[Federal Register Volume 77, Number 177 (Wednesday, September 12, 2012)]
[Rules and Regulations]
[Pages 56138-56168]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-22304]
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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.
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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: [email protected].
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.
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\1\ See PHS Act, Title XXXIII sec. 3312(a)(5).
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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$
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Societal Costs for 2013, 2011$
Annualized Transfers for 2013-
2016, 2011$
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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
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Cancer Rate
Cancer Rate
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U.S. Average U.S. + 21% U.S. Average U.S. + 21%
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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 ..............
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60,000 Total................................ 2,124,624 .............. 12,458,535 ..............
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[[Page 56140]]
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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
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110,000 Total............................... .............. 5,019,182 .............. 33,308,060
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Qualitative benefits
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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.
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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.
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\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.
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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\
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\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 http://www.cdc.gov/niosh/docket/archive/docket257.html.
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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).
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\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 http://www.cdc.gov/niosh/docket/archive/docket257.html.
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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.
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\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. http://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). http://ntp.niehs.nih.gov/?objectid=72016262-BDB7-CEBA-FA60E922B18C2540. Accessed May 9, 2012.
\8\ WHO International Agency for Research on Cancer (IARC).
http://monographs.iarc.fr/. Accessed May 8, 2012.
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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.
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\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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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.
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\10\ See PHS Act, sec.3312(a)(1); 42 U.S.C. 300mm-22(a)(1).
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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.)
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\11\ 28 CFR 104.21.
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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
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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
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.
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\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 http://www.regulations.gov and
http://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. http://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). http://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). http://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). http://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\
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\34\ United States Preventive Services Task Force (USPSTF)
[2008]. Screening for Colorectal Cancer. http://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.
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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\
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\37\ FECA rates for Mammography for New York; FECA code 77057.
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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.
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\38\ U.S. Census Bureau [2011]. Current Population Survey.
http://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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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.''
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\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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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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