E8-3003. Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA): Expansion of Benefit Coverage for Prostheses and Enuretic (Bed-wetting) Devices; Miscellaneous Provisions

AGENCY:

Department of Veterans Affairs.

ACTION:

Proposed rule.

SUMMARY:

This document proposes to amend the Department of Veterans Affairs (VA) regulations for the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) to expand the benefits available by covering, in addition to currently-covered prostheses, any non-dental prostheses determined medically necessary for treatment of certain medical conditions. It also proposes to no longer exclude coverage of enuretic (bed-wetting) devices. In addition, this document proposes to make changes in delegations of authority, technical changes, and nonsubstantive changes for purposes of clarity in VA's regulations governing CHAMPVA.

DATES:

Comments must be received on or before April 21, 2008.

ADDRESSES:

Written comments may be submitted through http://www.Regulations.gov;​; by mail or hand delivery to the Director, Regulations Management (00REG), Department of Veterans Affairs, 810 Vermont Ave., NW., Room 1068, Washington, DC 20420; or by fax to [phone]. Comments should indicate that they are submitted in response to “RIN 2900-AM22—Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA)—Expansion of Benefit Coverage for Prostheses and Enuretic (Bed-wetting) Devices; Miscellaneous Provisions.” Copies of comments received will be available for public inspection in the Office of Regulation Policy and Management, Room 1063B, between the hours of 8 a.m. and 4:30 p.m., Monday through Friday (except holidays). Please call [phone] for an appointment. (This is not a toll-free number.) In addition, during the comment period, comments may be viewed online through the Federal Docket Management System (FDMS) at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Richard M. Trabert, Policy & Compliance Division, VA Health Administration Center, P.O. Box 65020, Denver, CO 80206-9020; [phone]. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

This document proposes to amend VA's medical regulations in 38 CFR part 17 concerning CHAMPVA. CHAMPVA is a VA medical benefits program for certain (1) spouses and children of veterans who have a permanent and total service-connected disability and (2) surviving spouses and children of veterans who died as a result of a service-connected disability or while rated permanently or totally disabled from a service-connected disability, or who died in the active military, naval, or air service in the line of duty. CHAMPVA is authorized at 38 U.S.C. 1781 (formerly 38 U.S.C. 1713). To be eligible for CHAMPVA benefits, among other requirements, the spouses, surviving spouses, and children may not be otherwise eligible for medical care under 10 U.S.C. chapter 55 (authorizing TRICARE, formerly CHAMPUS; referred to in this preamble as TRICARE/CHAMPUS). By the terms of section 1781(b), VA is required to provide benefits under CHAMPVA in the same or similar manner and subject to the same or similar limitations as medical care that is furnished to certain dependents and survivors of active duty and retired members of the Armed Forces under TRICARE/CHAMPUS. Needed medical care is largely provided to CHAMPVA beneficiaries through non-VA providers.

This proposed rule would amend 38 CFR 17.272, “Benefits limitations/exclusions,” in accordance with the requirements under 38 U.S.C. 1781(b) to furnish CHAMPVA benefits “in the same or similar manner and with the same or similar limitations” as medical care under TRICARE/CHAMPUS.

First, we propose to add certain prostheses to the benefits available under the CHAMPVA program to be consistent with benefits authorized for TRICARE/CHAMPUS in section 702 of Public Law 105-85 (1999), the National Defense Authorization Act for Fiscal Year 1998. That statutory provision amended TRICARE/CHAMPUS coverage to include 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 of Defense (DoD) amended the TRICARE/CHAMPUS regulations in 32 CFR 199.4 accordingly. See 65 FR 58224-25, Sept. 28, 2000 (final rule); 64 FR 45453-45454, August 20, 1999 (interim final rule). As discussed in the preambles in those rulemaking documents, DoD determined that noses, ears, and fingers are examples of additional prostheses that are authorized under that statutory amendment for TRICARE/CHAMPUS coverage. See 65 FR 58224; 64 FR 45453-45454. The regulations promulgated by DoD exclude from coverage all dental prostheses, “except for those specifically required in connection with otherwise covered orthodontia directly related to the surgical correction of a cleft palate anomaly.” 32 CFR 199.4(g)(48).

Under VA's current regulations for CHAMPVA at 38 CFR 17.272(a)(44), coverage for the purchase of prosthetic devices is limited to artificial limbs, voice prostheses, eyes, items surgically inserted in the body as an integral part of a surgical procedure, and dental prostheses that are specifically required in connection with otherwise covered orthodontia directly related to the surgical correction of a cleft palate anomaly. (These are also subject to the requirements generally applicable to CHAMPVA benefits, including being medically necessary and appropriate for the treatment of a condition.) We propose to amend § 17.272(a)(44) to extend prosthetic coverage to any other prostheses (other than dental prostheses) considered medically necessary because of significant conditions resulting from trauma, congenital anomalies, or disease. The proposed changes to § 17.272(a)(44) are also intended to clarify that ears, noses, and fingers and the prostheses currently referred to in § 17.272(a)(44)(i) through (iv) are examples of what the newly-listed category would include. Consistent with 32 CFR 199.4(g)(48), dental prostheses would continue to be excluded except as specifically provided in current § 17.272(a)(44)(v).

As another change authorized under the statutory requirement to furnish CHAMPVA benefits in the same or similar manner and with the same or similar limitations as medical care under TRICARE/CHAMPUS, we propose to amend § 17.272(a)(52) to permit enuretic (bed-wetting) devices (alarms) to be furnished to CHAMPVA beneficiaries. This proposed change would be consistent with DoD's regulations at 32 CFR 199.4(g)(58). That paragraph was amended to no longer exclude such devices. See 67 FR 18825, Apr. 17, 2002. Currently, enuretic (bed-wetting) devices and enuretic conditioning programs are excluded from CHAMPVA coverage. The proposed rule would remove the exclusion for enuretic (bed-wetting) devices now found at § 17.272(a)(52), but would, like TRICARE/CHAMPUS, continue to exclude enuretic conditioning programs. We believe it is in the public interest to implement in the CHAMPVA program this TRICARE/CHAMPUS change. 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, a physician assistant, or a nurse practitioner.

This proposed rule would also amend the delegations of authority in 38 CFR 17.275, “Claim filing deadline,” and 38 CFR 17.276, “Appeal/review process.” Currently, § 17.275(b) provides that only the “Center Director” has the authority to grant exceptions to the claim filing deadline. This proposed rule would amend § 17.275(b) by referring to the Center Director by his or her title, the “Director, Health Administration Center”, and would permit the Director to extend that authority to his or her designee. Similarly, § 17.276 currently provides that, in response to a beneficiary's request for review of a decision by a CHAMPVA benefits advisor, only the Center Director has the authority to issue a decision that is the final decision with respect to benefit coverage and computation of benefits, and that affirms, reverses, or modifies the prior decision. This proposed rule would amend § 17.276 to permit the Director, Health Administration Center, or his or her designee, to issue that final decision.

Finally, the proposed rule would make technical changes and other nonsubstantive changes for purposes of clarity in §§ 17.270 through 17.278. These include technical changes to conform with Public Law 107-135, which redesignated the statutory section authorizing the CHAMPVA program as 38 U.S.C. 1781 (formerly 38 U.S.C. 1713).

Regulatory Flexibility Act

The Secretary of Veterans Affairs hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-612. Individuals eligible for CHAMPVA benefits are widely dispersed geographically and thus services provided to them would not have a significant impact on any small entity. Therefore, pursuant to 5 U.S.C. 605(b), this proposed rule is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

Paperwork Reduction Act of 1995

This document contains no provisions constituting a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).

Unfunded Mandates

The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any year. This proposed rule would have no such effect on State, local, and tribal governments, or on the private sector.

Executive Order 12866

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) unless OMB waives such review, as any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

The economic, interagency, budgetary, legal, and policy implications of this proposed rule have been examined and it has been determined not to be a significant regulatory action under Executive Order 12866.

Catalog of Federal Domestic Assistance

This proposed rule affects the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA), for which there is no Catalog of Federal Domestic Assistance program number.

List of Subjects in 38 CFR Part 17

• Administrative practice and procedure
• Alcohol abuse
• Alcoholism
• Claims
• Day care
• Dental health
• Drug abuse
• Foreign relations
• Government contracts
• Grant programs—health
• Grant programs—veterans
• Health care
• Health facilities
• Health professionals
• Health records
• Homeless
• Medical and dental schools
• Medical devices
• Medical research
• Mental health programs
• Nursing homes
• Philippines
• Reporting and recordkeeping requirements
• Scholarships and fellowships
• Travel and transportation expenses, and Veterans

Approved: February 11, 2008.

Gordon H. Mansfield,

Deputy Secretary of Veterans.

For the reasons stated above, the Department of Veterans Affairs proposes to amend 38 CFR part 17 as follows:

PART 17—MEDICAL

1. The authority citation for part 17 continues to read as follows:

Authority: 38 U.S.C. 501, 1721, and as noted in specific sections.

2. Amend § 17.270 by:

a. In paragraph (a), removing “1713” and adding, in its place, “1781”.

b. In paragraph (b), removing “this section” and adding, in its place, “§§ 17.270 through 17.278”, removing “ “fiscal” year refers to October 1”, and adding, in its place, “ “fiscal year” refers to October 1”.

c. Revising the authority citation.

The revision reads as follows:

§ 17.270

General provisions.

* * * * *

(Authority: 38 U.S.C. 501, 1781)

3. Amend § 17.271 by revising the authority citations after paragraph (a) and at the end of the section to read as follows:

§ 17.271

Eligibility.

(a) * * *

(Authority: 38 U.S.C. 501, 1781)

* * * * *

(Authority: 38 U.S.C. 501, 1781)

4. Amend § 17.272 by:

a. Redesignating paragraphs (a)(44)(i) through (a)(44)(iv) as paragraphs (a)(44)(ii)(A) through (D), respectively.

b. Redesignating paragraph (a)(44)(v) as new paragraph (a)(44)(i).

c. Adding paragraphs (a)(44)(ii) introductory text and (a)(44)(ii)(E).

d. Revising paragraph (a)(52) and the authority citation.

The additions and revisions read as follows:

§ 17.272

Benefits limitations/exclusions.

(a) * * *

(44) * * *

(ii) Any prostheses, other than dental prostheses, determined to be medically necessary because of significant conditions resulting from trauma, congenital anomalies, or disease, including, but not limited to:

* * * * *

(E) Ears, noses, and fingers.

* * * * *

(52) Enuretic (bed-wetting) conditioning programs.

* * * * *

(Authority: 38 U.S.C. 501, 1781)

5. Amend § 17.273 by revising the authority citation to read as follows:

§ 17.273

Preauthorization.

* * * * *

(Authority: 38 U.S.C. 501, 1781)

6. Amend § 17.274 by revising the authority citation to read as follows:

§ 17.274

Cost sharing.

* * * * *

(Authority: 38 U.S.C. 501, 1781)

7. Amend § 17.275 by:

a. In paragraph (b), removing “Center Director” and adding, in its place, “Director, Health Administration Center, or his or her designee”; and removing “paragraph (a) if” and adding, in its place, “paragraph (a) of this section if”.

b. Adding an authority citation at the end of the section.

The addition reads as follows:

§ 17.275

Claim filing deadline.

* * * * *

(Authority: 38 U.S.C. 501, 1781)

8. Amend § 17.276 by:

a. Removing “Center Director” and “Director” each time they appear and adding, in their place, “Director, Health Administration Center, or his or her designee”.

b. Revising the authority citation.

c. In the Note, removing “20 CFR” and adding, in its place “38 CFR”.

The revision reads as follows:

§ 17.276

Appeal/review process.

* * * * *

(Authority: 38 U.S.C. 501, 1781)

* * * * *

9. Amend § 17.277 by adding an authority citation to read as follows:

§ 17.277

Third-party liability/medical care cost recovery.

* * * * *

(Authority: 28 U.S.C. 2651; 38 U.S.C. 501, 1781)

10. Amend § 17.278 by adding an authority citation to read as follows:

§ 17.278

Confidentiality of records.

* * * * *

(Authority: 5 U.S.C. 552, 552a; 38 U.S.C. 501, 1781, 5701, 7332)