[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]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2012-0007; NIOSH-257]

42 CFR Part 88

RIN 0920-AA49


World Trade Center Health Program; Addition of Certain Types of 
Cancer to the List of WTC-Related Health Conditions

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: Title I of the James Zadroga 9/11 Health and Compensation Act 
of 2010 amended the Public Health Service Act (PHS Act) to establish 
the World Trade Center (WTC) Health Program. The WTC Health Program, 
which is administered by the Director of the National Institute for 
Occupational Safety and Health (NIOSH), within the Centers for Disease 
Control and Prevention (CDC), provides medical monitoring and treatment 
to eligible firefighters and related personnel, law enforcement 
officers, and rescue, recovery, and cleanup workers who responded to 
the September 11, 2001, terrorist attacks in New York City, at the 
Pentagon, and in Shanksville, Pennsylvania, and to eligible survivors 
of the New York City attacks. In accordance with WTC Health Program 
regulations, which establish procedures for adding a new condition to 
the list of covered health conditions, this final rule adds to the List 
of WTC-Related Health Conditions the types of cancer proposed for 
inclusion by the notice of proposed rulemaking.

DATES: This final rule is effective October 12, 2012.

FOR FURTHER INFORMATION CONTACT: Frank J. Hearl, PE, Chief of Staff, 
National Institute for Occupational Safety and Health, Centers for 
Disease Control and Prevention, Patriots Plaza, Suite 9200, 395 E St. 
SW., Washington, DC 20201. Telephone: (202) 245-0625 (this is not a 
toll-free number). Email: [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.
---------------------------------------------------------------------------

    \1\ See PHS Act, Title XXXIII sec. 3312(a)(5).
---------------------------------------------------------------------------

B. Summary of Major Provisions

    This rule modifies the List of WTC-Related Health Conditions in 42 
CFR 88.1 to add the following conditions (types of cancer identified by 
ICD-10 code are specified in the discussion below):

[ssquf] Malignant neoplasms of the lip, tongue, salivary gland, floor 
of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and 
other oral cavity and pharynx
[ssquf] Malignant neoplasm of the nasopharynx
[ssquf] Malignant neoplasms of the nose, nasal cavity, middle ear, and 
accessory sinuses
[ssquf] Malignant neoplasm of the larynx
[ssquf] Malignant neoplasm of the esophagus
[ssquf] Malignant neoplasm of the stomach
[ssquf] Malignant neoplasm of the colon and rectum
[ssquf] Malignant neoplasm of the liver and intrahepatic bile duct
[ssquf] Malignant neoplasms of the retroperitoneum and peritoneum, 
omentum, and mesentery
[ssquf] Malignant neoplasms of the trachea; bronchus and lung; heart, 
mediastinum and pleura; and other ill-defined sites in the respiratory 
system and intrathoracic organs
[ssquf] Mesothelioma
[ssquf] Malignant neoplasms of the soft tissues (sarcomas)
[ssquf] Malignant neoplasms of the skin (melanoma and non-melanoma), 
including scrotal cancer
[ssquf] Malignant neoplasm of the breast
[ssquf] Malignant neoplasm of the ovary
[ssquf] Malignant neoplasm of the urinary bladder
[ssquf] Malignant neoplasm of the kidney
[ssquf] Malignant neoplasms of renal pelvis, ureter and other urinary 
organs
[ssquf] Malignant neoplasms of the eye and orbit
[ssquf] Malignant neoplasm of the thyroid
[ssquf] Malignant neoplasms of the blood and lymphoid tissues 
(including, but not limited to, lymphoma, leukemia, and myeloma)
[ssquf] Childhood cancers
[ssquf] Rare cancers

    The Administrator developed a hierarchy of methods (detailed in 
Section IV of this preamble) for determining which cancers to propose 
for inclusion on the List of WTC-Related Health Conditions.

C. Costs and Benefits

    Annual costs, benefits, and transfers of this rule are listed in 
the table below. This analysis estimates the impact on WTC Health 
Program costs using the number of persons currently enrolled in the 
Program as responders and survivors and assumes that the rate of cancer 
in the population will be equal to the U.S. population average rate. An 
alternative analysis considers the impact on costs if the Program 
enrolls additional persons up to the Program's statutory limits, and 
that the expanded population experiences a 21 percent higher rate of 
cancer than the U.S. population average. The basis for these 
assumptions is explained in detail in the preamble of this rulemaking 
(see Section VII.A., below).
    Although we cannot quantify the benefits associated with the WTC 
Health Program, enrollees with cancer are expected to experience a 
higher quality of care than they would in the absence of the Program. 
Mortality and morbidity improvements for cancer patients expected to 
enroll in the WTC Health Program are anticipated because barriers may 
exist to access and delivery of quality health care services for cancer 
patients in the absence of the services provided by the WTC Health 
Program. HHS anticipates benefits to cancer patients treated through 
the WTC Health Program, who may otherwise not have access to health 
care services, to accrue in 2013. Starting in 2014, continued 
implementation of the Affordable Care Act will result in increased 
access to health insurance and improved health care services for the 
general responder and survivor population that currently is uninsured.

  Estimated annual WTC Health Program costs, transfers, and benefits, 55,000 responders and 5,000 survivors at
   U.S. population cancer rate, and 80,000 responders and 30,000 survivors at U.S. population cancer rate + 21
                                            percent, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                  Societal Costs for 2013, 2011$
                                                  Annualized Transfers for 2013-
                                                            2016, 2011$
                                                 ---------------------------------------------------------------
                                                   Based on the 16.3 percent of    Discounted at   Discounted at
                                                      general responders and         7 percent       3 percent
                                                   survivors who are expected to
                                                           be uninsured
                                                 ---------------------------------------------------------------
                                                            Cancer Rate
                                                            Cancer Rate
                                                 ---------------------------------------------------------------
                                                   U.S. Average     U.S. + 21%     U.S. Average     U.S. + 21%
                                                 ---------------------------------------------------------------
55,000 Responders...............................      $1,648,706  ..............     $10,172,308  ..............
5,000 Survivors.................................         271,427  ..............       1,572,907  ..............
Colorectal and Breast Screening.................         204,491  ..............         713,321  ..............
                                                 ---------------------------------------------------------------
    60,000 Total................................       2,124,624  ..............      12,458,535  ..............
                                                 ---------------------------------------------------------------
 

[[Page 56140]]

 
                                                 ---------------------------------------------------------------
80,000 Responders...............................  ..............       2,631,100  ..............      19,912,464
30,000 Survivors................................  ..............       1,970,560  ..............      12,124,118
Colorectal and Breast Screening.................  ..............         417,521  ..............       1,271,478
                                                 ---------------------------------------------------------------
    110,000 Total...............................  ..............       5,019,182  ..............      33,308,060
----------------------------------------------------------------------------------------------------------------
Qualitative benefits
----------------------------------------------------------------------------------------------------------------
Although we cannot quantify the benefits associated with the WTC Health Program, enrollees with cancer are
 expected to experience a higher quality of care than they would in the absence of the Program. Mortality and
 morbidity improvements for cancer patients expected to enroll in the WTC Health Program are anticipated because
 barriers may exist to access and delivery of quality health care services for cancer patients in the absence of
 the services provided by the WTC Health Program. HHS anticipates benefits to cancer patients treated through
 the WTC Health Program, who may otherwise not have access to health care services, to accrue in 2013. Starting
 in 2014, continued implementation of the Affordable Care Act will result in increased access to health
 insurance and improved health care services for the general responder and survivor population that currently is
 uninsured.
----------------------------------------------------------------------------------------------------------------

II. Public Participation

    On June 13, 2012 HHS published a notice of proposed rulemaking (77 
FR 35574) proposing to add certain cancers to the List of WTC-Related 
Health Conditions. HHS invited interested persons or organizations to 
submit written views, opinions, recommendations, and data on any topic 
related to the proposed rule. The Administrator specifically sought 
comments on the methodology proposed to evaluate evidence for the 
addition of types of cancer to the List of WTC-Related Health 
Conditions; the proposed cost estimates; information or published 
studies about the type of welding and/or metal cutting that occurred at 
any of the disaster sites and information about exposure to ultraviolet 
light; and information or published studies about the scheduling of 
work hours or shiftwork occurring at any of the disaster sites.
    HHS received 27 substantive submissions to the docket for this 
rulemaking. Commenters included labor unions that represent WTC 
responders, including police department members and others who 
conducted rescue, recovery, and clean-up; private citizens, including 
WTC responders; the spouse of a responder; survivors; relatives of 
victims and survivors; physicians who have treated WTC responders; 
health care professionals with no stated experience treating 9/11-
exposed patients; health and research organizations; the WTC Health 
Program Survivors Steering Committee; a chemical supplier; and an 
elected official. Additionally, one private citizen submitted a comment 
that was outside the scope of this rulemaking. The substantive comments 
are described below, followed by the Administrator's response to each 
(see Section V., below).

III. Background

A. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347), amended the PHS Act to add Title XXXIII \2\ 
establishing the WTC Health Program within HHS. The WTC Health Program 
provides medical monitoring and treatment benefits to eligible 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery, and cleanup workers who responded to the September 
11, 2001, terrorist attacks in New York City, at the Pentagon, and in 
Shanksville, Pennsylvania, and to eligible survivors of the New York 
City attacks.
---------------------------------------------------------------------------

    \2\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm 
to 300mm-61. Those portions of the Zadroga Act found in Titles II 
and III of Public Law 111-347 do not pertain to the WTC Health 
Program and are codified elsewhere.
---------------------------------------------------------------------------

    All references to the Administrator in this notice mean the NIOSH 
Director or his or her designee. Section 3312(a)(6) of the PHS Act 
requires the Administrator to conduct rulemaking to propose the 
addition of a health condition to the List of WTC-Related Health 
Conditions codified in 42 CFR 88.1.

B. Need for Rulemaking

    The PHS Act requires the Administrator to conduct rulemaking to 
propose the addition of a health condition to the List of WTC-Related 
Health Conditions codified in 42 CFR 88.1 regardless of whether the 
Administrator proposes to add a health condition based on the findings 
from periodic reviews of cancer,\3\ a request from a petition, or a 
determination made at the Administrator's discretion that a proposed 
rule adding a condition should be initiated. On September 7, 2011, the 
Administrator received a written petition to add a health condition to 
the List of WTC-Related Health Conditions (Petition 001). Petition 001 
requested that the Administrator ``consider adding coverage for 
cancer'' to the List in Sec.  88.1.\4\
---------------------------------------------------------------------------

    \3\ See PHS Act, sec, 3312(a)(5).
    \4\ Maloney CB, Nadler J, King PT, Schumer CE, Gillibrand KE, 
Rangel CB, Velazquez NM, Grimm MG, Clarke YD. [2011]. Letter from 
Congress to John Howard, MD, Director, National Institute for 
Occupational Safety and Health (NIOSH). WTC Health Program Petition 
001. Petition 001 is included in the docket for this rulemaking. See 
http:www.regulations.gov and http://www.cdc.gov/niosh/docket/archive/docket257.html.
---------------------------------------------------------------------------

    On October 5, 2011, the Administrator formally exercised his option 
to request a recommendation from the STAC regarding the petition (PHS 
Act, sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i)). The Administrator 
requested that the STAC ``review the available information on cancer 
outcomes associated with the exposures resulting from the September 11, 
2001, terrorist attacks, and provide advice on whether to add cancer, 
or a certain type of cancer, to the List specified in the Zadroga 
Act.'' \5\ In response, the STAC submitted its recommendation on April 
2, 2012, and the Administrator issued a notice of proposed rulemaking 
on June 13, 2012. The background to this rulemaking and a discussion of 
the STAC's recommendation are provided in the notice of proposed 
rulemaking published on June 13, 2012 (77 FR 35574).
---------------------------------------------------------------------------

    \5\ Howard J [2011]. October 5, 2011 Letter from John Howard, 
MD, Director, National Institute for Occupational Safety and Health 
(NIOSH) to the WTC Health Program Scientific/Technical Advisory 
Committee. This letter is included in the docket for this 
rulemaking. See http:www.regulations.gov and http://www.cdc.gov/niosh/docket/archive/docket257.html.
---------------------------------------------------------------------------

C. Review of Scientific Evidence

    As reviewed in detail in the June 13, 2012 notice of proposed 
rulemaking, the

[[Page 56141]]

Administrator considered data from five information sources to decide 
whether to propose the addition of cancers to the List of WTC-Related 
Health Conditions: (1) Peer-reviewed studies published in the 
scientific literature, including environmental sampling data, 
epidemiologic studies on the 9/11-exposed populations, and studies 
providing evidence of a causal relationship between a type of cancer 
and a condition already on the List of WTC-Related Health Conditions; 
\6\ (2) findings and recommendations solicited from the WTC Clinical 
Centers of Excellence and Data Centers, the WTC Health Registry at the 
New York City Department of Health and Mental Hygiene, and the New York 
State Department of Health; (3) information from the public solicited 
through a request for information published in the Federal Register on 
March 8, 2011 and March 29, 2011; (4) the findings of the National 
Toxicology Program (NTP) in the National Institute of Environmental 
Health Sciences, HHS,\7\ as well as the World Health Organization's 
International Agency for Research on Cancer (IARC); \8\ and (5) 
findings from other sources of information relevant to 9/11 exposures, 
including the expert judgment and personal experiences of STAC members, 
and comments from the public.
---------------------------------------------------------------------------

    \6\ The July 2011, First Periodic Review of the Scientific and 
Medical Evidence Related to Cancer for the World Trade Center Health 
Program (First Periodic Review), requested by the Administrator, was 
included among the information considered. NIOSH [2011]. First 
Periodic Review of Scientific and Medical Evidence Related to Cancer 
for the World Trade Center Health Program. NIOSH Publication No. 
2011-197. 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.
---------------------------------------------------------------------------

    In September 2011, an epidemiologic study by Rachel Zeig-Owens and 
colleagues (hereafter, ``Zeig-Owens''), ``identified a modest effect of 
WTC exposure for all cancers combined by comparing the ratios in the 
exposed group [of Fire Department of New York City firefighters] to 
those in the non-exposed group.'' \9\ This publication led to the 
submission of Petition 001. The Administrator requested that the STAC 
provide a recommendation on Petition 001. The STAC established 
evidentiary criteria and assessed the weight of the available 
scientific evidence provided by information sources (1), (4), and (5), 
described above. The STAC found support for including a number of types 
of cancer based in part on evidence of increased risk reported in Zeig-
Owens. The STAC also included a number of types of cancer based on the 
professional judgment of STAC members with scientific expertise, on the 
personal experience of some of the STAC members who were themselves WTC 
responders or survivors, and on comments made by members of the public.
---------------------------------------------------------------------------

    \9\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters After the 9/11 Attacks: An Observational Cohort 
Study. Lancet. 378(9794):898-905.
---------------------------------------------------------------------------

    Following review of the STAC recommendation, the Administrator 
agreed with the STAC that individual exposure assessment information 
arising from the terrorist attacks is extremely limited and that its 
absence impairs definitive scientific analysis of the relationship 
between exposures arising from the attacks and the occurrence of any 
specific type of cancer. The Administrator also found that multiple 
epidemiologic studies of cancer in exposed responders and survivors 
which definitively support an association between 9/11 exposures and 
specific types of cancer that would meet generally well-accepted 
criteria indicating that the association is a causal one are not 
currently available.
    After considering various approaches to evaluate the available 
scientific evidence (see discussion in the June 13, 2012 notice of 
proposed rulemaking), the Administrator has adopted the methodology 
outlined in the proposed rule and set out in Section IV below. This 
methodology follows on criteria used by the STAC in its recommendation. 
Using the methodology, the Administrator adds the types of cancer, 
identified in Section V below, to the List of WTC-Related Health 
Conditions.

D. Physician Determination and Program Certification of WTC-Related 
Health Conditions Including Types of Cancer

    In order for an individual enrolled as a WTC responder or survivor 
to obtain coverage for treatment of any health condition on the List of 
WTC-Related Health Conditions, including any type of cancer added to 
the List, a two-step process must be satisfied. First, a physician at a 
Clinical Center of Excellence (CCE) or in the nationwide provider 
network must make a determination that the particular type of cancer 
for which the responder or survivor seeks treatment coverage is both on 
the List of WTC-Related Health Conditions and that exposure to airborne 
toxins, other hazards, or adverse conditions resulting from the 
September 11, 2001, terrorist attacks is substantially likely to be a 
significant factor in aggravating, contributing to, or causing the type 
of cancer for which the responder or survivor seeks treatment 
coverage.\10\ Pursuant to 42 CFR 88.12(a), the physician's 
determination must be based on the following: (1) An assessment of the 
individual's exposure to airborne toxins, any other hazard, or any 
other adverse condition resulting from the September 11, 2001, attacks; 
and (2) the type of symptoms reported and the temporal sequence of 
those symptoms. In addition, the statute requires that all physician 
determinations are reviewed by the Administrator and are certified for 
treatment coverage unless the Administrator determines that the 
condition is not a health condition on the List of WTC-Related Health 
Conditions or that the exposure resulting from the September 1, 2001, 
terrorist attacks is not substantially likely to be a significant 
factor in aggravating, contributing to, or causing the condition. Thus, 
the inclusion of a condition on the List of WTC-Related Health 
Conditions, in and of itself, does not guarantee that a particular 
individual's condition will be certified as eligible for treatment. 
Responders and survivors denied certification have a right to appeal 
the denial of certification.
---------------------------------------------------------------------------

    \10\ See PHS Act, sec.3312(a)(1); 42 U.S.C. 300mm-22(a)(1).
---------------------------------------------------------------------------

E. Effects of Rulemaking on Federal Agencies

    Title II of the James Zadroga 9/11 Health and Compensation Act of 
2010 (Pub. L. 111-347) reactivated the September 11, 2001 Victim 
Compensation Fund (VCF). Administered by the U.S. Department of

[[Page 56142]]

Justice (DOJ), the VCF provides compensation to any individual or 
representative of a deceased individual who was physically injured or 
killed as a result of the September 11, 2001, terrorist attacks or 
during the debris removal. Eligibility criteria for compensation by the 
VCF include a list of presumptively covered health conditions, which 
are physical injuries determined to be WTC-related health conditions by 
the WTC Health Program. Pursuant to DOJ regulations, the VCF Special 
Master is required to update the list of presumptively covered 
conditions when the List of WTC-Related Health Conditions in 42 CFR 
88.1 is updated.\11\ (See also Section VII.A., Effects on Other Agency 
Programs, below.)
---------------------------------------------------------------------------

    \11\ 28 CFR 104.21.
---------------------------------------------------------------------------

IV. Methods Used by the Administrator To Determine Whether To Add 
Cancer or Types of Cancer to the List of WTC-Related Health Conditions

    For the reasons discussed above and detailed in the notice of 
proposed rulemaking published in the Federal Register on June 13, 2012, 
the Administrator developed the following hierarchy of methods for 
determining whether to add cancer or types of cancer to the List of 
WTC-Related Health Conditions in 42 CFR 88.1. In determining whether to 
propose that a type of cancer be included on the List, a review of the 
evidence must demonstrate fulfillment of at least one of the following 
four methods:
    [ssquf] Method 1. Epidemiologic Studies of September 11, 2001 
Exposed Populations. A type of cancer may be added to the List if 
published, peer-reviewed epidemiologic evidence supports a causal 
association between 9/11 exposures and the cancer type. The following 
criteria extrapolated from the Bradford Hill criteria will be used to 
evaluate the evidence of the exposure-cancer relationship:
    [cir] Strength of the association between a 9/11 exposure and a 
health effect (including the magnitude of the effect and statistical 
significance);
    [cir] consistency of the findings across multiple studies;
    [cir] biological gradient, or dose-response relationships between 
9/11 exposures and the cancer type; and
    [cir] plausibility and coherence with known facts about the biology 
of the cancer type.
    If only a single published epidemiologic study is available for 
review, the consistency of findings cannot be evaluated and strength of 
association will necessarily place greater emphasis on statistical 
significance than on the magnitude of the effect.
    [ssquf] Method 2. Established Causal Associations. A type of cancer 
may be added to the List if there is well-established scientific 
support published in multiple epidemiologic studies for a causal 
association between that cancer and a condition already on the List of 
WTC-Related Health Conditions.
    [ssquf] Method 3. Review of Evaluations of Carcinogenicity in 
Humans. A type of cancer may be added to the List only if both of the 
following criteria for Method 3 are satisfied:
    3A. Published Exposure Assessment Information. 9/11 agents were 
reported in a published, peer-reviewed exposure assessment study of 
responders or survivors who were present in either the New York City 
disaster area as defined in 42 CFR 88.1, or at the Pentagon, or in 
Shanksville, Pennsylvania; and
    3B. Evaluation of Carcinogenicity in Humans from Scientific 
Studies. NTP has determined that the 9/11 agent is known to be a human 
carcinogen or is reasonably anticipated to be a human carcinogen, and 
IARC has determined there is sufficient or limited evidence that the 9/
11 agent causes a type of cancer.
    [ssquf] Method 4. Review of Information Provided by the WTC Health 
Program Scientific/Technical Advisory Committee. A type of cancer may 
be added to the List if the STAC has provided a reasonable basis for 
adding a type of cancer and the basis for inclusion does not meet the 
criteria for Method 1, Method 2, or Method 3.
    The following schematic illustrates the methodology proposed in the 
notice of proposed rulemaking and established in this final rule.
BILLING CODE 4161-17-P

[[Page 56143]]

[GRAPHIC] [TIFF OMITTED] TR12SE12.012

BILLING CODE 4161-17-C

[[Page 56144]]

V. Administrator's Determination Concerning Petition 001: Addition of 
Cancers to the List of WTC-Related Health Conditions, 42 CFR 88.1

    Using the evidentiary standards established above for inclusion of 
a cancer on the List of WTC-Related Health Conditions in 42 CFR 88.1, 
and in accordance with the review of evidence discussed in the notice 
of proposed rulemaking published in the Federal Register on June 13, 
2012, the Administrator adds the specific types of cancers in the list 
below to the List of WTC-Related Health Conditions in 42 CFR 88.1. In 
the list below, the name of the cancer is followed by its ICD-10 code 
\12\ as well as the method used to include the cancer. A more detailed 
list, including sub-codes, is included in Table 1 in the regulatory 
text below.
---------------------------------------------------------------------------

    \12\ WHO (World Health Organization) [1997]. International 
Classification of Diseases, Tenth Revision. Geneva: World Health 
Organization. The International Classification of Diseases (ICD) is 
used to code and classify injuries and diseases and their signs, 
symptoms, and external causes for statistical presentation, disease 
analysis, hospital records indexing, and medical billing 
reimbursement.

[ssquf] Malignant neoplasms of the lip [C00], tongue [C01, C02], 
salivary gland [C07, C08], floor of mouth [C04], gum and other mouth 
[C03, C05, C06], tonsil [C09], oropharynx [C10], hypopharynx [C12, 
C13], other oral cavity and pharynx [C14] (Method 3)
[ssquf] Malignant neoplasm of the nasopharynx [C11] (Method 3)
[ssquf] Malignant neoplasms of the nasal cavity [C30] and accessory 
sinuses [C31] (Method 3)
[ssquf] Malignant neoplasm of the larynx [C32] (Method 3)
[ssquf] Malignant neoplasms of the esophagus [C15] (Method 2)
[ssquf] Malignant neoplasm of the stomach [C16] (Method 3)
[ssquf] Malignant neoplasms of the colon (and rectum) [C18, C19, C20, 
C26.0] (Method 3)
[ssquf] Malignant neoplasms of the liver and intrahepatic bile duct 
[C22] (Method 3)
[ssquf] Malignant neoplasms of the retroperitoneum and peritoneum [C48] 
(Method 3)
[ssquf] Malignant neoplasms of the trachea [C33]; bronchus and lung 
[C34]; heart, mediastinum and pleura [C38]; and other ill-defined sites 
in the respiratory system and intrathoracic organs [C39] (Method 3)
[ssquf] Mesothelioma [C45] (Method 3)
[ssquf] Malignant neoplasm of peripheral nerves and autonomic nervous 
system [C47) and malignant neoplasm of other connective and soft tissue 
[C49] (Method 3)
[ssquf] Other malignant neoplasms of skin (non-melanoma) [C44] (Method 
3), malignant melanoma of skin [C43] (Method 4), and malignant neoplasm 
of scrotum [C63.2] (Methods 3)
[ssquf] Malignant neoplasm of the breast [C50] (Method 4)
[ssquf] Malignant neoplasm of the ovary [C56] (Method 3)
[ssquf] Malignant neoplasm of the urinary bladder [C67] (Method 3)
[ssquf] Malignant neoplasm of the kidney [C64] (Method 3)
[ssquf] Malignant neoplasm of the renal pelvis, ureter and other 
urinary organs [C65, C66 and C68] (Method 3)
[ssquf] Malignant neoplasm of the eye and orbit [C69] (Method 4)
[ssquf] Malignant neoplasm of thyroid gland [C73] (Method 3)
[ssquf] Hodgkin's disease [C81]; follicular [nodular] non-Hodgkin 
lymphoma [C82]; diffuse non-Hodgkin lymphoma [C83]; peripheral and 
cutaneous T-cell lymphomas [C84]; other and unspecified types of non-
Hodgkin lymphoma [C85]; malignant immunoproliferative diseases [C88]; 
multiple myeloma and malignant plasma cell neoplasms [C90]; lymphoid 
leukemia [C91]; myeloid leukemia [C92]; monocytic leukemia [C93]; other 
leukemias of specified cell type [C94]; leukemia of unspecified cell 
type [C95]; other and unspecified malignant neoplasms of lymphoid, 
hematopoietic and related tissue [C96] (Method 3)
[ssquf] Childhood Cancers [any type of cancer occurring in a person 
less than 20 years of age] (Method 4)
[ssquf] Rare Cancers [any type of cancer affecting populations smaller 
than 200,000 individuals in the United States, i.e., occurring at an 
incidence rate less than 0.08 percent of the U.S. population] (Method 
4)

VI. Summary of Final Rule and Response to Public Comments

    The final rule amends the definition of ``List of WTC-Related 
Health Conditions'' in 42 CFR 88.1, to include the types of cancer 
referenced above in Section V, which are the cancers proposed in the 
June 13, 2012, notice of proposed rulemaking (77 FR 35574). Table 1 in 
the regulatory text describes types of cancers included in 42 CFR 88.1 
and identifies each by ICD-10 code. Because the ICD-10 modification 
will not be used by the U.S. healthcare system until October 1, 2014, 
the corresponding ICD-9 codes for the included cancer types are also 
provided in Table 1 in the regulatory text.
    The effect of this amendment is that, for the types of cancers 
added, an enrolled WTC responder, certified-eligible survivor, or 
screening-eligible survivor may seek certification of a physician's 
determination that the September 11, 2001, terrorist attacks were 
substantially likely to be a significant factor in aggravating, 
contributing to, or causing the individual's cancer. As discussed 
above, if the condition is certified by the Administrator, the 
individual may seek treatment and monitoring of this condition under 
the WTC Health Program.
    As described in the Public Participation section, above, the 
Administrator received 27 substantive submissions from the public on 
the methodology and the types of cancers proposed in the June 13, 2012 
Federal Register notice (77 FR 35574). Upon consideration of the public 
comments, the Administrator has determined not to amend the methodology 
or the list of cancers in Table 1 of the regulatory text proposed in 
the June 13, 2012 notice of proposed rulemaking (77 FR 35574). The 
comments are summarized below, followed by the Administrator's response 
to each.
    Comment: The Administrator received 12 comments in support of 
adding the proposed types of cancer to the List of WTC-Related Health 
Conditions. Some commenters expressed support for the specific 
methodologies proposed by the Administrator, including the use of the 
NTP and the IARC designations (Method 3). Commenters noted that 
requiring conclusive epidemiological evidence to add cancers to the 
List may not be fair to responders and survivors who are ill now, given 
the time required to collect sufficient data and publish studies in 
peer-reviewed journals. Some commenters correctly pointed out that an 
individual's diagnosis must be determined to be related to 9/11 
exposure by a WTC Health Program physician and then certified by the 
Administrator in order for that individual to receive treatment through 
the Program. Some commenters wrote in support of specific types of 
cancer for inclusion.
    Response: The Administrator agrees that establishing a broad 
continuum of decision-making methods is important to ensure that WTC 
responders and survivors receive care for health conditions associated 
with the September 11, 2001, terrorist attacks.
    Comment: The Administrator received three comments opposing the 
addition of the proposed types of cancer to the List of WTC-Related 
Health Conditions using the methodology established in this final rule. 
One commenter concurred with the use of

[[Page 56145]]

Methods 1 and 2, but stated that Methods 3 and 4 ``leave the door open 
for speculation and anecdotal evidence to influence the decision 
process.'' Two commenters questioned the use of the Zeig-Owens \13\ 
study by the STAC to recommend the addition of types of cancer to the 
List, e.g., thyroid and melanoma, mentioning the preliminary nature of 
the results and that the recommended types of cancer do not meet the 
traditional level of statistical significance. One commenter expressed 
opposition to Methods 3 and 4 as being overly broad, thus allowing into 
the Program those individuals who do not truly merit Program benefits.
---------------------------------------------------------------------------

    \13\ Zeig-Owens R, Webber MP, Hall CB, Schwartz T, Jaber N, 
Weakley J, Rohan TE, Cohen HW, Derman O, Aldrich TK, Kelly K, 
Prezant DJ [2011]. Early Assessment of Cancer Outcomes in New York 
City Firefighters After the 9/11 Attacks: An Observational Cohort 
Study. Lancet. 378(9794):898-905.
---------------------------------------------------------------------------

    Response: The Administrator appreciates the comments provided on 
the four methods proposed for listing types of cancer as WTC-related 
health conditions. The final rule adopts the methods outlined in the 
proposed rule. Under sec. 3312(a)(6) of the PHS Act, the Administrator 
is permitted to consider a wide range of approaches in adding 
conditions to the List.
    The Administrator agrees with the commenter that Methods 1 and 2, 
which rely on epidemiologic evidence (Method 1) and established medical 
relationships between a WTC-related health condition and the 
development of a type of cancer (Method 2), provide traditional methods 
for associating exposure and health effects as a means of adding 
conditions to the List of WTC-Related Health Conditions. However, the 
Administrator also recognizes that there is a continuum of methods that 
can be used to establish relationships between exposure and disease: 
some methods are more definitive and provide a higher level of 
certainty when establishing an association between exposure and disease 
outcomes. Adding cancers to the List by Methods 1 and 2 fall in that 
portion of the continuum of methods that provide greater certainty.
    However, Methods 1 and 2 are substantially limited in their ability 
to provide timely guidance on which types of cancer should be added to 
the List of WTC-Related Health Conditions to allow the WTC Health 
Program to provide services to the responders and survivors currently 
suffering from cancers following exposure to 9/11 agents. Due to the 
long latency period between exposure and cancer diagnosis for most 
types of cancer, many epidemiological studies of cancer associated with 
particular exposures are produced years after a given exposure event. 
Waiting for definitive, scientifically-unassailable epidemiologic 
results before adding types of cancer to the List would prevent 
treatment of currently-enrolled WTC responders and survivors.
    In addition, other factors make it difficult to establish 
definitive associations using traditional epidemiologic methods within 
any timeframe. The number of potentially exposed individuals is small, 
so the statistical power of any study will be substantially limited. 
Many of the cancers anticipated in the exposed population are uncommon. 
Thus, because of the anticipated small numbers of these cancers, 
detecting statistically significant increases will be difficult and may 
only be definitively established through a retrospective cohort study 
conducted decades from now. Upon thorough review of all available 
information, including peer-reviewed studies, expert opinion, the STAC 
recommendation, and comments from the public, the Administrator has 
determined that it is reasonable to acknowledge the limitations of 
traditional epidemiologic methods and to recognize other methods that 
incorporate additional sources of information.
    Because of the limitations of using epidemiologic studies to 
establish relationships between exposure and health effects, and the 
WTC Health Program's responsibility to provide services to affected 
individuals during their lifetime, the Administrator finds that this 
unique exposure situation merits the use of methods, in addition to 
Methods 1 and 2, that provide valuable information about the 
relationship between exposure and health effects. The Administrator 
acknowledges that Methods 3 and 4 provide less certainty about the 
relationship between exposure and cancer than do Methods 1 and 2.
    Method 3 relies on identifying those agents categorized by the NTP 
as known or reasonably anticipated to be human carcinogens and by IARC 
as being known, probable, or possible human carcinogens and having 
sufficient or limited evidence for causing specific types of cancer in 
humans. IARC and NTP findings, including IARC's identification of 
agents associated with specific cancer types, have undergone 
substantial peer review and/or scientific scrutiny in their 
development.
    Method 4 relies on findings from other sources of information 
relevant to 9/11 exposures and the potential occurrence of cancer, 
including the expert judgment and personal experiences of STAC members 
and comments from the public. The statute allows the Administrator to 
request a recommendation from the STAC. In this case, the Administrator 
requested a recommendation from the STAC as well as descriptions of the 
scientific and/or technical evidence members relied on, the quality of 
data supporting the evidence, and the methods used. The Administrator 
found the STAC recommendations and their bases to be reasonable.
    Two comments correctly pointed out that the Zeig-Owens study, which 
was cited as evidence by the STAC, was viewed by the Administrator as 
not meeting the statistical significance threshold for Method 1. 
However, the Administrator made the determination to include certain 
cancers (e.g. thyroid and melanoma) using Method 4 based on a 
reasonable recommendation from the STAC. The interpretation of 
statistical significance can vary between knowledgeable observers. The 
STAC interpreted the Zeig-Owens results as a sound basis for 
recommending the addition of some types of cancer to the List when the 
reported statistical significance of findings in the study was near the 
traditional 95 percent confidence level. The Administrator has 
determined that the STAC's interpretation is reasonable.
    The evidence cited by the STAC for including thyroid cancer and 
melanoma in their recommendation was that the Standardized Incidence 
Ratios (SIR) were substantially greater than 1.0 and approached the 95 
percent confidence level traditionally used for statistical 
significance. The STAC also considered other types of cancer that had 
an elevated SIR in the Zeig-Owens study, such as prostate cancer, and 
did not recommend them for addition after considering additional 
information on potential surveillance bias. Thus, the STAC made 
reasonable arguments for the addition or exclusion of certain types of 
cancer. The STAC did not limit the basis of its recommendations to a 
level of statistical significance that would be recognized by all 
knowledgeable observers of epidemiologic studies.
    Finally, the Administrator notes that listing a cancer as a WTC-
related health condition does not necessarily mean that a cancer in an 
individual WTC responder or survivor will be determined to be WTC-
related. Each WTC responder and survivor enrolled in the Program will 
go through a physician's determination and Program certification 
process to assess whether their individual cancer meets the

[[Page 56146]]

statutory definition of a WTC-related health condition. When 
determining whether an individual's cancer has been contributed to, 
aggravated by, or caused by their exposures at the 9/11 sites, 
individual medical history and exposure assessment are used as part of 
the determination and certification process. Guidelines for physician 
determinations regarding WTC-related health conditions are jointly 
developed by the CCEs and the WTC Health Program for all conditions 
currently on the List. The CCEs and WTC Health Program will develop 
additional assessment information for use by physicians in making 
determinations regarding whether an individual's 9/11 exposure may have 
contributed to, aggravated, or caused their cancer.
    Comment: One commenter stated that the STAC's recommendations do 
not merit the same decision-making weight as Methods 1 and 2 because 
most of the committee is not rigorously trained in epidemiology and 
biostatistics.
    Response: The Administrator acknowledges the diverse background of 
the STAC members, but notes that the composition of the STAC was 
established in sec. 3302(a) of the PHS Act to provide a broad spectrum 
of backgrounds and expertise to the Administrator. The inclusion of 
non-scientists on the STAC adds value, knowledge, and perspective to 
the STAC that might not otherwise be available to the Administrator.
    Comment: One commenter was concerned about the potential impact of 
adding the proposed types of cancer to the List of WTC-Related Health 
Conditions on the VCF administered by the Department of Justice, and 
believes that the use of Methods 3 and 4 will overextend the WTC Health 
Program and the VCF and leave them open to abuse.
    Response: The Administrator notes that individuals who are not 
currently enrolled in the WTC Health Program must first be found to be 
eligible and qualified to enroll. As discussed above, physician 
determination and Program certification are two additional steps that 
must be completed before an individual can receive treatment and 
monitoring benefits from the Program. Similarly, the VCF employs 
rigorous standards used to determine individual compensation awards. 
The Administrator acknowledges the issue of resource limits on the VCF, 
which is a capped-benefit program. This issue is discussed in Section 
VII.A below. Further consideration of the potential impact on the VCF 
is outside the scope of this rulemaking.
    Comment: One comment stated that asbestos-related cancers generally 
have latencies far beyond the 10 years that have passed since September 
11, 2001, and that there is great uncertainty in designating asbestos 
as a cause of stomach or colorectal cancers.
    Response: The methodology established in this final rule for adding 
types of cancer to the List includes identifying those agents 
categorized by IARC as being known, probable, or possible human 
carcinogens and having sufficient or limited evidence for causing 
specific types of cancer in humans, and by the NTP as being known or 
reasonably anticipated to be human carcinogens. IARC and NTP findings 
have undergone substantial peer review and/or other scientific scrutiny 
in their development. These authoritative bodies have categorized all 
forms of asbestos as known human carcinogens, and IARC has determined 
there is limited evidence that they cause cancer of the stomach and 
colon.
    When determining whether an individual's cancer has been 
contributed to, aggravated by, or caused by their exposures at the 9/11 
sites, an individual medical history and exposure assessment is used as 
part of the physician determination and Program certification process. 
Guidelines for physician determinations regarding WTC-related health 
conditions are jointly developed by the CCEs and the WTC Health Program 
for conditions on the List. The CCEs and WTC Health Program will 
develop additional assessment information for use by physicians in 
making determinations regarding whether an individual's 9/11 exposure 
may have contributed to, aggravated, or caused their cancer.
    Comment: One comment stated that beryllium and beryllium compounds 
should be removed as an identified exposure agent for all respiratory 
cancers listed in Table A. Among other reasons, the commenter indicated 
that the collapse of the World Trade Center was unlikely to have 
resulted in emissions of beryllium metal and beryllium compounds above 
levels found in the natural environment.
    Response: The quantitative exposures of individuals at the WTC, 
particularly during the collapse of the towers and for several days 
afterward, will likely never be fully known. While the concentrations 
of beryllium dust in settled dust samples collected from around the WTC 
sites approximate the concentrations in ``background'' samples, the 
exposure conditions that have been described (including thick dust 
clouds, individuals being coated with dust, and large deposits of dust 
in homes) result in very different exposures than would be expected to 
be found in industrial settings or in windblown dirt. The Administrator 
finds that such conditions are likely to result in large, short-term 
exposures.
    The methodology established in this final rule for adding types of 
cancer to the List includes identifying those agents categorized by 
IARC as being known, probable, or possible human carcinogens and having 
sufficient or limited evidence of carcinogenicity in humans, and by NTP 
as being known or reasonably anticipated to be human carcinogens. IARC 
and NTP findings have undergone substantial peer review and/or other 
scientific scrutiny in their development. These authoritative bodies 
have categorized beryllium and beryllium compounds as known human 
carcinogens, and IARC has determined there is sufficient evidence that 
they cause cancer of the lung.
    Comment: Several commenters recognized the important distinction 
between a cancer being included on the List of WTC-Related Health 
Conditions and the physician determination and Program certification of 
a specific cancer in an individual responder or survivor. One comment 
noted that physicians will need guidance to make a determination that a 
type of cancer is related to the September 11, 2001, terrorist attacks.
    Response: The Administrator recognizes the difficulty inherent in 
determining whether an individual's cancer can be considered WTC-
related. Guidelines for physician determinations regarding WTC-related 
health conditions are jointly developed by the CCEs and the WTC Health 
Program for all conditions on the List. The CCEs and WTC Health Program 
will develop additional assessment information for use by physicians in 
making determinations regarding whether an individual's 9/11 exposure 
may have contributed to, aggravated, or caused their cancer.
    Comment: One commenter asked that the Administrator exercise 
authority under the PHS Act to ``cover a specific type of cancer in 
individual cases, notwithstanding the review and determination of when 
to generally add a type of cancer to the list of covered WTC 
conditions.''
    Response: The Administrator will use his authority under sec. 3312 
of the Act and as detailed in 42 CFR 88.13 to cover a condition 
medically-associated with a condition on the List of WTC-Related Health 
conditions, as appropriate.
    Comment: The Administrator received a number of comments

[[Page 56147]]

requesting the addition of one or more types of cancer. Six commenters 
asked that cancer of the prostate be added to the List. One commenter 
asked that cancers of the brain and pancreas also be added to the List. 
Another commenter asked for the addition of melanoma, thyroid, and non-
Hodgkin lymphoma to the List. One of the commenters stated that the 
Administrator did not address a STAC recommendation to add pre-
malignant and myelodysplastic diseases.
    Response: The issue of whether to recommend the addition of cancers 
of the prostate, brain, and pancreas to the List of WTC-Related Health 
Conditions was considered and discussed by the STAC in the open meeting 
on March 28, 2012. In those discussions, the STAC considered the 
available evidence for recommending the addition of cancers of the 
prostate, brain, and pancreas, including the epidemiologic evidence and 
the NTP and IARC reviews. Following its deliberation on the matter, the 
STAC voted not to include prostate, brain, or pancreatic cancer in its 
recommendation.\14\ The Administrator concurs with the decision of the 
STAC and is not adding these cancers to the List of WTC-Related Health 
Conditions at this time. The addition of these cancers may be 
reconsidered if additional information on the association of 9/11 
exposures and those cancer outcomes becomes available. Regarding the 
request to add melanoma, thyroid cancer, and non-Hodgkin lymphoma, this 
final rule specifically includes the addition of melanoma, thyroid 
cancer, and non-Hodgkin lymphoma to the List of WTC-Related Health 
Conditions. Finally, the Administrator acknowledges that the STAC's 
recommendation to add pre-malignant and myelodysplastic diseases was 
not adopted. This final rule only addresses adding types of cancer to 
the List. The inclusion of pre-malignant or non-malignant conditions, 
such as myelodysplastic diseases, may be considered at a later time.
---------------------------------------------------------------------------

    \14\ See STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) Letter from Elizabeth Ward, Chair, to 
John Howard, MD, Administrator [2012]. This letter is included in 
the docket for this rulemaking. See 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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    The USPSTF recommends breast cancer screening using biennial 
mammography for women beginning at age 40. HHS assumed that the 
population of responders was 12 percent female and the population of 
survivors was 50 percent female. Based on age distribution information 
available, HHS estimated the number of women eligible for screening 
between 2013 and 2016. For those screened in 2013 HHS predicted repeat 
screening in 2015 and for those screened in 2014 HHS predicted repeat 
screening in 2016. The cost of a mammogram was estimated at $139.32 
based on FECA rates for mammography.\37\
---------------------------------------------------------------------------

    \37\ FECA rates for Mammography for New York; FECA code 77057.
---------------------------------------------------------------------------

    Some responders and survivors enrolled or expected to enroll in the 
WTC Health Program already have or have access to medical insurance 
coverage by private health insurance, employer-provided insurance, 
Medicare, or Medicaid. Therefore, costs to the WTC Health Program can 
be divided between societal costs and transfer payments.
    To describe these societal costs and transfers, the following 
assumptions were used. For the period of coverage between January 1, 
2013 and December 31, 2013, HHS has assumed that 16.3 percent of the 
survivor population will be uninsured, or based on grandfathered 
enrollment of responders, 16,925 are covered by the FDNY health plan, 
while 39,482 are listed as general responders and include construction 
workers, contractors, and others. For this analysis, HHS assumed that 
the non-FDNY general responders and all future responder-enrollees are 
uninsured at the same 16.3 percent rate that HHS applied to the 
survivor population, based on those without insurance coverage in the 
general U.S. population.\38\ Ward et al.\39\ found that access to 
health care services, quality of care received, stage of disease at 
diagnosis, and survival outcomes for cancer patients varied according 
to socioeconomic status and demographic characteristics.
---------------------------------------------------------------------------

    \38\ U.S. Census Bureau [2011]. Current Population Survey. 
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.
---------------------------------------------------------------------------

    Additionally, after the implementation of provisions of the ACA on 
January 1, 2014, all of the enrollees and future enrollees can be 
assumed to have or have access to medical insurance coverage other than 
through the WTC Health Program. Therefore, all treatment costs to be 
paid by the WTC Health Program from 2014 through 2016 are considered 
transfers.
    Table I describes the allocation of WTC Health Program costs 
between societal costs and transfer payments based on 55,000 responders 
and 5,000 survivors and, alternatively, 80,000 responders and 30,000 
survivors.

  Table I--Breakdown of Estimated Annual WTC Health Program Costs and Transfers, 80,000 & 55,000 Responders and
                                  30,000 and 5,000 Survivors, 2013-2016, 2011$
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
                                                  Societal Costs for 2013, 2011$
                                                  Annualized Transfers for 2013-
                                                            2016, 2011$
                                                                                 -------------------------------
                                                   Based on the 16.3 percent of    Discounted at   Discounted at
                                                      general responders and         7 percent       3 percent
                                                   survivors who are expected to
                                                           be uninsured
                                                 ---------------------------------------------------------------
                                                            Cancer rate
                                                            Cancer rate
                                                 ---------------------------------------------------------------
                                                   U.S. average     U.S. + 21%     U.S. average     U.S. + 21%
----------------------------------------------------------------------------------------------------------------
55,000 Responders...............................      $1,648,706  ..............     $10,172,308  ..............
5,000 Survivors.................................         271,427  ..............       1,572,907  ..............
Colorectal and Breast Screening.................         204,491  ..............         713,321  ..............
                                                 ---------------------------------------------------------------
    60,000 Total................................       2,124,624  ..............      12,458,535  ..............
                                                 ---------------------------------------------------------------
80,000 Responders...............................  ..............       2,631,100  ..............      19,912,464
30,000 Survivors................................  ..............       1,970,560  ..............      12,124,118
Colorectal and Breast Screening.................  ..............         417,521  ..............       1,271,478
                                                 ---------------------------------------------------------------
    110,000 Total...............................  ..............       5,019,182  ..............      33,308,060
----------------------------------------------------------------------------------------------------------------

Examination of Benefits (Health Impact)
    This section describes qualitatively the potential benefits of the 
final rule in terms of the expected improvements in the health and 
health-related quality of life of potential cancer patients treated 
through the WTC Health Program, compared to no Program. The assessment 
of the health benefits for cancer patients uses the number of expected 
cancer cases that was estimated in the cost analysis section.

[[Page 56156]]

    HHS does not have information on the health of the population that 
may have been exposed to 9/11 agents and is not currently enrolled in 
the WTC Health Program. In addition, HHS has only limited information 
about health insurance and health care services for cancers caused by 
exposure to 9/11 agents and suffered by any population of responders 
and survivors, including responders and survivors currently enrolled in 
the WTC Health Program and responders and survivors not enrolled in the 
Program. For the purposes of this analysis, HHS assumes that broad 
trends on demographics and access to health insurance reported by the 
U.S. Census Bureau and health care services for cancer similar to those 
reported by Ward would apply to the population of general responders 
(those individuals who are not members of the FDNY and who meet the 
eligibility criteria in 42 CFR part 88 for WTC responders) and 
survivors both within and outside the Program. For the purposes of this 
analysis, HHS assumes that access to health insurance and health care 
services for FDNY responders within and outside the Program would be 
equivalent because this population is overwhelmingly covered by 
employer-based health insurance.
    Although HHS cannot quantify the benefits associated with the WTC 
Health Program, enrollees with cancer are expected to experience a 
higher quality of care than they would in the absence of the Program. 
Mortality and morbidity improvements for cancer patients expected to 
enroll in the WTC Health Program are anticipated because barriers may 
exist to access and delivery of quality health care services for cancer 
patients in the absence of the services provided by the WTC Health 
Program. HHS anticipates benefits to cancer patients treated through 
the WTC Health Program, who may otherwise not have access to health 
care services (16.3 percent of general responders and survivors who are 
expected to be uninsured), to accrue in 2013. Starting in 2014, 
continued implementation of the ACA will result in increased access to 
health insurance and health care services will improve for the general 
responder and survivor population that currently is uninsured.
Limitations
    The analysis presented here was limited by the dearth of verifiable 
data on the cancer status of responders and survivors who have yet to 
apply for enrollment in the WTC Health Program. Because of the limited 
data, HHS was not able to estimate benefits in terms of averted 
healthcare costs. Nor was HHS able to estimate administrative costs, or 
indirect costs, such as averted absenteeism, short and long-term 
disability, and productivity losses averted due to premature mortality.
Regulatory Alternatives
    The Administrator considered alternative approaches to the methods 
set forth in this rulemaking. One alternative would involve a 
presumption that 9/11 exposures could have resulted in the development 
of any and all types of cancer in the exposed populations. A 
presumption that any and all types of cancer could occur after exposure 
to 9/11 agents does not require any scientific evidence of a positive 
association between exposure and a type of cancer. The Administrator 
declined to determine inclusion of types of cancer based on a 
presumption approach. The STAC affirmatively rejected a recommendation 
to include any and all types of cancer to the List of WTC-Related 
Health Conditions. The Administrator made the policy decision to 
include only those types of cancer when a positive relationship has 
been established between exposure to the 9/11 agent and human cancer.
    Another alternative would be to rely on epidemiologic studies of 
the association of 9/11 exposures and the development of cancer or a 
type of cancer in 9/11-exposed populations exclusively. There are 
several limitations to using an exclusive 9/11 populations study 
approach. The Administrator finds that vast uncertainties exist in 
conducting epidemiologic studies of cancer in 9/11-exposed populations. 
For example, there exists only very limited, individual exposure data 
in 9/11-exposed populations. This lack of personal, quantitative 
exposure data impedes the definitive epidemiologic evidence that 
exposure to 9/11 agents causes certain types of cancer in responder and 
survivor populations. In addition, cancer is generally a long latency 
set of diseases which in some cases may take many years or even decades 
to manifest clinically. Requiring evidence of positive associations 
from epidemiologic studies of 9/11-exposed populations exclusively does 
not serve the best interests of WTC Health Program members.
    By expanding the scope of scientific information reviewed to 
include three complementary methods (including studies in 9/11 exposed 
populations and generally available epidemiologic criteria), the 
Administrator has developed a hierarchy of methods to guide 
consideration of whether to include types of cancers on the List of 
WTC-Related Health Conditions.
Effects on Other Agency Programs
    HHS finds that this rulemaking also has an effect on the VCF \40\ 
administered by DOJ. DOJ administers the VCF under rules promulgated at 
28 CFR part 104. The DOJ regulations define, in 28 CFR 104.2 (f), the 
term ``WTC-related health condition'' to mean ''those health conditions 
identified as WTC-related by Title I of Public Law 111-347 and by 
regulations implementing that Title.'' The preamble to the VCF final 
rule (76 FR 54115) states, ``If the WTC Health Program determines that 
certain forms of cancer should be added to the list of WTC-related 
conditions, the final rule requires the Special Master to add such 
conditions to the list of presumptively covered conditions for the 
Fund.''
---------------------------------------------------------------------------

    \40\ The September 11th Victim Compensation Fund of 2001 (VCF) 
was initially established in 2001 pursuant to Title IV of Public Law 
107-42, 115 Stat. 230 (Air Transportation Safety and System 
Stabilization Act) and was open for claims from December 21, 2001, 
through December 22, 2003. Title II of the Zadroga Act amends and 
reactivates the September 11th Victim Compensation Fund of 2001. 
Public Law 111-347. Administered through DOJ by a Special Master, 
the VCF provides compensation to any individual (or a personal 
representative of a deceased individual) who suffered physical harm 
or was killed as a result of the terrorist-related aircraft crashes 
of September 11, 2001, or the debris removal efforts that took place 
in the immediate aftermath of those crashes.
---------------------------------------------------------------------------

    Under the VCF program, compensation awards are generally calculated 
using three components: Economic loss plus non-economic loss minus 
collateral source payments. To determine economic loss, the Special 
Master considers any prior loss of earnings or other benefits related 
to employment, medical expense loss, replacement services loss, and 
loss of business or employment opportunity. The regulations provide 
presumed non-economic awards for deceased individuals. Because every 
physical injury is unique, the Special Master may determine presumed 
non-economic losses on a case-by-case basis for physically injured 
claimants. The Special Master then subtracts any collateral offsets 
received or eligible to be received. The computation of individual 
compensation due under the fund is based on factors pertinent to each 
individual claimant.
    The statute caps the total amount of funds allocated to the VCF. 
The VCF regulation at 28 CFR 104.51 provides that, ``the total amount 
of Federal funds paid for expenditures including compensation with 
respect to claims filed on or after October 3, 2011, will not exceed 
$2,775,000,000. Furthermore, the total amount of

[[Page 56157]]

Federal funds expended during the period from October 3, 2011, through 
October 3, 2016, may not exceed $875,000,000.''
    To meet these requirements, the Special Master is authorized to 
reduce the amount of compensation due to each claimant by prorating the 
total amount of the compensation award determined for each individual 
claimant. The VCF intends to establish the fraction for proration such 
that all claimants receive some payment related to their claim within 
the overall funding limitation of the program. The Special Master may 
adjust the percentage of the total award that is to be paid to eligible 
claims based on experiential information as well as estimates related 
to potential future claims and availability of funds.
    The amount of compensation that would be awarded to each of the 
living claimants who develop, or the heirs of those who died from, a 
covered type of cancer during the years 2002 through 2016, would be 
determined by individual factors considered under the VCF. Depending on 
the total number of new claims and compensation eligibility, the 
overall impact on the VCF of increasing the number of eligible VCF 
claimants as a result of adding eligible health conditions under the 
WTC Health Program may be to reduce the proration fraction that is 
applied to all VCF claimants such that the total cost to the government 
remains unchanged. The additional costs to the VCF due to processing 
and computing the entitlement for the extra claimants eligible as a 
result of having a covered type of cancer, plus the costs of paying 
newly covered claimants their prorated share of the compensation award, 
would result in amounts that will not be available to pay increased 
shares for the claimants with non-cancer conditions.

B. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
requires each agency to consider the potential impact of its 
regulations on small entities including small businesses, small 
governmental units, and small not-for-profit organizations. HHS 
believes that this rule has ``no significant economic impact upon a 
substantial number of small entities'' within the meaning of the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.).
    The WTC Health Program has contracted with the following healthcare 
providers and provider network managers to offer treatment and 
monitoring to enrolled responders and survivors: Seven CCEs, which 
serve responders and survivors in the New York City metropolitan area 
(City of New York Fire Department; Mount Sinai School of Medicine; 
Research Foundation of State University of New York; New York 
University, Bellevue Hospital Center; University of Medicine and 
Dentistry of New Jersey; Long Island Jewish Medical Center; and New 
York City Health and Hospitals Corporation); Logistics Health 
Incorporated, which manages the nationwide provider network for 
populations geographically distant from New York City; three Data 
Centers, which analyze CCE data and coordinate activities (City of New 
York Fire Department; Mount Sinai School of Medicine; and New York City 
Health and Hospitals Corporation); and Emdeon, which manages pharmacy 
benefits.
    Of these entities, six of the seven CCEs and two of the three Data 
Centers are hospitals (NAICS 622110--General Medical and Surgical 
Hospitals). The Small Business Administration (SBA) identifies as a 
small business those hospitals with average annual receipts below $34.5 
million; none of the six fall below the SBA threshold for small 
businesses. The City of New York Fire Department's Bureau of Health 
Services, which provides medical monitoring and treatment for FDNY 
members as a CCE, and provides data analysis and other services for the 
FDNY CCE as a Data Center, is considered a local government agency 
(NAICS 922160--Fire Protection), and as such cannot be considered a 
small entity by SBA. Finally, neither Logistics Health Incorporated, 
which manages the national provider network, nor Emdeon, which manages 
pharmacy benefits, (NAICS 551112--Management of Companies and 
Enterprises) falls below SBA's $7 million threshold for small 
businesses in that sector.
    Because no small businesses are impacted by this rulemaking, HHS 
certifies that this rule will not have a significant economic impact on 
a substantial number of small entities within the meaning of the RFA. 
Therefore, a regulatory flexibility analysis as provided for under RFA 
is not required.

C. Paperwork Reduction Act

    The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires 
an agency to invite public comment on, and to obtain OMB approval of, 
any regulation that requires 10 or more people to report information to 
the agency or to keep certain records. Data collection and 
recordkeeping requirements for the WTC Health Program are approved by 
OMB under ``World Trade Center Health Program Enrollment, Appeals & 
Reimbursement'' (OMB Control No. 0920-0891, exp. December 31, 2014). 
HHS has determined that no changes are needed to the information 
collection request already approved by OMB.

D. Small Business Regulatory Enforcement Fairness Act

    As required by Congress under the Small Business Regulatory 
Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), HHS will 
report the promulgation of this rule to Congress prior to its effective 
date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this final rule does not include any 
Federal mandate that may result in increased annual expenditures in 
excess of $100 million by State, local or Tribal governments in the 
aggregate, or by the private sector. However, the rule may result in an 
increase in the contribution made by New York City for treatment and 
monitoring, as required by Title XXXIII, Sec.  3331(d)(2). For 2012, 
the inflation adjusted threshold is $139 million.

F. Executive Order 12988 (Civil Justice)

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

G. Executive Order 13132 (Federalism)

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

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

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this final rule on children. 
HHS has

[[Page 56158]]

determined that the rule would have no environmental health and safety 
effect on children, although an eligible child who has been diagnosed 
with a cancer type specified in this rulemaking may seek certification 
of the condition by the Administrator.

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

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

J. Plain Writing Act of 2010

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

VIII. Final Rule

List of Subjects in 42 CFR Part 88

    Aerodigestive disorders, Appeal procedures, Cancer, Health care, 
Mental health conditions, Musculoskeletal disorders, Respiratory and 
pulmonary diseases.

    For the reasons discussed in the preamble, the Department of Health 
and Human Services amends 42 CFR part 88 as follows:

PART 88--WORLD TRADE CENTER HEALTH PROGRAM

0
1. The authority citation for part 88 continues to read as follows:

    Authority:  42 U.S.C. 300mm-300mm-61, Pub. L. 111-347, 124 Stat. 
3623.


0
2. Amend Sec.  88.1 by adding paragraph (4) to the definition of ''List 
of WTC-related health conditions'' to read as follows:


Sec.  88.1  Definitions.

* * * * *
    List of WTC-Related Health Conditions
* * * * *
    (4) Cancers: This list includes those individual cancer types 
specified in Table 1, below, according to the International 
Classification of Diseases, 10th Edition (ICD-10) and International 
Classification of Diseases, 9th Edition (ICD-9).
BILLING CODE 4161-18-P

[[Page 56159]]

[GRAPHIC] [TIFF OMITTED] TR12SE12.013


[[Page 56160]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.014


[[Page 56161]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.015


[[Page 56162]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.016


[[Page 56163]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.017


[[Page 56164]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.018


[[Page 56165]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.019


[[Page 56166]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.020


[[Page 56167]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.021


[[Page 56168]]


[GRAPHIC] [TIFF OMITTED] TR12SE12.022

* * * * *

    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]
BILLING CODE 4161-18-C