Guidelines for Determining the Probability of Causation Under the Energy Employees Occupational Illness Compensation Program Act of 2000; Technical Amendments, 37587-37591 [2019-16347]
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Federal Register / Vol. 84, No. 148 / Thursday, August 1, 2019 / Rules and Regulations
EPA APPROVED OKLAHOMA REGULATIONS—Continued
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BILLING CODE 6560–50–P
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
Centers for Disease Control and
Prevention, HHS.
ACTION: Interim final rule.
AGENCY:
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CM, and remove outdated references to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 erulemaking portal at https://
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
SUMMARY:
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EPA approval date
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‘‘Public Participation’’ heading of the
section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
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
NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION:
SUPPLEMENTARY INFORMATION
[FR Doc. 2019–16229 Filed 7–31–19; 8:45 am]
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State effective date
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 https://www.regulations.gov
including any personal information
provided.
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Explanation
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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.
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
1 42
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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.
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
2 See https://www.cms.gov/Medicare/Coding/
ICD10/2019-ICD-10-CM.html.
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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references to this provision found
elsewhere in part 81.
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-andcomment 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
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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.
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.
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,
§ 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 § 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,
§ 81.4 is revised by adding a new
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4 45
CFR 162.1002(c)(2).
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U.S.C. 7384n(c).
FR 3026 (February 8, 2019).
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definition of ‘‘ICD–10–CM,’’ to include
a reference and web link.
In existing § 81.5(b), the term ‘‘ICD–9’’
is replaced with ‘‘ICD–10–CM.’’ In
§§ 81.21, 81.23, and 81.24, all references
to ICD–9 codes are changed to ICD–10–
CM codes. In §§ 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.
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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 costneutral 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.
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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
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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.
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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
1. The authority citation for part 81
continues to read as follows:
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§ 81.5 Use of personal and medical
information.
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Authority: 42 U.S.C. 7384n(c); E.O. 13179,
65 FR 77487, 3 CFR, 2000 Comp., p. 321.
2. Amend § 81.4 as follows:
a. Remove paragraph (l);
b. Redesignate paragraphs (g) through
(k) as paragraphs (h) through (l),
respectively;
■ c. Add a new paragraph (g);
■ 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:
■
■
■
§ 81.4
Definition of terms used in this part.
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(g) ICD–10–CM means the
International Statistical Classification of
Diseases and Related Health Problems,
Tenth Revision, Clinical Modification,
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(b) Cancer diagnosis (by ICD–10–CM
code) for primary and secondary
cancers.
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■ 4. Revise § 81.21 to read as follows:
§ 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.
§ 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.
Secondary cancer
(ICD–10–CM code)
ICD–10–CM code of likely primary cancers
Lymph nodes of head, face and neck (C77.0) ........................................
C01, C02, C07(M), C08(M), C09(M), C10(M), C14(F), C32(M), C33,
C34, C43, C44, C50(F), C73(F), D03.
C15(M), C33, C34, C50(F).
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).
C33, C34, C43, C50(F) , D03.
C19(M), C20(M), C21(M), C33, C34, C43, C44(F), C60(M), C63(M),
D03.
C18(M), C19(F), C20(F), C21(F), C33(M), C34(M), C53(F), C54(F),
C61(M), C67.
C15(M), C16(M), C18(M), C33, C34, C50(F).
C15(M), C16, C18, C33, C34, C43, C50(F), C61(M), D03.
C18, C33, C34, C43(M), C50(F), C61(M), C67(M), C64, C65, C66,
C68, D03(M).
C15(M), C33, C34, C50(F).
C15(M), C18(M), C33, C34, C50(F), C56(F), C57(F), C61(M), C64(M),
C65(M), C66(M), C68(M).
C15, C18(M), C32, C33, C34, C44(M), C50(F), C61(M), C73(F).
C17, C18, C25, C33, C34, C49, C43(M), C50(F), C56(F), C57(F),
C64(M), C65(M), C66(M), C68(M), D03(M).
C18, C19, C20, C21, C33, C34, C50(F), C56(F), C57(F), C61(M).
C16, C18, C19(M), C20(M), C21(M), C25, C33(M), C34(M), C49,
C50(F), C54(F), C56(F), C57(F).
C16(M), C18, C19(M), C20(M), C21(M), C25, C33, C34, C50(F).
C15(M), C16, C18, C25, C33, C34, C50(F), C61(M).
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).
C18, C50(F), C53(F), C56(F), C57(F), C61(M), C67, C64(F), C65(F),
C66(F), C68(F).
C18, C33, C34, C49(M), C43, C44(M), C50(F), C64(M), C65(M),
C66(M), C68(M), D03.
C33, C34, C43(M), C50(F), D03(M).
Intrathoracic lymph nodes (C77.1) ...........................................................
Intra-abdominal lymph nodes (C77.2) ......................................................
Lymph nodes of axilla and upper limb (C77.3) ........................................
Inguinal and lower limb lymph nodes (C77.4) .........................................
Intrapelvic lymph nodes (C77.5) ..............................................................
Lymph nodes of multiple sites (C77.8) ....................................................
Lymph nodes, site unspecified (C77.9) ....................................................
Lung (C78.0) .............................................................................................
Mediastinum (C78.1) ................................................................................
Pleura (C78.2) ..........................................................................................
Other respiratory organs (C78.3) .............................................................
Small intestine, including duodenum (C78.4) ..........................................
Large intestine and rectum (C78.5) .........................................................
Retroperitoneum and peritoneum (C78.6) ...............................................
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(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
§ 81.23(a) provides guidance for
assigning a primary site and calculating
probability of causation using NIOSH–
IREP.
■ 5. Amend § 81.23 by revising
paragraph (a) to read as follows:
https://www.cdc.gov/nchs/icd/
icd10cm.htm.
*
*
*
*
*
■ 3. Amend § 81.5 as follows:
■ a. Add a period at the end of
paragraph (a);
■ b. Revise paragraph (b); and
■ c. Add periods at the ends of
paragraphs (c) through (f).
The revision reads as follows:
Liver, specified as secondary (C78.7) ......................................................
Other digestive organs (C78.8) ................................................................
Kidney (C79.0) ..........................................................................................
Other urinary organs (C79.1) ...................................................................
Skin (C79.2) ..............................................................................................
Brain and spinal cord (C79.3) ..................................................................
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Federal Register / Vol. 84, No. 148 / Thursday, August 1, 2019 / Rules and Regulations
Secondary cancer
(ICD–10–CM code)
ICD–10–CM code of likely primary cancers
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).
C33, C34, C50(F), C61(M).
C18(F), C50(F), C56(F), C57(F).
C18(F), C33, C34, C50(F).
C18, C33, C34, C43(M), C50(F), C56(F), C57(F), C61(M), C67(M),
D03(M).
C18, C33, C34, C43(M), C50(F), C56(F), C57(F), C61(M), C67(M),
D03(M).
C15(M), C16, C18, C33, C34, C43, C50(F),C61(M), D03.
C16(M), C18, C19(M), C20(M), C21(M), C25, C33, C34, C50(F).
C33, C34, C50(F), C61(M).
C16, C18, C19(M), C20(M), C21(M), C25, C33(M), C34(M), C49,
C50(F), C54(F), C56(F), C57(F).
C18, C33, C34, C49(M), C43, C44(M), C50(F), C64(M), C65(M),
C66(M), C68(M), D03.
Bone and bone marrow (C79.5) ...............................................................
Ovary (C79.6) ...........................................................................................
Adrenal gland (C79.7) ..............................................................................
Other specified sites (C79.8) ....................................................................
Unspecified sites (C79.9) .........................................................................
Carcinoid
Carcinoid
Carcinoid
Carcinoid
tumor
tumor
tumor
tumor
of
of
of
of
distant lymph nodes (C7B.01) ...................................
liver (C7B.02) .............................................................
bone (C7B.03) ...........................................................
peritoneum (C7B.04) .................................................
Merkel cell carcinoma (C7B.1) .................................................................
*
*
*
*
*
6. Amend § 81.24 by revising
paragraph (a) to read as follows:
■
§ 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).
*
*
*
*
*
§ 81.25
[Amended]
7. Amend § 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
FEDERAL COMMUNICATIONS
COMMISSION
47 CFR Part 20
[WT Docket No. 17–228, FCC 18–167]
Revisions to Reporting Requirements
Governing Hearing Aid-Compatible
Handsets
jspears on DSK3GMQ082PROD with RULES
37591
Federal Communications
Commission.
ACTION: Final rule; announcement of
compliance dates.
AGENCY:
The Wireless
Telecommunications Bureau (WTB or
SUMMARY:
VerDate Sep<11>2014
16:12 Jul 31, 2019
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the Bureau) announces that the Office of
Management and Budget (OMB) has
approved the information-collection and
recordkeeping requirements associated
with the recently amended hearing aid
compatibility provisions addressing
wireless service provider record
retention, website posting, and
certification filing requirements and
announces the date by which service
providers must be in compliance with
these provisions.
DATES: Effective August 1, 2019.
Compliance Dates: Compliance with
47 CFR 20.19(e), (h) and (i) is required
as of September 3, 2019. The § 20.19(i)
service provider certification filing
requirement must be completed
between the compliance date and no
later than 30 days after the compliance
date.
FOR FURTHER INFORMATION CONTACT:
Susannah Larson, Wireless
Telecommunications Bureau, at (202)
418–1883 or via email:
susannah.larson@fcc.gov. For additional
information concerning the Paperwork
Reduction Act information collection
requirements contact Cathy Williams at
(202) 418–2918 or via email:
cathy.williams@fcc.gov.
SUPPLEMENTARY INFORMATION: This
document announces that OMB
approved the information collection
requirements in revised §§ 20.19(e), (h),
and (i) on June 25, 2019. Revised
§ 20.19(e) addresses the reporting and
certification requirements applicable to
de minimis wireless service providers.
Revised § 20.19(h) sets forth service
provider website posting and record
retention obligations and revised
§ 20.19(i) sets forth service provider
annual certification requirements. The
Commission adopted these revised rules
in the following Report and Order
Revisions to Reporting Requirements
Governing Hearing Aid-Compatible
PO 00000
Frm 00027
Fmt 4700
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Mobile Handsets, FCC 18–167,
published at 83 FR 63098 on December
7, 2018 (Report and Order).
The Report and Order provides that
the Bureau will publish a document in
the Federal Register announcing
compliance dates for revised §§ 20.19(e),
(h), and (i) once OMB approval is
obtained for the paperwork burden
associated with these sections. Further,
the Report and Order states that the
Bureau will revise § 20.19(m) once OMB
approval is obtained for §§ 20.19(e), (h),
and (i) and a compliance date for these
sections is established. Section 20.19(m)
states that compliance with the
paperwork obligations of §§ 20.19(e),
(h), and (i) is not required until OMB
approval is obtained and a compliance
date is established. The other rule
amendments that the Commission
adopted in the Report and Order did not
require OMB approval and compliance
with those rule sections was required as
of January 7, 2019. See Report and
Order at 83 FR 63098 (Dec. 7, 2018).
With respect to §§ 20.19(e) and (h),
service providers must be in compliance
with these sections by the compliance
date set out above, except to the extent
that these sections reference the
§ 20.19(i) certification requirement.
With respect to the § 20.19(i)
certification requirement, service
providers may begin filing their
certifications on the compliance date
announced above and must have their
certifications filed with the Commission
within 30 days of that date. Service
providers will be using new electronic
FCC Form 855 to make their
certifications. The OMB approved
instructions for how to fill out and file
the electronic FCC Form 855
certification will be available on the
hearing aid compatibility section of the
FCC website starting on the compliance
date listed above. We remind service
providers that the initial certifications
E:\FR\FM\01AUR1.SGM
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]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 https://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 https://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.
---------------------------------------------------------------------------
\1\ 42 U.S.C. 7384n(c).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ See https://www.cms.gov/Medicare/Coding/ICD10/2019-ICD-10-CM.html.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\4\ 45 CFR 162.1002(c)(2).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\5\ 42 U.S.C. 7384n(c).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\6\ 84 FR 3026 (February 8, 2019).
---------------------------------------------------------------------------
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.
------------------------------------------------------------------------
* * * * *
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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
