2010-26661. Schedule for Rating Disabilities; AL Amyloidosis (Primary Amyloidosis)

AGENCY:

Department of Veterans Affairs.

ACTION:

Proposed rule.

SUMMARY:

This document proposes to amend the Department of Veterans Affairs (VA) Schedule for Rating Disabilities (rating schedule) by updating the schedule of ratings for the hemic and lymphatic systems to include AL amyloidosis. This regulatory action is necessary to add AL amyloidosis as one of the disease conditions and establish criteria for disability evaluation to fully implement the decision by the Secretary of Veterans Affairs to grant presumptive service connection based on herbicide exposure for this disease. The intended effects are to provide consistency in disability ratings and to ease tracking of AL amyloidosis for statistical analysis.

DATES:

Comments must be received by VA on or before December 21, 2010.

ADDRESSES:

Written comments may be submitted through http://www.Regulations.gov;​; by mail or hand-delivery to Director, Regulations Management (02REG), 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-AN75—Schedule for Rating Disabilities; AL Amyloidosis (Primary Amyloidosis).” All 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 are available online through the Federal Docket Management System (FDMS) at http://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Thomas J. Kniffen, Chief, Regulations Staff (211D), Compensation and Pension Service, Veterans Benefits Administration, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, [phone]. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION:

A final rule was published in the Federal Register at 74 FR 21258 amending 38 CFR 3.309(e) by adding AL amyloidosis to the list of diseases associated with exposure to certain herbicide agents. Currently, the rating schedule does not have a diagnostic code for AL amyloidosis. As an unlisted condition, it is rated by analogy to non-Hodgkin's lymphoma using the “built-up” diagnostic code 7799-7715. However, AL amyloidosis is not part of the group of diseases under the non-Hodgkin's lymphoma classification, but a disorder of the bone marrow characterized by the accumulation and deposition of abnormal, insoluble proteins called light chain amyloid proteins in any organ of the body, interfering with the structure and function of the organ. Therefore, AL amyloidosis requires a set of evaluation criteria with a unique diagnostic code, which will serve as a basis for disability rating. VA proposes a regulation that would amend the rating schedule by adding rating guidance and a diagnostic code specifically for AL amyloidosis.

AL amyloidosis is a seriously disabling, progressive, and incurable condition. It is usually fatal within 1 to 2 years of diagnosis. Because of its rarity and rapid progression, AL amyloidosis may not be diagnosed until it has resulted in considerable multi-organ damage (to heart, kidney, liver, spleen, intestine, etc.). At the time of diagnosis, the most common findings are nephrotic syndrome with or without renal insufficiency, congestive cardiomyopathy, peripheral neuropathy, and hepatomegaly. The extent of the disease limits the specific types of treatments that can be used. Stem cell transplantation with high dose chemotherapy, an aggressive and risky treatment with serious side effects and a significant mortality rate, can be used in a limited number of patients who meet the criteria to undergo such severe treatment. This treatment has shown promise in prolonging life but does not cure the disease. Accumulations of amyloid in a specific area of the body can sometimes be removed surgically. Organ transplants (for example, of a kidney or the heart) have extended the lives of a small number of people with organ failure due to amyloidosis but eventually the transplanted organ accumulates amyloid. In general, treatment can slow the course of the disease and help alleviate the symptoms of organ damage, but it is not curative.

AL amyloidosis is a disease most closely aligned with other diseases of the hemic and lymphatic systems. Therefore, VA proposes diagnostic code 7717 for AL amyloidosis because it is the first available diagnostic code in the Hemic and Lymphatic Systems listed in § 4.117.

VA proposes to assign a 100 percent rating because the disease is incurable and progressive, generally causing death in a few years. While AL amyloidosis may or may not be totally disabling at the time of diagnosis or time of claim for VA compensation, its clinical course is usually associated with rapid disease progression and involvement of multiple organ systems. The usual cause of death is cardiac, hepatic, or renal failure, or infection. The median survival rate for AL amyloidosis is 12-18 months in the United States. Providing a 100-percent evaluation in all cases would obviate the need to reassess and reevaluate veterans with AL amyloidosis repeatedly over a short period of time. Because of the poor prognosis, no follow-up examination will be required for re-evaluation of this disability rating.

We also propose to refer to AL amyloidosis as “primary amyloidosis”, which is another common name for the same disease. Although the disease may also be identified as “immunocyte-derived amyloidosis” and “light chain-related amyloidosis”, these terms for the disease are much less common. Therefore, we propose not to include them under diagnostic code 7717 because their inclusion would not be useful to the public or VA personnel.

Finally, we propose to amend 38 CFR Part 4, Appendices A, B, and C to reflect the proposed addition of diagnostic code 7717 for AL amyloidosis to the rating schedule.

Regulatory Flexibility Act

The Secretary 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 et seq. This proposed rule will not directly affect small entities. Only VA beneficiaries will be directly affected. Therefore, pursuant to 5 U.S.C. 605(b), this amendment is exempt from the initial and final regulatory flexibility analysis requirements of sections 603 and 604.

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.

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 1 year. This proposed rule would have no such effect on State, local, and Tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance Numbers and Titles

The Catalog of Federal Domestic Assistance program numbers and titles for this proposal are 64.104, Pension for Non-Service-Connected Disability for Veterans, and 64.109, Veterans Compensation for Service-Connected Disability.

Paperwork Reduction Act

This action contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).

Signing Authority

The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. John R. Gingrich, Chief of Staff, Department of Veterans Affairs, approved this document on October 4, 2010, for publication.

List of Subjects in 38 CFR Part 4

• Disability benefits
• Pensions
• Veterans

Dated: October 18, 2010.

Robert C. McFetridge,

Director, Regulation Policy and Management, Office of the General Counsel, Department of Veterans Affairs.

For the reasons stated in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 4 as set forth below:

PART 4—SCHEDULE FOR RATING DISABILITIES

1. The authority citation for part 4 continues to read as follows:

Authority: 38 U.S.C. 1155, unless otherwise noted.

Subpart B—Disability Ratings

§ 4.117

[Amended]

2. In § 4.117, add diagnostic code 7717, immediately following the note at the end of diagnostic code 7716, to read as follows:

§ 4.117

Schedule of ratings—hemic and lymphatic systems.

	Rating
*    *    *    *    *
7717 AL amyloidosis (primary amyloidosis)	100
*    *    *    *    *

Appendix A to Part 4 [Amended]

3. In Appendix A to Part 4, under Sec. 4.117, add diagnostic code 7717 in numerical order (following diagnostic code number 7716) to the table to read as follows:

Appendix A to Part 4—Table of Amendments and Effective Dates Since 1946

Sec.	Diagnostic Code No.
*         *         *         *         *         *         *
4.117
*         *         *         *         *         *         *
7717		Added [Date 30 days after date of publication of the final rule in the Federal Register].

Appendix B to Part 4 [Amended]

4. In Appendix B to Part 4 add diagnostic code 7717 to the table in numerical order (following the entry for diagnostic code number 7716) and its disability entry “AL amyloidosis (primary amyloidosis)” to read as follows:

Appendix B to Part 4—Numerical Index of Disabilities

Diagnostic Code No.
*         *         *         *         *         *         *
THE HEMIC AND LYMPHATIC SYSTEMS
*         *         *         *         *         *         *
7717	AL amyloidosis (primary amyloidosis).
*         *         *         *         *         *         *

Appendix C to Part 4 [Amended]

5. Appendix C to Part 4 is amended by adding in alphabetical order (following “Agranulocytosis”) a new entry “AL amyloidosis” and its diagnostic code number “7717” to read as follows:

Appendix C to Part 4—Alphabetical Index of Disabilities

	Diagnostic Code No.
*    *    *    *    *
AL amyloidosis	7717
*    *    *    *    *