions are emergency admissions. 

Requiring a NAS for a relatively few 

non-emergency inpatient mental health 

admissions is disproportionate to the 

cost of maintaining the systems 

necessary to process and coordinate the 

NAS. This final rule eliminates the 

requirement for a NAS for nonemergency inpatient mental health care 

in order for the TRICARE Standard 

beneficiary’s claim to be paid. 

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

chapter 55. 

II. Summary of the Major Provisions of 

This Regulatory Action 

This final rule eliminates the 

requirement for a NAS for nonemergency inpatient mental health care 

in order for the TRICARE Standard 

beneficiary’s claim to be paid. 

The elimination of the requirement 

for a NAS for non-emergency inpatient 

mental health care for TRICARE 

Standard beneficiaries is separate and 

distinct from the ongoing right of first 

refusal for specialty services requested 

by a civilian provider under TRICARE 

Prime, if the services are available at the 

MTF, or the ongoing statutory 

requirement for preadmission 

authorization before inpatient mental 

health services may be provided. This 

final rule does not eliminate the right of 

first refusal or requirement for 

preadmission authorization. 

In reviewing the proposed rule, we 

discovered that we had inadvertently 

deleted not only the requirement to 

obtain a NAS for non-emergency 

inpatient mental health services for 

TRICARE Standard beneficiaries living 

within the 40-mile catchment area of a 

military treatment facility, but also the 

Department’s general implementation of 

section 721 of Public Law 106–398, as 

amended by section 735 of Public Law 

107–107, regarding the Secretary’s 

statutory authority to require a NAS. We 

have remedied that oversight in this 

final rule, thereby preserving the option 

to impose the requirement to obtain 

NASs in the future, consistent with 

existing statutory authority, should 

circumstances change and a 

demonstration be made that, by 

performing specific procedures at 

affected military medical treatment 

facilities, use of such facilities would be 

optimized and significant costs avoided. 

Section 199.4(a)(9) is thereby amended 

to retain this general authority while 

still eliminating the current requirement 

to obtain a NAS for non-emergency 

inpatient mental health services. 

III. Costs and Benefits of This 

Regulatory Action 

There are no anticipated budgetary 

health care cost increases. Requiring a 

NAS for a relatively few non-emergency 

inpatient mental health admissions is 

disproportionate to the cost of 

maintaining the systems necessary to 

process and coordinate the NAS. 

Public Comments 

The proposed rule was published in 

the Federal Register on September 16, 

2011 (76 FR 57690). No public 

comments were received. 

Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ and Executive 

Order 13563, ‘‘Improving Regulation 

and Regulatory Review’’ 

Executive Order 12866 requires that a 

comprehensive regulatory impact 

analysis be performed on any 

economically significant regulatory 

action, defined as one that would result 

in an annual effect of $100 million or 

more on the national economy or which 

would have other substantial impacts. 

This final rule is not economically 

significant nor a significant regulatory 

action as defined under these executives 

orders. 

Sec. 202, Public Law 104–4, ‘‘Unfunded 

Mandates Reform Act’’ 

This rule does not contain unfunded 

mandates. It 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 1 year. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. 601) 

The Regulatory Flexibility Act (RFA) 

requires that each Federal Agency 

prepare, and make available for public 

comment, a regulatory flexibility 

analysis when the agency issues a 

regulation which would have a 

significant impact on a substantial 

number of small entities. This final rule 

will not have a significant impact on a 

substantial number of small entities for 

purposes of the RFA. Thus this final 

rule is not subject to this requirement. 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3511) 

This final rule will not impose 

additional reporting or recordkeeping 

requirements under the Paperwork 

Reduction Act of 1995. 

Executive Order 13132, ‘‘Federalism’’ 

We have examined the impacts of the 

rule under Executive Order 13132 and 

it does not have policies that have 

federalism implications that would have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government, therefore, 

consultation with State and local 

officials is not required. 

List of Subjects in 32 CFR Part 199 

Claims, Dental health, Health care, 

Health insurance, Individuals with 

disabilities, Military personnel. 

Accordingly, 32 CFR part 199 is 

amended 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. Section 199.4 is amended by 

revising paragraph (a)(9) to read as 

follows: 

§ 199.4 Basic program benefits. 

* * * * * 

(a) * * * 

(9) Nonavailability Statements within 

a 40-mile catchment area. Unless 

required by action of the Assistant 

Secretary of Defense for Health Affairs 

(ASD(HA)) under this paragraph (a)(9), 

nonavailability statements are not 

required. If they are required by 

ASD(HA) action, in some geographic 

locations, CHAMPUS beneficiaries not 

enrolled in TRICARE Prime may be 

required to obtain a nonavailability 

statement from a military medical 

treatment facility in order to receive 

specifically identified health care 

services from a civilian provider. If the 

required care cannot be provided 

through the Uniformed Service facility, 

the hospital commander, or a designee, 

will issue a Nonavailability Statement 

(NAS) (DD Form 1251). Failure to secure 

such a statement may waive the 

beneficiary’s rights to benefits under 

CHAMPUS/TRICARE. 

(i) With the exception of maternity 

services, the ASD(HA) may require an 

NAS prior to TRICARE cost-sharing for 

additional services from civilian sources 

if such services are to be provided to a 

beneficiary who lives within a 40-mile 

catchment area of an MTF where such 

services are available and the ASD(HA): 

(A) Demonstrates that significant costs 

would be avoided by performing 

specific procedures at the affected MTF 

or MTFs; or 

(B) Determines that a specific 

procedure must be provided at the 


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Federal Register / Vol. 78, No. 38 / Tuesday, February 26, 2013 / Rules and Regulations 12953 

affected MTF or MTFs to ensure the 

proficiency levels of the practitioners at 

the MTF or MTFs; or 

(C) Determines that the lack of NAS 

data would significantly interfere with 

TRICARE contract administration; and 

(D) Provides notification of the 

ASD(HA)’s intent to require an NAS 

under this authority to covered 

beneficiaries who receive care at the 

MTF or MTFs that will be affected by 

the decision to require an NAS under 

this authority; and 

(E) Provides at least 60-day 

notification to the Committees on 

Armed Services of the House of 

Representatives and the Senate of the 

ASD(HA)’s intent to require an NAS 

under this authority, the reason for the 

NAS requirement, and the date that an 

NAS will be required. 

(ii) Rules in effect at the time civilian 

medical care is provided apply. The 

applicable rules and regulations 

regarding Nonavailability Statements in 

effect at the time the civilian care is 

rendered apply in determining whether 

a NAS is required. 

(iii) The Director, TMA is responsible 

for issuing the procedural rules and 

regulations regarding Nonavailability 

Statements. Such rules and regulations 

should address: 

(A) When and for what services a 

NAS is required. However, a NAS may 

not be required for services otherwise 

available at an MTF located within a 40- 

mile radius of the beneficiary’s 

residence when another insurance plan 

or program provides the beneficiary’s 

primary coverage for the services. This 

requirement for an NAS does not apply 

to beneficiaries enrolled in TRICARE 

Prime, even when those beneficiaries 

use the point-of-service option under 

§ 199.17(n)(3) of this part; and 

(B) When and how notifications will 

be made to a beneficiary who is not 

enrolled in TRICARE Prime as to 

whether or not he or she resides in a 

geographic area that requires obtaining 

a NAS; and 

(C) What information relating to 

claims submissions, including the 

documentation, if any, that is required 

to document that a valid NAS was 

issued. However, when documentation 

of a NAS is required, then that 

documentation shall be valid for the 

adjudication of CHAMPUS claims for all 

related care otherwise authorized by 

this part which is received from a 

civilian source while the beneficiary 

resided within the Uniformed Service 

facility catchment area which issued the 

NAS. 

(iv) In the case of any service subject 

to a NAS requirement under this 

paragraph (a)(9) and also subject to a 

preadmission (or other pre-service) 

authorization requirement under § 199.4 

or § 199.15 of this part, the 

administrative processes for the NAS 

and pre-service authorization may be 

combined. 

* * * * * 

Dated: February 1, 2013. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2013–03418 Filed 2–25–13; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[Docket ID: DOD–2011–HA–0035] 

RIN 0720–AB49 

TRICARE; TRICARE Sanction 

Authority for Third-Party Billing Agents 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Final rule. 

SUMMARY: This final rule will provide 

the Director, TRICARE Management 

Activity (TMA), or designee, with the 

authority to sanction third-party billing 

agents by invoking the administrative 

remedy of exclusion or suspension from 

the TRICARE program. Such sanctions 

may be invoked in situations involving 

fraud or abuse on the part of third-party 

billing agents that prepare or submit 

claims presented to TRICARE for 

payment. 

DATES: Effective date: This rule is 

effective March 28, 2013. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Ann N. Fazzini, Medical Benefits and 

Reimbursement Branch, TMA, 

telephone, (303) 676–3803. 

SUPPLEMENTARY INFORMATION: 

I. Executive Summary and Overview 

A. Purpose of the Regulatory Action 

As stated in the proposed rule, 

TRICARE has regulatory authority under 

32 Code of Federal Regulations (CFR) 

199.9 to invoke sanctions in situations 

involving fraud or abuse on the part of 

providers of TRICARE services. A 

provider is defined in 32 CFR 199.2 as, 

‘‘A hospital or other institutional 

provider, a physician, or other 

individual professional provider, or 

other provider of services or supplies as 

specified in § 199.6 of this part.’’ Thirdparty billing agents do not meet the 

definition of a provider as stated in 32 

CFR 199.2, nor do TRICARE regulations 

currently define third-party billing 

agents. 

Title 42 of the CFR subpart C— 

Exclusions at 42 CFR 402.200(b)(1) 

provides for the imposition of an 

exclusion from the Medicare and 

Medicaid programs (and, where 

applicable, other Federal health care 

programs) against persons that violate 

the provisions provided in § 402.1(e) 

(and further described in § 402.1(c)). 

However, TRICARE had no independent 

regulatory authority to sanction or 

exclude third-party billing agents. This 

final rule provides that authority. 

B. Summary of Major Provisions 

This final rule establishes that such 

entities, when acting on behalf of a 

provider, are held to an equal standard 

in regard to accuracy and honesty when 

filing claims for services and supplies 

under the TRICARE program. As such, 

these entities should be subject to the 

same administrative controls applied to 

providers in ensuring that funds are 

disbursed appropriately. This rule will 

allow TRICARE to sanction third-party 

billing agents to prevent the payment of 

false or improper billings. 

C. Summary of Costs and Benefits 

By expanding the scope of 

sanctioning authority to include thirdparty billing agents, TRICARE costs are 

not anticipated to increase in this area. 

Rather, by expanding the sanctioning 

authority to include third-party billing 

agents in situations of fraud or abuse, 

the program is safeguarding benefit 

dollars from being expended for 

fraudulent or abusive charges. The 

anticipated result of this final rule is a 

savings benefit to the program. 

II. Department of Defense Inspector 

General Report on TRICARE Controls 

Over Claims Prepared by Third-Party 

Billing Agents 

The Department of Defense, Office of 

Inspector General (DoD IG) initiated an 

audit in February 2008 to review 

TRICARE controls over claims 

submitted by third-party billing agents 

(Department of Defense Inspector 

General Report No. D–2009–037— 

‘‘TRICARE Controls Over Claims 

Prepared by Third-Party Billing 

Agencies’’). The DoD IG published a 

report on December 31, 2008. The report 

included a recommendation that the 

Director, TMA strengthen internal 

controls by initiating action to obtain 

statutory or regulatory authority to 

sanction billing agencies or any entities 

that prepare or submit improper health 

care claims to TRICARE contractors. 


wreier-aviles on DSK5TPTVN1PROD with RULES