[Federal Register Volume 67, Number 74 (Wednesday, April 17, 2002)]
[Rules and Regulations]
[Pages 18825-18827]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9180]



[[Page 18825]]

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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199

RIN-0720-AA70


Civilian Health and Medical Program of the Uniformed Service 
(CHAMPUS): Enuretic Devices, Breast Reconstructive Surgery, PFPWD Valid 
Authorization Period, Early Intervention Services

AGENCY: Office of the Secretary, DoD.

ACTION: Final rule.

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SUMMARY: This final rule removes the exclusion of enuresis alarms, 
corrects contradictory language as it relates to breast reconstructive 
surgery, changes the valid period of an authorization for services and 
items under the Program for Persons with Disabilities, implements 
Section 640 of Public Law 105-17, which establishes the Civilian Health 
and Medical Program of the Uniformed Service (CHAMPUS) payment 
relationship for IDEA Part C services and items.

EFFECTIVE DATE: This final rule is effective May 17, 2002.

FOR FURTHER INFORMATION CONTACT: Margaret Brown and Michael Kottyan, 
TRICARE Management Activity, Office of Medical Benefits and 
Reimbursement Systems (303) 676-3581 and (303) 676-3520 respectively.

SUPPLEMENTARY INFORMATION: On November 15, 2000 (65 FR 68957), the 
Department of Defense published a proposed rule with a public comment 
period. All respondents concurred with the proposed amendments. Five 
suggested several minor changes. Therefore, all comments were analyzed 
and considered in the formulation of this final rule.

Comments and Responses

    Comment: PFPWD--Early Intervention: One comment stated that it was 
not clear from the materials provided whether CHAMPUS as first payer 
for allowable medical services and items provided as early intervention 
services (EIS) is a change to comply with the law or whether it is a 
clarification of present policy.
    Response: This action is not a change in that it merely codifies 
Section 640 of Public Law 105-17, which defines the payment 
relationship of CHAMPUS and funds provided in accordance with that law.
    Comment: Another comment suggested that the rule stipulate that 
families who reside on base are not eligible for TRICARE/CHAMPUS 
payment if the on-base program can provide the required EIS.
    Response: Early Intervention Services (EIS) available from or 
through Military Treatment Facilities (MTFs), or other on-base 
programs, should be utilized to the extent appropriate. However, to 
restrict services to those not available from or through an MTF would 
require a mechanism similar to a non-availability statement, could 
precipitate a delay in delivery of necessary services, and is beyond 
the scope of this rule. Consequently, we have retained the language as 
originally proposed.
    Comment: PFPWD Double Coverage Plan--Another comment suggested that 
we change the sentence ``medical services and items that are provided 
under Part C of the IDEA'' to ``services and devices provided under 
Part C of the IDEA that are medically or psychologically necessary.''
    Response: We agreed to make this change. However, we did not change 
the term ``items'' to ``devices'' because items is the language used 
elsewhere in CHAMPUS' regulations and policies.
    Comment: PFPWD Valid Authorization Period--The last comment 
regarding PFPWD and suggested that we change the sentence ``maximum of 
twelve months'' to ``maximum of twelve consecutive months.''
    Response: We agreed to make this change.
    Comment: Breast reconstructive surgery--One comment suggested that 
we change ``structures of the body in order to improve the patient's 
appearance and self-esteem remains an exclusion'' to ``structures of 
the body for the sole purpose of electively improving the patient's 
appearance remains an exclusion'' to clarify the intent of when 
reconstructive surgery is not paid.
    Response: We agreed to make this change.
    Comment: Statement at the paragraph 199.4(g)(15)(i)(D)--It was also 
suggested that we define the term ``reliable evidence'' by making a 
reference to the definition of reliable evidence in 32 CFR 199.2.
    Response: This change is not necessary, because paragraph 
199.4(g)(15)(i)(D) already contains a reference to the definition at 
the end of the paragraph.
    Comment: Enuretic Devices--The last comment regarding enuretic 
devices suggested that we change the word ``physician'' to ``health 
care provider'' to expand the personnel available to provide 
professional guidance on the use of the enuretic devices, such as a 
physician's assistant or nurse practitioner.
    Response: We agreed to make this change.

Overview of Changes

    The following provides an overview of the changes in this final 
rule to Secs. 199.2; 199.4; 199.5; and 199.8.
    This final rule removes the exclusion of enuresis alarms, corrects 
contradictory language as it relates to breast reconstructive surgery, 
changes the valid period of an authorization for services and items 
under the Program for Persons with Disabilities (PFPWD), and 
establishes the CHAMPUS payment relationship for IDEA Part C services 
and items, and revises a statement to the paragraph at 32 CFR 
199.4(g)(15)(i)(D).

Enuretic Devices

    The TRICARE Management Activity received a request from the medical 
community that we re-evaluate our policy regarding enuretic devices, 
which currently are excluded from cost sharing under the CHAMPUS Basic 
Program. Recent literature review indicates that the medical community 
considers enuresis alarms the most effective method for treating 
enuresis. Having found no contradictory evidence, we agree that 
enuretic devices should be removed from the exclusions in the 
regulation. The removal of this exclusion allows physicians to select 
rational treatment options and insure that CHAMPUS pays only for the 
most appropriate and highest quality medical care possible.
    Enuretic conditioning programs are also specifically excluded from 
CHAMPUS cost sharing. Enuretic conditioning programs will continue to 
be excluded. The basis for excluding enuretic conditioning programs is 
to restrict the payment for professional guidance on the use of these 
devices to an authorized health care provider, such as, the attending 
physician or a physician's assistant or a nurse practitioner.

Breast Reconstructive Surgery.

    Benefits under the basic program are not available for cosmetic, 
reconstructive, or plastic surgery. However, the regulation provides 
exceptions for procedures that are essentially cosmetic when performed 
in response to a congenital anomaly, post mastectomy breast 
reconstruction for malignancy, fibrocystic disease, or other covered 
mastectomies, an accidental injury or disfiguring scars resulting from 
neoplastic surgery.

[[Page 18826]]

    The regulation currently contains contradictory provisions relating 
to post mastectomy breast reconstruction. Paragraph 199.4 (e)(8)(i)(D) 
specifically authorizes post mastectomy breast reconstruction. However, 
paragraph 199.4 (e)(8)(ii)(D) excludes breast augmentation mammoplasty 
even when performed as a part of post mastectomy breast reconstruction 
procedure. Because an augmentation mammoplasty is an integral part of 
most post mastectomy breast reconstruction procedures, it is 
inconsistent to exclude it as a part of that procedure.
    Further, in the context of post mastectomy breast reconstruction, 
reduction mammoplasty may be performed to achieve symmetry of the 
collateral breast. This too is an integral part of the post mastectomy 
breast reconstruction process and should not be excluded from cost 
sharing by CHAMPUS. We are adding language to clarify the rule that 
reduction mammoplasty on the collateral breast is an authorized part of 
the post mastectomy breast reconstruction procedure.
    Cosmetic, reconstructive or plastic surgery that is performed to 
reshape normal structures of the body for the sole purpose of 
electively improving the patient's appearance remains an exclusion.

PFPWD Valid Authorization Period

    The regulation currently provides that a valid authorization for 
receipt of services and items under the Program for Persons with 
Disabilities (PFPWD) shall not exceed six consecutive months. For 
services that are required for more than six months, and for the 
allowable cost of durable equipment and durable medical equipment that 
is prorated for more than six months, this requirement places 
unnecessary hardship on the family of an individual with a disability 
and additional administrative workload on the managed care support 
contractors. Changing the valid period of a PFPWD authorization to a 
maximum of twelve consecutive months enhances the PFPWD without 
compromising its accountability.

Early Intervention Services

    Part C of the Individuals with Disabilities Education Act (IDEA) 
Amendments of 1997, Public Law 105-17, enacted June 4, 1997, provides 
financial assistance to States to, among other provisions, facilitate 
the coordination of payment for early intervention services from 
Federal, State, local, and private sources (including public and 
private insurance coverage). Early intervention services are 
developmental services provided to individuals under age three (3) who 
have a developmental delay or who would be at risk of experiencing a 
substantial developmental delay if those services were not provided.
    Part C, Section 640, Payer of Last Resort, establishes that funds 
provided under the Act may not be used to satisfy a financial 
commitment for services that would have been paid for from another 
public or private source, including any medical program administered by 
the Secretary of Defense. This language establishes CHAMPUS as first 
payer for medical services and items provided as early intervention 
services in accordance with Part C and that are otherwise allowable 
under the CHAMPUS Basic Program or the Program for Persons with 
Disabilities.

Statement at Paragraph 32 CFR 199.4(g)(15)(i)(D)

    The revised statement clarifies that the consensus among experts 
must be based on reliable evidence.

Regulatory Procedures

    Executive Order 12866 requires certain regulatory assessments for 
any significant regulatory action, defined as one that would result in 
an annual effect on the economy of $100 million, or more or have other 
substantial impacts.
    The Regulatory Flexibility Act (RFA) requires that each Federal 
Agency prepare, and make available for public comment, a regulatory 
flexibility analysis when the agency issues a regulation which would 
have a significant impact on a substantial number of small entities.
    This rule has been designated as significant and has been reviewed 
by the Office Management and Budget as required under the provisions of 
Executive Order 12866.
    The changes set forth in this final rule are minor revisions to the 
existing regulation. This final rule will not impose additional 
information collection requirements on the public under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3511).

List of Subject in 32 CFR Part 199

    Claims, 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 is amended in the definition of ``Double coverage 
plan'', by removing ``or'' at the end of paragraph (iii), removing the 
period at the end of paragraph (iv) and adding ``; or'' in its place, 
and adding paragraph (v) to read as follows:


Sec. 199.2  Definitions.

* * * * *
    Double coverage plan. * * *
    (v) Part C of the Individuals with Disabilities Education Act for 
services and items provided in accordance with Part C of the IDEA that 
are medically or psychologically necessary in accordance with the 
Individualized Family Service Plan and that are otherwise allowable 
under the CHAMPUS Basic Program or the Program for Persons with 
Disabilities.
* * * * *

    3. Section 199.4 is amended by removing paragraph (e)(8)(ii)(D), 
and by revising paragraphs (e)(8)(iv)(C), (e)(8)(iv)(E), (g)(15)(i)(D), 
and (g)(58), to read as follows:


Sec. 199.4  Basic program benefits.

* * * * *
    (e) * * *
    (8) * * *
    (iv) * * *
    (C) Augmentation mammoplasties. Augmentation mammoplasties, except 
for breast reconstruction following a covered mastectomy and those 
specifically authorized in paragraph (e)(8)(i) of this section.
* * * * *
    (E) Reduction mammoplasties. Reduction mammoplasties (unless there 
is medical documentation of intractable pain, not amenable to other 
forms of treatment, resulting from large, pendulous breasts or unless 
performed as an integral part of an authorized breast reconstruction 
procedure under paragraph (e)(8)(i) of this section, including 
reduction of the collateral breast for purposes of ensuring breast 
symmetry)
* * * * *
    (g) * * *
    (15) * * *
    (i) * * *
    (D) If reliable evidence shows that the consensus among experts 
regarding the medical treatment or procedure is that further studies or 
clinical trials are necessary to determine its maximum tolerated doses, 
its toxicity, its safety, or its effectiveness as compared with the 
standard means of treatment or diagnosis (see the definition of 
reliable evidence in Sec. 199.2 for the procedures used in determining 
if a medical treatment or procedure is unproven).
* * * * *

[[Page 18827]]

    (g) * * *
    (58) Enuretic. Enuretic conditioning programs, but enuretic alarms 
may be cost-shared when determined to be medically necessary in the 
treatment of enuresis.
* * * * *
    4. Section 199.5 is amended by revising paragraph (a)(4)(iii) and 
adding paragraph (a)(5)(v) to read as follows:


Sec. 199.5  Program for Persons with Disabilities (PFPWD).

    (a) * * *
    (4) * * *
    (iii) Valid period. An authorization for a PFPWD service or item 
shall not exceed twelve consecutive months.
* * * * *
    (5) * * *
    (v) The requirements of this paragraph (a)(5) notwithstanding, no 
Public Facility Use Certification is required for medical services and 
items that are provided under Part C of the Individuals with 
Disabilities Education Act in accordance with the Individualized Family 
Service Plan and that are otherwise allowable under the CHAMPUS Basic 
Program or the PFPWD.
* * * * *

    5. Section 199.8 is amended by adding paragraph (d)(5) to read as 
follows:


Sec. 199.8.  Double coverage.

* * * * *
    (d) * * *
    (5) The requirements of paragraph (d)(4) of this section 
notwithstanding, CHAMPUS is primary payer for services and items that 
are provided under Part C of the IDEA that are medically or 
psychologically necessary in accordance with the Individualized Family 
Service Plan and that are otherwise allowable under the CHAMPUS Basic 
Program or the Program for Persons with Disabilities.
* * * * *

    Dated: April 10, 2002.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 02-9180 Filed 4-16-02; 8:45 am]
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