[Federal Register Volume 65, Number 221 (Wednesday, November 15, 2000)]
[Proposed Rules]
[Pages 68957-68959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29013]


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DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 199


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: Proposed rule.

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SUMMARY: This proposed rule amends CHAMPUS to remove the exclusion of 
enuresis alarms, to correct contradictory language as it relates to 
breast reconstructive surgery, to change the valid period of an 
authorization for services and items under the Program for Persons with 
Disabilities (PFPWD), to establish the CHAMPUS payment relationship for 
IDEA Part C services and items, and to provide for early intervention 
services.

DATES: Written comments will be accepted until January 16, 2001.

ADDRESSES: Forward comments to the Office of CHAMPUS Management 
Activity, 16401 East Centretech Parkway, Aurora, CO. 80011-9043.

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

SUPPLEMENTARY INFORMATION: The Civilian Health and Medical Program of 
the Uniformed Services (CHAMPUS) supplements the availability of health 
care in military hospitals and clinics. This proposed 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 Device

    The CHAMPUS 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 will allow 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 attending physician.

[[Page 68958]]

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.
    The regulation currently contains contradictory provisions relating 
to post mastectomy breast reconstruction. 32 CFR 199.4(e)(8)(i)(D) 
specifically authorizes post mastectomy breast reconstruction. However, 
32 CFR 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 in order to improve the patient's appearance and 
self-esteem 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 durable 
equipment and durable medical equipment that are 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 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 sectors (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 in accordance with 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 the 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 (EO) 12866 requires that a comprehensive regulatory 
impact analysis be performed on any economically significant regulatory 
action, defined as one that would result in an annual effect of $100 
million, or more on the national economy or which would have other 
substantial impacts.
    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 is neither a significant regulatory action under Executive 
Order 12886, nor would it have a significant impact on small entities. 
The changes set forth in the proposed rule are minor revisions to the 
existing regulation. In addition, this proposed rule does not impose 
new information collection requirements for purposes of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3511).

Paperwork Reduction Act

    The changes set forth in this proposed rule are minor revisions to 
the existing regulation. This rule, as written, imposes no burden as 
defined by the Paperwork Reduction Act of 1995. It will be seen as an 
enhancement of military benefits. It will provide greater parallel 
between CHAMPUS benefits and the standards of care now offered in the 
health care community. If however, any program implemented under this 
rule causes such a burden to be imposed, approval therefore will be 
sought of the Office of Management and Budget in accordance with the 
Act, before implementation. All public comments are invited.

List of Subjects 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]

    Civilian Health and Medical Program of the Uniformed Service 
(CHAMPUS)
    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 proposed to be amended by adding at the end of 
the definition for Double coverage plan a new paragraph (v) to read as 
follows:


Sec. 199.2  Definitions.

* * * * *
    Double coverage plan. * * *
    (v) Part C of the Individuals with Disabilities Education Act for 
medical services and items provided 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 proposed to be amended by removing paragraph 
(e)(8)(ii)(D); amending paragraph (g)(15)(i)(D) by adding ``the 
reliable evidence shows that the'' after the word ``If''; and by 
revising paragraphs (e)(8)(iv)(C), (e)(8)(iv)(E), 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

[[Page 68959]]

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)(C) of this section, including 
reduction of the collateral breast for purposes of ensuring breast 
symmetry.
* * * * *
    (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 proposed to be amended by revising paragraph 
(a)(4)(iii) and adding a new 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 paragraph (a)(5) of this section 
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 proposed to be 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 a primary payer 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 Program for Persons with Disabilities.
* * * * *

    Dated: November 7, 2000.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 00-29013 Filed 11-14-00; 8:45 am]
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