World Trade Center Health Program Requirements for Enrollment, Appeals, Certification of Health Conditions, and Reimbursement, 38914-38936 [2011-16488]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Rules and Regulations]
[Pages 38914-38936]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16488]



[[Page 38913]]

Vol. 76

Friday,

No. 127

July 1, 2011

Part VI





Department of Health and Human Services





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42 CFR Part 88





World Trade Center Health Program Requirements for Enrollment, Appeals, 
Certification of Health Conditions, and Reimbursement; Interim Final 
Rule

Federal Register / Vol. 76 , No. 127 / Friday, July 1, 2011 / Rules 
and Regulations

[[Page 38914]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Docket No. CDC-2011-0009]

42 CFR Part 88

RIN 0920-AA44


World Trade Center Health Program Requirements for Enrollment, 
Appeals, Certification of Health Conditions, and Reimbursement

AGENCY: Centers for Disease Control and Prevention, HHS.

ACTION: Interim final rule with request for comments.

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SUMMARY: Title I of the James Zadroga Health and Compensation Act of 
2010 amended the Public Health Service Act (PHS Act) by adding Title 
XXXIII, which establishes the World Trade Center (WTC) Health Program. 
Sections 3311, 3312, and 3321 of Title XXXIII of the PHS Act require 
that the WTC Program Administrator develop regulations to implement 
portions of the WTC Health Program established within the Department of 
Health and Human Services (HHS). The WTC Health Program, which will be 
administered in part by the Director of the National Institute for 
Occupational Safety and Health (NIOSH), within the Centers for Disease 
Control and Prevention (CDC), will provide medical monitoring and 
treatment to eligible firefighters and related personnel, law 
enforcement officers, and rescue, recovery and cleanup workers who 
responded to the September 11, 2001, terrorist attacks in New York 
City, Shanksville, PA, and at the Pentagon, and to eligible survivors 
of the New York City attacks. This interim final rule establishes the 
processes by which eligible responders and survivors may apply for 
enrollment in the WTC Health Program, obtain health monitoring and 
treatment for WTC-related health conditions, and appeal enrollment and 
treatment decisions. This interim final rule also establishes a process 
for the certification of health conditions, and reimbursement rates for 
providers who provide initial health evaluations, treatment, and health 
monitoring.

DATES: Effective July 1, 2011. Written comments from interested parties 
on this interim final rule and on the information collection approval 
request sought under the Paperwork Reduction Act must be received by 
August 30, 2011.

ADDRESSES: You may submit comments, identified by ``RIN 0920-AA44,'' by 
any of the following methods:
     Internet: Access the Federal e-rulemaking portal at https://www.regulations.gov. Follow the instructions for submitting comments.
     E-mail: NIOSH Docket Officer, nioshdocket@cdc.gov. Include 
``RIN 0920-AA44'' and ``42 CFR 88'' in the subject line of the message.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
    Instructions: All submissions received must include the agency name 
and docket number or Regulation Identifier Number (RIN) for this 
rulemaking. All comments will be posted without change to https://www.regulations.gov and https://www.cdc.gov/niosh/docket/NIOSHdocket0235.html, including any personal information provided. For 
detailed instructions on submitting comments and additional information 
on the rulemaking process, see the ``Public Participation'' heading of 
the SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, please go to https://www.regulations.gov or https://www.cdc.gov/niosh/docket/NIOSHdocket0235.html.

FOR FURTHER INFORMATION CONTACT: Roy M. Fleming, Sc.D., Senior Science 
Advisor, World Trade Center Health Program, Office of the Director, 
National Institute for Occupational Safety and Health, 1600 Clifton 
Road, NE., MS-E74, Atlanta, GA 30329; telephone 866-426-3673 (this is a 
toll-free number). Information requests may also be submitted by e-mail 
to wtcpublicinput@cdc.gov.

SUPPLEMENTARY INFORMATION: 
    This preamble is organized as follows:

I. Public Participation
II. Background
    A. WTC Medical Monitoring and Treatment Program and 
Environmental Health Center Community Program History
    B. WTC Health Program Statutory Authority
    C. Implementation of the WTC Health Program
III. Issuance of an Interim Final Rule With Immediate Effective Date
IV. Summary of Interim Final Rule
V. 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. Public Participation

    Interested persons or organizations are invited to participate in 
this rulemaking by submitting written views, opinions, recommendations, 
and data. Comments received, including attachments and other supporting 
materials, are part of the public record and subject to public 
disclosure. Do not include any information in your comment or 
supporting materials that you consider confidential or inappropriate 
for public disclosure. HHS will consider those submissions and may 
revise the final rule as appropriate.
    Comments are invited on any topic related to this interim final 
rule. In addition, HHS invites comments specifically on the following 
questions related to this rulemaking:
    1. The PHS Act requires ``1 day'' of presence for a number of 
eligibility criteria for firefighters and related personnel (see Sec.  
88.4(a)(1) of the interim final rule text), members of the New York 
City Police Department (see Sec.  88.4((a)(2)(ii)), and vehicle 
maintenance-workers (see Sec.  88.4(a)(5))to be enrolled. For the 
purposes of this regulation, the Department has interpreted the 
statutory intent of 1 day to be a full work shift, of at least 4 hours 
but less than 24 hours. Is there a different interpretation of 1 day 
that the Department should consider?
    2. The medical necessity standard established in this interim final 
rule relies heavily on the medical protocols to be developed by the 
Data Centers and approved by the WTC Program Administrator, and 
incorporates the qualitative factors that treatment be reasonable and 
appropriate based on scientific evidence, professional standards of 
care, expert opinion, and other relevant information. Is the 
substantial reliance on approved medical protocols appropriate? Are the 
factors specified necessary and sufficient? Are there specific 
standards currently in use by other programs, either Federal or in 
private sector health care organizations that would be appropriate for 
use in the WTC Health Program?
    3. The interim final rule implements Federal Employees Compensation 
Act (FECA) rates for reimbursing initial health evaluations, health 
monitoring, and medically necessary treatment

[[Page 38915]]

provided in the WTC Health Program. The use of FECA rates for treatment 
is specified by the PHS Act. The rule also employs applicable Medicare 
payment rate schedules for treatment that is not covered by FECA rates. 
Is there any system of rates other than Medicare that should be 
considered for treatment that is not covered by FECA? Note that section 
3312 of the PHS Act prohibits payments for products or services made at 
a higher rate than the Office of Workers' Compensation Programs in the 
Department of Labor.

II. Background

A. WTC Medical Monitoring and Treatment Program and Environmental 
Health Center Community Program History

    Since the tragic events of September 11, 2001, HHS, CDC, and NIOSH 
have facilitated health evaluations for those firefighters and related 
personnel, law enforcement officers, and rescue, recovery and cleanup 
workers who responded to the WTC disaster sites. A health screening 
program for responders began in 2002 under contracts awarded to the 
Mount Sinai School of Medicine (Mount Sinai) and the Fire Department, 
City of New York. Mount Sinai subcontracted with other specialty 
occupational health clinics in the New York metropolitan area to expand 
enrollment and provide a standardized and comprehensive health 
screening protocol.
    In 2003, Congress appropriated further funding to implement longer 
term medical monitoring for these responders. The occupational health 
specialty clinics involved in the screening program were each directly 
funded through cooperative agreements with NIOSH to work 
collaboratively and provide periodic standardized medical monitoring 
exams. Participants in the initial screening program were enrolled 
beginning in 2004.
    In 2006, Congress appropriated additional funds for diagnostic and 
treatment services to support medical care for health conditions 
associated with WTC-related work exposures. After receiving 
appropriations for treatment, the program was re-named the WTC Medical 
Monitoring and Treatment Program (MMTP) to reflect expanded services to 
eligible firefighters and related personnel, law enforcement officers, 
and rescue, recovery and cleanup workers The established program 
providers were funded as Clinical Centers of Excellence (Clinical 
Centers), reflecting their multidisciplinary expertise and extensive 
program experience with the WTC responder population. The MMTP made 
monitoring exams and treatment available to firefighters and related 
personnel, law enforcement officers, and rescue, recovery and cleanup 
workers living outside the New York metropolitan area and 
geographically distant from the established Clinical Centers through a 
network of providers. The health conditions covered under the MMTP were 
identified by the Clinical Centers based on assessments of the health 
needs of the firefighters and related personnel, law enforcement 
officers, and rescue, recovery and cleanup workers and with input from 
scientific and medical experts, and included certain upper and lower 
airway diseases, esophageal disorders from acid reflux, musculoskeletal 
injuries, and mental health problems (most notably post-traumatic 
stress disorder, anxiety, and depression).
    In 2008, Congress appropriated additional funds for the WTC 
Environmental Health Center (EHC) Community Program, which provided 
initial health evaluations, diagnostic and treatment services for 
residents, students, and others in the community who were affected by 
the September 11, 2001, terrorist attacks in New York City.

B. WTC Health Program Statutory Authority

    Title I of the James Zadroga 9/11 Health and Compensation Act of 
2010, (Pub. L. 111-347), amended the PHS Act to add Title XXXIII \1\ 
establishing the World Trade Center (WTC) Health Program within HHS. 
The WTC Health Program will assume the functions and goals of the MMTP 
and the WTC EHC Community Program to provide medical monitoring and 
treatment benefits to eligible firefighters and related personnel, law 
enforcement officers, and rescue, recovery and cleanup workers 
(including those who are Federal employees) who responded to the 
September 11, 2001, terrorist attacks, as well as those residents and 
other building occupants and area workers in New York City who were 
directly impacted and adversely affected by the attacks.
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    \1\ Title XXXIII of the Public Health Service Act is codified at 
42 U.S.C. 300mm to 300mm-61. Those portions of the Zadroga Act found 
in Titles II and III of Public Law 111-347 do not pertain to the 
World Trade Center Health Program and are codified elsewhere.
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    The WTC Health Program will expand to include any eligible 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery and cleanup workers who responded to the September 11, 
2001, terrorist attacks at the Pentagon and Shanksville, PA. Section 
3311(a)(2)(C)(ii) of Title XXXIII requires that the WTC Program 
Administrator develop eligibility criteria for Pentagon and 
Shanksville, PA emergency responders after consultation with the WTC 
Scientific/Technical Advisory Committee. HHS is in the process of 
establishing this new Federal advisory committee and the WTC Program 
Administrator will obtain the required consultation as soon as 
possible. However, because no Pentagon or Shanksville, PA responders 
have participated in the existing health program, the WTC Program 
Administrator currently lacks information that may serve as a basis for 
such enrollment, including information on participation in the response 
at these two sites and on hazard exposure circumstances at these sites 
relevant to currently established WTC health conditions. The WTC 
Program Administrator will be collecting such information.
    Title XXXIII of the PHS Act directs the Secretary of HHS to 
designate a Department official to be the WTC Program Administrator 
(Title XXXIII, Sec.  3306(14)). Certain specific activities of the WTC 
Program Administrator are reserved to the Secretary to delegate at her 
discretion; other WTC Program Administrator duties not explicitly 
reserved to the Secretary are assigned to the Director of NIOSH or his 
or her designee. This rule implements portions of the PHS Act which 
were both given to the Director of NIOSH and others for which the HHS 
Secretary has designated the Director of NIOSH to be the WTC Program 
Administrator. Another HHS component, Centers for Medicare & Medicaid 
Services, has been delegated responsibilities for disbursing payments 
to providers under the WTC Health Program (see Delegation of Authority, 
76 FR 31337, May 31, 2011). All references to the WTC Program 
Administrator in this notice mean the NIOSH Director or his or her 
designee.
    Under Sec.  3306 of Title XXXIII of the PHS Act, the WTC Program 
Administrator is responsible for a program to enroll qualified 
firefighters and related personnel, law enforcement officers, and 
rescue, recovery and cleanup workers who responded to the New York 
City, Pentagon, and Shanksville, PA disaster sites; screen and certify 
qualified survivors of the New York City attacks; and to establish a 
nationwide system of healthcare providers to provide monitoring and 
treatment to those individuals found eligible. The WTC Program 
Administrator is also required to promulgate regulations to determine 
medical necessity with respect to

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healthcare services and prescription pharmaceuticals; to certify WTC-
related health conditions identified in the statute; and to establish 
processes for appealing WTC Health Program determinations. Those 
statutory requirements are included in this interim final rule and are 
described in the summary of the proposed rule below.
    Title XXXIII of the PHS Act also authorizes the WTC Program 
Administrator to establish a process by which health conditions, 
including types of cancer, may be considered for addition to the list 
of WTC-related health conditions. Those provisions are included in a 
notice of proposed rulemaking published elsewhere in this issue of the 
Federal Register.
    Title XXXIII of the PHS Act further authorizes the WTC Program 
Administrator to promulgate regulations to add eligibility criteria for 
Pentagon and Shanksville, PA responders after consultation with the WTC 
Health Program Scientific/Technical Advisory Committee. The eligibility 
criteria for those responders will be developed by future rulemaking.

C. Implementation of the WTC Health Program

    As required by Title XXXIII of the PHS Act, this regulation 
establishes the process by which individuals who were firefighters and 
related personnel, law enforcement officers, rescue, recovery and 
cleanup workers who responded to the September 11, 2001, terrorist 
attacks in New York City or survivors associated with the September 11, 
2001, terrorist attacks in New York City may be enrolled in the WTC 
Health Program. For firefighters and related personnel, law enforcement 
officers, and rescue, recovery and cleanup workers who were included in 
the previous MMTP program before July 1, 2011, enrollment in the newly 
established WTC Health Program will not require any new application, 
although enrollment is predicated on ensuring that the individual's 
name is not found to be a positive match to the terrorist watch list 
maintained by the Federal government. Similarly, survivors of the New 
York City terrorist attack who have been identified as eligible for 
medical treatment and follow-up monitoring services in the WTC EHC 
Community Program as of January 2, 2011, will not be required to file a 
new application to the WTC Health Program, but are also subject to 
watch list screening.
    All firefighters and related personnel, law enforcement officers 
and rescue, recovery and cleanup workers who responded to the New York 
City attack who will be newly seeking medical monitoring and treatment 
and survivors of the attack who were not covered by the WTC EHC 
Community Program on or before January 2, 2011, may apply to obtain 
coverage under the new WTC Health Program established by this rule. The 
application process for responders and survivors is established by this 
interim final rule.
    An individual who believes that he or she qualifies as a WTC 
responder (a `WTC responder' is defined in the interim final rule text 
as an individual who has been identified as eligible for monitoring and 
treatment as described in Sec.  88.3 of the interim final rule, or who 
meets the eligibility criteria in Sec.  88.4) must fill out an 
application form indicating that he or she meets certain eligibility 
criteria described in Sec.  88.4. Firefighters and related personnel, 
law enforcement officers, and rescue, recovery and cleanup workers may 
submit an application to the WTC Health Program beginning on July 1, 
2011. An individual who can demonstrate that he or she was firefighter 
or related personnel, law enforcement officer, or rescue, recovery or 
cleanup worker who participated at or within a certain distance of the 
Ground Zero site or at a specified location for the requisite amount of 
time may be enrolled in the WTC Health Program. If no documentation of 
eligibility is submitted with the application (e.g., a pay stub or 
personnel roster), the individual must explain how he or she attempted 
to find documentation and why the attempt was unsuccessful. The 
application must be signed by the applicant. An applicant who knowingly 
provides false information may be subject to a fine and/or imprisonment 
of not more than 5 years.
    A similar application process is established for survivors who were 
not enrolled in the WTC EHC Community Program prior to January 2, 2011. 
Those survivors may submit applications to the WTC Health Program 
beginning on July 1, 2011. An individual who believes that he or she 
can qualify as a screening-eligible survivor must fill out an 
application form indicating that he or she meets certain eligibility 
criteria described in Sec.  88.8 of the regulatory text. An individual 
who can demonstrate that he or she was a survivor who was present in 
the New York City disaster area may be found eligible to receive 
medical screening to determine if he or she has a health condition 
covered by the WTC Health Program. As with the WTC responder 
application, if no documentation of eligibility (e.g., a lease or 
utility bill) is submitted with the application, the applicant must 
explain how he or she attempted to find documentation and why the 
attempt was unsuccessful. The application must be signed by the 
applicant. An applicant who knowingly provides false information may be 
subject to a fine and/or imprisonment of not more than 5 years. If the 
individual is found to have a covered health condition, he or she may 
be considered a certified-eligible survivor.
    Once enrolled in the WTC Health Program, a WTC responder or 
certified-eligible survivor may receive treatment for specific physical 
and mental health conditions that have been certified by the WTC Health 
Program and that are included on the list of WTC-related health 
conditions. The list of these health conditions was established by 
Congress and is repeated in Sec.  88.1, the definitions section of this 
rule. The list may be amended in the future to add other health 
conditions

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 experience in treating or diagnosing the health conditions 
included in the applicable list of WTC-related health conditions, is 
substantially likely to be a significant factor in aggravating, 
contributing to, or causing the illness or condition (Title XXXIII, 
Sec.  3312(a)(1)(A)(i)).

    The eligibility criteria and application process for individuals 
who responded to the September 11, 2001, terrorist attacks at the 
Pentagon and Shanksville, PA, will be developed as soon as possible. As 
discussed above, this will require additional research and consultation 
that could not be completed prior to this rulemaking (see Section 
II.B.).

III. Issuance of an Interim Final Rule With Immediate Effective Date

    Rulemaking under the Administrative Procedure Act (APA) generally 
requires a public notice and comment period and consideration of the 
submitted comments prior to promulgation of a final rule having the 
effect of law (5 U.S.C. 553). However, the APA provides for exceptions 
to its notice and comment procedures when an agency finds that there is 
good cause for dispensing with such procedures on the basis that they 
are impracticable, unnecessary, or contrary to the public interest. In 
the case of this interim final rule, we have determined that under 5 
U.S.C. 553(b)(B), good cause exists for waiving the notice and comment 
procedures. For similar reasons, HHS has also determined that good 
cause exists under 5 U.S.C. 553(d)(3) for this

[[Page 38917]]

interim final rule to become effective immediately.
    The James Zadroga 9/11 Health and Compensation Act of 2010 was 
signed by the President on January 2, 2011. It amended the PHS Act to 
establish the WTC Health Program, administered by the WTC Program 
Administrator, and mandated that this program begin on July 1, 2011, 
just 6 months after enactment.
    HHS has determined that interim regulatory provisions are necessary 
to implement certain provisions of Title XXXIII relating to: (1) The 
WTC Health Program's ability to ensure that those currently identified 
responders and survivors who are already receiving care under the 
previous program continue to receive medical monitoring and treatment 
benefits without interruption; (2) the WTC Health Program's ability to 
accept applications from responders beginning July 1, 2011 and 
survivors shortly thereafter; (3) the right of applicants and enrollees 
to appeal determinations made by the WTC Health Program; and (4) the 
guidelines by which WTC-related health conditions are diagnosed and 
certified. HHS has determined that it is not possible to complete the 
steps necessary for the usual notice and comment under the APA in time 
for the WTC Health Program to become effective by July 1, 2011.
    There is a strong public interest in ensuring the continuation of 
monitoring and treatment benefits for those responders and survivors 
who were previously receiving such care. Congress has also expressed 
the need for ensuring the continuation of monitoring and treatment 
(Title XXXIII, Sec.  3305(b)(1)(C)). In addition, there is an immediate 
need to initiate the process to continue to enroll those who responded 
to this nation's worst terrorist attacks and were harmed in the 
performance of their duties. These concerns are clearly reflected in 
the Congressional mandate to swiftly implement this program. It is 
especially important that currently identified responders and survivors 
who will be transferring to the new WTC Health Program be provided 
prompt guidance on how it will operate. Coalition for Parity, Inc. v. 
Sebelius, 709 F. Supp.2d 10, 15 (DC Cir. 2010) (need for prompt 
regulatory guidance among the factors in justifying an interim rule). 
HHS is working as quickly as possible to provide this guidance by 
issuing this interim final rule. An undue delay in enrolling and 
implementing certification of treatment procedures under the new 
program would result in real harm to those who were in the previous 
treatment program. With the publication of this interim final rule, we 
can ensure that the necessary guidance is provided promptly to those 
responders and survivors currently identified and to those responders 
seeking to enroll, and that monitoring and treatment benefits are 
continued.
    For similar reasons, HHS is making this interim final rule 
effective immediately. In making this determination, we have balanced 
the need for an immediately-effective rule in order to allow for 
continued treatment and care for responders and survivors against 
fairness considerations and the needs of affected parties to have time 
to adjust to the rule's requirements. Omnipoint Corporation v. Federal 
Communications Commission, 78 F.3d 620, 630 (DC Cir. 1996). HHS 
believes the need for continuation of monitoring and treatment is 
paramount and necessitates that this interim final rule be effective 
immediately.
    While developing this interim rule, HHS reached out to the affected 
community through a public meeting (76 FR 7862, February 11, 2011), a 
request for comments on the implementation of Title XXXIII of the PHS 
Act (76 FR 12360, March 7, 2011), and other outreach efforts to 
interested parties. Although HHS is adopting this rule on an interim 
final basis, we request public comment on this rule. After full 
consideration of public comments, HHS will work as expeditiously as 
possible to publish a final rule with any necessary changes.

IV. Summary of Interim Final Rule

    The section-by-section summaries provided below describe the 
components of the WTC Health Program for which the WTC Program 
Administrator has been delegated authority by the Secretary of HHS, 
under Title XXXIII. The components implemented here include: enrollment 
of WTC responders; certification of screening-eligible or certified-
eligible survivors; and payment for initial health evaluation, 
monitoring, and treatment of covered individuals. Certain paragraphs 
are reserved for provisions that will be promulgated by notice-and-
comment rulemaking at such time as is determined by the WTC Program 
Administrator.

Section 88.1 Definitions

    This section of the regulation includes definitions for the 
principal terms used in part 88. It includes terms specifically defined 
in Title XXXIII.
    The ``WTC Program Administrator'' is defined, for purposes of this 
regulation, as the Director of the National Institute for Occupational 
Safety and Health or his or her designee.
    ``WTC responder,'' ``screening-eligible survivor,'' and 
``certified-eligible survivor,'' refer to individuals who are found to 
be eligible to participate in certain aspects of the WTC Health 
Program. ``WTC responder'' is a term defined in Title XXXIII. It is 
used to refer not only to people who worked or volunteered in rescue, 
recovery, and clean-up at the site of the terrorist attacks in New York 
City but also to those individuals who participated in those activities 
at the sites in Shanksville, PA and the Pentagon. ``Screening-eligible 
survivors'' are individuals who meet the initial eligibility 
requirements found in Sec.  88.8 and are thus approved to have an 
initial health evaluation. ``Certified-eligible survivors'' are 
individuals who have at least one WTC-related health condition for 
which he or she qualified for treatment benefits and follow-up 
monitoring services.
    The terms ``list of WTC-related health conditions,'' and ``WTC-
related health condition'' refer to those conditions specifically 
designated in Title XXXIII and to any future conditions that may be 
added to that list by the WTC Program Administrator in subsequent 
rulemakings. A ``health condition medically associated with a WTC-
related health condition'' is a condition that results from the 
treatment of a condition on the list of WTC-related health conditions 
or from the natural progression of one of those conditions.
    ``Clinical Centers of Excellence'' and the ``nationwide provider 
network'' are the medical providers meeting specified statutory 
requirements and are affiliated with the WTC Health Program by 
contract.
    ``Terrorist watch list'' is included to incorporate the statutory 
requirement that no individual who is determined to be a positive match 
to the watch list maintained by the Federal government shall qualify to 
become a WTC responder or screening-eligible or certified-eligible 
survivor. The PHS Act inadvertently identifies the watch list as being 
maintained by the Department of Homeland Security; the watch list is in 
fact maintained by the Terrorist Screening Center of the Federal Bureau 
of Investigation, Department of Justice.

Section 88.2 General Provisions

    Paragraph (a) of this section establishes that an enrolled WTC 
responder, a screening-eligible survivor, or a certified-eligible 
survivor may designate one person to represent their interests related 
to applying to or seeking treatment from the WTC Health

[[Page 38918]]

Program. The provisions of this section specify that a WTC responder or 
eligible survivor can have only one individual represent him or her at 
a time; identifies those individuals for whom a Federal employee may 
act as a designated representative; and specifies that a parent or 
guardian may act on behalf of a minor seeking monitoring or treatment 
under the WTC Health Program. HHS believes it is important and 
necessary to provide a means for an enrollee who is a minor child or 
who is otherwise unable to represent himself or herself to be able to 
designate the person who will represent the enrollee in the Program.

Section 88.3 Eligibility--Currently Identified Responders

    This section restates the eligibility criteria, as outlined in 
Title XXXIII, Sec.  3311 of the PHS Act, for WTC responders who have 
received medical monitoring and treatment benefits from the MMTP 
program. Under Sec.  88.3(a), responders who have been identified as 
eligible for program benefits prior to July 1, 2011, by the MMTP will 
be automatically enrolled in the WTC Health Program. These individuals 
are not required to submit an application for enrollment. As required 
by statute, an individual who meets the eligibility criteria under (a) 
of this section is not qualified to enroll in the WTC Health Program if 
the individual is determined to be a positive match to the terrorist 
watch list.

Section 88.4 Eligibility Criteria--Status as a WTC Responder

    The eligibility criteria in Sec.  88.4 apply to those firefighters, 
law enforcement officers, certain employees of the Office of the Chief 
Medical Examiner of New York City, Port Authority Trans-Hudson 
Corporation Tunnel Workers, vehicle-maintenance workers, and other 
rescue, recovery, and cleanup workers not previously identified as 
eligible under the MMTP. New applicants will be considered for 
enrollment according to the criteria provided in paragraph(a), which 
describes individuals who conducted rescue, recovery, and cleanup at 
the World Trade Center sites (including Ground Zero, the Staten Island 
Landfill, or the New York City Chief Medical Examiner's Office), for 
specific lengths of time during the dates specified.
    Paragraphs (b) and (c) are reserved for eligibility criteria for 
responders to the September 11, 2001, terrorist attack sites in 
Shanksville, PA and at the Pentagon. Paragraph (d) is reserved for any 
modified eligibility criteria that may be developed in the future.
    Paragraph (e) states that the WTC Program Administrator will keep a 
list of enrolled WTC responders.

Section 88.5 Application Process--Status as a WTC Responder

    This section informs applicants who believe they meet the 
eligibility criteria for a WTC responder how to apply for enrollment in 
the WTC Health Program. The provisions of this section require that the 
individual submit an application and provide evidence of eligibility 
under the provisions of Sec.  88.4. The applicant must provide 
documentary evidence of his or her employment and type of work activity 
during the rescue, recovery, and debris cleanup periods after the 
terrorist attacks. The WTC Health Program will accept a pay stub, 
official personnel roster, site credentials or other similar documents 
to establish that the applicant meets the eligibility criteria. If no 
documentation is submitted with the application, the applicant must 
explain how he or she attempted to find documentation and why he or she 
was unsuccessful. The application must be signed by the applicant, 
under penalty of perjury. An applicant who knowingly provides false 
information may be subject to fines and criminal penalties under 18 
U.S.C. 1001 and 18 U.S.C. 1621.

Section 88.6 Enrollment Determination--Status as a WTC Responder

    This section explains how and when the WTC Program Administrator 
will promptly notify the applicant of the enrollment decision. The WTC 
Program Administrator will evaluate applications on a first-come, 
first-served basis; applicants will be promptly notified if there are 
any deficiencies in the application or supporting materials.
    An applicant will be denied enrollment in the Program if he or she 
does not meet the eligibility criteria in Sec.  88.4; if the numerical 
limitations established by Congress are met, or the WTC Program 
Administrator determines that funds are insufficient to continue 
accepting new enrollees into the Program; or if the individual is 
determined to be a positive match to the terrorist watch list 
maintained by the Federal government. Individuals denied enrollment 
because of the numerical limitation will be placed on a waitlist, and 
notified promptly when they are removed from the waitlist and enrolled 
in the Program.
    Title XXXIII expressly states that the total number of newly-
enrolled WTC responders ``shall not exceed 25,000 at any time,'' and 
similarly limits the total number of new certified-eligible survivors 
to 25,000 (Sec.  3311(a)(4), Sec.  3321(a)(3)). The WTC Program 
Administrator is authorized to limit enrollment to a number of WTC 
responders and certified-eligible survivors that is less than the limit 
set by Congress. That determination must be based on the best available 
information and on the amount available funding necessary to provide 
treatment and monitoring benefits to all individuals who are enrolled 
in the program.
    The qualified applicant will be notified in writing no later than 
60 days after the application date. An applicant who is found 
ineligible for enrollment will be provided an explanation, as 
appropriate for that determination, and given the opportunity to 
appeal.

Section 88.7 Eligibility--Currently Identified Survivors

    This section establishes that survivors who have been identified as 
eligible for medical treatment and monitoring benefits by the WTC EHC 
Community Program as of January 2, 2011, will be automatically enrolled 
in the WTC Health Program. These individuals are not required to submit 
an application for enrollment. As required by Title XXXIII of the PHS 
Act, an individual who meets the eligibility criteria under (a) of this 
section is not qualified to enroll in the WTC Health Program if the 
individual is determined to be a positive match to the terrorist watch 
list.

Section 88.8 Eligibility Criteria--Status as a WTC Survivor

    This section restates the eligibility criteria for screening-
eligible survivors established in Title XXXIII of the PHS Act. 
Individuals who wish to apply for benefits under the WTC Health Program 
may do so beginning on July 1, 2011.
    New applicants to the WTC Health Program will be considered for 
status as a screening-eligible survivor according to the criteria 
provided in (a), which describes an individual who is not a WTC 
responder, who claims symptoms of a WTC-related health condition, and 
who is not an individual identified in Sec.  88.7. Individuals who 
would be eligible for an initial health evaluation were, during the 
dates and durations specified, either present in the dust cloud; 
worked, lived, or attended school or daycare in the New York City 
disaster area; performed cleanup or maintenance work in the New York 
City disaster area; received a grant from the Lower Manhattan 
Development Corporation Residential Grant Program for a residence he or 
she leased or owned and lived in; or was employed in the

[[Page 38919]]

disaster area and received a grant from the Lower Manhattan Development 
Corporation or other government incentive program to revitalize the 
area economy.
    Paragraph (b) explains that screening-eligible survivors can become 
certified-eligible survivors by obtaining an initial health evaluation, 
provided by the WTC Health Program. If the exam results in a 
physician's diagnosis of a WTC-related health condition, the WTC 
Program Administrator may certify that condition. In that case, the 
survivor will be considered certified-eligible.

Section 88.9 Application Process--Status as a WTC Survivor

    This section informs applicants who believe they meet the 
eligibility criteria for a WTC survivor how to apply for screening-
eligible status in the WTC Health Program. The provisions of this 
section require that the individual submit an application and provide 
documentation of his or her presence, residence, or employment in the 
New York City disaster area. The WTC Health Program will accept various 
forms of proof of presence, residence, or work activity including a 
written statement, under penalty of perjury, from the applicant or the 
applicant's employer. An applicant who is unable to submit any required 
documentation must instead offer a written explanation of what the 
individual did to try to find proof of presence, residence, or work 
activity and why he or she was unsuccessful. The application will be 
signed under penalty of perjury. Any applicant who knowingly supplies 
false information may be subject to fines and criminal prosecution 
under 18 U.S.C. 1001 and 18 U.S.C. 1621. As required by Title XXXIII, 
Sec.  3321(a)(1)(A)(ii), the applicant would also be required to claim 
symptoms of a WTC-related health condition. A WTC-related health 
condition is defined as a health condition associated with exposure to 
adverse conditions resulting from the September 11, 2001, terrorist 
attacks, and identified in Title XXXIII of the PHS Act and in Sec.  
88.1. Paragraph (b) explains that an individual is not required to 
submit an additional application to become certified-eligible.

Section 88.10 Enrollment Determination--Status as a WTC Survivor

    This section explains how and when the WTC Program Administrator 
will notify the applicant of the decision to enroll the individual as a 
screening-eligible or certified-eligible survivor. The WTC Program 
Administrator will evaluate applications for screening-eligible status 
on a first-come, first-served basis; applicants will be promptly 
notified if there are any deficiencies in the application or supporting 
materials.
    An applicant will be denied enrollment in the Program if he or she 
does not meet the eligibility criteria for screening-eligible survivors 
in Sec.  88.8; if the numerical limitations established by Congress are 
met, or the WTC Program Administrator determines that funds are 
insufficient to continue accepting new screening-eligible or certified-
eligible survivors into the Program; or if the individual is determined 
to be a positive match to the terrorist watch list maintained by the 
Federal government. Individuals denied screening-eligible status 
because of the numerical limitation on certified-eligible survivors 
will be placed on a waitlist and notified promptly when they are 
removed from the waitlist and deemed screening-eligible.
    The qualified screening-eligible status applicant will be notified 
in writing no later than 60 days after the application date. An 
applicant who is found ineligible for enrollment will be provided an 
explanation, as appropriate for that determination, and given the 
opportunity to appeal.
    Paragraph (d) explains that a screening-eligible survivor will 
receive an initial health evaluation from a WTC Health Program Clinical 
Center of Excellence or a member of the nationwide provider network to 
determine if the individual has a WTC-related health condition. While 
the WTC Health Program will offer only one initial health evaluation, 
nothing in this rule will prohibit the screening-eligible survivor from 
requesting and paying for additional health evaluations.
    This section also establishes that the screening-eligible survivor 
may be denied certified-eligible status if the individual does not have 
a diagnosed WTC-related health condition or if the WTC Program 
Administrator does not find that the physician's determination 
sufficiently establishes the relationship between the individual's 
exposure to the conditions resulting from the September 11, 2001, 
terrorist attacks and the health condition being claimed. The 
screening-eligible survivor may also be denied certified-eligible 
status if the numerical limitations established by Congress are met, or 
the WTC Program Administrator determines that funds are insufficient to 
continue accepting new certified-eligible survivors into the Program; 
or if the individual is determined to be a positive match to the 
terrorist watch list maintained by the Federal government. Individuals 
denied enrollment because of the numerical limitation will be placed on 
a waitlist and notified promptly when they are removed from the 
waitlist and deemed certified-eligible.
    The newly certified-eligible survivor will be notified in writing. 
A screening-eligible survivor who is found ineligible for certified-
eligible status will be provided an explanation, as appropriate for 
that determination, and given the opportunity to appeal.

Section 88.11 Appeals Regarding Eligibility Determinations--Responders 
and Survivors

    This section establishes procedures for the appeal of a WTC Program 
Administrator's decision not to enroll an individual who believes he or 
she meets the eligibility criteria for enrollment as a WTC responder or 
screening-eligible survivor. The individual or his or her designated 
representative may appeal the decision in writing within 60 days of the 
decision. The appeal must contain the reasons the individual believes 
the decision is incorrect, and may also include relevant information 
that was not previously considered by the WTC Program Administrator. If 
the individual is denied because his or her name is determined to be a 
positive match to the terrorist watch list, the appeal will be 
forwarded to the appropriate Federal agency. Upon receipt and review of 
the appeal, the WTC Program Administrator will designate the NIOSH 
Associate Director for Science, a Federal official who is independent 
of the Program, to review the appeal and make a final decision on the 
matter. Status as a certified-eligible survivor is predicated on 
certification of a WTC-related health condition; appeal of a WTC 
Program Administrator denial of status as a certified-eligible survivor 
will be available only through the appeal process outlined in Sec.  
88.15.

Section 88.12 Physician's Determination of WTC-Related Health 
Conditions

    This section establishes the basis for a determination that an 
enrolled WTC responder or survivor has a health condition that can be 
certified and covered by the WTC Health Program. Paragraph (a) requires 
that a WTC Health Program physician promptly send his or her diagnosis 
to the WTC Program Administrator. The physician's diagnosis must 
include information establishing that the September 11, 2001, terrorist 
attacks were substantially likely to be a significant factor in 
aggravating, contributing to or causing the condition being claimed for

[[Page 38920]]

certification. Paragraph (b) establishes that the physician must 
provide documentation that a health condition medically associated with 
a WTC-related health condition is determined to be a result of 
treatment or progression of a previously-certified WTC-related health 
condition.

Section 88.13 WTC Program Administrator's Certification of Health 
Conditions

    This section establishes that the WTC Program Administrator will 
promptly assess the diagnosis submitted by the physician pursuant to 
Sec.  88.12. If the WTC Program Administrator determines that a 
diagnosed condition is a WTC-related health condition (paragraph (a)) 
or a health condition medically associated with a WTC-related health 
condition (paragraph (b)), the condition will be certified as eligible 
for coverage under the WTC Health Program. If the WTC Program 
Administrator determines that the condition is neither a WTC-related 
health condition nor a health condition medically associated with a 
WTC-related health condition, the applicant will be notified in 
writing. The WTC responder or the screening-eligible or certified-
eligible survivor may appeal the decision pursuant to the process in 
Sec.  88.15. Paragraph (c) establishes that prior authorization for 
treatment must be received from the WTC Program Administrator while 
certification of a WTC-related health condition or a health condition 
medically associated with a WTC-related health condition is pending, 
unless treatment is necessary for a medical emergency. As established 
by Sec.  88.16(a)(1), the provider will be reimbursed only for 
treatment of a certified WTC-related health condition or a health 
condition medically associated with a WTC-related health condition.

Section 88.14 Standard for Determining Medical Necessity

    This section establishes the standard for determining whether the 
treatment for a WTC-related health condition or a health condition 
medically associated with a WTC-related health condition is medically 
necessary. Medically necessary treatment is reasonable and appropriate, 
and is based on scientific evidence, professional standards of care, 
expert opinion, or other relevant information, and is in accordance 
with medical treatment protocols developed by the Data Centers and 
approved by the WTC Program Administrator. Treatment protocols 
developed using current medical information from previously established 
guidelines from both national professional standards of care and 
program-specific expertise will be used until the Data Centers are 
operational and are able to create a Program-wide, unified operations 
manual.

Section 88.15 Appeals Regarding Treatment

    This section explains that a WTC responder, a screening-eligible 
survivor denied status as certified-eligible, a certified-eligible 
survivor, or a designated representative may appeal the WTC Program 
Administrator's decision not to certify the health condition or not to 
authorize treatment for a certified WTC-related health condition or 
health condition medically associated with a WTC-related health 
condition.
    The individual or his or her designated representative may appeal 
the decision in writing within 60 calendar days of the decision. The 
appeal must be in writing and describe why the individual believes the 
WTC Program Administrator's initial determination not to certify the 
condition or authorize treatment was in error. Pursuant to paragraph 
(b)(1), the WTC Program Administrator will appoint the NIOSH Associate 
Director for Science, a Federal official independent of the WTC Health 
Program, who may convene one or more qualified experts to review the 
WTC Program Administrator's initial determination. The expert(s) will 
conduct a review of the documentation available at the time of the 
initial determination and submit the findings to the Federal official. 
The Federal official will review the expert findings and make a final 
determination which will not be further considered upon request of the 
WTC responder, screening-eligible or certified-eligible survivor, or 
designated representative.

Section 88.16 Reimbursement for Medically Necessary Treatment, 
Outpatient Prescription Pharmaceuticals, Monitoring, Initial Health 
Evaluations, and Travel Expenses

    This section establishes that the Clinical Center of Excellence or 
member of the nationwide provider network will be reimbursed by the WTC 
Health Program for the cost of medical treatment and outpatient 
prescription pharmaceuticals, and that a WTC responder or certified-
eligible survivor may be reimbursed for certain transportation 
expenses. Under section 3331 of the PHS Act, subject to certain 
limitations pertinent only to workers' compensation programs and other 
plans under which New York City is obligated to pay, the WTC Program 
Administrator may reduce or recoup payment for treatment of a WTC-
related health condition if it is determined that the individual's 
condition is work related, and the individual is covered by a workers' 
compensation or similar work-related injury or illness plan. For an 
individual who has a WTC-related health condition that is not work-
related and who has coverage under a public or private health insurance 
plan, the WTC Program Administrator may also take this insurance 
coverage into account in determining payment for treatment under Title 
XXXIII of the PHS Act.
    Paragraph (a)(1) establishes that payment for medical treatment 
will be based on the rates set by the Office of Workers' Compensation 
Programs to administer the Federal Employees Compensation Act (FECA, 5 
U.S.C. 8101 et seq., 20 CFR Part 20).\2\ Services or treatment not 
covered by the FECA rate structure will be reimbursed pursuant to the 
applicable Medicare fee for service rate, as determined appropriate by 
the WTC Program Administrator. Paragraph (a)(2) states that the cost of 
medically necessary outpatient prescription pharmaceuticals will be 
reimbursed according to rates established by contract between the WTC 
Health Program and one or more pharmaceutical providers through a 
competitive bidding process. Paragraph (b)(1) establishes that costs 
associated with monitoring and initial health evaluations will be 
reimbursed according to rates established by FECA. Paragraphs (c)(1) 
and (2) state that the WTC Program Administrator will review all claims 
for reimbursement and that reimbursement will be denied if the 
treatment is not medically necessary. Finally, paragraph (d) 
establishes that the WTC Program Administrator may provide 
reimbursement for necessary and reasonable transportation and other 
expenses that are related to securing medically necessary treatment 
through the nationwide provider network, involving travel of more than 
250 miles. The WTC Health Program will administer this provision 
consistently with the procedures of the Office of Workers' Compensation 
Programs of the Department of Labor, as specified in the statute.
---------------------------------------------------------------------------

    \2\ U.S. Department of Labor, Office of Workers' Compensation 
Programs Medical Fee Schedule, https://www.dol.gov/owcp/regs/feeschedule/fee.htm. Accessed June 3, 2011.

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

[[Page 38921]]

V. Regulatory Assessment Requirements

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). E.O. 
13563 emphasizes the importance of quantifying both costs and benefits, 
of reducing costs, of harmonizing rules, and of promoting flexibility.
    This rulemaking has been determined to be an ``economically 
significant'' regulatory action within the meaning of E.O. 12866. 
Providing medical monitoring and treatment through the WTC Health 
Program administered pursuant to this regulatory action will have an 
annual effect on the economy of $100 million or more.
Federal Cost Estimates
    Based on the factors and assumptions set forth below, HHS estimates 
the aggregate cost of medical monitoring and treatment to be provided 
and administrative expenses of this regulatory action, which partially 
implements Title XXXIII, in millions of dollars as presented in Table 
1, below. The table represents estimates, and is subject to change 
based on actual expenditures and future data analyses. These costs 
represent high and low estimates; actual costs and future estimates may 
be significantly below or above the estimated ranges.

                                         Table 1--Healthcare and Administrative Costs of the WTC Health Program
                                                               [$ millions; undiscounted]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                         FY 2011
                                                                     (fourth quarter      FY 2012          FY 2013          FY 2014          FY 2015
                                                                          only)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Administrative Costs:
    Low Estimate...................................................             $1.8            $15              $15              $15              $15
    High Estimate..................................................              1.8             22.5             22.2             22.2             22.2
Medical Monitoring and Treatment Costs:
    Low Estimate...................................................             33.7             91.8             91.8             91.8             91.8
    High Estimate..................................................             45.1            107.1            114.3            121.6            128.8
Total Costs:
    Low Estimate...................................................             35.5            106.8            106.8            106.8            106.8
    High Estimate..................................................             46.9            129.6            136.5            143.8            151.0
--------------------------------------------------------------------------------------------------------------------------------------------------------

    HHS's estimate of the costs of medical monitoring and treatment to 
be provided pursuant to the PHS Act and of the administrative costs of 
providing this monitoring and treatment is based on data from the WTC 
programs in operation to date. The current NIOSH WTC Medical Monitoring 
and Treatment Program and Environmental Health Center Program, referred 
to below as ``current NIOSH WTC programs,'' have operated over the past 
10 years. As a result, the current NIOSH WTC programs now approximate 
the starting point of the scope of the WTC Health Program's activities 
to be established by the PHS Act and implemented by this rule. The data 
from operational experience to date is the basis by which HHS has 
estimated costs for administrative activities, medical monitoring and 
treatment, and estimated related rates of enrollment and certification 
(respectively) of additional responders and survivors not currently 
participating in the current NIOSH WTC programs. Since the current 
NIOSH WTC grants are set to expire in FY 2011, the analyses of WTC 
Health Program costs (and health benefits) that follow use a low 
estimate reflecting actual costs associated with maintaining the 
existing program plus additional administrative activities, and a 
higher level that assumes a significant increase in enrollment and 
increase in both administrative costs and other health care costs.
    The WTC Health Program expects to enroll the approximately 58,000 
New York City responders and survivors who are enrolled in the current 
NIOSH WTC programs on July 1, 2011. In the high estimates, HHS assumes 
that up to 1,064 new responders and survivors in the final quarter of 
FY 2011 will be enrolled, resulting in a total of up to 59,064 
enrollees in the WTC Health Program for FY 2011. Over the first full 
year (FY 2012) of the WTC Health Program within the high estimate, HHS 
expects up to 4,255 new enrollees associated with the New York City 
terrorist attack, (3,018 responders and 1,237 survivors). The upper 
bound of this estimated range is based on the highest annual rates of 
enrollment over the past three years for responders and survivors, 
respectively. The lower bound assumes no new enrollment as the majority 
of responders affected by the WTC attacks have insurance and may not 
want to change healthcare providers. The actual enrollment is likely to 
fall within these bounds but is highly uncertain. HHS has not estimated 
enrollment for the Pentagon or Shanksville, PA populations as this is 
outside the scope of the rulemaking.
 Administrative Costs
    HHS estimates administrative costs ranging between $15,000,000 and 
$22,500,000 annually (higher start-up costs are projected for 2012), 
covering program management, enrollment of responders and survivors, 
certification of WTC-related health conditions in enrolled responders 
and certified eligible survivors, authorization of medical care, 
payment services, administration of appeals processes, education and 
outreach, and administration of the advisory and steering committee 
specified in the PHS Act. The range of the costs estimated reflects 
uncertainty associated with levels of activity for enrollment, appeals, 
the establishment and maintenance of new quality management and 
administrative data systems, and competitively established costs for 
contractual administrative services.
 Costs of Medical Monitoring and Treatment
    Initial health evaluations are estimated to cost between $0 and 
$59,000 in the final quarter of FY 2011 and between $0 and $2,360,000 
over the first full year (FY 2012) of the WTC Health Program, depending 
on the levels of actual enrollment and average

[[Page 38922]]

costs per patient. It is unclear how many new people may enroll in the 
new program within the first quarter. The high range of costs per 
patient are projected to be between $517 and $555 per individual, based 
on the average costs for patients having received these evaluations 
through the current NIOSH WTC programs and accounting for uncertainty 
in medical care inflation (3.4 percent in 2010) and the range of 
uncertainty in clinical infrastructure costs (discussed below).
    Annual medical monitoring for responders and survivors is estimated 
to cost between $8,380,000 and $8,990,000 in the final quarter of FY 
2011 for 10,875 responders and survivors and between $33,54,000 and 
$36,630,000 in FY 2012, the first full year of the WTC Health Program 
for between 43,500 and 44,298 responders and survivors and to increase 
with enrollment. This is based on an average cost of between $771 and 
$827 per patient for a medical monitoring exam. The range of average 
per patient costs is based on the average costs for patients having 
received a medical monitoring exam through the current NIOSH WTC 
programs and accounting for uncertainty in medical care inflation (3.4 
percent in 2010) and the range of uncertainty in clinical 
infrastructure costs (discussed below). Based on participation in the 
current program, these projections assume 75 percent of responders and 
survivors will obtain annual monitoring examinations. These 
examinations are provided in the years following the initial health 
evaluation, which is why there is a 1-year lag with respect to program 
enrollment numbers in the number of patients projected to receive these 
exams each fiscal year.
    Medical treatment is estimated to cost between $14,550,000 and 
$15,890,000 in the final quarter of FY 2011 for between 4,205 and 4,282 
responders and survivors and between $58,210,000 and $68,130,000 in the 
first full year (FY 2012) of the WTC Health Program for between 16,820 
and 18,363 responders and survivors and to increase with enrollment. 
This estimate is based on an average cost in the current NIOSH WTC 
programs for these services of between $3,461 and $3,710 per patient 
under treatment and an estimated 29 percent of enrolled participants in 
current NIOSH WTC programs receiving treatment annually. However, there 
are current grantees that provide treatment services per patient 
significantly below this average cost. The range of average per patient 
costs is based on the average costs for patients having received 
treatment through the current NIOSH WTC programs and accounting for 
uncertainty in medical care inflation (3.4 percent in 2010) and the 
range of uncertainty in clinical infrastructure costs (discussed 
below).
    The initial health evaluation, medical monitoring and treatment 
cost estimates include infrastructure costs for the Clinical Centers of 
Excellence, which will provide the medical services. The infrastructure 
costs are those that the Clinical Centers would need to operate the WTC 
Health Program that are not covered by FECA, such as the costs for 
retention of participants, case management, medical review and appeals, 
benefits counseling, quality management, data transfer, interpreter 
services, and the development of treatment protocols. Beginning in FY 
2012, HHS projects annual infrastructure costs ranging from $15,400,000 
to $28,220,000, depending on competitively established contractual 
costs for operating clinical centers of excellence to carry out the 
functions described above. These infrastructure costs will be obligated 
through contracts with the Clinical Centers annually. These costs are 
included within the initial health evaluation, medical monitoring, and 
treatment cost estimates but are shown as a non-additive total in Table 
2 for the fiscal years 2012-2015, without adjustment for inflation.

   Table 2--Summary of Medical Monitoring and Treatment and Clinical Centers of Excellence Infrastructure Cost
                                                  Calculations
                                                 [In $ millions]
----------------------------------------------------------------------------------------------------------------
                                            FY 2011  (4th qtr)         FY 2012    FY 2013    FY 2014    FY 2015
----------------------------------------------------------------------------------------------------------------
Total Number of WTC Health Program   58,000.........................     58,000     58,000     58,000     58,000
 Enrollees (Low & High Estimates).   59,064.........................     63,319     67,574     71,829     76,084
----------------------------------------------------------------------------------------------------------------
                                            Initial Health Evaluation
----------------------------------------------------------------------------------------------------------------
New Enrollees......................