47458 Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

32 CFR Part 199 

[DOD–2008–HA–0060] 

RIN 0720–AB26 

TRICARE; Rare Diseases Definition 

AGENCY: Office of the Secretary, DoD. 

ACTION: Final rule. 

SUMMARY: This final rule revises the 

definition of rare diseases to adopt the 

definition of a rare disease as 

promulgated by the National Institutes 

of Health, Office of Rare Diseases. The 

rule modification will result in the 

definition used by the TRICARE 

program for a rare disease to be 

consistent with the definition used by 

the National Institutes of Health and the 

Food and Drug Administration. 

TRICARE has generally been applying 

the broader National Institutes of Health 

and Food and Drug Administration 

definitions when making coverage 

decisions for treatments; therefore, there 

will be no practical changes for 

beneficiaries. 

DATES: Effective Date: This rule is 

effective September 7, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Commander James Ellzy, TRICARE 

Management Activity, Office of the 

Chief Medical Officer, telephone (703) 

681–0064. 

SUPPLEMENTARY INFORMATION: 

A. Background 

On January 6, 1997, the Office of the 

Secretary of Defense published a final 

rule in the Federal Register (62 FR 627– 

631) clarifying the TRICARE exclusion 

of unproven drugs, devices and medical 

treatments and procedures and adding a 

definition of rare diseases to be used in 

the TRICARE Program. TRICARE 

defined a rare disease as one which 

affects fewer than one in 200,000 

Americans. Upon further review, 

TRICARE is revising the definition to be 

in compliance with the definition of 

other federal agencies. The Office of 

Rare Diseases was initially established 

as part of the National Institutes of 

Health in 1993 to promote research and 

collaboration on rare and orphan 

diseases. The Rare Diseases Act of 2002 

(Pub. L. 107–280) codified the 

establishment of the Office of Rare 

Diseases by adding a section 404F to the 

Public Health Service Act (42 U.S.C. 

283h). This statute defines a rare disease 

as ‘‘any disease or condition that affects 

less than 200,000 persons in the United 

States.’’ Additionally, Section 526(a)(2) 

of the Federal Food, Drug and Cosmetic 

Act (21 U.S.C. 360bb(a)(2)), provides, in 

part, that the term ‘‘rare disease or 

condition’’ means any disease or 

condition which affects less than 

200,000 persons in the United States. 

This rule modification will result in the 

definition used by the TRICARE 

program for a rare disease to be 

consistent with the definition used by 

the National Institutes of Health and the 

Food and Drug Administration. 

B. Public Comments 

The Department of Defense published 

a proposed rule on July 24, 2009 (74 FR 

36639–36640). No comments were 

received on the proposed rule before the 

comment period closed. 

C. Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ 

Section 801 of title 5, United States 

Code (U.S.C.), and Executive Order 

(E.O.) 12866 requires 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 an 

economically significant rule, or a 

significant regulatory action under the 

provisions of E.O. 12866. 

Section 202, Public Law 104–4, 

‘‘Unfunded Mandates Reform Act’’ 

It has been certified that his 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) 

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 final 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 additional 

information collection requirements on 

the public under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3511). 

Executive Order 13132, ‘‘Federalism’’ 

This final 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 

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 199.2(b) is amended by 

revising the definition of ‘‘Rare diseases’’ 

as follows: 

§ 199.2 Definitions. 

* * * * * 

(b) * * * 

Rare diseases. TRICARE/CHAMPUS 

defines a rare disease as any disease or 

condition that has a prevalence of less 

than 200,000 persons in the United 

States. 

* * * * * 

Dated: July 26, 2010. 

Patricia Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2010–19308 Filed 8–5–10; 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: Final rule. 

SUMMARY: The Department of Defense is 

publishing this final rule to clarify 

TRICARE coverage for diabetic 

education. This rule introduces new 

definitions and addresses revisions or 


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Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 47459 

omissions in policy or procedure 

inadvertently missed in previous 

regulatory changes pertaining to 

diabetic education. 

DATES: Effective Date: This final rule is 

effective September 7, 2010. 

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 final 

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 

(DSMT) 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 

DSMT as a counseling service that was 

not medically necessary. Since all 

services provided under the TRICARE 

program must be medically necessary 

and appropriate, DSMT was excluded 

from coverage. In developing the 

TRICARE policy on self-management, 

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 DSMT. As such, TRICARE 

removed ‘‘diabetic self-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 final rule 

corrects the failure to amend the 

language of the regulation and brings 

the regulation into conformance with 

the current policy. 

Section 199.4 provides basic program 

benefits. 

Section 199.4(d)(3)(ix) 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. 

Section 199.4(g)(39) is revised to 

remove diabetic self-education programs 

as an exclusion. 

Section 199.6 addresses authorized 

providers. 

Section 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. 

Section 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. 

Public Comments 

A proposed rule (74 FR 44798–44800) 

was published on August 31, 2009, and 

provided a 60-day comment period. No 

comments were received. 

Regulatory Procedures 

Executive Order 12866, ‘‘Regulatory 

Planning and Review’’ 

Section 801 of Title 5, United States 

Code (U.S.C.), and Executive Order 

(E.O.) 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 (Pub. L.) 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 final rule 

will not have a significant impact on a 

substantial number of small entities. 

Therefore, this final 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 Pub. L. 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 final 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 

final rule is not subject to this 

requirement. 

Executive Order 13132, ‘‘Federalism’’ 

E.O. 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 final rule does not 

have federalism implications, as set 

forth in E.O. 13132. 

List of Subjects in 32 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 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 


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47460 Federal Register / Vol. 75, No. 151 / Friday, August 6, 2010 / Rules and Regulations 

condition: For example, educational 

counseling, vocational counseling, 

nutritional counseling, and counseling 

for socioeconomic purposes, stress 

management, lifestyle modification. 

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 

Section 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) to read 

as follows: 

§ 199.6 TRICARE-authorized providers. 

* * * * * 

(c) * * * 

(3) * * * 

(iii) * * * 

(L) Nutritionist. A nutritionist may 

provide 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 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. 

* * * * * 

Dated: July 26, 2010. 

Patricia L. Toppings, 

OSD Federal Register Liaison Officer, 

Department of Defense. 

[FR Doc. 2010–19311 Filed 8–5–10; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[DOD–2008–HA–0025; 0720–AB20] 

32 CFR Part 199 

TRICARE: Changes Included in the 

National Defense Authorization Act for 

Fiscal Year 2007; Improvements to 

Descriptions of Cancer Screening for 

Women 

AGENCY: Office of the Secretary, DoD. 

ACTION: Final rule. 

SUMMARY: The Department is publishing 

this final rule to implement section 703 

of the National Defense Authorization 

Act (NDAA) for Fiscal Year 2007 

(FY07), Public Law 109–364. 

Specifically, that legislation authorizes 

breast cancer screening and cervical 

cancer screening for female beneficiaries 

of the Military Health System, instead of 

constraining such testing to 

mammograms and Papanicolaou smears. 

The rule allows coverage for ‘‘breast 

cancer screening’’ and ‘‘cervical cancer 

screening’’ for female beneficiaries of the 

Military Health System, instead of 

constraining such testing to 

mammograms and Papanicolaou tests. 

This rule ensures new breast and 

cervical cancer screening procedures 

can be added to the TRICARE benefit as 

such procedures are proven to be a safe, 

effective, and nationally accepted 

medical practice. This amends the 

cancer specific recommendations for 

breast and cervical cancer screenings to 

be brought in line with the processes for 

updating other cancer screening 

recommendations. In response to public 

comment on the proposed rule, this 

final rule includes a clarification that 

the benefit encompasses screening 

based on Health and Human Services 

guidelines. 

DATES: Effective Date: This rule is 

effective September 7, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Commander James Ellzy, Office of the 

Chief Medical Officer, TRICARE 

Management Activity, telephone (703) 

681–0064. 

SUPPLEMENTARY INFORMATION: 

A. Background 

The Department of Defense updated 

coverage for screening with the use of 

the breast MRI for women in a 

designated high risk category as advised 

by the American Cancer Society. In the 

process of providing this additional 

coverage, it was discovered that because 

of statutory wording, there was a group 

of high risk women that are standard 

beneficiaries under the age of 35 for 

whom this coverage could not be 

provided without an amendment in the 

Code of Federal Regulations (CFR). 

Amending the CFR will provide 

coverage for breast MRI screening for all 

Department of Defense beneficiaries in 

the high risk category recommended by 

the American Cancer Society. 

B. Public Comments 

The Department of Defense published 

a proposed rule on July 24, 2009 (74 FR 

36638–36639). A single comment was 

received asking that the language be 

written more clearly. The final rule 

includes language in section (g)(37)(viii) 

that is more precise in terms of which 

cancers will be covered and notes that 

cervical and breast cancer screenings 

will be provided in accordance with the 

standards based on the guidelines from 

the U.S. Department of Health and 

Human Services. 

C. Regulatory Procedures 

Executive Order (EO) 12866 and 

Regulatory Flexibility Act 

E.O. 12866 requires 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. 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 that would 

have a significant impact on a 

substantial number of small entities. 

This rule is not an economically 

significant regulatory action and 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 any of these 

requirements. This rule, although not 

economically significant, is a significant 

rule under E.O. 12866 and has been 

reviewed by the Office of Management 

and Budget. Amending the CFR will 

provide coverage for breast MRI 

screening for all Department of Defense 

beneficiaries in the high risk category, if 

necessary. It is critically important that 

we eliminate any potential gaps in 

coverage for high risk individuals as 

quickly as possible. 

Paperwork Reduction Act 

This rule will not impose additional 

information collection requirements on 

the public under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3511). 

Unfunded Mandates Reform Act 

It has been certified that this rule does 

not contain a Federal mandate that may 

result in the expenditure by State, local 

and tribunal governments, in aggregate, 

or by the private section, of $100 

million or more in any one year. 

Executive Order (EO) 13132 

We have examined the impact(s) of 

the final rule under E.O. 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 


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