World Trade Center Health Program; Amendments to Definitions, Appeals, and Other Requirements, 90926-90947 [2016-29957]
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Federal Register / Vol. 81, No. 241 / Thursday, December 15, 2016 / Rules and Regulations
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 88
[Docket No. CDC–2016–0072; NIOSH–291]
RIN 0920–AA56, 0920–AA44, 0920–AA48,
0920–AA50
World Trade Center Health Program;
Amendments to Definitions, Appeals,
and Other Requirements
Centers for Disease Control and
Prevention, HHS.
ACTION: Final rule.
AGENCY:
In 2011 and 2012, the
Secretary, Department of Health and
Human Services (HHS), promulgated
regulations designed to govern the
World Trade Center (WTC) Health
Program (Program), including the
processes by which eligible responders
and survivors may apply for enrollment
in the Program, obtain health
monitoring and treatment for WTCrelated health conditions, and appeal
enrollment and treatment decisions, as
well as a process to add new conditions
to the List of WTC-Related Health
Conditions (List). After using the
regulations for a number of years, the
Administrator of the WTC Health
Program identified potential
improvements to certain existing
provisions, including, but not limited
to, appeals of enrollment, certification,
and treatment decisions, as well as the
procedures for the addition of health
conditions for WTC Health Program
coverage. He also identified the need to
add new regulatory provisions,
including, but not limited to, standards
for the disenrollment of a WTC Health
Program member and decertification of
a certified WTC-related health
condition. A notice of proposed
rulemaking was published on August
17, 2016; this action addresses public
comments received on that proposed
rulemaking, as well as three interim
final rules promulgated since 2011, and
finalizes the proposed rule and three
interim final rules.
DATES: This rule is effective on January
17, 2017.
FOR FURTHER INFORMATION CONTACT:
Rachel Weiss, Program Analyst; 1090
Tusculum Ave., MS: C–46, Cincinnati,
OH 45226; telephone (855) 818–1629
(this is a toll-free number); email
NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION: This
preamble is organized as follows:
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SUMMARY:
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs
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II. Public Participation
III. Background
IV. WTC Health Program Statutory Authority
V. Summary of Final Rule and Response to
Comments
VI. 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
C. Costs
The revisions to part 88 proposed in
the August 2016 NPRM and finalized in
this action are expected to result in
approximately $42,742 in costs to the
WTC Health Program associated with
updating existing Program policies and
developing new policies. As explained
below, the Program estimates that total
costs of the WTC Health Program were
$240.5 million in FY 2015 and may
range from $265.5 to $388.6 million in
FY 2025. Cumulative costs associated
with WTC Health Program
administration and monitoring and
treatment services for all health
conditions for fiscal years (FY) 2016
through 2025 are projected to range
from $2.9 billion (7% discount rate) to
$3.6 billion (3% discount rate).3
I. Executive Summary
II. Public Participation
Interested persons or organizations
were invited to participate in the August
2016 NPRM by submitting written
views, opinions, recommendations,
and/or data on any topic related to the
proposed rule. All communications
received on or before the closing date
for comments were fully considered by
the Administrator of the WTC Health
Program. The August 2016 NPRM as
well as public comments received are
available in the docket for this
rulemaking. Public comments received
on the three interim final rules are
available in those respective dockets.4
Submissions to the August 2016
NPRM docket were received from three
commenters, including a labor
organization, a joint labor/management
trust fund, and the contractor providing
care for survivors in the WTC Health
Program.
A. Purpose of Regulatory Action
On August 17, 2016, the Secretary,
HHS, and the Administrator of the WTC
Health Program published a notice of
proposed rulemaking proposing
amendments to some provisions in part
88 in Title 42 and the addition of others
(August 2016 NPRM).1 This final rule
includes the Administrator’s response to
public comments received on the
August 2016 NPRM, as well as public
comments received in response to three
interim final rules establishing portions
of 42 CFR part 88, published in 2011,
2013, and 2014, respectively.2 The
amendments to part 88 are intended to
benefit both the WTC Health Program
and its members by clarifying
requirements and improving
administrative processes.
B. Summary of Major Provisions
In this action, the Administrator
finalizes amendments to a number of
existing sections in part 88, including
provisions for appeals of enrollment
decisions, appeals of certification,
decertification, or treatment
authorization decisions, and the
addition of health conditions to the List
of WTC-Related Health Conditions.
Some existing language is moved into
new sections for clarity. Finally, new
language on disenrollment,
decertification, appeals of
reimbursement denials, and
coordination of benefits and
recoupment is added to part 88.
1 81
FR 55086 (Aug. 17, 2016).
include the July 2011 IFR (establishing
part 88 and implementing the Program), 76 FR
38914 (July 1, 2011); the March 2013 IFR
(establishing eligibility criteria for Shanksville and
Pentagon responders), 78 FR 18855 (Mar. 28, 2013);
and the February 2014 IFR (clarifying the definition
of ‘‘childhood cancers’’ and revising the definition
of ‘‘rare cancers’’), 79 FR 9100 (Feb. 18, 2014).
2 These
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III. Background
This final rule includes the
Administrator’s response to public
comments received on the August 2016
NPRM, as well as public comments
received in response to three interim
final rules (IFRs). The first IFR was
published on July 1, 2011 to establish
part 88 and implement the Program, and
included all of the original sections
establishing eligibility criteria and
enrollment processes, health condition
certification and treatment
requirements, mechanisms to appeal
Program decisions, and reimbursement
3 Costs for FY 2016–2025 have been evaluated for
all health conditions covered by the Program, both
those conditions included in the PHS Act at sec.
3312(a)(3) and 3322(b) and those added to the List
of WTC-Related Health Conditions in § 88.15,
including cancer, new-onset chronic obstructive
pulmonary disease, and WTC-related acute
traumatic injury.
4 See infra note 9.
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(July 2011 IFR).5 A second IFR was
published on March 28, 2013 to
establish new eligibility criteria for
Pentagon and Shanksville, Pennsylvania
responders (March 2013 IFR).6 A third
IFR was published on February 18, 2014
to clarify the definition of ‘‘childhood
cancers’’ and revise the definition of
‘‘rare cancers,’’ resulting in cancers of
the brain, the pancreas, and the testes,
and invasive cervical cancer becoming
eligible for Program coverage (February
2014 IFR).7 The Administrator
addressed some of the public comments
submitted on the three IFRs in the
August 2016 NPRM; this final rule
includes the Administrator’s responses
to the remainder of public comments on
the IFRs.
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IV. WTC Health Program Statutory
Authority
Title I of the James Zadroga 9/11
Health and Compensation Act of 2010
(Pub. L. 111–347, as amended by Pub.
L. 114–113), added Title XXXIII to the
Public Health Service Act (PHS Act),
establishing the WTC Health Program
within HHS. The WTC Health Program
provides medical monitoring and
treatment benefits to eligible firefighters
and related personnel, law enforcement
officers, and rescue, recovery, and
cleanup workers who responded to the
September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in
Shanksville, Pennsylvania (responders),
and to eligible persons 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 (survivors).
All references to the Administrator of
the WTC Health Program
(Administrator) in this notice mean the
WTC Program Administrator, the
Director of the National Institute for
Occupational Safety and Health
(NIOSH), or his or her designee. Section
3301(j) of the PHS Act authorizes the
Administrator to promulgate such
regulations as are necessary to
administer the WTC Health Program.
V. Summary of Final Rule and
Response to Comments
This rule adopts and finalizes all
amendments to 42 CFR part 88
promulgated by the July 2011, March
2013, and February 2014 IFRs and
proposed in the August 2016 NPRM.
Amendments to the regulatory text in
part 88 are finalized in accordance with
the discussion provided in the August
FR 38914 (July 1, 2011).
FR 18855 (Mar. 28, 2013.
7 79 FR 9100 (Feb. 18. 2014).
6 78
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Section 88.1
Definitions
The Administrator revised preexisting definitions and established new
definitions for terms commonly used in
the WTC Health Program in 42 CFR
88.1.
Comment: One July 2011 IFR
commenter asked the Program to amend
three definitions. The commenter asked
that the definition of ‘‘aggravating’’
include any health condition that
requires medical treatment ‘‘more
intensive than’’ would have been
required for such a condition in the
absence of 9/11 exposure; that
‘‘medically necessary treatment’’
include treatment modalities and
protocols developed specifically for
children; and that ‘‘New York City
disaster area’’ include 14th Street as the
northern boundary.
Administrator’s response: The term
‘‘aggravating’’ is defined in sec. 3306(1)
of the PHS Act and cannot be expanded
in the regulatory definition.
The Administrator also declines to
amend ‘‘medically necessary treatment’’
because the medical treatment protocols
developed by the Data Centers already
include treatment modalities developed
for children. The existing definition is
sufficiently broad to include all types of
patients treated by physicians affiliated
with the Clinical Centers of Excellence
(CCEs) or the Nationwide Provider
Network (NPN). No changes are made to
the regulatory text in response to these
comments.
Finally, ‘‘New York City disaster
area’’ is also defined in the PHS Act, at
sec. 3306(7), and cannot be expanded in
the regulatory definitions. No change is
made to the regulatory text in response
to the public comments.
The term ‘‘designated representative’’
is revised to clarify that an individual
applying for enrollment in the WTC
Health Program may designate a
representative. A new definition of
‘‘WTC,’’ meaning ‘‘World Trade
Center,’’ is added to this section; all
existing definitions beginning with
‘‘World Trade Center’’ are revised
accordingly to streamline the regulatory
text.
8 See
81 FR 55086 at 55087–96.
July 2011 IFR, docket CDC–2011–0009;
March 2013 IFR, docket CDC–2013–0002; February
2014 IFR, docket CDC–2014–0004; and August 2016
NPRM, docket CDC–2016–0072.
9 See
5 76
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public comments received on all four
rulemakings. All public comments are
available in the dockets for the four
respective rulemakings.9
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Section 88.2
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General Provisions
This section establishes the
appointment process for an applicant’s
or WTC Health Program member’s
designated representative and the
parameters of the representative’s
authority.
Comment: One July 2011 IFR
commenter asked that the Program
allow a parent or guardian to be the
designated representative for a mentally
impaired screening- or certified-eligible
survivor.
Administrator’s response: The
Administrator agrees with the comment
and has added a new paragraph (a)(7) to
address the concern. In addition,
paragraph (a)(6) has been revised to
clarify that a parent or guardian of a
minor applicant, as well as the parent or
guardian of a screening-eligible or
certified-eligible survivor who is a
minor, may act on behalf of the minor.
Comment: One July 2011 IFR
commenter asked that the Program offer
reimbursement to members in the NPN
for whom the cost of travel to the
provider is less than 250 miles but
nevertheless poses a financial burden,
which is a barrier to care.
Administrator’s response: PHS Act,
sec. 3312(b)(4)(C) allows the Program to
provide transportation expenses for
medically necessary treatment through
the NPN involving ‘‘travel of more than
250 miles.’’ The statutory language only
authorizes reimbursement of travel
expenses where travel exceeds 250
miles. No change is made to the
regulatory text in response to this
comment.
Section 88.3 Eligibility—Currently
Identified Responders
No public comment was received on
this section. No revisions are made to
this section, although it is included in
the regulatory text, below, for
completeness.
Section 88.4
Responders
Eligibility Criteria—WTC
This section establishes eligibility
criteria for individuals who participated
in response and recovery activities at
the New York City area sites, at the
Pentagon site, and at the Shanksville,
Pennsylvania site.
Comment: One July 2011 IFR
commenter asked the Program to
develop eligibility criteria for
responders engaged in the cleanup or
demolition of buildings at or near
Ground Zero, including 130 Liberty
Street (Deutsche Bank) and 245
Greenwich Street (Fiterman Hall),
which were heavily contaminated with
WTC dust. In the case of those buildings
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and others across Lower Manhattan,
cleanup took place years after
September 11, 2001 (e.g., cleanup of the
Deutsche Bank building began in 2007;
Fiterman Hall in 2008). Workers
exposed to the re-suspension of WTC
dust caused by cleanup activities ‘‘had
the potential to become ill from those
exposures and should be eligible under
modified criteria for monitoring and
treatment.’’
Administrator’s response: Workers
who engaged in cleanup or demolition
of buildings contaminated by WTC dust
outside of the eligibility criteria
identified in PHS Act, sec. 3311(a)(2)
cannot be included in the eligibility
criteria for WTC responders in § 88.4
without promulgating modified
eligibility criteria by rulemaking. At this
time, the Administrator is not aware of
any scientific evidence to support such
a rulemaking. No change is made to the
regulatory text in response to this
comment.
Comment: One March 2013 IFR
commenter suggested that the addition
of eligibility criteria for Pentagon and
Shanksville responders is unnecessary
because, the commenter believes, there
were no real hazards at the Shanksville,
Pennsylvania site, and the Pentagon site
was quickly cleaned up.
Administrator’s response: The
Administrator does not agree with the
sentiments expressed by this
commenter. The eligibility criteria for
Pentagon and Shanksville responders
were developed after consideration of a
report produced by NIOSH that
reviewed published literature and other
authoritative sources and consultations
with participating responders from both
sites.10 The report summarized the
results of environmental sampling at the
Pentagon and Shanksville, Pennsylvania
sites; estimated the length of time that
each of the various responder groups
participated in rescue, recovery,
demolition, debris cleanup, and other
related response activities; and
identified the types of exposures
potentially experienced by the site
responders. Based on the report’s
findings, the Administrator found it
reasonable to establish eligibility criteria
for Pentagon and Shanksville
responders.11 No change is made to the
10 Robert McCleery, Summary of Evidence for
Establishing Dates on which Cleanup of the
Pentagon and Shanksville, Pennsylvania Sites of
the Terrorist-Related Aircraft Crashes of September
11, 2001 Concluded, Prepared for the
Administrator, WTC Health Program, February 8,
2012, https://www.cdc.gov/niosh/docket/archive/
pdfs/NIOSH–248/0248–041312ShanksvilleResponse.pdf.
11 See generally 78 FR 18855.
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regulatory text in response to this
comment.
Section 88.5 Application Process—
WTC Responders
This section describes the application
process for individuals who participated
in response and recovery activities at
any of the three sites. Language from
§ 88.6(b), concerning notification of
deficient applications, is moved into a
new § 88.5(c). The word ‘‘shall’’ is
replaced with ‘‘must’’ throughout the
section, and ‘‘WTC Program
Administrator’’ is replaced with ‘‘WTC
Health Program.’’
Comment: One July 2011 IFR
commenter asked that the Program
contact an applicant by telephone to
notify the individual of deficiencies in
an application or supporting
documentation.
Administrator’s response: The
Program makes every effort to contact
applicants to correct any deficiencies in
the application and conducts follow-up
by telephone, mail, and/or email. No
change is made to the regulatory text in
response to this comment.
Section 88.6 Enrollment Decision—
WTC Responders
This section describes the basis for
enrollment and enrollment denial
decisions and explains the Program’s
notification procedures. Language from
§ 88.6(b), concerning notification of
deficient applications, is moved into a
new § 88.5(c) where it is better placed.
A sentence is added to paragraph (d) to
clarify that the 60-day time period for
Program enrollment decisions will be
tolled during any days in which the
applicant is correcting deficiencies, as
in § 88.10(a).
Comment: Two July 2011 IFR
commenters expressed concerns about
the requirement regarding use of the
terrorist watch list. Specifically, the
commenters asked about information
sharing protections and redress
procedures, and stated that the terrorist
watch list must not be used to harass,
jeopardize, and/or deport immigrants.
Administrator’s response: The
Program is required to screen applicants
against the terrorist watch list (see PHS
Act, secs. 3311(a)(5) and 3321(a)(4)).
Program applications as well as the
System of Records Notice (SORN) for
the WTC Health Program 12 state that
information will only be disclosed to
the Department of Justice (DOJ) and
others for the limited purposes of
12 Occupational Health Epidemiological Studies
and EEOICPA Program Records and WTC Health
Program Records, HHS/CDC/NIOSH, Privacy Act
System Notice 09–20–0147, https://www.gpo.gov/
fdsys/pkg/FR-2011-06-14/html/2011-14807.htm.
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ascertaining enrollment eligibility and
qualification. HHS does not conduct
terrorist watch list screening; the
Program submits limited information
collected from applications to DOJ, and
DOJ’s Terrorist Screening Center
conducts the screening. DOJ is a
signatory to the 2007 Memorandum of
Understanding on Terrorist Watchlist
Redress Procedures (MOU).13 There is
no change to the regulatory language in
response to these comments.
Comment: One July 2011 IFR
commenter asked that the Program
notify the applicant of an enrollment
decision within 30 calendar days of the
Program’s receipt of the application.
Administrator’s response: The
Program is required by statute to
respond to applications within 60
calendar days of receipt of the
application and makes every effort to
respond in less time; average response
time is approximately 4 weeks.
Applicants can impact the length of the
eligibility review process by submitting
a complete application. No change is
made to the regulatory text in response
to this comment.
Section 88.7 Eligibility—CurrentlyIdentified Survivors
No public comment was received on
this section. No revisions are made to
this section, although it is included in
the regulatory text, below, for
completeness.
Section 88.8 Eligibility Criteria—WTC
Survivors
This section establishes eligibility
criteria for individuals who do not meet
the eligibility criteria for WTC
responders.
Comment: One July 2011 IFR
commenter asked that the language in
§ 88.8(a)(1)(iii), regarding ‘‘extensive
exposure,’’ be interpreted liberally
because ‘‘this population may be least
likely to have employment related
documents or the ability to obtain
them.’’
Administrator’s response: This
eligibility criteria is based on section
3321(a)(1)(B)(iii) of the PHS Act, which
requires extensive exposure to WTC
dust for this specific population.
However, the Program takes an
applicant-favorable approach to
eligibility criteria. There is no change
made to the regulatory text in response
to this comment.
Comment: One July 2011 IFR
commenter pointed out that the
13 See DOJ press release, Federal Inter-Agency
Partners Sign Government-wide Watchlisting
Redress MOU, October 24, 2007, https://
www.justice.gov/archive/opa/pr/2007/October/
ustsc-102407.html.
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regulatory language in § 88.8(a)(1)(iv)(C)
implies that the individual must have
lived in the New York City disaster area
residence from September 11, 2001
through May 31, 2003 but asserts that
the Lower Manhattan Development
Corporation Residential Grant Program
did not begin until August 2002 and
participation requirements state that
‘‘renters must have leases commencing
on or after June 1, 2001 and on or prior
to May 31, 2003. Owners must purchase
apartments on or prior to May 31,
2003.’’ The commenter requests that the
text of the regulation indicate that the
individual was in residence for part of
that period.
Administrator’s response: The
Administrator appreciates the comment,
however, the language in this section
mirrors the eligibility language in PHS
Act, sec. 3321(a)(1)(B)(iv). No change is
made to the regulatory text in response
to this comment.
Comment: Similar to comments made
on § 88.4, one July 2011 IFR commenter
suggested that the section be amended
to include survivors who conducted
cleanup or demolition of buildings at or
near Ground Zero which were heavily
contaminated with WTC dust. In some
cases, cleanup took place years after
September 11, 2001 and workers were
exposed to the re-suspension of WTC
dust caused by cleanup activities.
Administrator’s response: As
discussed above, workers who engaged
in cleanup or demolition of buildings
contaminated by WTC dust outside of
the eligibility criteria identified in PHS
Act, sec. 3321(a)(1)(B) cannot be
included in the eligibility criteria for
WTC survivors in § 88.8 without
promulgating modified eligibility
criteria by rulemaking. At this time, the
Administrator is not aware of any
scientific evidence to support such a
rulemaking. There is no change made to
the regulatory text in response to this
comment.
Comment: One July 2011 IFR
commenter asked the Program to
establish modified eligibility criteria for
the ‘‘full cohort of affected children,’’
including those who were exposed in
utero (mothers who lived or worked in
the New York City disaster area); those
exposed to WTC dust brought home by
responder parents; those born after
September 11, 2001, to responder or
survivor parents and suffering mental
health impacts due to the parents’ WTCrelated mental health condition; and
those born to exposed responders or
survivors if evidence of environmental
reproductive health impacts is available.
Administrator’s response: Individuals
who were children at the time of the
terrorist attack in New York City or its
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aftermath may be enrolled WTC
survivors if they meet the eligibility
criteria for screening-eligible survivors.
Children who were exposed in-utero,
who experienced ‘take-home’ exposures,
who suffer from mental health
conditions resulting from their parents’
WTC-related mental health conditions,
and who suffer from health effects
resulting from parental exposures were
not identified in the PHS Act’s
eligibility criteria for survivors. To the
extent that language could be added to
the eligibility criteria to permit some or
all such cohorts of children to be
enrolled as WTC survivors under § 88.8,
the Administrator would be required to
promulgate modified eligibility criteria.
The Administrator is not contemplating
such modified criteria at this time.
Developmental disorders cannot be
added to the List without rulemaking
supported by scientific or medical
evidence, pursuant to the procedures
established in § 88.16 for adding new
WTC-related health conditions to the
List. There is no change made to the
regulatory text in response to this
comment.
Section 88.9 Application Process—
WTC Survivors
This section describes the application
process for individuals in the New York
City disaster area who did not
participate in response and recovery
activities.
Comment: One July 2011 IFR
commenter suggested that the
application process should allow
statements written under penalty of
perjury from fellow workers, neighbors,
and fellow students or teachers, and
allow a sworn statement of facts by the
applicant before a notary if no other
documentation is available.
Administrator’s response: The
Program accepts a wide range of
documentation to verify an applicant’s
status. Statements from co-workers and
others used as evidence of an
individual’s presence in the New York
City disaster area are contemplated by
§ 88.9(a)(1), which has been slightly
revised for clarity by replacing a comma
with a semi-colon, to state that
‘‘[d]ocumentation may include but is
not limited to: Proof of residence, such
as a lease or utility bill; attendance
roster at a school or daycare; or pay
stub, other employment documentation,
or written statement, under penalty of
perjury, by an employer indicating
employment location during the
relevant time period; or similar
documentation.’’ ‘‘Similar
documentation’’ could include written
statements from co-workers and fellow
students or neighbors. The types of
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written statements suggested by the
commenter are among those that are
routinely accepted by the Program. This
section is not changed in response to
this comment.
A new paragraph (a)(3), comprising
language concerning the notification of
deficiencies in an application, is moved
from § 88.10(a). ‘‘Shall’’ is replaced with
‘‘must’’ throughout the section, and
‘‘WTC Program Administrator’’ is
replaced with ‘‘WTC Health Program’’
in paragraph (b).
Section 88.10 Enrollment Decision—
Screening-Eligible Survivors
This section describes the basis for
enrollment as a screening-eligible
survivor and enrollment denial
decisions, and explains the Program’s
notification procedures.
Comment: One July 2011 IFR
comment asked that the Program
shorten the time frame for notifying
applicants of screening-eligible status
from 60 calendar days to no more than
30 days from NIOSH’s receipt of the
application. The commenter also asked
that the Program use telephone outreach
to follow up with applicants when
documentation is absent or deficient.
Administrator’s response: The
Program is required by statute to
respond to applications within 60
calendar days of receipt of the
application and makes every effort to
respond in less time; the average
response time is approximately 4 weeks.
Applicants can impact the length of the
eligibility review process by submitting
a complete application. The Program
makes every effort to contact applicants
to correct any deficiencies in the
application, and conducts follow-up by
telephone, mail, and/or email. This
section is not changed in response to
this comment.
Language in paragraph (a) concerning
notification of deficiencies in an
application is moved to § 88.9(a)(3).
Section 88.11 Initial Health Evaluation
for Screening-Eligible Survivors
This section describes the initial
health evaluation process for screeningeligible survivors.
Comment: One August 2016 NPRM
commenter shared a concern that the
language may permit survivors to obtain
an initial health evaluation and
treatment from any CCE.
Administrator’s response: The
language in this section is essentially
unchanged from the original language of
§ 88.10(d)(1), which reads ‘‘A WTC
Health Program Clinical Center of
Excellence or a member of the
nationwide network provider [sic] will
provide the screening-eligible survivor
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an initial health evaluation to determine
if the individual has a WTC-related
health condition. . . .’’ Although the
names are changed to acronyms for the
sake of brevity and clarity, the
Administrator’s intent is unchanged and
the language in this section continues to
mean that an initial health evaluation
will be provided by the Program. No
change is made to the regulatory text in
response to this comment.
rmajette on DSK2TPTVN1PROD with RULES2
Section 88.12 Enrollment Decision—
Certified-Eligible Survivors
This section describes the basis for
enrollment as a certified-eligible
survivor and enrollment denial
decisions, and explains the Program’s
notification procedures.
Comment: One July 2011 IFR
commenter asked that the Program
specify a time frame for notification of
certified-eligible status, no more than 30
days from receipt by the Program of a
physician determination.
Administrator’s response: Although
the WTC Health Program makes every
effort to provide certification decisions
in a timely manner, the establishment of
a deadline for notification of certifiedeligible status or a deadline for the
Program’s decision whether to certify a
WTC-related health condition (pursuant
to § 88.18) could impede the Program’s
ability to conduct a thorough analysis of
the member’s health condition and
exposure history. This could especially
be the case where the Administrator has
added a health condition to the List but
the Program has not yet established
implementation guidelines. Moreover, a
deadline may create confusion if
stakeholders believe that a certification
request not granted or denied within the
period is deemed to be either granted or
denied. No change is made to the
regulatory text in response to this
comment.
Section 88.13 Disenrollment
This section clarifies the process for
disenrolling a member from the WTC
Health Program.
Comment: One August 2016 NPRM
commenter agreed that the
disenrollment (and decertification,
pursuant to § 88.18) provisions are
important to ‘‘ensure program
integrity.’’
Comment: One August 2016 NPRM
commenter stated that there is no
language included in this section to
address grandfathered members (those
enrolled pursuant to §§ 88.3 and 88.7)
and stated the opinion that such
members should be ‘‘immune from
disenrollment.’’
Administrator’s response: It is
important to the integrity of the WTC
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Health Program to maintain the
authority to disenroll any member if
evidence indicates that the enrollment
was based on incorrect or fraudulent
information. The provisions in
paragraph (a)(1) only apply to members
enrolled under the eligibility criteria in
§§ 88.4 or 88.8 (which do not include
grandfathered members) and permit
disenrollment where there is
insufficient proof of meeting the
eligibility criteria required by those
sections. The provisions in paragraph
(a)(2) apply to all members (including
grandfathered members) and permit
disenrollment where the enrollment was
based on incorrect or fraudulent
information. No change to the regulatory
text is made in response to this
comment.
Section 88.14 Appeal of Enrollment or
Disenrollment Decision
This section establishes procedures
for the appeal of a WTC Health Program
decision to deny enrollment of an
applicant or disenroll a Program
member.
Comment: One August 2016 NPRM
commenter agreed that the proposed
extension of the deadline for filing an
appeal, from 60 to 90 days, is an
improvement but is still too short a time
frame for obtaining necessary records.
According to the commenter, the
deadline for filing an appeal should be
extended to at least 4 months (120
days).
Administrator’s response: The
Administrator agrees and extends the
deadline for appeal submission to 120
days. The regulatory text in paragraph
(b)(1) is amended accordingly.
Comment: One August 2016 NPRM
commenter requested that the Program
allow applicants and members to make
an oral statement during the appeal, as
is allowed in § 88.21.
Administrator’s response: Although
applicants and members are allowed to
submit new information in support of
Program enrollment denial or
disenrollment appeals, the
Administrator has determined that, in
the context of enrollment and
disenrollment appeals, the
administrative burden associated with
oral statements outweighs the benefits.
The factual bases and documentation
requirements for enrollment and
disenrollment decisions can be more
efficiently considered through a paperbased review. No changes to the
regulatory text are made in response to
this comment.
Comment: One July 2011 IFR
commenter asked that the Program
indicate from where the Federal Official
will be drawn and what expertise that
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individual may have with the
monitoring and treatment of WTCrelated health conditions.
Administrator’s response: The Federal
Officials appointed to hear appeals are
chosen from Centers, Institutes, or
Offices within the Centers for Disease
Control and Prevention. They have
relevant knowledge but do not work
within the WTC Health Program. No
change is made to the regulatory text in
response to this comment.
Comment: One August 2016 NPRM
commenter stated that the NPRM
provides no justification for having the
Administrator make final decisions on
appeals and appears unfair to the
claimant making the appeal.
Administrator’s response: To clarify
the processes by which certain
decisions are made within the Program,
language throughout Part 88 is changed
to indicate that some decisions are made
directly by the Administrator, while he
has designated WTC Health Program
staff to make other Program decisions,
such as certifications. In the case of
enrollment or disenrollment appeals,
the Administrator is reviewing
decisions made by Program staff. The
Program finds it important to shift the
final appeal decision-making authority
to the Administrator because the final
decision on eligibility appeals (and the
certification and treatment authorization
appeals in § 88.21) should be made by
the Administrator, who has a thorough
understanding of the WTC cohorts and
matters related to eligibility and
exposures and is best able to apply the
laws, policies, and procedures
governing the WTC Health Program. No
change is made to the regulatory text in
response to this comment.
Comment: One August 2016 NPRM
commenter expressed concern that some
appeals may take longer than the
average 45 days, and recommended a
final decision deadline of 120 days,
with a contingency for justifying longer
delays based on specific circumstances.
Administrator’s response: As
discussed above, the establishment of a
deadline for notification of a decision
such as a final appeal decision could
impede the Program’s ability to conduct
a thorough review of the prospective
member’s application and
documentation of eligibility. The
section is not changed in response to
this comment.
Section 88.15 List of WTC-Related
Health Conditions
This section contains the List
previously placed in § 88.1 Definitions.
No public comments were received on
this section and no substantive revisions
are made to the text. Some punctuation
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is corrected and the names of two types
of cancer are pluralized.
Section 88.16 Addition of Health
Conditions to the List of WTC-Related
Health Conditions
This section establishes the process
by which interested parties may petition
the Administrator to add a health
condition to the List. No public
comments were received on this section
and no revisions are made to the text.
Section 88.17 Physician’s
Determination of WTC-Related Health
Conditions
This section establishes the basis for
a CCE or NPN-affiliated physician’s
determination that a member has a
health condition that can be certified.
No public comments were received on
this section and no revisions are made
to the text.
rmajette on DSK2TPTVN1PROD with RULES2
Section 88.18
Certification
This section establishes that the WTC
Health Program will promptly assess
physician determinations submitted by
a CCE or NPN-affiliated physician and,
if the Program concurs with the
determination and decides that a health
condition is a WTC-related health
condition or a health condition
medically associated with a WTCrelated health condition, will certify the
condition as eligible for coverage under
the WTC Health Program.
Comment: One August 2016 NPRM
commenter recommended the
establishment of a deadline for Program
decisions concerning the certification of
WTC-related health conditions.
Administrator’s response: As
discussed above with regard to certifiedeligible status notification, the
establishment of a deadline for a final
appeal decision could impede the
Program’s ability to conduct a thorough
analysis of the member’s health
condition and exposure history.
Certification decisions may be
particularly time-consuming to resolve
if a condition has been added to the List
but the Program has not yet established
implementation guidelines. Moreover, a
deadline may create confusion if
stakeholders believe that a certification
request not granted or denied within the
period is deemed granted. The section is
not changed in response to this
comment.
Comment: Four July 2011 IFR
commenters stated their belief that PHS
Act, sec. 3312(b)(2) permits certification
of individual primary conditions
determined to be WTC-related that are
not on the List and the regulatory text
should be revised accordingly.
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Administrator’s response: The
Administrator has reviewed PHS Act,
sec. 3312(b)(2)(A)–(B) and finds that the
meaning of the text ‘‘determination
based on medically associated WTCrelated health conditions’’ and ‘‘if a . . .
WTC responder has a health condition
described in subsection (a)(1)(A) that is
not in the list in subsection (a)(3) but
which is medically associated with a
WTC-related health condition . . .’’ is
plain—the medically associated health
condition must be related to a health
condition listed in sec. 3312(a)(3). The
language of the enacted statute does not
permit physicians to recommend a
health condition for certification that is
not causally related to a listed WTCrelated health condition. The
Administrator finds the language of the
Act is clear, and the legislative history
is consistent with the Administrator’s
interpretation. While the language in the
introduced bill did give physicians the
authority requested by commenters,
subsequent amendments to the bill
changed the language and the intent of
the enacted Act is different from that
which was introduced. The regulatory
text in this section is not changed in
response to these comments.
Section 88.19 Decertification
This section clarifies the process for
decertification of a WTC-related health
condition or health condition medically
associated with a WTC-related health
condition.
Comment: One August 2016 NPRM
commenter asked that language be
added to this section ‘‘to clarify that a
member whose health condition has
been decertified retains the right to seek
recertification’’ in some circumstances.
For example, where new information
about the member’s exposure or
evidence of association between 9/11
exposure and the decertified condition
was previously not considered by the
Program.
Administrator’s response: In addition
to a right to appeal a WTC Health
Program decision to decertify a certified
WTC-related health condition, a
member who believes the decision was
made in error may ask the CCE or NPN
physician to resubmit the certification
request; the physician may include new
information to support the case for
certification. The Administrator finds it
unnecessary to revise the regulatory text
in § 88.19(b) and may address this
matter administratively.
Comment: Similar to a comment on
§ 88.13, one August 2016 NPRM
commenter expressed concern that there
is no language in this section addressing
grandfathered members (those enrolled
pursuant to §§ 88.3 and 88.7), who
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should be ‘‘immune from
decertification.’’
Administrator’s response: It is
important to the integrity of WTC
Health Program that any health
condition may be decertified if the
available evidence indicates that the
certification is based on inadequate
exposure or was otherwise certified in
error. This includes grandfathered
Program members. The section is not
changed in response to this comment.
Section 88.20
Treatment
Authorization of
This section describes the provision
of medically necessary treatment.
Comment: One July 2011 IFR
commenter asked the Program to use a
variety of mental health modalities to
treat mental health conditions. The
commenter recommended that such
treatment must be culturally sensitive
and allow patients to be treated by
private, community-based mental health
professionals.
Administrator’s response: The
Program allows a variety of treatment
modalities to address various diagnoses,
especially posttraumatic stress disorder
(PTSD) and other mental health
conditions. Many of the practitioners
affiliated with CCEs or the NPN have
community-based mental health
practices where they see Program
members and should be able to render
culturally-sensitive care. No change is
made to the regulatory text in response
to this comment.
Comment: One August 2016 NPRM
commenter recommended the addition
of flexibility to the regulatory text in
paragraph (b) to ‘‘accommodate complex
care situations’’ like cancer treatment or
organ transplant in medical protocols
developed by the Data Centers.
Administrator’s response: The
Program finds that the regulatory text in
paragraph (b) is sufficiently broad to
allow for the development of medical
protocols of any appropriate
complexity. No change is made to the
regulatory text in response to this
comment.
Comment: One August 2016 NPRM
commenter expressed concern that a
strict interpretation of the language in
paragraph (c) requires the Administrator
personally to authorize treatment
pending certification before any
treatment is provided (except for
emergency care). According to the
commenter, ‘‘[g]iven the growing length
of time between submission of
certification requests and the receipt of
decisions, a strict interpretation of this
language would be detrimental to
member wellbeing.’’
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Administrator’s response: The
Administrator agrees with the
commenter and changes the regulatory
text to replace ‘‘Administrator of the
WTC Health Program’’ with ‘‘WTC
Health Program.’’
Section 88.21 Appeal of Certification,
Decertification, or Treatment
Authorization Decision
This section establishes that a WTC
Health Program member or the
designated representative of such a
member may appeal the Program’s
decision to deny certification of a health
condition as WTC-related or medically
associated with a WTC-related health
condition, decertify a WTC-related
health condition or medically associated
health condition, or deny authorization
of treatment for a certified health
condition.
In response to public comment on
§ 88.14, concerning appeal of
enrollment decisions, the Administrator
agreed to extend enrollment appeal
submission deadlines to 120 days. To
maintain parity with that process, the
deadline for the submission of appeals
of certification, decertification, and
treatment authorization decisions is also
extended to 120 calendar days.
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Section 88.24 Coordination of Benefits
and Recoupment
This section addresses the matter of
coordination of benefits, including
recoupment from workers’
compensation settlements.
Comment: One August 2016 NPRM
commenter stated that the language in
paragraph (e) ‘‘does not address the
growing use of restricted networks by
health insurers which can make it very
difficult for a participant to find a
provider in their network for the
complicated specialty treatment
required for their medical condition.
Would they be forced to go to an innetwork provider which is not in the
WTC program?’’
Administrator’s response: The
Program is aware of the concern raised
by the commenter, especially in the
cancer care context. In very rare
circumstances, the Program may allow
for members who require ‘‘specialty
treatment,’’ such as cancer care and
transplants, to receive care from
providers outside of their insurance
networks. Otherwise, the CCE or NPN
will coordinate care through providers
within the members’ insurance
networks. The Program may provide
more specific administrative guidance
on this issue, as necessary. No changes
are made to the regulatory text in
response to this comment.
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General Comments
Comment: One July 2011 IFR
commenter asked that the Part 88
regulations address outreach, and
include radio, TV, newspaper
advertising, community meetings; fund
effective, culturally competent outreach;
partnership with community-based
social service providers; re-fund defunded outreach programs; and offer inperson assistance for completing
application for non-English speakers
and the mentally impaired.
Administrator’s response: Section
3303 of the PHS Act authorizes the
Administrator to conduct the following
outreach and education activities:
establish a public Web site with
information about the Program; hold
meetings with potentially eligible
populations; develop and disseminate
outreach and education materials about
the Program; and establish telephone
information services. The Act further
specifies that these activities will be
conducted in a manner intended to
reach all affected populations and
include materials for culturally and
linguistically diverse populations. The
WTC Health Program meets these
requirements by funding outreach and
education activities (including
culturally appropriate and diverse
programs) to be conducted by the CCEs
as well as community and labor groups.
These groups are able to provide faceto-face enrollment assistance.
Furthermore, the WTC Health Program
has a New York Field Coordinator who
also conducts outreach and provides
application assistance. No change is
made to Part 88 in response to this
comment.
VI. 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, and public health and
safety effects, distributive impacts, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility.
This final rule has been determined to
be a ‘‘significant regulatory action’’
under section 3(f) of Executive Order
12866.
This final rule includes changes
proposed in the August 2016 NPRM and
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final revisions made in response to
public comment and to clarify the
Program’s intent; it also finalizes three
IFRs issued in July 2011, March 2013,
and February 2014, respectively. This
final rule includes revisions to §§ 88.14
and 88.21 (enrollment and medical
appeals) and § 88.16 (addition of health
conditions) that will result in necessary
updates to several existing WTC Health
Program policies; novel regulatory
provisions in § 88.13 (disenrollment),
§ 88.19 (decertification), and § 88.23
(reimbursement appeals) will require
the revision of existing policies or
development of new policies. The
Administrator estimates that amending
the existing Policy and Procedures for
Handling Submissions and Petitions to
Add a Health Condition to the List of
WTC-Related Health Conditions and the
Web page containing frequently asked
questions regarding appeals, and
developing new disenrollment,
decertification, and reimbursement
appeal policies will require
approximately 568 hours of staff time.
The average WTC Health Program staff
member responsible for updating these
policies is a GS 14–5, earning $125,221
annually, pursuant to OPM’s Salary
Table 2016–DCB (Washington DC), or
$75.25 hourly, adjusted to include
benefits. Accordingly, the revisions to
Part 88 finalized in this final rule are
expected to cost the WTC Health
Program approximately $42,742 and
that amount is included in the
administrative costs discussed below.
This rulemaking is not expected to
change the number of applicants or
Program members; the Administrator
has not identified any other potential
impacts associated with this final rule.
In addition to the costs associated
with the August 2016 NPRM, this rule
also updates the regulatory impact
analyses for the July 2011, March 2013,
and February 2014 IFRs, which are all
finalized in this action. In the original
cost analysis conducted for the Part 88
WTC Health Program regulations,14
HHS estimated the aggregate cost of
medical monitoring and treatment to be
provided and administrative expenses
associated with implementing the WTC
Health Program for a period of 5 years.
HHS developed those estimates for the
health conditions included for Program
coverage in sections 3312 and 3321 of
the PHS Act, using data from the health
programs that were in place for WTC
responders and survivors prior to the
establishment of the WTC Health
Program. Since that original July 2011
rulemaking and cost analysis, the WTC
Health Program has expanded the list of
14 July
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health conditions eligible to receive
coverage in the Program through
regulations, as permitted by section
3312(a)(6) of the PHS Act; in addition to
the original statutory conditions of
specified aerodigestive disorders,
mental health conditions, and, for
certain responders, musculoskeletal
disorders, the WTC Health Program now
also provides coverage for numerous
types of cancer, new-onset chronic
obstructive pulmonary disease (COPD),
and WTC-related acute traumatic injury.
Data used to update this regulatory
impact analysis include data derived
from WTC Health Program health
services claims data as well as
administrative and infrastructure cost
data collected between FY 2012, the
first full year for which data are
available, and the end of FY 2015, the
last full year for which data are
available.
90933
The Program estimates that total
cumulative costs associated with the
WTC Health Program over the next 10
years will be $4,223,209,653,
undiscounted (from $2,874,481,628 at 7
percent discount rate to $3,553,658,528
at 3 percent discount rate). The cost of
the rule in FY 2025 is estimated to be
$522,307,538 (present value between
$265,514,667 and $388,645,860, at 7
percent and 3 percent discounts rates,
respectively).15
TABLE 1—SUMMARY OF WTC HEALTH PROGRAM COSTS *
FY 2015
FY 2025
Cumulative
FY 2016–2025
Total Costs
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
$240,571,579
....................................
....................................
$522,307,537
265,514,667
388,645,860
$4,223,209,653
2,874,481,628
3,553,658,528
134,485,132
68,365,421
100,069,568
1,194,966,221
825,867,165
1,012,191,361
887,401
....................................
....................................
2,387,362
1,213,614
1,776,421
18,641,297
12,610,885
15,644,794
17,583,046
....................................
....................................
47,303,408
24,046,654
35,198,178
369,360,390
249,873,253
309,987,399
13,131,585
....................................
....................................
35,327,709
17,958,816
26,287,133
275,850,234
186,613,392
231,508,572
112,554,583
....................................
....................................
302,803,927
153,930,162
225,314,560
2,364,391,511
1,599,516,932
1,984,326,403
387,822,405
197,149,246
288,576,292
3,028,243,432
2,048,614,463
2,541,467,168
Program Administration
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
96,414,964
....................................
....................................
Medical Monitoring and Treatment
Initial health evaluation (survivors only):
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
Annual medical monitoring:
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
Diagnostic evaluation/cancer screening:
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
Medical Treatment:
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
All Medical Monitoring and Treatment
Undiscounted ....................................................................................
7% discount rate ...............................................................................
3% discount rate ...............................................................................
144,156,615
....................................
....................................
Prior Rulemaking Cost Estimates
Cancer, September 2012 final rule (non-add) .................................................................................
Pentagon/Shanksville responders, March 2013 IFR (non-add) ......................................................
Prostate cancer, September 2013 final rule (non-add) ...................................................................
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Brain, invasive cervical pancreatic, testicular cancers, February 2014 IFR (non-add) ..................
COPD and acute traumatic injury, July 2016 final rule (non-add) ..................................................
Estimated cost per year FY 2013–2016 ($mil)
12.5–33.3.
Estimated cost per year FY 2013–2016 ($mil)
.9–3.2.
Estimated cost per year FY 2014–2016 ($mil)
3.5–7.0.
Estimated cost per year FY 2014–2016 ($mil)
2.2–5.0.
Estimated cost per year FY 2016–2019 ($mil)
4.6–5.7.
* Due to rounding, some totals may not correspond with the sum of the separate figures.
15 These estimates represent only a 60 percent
increase over the cost estimates provided in the July
2011 IFR, where the Program found that costs in
2015 could range from $106,800,000 to
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$151,000,000. That estimate was based not on WTC
Health Program experience, but on health programs
that pre-dated the current WTC Health Program.
The estimate in the July 2011 IFR was carried out
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until only FY 2015; the current analysis projects
Program costs through FY 2025 based on WTC
Health Program experience to date.
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Enrollment
As of the end of FY 2015, WTC Health
Program membership included 64,008
WTC responders and 9,144 screeningand certified-eligible survivors. Based
on enrollment numbers since FY 2012,
the first full year for which data are
available, responders (including
Pentagon and Shanksville responders)
enroll at an approximate rate of 2,087
per year, screening- and certifiedeligible survivors at an approximate rate
of 1,077 per year. Table 2 displays the
past annual enrollment of members, the
projected enrollment over the 10 years
between FY 2016 and FY 2025, and the
projected total number of members by
FY 2025.16
TABLE 2—WTC HEALTH PROGRAM ANNUAL ENROLLMENT
FY 2012
WTC responders ......................................
Screening- and certified-eligible survivors
Total ..................................................
FY 2013
886
1,017
1,903
Administrative Costs
The annual cost to the WTC Health
Program of conducting administrative
functions was approximately
$96,414,964 in FY 2015. Given the
aggregate rate of enrollment of WTC
responders and screening- and certifiedeligible survivors, a rise in operations
costs by 1.7 percent and a rise in
FY 2014
1,539
736
2,275
FY 2015
3,096
1,451
4,547
infrastructure costs of 3.3 percent,
annual administrative costs for FY 2025
are expected to be $134,485,132. Such
costs include program management,
enrollment, certification of health
conditions, pre-authorization of medical
care, payment services, administration
of appeals, education and outreach,
administration of the advisory and
2,205
1,170
3,375
FY 2016–2025
Total members
by 2025
20,873
10,770
31,643
84,545
19,809
104,354
steering committees, and infrastructure
costs for the CCEs/NPN.
Infrastructure costs for the CCEs/NPN
include the retention of participants,
case management, medical review,
benefits counseling, quality
management, data transfer, interpreter
services, and assisting with the
development of treatment protocols.
TABLE 3—WTC HEALTH PROGRAM ADMINISTRATIVE COSTS
[Undiscounted]
FY 2015
FY 2025
Administrative costs (not including CCE/NPN infrastructure—see below) .............................................................
CCE/NPN infrastructure cost ...................................................................................................................................
$39,672,004
56,742,690
$57,193,270
77,291,862
Total ..................................................................................................................................................................
96,414,694
134,485,132
Costs of Medical Monitoring and
Treatment
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In FY 2015, the total cost to the WTC
Health Program for medical monitoring
and treatment was $144,156,615, and
the breakdown by type of service is
shown in Table 1. Initial health
evaluations are for WTC screeningeligible survivors only. Diagnostic
evaluation and cancer screening is for
WTC screening- and certified-eligible
survivors and WTC responders. The
other two categories of services are for
WTC certified-eligible survivors and
WTC responders. These costs are based
on claims paid during FY 2015. The FY
2015 costs do not include costs
associated with monitoring and
treatment of new-onset COPD and WTCrelated acute traumatic injury because
the rulemaking adding those conditions
16 These enrollment numbers do not include
grandfathered members, the majority of whom were
automatically enrolled in the Program in July 2011.
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to the List was not completed until July
2016.17
For FY 2025, the WTC Health
Program estimated the total cost for all
health care service categories based on
linear cost projections from prior fiscal
years, with an adjustment (increase) to
account conservatively for statistical
uncertainty in the estimate. Also
included in the estimate are increases
for the treatment and monitoring of
new-onset COPD and WTC-related acute
traumatic injury, added to the List in
July 2016. The FY 2025 total for all
health care service categories is
$387,822,406. This estimate accounts
for an increase in enrollment, more
members receiving health care benefits,
higher-cost care related to cancer and
complications of other illnesses, and
general medical care cost increases. In
order to determine the breakout by
health care service category for FY 2025,
17 81
PO 00000
the WTC Health Program calculated the
percentage of the total cost in FY 2015
for each category and applied those
percentages to the total estimate for FY
2025.
Examination of Benefits
Through FY 2015, the last full year for
which Program data are available,
35,523 members (49 percent) have been
certified for at least one WTC-related
health condition. The number of
certifications of WTC-related health
conditions identified in the categories of
health conditions included in the List of
WTC-Related Health Conditions is in
Table 4, below. Based on the projected
FY 2025 enrollment number of 104,354
and an increase of 3 percent annually of
the number of members who are
estimated to be certified, there would be
158,415 certifications for 68,103
Program members in FY 2025.
FR 43510 (July 5, 2016).
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TABLE 4—NUMBER OF CERTIFIED WTC-RELATED HEALTH CONDITIONS AMONG WTC HEALTH PROGRAM MEMBERS
Health condition category
FY 2015
FY 2025
Aerodigestive disorders ...........................................................................................................................................
Mental health conditions ..........................................................................................................................................
Musculoskeletal disorders .......................................................................................................................................
Cancers ....................................................................................................................................................................
58,782
18,868
535
4,445
112,694
36,173
1,026
8,522
Total certifications .............................................................................................................................................
82,630
158,415
An evaluation of the health and
quality of life improvements associated
with medical treatment of several of the
most commonly-certified health
conditions is based on the prevalence of
certified WTC-related health conditions.
Quality-adjusted life year (QALY) is a
common metric of expected treatment
effectiveness for the health conditions
evaluated. For the purpose of this
evaluation, the Administrator assumes
that each health condition will continue
to be represented among new Program
members at the same rate at which it
occurs in current members. The health
benefits provided by the WTC Health
Program are compared with the effect of
no Program at all.
The Administrator assumes that WTC
Health Program members receive the
best care available, as CCE and NPN
providers are experts in treating the
types of health conditions on the List
eligible for certification. In order to
compare the benefits provided by the
WTC Health Program to a scenario with
no WTC Health Program, the
Administrator further assumes that the
9/11-exposed population of responders
and survivors would instead receive
some but not optimal treatment for their
health conditions. Accordingly, the
estimated benefits (QALYs) represent
the incremental improvement in health
that WTC Health Program members can
expect from receiving the optimal
treatment provided by the CCEs and
NPN versus standard treatments that are
commonly received outside of the
Program.
Below are summarized QALY
estimates for morbidity improvements
for aero-digestive conditions, PTSD and
depression, and cancer.18
Aerodigestive Disorders
rmajette on DSK2TPTVN1PROD with RULES2
• Gastroesophageal Reflux Disorder
(GERD)
18 Estimates for mental disorders other than PTSD
and depression and for musculoskeletal disorders
are not provided because these conditions only
account for approximately 9 percent of the total
certifications; estimates for WTC-related acute
traumatic injuries are not included because the FY
2015 data used to conduct this analysis pre-dates
the July 2016 rulemaking that added WTC-related
acute traumatic injuries to the List.
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In the July 2011 IFR, an estimated
0.012 QALYs were gained per year per
patient under treatment for GERD in the
Program compared with patients treated
outside the Program. Multiplying the
WTC Health Program’s GERD
population for each year during FY
2016–2025 by 0.012 results in 3,311
total undiscounted QALYs gained.
Discounting future health benefits at 3
and 7 percent results in 2,781 and 2,244
total QALYs gained, respectively.
• Chronic Rhinosinusitis and other
Upper Respiratory Diseases
In the July 2011 IFR, an estimated
0.0145 QALYs were gained per year per
patient under treatment for chronic
rhinosinusitis and other upper
respiratory diseases in the Program
compared with patients treated outside
the Program. Assuming the same gain is
achieved for patients treated for other
upper respiratory diseases, treating
patients for all upper respiratory
diseases would result in 4,877 total
undiscounted QALYs gained.
Discounting future health benefits at 3
and 7 percent results in 4,095 and 3,304
total QALYs gained, respectively.
• Asthma
In the July 2011 IFR, an estimated
0.029 QALYs were gained per year per
patient under treatment for asthma in
the Program resulting in 6,002 total
undiscounted QALYs gained.
Discounting future benefits at a rate of
3 percent and 7 percent results in 5,040
and 4,066 total QALYs, respectively.
• Chronic Obstructive Pulmonary
Disease (COPD) 19
In the July 2011 IFR, an estimated
0.077 QALYs were gained per year per
patient under treatment in the program
for WTC-exacerbated COPD in the
Program resulting in 3,320 total
undiscounted QALYs gained.
Discounting future health benefits at 3
and 7 percent results in 2,788 and 2,249
total QALYs gained, respectively.
19 Data used to develop QALYs for COPD were
derived from FY 2015 Program data regarding WTCexacerbated COPD; estimates for new-onset COPD
are not included because the FY 2015 data pre-dates
the addition of new-onset COPD to the List in the
July 2016 rulemaking.
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• Reactive Airways Dysfunction
Syndrome (RADS) and other
Aerodigestive Conditions
In the July 2011 IFR, an estimated
medical treatment similar to that for
asthma was discussed for patients
suffering from RADS. Assuming that
treating one patient results in 0.029
QALYs gained and that treating all other
aerodigestive conditions not examined
above would also result in 0.029 QALYs
gained would result in a total of 4,877
undiscounted QALYs gained.
Discounting future health benefits at 3
and 7 percent, results in 4,094 and 3,204
total QALYs gained, respectively.
Posttraumatic Stress Disorder (PTSD)
and Depression
In the July 2011 IFR, an estimated
0.013 QALYs were gained per year per
patient under treatment for PTSD and
depression in the Program resulting in
a total of 3,598 undiscounted QALYs
gained. Discounting future health
benefits at 3 and 7 percent results in
3,022 and 2,438 total QALYs gained,
respectively.
Cancer
It was assumed that all patients in FY
2016–2025 will live at a health-related
quality of life level similar overall to
that reported in Cutler and
Richardson 20 and Tengs and Wallace 21
for patients with cancer. A QALY for a
person living with cancer, without
specifying treatment, stage of disease, or
other specifics is approximately 0.7,
with 1 representing perfect health and 0
death. For comparison, Sullivan and
Ghushchyan 22 estimated the healthrelated quality of life for the age group
50–69 in the general U.S. population at
0.827.
20 David Cutler and Elizabeth Richardson, Your
Money and Your Life: The Value of Health and
What Affects It, in Frontiers in Health Policy
Research, vol. 2, 99–132 (National Bureau of
Economic Research, 1999).
21 Tammy Tengs and Amy Wallace, OneThousand Health-Related Quality of Life Estimates,
Med Care 2000;38(6):583–637.
22 Patrick Sullivan and Vahram Ghushchyan,
Preference-Based EQ–5D Index Scores for Chronic
Conditions in the United States, Med Decis Making
2006;26:410–420.
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Using the expected number of
prevalent cancer cases for FY 2016–
2025 and published information in
Tengs and Wallace on the health-related
quality of life of cancer patients who
respond to treatment for their cancer, a
rough estimate of 0.06 for the increase
in patients’ quality of life was estimated
for cancers treated in the WTC Health
Program compared to those not treated
in the Program.23 Using the prevalence
of cancers and an assumed difference in
health-related quality of life of 0.06
among patients treated in the Program
and those not treated in the Program for
the years FY 2016–2025 results in a total
of 3,913 undiscounted QALYs gained.
Discounting future benefits at 3 percent
and 7 percent, results in 3,285 and 2,651
total QALYs gained, respectively.
In summary, available information
indicates the WTC Health Program is
likely to provide substantial
improvements in health to responders
and survivors. The QALY estimates
discussed above and summarized and
annualized in Table 5 below are
illustrative of these benefits.
TABLE 5—POTENTIAL QALYS GAINED FROM THE WTC HEALTH PROGRAM TREATMENT OF SELECT WTC-RELATED
HEALTH CONDITIONS: FY 2016–2025 SUMMARY
Total
undiscounted
QALYs gained
by treatment
Present
value of
QALYs gained
by treatment
discounted
at 7%
Present
value of
QALYs gained
by treatment
discounted
at 3%
Aerodigestive disorders ...............................................................................................................
PTSD & Depression ....................................................................................................................
Cancers ........................................................................................................................................
17,510
3,598
3,913
11,863
2,438
2,651
14,704
3,022
3,285
Total ......................................................................................................................................
Annualized .....................................................................................................................
25,021
2,502
16,952
2,414
21,011
2,463
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Health condition
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.
September 30, 2018). HHS has
determined that substantive changes are
needed to the information collection
already approved by OMB. Accordingly,
HHS has published a notice of the
proposed changes to the existing
approved information collection and
invites comment from the public during
the 60-day comment period. The 60-day
notice, published in the Federal
Register on October 24, 2016, is open
for comment through December 23,
2016 (see 81 FR 73108); the 60-day
notice will be followed by a 30-day
notice, after which the revised
information collection request will be
finalized and approved by OMB.
Revisions to the approved information
collection include the following:
The cost analysis above is subject to
a number of limitations, some but not
all of which have been identified by the
Program. The enrollment,
administrative, and medical monitoring
and treatment cost estimates are based
on historical cost experience from the
first full year of the WTC Health
Program (FY 2012) to the end of FY
2015 and do not anticipate the costs of
WTC-related health conditions added to
the List in the future. The annual rate
of increase takes into account the
growth of the Program’s membership
based on enrollment data from the start
of the Program to present and does not
consider natural population mortality
and mortality due to the WTC-related
health conditions. The medical
monitoring and treatment cost estimates
are based on a combination of linear
regression analysis of aggregate medical
costs and adjustments for factors
described above.
The Program has also identified some,
but not all, limitations in deriving the
health benefits estimate. Some new
Program members, if they have not
received treatment for a certified WTCrelated health condition prior to
enrollment, may present in worse health
and may benefit less from medical
treatment than members who received
more timely treatment in the Program.
Furthermore, many Program members
may have more than one concurrent
certified WTC-related health condition
for which they are receiving treatment
in the Program, which can impact the
effectiveness of medical treatment for
any given condition.
This rule does not interfere with
State, local, or Tribal governments in
the exercise of their governmental
functions.
The Paperwork Reduction Act, 44
U.S.C. 3501 et seq., requires an agency
to invite public comment on, and to
obtain OMB approval of, any regulation
that requires 10 or more people to report
information to the agency or to keep
certain records. This final action
continues to impose the same
information collection requirements as
under the July 2011, March 2013, and
February 2014 IFRs, including the
submission of the following forms and
other information listed in the table
below.
• Disenrollment Letter and Appeal
Notification—Eligibility: Of the over 70,000
Program members, we expect that 0.014
percent (10) will be subsequently disenrolled
from the Program. Of those, we expect that
30 percent (3) will appeal the disenrollment
decisions. We estimate that the appeal
requests will take no more than 0.5 hours per
respondent. The annual burden estimate is
1.5 hours.
• Decertification Letter and Appeal
Notification—Health Condition: Of the
projected 51,472 enrollees who have at least
23 Tengs and Wallace, supra note 15, reports
ranges of differences in QALYs according to
different treatments for ovarian cancer patients and
whether these patients responded to these
treatments. The ranges of these differences varied
from 0.06 to 0.17. We used the low end of the range
as a conservative estimate. We are not aware of data
available with which to estimate the possible effect
more reliably.
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B. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA),
5 U.S.C. 601 et seq., requires each
agency to consider the potential impact
of its regulations on small entities
including small businesses, small
governmental units, and small not-forprofit organizations. The Administrator
certifies that this proposed rule has ‘‘no
significant economic impact upon a
substantial number of small entities’’
within the meaning of the RFA.
C. Paperwork Reduction Act
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one health condition certification, it is
estimated that 0.02 percent (10) will be
decertified, and 50 percent (5) of those will
appeal a decertification. We estimate that the
appeal request will take no more than 0.5
hours per respondent and providing
additional information and/or an oral
statement will take no more than 1 hour per
respondent. The annual burden estimate is
7.5 hours.
• Denial Letter and Appeal Notification—
Health Condition Certification: This
information collection, including the
submission of appeal requests, is currently
approved by OMB for 60 respondents (0.5
hours per respondent) and is expanded by
this final rule to include the provision of new
information and/or an oral statement. We do
not expect the OMB-approved estimated
number of respondents to change. We
estimate that the additional burden will be
no more than 1 hour per respondent. The
total burden estimate (1.5 hours) includes
both 0.5 hours per respondent for the
submission of an appeal request (currently
approved by OMB) as well as 1 hour per
respondent for new information and/or an
oral statement. The annual burden estimate
is 90 hours.
• Denial Letter and Appeal Notification—
Treatment Authorization: This information
collection, including the submission of
appeal requests, is currently approved by
OMB for 26 respondents (0.5 hours per
respondent) and is expanded by this final
rule to include the provision of new
information and/or an oral statement. We do
not expect the OMB-approved estimated
number of respondents to change. We
estimate that the additional burden will be
no more than 1 hour per respondent. The
total burden estimate (1.5 hours) includes
both 0.5 hours per respondent for the
submission of an appeal request (currently
approved by OMB) as well as 1 hour per
respondent for new information and/or an
oral statement. The annual burden estimate
is 39 hours.
• Reimbursement Denial Letter and
Appeal Notification—Providers: Of the nearly
52,000 providers affiliated with the Program,
it is estimated that 1.15 percent (600)
annually will appeal a denial of
reimbursement for treatment found to be not
Type of
respondent
Form name
FDNY Responder ..........
World Trade Center Health Program FDNY Responder Eligibility Application.
World Trade Center Health Program Responder
Eligibility Application (Other than FDNY).
World Trade Center Health Program Pentagon/
Shanksville Responder.
World Trade Center Health Program Survivor
Eligibility Application.
Postcard for new general responders in NY/NJ
to select a clinic.
WTC–3 Request for Certification ........................
General Responder .......
Pentagon/Shanksville
Responder.
WTC Survivor ................
General Responder .......
Program Medical Provider.
Responder/Survivor .......
Responder/Survivor .......
Responder/Survivor .......
Responder/Survivor .......
Responder/Survivor .......
Responder/Survivor .......
Responder/Survivor .......
Pharmacy .......................
Program Medical Provider.
Responder/Survivor .......
Responder/Survivor/Advocate (physician).
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Total ........................
D. Small Business Regulatory
Enforcement Fairness Act
As required by Congress under the
Small Business Regulatory Enforcement
24 The burden estimates provided here are subject
to change in the final approved information
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The Program estimates that the total
annual paperwork burden associated
with this rulemaking, including the
revised and new burden hour estimates,
is 14,178.95 hours.24
Average
burden per
response
(in hours)
1
0.5
22.5
2,475
1
0.5
1,237.5
630
1
0.5
315
1,350
1
0.5
675
2,475
1
0.25
618.75
20,000
1
0.5
10,000
45
1
0.5
22.5
3
1
0.5
1.5
5
60
1
1
1.5
1.5
7.5
90
26
1
1.5
39
10
1
0.17
1.7
10
150
600
1
261
1
0.25
0.02
0.5
2.5
783
300
10
60
1
1
0.25
1
2.5
60
........................
........................
........................
14,178.95
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
collection revision request, pending the collection
and review of public comments.
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Total burden
hours
45
Denial Letter and Appeal Notification—Enrollment.
Disenrollment Letter and Appeal Notification—
Eligibility.
Decertification Letter and Appeal Notification .....
Denial Letter and Appeal Notification—Health
Condition Certification.
Denial Letter and Appeal Notification—Treatment Authorization.
WTC Health Program Medical Travel Refund
Request.
Designated Representative form .........................
Outpatient prescription pharmaceuticals .............
Reimbursement Denial Letter and Appeal Notification.
Designated Representative HIPAA Authorization
Petition for the addition of health conditions .......
..............................................................................
medically necessary or in accordance with
treatment protocols. We estimate that the
appeal request will take no more than 0.5
hours per respondent to compile. The annual
burden estimate is 300 hours.
• Designated Representative HIPAA
Authorization: The Program also finds it
necessary to add a new form to allow
applicants and Program members to grant
permission to share protected health
information with an individual who has been
properly appointed the applicant’s or
member’s designated representative pursuant
to 42 CFR 88.2. We estimate that 10
applicants and members will submit the
Designated Representative Health Insurance
Portability and Accountability Act (HIPAA)
Authorization form annually. The form is
expected to take no longer than 0.25 hours
to complete. The burden estimate for the
HIPAA Authorization form is 2.5 hours.
Number
responses
per
respondent
Number of
respondents
90937
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seq., directs agencies to assess the
effects of Federal regulatory actions on
State, local, and Tribal governments,
and the private sector ‘‘other than to the
extent that such regulations incorporate
requirements specifically set forth in
law.’’ For purposes of the Unfunded
Mandates Reform Act, this final rule
does not include any Federal mandate
that may result in increased annual
expenditures in excess of $100 million
by State, local, or Tribal governments in
the aggregate, or by the private sector.
F. Executive Order 12988 (Civil Justice)
This final rule has been drafted and
reviewed in accordance with Executive
Order 12988, ‘‘Civil Justice Reform,’’
and will not unduly burden the Federal
court system. This rule has been
reviewed carefully to eliminate drafting
errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Administrator has reviewed this
final rule in accordance with Executive
Order 13132 regarding Federalism, and
has determined that it does not have
‘‘Federalism implications.’’ The rule
does not ‘‘have substantial direct effects
on the States, on the relationship
between the national government and
the States, or on the distribution of
power and responsibilities among the
various levels of government.’’
H. Executive Order 13045 (Protection of
Children From Environmental Health
Risks and Safety Risks)
In accordance with Executive Order
13045, the Administrator has evaluated
the environmental health and safety
effects of this final rule on children. The
Administrator has determined that the
rule would have no environmental
health and safety effect on children.
rmajette on DSK2TPTVN1PROD with RULES2
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 final rule on energy
supply, distribution or use, and has
determined that the rule will not have
a significant adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111–274 (October
13, 2010), executive Departments and
Agencies are required to use plain
language in documents that explain to
the public how to comply with a
requirement the Federal government
administers or enforces. The
Administrator has attempted to use
plain language in promulgating the final
rule consistent with the Federal Plain
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Writing Act guidelines and requests
public comment on this effort.
List of Subjects in 42 CFR Part 88
Aerodigestive disorders, Appeal
procedures, Health care, Mental health
conditions, Musculoskeletal disorders,
Respiratory and pulmonary diseases.
Final rule
For the reasons discussed in the
preamble, the Administrator revises 42
CFR part 88 to read as follows:
■
PART 88—WORLD TRADE CENTER
HEALTH PROGRAM
Sec.
88.1
88.2
88.3
Definitions.
General provisions.
Eligibility—currently-identified
responders.
88.4 Eligibility criteria—WTC responders.
88.5 Application process—WTC
responders.
88.6 Enrollment decision—WTC
responders.
88.7 Eligibility—currently-identified
survivors.
88.8 Eligibility criteria—WTC survivors.
88.9 Application process—WTC survivors.
88.10 Enrollment decision—screeningeligible survivors.
88.11 Initial health evaluation for
screening-eligible survivors.
88.12 Enrollment decision—certifiedeligible survivors.
88.13 Disenrollment.
88.14 Appeal of enrollment or
disenrollment decision.
88.15 List of WTC-Related Health
Conditions.
88.16 Addition of health conditions to the
List of WTC-Related Health Conditions.
88.17 Physician’s determination of WTCrelated health conditions.
88.18 Certification.
88.19 Decertification.
88.20 Authorization of treatment.
88.21 Appeal of certification,
decertification, or treatment
authorization decision.
88.22 Reimbursement for medical treatment
and services.
88.23 Appeal of reimbursement denial.
88.24 Coordination of benefits and
recoupment.
88.25 Reopening of WTC Health Program
final decisions.
Authority: 42 U.S.C. 300mm to 300mm-61,
Pub. L. 111–347, 124 Stat. 3623, as amended
by Pub. L. 114–113, 129 Stat. 2242.
§ 88.1
Definitions.
Act means Title XXXIII of the Public
Health Service Act, as amended, 42
U.S.C. 300mm through 300mm–61
(codifying Title I of the James Zadroga
9/11 Health and Compensation Act of
2010, Pub. L. 111–347, as amended by
Pub. L. 114–113), which created the
World Trade Center (WTC) Health
Program.
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Aggravating means a health condition
that existed on September 11, 2001, and
that, as a result of exposure to airborne
toxins, any other hazard, or any other
adverse condition resulting from the
September 11, 2001, terrorist attacks,
requires medical treatment that is (or
will be) in addition to, more frequent
than, or of longer duration than the
medical treatment that would have been
required for such condition in the
absence of such exposure.
Certification means WTC Health
Program review of a health condition in
a particular WTC Health Program
member for the purpose of identification
and approval of a WTC-related health
condition, as defined in this section and
included on the List of WTC-Related
Health Conditions in 42 CFR 88.15, or
a health condition medically associated
with a WTC-related health condition.
Certified-eligible survivor means (1)
an individual who has been identified
as eligible for medical monitoring and
treatment as of January 2, 2011; or (2)
a screening-eligible survivor who is
eligible for follow-up monitoring and
treatment pursuant to § 88.12(b).
Clinical Center of Excellence (CCE)
means a center or centers under contract
with the WTC Health Program. A CCE:
(1) Uses an integrated, centralized
health care provider approach to create
a comprehensive suite of health services
that are accessible to enrolled WTC
responders, screening-eligible survivors,
or certified-eligible survivors;
(2) Has experience in caring for WTC
responders and screening-eligible
survivors, or includes health care
providers who have received WTC
Health Program training;
(3) Employs health care provider staff
with expertise that includes, at a
minimum, occupational medicine,
environmental medicine, trauma-related
psychiatry and psychology, and social
services counseling; and
(4) Meets such other requirements as
specified by the Administrator of the
WTC Health Program.
Data Center means a center or centers
under contract with the WTC Health
Program to:
(1) Receive, analyze, and report to the
Administrator of the WTC Health
Program on data that have been
collected and reported to the Data
Center by the corresponding CCE(s);
(2) Develop monitoring, initial health
evaluation, and treatment protocols
with respect to WTC-related health
conditions;
(3) Coordinate the outreach activities
of the corresponding CCE;
(4) Establish criteria for credentialing
of medical providers participating in the
Nationwide Provider Network;
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(5) Coordinate and administer the
activities of the WTC Health Program
Steering Committees; and
(6) Meet periodically with the
corresponding CCE(s) to obtain input on
the analysis and reporting of data and
on development of monitoring, initial
health evaluation, and treatment
protocols.
Designated representative means an
individual selected by an applicant,
WTC responder, or a screening-eligible
or certified-eligible survivor to represent
his or her interests to the WTC Health
Program.
Ground Zero means a site in Lower
Manhattan bounded by Vesey Street to
the north, the West Side Highway to the
west, Liberty Street to the south, and
Church Street to the east in which stood
the former World Trade Center complex.
Health condition medically associated
with a WTC-related health condition
means a condition that results from
treatment of a WTC-related health
condition or results from progression of
a WTC-related health condition.
Initial health evaluation means
assessment of one or more symptoms
that may be associated with a WTCrelated health condition and includes a
medical and exposure history, a
physical examination, and additional
medical testing as needed to evaluate
whether the individual has a WTCrelated health condition and is eligible
for treatment under the WTC Health
Program.
Interested party means a
representative of any organization
representing WTC responders, a
nationally recognized medical
association, a WTC Health Program CCE
or Data Center, a State or political
subdivision, or any other interested
person.
List of WTC-Related Health
Conditions means those conditions
eligible for coverage in the WTC Health
Program as identified in § 88.15 of this
part.
Medical emergency means a physical
or mental health condition for which
immediate treatment is necessary.
Medically necessary treatment means
the provision of services to a WTC
Health Program member by physicians
and other health care providers,
including diagnostic and laboratory
tests, prescription drugs, inpatient and
outpatient hospital services, and other
care that is appropriate, to manage,
ameliorate, or cure a WTC-related health
condition or a health condition
medically associated with a WTCrelated health condition, and which
conforms to medical treatment protocols
developed by the Data Centers, with
input from the CCEs, and approved by
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the Administrator of the WTC Health
Program.
Monitoring means periodic physical
and mental health assessment of a WTC
responder or certified-eligible survivor
in relation to exposure to airborne
toxins, any other hazard, or any other
adverse condition resulting from the
September 11, 2001, terrorist attacks
and which includes a medical and
exposure history, a physical
examination and additional medical
testing as needed for surveillance or to
evaluate symptom(s) to determine
whether the individual has a WTCrelated health condition.
Nationwide Provider Network (NPN)
means a network of providers
throughout the United States under
contract with the WTC Health Program
to provide an initial health evaluation,
monitoring, and treatment to enrolled
WTC responders, screening-eligible
survivors, or certified-eligible survivors
who live outside the New York
metropolitan area.
New York City disaster area means an
area within New York City that is the
area of Manhattan that is south of
Houston Street and any block in
Brooklyn that is wholly or partially
contained within a 1.5-mile radius of
the former World Trade Center complex.
New York metropolitan area means
the combined statistical areas
comprising the Bridgeport-StamfordNorwalk, CT Metropolitan Statistical
Area; Kingston, NY Metropolitan
Statistical Area; New Haven-Milford, CT
Metropolitan Statistical Area; New
York-Northern New Jersey-Long Island,
NY-NJ-PA Metropolitan Statistical Area;
Poughkeepsie-Newburgh-Middletown,
NY Metropolitan Statistical Area;
Torrington, CT Micropolitan Statistical
Area; Trenton-Ewing, NJ Metropolitan
Statistical Area, as defined in OMB
Bulletin 10–02, December 1, 2009.
NIOSH means the National Institute
for Occupational Safety and Health,
Centers for Disease Control and
Prevention, U.S. Department of Health
and Human Services.
One (1) day means the length of a
standard work shift, or at least 4 hours
but less than 24 hours.
Pentagon site means any area of the
land (consisting of approximately 280
acres) and improvements thereon,
located in Arlington, Virginia, on which
the Pentagon Office Building, Federal
Building Number 2, the Pentagon
heating and sewage treatment plants,
and other related facilities are located,
including various areas designated for
the parking of vehicles, vehicle access,
and other areas immediately adjacent to
the land or improvements previously
described that were affected by the
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terrorist-related aircraft crash on
September 11, 2001; and those areas at
Fort Belvoir in Fairfax County, Virginia
and at the Dover Port Mortuary at Dover
Air Force Base in Delaware involved in
the recovery, identification, and
transportation of human remains for the
incident.
Police department means any law
enforcement department or agency,
whether under Federal, state, or local
jurisdiction, responsible for general
police duties, such as maintenance of
public order, safety, or health,
enforcement of laws, or otherwise
charged with prevention, detection,
investigation, or prosecution of crimes.
Scientific/Technical Advisory
Committee means the WTC Health
Program Scientific/Technical Advisory
Committee whose members are
appointed by the Administrator of the
WTC Health Program to review
scientific and medical evidence and to
make recommendations to the
Administrator on additional WTC
Health Program eligibility criteria and
on additional WTC-related health
conditions.
Screening-eligible survivor means an
individual who is not a WTC responder
and who claims symptoms of a WTCrelated health condition and meets the
eligibility criteria for a survivor
specified in § 88.8 of this part.
September 11, 2001, terrorist attacks
means the terrorist attacks that occurred
on September 11, 2001, in New York
City, at Shanksville, Pennsylvania, and
at the Pentagon, and includes the
aftermath of such attacks.
Shanksville, Pennsylvania site means
the property in Stonycreek Township,
Somerset County, Pennsylvania, which
is bounded by Route 30 (Lincoln
Highway), State Route 1019 (Buckstown
Road), and State Route 1007
(Lambertsville Road); and those areas at
the Pennsylvania National Guard
Armory in Friedens, Pennsylvania
involved in the recovery, identification,
and transportation of human remains for
the incident.
Staten Island Landfill means the
landfill in Staten Island, NY called
‘‘Fresh Kills.’’
Terrorist watch list means the lists
maintained by the Federal government
that will be utilized to screen for known
terrorists.
WTC means World Trade Center.
WTC Health Program means the
program established by Title XXXIII of
the Public Health Service Act as
amended, 42 U.S.C. 300mm to 300mm–
61 (codifying Title I of the James
Zadroga 9/11 Health and Compensation
Act of 2010, Pub. L. 111–347, as
amended by Pub. L. 114–113) to provide
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properly appointed, the WTC Health
Program will not recognize another
individual as the designated
representative until the appointment of
the previously designated representative
is withdrawn in a signed writing.
(3) A properly appointed designated
representative who is recognized by the
WTC Health Program may make a
request or give direction to the WTC
Health Program regarding the eligibility,
certification, or any other administrative
issue pertaining to the applicant or WTC
Health Program member under the WTC
Health Program, including appeals. Any
notice requirement contained in this
part or in the Act is fully satisfied if sent
to the designated representative.
(4) An applicant or WTC Health
Program member may authorize any
individual to represent him or her in
regard to the WTC Health Program,
unless that individual’s service as a
representative would violate any
applicable provision of law (such as 18
U.S.C. 205 or 18 U.S.C. 208) or is
otherwise prohibited by WTC Health
Program policies and procedures or
contract provisions.
(5) A Federal employee may act as a
representative only on behalf of the
individuals specified in, and in the
manner permitted by, 18 U.S.C. 203 and
18 U.S.C. 205.
(6) If an applicant or screeningeligible or certified-eligible survivor is a
minor, a parent or guardian may act on
his or her behalf.
(7) If an applicant or WTC Health
Program member is a mentally
incompetent adult, an individual
authorized under state or other
applicable law to act on the applicant’s
or member’s behalf may act as his or her
designated representative as described
in this section.
(b) Transportation and travel
expenses. The WTC Health Program
may provide for necessary and
reasonable transportation and expenses
incident to the securing of medically
necessary treatment through the NPN,
involving travel of more than 250 miles.
§ 88.2
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medical monitoring and treatment
benefits for eligible responders to the
September 11, 2001, terrorist attacks
and initial health evaluation,
monitoring, and treatment benefits for
residents and other building occupants
and area workers in New York City who
were directly impacted and adversely
affected by such attacks.
WTC Health Program member means
any responder, screening-eligible
survivor, or certified-eligible survivor
enrolled in the WTC Health Program.
WTC Program Administrator
(Administrator of the WTC Health
Program, or Administrator) means, for
the purposes of this part, the Director of
the National Institute for Occupational
Safety and Health, Centers for Disease
Control and Prevention, Department of
Health and Human Services, or his or
her designee.
WTC-related acute traumatic injury
means a health condition eligible for
coverage in the WTC Health Program as
described in § 88.15(e)(1) of this part.
WTC-related health condition means
an illness or health condition for which
exposure to airborne toxins, any other
hazard, or any other adverse condition
resulting from the September 11, 2001,
terrorist attacks, based on an
examination by a medical professional
with expertise in treating or diagnosing
the health conditions in the List of
WTC-Related Health Conditions, is
substantially likely to be a significant
factor in aggravating, contributing to, or
causing the illness or health condition,
including a mental health condition.
Only those conditions on the List of
WTC-Related Health Conditions
codified in 42 CFR 88.15 may be
considered WTC-related health
conditions.
WTC-related musculoskeletal disorder
means a health condition eligible for
coverage in the WTC Health Program as
described in § 88.15(c)(1) of this part.
WTC responder means an individual
who has been identified as eligible for
monitoring and treatment as described
in § 88.3 or who meets the eligibility
criteria in § 88.4.
§ 88.3 Eligibility—currently identified
responders.
General provisions.
(a) Designated representative. (1) An
applicant or WTC Health Program
member may appoint one individual to
represent his or her interests under the
WTC Health Program. The appointment
must be made in writing and consistent
with all relevant Federal laws and
regulations in order for the designated
representative to receive personal health
information.
(2) There may be only one designated
representative at any time. After one
designated representative has been
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(a) Responders who were identified as
eligible for monitoring and treatment
under the arrangements as in effect on
January 2, 2011, between NIOSH and
the consortium administered by Mount
Sinai School of Medicine in New York
City and the Fire Department, City of
New York, are enrolled in the WTC
Health Program.
(1) No individual who is determined
to be a positive match to the terrorist
watch list maintained by the Federal
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government will be considered to be
enrolled in the WTC Health Program.
(2) [Reserved]
(b) WTC responders identified as
enrolled under this section are not
required to submit an application to the
WTC Health Program.
§ 88.4
Eligibility criteria—WTC responders.
(a) Responders to the New York City
disaster area who have not been
previously identified as eligible as
provided for under § 88.3 of this part
may apply for enrollment in the WTC
Health Program on or after July 1, 2011.
Such individuals must meet the criteria
in one of the following categories to be
considered eligible for enrollment:
(1) Firefighters and related personnel
must meet the criteria specified in
paragraph (a)(1)(i) or (ii) of this section:
(i) The individual was an active or
retired member of the Fire Department,
City of New York (whether firefighter or
emergency personnel), and participated
at least 1 day in the rescue and recovery
effort at any of the former World Trade
Center sites (including Ground Zero, the
Staten Island Landfill, or the New York
City Chief Medical Examiner’s Office),
during the period beginning on
September 11, 2001, and ending on July
31, 2002; or
(ii) The individual is:
(A) A surviving immediate family
member of an individual who was an
active or retired member of the Fire
Department, City of New York (whether
firefighter or emergency personnel),
who was killed at Ground Zero on
September 11, 2001, and
(B) Received any treatment for a WTCrelated mental health condition on or
before September 1, 2008.
(2) Law enforcement officers and
WTC rescue, recovery, and cleanup
workers must meet the criteria specified
in paragraph (a)(2)(i) or (ii) of this
section:
(i) The individual worked or
volunteered onsite in rescue, recovery,
debris cleanup, or related support
services in lower Manhattan (south of
Canal Street), the Staten Island Landfill,
or the barge loading piers, for at least:
(A) 4 hours during the period
beginning on September 11, 2001, and
ending on September 14, 2001; or
(B) 24 hours during the period
beginning on September 11, 2001, and
ending on September 30, 2001; or
(C) 80 hours during the period
beginning on September 11, 2001, and
ending on July 31, 2002.
(ii) The individual was an active or
retired member of the New York City
Police Department or an active or retired
member of the Port Authority Police of
the Port Authority of New York and
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New Jersey who participated onsite in
rescue, recovery, debris cleanup, or
related support services, for at least:
(A) 4 hours during the period
beginning September 11, 2001, and
ending on September 14, 2001, in lower
Manhattan (south of Canal Street),
including Ground Zero, the Staten
Island Landfill, or the barge loading
piers; or
(B) 1 day beginning on September 11,
2001, and ending on July 31, 2002, at
Ground Zero, the Staten Island Landfill,
or the barge loading piers; or
(C) 24 hours during the period
beginning on September 11, 2001, and
ending on September 30, 2001, in lower
Manhattan (south of Canal Street); or
(D) 80 hours during the period
beginning on September 11, 2001, and
ending on July 31, 2002, in lower
Manhattan (south of Canal Street).
(3) Office of the Chief Medical
Examiner of New York City employee.
The individual was an employee of the
Office of the Chief Medical Examiner of
New York City involved in the
examination and handling of human
remains from the WTC attacks, or other
morgue worker who performed similar
post-September 11 functions for such
Office staff, during the period beginning
on September 11, 2001, and ending on
July 31, 2002.
(4) Port Authority Trans-Hudson
Corporation Tunnel worker. The
individual was a worker in the Port
Authority Trans-Hudson Corporation
Tunnel for at least 24 hours during the
period beginning on February 1, 2002,
and ending on July 1, 2002.
(5) Vehicle-maintenance worker. The
individual was a vehicle-maintenance
worker who was exposed to debris from
the former World Trade Center while
retrieving, driving, cleaning, repairing,
and maintaining vehicles contaminated
by airborne toxins from the September
11, 2001, terrorist attacks; and
conducted such work for at least 1 day
during the period beginning on
September 11, 2001, and ending on July
31, 2002.
(b) Responders to the Pentagon site of
the September 11, 2001, terrorist
attacks, may apply for enrollment in the
WTC Health Program on or after April
29, 2013. Individuals must meet the
criteria below to be considered eligible
for enrollment:
(1) The individual was an active or
retired member of a fire or police
department (fire or emergency
personnel), worked for a recovery or
cleanup contractor, or was a volunteer;
and
(2) Performed rescue, recovery,
demolition, debris cleanup, or other
related services at the Pentagon site of
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the September 11, 2001, terrorist
attacks, for at least 1 day beginning
September 11, 2001, and ending on
November 19, 2001.
(c) Responders to the Shanksville,
Pennsylvania site of the September 11,
2001, terrorist attacks, may apply for
enrollment in the WTC Health Program
on or after April 29, 2013. Individuals
must meet the criteria below to be
considered eligible for enrollment:
(1) The individual was an active or
retired member of a fire or police
department (fire or emergency
personnel), worked for a recovery or
cleanup contractor, or was a volunteer;
and
(2) Performed rescue, recovery,
demolition, debris cleanup, or other
related services at the Shanksville,
Pennsylvania site of the September 11,
2001, terrorist attacks, for at least 1 day
beginning September 11, 2001, and
ending on October 3, 2001.
(d) [Reserved]
(e) The WTC Health Program will
maintain a list of WTC responders.
§ 88.5 Application process—WTC
responders.
(a) An application to the WTC Health
Program based on the criteria in § 88.4
must be submitted with documentation
of the applicant’s employment
affiliation (if relevant) and work activity
during the dates, times, and locations
specified in § 88.4
(1) Documentation may include but is
not limited to a pay stub; official
personnel roster; a written statement,
under penalty of perjury by an
employer; site credentials; or similar
documentation.
(2) An applicant who is unable to
submit the required documentation
must instead offer a written explanation
of how he or she tried to obtain proof
of presence, residence, or work activity
and why the attempt was unsuccessful.
The applicant must attest, under penalty
of perjury, that he or she meets the
criteria specified in § 88.4.
(b) The application and supporting
documentation must be submitted to the
WTC Health Program for consideration.
(c) The WTC Health Program will
notify the applicant in writing (or by
email if an email address is provided by
the applicant) of any deficiencies in the
application or the supporting
documentation.
§ 88.6 Enrollment decision—WTC
responders.
(a) Enrollment priority. The WTC
Health Program will prioritize
applications in the order in which they
are received.
(b) Enrollment eligibility. The WTC
Health Program will decide if the
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applicant meets the eligibility criteria
provided in § 88.4.
(c) Denial of enrollment. (1) The WTC
Health Program will deny enrollment if
the applicant fails to meet the
applicable eligibility requirements.
(2) The WTC Health Program may
deny enrollment of a responder who is
otherwise eligible and qualified if the
Act’s numerical limitations for newly
enrolled responders have been met.
(i) No more than 25,000 WTC
responders, other than those enrolled
pursuant to §§ 88.3 and 88.4(a)(1)(ii),
may be enrolled at any time. The
Administrator of the WTC Health
Program may decide, based on the best
available evidence, that sufficient funds
are available under the WTC Health
Program Fund to provide treatment and
monitoring only for individuals who are
already enrolled as WTC responders at
that time.
(ii) [Reserved]
(3) No individual who is determined
to be a positive match to the terrorist
watch list maintained by the Federal
government may qualify to be enrolled
or be determined to be eligible for the
WTC Health Program.
(d) Notification of enrollment
decision. (1) The WTC Health Program
will decide if the applicant meets the
current eligibility criteria for WTC
responders in § 88.4 and is qualified,
and notify the applicant of the
enrollment decision in writing within
60 calendar days of the date of receipt
of the application. The 60-day time
period will not include any days during
which the applicant is correcting
deficiencies in the application or
supporting documentation.
(2) If the WTC Health Program
decides that an applicant is denied
enrollment, the written notification will
include an explanation, as appropriate,
for the decision to deny enrollment and
inform the applicant of the right to
appeal the initial denial of eligibility
and provide instructions on how to file
an appeal.
§ 88.7 Eligibility—currently identified
survivors.
(a) Survivors who have been
identified as eligible for medical
treatment and monitoring as of January
2, 2011, are considered certified-eligible
in the WTC Health Program.
(1) No individual who is determined
to be a positive match to the terrorist
watch list maintained by the Federal
government will be considered to be a
certified-eligible survivor in the WTC
Health Program.
(2) [Reserved]
(b) Survivors identified as certifiedeligible under this section are not
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required to submit an application to the
WTC Health Program.
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§ 88.8
Eligibility criteria—WTC survivors.
(a) Criteria for status as a screeningeligible survivor. An individual who is
not a WTC responder, claims symptoms
of a WTC-related health condition, and
who has not been previously identified
as eligible under § 88.7 may apply to the
WTC Health Program on or after July 1,
2011, for a determination of eligibility
for an initial health evaluation.
(1) The WTC Health Program will
determine an applicant’s eligibility for
an initial health evaluation based on
one of the following criteria:
(i) The screening applicant was
present in the dust or dust cloud in the
New York City disaster area on
September 11, 2001.
(ii) The screening applicant worked,
resided, or attended school, childcare,
or adult daycare in the New York City
disaster area, for at least:
(A) 4 days during the period
beginning on September 11, 2001, and
ending on January 10, 2002; or
(B) 30 days during the period
beginning on September 11, 2001, and
ending on July 31, 2002.
(iii) The screening applicant worked
as a cleanup worker or performed
maintenance work in the New York City
disaster area during the period
beginning on September 11, 2001, and
ending on January 10, 2002, and had
extensive exposure to WTC dust as a
result of such work.
(iv) The screening applicant:
(A) Was deemed eligible to receive a
grant from the Lower Manhattan
Development Corporation Residential
Grant Program;
(B) Possessed a lease for a residence
or purchased a residence in the New
York City disaster area; and
(C) Resided in such residence during
the period beginning on September 11,
2001, and ending on May 31, 2003.
(v) The screening applicant is an
individual whose place of
employment—
(A) At any time during the period
beginning on September 11, 2001, and
ending on May 31, 2003, was in the
New York City disaster area; and
(B) Was deemed eligible to receive a
grant from the Lower Manhattan
Development Corporation WTC Small
Firms Attraction and Retention Act
program or other government incentive
program designed to revitalize the lower
Manhattan economy after the September
11, 2001, terrorist attacks.
(2) [Reserved]
(b) Criteria for status as a certifiedeligible survivor. Survivors who have
been determined to have screening-
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eligible status under § 88.10(a), may
seek status as a certified-eligible
survivor. Status as a certified-eligible
survivor is based on a certification by
the WTC Health Program that, pursuant
to an initial health evaluation, the
screening-eligible survivor has a WTCrelated health condition and is eligible
for follow-up monitoring and treatment.
(c) The WTC Health Program will
maintain a list of screening-eligible and
certified-eligible survivors.
§ 88.9 Application process—WTC
survivors.
(a) Application for status as a
screening-eligible survivor. An
application to the WTC Health Program
based on the criteria in § 88.8(a) must be
submitted with documentation of the
applicant’s location, presence or
residence, and/or work activity during
the relevant time period.
(1) Documentation may include but is
not limited to: Proof of residence, such
as a lease or utility bill; attendance
roster at a school or daycare; or pay
stub, other employment documentation,
or written statement, under penalty of
perjury, by an employer indicating
employment location during the
relevant time period; or similar
documentation. The applicant must also
attest to symptoms of a WTC-related
health condition.
(2) An applicant who is unable to
submit the required documentation
must instead offer a written explanation
of how he or she tried to obtain proof
of location, presence, or residence, and/
or work activity and why the attempt
was unsuccessful. The applicant must
attest, under penalty of perjury, that he
or she meets the criteria specified in
§ 88.8.
(3) The applicant will be notified of
any deficiencies in the application or
the supporting documentation.
(b) Status as a certified-eligible
survivor. No additional application is
required for status as a certified-eligible
survivor. If, based upon the screeningeligible survivor’s initial health
evaluation (see § 88.11), the WTC Health
Program certifies the diagnosis of a
WTC-related health condition, then the
survivor will automatically receive the
status of a certified-eligible survivor.
§ 88.10 Enrollment decision—screeningeligible survivors.
(a) The WTC Health Program will
decide if the applicant meets the
screening-eligible survivor criteria
pursuant to § 88.8(a) and is qualified,
and notify the applicant of the
enrollment decision in writing within
60 calendar days of the date of receipt
of the application. The 60-day time
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period will not include any days during
which the applicant is correcting
deficiencies in the application or
supporting documentation.
(b) If the WTC Health Program
decides that an applicant is denied
enrollment, the written notification will
include an explanation for the decision
to deny enrollment and inform the
applicant of the right to appeal the
enrollment denial and provide
instructions on how to file an appeal.
(1) The WTC Health Program may
deny screening-eligible survivor status if
the applicant is ineligible under the
criteria specified in § 88.8(a).
(2) The WTC Health Program may
deny screening-eligible survivor status if
the numerical limitation on certifiedeligible survivors in § 88.12(b)(3)(i) has
been met.
(3) No individual who is determined
to be a positive match to the terrorist
watch list maintained by the Federal
government may qualify to be a
screening-eligible survivor in the WTC
Health Program.
§ 88.11 Initial health evaluation for
screening-eligible survivors.
(a) A CCE or an NPN-affiliated
physician will provide the screeningeligible survivor an initial health
evaluation to determine if the
individual has a WTC-related health
condition.
(b) The WTC Health Program will
provide only one initial health
evaluation per screening-eligible
survivor. The individual may request
additional health evaluations at his or
her own expense.
(c) If the physician determines that
the screening-eligible survivor has a
WTC-related health condition, the
physician will promptly transmit to the
WTC Health Program his or her
determination, consistent with the
requirements of § 88.17(a).
§ 88.12 Enrollment decision—certifiedeligible survivors.
(a) The WTC Health Program will
prioritize certification requests in the
order in which they are received.
(b) The WTC Health Program will
review the physician’s determination,
render a decision regarding certification
of the individual’s WTC-related health
condition, and notify the individual of
the decision and the reason for the
decision in writing, pursuant to §§ 88.17
and 88.18.
(1) If the individual is a screeningeligible survivor and the individual’s
condition is certified as a WTC-related
health condition, the individual will
automatically receive the status of a
certified-eligible survivor.
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(2) If a screening-eligible survivor’s
condition is not certified as a WTCrelated health condition pursuant to
§§ 88.17 and 88.18, the WTC Health
Program will deny certified-eligible
status. The screening-eligible survivor
may appeal the decision to deny
certification, as provided under § 88.21.
(3) The WTC Health Program may
deny certified-eligible survivor status of
an otherwise eligible and qualified
screening-eligible survivor if the Act’s
numerical limitations for certifiedeligible survivors have been met.
(i) No more than 25,000 individuals,
other than those described in § 88.7,
may be determined to be certifiedeligible survivors at any time. The
Administrator of the WTC Health
Program may decide, based on the best
available evidence, that sufficient funds
are available under the WTC Health
Program Fund to provide treatment and
monitoring only for individuals who
have already been certified as certifiedeligible survivors at that time.
(ii) [Reserved]
(4) No individual who is determined
to be a positive match to the terrorist
watch list maintained by the Federal
government may qualify to be a
certified-eligible survivor in the WTC
Health Program.
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§ 88.13
Disenrollment.
(a) The disenrollment of a WTC
Health Program member may be
initiated by the WTC Health Program in
the following circumstances:
(1) The WTC Health Program
mistakenly enrolled an individual under
§ 88.4 (WTC responders) or § 88.8
(screening-eligible survivors) who did
not provide sufficient proof of eligibility
consistent with the required eligibility
criteria; or
(2) The WTC Health Program
member’s enrollment was based on
incorrect or fraudulent information.
(b) The disenrollment of a WTC
Health Program member may be
initiated by the enrollee for any reason.
(c) A disenrolled WTC Health
Program member will be notified in
writing by the WTC Health Program of
a disenrollment decision, provided an
explanation, as appropriate, for the
decision, and provided information on
how to appeal the decision. A
disenrolled WTC Health Program
member disenrolled pursuant to
paragraph (a) may appeal the
disenrollment decision in accordance
with § 88.14.
(d) A disenrolled WTC Health
Program member who has been
disenrolled in accordance with
paragraphs (a) or (b) of this section may
seek to re-enroll in the WTC Health
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Program using the application and
enrollment procedures, provided that
the application is supported by new
information.
§ 88.14 Appeal of enrollment or
disenrollment decision.
(a) Right to appeal. An applicant
denied WTC Health Program
enrollment, a disenrolled WTC Health
Program member, or the applicant’s or
member’s designated representative
(appointed pursuant to § 88.2(a)) may
appeal the enrollment denial or
disenrollment decision.
(b) Appeal request. (1) A letter
requesting an appeal must be
postmarked within 120 calendar days of
the date of the letter from the
Administrator notifying the denied
applicant or disenrolled WTC Health
Program member of the adverse
decision. Electronic versions of a signed
letter will be accepted if transmitted
within 120 calendar days of the date of
the Administrator’s notification letter.
(2) A valid request for an appeal must:
(i) Be made in writing and signed;
(ii) Identify the denied applicant or
disenrolled WTC Health Program
member and designated representative
(if applicable);
(iii) Describe the decision being
appealed and state the reasons why the
denied applicant, disenrolled WTC
Health Program member, or designated
representative believes the enrollment
denial or disenrollment was incorrect
and should be reversed. The appeal
request may include relevant new
information not previously considered
by the WTC Health Program; and
(iv) Be sent to the WTC Health
Program at the address specified in the
notice of denial or disenrollment.
(3) Where the denial or disenrollment
is based on information from the
terrorist watch list, the appeal will be
forwarded to the appropriate Federal
agency.
(c) Appeal process. Upon receipt of a
valid appeal, the Administrator will
appoint a Federal Official independent
of the WTC Health Program to review
the case. The Federal Official will
review all available records relevant to
the WTC Health Program’s decision not
to enroll the applicant or to disenroll
the WTC Health Program member and
assess whether the appeal should be
granted. In conducting the review, the
Federal Official’s consideration will
include the following: Whether the
WTC Health Program substantially
complied with all relevant WTC Health
Program policies and procedures;
whether the information supporting the
WTC Health Program’s decision was
factually accurate; and whether the
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WTC Health Program’s decision was
reasonable as applied to the facts of the
case.
(1) The Federal Official may consider
additional relevant new information
submitted by the denied applicant,
disenrolled WTC Health Program
member, or designated representative.
(2) The Federal Official will provide
his or her recommendation regarding
the disposition of the appeal, including
his or her findings and any supporting
materials, to the Administrator.
(d) Final decision and notification.
The Administrator will review the
Federal Official’s recommendation and
any relevant information and make a
final decision on the appeal. The
Administrator will notify the denied
applicant or disenrolled WTC Health
Program member and/or designated
representative of the following in
writing:
(1) The recommendation and findings
made by the Federal Official as a result
of the review;
(2) The Administrator’s final decision
on the appeal;
(3) An explanation of the reason(s) for
the Administrator’s final decision on the
appeal; and
(4) Any administrative actions taken
by the WTC Health Program in response
to the Administrator’s final decision.
§ 88.15 List of WTC-Related Health
Conditions.
WTC-related health conditions
include the following disorders and
conditions:
(a) Aerodigestive disorders:
(1) Interstitial lung diseases.
(2) Chronic respiratory disorder—
fumes/vapors.
(3) Asthma.
(4) Reactive airways dysfunction
syndrome (RADS).
(5) WTC-exacerbated and new-onset
chronic obstructive pulmonary disease
(COPD).
(6) Chronic cough syndrome.
(7) Upper airway hyperreactivity.
(8) Chronic rhinosinusitis.
(9) Chronic nasopharyngitis.
(10) Chronic laryngitis.
(11) Gastroesophageal reflux disorder
(GERD).
(12) Sleep apnea exacerbated by or
related to a condition described in
preceding paragraphs (a)(1) through (11)
of this section.
(b) Mental health conditions:
(1) Posttraumatic stress disorder
(PTSD).
(2) Major depressive disorder.
(3) Panic disorder.
(4) Generalized anxiety disorder.
(5) Anxiety disorder (not otherwise
specified).
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(6) Depression (not otherwise
specified).
(7) Acute stress disorder.
(8) Dysthymic disorder.
(9) Adjustment disorder.
(10) Substance abuse.
(c) Musculoskeletal disorders:
(1) WTC-related musculoskeletal
disorder is a chronic or recurrent
disorder of the musculoskeletal system
caused by heavy lifting or repetitive
strain on the joints or musculoskeletal
system occurring during rescue or
recovery efforts in the New York City
disaster area in the aftermath of the
September 11, 2001, terrorist attacks.
For a WTC responder who received any
treatment for a WTC-related
musculoskeletal disorder on or before
September 11, 2003, such a health
condition includes:
(i) Low back pain.
(ii) Carpal tunnel syndrome (CTS).
(iii) Other musculoskeletal disorders.
(2) [Reserved].
(d) Cancers:
(1) Malignant neoplasms of the lip;
tongue; salivary gland; floor of mouth;
gum and other mouth; tonsil;
oropharynx; hypopharynx; and other
oral cavity and pharynx.
(2) Malignant neoplasm of the
nasopharynx.
(3) Malignant neoplasms of the nose;
nasal cavity; middle ear; and accessory
sinuses.
(4) Malignant neoplasm of the larynx.
(5) Malignant neoplasm of the
esophagus.
(6) Malignant neoplasm of the
stomach.
(7) Malignant neoplasms of the colon
and rectum.
(8) Malignant neoplasms of the liver
and intrahepatic bile duct.
(9) Malignant neoplasms of the
retroperitoneum and peritoneum;
omentum; and mesentery.
(10) Malignant neoplasms of the
trachea; bronchus and lung; heart,
mediastinum and pleura; and other illdefined sites in the respiratory system
and intrathoracic organs.
(11) Mesothelioma.
(12) Malignant neoplasms of the
peripheral nerves and autonomic
nervous system; and other connective
and soft tissue.
(13) Malignant neoplasms of the skin
(melanoma and non-melanoma),
including scrotal cancer.
(14) Malignant neoplasm of the female
breast.
(15) Malignant neoplasm of the ovary.
(16) Malignant neoplasm of the
prostate.
(17) Malignant neoplasm of the
urinary bladder.
(18) Malignant neoplasm of the
kidney.
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(19) Malignant neoplasms of the renal
pelvis; ureter; and other urinary organs.
(20) Malignant neoplasms of the eye
and orbit.
(21) Malignant neoplasm of the
thyroid.
(22) Malignant neoplasms of the blood
and lymphoid tissues (including, but
not limited to, lymphoma, leukemia,
and myeloma).
(23) Childhood cancers: any type of
cancer diagnosed in a person less than
20 years of age.
(24) Rare cancers: any type of cancer 1
that occurs in less than 15 cases per
100,000 persons per year in the United
States.
(e) Acute traumatic injuries:
(1) WTC-related acute traumatic
injury is physical damage to the body
caused by and occurring immediately
after a one-time exposure to energy,
such as heat, electricity, or impact from
a crash or fall, resulting from a specific
event or incident. For a WTC responder
or screening-eligible or certified-eligible
survivors who received any medical
treatment for a WTC-related acute
traumatic injury on or before September
11, 2003, such a health condition
includes:
(i) Eye injury.
(ii) Burn.
(iii) Head trauma.
(iv) Fracture.
(v) Tendon tear.
(vi) Complex sprain.
(vii) Other similar acute traumatic
injuries.
(2) [Reserved]
§ 88.16 Addition of health conditions to
the List of WTC-Related Health Conditions.
(a) Any interested party may submit a
request to the Administrator of the WTC
Health Program to add a condition to
the List of WTC-Related Health
Conditions in § 88.15. The
Administrator will evaluate the
submission to decide whether it is a
valid petition.
(1) Each valid petition must include
the following:
(i) An explicit statement of an intent
to petition the Administrator to add a
health condition to the List of WTCRelated Health Conditions;
(ii) Name, contact information, and
signature of the interested party
petitioning for the addition;
(iii) Name and/or description of the
condition(s) to be added;
1 Based on 2005–2009 average annual data ageadjusted to the 2000 U.S. population. See Glenn
Copeland, Andrew Lake, Rick Firth, et al. (eds),
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., June 2012.
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(iv) Reasons for adding the
condition(s), including the medical
basis for the association between the
September 11, 2001, terrorist attacks
and the condition(s) to be added.
(2) Not later than 90 calendar days
after the receipt of a valid petition, the
Administrator will take one of the
following actions:
(i) Request a recommendation of the
WTC Health Program Scientific/
Technical Advisory Committee;
(ii) Publish in the Federal Register a
proposed rule to add such health
condition;
(iii) Publish in the Federal Register
the Administrator’s decision not to
publish a proposed rule and the basis
for that decision; or
(iv) Publish in the Federal Register a
decision that insufficient evidence
exists to take action under paragraph
(a)(2)(i) through (iii) of this section.
(3) The 90-day time period will not
include any days during which the
Administrator is consulting with the
interested party to clarify the
submission.
(4) The Administrator may consider
more than one petition simultaneously
when the petitions propose the addition
of the same health condition. Scientific/
Technical Advisory Committee
recommendations and Federal Register
notices initiated by the Administrator
pursuant to paragraph (a)(2) of this
section may respond to more than one
petition.
(5) The Administrator will be required
to consider a submission for a health
condition previously reviewed by the
Administrator and found not to qualify
for addition to the List of WTC-Related
Health Conditions as a valid new
petition only if the submission presents
a new medical basis (i.e., a basis not
previously reviewed) for the association
between the September 11, 2001,
terrorist attacks and the condition to be
added. A submission that provides no
new medical basis and is received after
the publication of a response in the
Federal Register to a petition requesting
the addition of the same health
condition will not be considered a valid
petition and will not be answered in a
Federal Register notice pursuant to
paragraph (a)(2), above. The interested
party will be informed of the WTC
Health Program’s decision in writing.
(b) The Administrator may propose to
add a condition to the List of WTCRelated Health Conditions in § 88.15 of
this part by publishing a proposed rule
in the Federal Register and providing
interested parties a period of 30
calendar days to submit written
comments. The Administrator may
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extend the comment period for good
cause.
(1) If the Administrator requests a
recommendation from the WTC Health
Program Scientific/Technical Advisory
Committee, the Advisory Committee
will submit its recommendation to the
Administrator no later than 90 calendar
days after the date of the transmission
of the request or no later than a date
specified by the Administrator (but not
more than 180 calendar days after the
request). The Administrator will publish
a proposed rule or a decision not to
publish a proposed rule in the Federal
Register no later than 90 calendar days
after the date of transmission of the
Advisory Committee recommendation.
(2) Before issuing a final rule to add
a health condition to the List of WTCRelated Health Conditions, the
Administrator will provide for an
independent peer review of the
scientific and technical evidence that
would be the basis for issuing such final
rule.
rmajette on DSK2TPTVN1PROD with RULES2
§ 88.17 Physician’s determination of WTCrelated health conditions.
(a) A physician affiliated with either
a CCE or NPN will promptly transmit to
the WTC Health Program a
determination that a member’s exposure
to airborne toxins, any other hazard, or
any other adverse condition resulting
from the September 11, 2001, terrorist
attacks is substantially likely to be a
significant factor in aggravating,
contributing to, or causing the illness or
health condition, including a mental
health condition. The transmission will
also include the basis for such
determination. The physician’s
determination will be made based on an
assessment of the following:
(1) The individual’s exposure to
airborne toxins, any other hazard, or any
other adverse condition resulting from
the September 11, 2001, terrorist
attacks.
(2) The type of symptoms experienced
by the individual and the temporal
sequence of those symptoms.
(b) For a health condition medically
associated with a WTC-related health
condition, the physician’s
determination must contain information
establishing how the health condition
has resulted from treatment of a
previously certified WTC-related health
condition or how it has resulted from
progression of the certified WTC-related
health condition.
§ 88.18
Certification.
(a) WTC-related health condition. The
WTC Health Program will review each
physician determination and render a
decision regarding certification of the
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condition as a WTC-related health
condition. The WTC Health Program
will notify the WTC Health Program
member of the decision and the reason
for the decision in writing.
(b) Health condition medically
associated with a WTC-related health
condition. The WTC Health Program
will review each physician
determination and render a decision
regarding certification of the condition
as a health condition medically
associated with a WTC-related health
condition. The WTC Health Program
will notify the WTC Health Program
member in writing of the decision and
the reason for the decision within 60
calendar days after the date the
physician’s determination is received.
(1) In the course of review, the WTC
Health Program may seek a
recommendation about certification
from a physician panel with appropriate
expertise for the condition.
(2) [Reserved]
(c) Appeal right. If certification of a
condition as a WTC-related health
condition or a health condition
medically associated with a WTCrelated health condition is denied, the
WTC Health Program member may
appeal the WTC Health Program’s
decision to deny certification, as
provided under § 88.21.
§ 88.19
Decertification.
(a) The decertification of a WTC
Health Program member’s certified
WTC-related health condition or health
condition medically associated with a
WTC-related health condition may be
initiated by the WTC Health Program in
the following circumstances:
(1) The WTC Health Program finds
that the member’s exposure is
inadequate or is otherwise not covered;
(2) The WTC Health Program finds
that the member’s certified WTC-related
health condition was certified in error
or erroneously considered to have been
aggravated, contributed to, or caused by
exposure to airborne toxins, any other
hazard, or any other adverse condition
resulting from the September 11, 2001,
terrorist attacks, pursuant to § 88.17(a);
or
(3) The WTC Health Program finds
that the member’s health condition was
erroneously determined to be medically
associated with a WTC-related health
condition, pursuant to § 88.17(b).
(b) A WTC Health Program member
will be notified in writing by the WTC
Health Program of a decertification
decision, provided an explanation, as
appropriate, for the decision, and
provided information on how to appeal
the decision. A WTC Health Program
member whose WTC-related health
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90945
condition or health condition medically
associated with a WTC-related health
condition is decertified may appeal the
decertification decision in accordance
with § 88.21 of this part.
§ 88.20
Authorization of treatment.
(a) Generally. Medically necessary
treatment of certified WTC-related
health conditions and certified health
conditions medically associated with
WTC-related health conditions will be
provided through the CCEs or the NPN
as permitted under WTC Health
Program treatment protocols and in
accordance with all applicable WTC
Health Program policies and
procedures.
(b) Standard for determining medical
necessity. All treatment provided under
the WTC Health Program will adhere to
a standard which is reasonable and
appropriate; based on scientific
evidence, professional standards of care,
expert opinion or any other relevant
information; and which has been
included in the medical treatment
protocols developed by the Data
Centers, with input from the CCEs, and
approved by the Administrator of the
WTC Health Program.
(c) Treatment pending certification.
While certification of a condition is
pending, authorization for treatment of
a WTC-related health condition or a
health condition medically associated
with a WTC-related health condition
must be obtained from the WTC Health
Program before treatment is provided,
except for the provision of treatment for
a medical emergency.
§ 88.21 Appeal of certification,
decertification, or treatment authorization
decision.
(a) Right to appeal. A WTC Health
Program member or the member’s
designated representative (appointed
pursuant to § 88.2(a)) may appeal the
following four types of decisions made
by the WTC Health Program:
(1) To deny certification of a health
condition as a WTC-related health
condition;
(2) To deny certification of a health
condition as medically associated with
a WTC-related health condition;
(3) To decertify a WTC-related health
condition or a health condition
medically associated with a WTCrelated health condition; or
(4) To deny authorization of treatment
for a certified health condition based on
a finding that the treatment is not
medically necessary.
(b) Appeal request. (1) A letter
requesting an appeal must be
postmarked within 120 calendar days of
the date of the letter from the
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Administrator of the WTC Health
Program notifying the member of the
adverse decision. Electronic versions of
a signed letter will be accepted if
transmitted within 120 calendar days of
the date of the Administrator’s
notification letter.
(2) A valid request for an appeal must:
(i) Be made in writing and signed;
(ii) Identify the member and
designated representative (if applicable);
(iii) Describe the decision being
appealed and the reason(s) why the
member or designated representative
believes the decision is incorrect and
should be reversed. The description
may include, but is not limited to, the
following: Scientific or medical
information correcting factual errors
that may have been submitted to the
WTC Health Program by the CCE or
NPN; information demonstrating that
the WTC Health Program did not
correctly follow or apply relevant WTC
Health Program policies or procedures;
or any information demonstrating that
the WTC Health Program’s decision was
not reasonable given the facts of the
case. The basis provided in the appeal
request must be sufficiently detailed
and supported by information to permit
a review of the appeal. Any new
information not previously considered
by the WTC Health Program must be
included with the appeal request, unless
later requested by the WTC Health
Program; and
(iv) Be sent to the WTC Health
Program at the address specified in the
notice of denial.
(3) The appeal request may also state
an intent to make a 15-minute oral
statement by telephone. The WTC
Health Program member or designated
representative will have a second
opportunity to schedule an oral
statement after being contacted by the
WTC Health Program regarding the
appeal.
(c) Appeal process. Upon receipt of a
valid appeal, the Administrator will
appoint a Federal Official independent
of the WTC Health Program to review
the case. The Federal Official will
review all available records relevant to
the WTC Health Program’s decision to
deny certification of a health condition
as a WTC-related health condition, deny
certification of a health condition as
medically associated with a WTCrelated health condition, decertify the
WTC-related health condition or health
condition medically associated with a
WTC-related health condition, or deny
treatment authorization, and assess
whether the appeal should be granted.
The Federal Official’s consideration will
include the following: Whether the
WTC Health Program substantially
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complied with all relevant WTC Health
Program policies and procedures;
whether the information supporting the
WTC Health Program’s decision was
factually accurate; and whether the
WTC Health Program’s decision was
reasonable as applied to the facts of the
case.
(1) In conducting his or her review,
the Federal Official will review the case
record, including any oral statement
made by the WTC Health Program
member or the member’s designated
representative, as well as additional
relevant new information submitted
with the appeal request or provided by
the WTC Health Program member or the
member’s designated representative at
the request of the WTC Health Program.
(2) The Federal Official may consult
one or more qualified experts to review
the WTC Health Program’s decision and
any additional information provided by
the WTC Health Program member or the
member’s designated representative.
The expert reviewer(s) will submit their
findings to the Federal Official.
(3) The Federal Official will provide
his or her recommendation regarding
the disposition of the appeal, including
his or her findings and any supporting
materials (including the transcript of
any oral statement and any expert
reviewers’ findings), to the
Administrator.
(d) Final decision and notification.
The Administrator will review the
Federal Official’s recommendation and
any relevant information and make a
final decision on the appeal. The
Administrator will notify the WTC
Health Program member and/or the
member’s designated representative of
the following in writing:
(1) The recommendation and findings
made by the Federal Official as a result
of the review;
(2) The Administrator’s final decision
on the appeal;
(3) An explanation of the reason(s) for
the Administrator’s final decision on the
appeal; and
(4) Any administrative actions taken
by the WTC Health Program in response
to the Administrator’s final decision.
§ 88.22 Reimbursement for medical
treatment and services.
(a) Review of claims. Each claim for
reimbursement for treatment will be
reviewed by the WTC Health Program.
Claims that cannot be validated by that
process will be further assessed by the
Administrator of the WTC Health
Program.
(b) Initial health evaluations, medical
monitoring, and medically necessary
treatment. (1) The costs incurred by a
CCE or NPN-affiliated provider for
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providing a WTC Health Program
member an initial health evaluation,
medical monitoring, and/or medically
necessary treatment or services for a
WTC-related health condition or a
health condition medically associated
with a WTC-related health condition
will be reimbursed according to the
payment rates that apply to the
provision of such treatment and services
under the Federal Employees
Compensation Act (FECA), 5 U.S.C.
8101 et seq., 20 CFR part 10.
(i) The Administrator will reimburse
a CCE or NPN-affiliated provider for
treatment for which FECA rates have
not been established pursuant to the
applicable Medicare fee for service rate,
as determined appropriate by the
Administrator.
(ii) The Administrator will reimburse
a CCE or NPN-affiliated provider for
treatment for which neither FECA nor
Medicare fee for service rates have been
established, at rates as determined
appropriate by the Administrator.
(2) If the treatment is determined not
to be medically necessary or is
inconsistent with WTC Health Program
protocols, the Administrator will
withhold reimbursement.
(c) Outpatient prescription
pharmaceuticals. Payment for costs of
medically necessary outpatient
prescription pharmaceuticals for a
WTC-related health condition or health
condition medically associated with a
WTC-related health condition will be
reimbursed by the WTC Health Program
under a contract with one or more
pharmaceutical benefit management
services.
§ 88.23
Appeal of reimbursement denial.
After exhausting procedural and/or
contractual administrative remedies, a
CCE or NPN medical director or
affiliated provider may submit a written
appeal of a WTC Health Program
decision to withhold reimbursement or
payment for treatment found to be not
medically necessary or not in
accordance with approved WTC Health
Program medical treatment protocols
pursuant to § 88.20 of this part. Appeal
procedures are published on the WTC
Health Program Web site.
§ 88.24 Coordination of benefits and
recoupment.
The WTC Health Program will
attempt to recover the cost of payment
for treatment, including pharmacy
benefits, for a WTC Health Program
member’s certified WTC-related health
condition or health condition medically
associated with a WTC-related health
condition by coordinating benefits with
any workers’ compensation insurance
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available 2 for members’ work-related
health conditions, and with any public
or private health insurance available 3
for members’ non-work-related health
conditions.
(a) Where a WTC Health Program
member’s WTC-related health condition
or health condition medically associated
with a WTC-related health condition is
eligible for workers’ compensation or
another illness or injury benefit plan to
which New York City is obligated to
pay, the WTC Health Program is the
primary payer.
(b) Where a WTC Health Program
member has filed a workers’
compensation claim for a WTC-related
health condition or health condition
medically associated with a WTCrelated health condition and the claim
is pending, the WTC Health Program is
the primary payer; however, if the claim
is ultimately accepted by the workers’
compensation board, the workers’
compensation insurer in question is
responsible for reimbursing the WTC
Health Program for any treatment
provided and/or paid for during the
pendency of the claim.
(c) Where a WTC Health Program
member has filed a workers’
compensation claim for a WTC-related
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2 As described in PHS Act, sec. 3331(b). To the
extent that payment for treatment of the member’s
work-related condition has been made, or can
reasonably be expected to be made, under any other
work-related injury or illness benefit plan of the
member’s employer, the WTC Health Program will
also attempt to recover the costs associated with
treatment, including pharmacy benefits, for the
member’s certified WTC-related health condition or
health condition medically associated with a WTCrelated health condition. See PHS Act, sec.
3331(b)(1). For purposes of this regulation,
‘‘workers’ compensation law or plan’’ or ‘‘workers’
compensation insurance’’ includes any other workrelated injury or illness benefit plan of the WTC
Health Program member’s employer.
3 As described in PHS Act, sec. 3331(c).
VerDate Sep<11>2014
15:21 Dec 14, 2016
Jkt 241001
health condition or health condition
medically associated with a WTCrelated health condition, but a final
decision is issued denying the
compensation for the claim, the WTC
Health Program is the primary payer.
(d) Where a WTC Health Program
member has filed a workers’
compensation claim for a WTC-related
health condition or health condition
medically associated with a WTCrelated health condition with a workers’
compensation plan to which New York
City is not obligated to pay, the workers’
compensation insurer is the primary
payer. The WTC Health Program is the
secondary payer.
(1) If a WTC Health Program member
settles a workers’ compensation claim
by entering into a settlement agreement
that releases the employer or insurance
carrier from paying for future medical
care, the settlement must protect the
interests of the WTC Health Program.
This may include setting aside adequate
funds to pay for future medical
expenses, as required by the WTC
Health Program, which would otherwise
have been paid by workers’
compensation. In such situations, the
WTC Health Program may require
reimbursement for treatment services of
a WTC-related health condition or
health condition medically associated
with a WTC-related health condition
directly from the member.
(2) The WTC Health Program will pay
providers for treatment in accordance
with § 88.22(b); to the extent that the
workers’ compensation insurance pays
for treatment at a lower rate, the WTC
Health Program will recoup treatment
costs at the workers’ compensation
insurance rate.
(e) Where a WTC Health Program
member’s WTC-related health condition
or health condition medically associated
PO 00000
Frm 00023
Fmt 4701
Sfmt 9990
90947
with a WTC-related health condition is
not work-related, the WTC Health
Program member’s public or private
health insurance plan is the primary
payer. The WTC Health Program will
pay costs not reimbursed by the public
or private health insurance plan due to
the application of deductibles, copayments, co-insurance, other cost
sharing arrangements, or payment caps
up to and in accordance with the rates
described in § 88.22(b).
(f) Any coordination of benefits or
recoupment situation not described in
paragraphs (a) through (e) of this section
will be handled pursuant to WTC
Health Program policies and
procedures, as found on the WTC
Health Program Web site.
§ 88.25 Reopening of WTC Health Program
final decisions.
At any time, and without regard to
whether new evidence or information is
provided or obtained, the Administrator
of the WTC Health Program may reopen
any final decision made by the WTC
Health Program pursuant to the
provisions of this part. The
Administrator may affirm, vacate, or
modify such decision, or take any other
action he or she deems appropriate.
Dated: November 22, 2016.
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.
Dated: November 28, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human
Services.
[FR Doc. 2016–29957 Filed 12–12–16; 11:15 am]
BILLING CODE 4163–18–P
E:\FR\FM\15DER2.SGM
15DER2
]]>Agencies
[Federal Register Volume 81, Number 241 (Thursday, December 15, 2016)]
[Rules and Regulations]
[Pages 90926-90947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-29957]
[[Page 90925]]
Vol. 81
Thursday,
No. 241
December 15, 2016
Part II
Department of Health and Human Services
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42 CFR Part 88
World Trade Center Health Program; Amendments to Definitions, Appeals,
and Other Requirements; Final Rule
Federal Register / Vol. 81 , No. 241 / Thursday, December 15, 2016 /
Rules and Regulations
[[Page 90926]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 88
[Docket No. CDC-2016-0072; NIOSH-291]
RIN 0920-AA56, 0920-AA44, 0920-AA48, 0920-AA50
World Trade Center Health Program; Amendments to Definitions,
Appeals, and Other Requirements
AGENCY: Centers for Disease Control and Prevention, HHS.
ACTION: Final rule.
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SUMMARY: In 2011 and 2012, the Secretary, Department of Health and
Human Services (HHS), promulgated regulations designed to govern the
World Trade Center (WTC) Health Program (Program), including the
processes by which eligible responders and survivors may apply for
enrollment in the Program, obtain health monitoring and treatment for
WTC-related health conditions, and appeal enrollment and treatment
decisions, as well as a process to add new conditions to the List of
WTC-Related Health Conditions (List). After using the regulations for a
number of years, the Administrator of the WTC Health Program identified
potential improvements to certain existing provisions, including, but
not limited to, appeals of enrollment, certification, and treatment
decisions, as well as the procedures for the addition of health
conditions for WTC Health Program coverage. He also identified the need
to add new regulatory provisions, including, but not limited to,
standards for the disenrollment of a WTC Health Program member and
decertification of a certified WTC-related health condition. A notice
of proposed rulemaking was published on August 17, 2016; this action
addresses public comments received on that proposed rulemaking, as well
as three interim final rules promulgated since 2011, and finalizes the
proposed rule and three interim final rules.
DATES: This rule is effective on January 17, 2017.
FOR FURTHER INFORMATION CONTACT: Rachel Weiss, Program Analyst; 1090
Tusculum Ave., MS: C-46, Cincinnati, OH 45226; telephone (855) 818-1629
(this is a toll-free number); email NIOSHregs@cdc.gov.
SUPPLEMENTARY INFORMATION: This preamble is organized as follows:
I. Executive Summary
A. Purpose of Regulatory Action
B. Summary of Major Provisions
C. Costs
II. Public Participation
III. Background
IV. WTC Health Program Statutory Authority
V. Summary of Final Rule and Response to Comments
VI. 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
On August 17, 2016, the Secretary, HHS, and the Administrator of
the WTC Health Program published a notice of proposed rulemaking
proposing amendments to some provisions in part 88 in Title 42 and the
addition of others (August 2016 NPRM).\1\ This final rule includes the
Administrator's response to public comments received on the August 2016
NPRM, as well as public comments received in response to three interim
final rules establishing portions of 42 CFR part 88, published in 2011,
2013, and 2014, respectively.\2\ The amendments to part 88 are intended
to benefit both the WTC Health Program and its members by clarifying
requirements and improving administrative processes.
---------------------------------------------------------------------------
\1\ 81 FR 55086 (Aug. 17, 2016).
\2\ These include the July 2011 IFR (establishing part 88 and
implementing the Program), 76 FR 38914 (July 1, 2011); the March
2013 IFR (establishing eligibility criteria for Shanksville and
Pentagon responders), 78 FR 18855 (Mar. 28, 2013); and the February
2014 IFR (clarifying the definition of ``childhood cancers'' and
revising the definition of ``rare cancers''), 79 FR 9100 (Feb. 18,
2014).
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B. Summary of Major Provisions
In this action, the Administrator finalizes amendments to a number
of existing sections in part 88, including provisions for appeals of
enrollment decisions, appeals of certification, decertification, or
treatment authorization decisions, and the addition of health
conditions to the List of WTC-Related Health Conditions. Some existing
language is moved into new sections for clarity. Finally, new language
on disenrollment, decertification, appeals of reimbursement denials,
and coordination of benefits and recoupment is added to part 88.
C. Costs
The revisions to part 88 proposed in the August 2016 NPRM and
finalized in this action are expected to result in approximately
$42,742 in costs to the WTC Health Program associated with updating
existing Program policies and developing new policies. As explained
below, the Program estimates that total costs of the WTC Health Program
were $240.5 million in FY 2015 and may range from $265.5 to $388.6
million in FY 2025. Cumulative costs associated with WTC Health Program
administration and monitoring and treatment services for all health
conditions for fiscal years (FY) 2016 through 2025 are projected to
range from $2.9 billion (7% discount rate) to $3.6 billion (3% discount
rate).\3\
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\3\ Costs for FY 2016-2025 have been evaluated for all health
conditions covered by the Program, both those conditions included in
the PHS Act at sec. 3312(a)(3) and 3322(b) and those added to the
List of WTC-Related Health Conditions in Sec. 88.15, including
cancer, new-onset chronic obstructive pulmonary disease, and WTC-
related acute traumatic injury.
---------------------------------------------------------------------------
II. Public Participation
Interested persons or organizations were invited to participate in
the August 2016 NPRM by submitting written views, opinions,
recommendations, and/or data on any topic related to the proposed rule.
All communications received on or before the closing date for comments
were fully considered by the Administrator of the WTC Health Program.
The August 2016 NPRM as well as public comments received are available
in the docket for this rulemaking. Public comments received on the
three interim final rules are available in those respective dockets.\4\
---------------------------------------------------------------------------
\4\ See infra note 9.
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Submissions to the August 2016 NPRM docket were received from three
commenters, including a labor organization, a joint labor/management
trust fund, and the contractor providing care for survivors in the WTC
Health Program.
III. Background
This final rule includes the Administrator's response to public
comments received on the August 2016 NPRM, as well as public comments
received in response to three interim final rules (IFRs). The first IFR
was published on July 1, 2011 to establish part 88 and implement the
Program, and included all of the original sections establishing
eligibility criteria and enrollment processes, health condition
certification and treatment requirements, mechanisms to appeal Program
decisions, and reimbursement
[[Page 90927]]
(July 2011 IFR).\5\ A second IFR was published on March 28, 2013 to
establish new eligibility criteria for Pentagon and Shanksville,
Pennsylvania responders (March 2013 IFR).\6\ A third IFR was published
on February 18, 2014 to clarify the definition of ``childhood cancers''
and revise the definition of ``rare cancers,'' resulting in cancers of
the brain, the pancreas, and the testes, and invasive cervical cancer
becoming eligible for Program coverage (February 2014 IFR).\7\ The
Administrator addressed some of the public comments submitted on the
three IFRs in the August 2016 NPRM; this final rule includes the
Administrator's responses to the remainder of public comments on the
IFRs.
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\5\ 76 FR 38914 (July 1, 2011).
\6\ 78 FR 18855 (Mar. 28, 2013.
\7\ 79 FR 9100 (Feb. 18. 2014).
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IV. WTC Health Program Statutory Authority
Title I of the James Zadroga 9/11 Health and Compensation Act of
2010 (Pub. L. 111-347, as amended by Pub. L. 114-113), added Title
XXXIII to the Public Health Service Act (PHS Act), establishing the WTC
Health Program within HHS. The WTC Health Program provides medical
monitoring and treatment benefits to eligible firefighters and related
personnel, law enforcement officers, and rescue, recovery, and cleanup
workers who responded to the September 11, 2001, terrorist attacks in
New York City, at the Pentagon, and in Shanksville, Pennsylvania
(responders), and to eligible persons 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
(survivors).
All references to the Administrator of the WTC Health Program
(Administrator) in this notice mean the WTC Program Administrator, the
Director of the National Institute for Occupational Safety and Health
(NIOSH), or his or her designee. Section 3301(j) of the PHS Act
authorizes the Administrator to promulgate such regulations as are
necessary to administer the WTC Health Program.
V. Summary of Final Rule and Response to Comments
This rule adopts and finalizes all amendments to 42 CFR part 88
promulgated by the July 2011, March 2013, and February 2014 IFRs and
proposed in the August 2016 NPRM. Amendments to the regulatory text in
part 88 are finalized in accordance with the discussion provided in the
August 2016 NPRM \8\ and below, responding to public comments received
on all four rulemakings. All public comments are available in the
dockets for the four respective rulemakings.\9\
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\8\ See 81 FR 55086 at 55087-96.
\9\ See July 2011 IFR, docket CDC-2011-0009; March 2013 IFR,
docket CDC-2013-0002; February 2014 IFR, docket CDC-2014-0004; and
August 2016 NPRM, docket CDC-2016-0072.
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Section 88.1 Definitions
The Administrator revised pre-existing definitions and established
new definitions for terms commonly used in the WTC Health Program in 42
CFR 88.1.
Comment: One July 2011 IFR commenter asked the Program to amend
three definitions. The commenter asked that the definition of
``aggravating'' include any health condition that requires medical
treatment ``more intensive than'' would have been required for such a
condition in the absence of 9/11 exposure; that ``medically necessary
treatment'' include treatment modalities and protocols developed
specifically for children; and that ``New York City disaster area''
include 14th Street as the northern boundary.
Administrator's response: The term ``aggravating'' is defined in
sec. 3306(1) of the PHS Act and cannot be expanded in the regulatory
definition.
The Administrator also declines to amend ``medically necessary
treatment'' because the medical treatment protocols developed by the
Data Centers already include treatment modalities developed for
children. The existing definition is sufficiently broad to include all
types of patients treated by physicians affiliated with the Clinical
Centers of Excellence (CCEs) or the Nationwide Provider Network (NPN).
No changes are made to the regulatory text in response to these
comments.
Finally, ``New York City disaster area'' is also defined in the PHS
Act, at sec. 3306(7), and cannot be expanded in the regulatory
definitions. No change is made to the regulatory text in response to
the public comments.
The term ``designated representative'' is revised to clarify that
an individual applying for enrollment in the WTC Health Program may
designate a representative. A new definition of ``WTC,'' meaning
``World Trade Center,'' is added to this section; all existing
definitions beginning with ``World Trade Center'' are revised
accordingly to streamline the regulatory text.
Section 88.2 General Provisions
This section establishes the appointment process for an applicant's
or WTC Health Program member's designated representative and the
parameters of the representative's authority.
Comment: One July 2011 IFR commenter asked that the Program allow a
parent or guardian to be the designated representative for a mentally
impaired screening- or certified-eligible survivor.
Administrator's response: The Administrator agrees with the comment
and has added a new paragraph (a)(7) to address the concern. In
addition, paragraph (a)(6) has been revised to clarify that a parent or
guardian of a minor applicant, as well as the parent or guardian of a
screening-eligible or certified-eligible survivor who is a minor, may
act on behalf of the minor.
Comment: One July 2011 IFR commenter asked that the Program offer
reimbursement to members in the NPN for whom the cost of travel to the
provider is less than 250 miles but nevertheless poses a financial
burden, which is a barrier to care.
Administrator's response: PHS Act, sec. 3312(b)(4)(C) allows the
Program to provide transportation expenses for medically necessary
treatment through the NPN involving ``travel of more than 250 miles.''
The statutory language only authorizes reimbursement of travel expenses
where travel exceeds 250 miles. No change is made to the regulatory
text in response to this comment.
Section 88.3 Eligibility--Currently Identified Responders
No public comment was received on this section. No revisions are
made to this section, although it is included in the regulatory text,
below, for completeness.
Section 88.4 Eligibility Criteria--WTC Responders
This section establishes eligibility criteria for individuals who
participated in response and recovery activities at the New York City
area sites, at the Pentagon site, and at the Shanksville, Pennsylvania
site.
Comment: One July 2011 IFR commenter asked the Program to develop
eligibility criteria for responders engaged in the cleanup or
demolition of buildings at or near Ground Zero, including 130 Liberty
Street (Deutsche Bank) and 245 Greenwich Street (Fiterman Hall), which
were heavily contaminated with WTC dust. In the case of those buildings
[[Page 90928]]
and others across Lower Manhattan, cleanup took place years after
September 11, 2001 (e.g., cleanup of the Deutsche Bank building began
in 2007; Fiterman Hall in 2008). Workers exposed to the re-suspension
of WTC dust caused by cleanup activities ``had the potential to become
ill from those exposures and should be eligible under modified criteria
for monitoring and treatment.''
Administrator's response: Workers who engaged in cleanup or
demolition of buildings contaminated by WTC dust outside of the
eligibility criteria identified in PHS Act, sec. 3311(a)(2) cannot be
included in the eligibility criteria for WTC responders in Sec. 88.4
without promulgating modified eligibility criteria by rulemaking. At
this time, the Administrator is not aware of any scientific evidence to
support such a rulemaking. No change is made to the regulatory text in
response to this comment.
Comment: One March 2013 IFR commenter suggested that the addition
of eligibility criteria for Pentagon and Shanksville responders is
unnecessary because, the commenter believes, there were no real hazards
at the Shanksville, Pennsylvania site, and the Pentagon site was
quickly cleaned up.
Administrator's response: The Administrator does not agree with the
sentiments expressed by this commenter. The eligibility criteria for
Pentagon and Shanksville responders were developed after consideration
of a report produced by NIOSH that reviewed published literature and
other authoritative sources and consultations with participating
responders from both sites.\10\ The report summarized the results of
environmental sampling at the Pentagon and Shanksville, Pennsylvania
sites; estimated the length of time that each of the various responder
groups participated in rescue, recovery, demolition, debris cleanup,
and other related response activities; and identified the types of
exposures potentially experienced by the site responders. Based on the
report's findings, the Administrator found it reasonable to establish
eligibility criteria for Pentagon and Shanksville responders.\11\ No
change is made to the regulatory text in response to this comment.
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\10\ Robert McCleery, Summary of Evidence for Establishing Dates
on which Cleanup of the Pentagon and Shanksville, Pennsylvania Sites
of the Terrorist-Related Aircraft Crashes of September 11, 2001
Concluded, Prepared for the Administrator, WTC Health Program,
February 8, 2012, https://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-041312-ShanksvilleResponse.pdf.
\11\ See generally 78 FR 18855.
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Section 88.5 Application Process--WTC Responders
This section describes the application process for individuals who
participated in response and recovery activities at any of the three
sites. Language from Sec. 88.6(b), concerning notification of
deficient applications, is moved into a new Sec. 88.5(c). The word
``shall'' is replaced with ``must'' throughout the section, and ``WTC
Program Administrator'' is replaced with ``WTC Health Program.''
Comment: One July 2011 IFR commenter asked that the Program contact
an applicant by telephone to notify the individual of deficiencies in
an application or supporting documentation.
Administrator's response: The Program makes every effort to contact
applicants to correct any deficiencies in the application and conducts
follow-up by telephone, mail, and/or email. No change is made to the
regulatory text in response to this comment.
Section 88.6 Enrollment Decision--WTC Responders
This section describes the basis for enrollment and enrollment
denial decisions and explains the Program's notification procedures.
Language from Sec. 88.6(b), concerning notification of deficient
applications, is moved into a new Sec. 88.5(c) where it is better
placed. A sentence is added to paragraph (d) to clarify that the 60-day
time period for Program enrollment decisions will be tolled during any
days in which the applicant is correcting deficiencies, as in Sec.
88.10(a).
Comment: Two July 2011 IFR commenters expressed concerns about the
requirement regarding use of the terrorist watch list. Specifically,
the commenters asked about information sharing protections and redress
procedures, and stated that the terrorist watch list must not be used
to harass, jeopardize, and/or deport immigrants.
Administrator's response: The Program is required to screen
applicants against the terrorist watch list (see PHS Act, secs.
3311(a)(5) and 3321(a)(4)). Program applications as well as the System
of Records Notice (SORN) for the WTC Health Program \12\ state that
information will only be disclosed to the Department of Justice (DOJ)
and others for the limited purposes of ascertaining enrollment
eligibility and qualification. HHS does not conduct terrorist watch
list screening; the Program submits limited information collected from
applications to DOJ, and DOJ's Terrorist Screening Center conducts the
screening. DOJ is a signatory to the 2007 Memorandum of Understanding
on Terrorist Watchlist Redress Procedures (MOU).\13\ There is no change
to the regulatory language in response to these comments.
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\12\ Occupational Health Epidemiological Studies and EEOICPA
Program Records and WTC Health Program Records, HHS/CDC/NIOSH,
Privacy Act System Notice 09-20-0147, https://www.gpo.gov/fdsys/pkg/FR-2011-06-14/html/2011-14807.htm.
\13\ See DOJ press release, Federal Inter-Agency Partners Sign
Government-wide Watchlisting Redress MOU, October 24, 2007, https://www.justice.gov/archive/opa/pr/2007/October/ustsc-102407.html.
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Comment: One July 2011 IFR commenter asked that the Program notify
the applicant of an enrollment decision within 30 calendar days of the
Program's receipt of the application.
Administrator's response: The Program is required by statute to
respond to applications within 60 calendar days of receipt of the
application and makes every effort to respond in less time; average
response time is approximately 4 weeks. Applicants can impact the
length of the eligibility review process by submitting a complete
application. No change is made to the regulatory text in response to
this comment.
Section 88.7 Eligibility--Currently-Identified Survivors
No public comment was received on this section. No revisions are
made to this section, although it is included in the regulatory text,
below, for completeness.
Section 88.8 Eligibility Criteria--WTC Survivors
This section establishes eligibility criteria for individuals who
do not meet the eligibility criteria for WTC responders.
Comment: One July 2011 IFR commenter asked that the language in
Sec. 88.8(a)(1)(iii), regarding ``extensive exposure,'' be interpreted
liberally because ``this population may be least likely to have
employment related documents or the ability to obtain them.''
Administrator's response: This eligibility criteria is based on
section 3321(a)(1)(B)(iii) of the PHS Act, which requires extensive
exposure to WTC dust for this specific population. However, the Program
takes an applicant-favorable approach to eligibility criteria. There is
no change made to the regulatory text in response to this comment.
Comment: One July 2011 IFR commenter pointed out that the
[[Page 90929]]
regulatory language in Sec. 88.8(a)(1)(iv)(C) implies that the
individual must have lived in the New York City disaster area residence
from September 11, 2001 through May 31, 2003 but asserts that the Lower
Manhattan Development Corporation Residential Grant Program did not
begin until August 2002 and participation requirements state that
``renters must have leases commencing on or after June 1, 2001 and on
or prior to May 31, 2003. Owners must purchase apartments on or prior
to May 31, 2003.'' The commenter requests that the text of the
regulation indicate that the individual was in residence for part of
that period.
Administrator's response: The Administrator appreciates the
comment, however, the language in this section mirrors the eligibility
language in PHS Act, sec. 3321(a)(1)(B)(iv). No change is made to the
regulatory text in response to this comment.
Comment: Similar to comments made on Sec. 88.4, one July 2011 IFR
commenter suggested that the section be amended to include survivors
who conducted cleanup or demolition of buildings at or near Ground Zero
which were heavily contaminated with WTC dust. In some cases, cleanup
took place years after September 11, 2001 and workers were exposed to
the re-suspension of WTC dust caused by cleanup activities.
Administrator's response: As discussed above, workers who engaged
in cleanup or demolition of buildings contaminated by WTC dust outside
of the eligibility criteria identified in PHS Act, sec. 3321(a)(1)(B)
cannot be included in the eligibility criteria for WTC survivors in
Sec. 88.8 without promulgating modified eligibility criteria by
rulemaking. At this time, the Administrator is not aware of any
scientific evidence to support such a rulemaking. There is no change
made to the regulatory text in response to this comment.
Comment: One July 2011 IFR commenter asked the Program to establish
modified eligibility criteria for the ``full cohort of affected
children,'' including those who were exposed in utero (mothers who
lived or worked in the New York City disaster area); those exposed to
WTC dust brought home by responder parents; those born after September
11, 2001, to responder or survivor parents and suffering mental health
impacts due to the parents' WTC-related mental health condition; and
those born to exposed responders or survivors if evidence of
environmental reproductive health impacts is available.
Administrator's response: Individuals who were children at the time
of the terrorist attack in New York City or its aftermath may be
enrolled WTC survivors if they meet the eligibility criteria for
screening-eligible survivors. Children who were exposed in-utero, who
experienced `take-home' exposures, who suffer from mental health
conditions resulting from their parents' WTC-related mental health
conditions, and who suffer from health effects resulting from parental
exposures were not identified in the PHS Act's eligibility criteria for
survivors. To the extent that language could be added to the
eligibility criteria to permit some or all such cohorts of children to
be enrolled as WTC survivors under Sec. 88.8, the Administrator would
be required to promulgate modified eligibility criteria. The
Administrator is not contemplating such modified criteria at this time.
Developmental disorders cannot be added to the List without rulemaking
supported by scientific or medical evidence, pursuant to the procedures
established in Sec. 88.16 for adding new WTC-related health conditions
to the List. There is no change made to the regulatory text in response
to this comment.
Section 88.9 Application Process--WTC Survivors
This section describes the application process for individuals in
the New York City disaster area who did not participate in response and
recovery activities.
Comment: One July 2011 IFR commenter suggested that the application
process should allow statements written under penalty of perjury from
fellow workers, neighbors, and fellow students or teachers, and allow a
sworn statement of facts by the applicant before a notary if no other
documentation is available.
Administrator's response: The Program accepts a wide range of
documentation to verify an applicant's status. Statements from co-
workers and others used as evidence of an individual's presence in the
New York City disaster area are contemplated by Sec. 88.9(a)(1), which
has been slightly revised for clarity by replacing a comma with a semi-
colon, to state that ``[d]ocumentation may include but is not limited
to: Proof of residence, such as a lease or utility bill; attendance
roster at a school or daycare; or pay stub, other employment
documentation, or written statement, under penalty of perjury, by an
employer indicating employment location during the relevant time
period; or similar documentation.'' ``Similar documentation'' could
include written statements from co-workers and fellow students or
neighbors. The types of written statements suggested by the commenter
are among those that are routinely accepted by the Program. This
section is not changed in response to this comment.
A new paragraph (a)(3), comprising language concerning the
notification of deficiencies in an application, is moved from Sec.
88.10(a). ``Shall'' is replaced with ``must'' throughout the section,
and ``WTC Program Administrator'' is replaced with ``WTC Health
Program'' in paragraph (b).
Section 88.10 Enrollment Decision--Screening-Eligible Survivors
This section describes the basis for enrollment as a screening-
eligible survivor and enrollment denial decisions, and explains the
Program's notification procedures.
Comment: One July 2011 IFR comment asked that the Program shorten
the time frame for notifying applicants of screening-eligible status
from 60 calendar days to no more than 30 days from NIOSH's receipt of
the application. The commenter also asked that the Program use
telephone outreach to follow up with applicants when documentation is
absent or deficient.
Administrator's response: The Program is required by statute to
respond to applications within 60 calendar days of receipt of the
application and makes every effort to respond in less time; the average
response time is approximately 4 weeks. Applicants can impact the
length of the eligibility review process by submitting a complete
application. The Program makes every effort to contact applicants to
correct any deficiencies in the application, and conducts follow-up by
telephone, mail, and/or email. This section is not changed in response
to this comment.
Language in paragraph (a) concerning notification of deficiencies
in an application is moved to Sec. 88.9(a)(3).
Section 88.11 Initial Health Evaluation for Screening-Eligible
Survivors
This section describes the initial health evaluation process for
screening-eligible survivors.
Comment: One August 2016 NPRM commenter shared a concern that the
language may permit survivors to obtain an initial health evaluation
and treatment from any CCE.
Administrator's response: The language in this section is
essentially unchanged from the original language of Sec. 88.10(d)(1),
which reads ``A WTC Health Program Clinical Center of Excellence or a
member of the nationwide network provider [sic] will provide the
screening-eligible survivor
[[Page 90930]]
an initial health evaluation to determine if the individual has a WTC-
related health condition. . . .'' Although the names are changed to
acronyms for the sake of brevity and clarity, the Administrator's
intent is unchanged and the language in this section continues to mean
that an initial health evaluation will be provided by the Program. No
change is made to the regulatory text in response to this comment.
Section 88.12 Enrollment Decision--Certified-Eligible Survivors
This section describes the basis for enrollment as a certified-
eligible survivor and enrollment denial decisions, and explains the
Program's notification procedures.
Comment: One July 2011 IFR commenter asked that the Program specify
a time frame for notification of certified-eligible status, no more
than 30 days from receipt by the Program of a physician determination.
Administrator's response: Although the WTC Health Program makes
every effort to provide certification decisions in a timely manner, the
establishment of a deadline for notification of certified-eligible
status or a deadline for the Program's decision whether to certify a
WTC-related health condition (pursuant to Sec. 88.18) could impede the
Program's ability to conduct a thorough analysis of the member's health
condition and exposure history. This could especially be the case where
the Administrator has added a health condition to the List but the
Program has not yet established implementation guidelines. Moreover, a
deadline may create confusion if stakeholders believe that a
certification request not granted or denied within the period is deemed
to be either granted or denied. No change is made to the regulatory
text in response to this comment.
Section 88.13 Disenrollment
This section clarifies the process for disenrolling a member from
the WTC Health Program.
Comment: One August 2016 NPRM commenter agreed that the
disenrollment (and decertification, pursuant to Sec. 88.18) provisions
are important to ``ensure program integrity.''
Comment: One August 2016 NPRM commenter stated that there is no
language included in this section to address grandfathered members
(those enrolled pursuant to Sec. Sec. 88.3 and 88.7) and stated the
opinion that such members should be ``immune from disenrollment.''
Administrator's response: It is important to the integrity of the
WTC Health Program to maintain the authority to disenroll any member if
evidence indicates that the enrollment was based on incorrect or
fraudulent information. The provisions in paragraph (a)(1) only apply
to members enrolled under the eligibility criteria in Sec. Sec. 88.4
or 88.8 (which do not include grandfathered members) and permit
disenrollment where there is insufficient proof of meeting the
eligibility criteria required by those sections. The provisions in
paragraph (a)(2) apply to all members (including grandfathered members)
and permit disenrollment where the enrollment was based on incorrect or
fraudulent information. No change to the regulatory text is made in
response to this comment.
Section 88.14 Appeal of Enrollment or Disenrollment Decision
This section establishes procedures for the appeal of a WTC Health
Program decision to deny enrollment of an applicant or disenroll a
Program member.
Comment: One August 2016 NPRM commenter agreed that the proposed
extension of the deadline for filing an appeal, from 60 to 90 days, is
an improvement but is still too short a time frame for obtaining
necessary records. According to the commenter, the deadline for filing
an appeal should be extended to at least 4 months (120 days).
Administrator's response: The Administrator agrees and extends the
deadline for appeal submission to 120 days. The regulatory text in
paragraph (b)(1) is amended accordingly.
Comment: One August 2016 NPRM commenter requested that the Program
allow applicants and members to make an oral statement during the
appeal, as is allowed in Sec. 88.21.
Administrator's response: Although applicants and members are
allowed to submit new information in support of Program enrollment
denial or disenrollment appeals, the Administrator has determined that,
in the context of enrollment and disenrollment appeals, the
administrative burden associated with oral statements outweighs the
benefits. The factual bases and documentation requirements for
enrollment and disenrollment decisions can be more efficiently
considered through a paper-based review. No changes to the regulatory
text are made in response to this comment.
Comment: One July 2011 IFR commenter asked that the Program
indicate from where the Federal Official will be drawn and what
expertise that individual may have with the monitoring and treatment of
WTC-related health conditions.
Administrator's response: The Federal Officials appointed to hear
appeals are chosen from Centers, Institutes, or Offices within the
Centers for Disease Control and Prevention. They have relevant
knowledge but do not work within the WTC Health Program. No change is
made to the regulatory text in response to this comment.
Comment: One August 2016 NPRM commenter stated that the NPRM
provides no justification for having the Administrator make final
decisions on appeals and appears unfair to the claimant making the
appeal.
Administrator's response: To clarify the processes by which certain
decisions are made within the Program, language throughout Part 88 is
changed to indicate that some decisions are made directly by the
Administrator, while he has designated WTC Health Program staff to make
other Program decisions, such as certifications. In the case of
enrollment or disenrollment appeals, the Administrator is reviewing
decisions made by Program staff. The Program finds it important to
shift the final appeal decision-making authority to the Administrator
because the final decision on eligibility appeals (and the
certification and treatment authorization appeals in Sec. 88.21)
should be made by the Administrator, who has a thorough understanding
of the WTC cohorts and matters related to eligibility and exposures and
is best able to apply the laws, policies, and procedures governing the
WTC Health Program. No change is made to the regulatory text in
response to this comment.
Comment: One August 2016 NPRM commenter expressed concern that some
appeals may take longer than the average 45 days, and recommended a
final decision deadline of 120 days, with a contingency for justifying
longer delays based on specific circumstances.
Administrator's response: As discussed above, the establishment of
a deadline for notification of a decision such as a final appeal
decision could impede the Program's ability to conduct a thorough
review of the prospective member's application and documentation of
eligibility. The section is not changed in response to this comment.
Section 88.15 List of WTC-Related Health Conditions
This section contains the List previously placed in Sec. 88.1
Definitions. No public comments were received on this section and no
substantive revisions are made to the text. Some punctuation
[[Page 90931]]
is corrected and the names of two types of cancer are pluralized.
Section 88.16 Addition of Health Conditions to the List of WTC-Related
Health Conditions
This section establishes the process by which interested parties
may petition the Administrator to add a health condition to the List.
No public comments were received on this section and no revisions are
made to the text.
Section 88.17 Physician's Determination of WTC-Related Health
Conditions
This section establishes the basis for a CCE or NPN-affiliated
physician's determination that a member has a health condition that can
be certified. No public comments were received on this section and no
revisions are made to the text.
Section 88.18 Certification
This section establishes that the WTC Health Program will promptly
assess physician determinations submitted by a CCE or NPN-affiliated
physician and, if the Program concurs with the determination and
decides that a health condition is a WTC-related health condition or a
health condition medically associated with a WTC-related health
condition, will certify the condition as eligible for coverage under
the WTC Health Program.
Comment: One August 2016 NPRM commenter recommended the
establishment of a deadline for Program decisions concerning the
certification of WTC-related health conditions.
Administrator's response: As discussed above with regard to
certified-eligible status notification, the establishment of a deadline
for a final appeal decision could impede the Program's ability to
conduct a thorough analysis of the member's health condition and
exposure history. Certification decisions may be particularly time-
consuming to resolve if a condition has been added to the List but the
Program has not yet established implementation guidelines. Moreover, a
deadline may create confusion if stakeholders believe that a
certification request not granted or denied within the period is deemed
granted. The section is not changed in response to this comment.
Comment: Four July 2011 IFR commenters stated their belief that PHS
Act, sec. 3312(b)(2) permits certification of individual primary
conditions determined to be WTC-related that are not on the List and
the regulatory text should be revised accordingly.
Administrator's response: The Administrator has reviewed PHS Act,
sec. 3312(b)(2)(A)-(B) and finds that the meaning of the text
``determination based on medically associated WTC-related health
conditions'' and ``if a . . . WTC responder has a health condition
described in subsection (a)(1)(A) that is not in the list in subsection
(a)(3) but which is medically associated with a WTC-related health
condition . . .'' is plain--the medically associated health condition
must be related to a health condition listed in sec. 3312(a)(3). The
language of the enacted statute does not permit physicians to recommend
a health condition for certification that is not causally related to a
listed WTC-related health condition. The Administrator finds the
language of the Act is clear, and the legislative history is consistent
with the Administrator's interpretation. While the language in the
introduced bill did give physicians the authority requested by
commenters, subsequent amendments to the bill changed the language and
the intent of the enacted Act is different from that which was
introduced. The regulatory text in this section is not changed in
response to these comments.
Section 88.19 Decertification
This section clarifies the process for decertification of a WTC-
related health condition or health condition medically associated with
a WTC-related health condition.
Comment: One August 2016 NPRM commenter asked that language be
added to this section ``to clarify that a member whose health condition
has been decertified retains the right to seek recertification'' in
some circumstances. For example, where new information about the
member's exposure or evidence of association between 9/11 exposure and
the decertified condition was previously not considered by the Program.
Administrator's response: In addition to a right to appeal a WTC
Health Program decision to decertify a certified WTC-related health
condition, a member who believes the decision was made in error may ask
the CCE or NPN physician to resubmit the certification request; the
physician may include new information to support the case for
certification. The Administrator finds it unnecessary to revise the
regulatory text in Sec. 88.19(b) and may address this matter
administratively.
Comment: Similar to a comment on Sec. 88.13, one August 2016 NPRM
commenter expressed concern that there is no language in this section
addressing grandfathered members (those enrolled pursuant to Sec. Sec.
88.3 and 88.7), who should be ``immune from decertification.''
Administrator's response: It is important to the integrity of WTC
Health Program that any health condition may be decertified if the
available evidence indicates that the certification is based on
inadequate exposure or was otherwise certified in error. This includes
grandfathered Program members. The section is not changed in response
to this comment.
Section 88.20 Authorization of Treatment
This section describes the provision of medically necessary
treatment.
Comment: One July 2011 IFR commenter asked the Program to use a
variety of mental health modalities to treat mental health conditions.
The commenter recommended that such treatment must be culturally
sensitive and allow patients to be treated by private, community-based
mental health professionals.
Administrator's response: The Program allows a variety of treatment
modalities to address various diagnoses, especially posttraumatic
stress disorder (PTSD) and other mental health conditions. Many of the
practitioners affiliated with CCEs or the NPN have community-based
mental health practices where they see Program members and should be
able to render culturally-sensitive care. No change is made to the
regulatory text in response to this comment.
Comment: One August 2016 NPRM commenter recommended the addition of
flexibility to the regulatory text in paragraph (b) to ``accommodate
complex care situations'' like cancer treatment or organ transplant in
medical protocols developed by the Data Centers.
Administrator's response: The Program finds that the regulatory
text in paragraph (b) is sufficiently broad to allow for the
development of medical protocols of any appropriate complexity. No
change is made to the regulatory text in response to this comment.
Comment: One August 2016 NPRM commenter expressed concern that a
strict interpretation of the language in paragraph (c) requires the
Administrator personally to authorize treatment pending certification
before any treatment is provided (except for emergency care). According
to the commenter, ``[g]iven the growing length of time between
submission of certification requests and the receipt of decisions, a
strict interpretation of this language would be detrimental to member
wellbeing.''
[[Page 90932]]
Administrator's response: The Administrator agrees with the
commenter and changes the regulatory text to replace ``Administrator of
the WTC Health Program'' with ``WTC Health Program.''
Section 88.21 Appeal of Certification, Decertification, or Treatment
Authorization Decision
This section establishes that a WTC Health Program member or the
designated representative of such a member may appeal the Program's
decision to deny certification of a health condition as WTC-related or
medically associated with a WTC-related health condition, decertify a
WTC-related health condition or medically associated health condition,
or deny authorization of treatment for a certified health condition.
In response to public comment on Sec. 88.14, concerning appeal of
enrollment decisions, the Administrator agreed to extend enrollment
appeal submission deadlines to 120 days. To maintain parity with that
process, the deadline for the submission of appeals of certification,
decertification, and treatment authorization decisions is also extended
to 120 calendar days.
Section 88.24 Coordination of Benefits and Recoupment
This section addresses the matter of coordination of benefits,
including recoupment from workers' compensation settlements.
Comment: One August 2016 NPRM commenter stated that the language in
paragraph (e) ``does not address the growing use of restricted networks
by health insurers which can make it very difficult for a participant
to find a provider in their network for the complicated specialty
treatment required for their medical condition. Would they be forced to
go to an in-network provider which is not in the WTC program?''
Administrator's response: The Program is aware of the concern
raised by the commenter, especially in the cancer care context. In very
rare circumstances, the Program may allow for members who require
``specialty treatment,'' such as cancer care and transplants, to
receive care from providers outside of their insurance networks.
Otherwise, the CCE or NPN will coordinate care through providers within
the members' insurance networks. The Program may provide more specific
administrative guidance on this issue, as necessary. No changes are
made to the regulatory text in response to this comment.
General Comments
Comment: One July 2011 IFR commenter asked that the Part 88
regulations address outreach, and include radio, TV, newspaper
advertising, community meetings; fund effective, culturally competent
outreach; partnership with community-based social service providers;
re-fund de-funded outreach programs; and offer in-person assistance for
completing application for non-English speakers and the mentally
impaired.
Administrator's response: Section 3303 of the PHS Act authorizes
the Administrator to conduct the following outreach and education
activities: establish a public Web site with information about the
Program; hold meetings with potentially eligible populations; develop
and disseminate outreach and education materials about the Program; and
establish telephone information services. The Act further specifies
that these activities will be conducted in a manner intended to reach
all affected populations and include materials for culturally and
linguistically diverse populations. The WTC Health Program meets these
requirements by funding outreach and education activities (including
culturally appropriate and diverse programs) to be conducted by the
CCEs as well as community and labor groups. These groups are able to
provide face-to-face enrollment assistance. Furthermore, the WTC Health
Program has a New York Field Coordinator who also conducts outreach and
provides application assistance. No change is made to Part 88 in
response to this comment.
VI. 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, and public
health and safety effects, distributive impacts, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
This final rule has been determined to be a ``significant
regulatory action'' under section 3(f) of Executive Order 12866.
This final rule includes changes proposed in the August 2016 NPRM
and final revisions made in response to public comment and to clarify
the Program's intent; it also finalizes three IFRs issued in July 2011,
March 2013, and February 2014, respectively. This final rule includes
revisions to Sec. Sec. 88.14 and 88.21 (enrollment and medical
appeals) and Sec. 88.16 (addition of health conditions) that will
result in necessary updates to several existing WTC Health Program
policies; novel regulatory provisions in Sec. 88.13 (disenrollment),
Sec. 88.19 (decertification), and Sec. 88.23 (reimbursement appeals)
will require the revision of existing policies or development of new
policies. The Administrator estimates that amending the existing Policy
and Procedures for Handling Submissions and Petitions to Add a Health
Condition to the List of WTC-Related Health Conditions and the Web page
containing frequently asked questions regarding appeals, and developing
new disenrollment, decertification, and reimbursement appeal policies
will require approximately 568 hours of staff time. The average WTC
Health Program staff member responsible for updating these policies is
a GS 14-5, earning $125,221 annually, pursuant to OPM's Salary Table
2016-DCB (Washington DC), or $75.25 hourly, adjusted to include
benefits. Accordingly, the revisions to Part 88 finalized in this final
rule are expected to cost the WTC Health Program approximately $42,742
and that amount is included in the administrative costs discussed
below. This rulemaking is not expected to change the number of
applicants or Program members; the Administrator has not identified any
other potential impacts associated with this final rule.
In addition to the costs associated with the August 2016 NPRM, this
rule also updates the regulatory impact analyses for the July 2011,
March 2013, and February 2014 IFRs, which are all finalized in this
action. In the original cost analysis conducted for the Part 88 WTC
Health Program regulations,\14\ HHS estimated the aggregate cost of
medical monitoring and treatment to be provided and administrative
expenses associated with implementing the WTC Health Program for a
period of 5 years. HHS developed those estimates for the health
conditions included for Program coverage in sections 3312 and 3321 of
the PHS Act, using data from the health programs that were in place for
WTC responders and survivors prior to the establishment of the WTC
Health Program. Since that original July 2011 rulemaking and cost
analysis, the WTC Health Program has expanded the list of
[[Page 90933]]
health conditions eligible to receive coverage in the Program through
regulations, as permitted by section 3312(a)(6) of the PHS Act; in
addition to the original statutory conditions of specified
aerodigestive disorders, mental health conditions, and, for certain
responders, musculoskeletal disorders, the WTC Health Program now also
provides coverage for numerous types of cancer, new-onset chronic
obstructive pulmonary disease (COPD), and WTC-related acute traumatic
injury. Data used to update this regulatory impact analysis include
data derived from WTC Health Program health services claims data as
well as administrative and infrastructure cost data collected between
FY 2012, the first full year for which data are available, and the end
of FY 2015, the last full year for which data are available.
---------------------------------------------------------------------------
\14\ July 2011 IFR, 76 FR 38914 at 38921.
---------------------------------------------------------------------------
The Program estimates that total cumulative costs associated with
the WTC Health Program over the next 10 years will be $4,223,209,653,
undiscounted (from $2,874,481,628 at 7 percent discount rate to
$3,553,658,528 at 3 percent discount rate). The cost of the rule in FY
2025 is estimated to be $522,307,538 (present value between
$265,514,667 and $388,645,860, at 7 percent and 3 percent discounts
rates, respectively).\15\
---------------------------------------------------------------------------
\15\ These estimates represent only a 60 percent increase over
the cost estimates provided in the July 2011 IFR, where the Program
found that costs in 2015 could range from $106,800,000 to
$151,000,000. That estimate was based not on WTC Health Program
experience, but on health programs that pre-dated the current WTC
Health Program. The estimate in the July 2011 IFR was carried out
until only FY 2015; the current analysis projects Program costs
through FY 2025 based on WTC Health Program experience to date.
Table 1--Summary of WTC Health Program Costs *
----------------------------------------------------------------------------------------------------------------
Cumulative FY 2016-
FY 2015 FY 2025 2025
----------------------------------------------------------------------------------------------------------------
Total Costs
----------------------------------------------------------------------------------------------------------------
Undiscounted.............................. $240,571,579 $522,307,537 $4,223,209,653
7% discount rate.......................... .................... 265,514,667 2,874,481,628
3% discount rate.......................... .................... 388,645,860 3,553,658,528
----------------------------------------------------------------------------------------------------------------
Program Administration
----------------------------------------------------------------------------------------------------------------
Undiscounted.............................. 96,414,964 134,485,132 1,194,966,221
7% discount rate.......................... .................... 68,365,421 825,867,165
3% discount rate.......................... .................... 100,069,568 1,012,191,361
----------------------------------------------------------------------------------------------------------------
Medical Monitoring and Treatment
----------------------------------------------------------------------------------------------------------------
Initial health evaluation (survivors only):
Undiscounted.............................. 887,401 2,387,362 18,641,297
7% discount rate.......................... .................... 1,213,614 12,610,885
3% discount rate.......................... .................... 1,776,421 15,644,794
Annual medical monitoring:
Undiscounted.............................. 17,583,046 47,303,408 369,360,390
7% discount rate.......................... .................... 24,046,654 249,873,253
3% discount rate.......................... .................... 35,198,178 309,987,399
Diagnostic evaluation/cancer screening:
Undiscounted.............................. 13,131,585 35,327,709 275,850,234
7% discount rate.......................... .................... 17,958,816 186,613,392
3% discount rate.......................... .................... 26,287,133 231,508,572
Medical Treatment:
Undiscounted.............................. 112,554,583 302,803,927 2,364,391,511
7% discount rate.......................... .................... 153,930,162 1,599,516,932
3% discount rate.......................... .................... 225,314,560 1,984,326,403
----------------------------------------------------------------------------------------------------------------
All Medical Monitoring and Treatment
----------------------------------------------------------------------------------------------------------------
Undiscounted.............................. 144,156,615 387,822,405 3,028,243,432
7% discount rate.......................... .................... 197,149,246 2,048,614,463
3% discount rate.......................... .................... 288,576,292 2,541,467,168
----------------------------------------------------------------------------------------------------------------
Prior Rulemaking Cost Estimates
----------------------------------------------------------------------------------------------------------------
Cancer, September 2012 final rule (non-add).....Estimated cost per year FY 2013-2016
($mil)
12.5-33.3.
Pentagon/Shanksville responders, March 2013 IFR Estimated cost per year FY 2013-2016
($mil)
.9-3.2.
Prostate cancer, September 2013 final rule (non-Estimated cost per year FY 2014-2016
($mil)
3.5-7.0.
Brain, invasive cervical pancreatic, testicular cancers, February
2014 IFR (non-add).............................Estimated cost per year FY 2014-2016
($mil)
2.2-5.0.
COPD and acute traumatic injury, July 2016 finalEstimated cost per year FY 2016-2019
($mil)
4.6-5.7.
----------------------------------------------------------------------------------------------------------------
* Due to rounding, some totals may not correspond with the sum of the separate figures.
[[Page 90934]]
Enrollment
As of the end of FY 2015, WTC Health Program membership included
64,008 WTC responders and 9,144 screening- and certified-eligible
survivors. Based on enrollment numbers since FY 2012, the first full
year for which data are available, responders (including Pentagon and
Shanksville responders) enroll at an approximate rate of 2,087 per
year, screening- and certified-eligible survivors at an approximate
rate of 1,077 per year. Table 2 displays the past annual enrollment of
members, the projected enrollment over the 10 years between FY 2016 and
FY 2025, and the projected total number of members by FY 2025.\16\
---------------------------------------------------------------------------
\16\ These enrollment numbers do not include grandfathered
members, the majority of whom were automatically enrolled in the
Program in July 2011.
Table 2--WTC Health Program Annual Enrollment
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total members
FY 2012 FY 2013 FY 2014 FY 2015 FY 2016-2025 by 2025
--------------------------------------------------------------------------------------------------------------------------------------------------------
WTC responders.......................................... 886 1,539 3,096 2,205 20,873 84,545
Screening- and certified-eligible survivors............. 1,017 736 1,451 1,170 10,770 19,809
Total............................................... 1,903 2,275 4,547 3,375 31,643 104,354
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Costs
The annual cost to the WTC Health Program of conducting
administrative functions was approximately $96,414,964 in FY 2015.
Given the aggregate rate of enrollment of WTC responders and screening-
and certified-eligible survivors, a rise in operations costs by 1.7
percent and a rise in infrastructure costs of 3.3 percent, annual
administrative costs for FY 2025 are expected to be $134,485,132. Such
costs include program management, enrollment, certification of health
conditions, pre-authorization of medical care, payment services,
administration of appeals, education and outreach, administration of
the advisory and steering committees, and infrastructure costs for the
CCEs/NPN.
Infrastructure costs for the CCEs/NPN include the retention of
participants, case management, medical review, benefits counseling,
quality management, data transfer, interpreter services, and assisting
with the development of treatment protocols.
Table 3--WTC Health Program Administrative Costs
[Undiscounted]
------------------------------------------------------------------------
FY 2015 FY 2025
------------------------------------------------------------------------
Administrative costs (not including CCE/ $39,672,004 $57,193,270
NPN infrastructure--see below).........
CCE/NPN infrastructure cost............. 56,742,690 77,291,862
-------------------------------
Total............................... 96,414,694 134,485,132
------------------------------------------------------------------------
Costs of Medical Monitoring and Treatment
In FY 2015, the total cost to the WTC Health Program for medical
monitoring and treatment was $144,156,615, and the breakdown by type of
service is shown in Table 1. Initial health evaluations are for WTC
screening-eligible survivors only. Diagnostic evaluation and cancer
screening is for WTC screening- and certified-eligible survivors and
WTC responders. The other two categories of services are for WTC
certified-eligible survivors and WTC responders. These costs are based
on claims paid during FY 2015. The FY 2015 costs do not include costs
associated with monitoring and treatment of new-onset COPD and WTC-
related acute traumatic injury because the rulemaking adding those
conditions to the List was not completed until July 2016.\17\
---------------------------------------------------------------------------
\17\ 81 FR 43510 (July 5, 2016).
---------------------------------------------------------------------------
For FY 2025, the WTC Health Program estimated the total cost for
all health care service categories based on linear cost projections
from prior fiscal years, with an adjustment (increase) to account
conservatively for statistical uncertainty in the estimate. Also
included in the estimate are increases for the treatment and monitoring
of new-onset COPD and WTC-related acute traumatic injury, added to the
List in July 2016. The FY 2025 total for all health care service
categories is $387,822,406. This estimate accounts for an increase in
enrollment, more members receiving health care benefits, higher-cost
care related to cancer and complications of other illnesses, and
general medical care cost increases. In order to determine the breakout
by health care service category for FY 2025, the WTC Health Program
calculated the percentage of the total cost in FY 2015 for each
category and applied those percentages to the total estimate for FY
2025.
Examination of Benefits
Through FY 2015, the last full year for which Program data are
available, 35,523 members (49 percent) have been certified for at least
one WTC-related health condition. The number of certifications of WTC-
related health conditions identified in the categories of health
conditions included in the List of WTC-Related Health Conditions is in
Table 4, below. Based on the projected FY 2025 enrollment number of
104,354 and an increase of 3 percent annually of the number of members
who are estimated to be certified, there would be 158,415
certifications for 68,103 Program members in FY 2025.
[[Page 90935]]
Table 4--Number of Certified WTC-Related Health Conditions Among WTC
Health Program Members
------------------------------------------------------------------------
Health condition category FY 2015 FY 2025
------------------------------------------------------------------------
Aerodigestive disorders................. 58,782 112,694
Mental health conditions................ 18,868 36,173
Musculoskeletal disorders............... 535 1,026
Cancers................................. 4,445 8,522
-------------------------------
1Total certifications............... 82,630 158,415
------------------------------------------------------------------------
An evaluation of the health and quality of life improvements
associated with medical treatment of several of the most commonly-
certified health conditions is based on the prevalence of certified
WTC-related health conditions. Quality-adjusted life year (QALY) is a
common metric of expected treatment effectiveness for the health
conditions evaluated. For the purpose of this evaluation, the
Administrator assumes that each health condition will continue to be
represented among new Program members at the same rate at which it
occurs in current members. The health benefits provided by the WTC
Health Program are compared with the effect of no Program at all.
The Administrator assumes that WTC Health Program members receive
the best care available, as CCE and NPN providers are experts in
treating the types of health conditions on the List eligible for
certification. In order to compare the benefits provided by the WTC
Health Program to a scenario with no WTC Health Program, the
Administrator further assumes that the 9/11-exposed population of
responders and survivors would instead receive some but not optimal
treatment for their health conditions. Accordingly, the estimated
benefits (QALYs) represent the incremental improvement in health that
WTC Health Program members can expect from receiving the optimal
treatment provided by the CCEs and NPN versus standard treatments that
are commonly received outside of the Program.
Below are summarized QALY estimates for morbidity improvements for
aero-digestive conditions, PTSD and depression, and cancer.\18\
---------------------------------------------------------------------------
\18\ Estimates for mental disorders other than PTSD and
depression and for musculoskeletal disorders are not provided
because these conditions only account for approximately 9 percent of
the total certifications; estimates for WTC-related acute traumatic
injuries are not included because the FY 2015 data used to conduct
this analysis pre-dates the July 2016 rulemaking that added WTC-
related acute traumatic injuries to the List.
---------------------------------------------------------------------------
Aerodigestive Disorders
Gastroesophageal Reflux Disorder (GERD)
In the July 2011 IFR, an estimated 0.012 QALYs were gained per year
per patient under treatment for GERD in the Program compared with
patients treated outside the Program. Multiplying the WTC Health
Program's GERD population for each year during FY 2016-2025 by 0.012
results in 3,311 total undiscounted QALYs gained. Discounting future
health benefits at 3 and 7 percent results in 2,781 and 2,244 total
QALYs gained, respectively.
Chronic Rhinosinusitis and other Upper Respiratory Diseases
In the July 2011 IFR, an estimated 0.0145 QALYs were gained per
year per patient under treatment for chronic rhinosinusitis and other
upper respiratory diseases in the Program compared with patients
treated outside the Program. Assuming the same gain is achieved for
patients treated for other upper respiratory diseases, treating
patients for all upper respiratory diseases would result in 4,877 total
undiscounted QALYs gained. Discounting future health benefits at 3 and
7 percent results in 4,095 and 3,304 total QALYs gained, respectively.
Asthma
In the July 2011 IFR, an estimated 0.029 QALYs were gained per year
per patient under treatment for asthma in the Program resulting in
6,002 total undiscounted QALYs gained. Discounting future benefits at a
rate of 3 percent and 7 percent results in 5,040 and 4,066 total QALYs,
respectively.
Chronic Obstructive Pulmonary Disease (COPD) \19\
---------------------------------------------------------------------------
\19\ Data used to develop QALYs for COPD were derived from FY
2015 Program data regarding WTC-exacerbated COPD; estimates for new-
onset COPD are not included because the FY 2015 data pre-dates the
addition of new-onset COPD to the List in the July 2016 rulemaking.
In the July 2011 IFR, an estimated 0.077 QALYs were gained per year
per patient under treatment in the program for WTC-exacerbated COPD in
the Program resulting in 3,320 total undiscounted QALYs gained.
Discounting future health benefits at 3 and 7 percent results in 2,788
---------------------------------------------------------------------------
and 2,249 total QALYs gained, respectively.
Reactive Airways Dysfunction Syndrome (RADS) and other
Aerodigestive Conditions
In the July 2011 IFR, an estimated medical treatment similar to
that for asthma was discussed for patients suffering from RADS.
Assuming that treating one patient results in 0.029 QALYs gained and
that treating all other aerodigestive conditions not examined above
would also result in 0.029 QALYs gained would result in a total of
4,877 undiscounted QALYs gained. Discounting future health benefits at
3 and 7 percent, results in 4,094 and 3,204 total QALYs gained,
respectively.
Posttraumatic Stress Disorder (PTSD) and Depression
In the July 2011 IFR, an estimated 0.013 QALYs were gained per year
per patient under treatment for PTSD and depression in the Program
resulting in a total of 3,598 undiscounted QALYs gained. Discounting
future health benefits at 3 and 7 percent results in 3,022 and 2,438
total QALYs gained, respectively.
Cancer
It was assumed that all patients in FY 2016-2025 will live at a
health-related quality of life level similar overall to that reported
in Cutler and Richardson \20\ and Tengs and Wallace \21\ for patients
with cancer. A QALY for a person living with cancer, without specifying
treatment, stage of disease, or other specifics is approximately 0.7,
with 1 representing perfect health and 0 death. For comparison,
Sullivan and Ghushchyan \22\ estimated the health-related quality of
life for the age group 50-69 in the general U.S. population at 0.827.
---------------------------------------------------------------------------
\20\ David Cutler and Elizabeth Richardson, Your Money and Your
Life: The Value of Health and What Affects It, in Frontiers in
Health Policy Research, vol. 2, 99-132 (National Bureau of Economic
Research, 1999).
\21\ Tammy Tengs and Amy Wallace, One-Thousand Health-Related
Quality of Life Estimates, Med Care 2000;38(6):583-637.
\22\ Patrick Sullivan and Vahram Ghushchyan, Preference-Based
EQ-5D Index Scores for Chronic Conditions in the United States, Med
Decis Making 2006;26:410-420.
---------------------------------------------------------------------------
[[Page 90936]]
Using the expected number of prevalent cancer cases for FY 2016-
2025 and published information in Tengs and Wallace on the health-
related quality of life of cancer patients who respond to treatment for
their cancer, a rough estimate of 0.06 for the increase in patients'
quality of life was estimated for cancers treated in the WTC Health
Program compared to those not treated in the Program.\23\ Using the
prevalence of cancers and an assumed difference in health-related
quality of life of 0.06 among patients treated in the Program and those
not treated in the Program for the years FY 2016-2025 results in a
total of 3,913 undiscounted QALYs gained. Discounting future benefits
at 3 percent and 7 percent, results in 3,285 and 2,651 total QALYs
gained, respectively.
---------------------------------------------------------------------------
\23\ Tengs and Wallace, supra note 15, reports ranges of
differences in QALYs according to different treatments for ovarian
cancer patients and whether these patients responded to these
treatments. The ranges of these differences varied from 0.06 to
0.17. We used the low end of the range as a conservative estimate.
We are not aware of data available with which to estimate the
possible effect more reliably.
---------------------------------------------------------------------------
In summary, available information indicates the WTC Health Program
is likely to provide substantial improvements in health to responders
and survivors. The QALY estimates discussed above and summarized and
annualized in Table 5 below are illustrative of these benefits.
Table 5--Potential QALYs Gained From the WTC Health Program Treatment of Select WTC-Related Health Conditions:
FY 2016-2025 Summary
----------------------------------------------------------------------------------------------------------------
Present value Present value
Total of QALYs of QALYs
undiscounted gained by gained by
Health condition QALYs gained treatment treatment
by treatment discounted at discounted at
7% 3%
----------------------------------------------------------------------------------------------------------------
Aerodigestive disorders......................................... 17,510 11,863 14,704
PTSD & Depression............................................... 3,598 2,438 3,022
Cancers......................................................... 3,913 2,651 3,285
-----------------------------------------------
Total....................................................... 25,021 16,952 21,011
Annualized.............................................. 2,502 2,414 2,463
----------------------------------------------------------------------------------------------------------------
The cost analysis above is subject to a number of limitations, some
but not all of which have been identified by the Program. The
enrollment, administrative, and medical monitoring and treatment cost
estimates are based on historical cost experience from the first full
year of the WTC Health Program (FY 2012) to the end of FY 2015 and do
not anticipate the costs of WTC-related health conditions added to the
List in the future. The annual rate of increase takes into account the
growth of the Program's membership based on enrollment data from the
start of the Program to present and does not consider natural
population mortality and mortality due to the WTC-related health
conditions. The medical monitoring and treatment cost estimates are
based on a combination of linear regression analysis of aggregate
medical costs and adjustments for factors described above.
The Program has also identified some, but not all, limitations in
deriving the health benefits estimate. Some new Program members, if
they have not received treatment for a certified WTC-related health
condition prior to enrollment, may present in worse health and may
benefit less from medical treatment than members who received more
timely treatment in the Program. Furthermore, many Program members may
have more than one concurrent certified WTC-related health condition
for which they are receiving treatment in the Program, which can impact
the effectiveness of medical treatment for any given condition.
This rule does not interfere with State, local, or Tribal
governments in the exercise of their governmental functions.
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 proposed rule has ``no significant
economic impact upon a substantial number of small entities'' within
the meaning of the RFA.
C. Paperwork Reduction Act
The Paperwork Reduction Act, 44 U.S.C. 3501 et seq., requires an
agency to invite public comment on, and to obtain OMB approval of, any
regulation that requires 10 or more people to report information to the
agency or to keep certain records. This final action continues to
impose the same information collection requirements as under the July
2011, March 2013, and February 2014 IFRs, including the submission of
the following forms and other information listed in the table below.
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.
September 30, 2018). HHS has determined that substantive changes are
needed to the information collection already approved by OMB.
Accordingly, HHS has published a notice of the proposed changes to the
existing approved information collection and invites comment from the
public during the 60-day comment period. The 60-day notice, published
in the Federal Register on October 24, 2016, is open for comment
through December 23, 2016 (see 81 FR 73108); the 60-day notice will be
followed by a 30-day notice, after which the revised information
collection request will be finalized and approved by OMB. Revisions to
the approved information collection include the following:
Disenrollment Letter and Appeal Notification--
Eligibility: Of the over 70,000 Program members, we expect that
0.014 percent (10) will be subsequently disenrolled from the
Program. Of those, we expect that 30 percent (3) will appeal the
disenrollment decisions. We estimate that the appeal requests will
take no more than 0.5 hours per respondent. The annual burden
estimate is 1.5 hours.
Decertification Letter and Appeal Notification--Health
Condition: Of the projected 51,472 enrollees who have at least
[[Page 90937]]
one health condition certification, it is estimated that 0.02
percent (10) will be decertified, and 50 percent (5) of those will
appeal a decertification. We estimate that the appeal request will
take no more than 0.5 hours per respondent and providing additional
information and/or an oral statement will take no more than 1 hour
per respondent. The annual burden estimate is 7.5 hours.
Denial Letter and Appeal Notification--Health Condition
Certification: This information collection, including the submission
of appeal requests, is currently approved by OMB for 60 respondents
(0.5 hours per respondent) and is expanded by this final rule to
include the provision of new information and/or an oral statement.
We do not expect the OMB-approved estimated number of respondents to
change. We estimate that the additional burden will be no more than
1 hour per respondent. The total burden estimate (1.5 hours)
includes both 0.5 hours per respondent for the submission of an
appeal request (currently approved by OMB) as well as 1 hour per
respondent for new information and/or an oral statement. The annual
burden estimate is 90 hours.
Denial Letter and Appeal Notification--Treatment
Authorization: This information collection, including the submission
of appeal requests, is currently approved by OMB for 26 respondents
(0.5 hours per respondent) and is expanded by this final rule to
include the provision of new information and/or an oral statement.
We do not expect the OMB-approved estimated number of respondents to
change. We estimate that the additional burden will be no more than
1 hour per respondent. The total burden estimate (1.5 hours)
includes both 0.5 hours per respondent for the submission of an
appeal request (currently approved by OMB) as well as 1 hour per
respondent for new information and/or an oral statement. The annual
burden estimate is 39 hours.
Reimbursement Denial Letter and Appeal Notification--
Providers: Of the nearly 52,000 providers affiliated with the
Program, it is estimated that 1.15 percent (600) annually will
appeal a denial of reimbursement for treatment found to be not
medically necessary or in accordance with treatment protocols. We
estimate that the appeal request will take no more than 0.5 hours
per respondent to compile. The annual burden estimate is 300 hours.
Designated Representative HIPAA Authorization: The
Program also finds it necessary to add a new form to allow
applicants and Program members to grant permission to share
protected health information with an individual who has been
properly appointed the applicant's or member's designated
representative pursuant to 42 CFR 88.2. We estimate that 10
applicants and members will submit the Designated Representative
Health Insurance Portability and Accountability Act (HIPAA)
Authorization form annually. The form is expected to take no longer
than 0.25 hours to complete. The burden estimate for the HIPAA
Authorization form is 2.5 hours.
The Program estimates that the total annual paperwork burden
associated with this rulemaking, including the revised and new burden
hour estimates, is 14,178.95 hours.\24\
---------------------------------------------------------------------------
\24\ The burden estimates provided here are subject to change in
the final approved information collection revision request, pending
the collection and review of public comments.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of respondent Form name respondents responses per response (in hours
respondent hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
FDNY Responder................................. World Trade Center Health Program FDNY 45 1 0.5 22.5
Responder Eligibility Application.
General Responder.............................. World Trade Center Health Program 2,475 1 0.5 1,237.5
Responder Eligibility Application
(Other than FDNY).
Pentagon/Shanksville Responder................. World Trade Center Health Program 630 1 0.5 315
Pentagon/Shanksville Responder.
WTC Survivor................................... World Trade Center Health Program 1,350 1 0.5 675
Survivor Eligibility Application.
General Responder.............................. Postcard for new general responders in 2,475 1 0.25 618.75
NY/NJ to select a clinic.
Program Medical Provider....................... WTC-3 Request for Certification........ 20,000 1 0.5 10,000
Responder/Survivor............................. Denial Letter and Appeal Notification-- 45 1 0.5 22.5
Enrollment.
Responder/Survivor............................. Disenrollment Letter and Appeal 3 1 0.5 1.5
Notification--Eligibility.
Responder/Survivor............................. Decertification Letter and Appeal 5 1 1.5 7.5
Notification.
Responder/Survivor............................. Denial Letter and Appeal Notification-- 60 1 1.5 90
Health Condition Certification.
Responder/Survivor............................. Denial Letter and Appeal Notification-- 26 1 1.5 39
Treatment Authorization.
Responder/Survivor............................. WTC Health Program Medical Travel 10 1 0.17 1.7
Refund Request.
Responder/Survivor............................. Designated Representative form......... 10 1 0.25 2.5
Pharmacy....................................... Outpatient prescription pharmaceuticals 150 261 0.02 783
Program Medical Provider....................... Reimbursement Denial Letter and Appeal 600 1 0.5 300
Notification.
Responder/Survivor............................. Designated Representative HIPAA 10 1 0.25 2.5
Authorization.
Responder/Survivor/Advocate (physician)........ Petition for the addition of health 60 1 1 60
conditions.
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. .............. 14,178.95
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 90938]]
seq., directs agencies to assess the effects of Federal regulatory
actions on State, local, and Tribal governments, and the private sector
``other than to the extent that such regulations incorporate
requirements specifically set forth in law.'' For purposes of the
Unfunded Mandates Reform Act, this final rule does not include any
Federal mandate that may result in increased annual expenditures in
excess of $100 million by State, local, or Tribal governments in the
aggregate, or by the private sector.
F. Executive Order 12988 (Civil Justice)
This final rule has been drafted and reviewed in accordance with
Executive Order 12988, ``Civil Justice Reform,'' and will not unduly
burden the Federal court system. This rule has been reviewed carefully
to eliminate drafting errors and ambiguities.
G. Executive Order 13132 (Federalism)
The Administrator has reviewed this final rule in accordance with
Executive Order 13132 regarding Federalism, and has determined that it
does not have ``Federalism implications.'' The rule does not ``have
substantial direct effects on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.''
H. Executive Order 13045 (Protection of Children From Environmental
Health Risks and Safety Risks)
In accordance with Executive Order 13045, the Administrator has
evaluated the environmental health and safety effects of this final
rule on children. The Administrator has determined that the rule would
have no environmental health and safety effect on children.
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 final rule on energy supply, distribution
or use, and has determined that the rule will not have a significant
adverse effect.
J. Plain Writing Act of 2010
Under Public Law 111-274 (October 13, 2010), executive Departments
and Agencies are required to use plain language in documents that
explain to the public how to comply with a requirement the Federal
government administers or enforces. The Administrator has attempted to
use plain language in promulgating the final rule consistent with the
Federal Plain Writing Act guidelines and requests public comment on
this effort.
List of Subjects in 42 CFR Part 88
Aerodigestive disorders, Appeal procedures, Health care, Mental
health conditions, Musculoskeletal disorders, Respiratory and pulmonary
diseases.
Final rule
0
For the reasons discussed in the preamble, the Administrator revises 42
CFR part 88 to read as follows:
PART 88--WORLD TRADE CENTER HEALTH PROGRAM
Sec.
88.1 Definitions.
88.2 General provisions.
88.3 Eligibility--currently-identified responders.
88.4 Eligibility criteria--WTC responders.
88.5 Application process--WTC responders.
88.6 Enrollment decision--WTC responders.
88.7 Eligibility--currently-identified survivors.
88.8 Eligibility criteria--WTC survivors.
88.9 Application process--WTC survivors.
88.10 Enrollment decision--screening-eligible survivors.
88.11 Initial health evaluation for screening-eligible survivors.
88.12 Enrollment decision--certified-eligible survivors.
88.13 Disenrollment.
88.14 Appeal of enrollment or disenrollment decision.
88.15 List of WTC-Related Health Conditions.
88.16 Addition of health conditions to the List of WTC-Related
Health Conditions.
88.17 Physician's determination of WTC-related health conditions.
88.18 Certification.
88.19 Decertification.
88.20 Authorization of treatment.
88.21 Appeal of certification, decertification, or treatment
authorization decision.
88.22 Reimbursement for medical treatment and services.
88.23 Appeal of reimbursement denial.
88.24 Coordination of benefits and recoupment.
88.25 Reopening of WTC Health Program final decisions.
Authority: 42 U.S.C. 300mm to 300mm-61, Pub. L. 111-347, 124
Stat. 3623, as amended by Pub. L. 114-113, 129 Stat. 2242.
Sec. 88.1 Definitions.
Act means Title XXXIII of the Public Health Service Act, as
amended, 42 U.S.C. 300mm through 300mm-61 (codifying Title I of the
James Zadroga 9/11 Health and Compensation Act of 2010, Pub. L. 111-
347, as amended by Pub. L. 114-113), which created the World Trade
Center (WTC) Health Program.
Aggravating means a health condition that existed on September 11,
2001, and that, as a result of exposure to airborne toxins, any other
hazard, or any other adverse condition resulting from the September 11,
2001, terrorist attacks, requires medical treatment that is (or will
be) in addition to, more frequent than, or of longer duration than the
medical treatment that would have been required for such condition in
the absence of such exposure.
Certification means WTC Health Program review of a health condition
in a particular WTC Health Program member for the purpose of
identification and approval of a WTC-related health condition, as
defined in this section and included on the List of WTC-Related Health
Conditions in 42 CFR 88.15, or a health condition medically associated
with a WTC-related health condition.
Certified-eligible survivor means (1) an individual who has been
identified as eligible for medical monitoring and treatment as of
January 2, 2011; or (2) a screening-eligible survivor who is eligible
for follow-up monitoring and treatment pursuant to Sec. 88.12(b).
Clinical Center of Excellence (CCE) means a center or centers under
contract with the WTC Health Program. A CCE:
(1) Uses an integrated, centralized health care provider approach
to create a comprehensive suite of health services that are accessible
to enrolled WTC responders, screening-eligible survivors, or certified-
eligible survivors;
(2) Has experience in caring for WTC responders and screening-
eligible survivors, or includes health care providers who have received
WTC Health Program training;
(3) Employs health care provider staff with expertise that
includes, at a minimum, occupational medicine, environmental medicine,
trauma-related psychiatry and psychology, and social services
counseling; and
(4) Meets such other requirements as specified by the Administrator
of the WTC Health Program.
Data Center means a center or centers under contract with the WTC
Health Program to:
(1) Receive, analyze, and report to the Administrator of the WTC
Health Program on data that have been collected and reported to the
Data Center by the corresponding CCE(s);
(2) Develop monitoring, initial health evaluation, and treatment
protocols with respect to WTC-related health conditions;
(3) Coordinate the outreach activities of the corresponding CCE;
(4) Establish criteria for credentialing of medical providers
participating in the Nationwide Provider Network;
[[Page 90939]]
(5) Coordinate and administer the activities of the WTC Health
Program Steering Committees; and
(6) Meet periodically with the corresponding CCE(s) to obtain input
on the analysis and reporting of data and on development of monitoring,
initial health evaluation, and treatment protocols.
Designated representative means an individual selected by an
applicant, WTC responder, or a screening-eligible or certified-eligible
survivor to represent his or her interests to the WTC Health Program.
Ground Zero means a site in Lower Manhattan bounded by Vesey Street
to the north, the West Side Highway to the west, Liberty Street to the
south, and Church Street to the east in which stood the former World
Trade Center complex.
Health condition medically associated with a WTC-related health
condition means a condition that results from treatment of a WTC-
related health condition or results from progression of a WTC-related
health condition.
Initial health evaluation means assessment of one or more symptoms
that may be associated with a WTC-related health condition and includes
a medical and exposure history, a physical examination, and additional
medical testing as needed to evaluate whether the individual has a WTC-
related health condition and is eligible for treatment under the WTC
Health Program.
Interested party means a representative of any organization
representing WTC responders, a nationally recognized medical
association, a WTC Health Program CCE or Data Center, a State or
political subdivision, or any other interested person.
List of WTC-Related Health Conditions means those conditions
eligible for coverage in the WTC Health Program as identified in Sec.
88.15 of this part.
Medical emergency means a physical or mental health condition for
which immediate treatment is necessary.
Medically necessary treatment means the provision of services to a
WTC Health Program member by physicians and other health care
providers, including diagnostic and laboratory tests, prescription
drugs, inpatient and outpatient hospital services, and other care that
is appropriate, to manage, ameliorate, or cure a WTC-related health
condition or a health condition medically associated with a WTC-related
health condition, and which conforms to medical treatment protocols
developed by the Data Centers, with input from the CCEs, and approved
by the Administrator of the WTC Health Program.
Monitoring means periodic physical and mental health assessment of
a WTC responder or certified-eligible survivor in relation to exposure
to airborne toxins, any other hazard, or any other adverse condition
resulting from the September 11, 2001, terrorist attacks and which
includes a medical and exposure history, a physical examination and
additional medical testing as needed for surveillance or to evaluate
symptom(s) to determine whether the individual has a WTC-related health
condition.
Nationwide Provider Network (NPN) means a network of providers
throughout the United States under contract with the WTC Health Program
to provide an initial health evaluation, monitoring, and treatment to
enrolled WTC responders, screening-eligible survivors, or certified-
eligible survivors who live outside the New York metropolitan area.
New York City disaster area means an area within New York City that
is the area of Manhattan that is south of Houston Street and any block
in Brooklyn that is wholly or partially contained within a 1.5-mile
radius of the former World Trade Center complex.
New York metropolitan area means the combined statistical areas
comprising the Bridgeport-Stamford-Norwalk, CT Metropolitan Statistical
Area; Kingston, NY Metropolitan Statistical Area; New Haven-Milford, CT
Metropolitan Statistical Area; New York-Northern New Jersey-Long
Island, NY-NJ-PA Metropolitan Statistical Area; Poughkeepsie-Newburgh-
Middletown, NY Metropolitan Statistical Area; Torrington, CT
Micropolitan Statistical Area; Trenton-Ewing, NJ Metropolitan
Statistical Area, as defined in OMB Bulletin 10-02, December 1, 2009.
NIOSH means the National Institute for Occupational Safety and
Health, Centers for Disease Control and Prevention, U.S. Department of
Health and Human Services.
One (1) day means the length of a standard work shift, or at least
4 hours but less than 24 hours.
Pentagon site means any area of the land (consisting of
approximately 280 acres) and improvements thereon, located in
Arlington, Virginia, on which the Pentagon Office Building, Federal
Building Number 2, the Pentagon heating and sewage treatment plants,
and other related facilities are located, including various areas
designated for the parking of vehicles, vehicle access, and other areas
immediately adjacent to the land or improvements previously described
that were affected by the terrorist-related aircraft crash on September
11, 2001; and those areas at Fort Belvoir in Fairfax County, Virginia
and at the Dover Port Mortuary at Dover Air Force Base in Delaware
involved in the recovery, identification, and transportation of human
remains for the incident.
Police department means any law enforcement department or agency,
whether under Federal, state, or local jurisdiction, responsible for
general police duties, such as maintenance of public order, safety, or
health, enforcement of laws, or otherwise charged with prevention,
detection, investigation, or prosecution of crimes.
Scientific/Technical Advisory Committee means the WTC Health
Program Scientific/Technical Advisory Committee whose members are
appointed by the Administrator of the WTC Health Program to review
scientific and medical evidence and to make recommendations to the
Administrator on additional WTC Health Program eligibility criteria and
on additional WTC-related health conditions.
Screening-eligible survivor means an individual who is not a WTC
responder and who claims symptoms of a WTC-related health condition and
meets the eligibility criteria for a survivor specified in Sec.
[thinsp]88.8 of this part.
September 11, 2001, terrorist attacks means the terrorist attacks
that occurred on September 11, 2001, in New York City, at Shanksville,
Pennsylvania, and at the Pentagon, and includes the aftermath of such
attacks.
Shanksville, Pennsylvania site means the property in Stonycreek
Township, Somerset County, Pennsylvania, which is bounded by Route 30
(Lincoln Highway), State Route 1019 (Buckstown Road), and State Route
1007 (Lambertsville Road); and those areas at the Pennsylvania National
Guard Armory in Friedens, Pennsylvania involved in the recovery,
identification, and transportation of human remains for the incident.
Staten Island Landfill means the landfill in Staten Island, NY
called ``Fresh Kills.''
Terrorist watch list means the lists maintained by the Federal
government that will be utilized to screen for known terrorists.
WTC means World Trade Center.
WTC Health Program means the program established by Title XXXIII of
the Public Health Service Act as amended, 42 U.S.C. 300mm to 300mm-61
(codifying Title I of the James Zadroga 9/11 Health and Compensation
Act of 2010, Pub. L. 111-347, as amended by Pub. L. 114-113) to provide
[[Page 90940]]
medical monitoring and treatment benefits for eligible responders to
the September 11, 2001, terrorist attacks and initial health
evaluation, monitoring, and treatment benefits for residents and other
building occupants and area workers in New York City who were directly
impacted and adversely affected by such attacks.
WTC Health Program member means any responder, screening-eligible
survivor, or certified-eligible survivor enrolled in the WTC Health
Program.
WTC Program Administrator (Administrator of the WTC Health Program,
or Administrator) means, for the purposes of this part, the Director of
the National Institute for Occupational Safety and Health, Centers for
Disease Control and Prevention, Department of Health and Human
Services, or his or her designee.
WTC-related acute traumatic injury means a health condition
eligible for coverage in the WTC Health Program as described in Sec.
88.15(e)(1) of this part.
WTC-related health condition means an illness or health condition
for which exposure to airborne toxins, any other hazard, or any other
adverse condition resulting from the September 11, 2001, terrorist
attacks, based on an examination by a medical professional with
expertise in treating or diagnosing the health conditions in the List
of WTC-Related Health Conditions, is substantially likely to be a
significant factor in aggravating, contributing to, or causing the
illness or health condition, including a mental health condition. Only
those conditions on the List of WTC-Related Health Conditions codified
in 42 CFR 88.15 may be considered WTC-related health conditions.
WTC-related musculoskeletal disorder means a health condition
eligible for coverage in the WTC Health Program as described in Sec.
88.15(c)(1) of this part.
WTC responder means an individual who has been identified as
eligible for monitoring and treatment as described in Sec. 88.3 or who
meets the eligibility criteria in Sec. 88.4.
Sec. 88.2 General provisions.
(a) Designated representative. (1) An applicant or WTC Health
Program member may appoint one individual to represent his or her
interests under the WTC Health Program. The appointment must be made in
writing and consistent with all relevant Federal laws and regulations
in order for the designated representative to receive personal health
information.
(2) There may be only one designated representative at any time.
After one designated representative has been properly appointed, the
WTC Health Program will not recognize another individual as the
designated representative until the appointment of the previously
designated representative is withdrawn in a signed writing.
(3) A properly appointed designated representative who is
recognized by the WTC Health Program may make a request or give
direction to the WTC Health Program regarding the eligibility,
certification, or any other administrative issue pertaining to the
applicant or WTC Health Program member under the WTC Health Program,
including appeals. Any notice requirement contained in this part or in
the Act is fully satisfied if sent to the designated representative.
(4) An applicant or WTC Health Program member may authorize any
individual to represent him or her in regard to the WTC Health Program,
unless that individual's service as a representative would violate any
applicable provision of law (such as 18 U.S.C. 205 or 18 U.S.C. 208) or
is otherwise prohibited by WTC Health Program policies and procedures
or contract provisions.
(5) A Federal employee may act as a representative only on behalf
of the individuals specified in, and in the manner permitted by, 18
U.S.C. 203 and 18 U.S.C. 205.
(6) If an applicant or screening-eligible or certified-eligible
survivor is a minor, a parent or guardian may act on his or her behalf.
(7) If an applicant or WTC Health Program member is a mentally
incompetent adult, an individual authorized under state or other
applicable law to act on the applicant's or member's behalf may act as
his or her designated representative as described in this section.
(b) Transportation and travel expenses. The WTC Health Program may
provide for necessary and reasonable transportation and expenses
incident to the securing of medically necessary treatment through the
NPN, involving travel of more than 250 miles.
Sec. [thinsp]88.3 Eligibility--currently identified responders.
(a) Responders who were identified as eligible for monitoring and
treatment under the arrangements as in effect on January 2, 2011,
between NIOSH and the consortium administered by Mount Sinai School of
Medicine in New York City and the Fire Department, City of New York,
are enrolled in the WTC Health Program.
(1) No individual who is determined to be a positive match to the
terrorist watch list maintained by the Federal government will be
considered to be enrolled in the WTC Health Program.
(2) [Reserved]
(b) WTC responders identified as enrolled under this section are
not required to submit an application to the WTC Health Program.
Sec. 88.4 Eligibility criteria--WTC responders.
(a) Responders to the New York City disaster area who have not been
previously identified as eligible as provided for under Sec. 88.3 of
this part may apply for enrollment in the WTC Health Program on or
after July 1, 2011. Such individuals must meet the criteria in one of
the following categories to be considered eligible for enrollment:
(1) Firefighters and related personnel must meet the criteria
specified in paragraph (a)(1)(i) or (ii) of this section:
(i) The individual was an active or retired member of the Fire
Department, City of New York (whether firefighter or emergency
personnel), and participated at least 1 day in the rescue and recovery
effort at any of the former World Trade Center sites (including Ground
Zero, the Staten Island Landfill, or the New York City Chief Medical
Examiner's Office), during the period beginning on September 11, 2001,
and ending on July 31, 2002; or
(ii) The individual is:
(A) A surviving immediate family member of an individual who was an
active or retired member of the Fire Department, City of New York
(whether firefighter or emergency personnel), who was killed at Ground
Zero on September 11, 2001, and
(B) Received any treatment for a WTC-related mental health
condition on or before September 1, 2008.
(2) Law enforcement officers and WTC rescue, recovery, and cleanup
workers must meet the criteria specified in paragraph (a)(2)(i) or (ii)
of this section:
(i) The individual worked or volunteered onsite in rescue,
recovery, debris cleanup, or related support services in lower
Manhattan (south of Canal Street), the Staten Island Landfill, or the
barge loading piers, for at least:
(A) 4 hours during the period beginning on September 11, 2001, and
ending on September 14, 2001; or
(B) 24 hours during the period beginning on September 11, 2001, and
ending on September 30, 2001; or
(C) 80 hours during the period beginning on September 11, 2001, and
ending on July 31, 2002.
(ii) The individual was an active or retired member of the New York
City Police Department or an active or retired member of the Port
Authority Police of the Port Authority of New York and
[[Page 90941]]
New Jersey who participated onsite in rescue, recovery, debris cleanup,
or related support services, for at least:
(A) 4 hours during the period beginning September 11, 2001, and
ending on September 14, 2001, in lower Manhattan (south of Canal
Street), including Ground Zero, the Staten Island Landfill, or the
barge loading piers; or
(B) 1 day beginning on September 11, 2001, and ending on July 31,
2002, at Ground Zero, the Staten Island Landfill, or the barge loading
piers; or
(C) 24 hours during the period beginning on September 11, 2001, and
ending on September 30, 2001, in lower Manhattan (south of Canal
Street); or
(D) 80 hours during the period beginning on September 11, 2001, and
ending on July 31, 2002, in lower Manhattan (south of Canal Street).
(3) Office of the Chief Medical Examiner of New York City employee.
The individual was an employee of the Office of the Chief Medical
Examiner of New York City involved in the examination and handling of
human remains from the WTC attacks, or other morgue worker who
performed similar post-September 11 functions for such Office staff,
during the period beginning on September 11, 2001, and ending on July
31, 2002.
(4) Port Authority Trans-Hudson Corporation Tunnel worker. The
individual was a worker in the Port Authority Trans-Hudson Corporation
Tunnel for at least 24 hours during the period beginning on February 1,
2002, and ending on July 1, 2002.
(5) Vehicle-maintenance worker. The individual was a vehicle-
maintenance worker who was exposed to debris from the former World
Trade Center while retrieving, driving, cleaning, repairing, and
maintaining vehicles contaminated by airborne toxins from the September
11, 2001, terrorist attacks; and conducted such work for at least 1 day
during the period beginning on September 11, 2001, and ending on July
31, 2002.
(b) Responders to the Pentagon site of the September 11, 2001,
terrorist attacks, may apply for enrollment in the WTC Health Program
on or after April 29, 2013. Individuals must meet the criteria below to
be considered eligible for enrollment:
(1) The individual was an active or retired member of a fire or
police department (fire or emergency personnel), worked for a recovery
or cleanup contractor, or was a volunteer; and
(2) Performed rescue, recovery, demolition, debris cleanup, or
other related services at the Pentagon site of the September 11, 2001,
terrorist attacks, for at least 1 day beginning September 11, 2001, and
ending on November 19, 2001.
(c) Responders to the Shanksville, Pennsylvania site of the
September 11, 2001, terrorist attacks, may apply for enrollment in the
WTC Health Program on or after April 29, 2013. Individuals must meet
the criteria below to be considered eligible for enrollment:
(1) The individual was an active or retired member of a fire or
police department (fire or emergency personnel), worked for a recovery
or cleanup contractor, or was a volunteer; and
(2) Performed rescue, recovery, demolition, debris cleanup, or
other related services at the Shanksville, Pennsylvania site of the
September 11, 2001, terrorist attacks, for at least 1 day beginning
September 11, 2001, and ending on October 3, 2001.
(d) [Reserved]
(e) The WTC Health Program will maintain a list of WTC responders.
Sec. 88.5 Application process--WTC responders.
(a) An application to the WTC Health Program based on the criteria
in Sec. 88.4 must be submitted with documentation of the applicant's
employment affiliation (if relevant) and work activity during the
dates, times, and locations specified in Sec. 88.4
(1) Documentation may include but is not limited to a pay stub;
official personnel roster; a written statement, under penalty of
perjury by an employer; site credentials; or similar documentation.
(2) An applicant who is unable to submit the required documentation
must instead offer a written explanation of how he or she tried to
obtain proof of presence, residence, or work activity and why the
attempt was unsuccessful. The applicant must attest, under penalty of
perjury, that he or she meets the criteria specified in Sec. 88.4.
(b) The application and supporting documentation must be submitted
to the WTC Health Program for consideration.
(c) The WTC Health Program will notify the applicant in writing (or
by email if an email address is provided by the applicant) of any
deficiencies in the application or the supporting documentation.
Sec. 88.6 Enrollment decision--WTC responders.
(a) Enrollment priority. The WTC Health Program will prioritize
applications in the order in which they are received.
(b) Enrollment eligibility. The WTC Health Program will decide if
the applicant meets the eligibility criteria provided in Sec. 88.4.
(c) Denial of enrollment. (1) The WTC Health Program will deny
enrollment if the applicant fails to meet the applicable eligibility
requirements.
(2) The WTC Health Program may deny enrollment of a responder who
is otherwise eligible and qualified if the Act's numerical limitations
for newly enrolled responders have been met.
(i) No more than 25,000 WTC responders, other than those enrolled
pursuant to Sec. Sec. 88.3 and 88.4(a)(1)(ii), may be enrolled at any
time. The Administrator of the WTC Health Program may decide, based on
the best available evidence, that sufficient funds are available under
the WTC Health Program Fund to provide treatment and monitoring only
for individuals who are already enrolled as WTC responders at that
time.
(ii) [Reserved]
(3) No individual who is determined to be a positive match to the
terrorist watch list maintained by the Federal government may qualify
to be enrolled or be determined to be eligible for the WTC Health
Program.
(d) Notification of enrollment decision. (1) The WTC Health Program
will decide if the applicant meets the current eligibility criteria for
WTC responders in Sec. 88.4 and is qualified, and notify the applicant
of the enrollment decision in writing within 60 calendar days of the
date of receipt of the application. The 60-day time period will not
include any days during which the applicant is correcting deficiencies
in the application or supporting documentation.
(2) If the WTC Health Program decides that an applicant is denied
enrollment, the written notification will include an explanation, as
appropriate, for the decision to deny enrollment and inform the
applicant of the right to appeal the initial denial of eligibility and
provide instructions on how to file an appeal.
Sec. [thinsp]88.7 Eligibility--currently identified survivors.
(a) Survivors who have been identified as eligible for medical
treatment and monitoring as of January 2, 2011, are considered
certified-eligible in the WTC Health Program.
(1) No individual who is determined to be a positive match to the
terrorist watch list maintained by the Federal government will be
considered to be a certified-eligible survivor in the WTC Health
Program.
(2) [Reserved]
(b) Survivors identified as certified-eligible under this section
are not
[[Page 90942]]
required to submit an application to the WTC Health Program.
Sec. 88.8 Eligibility criteria--WTC survivors.
(a) Criteria for status as a screening-eligible survivor. An
individual who is not a WTC responder, claims symptoms of a WTC-related
health condition, and who has not been previously identified as
eligible under Sec. 88.7 may apply to the WTC Health Program on or
after July 1, 2011, for a determination of eligibility for an initial
health evaluation.
(1) The WTC Health Program will determine an applicant's
eligibility for an initial health evaluation based on one of the
following criteria:
(i) The screening applicant was present in the dust or dust cloud
in the New York City disaster area on September 11, 2001.
(ii) The screening applicant worked, resided, or attended school,
childcare, or adult daycare in the New York City disaster area, for at
least:
(A) 4 days during the period beginning on September 11, 2001, and
ending on January 10, 2002; or
(B) 30 days during the period beginning on September 11, 2001, and
ending on July 31, 2002.
(iii) The screening applicant worked as a cleanup worker or
performed maintenance work in the New York City disaster area during
the period beginning on September 11, 2001, and ending on January 10,
2002, and had extensive exposure to WTC dust as a result of such work.
(iv) The screening applicant:
(A) Was deemed eligible to receive a grant from the Lower Manhattan
Development Corporation Residential Grant Program;
(B) Possessed a lease for a residence or purchased a residence in
the New York City disaster area; and
(C) Resided in such residence during the period beginning on
September 11, 2001, and ending on May 31, 2003.
(v) The screening applicant is an individual whose place of
employment--
(A) At any time during the period beginning on September 11, 2001,
and ending on May 31, 2003, was in the New York City disaster area; and
(B) Was deemed eligible to receive a grant from the Lower Manhattan
Development Corporation WTC Small Firms Attraction and Retention Act
program or other government incentive program designed to revitalize
the lower Manhattan economy after the September 11, 2001, terrorist
attacks.
(2) [Reserved]
(b) Criteria for status as a certified-eligible survivor. Survivors
who have been determined to have screening-eligible status under Sec.
88.10(a), may seek status as a certified-eligible survivor. Status as a
certified-eligible survivor is based on a certification by the WTC
Health Program that, pursuant to an initial health evaluation, the
screening-eligible survivor has a WTC-related health condition and is
eligible for follow-up monitoring and treatment.
(c) The WTC Health Program will maintain a list of screening-
eligible and certified-eligible survivors.
Sec. 88.9 Application process--WTC survivors.
(a) Application for status as a screening-eligible survivor. An
application to the WTC Health Program based on the criteria in Sec.
88.8(a) must be submitted with documentation of the applicant's
location, presence or residence, and/or work activity during the
relevant time period.
(1) Documentation may include but is not limited to: Proof of
residence, such as a lease or utility bill; attendance roster at a
school or daycare; or pay stub, other employment documentation, or
written statement, under penalty of perjury, by an employer indicating
employment location during the relevant time period; or similar
documentation. The applicant must also attest to symptoms of a WTC-
related health condition.
(2) An applicant who is unable to submit the required documentation
must instead offer a written explanation of how he or she tried to
obtain proof of location, presence, or residence, and/or work activity
and why the attempt was unsuccessful. The applicant must attest, under
penalty of perjury, that he or she meets the criteria specified in
Sec. 88.8.
(3) The applicant will be notified of any deficiencies in the
application or the supporting documentation.
(b) Status as a certified-eligible survivor. No additional
application is required for status as a certified-eligible survivor.
If, based upon the screening-eligible survivor's initial health
evaluation (see Sec. 88.11), the WTC Health Program certifies the
diagnosis of a WTC-related health condition, then the survivor will
automatically receive the status of a certified-eligible survivor.
Sec. 88.10 Enrollment decision--screening-eligible survivors.
(a) The WTC Health Program will decide if the applicant meets the
screening-eligible survivor criteria pursuant to Sec. 88.8(a) and is
qualified, and notify the applicant of the enrollment decision in
writing within 60 calendar days of the date of receipt of the
application. The 60-day time period will not include any days during
which the applicant is correcting deficiencies in the application or
supporting documentation.
(b) If the WTC Health Program decides that an applicant is denied
enrollment, the written notification will include an explanation for
the decision to deny enrollment and inform the applicant of the right
to appeal the enrollment denial and provide instructions on how to file
an appeal.
(1) The WTC Health Program may deny screening-eligible survivor
status if the applicant is ineligible under the criteria specified in
Sec. 88.8(a).
(2) The WTC Health Program may deny screening-eligible survivor
status if the numerical limitation on certified-eligible survivors in
Sec. 88.12(b)(3)(i) has been met.
(3) No individual who is determined to be a positive match to the
terrorist watch list maintained by the Federal government may qualify
to be a screening-eligible survivor in the WTC Health Program.
Sec. 88.11 Initial health evaluation for screening-eligible
survivors.
(a) A CCE or an NPN-affiliated physician will provide the
screening-eligible survivor an initial health evaluation to determine
if the individual has a WTC-related health condition.
(b) The WTC Health Program will provide only one initial health
evaluation per screening-eligible survivor. The individual may request
additional health evaluations at his or her own expense.
(c) If the physician determines that the screening-eligible
survivor has a WTC-related health condition, the physician will
promptly transmit to the WTC Health Program his or her determination,
consistent with the requirements of Sec. 88.17(a).
Sec. 88.12 Enrollment decision--certified-eligible survivors.
(a) The WTC Health Program will prioritize certification requests
in the order in which they are received.
(b) The WTC Health Program will review the physician's
determination, render a decision regarding certification of the
individual's WTC-related health condition, and notify the individual of
the decision and the reason for the decision in writing, pursuant to
Sec. Sec. 88.17 and 88.18.
(1) If the individual is a screening-eligible survivor and the
individual's condition is certified as a WTC-related health condition,
the individual will automatically receive the status of a certified-
eligible survivor.
[[Page 90943]]
(2) If a screening-eligible survivor's condition is not certified
as a WTC-related health condition pursuant to Sec. Sec. 88.17 and
88.18, the WTC Health Program will deny certified-eligible status. The
screening-eligible survivor may appeal the decision to deny
certification, as provided under Sec. 88.21.
(3) The WTC Health Program may deny certified-eligible survivor
status of an otherwise eligible and qualified screening-eligible
survivor if the Act's numerical limitations for certified-eligible
survivors have been met.
(i) No more than 25,000 individuals, other than those described in
Sec. 88.7, may be determined to be certified-eligible survivors at any
time. The Administrator of the WTC Health Program may decide, based on
the best available evidence, that sufficient funds are available under
the WTC Health Program Fund to provide treatment and monitoring only
for individuals who have already been certified as certified-eligible
survivors at that time.
(ii) [Reserved]
(4) No individual who is determined to be a positive match to the
terrorist watch list maintained by the Federal government may qualify
to be a certified-eligible survivor in the WTC Health Program.
Sec. 88.13 Disenrollment.
(a) The disenrollment of a WTC Health Program member may be
initiated by the WTC Health Program in the following circumstances:
(1) The WTC Health Program mistakenly enrolled an individual under
Sec. 88.4 (WTC responders) or Sec. 88.8 (screening-eligible
survivors) who did not provide sufficient proof of eligibility
consistent with the required eligibility criteria; or
(2) The WTC Health Program member's enrollment was based on
incorrect or fraudulent information.
(b) The disenrollment of a WTC Health Program member may be
initiated by the enrollee for any reason.
(c) A disenrolled WTC Health Program member will be notified in
writing by the WTC Health Program of a disenrollment decision, provided
an explanation, as appropriate, for the decision, and provided
information on how to appeal the decision. A disenrolled WTC Health
Program member disenrolled pursuant to paragraph (a) may appeal the
disenrollment decision in accordance with Sec. 88.14.
(d) A disenrolled WTC Health Program member who has been
disenrolled in accordance with paragraphs (a) or (b) of this section
may seek to re-enroll in the WTC Health Program using the application
and enrollment procedures, provided that the application is supported
by new information.
Sec. 88.14 Appeal of enrollment or disenrollment decision.
(a) Right to appeal. An applicant denied WTC Health Program
enrollment, a disenrolled WTC Health Program member, or the applicant's
or member's designated representative (appointed pursuant to Sec.
88.2(a)) may appeal the enrollment denial or disenrollment decision.
(b) Appeal request. (1) A letter requesting an appeal must be
postmarked within 120 calendar days of the date of the letter from the
Administrator notifying the denied applicant or disenrolled WTC Health
Program member of the adverse decision. Electronic versions of a signed
letter will be accepted if transmitted within 120 calendar days of the
date of the Administrator's notification letter.
(2) A valid request for an appeal must:
(i) Be made in writing and signed;
(ii) Identify the denied applicant or disenrolled WTC Health
Program member and designated representative (if applicable);
(iii) Describe the decision being appealed and state the reasons
why the denied applicant, disenrolled WTC Health Program member, or
designated representative believes the enrollment denial or
disenrollment was incorrect and should be reversed. The appeal request
may include relevant new information not previously considered by the
WTC Health Program; and
(iv) Be sent to the WTC Health Program at the address specified in
the notice of denial or disenrollment.
(3) Where the denial or disenrollment is based on information from
the terrorist watch list, the appeal will be forwarded to the
appropriate Federal agency.
(c) Appeal process. Upon receipt of a valid appeal, the
Administrator will appoint a Federal Official independent of the WTC
Health Program to review the case. The Federal Official will review all
available records relevant to the WTC Health Program's decision not to
enroll the applicant or to disenroll the WTC Health Program member and
assess whether the appeal should be granted. In conducting the review,
the Federal Official's consideration will include the following:
Whether the WTC Health Program substantially complied with all relevant
WTC Health Program policies and procedures; whether the information
supporting the WTC Health Program's decision was factually accurate;
and whether the WTC Health Program's decision was reasonable as applied
to the facts of the case.
(1) The Federal Official may consider additional relevant new
information submitted by the denied applicant, disenrolled WTC Health
Program member, or designated representative.
(2) The Federal Official will provide his or her recommendation
regarding the disposition of the appeal, including his or her findings
and any supporting materials, to the Administrator.
(d) Final decision and notification. The Administrator will review
the Federal Official's recommendation and any relevant information and
make a final decision on the appeal. The Administrator will notify the
denied applicant or disenrolled WTC Health Program member and/or
designated representative of the following in writing:
(1) The recommendation and findings made by the Federal Official as
a result of the review;
(2) The Administrator's final decision on the appeal;
(3) An explanation of the reason(s) for the Administrator's final
decision on the appeal; and
(4) Any administrative actions taken by the WTC Health Program in
response to the Administrator's final decision.
Sec. 88.15 List of WTC-Related Health Conditions.
WTC-related health conditions include the following disorders and
conditions:
(a) Aerodigestive disorders:
(1) Interstitial lung diseases.
(2) Chronic respiratory disorder--fumes/vapors.
(3) Asthma.
(4) Reactive airways dysfunction syndrome (RADS).
(5) WTC-exacerbated and new-onset chronic obstructive pulmonary
disease (COPD).
(6) Chronic cough syndrome.
(7) Upper airway hyperreactivity.
(8) Chronic rhinosinusitis.
(9) Chronic nasopharyngitis.
(10) Chronic laryngitis.
(11) Gastroesophageal reflux disorder (GERD).
(12) Sleep apnea exacerbated by or related to a condition described
in preceding paragraphs (a)(1) through (11) of this section.
(b) Mental health conditions:
(1) Posttraumatic stress disorder (PTSD).
(2) Major depressive disorder.
(3) Panic disorder.
(4) Generalized anxiety disorder.
(5) Anxiety disorder (not otherwise specified).
[[Page 90944]]
(6) Depression (not otherwise specified).
(7) Acute stress disorder.
(8) Dysthymic disorder.
(9) Adjustment disorder.
(10) Substance abuse.
(c) Musculoskeletal disorders:
(1) WTC-related musculoskeletal disorder is a chronic or recurrent
disorder of the musculoskeletal system caused by heavy lifting or
repetitive strain on the joints or musculoskeletal system occurring
during rescue or recovery efforts in the New York City disaster area in
the aftermath of the September 11, 2001, terrorist attacks. For a WTC
responder who received any treatment for a WTC-related musculoskeletal
disorder on or before September 11, 2003, such a health condition
includes:
(i) Low back pain.
(ii) Carpal tunnel syndrome (CTS).
(iii) Other musculoskeletal disorders.
(2) [Reserved].
(d) Cancers:
(1) Malignant neoplasms of the lip; tongue; salivary gland; floor
of mouth; gum and other mouth; tonsil; oropharynx; hypopharynx; and
other oral cavity and pharynx.
(2) Malignant neoplasm of the nasopharynx.
(3) Malignant neoplasms of the nose; nasal cavity; middle ear; and
accessory sinuses.
(4) Malignant neoplasm of the larynx.
(5) Malignant neoplasm of the esophagus.
(6) Malignant neoplasm of the stomach.
(7) Malignant neoplasms of the colon and rectum.
(8) Malignant neoplasms of the liver and intrahepatic bile duct.
(9) Malignant neoplasms of the retroperitoneum and peritoneum;
omentum; and mesentery.
(10) Malignant neoplasms of the trachea; bronchus and lung; heart,
mediastinum and pleura; and other ill-defined sites in the respiratory
system and intrathoracic organs.
(11) Mesothelioma.
(12) Malignant neoplasms of the peripheral nerves and autonomic
nervous system; and other connective and soft tissue.
(13) Malignant neoplasms of the skin (melanoma and non-melanoma),
including scrotal cancer.
(14) Malignant neoplasm of the female breast.
(15) Malignant neoplasm of the ovary.
(16) Malignant neoplasm of the prostate.
(17) Malignant neoplasm of the urinary bladder.
(18) Malignant neoplasm of the kidney.
(19) Malignant neoplasms of the renal pelvis; ureter; and other
urinary organs.
(20) Malignant neoplasms of the eye and orbit.
(21) Malignant neoplasm of the thyroid.
(22) Malignant neoplasms of the blood and lymphoid tissues
(including, but not limited to, lymphoma, leukemia, and myeloma).
(23) Childhood cancers: any type of cancer diagnosed in a person
less than 20 years of age.
(24) Rare cancers: any type of cancer \1\ that occurs in less than
15 cases per 100,000 persons per year in the United States.
---------------------------------------------------------------------------
\1\ Based on 2005-2009 average annual data age-adjusted to the
2000 U.S. population. See Glenn Copeland, Andrew Lake, Rick Firth,
et al. (eds), 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., June 2012.
---------------------------------------------------------------------------
(e) Acute traumatic injuries:
(1) WTC-related acute traumatic injury is physical damage to the
body caused by and occurring immediately after a one-time exposure to
energy, such as heat, electricity, or impact from a crash or fall,
resulting from a specific event or incident. For a WTC responder or
screening-eligible or certified-eligible survivors who received any
medical treatment for a WTC-related acute traumatic injury on or before
September 11, 2003, such a health condition includes:
(i) Eye injury.
(ii) Burn.
(iii) Head trauma.
(iv) Fracture.
(v) Tendon tear.
(vi) Complex sprain.
(vii) Other similar acute traumatic injuries.
(2) [Reserved]
Sec. 88.16 Addition of health conditions to the List of WTC-Related
Health Conditions.
(a) Any interested party may submit a request to the Administrator
of the WTC Health Program to add a condition to the List of WTC-Related
Health Conditions in Sec. 88.15. The Administrator will evaluate the
submission to decide whether it is a valid petition.
(1) Each valid petition must include the following:
(i) An explicit statement of an intent to petition the
Administrator to add a health condition to the List of WTC-Related
Health Conditions;
(ii) Name, contact information, and signature of the interested
party petitioning for the addition;
(iii) Name and/or description of the condition(s) to be added;
(iv) Reasons for adding the condition(s), including the medical
basis for the association between the September 11, 2001, terrorist
attacks and the condition(s) to be added.
(2) Not later than 90 calendar days after the receipt of a valid
petition, the Administrator will take one of the following actions:
(i) Request a recommendation of the WTC Health Program Scientific/
Technical Advisory Committee;
(ii) Publish in the Federal Register a proposed rule to add such
health condition;
(iii) Publish in the Federal Register the Administrator's decision
not to publish a proposed rule and the basis for that decision; or
(iv) Publish in the Federal Register a decision that insufficient
evidence exists to take action under paragraph (a)(2)(i) through (iii)
of this section.
(3) The 90-day time period will not include any days during which
the Administrator is consulting with the interested party to clarify
the submission.
(4) The Administrator may consider more than one petition
simultaneously when the petitions propose the addition of the same
health condition. Scientific/Technical Advisory Committee
recommendations and Federal Register notices initiated by the
Administrator pursuant to paragraph (a)(2) of this section may respond
to more than one petition.
(5) The Administrator will be required to consider a submission for
a health condition previously reviewed by the Administrator and found
not to qualify for addition to the List of WTC-Related Health
Conditions as a valid new petition only if the submission presents a
new medical basis (i.e., a basis not previously reviewed) for the
association between the September 11, 2001, terrorist attacks and the
condition to be added. A submission that provides no new medical basis
and is received after the publication of a response in the Federal
Register to a petition requesting the addition of the same health
condition will not be considered a valid petition and will not be
answered in a Federal Register notice pursuant to paragraph (a)(2),
above. The interested party will be informed of the WTC Health
Program's decision in writing.
(b) The Administrator may propose to add a condition to the List of
WTC-Related Health Conditions in Sec. 88.15 of this part by publishing
a proposed rule in the Federal Register and providing interested
parties a period of 30 calendar days to submit written comments. The
Administrator may
[[Page 90945]]
extend the comment period for good cause.
(1) If the Administrator requests a recommendation from the WTC
Health Program Scientific/Technical Advisory Committee, the Advisory
Committee will submit its recommendation to the Administrator no later
than 90 calendar days after the date of the transmission of the request
or no later than a date specified by the Administrator (but not more
than 180 calendar days after the request). The Administrator will
publish a proposed rule or a decision not to publish a proposed rule in
the Federal Register no later than 90 calendar days after the date of
transmission of the Advisory Committee recommendation.
(2) Before issuing a final rule to add a health condition to the
List of WTC-Related Health Conditions, the Administrator will provide
for an independent peer review of the scientific and technical evidence
that would be the basis for issuing such final rule.
Sec. 88.17 Physician's determination of WTC-related health
conditions.
(a) A physician affiliated with either a CCE or NPN will promptly
transmit to the WTC Health Program a determination that a member's
exposure to airborne toxins, any other hazard, or any other adverse
condition resulting from the September 11, 2001, terrorist attacks is
substantially likely to be a significant factor in aggravating,
contributing to, or causing the illness or health condition, including
a mental health condition. The transmission will also include the basis
for such determination. The physician's determination will be made
based on an assessment of the following:
(1) The individual's exposure to airborne toxins, any other hazard,
or any other adverse condition resulting from the September 11, 2001,
terrorist attacks.
(2) The type of symptoms experienced by the individual and the
temporal sequence of those symptoms.
(b) For a health condition medically associated with a WTC-related
health condition, the physician's determination must contain
information establishing how the health condition has resulted from
treatment of a previously certified WTC-related health condition or how
it has resulted from progression of the certified WTC-related health
condition.
Sec. 88.18 Certification.
(a) WTC-related health condition. The WTC Health Program will
review each physician determination and render a decision regarding
certification of the condition as a WTC-related health condition. The
WTC Health Program will notify the WTC Health Program member of the
decision and the reason for the decision in writing.
(b) Health condition medically associated with a WTC-related health
condition. The WTC Health Program will review each physician
determination and render a decision regarding certification of the
condition as a health condition medically associated with a WTC-related
health condition. The WTC Health Program will notify the WTC Health
Program member in writing of the decision and the reason for the
decision within 60 calendar days after the date the physician's
determination is received.
(1) In the course of review, the WTC Health Program may seek a
recommendation about certification from a physician panel with
appropriate expertise for the condition.
(2) [Reserved]
(c) Appeal right. If certification of a condition as a WTC-related
health condition or a health condition medically associated with a WTC-
related health condition is denied, the WTC Health Program member may
appeal the WTC Health Program's decision to deny certification, as
provided under Sec. 88.21.
Sec. 88.19 Decertification.
(a) The decertification of a WTC Health Program member's certified
WTC-related health condition or health condition medically associated
with a WTC-related health condition may be initiated by the WTC Health
Program in the following circumstances:
(1) The WTC Health Program finds that the member's exposure is
inadequate or is otherwise not covered;
(2) The WTC Health Program finds that the member's certified WTC-
related health condition was certified in error or erroneously
considered to have been aggravated, contributed to, or caused by
exposure to airborne toxins, any other hazard, or any other adverse
condition resulting from the September 11, 2001, terrorist attacks,
pursuant to Sec. 88.17(a); or
(3) The WTC Health Program finds that the member's health condition
was erroneously determined to be medically associated with a WTC-
related health condition, pursuant to Sec. 88.17(b).
(b) A WTC Health Program member will be notified in writing by the
WTC Health Program of a decertification decision, provided an
explanation, as appropriate, for the decision, and provided information
on how to appeal the decision. A WTC Health Program member whose WTC-
related health condition or health condition medically associated with
a WTC-related health condition is decertified may appeal the
decertification decision in accordance with Sec. 88.21 of this part.
Sec. 88.20 Authorization of treatment.
(a) Generally. Medically necessary treatment of certified WTC-
related health conditions and certified health conditions medically
associated with WTC-related health conditions will be provided through
the CCEs or the NPN as permitted under WTC Health Program treatment
protocols and in accordance with all applicable WTC Health Program
policies and procedures.
(b) Standard for determining medical necessity. All treatment
provided under the WTC Health Program will adhere to a standard which
is reasonable and appropriate; based on scientific evidence,
professional standards of care, expert opinion or any other relevant
information; and which has been included in the medical treatment
protocols developed by the Data Centers, with input from the CCEs, and
approved by the Administrator of the WTC Health Program.
(c) Treatment pending certification. While certification of a
condition is pending, authorization for treatment of a WTC-related
health condition or a health condition medically associated with a WTC-
related health condition must be obtained from the WTC Health Program
before treatment is provided, except for the provision of treatment for
a medical emergency.
Sec. 88.21 Appeal of certification, decertification, or treatment
authorization decision.
(a) Right to appeal. A WTC Health Program member or the member's
designated representative (appointed pursuant to Sec. 88.2(a)) may
appeal the following four types of decisions made by the WTC Health
Program:
(1) To deny certification of a health condition as a WTC-related
health condition;
(2) To deny certification of a health condition as medically
associated with a WTC-related health condition;
(3) To decertify a WTC-related health condition or a health
condition medically associated with a WTC-related health condition; or
(4) To deny authorization of treatment for a certified health
condition based on a finding that the treatment is not medically
necessary.
(b) Appeal request. (1) A letter requesting an appeal must be
postmarked within 120 calendar days of the date of the letter from the
[[Page 90946]]
Administrator of the WTC Health Program notifying the member of the
adverse decision. Electronic versions of a signed letter will be
accepted if transmitted within 120 calendar days of the date of the
Administrator's notification letter.
(2) A valid request for an appeal must:
(i) Be made in writing and signed;
(ii) Identify the member and designated representative (if
applicable);
(iii) Describe the decision being appealed and the reason(s) why
the member or designated representative believes the decision is
incorrect and should be reversed. The description may include, but is
not limited to, the following: Scientific or medical information
correcting factual errors that may have been submitted to the WTC
Health Program by the CCE or NPN; information demonstrating that the
WTC Health Program did not correctly follow or apply relevant WTC
Health Program policies or procedures; or any information demonstrating
that the WTC Health Program's decision was not reasonable given the
facts of the case. The basis provided in the appeal request must be
sufficiently detailed and supported by information to permit a review
of the appeal. Any new information not previously considered by the WTC
Health Program must be included with the appeal request, unless later
requested by the WTC Health Program; and
(iv) Be sent to the WTC Health Program at the address specified in
the notice of denial.
(3) The appeal request may also state an intent to make a 15-minute
oral statement by telephone. The WTC Health Program member or
designated representative will have a second opportunity to schedule an
oral statement after being contacted by the WTC Health Program
regarding the appeal.
(c) Appeal process. Upon receipt of a valid appeal, the
Administrator will appoint a Federal Official independent of the WTC
Health Program to review the case. The Federal Official will review all
available records relevant to the WTC Health Program's decision to deny
certification of a health condition as a WTC-related health condition,
deny certification of a health condition as medically associated with a
WTC-related health condition, decertify the WTC-related health
condition or health condition medically associated with a WTC-related
health condition, or deny treatment authorization, and assess whether
the appeal should be granted. The Federal Official's consideration will
include the following: Whether the WTC Health Program substantially
complied with all relevant WTC Health Program policies and procedures;
whether the information supporting the WTC Health Program's decision
was factually accurate; and whether the WTC Health Program's decision
was reasonable as applied to the facts of the case.
(1) In conducting his or her review, the Federal Official will
review the case record, including any oral statement made by the WTC
Health Program member or the member's designated representative, as
well as additional relevant new information submitted with the appeal
request or provided by the WTC Health Program member or the member's
designated representative at the request of the WTC Health Program.
(2) The Federal Official may consult one or more qualified experts
to review the WTC Health Program's decision and any additional
information provided by the WTC Health Program member or the member's
designated representative. The expert reviewer(s) will submit their
findings to the Federal Official.
(3) The Federal Official will provide his or her recommendation
regarding the disposition of the appeal, including his or her findings
and any supporting materials (including the transcript of any oral
statement and any expert reviewers' findings), to the Administrator.
(d) Final decision and notification. The Administrator will review
the Federal Official's recommendation and any relevant information and
make a final decision on the appeal. The Administrator will notify the
WTC Health Program member and/or the member's designated representative
of the following in writing:
(1) The recommendation and findings made by the Federal Official as
a result of the review;
(2) The Administrator's final decision on the appeal;
(3) An explanation of the reason(s) for the Administrator's final
decision on the appeal; and
(4) Any administrative actions taken by the WTC Health Program in
response to the Administrator's final decision.
Sec. 88.22 Reimbursement for medical treatment and services.
(a) Review of claims. Each claim for reimbursement for treatment
will be reviewed by the WTC Health Program. Claims that cannot be
validated by that process will be further assessed by the Administrator
of the WTC Health Program.
(b) Initial health evaluations, medical monitoring, and medically
necessary treatment. (1) The costs incurred by a CCE or NPN-affiliated
provider for providing a WTC Health Program member an initial health
evaluation, medical monitoring, and/or medically necessary treatment or
services for a WTC-related health condition or a health condition
medically associated with a WTC-related health condition will be
reimbursed according to the payment rates that apply to the provision
of such treatment and services under the Federal Employees Compensation
Act (FECA), 5 U.S.C. 8101 et seq., 20 CFR part 10.
(i) The Administrator will reimburse a CCE or NPN-affiliated
provider for treatment for which FECA rates have not been established
pursuant to the applicable Medicare fee for service rate, as determined
appropriate by the Administrator.
(ii) The Administrator will reimburse a CCE or NPN-affiliated
provider for treatment for which neither FECA nor Medicare fee for
service rates have been established, at rates as determined appropriate
by the Administrator.
(2) If the treatment is determined not to be medically necessary or
is inconsistent with WTC Health Program protocols, the Administrator
will withhold reimbursement.
(c) Outpatient prescription pharmaceuticals. Payment for costs of
medically necessary outpatient prescription pharmaceuticals for a WTC-
related health condition or health condition medically associated with
a WTC-related health condition will be reimbursed by the WTC Health
Program under a contract with one or more pharmaceutical benefit
management services.
Sec. 88.23 Appeal of reimbursement denial.
After exhausting procedural and/or contractual administrative
remedies, a CCE or NPN medical director or affiliated provider may
submit a written appeal of a WTC Health Program decision to withhold
reimbursement or payment for treatment found to be not medically
necessary or not in accordance with approved WTC Health Program medical
treatment protocols pursuant to Sec. 88.20 of this part. Appeal
procedures are published on the WTC Health Program Web site.
Sec. 88.24 Coordination of benefits and recoupment.
The WTC Health Program will attempt to recover the cost of payment
for treatment, including pharmacy benefits, for a WTC Health Program
member's certified WTC-related health condition or health condition
medically associated with a WTC-related health condition by
coordinating benefits with any workers' compensation insurance
[[Page 90947]]
available \2\ for members' work-related health conditions, and with any
public or private health insurance available \3\ for members' non-work-
related health conditions.
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\2\ As described in PHS Act, sec. 3331(b). To the extent that
payment for treatment of the member's work-related condition has
been made, or can reasonably be expected to be made, under any other
work-related injury or illness benefit plan of the member's
employer, the WTC Health Program will also attempt to recover the
costs associated with treatment, including pharmacy benefits, for
the member's certified WTC-related health condition or health
condition medically associated with a WTC-related health condition.
See PHS Act, sec. 3331(b)(1). For purposes of this regulation,
``workers' compensation law or plan'' or ``workers' compensation
insurance'' includes any other work-related injury or illness
benefit plan of the WTC Health Program member's employer.
\3\ As described in PHS Act, sec. 3331(c).
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(a) Where a WTC Health Program member's WTC-related health
condition or health condition medically associated with a WTC-related
health condition is eligible for workers' compensation or another
illness or injury benefit plan to which New York City is obligated to
pay, the WTC Health Program is the primary payer.
(b) Where a WTC Health Program member has filed a workers'
compensation claim for a WTC-related health condition or health
condition medically associated with a WTC-related health condition and
the claim is pending, the WTC Health Program is the primary payer;
however, if the claim is ultimately accepted by the workers'
compensation board, the workers' compensation insurer in question is
responsible for reimbursing the WTC Health Program for any treatment
provided and/or paid for during the pendency of the claim.
(c) Where a WTC Health Program member has filed a workers'
compensation claim for a WTC-related health condition or health
condition medically associated with a WTC-related health condition, but
a final decision is issued denying the compensation for the claim, the
WTC Health Program is the primary payer.
(d) Where a WTC Health Program member has filed a workers'
compensation claim for a WTC-related health condition or health
condition medically associated with a WTC-related health condition with
a workers' compensation plan to which New York City is not obligated to
pay, the workers' compensation insurer is the primary payer. The WTC
Health Program is the secondary payer.
(1) If a WTC Health Program member settles a workers' compensation
claim by entering into a settlement agreement that releases the
employer or insurance carrier from paying for future medical care, the
settlement must protect the interests of the WTC Health Program. This
may include setting aside adequate funds to pay for future medical
expenses, as required by the WTC Health Program, which would otherwise
have been paid by workers' compensation. In such situations, the WTC
Health Program may require reimbursement for treatment services of a
WTC-related health condition or health condition medically associated
with a WTC-related health condition directly from the member.
(2) The WTC Health Program will pay providers for treatment in
accordance with Sec. 88.22(b); to the extent that the workers'
compensation insurance pays for treatment at a lower rate, the WTC
Health Program will recoup treatment costs at the workers' compensation
insurance rate.
(e) Where a WTC Health Program member's WTC-related health
condition or health condition medically associated with a WTC-related
health condition is not work-related, the WTC Health Program member's
public or private health insurance plan is the primary payer. The WTC
Health Program will pay costs not reimbursed by the public or private
health insurance plan due to the application of deductibles, co-
payments, co-insurance, other cost sharing arrangements, or payment
caps up to and in accordance with the rates described in Sec.
88.22(b).
(f) Any coordination of benefits or recoupment situation not
described in paragraphs (a) through (e) of this section will be handled
pursuant to WTC Health Program policies and procedures, as found on the
WTC Health Program Web site.
Sec. 88.25 Reopening of WTC Health Program final decisions.
At any time, and without regard to whether new evidence or
information is provided or obtained, the Administrator of the WTC
Health Program may reopen any final decision made by the WTC Health
Program pursuant to the provisions of this part. The Administrator may
affirm, vacate, or modify such decision, or take any other action he or
she deems appropriate.
Dated: November 22, 2016.
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.
Dated: November 28, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-29957 Filed 12-12-16; 11:15 am]
BILLING CODE 4163-18-P
