World Trade Center Health Program; Addition of Certain Types of Cancer to the List of WTC-Related Health Conditions, 56138-56168 [2012-22304]
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56138
Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations
of FFDCA section 408(n)(4). As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA) (15 U.S.C. 272 note).
§ 180.603 Dinotefuran; tolerances for
residues.
VII. Congressional Review Act
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Vegetable, tuberous and
corm, subgroup 1C .............
Watercress ..............................
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: August 28, 2012.
Lois Rossi,
Director, Registration Division, Office of
Pesticide Programs.
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Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ......................
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Onion, bulb, subgroup 3–07A
Onion, green, subgroup 3–
07B ......................................
Peach ......................................
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Tea, dried1 ..............................
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1 There
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Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section § 180.603 is amended by
removing the entries for ‘‘Grape’’ and
‘‘Potato’’ and alphabetically adding the
following entries and a footnote to the
table in paragraph (a)(1) to read as
follows:
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8.0
are no U.S. registrations for tea.
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[FR Doc. 2012–22205 Filed 9–11–12; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. CDC–2012–0007; NIOSH–257]
42 CFR Part 88
RIN 0920–AA49
World Trade Center Health Program;
Addition of Certain Types of Cancer to
the List of WTC-Related Health
Conditions
Title I of the James Zadroga 9/
11 Health and Compensation Act of
2010 amended the Public Health Service
Act (PHS Act) to establish the World
Trade Center (WTC) Health Program.
The WTC Health Program, which is
administered by the Director of the
National Institute for Occupational
Safety and Health (NIOSH), within the
Centers for Disease Control and
Prevention (CDC), provides medical
SUMMARY:
1. The authority citation for part 180
continues to read as follows:
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Berry, low growing, except
strawberry, subgroup 13–
07H ......................................
Centers for Disease Control and
Prevention, HHS.
ACTION: Final rule.
PART 180—[AMENDED]
17:19 Sep 11, 2012
Commodity
AGENCY:
Therefore, 40 CFR chapter I is
amended as follows:
VerDate Mar<15>2010
(a) * * *
(1) * * *
monitoring and treatment to eligible
firefighters and related personnel, law
enforcement officers, and rescue,
recovery, and cleanup workers who
responded to the September 11, 2001,
Parts per
terrorist attacks in New York City, at the
million
Pentagon, and in Shanksville,
Pennsylvania, and to eligible survivors
of the New York City attacks. In
accordance with WTC Health Program
0.2
regulations, which establish procedures
*
for adding a new condition to the list of
*
covered health conditions, this final
*
rule adds to the List of WTC-Related
Health Conditions the types of cancer
proposed for inclusion by the notice of
0.9
proposed rulemaking.
DATES: This final rule is effective
*
*
October 12, 2012.
*
FOR FURTHER INFORMATION CONTACT:
0.15 Frank J. Hearl, PE, Chief of Staff,
National Institute for Occupational
5.0
Safety and Health, Centers for Disease
1.0
Control and Prevention, Patriots Plaza,
Suite 9200, 395 E St. SW., Washington,
*
DC 20201. Telephone: (202) 245–0625
*
*
(this is not a toll-free number). Email:
50
WTCpublicinput@cdc.gov.
SUPPLEMENTARY INFORMATION: This
*
notice of final rulemaking is organized
*
as follows:
*
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I. Executive Summary
II. Public Participation
III. Background
A. WTC Health Program Statutory
Authority
B. Need for Rulemaking
C. Review of Scientific Evidence
D. Physician Determination and Program
Certification of WTC-Related Health
Conditions Including Types of Cancer
E. Effects of Rulemaking on Federal
Agencies
IV. Methods Used by the Administrator To
Determine Whether To Add Cancer or
Types of Cancer to the List of WTCRelated Health Conditions
V. Administrator’s Determination Concerning
Petition 001: Addition of Cancers to the
List of WTC-Related Health Conditions,
42 CFR 88.1
VI. Summary of Final Rule and Response to
Public Comments
VII. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive
Order 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement
Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
I. Executive Order 13211 (Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use)
J. Plain Writing Act of 2010
VIII. Final Rule
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Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations
I. Executive Summary
A. Purpose of Regulatory Action
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347), amended the Public
Health Service Act (PHS Act) to
establish the World Trade Center (WTC)
Health Program within the Department
of Health and Human Services (HHS).
The PHS Act requires the WTC Program
Administrator (Administrator) to
conduct rulemaking to propose the
addition of a health condition to the List
of WTC-Related Health Conditions (List)
codified in 42 CFR 88.1 regardless of
whether the Administrator proposes to
add a health condition based on the
findings from periodic reviews of
cancer,1 a request from a petition, or a
determination made at the
Administrator’s discretion that a
proposed rule adding a condition
should be initiated. Following a petition
to add cancer or certain types of cancer
to the List and a recommendation by the
WTC Health Program’s Scientific/
Technical Advisory Committee (STAC),
the Administrator is following the
procedures established in 42 CFR 88.17
to add the types of cancer recommended
by the STAC to the List in § 88.1.
B. Summary of Major Provisions
This rule modifies the List of WTCRelated Health Conditions in 42 CFR
88.1 to add the following conditions
(types of cancer identified by ICD–10
code are specified in the discussion
below):
D Malignant neoplasms of the lip,
tongue, salivary gland, floor of mouth,
gum and other mouth, tonsil,
oropharynx, hypopharynx, and other
oral cavity and pharynx
D Malignant neoplasm of the
nasopharynx
D Malignant neoplasms of the nose,
nasal cavity, middle ear, and
accessory sinuses
D Malignant neoplasm of the larynx
D Malignant neoplasm of the esophagus
D Malignant neoplasm of the stomach
D Malignant neoplasm of the colon and
rectum
D Malignant neoplasm of the liver and
intrahepatic bile duct
D Malignant neoplasms of the
retroperitoneum and peritoneum,
omentum, and mesentery
D Malignant neoplasms of the trachea;
bronchus and lung; heart,
mediastinum and pleura; and other
ill-defined sites in the respiratory
system and intrathoracic organs
D Mesothelioma
D Malignant neoplasms of the soft
tissues (sarcomas)
D Malignant neoplasms of the skin
(melanoma and non-melanoma),
including scrotal cancer
D Malignant neoplasm of the breast
D Malignant neoplasm of the ovary
D Malignant neoplasm of the urinary
bladder
D Malignant neoplasm of the kidney
D Malignant neoplasms of renal pelvis,
ureter and other urinary organs
D Malignant neoplasms of the eye and
orbit
D Malignant neoplasm of the thyroid
D Malignant neoplasms of the blood and
lymphoid tissues (including, but not
limited to, lymphoma, leukemia, and
myeloma)
D Childhood cancers
D Rare cancers
The Administrator developed a
hierarchy of methods (detailed in
Section IV of this preamble) for
determining which cancers to propose
for inclusion on the List of WTC-Related
Health Conditions.
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C. Costs and Benefits
Annual costs, benefits, and transfers
of this rule are listed in the table below.
This analysis estimates the impact on
WTC Health Program costs using the
number of persons currently enrolled in
the Program as responders and survivors
and assumes that the rate of cancer in
the population will be equal to the U.S.
population average rate. An alternative
analysis considers the impact on costs if
the Program enrolls additional persons
up to the Program’s statutory limits, and
that the expanded population
experiences a 21 percent higher rate of
cancer than the U.S. population average.
The basis for these assumptions is
explained in detail in the preamble of
this rulemaking (see Section VII.A.,
below).
Although we cannot quantify the
benefits associated with the WTC Health
Program, enrollees with cancer are
expected to experience a higher quality
of care than they would in the absence
of the Program. Mortality and morbidity
improvements for cancer patients
expected to enroll in the WTC Health
Program are anticipated because barriers
may exist to access and delivery of
quality health care services for cancer
patients in the absence of the services
provided by the WTC Health Program.
HHS anticipates benefits to cancer
patients treated through the WTC Health
Program, who may otherwise not have
access to health care services, to accrue
in 2013. Starting in 2014, continued
implementation of the Affordable Care
Act will result in increased access to
health insurance and improved health
care services for the general responder
and survivor population that currently
is uninsured.
ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS, TRANSFERS, AND BENEFITS, 55,000 RESPONDERS AND 5,000 SURVIVORS AT U.S. POPULATION CANCER RATE, AND 80,000 RESPONDERS AND 30,000 SURVIVORS AT U.S. POPULATION
CANCER RATE + 21 PERCENT, 2013–2016, 2011$
Societal Costs for 2013, 2011$
Annualized Transfers for 2013–
2016, 2011$
Based on the 16.3 percent of
general responders and survivors who are expected to
be uninsured
Discounted at
7 percent
Cancer Rate
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U.S. Average
Discounted at
3 percent
Cancer Rate
U.S. + 21%
U.S. Average
U.S. + 21%
55,000 Responders .........................................................................................
5,000 Survivors ................................................................................................
Colorectal and Breast Screening .....................................................................
$1,648,706
271,427
204,491
........................
........................
........................
$10,172,308
1,572,907
713,321
........................
........................
........................
60,000 Total ..............................................................................................
2,124,624
........................
12,458,535
........................
.
1 See
PHS Act, Title XXXIII sec. 3312(a)(5).
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Federal Register / Vol. 77, No. 177 / Wednesday, September 12, 2012 / Rules and Regulations
ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS, TRANSFERS, AND BENEFITS, 55,000 RESPONDERS AND 5,000 SURVIVORS AT U.S. POPULATION CANCER RATE, AND 80,000 RESPONDERS AND 30,000 SURVIVORS AT U.S. POPULATION
CANCER RATE + 21 PERCENT, 2013–2016, 2011$—Continued
80,000 Responders .........................................................................................
........................
2,631,100
........................
19,912,464
30,000 Survivors ..............................................................................................
Colorectal and Breast Screening .....................................................................
........................
........................
1,970,560
417,521
........................
........................
12,124,118
1,271,478
110,000 Total ............................................................................................
........................
5,019,182
........................
33,308,060
Qualitative benefits
Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are expected to experience a higher
quality of care than they would in the absence of the Program. Mortality and morbidity improvements for cancer patients expected to enroll in
the WTC Health Program are anticipated because barriers may exist to access and delivery of quality health care services for cancer patients
in the absence of the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through the WTC
Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting in 2014, continued implementation
of the Affordable Care Act will result in increased access to health insurance and improved health care services for the general responder
and survivor population that currently is uninsured.
srobinson on DSK4SPTVN1PROD with RULES
II. Public Participation
III. Background
On June 13, 2012 HHS published a
notice of proposed rulemaking (77 FR
35574) proposing to add certain cancers
to the List of WTC-Related Health
Conditions. HHS invited interested
persons or organizations to submit
written views, opinions,
recommendations, and data on any
topic related to the proposed rule. The
Administrator specifically sought
comments on the methodology
proposed to evaluate evidence for the
addition of types of cancer to the List of
WTC-Related Health Conditions; the
proposed cost estimates; information or
published studies about the type of
welding and/or metal cutting that
occurred at any of the disaster sites and
information about exposure to
ultraviolet light; and information or
published studies about the scheduling
of work hours or shiftwork occurring at
any of the disaster sites.
HHS received 27 substantive
submissions to the docket for this
rulemaking. Commenters included labor
unions that represent WTC responders,
including police department members
and others who conducted rescue,
recovery, and clean-up; private citizens,
including WTC responders; the spouse
of a responder; survivors; relatives of
victims and survivors; physicians who
have treated WTC responders; health
care professionals with no stated
experience treating 9/11-exposed
patients; health and research
organizations; the WTC Health Program
Survivors Steering Committee; a
chemical supplier; and an elected
official. Additionally, one private
citizen submitted a comment that was
outside the scope of this rulemaking.
The substantive comments are described
below, followed by the Administrator’s
response to each (see Section V., below).
A. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347), amended the PHS
Act to add Title XXXIII 2 establishing
the WTC Health Program within HHS.
The WTC Health Program provides
medical monitoring and treatment
benefits to eligible firefighters and
related personnel, law enforcement
officers, and rescue, recovery, and
cleanup workers who responded to the
September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in
Shanksville, Pennsylvania, and to
eligible survivors of the New York City
attacks.
All references to the Administrator in
this notice mean the NIOSH Director or
his or her designee. Section 3312(a)(6)
of the PHS Act requires the
Administrator to conduct rulemaking to
propose the addition of a health
condition to the List of WTC-Related
Health Conditions codified in 42 CFR
88.1.
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B. Need for Rulemaking
The PHS Act requires the
Administrator to conduct rulemaking to
propose the addition of a health
condition to the List of WTC-Related
Health Conditions codified in 42 CFR
88.1 regardless of whether the
Administrator proposes to add a health
condition based on the findings from
periodic reviews of cancer,3 a request
from a petition, or a determination made
at the Administrator’s discretion that a
proposed rule adding a condition
should be initiated. On September 7,
2 Title XXXIII of the PHS Act is codified at 42
U.S.C. 300mm to 300mm–61. Those portions of the
Zadroga Act found in Titles II and III of Public Law
111–347 do not pertain to the WTC Health Program
and are codified elsewhere.
3 See PHS Act, sec, 3312(a)(5).
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2011, the Administrator received a
written petition to add a health
condition to the List of WTC-Related
Health Conditions (Petition 001).
Petition 001 requested that the
Administrator ‘‘consider adding
coverage for cancer’’ to the List in
§ 88.1.4
On October 5, 2011, the Administrator
formally exercised his option to request
a recommendation from the STAC
regarding the petition (PHS Act, sec.
3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)).
The Administrator requested that the
STAC ‘‘review the available information
on cancer outcomes associated with the
exposures resulting from the September
11, 2001, terrorist attacks, and provide
advice on whether to add cancer, or a
certain type of cancer, to the List
specified in the Zadroga Act.’’ 5 In
response, the STAC submitted its
recommendation on April 2, 2012, and
the Administrator issued a notice of
proposed rulemaking on June 13, 2012.
The background to this rulemaking and
a discussion of the STAC’s
recommendation are provided in the
notice of proposed rulemaking
published on June 13, 2012 (77 FR
35574).
C. Review of Scientific Evidence
As reviewed in detail in the June 13,
2012 notice of proposed rulemaking, the
4 Maloney CB, Nadler J, King PT, Schumer CE,
Gillibrand KE, Rangel CB, Velazquez NM, Grimm
MG, Clarke YD. [2011]. Letter from Congress to John
Howard, MD, Director, National Institute for
Occupational Safety and Health (NIOSH). WTC
Health Program Petition 001. Petition 001 is
included in the docket for this rulemaking. See
http:www.regulations.gov and https://www.cdc.gov/
niosh/docket/archive/docket257.html.
5 Howard J [2011]. October 5, 2011 Letter from
John Howard, MD, Director, National Institute for
Occupational Safety and Health (NIOSH) to the
WTC Health Program Scientific/Technical Advisory
Committee. This letter is included in the docket for
this rulemaking. See http:www.regulations.gov and
https://www.cdc.gov/niosh/docket/archive/
docket257.html.
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Administrator considered data from five
information sources to decide whether
to propose the addition of cancers to the
List of WTC-Related Health Conditions:
(1) Peer-reviewed studies published in
the scientific literature, including
environmental sampling data,
epidemiologic studies on the 9/11exposed populations, and studies
providing evidence of a causal
relationship between a type of cancer
and a condition already on the List of
WTC-Related Health Conditions; 6 (2)
findings and recommendations solicited
from the WTC Clinical Centers of
Excellence and Data Centers, the WTC
Health Registry at the New York City
Department of Health and Mental
Hygiene, and the New York State
Department of Health; (3) information
from the public solicited through a
request for information published in the
Federal Register on March 8, 2011 and
March 29, 2011; (4) the findings of the
National Toxicology Program (NTP) in
the National Institute of Environmental
Health Sciences, HHS,7 as well as the
World Health Organization’s
International Agency for Research on
Cancer (IARC); 8 and (5) findings from
other sources of information relevant to
9/11 exposures, including the expert
judgment and personal experiences of
STAC members, and comments from the
public.
In September 2011, an epidemiologic
study by Rachel Zeig-Owens and
6 The July 2011, First Periodic Review of the
Scientific and Medical Evidence Related to Cancer
for the World Trade Center Health Program (First
Periodic Review), requested by the Administrator,
was included among the information considered.
NIOSH [2011]. First Periodic Review of Scientific
and Medical Evidence Related to Cancer for the
World Trade Center Health Program. NIOSH
Publication No. 2011–197. https://www.cdc.gov/
niosh/docs/2011–197/pdfs/2011–197.pdf/.
Accessed April 18, 2012. As required by
sec.3312(a)(5)(A) of the PHS Act, the review
considered ’’all available scientific and medical
evidence, including findings and recommendations
of Clinical Centers of Excellence, published in peerreviewed journals to determine if, based on such
evidence, cancer or a certain type of cancer should
be added to the applicable list of WTC-related
health conditions.’’ At the time of publication, the
First Periodic Review identified only one peerreviewed article addressing the association of
exposures arising from the September 11, 2001,
terrorist attacks and cancer in responders and
survivors, and two publications that used models to
estimate the risk of cancer among residents in
Lower Manhattan. Unlike the explicit standard
prescribed for periodic reviews of cancer under sec.
3312(a)(5)(A), sec. 3312(a)(6) of the PHS Act does
not specify the sources upon which the
Administrator may base his or her determination to
propose the addition of cancer or types of cancer
to the List of WTC-Related Health Conditions.
7 NTP Report on Carcinogens (RoC). https://
ntp.niehs.nih.gov/?objectid=72016262–BDB7-CEBAFA60E922B18C2540. Accessed May 9, 2012.
8 WHO International Agency for Research on
Cancer (IARC). https://monographs.iarc.fr/.
Accessed May 8, 2012.
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colleagues (hereafter, ‘‘Zeig-Owens’’),
‘‘identified a modest effect of WTC
exposure for all cancers combined by
comparing the ratios in the exposed
group [of Fire Department of New York
City firefighters] to those in the nonexposed group.’’ 9 This publication led
to the submission of Petition 001. The
Administrator requested that the STAC
provide a recommendation on Petition
001. The STAC established evidentiary
criteria and assessed the weight of the
available scientific evidence provided
by information sources (1), (4), and (5),
described above. The STAC found
support for including a number of types
of cancer based in part on evidence of
increased risk reported in Zeig-Owens.
The STAC also included a number of
types of cancer based on the
professional judgment of STAC
members with scientific expertise, on
the personal experience of some of the
STAC members who were themselves
WTC responders or survivors, and on
comments made by members of the
public.
Following review of the STAC
recommendation, the Administrator
agreed with the STAC that individual
exposure assessment information arising
from the terrorist attacks is extremely
limited and that its absence impairs
definitive scientific analysis of the
relationship between exposures arising
from the attacks and the occurrence of
any specific type of cancer. The
Administrator also found that multiple
epidemiologic studies of cancer in
exposed responders and survivors
which definitively support an
association between 9/11 exposures and
specific types of cancer that would meet
generally well-accepted criteria
indicating that the association is a
causal one are not currently available.
After considering various approaches
to evaluate the available scientific
evidence (see discussion in the June 13,
2012 notice of proposed rulemaking),
the Administrator has adopted the
methodology outlined in the proposed
rule and set out in Section IV below.
This methodology follows on criteria
used by the STAC in its
recommendation. Using the
methodology, the Administrator adds
the types of cancer, identified in Section
V below, to the List of WTC-Related
Health Conditions.
9 Zeig-Owens R, Webber MP, Hall CB, Schwartz
T, Jaber N, Weakley J, Rohan TE, Cohen HW,
Derman O, Aldrich TK, Kelly K, Prezant DJ [2011].
Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An
Observational Cohort Study. Lancet. 378(9794):898–
905.
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D. Physician Determination and
Program Certification of WTC-Related
Health Conditions Including Types of
Cancer
In order for an individual enrolled as
a WTC responder or survivor to obtain
coverage for treatment of any health
condition on the List of WTC-Related
Health Conditions, including any type
of cancer added to the List, a two-step
process must be satisfied. First, a
physician at a Clinical Center of
Excellence (CCE) or in the nationwide
provider network must make a
determination that the particular type of
cancer for which the responder or
survivor seeks treatment coverage is
both on the List of WTC-Related Health
Conditions and that exposure to
airborne toxins, other hazards, or
adverse conditions resulting from the
September 11, 2001, terrorist attacks is
substantially likely to be a significant
factor in aggravating, contributing to, or
causing the type of cancer for which the
responder or survivor seeks treatment
coverage.10 Pursuant to 42 CFR 88.12(a),
the physician’s determination must be
based on the following: (1) An
assessment of the individual’s exposure
to airborne toxins, any other hazard, or
any other adverse condition resulting
from the September 11, 2001, attacks;
and (2) the type of symptoms reported
and the temporal sequence of those
symptoms. In addition, the statute
requires that all physician
determinations are reviewed by the
Administrator and are certified for
treatment coverage unless the
Administrator determines that the
condition is not a health condition on
the List of WTC-Related Health
Conditions or that the exposure
resulting from the September 1, 2001,
terrorist attacks is not substantially
likely to be a significant factor in
aggravating, contributing to, or causing
the condition. Thus, the inclusion of a
condition on the List of WTC-Related
Health Conditions, in and of itself, does
not guarantee that a particular
individual’s condition will be certified
as eligible for treatment. Responders
and survivors denied certification have
a right to appeal the denial of
certification.
E. Effects of Rulemaking on Federal
Agencies
Title II of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347) reactivated the
September 11, 2001 Victim
Compensation Fund (VCF).
Administered by the U.S. Department of
10 See PHS Act, sec.3312(a)(1); 42 U.S.C. 300mm–
22(a)(1).
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Justice (DOJ), the VCF provides
compensation to any individual or
representative of a deceased individual
who was physically injured or killed as
a result of the September 11, 2001,
terrorist attacks or during the debris
removal. Eligibility criteria for
compensation by the VCF include a list
of presumptively covered health
conditions, which are physical injuries
determined to be WTC-related health
conditions by the WTC Health Program.
Pursuant to DOJ regulations, the VCF
Special Master is required to update the
list of presumptively covered conditions
when the List of WTC-Related Health
Conditions in 42 CFR 88.1 is updated.11
(See also Section VII.A., Effects on
Other Agency Programs, below.)
IV. Methods Used by the Administrator
To Determine Whether To Add Cancer
or Types of Cancer to the List of WTCRelated Health Conditions
For the reasons discussed above and
detailed in the notice of proposed
rulemaking published in the Federal
Register on June 13, 2012, the
Administrator developed the following
hierarchy of methods for determining
whether to add cancer or types of cancer
to the List of WTC-Related Health
Conditions in 42 CFR 88.1. In
determining whether to propose that a
type of cancer be included on the List,
a review of the evidence must
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11 28
CFR 104.21.
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demonstrate fulfillment of at least one of
the following four methods:
D Method 1. Epidemiologic Studies of
September 11, 2001 Exposed
Populations. A type of cancer may be
added to the List if published, peerreviewed epidemiologic evidence
supports a causal association between 9/
11 exposures and the cancer type. The
following criteria extrapolated from the
Bradford Hill criteria will be used to
evaluate the evidence of the exposurecancer relationship:
Æ Strength of the association between
a 9/11 exposure and a health effect
(including the magnitude of the effect
and statistical significance);
Æ consistency of the findings across
multiple studies;
Æ biological gradient, or dose-response
relationships between 9/11 exposures
and the cancer type; and
Æ plausibility and coherence with
known facts about the biology of the
cancer type.
If only a single published
epidemiologic study is available for
review, the consistency of findings
cannot be evaluated and strength of
association will necessarily place
greater emphasis on statistical
significance than on the magnitude of
the effect.
D Method 2. Established Causal
Associations. A type of cancer may be
added to the List if there is wellestablished scientific support published
in multiple epidemiologic studies for a
causal association between that cancer
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and a condition already on the List of
WTC-Related Health Conditions.
D Method 3. Review of Evaluations of
Carcinogenicity in Humans. A type of
cancer may be added to the List only if
both of the following criteria for Method
3 are satisfied:
3A. Published Exposure Assessment
Information. 9/11 agents were reported
in a published, peer-reviewed exposure
assessment study of responders or
survivors who were present in either the
New York City disaster area as defined
in 42 CFR 88.1, or at the Pentagon, or
in Shanksville, Pennsylvania; and
3B. Evaluation of Carcinogenicity in
Humans from Scientific Studies. NTP
has determined that the 9/11 agent is
known to be a human carcinogen or is
reasonably anticipated to be a human
carcinogen, and IARC has determined
there is sufficient or limited evidence
that the 9/11 agent causes a type of
cancer.
D Method 4. Review of Information
Provided by the WTC Health Program
Scientific/Technical Advisory
Committee. A type of cancer may be
added to the List if the STAC has
provided a reasonable basis for adding
a type of cancer and the basis for
inclusion does not meet the criteria for
Method 1, Method 2, or Method 3.
The following schematic illustrates
the methodology proposed in the notice
of proposed rulemaking and established
in this final rule.
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V. Administrator’s Determination
Concerning Petition 001: Addition of
Cancers to the List of WTC-Related
Health Conditions, 42 CFR 88.1
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Using the evidentiary standards
established above for inclusion of a
cancer on the List of WTC-Related
Health Conditions in 42 CFR 88.1, and
in accordance with the review of
evidence discussed in the notice of
proposed rulemaking published in the
Federal Register on June 13, 2012, the
Administrator adds the specific types of
cancers in the list below to the List of
WTC-Related Health Conditions in 42
CFR 88.1. In the list below, the name of
the cancer is followed by its ICD–10
code 12 as well as the method used to
include the cancer. A more detailed list,
including sub-codes, is included in
Table 1 in the regulatory text below.
D Malignant neoplasms of the lip [C00],
tongue [C01, C02], salivary gland
[C07, C08], floor of mouth [C04], gum
and other mouth [C03, C05, C06],
tonsil [C09], oropharynx [C10],
hypopharynx [C12, C13], other oral
cavity and pharynx [C14] (Method 3)
D Malignant neoplasm of the
nasopharynx [C11] (Method 3)
D Malignant neoplasms of the nasal
cavity [C30] and accessory sinuses
[C31] (Method 3)
D Malignant neoplasm of the larynx
[C32] (Method 3)
D Malignant neoplasms of the
esophagus [C15] (Method 2)
D Malignant neoplasm of the stomach
[C16] (Method 3)
D Malignant neoplasms of the colon
(and rectum) [C18, C19, C20, C26.0]
(Method 3)
D Malignant neoplasms of the liver and
intrahepatic bile duct [C22] (Method
3)
D Malignant neoplasms of the
retroperitoneum and peritoneum
[C48] (Method 3)
D Malignant neoplasms of the trachea
[C33]; bronchus and lung [C34]; heart,
mediastinum and pleura [C38]; and
other ill-defined sites in the
respiratory system and intrathoracic
organs [C39] (Method 3)
D Mesothelioma [C45] (Method 3)
D Malignant neoplasm of peripheral
nerves and autonomic nervous system
[C47) and malignant neoplasm of
other connective and soft tissue [C49]
(Method 3)
12 WHO (World Health Organization) [1997].
International Classification of Diseases, Tenth
Revision. Geneva: World Health Organization. The
International Classification of Diseases (ICD) is used
to code and classify injuries and diseases and their
signs, symptoms, and external causes for statistical
presentation, disease analysis, hospital records
indexing, and medical billing reimbursement.
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D Other malignant neoplasms of skin
(non-melanoma) [C44] (Method 3),
malignant melanoma of skin [C43]
(Method 4), and malignant neoplasm
of scrotum [C63.2] (Methods 3)
D Malignant neoplasm of the breast
[C50] (Method 4)
D Malignant neoplasm of the ovary
[C56] (Method 3)
D Malignant neoplasm of the urinary
bladder [C67] (Method 3)
D Malignant neoplasm of the kidney
[C64] (Method 3)
D Malignant neoplasm of the renal
pelvis, ureter and other urinary organs
[C65, C66 and C68] (Method 3)
D Malignant neoplasm of the eye and
orbit [C69] (Method 4)
D Malignant neoplasm of thyroid gland
[C73] (Method 3)
D Hodgkin’s disease [C81]; follicular
[nodular] non-Hodgkin lymphoma
[C82]; diffuse non-Hodgkin
lymphoma [C83]; peripheral and
cutaneous T-cell lymphomas [C84];
other and unspecified types of nonHodgkin lymphoma [C85]; malignant
immunoproliferative diseases [C88];
multiple myeloma and malignant
plasma cell neoplasms [C90];
lymphoid leukemia [C91]; myeloid
leukemia [C92]; monocytic leukemia
[C93]; other leukemias of specified
cell type [C94]; leukemia of
unspecified cell type [C95]; other and
unspecified malignant neoplasms of
lymphoid, hematopoietic and related
tissue [C96] (Method 3)
D Childhood Cancers [any type of
cancer occurring in a person less than
20 years of age] (Method 4)
D Rare Cancers [any type of cancer
affecting populations smaller than
200,000 individuals in the United
States, i.e., occurring at an incidence
rate less than 0.08 percent of the U.S.
population] (Method 4)
VI. Summary of Final Rule and
Response to Public Comments
The final rule amends the definition
of ‘‘List of WTC-Related Health
Conditions’’ in 42 CFR 88.1, to include
the types of cancer referenced above in
Section V, which are the cancers
proposed in the June 13, 2012, notice of
proposed rulemaking (77 FR 35574).
Table 1 in the regulatory text describes
types of cancers included in 42 CFR
88.1 and identifies each by ICD–10
code. Because the ICD–10 modification
will not be used by the U.S. healthcare
system until October 1, 2014, the
corresponding ICD–9 codes for the
included cancer types are also provided
in Table 1 in the regulatory text.
The effect of this amendment is that,
for the types of cancers added, an
enrolled WTC responder, certified-
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eligible survivor, or screening-eligible
survivor may seek certification of a
physician’s determination that the
September 11, 2001, terrorist attacks
were substantially likely to be a
significant factor in aggravating,
contributing to, or causing the
individual’s cancer. As discussed above,
if the condition is certified by the
Administrator, the individual may seek
treatment and monitoring of this
condition under the WTC Health
Program.
As described in the Public
Participation section, above, the
Administrator received 27 substantive
submissions from the public on the
methodology and the types of cancers
proposed in the June 13, 2012 Federal
Register notice (77 FR 35574). Upon
consideration of the public comments,
the Administrator has determined not to
amend the methodology or the list of
cancers in Table 1 of the regulatory text
proposed in the June 13, 2012 notice of
proposed rulemaking (77 FR 35574).
The comments are summarized below,
followed by the Administrator’s
response to each.
Comment: The Administrator
received 12 comments in support of
adding the proposed types of cancer to
the List of WTC-Related Health
Conditions. Some commenters
expressed support for the specific
methodologies proposed by the
Administrator, including the use of the
NTP and the IARC designations
(Method 3). Commenters noted that
requiring conclusive epidemiological
evidence to add cancers to the List may
not be fair to responders and survivors
who are ill now, given the time required
to collect sufficient data and publish
studies in peer-reviewed journals. Some
commenters correctly pointed out that
an individual’s diagnosis must be
determined to be related to 9/11
exposure by a WTC Health Program
physician and then certified by the
Administrator in order for that
individual to receive treatment through
the Program. Some commenters wrote in
support of specific types of cancer for
inclusion.
Response: The Administrator agrees
that establishing a broad continuum of
decision-making methods is important
to ensure that WTC responders and
survivors receive care for health
conditions associated with the
September 11, 2001, terrorist attacks.
Comment: The Administrator
received three comments opposing the
addition of the proposed types of cancer
to the List of WTC-Related Health
Conditions using the methodology
established in this final rule. One
commenter concurred with the use of
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Methods 1 and 2, but stated that
Methods 3 and 4 ‘‘leave the door open
for speculation and anecdotal evidence
to influence the decision process.’’ Two
commenters questioned the use of the
Zeig-Owens 13 study by the STAC to
recommend the addition of types of
cancer to the List, e.g., thyroid and
melanoma, mentioning the preliminary
nature of the results and that the
recommended types of cancer do not
meet the traditional level of statistical
significance. One commenter expressed
opposition to Methods 3 and 4 as being
overly broad, thus allowing into the
Program those individuals who do not
truly merit Program benefits.
Response: The Administrator
appreciates the comments provided on
the four methods proposed for listing
types of cancer as WTC-related health
conditions. The final rule adopts the
methods outlined in the proposed rule.
Under sec. 3312(a)(6) of the PHS Act,
the Administrator is permitted to
consider a wide range of approaches in
adding conditions to the List.
The Administrator agrees with the
commenter that Methods 1 and 2, which
rely on epidemiologic evidence (Method
1) and established medical relationships
between a WTC-related health condition
and the development of a type of cancer
(Method 2), provide traditional methods
for associating exposure and health
effects as a means of adding conditions
to the List of WTC-Related Health
Conditions. However, the Administrator
also recognizes that there is a
continuum of methods that can be used
to establish relationships between
exposure and disease: some methods are
more definitive and provide a higher
level of certainty when establishing an
association between exposure and
disease outcomes. Adding cancers to the
List by Methods 1 and 2 fall in that
portion of the continuum of methods
that provide greater certainty.
However, Methods 1 and 2 are
substantially limited in their ability to
provide timely guidance on which types
of cancer should be added to the List of
WTC-Related Health Conditions to
allow the WTC Health Program to
provide services to the responders and
survivors currently suffering from
cancers following exposure to 9/11
agents. Due to the long latency period
between exposure and cancer diagnosis
for most types of cancer, many
epidemiological studies of cancer
13 Zeig-Owens R, Webber MP, Hall CB, Schwartz
T, Jaber N, Weakley J, Rohan TE, Cohen HW,
Derman O, Aldrich TK, Kelly K, Prezant DJ [2011].
Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An
Observational Cohort Study. Lancet. 378(9794):898–
905.
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associated with particular exposures are
produced years after a given exposure
event. Waiting for definitive,
scientifically-unassailable
epidemiologic results before adding
types of cancer to the List would
prevent treatment of currently-enrolled
WTC responders and survivors.
In addition, other factors make it
difficult to establish definitive
associations using traditional
epidemiologic methods within any
timeframe. The number of potentially
exposed individuals is small, so the
statistical power of any study will be
substantially limited. Many of the
cancers anticipated in the exposed
population are uncommon. Thus,
because of the anticipated small
numbers of these cancers, detecting
statistically significant increases will be
difficult and may only be definitively
established through a retrospective
cohort study conducted decades from
now. Upon thorough review of all
available information, including peerreviewed studies, expert opinion, the
STAC recommendation, and comments
from the public, the Administrator has
determined that it is reasonable to
acknowledge the limitations of
traditional epidemiologic methods and
to recognize other methods that
incorporate additional sources of
information.
Because of the limitations of using
epidemiologic studies to establish
relationships between exposure and
health effects, and the WTC Health
Program’s responsibility to provide
services to affected individuals during
their lifetime, the Administrator finds
that this unique exposure situation
merits the use of methods, in addition
to Methods 1 and 2, that provide
valuable information about the
relationship between exposure and
health effects. The Administrator
acknowledges that Methods 3 and 4
provide less certainty about the
relationship between exposure and
cancer than do Methods 1 and 2.
Method 3 relies on identifying those
agents categorized by the NTP as known
or reasonably anticipated to be human
carcinogens and by IARC as being
known, probable, or possible human
carcinogens and having sufficient or
limited evidence for causing specific
types of cancer in humans. IARC and
NTP findings, including IARC’s
identification of agents associated with
specific cancer types, have undergone
substantial peer review and/or scientific
scrutiny in their development.
Method 4 relies on findings from
other sources of information relevant to
9/11 exposures and the potential
occurrence of cancer, including the
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56145
expert judgment and personal
experiences of STAC members and
comments from the public. The statute
allows the Administrator to request a
recommendation from the STAC. In this
case, the Administrator requested a
recommendation from the STAC as well
as descriptions of the scientific and/or
technical evidence members relied on,
the quality of data supporting the
evidence, and the methods used. The
Administrator found the STAC
recommendations and their bases to be
reasonable.
Two comments correctly pointed out
that the Zeig-Owens study, which was
cited as evidence by the STAC, was
viewed by the Administrator as not
meeting the statistical significance
threshold for Method 1. However, the
Administrator made the determination
to include certain cancers (e.g. thyroid
and melanoma) using Method 4 based
on a reasonable recommendation from
the STAC. The interpretation of
statistical significance can vary between
knowledgeable observers. The STAC
interpreted the Zeig-Owens results as a
sound basis for recommending the
addition of some types of cancer to the
List when the reported statistical
significance of findings in the study was
near the traditional 95 percent
confidence level. The Administrator has
determined that the STAC’s
interpretation is reasonable.
The evidence cited by the STAC for
including thyroid cancer and melanoma
in their recommendation was that the
Standardized Incidence Ratios (SIR)
were substantially greater than 1.0 and
approached the 95 percent confidence
level traditionally used for statistical
significance. The STAC also considered
other types of cancer that had an
elevated SIR in the Zeig-Owens study,
such as prostate cancer, and did not
recommend them for addition after
considering additional information on
potential surveillance bias. Thus, the
STAC made reasonable arguments for
the addition or exclusion of certain
types of cancer. The STAC did not limit
the basis of its recommendations to a
level of statistical significance that
would be recognized by all
knowledgeable observers of
epidemiologic studies.
Finally, the Administrator notes that
listing a cancer as a WTC-related health
condition does not necessarily mean
that a cancer in an individual WTC
responder or survivor will be
determined to be WTC-related. Each
WTC responder and survivor enrolled in
the Program will go through a
physician’s determination and Program
certification process to assess whether
their individual cancer meets the
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statutory definition of a WTC-related
health condition. When determining
whether an individual’s cancer has been
contributed to, aggravated by, or caused
by their exposures at the 9/11 sites,
individual medical history and
exposure assessment are used as part of
the determination and certification
process. Guidelines for physician
determinations regarding WTC-related
health conditions are jointly developed
by the CCEs and the WTC Health
Program for all conditions currently on
the List. The CCEs and WTC Health
Program will develop additional
assessment information for use by
physicians in making determinations
regarding whether an individual’s 9/11
exposure may have contributed to,
aggravated, or caused their cancer.
Comment: One commenter stated that
the STAC’s recommendations do not
merit the same decision-making weight
as Methods 1 and 2 because most of the
committee is not rigorously trained in
epidemiology and biostatistics.
Response: The Administrator
acknowledges the diverse background of
the STAC members, but notes that the
composition of the STAC was
established in sec. 3302(a) of the PHS
Act to provide a broad spectrum of
backgrounds and expertise to the
Administrator. The inclusion of nonscientists on the STAC adds value,
knowledge, and perspective to the
STAC that might not otherwise be
available to the Administrator.
Comment: One commenter was
concerned about the potential impact of
adding the proposed types of cancer to
the List of WTC-Related Health
Conditions on the VCF administered by
the Department of Justice, and believes
that the use of Methods 3 and 4 will
overextend the WTC Health Program
and the VCF and leave them open to
abuse.
Response: The Administrator notes
that individuals who are not currently
enrolled in the WTC Health Program
must first be found to be eligible and
qualified to enroll. As discussed above,
physician determination and Program
certification are two additional steps
that must be completed before an
individual can receive treatment and
monitoring benefits from the Program.
Similarly, the VCF employs rigorous
standards used to determine individual
compensation awards. The
Administrator acknowledges the issue
of resource limits on the VCF, which is
a capped-benefit program. This issue is
discussed in Section VII.A below.
Further consideration of the potential
impact on the VCF is outside the scope
of this rulemaking.
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Comment: One comment stated that
asbestos-related cancers generally have
latencies far beyond the 10 years that
have passed since September 11, 2001,
and that there is great uncertainty in
designating asbestos as a cause of
stomach or colorectal cancers.
Response: The methodology
established in this final rule for adding
types of cancer to the List includes
identifying those agents categorized by
IARC as being known, probable, or
possible human carcinogens and having
sufficient or limited evidence for
causing specific types of cancer in
humans, and by the NTP as being
known or reasonably anticipated to be
human carcinogens. IARC and NTP
findings have undergone substantial
peer review and/or other scientific
scrutiny in their development. These
authoritative bodies have categorized all
forms of asbestos as known human
carcinogens, and IARC has determined
there is limited evidence that they cause
cancer of the stomach and colon.
When determining whether an
individual’s cancer has been
contributed to, aggravated by, or caused
by their exposures at the 9/11 sites, an
individual medical history and
exposure assessment is used as part of
the physician determination and
Program certification process.
Guidelines for physician determinations
regarding WTC-related health
conditions are jointly developed by the
CCEs and the WTC Health Program for
conditions on the List. The CCEs and
WTC Health Program will develop
additional assessment information for
use by physicians in making
determinations regarding whether an
individual’s 9/11 exposure may have
contributed to, aggravated, or caused
their cancer.
Comment: One comment stated that
beryllium and beryllium compounds
should be removed as an identified
exposure agent for all respiratory
cancers listed in Table A. Among other
reasons, the commenter indicated that
the collapse of the World Trade Center
was unlikely to have resulted in
emissions of beryllium metal and
beryllium compounds above levels
found in the natural environment.
Response: The quantitative exposures
of individuals at the WTC, particularly
during the collapse of the towers and for
several days afterward, will likely never
be fully known. While the
concentrations of beryllium dust in
settled dust samples collected from
around the WTC sites approximate the
concentrations in ‘‘background’’
samples, the exposure conditions that
have been described (including thick
dust clouds, individuals being coated
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with dust, and large deposits of dust in
homes) result in very different
exposures than would be expected to be
found in industrial settings or in
windblown dirt. The Administrator
finds that such conditions are likely to
result in large, short-term exposures.
The methodology established in this
final rule for adding types of cancer to
the List includes identifying those
agents categorized by IARC as being
known, probable, or possible human
carcinogens and having sufficient or
limited evidence of carcinogenicity in
humans, and by NTP as being known or
reasonably anticipated to be human
carcinogens. IARC and NTP findings
have undergone substantial peer review
and/or other scientific scrutiny in their
development. These authoritative
bodies have categorized beryllium and
beryllium compounds as known human
carcinogens, and IARC has determined
there is sufficient evidence that they
cause cancer of the lung.
Comment: Several commenters
recognized the important distinction
between a cancer being included on the
List of WTC-Related Health Conditions
and the physician determination and
Program certification of a specific
cancer in an individual responder or
survivor. One comment noted that
physicians will need guidance to make
a determination that a type of cancer is
related to the September 11, 2001,
terrorist attacks.
Response: The Administrator
recognizes the difficulty inherent in
determining whether an individual’s
cancer can be considered WTC-related.
Guidelines for physician determinations
regarding WTC-related health
conditions are jointly developed by the
CCEs and the WTC Health Program for
all conditions on the List. The CCEs and
WTC Health Program will develop
additional assessment information for
use by physicians in making
determinations regarding whether an
individual’s 9/11 exposure may have
contributed to, aggravated, or caused
their cancer.
Comment: One commenter asked that
the Administrator exercise authority
under the PHS Act to ‘‘cover a specific
type of cancer in individual cases,
notwithstanding the review and
determination of when to generally add
a type of cancer to the list of covered
WTC conditions.’’
Response: The Administrator will use
his authority under sec. 3312 of the Act
and as detailed in 42 CFR 88.13 to cover
a condition medically-associated with a
condition on the List of WTC-Related
Health conditions, as appropriate.
Comment: The Administrator
received a number of comments
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requesting the addition of one or more
types of cancer. Six commenters asked
that cancer of the prostate be added to
the List. One commenter asked that
cancers of the brain and pancreas also
be added to the List. Another
commenter asked for the addition of
melanoma, thyroid, and non-Hodgkin
lymphoma to the List. One of the
commenters stated that the
Administrator did not address a STAC
recommendation to add pre-malignant
and myelodysplastic diseases.
Response: The issue of whether to
recommend the addition of cancers of
the prostate, brain, and pancreas to the
List of WTC-Related Health Conditions
was considered and discussed by the
STAC in the open meeting on March 28,
2012. In those discussions, the STAC
considered the available evidence for
recommending the addition of cancers
of the prostate, brain, and pancreas,
including the epidemiologic evidence
and the NTP and IARC reviews.
Following its deliberation on the matter,
the STAC voted not to include prostate,
brain, or pancreatic cancer in its
recommendation.14 The Administrator
concurs with the decision of the STAC
and is not adding these cancers to the
List of WTC-Related Health Conditions
at this time. The addition of these
cancers may be reconsidered if
additional information on the
association of 9/11 exposures and those
cancer outcomes becomes available.
Regarding the request to add melanoma,
thyroid cancer, and non-Hodgkin
lymphoma, this final rule specifically
includes the addition of melanoma,
thyroid cancer, and non-Hodgkin
lymphoma to the List of WTC-Related
Health Conditions. Finally, the
Administrator acknowledges that the
STAC’s recommendation to add premalignant and myelodysplastic diseases
was not adopted. This final rule only
addresses adding types of cancer to the
List. The inclusion of pre-malignant or
non-malignant conditions, such as
myelodysplastic diseases, may be
considered at a later time.
Comment: The Administrator
received three comments expressing
concern that gaps in data preclude the
Administrator from considering cancers
and other possible WTC-related health
conditions that may affect WTC
responders and survivors. Two of the
comments expressed concern that the
study of female responders and
14 See STAC (World Trade Center Health Program
Scientific/Technical Advisory Committee) Letter
from Elizabeth Ward, Chair, to John Howard, MD,
Administrator [2012]. This letter is included in the
docket for this rulemaking. See https://
www.regulations.gov and https://www.cdc.gov/
niosh/docket/archive/docket257.html.
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survivors has been lacking. Another
commenter also expressed concern for
those whose cancer has not been
adequately studied or studied at all.
Response: The Administrator is aware
of the limitations on the availability of
data on cancers and other possible
WTC-related health conditions,
including the limited information on
female responders and survivors. The
inclusion of additional types of cancer
will be considered at an appropriate
time if additional information on the
association of 9/11 exposures and
cancer outcomes becomes available. The
limitations on the availability of data on
female responders and survivors will be
addressed to the extent possible through
analysis of clinical data from medical
monitoring examination of responders
and survivors, as well as through
research studies. The issue of gaps in
data regarding non-cancer WTC-related
health conditions is outside the scope of
this rulemaking.
Comment: Two commenters offered
general thoughts about the uncertainty
associated with attributing 9/11
exposures to types of cancer, stating that
it is not possible to determine which
WTC responders and survivors would
have been diagnosed with cancer in the
absence of 9/11 exposures. These
commenters asserted that NYC
responders are overcompensated.
Response: For the reasons discussed
above, the Administrator has
determined that it is appropriate to add
the types of cancer in this final rule to
the List of WTC-Related Health
Conditions in 42 CFR 88.1. While
Congress did not include cancers in the
statute, the PHS Act directs the
Administrator to review all available
scientific and medical evidence to
determine if cancer or types of cancer
should be added to the List and creates
various mechanisms for the addition of
cancers.15 The Administrator recognizes
the inherent difficulty in determining
whether an individual’s cancer can be
considered WTC-related. Guidelines for
physician determinations regarding
WTC-related health conditions are
jointly developed by the CCEs and the
WTC Health Program for all conditions
on the List. The CCEs and WTC Health
Program will develop additional
assessment information for use by
physicians in making determinations
regarding whether an individual’s 9/11
exposure may have contributed to,
aggravated, or caused their cancer.
15 See
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56147
VII. Regulatory Assessment
Requirements
A. Executive Order 12866 and Executive
Order 13563
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 rule has been determined to be
a ‘‘significant regulatory action,’’ under
sec. 3(f) of E.O. 12866. Accordingly, this
rule has been reviewed by the Office of
Management and Budget. The addition
of specific types of cancer to the List of
WTC-Related Health Conditions by this
rule is estimated to cost the WTC Health
Program between $2,124,624 16 and
$5,019,182 17 (see Table I) for the first
year (2013). Because a portion of
responders and survivors are also
covered by private health insurance,
employer-provided insurance (such as
FDNY), or Medicare or Medicaid, only
a portion of the costs, those costs
representing the uninsured, are societal
costs. All other costs to the WTC Health
Program are transfers. After the
implementation of provisions of the
Patient Protection and Affordable Care
Act (ACA)(Pub. L. 111–148) on January
1, 2014, all of the costs to the WTC
Health Program will be transfers.
Transfers from FY 2013 through FY
2016 are expected to be between
$12,458,535 and $33,308,060 per
annum. The final rule does not interfere
with State, local, and Tribal
governments in the exercise of their
governmental functions.
Cost Estimates
The WTC Health Program has, to date,
enrolled approximately 55,000 New
York City responders and approximately
5,000 survivors, or approximately
60,000 individuals in total. Of that total
population, approximately 59,000
individuals were participants in
previous WTC medical programs and
were ‘grandfathered’ into the WTC
Health Program established by Title
XXXIII. These grandfathered members
were enrolled without having to
16 Based on a population of 60,000 at the U.S.
cancer rate and discounted at 7 percent.
17 Based on a population of 110,000 at 21 percent
above the U.S. cancer rate and discounted at 3
percent.
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complete a new member application
when the WTC Health Program started
on July 1, 2011 and are referred to in the
WTC Health Program regulations in 42
CFR part 88 as ‘‘currently identified
responders’’ and ‘‘currently identified
survivors.’’ In addition to those
currently identified WTC responders
and survivors already enrolled, the PHS
Act 18 sets a numerical limitation on the
number of eligible members who can
enroll in the WTC Health Program
beginning July 1, 2011 at 25,000 new
WTC responders and 25,000 new
certified-eligible WTC survivors 19 (i.e.,
the statute restricts new enrollment).
Since July 1, 2011, a total of
approximately 1,000 new WTC
responders and new WTC survivors
have enrolled in the WTC Health
Program, resulting in only a minor
impact on the statutory enrollment
limits for new members. For the
purpose of calculating a baseline
estimate of cancer prevalence only, HHS
assumed that this gradual rate of
enrollment would continue, and that the
currently enrolled population numbers
would remain around 55,000 WTC
responders and 5,000 WTC survivors.
The estimate is further based on the
average U.S. cancer prevalence rate and
7 percent discount rate.
As it is not possible to identify an
upper bound estimate, HHS has
modeled another possible point on the
continuum. For the purpose of
calculating the impact of an increased
rate of cancer on the WTC Health
Program, this analysis assumes that the
entire statutory cap for new WTC
responders (25,000) and WTC survivors
(25,000) will be filled. Accordingly, this
estimate is based on a population of
80,000 responders (55,000 currently
identified + 25,000 new) and 30,000
survivors (5,000 currently identified +
25,000 new). The upper cost estimate
also assumes an overall increase in
population cancer rates of 21 percent
due to 9/11 exposure,20 and costs were
discounted at 3 percent. The choice of
a 21 percent increase in the risk of
18 PHS Act, sec. 3311(a)(4)(A) and sec.
3321(a)(3)(A).
19 See 42 CFR 88.8(b) for explanation of a
certified-eligible survivor.
20 Zeig-Owens R, Webber MP, Hall CB, Schwartz
T, Jaber N, Weakley J, Rohan TE, Cohen HW,
Derman O, Aldrich TK, Kelly K, Prezant DJ [2011].
Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An
Observational Cohort Study. Lancet. 378(9794):898–
905.
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cancer of the rate found in the unexposed population is based on findings
presented in the only published
epidemiologic study of September 11,
2001 exposed populations to date.21
Given the challenges associated with
interpreting the Zeig-Owens findings,22
we simply characterize 21 percent as a
possible outcome rather than asserting
the probability that 21 percent is a
‘‘likely’’ outcome.
HHS acknowledges that some cancer
cases are not likely to have been caused
by exposure to 9/11 agents. The
certification of individual cancer
diagnoses will be conducted on a caseby-case basis. However, for the purpose
of this analysis, HHS has estimated that
all diagnosed cancers added to the List
will be certified for treatment by the
WTC Health Program. Finally, because
there are no existing data on cancer
rates related to exposure to 9/11 agents
at either the Pentagon or in Shanksville,
Pennsylvania, HHS has used only data
from studies of individuals who were
responders or survivors in the New York
City disaster area.
Costs of Cancer Treatment
HHS estimated the treatment costs
associated with covering the types of
cancer in this rulemaking using the
methods described below. In the
following discussion, the category of
‘‘Head and Neck’’ includes all cancer
cases from nasal cavity, nasopharynx,
accessory sinuses, and larynx. The
survival rates for all cancers in the
‘‘Head and Neck’’ category were
approximated using survival rates for
cancer of the larynx. The category
described as ‘‘Lung’’ in this discussion
includes cancer of the trachea, bronchus
and lung, heart, mediastinum and
pleura, and other sites in the respiratory
system and intrathoracic organs.
Treatment costs for all respiratory
system cancers including
‘‘mesothelioma’’ were approximated by
21 Zeig-Owens R, Webber MP, Hall CB, Schwartz
T, Jaber N, Weakley J, Rohan TE, Cohen HW,
Derman O, Aldrich TK, Kelly K, Prezant DJ [2011].
Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An
Observational Cohort Study. Lancet. 378(9794):898–
905.
22 As Zeig-Owens et al point out, the time interval
since 9/11 is short for cancer outcomes, the
recorded excess of cancers is not limited to specific
sites, and the biological plausibility of chronic
inflammation as a possible mediator between WTCexposure and cancer means that the outcomes
remain speculative.
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treatment costs for lung cancer. Costs of
treatment for the ‘‘digestive system’’
were approximated using the costs of
gastric cancer; costs for cancer of the
‘‘skin’’ were approximated using costs
for melanoma of the skin; ‘‘female
reproductive organs’’ were
approximated using costs for cancer of
the ovary; ‘‘urinary system’’ cancer was
approximated by costs of urinary
bladder cancer; and ‘‘blood and
lymphoid tissue’’ cancers were
approximated using leukemia and
lymphoma. The costs for cancer
identified with the ‘‘endocrine system,’’
the ‘‘soft tissue sarcomas,’’ and ‘‘eye/
orbit’’ were approximated using costs
for treatment of ‘‘other’’ tumors. The
‘‘other’’ category includes treatments
costs from the following: salivary gland,
nasopharynx, tonsil, small intestine,
anus, intrahepatic bile duct, gallbladder,
other biliary, retroperitoneum,
peritoneum, other digestive organs,
nose, nasal cavity, middle ear, larynx,
pleura, trachea, mediastinum and other
respiratory organs, bones and joints, soft
tissue, other nonepithelial skin, vagina,
vulva, other female genital organs,
penis, other male genital organs, ureter,
other urinary organs, eye and orbit,
thyroid, other endocrine multiple
myeloma, and miscellaneous.
The WTC Health Program obtained
data for the cost of providing medical
treatment for each cancer type. The
costs of treatment for each type of
cancer are described in Table A. The
costs of treatment are divided into three
phases: the costs for the first year
following diagnosis, the costs of
intervening years or continuing
treatment after the first year, and the
costs of treatment for the last year of
life. The first year costs of cancer
treatment are higher due to the initial
need for aggressive medical (e.g.,
radiation, chemotherapy) and surgical
care. The costs during last year of life
are often dominated by increased
hospitalization costs.23 Therefore, we
used three different treatment phase
costs to estimate the costs of treatment
to be able to best estimate costs in
conjunction with expected incidence
and long-term survival for each type of
cancer.
23 Yabroff KR, Lamont EB, Mariotto A, Warren JL,
Topor M, Meekins A, Brown ML [2008]. Cost of
Care for Elderly Cancer Patients in the United
States. Journal: J Natl Cancer Inst 100(9):630–41.
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TABLE A—AVERAGE COSTS OF TREATMENT, MALE AND FEMALE (2011)
Initial
(12 month)
Category
Head and Neck ............................................................................................................................
Digestive System .........................................................................................................................
Respiratory System .....................................................................................................................
Mesothelium .................................................................................................................................
Skin ..............................................................................................................................................
Female Reproductive Organs ......................................................................................................
Urinary System ............................................................................................................................
Blood & Lymphoid Tissue ............................................................................................................
Endocrine System ........................................................................................................................
Soft Tissue Sarcomas .................................................................................................................
Melanoma ....................................................................................................................................
Breast ...........................................................................................................................................
Eye/Orbit ......................................................................................................................................
Last year
of life
(12 mos.)
Continuing
(annual)
$28,265
59,551
45,493
45,493
3,938
66,527
16,926
33,312
30,859
30,859
3,938
15,136
30,859
$3,136
2,544
5,026
5,026
1,040
5,023
3,630
5,782
3,791
3,791
1,040
1,550
3,791
$47,730
68,242
65,592
65,592
25,351
64,728
40,905
69,070
58,623
58,623
25,351
37,684
58,623
Source: Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients in
the United States. Journal: J Natl Cancer Inst 100(9):630–41.
These cost figures were based on a
study of elderly cancer patients from the
Surveillance, Epidemiology, and End
Results (SEER) program maintained by
the National Cancer Institute using
Medicare files.24 The average costs of
treatment described above are given in
2011 prices adjusted using the Medical
Consumer Price Index for all urban
consumers.25
Incident Cases of Cancer
HHS estimated the expected number
of cases of cancer that would be
observed in a cohort of responders and
survivors followed for cancer incidence
after September 11, 2001 using U.S.
population cancer rates for the cancer
types added to the List of WTC-Related
Health Conditions under this
rulemaking. Demographic
characteristics of the cohort were
assigned since the actual data are not
available for individuals in the
responder and survivor populations
who have not yet enrolled in the WTC
Health Program. Gender and age (at the
time of exposure) distributions for
responders and survivors were assumed
to be the same as current enrollees in
the WTC Health Program. According to
WTC Health Program data, males
comprise 88 percent of the current
responder enrollees and 50 percent of
survivor enrollees. The age distribution
for current enrollees by gender and
responder/survivor status is presented
in Table B.
TABLE B—PERCENTILES OF CURRENT AGE (ON APRIL 11, 2012) FOR CURRENT ENROLLEES IN THE WTC HEALTH
PROGRAM BY GENDER AND RESPONDER/SURVIVOR STATUS
Age percentile (years)
Group
Min
Male responders ..............................................................
Female responders ..........................................................
Male survivors ..................................................................
Female survivors ..............................................................
1
28
28
12
12
10
32
30
23
21
30
39
38
35
38
50
44
44
46
49
70
49
49
52
54
90
54
54
58
60
99
62
62
67
68
Max
74
76
81
84
92
92
99
95
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HHS assumed race and ethnic origin
distributions for responders and
survivors according to distributions in
the WTC Health Registry cohort: 26 57
percent non-Hispanic white, 15 percent
non-Hispanic black, 21 percent
Hispanic, and 8 percent other race/
ethnicity for responders and 50 percent
non-Hispanic white, 17 percent nonHispanic black, 15 percent Hispanic,
and 18 percent other race/ethnicity for
survivors. Follow-up for cancer
morbidity for each person began on
January 1, 2002 or age 15 years,
whichever was later. Age 15 was
considered because the cancer
incidence rate file did not include rates
for persons less than 15 years of age.
Follow-up ended on December 31, 2016
or the estimated last year of life,
whichever was earlier. The estimated
last year of life was used since not all
persons would be expected to remain
alive at the end of 2016. The estimated
last year of life was based on U.S.
gender, race, age, and year-specific
death rates from CDC Wonder (since
rates are currently available through
2008, the rate from 2008 was applied to
2009 and later).27 A life-table analysis
program, LTAS.NET, was used to
estimate the expected number of
incident cancers for cancer types
24 Surveillance, Epidemiology, and End Results
(SEER) Program (www.seer.cancer.gov) Research
Data (1973–2006), National Cancer Institute,
DCCPS, Surveillance Research Program,
Surveillance Systems Branch, released April 2009,
based on the November 2008 submission.
25 Bureau of Labor Statistics. Consumer Price
Index https://research.stlouisfed.org/fred2/series/
CPIMEDSL/downloaddata?cid=32419. Accessed
April 23, 2012.
26 Jordan HT, Brackbill RM, Cone JE,
Debchoudhury I, Farfel MR, Greene CM, Hadler JL,
Kennedy J, Li J, Liff J, Stayner L, Stellman SD.
Mortality Among Survivors of the Sept 11, 2001,
Word Trade Center Disaster: Results from the World
Trade Center Health Registry Cohort. Lancet
2011;378:879–887. Note: percentages may not sum
to 100 percent due to rounding.
27 Centers for Disease Control and Prevention,
National Center for Health Statistics. Compressed
Mortality File 1999–2008. CDC WONDER Online
Database, compiled from Compressed Mortality File
1999–2008 Series 20 No. 2N, 2011. https://
wonder.cdc.gov/cmf-icd10.html. Accessed February
15, 2012.
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added.28 HHS calculated cancer
incidence rates using data through 2006
from the Surveillance Epidemiology and
End Results (SEER) Program, and
estimated rates for 2007–2016.29 The
Program applied the resulting gender,
race, age, and year-specific cancer
incidence rates to the estimated personyears at risk to estimate the expected
number of cancer cases for each cancer
type starting from year 2002, the first
full year following the September 11,
2001, terrorist attacks, to 2016, the last
year for which this Program is currently
funded.
Prevalence of Cancer
To determine the potential number of
persons in the responder and survivor
populations with cancer, HHS used the
number of incident cases described
above for each year starting with 2002
and estimated the prevalence of cancer
using survival rate statistics for each
incident cancer group through 2016.30
Using the incident cases and survival
rate statistics for each cancer type, HHS
has estimated the prevalence (number of
persons living with cancer) of cases
during the 15 year period (2002–2016)
since September 11, 2001. The resulting
table provides for each year from 2002
through 2016, the number of new cases
occurring in that year (incidence), the
number of individuals who died from
their cancer in that year, and the
number of persons surviving up to 15
years beyond their first diagnosis with
one table for each type of cancer
(prevalence).31 For example, in 2002
there are 23.47 projected new lung
cancer cases, which would be listed as
incident cases for that year. The survival
rate for lung cancer in the first year of
diagnosis is 40.6 percent.32 Therefore
the number of deceased persons in 2002
would be 18.78 x (1—0.406) = 11.15. For
the lung cancer prevalence table, in year
2003, the number of incident cases
would be 20.88 cases. In addition to
20.88 newly diagnosed cases in 2003,
there would be the one-year survivors
from 2002 which would be 18.78—11.15
(or 18.78 x 0.406) = 7.62 cases. This
computation process can be repeated for
each year through year 2016. A portion
of the lung cancer prevalence table is
provided in Table C as an example.
Prevalence tables were created for
each type of covered cancer and the
results are summarized in Tables E and
G. This analysis considers cancers
diagnosed in 2002 through 2016.
TABLE C—EXAMPLE FROM PREVALENCE TABLE FOR LUNG CANCER
[Based on 80,000 responders]
Years since exposure to 9/11 agents
Years covered by WTC Health Program
Year
2002
1 (incidence) ............................................
2 ...............................................................
3 ...............................................................
4 ...............................................................
5 ...............................................................
6 ...............................................................
7 ...............................................................
8 ...............................................................
9 ...............................................................
10 .............................................................
11 .............................................................
12 .............................................................
13 .............................................................
14 .............................................................
15 .............................................................
Live cases from previous years ...............
Prevalence ...............................................
Last year of life ........................................
2003
2012
2013
2014
2015
18.78
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
18.78
11.15
20.88
7.62
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
....................
28.50
15.46
46.53
17.00
9.25
6.42
4.95
4.01
3.28
2.71
2.55
2.15
1.78
....................
....................
....................
....................
54.11
100.64
39.38
51.22
18.89
10.18
7.08
5.46
4.45
3.67
3.03
2.49
2.38
1.98
1.66
....................
....................
....................
61.26
112.48
43.54
56.10
20.79
11.30
7.79
6.02
4.90
4.07
3.38
2.78
2.33
2.20
1.84
1.52
....................
....................
68.94
125.03
47.87
60.69
22.78
12.45
8.66
6.62
5.40
4.49
3.76
3.10
2.60
2.14
2.04
1.69
1.42
....................
77.16
137.85
52.10
2016
66.03
24.64
13.63
9.53
7.35
5.94
4.94
4.14
3.45
2.90
2.40
1.99
1.88
1.58
1.35
85.74
151.78
56.79
To compute the costs for each type of
cancer, HHS assumes that all of the
individuals who are diagnosed with a
cancer type will be certified by the WTC
Health Program for treatment and
monitoring services. The treatment costs
for the first year of treatment (Table A,
year adjusted) were applied to the
predicted newly incident (Year 1) cases
for each year. Likewise, the costs of
treatment for the last year of life were
applied in each year to the number of
people predicted to die from their
cancer in that year. The costs of
continuing treatment from Table 1 were
applied to the number of prevalent cases
who had survived their cancers beyond
their year of diagnosis, for each year of
survival (Year 2–15).
Using this procedure, a cost table is
constructed for each year covered by the
WTC Health Program. Table D provides
an illustrative example for lung cancer.
The row for Year 1 is the cost of
incident cases for that year. Rows 2–15
show the cost from continuing care for
persons surviving n-years beyond the
year of diagnosis. Finally, the cost of
last year of life treatment is computed
by multiplying the cost for last year of
life from Table A by the number of
persons dying in that year from that
type of cancer.
28 Schubauer-Berigan MK, Hein MJ, Raudabaugh
WM, Ruder AM, Silver SR, Spaeth S, Steenland K,
Petersen MR, and Waters KM [2011]. Update of the
NIOSH Life Table Analysis System: A Person-Years
Analysis program for the Windows Computing
Environment. American Journal of Industrial
Medicine 54:915–924.
29 National Cancer Institute, Surveillance
Epidemiology and End Results (SEER). https://
seer.cancer.gov/. Accessed May 27, 2012.
30 National Cancer Institute, Surveillance
Epidemiology and End Results (SEER). https://
seer.cancer.gov/. Accessed May 27, 2012.
31 The 15-year survival limit is imposed based on
the analytic time horizon.
32 National Cancer Institute, Surveillance
Epidemiology and End Results (SEER). https://
seer.cancer.gov/. Accessed May 27, 2012.
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TABLE D—COST PER 80,000 RESPONDERS FOR LUNG CANCER (2011$)
Years covered by the WTC Health Program
Year
2013
2014
2015
1 .......................................................................................................................
2 .......................................................................................................................
3 .......................................................................................................................
4 .......................................................................................................................
5 .......................................................................................................................
6 .......................................................................................................................
7 .......................................................................................................................
8 .......................................................................................................................
9 .......................................................................................................................
10 .....................................................................................................................
11 .....................................................................................................................
12 .....................................................................................................................
13 .....................................................................................................................
14 .....................................................................................................................
15 .....................................................................................................................
Prevalent care ..................................................................................................
Last year of life care ........................................................................................
$914,986
91,825
49,469
34,408
26,537
21,624
17,840
14,727
12,080
11,608
9,642
8,032
........................
........................
........................
1,212,778
2,762,609
$1,002,168
101,077
54,959
37,865
29,228
23,850
19,797
16,468
13,500
11,311
10,706
8,932
7,393
........................
........................
1,337,254
3,037,261
$1,084,205
110,708
60,497
42,068
32,165
26,268
21,834
18,274
15,096
12,641
10,433
9,917
8,221
6,936
........................
1,459,263
3,305,416
$1,179,677
119,770
66,261
46,306
35,735
28,908
24,048
20,155
16,751
14,135
11,659
9,664
9,128
7,714
6,571
1,589,911
3,603,198
Total ..........................................................................................................
3,975,387
4,374,515
4,764,679
5,193,109
The sum of the annual costs for the
years 2013 through 2016 represents the
estimated treatment costs to the WTC
Health Program for coverage of lung
cancer for 80,000 responders. The cost
projections in Table D are based on an
assumed responder population size of
80,000.
The same process described above
was applied to the survivor cohort.
Based on the incidence rate expected
from the survivor cohort, prevalence
tables were constructed for each covered
type of cancer.
The estimated treatment costs for
responders and survivors were re-
computed under the following two
assumptions: (1) the rate of cancer in the
WTC Health Program is equal to the rate
of cancer observed in the general
population; and (2) the rate of cancer
exceeds the general population rate by
21 percent due to their exposures in the
New York City disaster area.33 HHS is
not aware of any other estimates of
excess cancer rates in the 9/11-exposed
population in the peer-reviewed
literature.
A summary of the estimated
prevalence at the U.S. population
average for the assumed population of
55,000 responders and 5,000 survivors
2016
is provided in Table E. A summary of
the estimated treatment costs to the
WTC Health Program is provided in
Table F.
A summary of the estimated
prevalence using cancer rates 21 percent
over the U.S. population average for the
increased rate of 80,000 responders and
30,000 survivors is given in Table G. A
summary of the estimated treatment
costs to the WTC Health Program is
provided in Table H.
TABLE E—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND
SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE
Prevalence (incident + live cases)
Cancer type
2013
2014
2015
2016
srobinson on DSK4SPTVN1PROD with RULES
Based on 55,000 responder population
Head & Neck ...................................................................................................
Digestive System .............................................................................................
Respiratory System .........................................................................................
Mesothelioma ...................................................................................................
Skin ..................................................................................................................
Female Reproductive Organs ..........................................................................
Urinary System ................................................................................................
Blood & Lymphoid Tissue ................................................................................
Endocrine System ............................................................................................
Soft Tissue Sarcomas .....................................................................................
Melanoma ........................................................................................................
Breast ...............................................................................................................
Eye/Orbit ..........................................................................................................
33 Zeig-Owens R, Webber MP, Hall CB, Schwartz
T, Jaber N, Weakley J, Rohan TE, Cohen HW,
Derman O, Aldrich TK, Kelly K, Prezant DJ [2011].
Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An
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89.41
136.54
77.91
1.02
11.04
5.14
108.78
119.72
53.50
11.02
134.33
102.30
3.89
Observational Cohort Study. Lancet. 378(9794):898–
905. Limitations of the Zeig-Owens study include:
limited information on specific exposures
experienced by firefighters; short time for follow-up
of cancer outcomes; speculation about the
PO 00000
Frm 00059
Fmt 4700
Sfmt 4700
99.20
150.69
86.61
1.12
12.22
5.64
121.39
130.72
58.75
11.86
149.37
113.46
4.29
109.35
165.19
95.50
1.23
13.43
6.14
134.69
141.97
64.05
12.67
165.05
124.91
4.71
119.83
180.38
105.16
1.35
14.71
6.65
148.90
153.71
69.40
13.47
181.42
136.66
5.14
biological plausibility of chronic inflammation as a
possible mediator between WTC-exposure and
cancer outcomes; and potential unmeasured
confounders.
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TABLE E—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND
SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE—Continued
Prevalence (incident + live cases)
Cancer type
2013
Total ..........................................................................................................
854.59
2014
2015
2016
945.32
1038.88
1136.78
Based on 5,000 survivor population
Head & Neck ...................................................................................................
Digestive System .............................................................................................
Respiratory System .........................................................................................
Mesothelioma ...................................................................................................
Skin ..................................................................................................................
Female Reproductive Organs ..........................................................................
Urinary System ................................................................................................
Blood & Lymphoid Tissue ................................................................................
Endocrine System ............................................................................................
Soft Tissue Sarcomas .....................................................................................
Melanoma ........................................................................................................
Breast ...............................................................................................................
Eye/Orbit ..........................................................................................................
7.78
15.48
10.28
0.10
1.13
2.58
10.47
12.48
4.29
0.96
12.21
9.30
0.35
7.78
15.48
10.28
0.10
1.13
2.58
10.47
12.48
4.29
0.96
13.58
10.31
0.39
7.78
15.48
10.28
0.10
1.13
2.58
10.47
12.48
4.29
0.96
15.00
11.36
0.43
7.78
15.48
10.28
0.10
1.13
2.58
10.47
12.48
4.29
0.96
16.49
12.42
0.47
Total ..........................................................................................................
87.41
89.83
92.33
94.93
TABLE F—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND
SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE (2011$)
Cancer type
2013
2014
2015
2016
2013–2016
Based on 55,000 responder population
Head & Neck ........................................................................
Digestive System .................................................................
Respiratory System ..............................................................
Mesothelioma .......................................................................
Skin ......................................................................................
Female Reproductive Organs ..............................................
Urinary System ....................................................................
Blood & Lymphoid Tissue ....................................................
Endocrine System ................................................................
Soft Tissue Sarcomas ..........................................................
Melanoma ............................................................................
Breast ...................................................................................
Eye/Orbit ..............................................................................
$925,673
4,181,699
2,832,704
49,088
18,078
121,957
1,278,299
2,224,916
362,248
148,358
229,538
420,290
36,018
$1,007,744
4,525,672
3,117,317
54,012
20,075
130,292
1,398,867
2,391,015
385,533
158,024
249,805
453,613
39,242
$1,089,966
4,856,402
3,395,504
58,869
21,834
137,643
1,521,993
2,551,304
408,544
167,208
270,744
485,454
42,470
$1,164,226
5,191,940
3,701,062
64,417
23,072
144,194
1,642,997
2,697,317
419,353
175,680
284,528
510,289
45,255
$4,187,609
18,755,713
13,046,587
226,387
83,059
534,086
5,842,157
9,864,552
1,575,678
649,270
1,034,615
1,869,646
162,985
Total ..............................................................................
12,828,867
13,931,212
15,007,935
16,064,330
57,832,344
Based on 5,000 survivor population
77,325
471,917
362,274
4,625
1,843
58,454
119,698
229,578
60,893
14,017
30,943
230,196
3,434
82,580
502,369
389,675
4,974
2,034
61,173
128,808
245,051
62,633
14,748
32,541
241,382
3,642
87,736
531,352
416,326
5,291
2,196
63,740
137,954
259,869
63,909
15,415
33,962
251,227
3,832
92,044
559,893
444,551
5,659
2,300
65,729
146,467
272,842
64,476
15,960
35,142
258,804
3,994
339,685
2,065,532
1,612,827
20,549
8,372
249,097
532,927
1,007,340
251,910
60,140
132,588
981,609
14,903
Total ..............................................................................
srobinson on DSK4SPTVN1PROD with RULES
Head & Neck ........................................................................
Digestive System .................................................................
Respiratory System ..............................................................
Mesothelioma .......................................................................
Skin ......................................................................................
Female Reproductive Organs ..............................................
Urinary System ....................................................................
Blood & Lymphoid Tissue ....................................................
Endocrine System ................................................................
Soft Tissue Sarcomas ..........................................................
Melanoma ............................................................................
Breast ...................................................................................
Eye/Orbit ..............................................................................
1,665,197
1,771,611
1,872,809
1,967,862
7,277,478
1,090,324
5,028,041
3,506,992
58,987
22,109
1,177,702
5,387,754
3,811,830
64,160
24,030
1,256,270
5,751,833
4,145,613
70,076
25,371
4,527,294
20,821,244
14,659,414
246,936
91,431
Total
Head & Neck ........................................................................
Digestive System .................................................................
Respiratory System ..............................................................
Mesothelioma .......................................................................
Skin ......................................................................................
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4,653,616
3,194,979
53,713
19,921
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TABLE F—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 55,000 AND 5,000 RESPONDER AND
SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING CANCER RATES AT U.S. POPULATION AVERAGE (2011$)—
Continued
Cancer type
2013
2014
2015
2016
2013–2016
Female Reproductive Organs ..............................................
Urinary System ....................................................................
Blood & Lymphoid Tissue ....................................................
Endocrine System ................................................................
Soft Tissue Sarcomas ..........................................................
Melanoma ............................................................................
Breast ...................................................................................
Eye/Orbit ..............................................................................
180,411
1,397,997
2,454,494
423,141
162,376
260,481
650,486
39,452
191,466
1,527,675
2,636,067
448,166
172,772
282,346
694,995
42,885
201,383
1,659,948
2,811,173
472,452
182,622
304,706
736,681
46,302
209,923
1,789,465
2,970,159
483,829
191,640
319,670
769,093
49,250
783,183
6,375,084
10,871,892
1,827,588
709,410
1,167,203
2,851,255
177,888
Total ..............................................................................
14,494,064
15,702,823
16,880,744
18,032,192
65,109,823
TABLE G—ESTIMATED PREVALENCE BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE
Prevalence (incident + live cases)
Cancer type
2013
2014
2015
2016
Based on 80,000 responder population
Head & Neck ...................................................................................................
Digestive System .............................................................................................
Respiratory System .........................................................................................
Mesothelioma ...................................................................................................
Skin ..................................................................................................................
Female Reproductive Organs ..........................................................................
Urinary System ................................................................................................
Blood & Lymphoid Tissue ................................................................................
Endocrine System ............................................................................................
Soft Tissue Sarcomas .....................................................................................
Melanoma ........................................................................................................
Breast ...............................................................................................................
Eye/Orbit ..........................................................................................................
157.36
240.31
137.12
1.79
19.43
9.05
191.45
210.70
94.16
19.40
236.42
180.05
6.85
174.59
265.21
152.43
1.98
21.50
9.92
213.66
230.07
103.40
20.87
262.90
199.69
7.56
192.45
290.74
168.07
2.16
23.64
10.81
237.05
249.86
112.73
22.29
290.50
219.84
8.29
210.91
317.47
185.08
2.38
25.89
11.71
262.06
270.52
122.15
23.70
319.30
240.52
9.05
Total ..........................................................................................................
1504.09
1663.77
1828.43
2000.74
Based on 30,000 survivor population
Head & Neck ...................................................................................................
Digestive System .............................................................................................
Respiratory System .........................................................................................
Mesothelioma ...................................................................................................
Skin ..................................................................................................................
Female Reproductive Organs ..........................................................................
Urinary System ................................................................................................
Blood & Lymphoid Tissue ................................................................................
Endocrine System ............................................................................................
Soft Tissue Sarcomas .....................................................................................
Melanoma ........................................................................................................
Breast ...............................................................................................................
Eye/Orbit ..........................................................................................................
56.51
112.39
74.61
0.70
8.21
18.73
76.04
90.61
31.11
6.94
88.66
67.52
2.57
56.51
112.39
74.61
0.70
8.21
18.73
76.04
90.61
31.11
6.94
98.59
74.88
2.83
56.51
112.39
74.61
0.70
8.21
18.73
76.04
90.61
31.11
6.94
108.94
82.44
3.11
56.51
112.39
74.61
0.70
8.21
18.73
76.04
90.61
31.11
6.94
119.74
90.20
3.39
Total ..........................................................................................................
634.60
652.16
670.34
689.18
srobinson on DSK4SPTVN1PROD with RULES
TABLE H—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND
SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE (2011$)
Cancer type
2013
2014
2015
2016
2013–2016
Based on 80,000 responder population
Head & Neck ........................................................................
Digestive System .................................................................
Respiratory System ..............................................................
Mesothelioma .......................................................................
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$1,656,113
7,481,440
5,067,965
87,823
Fmt 4700
$1,802,945
8,096,839
5,577,164
96,633
Sfmt 4700
$1,950,049
8,688,544
6,074,865
105,323
E:\FR\FM\12SER1.SGM
12SER1
$2,082,906
9,288,852
6,621,536
115,248
$7,492,013
33,555,675
23,341,531
405,027
56154
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TABLE H—ESTIMATED TREATMENT COSTS BY YEAR AND CANCER TYPE BASED ON 80,000 AND 30,000 RESPONDER AND
SURVIVOR POPULATION, RESPECTIVELY AND ASSUMING INCIDENCE OF CANCER IS 21% HIGHER THAN THE U.S. POPULATION DUE TO 9/11 EXPOSURE (2011$)—Continued
Cancer type
2013
2014
2015
2016
2013–2016
Skin ......................................................................................
Female Reproductive Organs ..............................................
Urinary System ....................................................................
Blood & Lymphoid Tissue ....................................................
Endocrine System ................................................................
Soft Tissue Sarcomas ..........................................................
Melanoma ............................................................................
Breast ...................................................................................
Eye/Orbit ..............................................................................
32,344
218,192
2,286,993
3,980,577
648,095
265,426
410,664
751,937
64,439
35,916
233,104
2,502,701
4,277,744
689,754
282,719
446,924
811,554
70,208
39,063
246,256
2,722,984
4,564,514
730,922
299,150
484,385
868,522
75,983
41,278
257,976
2,939,472
4,825,745
750,261
314,308
509,047
912,953
80,965
148,600
955,528
10,452,150
17,648,581
2,819,031
1,161,603
1,851,021
3,344,966
291,595
Total ..............................................................................
22,952,009
24,924,205
26,850,560
28,740,547
44,654,652
Based on 30,000 survivor population
Head & Neck ........................................................................
Digestive System .................................................................
Respiratory System ..............................................................
Mesothelioma .......................................................................
Skin ......................................................................................
Female Reproductive Organs ..............................................
Urinary System ....................................................................
Blood & Lymphoid Tissue ....................................................
Endocrine System ................................................................
Soft Tissue Sarcomas ..........................................................
Melanoma ............................................................................
Breast ...................................................................................
Eye/Orbit ..............................................................................
467,817
2,855,098
2,191,761
27,979
11,149
353,646
724,172
1,388,944
368,403
84,805
187,204
1,392,687
20,776
499,610
3,039,331
2,357,535
30,096
12,304
370,100
779,285
1,482,561
378,927
89,226
196,873
1,460,361
22,037
530,802
3,214,682
2,518,774
32,010
13,285
385,629
834,625
1,572,207
386,647
93,258
205,471
1,519,924
23,182
556,869
3,387,354
2,689,533
34,239
13,912
397,662
886,127
1,650,695
390,079
96,557
212,608
1,565,763
24,166
2,055,097
12,496,466
9,757,602
124,324
50,650
1,507,036
3,224,209
6,094,408
1,524,055
363,846
802,156
5,938,735
90,160
Total ..............................................................................
4,912,377
5,256,038
5,588,087
5,914,152
21,670,654
Total
Head & Neck ........................................................................
Digestive System .................................................................
Respiratory System ..............................................................
Mesothelioma .......................................................................
Skin ......................................................................................
Female Reproductive Organs ..............................................
Urinary System ....................................................................
Blood & Lymphoid Tissue ....................................................
Endocrine System ................................................................
Soft Tissue Sarcomas ..........................................................
Melanoma ............................................................................
Breast ...................................................................................
Eye/Orbit ..............................................................................
2,123,930
10,336,538
7,259,726
115,803
43,493
571,838
3,011,165
5,369,522
1,016,497
350,231
597,868
2,144,624
85,215
2,302,555
11,136,171
7,934,699
126,729
48,220
603,204
3,281,986
5,760,305
1,068,681
371,945
643,798
2,271,916
92,244
2,480,851
11,903,227
8,593,639
137,333
52,348
631,884
3,557,609
6,136,721
1,117,568
392,408
689,857
2,388,445
99,165
2,639,775
12,676,206
9,311,069
149,487
55,190
655,638
3,825,599
6,476,440
1,140,340
410,864
721,654
2,478,716
105,132
9,547,110
46,052,141
33,099,133
529,350
199,251
2,462,564
13,676,358
23,742,988
4,343,086
1,525,449
2,653,177
9,283,702
381,756
Total ..............................................................................
33,026,449
35,642,452
38,181,054
40,646,111
147,496,066
srobinson on DSK4SPTVN1PROD with RULES
Summary of Costs and Transfers
Because HHS lacks data to account for
either recoupment by health insurance
or workers’ compensation insurance or
reduction by Medicare/Medicaid
payments, the estimates offered here are
reflective of estimated WTC Health
Program costs only. This analysis offers
an assumption about the number of
individuals who might enroll in the
WTC Health Program, and estimates the
impact of both a low rate of cancer (U.S.
population average rate) and an
increased rate (21 percent greater than
the U.S. population average) on the
number of cases and the resulting
estimated treatment costs to the WTC
VerDate Mar<15>2010
17:19 Sep 11, 2012
Jkt 226001
Health Program. This analysis does not
include administrative costs associated
with certifying additional diagnoses of
cancers that are WTC-related health
conditions that might result from this
action. Those costs were addressed in
the interim final rule that established
regulations for the WTC Health Program
(76 FR 38914, July 1, 2011).
Costs and transfers of screening have
been added to the summary estimates.
The screening indicated by this
rulemaking follows U.S. Preventive
Services Task Force (USPSTF)
guidelines.
The USPSTF recommends screening
for colorectal cancer (cancer of the colon
and rectum) using fecal occult blood
PO 00000
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testing (FOBT), sigmoidoscopy, or
colonoscopy, in adults, beginning at age
50 years and continuing until age 75
years.34 The costs and transfers include
the costs of one FOBT for all Program
enrollees who are over the age of 50 in
2013, and for those who will reach 50
years of age in 2014 through 2016. In the
general population, HHS expects there
to be 9 percent positive tests. In a
previous study 35 of those with positive
34 United States Preventive Services Task Force
(USPSTF) [2008]. Screening for Colorectal Cancer.
https://www.uspreventiveservicestaskforce.org/
uspstf/uspscolo.htm. Accessed May 28, 2012.
35 Mandel JS, et. al, Reducing Mortality From
Colorectal Cancer by Screening for Fecal Occult
Blood, NEJM 328(19): 1365–1371 (1993).
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tests who were outside the study
university system, 44 percent had a
colonoscopy, 42 percent had flexible
sigmoidoscopy, 11 percent had repeat
FOBT, and 3 percent were told by their
physician that no further examination
was necessary. HHS applied these rates
to the population and assigned costs for
each test assuming FOBT cost was
$7.60, sigmoidoscopy was $238, and a
colonoscopy was $674.36
The USPSTF recommends breast
cancer screening using biennial
mammography for women beginning at
age 40. HHS assumed that the
population of responders was 12
percent female and the population of
survivors was 50 percent female. Based
on age distribution information
available, HHS estimated the number of
women eligible for screening between
2013 and 2016. For those screened in
2013 HHS predicted repeat screening in
2015 and for those screened in 2014
HHS predicted repeat screening in 2016.
The cost of a mammogram was
estimated at $139.32 based on FECA
rates for mammography.37
Some responders and survivors
enrolled or expected to enroll in the
WTC Health Program already have or
have access to medical insurance
coverage by private health insurance,
employer-provided insurance,
Medicare, or Medicaid. Therefore, costs
to the WTC Health Program can be
divided between societal costs and
transfer payments.
To describe these societal costs and
transfers, the following assumptions
were used. For the period of coverage
between January 1, 2013 and December
31, 2013, HHS has assumed that 16.3
percent of the survivor population will
be uninsured, or based on grandfathered
enrollment of responders, 16,925 are
covered by the FDNY health plan, while
39,482 are listed as general responders
and include construction workers,
contractors, and others. For this
analysis, HHS assumed that the nonFDNY general responders and all future
responder-enrollees are uninsured at the
same 16.3 percent rate that HHS applied
to the survivor population, based on
those without insurance coverage in the
general U.S. population.38 Ward et al.39
found that access to health care services,
quality of care received, stage of disease
at diagnosis, and survival outcomes for
cancer patients varied according to
socioeconomic status and demographic
characteristics.
Additionally, after the
implementation of provisions of the
ACA on January 1, 2014, all of the
enrollees and future enrollees can be
assumed to have or have access to
medical insurance coverage other than
through the WTC Health Program.
Therefore, all treatment costs to be paid
by the WTC Health Program from 2014
through 2016 are considered transfers.
Table I describes the allocation of
WTC Health Program costs between
societal costs and transfer payments
based on 55,000 responders and 5,000
survivors and, alternatively, 80,000
responders and 30,000 survivors.
TABLE I—BREAKDOWN OF ESTIMATED ANNUAL WTC HEALTH PROGRAM COSTS AND TRANSFERS, 80,000 & 55,000
RESPONDERS AND 30,000 AND 5,000 SURVIVORS, 2013–2016, 2011$
Societal Costs for 2013, 2011$
Annualized Transfers for 2013–
2016, 2011$
Based on the 16.3 percent of
general responders and
survivors who are expected to
be uninsured
Discounted at
7 percent
Cancer rate
U.S. average
Discounted at
3 percent
Cancer rate
U.S. + 21%
U.S. average
U.S. + 21%
55,000 Responders .........................................................................................
5,000 Survivors ................................................................................................
Colorectal and Breast Screening .....................................................................
$1,648,706
271,427
204,491
........................
........................
........................
$10,172,308
1,572,907
713,321
........................
........................
........................
60,000 Total ..............................................................................................
2,124,624
........................
12,458,535
........................
80,000 Responders .........................................................................................
30,000 Survivors ..............................................................................................
Colorectal and Breast Screening .....................................................................
........................
........................
........................
2,631,100
1,970,560
417,521
........................
........................
........................
19,912,464
12,124,118
1,271,478
110,000 Total ............................................................................................
........................
5,019,182
........................
33,308,060
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Examination of Benefits (Health Impact)
This section describes qualitatively
the potential benefits of the final rule in
terms of the expected improvements in
36 Subramanian S, et. al. When Budgets Are Tight,
There Are Better Options Than Colonoscopies For
Colorectal Cancer Screening. Health Affairs,
September 2010, 29:9, 1734–1740.
FECA Rates for FOBT, sigmoidoscopy and
colonoscopy at non-facility rates: codes 82270,
45330, and 45378 respectively.
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the health and health-related quality of
life of potential cancer patients treated
through the WTC Health Program,
compared to no Program. The
assessment of the health benefits for
cancer patients uses the number of
expected cancer cases that was
estimated in the cost analysis section.
37 FECA rates for Mammography for New York;
FECA code 77057.
38 U.S. Census Bureau [2011]. Current Population
Survey. https://www.census.gov/cps/data/. Accessed
May 26, 2012.
39 Ward E, Halpern M, Schrag N, Cokkinides V,
DeSantis C, Bandi P, Siegel R, Stewart A, Jemal A
[2008]. Association of Insurance with Cancer Care
Utilization and Outcomes. CA Cancer J Clin 58:9–
31.
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HHS does not have information on the
health of the population that may have
been exposed to 9/11 agents and is not
currently enrolled in the WTC Health
Program. In addition, HHS has only
limited information about health
insurance and health care services for
cancers caused by exposure to 9/11
agents and suffered by any population
of responders and survivors, including
responders and survivors currently
enrolled in the WTC Health Program
and responders and survivors not
enrolled in the Program. For the
purposes of this analysis, HHS assumes
that broad trends on demographics and
access to health insurance reported by
the U.S. Census Bureau and health care
services for cancer similar to those
reported by Ward would apply to the
population of general responders (those
individuals who are not members of the
FDNY and who meet the eligibility
criteria in 42 CFR part 88 for WTC
responders) and survivors both within
and outside the Program. For the
purposes of this analysis, HHS assumes
that access to health insurance and
health care services for FDNY
responders within and outside the
Program would be equivalent because
this population is overwhelmingly
covered by employer-based health
insurance.
Although HHS cannot quantify the
benefits associated with the WTC Health
Program, enrollees with cancer are
expected to experience a higher quality
of care than they would in the absence
of the Program. Mortality and morbidity
improvements for cancer patients
expected to enroll in the WTC Health
Program are anticipated because barriers
may exist to access and delivery of
quality health care services for cancer
patients in the absence of the services
provided by the WTC Health Program.
HHS anticipates benefits to cancer
patients treated through the WTC Health
Program, who may otherwise not have
access to health care services (16.3
percent of general responders and
survivors who are expected to be
uninsured), to accrue in 2013. Starting
in 2014, continued implementation of
the ACA will result in increased access
to health insurance and health care
services will improve for the general
responder and survivor population that
currently is uninsured.
Limitations
The analysis presented here was
limited by the dearth of verifiable data
on the cancer status of responders and
survivors who have yet to apply for
enrollment in the WTC Health Program.
Because of the limited data, HHS was
not able to estimate benefits in terms of
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averted healthcare costs. Nor was HHS
able to estimate administrative costs, or
indirect costs, such as averted
absenteeism, short and long-term
disability, and productivity losses
averted due to premature mortality.
Regulatory Alternatives
The Administrator considered
alternative approaches to the methods
set forth in this rulemaking. One
alternative would involve a
presumption that 9/11 exposures could
have resulted in the development of any
and all types of cancer in the exposed
populations. A presumption that any
and all types of cancer could occur after
exposure to 9/11 agents does not require
any scientific evidence of a positive
association between exposure and a
type of cancer. The Administrator
declined to determine inclusion of types
of cancer based on a presumption
approach. The STAC affirmatively
rejected a recommendation to include
any and all types of cancer to the List
of WTC-Related Health Conditions. The
Administrator made the policy decision
to include only those types of cancer
when a positive relationship has been
established between exposure to the 9/
11 agent and human cancer.
Another alternative would be to rely
on epidemiologic studies of the
association of 9/11 exposures and the
development of cancer or a type of
cancer in 9/11-exposed populations
exclusively. There are several
limitations to using an exclusive 9/11
populations study approach. The
Administrator finds that vast
uncertainties exist in conducting
epidemiologic studies of cancer in 9/11exposed populations. For example,
there exists only very limited,
individual exposure data in 9/11exposed populations. This lack of
personal, quantitative exposure data
impedes the definitive epidemiologic
evidence that exposure to 9/11 agents
causes certain types of cancer in
responder and survivor populations. In
addition, cancer is generally a long
latency set of diseases which in some
cases may take many years or even
decades to manifest clinically.
Requiring evidence of positive
associations from epidemiologic studies
of 9/11-exposed populations exclusively
does not serve the best interests of WTC
Health Program members.
By expanding the scope of scientific
information reviewed to include three
complementary methods (including
studies in 9/11 exposed populations and
generally available epidemiologic
criteria), the Administrator has
developed a hierarchy of methods to
guide consideration of whether to
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include types of cancers on the List of
WTC-Related Health Conditions.
Effects on Other Agency Programs
HHS finds that this rulemaking also
has an effect on the VCF 40 administered
by DOJ. DOJ administers the VCF under
rules promulgated at 28 CFR part 104.
The DOJ regulations define, in 28 CFR
104.2 (f), the term ‘‘WTC-related health
condition’’ to mean ’’those health
conditions identified as WTC-related by
Title I of Public Law 111–347 and by
regulations implementing that Title.’’
The preamble to the VCF final rule (76
FR 54115) states, ‘‘If the WTC Health
Program determines that certain forms
of cancer should be added to the list of
WTC-related conditions, the final rule
requires the Special Master to add such
conditions to the list of presumptively
covered conditions for the Fund.’’
Under the VCF program,
compensation awards are generally
calculated using three components:
Economic loss plus non-economic loss
minus collateral source payments. To
determine economic loss, the Special
Master considers any prior loss of
earnings or other benefits related to
employment, medical expense loss,
replacement services loss, and loss of
business or employment opportunity.
The regulations provide presumed noneconomic awards for deceased
individuals. Because every physical
injury is unique, the Special Master may
determine presumed non-economic
losses on a case-by-case basis for
physically injured claimants. The
Special Master then subtracts any
collateral offsets received or eligible to
be received. The computation of
individual compensation due under the
fund is based on factors pertinent to
each individual claimant.
The statute caps the total amount of
funds allocated to the VCF. The VCF
regulation at 28 CFR 104.51 provides
that, ‘‘the total amount of Federal funds
paid for expenditures including
compensation with respect to claims
filed on or after October 3, 2011, will
not exceed $2,775,000,000.
Furthermore, the total amount of
40 The September 11th Victim Compensation
Fund of 2001 (VCF) was initially established in
2001 pursuant to Title IV of Public Law 107–42, 115
Stat. 230 (Air Transportation Safety and System
Stabilization Act) and was open for claims from
December 21, 2001, through December 22, 2003.
Title II of the Zadroga Act amends and reactivates
the September 11th Victim Compensation Fund of
2001. Public Law 111–347. Administered through
DOJ by a Special Master, the VCF provides
compensation to any individual (or a personal
representative of a deceased individual) who
suffered physical harm or was killed as a result of
the terrorist-related aircraft crashes of September
11, 2001, or the debris removal efforts that took
place in the immediate aftermath of those crashes.
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Federal funds expended during the
period from October 3, 2011, through
October 3, 2016, may not exceed
$875,000,000.’’
To meet these requirements, the
Special Master is authorized to reduce
the amount of compensation due to each
claimant by prorating the total amount
of the compensation award determined
for each individual claimant. The VCF
intends to establish the fraction for
proration such that all claimants receive
some payment related to their claim
within the overall funding limitation of
the program. The Special Master may
adjust the percentage of the total award
that is to be paid to eligible claims based
on experiential information as well as
estimates related to potential future
claims and availability of funds.
The amount of compensation that
would be awarded to each of the living
claimants who develop, or the heirs of
those who died from, a covered type of
cancer during the years 2002 through
2016, would be determined by
individual factors considered under the
VCF. Depending on the total number of
new claims and compensation
eligibility, the overall impact on the
VCF of increasing the number of eligible
VCF claimants as a result of adding
eligible health conditions under the
WTC Health Program may be to reduce
the proration fraction that is applied to
all VCF claimants such that the total
cost to the government remains
unchanged. The additional costs to the
VCF due to processing and computing
the entitlement for the extra claimants
eligible as a result of having a covered
type of cancer, plus the costs of paying
newly covered claimants their prorated
share of the compensation award, would
result in amounts that will not be
available to pay increased shares for the
claimants with non-cancer conditions.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA),
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-forprofit organizations. HHS believes that
this rule has ‘‘no significant economic
impact upon a substantial number of
small entities’’ within the meaning of
the Regulatory Flexibility Act (5 U.S.C.
601 et seq.).
The WTC Health Program has
contracted with the following healthcare
providers and provider network
managers to offer treatment and
monitoring to enrolled responders and
survivors: Seven CCEs, which serve
responders and survivors in the New
York City metropolitan area (City of
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New York Fire Department; Mount Sinai
School of Medicine; Research
Foundation of State University of New
York; New York University, Bellevue
Hospital Center; University of Medicine
and Dentistry of New Jersey; Long
Island Jewish Medical Center; and New
York City Health and Hospitals
Corporation); Logistics Health
Incorporated, which manages the
nationwide provider network for
populations geographically distant from
New York City; three Data Centers,
which analyze CCE data and coordinate
activities (City of New York Fire
Department; Mount Sinai School of
Medicine; and New York City Health
and Hospitals Corporation); and
Emdeon, which manages pharmacy
benefits.
Of these entities, six of the seven
CCEs and two of the three Data Centers
are hospitals (NAICS 622110—General
Medical and Surgical Hospitals). The
Small Business Administration (SBA)
identifies as a small business those
hospitals with average annual receipts
below $34.5 million; none of the six fall
below the SBA threshold for small
businesses. The City of New York Fire
Department’s Bureau of Health Services,
which provides medical monitoring and
treatment for FDNY members as a CCE,
and provides data analysis and other
services for the FDNY CCE as a Data
Center, is considered a local government
agency (NAICS 922160—Fire
Protection), and as such cannot be
considered a small entity by SBA.
Finally, neither Logistics Health
Incorporated, which manages the
national provider network, nor Emdeon,
which manages pharmacy benefits,
(NAICS 551112—Management of
Companies and Enterprises) falls below
SBA’s $7 million threshold for small
businesses in that sector.
Because no small businesses are
impacted by this rulemaking, HHS
certifies that this rule will not have a
significant economic impact on a
substantial number of small entities
within the meaning of the RFA.
Therefore, a regulatory flexibility
analysis as provided for under RFA is
not required.
C. Paperwork Reduction Act
The Paperwork Reduction Act (PRA),
44 U.S.C. 3501 et seq., requires an
agency to invite public comment on,
and to obtain OMB approval of, any
regulation that requires 10 or more
people to report information to the
agency or to keep certain records. Data
collection and recordkeeping
requirements for the WTC Health
Program are approved by OMB under
‘‘World Trade Center Health Program
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56157
Enrollment, Appeals & Reimbursement’’
(OMB Control No. 0920–0891, exp.
December 31, 2014). HHS has
determined that no changes are needed
to the information collection request
already approved by OMB.
D. 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.), HHS will report the promulgation
of this rule to Congress prior to its
effective date.
E. 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 final 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.
However, the rule may result in an
increase in the contribution made by
New York City for treatment and
monitoring, as required by Title XXXIII,
§ 3331(d)(2). For 2012, the inflation
adjusted threshold is $139 million.
F. Executive Order 12988 (Civil Justice)
This final 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.
G. Executive Order 13132 (Federalism)
HHS has reviewed this final 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.’’
H. 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 final rule on children. HHS has
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determined that the rule would have no
environmental health and safety effect
on children, although an eligible child
who has been diagnosed with a cancer
type specified in this rulemaking may
seek certification of the condition by the
Administrator.
I. 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 final rule on energy supply,
distribution or use, and has determined
that the rule will not have a significant
adverse effect.
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J. 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
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requirement the Federal Government
administers or enforces. HHS has
attempted to use plain language in
promulgating the final rule consistent
with the Federal Plain Writing Act
guidelines.
VIII. Final Rule
List of Subjects in 42 CFR Part 88
Aerodigestive disorders, Appeal
procedures, Cancer, Health care, Mental
health conditions, Musculoskeletal
disorders, Respiratory and pulmonary
diseases.
For the reasons discussed in the
preamble, the Department of Health and
Human Services amends 42 CFR part 88
as follows:
PART 88—WORLD TRADE CENTER
HEALTH PROGRAM
Authority: 42 U.S.C. 300mm–300mm–61,
Pub. L. 111–347, 124 Stat. 3623.
2. Amend § 88.1 by adding paragraph
(4) to the definition of ’’List of WTCrelated health conditions’’ to read as
follows:
■
§ 88.1
Definitions.
*
*
*
*
*
List of WTC-Related Health
Conditions
*
*
*
*
*
(4) Cancers: This list includes those
individual cancer types specified in
Table 1, below, according to the
International Classification of Diseases,
10th Edition (ICD–10) and International
Classification of Diseases, 9th Edition
(ICD–9).
BILLING CODE 4161–18–P
1. The authority citation for part 88
continues to read as follows:
■
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*
*
*
*
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric
Administration
50 CFR Part 622
[Docket No. 090206140–91081–03]
RIN 0648–XC227
[FR Doc. 2012–22304 Filed 9–10–12; 4:15 pm]
Reef Fish Fishery of the Gulf of
Mexico; Gulf of Mexico Individual
Fishing Quota Programs
BILLING CODE 4161–18–C
National Marine Fisheries
Service (NMFS), National Oceanic and
Atmospheric Administration (NOAA),
Commerce.
ACTION: Temporary rule; determination
of catastrophic conditions.
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AGENCY:
In accordance with the
regulations implementing the individual
fishing quota (IFQ) programs for the
commercial red snapper and grouper/
tilefish components of the reef fish
fishery in the Gulf of Mexico (Gulf), the
Regional Administrator, Southeast
SUMMARY:
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Region, NMFS (RA) has determined that
catastrophic conditions exist in the
following Louisiana Parishes:
Lafourche, St. Bernard, Plaquemines,
and Jefferson, as a result of Hurricane
Isaac. Consistent with those regulations,
the RA has authorized IFQ participants
within this affected area to temporarily
use paper-based forms, if necessary, for
basic required IFQ administrative
functions, e.g., landing transactions.
This temporary rule announcing the
determination of catastrophic
conditions and allowance of alternative
methods for completing required IFQ
administrative functions is intended to
facilitate continuation of IFQ operations
during the period of catastrophic
conditions.
This temporary rule is effective
from September 12, 2012, through
October 9, 2012.
DATES:
FOR FURTHER INFORMATION CONTACT:
Anik Clemens, (727) 551–5611, email
Anik.Clemens@noaa.gov.
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*
Dated: September 5, 2012.
John Howard,
Administrator, World Trade Center Health
Program and Director, National Institute for
Occupational Safety and Health, Centers for
Disease Control and Prevention, Department
of Health and Human Services.
]]>Agencies
[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Rules and Regulations]
[Pages 56138-56168]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22304]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. CDC-2012-0007; NIOSH-257]
42 CFR Part 88
RIN 0920-AA49
World Trade Center Health Program; Addition of Certain Types of
Cancer to the List of WTC-Related Health Conditions
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: Title I of the James Zadroga 9/11 Health and Compensation Act
of 2010 amended the Public Health Service Act (PHS Act) to establish
the World Trade Center (WTC) Health Program. The WTC Health Program,
which is administered by the Director of the National Institute for
Occupational Safety and Health (NIOSH), within the Centers for Disease
Control and Prevention (CDC), provides medical monitoring and treatment
to eligible firefighters and related personnel, law enforcement
officers, and rescue, recovery, and cleanup workers who responded to
the September 11, 2001, terrorist attacks in New York City, at the
Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors
of the New York City attacks. In accordance with WTC Health Program
regulations, which establish procedures for adding a new condition to
the list of covered health conditions, this final rule adds to the List
of WTC-Related Health Conditions the types of cancer proposed for
inclusion by the notice of proposed rulemaking.
DATES: This final rule is effective October 12, 2012.
FOR FURTHER INFORMATION CONTACT: Frank J. Hearl, PE, Chief of Staff,
National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, Patriots Plaza, Suite 9200, 395 E St.
SW., Washington, DC 20201. Telephone: (202) 245-0625 (this is not a
toll-free number). Email: WTCpublicinput@cdc.gov.
SUPPLEMENTARY INFORMATION: This notice of final rulemaking is organized
as follows:
I. Executive Summary
II. Public Participation
III. Background
A. WTC Health Program Statutory Authority
B. Need for Rulemaking
C. Review of Scientific Evidence
D. Physician Determination and Program Certification of WTC-
Related Health Conditions Including Types of Cancer
E. Effects of Rulemaking on Federal Agencies
IV. Methods Used by the Administrator To Determine Whether To Add
Cancer or Types of Cancer to the List of WTC-Related Health
Conditions
V. Administrator's Determination Concerning Petition 001: Addition
of Cancers to the List of WTC-Related Health Conditions, 42 CFR 88.1
VI. Summary of Final Rule and Response to Public Comments
VII. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
B. Regulatory Flexibility Act
C. Paperwork Reduction Act
D. Small Business Regulatory Enforcement Fairness Act
E. Unfunded Mandates Reform Act of 1995
F. Executive Order 12988 (Civil Justice)
G. Executive Order 13132 (Federalism)
H. Executive Order 13045 (Protection of Children From
Environmental Health Risks and Safety Risks)
I. Executive Order 13211 (Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use)
J. Plain Writing Act of 2010
VIII. Final Rule
[[Page 56139]]
I. Executive Summary
A. Purpose of Regulatory Action
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the Public Health Service Act (PHS Act)
to establish the World Trade Center (WTC) Health Program within the
Department of Health and Human Services (HHS). The PHS Act requires the
WTC Program Administrator (Administrator) to conduct rulemaking to
propose the addition of a health condition to the List of WTC-Related
Health Conditions (List) codified in 42 CFR 88.1 regardless of whether
the Administrator proposes to add a health condition based on the
findings from periodic reviews of cancer,\1\ a request from a petition,
or a determination made at the Administrator's discretion that a
proposed rule adding a condition should be initiated. Following a
petition to add cancer or certain types of cancer to the List and a
recommendation by the WTC Health Program's Scientific/Technical
Advisory Committee (STAC), the Administrator is following the
procedures established in 42 CFR 88.17 to add the types of cancer
recommended by the STAC to the List in Sec. 88.1.
---------------------------------------------------------------------------
\1\ See PHS Act, Title XXXIII sec. 3312(a)(5).
---------------------------------------------------------------------------
B. Summary of Major Provisions
This rule modifies the List of WTC-Related Health Conditions in 42
CFR 88.1 to add the following conditions (types of cancer identified by
ICD-10 code are specified in the discussion below):
[ssquf] Malignant neoplasms of the lip, tongue, salivary gland, floor
of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and
other oral cavity and pharynx
[ssquf] Malignant neoplasm of the nasopharynx
[ssquf] Malignant neoplasms of the nose, nasal cavity, middle ear, and
accessory sinuses
[ssquf] Malignant neoplasm of the larynx
[ssquf] Malignant neoplasm of the esophagus
[ssquf] Malignant neoplasm of the stomach
[ssquf] Malignant neoplasm of the colon and rectum
[ssquf] Malignant neoplasm of the liver and intrahepatic bile duct
[ssquf] Malignant neoplasms of the retroperitoneum and peritoneum,
omentum, and mesentery
[ssquf] Malignant neoplasms of the trachea; bronchus and lung; heart,
mediastinum and pleura; and other ill-defined sites in the respiratory
system and intrathoracic organs
[ssquf] Mesothelioma
[ssquf] Malignant neoplasms of the soft tissues (sarcomas)
[ssquf] Malignant neoplasms of the skin (melanoma and non-melanoma),
including scrotal cancer
[ssquf] Malignant neoplasm of the breast
[ssquf] Malignant neoplasm of the ovary
[ssquf] Malignant neoplasm of the urinary bladder
[ssquf] Malignant neoplasm of the kidney
[ssquf] Malignant neoplasms of renal pelvis, ureter and other urinary
organs
[ssquf] Malignant neoplasms of the eye and orbit
[ssquf] Malignant neoplasm of the thyroid
[ssquf] Malignant neoplasms of the blood and lymphoid tissues
(including, but not limited to, lymphoma, leukemia, and myeloma)
[ssquf] Childhood cancers
[ssquf] Rare cancers
The Administrator developed a hierarchy of methods (detailed in
Section IV of this preamble) for determining which cancers to propose
for inclusion on the List of WTC-Related Health Conditions.
C. Costs and Benefits
Annual costs, benefits, and transfers of this rule are listed in
the table below. This analysis estimates the impact on WTC Health
Program costs using the number of persons currently enrolled in the
Program as responders and survivors and assumes that the rate of cancer
in the population will be equal to the U.S. population average rate. An
alternative analysis considers the impact on costs if the Program
enrolls additional persons up to the Program's statutory limits, and
that the expanded population experiences a 21 percent higher rate of
cancer than the U.S. population average. The basis for these
assumptions is explained in detail in the preamble of this rulemaking
(see Section VII.A., below).
Although we cannot quantify the benefits associated with the WTC
Health Program, enrollees with cancer are expected to experience a
higher quality of care than they would in the absence of the Program.
Mortality and morbidity improvements for cancer patients expected to
enroll in the WTC Health Program are anticipated because barriers may
exist to access and delivery of quality health care services for cancer
patients in the absence of the services provided by the WTC Health
Program. HHS anticipates benefits to cancer patients treated through
the WTC Health Program, who may otherwise not have access to health
care services, to accrue in 2013. Starting in 2014, continued
implementation of the Affordable Care Act will result in increased
access to health insurance and improved health care services for the
general responder and survivor population that currently is uninsured.
Estimated annual WTC Health Program costs, transfers, and benefits, 55,000 responders and 5,000 survivors at
U.S. population cancer rate, and 80,000 responders and 30,000 survivors at U.S. population cancer rate + 21
percent, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Societal Costs for 2013, 2011$
Annualized Transfers for 2013-
2016, 2011$
---------------------------------------------------------------
Based on the 16.3 percent of Discounted at Discounted at
general responders and 7 percent 3 percent
survivors who are expected to
be uninsured
---------------------------------------------------------------
Cancer Rate
Cancer Rate
---------------------------------------------------------------
U.S. Average U.S. + 21% U.S. Average U.S. + 21%
---------------------------------------------------------------
55,000 Responders............................... $1,648,706 .............. $10,172,308 ..............
5,000 Survivors................................. 271,427 .............. 1,572,907 ..............
Colorectal and Breast Screening................. 204,491 .............. 713,321 ..............
---------------------------------------------------------------
60,000 Total................................ 2,124,624 .............. 12,458,535 ..............
---------------------------------------------------------------
[[Page 56140]]
---------------------------------------------------------------
80,000 Responders............................... .............. 2,631,100 .............. 19,912,464
30,000 Survivors................................ .............. 1,970,560 .............. 12,124,118
Colorectal and Breast Screening................. .............. 417,521 .............. 1,271,478
---------------------------------------------------------------
110,000 Total............................... .............. 5,019,182 .............. 33,308,060
----------------------------------------------------------------------------------------------------------------
Qualitative benefits
----------------------------------------------------------------------------------------------------------------
Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are
expected to experience a higher quality of care than they would in the absence of the Program. Mortality and
morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because
barriers may exist to access and delivery of quality health care services for cancer patients in the absence of
the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through
the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting
in 2014, continued implementation of the Affordable Care Act will result in increased access to health
insurance and improved health care services for the general responder and survivor population that currently is
uninsured.
----------------------------------------------------------------------------------------------------------------
II. Public Participation
On June 13, 2012 HHS published a notice of proposed rulemaking (77
FR 35574) proposing to add certain cancers to the List of WTC-Related
Health Conditions. HHS invited interested persons or organizations to
submit written views, opinions, recommendations, and data on any topic
related to the proposed rule. The Administrator specifically sought
comments on the methodology proposed to evaluate evidence for the
addition of types of cancer to the List of WTC-Related Health
Conditions; the proposed cost estimates; information or published
studies about the type of welding and/or metal cutting that occurred at
any of the disaster sites and information about exposure to ultraviolet
light; and information or published studies about the scheduling of
work hours or shiftwork occurring at any of the disaster sites.
HHS received 27 substantive submissions to the docket for this
rulemaking. Commenters included labor unions that represent WTC
responders, including police department members and others who
conducted rescue, recovery, and clean-up; private citizens, including
WTC responders; the spouse of a responder; survivors; relatives of
victims and survivors; physicians who have treated WTC responders;
health care professionals with no stated experience treating 9/11-
exposed patients; health and research organizations; the WTC Health
Program Survivors Steering Committee; a chemical supplier; and an
elected official. Additionally, one private citizen submitted a comment
that was outside the scope of this rulemaking. The substantive comments
are described below, followed by the Administrator's response to each
(see Section V., below).
III. Background
A. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347), amended the PHS Act to add Title XXXIII \2\
establishing the WTC Health Program within HHS. The WTC Health Program
provides medical monitoring and treatment benefits to eligible
firefighters and related personnel, law enforcement officers, and
rescue, recovery, and cleanup workers who responded to the September
11, 2001, terrorist attacks in New York City, at the Pentagon, and in
Shanksville, Pennsylvania, and to eligible survivors of the New York
City attacks.
---------------------------------------------------------------------------
\2\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-61. Those portions of the Zadroga Act found in Titles II
and III of Public Law 111-347 do not pertain to the WTC Health
Program and are codified elsewhere.
---------------------------------------------------------------------------
All references to the Administrator in this notice mean the NIOSH
Director or his or her designee. Section 3312(a)(6) of the PHS Act
requires the Administrator to conduct rulemaking to propose the
addition of a health condition to the List of WTC-Related Health
Conditions codified in 42 CFR 88.1.
B. Need for Rulemaking
The PHS Act requires the Administrator to conduct rulemaking to
propose the addition of a health condition to the List of WTC-Related
Health Conditions codified in 42 CFR 88.1 regardless of whether the
Administrator proposes to add a health condition based on the findings
from periodic reviews of cancer,\3\ a request from a petition, or a
determination made at the Administrator's discretion that a proposed
rule adding a condition should be initiated. On September 7, 2011, the
Administrator received a written petition to add a health condition to
the List of WTC-Related Health Conditions (Petition 001). Petition 001
requested that the Administrator ``consider adding coverage for
cancer'' to the List in Sec. 88.1.\4\
---------------------------------------------------------------------------
\3\ See PHS Act, sec, 3312(a)(5).
\4\ Maloney CB, Nadler J, King PT, Schumer CE, Gillibrand KE,
Rangel CB, Velazquez NM, Grimm MG, Clarke YD. [2011]. Letter from
Congress to John Howard, MD, Director, National Institute for
Occupational Safety and Health (NIOSH). WTC Health Program Petition
001. Petition 001 is included in the docket for this rulemaking. See
http:www.regulations.gov and https://www.cdc.gov/niosh/docket/archive/docket257.html.
---------------------------------------------------------------------------
On October 5, 2011, the Administrator formally exercised his option
to request a recommendation from the STAC regarding the petition (PHS
Act, sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)). The Administrator
requested that the STAC ``review the available information on cancer
outcomes associated with the exposures resulting from the September 11,
2001, terrorist attacks, and provide advice on whether to add cancer,
or a certain type of cancer, to the List specified in the Zadroga
Act.'' \5\ In response, the STAC submitted its recommendation on April
2, 2012, and the Administrator issued a notice of proposed rulemaking
on June 13, 2012. The background to this rulemaking and a discussion of
the STAC's recommendation are provided in the notice of proposed
rulemaking published on June 13, 2012 (77 FR 35574).
---------------------------------------------------------------------------
\5\ Howard J [2011]. October 5, 2011 Letter from John Howard,
MD, Director, National Institute for Occupational Safety and Health
(NIOSH) to the WTC Health Program Scientific/Technical Advisory
Committee. This letter is included in the docket for this
rulemaking. See http:www.regulations.gov and https://www.cdc.gov/niosh/docket/archive/docket257.html.
---------------------------------------------------------------------------
C. Review of Scientific Evidence
As reviewed in detail in the June 13, 2012 notice of proposed
rulemaking, the
[[Page 56141]]
Administrator considered data from five information sources to decide
whether to propose the addition of cancers to the List of WTC-Related
Health Conditions: (1) Peer-reviewed studies published in the
scientific literature, including environmental sampling data,
epidemiologic studies on the 9/11-exposed populations, and studies
providing evidence of a causal relationship between a type of cancer
and a condition already on the List of WTC-Related Health Conditions;
\6\ (2) findings and recommendations solicited from the WTC Clinical
Centers of Excellence and Data Centers, the WTC Health Registry at the
New York City Department of Health and Mental Hygiene, and the New York
State Department of Health; (3) information from the public solicited
through a request for information published in the Federal Register on
March 8, 2011 and March 29, 2011; (4) the findings of the National
Toxicology Program (NTP) in the National Institute of Environmental
Health Sciences, HHS,\7\ as well as the World Health Organization's
International Agency for Research on Cancer (IARC); \8\ and (5)
findings from other sources of information relevant to 9/11 exposures,
including the expert judgment and personal experiences of STAC members,
and comments from the public.
---------------------------------------------------------------------------
\6\ The July 2011, First Periodic Review of the Scientific and
Medical Evidence Related to Cancer for the World Trade Center Health
Program (First Periodic Review), requested by the Administrator, was
included among the information considered. NIOSH [2011]. First
Periodic Review of Scientific and Medical Evidence Related to Cancer
for the World Trade Center Health Program. NIOSH Publication No.
2011-197. https://www.cdc.gov/niosh/docs/2011-197/pdfs/2011-197.pdf/.
Accessed April 18, 2012. As required by sec.3312(a)(5)(A) of the PHS
Act, the review considered ''all available scientific and medical
evidence, including findings and recommendations of Clinical Centers
of Excellence, published in peer-reviewed journals to determine if,
based on such evidence, cancer or a certain type of cancer should be
added to the applicable list of WTC-related health conditions.'' At
the time of publication, the First Periodic Review identified only
one peer-reviewed article addressing the association of exposures
arising from the September 11, 2001, terrorist attacks and cancer in
responders and survivors, and two publications that used models to
estimate the risk of cancer among residents in Lower Manhattan.
Unlike the explicit standard prescribed for periodic reviews of
cancer under sec. 3312(a)(5)(A), sec. 3312(a)(6) of the PHS Act does
not specify the sources upon which the Administrator may base his or
her determination to propose the addition of cancer or types of
cancer to the List of WTC-Related Health Conditions.
\7\ NTP Report on Carcinogens (RoC). https://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. Accessed May 9, 2012.
\8\ WHO International Agency for Research on Cancer (IARC).
https://monographs.iarc.fr/. Accessed May 8, 2012.
---------------------------------------------------------------------------
In September 2011, an epidemiologic study by Rachel Zeig-Owens and
colleagues (hereafter, ``Zeig-Owens''), ``identified a modest effect of
WTC exposure for all cancers combined by comparing the ratios in the
exposed group [of Fire Department of New York City firefighters] to
those in the non-exposed group.'' \9\ This publication led to the
submission of Petition 001. The Administrator requested that the STAC
provide a recommendation on Petition 001. The STAC established
evidentiary criteria and assessed the weight of the available
scientific evidence provided by information sources (1), (4), and (5),
described above. The STAC found support for including a number of types
of cancer based in part on evidence of increased risk reported in Zeig-
Owens. The STAC also included a number of types of cancer based on the
professional judgment of STAC members with scientific expertise, on the
personal experience of some of the STAC members who were themselves WTC
responders or survivors, and on comments made by members of the public.
---------------------------------------------------------------------------
\9\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905.
---------------------------------------------------------------------------
Following review of the STAC recommendation, the Administrator
agreed with the STAC that individual exposure assessment information
arising from the terrorist attacks is extremely limited and that its
absence impairs definitive scientific analysis of the relationship
between exposures arising from the attacks and the occurrence of any
specific type of cancer. The Administrator also found that multiple
epidemiologic studies of cancer in exposed responders and survivors
which definitively support an association between 9/11 exposures and
specific types of cancer that would meet generally well-accepted
criteria indicating that the association is a causal one are not
currently available.
After considering various approaches to evaluate the available
scientific evidence (see discussion in the June 13, 2012 notice of
proposed rulemaking), the Administrator has adopted the methodology
outlined in the proposed rule and set out in Section IV below. This
methodology follows on criteria used by the STAC in its recommendation.
Using the methodology, the Administrator adds the types of cancer,
identified in Section V below, to the List of WTC-Related Health
Conditions.
D. Physician Determination and Program Certification of WTC-Related
Health Conditions Including Types of Cancer
In order for an individual enrolled as a WTC responder or survivor
to obtain coverage for treatment of any health condition on the List of
WTC-Related Health Conditions, including any type of cancer added to
the List, a two-step process must be satisfied. First, a physician at a
Clinical Center of Excellence (CCE) or in the nationwide provider
network must make a determination that the particular type of cancer
for which the responder or survivor seeks treatment coverage is both on
the List of WTC-Related Health Conditions and that exposure to airborne
toxins, other hazards, or adverse conditions resulting from the
September 11, 2001, terrorist attacks is substantially likely to be a
significant factor in aggravating, contributing to, or causing the type
of cancer for which the responder or survivor seeks treatment
coverage.\10\ Pursuant to 42 CFR 88.12(a), the physician's
determination must be based on the following: (1) An assessment of the
individual's exposure to airborne toxins, any other hazard, or any
other adverse condition resulting from the September 11, 2001, attacks;
and (2) the type of symptoms reported and the temporal sequence of
those symptoms. In addition, the statute requires that all physician
determinations are reviewed by the Administrator and are certified for
treatment coverage unless the Administrator determines that the
condition is not a health condition on the List of WTC-Related Health
Conditions or that the exposure resulting from the September 1, 2001,
terrorist attacks is not substantially likely to be a significant
factor in aggravating, contributing to, or causing the condition. Thus,
the inclusion of a condition on the List of WTC-Related Health
Conditions, in and of itself, does not guarantee that a particular
individual's condition will be certified as eligible for treatment.
Responders and survivors denied certification have a right to appeal
the denial of certification.
---------------------------------------------------------------------------
\10\ See PHS Act, sec.3312(a)(1); 42 U.S.C. 300mm-22(a)(1).
---------------------------------------------------------------------------
E. Effects of Rulemaking on Federal Agencies
Title II of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347) reactivated the September 11, 2001 Victim
Compensation Fund (VCF). Administered by the U.S. Department of
[[Page 56142]]
Justice (DOJ), the VCF provides compensation to any individual or
representative of a deceased individual who was physically injured or
killed as a result of the September 11, 2001, terrorist attacks or
during the debris removal. Eligibility criteria for compensation by the
VCF include a list of presumptively covered health conditions, which
are physical injuries determined to be WTC-related health conditions by
the WTC Health Program. Pursuant to DOJ regulations, the VCF Special
Master is required to update the list of presumptively covered
conditions when the List of WTC-Related Health Conditions in 42 CFR
88.1 is updated.\11\ (See also Section VII.A., Effects on Other Agency
Programs, below.)
---------------------------------------------------------------------------
\11\ 28 CFR 104.21.
---------------------------------------------------------------------------
IV. Methods Used by the Administrator To Determine Whether To Add
Cancer or Types of Cancer to the List of WTC-Related Health Conditions
For the reasons discussed above and detailed in the notice of
proposed rulemaking published in the Federal Register on June 13, 2012,
the Administrator developed the following hierarchy of methods for
determining whether to add cancer or types of cancer to the List of
WTC-Related Health Conditions in 42 CFR 88.1. In determining whether to
propose that a type of cancer be included on the List, a review of the
evidence must demonstrate fulfillment of at least one of the following
four methods:
[ssquf] Method 1. Epidemiologic Studies of September 11, 2001
Exposed Populations. A type of cancer may be added to the List if
published, peer-reviewed epidemiologic evidence supports a causal
association between 9/11 exposures and the cancer type. The following
criteria extrapolated from the Bradford Hill criteria will be used to
evaluate the evidence of the exposure-cancer relationship:
[cir] Strength of the association between a 9/11 exposure and a
health effect (including the magnitude of the effect and statistical
significance);
[cir] consistency of the findings across multiple studies;
[cir] biological gradient, or dose-response relationships between
9/11 exposures and the cancer type; and
[cir] plausibility and coherence with known facts about the biology
of the cancer type.
If only a single published epidemiologic study is available for
review, the consistency of findings cannot be evaluated and strength of
association will necessarily place greater emphasis on statistical
significance than on the magnitude of the effect.
[ssquf] Method 2. Established Causal Associations. A type of cancer
may be added to the List if there is well-established scientific
support published in multiple epidemiologic studies for a causal
association between that cancer and a condition already on the List of
WTC-Related Health Conditions.
[ssquf] Method 3. Review of Evaluations of Carcinogenicity in
Humans. A type of cancer may be added to the List only if both of the
following criteria for Method 3 are satisfied:
3A. Published Exposure Assessment Information. 9/11 agents were
reported in a published, peer-reviewed exposure assessment study of
responders or survivors who were present in either the New York City
disaster area as defined in 42 CFR 88.1, or at the Pentagon, or in
Shanksville, Pennsylvania; and
3B. Evaluation of Carcinogenicity in Humans from Scientific
Studies. NTP has determined that the 9/11 agent is known to be a human
carcinogen or is reasonably anticipated to be a human carcinogen, and
IARC has determined there is sufficient or limited evidence that the 9/
11 agent causes a type of cancer.
[ssquf] Method 4. Review of Information Provided by the WTC Health
Program Scientific/Technical Advisory Committee. A type of cancer may
be added to the List if the STAC has provided a reasonable basis for
adding a type of cancer and the basis for inclusion does not meet the
criteria for Method 1, Method 2, or Method 3.
The following schematic illustrates the methodology proposed in the
notice of proposed rulemaking and established in this final rule.
BILLING CODE 4161-17-P
[[Page 56143]]
[GRAPHIC] [TIFF OMITTED] TR12SE12.012
BILLING CODE 4161-17-C
[[Page 56144]]
V. Administrator's Determination Concerning Petition 001: Addition of
Cancers to the List of WTC-Related Health Conditions, 42 CFR 88.1
Using the evidentiary standards established above for inclusion of
a cancer on the List of WTC-Related Health Conditions in 42 CFR 88.1,
and in accordance with the review of evidence discussed in the notice
of proposed rulemaking published in the Federal Register on June 13,
2012, the Administrator adds the specific types of cancers in the list
below to the List of WTC-Related Health Conditions in 42 CFR 88.1. In
the list below, the name of the cancer is followed by its ICD-10 code
\12\ as well as the method used to include the cancer. A more detailed
list, including sub-codes, is included in Table 1 in the regulatory
text below.
---------------------------------------------------------------------------
\12\ WHO (World Health Organization) [1997]. International
Classification of Diseases, Tenth Revision. Geneva: World Health
Organization. The International Classification of Diseases (ICD) is
used to code and classify injuries and diseases and their signs,
symptoms, and external causes for statistical presentation, disease
analysis, hospital records indexing, and medical billing
reimbursement.
[ssquf] Malignant neoplasms of the lip [C00], tongue [C01, C02],
salivary gland [C07, C08], floor of mouth [C04], gum and other mouth
[C03, C05, C06], tonsil [C09], oropharynx [C10], hypopharynx [C12,
C13], other oral cavity and pharynx [C14] (Method 3)
[ssquf] Malignant neoplasm of the nasopharynx [C11] (Method 3)
[ssquf] Malignant neoplasms of the nasal cavity [C30] and accessory
sinuses [C31] (Method 3)
[ssquf] Malignant neoplasm of the larynx [C32] (Method 3)
[ssquf] Malignant neoplasms of the esophagus [C15] (Method 2)
[ssquf] Malignant neoplasm of the stomach [C16] (Method 3)
[ssquf] Malignant neoplasms of the colon (and rectum) [C18, C19, C20,
C26.0] (Method 3)
[ssquf] Malignant neoplasms of the liver and intrahepatic bile duct
[C22] (Method 3)
[ssquf] Malignant neoplasms of the retroperitoneum and peritoneum [C48]
(Method 3)
[ssquf] Malignant neoplasms of the trachea [C33]; bronchus and lung
[C34]; heart, mediastinum and pleura [C38]; and other ill-defined sites
in the respiratory system and intrathoracic organs [C39] (Method 3)
[ssquf] Mesothelioma [C45] (Method 3)
[ssquf] Malignant neoplasm of peripheral nerves and autonomic nervous
system [C47) and malignant neoplasm of other connective and soft tissue
[C49] (Method 3)
[ssquf] Other malignant neoplasms of skin (non-melanoma) [C44] (Method
3), malignant melanoma of skin [C43] (Method 4), and malignant neoplasm
of scrotum [C63.2] (Methods 3)
[ssquf] Malignant neoplasm of the breast [C50] (Method 4)
[ssquf] Malignant neoplasm of the ovary [C56] (Method 3)
[ssquf] Malignant neoplasm of the urinary bladder [C67] (Method 3)
[ssquf] Malignant neoplasm of the kidney [C64] (Method 3)
[ssquf] Malignant neoplasm of the renal pelvis, ureter and other
urinary organs [C65, C66 and C68] (Method 3)
[ssquf] Malignant neoplasm of the eye and orbit [C69] (Method 4)
[ssquf] Malignant neoplasm of thyroid gland [C73] (Method 3)
[ssquf] Hodgkin's disease [C81]; follicular [nodular] non-Hodgkin
lymphoma [C82]; diffuse non-Hodgkin lymphoma [C83]; peripheral and
cutaneous T-cell lymphomas [C84]; other and unspecified types of non-
Hodgkin lymphoma [C85]; malignant immunoproliferative diseases [C88];
multiple myeloma and malignant plasma cell neoplasms [C90]; lymphoid
leukemia [C91]; myeloid leukemia [C92]; monocytic leukemia [C93]; other
leukemias of specified cell type [C94]; leukemia of unspecified cell
type [C95]; other and unspecified malignant neoplasms of lymphoid,
hematopoietic and related tissue [C96] (Method 3)
[ssquf] Childhood Cancers [any type of cancer occurring in a person
less than 20 years of age] (Method 4)
[ssquf] Rare Cancers [any type of cancer affecting populations smaller
than 200,000 individuals in the United States, i.e., occurring at an
incidence rate less than 0.08 percent of the U.S. population] (Method
4)
VI. Summary of Final Rule and Response to Public Comments
The final rule amends the definition of ``List of WTC-Related
Health Conditions'' in 42 CFR 88.1, to include the types of cancer
referenced above in Section V, which are the cancers proposed in the
June 13, 2012, notice of proposed rulemaking (77 FR 35574). Table 1 in
the regulatory text describes types of cancers included in 42 CFR 88.1
and identifies each by ICD-10 code. Because the ICD-10 modification
will not be used by the U.S. healthcare system until October 1, 2014,
the corresponding ICD-9 codes for the included cancer types are also
provided in Table 1 in the regulatory text.
The effect of this amendment is that, for the types of cancers
added, an enrolled WTC responder, certified-eligible survivor, or
screening-eligible survivor may seek certification of a physician's
determination that the September 11, 2001, terrorist attacks were
substantially likely to be a significant factor in aggravating,
contributing to, or causing the individual's cancer. As discussed
above, if the condition is certified by the Administrator, the
individual may seek treatment and monitoring of this condition under
the WTC Health Program.
As described in the Public Participation section, above, the
Administrator received 27 substantive submissions from the public on
the methodology and the types of cancers proposed in the June 13, 2012
Federal Register notice (77 FR 35574). Upon consideration of the public
comments, the Administrator has determined not to amend the methodology
or the list of cancers in Table 1 of the regulatory text proposed in
the June 13, 2012 notice of proposed rulemaking (77 FR 35574). The
comments are summarized below, followed by the Administrator's response
to each.
Comment: The Administrator received 12 comments in support of
adding the proposed types of cancer to the List of WTC-Related Health
Conditions. Some commenters expressed support for the specific
methodologies proposed by the Administrator, including the use of the
NTP and the IARC designations (Method 3). Commenters noted that
requiring conclusive epidemiological evidence to add cancers to the
List may not be fair to responders and survivors who are ill now, given
the time required to collect sufficient data and publish studies in
peer-reviewed journals. Some commenters correctly pointed out that an
individual's diagnosis must be determined to be related to 9/11
exposure by a WTC Health Program physician and then certified by the
Administrator in order for that individual to receive treatment through
the Program. Some commenters wrote in support of specific types of
cancer for inclusion.
Response: The Administrator agrees that establishing a broad
continuum of decision-making methods is important to ensure that WTC
responders and survivors receive care for health conditions associated
with the September 11, 2001, terrorist attacks.
Comment: The Administrator received three comments opposing the
addition of the proposed types of cancer to the List of WTC-Related
Health Conditions using the methodology established in this final rule.
One commenter concurred with the use of
[[Page 56145]]
Methods 1 and 2, but stated that Methods 3 and 4 ``leave the door open
for speculation and anecdotal evidence to influence the decision
process.'' Two commenters questioned the use of the Zeig-Owens \13\
study by the STAC to recommend the addition of types of cancer to the
List, e.g., thyroid and melanoma, mentioning the preliminary nature of
the results and that the recommended types of cancer do not meet the
traditional level of statistical significance. One commenter expressed
opposition to Methods 3 and 4 as being overly broad, thus allowing into
the Program those individuals who do not truly merit Program benefits.
---------------------------------------------------------------------------
\13\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905.
---------------------------------------------------------------------------
Response: The Administrator appreciates the comments provided on
the four methods proposed for listing types of cancer as WTC-related
health conditions. The final rule adopts the methods outlined in the
proposed rule. Under sec. 3312(a)(6) of the PHS Act, the Administrator
is permitted to consider a wide range of approaches in adding
conditions to the List.
The Administrator agrees with the commenter that Methods 1 and 2,
which rely on epidemiologic evidence (Method 1) and established medical
relationships between a WTC-related health condition and the
development of a type of cancer (Method 2), provide traditional methods
for associating exposure and health effects as a means of adding
conditions to the List of WTC-Related Health Conditions. However, the
Administrator also recognizes that there is a continuum of methods that
can be used to establish relationships between exposure and disease:
some methods are more definitive and provide a higher level of
certainty when establishing an association between exposure and disease
outcomes. Adding cancers to the List by Methods 1 and 2 fall in that
portion of the continuum of methods that provide greater certainty.
However, Methods 1 and 2 are substantially limited in their ability
to provide timely guidance on which types of cancer should be added to
the List of WTC-Related Health Conditions to allow the WTC Health
Program to provide services to the responders and survivors currently
suffering from cancers following exposure to 9/11 agents. Due to the
long latency period between exposure and cancer diagnosis for most
types of cancer, many epidemiological studies of cancer associated with
particular exposures are produced years after a given exposure event.
Waiting for definitive, scientifically-unassailable epidemiologic
results before adding types of cancer to the List would prevent
treatment of currently-enrolled WTC responders and survivors.
In addition, other factors make it difficult to establish
definitive associations using traditional epidemiologic methods within
any timeframe. The number of potentially exposed individuals is small,
so the statistical power of any study will be substantially limited.
Many of the cancers anticipated in the exposed population are uncommon.
Thus, because of the anticipated small numbers of these cancers,
detecting statistically significant increases will be difficult and may
only be definitively established through a retrospective cohort study
conducted decades from now. Upon thorough review of all available
information, including peer-reviewed studies, expert opinion, the STAC
recommendation, and comments from the public, the Administrator has
determined that it is reasonable to acknowledge the limitations of
traditional epidemiologic methods and to recognize other methods that
incorporate additional sources of information.
Because of the limitations of using epidemiologic studies to
establish relationships between exposure and health effects, and the
WTC Health Program's responsibility to provide services to affected
individuals during their lifetime, the Administrator finds that this
unique exposure situation merits the use of methods, in addition to
Methods 1 and 2, that provide valuable information about the
relationship between exposure and health effects. The Administrator
acknowledges that Methods 3 and 4 provide less certainty about the
relationship between exposure and cancer than do Methods 1 and 2.
Method 3 relies on identifying those agents categorized by the NTP
as known or reasonably anticipated to be human carcinogens and by IARC
as being known, probable, or possible human carcinogens and having
sufficient or limited evidence for causing specific types of cancer in
humans. IARC and NTP findings, including IARC's identification of
agents associated with specific cancer types, have undergone
substantial peer review and/or scientific scrutiny in their
development.
Method 4 relies on findings from other sources of information
relevant to 9/11 exposures and the potential occurrence of cancer,
including the expert judgment and personal experiences of STAC members
and comments from the public. The statute allows the Administrator to
request a recommendation from the STAC. In this case, the Administrator
requested a recommendation from the STAC as well as descriptions of the
scientific and/or technical evidence members relied on, the quality of
data supporting the evidence, and the methods used. The Administrator
found the STAC recommendations and their bases to be reasonable.
Two comments correctly pointed out that the Zeig-Owens study, which
was cited as evidence by the STAC, was viewed by the Administrator as
not meeting the statistical significance threshold for Method 1.
However, the Administrator made the determination to include certain
cancers (e.g. thyroid and melanoma) using Method 4 based on a
reasonable recommendation from the STAC. The interpretation of
statistical significance can vary between knowledgeable observers. The
STAC interpreted the Zeig-Owens results as a sound basis for
recommending the addition of some types of cancer to the List when the
reported statistical significance of findings in the study was near the
traditional 95 percent confidence level. The Administrator has
determined that the STAC's interpretation is reasonable.
The evidence cited by the STAC for including thyroid cancer and
melanoma in their recommendation was that the Standardized Incidence
Ratios (SIR) were substantially greater than 1.0 and approached the 95
percent confidence level traditionally used for statistical
significance. The STAC also considered other types of cancer that had
an elevated SIR in the Zeig-Owens study, such as prostate cancer, and
did not recommend them for addition after considering additional
information on potential surveillance bias. Thus, the STAC made
reasonable arguments for the addition or exclusion of certain types of
cancer. The STAC did not limit the basis of its recommendations to a
level of statistical significance that would be recognized by all
knowledgeable observers of epidemiologic studies.
Finally, the Administrator notes that listing a cancer as a WTC-
related health condition does not necessarily mean that a cancer in an
individual WTC responder or survivor will be determined to be WTC-
related. Each WTC responder and survivor enrolled in the Program will
go through a physician's determination and Program certification
process to assess whether their individual cancer meets the
[[Page 56146]]
statutory definition of a WTC-related health condition. When
determining whether an individual's cancer has been contributed to,
aggravated by, or caused by their exposures at the 9/11 sites,
individual medical history and exposure assessment are used as part of
the determination and certification process. Guidelines for physician
determinations regarding WTC-related health conditions are jointly
developed by the CCEs and the WTC Health Program for all conditions
currently on the List. The CCEs and WTC Health Program will develop
additional assessment information for use by physicians in making
determinations regarding whether an individual's 9/11 exposure may have
contributed to, aggravated, or caused their cancer.
Comment: One commenter stated that the STAC's recommendations do
not merit the same decision-making weight as Methods 1 and 2 because
most of the committee is not rigorously trained in epidemiology and
biostatistics.
Response: The Administrator acknowledges the diverse background of
the STAC members, but notes that the composition of the STAC was
established in sec. 3302(a) of the PHS Act to provide a broad spectrum
of backgrounds and expertise to the Administrator. The inclusion of
non-scientists on the STAC adds value, knowledge, and perspective to
the STAC that might not otherwise be available to the Administrator.
Comment: One commenter was concerned about the potential impact of
adding the proposed types of cancer to the List of WTC-Related Health
Conditions on the VCF administered by the Department of Justice, and
believes that the use of Methods 3 and 4 will overextend the WTC Health
Program and the VCF and leave them open to abuse.
Response: The Administrator notes that individuals who are not
currently enrolled in the WTC Health Program must first be found to be
eligible and qualified to enroll. As discussed above, physician
determination and Program certification are two additional steps that
must be completed before an individual can receive treatment and
monitoring benefits from the Program. Similarly, the VCF employs
rigorous standards used to determine individual compensation awards.
The Administrator acknowledges the issue of resource limits on the VCF,
which is a capped-benefit program. This issue is discussed in Section
VII.A below. Further consideration of the potential impact on the VCF
is outside the scope of this rulemaking.
Comment: One comment stated that asbestos-related cancers generally
have latencies far beyond the 10 years that have passed since September
11, 2001, and that there is great uncertainty in designating asbestos
as a cause of stomach or colorectal cancers.
Response: The methodology established in this final rule for adding
types of cancer to the List includes identifying those agents
categorized by IARC as being known, probable, or possible human
carcinogens and having sufficient or limited evidence for causing
specific types of cancer in humans, and by the NTP as being known or
reasonably anticipated to be human carcinogens. IARC and NTP findings
have undergone substantial peer review and/or other scientific scrutiny
in their development. These authoritative bodies have categorized all
forms of asbestos as known human carcinogens, and IARC has determined
there is limited evidence that they cause cancer of the stomach and
colon.
When determining whether an individual's cancer has been
contributed to, aggravated by, or caused by their exposures at the 9/11
sites, an individual medical history and exposure assessment is used as
part of the physician determination and Program certification process.
Guidelines for physician determinations regarding WTC-related health
conditions are jointly developed by the CCEs and the WTC Health Program
for conditions on the List. The CCEs and WTC Health Program will
develop additional assessment information for use by physicians in
making determinations regarding whether an individual's 9/11 exposure
may have contributed to, aggravated, or caused their cancer.
Comment: One comment stated that beryllium and beryllium compounds
should be removed as an identified exposure agent for all respiratory
cancers listed in Table A. Among other reasons, the commenter indicated
that the collapse of the World Trade Center was unlikely to have
resulted in emissions of beryllium metal and beryllium compounds above
levels found in the natural environment.
Response: The quantitative exposures of individuals at the WTC,
particularly during the collapse of the towers and for several days
afterward, will likely never be fully known. While the concentrations
of beryllium dust in settled dust samples collected from around the WTC
sites approximate the concentrations in ``background'' samples, the
exposure conditions that have been described (including thick dust
clouds, individuals being coated with dust, and large deposits of dust
in homes) result in very different exposures than would be expected to
be found in industrial settings or in windblown dirt. The Administrator
finds that such conditions are likely to result in large, short-term
exposures.
The methodology established in this final rule for adding types of
cancer to the List includes identifying those agents categorized by
IARC as being known, probable, or possible human carcinogens and having
sufficient or limited evidence of carcinogenicity in humans, and by NTP
as being known or reasonably anticipated to be human carcinogens. IARC
and NTP findings have undergone substantial peer review and/or other
scientific scrutiny in their development. These authoritative bodies
have categorized beryllium and beryllium compounds as known human
carcinogens, and IARC has determined there is sufficient evidence that
they cause cancer of the lung.
Comment: Several commenters recognized the important distinction
between a cancer being included on the List of WTC-Related Health
Conditions and the physician determination and Program certification of
a specific cancer in an individual responder or survivor. One comment
noted that physicians will need guidance to make a determination that a
type of cancer is related to the September 11, 2001, terrorist attacks.
Response: The Administrator recognizes the difficulty inherent in
determining whether an individual's cancer can be considered WTC-
related. Guidelines for physician determinations regarding WTC-related
health conditions are jointly developed by the CCEs and the WTC Health
Program for all conditions on the List. The CCEs and WTC Health Program
will develop additional assessment information for use by physicians in
making determinations regarding whether an individual's 9/11 exposure
may have contributed to, aggravated, or caused their cancer.
Comment: One commenter asked that the Administrator exercise
authority under the PHS Act to ``cover a specific type of cancer in
individual cases, notwithstanding the review and determination of when
to generally add a type of cancer to the list of covered WTC
conditions.''
Response: The Administrator will use his authority under sec. 3312
of the Act and as detailed in 42 CFR 88.13 to cover a condition
medically-associated with a condition on the List of WTC-Related Health
conditions, as appropriate.
Comment: The Administrator received a number of comments
[[Page 56147]]
requesting the addition of one or more types of cancer. Six commenters
asked that cancer of the prostate be added to the List. One commenter
asked that cancers of the brain and pancreas also be added to the List.
Another commenter asked for the addition of melanoma, thyroid, and non-
Hodgkin lymphoma to the List. One of the commenters stated that the
Administrator did not address a STAC recommendation to add pre-
malignant and myelodysplastic diseases.
Response: The issue of whether to recommend the addition of cancers
of the prostate, brain, and pancreas to the List of WTC-Related Health
Conditions was considered and discussed by the STAC in the open meeting
on March 28, 2012. In those discussions, the STAC considered the
available evidence for recommending the addition of cancers of the
prostate, brain, and pancreas, including the epidemiologic evidence and
the NTP and IARC reviews. Following its deliberation on the matter, the
STAC voted not to include prostate, brain, or pancreatic cancer in its
recommendation.\14\ The Administrator concurs with the decision of the
STAC and is not adding these cancers to the List of WTC-Related Health
Conditions at this time. The addition of these cancers may be
reconsidered if additional information on the association of 9/11
exposures and those cancer outcomes becomes available. Regarding the
request to add melanoma, thyroid cancer, and non-Hodgkin lymphoma, this
final rule specifically includes the addition of melanoma, thyroid
cancer, and non-Hodgkin lymphoma to the List of WTC-Related Health
Conditions. Finally, the Administrator acknowledges that the STAC's
recommendation to add pre-malignant and myelodysplastic diseases was
not adopted. This final rule only addresses adding types of cancer to
the List. The inclusion of pre-malignant or non-malignant conditions,
such as myelodysplastic diseases, may be considered at a later time.
---------------------------------------------------------------------------
\14\ See STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) Letter from Elizabeth Ward, Chair, to
John Howard, MD, Administrator [2012]. This letter is included in
the docket for this rulemaking. See https://www.regulations.gov and
https://www.cdc.gov/niosh/docket/archive/docket257.html.
---------------------------------------------------------------------------
Comment: The Administrator received three comments expressing
concern that gaps in data preclude the Administrator from considering
cancers and other possible WTC-related health conditions that may
affect WTC responders and survivors. Two of the comments expressed
concern that the study of female responders and survivors has been
lacking. Another commenter also expressed concern for those whose
cancer has not been adequately studied or studied at all.
Response: The Administrator is aware of the limitations on the
availability of data on cancers and other possible WTC-related health
conditions, including the limited information on female responders and
survivors. The inclusion of additional types of cancer will be
considered at an appropriate time if additional information on the
association of 9/11 exposures and cancer outcomes becomes available.
The limitations on the availability of data on female responders and
survivors will be addressed to the extent possible through analysis of
clinical data from medical monitoring examination of responders and
survivors, as well as through research studies. The issue of gaps in
data regarding non-cancer WTC-related health conditions is outside the
scope of this rulemaking.
Comment: Two commenters offered general thoughts about the
uncertainty associated with attributing 9/11 exposures to types of
cancer, stating that it is not possible to determine which WTC
responders and survivors would have been diagnosed with cancer in the
absence of 9/11 exposures. These commenters asserted that NYC
responders are overcompensated.
Response: For the reasons discussed above, the Administrator has
determined that it is appropriate to add the types of cancer in this
final rule to the List of WTC-Related Health Conditions in 42 CFR 88.1.
While Congress did not include cancers in the statute, the PHS Act
directs the Administrator to review all available scientific and
medical evidence to determine if cancer or types of cancer should be
added to the List and creates various mechanisms for the addition of
cancers.\15\ The Administrator recognizes the inherent difficulty in
determining whether an individual's cancer can be considered WTC-
related. Guidelines for physician determinations regarding WTC-related
health conditions are jointly developed by the CCEs and the WTC Health
Program for all conditions on the List. The CCEs and WTC Health Program
will develop additional assessment information for use by physicians in
making determinations regarding whether an individual's 9/11 exposure
may have contributed to, aggravated, or caused their cancer.
---------------------------------------------------------------------------
\15\ See PHS Act, sec. 3312(a)(5) and (6).
---------------------------------------------------------------------------
VII. Regulatory Assessment Requirements
A. Executive Order 12866 and Executive Order 13563
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 rule has been determined to be a ``significant regulatory
action,'' under sec. 3(f) of E.O. 12866. Accordingly, this rule has
been reviewed by the Office of Management and Budget. The addition of
specific types of cancer to the List of WTC-Related Health Conditions
by this rule is estimated to cost the WTC Health Program between
$2,124,624 \16\ and $5,019,182 \17\ (see Table I) for the first year
(2013). Because a portion of responders and survivors are also covered
by private health insurance, employer-provided insurance (such as
FDNY), or Medicare or Medicaid, only a portion of the costs, those
costs representing the uninsured, are societal costs. All other costs
to the WTC Health Program are transfers. After the implementation of
provisions of the Patient Protection and Affordable Care Act (ACA)(Pub.
L. 111-148) on January 1, 2014, all of the costs to the WTC Health
Program will be transfers. Transfers from FY 2013 through FY 2016 are
expected to be between $12,458,535 and $33,308,060 per annum. The final
rule does not interfere with State, local, and Tribal governments in
the exercise of their governmental functions.
---------------------------------------------------------------------------
\16\ Based on a population of 60,000 at the U.S. cancer rate and
discounted at 7 percent.
\17\ Based on a population of 110,000 at 21 percent above the
U.S. cancer rate and discounted at 3 percent.
---------------------------------------------------------------------------
Cost Estimates
The WTC Health Program has, to date, enrolled approximately 55,000
New York City responders and approximately 5,000 survivors, or
approximately 60,000 individuals in total. Of that total population,
approximately 59,000 individuals were participants in previous WTC
medical programs and were `grandfathered' into the WTC Health Program
established by Title XXXIII. These grandfathered members were enrolled
without having to
[[Page 56148]]
complete a new member application when the WTC Health Program started
on July 1, 2011 and are referred to in the WTC Health Program
regulations in 42 CFR part 88 as ``currently identified responders''
and ``currently identified survivors.'' In addition to those currently
identified WTC responders and survivors already enrolled, the PHS Act
\18\ sets a numerical limitation on the number of eligible members who
can enroll in the WTC Health Program beginning July 1, 2011 at 25,000
new WTC responders and 25,000 new certified-eligible WTC survivors \19\
(i.e., the statute restricts new enrollment). Since July 1, 2011, a
total of approximately 1,000 new WTC responders and new WTC survivors
have enrolled in the WTC Health Program, resulting in only a minor
impact on the statutory enrollment limits for new members. For the
purpose of calculating a baseline estimate of cancer prevalence only,
HHS assumed that this gradual rate of enrollment would continue, and
that the currently enrolled population numbers would remain around
55,000 WTC responders and 5,000 WTC survivors. The estimate is further
based on the average U.S. cancer prevalence rate and 7 percent discount
rate.
---------------------------------------------------------------------------
\18\ PHS Act, sec. 3311(a)(4)(A) and sec. 3321(a)(3)(A).
\19\ See 42 CFR 88.8(b) for explanation of a certified-eligible
survivor.
---------------------------------------------------------------------------
As it is not possible to identify an upper bound estimate, HHS has
modeled another possible point on the continuum. For the purpose of
calculating the impact of an increased rate of cancer on the WTC Health
Program, this analysis assumes that the entire statutory cap for new
WTC responders (25,000) and WTC survivors (25,000) will be filled.
Accordingly, this estimate is based on a population of 80,000
responders (55,000 currently identified + 25,000 new) and 30,000
survivors (5,000 currently identified + 25,000 new). The upper cost
estimate also assumes an overall increase in population cancer rates of
21 percent due to 9/11 exposure,\20\ and costs were discounted at 3
percent. The choice of a 21 percent increase in the risk of cancer of
the rate found in the un-exposed population is based on findings
presented in the only published epidemiologic study of September 11,
2001 exposed populations to date.\21\ Given the challenges associated
with interpreting the Zeig-Owens findings,\22\ we simply characterize
21 percent as a possible outcome rather than asserting the probability
that 21 percent is a ``likely'' outcome.
---------------------------------------------------------------------------
\20\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905.
\21\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905.
\22\ As Zeig-Owens et al point out, the time interval since 9/11
is short for cancer outcomes, the recorded excess of cancers is not
limited to specific sites, and the biological plausibility of
chronic inflammation as a possible mediator between WTC-exposure and
cancer means that the outcomes remain speculative.
---------------------------------------------------------------------------
HHS acknowledges that some cancer cases are not likely to have been
caused by exposure to 9/11 agents. The certification of individual
cancer diagnoses will be conducted on a case-by-case basis. However,
for the purpose of this analysis, HHS has estimated that all diagnosed
cancers added to the List will be certified for treatment by the WTC
Health Program. Finally, because there are no existing data on cancer
rates related to exposure to 9/11 agents at either the Pentagon or in
Shanksville, Pennsylvania, HHS has used only data from studies of
individuals who were responders or survivors in the New York City
disaster area.
Costs of Cancer Treatment
HHS estimated the treatment costs associated with covering the
types of cancer in this rulemaking using the methods described below.
In the following discussion, the category of ``Head and Neck'' includes
all cancer cases from nasal cavity, nasopharynx, accessory sinuses, and
larynx. The survival rates for all cancers in the ``Head and Neck''
category were approximated using survival rates for cancer of the
larynx. The category described as ``Lung'' in this discussion includes
cancer of the trachea, bronchus and lung, heart, mediastinum and
pleura, and other sites in the respiratory system and intrathoracic
organs. Treatment costs for all respiratory system cancers including
``mesothelioma'' were approximated by treatment costs for lung cancer.
Costs of treatment for the ``digestive system'' were approximated using
the costs of gastric cancer; costs for cancer of the ``skin'' were
approximated using costs for melanoma of the skin; ``female
reproductive organs'' were approximated using costs for cancer of the
ovary; ``urinary system'' cancer was approximated by costs of urinary
bladder cancer; and ``blood and lymphoid tissue'' cancers were
approximated using leukemia and lymphoma. The costs for cancer
identified with the ``endocrine system,'' the ``soft tissue sarcomas,''
and ``eye/orbit'' were approximated using costs for treatment of
``other'' tumors. The ``other'' category includes treatments costs from
the following: salivary gland, nasopharynx, tonsil, small intestine,
anus, intrahepatic bile duct, gallbladder, other biliary,
retroperitoneum, peritoneum, other digestive organs, nose, nasal
cavity, middle ear, larynx, pleura, trachea, mediastinum and other
respiratory organs, bones and joints, soft tissue, other nonepithelial
skin, vagina, vulva, other female genital organs, penis, other male
genital organs, ureter, other urinary organs, eye and orbit, thyroid,
other endocrine multiple myeloma, and miscellaneous.
The WTC Health Program obtained data for the cost of providing
medical treatment for each cancer type. The costs of treatment for each
type of cancer are described in Table A. The costs of treatment are
divided into three phases: the costs for the first year following
diagnosis, the costs of intervening years or continuing treatment after
the first year, and the costs of treatment for the last year of life.
The first year costs of cancer treatment are higher due to the initial
need for aggressive medical (e.g., radiation, chemotherapy) and
surgical care. The costs during last year of life are often dominated
by increased hospitalization costs.\23\ Therefore, we used three
different treatment phase costs to estimate the costs of treatment to
be able to best estimate costs in conjunction with expected incidence
and long-term survival for each type of cancer.
---------------------------------------------------------------------------
\23\ Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M,
Meekins A, Brown ML [2008]. Cost of Care for Elderly Cancer Patients
in the United States. Journal: J Natl Cancer Inst 100(9):630-41.
[[Page 56149]]
Table A--Average Costs of Treatment, Male and Female (2011)
----------------------------------------------------------------------------------------------------------------
Last year of
Category Initial (12 Continuing life (12
month) (annual) mos.)
----------------------------------------------------------------------------------------------------------------
Head and Neck................................................... $28,265 $3,136 $47,730
Digestive System................................................ 59,551 2,544 68,242
Respiratory System.............................................. 45,493 5,026 65,592
Mesothelium..................................................... 45,493 5,026 65,592
Skin............................................................ 3,938 1,040 25,351
Female Reproductive Organs...................................... 66,527 5,023 64,728
Urinary System.................................................. 16,926 3,630 40,905
Blood & Lymphoid Tissue......................................... 33,312 5,782 69,070
Endocrine System................................................ 30,859 3,791 58,623
Soft Tissue Sarcomas............................................ 30,859 3,791 58,623
Melanoma........................................................ 3,938 1,040 25,351
Breast.......................................................... 15,136 1,550 37,684
Eye/Orbit....................................................... 30,859 3,791 58,623
----------------------------------------------------------------------------------------------------------------
Source: Yabroff KR, Lamont EB, Mariotto A, Warren JL, Topor M, Meekins A, Brown ML [2008]. Cost of Care for
Elderly Cancer Patients in the United States. Journal: J Natl Cancer Inst 100(9):630-41.
These cost figures were based on a study of elderly cancer patients
from the Surveillance, Epidemiology, and End Results (SEER) program
maintained by the National Cancer Institute using Medicare files.\24\
The average costs of treatment described above are given in 2011 prices
adjusted using the Medical Consumer Price Index for all urban
consumers.\25\
---------------------------------------------------------------------------
\24\ Surveillance, Epidemiology, and End Results (SEER) Program
(www.seer.cancer.gov) Research Data (1973-2006), National Cancer
Institute, DCCPS, Surveillance Research Program, Surveillance
Systems Branch, released April 2009, based on the November 2008
submission.
\25\ Bureau of Labor Statistics. Consumer Price Index https://research.stlouisfed.org/fred2/series/CPIMEDSL/downloaddata?cid=32419. Accessed April 23, 2012.
---------------------------------------------------------------------------
Incident Cases of Cancer
HHS estimated the expected number of cases of cancer that would be
observed in a cohort of responders and survivors followed for cancer
incidence after September 11, 2001 using U.S. population cancer rates
for the cancer types added to the List of WTC-Related Health Conditions
under this rulemaking. Demographic characteristics of the cohort were
assigned since the actual data are not available for individuals in the
responder and survivor populations who have not yet enrolled in the WTC
Health Program. Gender and age (at the time of exposure) distributions
for responders and survivors were assumed to be the same as current
enrollees in the WTC Health Program. According to WTC Health Program
data, males comprise 88 percent of the current responder enrollees and
50 percent of survivor enrollees. The age distribution for current
enrollees by gender and responder/survivor status is presented in Table
B.
Table B--Percentiles of Current Age (on April 11, 2012) for Current Enrollees in the WTC Health Program by
Gender and Responder/Survivor Status
----------------------------------------------------------------------------------------------------------------
Age percentile (years)
Group --------------------------------------------------------------------------------
Min 1 10 30 50 70 90 99 Max
----------------------------------------------------------------------------------------------------------------
Male responders................ 28 32 39 44 49 54 62 74 92
Female responders.............. 28 30 38 44 49 54 62 76 92
Male survivors................. 12 23 35 46 52 58 67 81 99
Female survivors............... 12 21 38 49 54 60 68 84 95
----------------------------------------------------------------------------------------------------------------
HHS assumed race and ethnic origin distributions for responders and
survivors according to distributions in the WTC Health Registry cohort:
\26\ 57 percent non-Hispanic white, 15 percent non-Hispanic black, 21
percent Hispanic, and 8 percent other race/ethnicity for responders and
50 percent non-Hispanic white, 17 percent non-Hispanic black, 15
percent Hispanic, and 18 percent other race/ethnicity for survivors.
Follow-up for cancer morbidity for each person began on January 1, 2002
or age 15 years, whichever was later. Age 15 was considered because the
cancer incidence rate file did not include rates for persons less than
15 years of age. Follow-up ended on December 31, 2016 or the estimated
last year of life, whichever was earlier. The estimated last year of
life was used since not all persons would be expected to remain alive
at the end of 2016. The estimated last year of life was based on U.S.
gender, race, age, and year-specific death rates from CDC Wonder (since
rates are currently available through 2008, the rate from 2008 was
applied to 2009 and later).\27\ A life-table analysis program,
LTAS.NET, was used to estimate the expected number of incident cancers
for cancer types
[[Page 56150]]
added.\28\ HHS calculated cancer incidence rates using data through
2006 from the Surveillance Epidemiology and End Results (SEER) Program,
and estimated rates for 2007-2016.\29\ The Program applied the
resulting gender, race, age, and year-specific cancer incidence rates
to the estimated person-years at risk to estimate the expected number
of cancer cases for each cancer type starting from year 2002, the first
full year following the September 11, 2001, terrorist attacks, to 2016,
the last year for which this Program is currently funded.
---------------------------------------------------------------------------
\26\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L,
Stellman SD. Mortality Among Survivors of the Sept 11, 2001, Word
Trade Center Disaster: Results from the World Trade Center Health
Registry Cohort. Lancet 2011;378:879-887. Note: percentages may not
sum to 100 percent due to rounding.
\27\ Centers for Disease Control and Prevention, National Center
for Health Statistics. Compressed Mortality File 1999-2008. CDC
WONDER Online Database, compiled from Compressed Mortality File
1999-2008 Series 20 No. 2N, 2011. https://wonder.cdc.gov/cmf-icd10.html. Accessed February 15, 2012.
\28\ Schubauer-Berigan MK, Hein MJ, Raudabaugh WM, Ruder AM,
Silver SR, Spaeth S, Steenland K, Petersen MR, and Waters KM [2011].
Update of the NIOSH Life Table Analysis System: A Person-Years
Analysis program for the Windows Computing Environment. American
Journal of Industrial Medicine 54:915-924.
\29\ National Cancer Institute, Surveillance Epidemiology and
End Results (SEER). https://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------
Prevalence of Cancer
To determine the potential number of persons in the responder and
survivor populations with cancer, HHS used the number of incident cases
described above for each year starting with 2002 and estimated the
prevalence of cancer using survival rate statistics for each incident
cancer group through 2016.\30\
---------------------------------------------------------------------------
\30\ National Cancer Institute, Surveillance Epidemiology and
End Results (SEER). https://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------
Using the incident cases and survival rate statistics for each
cancer type, HHS has estimated the prevalence (number of persons living
with cancer) of cases during the 15 year period (2002-2016) since
September 11, 2001. The resulting table provides for each year from
2002 through 2016, the number of new cases occurring in that year
(incidence), the number of individuals who died from their cancer in
that year, and the number of persons surviving up to 15 years beyond
their first diagnosis with one table for each type of cancer
(prevalence).\31\ For example, in 2002 there are 23.47 projected new
lung cancer cases, which would be listed as incident cases for that
year. The survival rate for lung cancer in the first year of diagnosis
is 40.6 percent.\32\ Therefore the number of deceased persons in 2002
would be 18.78 x (1--0.406) = 11.15. For the lung cancer prevalence
table, in year 2003, the number of incident cases would be 20.88 cases.
In addition to 20.88 newly diagnosed cases in 2003, there would be the
one-year survivors from 2002 which would be 18.78--11.15 (or 18.78 x
0.406) = 7.62 cases. This computation process can be repeated for each
year through year 2016. A portion of the lung cancer prevalence table
is provided in Table C as an example.
---------------------------------------------------------------------------
\31\ The 15-year survival limit is imposed based on the analytic
time horizon.
\32\ National Cancer Institute, Surveillance Epidemiology and
End Results (SEER). https://seer.cancer.gov/. Accessed May 27, 2012.
---------------------------------------------------------------------------
Prevalence tables were created for each type of covered cancer and
the results are summarized in Tables E and G. This analysis considers
cancers diagnosed in 2002 through 2016.
Table C--Example From Prevalence Table for Lung Cancer
[Based on 80,000 responders]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Years since exposure to 9/11 agents Years covered by WTC Health Program
Year ------------------------------------------------------------------------------------------
2002 2003 2012 2013 2014 2015 2016
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 (incidence)................................................ 18.78 20.88 46.53 51.22 56.10 60.69 66.03
2............................................................ ........... 7.62 17.00 18.89 20.79 22.78 24.64
3............................................................ ........... ........... 9.25 10.18 11.30 12.45 13.63
4............................................................ ........... ........... 6.42 7.08 7.79 8.66 9.53
5............................................................ ........... ........... 4.95 5.46 6.02 6.62 7.35
6............................................................ ........... ........... 4.01 4.45 4.90 5.40 5.94
7............................................................ ........... ........... 3.28 3.67 4.07 4.49 4.94
8............................................................ ........... ........... 2.71 3.03 3.38 3.76 4.14
9............................................................ ........... ........... 2.55 2.49 2.78 3.10 3.45
10........................................................... ........... ........... 2.15 2.38 2.33 2.60 2.90
11........................................................... ........... ........... 1.78 1.98 2.20 2.14 2.40
12........................................................... ........... ........... ........... 1.66 1.84 2.04 1.99
13........................................................... ........... ........... ........... ........... 1.52 1.69 1.88
14........................................................... ........... ........... ........... ........... ........... 1.42 1.58
15........................................................... ........... ........... ........... ........... ........... ........... 1.35
Live cases from previous years............................... ........... ........... 54.11 61.26 68.94 77.16 85.74
Prevalence................................................... 18.78 28.50 100.64 112.48 125.03 137.85 151.78
Last year of life............................................ 11.15 15.46 39.38 43.54 47.87 52.10 56.79
--------------------------------------------------------------------------------------------------------------------------------------------------------
Cost Computation
To compute the costs for each type of cancer, HHS assumes that all
of the individuals who are diagnosed with a cancer type will be
certified by the WTC Health Program for treatment and monitoring
services. The treatment costs for the first year of treatment (Table A,
year adjusted) were applied to the predicted newly incident (Year 1)
cases for each year. Likewise, the costs of treatment for the last year
of life were applied in each year to the number of people predicted to
die from their cancer in that year. The costs of continuing treatment
from Table 1 were applied to the number of prevalent cases who had
survived their cancers beyond their year of diagnosis, for each year of
survival (Year 2-15).
Using this procedure, a cost table is constructed for each year
covered by the WTC Health Program. Table D provides an illustrative
example for lung cancer. The row for Year 1 is the cost of incident
cases for that year. Rows 2-15 show the cost from continuing care for
persons surviving n-years beyond the year of diagnosis. Finally, the
cost of last year of life treatment is computed by multiplying the cost
for last year of life from Table A by the number of persons dying in
that year from that type of cancer.
[[Page 56151]]
Table D--Cost per 80,000 Responders for Lung Cancer (2011$)
----------------------------------------------------------------------------------------------------------------
Years covered by the WTC Health Program
Year ---------------------------------------------------------------
2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1............................................... $914,986 $1,002,168 $1,084,205 $1,179,677
2............................................... 91,825 101,077 110,708 119,770
3............................................... 49,469 54,959 60,497 66,261
4............................................... 34,408 37,865 42,068 46,306
5............................................... 26,537 29,228 32,165 35,735
6............................................... 21,624 23,850 26,268 28,908
7............................................... 17,840 19,797 21,834 24,048
8............................................... 14,727 16,468 18,274 20,155
9............................................... 12,080 13,500 15,096 16,751
10.............................................. 11,608 11,311 12,641 14,135
11.............................................. 9,642 10,706 10,433 11,659
12.............................................. 8,032 8,932 9,917 9,664
13.............................................. .............. 7,393 8,221 9,128
14.............................................. .............. .............. 6,936 7,714
15.............................................. .............. .............. .............. 6,571
Prevalent care.................................. 1,212,778 1,337,254 1,459,263 1,589,911
Last year of life care.......................... 2,762,609 3,037,261 3,305,416 3,603,198
---------------------------------------------------------------
Total....................................... 3,975,387 4,374,515 4,764,679 5,193,109
----------------------------------------------------------------------------------------------------------------
The sum of the annual costs for the years 2013 through 2016
represents the estimated treatment costs to the WTC Health Program for
coverage of lung cancer for 80,000 responders. The cost projections in
Table D are based on an assumed responder population size of 80,000.
The same process described above was applied to the survivor
cohort. Based on the incidence rate expected from the survivor cohort,
prevalence tables were constructed for each covered type of cancer.
The estimated treatment costs for responders and survivors were re-
computed under the following two assumptions: (1) the rate of cancer in
the WTC Health Program is equal to the rate of cancer observed in the
general population; and (2) the rate of cancer exceeds the general
population rate by 21 percent due to their exposures in the New York
City disaster area.\33\ HHS is not aware of any other estimates of
excess cancer rates in the 9/11-exposed population in the peer-reviewed
literature.
---------------------------------------------------------------------------
\33\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N,
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K,
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York
City Firefighters After the 9/11 Attacks: An Observational Cohort
Study. Lancet. 378(9794):898-905. Limitations of the Zeig-Owens
study include: limited information on specific exposures experienced
by firefighters; short time for follow-up of cancer outcomes;
speculation about the biological plausibility of chronic
inflammation as a possible mediator between WTC-exposure and cancer
outcomes; and potential unmeasured confounders.
---------------------------------------------------------------------------
A summary of the estimated prevalence at the U.S. population
average for the assumed population of 55,000 responders and 5,000
survivors is provided in Table E. A summary of the estimated treatment
costs to the WTC Health Program is provided in Table F.
A summary of the estimated prevalence using cancer rates 21 percent
over the U.S. population average for the increased rate of 80,000
responders and 30,000 survivors is given in Table G. A summary of the
estimated treatment costs to the WTC Health Program is provided in
Table H.
Table E--Estimated Prevalence by Year and Cancer Type Based on 55,000 and 5,000 Responder and Survivor
Population, Respectively and Assuming Cancer Rates at U.S. Population Average
----------------------------------------------------------------------------------------------------------------
Prevalence (incident + live cases)
Cancer type ---------------------------------------------------------------------------
2013 2014 2015 2016 2013-2016
------------------------------------------------------------------------------------------------------- -----------
Based on 55,000 responder population
----------------------------------------------------------------------------------------------------------------
Head & Neck............................ 89.41 99.20 109.35 119.83
Digestive System....................... 136.54 150.69 165.19 180.38
Respiratory System..................... 77.91 86.61 95.50 105.16
Mesothelioma........................... 1.02 1.12 1.23 1.35
Skin................................... 11.04 12.22 13.43 14.71
Female Reproductive Organs............. 5.14 5.64 6.14 6.65
Urinary System......................... 108.78 121.39 134.69 148.90
Blood & Lymphoid Tissue................ 119.72 130.72 141.97 153.71
Endocrine System....................... 53.50 58.75 64.05 69.40
Soft Tissue Sarcomas................... 11.02 11.86 12.67 13.47
Melanoma............................... 134.33 149.37 165.05 181.42
Breast................................. 102.30 113.46 124.91 136.66
Eye/Orbit.............................. 3.89 4.29 4.71 5.14
------------------------------------------------------------------------
[[Page 56152]]
Total.............................. 854.59 945.32 1038.88 1136.78
----------------------------------------------------------------------------------------------------------------
Based on 5,000 survivor population
----------------------------------------------------------------------------------------------------------------
Head & Neck............................ 7.78 7.78 7.78 7.78
Digestive System....................... 15.48 15.48 15.48 15.48
Respiratory System..................... 10.28 10.28 10.28 10.28
Mesothelioma........................... 0.10 0.10 0.10 0.10
Skin................................... 1.13 1.13 1.13 1.13
Female Reproductive Organs............. 2.58 2.58 2.58 2.58
Urinary System......................... 10.47 10.47 10.47 10.47
Blood & Lymphoid Tissue................ 12.48 12.48 12.48 12.48
Endocrine System....................... 4.29 4.29 4.29 4.29
Soft Tissue Sarcomas................... 0.96 0.96 0.96 0.96
Melanoma............................... 12.21 13.58 15.00 16.49
Breast................................. 9.30 10.31 11.36 12.42
Eye/Orbit.............................. 0.35 0.39 0.43 0.47
------------------------------------------------------------------------
Total.............................. 87.41 89.83 92.33 94.93
----------------------------------------------------------------------------------------------------------------
Table F--Estimated Treatment Costs by Year and Cancer Type Based on 55,000 and 5,000 Responder and Survivor
Population, Respectively and Assuming Cancer Rates at U.S. Population Average (2011$)
----------------------------------------------------------------------------------------------------------------
Cancer type 2013 2014 2015 2016 2013-2016
----------------------------------------------------------------------------------------------------------------
Based on 55,000 responder population
----------------------------------------------------------------------------------------------------------------
Head & Neck..................... $925,673 $1,007,744 $1,089,966 $1,164,226 $4,187,609
Digestive System................ 4,181,699 4,525,672 4,856,402 5,191,940 18,755,713
Respiratory System.............. 2,832,704 3,117,317 3,395,504 3,701,062 13,046,587
Mesothelioma.................... 49,088 54,012 58,869 64,417 226,387
Skin............................ 18,078 20,075 21,834 23,072 83,059
Female Reproductive Organs...... 121,957 130,292 137,643 144,194 534,086
Urinary System.................. 1,278,299 1,398,867 1,521,993 1,642,997 5,842,157
Blood & Lymphoid Tissue......... 2,224,916 2,391,015 2,551,304 2,697,317 9,864,552
Endocrine System................ 362,248 385,533 408,544 419,353 1,575,678
Soft Tissue Sarcomas............ 148,358 158,024 167,208 175,680 649,270
Melanoma........................ 229,538 249,805 270,744 284,528 1,034,615
Breast.......................... 420,290 453,613 485,454 510,289 1,869,646
Eye/Orbit....................... 36,018 39,242 42,470 45,255 162,985
-------------------------------------------------------------------------------
Total....................... 12,828,867 13,931,212 15,007,935 16,064,330 57,832,344
----------------------------------------------------------------------------------------------------------------
Based on 5,000 survivor population
----------------------------------------------------------------------------------------------------------------
Head & Neck..................... 77,325 82,580 87,736 92,044 339,685
Digestive System................ 471,917 502,369 531,352 559,893 2,065,532
Respiratory System.............. 362,274 389,675 416,326 444,551 1,612,827
Mesothelioma.................... 4,625 4,974 5,291 5,659 20,549
Skin............................ 1,843 2,034 2,196 2,300 8,372
Female Reproductive Organs...... 58,454 61,173 63,740 65,729 249,097
Urinary System.................. 119,698 128,808 137,954 146,467 532,927
Blood & Lymphoid Tissue......... 229,578 245,051 259,869 272,842 1,007,340
Endocrine System................ 60,893 62,633 63,909 64,476 251,910
Soft Tissue Sarcomas............ 14,017 14,748 15,415 15,960 60,140
Melanoma........................ 30,943 32,541 33,962 35,142 132,588
Breast.......................... 230,196 241,382 251,227 258,804 981,609
Eye/Orbit....................... 3,434 3,642 3,832 3,994 14,903
-------------------------------------------------------------------------------
Total....................... 1,665,197 1,771,611 1,872,809 1,967,862 7,277,478
----------------------------------------------------------------------------------------------------------------
Total
----------------------------------------------------------------------------------------------------------------
Head & Neck..................... 1,002,998 1,090,324 1,177,702 1,256,270 4,527,294
Digestive System................ 4,653,616 5,028,041 5,387,754 5,751,833 20,821,244
Respiratory System.............. 3,194,979 3,506,992 3,811,830 4,145,613 14,659,414
Mesothelioma.................... 53,713 58,987 64,160 70,076 246,936
Skin............................ 19,921 22,109 24,030 25,371 91,431
[[Page 56153]]
Female Reproductive Organs...... 180,411 191,466 201,383 209,923 783,183
Urinary System.................. 1,397,997 1,527,675 1,659,948 1,789,465 6,375,084
Blood & Lymphoid Tissue......... 2,454,494 2,636,067 2,811,173 2,970,159 10,871,892
Endocrine System................ 423,141 448,166 472,452 483,829 1,827,588
Soft Tissue Sarcomas............ 162,376 172,772 182,622 191,640 709,410
Melanoma........................ 260,481 282,346 304,706 319,670 1,167,203
Breast.......................... 650,486 694,995 736,681 769,093 2,851,255
Eye/Orbit....................... 39,452 42,885 46,302 49,250 177,888
-------------------------------------------------------------------------------
Total....................... 14,494,064 15,702,823 16,880,744 18,032,192 65,109,823
----------------------------------------------------------------------------------------------------------------
Table G--Estimated Prevalence by Year and Cancer Type Based on 80,000 and 30,000 Responder and Survivor
Population, Respectively and Assuming Incidence of Cancer Is 21% Higher Than the U.S. Population Due to 9/11
Exposure
----------------------------------------------------------------------------------------------------------------
Prevalence (incident + live cases)
Cancer type ---------------------------------------------------------------
2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responder population
----------------------------------------------------------------------------------------------------------------
Head & Neck..................................... 157.36 174.59 192.45 210.91
Digestive System................................ 240.31 265.21 290.74 317.47
Respiratory System.............................. 137.12 152.43 168.07 185.08
Mesothelioma.................................... 1.79 1.98 2.16 2.38
Skin............................................ 19.43 21.50 23.64 25.89
Female Reproductive Organs...................... 9.05 9.92 10.81 11.71
Urinary System.................................. 191.45 213.66 237.05 262.06
Blood & Lymphoid Tissue......................... 210.70 230.07 249.86 270.52
Endocrine System................................ 94.16 103.40 112.73 122.15
Soft Tissue Sarcomas............................ 19.40 20.87 22.29 23.70
Melanoma........................................ 236.42 262.90 290.50 319.30
Breast.......................................... 180.05 199.69 219.84 240.52
Eye/Orbit....................................... 6.85 7.56 8.29 9.05
---------------------------------------------------------------
Total....................................... 1504.09 1663.77 1828.43 2000.74
----------------------------------------------------------------------------------------------------------------
Based on 30,000 survivor population
----------------------------------------------------------------------------------------------------------------
Head & Neck..................................... 56.51 56.51 56.51 56.51
Digestive System................................ 112.39 112.39 112.39 112.39
Respiratory System.............................. 74.61 74.61 74.61 74.61
Mesothelioma.................................... 0.70 0.70 0.70 0.70
Skin............................................ 8.21 8.21 8.21 8.21
Female Reproductive Organs...................... 18.73 18.73 18.73 18.73
Urinary System.................................. 76.04 76.04 76.04 76.04
Blood & Lymphoid Tissue......................... 90.61 90.61 90.61 90.61
Endocrine System................................ 31.11 31.11 31.11 31.11
Soft Tissue Sarcomas............................ 6.94 6.94 6.94 6.94
Melanoma........................................ 88.66 98.59 108.94 119.74
Breast.......................................... 67.52 74.88 82.44 90.20
Eye/Orbit....................................... 2.57 2.83 3.11 3.39
---------------------------------------------------------------
Total....................................... 634.60 652.16 670.34 689.18
----------------------------------------------------------------------------------------------------------------
Table H--Estimated Treatment Costs by Year and Cancer Type Based on 80,000 and 30,000 Responder and Survivor
Population, Respectively and Assuming Incidence of Cancer Is 21% Higher Than the U.S. Population Due to 9/11
Exposure (2011$)
----------------------------------------------------------------------------------------------------------------
Cancer type 2013 2014 2015 2016 2013-2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responder population
----------------------------------------------------------------------------------------------------------------
Head & Neck..................... $1,656,113 $1,802,945 $1,950,049 $2,082,906 $7,492,013
Digestive System................ 7,481,440 8,096,839 8,688,544 9,288,852 33,555,675
Respiratory System.............. 5,067,965 5,577,164 6,074,865 6,621,536 23,341,531
Mesothelioma.................... 87,823 96,633 105,323 115,248 405,027
[[Page 56154]]
Skin............................ 32,344 35,916 39,063 41,278 148,600
Female Reproductive Organs...... 218,192 233,104 246,256 257,976 955,528
Urinary System.................. 2,286,993 2,502,701 2,722,984 2,939,472 10,452,150
Blood & Lymphoid Tissue......... 3,980,577 4,277,744 4,564,514 4,825,745 17,648,581
Endocrine System................ 648,095 689,754 730,922 750,261 2,819,031
Soft Tissue Sarcomas............ 265,426 282,719 299,150 314,308 1,161,603
Melanoma........................ 410,664 446,924 484,385 509,047 1,851,021
Breast.......................... 751,937 811,554 868,522 912,953 3,344,966
Eye/Orbit....................... 64,439 70,208 75,983 80,965 291,595
-------------------------------------------------------------------------------
Total....................... 22,952,009 24,924,205 26,850,560 28,740,547 44,654,652
----------------------------------------------------------------------------------------------------------------
Based on 30,000 survivor population
----------------------------------------------------------------------------------------------------------------
Head & Neck..................... 467,817 499,610 530,802 556,869 2,055,097
Digestive System................ 2,855,098 3,039,331 3,214,682 3,387,354 12,496,466
Respiratory System.............. 2,191,761 2,357,535 2,518,774 2,689,533 9,757,602
Mesothelioma.................... 27,979 30,096 32,010 34,239 124,324
Skin............................ 11,149 12,304 13,285 13,912 50,650
Female Reproductive Organs...... 353,646 370,100 385,629 397,662 1,507,036
Urinary System.................. 724,172 779,285 834,625 886,127 3,224,209
Blood & Lymphoid Tissue......... 1,388,944 1,482,561 1,572,207 1,650,695 6,094,408
Endocrine System................ 368,403 378,927 386,647 390,079 1,524,055
Soft Tissue Sarcomas............ 84,805 89,226 93,258 96,557 363,846
Melanoma........................ 187,204 196,873 205,471 212,608 802,156
Breast.......................... 1,392,687 1,460,361 1,519,924 1,565,763 5,938,735
Eye/Orbit....................... 20,776 22,037 23,182 24,166 90,160
-------------------------------------------------------------------------------
Total....................... 4,912,377 5,256,038 5,588,087 5,914,152 21,670,654
----------------------------------------------------------------------------------------------------------------
Total
----------------------------------------------------------------------------------------------------------------
Head & Neck..................... 2,123,930 2,302,555 2,480,851 2,639,775 9,547,110
Digestive System................ 10,336,538 11,136,171 11,903,227 12,676,206 46,052,141
Respiratory System.............. 7,259,726 7,934,699 8,593,639 9,311,069 33,099,133
Mesothelioma.................... 115,803 126,729 137,333 149,487 529,350
Skin............................ 43,493 48,220 52,348 55,190 199,251
Female Reproductive Organs...... 571,838 603,204 631,884 655,638 2,462,564
Urinary System.................. 3,011,165 3,281,986 3,557,609 3,825,599 13,676,358
Blood & Lymphoid Tissue......... 5,369,522 5,760,305 6,136,721 6,476,440 23,742,988
Endocrine System................ 1,016,497 1,068,681 1,117,568 1,140,340 4,343,086
Soft Tissue Sarcomas............ 350,231 371,945 392,408 410,864 1,525,449
Melanoma........................ 597,868 643,798 689,857 721,654 2,653,177
Breast.......................... 2,144,624 2,271,916 2,388,445 2,478,716 9,283,702
Eye/Orbit....................... 85,215 92,244 99,165 105,132 381,756
-------------------------------------------------------------------------------
Total....................... 33,026,449 35,642,452 38,181,054 40,646,111 147,496,066
----------------------------------------------------------------------------------------------------------------
Summary of Costs and Transfers
Because HHS lacks data to account for either recoupment by health
insurance or workers' compensation insurance or reduction by Medicare/
Medicaid payments, the estimates offered here are reflective of
estimated WTC Health Program costs only. This analysis offers an
assumption about the number of individuals who might enroll in the WTC
Health Program, and estimates the impact of both a low rate of cancer
(U.S. population average rate) and an increased rate (21 percent
greater than the U.S. population average) on the number of cases and
the resulting estimated treatment costs to the WTC Health Program. This
analysis does not include administrative costs associated with
certifying additional diagnoses of cancers that are WTC-related health
conditions that might result from this action. Those costs were
addressed in the interim final rule that established regulations for
the WTC Health Program (76 FR 38914, July 1, 2011).
Costs and transfers of screening have been added to the summary
estimates. The screening indicated by this rulemaking follows U.S.
Preventive Services Task Force (USPSTF) guidelines.
The USPSTF recommends screening for colorectal cancer (cancer of
the colon and rectum) using fecal occult blood testing (FOBT),
sigmoidoscopy, or colonoscopy, in adults, beginning at age 50 years and
continuing until age 75 years.\34\ The costs and transfers include the
costs of one FOBT for all Program enrollees who are over the age of 50
in 2013, and for those who will reach 50 years of age in 2014 through
2016. In the general population, HHS expects there to be 9 percent
positive tests. In a previous study \35\ of those with positive
[[Page 56155]]
tests who were outside the study university system, 44 percent had a
colonoscopy, 42 percent had flexible sigmoidoscopy, 11 percent had
repeat FOBT, and 3 percent were told by their physician that no further
examination was necessary. HHS applied these rates to the population
and assigned costs for each test assuming FOBT cost was $7.60,
sigmoidoscopy was $238, and a colonoscopy was $674.\36\
---------------------------------------------------------------------------
\34\ United States Preventive Services Task Force (USPSTF)
[2008]. Screening for Colorectal Cancer. https://www.uspreventiveservicestaskforce.org/uspstf/uspscolo.htm. Accessed
May 28, 2012.
\35\ Mandel JS, et. al, Reducing Mortality From Colorectal
Cancer by Screening for Fecal Occult Blood, NEJM 328(19): 1365-1371
(1993).
\36\ Subramanian S, et. al. When Budgets Are Tight, There Are
Better Options Than Colonoscopies For Colorectal Cancer Screening.
Health Affairs, September 2010, 29:9, 1734-1740.
FECA Rates for FOBT, sigmoidoscopy and colonoscopy at non-
facility rates: codes 82270, 45330, and 45378 respectively.
---------------------------------------------------------------------------
The USPSTF recommends breast cancer screening using biennial
mammography for women beginning at age 40. HHS assumed that the
population of responders was 12 percent female and the population of
survivors was 50 percent female. Based on age distribution information
available, HHS estimated the number of women eligible for screening
between 2013 and 2016. For those screened in 2013 HHS predicted repeat
screening in 2015 and for those screened in 2014 HHS predicted repeat
screening in 2016. The cost of a mammogram was estimated at $139.32
based on FECA rates for mammography.\37\
---------------------------------------------------------------------------
\37\ FECA rates for Mammography for New York; FECA code 77057.
---------------------------------------------------------------------------
Some responders and survivors enrolled or expected to enroll in the
WTC Health Program already have or have access to medical insurance
coverage by private health insurance, employer-provided insurance,
Medicare, or Medicaid. Therefore, costs to the WTC Health Program can
be divided between societal costs and transfer payments.
To describe these societal costs and transfers, the following
assumptions were used. For the period of coverage between January 1,
2013 and December 31, 2013, HHS has assumed that 16.3 percent of the
survivor population will be uninsured, or based on grandfathered
enrollment of responders, 16,925 are covered by the FDNY health plan,
while 39,482 are listed as general responders and include construction
workers, contractors, and others. For this analysis, HHS assumed that
the non-FDNY general responders and all future responder-enrollees are
uninsured at the same 16.3 percent rate that HHS applied to the
survivor population, based on those without insurance coverage in the
general U.S. population.\38\ Ward et al.\39\ found that access to
health care services, quality of care received, stage of disease at
diagnosis, and survival outcomes for cancer patients varied according
to socioeconomic status and demographic characteristics.
---------------------------------------------------------------------------
\38\ U.S. Census Bureau [2011]. Current Population Survey.
https://www.census.gov/cps/data/. Accessed May 26, 2012.
\39\ Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C,
Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of
Insurance with Cancer Care Utilization and Outcomes. CA Cancer J
Clin 58:9-31.
---------------------------------------------------------------------------
Additionally, after the implementation of provisions of the ACA on
January 1, 2014, all of the enrollees and future enrollees can be
assumed to have or have access to medical insurance coverage other than
through the WTC Health Program. Therefore, all treatment costs to be
paid by the WTC Health Program from 2014 through 2016 are considered
transfers.
Table I describes the allocation of WTC Health Program costs
between societal costs and transfer payments based on 55,000 responders
and 5,000 survivors and, alternatively, 80,000 responders and 30,000
survivors.
Table I--Breakdown of Estimated Annual WTC Health Program Costs and Transfers, 80,000 & 55,000 Responders and
30,000 and 5,000 Survivors, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Societal Costs for 2013, 2011$
Annualized Transfers for 2013-
2016, 2011$
-------------------------------
Based on the 16.3 percent of Discounted at Discounted at
general responders and 7 percent 3 percent
survivors who are expected to
be uninsured
---------------------------------------------------------------
Cancer rate
Cancer rate
---------------------------------------------------------------
U.S. average U.S. + 21% U.S. average U.S. + 21%
----------------------------------------------------------------------------------------------------------------
55,000 Responders............................... $1,648,706 .............. $10,172,308 ..............
5,000 Survivors................................. 271,427 .............. 1,572,907 ..............
Colorectal and Breast Screening................. 204,491 .............. 713,321 ..............
---------------------------------------------------------------
60,000 Total................................ 2,124,624 .............. 12,458,535 ..............
---------------------------------------------------------------
80,000 Responders............................... .............. 2,631,100 .............. 19,912,464
30,000 Survivors................................ .............. 1,970,560 .............. 12,124,118
Colorectal and Breast Screening................. .............. 417,521 .............. 1,271,478
---------------------------------------------------------------
110,000 Total............................... .............. 5,019,182 .............. 33,308,060
----------------------------------------------------------------------------------------------------------------
Examination of Benefits (Health Impact)
This section describes qualitatively the potential benefits of the
final rule in terms of the expected improvements in the health and
health-related quality of life of potential cancer patients treated
through the WTC Health Program, compared to no Program. The assessment
of the health benefits for cancer patients uses the number of expected
cancer cases that was estimated in the cost analysis section.
[[Page 56156]]
HHS does not have information on the health of the population that
may have been exposed to 9/11 agents and is not currently enrolled in
the WTC Health Program. In addition, HHS has only limited information
about health insurance and health care services for cancers caused by
exposure to 9/11 agents and suffered by any population of responders
and survivors, including responders and survivors currently enrolled in
the WTC Health Program and responders and survivors not enrolled in the
Program. For the purposes of this analysis, HHS assumes that broad
trends on demographics and access to health insurance reported by the
U.S. Census Bureau and health care services for cancer similar to those
reported by Ward would apply to the population of general responders
(those individuals who are not members of the FDNY and who meet the
eligibility criteria in 42 CFR part 88 for WTC responders) and
survivors both within and outside the Program. For the purposes of this
analysis, HHS assumes that access to health insurance and health care
services for FDNY responders within and outside the Program would be
equivalent because this population is overwhelmingly covered by
employer-based health insurance.
Although HHS cannot quantify the benefits associated with the WTC
Health Program, enrollees with cancer are expected to experience a
higher quality of care than they would in the absence of the Program.
Mortality and morbidity improvements for cancer patients expected to
enroll in the WTC Health Program are anticipated because barriers may
exist to access and delivery of quality health care services for cancer
patients in the absence of the services provided by the WTC Health
Program. HHS anticipates benefits to cancer patients treated through
the WTC Health Program, who may otherwise not have access to health
care services (16.3 percent of general responders and survivors who are
expected to be uninsured), to accrue in 2013. Starting in 2014,
continued implementation of the ACA will result in increased access to
health insurance and health care services will improve for the general
responder and survivor population that currently is uninsured.
Limitations
The analysis presented here was limited by the dearth of verifiable
data on the cancer status of responders and survivors who have yet to
apply for enrollment in the WTC Health Program. Because of the limited
data, HHS was not able to estimate benefits in terms of averted
healthcare costs. Nor was HHS able to estimate administrative costs, or
indirect costs, such as averted absenteeism, short and long-term
disability, and productivity losses averted due to premature mortality.
Regulatory Alternatives
The Administrator considered alternative approaches to the methods
set forth in this rulemaking. One alternative would involve a
presumption that 9/11 exposures could have resulted in the development
of any and all types of cancer in the exposed populations. A
presumption that any and all types of cancer could occur after exposure
to 9/11 agents does not require any scientific evidence of a positive
association between exposure and a type of cancer. The Administrator
declined to determine inclusion of types of cancer based on a
presumption approach. The STAC affirmatively rejected a recommendation
to include any and all types of cancer to the List of WTC-Related
Health Conditions. The Administrator made the policy decision to
include only those types of cancer when a positive relationship has
been established between exposure to the 9/11 agent and human cancer.
Another alternative would be to rely on epidemiologic studies of
the association of 9/11 exposures and the development of cancer or a
type of cancer in 9/11-exposed populations exclusively. There are
several limitations to using an exclusive 9/11 populations study
approach. The Administrator finds that vast uncertainties exist in
conducting epidemiologic studies of cancer in 9/11-exposed populations.
For example, there exists only very limited, individual exposure data
in 9/11-exposed populations. This lack of personal, quantitative
exposure data impedes the definitive epidemiologic evidence that
exposure to 9/11 agents causes certain types of cancer in responder and
survivor populations. In addition, cancer is generally a long latency
set of diseases which in some cases may take many years or even decades
to manifest clinically. Requiring evidence of positive associations
from epidemiologic studies of 9/11-exposed populations exclusively does
not serve the best interests of WTC Health Program members.
By expanding the scope of scientific information reviewed to
include three complementary methods (including studies in 9/11 exposed
populations and generally available epidemiologic criteria), the
Administrator has developed a hierarchy of methods to guide
consideration of whether to include types of cancers on the List of
WTC-Related Health Conditions.
Effects on Other Agency Programs
HHS finds that this rulemaking also has an effect on the VCF \40\
administered by DOJ. DOJ administers the VCF under rules promulgated at
28 CFR part 104. The DOJ regulations define, in 28 CFR 104.2 (f), the
term ``WTC-related health condition'' to mean ''those health conditions
identified as WTC-related by Title I of Public Law 111-347 and by
regulations implementing that Title.'' The preamble to the VCF final
rule (76 FR 54115) states, ``If the WTC Health Program determines that
certain forms of cancer should be added to the list of WTC-related
conditions, the final rule requires the Special Master to add such
conditions to the list of presumptively covered conditions for the
Fund.''
---------------------------------------------------------------------------
\40\ The September 11th Victim Compensation Fund of 2001 (VCF)
was initially established in 2001 pursuant to Title IV of Public Law
107-42, 115 Stat. 230 (Air Transportation Safety and System
Stabilization Act) and was open for claims from December 21, 2001,
through December 22, 2003. Title II of the Zadroga Act amends and
reactivates the September 11th Victim Compensation Fund of 2001.
Public Law 111-347. Administered through DOJ by a Special Master,
the VCF provides compensation to any individual (or a personal
representative of a deceased individual) who suffered physical harm
or was killed as a result of the terrorist-related aircraft crashes
of September 11, 2001, or the debris removal efforts that took place
in the immediate aftermath of those crashes.
---------------------------------------------------------------------------
Under the VCF program, compensation awards are generally calculated
using three components: Economic loss plus non-economic loss minus
collateral source payments. To determine economic loss, the Special
Master considers any prior loss of earnings or other benefits related
to employment, medical expense loss, replacement services loss, and
loss of business or employment opportunity. The regulations provide
presumed non-economic awards for deceased individuals. Because every
physical injury is unique, the Special Master may determine presumed
non-economic losses on a case-by-case basis for physically injured
claimants. The Special Master then subtracts any collateral offsets
received or eligible to be received. The computation of individual
compensation due under the fund is based on factors pertinent to each
individual claimant.
The statute caps the total amount of funds allocated to the VCF.
The VCF regulation at 28 CFR 104.51 provides that, ``the total amount
of Federal funds paid for expenditures including compensation with
respect to claims filed on or after October 3, 2011, will not exceed
$2,775,000,000. Furthermore, the total amount of
[[Page 56157]]
Federal funds expended during the period from October 3, 2011, through
October 3, 2016, may not exceed $875,000,000.''
To meet these requirements, the Special Master is authorized to
reduce the amount of compensation due to each claimant by prorating the
total amount of the compensation award determined for each individual
claimant. The VCF intends to establish the fraction for proration such
that all claimants receive some payment related to their claim within
the overall funding limitation of the program. The Special Master may
adjust the percentage of the total award that is to be paid to eligible
claims based on experiential information as well as estimates related
to potential future claims and availability of funds.
The amount of compensation that would be awarded to each of the
living claimants who develop, or the heirs of those who died from, a
covered type of cancer during the years 2002 through 2016, would be
determined by individual factors considered under the VCF. Depending on
the total number of new claims and compensation eligibility, the
overall impact on the VCF of increasing the number of eligible VCF
claimants as a result of adding eligible health conditions under the
WTC Health Program may be to reduce the proration fraction that is
applied to all VCF claimants such that the total cost to the government
remains unchanged. The additional costs to the VCF due to processing
and computing the entitlement for the extra claimants eligible as a
result of having a covered type of cancer, plus the costs of paying
newly covered claimants their prorated share of the compensation award,
would result in amounts that will not be available to pay increased
shares for the claimants with non-cancer conditions.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA), 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. HHS
believes that this rule has ``no significant economic impact upon a
substantial number of small entities'' within the meaning of the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
The WTC Health Program has contracted with the following healthcare
providers and provider network managers to offer treatment and
monitoring to enrolled responders and survivors: Seven CCEs, which
serve responders and survivors in the New York City metropolitan area
(City of New York Fire Department; Mount Sinai School of Medicine;
Research Foundation of State University of New York; New York
University, Bellevue Hospital Center; University of Medicine and
Dentistry of New Jersey; Long Island Jewish Medical Center; and New
York City Health and Hospitals Corporation); Logistics Health
Incorporated, which manages the nationwide provider network for
populations geographically distant from New York City; three Data
Centers, which analyze CCE data and coordinate activities (City of New
York Fire Department; Mount Sinai School of Medicine; and New York City
Health and Hospitals Corporation); and Emdeon, which manages pharmacy
benefits.
Of these entities, six of the seven CCEs and two of the three Data
Centers are hospitals (NAICS 622110--General Medical and Surgical
Hospitals). The Small Business Administration (SBA) identifies as a
small business those hospitals with average annual receipts below $34.5
million; none of the six fall below the SBA threshold for small
businesses. The City of New York Fire Department's Bureau of Health
Services, which provides medical monitoring and treatment for FDNY
members as a CCE, and provides data analysis and other services for the
FDNY CCE as a Data Center, is considered a local government agency
(NAICS 922160--Fire Protection), and as such cannot be considered a
small entity by SBA. Finally, neither Logistics Health Incorporated,
which manages the national provider network, nor Emdeon, which manages
pharmacy benefits, (NAICS 551112--Management of Companies and
Enterprises) falls below SBA's $7 million threshold for small
businesses in that sector.
Because no small businesses are impacted by this rulemaking, HHS
certifies that this rule will not have a significant economic impact on
a substantial number of small entities within the meaning of the RFA.
Therefore, a regulatory flexibility analysis as provided for under RFA
is not required.
C. Paperwork Reduction Act
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires
an agency to invite public comment on, and to obtain OMB approval of,
any regulation that requires 10 or more people to report information to
the agency or to keep certain records. Data collection and
recordkeeping requirements for the WTC Health Program are approved by
OMB under ``World Trade Center Health Program Enrollment, Appeals &
Reimbursement'' (OMB Control No. 0920-0891, exp. December 31, 2014).
HHS has determined that no changes are needed to the information
collection request already approved by OMB.
D. 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.), HHS will
report the promulgation of this rule to Congress prior to its effective
date.
E. 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 final 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. However, the rule may result in an
increase in the contribution made by New York City for treatment and
monitoring, as required by Title XXXIII, Sec. 3331(d)(2). For 2012,
the inflation adjusted threshold is $139 million.
F. Executive Order 12988 (Civil Justice)
This final 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.
G. Executive Order 13132 (Federalism)
HHS has reviewed this final 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.''
H. 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 final rule on children.
HHS has
[[Page 56158]]
determined that the rule would have no environmental health and safety
effect on children, although an eligible child who has been diagnosed
with a cancer type specified in this rulemaking may seek certification
of the condition by the Administrator.
I. 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 final rule on energy supply, distribution or use, and
has determined that the rule will not have a significant adverse
effect.
J. 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 final rule consistent with the Federal
Plain Writing Act guidelines.
VIII. Final Rule
List of Subjects in 42 CFR Part 88
Aerodigestive disorders, Appeal procedures, Cancer, Health care,
Mental health conditions, Musculoskeletal disorders, Respiratory and
pulmonary diseases.
For the reasons discussed in the preamble, the Department of Health
and Human Services amends 42 CFR part 88 as follows:
PART 88--WORLD TRADE CENTER HEALTH PROGRAM
0
1. The authority citation for part 88 continues to read as follows:
Authority: 42 U.S.C. 300mm-300mm-61, Pub. L. 111-347, 124 Stat.
3623.
0
2. Amend Sec. 88.1 by adding paragraph (4) to the definition of ''List
of WTC-related health conditions'' to read as follows:
Sec. 88.1 Definitions.
* * * * *
List of WTC-Related Health Conditions
* * * * *
(4) Cancers: This list includes those individual cancer types
specified in Table 1, below, according to the International
Classification of Diseases, 10th Edition (ICD-10) and International
Classification of Diseases, 9th Edition (ICD-9).
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* * * * *
Dated: September 5, 2012.
John Howard,
Administrator, World Trade Center Health Program and Director, National
Institute for Occupational Safety and Health, Centers for Disease
Control and Prevention, Department of Health and Human Services.
[FR Doc. 2012-22304 Filed 9-10-12; 4:15 pm]
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