Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 60547

Directorate of Defense Trade Controls 

(DDTC). The office at the Department of 

State, formerly known as the Office of 

Defense Trade Controls and before that 

as the Office of Munitions Control, 

responsible for reviewing applications 

to export and reexport items on the U.S. 

Munitions List. (See 22 CFR parts 120 

through 130.)

* * * * *

PART 774—[AMENDED]

■ 11. The authority citation for part 774 

continues to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50 

U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 

7430(e); 18 U.S.C. 2510 et seq.; 22 U.S.C. 

287c, 22 U.S.C. 3201 et seq., 22 U.S.C. 6004; 

30 U.S.C. 185(s), 185(u); 42 U.S.C. 2139a; 42 

U.S.C. 6212; 43 U.S.C. 1354; 46 U.S.C. app. 

466c; 50 U.S.C. app. 5; Sec. 901–911, Pub. L. 

106–387; Sec. 221, Pub. L. 107–56; E.O. 

13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 

228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 

Comp., p. 783; Notice of August 6, 2004, 69 

FR 48763 (August 10, 2004).

■ 12. In Supplement No. 1 to Part 774, 

revise all references to the ‘‘Office of 

Defense Trade Controls’’ to read 

‘‘Directorate of Defense Trade Controls’’; 

revise all references to ‘‘Directorate of 

Defense Trade Control’’ to read 

‘‘Directorate of Defense Trade Controls’’; 

and revise all references to ‘‘DTC’’ to 

read ‘‘DDTC’’.

Dated: October 4, 2004. 

Peter Lichtenbaum, 

Assistant Secretary for Export 

Administration.

[FR Doc. 04–22861 Filed 10–8–04; 8:45 am] 

BILLING CODE 3510–33–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 520 and 558 

New Animal Drugs; Change of 

Sponsor; Sulfaquinoxaline

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor for an approved new 

animal drug application (NADA) from 

Hess & Clark, Inc., to Phoenix Scientific, 

Inc.

DATES: This rule is effective October 12, 

2004.

FOR FURTHER INFORMATION CONTACT:

David R. Newkirk, Center for Veterinary 

Medicine (HFV–100), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–6967, email: david.newkirk@fda.gov.

SUPPLEMENTARY INFORMATION: Hess & 

Clark, Inc., 944 Nandino Blvd., 

Lexington, KY 40511, has informed FDA 

that it has transferred ownership of , 

and all rights and interest in, the 

following three approved NADAs, to 

Phoenix Scientific, Inc., 3915 South 

48th Street Ter., St. Joseph, MO 64503:

NADA 

Number Trade Name 

6–391 S.Q. (sulfaquinoxaline) 40% 

Medicated Feed 

6–677 S.Q. (sulfaquinoxaline) 20% Solution 

7–087 Sulfaquinoxaline Solubilized 

Accordingly, the agency is amending 

the regulations in 21 CFR 520.2325a and 

558.586 to reflect the transfer of 

ownership and a current format. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808.

List of Subjects 

21 CFR Part 520 

Animal drugs. 

21 CFR Part 558 

Animal drugs, Animal feeds.

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to the 

Center for Veterinary Medicine, 21 CFR 

parts 520 and 558 are amended as 

follows:

PART 520—ORAL DOSAGE FORM 

NEW ANIMAL DRUGS

■ 1. The authority citation for 21 CFR 

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.2325a [Amended]

■ 2. Section 520.2325a is amended in 

paragraph (a)(1) by removing ‘‘050749’’

and by adding in its place ‘‘059130’’.

PART 558—NEW ANIMAL DRUGS FOR 

USE IN ANIMAL FEEDS

■ 3. The authority citation for 21 CFR 

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

■ 4. Section 558.586 is amended by 

revising the section heading; by 

removing paragraphs (c) and (d); by 

redesignating paragraphs (e) and (f) as 

paragraphs (c) and (d); and by revising 

paragraph (a) and adding paragraph (b) to 

read as follows:

§ 558.586 Sulfaquinoxaline. 

(a) Specifications. Type A medicated 

articles containing 40 percent 

sulfaquinoxaline. 

(b) Approvals. See No. 059130 in 

§ 510.600(c) of this chapter.

* * * * *

Dated: September 27, 2004. 

Steven D. Vaughn, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine.

[FR Doc. 04–22760 Filed 10–8–04; 8:45 am] 

BILLING CODE 4160–01–S

DEPARTMENT OF DEFENSE

Office of the Secretary 

32 CFR Part 199 

RIN 0720–AA89 

TRICARE; Changes Included in the 

National Defense Authorization Act for 

Fiscal Year 2002, (NDAA–02), and a 

Technical Correction Included in the 

NDAA–03

AGENCY: Office of the Secretary, DoD.

ACTION: Final rule.

SUMMARY: This rule makes several 

changes to the TRICARE program 

authorized by Congress in the NDAA–

02. Specifically, revisions to the 

definition of durable medical equipment 

(DME); adoption of the same pricing 

methods for durable medical 

equipment, prosthetics, orthotics and 

supplies (DMEPOS) as are in effect for 

the Centers for Medicare & Medicaid 

Services (CMS); clarification that 

rehabilitative therapy is a TRICARE 

benefit; addition of augmentative 

communication devices (ACD)/speech 

generating devices (SGDs) as a TRICARE 

benefit; addition of hearing aids for 

family members of active duty members 

as a TRICARE Basic Program benefit; 

revisions to the definition of prosthetics; 

permanent authority for transitional 

health care for certain members 

separated from active duty; and 

revisions to the time period of eligibility 

for transitional health care. 

This final rule also addresses a 

technical correction found in section 

706 of the Bob Stump NDAA–03, 

relating to transitional health care for 

dependents of certain members 

separated from active duty.

DATES: This rule is effective December 

13, 2004. Actual implementation will 

coincide with the transition in each 

TRICARE Region to the next generation

60548 Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 

TRICARE Managed Care Support 

Contracts, which are scheduled to take 

effect over a period of months ending on 

November 1, 2004.

ADDRESSES: TRICARE Management 

Activity, Medical Benefits and 

Reimbursement Systems, 16401 East 

Centretech Parkway, Aurora, Colorado 

80011–9066.

FOR FURTHER INFORMATION CONTACT: Ann 

N. Fazzini, Medical Benefits and 

Reimbursement Systems, TRICARE 

Management Activity, telephone, (303) 

676–3803. Questions regarding payment 

of specific claims should be addressed 

to the appropriate TRICARE contractor.

SUPPLEMENTARY INFORMATION: 

Background 

In the Federal Register of April 16, 

2003, (68 FR 18575), the Office of the 

Secretary of Defense published for 

public comment a proposed rule 

regarding a number of changes included 

in the NDAA–02 (Pub. L. 107–107, 

December 28, 2001). These changes 

include revisions to the definition of 

durable medical equipment (DME); 

adoption of the same pricing methods 

for durable medical equipment, 

prosthetics, orthotics and supplies 

(DMEPOS) as are in effect for the 

Centers for Medicare & Medicaid 

Services (CMS); clarification that 

rehabilitative therapy is a TRICARE 

benefit; addition of augmentative 

communication devices (ACD)/speech 

generating devices (SGDs) as a TRICARE 

benefit; addition of hearing aids for 

family members of active duty members 

as a TRICARE Basic Program benefit; 

and revisions to the definition of 

prosthetics. 

In addition to the above benefit 

changes, the NDAA 02 gave permanent 

authority for transitional health care for 

certain members separated from active 

duty. Prior to the NDAA 02, the 

Transitional Assistance Management 

Program (TAMP)—the program through 

which certain separating members and 

their dependents receive transitional 

health care—was scheduled to cease as 

of December 30, 2001. The NDAA 02, 

deleted the expiration date and made 

the TAMP program a permanent 

program. 

Another change was made to 

transitional health care by the NDAA 

02. Prior to the NDAA 02, certain 

separating members and their 

dependents received transitional health 

care until the earlier of: (1) 30 days after 

the date of the release of the member 

from active duty; or (2) the date on 

which the member and the dependents 

of the member are covered by a health 

plan sponsored by an employer. The 

groups who received transitional health 

care within the above parameters 

included: (1) A member of a reserve 

component called or ordered to active 

duty in support of a contingency 

operation; (2) a member involuntarily 

retained on active duty under section 

12305 in support of a contingency 

operation; or (3) a member who 

voluntarily agrees to remain on active 

duty for a period of less than one year 

in support of a contingency operation. 

The changes made in the NDAA 02 

deleted the 30 day limit and changed 

the coverage period to 60 days of 

coverage for those separated with less 

than six years of active service or 120 

days of coverage for those separated 

with six or more years of active service. 

This final rule also provides for a 

technical correction found in the Bob 

Stump NDAA 03. 

The NDAA 04, Pub. L. 108–136, 

contains additional changes to the 

transitional health care coverage period. 

These changes expire on December 31, 

2004. If these changes are extended or 

made permanent they will be addressed 

in a separate rule. 

As a result of the publication of the 

proposed rule, the following comments 

were received from interested parties, 

associations and the government 

agencies that by law TRICARE is 

required to consult during the rule 

making process. 

Review of Comments

We noticed the comments that we 

received could be classified into four 

major areas. The first is that there is a 

perception that the NDAA 02 language 

somehow eliminates or diminishes the 

‘‘medical necessity’’ provision and other 

provisions found in TRICARE law. The 

second is a lack of understanding or 

awareness that the Program for Persons 

with Disabilities (PWPWD) and the 

TRICARE Basic Program are separate 

and distinct programs. The third is 

disagreement with our statement in the 

proposed rule that TRICARE’s current 

policies in place at the time provide 

coverage within the NDAA 02 criteria. 

The fourth and final area is a concern 

with our proposed definition of 

rehabilitative therapy. 

We address each of these major areas 

separately and then address the general 

comments that we received on the 

proposed rule. 

I. Medical Necessity and Other 

Provision 

Several of the changes authorized by 

Congress permit therapy for the purpose 

of either improving, restoring, 

maintaining, or preventing deterioration 

of function, or an accessory or item of 

supply that is used in conjunction with 

a device for the purpose of achieving 

therapeutic benefit and proper 

functioning. We received comments 

from several entities stating that they 

believe the statutory reference to the 

‘‘functional status’’ of a beneficiary is to 

be used as the sole basis for determining 

coverage, rather than using the 

requirement that a service or supply 

must be medically or psychologically 

necessary as required by 10 U.S.C. 

1079(a)(13). This belief is incorrect. One 

is to keep in mind that the provisions 

found in the NDAA 02 must be read in 

conjunction with the all other statutory 

provisions and parameters that govern 

the TRICARE program under title 10, 

United States Code, chapter 55. The 

most significant parameter for the 

TRICARE program is found at 

1079(a)(13) and excludes:

Any service or supply which is not 

medically or psychologically necessary to 

prevent, diagnose, or treat a mental or 

physical illness, injury, or bodily 

malfunction as assessed or diagnosed by a 

physician, dentist, clinical psychologist, 

certified marriage and family therapist, 

optometrist, podiatrist, certified nursemidwife, certified nurse practitioner, or 

certified clinical social worker, as 

appropriate, may not be provided, except as 

authorized elsewhere * * *.

The types of health care services 

authorized by Congress in the NDAA–02 

that this rule implements provide for 

the types of health care that ‘‘may be’’

provided by the TRICARE program. This 

must be read in conjunction with the 

medical necessity requirement. 

Consequently, any therapy for the 

purpose of either improving, restoring, 

maintaining, or preventing deterioration 

of function, or an accessory or item off 

supply that is used in conjunction with 

a device for the purpose of achieving 

therapeutic benefit and proper 

functioning must be medically 

necessary before it can be cost shared by 

TRICARE. 

Another provision/parameter of the 

TRICARE program that must be 

considered when interpreting the NDAA 

02 legislation is the prohibition against 

providing custodial care. Custodial care 

is excluded from TRICARE coverage 

under section 1077(b)(1) and is defined 

in section 1072(a) as:

Custodial care 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 

activities of daily living.

In summary, we do not concur with 

the interpretation that the NDAA 02

Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 60549

language reduces the significance of or 

eliminates the use of the medical 

necessity provision and other provisions 

found in TRICARE law. TRICARE 

considers the functional status of an 

individual as a factor, but that factor 

does not usurp the requirement of 

medical necessity or custodial care. The 

medical necessity and custodial care 

provisions, as well as all other 

parameters and provisions that govern 

the TRICARE program, must be 

considered concurrently with the 

provisions added in the NDAA 02, 

consistent with the rules of statutory 

construction defined in title 10, Untied 

States Code. 

II. PFPWD in Relation to the Basic 

Program 

The PFPWD and the TRICARE Basic 

Program are separate and distinct 

programs with their own statutory basis, 

to include separate/different eligibility 

provisions, cost-sharing provisions, and 

benefit provisions. The PFPWD, based 

upon 10 U.S.C. 1079(d)–(f), is 

implemented in 32 CFR 199.5, and 

describes eligibility provisions, costsharing provisions, and benefit 

provisions under the PFPWD. The 

changes to the PFPWD authorized by 

section 701(d) of the NDAA 02 are being 

implemented under a separate rule. The 

TRICARE Basic Program Benefits are 

implemented in 32 CFR 199.4. While 

the programs are separate and distinct, 

the PFPWD is available for use in 

conjunction with the TRICARE Basic 

Program. The PFPWD was 

congressionally established 

approximately 35 years ago to help 

defray the costs of services not available 

either through the TRICARE Basic 

Program or through other public 

agencies. This includes, but is not 

limited to, services such as training, 

special education and adjunct services 

(e.g., equipment adaptation). 

This rule makes no changes to the 

PFPWD program found at 32 CFR 199.5. 

There are some services and supplies 

that are currently covered under the 

PFPWD but are not covered under the 

TRICARE Basic Program. This will 

continue. For example, training, special 

education, and eyeglasses may be 

covered under the PFPWD but they are 

excluded from the TRICARE Basic 

Program.

Hearing aids are currently allowed 

exclusively as a benefit under the 

PFPWD; however, upon implementation 

of this final rule, hearing aids will be 

considered a benefit under the TRICARE 

Basic Program, although still statutorily 

limited to dependents of active duty 

members. 

Additionally, upon implementation of 

this rule, those ACDs/SGDs defined in 

this rule and that otherwise meet the 

policies and provisions of the TRICARE 

Basic Program will be covered as a 

benefit under the Basic Program. There 

will be some communicative devices, 

that do not meet the definition of ACD/

SGD, but that are considered 

communication devices, that have been 

allowed for coverage under the PFPWD. 

This will not change and those devices 

will continue to be provided. 

Again, this rule makes no change to 

the regulatory section that governs the 

PFPWD. 

III. TRICARE’s Current Policies 

We received comments stating that 

the NDAA 02 provisions ‘‘Congress 

intended that this new law would 

stimulate TRICARE to provide greater 

access to appropriate assistive devices, 

technologies and related services.’’ The 

comments subsequently expressed 

concerns with our position that 

TRICARE’s policies in place at this time 

provide coverage within these criteria. 

When we made the ‘‘current policies’’

statement, we were referring to the 

policies found in the TRICARE Policy 

Manual and the TRICARE 

Reimbursement Manual. These manuals 

contain detailed policies on a variety of 

topics, to include DME and prosthetics. 

They may be accessed through the 

TRICARE Web site at http://

www.tma.osd.mil. The policies 

expressed in these manuals are 

TRICARE’s interpretation of its 

governing statutes (primarily title 10, 

United States Code, chapter 55) and our 

regulation implementing these statutes 

(32 CFR part 199). 

We reviewed the proposed rule and 

found that we made the statement 

regarding our current policies in the 

SUPPLEMENTARY INFORMATION Section of 

the rule in two places: the durable 

medical equipment section and the 

prosthetics section. Regarding DME, we 

received comments stressing that 

TRICARE needs to be aware of the 

necessity to customize DME to meet an 

individual’s needs. We are. The Durable 

Medical Equipment policy is found at 

chapter 7, section 3.1 in the TRICARE 

Policy Manual. This policy defines DME 

and provides guidance on when DME 

may be repaired, replaced, modified, 

and/or customized. The policy currently 

reflects the provisions added in the 

NDAA–02. This final rule incorporates 

the new statutory authorization into 32 

CFR part 199. In the Supplementary 

Information we were simply saying that 

our interpretation of previous statutory 

authorizations and implementing 

regulations in the TRICARE Policy 

Manual were consistent with how we 

interpret the new authorizations. Hence, 

TRICARE’s current policies in place 

provide coverage within the NDAA 02 

criteria. 

With regard to prosthetics, section 

702 of NDAA–02, gives the Department 

the authority to provide a prosthetic 

device that includes the following: (1) 

Any accessory or item of supply that is 

used in conjunction with the device for 

the purpose of achieving therapeutic 

benefit and proper functioning. (2) 

Services necessary to train the recipient 

of the device in the use of the device. 

(3) Repair of the device for normal wear 

and tear or damage. (4) Replacement of 

the device if the device is lost or 

irreparably damaged or the cost of repair 

would exceed 60 percent of the cost of 

replacement. (5) A prosthetic device 

customized for a patient may be 

provided under this section only by a 

prosthetic practitioner who is qualified 

to customize the device, as determined 

under regulations prescribed by the 

Secretary of Defense in consultation 

with the other Secretaries. 

As stated in the proposed rule, 

TRICARE’s current policies do offer 

benefits for the above criteria 1, 2, 3, 

and 5. Regarding criterion (4), TRICARE 

currently allows for replacement when 

required due to growth or change in the 

patient’s condition. Nonetheless, our 

policies will be revised to ensure 

consistency with the language found in 

section 702 and will reflect a greater 

opportunity to acquire replacement 

prosthesis. 

Regarding criterion 5, TRICARE has 

no specific provider requirements for a 

prosthetic practitioner to be qualified to 

customize the device. Rather, otherwise 

authorized TRICARE providers 

currently provide prostheses and 

customization of prostheses, such as 

medical equipment firms, medical 

supply firms, and Durable Medical 

Equipment, Prosthetic, Orthotic 

supplies providers/suppliers. As stated 

in the proposed rule, we are aware that 

CMS has established a Negotiated 

Rulemaking Committee on Special 

Payment Provisions and Requirements 

for Prosthetics and Certain CustomFabricated Orthotics. The purpose of 

this committee is to advise CMS on 

developing a proposed rule that would 

establish payment provisions and 

requirements for providers of prostheses 

and custom-fabricated orthotics under 

the CMS. Once the Committee provides 

its findings, we will review them for 

consideration under the TRICARE 

program. After our review, we will use 

the rulemaking process and the public 

will have an opportunity to comment on 

our proposed provisions regarding these

60550 Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 

types of providers. In the meantime, we 

will continue to allow prostheses 

customization by otherwise authorized 

TRICARE providers.

The proposed rule states that where 

our current policies deviate from the 

new statutory language, we are adopting 

the new statutory language and will 

amend our policies to reflect that 

language. 

IV. Rehabilitative Therapy 

We received numerous comments 

from entities who expressed concern 

with our definition of rehabilitative 

therapy. The commenters stated that 

defining rehabilitative therapy to 

include only physical therapy (PT), 

speech therapy (ST), and occupational 

therapy (OT) violates that intent of the 

statute. The commenters listed 

numerous additional therapies that they 

believe should be available for coverage 

under the statutory language. 

Again, parameters and provisions that 

govern the TRICARE program must be 

read in their entirety. By defining 

rehabilitative therapy as PT, OT, and 

ST, we did not mean to imply that all 

other therapies are excluded and are not 

eligible for TRICARE coverage. Other 

therapies that are medically necessary 

and appropriate, that are proven 

medical treatment, that are not 

considered as custodial care, that are 

provided by an authorized TRICARE 

provider and that are not otherwise 

excluded as a TRICARE benefit may be 

considered for TRICARE coverage. 

However, in order to avoid any 

misunderstanding, we have revised the 

definition of rehabilitative therapy to 

reflect the statutory language rather than 

define it as PT, OT, and ST only. 

V. Additional Comments 

In addition to the four major areas in 

which we received comments, we 

received general comments regarding 

most of the proposed provisions. Those 

comments are responded to as follows: 

ACD/SGD 

Comment 1: One commenter 

questioned whether including the 

highly specific definition of an ACD/

SGD in the TRICARE regulation is 

appropriate. The commenter proposed 

that TRICARE adopt a more general 

definition of ACD/SGD devices in its 

regulations, leaving the specific 

distinctions of the TRICARE Policy 

Manual. 

Response: We concur with this 

recommendation. The purpose of the 

CFR is to provide broad guidelines and 

policies. The publishing of detailed 

criteria for a speech generating device in 

section 32 CFR 199.2 may prove 

difficult to maintain and update, if 

necessary. To assist our beneficiaries in 

obtaining benefit coverage in a timely 

manner, the detailed ACD/SGD 

definition included in the proposed rule 

has been replaced with the statutory 

language. We will, place the specific 

ACD/SGD criteria that were included in 

the proposed rule into the TRICARE 

Policy Manual (TPM). That is, we will 

be adopting CMS’s augmentative 

communication device guidelines as we 

indicated in the proposed rule and we 

will incorporate CMS’s guidelines into 

the TPM. The TPM contains policies to 

implement 32 CFR Part 199 and must be 

used in conjunction with the CFR for 

complete policy information. The TPM 

can be accessed through the TRICARE 

Web site at http://www.tricare.osd.mil.

Comment 2: We received comments 

regarding the specific ACD/SGD criteria. 

For example, it was pointed out to us 

that we failed to include one of CMS’s 

criteria in our definition. 

Response: The omission of the 

criterion was an oversight and will be 

corrected. We have decided to include 

only the NDAA 02 statutory 

requirements in the regulation rather 

than listing the specific ACD/SGD 

criteria. We plan to include the specifics 

regarding ACD/SGD coverage (i.e.,

criteria similar to CMS’s coverage 

criteria) in the TRICARE Policy Manual.

Comment 3: We received comments 

regarding our decision to adopt CMS’s 

coverage of SGDs for ACDs. Some of the 

commenters applauded our decision to 

adopt CMS’s policy. Others expressed 

dissatisfaction. 

Response: The NDAA 02 amended 

title 10, United States Code, by adding 

a new subsection 1077(e)(2), which 

says, ‘‘An augmentative communication 

device may be provided under 

subsection (a)(15).’’ Subsection (a)(15) 

states that the Department may provide, 

‘‘Prosthetic devices, as determined by 

the Secretary of Defense to be necessary 

because of significant conditions 

resulting from trauma, congenital 

anomalies, or disease.’’ The Department, 

in developing its guidelines, policies, 

and coverage criteria of ACDs/SGDs, is 

required to classify them as voice 

prosthesis, while CMS may classify 

ACDs/SGDs as durable medical 

equipment. Although we are required to 

classify them as voice prosthesis, our 

decision to adopt CMS’s coverage of 

SGDs for ACDs is consistent with 

TRICARE seeking consistency with 

CMS. CMS, like TRICARE, is a federal 

program, and where appropriate, 

adoption of their national standard 

helps ensure delivery of a uniform 

benefit. 

Comment 4: A commenter asked 

whether argumentative communication 

devices/or speech generating devices 

were covered previously only under the 

PFPWD. They also asked whether 

tracheostomy valves and cochlear 

implants were purchased under 

TRICARE and whether these provisions 

will remain unchanged. 

Response: ACDs/SGDs are currently 

allowed under the PFPWD when there 

is a serious physical disability and the 

individual qualifies for the PFPWD. 

Since certain ACDs/SGDs will now be a 

benefit under the Basic Program, the 

individual will no longer have to qualify 

for PFPWD. Also, unlike hearing aids, 

this benefit is not limited to dependents 

of active duty members. The PFPWD is 

a program statutorily limited to only 

active duty dependents, so this is an 

expansion of benefits. 

Tracheostomy valves and cochlear 

implants have been TRICARE benefits 

and this remains unchanged. 

Comment 5: A commenter 

recommended that ACDs/SGDs also 

include non-speech generating devices 

which also help an individual to 

maximize communication skills for 

functional and effective communication. 

Response: The statutory language 

states that ACDs may be provided as a 

voice prosthesis. We interpret this as 

speech generating devices only. There 

will be some communicative devices 

that do not meet the definition of ACD/

SGD, but that are considered 

communication devices, that have been 

allowed for coverage under the PFPWD. 

This will not change and those devices 

will continue to be provided. 

Comment 6: The narrative 

introduction to the proposed ACD/SGD 

regulations states that ‘‘In proposing this 

policy, we have also taken into 

consideration recommendations 

provided to us by the American Speech 

Language Hearing Association (ASHA) 

in defining this benefit.’’ ASHA’s 

recommendations, submitted in March 

22, 2002, did not infer that covered 

ACDs should be limited to SGDs as 

currently proposed. 

Response: We apologize for inferring 

that the ASHA recommended that ACDs 

should be limited to those SGDs 

outlined in the proposed rule. 

Comment 7: A commenter 

recommended that the services of 

speech-language pathologists be 

required as related to ACD/SGD 

evaluation and establishment of a 

treatment plan. Such is the requirement 

specified in the DMERC Supplier 

Manual reference above. If it is not 

appropriate to include this requirement 

in the regulation, then it should appear 

in the policy manual.

Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 60551

Response: TRICARE will allow 

otherwise covered medically necessary 

and appropriate services required and 

prescribed by a physician that are 

associated with the ACD/SGD. 

Prosthetics 

Comment 8: One commenter restated 

the changes regarding prosthetics and 

expressed concern that the same 

coverage policies are not being applied 

to TRICARE’s orthotic benefit. 

Response: The NDAA 02 statutory 

language refers only to prosthetic 

devices and makes no mention of 

orthotic care. Therefore, orthotic care is 

not addressed in this regulation. 

Comment 9: We have concerns about 

the future findings of the CMS 

established Negotiated Rulemaking 

Committee on Special Payment 

Provisions and Requirements for 

Prosthetics and Orthotics. 

Response: If TRICARE decides to 

make any changes based on CMS’s 

negotiated rulemaking, we will publish 

a proposed rule with a comment period 

giving the public an opportunity to 

voice their concerns. 

Hearing Aids 

Comment 10: Two commenters stated 

that they agree that there is not industry 

standard or industry definition of 

‘‘profound’’ hearing loss and they 

proposed changing the dB level of 

profound hearing loss for children. The 

dB level in the proposed rule was 26 dB. 

The commenter asked us to change it to 

15dB.

Response: The statutory language 

provides coverage for a hearing aid 

when a ‘‘profound hearing loss’’ is 

present. There is no industry standard 

or industry definition of ‘‘profound’’, we 

consulted with TRICARE, Veterans 

Affairs, and Service physicians and 

Audiology Consultants who informed us 

a 26dB level falls within a mild hearing 

loss range. Consequently, we believe 

26dB is a reasonable and generous 

interpretation of profound hearing loss. 

Under PFPWD, the dB level was 45dB 

or greater in one ear or 30dB in both 

ears. By lowering the dB level to 26 we 

are making this benefit much more 

generous than what was previously 

available under the PFPWD. 

Comment 11: We were asked to 

include a statement that testing areas 

should be in compliance with ANSI 

standard S3.1–1999, Maximum 

Permissible Ambient Noise Levels for 

Audiometric Test Rooms, or any future 

revision thereof. 

Response: We have taken this under 

advisement. If necessary and 

appropriate, we will include such a 

statement in the TRICARE Policy 

Manual hearing aid issuance. 

Comment 12: A commenter urged 

TRICARE to require that any hearing aid 

fitting services for a TRICARE 

beneficiary be provided by an ASHAcertified, and where applicable, licensed 

audiologist. We believe that audiologists 

holding the Certificate of Clinical 

Competence in Audiology (CCC–A) as 

granted by ASHA will help assure a 

high level of quality in the delivery of 

this important benefit. 

Response: TRICARE has established 

the regulatory criteria for being an 

authorized TRICARE provider based 

upon the broad statutory guidelines 

contained in title 10, United States 

Code, chapter 55, and primarily 10 

U.S.C. 1079(a)(13) and 1079(a)(8). For 

individual paramedical providers under 

TRICARE, 32 CFR 199.6(c)(3)(iii)(I)(4) 

lists audiologists. Paramedical providers 

may be reimbursed for services 

provided on a fee-for-service basis only 

if the beneficiary is referred by a 

physician for the treatment of a 

medically diagnosed condition and a 

physician must also provide continuing 

and ongoing oversight and supervision 

of the program or episode of treatment 

provided by the audiologists. All 

paramedical providers must be licensed 

if required in that state, and where a 

state does not license a specific category 

or paramedical, certification by a 

Qualified Accreditation Organization as 

defined in § 199.2 is required. 

Certification must be at full clinical 

practice level. 

Comment 13. One commenter stated 

that they prefer that the limitation exists 

that anyone with hearing loss ‘‘that 

interferes with communication’’ would 

be eligible for coverage. 

Response: The term ‘‘profound’’

hearing loss appears in the statute and 

TRICARE has used its discretion in 

interpreting that term. Prior to the 

implementation of this rule, and when 

the benefit was available under PFPWD, 

the dB level was 45dB or greater in one 

ear or 30dB in both ears. By lowering 

the dB level to 26 we are making this 

benefit much more generous than what 

was previously available under the 

PFPWD. 

Comment 14: One commenter stated 

that the proposed criteria for adults and 

children listed in this new rule will 

appropriately allow patients with 

vocational, social, psychological and 

environmental needs to receive benefits 

from hearing amplification. However, 

they also stated that the evaluation and 

treatment process would be greatly 

enhanced by the development of a 

comprehensive protocol utilizing nonaudiometric data. They state that a 

comprehensive protocol for determining 

hearing aid candidacy and treatment 

strategies would include data such as 

the client’s physical status (dexterity, 

visual status), psychological status 

(attitude, motivation, cognitive and 

mental status), and communication 

status (auditory-visual speech 

perception abilities, auditory speech 

perception abilities) and the unique 

communication environments in which 

the client must function. 

Response: In addition to now paying 

for a hearing aid for a dependent of an 

active duty member who has a profound 

hearing loss, TRICARE will also cover 

all medically necessary and appropriate 

services and supplies associated with 

the hearing aid. 

Comment 15: A commenter advised 

us that we may receive some comments 

which dispute the proposed rule’s 

proposed definition of what constitutes 

a ‘‘profound’’ hearing loss, since typical 

clinical categorizations (using pure tone 

hearing thresholds alone) would not 

typically associate ‘‘profound’’ with the 

range of hearing thresholds listed in 

section 199.2. They stated that they are 

aware of, and agree with, the intentions 

of the audiologist consultants from the 

Department of Defense and the 

Department of Veterans Affairs who 

provided guidance in the drafting of this 

rule. They also agree that there is no 

universal standard for ‘‘profound’’ loss. 

The comment continued by stating that 

if hearing aids were only made available 

to individuals with audiometric 

thresholds exceeding 90dBHL 

(considered by many physicians to 

represent a profound loss, using only 

pure tone audiometry results), most 

hearing impaired patients would be 

inappropriately excluded. 

Response: We thank the commenter 

for their support and acknowledgement 

of the sufficiency and appropriateness 

of our criteria of 40dB and 26db when 

defining a profound hearing loss.

Comment 16: A comment was 

received recommending that the 

Supplementary Information portion of 

Section V. Hearing Aids include the 

requirements for a qualified audiologist. 

Response: Audiologists are currently 

authorized providers under TRICARE. 

See 32 CFR 199.6 (c)(3)(iii)(I). Now that 

hearing aids are a Basic Program benefit 

for active duty family members, 

otherwise covered services and supplies 

associated with audiologists and speech 

therapists may be covered. 

Consequently, we have deleted the 

Basic Program exclusion found at 32 

CFR 199.4 (g)(45) regarding audiologists 

and speech therapists. While we are 

deleting the exclusion, it is necessary to 

point out that otherwise covered

60552 Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 

services and supplies from these types 

of providers may be provided only if the 

beneficiary is referred by a physician for 

the treatment of a medically diagnosed 

condition and a physician must also 

provide continuing and ongoing 

oversight and supervision of these 

providers. 

Comment 17: We find no reference in 

the rule to how TRICARE payment 

methods would apply. We anticipate 

that TRICARE payments for hearing aids 

will remain consistent with what the 

standard had been under the PFPWD. 

Under this program, the active duty 

sponsor was responsible for a copayment based on their rank (e.g.

ranging from $25 to $250 per $1000, per 

device). 

Response: Under the TRICARE Basic 

Program, the beneficiary’s cost share 

(and deductible, if any) will be based 

upon which program they are 

participating in (TRICARE Prime, 

Standard, or Extra), and their status as 

the dependent of an active duty member 

(statutorily hearing aids are available to 

only the dependent of an active duty 

family member). Cost shares and 

deductibles are also statutorily based 

upon these two factors. The copayments 

and cost-shares for the TRICARE Basic 

Program have a different statutory basis 

than the PFPWD. Because hearing aids 

will now be obtained by dependents of 

an active duty family member under the 

Basic Program, the Basic Program costsharing provisions must apply. These 

copayments are as follows: TRICARE 

Prime active duty beneficiaries will 

have no copayment (i.e., a $0.00 

copayment); those who use TRICARE 

Standard will have a 20% cost share 

after meeting their statutory fiscal year 

deductible ($150 for an individual/$300 

for a family; $50/$100 for dependents of 

E—4 or below); those who use TRICARE 

Extra will have 15% cost-sharing after 

meeting their statutory deductible. 

Comment 18: Is this really an 

expansion of hearing aid benefits to AD 

dependents since it is already being 

provided under the PFPWD guidelines 

and all who need an aid qualify for 

PFPWD? 

Response: Hearing aids will be offered 

under the Basic Program only and will 

not be offered as a benefit under the 

PFPWD once this rule is implemented. 

It is an enhancement of benefits because 

we have relaxed the hearing levels 

necessary to qualify for a hearing aid 

and have offered hearing aids to all 

active duty family members who meet 

the criteria. Additionally, those enrolled 

in TRICARE Prime will have no cost 

share, as opposed to the statutory cost 

share based on rank that they pay today 

when they access the benefit under the 

PFPWD. 

Comment 19: Does the change mean 

that the military treatment facility 

(MTFs) will be fitting and purchasing 

the aids through our VA contract, rather 

than in the civilian sector, thus saving 

tax dollars and that is the reason for the 

change?

Response: The reason for the change 

is that the NDAA–02 authorized hearing 

aids as a TRICARE benefit under the 

Basic program. The use of a VA contract 

to fit and purchase hearing aids is a 

decision that needs to be made by the 

MTF. 

Comment 20: Currently assistive 

listening devices are purchased via the 

PFPWD. The exclusion of auditory 

sensory enhancing devices in the 

proposed rule will not affect what we 

currently purchase through the PFPWD 

correct? 

Response: Correct. The exclusion 

found in the proposed rule applies to 

the TRICARE Basic program, not the 

PFPWD. 

DME 

Comment 21: Under the new statute, 

we would anticipate, assuming that 

other conditions of coverage are met, 

that TRICARE would cover certain 

sensory or communication aids such as 

screen readers, Closed Circuit TVs, or 

other optical scanners for people with 

vision impairments. Similarly we would 

expect that TRICARE would potentially 

cover certain home modifications such 

as grab bars and raised toilet seats that 

facilitate better functioning with self 

care, safety, and may prevent conditions 

such as hip fractures and other injuries 

from falls. 

Response: As previously discussed, 

under 10 U.S.C. 1079(a)(13), TRICARE 

may not provide any service or supply 

which is not medically or 

psychologically necessary to prevent, 

diagnose, or treat a mental or physical 

illness, injury, or bodily malfunction as 

assessed or diagnosed by a physician or 

other authorized provider. Those items 

of DME as defined in section 199.2 that 

are also medically necessary and 

appropriate are covered. There are some 

items that may serve a preventive 

purpose, but TRICARE has a very 

limited preventive benefit that is based 

on statute. Consequently, some of those 

items listed by the commenter do not 

meet coverage provisions. 

Comment 22: A commenter stated that 

the Medicaid program makes no express 

reference to DME in contrast to the 

CMS. They continued to express that for 

the Medicaid program, the operative 

term is equipment. In their opinion, the 

TRICARE program continues to require 

covered DME to be ‘‘primarily and 

customarily designed and intended to 

serve a medical purpose rather than 

primarily for transportation, comfort or 

convenience. The regulations also 

continue to prohibit coverage for 

‘‘luxury’’ or ‘‘deluxe’’ items. These 

requirements appear out of step with the 

new statute’s standard of maximizing 

function and preventing deterioration of 

function. 

Response: Medicaid and TRICARE are 

separate programs each with their own 

governing statutes and provisions. 

Medical necessity is a requirement for 

the TRICARE program and the NDAA 02 

statutory language must be read in 

conjunction with the existing medical 

necessity requirement. DME with 

deluxe, luxury, or immaterial features 

which increase the cost of the item to 

the government relative to a similar item 

without those features is excluded. See

32 CFR 199.4(d)(3)(ii)((D)(3). 

Comment 23: A commenter opined 

that technology has blurred the line 

between what can legitimately be called 

a convenience or luxury and what 

improves the functionality of quality of 

life of the person, thereby improving his 

or her health status. 

Response: We will allow DME that 

meets the definition described in this 

final rule, is medically or 

psychologically necessary, and meets all 

parameters of TRICARE coverage. 

Comment 24: One commenter 

indicated that in the final rule, 

TRICARE should specifically address 

the issue of accessing power mobility 

before a long term manual wheelchair 

user is no longer able to propel him or 

herself due to secondary injury as a 

result of such wheelchair use. 

Response: Current regulatory 

provisions (32 CFR 199.4(d)(3)(iv)(C)) 

cover a wheelchair, or a CHAMPUS 

approved alternative, which is 

medically necessary to provide basic 

mobility, including additional cost for 

medically necessary modifications to 

accommodate a particular disability. 

These may be covered as durable 

medical equipment. Additionally, the 

Policy Manual allows for electricpowered, cart-type transports as an 

alternative to an electric wheelchair. 

DME with deluxe, luxury, or immaterial 

features which increase the cost of the 

term to the government relative to a 

similar item without those features 

remains a TRICARE exclusion. 

Comment 25: A commenter suggested 

that we change the current definition of 

DME to conform to CMS’s definition of 

DME. CMS defines DME as equipment 

furnished by a supplier or a home 

health agency that—(1) Can withstand 

repeated use; (2) is primarily and

Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 60553

customarily used to serve a medical use; 

(3) generally is not useful to an 

individual in the absence of an illness 

or injury; (4) is appropriate for use in 

the home. Alternatively, the commenter 

suggested that TRICARE revise its 

definition of DME by deleting the 

wording ‘‘* * * rather than primarily 

for transportation, comfort or 

convenience * * *’’ and adding a 

separate criterion that DME ‘‘generally 

is not useful to an individual in the 

absence of an illness or injury’’. 

Response: The proposed rule stated 

that we intended to modify the DME 

definition to incorporate the NDAA 02 

language into the DME definition. The 

revised DME definition was proposed to 

read as follows: Equipment for which 

the allowable charge is over $100 and 

which:

(1) Is medically necessary for the 

treatment of a covered illness or injury; 

(2) Improves, restores, or maintains 

the function of a malformed, diseased, 

or injured body part, or can otherwise 

minimize or prevent the deterioration of 

the patient’s function or condition; 

(3) Can maximize the patient’s 

function consistent with the patient’s 

physiological or medical needs. 

(4) Is primarily and customarily 

designed and intended to serve a 

medical purpose rather than primarily 

for transportation, comfort, or 

convenience 

(5) Can withstand repeated use; 

(6) Provides the medically appropriate 

level of performance and quality for the 

medical condition present (that is, 

nonluxury or nondeluxe); 

(7) Is other than spectacles, 

eyeglasses, contact lenses, or other 

optical devices, hearing aids (unless 

otherwise provided as a covered 

TRICARE benefit), or other 

communication devices (unless 

otherwise provided as a covered 

TRICARE benefit); and 

(8) Is other than exercise equipment, 

spas, whirlpools, hot tubs, swimming 

pools or other such items. 

When we received this comment, we 

reviewed both our current and proposed 

DME definition. It became clear to us 

that some of the criteria included in the 

definition were actually coverage 

criteria rather than criteria that identify 

DME. We then compared the current 

and proposed TRICARE definitions for 

DME to the definition used by CMS. 

Based on that side-by-side comparison, 

we decided to update our DME 

definition by adopting the same first 

three criteria listed in CMS’s definition 

for use in TRICARE’s definition as that 

these criteria have a crosswalk to 

criteria found in our current DME 

definition. We did not adopt the fourth 

criteria in the CMS definition regarding 

in-home use because it provides a 

restriction not currently found under 

the TRICARE program. Additionally, we 

moved the coverage criteria currently 

found in the DME definition at 32 CFR 

199.2, to 32 CFR 199.4(d)(3)(ii)(A) 

which outlines the scope of the DME 

benefit. This final rule has been revised 

accordingly. 

Misc. Comments/Admin Comments 

Comment 26: A commenter expressed 

concern with the statement in the 

‘‘Regulatory Procedures’’ section of the 

proposed rule stating that this 

regulation is ‘‘not economically 

significant.’’ They interpreted this to 

mean that the TRICARE program ‘‘does 

not anticipate spending any more 

resources on this benefit category than 

the program did before this new law 

was adopted.’’

Response: The language does not 

mean that the TRICARE program does 

not anticipate spending any more 

resources on this benefit category than 

the program did before the new law. 

The statement is a requirement in 

rulemaking under the Regulatory 

Flexibility Act (RFA). There are three 

specific RFA requirements applicable to 

rulemaking: 

1. Analysis of the impact of each 

rulemaking on small entities and 

evaluation of alternatives that would 

accomplish regulatory objectives 

without unduly burdening small entities 

or erecting barriers to competition. 

2. The periodic review of existing 

agency rules which have a significant 

economic impact on a substantial 

number of small entities. 

3. Preparation and publication of a 

semiannual agenda listing rules under 

development that may have a significant 

economic impact on a substantial 

number of small entities. 

Additionally, Executive Order 12866 

requires that 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. 

Neither the RFA or Executive Order 

12866 provide spending limits for these 

additional benefits and our statement in 

the proposed rule shall have no impact 

on the resources provided for this new 

benefit. TRICARE shall provide the 

benefits within the provisions outlined 

in this final rule. 

Comment 27: Add ‘‘Bob Stump’’ in 

front of NDAA–03. 

Response: Done. 

Summary of Regulatory Modifications 

The following modifications were 

made as a result of suggestions received 

during the public comment period: 

(1) We revised the definition of ACD/

SGD to comply with the statutory 

language. Additionally, we eliminated 

the specific criteria for an ACD/SGD and 

will be placing that into the TRICARE 

Policy Manual. 

(2) We adopted a modified version of 

CMS’s definition of DME and moved 

criteria found in the current DME 

definition to 32 CFR 199.4. 

(3) We revised the definition of 

prosthetics to comply with the statutory 

language. 

(4) We revised the definition of 

rehabilitative therapy to comply with 

the statutory language. 

(5) We clarified that rehabilitative 

therapy are therapies that are medically 

necessary and appropriate, that are 

proven medical treatment, that are not 

considered custodial care, that are 

provided by an authorized TRICARE 

provider and that are not otherwise 

excluded as a TRICARE benefit may be 

considered for TRICARE coverage. 

Regulatory Procedures 

Executive Order 12866 requires that a 

regulatory impact analysis be performed 

on any economically significant rule. 

An economically significant rule is 

defined as one that would result in the 

annual effect on the national economy 

of $100 million or more, or have other 

substantial impact. 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 regulations which would 

have a significant impact on a 

substantial number of small entities. 

As previously mentioned this final 

rule is not a major rule under the 

Congressional Review Act, because its 

economic impact will be less than $100 

million. The changes set forth in this 

final rule are revisions to existing 

regulation. The changes made in this 

final rule involve an expansion of 

TRICARE benefits. In addition, this final 

rule will have minor impact and will 

not significantly affect a substantial 

number of small entities. In light of the 

above, no regulatory impact analysis is 

required. 

This final rule will not impose 

additional information collection 

requirements on the public under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 55).

60554 Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 

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. 55.

■ 2. Section 199.2(b) is amended by 

revising the definitions of ‘‘Durable 

medical eqiupment’’, and ‘‘Prosthetic 

devices (prosthesis)’’, by adding 

definitions of ‘‘Augmentative 

communication device’’, ‘‘Profound 

hearing loss’’, ‘‘Prosthetic’’, ‘‘Prosthetic 

supplies’’, ‘‘Rehabilitative therapy’’, and 

‘‘Speech generating device’’ in 

alphabetical order to read as follows:

§ 199.2 Definitions.

* * * * *

(b) * * * 

Augmentative communication device 

(ACD). A voice prosthesis as determined 

by the Secretary of Defense to be 

necessary because of significant 

conditions resulting from trauma, 

congenital anomalies, or disease. Also 

referred to as Speech Generating Device.

* * * * *

Durable medical equipment.

Equipment that—

(1) Can withstand repeated use; 

(2) Is primarily and customarily used 

to serve a medical purpose; and 

(3) Generally is not useful to an 

individual in the absence of an illness 

or injury. 

Profound hearing loss (adults). An 

‘‘adult’’ (a spouse as defined in section 

32 CFR 199.3(b) of this part of a member 

of the Uniformed Services on active 

duty for more than 30 days) with a 

hearing threshold of: 

(1) 40 dB HL or greater in one or both 

ears when tested at 500, 1,000, 1,500, 

2,000, 3,000, or 4,000Hz; or 

(2) 26 dB HL or greater in one or both 

ears at any three or more of those 

frequencies; or 

(3) A speech recognition score less 

than 94 percent. 

Profound hearing loss (children). A 

‘‘child’’ (an unmarried child of an active 

duty member who otherwise meets the 

criteria (including age requirements) in 

32 CFR 199.3 of this part) with a 26dB 

HL or greater hearing threshold level in 

one or both ears when tested in the 

frequency range at 500, 1,000, 2,000, 

3,000 or 4,000 Hz.

* * * * *

Prosthetic or Prosthetic Device 

(prosthesis). A prosthetic or prosthetic 

device (prosthesis) determined by the 

Secretary of Defense to be necessary 

because of significant conditions 

resulting from trauma, congenital 

anomalies, or diseases. 

Prosthetic supplies. Supplies that are 

necessary for the effective use of a 

prosthetic or prosthetic device.

* * * * *

Rehabilitative therapy. Any 

rehabilitative therapy that is necessary 

to improve, restore, or maintain 

function, or to minimize or prevent 

deterioration of function, of a patient 

and prescribed by a physician.

* * * * *

Speech generating device (SGD). See 

Augmentative Communication Device.

* * * * *

■ 3. Section 199.3 is amended by 

revising paragraph (e) to read as follows:

§ 199.3 Eligibility.

* * * * *

(e) Eligibility Under the Transitional 

Assistance Management Program 

(TAMP). (1) Transitional health care 

benefits under TRICARE are authorized 

for the following eligibles:

(i) A member who is involuntarily 

separated from active duty and the 

dependents of the member. 

(ii) A member of a reserve component 

who is separated from active duty to 

which called or ordered in support of a 

contingency operation if the active duty 

is active duty for a period of more than 

30 days and the dependents of the 

member. 

(iii) A member who is separated from 

active duty for which the member is 

involuntarily retained under 10 U.S.C. 

12305, is support of a contingency 

operation and the dependents of the 

member. 

(iv) A member who is separated from 

active duty pursuant to a voluntary 

agreement of the member to remain on 

active duty for a period of less than one 

year in support of a contingency 

operation and the dependents of the 

member. 

(2) Time period of eligibility. 

Transitional health care shall be 

available for a specified period of time 

for members and dependents beginning 

on the date which the member is 

separated as follows: 

(i) For members separated with less 

than 6 years of active service, 60 days. 

(ii) For members separated with 6 or 

more years of active service, 120 days.

* * * * *

■ 4. Section 199.4 is amended by 

revising paragraph (d)(3)(ii)(A), 

paragraph (d)(3)(vii), the text of 

paragraph (g)(41) preceding the note, 

paragraph (g)(47), paragraph (g)(51), by 

adding new paragraphs (e)(23), (e)(24), 

(e)(25), and by removing and reserving 

(g)(45) to read as follows:

§ 199.4 Basic program benefits.

* * * * *

(d) * * * 

(3) * * * 

(ii) * * * 

(A) Scope of benefit. (1) Subject to the 

exceptions in paragraphs (d)(3)(ii)(B) 

and (d)(3)(ii)(C) of this section, only 

durable medical equipment (DME) 

which is ordered by a physician for the 

specific use of the beneficiary shall be 

covered. 

(2) In addition, any customization of 

durable medical equipment owned by 

the patient is authorized to be provided 

to the patient and any accessory or item 

of supply for any such authorized 

durable medical equipment, may be 

provided to the patient if the 

customization, accessory, or item of 

supply is essential for—

(i) Achieving therapeutic benefit for 

the patient 

(ii) Making the equipment serviceable; 

or 

(iii) Otherwise assuring the proper 

functioning of the equipment. 

(3) Further, equipment as defined in 

§ 199.2 of this part and which: 

(i) Is medically necessary for the 

treatment of a covered illness or injury; 

(ii) Improves, restores, or maintains 

the function of a malformed, diseased, 

or injured body part, or can otherwise 

minimize or prevent the deterioration of 

the patient’s function or condition; 

(iii) Can maximize the patient’s 

function consistent with the patient’s 

physiological or medical needs; 

(iv) Provides the medically 

appropriate level of performance and 

quality for the medical condition 

present (that is, nonluxury or 

nondeluxe); 

(v) Is not otherwise excluded by this 

Regulation.

* * * * *

(vii) Prosthetics, prosthetic devices, 

and prosthetic supplies, as determined 

by the Secretary of Defense to be 

necessary because of significant 

conditions resulting from trauma, 

congenital anomalies, or disease. 

Additionally, the following are covered: 

(A) Any accessory or item of supply 

that is used in conjunction with the 

device for the purpose of achieving 

therapeutic benefit and proper 

functioning; 

(B) Services necessary to train the 

recipient of the device in the use of the 

device; 

(C) Repair of the device for normal 

wear and tear or damage; 

(D) Replacement of the device if the 

device is lost or irreparably damaged or

Federal Register / Vol. 69, No. 196 / Tuesday, October 12, 2004 / Rules and Regulations 60555

the cost of repair would exceed 60 

percent of the cost of replacement.

* * * * *

(e) * * * 

(23) A speech generating device (SGD) 

as defined in § 199.2 of this part is 

covered as a voice prosthesis. The 

prosthesis provisions found in 

paragraph (d)(3)(vii) of this section 

apply. 

(24) A hearing aid, but only for a 

dependent of a member of the 

uniformed services on active duty and 

only if the dependent has a profound 

hearing loss as defined in § 199.2 of this 

part. Medically necessary and 

appropriate services and supplies, 

including hearing examinations, 

required in connection with this hearing 

aid benefit are covered. 

(25) Rehabilitation therapy as defined 

in § 199.2 of this part to improve, 

restore, or maintain function, or to 

minimize or prevent deterioration of 

function, of a patient when prescribed 

by a physician. The rehabilitation 

therapy must be medically necessary 

and appropriate medical care, rendered 

by an authorized provider, necessary to 

the establishment of a safe and effective 

maintenance program in connecti9n 

with a specific medical condition, and 

must not be custodial care or otherwise 

excluded from coverage.

* * * * *

(g) * * * 

(41) Hair transplants, wigs/hair 

pieces/cranial prosthesis.

Note: ***

* * * * *

(45) [Reserved]

* * * * *

(47) Eye and hearing examinations.

Eye and hearing examinations except as 

specifically provided in paragraphs 

(c)(2)(xvi), (c)(3)(xi), and (e)(24) of this 

section, or except when rendered in 

connection with medical or surgical 

treatment of a covered illness or injury.

* * * * *

(51) Hearing aids. Hearing aids or 

other auditory sensory enhancing 

devices, except those allowed in 

paragraph (e)(24) of this section.

* * * * *

■ 4. Section 199.14 is amended by 

redesignating paragraphs (k) through (n) 

as (l) through (o) and by adding a new 

paragraph (k) to read as follows:

§ 199.14 Provider reimbursement 

methods.

* * * * *

(k) Reimbursement of Durable 

Medical Equipment, Prosthetics, 

orthotics and Supplies 9DMEPOS).

Reimbursement of DMEPOS may be 

based on the same amounts established 

under the Centers for Medicare and 

Medicaid Services (CMS) DMEPOS fee 

schedule under 42 CFR part 414, 

subpart D.

* * * * *

Dated: September 28, 2004 

L.M. Bynum, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense.

[FR Doc. 04–22684 Filed 10–8–04; 8:45 am] 

BILLING CODE 5001–06–M

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD08–04–034] 

RIN 1625–AA09 

Drawbridge Operation Regulation; 

Tensas River, Clayton, LA

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

SUMMARY: The Coast Guard is removing 

the existing drawbridge operation 

regulation for the draw of the Union 

Pacific Railroad bridge across the 

Tensas River, mile 27.2, at Clayton, 

Louisiana. The movable span of the 

bridge has been removed and the 

remains of the bridge are still in place. 

Since the movable span of the bridge 

has been removed, the regulation 

controlling the opening and closing of 

the bridge is no longer necessary.

DATES: This rule is effective October 12, 

2004.

ADDRESSES: Documents referred to in 

this rule are available for inspection or 

copying at the office of the Eighth Coast 

Guard District, Bridge Administration 

Branch, 500 Poydras Street, New 

Orleans, Louisiana 70130–3310, 

between 7 a.m. and 3 p.m., Monday 

through Friday, except Federal holidays. 

The telephone number is (504) 589–

2965. The Eighth District Bridge 

Administration Branch maintains the 

public docket for this rulemaking.

FOR FURTHER INFORMATION CONTACT:

David Frank, Bridge Administration 

Branch, at (504) 589–2965.

SUPPLEMENTARY INFORMATION: 

Good Cause for Not Publishing an 

NPRM 

We did not publish a notice of 

proposed rulemaking (NPRM) for this 

regulation. Under 5 U.S.C. 553(b)(B), the 

Coast Guard finds good cause exists for 

not publishing an NPRM. Public 

comment is not necessary since the 

bridge that the regulation governed is 

out of service and mariners are no 

longer required to request an opening to 

transit through the bridge. 

Good Cause for Making Rule Effective 

in Less Than 30 Days 

Under 5 U.S.C. 553(d)(3), the Coast 

Guard finds good cause exists for 

making this rule effective in less than 30 

days after publication in the Federal 

Register. There is no need to delay the 

implementation of this rule because the 

bridge it governs is already out of 

service and mariners are no longer 

required to request an opening. 

Background and Purpose 

The movable span of the railroad 

bridge across the Tensas River, mile 

27.2, which had previously serviced the 

area has been removed and the 

remaining portions of the bridge 

presently remain in place. These 

remaining portions of the bridge will be 

removed in the near future or permitted 

to remain in place by the U.S. Army 

Corps of Engineers. Since the movable 

span has been removed, mariners are no 

longer required to request openings for 

the bridge. The regulation governing the 

operation of the bridge is found in 33 

CFR 117.503(a). The purpose of this rule 

is to remove 33 CFR 117.503(a) from the 

Code of Federal Regulations since it 

governs a bridge that is no longer in 

service and the movable span has been 

removed. 

Regulatory Evaluation 

This rule is not a ‘‘significant 

regulatory action’’ under section 3(f) of 

Executive Order 12866, Regulatory 

Planning and Review, and does not 

require an assessment of potential costs 

and benefits under section 6(a)(3) of that 

Order. The Office of Management and 

Budget has not reviewed it under that 

Order. It is not ‘‘significant’’ under the 

regulatory policies and procedures of 

the Department of Homeland Security 

(DHS). 

We expect the economic impact of 

this rule to be so minimal that a full 

Regulatory Evaluation under the 

regulatory policies and procedures of 

DHS is unnecessary. 

This rule removes the special 

regulation for a bridge that is already 

out of service. 

Small Entities 

Under the Regulatory Flexibility Act 

(5 U.S.C. 601–612), we have considered 

whether this rule would have a 

significant economic impact on a 

substantial number of small entities. 

The term ‘‘small entities’’ comprises