[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Proposed Rules]
[Pages 65279-65281]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26661]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 4

RIN 2900-AN75


Schedule for Rating Disabilities; AL Amyloidosis (Primary 
Amyloidosis)

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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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 (202) 273-9026. 
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 (202) 461-4902 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, (202) 461-9725. (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

[[Page 65280]]

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 
Sec.  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


Sec.  4.117  [Amended]

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


Sec.  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:

[[Page 65281]]



Appendix A to Part 4--Table of Amendments and Effective Dates Since 1946
------------------------------------------------------------------------
                                     Diagnostic
               Sec.                   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
 
                                * * * * *
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[FR Doc. 2010-26661 Filed 10-21-10; 8:45 am]
BILLING CODE 8320-01-P