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###### Department of Defense

###### Office of the Secretary

          - 32 CFR Part 199

# AGENCY:

Office of the Secretary, DoD.

# ACTION:

Proposed rule.

# 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.                          ( print 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:                    

§ 199.2

* * * * *

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: 

§ 199.4

* * * * *

(e) * * *

(8) * * *

(iv) * * *

                            (C)                             *Augmentation mammoplasties.*                             Augmentation mammoplasties, except for breast reconstruction following a covered mastectomy and those                                   ( print 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:

§ 199.5

(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:

§ 199.8

* * * * *

(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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