[Federal Register Volume 79, Number 32 (Tuesday, February 18, 2014)]
[Rules and Regulations]
[Pages 9100-9117]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-03370]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. CDC-2014-0004; NIOSH-268]
42 CFR Part 88
RIN 0920-AA50
World Trade Center Health Program; Amendments to List of WTC-
Related Health Conditions; Cancer; Revision
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Interim final rule.
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SUMMARY: On September 12, 2012, the Administrator of the WTC Health
Program (Administrator) published a final rule in the Federal Register
adding certain types of cancer to the List of World Trade Center (WTC)-
Related Health Conditions (List) in the WTC Health Program regulations;
an additional final rule was published on September 19, 2013 adding
prostate cancer to the List. Through the process of implementing the
addition of cancers to the List and integrating cancer coverage into
the WTC Health Program, the Administrator has identified the need to
amend the rule to remove the ICD codes and specific cancer sub-sites,
clarify the definition of ``childhood cancers,'' revise the definition
of ``rare cancers,'' and notify stakeholders that the Administrator is
revising WTC Health Program policy related to coverage of cancers of
the brain and the pancreas. No types of cancer covered by the WTC
Health Program will be removed by this action; four types of cancer--
malignant neoplasms of the brain, the cervix uteri, the pancreas, and
the testis--are newly eligible for certification as WTC-related health
conditions as a result of this action.
DATES: This interim final rule will be effective February 18, 2014. The
Administrator invites written comments from interested parties on this
interim final rule. Comments must be received by April 21, 2014.
ADDRESSES: Written Comments: You may submit comments by any of the
following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Instructions: All submissions received must include the agency name
(Centers for Disease Control and Prevention, HHS) and docket number
(CDC-2014-0004; NIOSH-268) or Regulation Identifier Number (0920-AA50)
for this rulemaking. All relevant comments, including any personal
information provided, will be posted without change to http://www.regulations.gov. For detailed instructions on submitting public
comments, see the ``Public Participation'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents, go
to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Paul Middendorf, Senior Health
Scientist, 1600 Clifton Rd. NE., MS: E-20, Atlanta, GA 30329; telephone
(404) 498-2500 (this is not a toll-free number); email
[email protected].
SUPPLEMENTARY INFORMATION:
This rule is organized as follows:
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs and Benefits
II. Public Participation
III. Background
A. WTC Health Program Statutory Authority
B. Rulemaking History
C. Need for Rulemaking
1. Table 1
2. Childhood Cancers
3. Rare Cancers
4. Cancers of the Brain and the Pancreas
IV. Rare Cancers
A. STAC Recommendation
[[Page 9101]]
B. WTC Health Program Rare Cancers Definition and Numeric
Threshold Determination
1. Rare Cancers Numeric Threshold
2. Application of Rare Cancers Numeric Threshold
V. Cancers of the Brain and the Pancreas
A. STAC Recommendation
B. WTC Health Program Determination
VI. Effects of Rulemaking on Federal Agencies
VII. Issuance of an Interim Final Rule With Immediate Effective Date
VIII. Summary of Interim Final Rule
IX. 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
I. Executive Summary
A. Purpose of Regulatory Action
The purpose of this action is to amend regulatory language added to
42 CFR 88.1 in paragraph (4) of the definition of ``List of WTC-related
health conditions'' by the final rule published in the Federal Register
on September 12, 2012 (77 FR 56138) and announce a revision to the
Administrator's decision to exclude certain types of cancer from WTC
Health Program coverage. The Administrator has found that a detailed
list of sub-codes unnecessarily constrains the WTC Health Program's
ability to appropriately identify which members' cancers are eligible
for certification. The Administrator has also identified the need to
clarify that childhood cancers are cancers that are first diagnosed in
a person under the age of 20 years. The current definition does not
clearly indicate that the Administrator has always intended to certify
cases of cancer in WTC Program members who were under the age of 20
when they were first diagnosed, even though they may be over the age of
20 when they enter the WTC Health Program. Finally, the Administrator
has also identified problems with the definition of ``rare cancers''
established in Sec. 88.1.\1\ In application, the definition has proven
confusing and imprecise, reflecting neither the intent of the
Administrator nor the concern of the WTC Health Program Scientific/
Technical Advisory Committee (STAC) that led the STAC to recommend
adding such a category of cancers.
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\1\ Rare cancers were defined in Table 1 as, ``Any type of
cancer affecting the [sic] populations smaller than 200,000
individuals in the Unites [sic] States, i.e., occurring at an
incidence rate less than 0.08 percent of the U.S. population. Rare
cancers will be determined on a case-by-case basis.''
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In addition, the Administrator has found it appropriate to
reconsider and reverse the WTC Health Program policy to deny
certification of cases of malignant neoplasms of the brain (brain
cancer) and the pancreas (pancreatic cancer) as WTC-Related Health
Conditions. With this rulemaking, these two types of cancer become
eligible for certification and Program coverage.
B. Summary of Major Provisions
The Administrator is striking the regulatory language indicating
that covered cancer types would be specified by medical diagnostic
codes (ICD-9 \2\ and ICD-10 \3\). The rule is further amended to remove
Table 1 in its entirety and to replace it with the narrative list of 24
broadly specified cancer types by body organ or region identified by
the September 2012 final rule and in a subsequent final rulemaking
published September 19, 2013 adding prostate cancer to the List.
Although the codes and subcodes have been removed, all of the
specifically identified types of cancers that were included in Table 1
are still covered by the Program.
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\2\ WHO (World Health Organization) [1978]. International
Classification of Diseases, Ninth Revision. Geneva: World Health
Organization.
\3\ WHO (World Health Organization) [1997]. International
Classification of Diseases, Tenth Revision. Geneva: World Health
Organization.
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The Administrator is amending the definition of ``childhood
cancers'' to clarify that childhood cancers are any type of cancer
diagnosed in a person less than 20 years of age.
The Administrator is amending the definition of ``rare cancers'' to
revise the numeric threshold which determines those cancers which are
considered rare. This amendment will result in two additional types of
cancer meeting the definition of ``rare cancers'' and being eligible
for coverage--malignant neoplasm of the cervix uteri (invasive cervical
cancer) and malignant neoplasm of the testis (testicular cancer). (See
discussion in Section IV.B., below.)
The Administrator also announces that he has reviewed and reversed
the policy of considering cancers of the brain and the pancreas
ineligible for WTC Health Program coverage. With this rule, the
Administrator establishes that these two types of cancer will now be
considered eligible for coverage as rare cancers.
C. Costs and Benefits
The total costs and benefits resulting from this regulatory action
are due to brain cancer, invasive cervical cancer, pancreatic cancer,
and testicular cancer being eligible for coverage by the Program as
``rare cancers.'' The Administrator estimates the costs of medical
treatment for the four cancers now considered eligible under the
definition of rare cancers, as well as screening costs associated with
invasive cervical cancer, to be between $2,287,933 and $4,933,280
annually for FY 2014 through FY 2016.
II. Public Participation
Interested persons or organizations are invited to participate in
this rulemaking by submitting written views, opinions, recommendations,
and/or data. Comments are invited on any topic related to this interim
final rule. In addition, the Administrator invites comments
specifically on the following question related to this rulemaking:
1. What incidence per 100,000 persons per year in the United States
(``incidence rate'') should be used by the WTC Health Program as the
threshold for determining whether a type of cancer is rare in relation
to the incidence rates for all types of cancer in the U.S. population?
Please provide a justification for the suggested incidence rate.
Comments received, including attachments and other supporting
materials, are part of the public record and subject to public
disclosure. Do not include any information in your comment or
supporting materials that you consider confidential or inappropriate
for public disclosure. The Administrator will consider the comments
submitted and may revise the final rule as appropriate.
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 Public Health Service Act (PHS Act)
to add Title XXXIII \4\ establishing the WTC Health Program within the
Department of Health and Human Services (HHS). The WTC Health Program
provides medical monitoring and treatment
[[Page 9102]]
benefits to eligible firefighters and related personnel, law
enforcement officers, and rescue, recovery, and cleanup workers
(responders) who responded to the September 11, 2001, terrorist attacks
in New York City, at the Pentagon, and in Shanksville, Pennsylvania,
and to eligible persons (survivors) who were present in the dust or
dust cloud on September 11, 2001 or who worked, resided, or attended
school, childcare, or adult daycare in the New York City disaster area.
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\4\ Title XXXIII of the PHS Act is codified at 42 U.S.C. 300mm
to 300mm-61. Those portions of the Zadroga Act found in Titles II
and III of Public Law 111-347 do not pertain to the WTC Health
Program and are codified elsewhere.
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All references to the Administrator of the WTC Health Program in
this rule mean the National Institute for Occupational Safety and
Health (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 (List) codified in 42 CFR 88.1.
B. Rulemaking History
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 of WTC-Related
Health Conditions specified in Sec. 88.1. On October 5, 2011, the
Administrator formally exercised his option to request a recommendation
from the STAC regarding the petition.\5\ 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.'' \6\
In response, the STAC submitted its recommendation on April 2, 2012.
After considering the STAC's recommendation, the Administrator issued a
notice of proposed rulemaking on June 13, 2012 (77 FR 35574). On
September 12, 2012, the Administrator published a final rule in the
Federal Register adding certain types of cancer \7\ to the List of WTC-
Related Health Conditions in 42 CFR 88.1 (77 FR 56138).\8\ On May 2,
2013, the Administrator received a written petition to add prostate
cancer to the List (Petition 002). After considering the petition, the
Administrator published a notice of proposed rulemaking on July 2, 2013
(78 FR 39670) and a final rule on September 19, 2013 (78 FR 57505)
adding prostate cancer to the List.
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\5\ PHS Act, sec. 3312(a)(6)(B)(i); 42 CFR 88.17(a)(2)(i).
\6\ 77 FR 35574, 35576 (June 13, 2012).
\7\ Including a categorical definition of childhood cancers,
which includes any type of cancer diagnosed in an individual under
the age of 20 years.
\8\ On October 12, 2012, the Administrator published a Federal
Register notice to correct errors in Table 1 of the final rule (the
list of cancers covered by the Program) (77 FR 62167).
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C. Need for Rulemaking
1. Table 1
The final rule adding certain types of cancer to the List became
effective on October 12, 2012 (the addition of prostate cancer became
effective October 21, 2013). Since that time, the WTC Health Program
has worked to develop guidelines and procedures to incorporate those
types of cancers into existing Program health condition certification
practices. However, during the first year of implementation, the
Program discovered that the complex process of translating the ICD-9
codes to ICD-10 codes has resulted in confusion among Program medical
staff and Clinical Centers of Excellence (CCEs) and Nationwide Provider
Network physicians. The Administrator finds that the detailed list of
ICD codes in Table 1, including sub-codes, is inappropriately
restrictive and often results in coding errors. For instance, CCE
physicians have at times submitted requests for certification using a
different ICD code for the listed cancer type than the Administrator
used in Table 1. ICD codes are highly nuanced and, for some cancers,
choosing the precise code may be a matter of professional judgment on
the part of the physician making a health condition determination. When
a physician submits an ICD code that differs from codes included in
Table 1, the Administrator must then determine whether the specific
code chosen by the physician references a type of cancer that was
actually intended to be covered by the Program or could be otherwise
correctly characterized. In some instances, the determining physician
used a different or more-specific subcode than was included in the
List; however, after review, the Administrator agreed that the type of
cancer submitted by the physician fits within the intent of the final
rule on cancer. A detailed list of sub-codes is unnecessary, confusing
to providers, and limits the WTC Health Program's ability to
appropriately identify which members' cancers are eligible for
certification, therefore, the Administrator is replacing Table 1 with a
narrative list of cancer categories.
2. Childhood Cancers
The Administrator has also identified the need to clarify that
childhood cancers are cancers that are first diagnosed in a person
under the age of 20 years. The current definition does not clearly
indicate that the Administrator has always intended to certify cases of
cancer in WTC Health Program members who were under the age of 20 when
they were first diagnosed, even though they may be over the age of 20
when they enter the WTC Health Program. The existing language could be
interpreted to mean that only a WTC Health Program member under the age
of 20 years can be certified for treatment of a WTC-related childhood
cancer. The revised language clarifies that a childhood cancer is
defined based on age at diagnosis rather than the current age of the
WTC Health Program member.
3. Rare Cancers
In addition to the detailed list of ICD codes, the Program has also
identified problems with the definition of ``rare cancers'' established
in Sec. 88.1.\9\ In application, the definition has proven confusing
and imprecise, reflecting neither the intent of the Administrator nor
the STAC's concern regarding difficulties identifying associations
between exposure and some cancers in epidemiologic studies.
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\9\ Rare cancers were defined in Table 1 as, ``Any type of
cancer affecting the [sic] populations smaller than 200,000
individuals in the Unites States, i.e., occurring at an incidence
rate less than 0.08 percent of the U.S. population. Rare cancers
will be determined on a case-by-case basis.''
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The Administrator has identified several problems with the
definition of rare cancers for the purpose of identifying such
conditions for WTC Health Program coverage as specified in 42 CFR 88.1.
First, the original definition was derived from the Rare Diseases Act
of 2002, which states that, ``[r]are diseases and disorders are those
which affect small patient populations, typically populations smaller
than 200,000 individuals in the United States.''\10\ The Rare Diseases
Act addresses the rarity of disease as considered against all possible
types of diseases, which is different than the Administrator's intent
to define the rarity of a type of cancer as considered against all
types of cancer only.
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\10\ Public Law 107-280, sec. 2(a)(1); 42 U.S.C. 283h(c).
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Second, the Rare Diseases Act establishes the threshold for the
number of cases qualifying a disease as rare using ``prevalence''
(i.e., the number of persons in the United States living with a
particular disease) instead of
[[Page 9103]]
``incidence'' (i.e., the number of persons in the United States that
acquire a particular disease over a given time period). Because life
expectancy varies greatly across cancer types, some cancers occur
infrequently but have a high survival rate and therefore a high
prevalence. Similarly, cancers that occur more frequently but have a
high mortality rate have a low prevalence. As a result, the prevalence
of a type of cancer varies substantially depending on the life
expectancy associated with the cancer type. Therefore, the
Administrator finds that incidence is a more useful and appropriate
indicator to select a rarity threshold for cancer.
Third, the ``case-by-case basis'' text is misleading. There is no
case-specific approach to ``determine'' which cancers would qualify as
rare cancers. Rare cancers will be determined based on their incidence
as specified in this rule.
4. Cancers of the Brain and the Pancreas
In the preamble to the September 12, 2012 final rule, the
Administrator concurred with the STAC's decision to not recommend
malignant neoplasms of the brain and the pancreas for inclusion on the
List of WTC-Related Health Conditions (77 FR 56138, 56147), indicating
that no compelling evidence was found to support their inclusion:
The issue of whether to recommend the addition of cancers of the
* * * 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 * * * brain and pancreas, including the epidemiologic evidence
and the NTP [NIH's National Toxicology Program] and IARC reviews.
Following its deliberation on the matter, the STAC voted not to
include * * * brain or pancreatic cancer in its recommendation. [See
STAC (World Trade Center Health Program Scientific/Technical
Advisory Committee) Letter from Elizabeth Ward, Chair, to John
Howard, MD, Administrator [2012].] 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.\11\
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\11\ 77 FR 56138, 56147 (September 12, 2012).
As a result of that determination, the WTC Health Program denied
certification of cancers of the brain and the pancreas, even though
they were found to meet the numeric threshold in the definition of rare
cancers. After review, the Administrator has reconsidered that decision
and determined, for the reasons discussed below, that cancers of the
brain and the pancreas will be considered eligible for certification as
rare cancers. With this rulemaking, a WTC Health Program member whose
9/11 exposure is found substantially likely to be a significant factor
in aggravating, contributing to, or causing the individual's brain and/
or pancreatic cancer, will be certified for WTC Health Program
treatment services. The WTC Health Program will review and reassess
cases of brain and pancreatic cancer that were denied certification
prior to this rulemaking.
IV. Rare Cancers
A. STAC Recommendation
As noted above, the Administrator asked the STAC to deliberate and
develop recommendations on a petition to add cancers to the List of
WTC-Related Health Conditions. The STAC met on three occasions between
November 2011 and March 2012, and offered its final recommendation to
the Administrator on April 2, 2012.\12\ The STAC expressed a sense that
insufficient exposure data from the WTC terrorist attack site limited
the Committee's ability to identify specific cancers definitively
linked to the terrorist attacks.\13\ The STAC further noted the
difficulty of detecting excesses of rare cancers in epidemiologic
studies, concluding that rare cancers should be covered on a
precautionary basis.\14\ As the Administrator understands the STAC's
basis for recommending inclusion of a rare cancers category, the STAC
intended for the WTC Health Program to establish a category of types of
cancers that are sufficiently rare that such cancers are difficult to
evaluate in epidemiologic studies in general, and 9/11 cohorts in
particular.
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\12\ The STAC premised its recommendation on evidence from four
main sources: carcinogens present at the New York City attack site
with limited or sufficient evidence of carcinogenicity in humans
based on the International Agency for Research on Cancer (IARC)
Monographs on the Evaluation of Carcinogenic Risks to Humans;
cancers arising from regions of the respiratory and digestive tracts
where inflammatory conditions have been documented; cancers for
which epidemiologic studies have found some evidence of increased
risk in WTC responder and survivor populations; and 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 STAC evaluated the only peer-reviewed study available at the
time of its deliberations, an epidemiologic study of Fire Department
of New York (FDNY) firefighters conducted by Rachel Zeig-Owens and
colleagues, which was published in The Lancet in September 2011.
[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.
The Lancet. 378(9794):898-905.] This was also the only study
available to the Administrator at the time of the Petition 001
rulemaking in June and September, 2012.
\13\ STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) [2012]. Letter from Elizabeth Ward,
Chair, to John Howard MD, Administrator at 1-2. NIOSH Docket 257.
http://www.cdc.gov/niosh/docket/archive/docket257.html.
\14\ Id. at 25.
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In its April 2, 2012 letter to the Administrator, the STAC formally
recommended that the Administrator add rare cancers to the List of WTC
Related Health Conditions. According to the STAC:
Excesses in rare cancers are difficult to detect in
epidemiologic studies. Even large studies may have very low numbers
of expected cases of rare cancers, and thus very low statistical
power to detect any but very large effects. In addition, most cancer
studies analyze data by organ site, and not by site and histology.
This can result in inability to detect rare site and histology
combinations, such as angiosarcoma of the liver, associated with
vinyl chloride monomer exposure, and small cell carcinoma of the
lung, associated with bischloromethyl ether. Cancers can also be
defined as rare based on the patient's gender (male breast cancer),
age (prostate cancer in men under 40) or race (melanoma in African
Americans). Since customary study methods are unlikely to identify
increased risks for rare cancers among WTC-exposed populations
unless they occur in sizable clusters. Nonetheless, given the
sizable number of carcinogens (and related cancer sites) present in
WTC smoke and dust, it is reasonable to consider the possibility
that an increased risk of specific rare cancers may occur or that
the incidence of common cancers would be increased at younger ages
in WTC-exposed populations. One approach that has been used is to
consider rare cancers as cancers with age-adjusted incidence rates
less than 15 per 100,000, which would result in defining 25% of all
adult cancers in the US as rare. Additional definitions--10 cases
per million per year, or 1 case per million per year--have also been
examined.\15\ [citations omitted]
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\15\ STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) [2012]. Letter from Elizabeth Ward,
Chair to John Howard, MD, Administrator, at 25. This letter is
included in NIOSH Docket 257, http://www.cdc.gov/niosh/docket/archive/docket257.html.
Further, the STAC specifically referenced an incidence rate of less
than 15 cases per 100,000 population to characterize the cancer rate
among children as rare.\16\ Based on the reference to an incidence rate
of 15 cases per 100,000 persons per year in the United States, the
Administrator
[[Page 9104]]
concludes that the STAC sought to identify types of cancer that are
rare relative to other types of cancer rather than identifying cancers
that are rare diseases compared to the universe of all diseases.
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\16\ STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) [2012]. Letter from Elizabeth Ward,
Chair to John Howard, MD, Administrator, at 6. This letter is
included in NIOSH Docket 257, http://www.cdc.gov/niosh/docket/archive/docket257.html.
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B. WTC Health Program Rare Cancers Definition and Numeric Threshold
Determination
1. Rare Cancers Numeric Threshold
In the preamble to the September 2012 final rule, the Administrator
developed a four-part methodology for evaluating whether to add a type
of cancer to the List.\17\ The definition of ``rare cancers'' was
established under Method 4, which requires that the STAC provide a
reasonable basis for the inclusion of a type or category of cancer. The
Administrator found the STAC's recommendation to develop a categorical
definition of rare cancers to be reasonable, and at that time thought
it appropriate to establish a numeric threshold derived from the Rare
Diseases Act of 2002.\18\ However, in hindsight, the definition of rare
cancers created in the September 2012 WTC Health Program final rule
established a numeric threshold that reflected neither the
Administrator's nor the STAC's intent.
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\17\ 77 FR 56138, 56143.
\18\ 77 FR 35574, 35592 (June 13, 2012).
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In order to revise the definition of ``rare cancers'' and develop a
threshold better suited to WTC Health Program purposes, the
Administrator reconsidered the STAC's recommendation, and evaluated the
incidence rates used by research organizations in the United States and
Europe, including the North American Association of Central Cancer
Registries (NAACCR), the National Institutes of Health (NIH), the
International Rare Cancers Initiative (IRCI), the European Society for
Medical Oncology (ESMO), and RARECARE.
There is no single, universally agreed-upon, quantitative
definition of ``rare cancers.'' A rarity threshold is a matter on which
informed experts differ; established rarity thresholds also depend on
the purpose for which the definition is applied. The different
thresholds used by the various organizations were developed to
stimulate epidemiologic studies and clinical research on rare cancer
therapeutics; the Administrator was unable to identify any incidence
rate used by any other organizations for purposes similar to the WTC
Health Program. The European organizations IRCI, ESMO, and RARECARE use
lower incidence thresholds for rare cancers than do researchers in the
United States: IRCI uses a threshold of less than or equal to 2 cases
per 100,000 persons per year; \19\ ESMO uses a threshold of less than
or equal to 5 cases per 100,000 persons per year; \20\ and RARECARE
uses a threshold of less than or equal to 6 cases per 100,000 persons
per year.\21\ By contrast, the incidence rate employed by NAACCR is
less than 15 cases per 100,000 persons per year.\22\ This rate of less
than 15 cases per 100,000 persons per year is also used by NIH's Office
of Rare Diseases (ORD) and the National Cancer Institute's Epidemiology
and Genomics Research Program (EGRP).\23\ During a May 2007 ORD/EGRP
workshop, ``Synergizing Epidemiologic Research on Rare Cancers,''
meeting participants noted:
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\19\ International Rare Cancers Initiative. http://www.irci.info/abouttheinitiative/.
\20\ European Society for Medical Oncology. Improving Rare
Cancer Care in Europe; Recommendation on Stakeholder Actions and
Public Policies. http://www.rarecancerseurope.org/IMG/pdf/ESMO_Rare_Cancers_RECOMMENDATIONS_FINAL.pdf.
\21\ RARECARE. http://www.rarecare.eu/rarecancers/rarecancers.asp.
\22\ Greenlee RT, Goodman MT, Lynch CF, Platz CE, Havener LA,
Howe HL [2010]. The Occurrence of Rare Cancers in U.S. Adults, 1995-
2004. Public Health Reports 125:28-43.
\23\ NCI Epidemiology and Genomics Research Program. Synergizing
Epidemiologic Research on Rare Cancers, May 10-11, 2007, Bethesda,
MD. http://epi.grants.cancer.gov/Synergizing/.
[r]are cancers were defined as those cancers for which the incidence
rate is less than 15 cases per 100,000 population or fewer than
40,000 new cases per year in the United States. Although these
numbers are relatively small, all rare cancers combined account for
27 percent of cancers diagnosed each year and 25 percent of cancer-
related deaths, and the morbidity and mortality that they cause are
increasing.\24\
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\24\ Id.
The Administrator has determined that the incidence rate used by
U.S. researchers--less than 15 cases per 100,000 persons per year in
the United States--is most representative of his intent and that of the
STAC. The Administrator has further determined that, because incidence
rates change from year-to-year, rare cancers will be identified using
average annual data from the 2005-2009 period which has been age-
adjusted \25\ to the U.S. population in 2000.\26\ In other words, the
Administrator will identify each rare cancer type based on its average
incidence rate during the years 2005-2009; therefore, for each rare
cancer type, the incidence rate is static and will not be adjusted to
reflect current incidence rates. Accordingly, the threshold incidence
rate for rare cancers will be less than 15 cases per 100,000 persons
per year in the United States.
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\25\ An age-adjusted incidence rate is a weighted average of the
age-specific rates, where weighted in proportion to the number of
individuals in the corresponding age groups of a standard
population. The potential confounding effect of age is reduced when
comparing age-adjusted rates computed using the same standard
population.
\26\ Copeland G, Lake A, Firth R, Wohler B, Wu XC, Stroup A,
Russell C, Boyuk K, Schymura M, Hofferkamp J, Kohler B (eds) [2012].
Cancer in North America: 2005-2009. Volume One: Combined Cancer
Incidence for the United States, Canada and North America.
Springfield, IL: North American Association of Central Cancer
Registries, Inc.
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2. Application of Rare Cancers Numeric Threshold
All types of cancer that are not listed in 42 CFR 88.1 and that
meet the threshold of less than of 15 cases per 100,000 persons per
year (based on age-adjusted 2005-2009 average annual data) \27\ will be
considered rare cancers and eligible for certification by the Program;
members whose cancers are certified by the WTC Health Program will
receive medical treatment and services.
---------------------------------------------------------------------------
\27\ Copeland G, Lake A, Firth R, Wohler B, Wu XC, Stroup A,
Russell C, Boyuk K, Schymura M, Hofferkamp J, Kohler B (eds) [2012].
Cancer in North America: 2005-2009. Volume One: Combined Cancer
Incidence for the United States, Canada and North America.
Springfield, IL: North American Association of Central Cancer
Registries, Inc.
---------------------------------------------------------------------------
The revised numeric threshold in the definition of rare cancers
will result in two types of cancer becoming newly eligible for
consideration as rare cancers. Under the former numeric threshold in
the definition of rare cancers (prevalence of fewer than 200,000
persons), malignant neoplasms of the cervix uteri (invasive cervical
cancer) and the testis (testicular cancer) were not eligible for
coverage because their respective prevalence estimates are greater than
the threshold of 200,000 persons in the United States with these
conditions. Both invasive cervical cancer and testicular cancer,
however, will be considered rare cancers under the new definition
because their incidence rates are less than 15 cases per 100,000
persons per year in the United States based on age-adjusted 2005-2009
average annual data.\28\ Moreover, all types of cancer which are
considered rare under the former prevalence-based definition based on
the Rare Diseases Act definition are also considered rare under the new
incidence-based definition.
---------------------------------------------------------------------------
\28\ Id.
---------------------------------------------------------------------------
V. Cancers of the Brain and the Pancreas
A. STAC Recommendation
During a meeting held on March 28, 2012, STAC members discussed
[[Page 9105]]
evidence of associations between 9/11 exposures and cancers of the
brain and the pancreas, and voted to not recommend cancers of the brain
or the pancreas for inclusion as specifically-identified cancers on the
List of WTC-Related Health Conditions. The Committee Chair acknowledged
that coverage of brain cancer as a rare cancer would depend on the
categorical definition of rare cancer adopted by the Administrator;
however, the matter of whether brain and pancreatic cancers should be
eligible for consideration as ``rare cancers'' was not brought to a
formal vote.\29\ The Administrator understands that the STAC was
distinguishing between the standard for a specific cancer type to be
named to the List, and the relatively lower standard for a cancer type
to fall under the definition of rare cancers, which is predicated on
the condition that those cancers occur so infrequently that
epidemiologic study would be difficult and usually inconclusive.
---------------------------------------------------------------------------
\29\ STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) March 28, 2012 meeting transcript at
102. NIOSH Docket 248. http://www.cdc.gov/niosh/docket/archive/docket248.html.
---------------------------------------------------------------------------
B. WTC Health Program Determination
When applying the Administrator's four-part methodology established
in the September 12, 2012 final rule, neither cancers of the brain nor
the pancreas were found to satisfy any of the four methods.\30\
Additionally, although the STAC voted specifically not to recommend
adding malignant neoplasms of either the brain or the pancreas to the
List of WTC-Related Health Conditions, the STAC did recommend that the
Administrator establish a definition of rare cancers (as discussed
above, rare cancers were added to the List using Method 4, which
requires that the STAC provide a reasonable basis for inclusion).\31\
Considering the numeric thresholds in both the former and revised
definitions of rare cancers, malignant neoplasms of both the brain and
the pancreas meet the definition of rare cancers. As discussed below,
after reconsideration of the STAC recommendation and re-evaluation of
the available scientific evidence, the Administrator finds it
appropriate to revise his prior decision to exclude cancers of the
brain and the pancreas from consideration under the rare cancers
category and allow these two cancers to be recognized as ``rare,'' for
the purposes of the WTC Health Program, and therefore eligible for
certification.
---------------------------------------------------------------------------
\30\ 77 FR 56138 (September 12, 2012).
\31\ Id. at 56144 (September 12, 2012).
---------------------------------------------------------------------------
The rationale provided by the STAC for the inclusion of rare
cancers as a category on the List was that there is large uncertainty
in associating a rare cancer to a specific exposure. Most rare cancers
have not been adequately investigated in epidemiologic studies and the
relatively small number of cases of such cancers may preclude
epidemiologic study in the future. Moreover, future epidemiologic study
of the small number of expected cancer cases in the 9/11-exposed
population would be of little help in determining an association
between 9/11 exposures and most types of cancer. Although malignant
neoplasms of the brain and the pancreas qualify as rare cancers under
various numeric thresholds,\32\ the Administrator determined, pursuant
to the September 2012 final rulemaking, that neither type of cancer
would be considered a rare cancer within the WTC Health Program. That
determination was premised on the availability of numerous published
studies which did not support an association between brain and
pancreatic cancers and environmental agents, including certain agents
identified in 9/11 exposure assessment studies. In the September 2012
final rule, the Administrator distinguished malignant neoplasms of the
brain and the pancreas from other rare cancers for which evidence of
causation by environmental or occupational exposure is lacking and for
which there is little likelihood that statistically significant
evidence of association with 9/11 exposures can be obtained through
epidemiologic studies. Other rare cancers were considered WTC-related
health conditions because limitations in the available information did
not allow their relationships to the September 11, 2001, terrorist
attacks to be adequately studied in the published epidemiologic studies
and are not likely to be adequately studied in the near future.
---------------------------------------------------------------------------
\32\ Brain and pancreatic cancers each meet both the previous
prevalence-based numeric threshold and the new incidence-based
numeric threshold established in this interim final rule to be
considered rare within the WTC Health Program.
---------------------------------------------------------------------------
At the time of the September 2012 final rulemaking, in accordance
with the STAC's stated basis for recommending the inclusion of a rare
cancers category (see prior discussion, Section IV.A.), the
Administrator had interpreted the presence of many studies addressing
brain and pancreatic cancer as an indication that they could be
studied, and that associations would be identified if present; he
originally determined that those studies indicate that neither cancers
of the brain nor the pancreas are associated with the exposures
experienced by WTC responders and survivors, and therefore they could
not be considered WTC-related.
In the process of revising the definition of rare cancers, the
Administrator re-visited the STAC's rationale for including the
category of rare cancers. During its March 2012 meeting, the STAC
considered the exposure data collected in the days following the
September 11, 2001, terrorist attacks, and found it extremely limited.
STAC members acknowledged the difficulties in attempting to identify
associations between 9/11 exposures and specific cancer types. This
sentiment was clearly expressed by the STAC Chair, who stated, ``we
know something but we don't know everything'' with regard to 9/11
exposures.\33\ Following his review of the STAC's findings, the
Administrator has reconsidered his previous determination. He concurs
with concerns expressed by the STAC, including one STAC member's
recognition that for many types of cancer, such as brain cancer, there
are difficulties in identifying associations with environmental and
occupational exposures.\34\ Upon further reflection, the Administrator
finds it appropriate to take a more cautious approach when excluding
rare cancers from WTC Health Program coverage.
---------------------------------------------------------------------------
\33\ STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) February 15, 2012 meeting transcript
at 160. NIOSH Docket 248. http://www.cdc.gov/niosh/docket/archive/docket248.html.
\34\ STAC (World Trade Center Health Program Scientific/
Technical Advisory Committee) March 28, 2012 meeting transcript at
45. NIOSH Docket 248. http://www.cdc.gov/niosh/docket/archive/docket248.html.
---------------------------------------------------------------------------
The Administrator now finds that while brain cancer or pancreatic
cancer may be evaluated in a number of epidemiologic studies, the
limitations of those studies are substantial, leading the Administrator
to conclude that the uncertainties surrounding the causes of brain and
pancreatic cancers are not unlike the uncertainties surrounding other
rare cancers. The Administrator reviewed epidemiologic studies of brain
and pancreatic cancers involving some of the carcinogens involved in 9/
11 exposures and identified five significant study limitations: (1) The
low frequency of and difficulty in diagnosing cancers of the brain and
pancreas; \35\ (2) the
[[Page 9106]]
difficulty in identifying appropriate referent populations (ideally,
referent populations would have very similar demographic
characteristics and exposures except for the agent being studied); \36\
(3) the difficulty of conducting studies of brain or pancreatic
cancers, which typically have long latency periods, before disease
symptoms might manifest in exposed individuals; \37\ (4) inaccurate or
inconsistent exposure assessment; \38\ and (5) observations of multiple
health effects which may identify statistically significant increases
in brain or pancreatic cancers by chance.\39\ The limitations
identified in this review are consistent with the findings from other
reviews of rare cancers.\40\
---------------------------------------------------------------------------
\35\ Anntila A, Pukkala E, Sallmen M, Hernberg S, Hemminki K
[1995]. Cancer incidence among Finnish workers exposed to
halogenated hydrocarbons. JOEM 37:797-806; Blair A, Grauman DJ,
Lubin JH, Fraumeni JF [1983]. Lung cancer and other causes of death
among licensed pesticide applicators. JNCI 71:31-37; Davis JR,
Brownson, Garcia, R, Bentz BJ, Turner A [1993]. Family pesticide use
and childhood brain cancer. Arch Environ Contam Toxicol 24:87-92;
Garabrant DH, Held J, Langholz B, Bernstein L [1988]. Mortality of
aircraft manufacturing workers in Southern California. Am J Ind Med
13:683-693; IARC (International Agency for Research on Cancer)
[2009]. IARC monographs on the evaluation of carcinogenic risks to
humans. Vol 100 Part C: Arsenic, metals, fibres and dusts. Lyon,
France; Li J, Cone JE, Kahn AR, Brackbill RM, Farfel MR, Greene CM,
Hadler JL, Stayner LT, Stellman ST [2012]. Association between World
Trade Center exposure and excess cancer risk. JAMA 308:2479-2488;
Pesatori AC, Sontag JM, Lubin JH, Consonni D, Blair A [1994]. Cohort
mortality and nested case-control study of lung cancer among
structural pest control workers in Florida (United States). Cancer
Cause Control 5:310-318; Spirtas R, Steward PA, Lee JS, Marano DE,
Forbes, CD, Grauman DJ, Pettigrew HM, Blair A, Hoover RN, Cohen JL
[1991]. Retrospective cohort mortality study of workers at an
aircraft maintenance facility. I Epidemiologic results. Br J Ind Med
48:515-530; Stroup NE., Blair A, Erikson GE [1986]. Brain cancer and
other causes of death in anatomists. JNCI 77:1217-1224; Zeig-Owens
R, Webber MP, Hall CB, Schwartz T, Javer 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. The Lancet 378:898-
905.
\36\ Blair et al. [1983]; Stroup et al. [1986]; Zeig-Owens et
al. [2011].
\37\ Garabrant et al. [1988]; Hauptman M, Lubin JH, Stewart
PA,Hayes R, Blair A [2004]. Mortality from cancers among workers in
formaldehyde industries. Am J Epidemiol 159:1117-1130; Solan S,
Wallenstein S, Shapiro M, Teitelbaum SL, Stevenson L, Kochman A,
Kaplan J, Dellenbaugh C, Kahn A, Biro FN, Crane M, Crowley L,
Gabrilove J, Gonsalves L, Harrison D, Herbert R, Luft B, Markowitz
SB, Moline J, Niu X, Sacks H, Shukla G, Udasin I, Lucchini RG,
Boffetta P, Landrigan PJ. [2013] Cancer incidence in World Trade
Center rescue and recovery workers, 2001-2008. Environ Health
Perspect 121(6):699-704; Zeig-Owens et al. [2011].
\38\ Anntila et al. [1995]; Blair et al. [1983]; Coggon D,
Harris EC, Poole J, Palmer KT [2003]. Extended follow-up of a cohort
of British chemical workers exposed to formaldehyde. JNCI 95:1608-
1615; Davis JR, Brownson, Garcia, R, Bentz BJ, Turner A [1993].
Family pesticide use and childhood brain cancer. Arch Environ Contam
Toxicol 24:87-92; Hauptmann et al. [2004]; Pan SY, Ugnat AM, Mao Y
[2005]. Canadian Cancer Registries Epidemiology Research Group.
Occupational risk factors for brain cancer in Canada. J Occup
Environ Med 47: 704-717; Solan et al. [2013]; Spirtas et al. [1991].
\39\ Davis et al. [1993]; Li et al. [2012]; Pan et al. [2005].
The identification of this limitation offers further evidence of the
uncertainties associated with identifying causes of brain and
pancreatic cancer.
\40\ Charbotel B, Fervers B, Droz JP [2013]. Occupational
exposures in rare cancers: a critical review of the literature. Crit
Rev Oncol/Hematol. http://dx.doi.org/10.1016/j.critrevonc.2013.12.004.
---------------------------------------------------------------------------
Upon re-evaluation of these studies, the Administrator finds that
brain or pancreatic cancer may be associated with an exposure, but the
studies' limitations prevent adequate evaluation of this association.
Accordingly, the Administrator has determined that the availability of
numerous studies evaluating the associations between brain and
pancreatic cancers and environmental exposures should not be given more
weight in his decision-making than the inherent limitations of these
studies. While the Administrator previously relied on the lack of an
identified association between environmental exposures and brain or
pancreatic cancers in these epidemiologic studies to conclude that they
should not be considered WTC-related, he now determines that those
studies are not likely to identify associations because of study
limitations and concludes that, because the uncertainty associated with
brain and pancreatic cancers is similar to the uncertainty associated
with other rare cancers, they should be similarly eligible for
consideration as WTC-related.
For the reasons discussed above, the Administrator has determined
that brain and pancreatic cancers are considered rare cancers, and that
they are eligible for WTC Health Program certification.
VI. 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 11th Victim
Compensation Fund (VCF). Administered by the U.S. Department of 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.\41\
---------------------------------------------------------------------------
\41\ 28 CFR 104.21.
---------------------------------------------------------------------------
VII. Issuance of an Interim Final Rule With Immediate Effective Date
In accordance with the provisions of the Administrative Procedure
Act at 5 U.S.C. 553(b)(3)(B), the Administrator finds good cause to
waive the use of prior notice and comment procedures for issuing this
interim final rule (IFR), and that the use of such procedures would be
contrary to the public interest. This IFR amends 42 CFR 88.1 to remove
Table 1 and replace it with a narrative list of covered cancers,
clarify the definition of childhood cancers, and revise the definition
of rare cancers; it also notifies stakeholders that the Administrator
now considers malignant neoplasms of the brain and the pancreas to be
eligible for coverage as rare cancers. The Administrator has determined
that it is contrary to the public interest to delay these necessary
amendments. Postponement of the implementation of these amendments
could result in real harm to those individuals who are currently
suffering from a subtype of cancer that was inadvertently excluded from
the detailed list of cancer codes, or from a rare cancer that was not
identified by the former prevalence-based numeric threshold (U.S.
population size of 200,000 persons), or from cancer of the brain or the
pancreas. Thus, the Administrator is waiving the prior notice and
comment procedures in the interest of protecting the health of WTC
Health Program members whose cancer may now be eligible for
certification.
The amendments to replace Table 1 with a narrative list of covered
cancers and clarify the definition of childhood cancers will not result
in any substantive change to the types of cancers added to the List of
WTC-Related Health Conditions by the final rule published on September
12, 2012 (77 FR 56138) or by the final rule published on September 19,
2013 adding prostate cancer (78 FR 57505); however, changing the
numeric threshold for rare cancers will result in of two types of
cancer becoming newly eligible for consideration as rare cancers.
Additionally, cancers of the brain and the pancreas may now be
considered for certification as rare cancers. The Administrator expects
that most stakeholders will be supportive of the amendments, because
the determinations established in this rulemaking will result in more
WTC Health Program members becoming eligible for certification of a
WTC-
[[Page 9107]]
Related Health Condition. Interested parties were given an opportunity
to comment on the covered cancers during the June 2012 notice of
proposed rulemaking's 30-day public comment period. During the public
comment period for the initial notice of proposed rulemaking, no
commenters reflected on the proposed definition of ``rare cancers.''
Under 5 U.S.C. 553(d)(3), the Administrator finds good cause to
make this IFR effective immediately. As stated above, in order to
ensure that the WTC Health Program is able to promptly respond to a
member WTC responder or survivor who is suffering from a type of cancer
that may now be eligible for certification, including individuals who
may have been denied certification for brain or pancreatic cancer, it
is necessary that the Administrator act quickly to promulgate the
amendments discussed above. While the amendments to Sec. 88.1 are
effective on the date of publication of this IFR, they are interim and
will be finalized following the receipt of any substantive public
comments. (See Section II.)
VIII. Summary of Interim Final Rule
For the reasons discussed above, the Administrator of the WTC
Health Program is amending 42 CFR 88.1, paragraph (4) of the definition
of ``List of WTC-related health conditions,'' to strike the former
regulatory language indicating that covered cancer types would be
specified by ICD-10 and ICD-9 codes. The rule is further amended to
remove Table 1 in its entirety and to replace it with the narrative
list of 24 broadly specified cancer types by body organ or region
included in both the 2012 notice of proposed rulemaking and final rule
preambles, as well as prostate cancer which was added to the List in
the September 2013 rulemaking.\42\ Although the codes and subcodes are
removed, all of the specifically identified types of cancers that were
added to the List of WTC-Related Health Conditions by the September 12,
2012 final rule, and which were identified in Table 1 (as well as
prostate cancer, added by the September 19, 2013 final rule), remain
covered by the Program. This amendment will have the effect of
retaining all of the currently covered cancer types but will allow WTC
Health Program staff to administratively determine the corresponding
codes for the specific types of cancer covered by the Program,
regardless of classification system (ICD-9, ICD-10, etc.).
---------------------------------------------------------------------------
\42\ NPRM 77 FR 35574, 35589-35592 (June 13, 2012); Final rule
77 FR 56138, 56144 (September 12, 2012). A notice of proposed
rulemaking proposing to add prostate cancer to the List of WTC-
Related Health Conditions was published on July 2, 2013 (78 FR
39670), and a final rule was published on September 19, 2013 (78 FR
57505).
---------------------------------------------------------------------------
For the reasons discussed above, the Administrator clarifying the
definition of ``childhood cancers'' to replace the words ``occurring
in'' with ``diagnosed in.''
Finally, the Administrator is also revising the definition of
``rare cancers'' to remove the 200,000 persons prevalence and 0.08
percent incidence rate in the former definition and instead reflect the
revised incidence rate, less than 15 cases per 100,000 persons per year
in the United States based on 2005-2009 average annual data.\43\ The
phrase ``Rare cancers will be determined on a case-by-case basis'' is
stricken.
---------------------------------------------------------------------------
\43\ Copeland G, Lake A, Firth R, Wohler B,Wu XC, Stroup A,
Russell C, Boyuk K, Schymura M, Hofferkamp J, Kohler B (eds) [2012].
Cancer in North America: 2005-2009. Volume One: Combined Cancer
Incidence for the United States, Canada and North America.
Springfield, IL: North American Association of Central Cancer
Registries, Inc.
---------------------------------------------------------------------------
IX. 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 interim final rule has been determined not to be a
``significant regulatory action'' under sec. 3(f) of E.O. 12866. The
amendments in this rule modify the format of the list of named cancers
covered by the WTC Health Program, clarify the definition of
``childhood cancers,'' and modify the definition of ``rare cancers.''
In addition to amendments to the rule text, in this action the
Administrator also recognizes malignant neoplasms of the brain and the
pancreas as rare cancers. The revised definition and determinations
regarding ``rare cancers,'' have resulted in four additional cancer
types being considered eligible for coverage under the Program: Brain
cancer (malignant neoplasm of the brain), invasive cervical cancer
(malignant neoplasm of the cervix uteri), pancreatic cancer (malignant
neoplasm of the pancreas), and testicular cancer (malignant neoplasm of
the testis). Treatment and monitoring services for these four cancer
types is estimated to cost the WTC Health Program between $2,287,933
\44\ and $4,933,280 \45\ annually. All of the costs to the WTC Health
Program will be transfers after the implementation of provisions of the
Patient Protection and Affordable Care Act (Pub. L. 111-148) on January
1, 2014.
---------------------------------------------------------------------------
\44\ Based on a population of 65,000 at the U.S. cancer rate and
discounted at 7 percent.
\45\ Based on a population of 110,000 at 21 percent above the
U.S. cancer rate and discounted at 3 percent.
---------------------------------------------------------------------------
The Administrator did not identify any costs associated with the
removal of Table 1 from 42 CFR 88.1.
The rule would not interfere with State, local, and Tribal
governments in the exercise of their governmental functions.
Cost Estimates
The WTC Health Program has, to date, enrolled approximately 58,500
New York City responders and approximately 6,500 survivors, or
approximately 65,000 individuals in total. Of that total population,
approximately 60,000 individuals were participants in previous WTC
medical programs and were `grandfathered' into the WTC Health Program
established by Title XXXIII.\46\ In addition to those grandfathered WTC
responders and survivors already enrolled, the PHS Act \47\ sets a
numeric 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 WTC survivors (i.e., the statute restricts
new enrollment). For the purpose of calculating a baseline estimate of
cancer prevalence only, the Administrator assumed that the gradual rate
of enrollment seen in the Program to date would continue, and that
Program membership would remain around 58,500 WTC responders and 6,500
WTC survivors. The estimate is further based on the average U.S. cancer
prevalence rate and 7 percent discount rate.
---------------------------------------------------------------------------
\46\ These grandfathered members were enrolled without having to
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.''
\47\ PHS Act, sec. 3311(a)(4)(A) and sec. 3321(a)(3)(A).
---------------------------------------------------------------------------
As it is not possible to identify an upper bound estimate, the
Administrator 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
[[Page 9108]]
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 grandfathered + 25,000
new) and 30,000 survivors (5,000 grandfathered + 25,000 new). The upper
cost estimate also assumes an overall increase in population cancer
rates (for malignant neoplasm of the brain [brain cancer], malignant
neoplasm of the cervix uteri [invasive cervical cancer], malignant
neoplasm of the pancreas [pancreatic cancer], malignant neoplasm of the
testis [testicular cancer]) of 21 percent due to 9/11 exposure,\48\ 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 unexposed population is
based on findings presented in the first published epidemiologic study
of September 11, 2001 exposed populations.\49\ Given the challenges
associated with interpreting the Zeig-Owens findings,\50\ this analysis
uses 21 percent as a possible outcome rather than asserting the
probability that 21 percent is a ``likely'' outcome.
---------------------------------------------------------------------------
\48\ 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. The Lancet. 378 (9794): 898-905.
\49\ Id.
\50\ 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 9/11 exposure
and cancer means that the outcomes remain speculative.
---------------------------------------------------------------------------
The Administrator acknowledges that some cancer cases are not
likely to have been caused by 9/11 exposures. The certification of
individual cancer diagnoses will be conducted on a case-by-case basis.
However, for the purpose of this analysis, the Administrator has
estimated that all diagnosed cancers added to the List or meeting the
definition of rare cancer will be certified for treatment by the WTC
Health Program. Finally, because there are no existing data on cancer
rates related to 9/11 exposures at either the Pentagon or in
Shanksville, Pennsylvania, the Administrator has used only data from
studies of individuals who were responders or survivors in the New York
City disaster area.
Costs of Cancer Treatment
The Administrator estimated the treatment costs associated with
covering malignant neoplasm of the brain, malignant neoplasm of the
cervix uteri, malignant neoplasm of the pancreas, and malignant
neoplasm of the testis in this rulemaking using the methods described
below. Costs associated with cancer screening are discussed separately
below.
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. Therefore, this analysis uses 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.\51\
---------------------------------------------------------------------------
\51\ 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.
Table A--Average Costs of Treatment, Male and Female (2011)
----------------------------------------------------------------------------------------------------------------
Initial (first Last year of
Type of cancer 12 months after Continuing life (last 12
diagnosis) (annual) months of life)
----------------------------------------------------------------------------------------------------------------
Brain..................................................... $87,319 $6,372 $101,372
Pancreas.................................................. 74,205 5,270 84,809
Cervix Uteri.............................................. 33,945 1,072 36,503
Testis \+\................................................ 13,696 2,754 43,481
----------------------------------------------------------------------------------------------------------------
+ Approximated by the costs of other tumor sites.
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.\52\
The average costs of treatment described above are given in 2011 prices
adjusted using the Medical Consumer Price Index for all urban
consumers.\53\
---------------------------------------------------------------------------
\52\ 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.
\53\ 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
The Administrator 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 four cancer types considered eligible for coverage
under the Program pursuant to 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.
Because invasive cervical cancer occurs only in females and testicular
cancer only occurs in males, the calculations take into account the
applicable gender of the WTC Health Program members for the respective
cancer type. The age distribution for current enrollees by gender and
responder/survivor status is presented in Table B.
[[Page 9109]]
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
----------------------------------------------------------------------------------------------------------------
The Administrator assumed race and ethnic origin distributions for
responders and survivors according to distributions in the WTC Health
Registry cohort: \54\ 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 individuals 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
individuals 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).\55\ A life-table analysis program, LTAS.NET, was used to
estimate the expected number of incident cancers for cancer types
added.\56\ The Administrator calculated cancer incidence rates using
data through 2006 from the Surveillance Epidemiology and End Results
(SEER) Program, and estimated rates for 2007-2016.\57\ 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.
---------------------------------------------------------------------------
\54\ Jordan HT, Brackbill RM, Cone JE, Debchoudhury I, Farfel
MR, Greene CM, Hadler JL, Kennedy J, Li J, Liff J, Stayner L,
Stellman SD [2011]. Mortality Among Survivors of the Sept 11, 2001,
Word Trade Center Disaster: Results from the World Trade Center
Health Registry Cohort. The Lancet 378:879-887. Note: Percentages
may not sum to 100 percent due to rounding.
\55\ 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.
\56\ 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.
\57\ 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 individuals in the responder
and survivor populations with cancer, the Administrator 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.\58\
---------------------------------------------------------------------------
\58\ Id.
---------------------------------------------------------------------------
Using the incident cases and survival rate statistics for each
cancer type, the Administrator has estimated the prevalence (number of
individuals 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 individuals surviving up to 15
years beyond their first diagnosis (prevalence).\59\ For example, in
2002 there are 6.82 projected new cases of testicular cancer, which
would be listed as incident cases for that year. The survival rate for
testicular cancer in the first year of diagnosis is 94.68 percent.\60\
Therefore the number of deceased individuals in 2002 would be 6.82 x
(1-0.9468) = 0.36. For the testicular cancer prevalence table, in year
2003, the number of incident cases would be 6.61 cases. In addition to
6.61 newly diagnosed cases in 2003, there would be the one-year
survivors from 2002 which would be 6.82-0.36 (or 6.82 x 0.9468) = 6.46
cases. This computation process can be repeated for each year through
year 2016. A portion of the brain, invasive cervical, pancreatic, and
testicular cancers prevalence tables are provided in Table C1, C2, C3,
and C4 respectively.
---------------------------------------------------------------------------
\59\ The 15-year survival limit is imposed based on the analytic
time horizon established between the triggering events of September
11, 2001 and the authorization of the WTC Health Program through
2016.
\60\ 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 C1--Prevalence Table for Brain Cancer
[Based on 80,000 responders]
----------------------------------------------------------------------------------------------------------------
Year Years since exposure to 9/11 Years covered by WTC Health Program
----------------------------- agents -----------------------------------------------
------------------------------------
New/surv. 2002 2003 2012 2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1........................... 4.38 4.54 6.18 6.43 6.70 6.94 7.20
2........................... .......... 2.73 3.69 3.85 4.01 4.18 4.32
3........................... .......... .......... 2.58 2.68 2.80 2.91 3.04
4........................... .......... .......... 2.24 2.34 2.43 2.53 2.64
[[Page 9110]]
5........................... .......... .......... 2.02 2.11 2.20 2.28 2.38
6........................... .......... .......... 1.85 1.93 2.01 2.10 2.18
7........................... .......... .......... 1.72 1.79 1.87 1.95 2.03
8........................... .......... .......... 1.58 1.64 1.71 1.78 1.86
9........................... .......... .......... 1.59 1.56 1.63 1.69 1.76
10.......................... .......... .......... 1.48 1.54 1.52 1.58 1.65
11.......................... .......... .......... 1.39 1.44 1.50 1.47 1.54
12.......................... .......... .......... .......... 1.36 1.41 1.47 1.45
13.......................... .......... .......... .......... .......... 1.32 1.37 1.42
14.......................... .......... .......... .......... .......... .......... 1.30 1.35
15.......................... .......... .......... .......... .......... .......... .......... 1.25
Live cases from previous .......... .......... 20.15 22.25 24.39 26.61 28.85
years......................
Prevalence.................. .......... .......... 26.32 28.68 31.09 33.55 36.05
Last year of life........... 1.65 2.46 4.07 4.29 4.49 4.70 4.91
----------------------------------------------------------------------------------------------------------------
Table C2--Prevalence Table for Invasive Cervical Cancer
[Based on 80,000 responders]
----------------------------------------------------------------------------------------------------------------
Year Years since 9/11 exposures Years covered by WTC Health Program
----------------------------------------------------------------------------------------------------------------
New/surviving 2002 2003 2012 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1................................. 1.17 1.21 1.24 1.23 1.22 1.22
2................................. ........... 1.06 1.12 1.12 1.12 1.11
3................................. ........... ........... 1.01 1.01 1.00 1.00
4................................. ........... ........... 0.95 0.95 0.95 0.95
5................................. ........... ........... 0.91 0.92 0.92 0.92
6................................. ........... ........... 0.87 0.89 0.89 0.89
7................................. ........... ........... 0.86 0.88 0.88 0.89
8................................. ........... ........... 0.83 0.86 0.87 0.87
9................................. ........... ........... 0.87 0.84 0.85 0.86
10................................ ........... ........... 0.84 0.82 0.83 0.84
11................................ ........... ........... 0.81 0.86 0.82 0.83
12................................ ........... ........... ........... 0.83 0.85 0.81
13................................ ........... ........... ........... 0.80 0.82 0.85
14................................ ........... ........... ........... ........... 0.80 0.82
15................................ ........... ........... ........... ........... ........... 0.79
Live cases from previous years.... ........... ........... 9.06 10.76 11.60 12.42
Prevalence........................ 1.17 2.27 10.30 12.00 12.82 13.63
Last year of life................. 0.11 0.23 0.38 0.40 0.41 0.41
----------------------------------------------------------------------------------------------------------------
Table C3--Prevalence Table for Pancreatic Cancer
[Based on 80,000 responders]
----------------------------------------------------------------------------------------------------------------
Year Years since exposure to 9/11 Years covered by WTC Health Program
----------------------------- agents -----------------------------------------------
------------------------------------
New/surv. 2002 2003 2012 2013 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1........................... 3.43 3.80 8.93 9.73 10.56 11.34 12.21
2........................... .......... 0.98 2.34 2.56 2.79 3.03 3.26
3........................... .......... .......... 0.99 1.08 1.18 1.29 1.40
4........................... .......... .......... 0.56 0.61 0.67 0.73 0.80
5........................... .......... .......... 0.42 0.46 0.51 0.55 0.61
6........................... .......... .......... 0.31 0.34 0.38 0.41 0.45
7........................... .......... .......... 0.26 0.29 0.31 0.35 0.38
8........................... .......... .......... 0.22 0.24 0.27 0.30 0.32
9........................... .......... .......... 0.20 0.22 0.24 0.27 0.30
10.......................... .......... .......... 0.17 0.19 0.20 0.23 0.25
11.......................... .......... .......... 0.14 0.15 0.17 0.18 0.20
12.......................... .......... .......... .......... 0.13 0.14 0.16 0.17
13.......................... .......... .......... .......... .......... 0.12 0.13 0.15
14.......................... .......... .......... .......... .......... .......... 0.12 0.13
15.......................... .......... .......... .......... .......... .......... .......... 0.11
Live cases from previous .......... .......... 5.60 6.27 6.98 7.74 8.51
years......................
Prevalence.................. 3.43 4.78 14.53 15.87 17.28 18.67 20.17
Last year of life........... 2.45 3.24 8.25 9.02 9.80 10.57 11.39
----------------------------------------------------------------------------------------------------------------
[[Page 9111]]
Table C4--Prevalence Table for Testicular Cancer
[Based on 80,000 responders]
----------------------------------------------------------------------------------------------------------------
Year Years since 9/11 exposures Years covered by WTC Health Program
----------------------------------------------------------------------------------------------------------------
New/surviving 2002 2003 2012 2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1................................. 6.82 6.61 4.23 3.72 3.44 3.20
2................................. ........... 6.46 4.24 3.76 3.52 3.26
3................................. ........... ........... 4.27 3.80 3.56 3.34
4................................. ........... ........... 4.41 3.93 3.71 3.48
5................................. ........... ........... 4.60 4.13 3.89 3.67
6................................. ........... ........... 4.80 4.33 4.10 3.86
7................................. ........... ........... 5.02 4.55 4.32 4.09
8................................. ........... ........... 5.20 4.78 4.54 4.31
9................................. ........... ........... 5.47 5.00 4.77 4.54
10................................ ........... ........... 5.65 5.19 5.00 4.77
11................................ ........... ........... 5.78 5.42 5.14 4.96
12................................ ........... ........... ........... 5.57 5.38 5.11
13................................ ........... ........... ........... 5.73 5.55 5.36
14................................ ........... ........... ........... ........... 5.70 5.53
15................................ ........... ........... ........... ........... ........... 5.66
Live cases from previous years.... ........... ........... 49.45 56.18 59.19 61.93
Prevalence........................ 6.82 13.07 53.68 59.89 62.63 65.13
Last year of life................. 0.36 0.68 0.75 0.70 0.70 0.68
----------------------------------------------------------------------------------------------------------------
Cost Computation
To compute the costs for each type of cancer, the Administrator
assumes that all of the individuals who are diagnosed with a cancer
type will be certified by the WTC Health Program for treatment
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 A 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 was constructed for each year
covered by the WTC Health Program and the results are presented in
Tables D1, D2, D3, and D4. The row for Year 1 in each table is the cost
of incident cases for that year. Rows for Years 2-15 show the cost from
continuing care for individuals 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 by the number of
individuals dying in that year from that type of cancer from Tables C1-
C4.
Table D1--Cost per 80,000 Responders for Brain Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
Years covered by the WTC Health Program
Year -----------------------------------------------------
2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1......................................................... $364,737 $377,541 $391,595
2......................................................... 25,526 26,617 27,552
3......................................................... 17,833 18,569 19,363
4......................................................... 15,463 16,128 16,793
5......................................................... 14,003 14,535 15,160
6......................................................... 12,812 13,365 13,872
7......................................................... 11,906 12,404 12,939
8......................................................... 10,899 11,358 11,832
9......................................................... 10,369 10,786 11,240
10........................................................ 9,661 10,080 10,485
11........................................................ 9,543 9,384 9,791
12........................................................ 9,015 9,367 9,211
13........................................................ 8,391 8,710 9,050
14........................................................ ................ 8,261 8,574
15........................................................ ................ ................ 7,967
Prevalent care............................................ 520,157 547,103 567,459
Last year of life care.................................... 454,701 476,561 497,829
-----------------------------------------------------
Total................................................. 974,859 1,023,664 1,065,288
----------------------------------------------------------------------------------------------------------------
Table D2--Cost per 80,000 Responders for Invasive Cervical Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
Years covered by the WTC Health Program
Year -----------------------------------------------------
2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1......................................................... $37,922 $37,599 $37,379
[[Page 9112]]
2......................................................... 1,200 1,198 1,188
3......................................................... 1,078 1,075 1,073
4......................................................... 1,021 1,022 1,019
5......................................................... 984 983 984
6......................................................... 951 957 956
7......................................................... 938 944 951
8......................................................... 919 928 933
9......................................................... 902 911 920
10........................................................ 880 894 903
11........................................................ 917 875 889
12........................................................ 893 916 873
13........................................................ 858 883 906
14........................................................ ................ 853 878
15........................................................ ................ ................ 843
Prevalent care............................................ 49,464 50,039 49,854
Last year of life care.................................... 14,485 14,806 15,008
-----------------------------------------------------
Total................................................. 63,949 64,845 64,862
----------------------------------------------------------------------------------------------------------------
Table D3--Cost per 80,000 Responders for Pancreatic Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
Years covered by the WTC Health Program
Year -----------------------------------------------------
2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1......................................................... $224,967 $241,545 $260,083
2......................................................... 14,713 15,977 17,155
3......................................................... 6,232 6,791 7,374
4......................................................... 3,516 3,858 4,204
5......................................................... 2,671 2,908 3,190
6......................................................... 1,989 2,174 2,367
7......................................................... 1,660 1,818 1,988
8......................................................... 1,411 1,556 1,705
9......................................................... 1,273 1,411 1,556
10........................................................ 1,072 1,188 1,317
11........................................................ 871 957 1,061
12........................................................ 757 836 919
13........................................................ 627 694 767
14........................................................ ................ 627 694
15........................................................ ................ ................ 570
Prevalent care............................................ 261,759 282,340 304,378
Last year of life care.................................... 831,446 896,398 965,711
-----------------------------------------------------
Total................................................. 1,093,205 1,178,738 1,270,089
----------------------------------------------------------------------------------------------------------------
Table D4--Cost per 80,000 Responders for Testicular Cancer, 2011$
----------------------------------------------------------------------------------------------------------------
Years covered by the WTC Health Program
Year -----------------------------------------------------
2014 2015 2016
----------------------------------------------------------------------------------------------------------------
1......................................................... $48,191 $44,628 $41,507
2......................................................... 10,348 9,691 8,974
3......................................................... 10,456 9,816 9,193
4......................................................... 10,817 10,208 9,584
5......................................................... 11,373 10,705 10,102
6......................................................... 11,930 11,294 10,630
7......................................................... 12,541 11,888 11,254
8......................................................... 13,152 12,512 11,859
9......................................................... 13,779 13,136 12,497
10........................................................ 14,303 13,779 13,136
11........................................................ 14,918 14,167 13,649
12........................................................ 15,327 14,829 14,082
13........................................................ 15,768 15,272 14,775
14........................................................ ................ 15,711 15,217
15........................................................ ................ ................ 15,597
[[Page 9113]]
Prevalent care............................................ 202,903 207,634 196,458
Last year of life care.................................... 30,644 30,588 29,604
-----------------------------------------------------
Total................................................. 233,548 238,222 226,062
----------------------------------------------------------------------------------------------------------------
The sum of the annual costs in each table for the years 2014
through 2016 represents the estimated treatment costs to the WTC Health
Program for coverage of brain, invasive cervical, pancreatic, and
testicular cancers, respectively, for 80,000 responders. The cost
projections in Tables D1, D2, D3, and D4 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 9/11 exposures.\61\
---------------------------------------------------------------------------
\61\ 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. The 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 9/11-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 58,500 responders and 6,500
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 58,500 and 6,500 Responder and Survivor
Population, Respectively and Assuming Cancer Rates at U.S. Population Average
----------------------------------------------------------------------------------------------------------------
Prevalence (incident + live cases)
Cancer type -----------------------------------------------------
2014 2015 2016
----------------------------------------------------------------------------------------------------------------
Based on 58,500 responder population
----------------------------------------------------------------------------------------------------------------
Brain..................................................... 22.74 24.53 26.36
Cervix Uteri.............................................. 8.77 9.38 9.97
Pancreas.................................................. 12.83 13.95 15.16
Testis.................................................... 43.80 45.80 47.62
-----------------------------------------------------
Total................................................. 88.14 93.66 99.11
----------------------------------------------------------------------------------------------------------------
Based on 6,500 survivor population
----------------------------------------------------------------------------------------------------------------
Brain..................................................... 2.53 2.73 2.93
Cervix Uteri.............................................. 0.97 1.04 1.11
Pancreas.................................................. 1.43 1.55 1.68
Testis.................................................... 4.87 5.09 5.29
-----------------------------------------------------
Total................................................. 9.79 10.41 11.01
----------------------------------------------------------------------------------------------------------------
Table F--Estimated Treatment Costs by Year and Cancer Type Based on 58,500 and 6,500 Responder and Survivor
Population, Respectively and Assuming Cancer Rates at U.S. Population Average (2011 $)
----------------------------------------------------------------------------------------------------------------
Cancer type 2014 2015 2016 2014-2016
----------------------------------------------------------------------------------------------------------------
Based on 58,500 responder population
----------------------------------------------------------------------------------------------------------------
Brain................................... $712,865 $748,555 $778,992 $2,240,412
Cervix Uteri............................ 46,763 47,418 47,430 153,115
Pancreas................................ 799,406 861,952 928,753 2,590,111
Testis.................................. 170,782 174,200 165,308 552,115
-----------------------------------------------------------------------
Total............................... 1,729,816 1,832,125 1,920,482 5,482,423
----------------------------------------------------------------------------------------------------------------
[[Page 9114]]
Based on 6,500 survivor population
----------------------------------------------------------------------------------------------------------------
Brain................................... 76,302 79,634 82,372 238,308
Cervix Uteri............................ 32,741 33,935 33,944 108,512
Pancreas................................ 116,940 124,458 132,382 373,780
Testis.................................. 13,130 13,333 12,728 42,417
-----------------------------------------------------------------------
Total............................... 239,113 251,360 261,426 751,898
----------------------------------------------------------------------------------------------------------------
Total
----------------------------------------------------------------------------------------------------------------
Brain................................... 789,167 828,189 861,364 2,478,720
Pancreas................................ 916,346 986,410 1,061,135 2,963,891
Cervix Uteri............................ 79,504 81,353 81,374 261,627
Testis.................................. 183,911 187,533 178,036 594,532
-----------------------------------------------------------------------
Total............................... 1,968,928 2,083,485 2,181,909 6,298,770
----------------------------------------------------------------------------------------------------------------
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 -----------------------------------------------------
2014 2015 2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responder population
----------------------------------------------------------------------------------------------------------------
Brain..................................................... 37.62 40.60 43.62
Cervix Uteri.............................................. 14.52 15.52 16.50
Pancreas.................................................. 21.23 23.09 25.08
Testis.................................................... 72.47 75.78 78.80
-----------------------------------------------------
Total................................................. 145.84 154.98 163.99
----------------------------------------------------------------------------------------------------------------
Based on 30,000 survivor population
----------------------------------------------------------------------------------------------------------------
Brain..................................................... 14.11 15.22 16.36
Cervix Uteri.............................................. 5.44 5.82 6.19
Pancreas.................................................. 7.96 8.66 9.40
Testis.................................................... 27.18 28.42 29.55
-----------------------------------------------------
Total................................................. 54.69 58.12 61.50
----------------------------------------------------------------------------------------------------------------
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 2014 2015 2016 2014-2016
----------------------------------------------------------------------------------------------------------------
Based on 80,000 responder population
----------------------------------------------------------------------------------------------------------------
Brain................................... 1,199,076 1,259,107 1,310,304 3,768,487
Cervix Uteri............................ 78,658 79,760 79,780 238,198
Pancreas................................ 1,344,642 1,449,848 1,562,209 4,356,699
Testis.................................. 287,263 293,014 278,056 858,333
-----------------------------------------------------------------------
Total............................... 2,909,639 3,081,728 3,230,350 9,221,717
----------------------------------------------------------------------------------------------------------------
Based on 30,000 survivor population
----------------------------------------------------------------------------------------------------------------
Brain................................... 355,098 370,605 383,345 1,109,048
Cervix Uteri............................ 152,371 157,927 157,972 468,270
Pancreas................................ 544,220 579,209 616,087 1,739,515
[[Page 9115]]
Testis.................................. 61,103 62,050 59,234 182,387
-----------------------------------------------------------------------
Total............................... 1,112,792 1,169,790 1,216,638 3,499,221
----------------------------------------------------------------------------------------------------------------
Total
----------------------------------------------------------------------------------------------------------------
Brain................................... 1,554,174 1,629,712 1,693,649 4,877,535
Cervix Uteri............................ 231,029 237,686 237,752 706,468
Pancreas................................ 1,888,862 2,029,057 2,178,296 6,096,215
Testis.................................. 348,366 355,063 337,290 1,040,719
-----------------------------------------------------------------------
Total............................... 4,022,431 4,251,519 4,446,987 12,720,937
----------------------------------------------------------------------------------------------------------------
Cost of Cancer Screening
Costs of screening have been added to the summary estimates table
below. The screening indicated by this rulemaking follows U.S.
Preventive Services Task Force (USPSTF) guidelines. The USPSTF
recommends cervical cancer screening but does not recommend screening
for brain, pancreatic, or testicular cancer. For cervical cancer,
USPSTF recommends that females age 21-65 receive one Pap test every 3
years; females age 30-65, are recommended to receive one HPV screening
every 5 years.\62\ Costs for screening were distributed according to
these recommended screening rates. The cost for cytology (Pap test) was
estimated at between $26 and $78 per person and the cost for HPV
screening at between $35 and $77 per person based on current FECA
rates.
---------------------------------------------------------------------------
\62\ U.S. Preventive Services Task Force [2012]. Recommendation:
Screening for Cervical Cancer. http://www.uspreventiveservicestaskforce.org/uspstf/uspscerv.htm. Accessed
June 26, 2013.
---------------------------------------------------------------------------
Summary of Costs
Because the Administrator lacks data to account for either
recoupment by health insurance or workers' compensation insurance or
reduction by either health insurance or 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).
After the implementation of provisions of the Patient Protection
and Affordable Care Act (Pub. L. 111-148) on January 1, 2014, all of
the members and future members can be assumed to have or have access to
medical insurance coverage other than through the WTC Health Program.
Therefore, all treatment and screening 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 transfer
payments based on 58,500 responders and 6,500 survivors and,
alternatively, 80,000 responders and 30,000 survivors.
Table I--Breakdown of Estimated Annual WTC Health Program Costs and
Transfers, 58,500 and 80,000 Responders and 6,500 and 30,000 Survivors,
2014-2016, 2011$
------------------------------------------------------------------------
Annualized transfers for 2014-
2016, 2011$
-----------------------------------
Discounted at 7 Discounted at 3
percent percent
------------------------------------------------------------------------
Cancer rate
------------------------------------------------------------------------
U.S. average U.S. + 21%
------------------------------------------------------------------------
58,500 Responders................... $1,706,502 ................
6,500 Survivors..................... 234,123 ................
Cervical cancer screening........... 347,368 ................
-----------------------------------
65,000 Total................ 2,287,993 ................
------------------------------------------------------------------------
80,000 Responders................... ................ $2,982,174
30,000 Survivors.................... ................ 1,131,770
Cervical cancer screening........... ................ 819,336
-----------------------------------
110,000 Total............... ................ 4,933,280
------------------------------------------------------------------------
[[Page 9116]]
Examination of Benefits (Health Impact)
This section describes qualitatively the potential benefits of the
interim 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.
The Administrator does not have information on the health of the
population that may have experienced 9/11 exposures and is not
currently enrolled in the WTC Health Program. In addition, the
Administrator has only limited information about health insurance and
health care services for cancers caused by 9/11 exposures 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, the Administrator 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 et
al.\63\ 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, the Administrator 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 likely covered by
employer-based health insurance.
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\63\ Ward E, Halpern M, Schrag N, Cokkinides V, DeSantis C,
Bandi P, Siegel R, Stewart A, Jemal A [2008]. Association of
Insurance with Cancer Care Utilization and Outcomes. CA Cancer J
Clin 58:9-31.
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Although the Administrator cannot quantify the benefits associated
with the WTC Health Program, enrollees with cancer would have improved
access to care and thereby the Program should produce better treatment
outcomes than in its absence. Under other insurance plans, patients
would have deductibles and copays, which impact access to care and
particularly its timeliness. WTC Health Program members would have
first-dollar coverage and hence are likely to seek care sooner when
indicated, resulting in improved treatment outcomes.
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, the Administrator was not able to estimate benefits in terms of
averted healthcare costs. Nor was the Administrator 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.
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. The
Administrator certifies 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.).
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).
The Administrator 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 interim final rule does not include
any Federal mandate that may result in increased annual expenditures in
excess of $100 million in 1995 dollars 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 the PHS Act Sec.
3331(d)(2). For 2013, the inflation adjusted threshold is $150 million.
F. Executive Order 12988 (Civil Justice)
This interim 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)
The Administrator has reviewed this interim 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, the Administrator has
evaluated the environmental health and safety effects of this interim
final rule on children. The Administrator has determined that the rule
would have no environmental health and safety effect on children,
although an eligible child who has been diagnosed with any cancer type
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, the Administrator has
evaluated the effects of this interim 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
[[Page 9117]]
the public how to comply with a requirement the Federal Government
administers or enforces. The Administrator has attempted to use plain
language in promulgating the interim final rule consistent with the
Federal Plain Writing Act guidelines and requests public comment on
this effort.
List of Subjects
42 CFR Part 88
Aerodigestive disorders, Appeal procedures, Cancer, Health care,
Mental health conditions, Musculoskeletal disorders, Respiratory and
pulmonary diseases.
Final Rule
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. In Sec. 88.1, revise paragraph (4) of 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:
(i) Malignant neoplasms of the lip, tongue, salivary gland, floor
of mouth, gum and other mouth, tonsil, oropharynx, hypopharynx, and
other oral cavity and pharynx.
(ii) Malignant neoplasm of the nasopharynx.
(iii) Malignant neoplasms of the nose, nasal cavity, middle ear,
and accessory sinuses.
(iv) Malignant neoplasm of the larynx.
(v) Malignant neoplasm of the esophagus.
(vi) Malignant neoplasm of the stomach.
(vii) Malignant neoplasm of the colon and rectum.
(viii) Malignant neoplasm of the liver and intrahepatic bile duct.
(ix) Malignant neoplasms of the retroperitoneum and peritoneum,
omentum, and mesentery.
(x) Malignant neoplasms of the trachea; bronchus and lung; heart,
mediastinum and pleura; and other ill-defined sites in the respiratory
system and intrathoracic organs.
(xi) Mesothelioma.
(xii) Malignant neoplasms of the peripheral nerves and autonomic
nervous system, and other connective and soft tissue.
(xiii) Malignant neoplasms of the skin (melanoma and non-melanoma),
including scrotal cancer.
(xiv) Malignant neoplasm of the female breast.
(xv) Malignant neoplasm of the ovary.
(xvi) Malignant neoplasm of the prostate.
(xvii) Malignant neoplasm of the urinary bladder.
(xviii) Malignant neoplasm of the kidney.
(xix) Malignant neoplasms of the renal pelvis, ureter and other
urinary organs.
(xx) Malignant neoplasms of the eye and orbit.
(xxi) Malignant neoplasm of the thyroid.
(xxii) Malignant neoplasms of the blood and lymphoid tissues
(including, but not limited to, lymphoma, leukemia, and myeloma).
(xxiii) Childhood cancers: Any type of cancer diagnosed in a person
less than 20 years of age.
(xxiv) Rare cancers: any type of cancer \1\ that occurs in less
than 15 cases per 100,000 persons per year in the United States.
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\1\ Based on 2005-2009 average annual data age-adjusted to the
2000 U.S. population. See, Copeland G, Lake A, Firth R, Wohler B,Wu
XC, Stroup A, Russell C, Boyuk K, Schymura M, Hofferkamp J, Kohler B
(eds) [2012]. Cancer in North America: 2005-2009. Volume One:
Combined Cancer Incidence for the United States, Canada and North
America. Springfield, IL: North American Association of Central
Cancer Registries, Inc.
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* * * * *
Dated: January 8, 2014.
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. 2014-03370 Filed 2-14-14; 8:45 am]
BILLING CODE 4163-18-P