44798 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (5 U.S.C. 601) 

The Regulatory Flexibility Act (RFA) 

requires 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 proposed rule will not significantly 

affect a substantial number of small 

entities for purposes of the RFA. 

Public Law 96–511, ‘‘Paperwork 

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

This rule will not impose significant 

additional information collection 

requirements on the public under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3511). Existing information 

collection requirements of the TRICARE 

and Medicare programs will be utilized. 

Executive Order 13132, ‘‘Federalism’’ 

This proposed rule has been 

examined for its impact under E.O. 

13132 and it does not contain 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 

proposed to be amended as follows: 

PART 199—[AMENDED] 

1. The authority citation for 32 CFR 

part 199 continues to read as follows: 

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

55. 

2. Section 199.2(b) is amended by 

removing the definition of Unlabeled or 

Off-Label Drugs and adding a new 

definition of Off-Label Use of a Drug or 

Device in alphabetical order to read as 

follows: 

§ 199.2 Definitions. 

* * * * * 

(b) * * * 

* * * * * 

Off-Label Use of a Drug or Device. A 

use other than an intended use for 

which the drug or device is legally 

marketed under the Federal Food, Drug, 

and Cosmetic Act. This includes any 

use that is not included in the approved 

labeling for an approved drug or 

approved device; any use that is not 

included in the cleared statement of 

intended use for a device that has been 

determined by the Food and Drug 

Administration (FDA) to be 

substantially equivalent to a legally 

marketed predicate device and cleared 

for marketing; and any use of a device 

for which a manufacturer or distributor 

would be required to seek pre-market 

review by the FDA in order to legally 

include that use in the device’s labeling. 

* * * * * 

3. Section 199.4 is amended by 

revising the third paragraph of the Note 

to paragraph (g)(15)(i)(A), and removing 

paragraph (g)(15)(iv) as follows: 

§ 199.4 Basic program benefits. 

* * * * * 

(g) * * * 

(15) * * * 

(i) * * * 

(A) * * * 

Note: * * * CHAMPUS will consider 

coverage of off-label uses of drugs and 

devices that meet the definition of Off-Label 

Use of a Drug or Device in Section 199.2(b). 

Approval for reimbursement of off-label uses 

requires review for medical necessity, and 

also requires demonstrations from reliable 

evidence, as defined in § 199.2, that the offlabel use of the drug or device is safe, 

effective and in accordance with nationally 

accepted standards of practice in the medical 

community. 

* * * * * 

Dated: August 21, 2009. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. E9–20683 Filed 8–28–09; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DoD–2009–HA–0094] 

RIN 0720–AB32 

TRICARE; Diabetic Education 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense is 

publishing this proposed rule to clarify 

TRICARE coverage for diabetic 

education. This rule introduces new 

definitions and addresses revisions or 

omissions in policy or procedure 

inadvertently missed in previous 

regulatory changes pertaining to 

diabetic education. 

DATES: Written comments received at 

the address indicated below by October 

30, 2009 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number or 

Regulatory Information Number (RIN) 

and title, by either of the following 

methods: 

The Web site: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Mail: Federal Docket Management 

System Office, Room 3C843 Pentagon, 

1160 Defense Pentagon, Washington, DC 

20301–1160. 

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:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: Joy 

Saly, Medical Benefits and 

Reimbursement Branch, TRICARE 

Management Activity, telephone (303) 

676–3742. Questions regarding payment 

of specific claims should be addressed 

to the appropriate TRICARE contractor. 

SUPPLEMENTARY INFORMATION: This 

proposed rule introduces new 

definitions and addresses revisions or 

omissions in policy or procedure 

inadvertently missed in previous 

regulatory changes pertaining to 

diabetic education. 

Diabetes self-management training is 

an interactive, collaborative process 

involving beneficiaries with diabetes, 

their physician(s) and their educators. 

The educational process should provide 

the beneficiary with the knowledge and 

skills needed to perform self-care, 

manage crises, and make lifestyle 

changes required to manage the diabetes 

successfully. 

TRICARE had previously classified 

diabetes self-management training as a 

counseling service that was not 

medically necessary. Since all services 

provided under the TRICARE program 

must be medically necessary and 

appropriate, diabetes self-management 

training was excluded from coverage. In 

developing the TRICARE policy on selfmanagement, however, it was 

determined that diabetes educational 

services are consistent with the 

medically necessary and appropriate 

provision and it was decided to conform 

with Medicare’s policy on diabetes selfmanagement training. As such, 

TRICARE removed ‘‘diabetic selfVerDate Nov<24>2008 16:24 Aug 28, 2009 Jkt 217001 PO 00000 Frm 00026 Fmt 4702 Sfmt 4702 E:\FR\FM\31AUP1.SGM 31AUP1

sroberts on DSKD5P82C1PROD with PROPOSALS
Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 44799 

management training’’ programs as an 

excluded benefit effective July 1, 1998. 

Although the policy change conflicted 

with existing regulation language, 

TRICARE determined to move forward 

with the policy change because 

TRICARE was expanding and not 

restricting a benefit, and the change was 

in line with Medicare’s benefit. This 

proposed rule corrects the failure to 

amend the language of the regulation 

and brings the regulation into 

conformance with the current policy. 

Sec. 199.4 provides basic program 

benefits. 

Sec. 199.4(d)(3)(xiv) Diabetic SelfManagement Training (DSMT) is added 

as a benefit under other covered services 

and supplies. This addition brings the 

regulation into conformance with the 

current policy. 

Sec. 199.4(g)(39) is revised to remove 

diabetic self-education programs as an 

exclusion. 

Sec. 199.6 addresses authorized 

providers. 

Sec. 199.6(c)(3)(iii)(L) adds 

Nutritionist to the list of individual 

professional providers of medical care 

authorized to provide services to 

CHAMPUS beneficiaries. 

Sec.199.6(c)(3)(iii)(M) adds Registered 

Dietitian to the list of individual 

professional providers of medical care 

authorized to provide services to 

CHAMPUS beneficiaries. 

Regulatory Procedures. 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ 

Section 801 of title 5, United States 

Code, and Executive Order 12866 

require certain regulatory assessments 

and procedures for any major rule or 

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. It has been certified 

that this rule is not a significant 

regulatory action. 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (RFA) (5 U.S.C. 601) 

Public Law 96–354, ‘‘Regulatory 

Flexibility Act’’ (RFA) (5 U.S.C. 601), 

requires that each Federal agency 

prepare a regulatory flexibility analysis 

when the agency issues a regulation 

which would have a significant impact 

on a substantial number of small 

entities. This proposed rule will not 

have a significant impact on a 

substantial number of small entities. 

Therefore, this proposed rule is not 

subject to the requirements of the RFA. 

Public Law 96–511, ‘‘Paperwork 

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

This rule does not contain a 

‘‘collection of information’’ 

requirement, and will not impose 

additional information collection 

requirements on the public under Public 

Law 96–511, ‘‘Paperwork Reduction 

Act’’ (44 U.S.C. Chapter 35). 

Public Law 104–4, Section 202, 

‘‘Unfunded Mandates Reform Act’’ 

Section 202 of Public Law 104–4, 

‘‘Unfunded Mandates Reform Act,’’ 

requires that an analysis be performed 

to determine whether any federal 

mandate may result in the expenditure 

by State, local and tribal governments, 

in the aggregate, or by the private sector 

of $100 million in any one year. 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, 

and thus this proposed rule is not 

subject to this requirement. 

Executive Order 13132, ‘‘Federalism’’ 

Executive Order 13132, ‘‘Federalism,’’ 

requires that an impact analysis be 

performed to determine whether the 

rule has 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. It has been 

certified that this proposed rule does 

not have federalism implications, as set 

forth in Executive Order 13132. 

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 

proposed to be 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 

adding paragraph (d)(3)(ix), and revising 

paragraph (g)(39) to read as follows: 

§ 199.4 Basic program benefits. 

* * * * * 

(d) * * * 

(3) * * * 

(ix) Diabetes Self-Management 

Training (DSMT). A training service or 

program that educates diabetic patients 

about the successful self-management of 

diabetes. It includes the following 

criteria: education about self-monitoring 

of blood glucose, diet, and exercise; an 

insulin treatment plan developed 

specifically for the patient who is 

insulin-dependent; and motivates the 

patient to use the skills for selfmanagement. The DSMT service or 

program must be accredited by the 

American Diabetes Association. 

Coverage limitations on the provision of 

this benefit will be as determined by the 

Director, TRICARE Management 

Activity, or designee. 

* * * * * 

(g) * * * 

(39) Counseling. Counseling services 

that are not medically necessary in the 

treatment of a diagnosed medical 

condition: For example, educational 

counseling, vocational counseling, 

nutritional counseling, and counseling 

for socioeconomic purposes, stress 

management, lifestyle modification, etc. 

Services provided by a certified 

marriage and family therapist, pastoral 

or mental health counselor in the 

treatment of a mental disorder are 

covered only as specifically provided in 

§ 199.6. Services provided by 

alcoholism rehabilitation counselors are 

covered only when rendered in a 

CHAMPUS-authorized treatment setting 

and only when the cost of those services 

is included in the facility’s CHAMPUSdetermined allowable cost rate. 

* * * * * 

3. Section 199.6 is amended by 

adding paragraphs (c)(3)(iii)(L) and (M). 

§ 199.6 TRICARE—authorized providers. 

* * * * * 

(c) * * * 

(3) * * * 

(iii) * * * 

(L) Nutritionist. A nutritionist may 

provide diabetes self-management 

training (DSMT) via an accredited 

DSMT program. The nutritionist must 

be licensed by the State in which the 

care is provided, and must be under the 

supervision of a physician who is 

overseeing the DSMT program. 

(M) Registered Dietitian. A dietitian 

may provide diabetes self-management 

training (DSMT) via an accredited 

DSMT program. The dietitian must be 

licensed by the State in which the care 

is provided, and must be under the 

supervision of a physician who is 

overseeing the DSMT program. 

* * * * * 


sroberts on DSKD5P82C1PROD with PROPOSALS
44800 Federal Register / Vol. 74, No. 167 / Monday, August 31, 2009 / Proposed Rules 

Dated: August 21, 2009. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. E9–20684 Filed 8–28–09; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DoD–2009–HA–0095] 

RIN 0720–AB33 

TRICARE; Extended Care Health 

Option 

AGENCY: Office of the Secretary, 

Department of Defense. 

ACTION: Proposed rule. 

SUMMARY: The Department of Defense is 

publishing this proposed rule to 

implement the requirements enacted by 

Congress in Section 732 of the Duncan 

Hunter National Defense Authorization 

Act for Fiscal Year 2009 which changes 

the limit of the Government’s share of 

providing certain benefits under the 

Extended Care Health Option (ECHO) 

from $2,500 per month to $36,000 per 

year, and for other non-legislated 

changes to the ECHO. 

DATES: Comments received at the 

address indicated below by October 30, 

2009 will be accepted. 

ADDRESSES: You may submit comments, 

identified by docket number and or 

Regulatory Information Number (RIN) 

number and title, by either of the 

following methods: 

• Federal Rulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, Room 3C843 Pentagon, 

1160 Defense Pentagon, Washington, DC 

20301–1160. 

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:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: 

Michael Kottyan, TRICARE 

Management Activity, Medical Benefits 

and Reimbursement Branch, telephone 

(303) 676–3520. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1079 of title 10, United States 

Code (U.S.C.), as amended by Section 

701(b) of the National Defense 

Authorization Act for Fiscal Year 2002 

[Pub. L. 107–107], required the 

Department of Defense to establish a 

program of extended benefits for eligible 

dependents. That program, known as 

the Extended Care Heath Option 

(ECHO), replaced the Program for 

Persons with Disabilities (PFPWD) and 

was implemented on September 1, 2005. 

The primary purpose of the ECHO is to 

provide eligible beneficiaries with 

benefits that are not available through 

the TRICARE Basic Program. The term 

‘‘eligible beneficiary’’ means an 

individual who is a dependent of an 

Active Duty Service Member (ADSM) or 

is a Transitional Survivor of a deceased 

ADSM and who has a qualifying 

condition. Qualifying conditions 

include moderate or severe mental 

retardation, serious physical disability, 

or an extraordinary physical or 

psychological condition. The benefits 

available through the ECHO are 

intended to assist in the reduction of the 

disabling effects of an ECHO qualifying 

condition. 

Section 1079(e)(3) and (4) authorized 

benefits, including training, 

rehabilitation, special education, 

assistive technology devices, 

institutional care in private, nonprofit, 

public, and State institutions and 

facilities and, if appropriate, 

transportation to and from such 

institutions and facilities in which the 

beneficiary is receiving institutional 

care. 

Section 1079(f)(2) limited the 

Government’s liability for benefits 

authorized by Section 1079(e) and (4) to 

$2,500 per month and required that the 

beneficiary’s sponsor be liable for any 

amount of the monthly total cost for 

those benefits that exceeded the 

Government’s limit. Section 1079(e) also 

authorized the extended benefits 

program to provide additional benefits 

including diagnostic services, inpatient 

and outpatient care, comprehensive 

home health care, respite care, and other 

services and supplies as determined 

appropriate by the Secretary. However, 

Section 1079(f) did not limit the 

Government’s liability for those 

additional benefits. By Final Rule 

published in the Federal Register on 

August 20, 2004, (69 FR 51559) the 

Department established that those 

additional benefits accrued to the 

$2,500 per month limit. 

Section 732 of the Duncan Hunter 

National Defense Authorization Act for 

Fiscal Year 2009 [Public Law 110–417] 

(NDAA 2009) changed the limit of the 

Government’s liability for benefits 

authorized under Section 1079(e)(3) and 

(4) from $2,500 per month to $36,000 

per year, prorated as determined by the 

Secretary. This rule does not prorate the 

annual limit of Government liability. 

Section 732 does not affect other 

benefits authorized under Section 

1079(e). 

This proposed rule changes the 

Government’s share of providing all 

benefits available through the Extended 

Care Health Option from $2,500 per 

month to $36,000 per fiscal year. This 

rule does not change the Government’s 

liability for benefits provided by the 

ECHO Home Health Care (EHHC) 

benefit or the EHHC Respite Care 

benefit. 

Additionally, Section 732 changed the 

sponsor’s liability for costs exceeding 

the limit of the Government’s liability 

from a per-month basis to a per-year 

basis; this rule includes that change. 

The following additional changes 

contained in this rule are further 

discussed below: deletes references to 

the PFPWD, eliminates allocating the 

allowable cost of durable equipment 

authorized for purchase through the 

ECHO, clarifies the monthly 

reimbursement for benefits received 

through the ECHO Home Health Care 

(EHHC), and allows a waiver of the 

requirement to enroll in the sponsor’s 

branch of Service Exceptional Family 

Member Program (EFMP) in order to 

register in the ECHO. 

Active Duty Family Members who 

have a qualifying condition are eligible 

to receive benefits through the ECHO. 

Qualifying conditions include moderate 

or severe mental retardation, a serious 

physical disability, or an extraordinary 

physical or psychological condition 

such that the beneficiary is homebound. 

Serious physical disabilities include 

those conditions that preclude an 

individual from the unaided 

performance of at least one major life 

activity such as breathing, cognition, 

hearing, seeing, and age appropriate 

ability essential to bathing, dressing, 

eating, grooming, speaking, stair use, 

toilet use, transferring, and walking. 

The ECHO, as the replacement for the 

PFPWD, has been fully implemented for 

several years; it is therefore appropriate 

to delete references in the regulations to 

the transition of the PFPWD to the 

ECHO. 

Durable equipment, which is defined 

as a device or apparatus which does not 

qualify as ‘‘Durable Medical 

Equipment’’ under the TRICARE Basic 

Program but which is essential to the 

efficient arrest or reduction of the 

functional loss resulting from, or the 


sroberts on DSKD5P82C1PROD with PROPOSALS