[Federal Register Volume 84, Number 148 (Thursday, August 1, 2019)]
[Rules and Regulations]
[Pages 37587-37591]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-16347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 81

[Docket Number CDC-2019-0050; NIOSH-329]
RIN 0920-AA74


Guidelines for Determining the Probability of Causation Under the 
Energy Employees Occupational Illness Compensation Program Act of 2000; 
Technical Amendments

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Interim final rule.

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SUMMARY: The Department of Health and Human Services (HHS) is revising 
its regulations to update references to the International 
Classification of Disease (ICD) codes from ICD-9-CM to ICD-10-CM, and 
remove outdated references to chronic lymphocytic leukemia from Energy 
Employees Occupational Illness Compensation Program regulations. These 
technical amendments have no effect on the cancer eligibility 
requirement under the Program because all cancer types are eligible to 
receive a dose reconstruction from NIOSH. Thus, no eligible claimant 
will be adversely impacted by this rulemaking.

DATES: This rule is effective on August 1, 2019. Comments must be 
received by September 30, 2019.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA74,'' by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at http://www.regulations.gov. Follow the instructions for submitting comments 
to docket CDC-2019-0050.
     Mail: NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, 
Cincinnati, OH 45226-1998.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. For detailed instructions on submitting comments and 
additional information on the rulemaking process, see the ``Public 
Participation'' heading of the SUPPLEMENTARY INFORMATION section of 
this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and search for CDC-
2019-0050.

FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090 
Tusculum Ave., MS: C-48, Cincinnati, OH 45226; telephone (855) 818-1629 
(this is a toll-free number); email [email protected].

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Public Participation
II. Background
III. Issuance of an Interim Final Rule With Immediate Effective Date
IV. Technical Review by the Advisory Board on Radiation and Worker 
Health
V. Summary of Interim Final Rule
VI. Regulatory Assessment Requirements
    A. Executive Orders 12866 (Regulatory Planning and Review) and 
13563 (Improving Regulation and Regulatory Review)
    B. Executive Order 13771 (Reducing Regulation and Controlling 
Regulatory Costs)
    C. Regulatory Flexibility Act
    D. Paperwork Reduction Act
    E. Small Business Regulatory Enforcement Fairness Act
    F. Unfunded Mandates Reform Act of 1995
    G. Executive Order 12988 (Civil Justice)
    H. Executive Order 13132 (Federalism)
    I. Executive Order 13045 (Protection of Children From 
Environmental Health Risks and Safety Risks)
    J. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)
    K. Plain Writing Act of 2010

I. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, arguments, 
recommendations, and data. Comments are invited on any topic related to 
this rulemaking.
    All relevant comments submitted will be available for examination 
in the docket for this rulemaking both before and after the closing 
date for comments. All relevant comments will be posted without change 
to Docket CDC-2019-0050 at http://www.regulations.gov including any 
personal information provided.
    All relevant communications received on or before the closing date 
for comments will be fully considered by HHS.

II. Background

    The Energy Employees Occupational Illness Compensation Program Act 
of 2000 (EEOICPA) \1\ was established to provide financial compensation 
and prospective medical benefits to employees for illness caused by 
exposure to radiation, beryllium, silica, and toxic substances during 
their employment at facilities of the Department of Energy, its 
predecessor agencies, and certain of its contractors and vendors. It is 
administered by the Department of Labor's Office of Workers' 
Compensation Programs (OWCP) with radiation dose reconstructions for 
claims involving radiogenic cancers provided by CDC's National 
Institute for Occupational Safety and Health (NIOSH). For these 
radiogenic cancer claims, OWCP is responsible for developing a claim 
file upon receipt of an application for benefits under EEOICPA from a 
claimant. The claim file includes, among other things, employment 
history and an International Classification of Disease (ICD) diagnosis 
code(s) indicating the type and location of a radiogenic cancer for the 
claimant. After a claim file is developed, OWCP then transmits the 
claim file to NIOSH, which uses that information to estimate the amount 
of radiation (radiation ``dose'') the worker might have received during 
covered employment. OWCP then makes determinations regarding the 
likelihood that an individual's cancer is associated with workplace 
radiation exposures using a number of factors, including the radiation 
doses estimated by NIOSH. Existing HHS regulations in 42 CFR part 81 
require the use of International Classification of Disease, 9th 
Revision, Clinical Modification (ICD-9-CM) codes to identify specific 
cancer types used in making these determinations.
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    \1\ 42 U.S.C. 7384n(c).
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    The World Health Organization (WHO) develops diagnostic codes for 
the identification of health conditions; these ICD codes are 
periodically updated to reflect advances in health and medicine. WHO 
developed the 10th

[[Page 37588]]

version (ICD-10) to replace the 9th in 1999. CDC's National Center for 
Health Statistics developed the ICD-10-CM classification, which is a 
``clinical modification'' of WHO's ICD-10 codes, for use in coding and 
classifying disease in the clinical setting. Since the development of 
the ICD-10-CM codes, health facilities and other organizations, 
including OWCP, have relied on HHS' Centers for Medicare & Medicaid 
Services (CMS) to provide ``general equivalence mapping'' between ICD-
9-CM codes and ICD-10-CM codes. However, CMS will discontinue that 
service on September 30, 2019.\2\ Accordingly, OWCP informed NIOSH in 
January 2019 that it will be unable to continue providing both ICD-9-CM 
and ICD-10-CM codes in the claim files without potentially causing 
delay to claim processing. Therefore, the ICD-9-CM codes in part 81 
must be replaced with ICD-10-CM codes to bring the regulations up to 
date and allow NIOSH to efficiently develop dose estimates and improve 
the overall efficiency in claim processing.
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    \2\ See https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-CM.html.
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    Updating the ICD codes and references in part 81 will inform the 
claimant population of the current diagnosis codes used in the 
compensation program and the dose reconstruction process. This 
rulemaking will benefit the population of energy workers who submit 
claims to OWCP for benefits under EEOICPA by allowing NIOSH to complete 
radiation dose reconstructions in support of OWCP's adjudication of the 
claims in a timely manner. This technical amendment has no effect on 
the cancer eligibility requirement under the dose reconstruction 
program (Program) because all cancer types are eligible to receive a 
dose reconstruction from NIOSH. Thus, no eligible claimant will be 
adversely impacted by this rulemaking.
    In addition to updating the ICD codes, NIOSH will also remove 
outdated references to chronic lymphocytic leukemia (CLL) from part 81. 
Until promulgation of a final rule in 2012,\3\ CLL was not covered 
under the EEOICPA program. The 2012 final rule removed 42 CFR 81.30, 
which excluded this cancer, thereby allowing claimants to seek 
compensation through the dose reconstruction process. That rulemaking 
mistakenly did not remove other references to this provision found 
elsewhere in part 81.
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    \3\ Final Rule; Guidelines for Determining Probability of 
Causation Under the Energy Employees Occupational Illness 
Compensation Program Act of 2000; Revision of Guidelines on Non-
Radiogenic Cancers, February 6, 2012 (77 FR 5711).
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    Finally, a recent Department of Labor rulemaking renumbered a CFR 
section that defines the term ``specified cancer'' used in that part. 
Because that term is referenced in HHS' rules in part 81, the citation 
to the Department of Labor regulations is no longer accurate and should 
be updated.

III. Issuance of an Interim Final Rule With Immediate Effective Date

    Rulemaking under the Administrative Procedure Act (APA) generally 
requires a public notice and comment period and consideration of the 
submitted comments prior to promulgation of a final rule (5 U.S.C. 
553). However, the APA provides for exceptions to its notice and 
comment procedures when an agency finds that there is good cause for 
dispensing with such procedures on the basis that they are 
impracticable, unnecessary, or contrary to the public interest. In 
accordance with the provisions in 5 U.S.C. 553(b)(3)(B), HHS finds good 
cause to waive the use of prior notice and comment procedures when 
issuing this IFR and to make updates to references and ICD codes in 42 
CFR part 81 effective immediately.
    This IFR amends 42 CFR part 81 to update references and ICD codes. 
HHS has determined that it is unnecessary to use prior notice and 
comment procedures for this IFR because HHS has already issued through 
notice-and-comment rulemaking a requirement that covered entities, such 
as physicians and hospitals, use ICD-10-CM for covered transactions.\4\ 
Updating the ICD codes is a technical amendment in which CDC exercises 
little discretion. Soliciting public comment prior to promulgation of 
this rulemaking would be unnecessary since mapping between ICD-9 and -
10 codes is straightforward and all cancer types are eligible to 
receive a dose reconstruction from NIOSH. Moreover, notice and comment 
rulemaking would be impracticable and contrary to the public interest 
because the rulemaking process may take up to 2 years to complete, 
resulting in the public not being provided timely information about the 
updated diagnosis codes as well as a lack of transparency in NIOSH's 
dose reconstruction process. NIOSH was not notified until January 2019 
that OWCP will no longer provide both sets of ICD codes when CMS phases 
out the general equivalence mapping in September 2019. Thus, there is 
limited time in which to promulgate this regulation. For similar 
reasons, HHS has also determined that the need for immediate 
implementation of the proposed updates to ensure transparency and 
expediency in the NIOSH dose reconstruction process outweighs the 
fairness consideration and any need of potential stakeholders to adjust 
to the use of ICD-10-CM codes. Accordingly, HHS is waiving the prior 
notice and comment procedures in the interest of regulatory compliance 
and administrative efficiency.
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    \4\ 45 CFR 162.1002(c)(2).
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    Under 5 U.S.C. 553(d)(3), HHS finds good cause to make this IFR 
effective immediately. As stated above, in order to facilitate the 
complete transition of the Program from ICD-9-CM to ICD-10-CM, it is 
necessary that HHS act quickly to amend 42 CFR part 81 to allow NIOSH 
to replace all references to ICD-9-CM codes with ICD-10-CM codes. While 
amendments to 42 CFR part 81 are effective on the date of publication 
of this IFR, they are interim and a final rule will be published 
following the receipt and consideration of any substantive public 
comments.

IV. Technical Review by the Advisory Board on Radiation and Worker 
Health

    EEOICPA requires that HHS obtain a technical review by the Advisory 
Board on Radiation and Worker Health (the Board) prior to establishing 
the probability of causation guidelines to be amended through this 
rulemaking.\5\ HHS interprets this requirement also to apply to any 
revisions HHS would make to these guidelines. Hence, HHS will obtain a 
technical review by the Board and consider the findings of this review 
in promulgating the final regulation.
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    \5\ 42 U.S.C. 7384n(c).
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V. Summary of Interim Final Rule

    This interim final rule amends 42 CFR part 81 to allow NIOSH to 
update references and ICD codes. No substantive changes are being made 
to part 81.
    In the existing definitions section, Sec.  81.4, the term 
``specified cancer'' includes a reference to a corresponding DOL 
regulation (i.e., 20 CFR 30.5(dd)). DOL has recently conducted a 
rulemaking to revise 20 CFR part 30 that resulted in the reordering of 
this reference from 20 CFR 30.5(dd) to 20 CFR 30.5(gg).\6\ Therefore, 
in Sec.  81.4, HHS is revising the reference to ``20 CFR 30.5(gg).'' In 
addition, the definition of the term ``non-radiogenic cancer'' is 
removed because all cancers are considered radiogenic and there are no 
longer any non-radiogenic cancers ineligible for receiving a dose 
reconstruction from NIOSH. Finally, Sec.  81.4 is revised by adding a 
new

[[Page 37589]]

definition of ``ICD-10-CM,'' to include a reference and web link.
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    \6\ 84 FR 3026 (February 8, 2019).
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    In existing Sec.  81.5(b), the term ``ICD-9'' is replaced with 
``ICD-10-CM.'' In Sec. Sec.  81.21, 81.23, and 81.24, all references to 
ICD-9 codes are changed to ICD-10-CM codes. In Sec. Sec.  81.21(a) and 
81.24(a), outdated references to CLL are also removed. Finally, 
Appendix A is removed in its entirety because it is a glossary of ICD-9 
codes and their cancer descriptions, and such reference tables, 
including tables of ICD-10 codes and their cancer descriptions, are 
readily available online.

VI. Regulatory Assessment Requirements

A. Executive Orders 12866 (Regulatory Planning and Review) and 13563 
(Improving Regulation and Regulatory Review)

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This interim final rule is not being treated as a ``significant'' 
action under E.O. 12866. It updates references and ICD codes in 
existing 42 CFR part 81 to allow better administrative efficiency in 
the processing of dose reconstruction claims. The rule does not result 
in costs to the Program, claimants, or any other interested parties. 
Accordingly, HHS has not prepared an economic analysis and the Office 
of Management and Budget (OMB) has not reviewed this rulemaking.
    The rule does not interfere with State, local, or tribal 
governments in the exercise of their governmental functions.

B. Executive Order 13771 (Reducing Regulation and Controlling 
Regulatory Costs)

    Executive Order 13771 requires executive departments and agencies 
to eliminate at least two existing regulations for every new 
significant regulation that imposes costs. HHS has determined that this 
rulemaking is cost-neutral because it does not require any new action 
by stakeholders. The rulemaking ensures that the dose reconstructions 
developed by the Program can be conducted efficiently. Because OMB has 
determined that this rulemaking is not significant, pursuant to E.O. 
12866, and because it does not impose costs, OMB has determined that 
this rulemaking is exempt from the requirements of E.O. 13771. Thus it 
has not been reviewed by OMB.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act, 5 U.S.C. 601 et seq., requires each 
agency to consider the potential impact of its regulations on small 
entities including small businesses, small governmental units, and 
small not-for-profit organizations. The rule affects only Federal 
agencies and certain individuals covered by EEOICPA. Therefore, HHS 
certifies that this interim final rule will not have a significant 
economic impact on a substantial number of small entities.

D. Paperwork Reduction Act

    The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an 
agency to invite public comment on and to obtain OMB approval of any 
rule of general applicability that requires recordkeeping, reporting, 
or disclosure requirements.
    NIOSH has obtained approval from OMB to collect information from 
claimants under ``Energy Employees Occupational Illness Compensation 
Program Act Dose Reconstruction Interviews and Forms (EEOICPA)'' (OMB 
Control No. 0920-0530, exp. January 31, 2022), which covers information 
collected under 42 CFR part 81. This rulemaking does not change the 
reporting burden on any respondents.

E. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the Department 
will report the promulgation of this rule to Congress prior to its 
effective date. The report will state that the Department has concluded 
that this rule is not a ``major rule'' because it is not likely to 
result in an annual effect on the economy of $100 million or more.

F. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this rule does not include any Federal 
mandate that may result in increased annual expenditures in excess of 
$100 million by State, local or tribal governments in the aggregate, or 
by the private sector.

G. Executive Order 12988 (Civil Justice)

    This rule has been drafted and reviewed in accordance with 
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly 
burden the Federal court system. This rule has been reviewed carefully 
to eliminate drafting errors and ambiguities.

H. Executive Order 13132 (Federalism)

    The Department has reviewed this rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

I. Executive Order 13045 (Protection of Children From Environmental 
Health Risks and Safety Risks)

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this rule on children. HHS 
has determined that the rule would have no effect on children.

J. Executive Order 13211 (Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use)

    In accordance with Executive Order 13211, HHS has evaluated the 
effects of this rule on energy supply, distribution or use, and has 
determined that the rule will not have a significant adverse effect.

K. Plain Writing Act of 2010

    Under Public Law 111-274 (October 13, 2010), executive Departments 
and Agencies are required to use plain language in documents that 
explain to the public how to comply with a requirement the Federal 
Government administers or enforces. HHS has attempted to use plain 
language in promulgating the interim final rule consistent with the 
Federal Plain Writing Act guidelines.

List of Subjects in 42 CFR Part 81

    Cancer, Government employees, Nuclear materials, Occupational 
safety and health, Radiation protection, Radioactive materials, 
Workers' compensation.

[[Page 37590]]

Interim Final Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR part 81 as follows:

PART 81--GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER 
THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT 
OF 2000

0
1. The authority citation for part 81 continues to read as follows:

    Authority:  42 U.S.C. 7384n(c); E.O. 13179, 65 FR 77487, 3 CFR, 
2000 Comp., p. 321.


0
2. Amend Sec.  81.4 as follows:
0
a. Remove paragraph (l);
0
b. Redesignate paragraphs (g) through (k) as paragraphs (h) through 
(l), respectively;
0
c. Add a new paragraph (g);
0
d. In paragraph (s), remove the reference ``20 CFR 30.5(dd)'' and add 
in its place ``20 CFR 30.5(gg)''.
    The addition reads as follows:


Sec.  81.4   Definition of terms used in this part.

* * * * *
    (g) ICD-10-CM means the International Statistical Classification of 
Diseases and Related Health Problems, Tenth Revision, Clinical 
Modification, https://www.cdc.gov/nchs/icd/icd10cm.htm.
* * * * *

0
3. Amend Sec.  81.5 as follows:
0
a. Add a period at the end of paragraph (a);
0
b. Revise paragraph (b); and
0
c. Add periods at the ends of paragraphs (c) through (f).
    The revision reads as follows:


Sec.  81.5   Use of personal and medical information.

* * * * *
    (b) Cancer diagnosis (by ICD-10-CM code) for primary and secondary 
cancers.
* * * * *

0
4. Revise Sec.  81.21 to read as follows:


Sec.  81.21   Cancers requiring the use of NIOSH-IREP.

    (a) DOL will calculate probability of causation for all cancers 
using NIOSH-IREP.
    (b) Carcinoma in situ (ICD-10-CM codes D00-D09), neoplasms of 
uncertain behavior (ICD-10-CM codes D37-D44 and D48), and neoplasms of 
unspecified nature (ICD-10-CM code D49) are assumed to be malignant, 
for purposes of estimating probability of causation.
    (c) All secondary and unspecified cancers of the lymph node (ICD-
10-CM codes C77 and C7B.01) shall be considered secondary cancers 
(cancers resulting from metastasis of cancer from a primary site). For 
claims identifying cancers of the lymph node, Table 1 in Sec.  81.23(a) 
provides guidance for assigning a primary site and calculating 
probability of causation using NIOSH-IREP.

0
5. Amend Sec.  81.23 by revising paragraph (a) to read as follows:


Sec.  81.23   Guidelines for cancers for which primary site is unknown.

    (a) In claims for which the primary cancer site cannot be 
determined, but a site of metastasis is known, DOL will calculate 
probability of causation estimates for various likely primary sites. 
Table 1 of this paragraph (a) indicates the primary cancer site(s) DOL 
will use in NIOSH-IREP when the primary cancer site is unknown.

Table 1 to Paragraph (a)

Primary cancers (ICD-10-CM codes) for which probability of causation is 
to be calculated, if only a secondary cancer site is known. ``M'' 
indicates cancer site should be used for males only, and ``F'' 
indicates the cancer site should be used for females only.

------------------------------------------------------------------------
                                             ICD-10-CM code of likely
   Secondary cancer (ICD-10-CM code)             primary cancers
------------------------------------------------------------------------
Lymph nodes of head, face and neck       C01, C02, C07(M), C08(M),
 (C77.0).                                 C09(M), C10(M), C14(F),
                                          C32(M), C33, C34, C43, C44,
                                          C50(F), C73(F), D03.
Intrathoracic lymph nodes (C77.1)......  C15(M), C33, C34, C50(F).
Intra-abdominal lymph nodes (C77.2)....  C15(M), C16(M), C18, C25(F),
                                          C33, C34, C50(F), C53(F),
                                          C61(M), C64, C65, C66, C68,
                                          C82(F), C84(F) (excluding
                                          C84.6, C84.7), C85(F), C86(F)
                                          (excluding C86.5, C86.6),
                                          C91.4(F), C96(F).
Lymph nodes of axilla and upper limb     C33, C34, C43, C50(F) , D03.
 (C77.3).
Inguinal and lower limb lymph nodes      C19(M), C20(M), C21(M), C33,
 (C77.4).                                 C34, C43, C44(F), C60(M),
                                          C63(M), D03.
Intrapelvic lymph nodes (C77.5)........  C18(M), C19(F), C20(F), C21(F),
                                          C33(M), C34(M), C53(F),
                                          C54(F), C61(M), C67.
Lymph nodes of multiple sites (C77.8)..  C15(M), C16(M), C18(M), C33,
                                          C34, C50(F).
Lymph nodes, site unspecified (C77.9)..  C15(M), C16, C18, C33, C34,
                                          C43, C50(F), C61(M), D03.
Lung (C78.0)...........................  C18, C33, C34, C43(M), C50(F),
                                          C61(M), C67(M), C64, C65, C66,
                                          C68, D03(M).
Mediastinum (C78.1)....................  C15(M), C33, C34, C50(F).
Pleura (C78.2).........................  C15(M), C18(M), C33, C34,
                                          C50(F), C56(F), C57(F),
                                          C61(M), C64(M), C65(M),
                                          C66(M), C68(M).
Other respiratory organs (C78.3).......  C15, C18(M), C32, C33, C34,
                                          C44(M), C50(F), C61(M),
                                          C73(F).
Small intestine, including duodenum      C17, C18, C25, C33, C34, C49,
 (C78.4).                                 C43(M), C50(F), C56(F),
                                          C57(F), C64(M), C65(M),
                                          C66(M), C68(M), D03(M).
Large intestine and rectum (C78.5).....  C18, C19, C20, C21, C33, C34,
                                          C50(F), C56(F), C57(F),
                                          C61(M).
Retroperitoneum and peritoneum (C78.6).  C16, C18, C19(M), C20(M),
                                          C21(M), C25, C33(M), C34(M),
                                          C49, C50(F), C54(F), C56(F),
                                          C57(F).
Liver, specified as secondary (C78.7)..  C16(M), C18, C19(M), C20(M),
                                          C21(M), C25, C33, C34, C50(F).
Other digestive organs (C78.8).........  C15(M), C16, C18, C25, C33,
                                          C34, C50(F), C61(M).
Kidney (C79.0).........................  C18, C33, C34, C50(F), C53(F),
                                          C61(M), C67, C64, C65, C66,
                                          C68, C82(F), C84(F) (excluding
                                          C84.6, C84.7), C85(F), C86(F)
                                          (excluding C86.5, C86.6),
                                          C91.4(F), C96(F).
Other urinary organs (C79.1)...........  C18, C50(F), C53(F), C56(F),
                                          C57(F), C61(M), C67, C64(F),
                                          C65(F), C66(F), C68(F).
Skin (C79.2)...........................  C18, C33, C34, C49(M), C43,
                                          C44(M), C50(F), C64(M),
                                          C65(M), C66(M), C68(M), D03.
Brain and spinal cord (C79.3)..........  C33, C34, C43(M), C50(F),
                                          D03(M).

[[Page 37591]]

 
Other parts of nervous system (C79.4)..  C33, C34, C43(M), C50(F),
                                          C61(M), C82, C84 (excluding
                                          C84.6, C84.7), C85, C86
                                          (excluding C86.5, C86.6),
                                          C91.4, C96, D03(M).
Bone and bone marrow (C79.5)...........  C33, C34, C50(F), C61(M).
Ovary (C79.6)..........................  C18(F), C50(F), C56(F), C57(F).
Adrenal gland (C79.7)..................  C18(F), C33, C34, C50(F).
Other specified sites (C79.8)..........  C18, C33, C34, C43(M), C50(F),
                                          C56(F), C57(F), C61(M),
                                          C67(M), D03(M).
Unspecified sites (C79.9)..............  C18, C33, C34, C43(M), C50(F),
                                          C56(F), C57(F), C61(M),
                                          C67(M), D03(M).
Carcinoid tumor of distant lymph nodes   C15(M), C16, C18, C33, C34,
 (C7B.01).                                C43, C50(F),C61(M), D03.
Carcinoid tumor of liver (C7B.02)......  C16(M), C18, C19(M), C20(M),
                                          C21(M), C25, C33, C34, C50(F).
Carcinoid tumor of bone (C7B.03).......  C33, C34, C50(F), C61(M).
Carcinoid tumor of peritoneum (C7B.04).  C16, C18, C19(M), C20(M),
                                          C21(M), C25, C33(M), C34(M),
                                          C49, C50(F), C54(F), C56(F),
                                          C57(F).
Merkel cell carcinoma (C7B.1)..........  C18, C33, C34, C49(M), C43,
                                          C44(M), C50(F), C64(M),
                                          C65(M), C66(M), C68(M), D03.
------------------------------------------------------------------------

* * * * *

0
6. Amend Sec.  81.24 by revising paragraph (a) to read as follows:


Sec.  81.24   Guidelines for leukemia.

    (a) For claims involving leukemia, DOL will calculate one or more 
probability of causation estimates from up to three of the four 
alternate leukemia risk models included in NIOSH-IREP, as specified in 
the NIOSH-IREP Operating Guide. These include: ``Leukemia, all types'' 
(ICD-10-CM codes C91-C95), ``acute lymphocytic leukemia'' (ICD-10-CM 
code C91.0), and ``acute myelogenous leukemia'' (ICD-10-CM codes C92.6 
and C92.A).
* * * * *


Sec.  81.25   [Amended]

0
7. Amend Sec.  81.25 by redesignating footnote 4 as footnote 3.

    Dated: July 25, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-16347 Filed 7-31-19; 8:45 am]
 BILLING CODE 4163-18-P