[Federal Register Volume 76, Number 127 (Friday, July 1, 2011)]
[Rules and Regulations]
[Pages 38913-38936]
From the Federal Register Online via the Government Publishing 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 http://www.regulations.gov. Follow the instructions for submitting comments.
     E-mail: NIOSH Docket Officer, [email protected]. 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 http://www.regulations.gov and http://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 http://www.regulations.gov or http://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 [email protected].

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

[[Page 38916]]

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, http://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......................  0..............................          0          0          0          0
                                     1,064..........................      4,255      4,255      4,255      4,255
Total Undiscounted Cost of Initial
 Health Evaluation:
    Low Estimate = $517 per person.  $0.00..........................      $0.00      $0.00      $0.00      $0.00
    High Estimate = $555 per person  $0.59..........................      $2.36      $2.36      $2.36      $2.36
----------------------------------------------------------------------------------------------------------------
                                            Annual Medical Monitoring
----------------------------------------------------------------------------------------------------------------
75% of All Enrollees, (1-year lag).  10,875.........................     43,500     43,500     43,500     43,500
                                     10,875.........................     44,298     47,489     50,681     53,872
Total Undiscounted Cost of Medical
 Monitoring:
    Low Estimate = $771 per person.  $8.38..........................     $33.54     $33.54     $33.54     $33.54
    High Estimate = $827 per person  $8.99..........................     $36.63     $39.27     $41.91     $44.55
----------------------------------------------------------------------------------------------------------------
                                                Medical Treatment
----------------------------------------------------------------------------------------------------------------
29% of All Enrollees...............  4,205..........................     16,820     16,820     16,820     16,820
                                     4,282..........................     18,363     19,596     20,830     22,064
Total Undiscounted Cost of Medical
 Treatment:
    Low Estimate = $3,461 per        $14.55.........................     $58.21     $58.21     $58.21     $58.21
     person.
    High Estimate = $3,710 per       $15.89.........................     $68.13     $72.70     $77.28     $81.86
     person.
----------------------------------------------------------------------------------------------------------------

[[Page 38923]]

 
                                             Medical Treatment Total
----------------------------------------------------------------------------------------------------------------
Low Estimate.......................  $33.73.........................     $91.75     $91.75     $91.75     $91.75
High Estimate......................  $45.14.........................    $107.12    $114.33    $121.55    $128.77
Clinical Centers Fixed
 Infrastructure Costs (non-add)
    Low Estimate...................  $10.80 (obligated).............     $15.40     $15.40     $15.40     $15.40
                                     + $3.60 (non-add)..............  .........  .........  .........  .........
    High Estimate..................  $19.67 (obligated).............     $28.22     $28.22     $28.22     $28.22
                                     + $6.56 (non-add)..............  .........  .........  .........  .........
----------------------------------------------------------------------------------------------------------------

 Congressional Budget Office Estimates Comparison
    HHS has compared the cost estimates it has derived above, based on 
the actual expenditures of the current NIOSH WTC programs, with 
estimates prepared by the Congressional Budget Office (CBO) during the 
legislative process that led to the enactment of Title XXXIII of the 
PHS Act (Congressional Budget Office, June 25, 2010). CBO used 
different methods and assumptions to produce its estimates. The purpose 
of the comparison was to consider further the baselines, assumptions 
and results of the HHS cost estimates. Excluding costs under Title 
XXXIII extraneous to this rulemaking, the CBO estimates for the first 5 
years are somewhat higher than those of HHS for each full year, but 
well within a factor of two.
    Although many of the details of CBO's methodology are not presented 
in its report, it appears to HHS that this difference is likely to be 
driven by the difference in the estimation of the prevalence of WTC-
related health conditions among responders and survivors and medical 
costs for their treatment. CBO based its health care cost estimates on 
national data summarizing medical expenditures for the health 
conditions covered by the WTC Health Program, whereas these estimates 
by HHS are based on actual expenditures in the current NIOSH WTC 
programs for these conditions. While it is unclear what prevalence of 
each individual health condition CBO applied to calculate its health 
care costs, the current actual prevalence of these conditions, to the 
extent they are receiving monitoring and treatment, is integrated in 
the HHS estimate.
    Enrollment estimates projected by CBO fall within the range of 
estimates provided in the RIA for this interim final rule. CBO 
estimated a WTC Health Program enrollment of New York City responders 
and survivors of 3,750 annually. HHS estimated enrollment of up to 
4,255 New York City responders and survivors in FY 2012 as the high 
range, the first full year, and each year following.
    CBO estimated a higher overall prevalence of WTC conditions among 
responders and survivors than HHS. CBO projected 40 percent of 
enrollees in the WTC Health Program would develop a WTC-related health 
condition; HHS cost estimates are based on 29 percent of enrollees in 
current NIOSH WTC programs currently receiving treatment for one or 
more WTC-related health conditions in the last 12 months.
Examination of Benefits (Potential Health Impacts)
    The purpose of this examination is to describe generally with 
illustrative detail the benefits that may be expected to result from 
this rule in terms of improved health of patients treated through the 
WTC Health Program.
    An assessment of the health benefits for patients treated through 
the WTC Health Program begins with identifying and estimating the 
prevalence of health conditions for which participants would be treated 
under this rule and the numbers of participants to be treated for these 
health conditions. NIOSH has information on the numbers and proportion 
of responders and survivors receiving medical treatment in the current 
NIOSH WTC programs and has projected enrollment rates in the WTC Health 
Program, as specified in the cost discussion above. This information, 
and projections of increase associated with new enrollments of 
responders and survivors in the WTC Health Program, is summarized in 
Table 3, below, which presents the upper bound annual projections of 
the total expected population of patients who will be treated under the 
WTC Health Program. These figures assume that the prevalence of each 
health condition will be and remain the same across all subgroups among 
responders and survivors in the WTC Health Program as exists presently 
for the participants in current NIOSH WTC programs. If Table 3 were 
also to present the lower bound projections of the expected population 
of patients who will be treated under the program, assuming there would 
be no increase in the enrolled population from 2010, the figures for FY 
2012-2015 would be approximately seven percent lower than the figures 
presented for FY 2012.

   TABLE 3--Estimated Prevalence of WTC-Related Health Conditions Among Enrolled/Certified WTC Health Program
                                            Responders and Survivors
                                                [High range only]
----------------------------------------------------------------------------------------------------------------
                                                              2011       2012       2013       2014       2015
----------------------------------------------------------------------------------------------------------------
Total Patients...........................................      4,282     18,363     19,596     20,830     22,064
Patients with any Physical Health Condition..............      3,775     16,190     17,277     18,365     19,453
    Upper Airway.........................................      3,175     13,616     14,530     15,445     16,360
        Chronic rhinosinusitis...........................      2,858     12,254     13,077     13,900     14,724
        Chronic nasopharyngitis..........................         64        272        291        309        327
        Chronic laryngitis...............................        222        953      1,017      1,081      1,145

[[Page 38924]]

 
        Upper airway hyperreactivity.....................          0          0          0          0          0
        Cough............................................        413      1,770      1,889      2,008      2,127
        Sleep apnea......................................        953      4,085      4,359      4,633      4,908
    Lower Airway.........................................      1,952      8,372      8,934      9,496     10,059
        Asthma...........................................      1,113      4,772      5,092      5,413      5,734
        Reactive airway dysfunction syndrome.............        683      2,930      3,127      3,324      3,521
        Chronic obstructive pulmonary disease (COPD).....        390      1,674      1,787      1,899      2,012
        Other chronic respiratory disorder due to fumes           78        335        357        380        402
         and vapors......................................
        Interstitial lung diseases.......................         98        419        447        475        503
    Gastrointestinal.....................................      2,316      9,931     10,597     11,265     11,932
        Gastroesphageal reflux...........................      2,304      9,881     10,545     11,209     11,873
    Musculoskeletal......................................        505      2,166      2,312      2,457      2,603
        Low back pain....................................        197        845        902        958      1,015
        Carpal tunnel syndrome...........................         30        130        139        147        156
        Other musculoskeletal conditions.................        424      1,820      1,942      2,064      2,186
Patients with any Mental Health Condition................      1,416      6,072      6,479      6,887      7,296
    Post traumatic stress disorder (PTSD)................        750      3,218      3,434      3,650      3,867
    Depression...........................................        878      3,764      4,017      4,270      4,523
    Panic disorder with agoraphobia......................         85        364        389        413        438
    Generalized anxiety disorder.........................        184        789        842        895        948
    Anxiety disorder NOS.................................        524      2,247      2,397      2,548      2,699
    Acute stress disorder................................         42        182        194        207        219
    Dysthymic disorder...................................         99        425        454        482        511
    Adjustment disorder..................................         71        304        324        344        365
    Substance abuse......................................      * nda        nda        nda        nda        nda
All Patients with both Physical and Mental Conditions....      1,170      5,017      5,354      5,691      6,028
----------------------------------------------------------------------------------------------------------------
* No data available.

    Based on this prevalence information, HHS has examined the health 
and quality of life improvements associated with medical treatment of 
several of the most common conditions in the covered population. The 
expected health benefits of the WTC Health Program are compared with 
those expected if there was no program after June 30, 2011. Where HHS 
has estimated such improvements quantitatively, it has assumed that the 
condition would continue to be represented among new participants in 
the WTC Health Program with the same prevalence with which it is 
occurring in current NIOSH WTC programs, as noted above. 
Notwithstanding these and other uncertainties discussed in more detail 
in the limitations section below, HHS finds the following information 
indicative of the nature and scope of health benefits expected to 
result from implementation of this rule.
    Using the expected number of patients for FY 2011-2015 from Table 
3, above, and published information on treatment effectiveness, when 
possible, a rough estimate of patient increased quality of life 
attributable to the WTC Health Program is presented for several WTC-
related health conditions. HHS used quality of life as a common metric 
of expected treatment effectiveness for all the conditions assessed. 
The assessment is based on a series of assumptions and relies on very 
limited information. As a starting point, HHS assumed that participants 
in the WTC Health Program will receive medical treatment that follows 
the New York City Department of Health and Mental Hygiene's ``Clinical 
Guidelines for Adults Exposed to the World Trade Center Disaster'' 
(Guidelines) when possible, along with published information about the 
effectiveness of specific medical treatment. The Guidelines recommend a 
coordinated approach to assessing and treating mental and physical 
health conditions but, as noted above, HHS lacks information 
identifying the occurrence of specific single or multiple health 
conditions among the patients of current NIOSH WTC programs. Therefore, 
HHS assessed the medical treatment of each condition expected to be 
prevalent in WTC Health Program participants individually. HHS also 
assumes that patients treated through the WTC Health Program will 
receive the best care available, based on the assumption that WTC 
Health Program healthcare providers would be experts in treating WTC-
related health conditions, both individually and as syndromes. Given 
the many unaddressed uncertainties of this assessment, HHS deliberately 
used methods that would underestimate potential benefits. One general 
method used for all the health conditions addressed was to assume that 
all responders and survivors will receive some but not optimal 
treatment for their conditions in the absence of the WTC Health 
Program. So the benefits estimated represent the incremental 
improvement in health patients in the WTC Health Program can expect 
from receiving the optimal treatment provided by the WTC Centers of 
Clinical Excellence versus standard treatments that are commonly 
received outside of this program.
    Limitations in deriving health benefits estimates include the 
following. There is considerable uncertainty involved in the findings 
described below due to the lack of specificity of the condition 
information (NIOSH does not have access to condition information in 
current NIOSH WTC programs by specific International Classification of 
Diseases codes), the availability of multiple medical treatments for 
each condition, and limitations of published studies on the 
effectiveness of the medical treatments available. There are other 
sources of uncertainty as well. For example, some new participants in 
the WTC Health Program, if they have not obtained treatment previously, 
may present in worse health and may benefit less from medical treatment 
than

[[Page 38925]]

participants who received timely treatment through current NIOSH WTC 
programs. Also, HHS has not given consideration in these analyses to 
the fact that some WTC Health Program participants have or will have 
multiple illnesses concurrently, which can impact the effectiveness of 
medical treatment for any given condition. HHS has also not estimated 
what the likely impact of expanded coverage and more affordable health 
care would be through health reform.
 Asthma
    The recommended treatment for asthma in the Guidelines is a 
combination of a daily inhaled corticosteroid (ICS) and a short-acting 
inhaled bronchodilator. HHS assumes that all patients in the WTC Health 
Program would be treated accordingly, compared to a hypothetical 
scenario according to which patients would be treated with a 
bronchodilator only, and compared the quality of life of these two 
groups. An alternative would have been to compare the presumed quality 
of life of WTC Health Program patients to that of untreated patients 
suffering from asthma. HHS chose the former approach because HHS lacks 
good quality empirical evidence of the effectiveness of treatment 
inside or outside WTC Health Program, and because this approach likely 
results in an underestimate of the true health benefits for these 
patients. Paltiel et al. studied adult asthma patients and projected 
their health-related quality of life outcomes for 10 years into the 
future, with and without ICS treatment.\3\ Without ICS, the quality-
adjusted life years (QALYs) of each such patient for a 10-year-long 
period were estimated to be 8.65, while with ICS they were estimated to 
be 8.94 QALYs (without discounting). The difference in QALYs between 
treatment outcomes for the period was 0.29 QALYs for each patient, 
which divided by 10 years results in 0.029 QALYs annually. Multiplying 
the WTC Health Program's asthma patient population for each year during 
FY 2011-2015 by 0.029 results in 642 total or 151 annualized 
undiscounted QALYs gained from treating asthma patients in the Program 
with ICS versus no ICS (without adjusting for deaths based on life 
expectancy tables, which would mostly be attributed to non-asthma 
related causes). As discussed above, this estimate has a high degree of 
uncertainty. To illustrate this uncertainty, HHS assumes a lower or 
higher degree of treatment effectiveness by halving or doubling the 
estimated improvement in quality of life, which results in a low 
estimate of 321 total or 76 annualized undiscounted QALYs to a high 
estimate of 1,284 total or 302 annualized undiscounted QALYs. HHS also 
applies a standard low and high discount rate of 3 percent and 7 
percent, respectively, to estimate the present value of health benefits 
occurring in the future. Under the assumption of 0.029 QALYs gained per 
year per patient under treatment, this results in 581 total or 150 
annualized QALYs when discounting future health benefits at 3 percent 
and 510 total or 146 annualized QALYs when discounting at 7 percent, 
respectively.
---------------------------------------------------------------------------

    \3\ Paltiel AD, Fuhlbrigge AL, Kitch BT, Lijas B, Weiss ST, 
Neumann PJ, Kuntz KM. 2001. Cost effectiveness of inhaled 
corticosteroids in adults with mild to moderate asthma: results from 
the Asthma Policy Model. J Allergy Clin Immunol 108(1):39-46.
---------------------------------------------------------------------------

 Reactive Airways Dysfunction Syndrome (RADS)
    According to the Guidelines, medical treatment similar to that for 
asthma can be provided for patients suffering from RADS. Using the 
assumptions described above, HHS estimates this would result in 394 
total or 93 annualized undiscounted QALYs gained from treatment of 
RADS. HHS estimates of positive health impact range from a low of 197 
total or 47 annualized undiscounted QALYs to a high of 788 total or 186 
annualized undiscounted QALYs, when assuming that half or double the 
effectiveness of treatment in improving quality of life. Assuming that 
treating one patient results in 0.029 QALYs gained and discounting 
future health benefits at 3 and 7 percent, results in 67 total or 92 
annualized QALYs and 313 total or 90 annualized QALYs, respectively.
 Chronic Obstructive Pulmonary Disease (COPD)
    The Guidelines do not address COPD treatment in detail. HHS used 
information from Briggs et al., who compared treatments of adult COPD 
patients in several countries, including the United States.\4\ 
Comparison treatments included placebo, salmeterol only, fluticasone 
propionate only, and a combination salmeterol/fluticasone propionate. 
The authors found the combination treatment was the most effective. HHS 
used the difference in QALYs between the combination treatment and 
salmeterol (0.067), which yields less health improvement than the 
combination compared to a placebo (0.077). Multiplying the WTC Health 
Program's COPD population for each year during FY 2011-2015 by 0.077 
results in 598 total or 141 annualized undiscounted QALYs gained. 
Assuming half and double the improvement in quality of life results in 
299 total or 71 annualized undiscounted QALYs gained and 1,196 total or 
282 annualized undiscounted QALYs gained, respectively. Assuming that 
treatment of one patient results in 0.077 QALYs gained and discounting 
future health benefits at 3 and 7 percent results in 541 total or 140 
annualized QALYs gained and 475 total or 137 annualized QALYs gained, 
respectively.
---------------------------------------------------------------------------

    \4\ Briggs AH, Glick HA, Lozano-Ortega G, Spencer M, Caverley 
PMA, Jones PW, Vestbo J on behalf of the Towards a Revolution in 
COPD Health (TORCH) investigators. 2010. Is treatment with ICS and 
LABA cost-effective for COPD? Multinational economic analysis of the 
TORCH study. European Respiratory Journal 35(3):532-539.
---------------------------------------------------------------------------

 Chronic Rhinosinusitis (CRS)
    The literature provides some evidence that medical treatment of 
CRS, similar to what is recommended in the Guidelines, would be as 
effective as surgery for many levels of severity of CRS.\5\ HHS did not 
find any published studies on CRS that included health-related quality 
of life related information. Ko and Coons report on mean quality of 
life for several chronic conditions in U.S. adults, that include asthma 
(0.924) and sinusitis (0.933).\6\ However, in general CRS is probably 
associated with a lower quality of life than sinusitis. Assuming that 
the improvement in CRS-related quality of life with effective treatment 
is only half that of asthma (i.e., 0.0145, see above), treating CRS 
patients through the WTC Health Program would result in 824 total or 
194 annualized undiscounted QALYs gained. Assuming half and double the 
improvement in quality of life results in 52 total or 97 annualized 
undiscounted QALYs gained and 1,648 total or 388 annualized 
undiscounted QALYs gained, respectively. Assuming that annual treatment 
of one patient results in 0.0145 QALYs gained and discounting future 
health benefits at 3 and 7 percent results in 746 total or 192 
annualized QALYs gained and 655 total or 188 annualized QALYs gained, 
respectively.
---------------------------------------------------------------------------

    \5\ Ragab SM, Lund VJ, Scadding G. 2004. Evaluation of the 
medical and surgical treatment of chronic rhinosinusitis: a 
prospective, randomized, controlled trial. Laryngoscope 11:923-930.
    \6\ Ko Y, Coons SJ. Self-reported chronic conditions and EQ-5D 
index scores in the US adult population. 2006. Current Medical 
Research and Opinions 22(10):2065-2071.
---------------------------------------------------------------------------

 Gastroesophageal Reflux (GERD)
    The Guidelines recommend the use of proton pump inhibitors (PPIs) 
for 4-8 weeks, followed by maintenance PPI (PPI on demand) to treat 
GERD. Gerson

[[Page 38926]]

et al. compared PPI on demand to several other treatments.\7\ The 
authors report 0.012 QALYs gained when comparing PPI on demand to the 
next most effective treatment they examined (continuous PPI). 
Multiplying the WTC Health Program's GERD population for each year 
during FY 2011-2015 by 0.012 results in 550 total or 129 annualized 
undiscounted QALYs gained. Assuming half and double the improvement in 
quality of life results in 275 total or 65 annualized undiscounted 
QALYs gained and 1,100 total or 258 annualized undiscounted QALYs 
gained, respectively. Assuming that annual treatment of one patient 
results in 0.012 QALYs gained and discounting future health benefits at 
3 and 7 percent results in 498 total or 128 annualized QALYs gained and 
437 total or 125 annualized QALYs gained, respectively.
---------------------------------------------------------------------------

    \7\ Gerson LB, Robbins AS, Garber A, Hornberger J, 
Triadafilopoulos G. 2000 A cost-effectiveness analysis of 
prescribing strategies in the management of gastroesophageal reflux 
disease. The American Journal of Gastroenterology 95(2): 395-407.
---------------------------------------------------------------------------

 PTSD and Depression
    One of the treatments for PTSD addressed in the Guidelines is 
exposure therapy (in combination with medication or other treatment as 
needed). Nacash et al. found a significant reduction of over 50 percent 
of PTSD and depression symptoms measured by the PSS-I (PTSD Symptom 
Scale-Interview Version) between ``treatment as usual'' and prolonged 
exposure therapy.\8\ PSS-I is roughly equivalent to CAPS, another 
longer diagnostic tool for PTSD, according to Foa and Tolin; \9\ CAPS 
has been studied in relation to quality of life by Mancino et al.\10\ 
HHS assumed that the exposure therapy treatment would result in an 
increase in quality of life that is approximately half that reported by 
Mancino as the difference between moderately severe and moderate PTSD, 
or 0.013 QALYs. This result means that WTC Health Program patients 
suffering from PTSD and depression would gain 421 total or 99 
annualized undiscounted QALYs. Assuming half and double the improvement 
in quality of life results in 211 total or 47 annualized undiscounted 
QALYs gained and 842 total or 198 annualized undiscounted QALYs gained, 
respectively. Assuming that annual treatment of one patient results in 
0.013 QALYs gained and discounting future health benefits at 3 and 7 
percent results in 381 total or 98 annualized QALYs gained and 334 
total or 96 annualized QALYs gained, respectively.
---------------------------------------------------------------------------

    \8\ Nacasch N, Foa EB, Huppert JD, Tzur D, Fostick L, Dinstein 
Y, Polliack M, Zohar J. 2010. Prolonged exposure therapy for combat- 
and terror-related posttraumatic stress disorder: a randomized 
control comparison with treatment as usual. J Clin Psychiatry 
(published online ahead of print): doi:10.4088/JCP.09m05682blu.
    \9\ Foa EB, Tolin DF. 2000. Comparison of the PTSD Symptom 
Scale-Interview Version and the Clinician-Administered PTSD Scale. 
Journal of Traumatic Stress 13(2):181-191.
    \10\ Mancino MJ, Pyne JM, Tripathi S, Constans J, Roca V, 
Freeman T. 2006. Quality-adjusted health status in veterans with 
posttraumatic stress disorder. J Nerv Ment Dis 194:877-879.
---------------------------------------------------------------------------

    In summary, available information indicates the WTC Health Program 
is likely to provide substantial improvements in health to responders 
and survivors. The discounted QALY estimates discussed above and 
summarized in Table 4 below are illustrative of these benefits. 
Annualized mid-range estimates for these six health conditions, as well 
as annualized cost estimates, are provided in Table 5 concluding these 
analyses of costs and benefits. Table 5 presents the benefits in terms 
of a range from no effect or benefit to the midrange estimated values 
of benefit to account for uncertainty regarding the number of WTC 
health program responders and survivors who might receive the same 
medical treatments for these conditions using other sources of health 
insurance coverage.

 Table 4--Potential QALYs Gained From the WTC Health Program Treatment of Select WTC-Related Health Conditions:
                                              FY 2011-2015 Summary
----------------------------------------------------------------------------------------------------------------
                                                                       Total       Present value   Present Value
                                                                   undiscounted      of QALYs        of QALYs
                                                                   QALYs gained      gained by       gained by
                        Health condition                           by treatment      treatment       treatment
                                                                    (mid-range     discounted at   discounted at
                                                                    estimates)          3%              7%
----------------------------------------------------------------------------------------------------------------
Asthma..........................................................             642             581             510
RADS............................................................             394             357             313
COPD............................................................             598             541             475
CRS.............................................................             824             746             655
GERD............................................................             550             498             437
PTSD & Depression...............................................             421             381             335
----------------------------------------------------------------------------------------------------------------


      Table 5--Accounting Statement: Annualized Costs and Select Health Benefits of the WTC Health Program
----------------------------------------------------------------------------------------------------------------
                                                 Estimate range                    Discount rate      Period
                                                   (low/high)       Year dollar         (%)           covered
----------------------------------------------------------------------------------------------------------------
Benefits (Quantified, unmonetized)
----------------------------------------------------------------------------------------------------------------
                                         Annualized (QALYs gained/year)
----------------------------------------------------------------------------------------------------------------
Asthma.......................................              0-146  ..............               7               5
                                                           0-150  ..............               3               5
RADS.........................................               0-90  ..............               7               5
                                                            0-92  ..............               3               5
COPD.........................................              0-137  ..............               7               5
                                                             140  ..............               3               5
CRS..........................................               0-88  ..............               7               5
                                                              92  ..............               3               5
GERD.........................................              0-125  ..............               7               5

[[Page 38927]]

 
                                                           0-128  ..............               3               5
PTSD & Depression............................               0-96  ..............               7               5
                                                            0-98  ..............               3               5
----------------------------------------------------------------------------------------------------------------
Transfers (Federal Government to centers under contract with the WTC Health Program)
----------------------------------------------------------------------------------------------------------------
Annualized monetized ($ million/year)........       $104-$136.08            2011               7               5
                                                 $106.70-$139.93  ..............               3               5
----------------------------------------------------------------------------------------------------------------

Regulatory Options
    Under E.O. 13563, HHS is required to ``identify and assess 
available alternatives to direct regulation.'' The provisions of this 
rule are either specifically mandated by the PHS Act to be established 
by regulation or they establish substantive rights for members of the 
public, which are issued through notice and comment rulemaking and 
codified as Federal regulations.
    E.O. 13563 also requires HHS to ``tailor its regulations to impose 
the least burden on society,'' consistent with the regulatory 
objectives, and to choose among ``alternative regulatory approaches 
those that maximize net benefits.'' However, the PHS Act provides only 
minor discretion or no discretion to HHS for the most significant 
provisions of the rule. Title XXXIII of the PHS Act specifies without 
ambiguity the following major elements: eligibility criteria for 
responders and certain survivors of the New York City attacks and 
procedures for their enrollment or certification; an initial list of 
WTC-related health conditions that may be covered by the Program and 
criteria and certain procedures for determining whether one or more of 
these conditions shall be covered for a given responder or survivor; 
criteria and procedures for determining whether a condition medically 
associated with a WTC-related health condition shall also be covered 
for a given responder or survivor; procedures for determining the 
medical necessity and hence the coverage of specific treatments for 
covered conditions; the opportunity for responders and survivors to 
appeal adverse decisions determined by the program regarding their 
enrollment, coverage for specific health conditions, or coverage of 
specific medical treatments; and the use of Federal Employee 
Compensation Act (FECA) reimbursement rates for treatments provided, 
when applicable. As a result, the very limited discretion granted to 
HHS by the PHS Act does not provide substantial opportunities for 
policy choices that would have any significant impact on burdens on 
society. Similarly, the options for alternative regulatory approaches 
are minor and can have little or no bearing on maximizing net benefits. 
However, in accordance with this latter requirement, HHS examined 
several alternative approaches to specific provisions in this rule for 
which the PHS Act provides discretion in determining the policy to be 
established. A summary of the three more substantive of these 
alternatives follows:
    Verifying Applicant Qualifications: The PHS Act does not specify 
the procedure or requirements by which the WTC Program Administrator is 
to verify the qualifications of a responder applicant in relation to 
the eligibility criteria specified by the PHS Act. The rule could 
require written documentation from the applicant's employer or other 
entity that might verify an individual's presence, residence, or 
employment, as proof of their eligibility. The rule prioritizes such 
documentation but requires applicants to attest to their eligibility as 
an alternative, together with explanation of the lack of documentation 
and their efforts to obtain such. Attestations made in lieu of 
documentation would be verified as described below. False attestations 
would be subject to penalty as noticed and specified on the application 
forms.
    HHS decided not to exclusively rely on documentation because 
experience in the current NIOSH WTC programs has demonstrated that many 
responders do not have access to such documentation; this includes many 
of the unpaid volunteers who were involved in the response effort as 
well as day laborers and other contingent workers common to the 
construction industry involved in the site remediation activities. The 
current NIOSH WTC programs have verified the eligibility of applicants 
despite this documentary limitation by comparing the specific 
information provided by an applicant during the application process 
with the applicant's exposure history obtained during the initial 
health evaluation. The WTC Health Program will continue to verify the 
responses provided by individuals on the application form by checking 
them against the responses given during the exposure assessment. Doing 
so will allow Program staff to evaluate the veracity of information 
provided by the individual and thereby assess eligibility. HHS has 
rejected the specification of a more restrictive documentary 
requirement for verifying the eligibility of responders, which would 
exclude responders who meet the statutory criteria for enrollment and 
is unnecessary for effectively assessing eligibility. HHS invites 
public comment on the appropriateness of this verification process.
    Medical Necessity Standard: The PHS Act authorizes the WTC Program 
Administrator to establish a medical necessity standard, which governs 
the approval of specific medical treatments, together with the use of 
treatment protocols to be approved by the Administrator. Public and 
private health plans all have such standards, which typically require a 
determination that procedures are reasonable and appropriate on the 
basis of professional standards of care and scientific evidence. They 
vary substantially regarding their level of detail and particular 
features, such as considerations of cost-effectiveness or exclusions of 
experimental procedures. HHS could have adopted a medical necessity 
standard from another public or private health care plan or program. 
However, HHS did not identify useful distinctions among these standards 
aside from the salient features of relying on professional standards of 
care and scientific evidence. HHS does recognize that the very 
particular exposure history of the population under care would require 
some latitude for considering expert opinion when the current state of

[[Page 38928]]

science or professional standards of care might be deficient.
    Accordingly, in the medical necessity standard included in this 
rule, HHS coupled the two salient features of other standards, relying 
on professional standards of care and scientific evidence, as well as 
the option of relying on expert opinion, with the requirement that 
treatments adhere to treatment protocols approved by the WTC Program 
Administrator, as specified in Title XXXIII of the PHS Act. HHS 
believes that this standard will adequately support the WTC Program 
Administrator to effectively and efficiently manage determinations of 
medical necessity in this Program and ensure that responders and 
survivors receive necessary medical treatments. HHS invites public 
comment on the appropriateness of this standard and whether any 
additional elements or criteria should be considered.
    Treatment Payment Rates: Title XXXIII of the PHS Act requires the 
WTC Program Administrator to reimburse costs using the FECA payment 
rate for medically necessary treatment that is covered by the FECA 
rates. For any treatment that is not covered by FECA rates, the WTC 
Program Administrator is authorized to establish payment rates, within 
the limitation that payment rates for such treatment not exceed the 
rates paid for these products and services by the Department of Labor's 
Office of Workers' Compensation. HHS is not aware of any treatment to 
be provided that is not currently covered by FECA rates. However, NIOSH 
is not fully expert in FECA coding and such a deficiency is possible. 
To address this need, HHS considered establishing rates uniquely for 
this program. HHS could have promulgated the basis for rate setting in 
this rule and then would have published rate schedules periodically to 
account for the additions of treatments, health care inflation, and 
local health care market changes. HHS decided against this approach 
because it would be highly inefficient, as such rate setting is already 
conducted by the Centers for Medicare & Medicaid Services for the far 
larger populations of patients served by its programs. Moreover, most, 
if not all, of the treatments required in this Program are covered by 
FECA rates, so the extent of the rate-setting that might be needed for 
this Program would be minor. Finally, although this Program covers a 
small population, its scope is national, as responders and survivors 
are covered wherever they might live, and over time one can expect this 
population to continually disperse for employment, retirement, and 
other reasons.
    Accordingly, HHS has decided it would adopt Medicare payment rates, 
which are updated periodically and cover all U.S. localities 
nationally. HHS believes this is optimal for several reasons: (1) The 
rates are promulgated on the basis of extensive expert analysis, which 
ensures competence in the rate setting; (2) the rates are already 
widely applied in every locality throughout the nation and hence, their 
application for this relatively minor use is unlikely to significantly 
impact any health care organization involved in this program; and (3) 
the rates meet the statutory requirement under the PHS Act of not 
exceeding rates paid by the Department of Labor's Office of Workers' 
Compensation Programs. HHS invites public comment on the 
appropriateness of this approach and whether any additional 
possibilities should be considered.

C. Paperwork Reduction Act

    CDC has determined that this interim final rule contains 
information collection and record keeping requirements that are subject 
to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3420). A 
description of these provisions is given below with an estimate of the 
annual reporting burden. Included in the estimate of the annual 
reporting burden is the time for reviewing instructions, searching 
existing data sources, gathering and maintaining the data needed, and 
completing and reviewing each collection of information. In compliance 
with the requirement of Sec.  3506(c)(2)(A) of the PRA for opportunity 
for public comment on proposed data collection projects, CDC will 
publish periodic summaries of proposed projects. To request more 
information on the proposed projects or to obtain a copy of the data 
collection plans and instruments, call 404-639-5960 and send comments 
to Daniel Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, 
MS-D74, Atlanta, GA 30333 or send an e-mail to [email protected].
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the Agency, including whether the information shall have practical 
utility; (b) the accuracy of the Agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents. 
Written comments should be received within 60 days of this notice.
    Proposed Project: World Trade Center Health Program (42 CFR 88) 
(OMB Control Number 0920-0891, expiration date 12/31/2011)--New--
National Institute for Occupational Safety and Health, Centers for 
Disease Control and Prevention.
    Background and Brief Description: Title XXXIII of the Public Health 
Service Act as amended establishes the WTC Health Program within HHS. 
The Program will provide medical monitoring and treatment benefits to 
responders to the September 11, 2001, terrorist attacks in New York 
City, at the Pentagon, and at Shanksville, PA, and survivors of the 
terrorist attacks in New York City. Title XXXIII of the PHS Act 
requires that various program provisions be established by regulation, 
and also requires that the Program begin providing benefits on July 1, 
2011.
    This interim final rule contains the data collection requirements 
that have been approved by OMB through their emergency clearance 
process under OMB Control Number 0920-0891, with an expiration date of 
December 31, 2011. The provisions in the interim final rule that 
contain data collection requirements are:
    Section 88.3 Eligibility--currently identified responders; Section 
88.7 Eligibility--currently identified survivors. These sections 
restate the eligibility criteria, as outlined in Title XXXIII, Sec.  
3311 and Sec.  3321 of the PHS Act, for WTC responders and survivors 
who have received medical monitoring and treatment benefits from the 
NIOSH WTC program. HHS estimates that approximately .5 percent of 
currently identified responders and survivors, or 290, will asked to 
provide the Program with additional information to ensure that the 
individual meets all eligibility criteria. We expect that responding to 
this inquiry will take no more than 10 minutes.
    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, and describes the types of documentation the WTC 
Program Administrator will accept as proof of eligibility.
    Two distinct but equivalent application forms will be available, 
one appropriate to members of the Fire Department, City of New York 
(FDNY) (and their eligible family members), and a second appropriate to 
members of specified law enforcement organizations and certain other 
rescue, recovery, and cleanup workers.

[[Page 38929]]

    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, and describes the types of documentation the 
WTC Program Administrator will accept as proof of eligibility.
    Section 88.11 Appeals regarding eligibility determination--
responders and survivors. This section establishes the process for 
appeals regarding eligibility determinations. The burden table reflects 
the annualized total burden (14,184/3 = 4,728), broken into the three 
separate applicant groups (Fire Department of New York responders 
(189), general responders (2,979), and survivors (1,560)). Of those 
applications, we expect that 10 percent will fail due to ineligibility. 
We further assume that 10 percent of those individuals (47 respondents) 
will appeal the decision.
    Section 88.12 Physician's Determination of WTC-Related Health 
Conditions. This section requires the collection and reporting of 
information related to the diagnosis of a WTC-related health condition 
or health condition medically associated with a WTC-related health 
condition in a WTC responder or certified-eligible survivor.
    Data collection activities in Sec.  88.12, ``Physician's 
Determination of WTC-Related Health Conditions,'' do not fall under the 
PRA because they are within one of the ten categories of inquiry 
generally not deemed to constitute information (5 CFR 1320.3(h)(1)-
(10)). Medical diagnosis and treatment, which falls under Sec.  88.12 
and Sec.  88.14 of this part, includes an initial and follow-up 
clinical examinations designed to detect health disorders, as well as 
direct treatment of clinical disorders to improve or prevent 
progression of the disorders. Results of clinical examinations and 
treatment will be used in connection with research to understand the 
disease processes and to develop better prophylactic procedures for 
healthcare of the served population. Burden associated with 
epidemiologic and other research regarding certain health conditions 
related to the September 11, 2001, terrorist attacks is not 
contemplated as part of this rulemaking.
    Data reporting from physicians to the WTC Program Administrator 
under Sec.  88.12 is subject to the PRA. Physicians will report this 
data electronically and on paper. HHS expects that 2,300 program 
physicians will spend approximately 30 minutes extracting the required 
elements from the patient records and transmitting them to NIOSH, and 
that approximately 32,361 diagnoses, or 14 per provider, will be 
reported to the WTC Health Program each year.
    Section 88.15 Appeals regarding treatment. This section establishes 
the timeline and process to appeal decisions regarding treatment 
decisions. HHS estimates that program participants will request 
certification for 32,361 health conditions each year. Of those 32,361, 
we expect that .001 percent (32) will be denied certification by the 
WTC Program Administrator. We further expect that such a denial will be 
appealed 95 percent of the time. Of the projected 19,596 enrollees who 
will receive medical care, it is estimated that 3 percent (588) will 
appeal decisions of unnecessary treatment. We estimate that the appeals 
letter will take no more than 30 minutes.
    Section 88.16 Reimbursement for medically necessary treatment, 
outpatient prescription pharmaceuticals, monitoring, initial health 
evaluations, and travel expenses. This section establishes the process 
by which a 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 a WTC responder or certified-eligible survivor may be reimbursed 
for certain transportation expenses.
    Standard U.S. Treasury form SF 3881 (OMB No. 1510-0056) will be 
used to gather necessary information from Program healthcare providers 
so that they can be reimbursed directly from the Treasury Department. 
HHS expects that approximately 200 providers and provider groups will 
submit SF 3881, which is estimated to take 15 minutes to complete. 
Providers will submit only one SF 3881.
    Pharmacies will electronically transmit reimbursement claims to the 
WTC Health Program. HHS estimates that 150 pharmacies will submit 
reimbursement claims for 39,192 prescriptions per year, or 261 per 
pharmacy; we estimate that each submission will take 1 minute.
    WTC responders or certified eligible survivors who travel more than 
250 miles to a nationwide network provider for medically necessary 
treatment may be provided necessary and reasonable transportation and 
other expenses. These individuals may submit a travel refund request 
form, which should take respondents 10 minutes. HHS expects no more 
than 10 claims per year.
    The reporting and record keeping requirements contained in these 
regulations are used by NIOSH to carry out its responsibilities related 
to the implementation of the WTC Health Program as required by law. The 
burdens imposed have been reduced to the absolute minimum considered 
necessary to permit NIOSH to carry out the purpose of the legislation, 
i.e., to implement the WTC Health Program. This emergency data 
collection is warranted because it is essential that individuals who 
wish to be enrolled, apply to the WTC Health Program, appeal a 
determination made by the WTC Program Administrator, or submit a claim 
for reimbursement have the opportunity to do so as soon as the Program 
begins.
    This new information collection request is for 19,111 burden hours.

----------------------------------------------------------------------------------------------------------------
                                                     Number of     Responses per  Average burden   Total burden
      Section                   Title               respondents     respondent     per response     (in hours)
----------------------------------------------------------------------------------------------------------------
88.3...............  Eligibility--currently                  290               1           10/60              48
                      identified responders;.
88.7...............  Eligibility--currently
                      identified survivors.
88.5...............  Application process--status             189               1           30/60              95
                      as a WTC responder (FDNY).
88.5...............  Application process--status           2,979               1           30/60           1,490
                      as a WTC responder
                      (general).
88.9...............  Application process--status           1,560               1           15/60             390
                      as a WTC survivor.
88.11..............  Appeals regarding                        47               1           30/60              24
                      eligibility
                      determinations--responders
                      and survivors.
88.12..............  Physician's determination             2,300              14           30/60          16,100
                      of health conditions in
                      WTC responders and
                      certified-eligible
                      survivors [physician
                      reporting].
88.15..............  Appeals regarding treatment             588               1           30/60             294
88.15..............  Appeals regarding                        30               1           30/60              15
                      certification of health
                      conditions.
88.16..............  Reimbursement for medically             200               1           15/60              50
                      necessary treatment,
                      monitoring, initial health
                      evaluations.

[[Page 38930]]

 
                     Outpatient prescription                 150             261            1/60             653
                      pharmaceuticals.
                     Travel expenses............              10               1           10/60               2
                                                 ---------------------------------------------------------------
    Total..........  ...........................  ..............  ..............  ..............        * 19,111
----------------------------------------------------------------------------------------------------------------
* The physician reimbursement claim under Sec.   88.16 is subtracted from the total because it is captured
  elsewhere.

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.), the Department 
will report the promulgation of this rule to Congress prior to its 
effective date.

E. Unfunded Mandates Reform Act of 1995

    Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531 
et seq.) directs agencies to assess the effects of Federal regulatory 
actions on State, local, and Tribal governments, and the private sector 
``other than to the extent that such regulations incorporate 
requirements specifically set forth in law.'' For purposes of the 
Unfunded Mandates Reform Act, this 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 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 Department has reviewed this rule in accordance with Executive 
Order 13132 regarding federalism, and has determined that it does not 
have ``federalism implications.'' The rule does not ``have substantial 
direct effects on the States, on the relationship between the national 
government and the States, or on the distribution of power and 
responsibilities among the various levels of government.''

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

    In accordance with Executive Order 13045, HHS has evaluated the 
environmental health and safety effects of this rule on children. HHS 
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, HHS has evaluated the 
effects of this rule on energy supply, distribution or use, and has 
determined that the rule will not have a significant adverse effect.

J. Plain Writing Act of 2010

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

List of Subjects in 42 CFR Part 88

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

Text of the Rule

    For the reasons discussed in the preamble, the Department of Health 
and Human Services adds 42 CFR Part 88 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--status as a WTC responder.
88.5 Application process--status as a WTC responder.
88.6 Enrollment determination--status as a WTC responder.
88.7 Eligibility--currently-identified survivors.
88.8 Eligibility criteria--status as a WTC survivor.
88.9 Application process--status as a WTC survivor.
88.10 Enrollment determination--status as a WTC survivor.
88.11 Appeals regarding eligibility determinations--responders and 
survivors.
88.12 Physician's determination of WTC-related health conditions.
88.13 WTC Program Administrator's certification of health 
conditions.
88.14 Standard for determining medical necessity.
88.15 Appeals regarding treatment.
88.16 Reimbursement for medically necessary treatment, outpatient 
prescription pharmaceuticals, monitoring, and initial health 
evaluations, and travel expenses.

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


Sec.  88.1  Definitions.

    Act means the 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), 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 review and approval by the WTC Program 
Administrator of a screening-eligible survivor as eligible for 
monitoring and treatment, or a WTC-related health condition or a health 
condition medically associated with a WTC-related health condition in a 
particular WTC responder or certified-eligible survivor for the purpose 
of reimbursement of expenses for medically necessary treatment.
    Certified-eligible survivor means:
    (1) An individual who has been identified as eligible for medical 
treatment and monitoring as of January 2, 2011; or
    (2) A screening-eligible WTC survivor who the WTC Program 
Administrator certifies to be eligible for follow-up

[[Page 38931]]

monitoring and treatment under Sec.  88.10(f).
    Clinical Center of Excellence means a center or centers under 
contract with the WTC Health Program. A Clinical Center of Excellence:
    (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 WTC survivors, or 
certified-eligible survivors;
    (2) Has experience in caring for WTC responders or screening-
eligible and certified-eligible WTC survivors;
    (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 WTC Program 
Administrator.
    Data Center means a center or centers under contract with the WTC 
Health Program to:
    (1) Receive, analyze, and report to the WTC Program Administrator 
on data that have been collected and reported to the Data Center by the 
corresponding Clinical Center(s) of Excellence;
    (2) Develop monitoring, initial health evaluation, and treatment 
protocols with respect to WTC-related health conditions;
    (3) Coordinate the outreach activities of the corresponding 
Clinical Centers of Excellence;
    (4) Establish criteria for credentialing of medical providers 
participating in the nationwide provider network;
    (5) Coordinate and administer the activities of the WTC Health 
Program Steering Committees; and
    (6) Meet periodically with the corresponding Clinical Center(s) of 
Excellence 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 a WTC 
responder, a screening-eligible or a 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 World Trade Center 
(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.
    List of WTC-related health conditions means the following disorders 
and conditions, including any other condition added to the list through 
procedures specified by the Act and under this part:
    (1) Aerodigestive disorders:
    (i) Interstitial lung disease.
    (ii) Chronic respiratory disorder [fumes/vapors].
    (iii) Asthma.
    (iv) Reactive airways dysfunction syndrome [RADS].
    (v) WTC-exacerbated chronic obstructive pulmonary disease [COPD].
    (vi) Chronic cough syndrome.
    (vii) Upper airway hyperactivity.
    (viii) Chronic rhinosinusitis.
    (ix) Chronic nasopharyngitis.
    (x) Chronic laryngitis.
    (xi) Gastroesophageal reflux disorder [GERD].
    (xii) Sleep apnea exacerbated by or related to a condition 
described in preceding paragraphs (1)(i) through (1)(xi)of this 
definition.
    (2) Mental health conditions:
    (i) Posttraumatic stress disorder.
    (ii) Major depressive disorder.
    (iii) Panic disorder.
    (iv) Generalized anxiety disorder.
    (v) Anxiety disorder [not otherwise specified].
    (vi) Depression [not otherwise specified].
    (vii) Acute stress disorder.
    (viii) Dysthymic disorder.
    (ix) Adjustment disorder.
    (x) Substance abuse.
    (3) Musculoskeletal disorders for those WTC responders who received 
any treatment for a World Trade Center (WTC)-related musculoskeletal 
disorder (as defined in this section) on or before September 11, 2003:
    (i) Low back pain.
    (ii) Carpal tunnel syndrome [CTS].
    (iii) Other musculoskeletal disorders.
    Medical emergency means a physical or mental health condition for 
which immediate treatment is necessary.
    Medically necessary treatment means the provision of services by 
physicians and other health care providers, 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 and approved by the 
WTC Program Administrator.
    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 means a network of providers throughout 
the United States under contracts with the WTC Health Program to 
provide an initial health evaluation, monitoring and treatment to 
enrolled responders and screening-eligible 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.
    Scientific/Technical Advisory Committee means the WTC Health 
Program Scientific/Technical Advisory Committee whose members are 
appointed by the WTC Program

[[Page 38932]]

Administrator to review scientific and medical evidence and to make 
recommendations to the WTC Program 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.  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.
    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.
    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-300mm-61 (codifying Title I of the James 
Zadroga 9/11 Health and Compensation Act of 2010 (Pub. L. 111-347)), to 
provide 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.
    World Trade Center (WTC) Program Administrator means 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.
    World Trade Center (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 conditions, is substantially likely to be a 
significant factor in aggravating, contributing to, or causing the 
illness or health condition or a mental health condition. A WTC-related 
health condition includes conditions on the list of WTC-related health 
conditions as specified in this definition for WTC responders and 
certified-eligible survivors, and any other condition added to the list 
of WTC-related health conditions through procedures specified by the 
Act and under this part.
    World Trade Center (WTC)-related musculoskeletal disorder means 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.
    World Trade Center (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, enrolled 
responder, screening-eligible survivor, or certified-eligible survivor 
may appoint one individual to represent his or her interests under the 
WTC Health Program. The appointment must be in writing.
    (2) There may be only one representative at any time. After one 
representative has been properly appointed, the WTC Health Program will 
not recognize another individual as a representative until the 
appointment of the first designated representative is withdrawn.
    (3) A properly appointed representative who is recognized by the 
WTC Health Program may make a request or give direction to the WTC 
Health Program regarding the eligibility or certification 
determinations 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 enrolled responder, screening-eligible survivor, or 
certified-eligible survivor 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 and 208).
    (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 a screening-eligible or certified-eligible survivor is a 
minor, a parent or guardian may act on his or her behalf.
    (b) [Reserved]


Sec.  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--status as a WTC responder.

    (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

[[Page 38933]]

    (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 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) [Reserved]
    (c) [Reserved]
    (d) [Reserved]
    (e) The WTC Program Administrator will maintain a list of WTC 
responders.


Sec.  88.5  Application process--status as a WTC responder.

    (a) An application to the WTC Health Program based on the criteria 
in Sec.  88.4 shall 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 shall attest, under penalty of 
perjury, that he or she meets the criteria specified in Sec.  88.4.
    (b) The application and supporting documentation shall be submitted 
to the WTC Program Administrator for consideration.


Sec.  88.6  Enrollment determination--status as a WTC responder.

    (a) The WTC Program Administrator will prioritize applications in 
the order in which they are received.
    (b) The WTC Program Administrator will determine if the applicant 
meets the eligibility criteria provided in Sec.  88.4 and notify the 
applicant in writing (or by e-mail if an e-mail address is provided by 
the applicant) of any deficiencies in the application or the supporting 
documentation.
    (c) Denial of enrollment.
    (1) The WTC Program Administrator will deny enrollment if the 
applicant fails to meet the applicable eligibility requirements.
    (2) The WTC Program Administrator may deny enrollment of a 
responder who is otherwise eligible and qualified if the WTC Program 
Administrator determines that 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.  88.3 and Sec.  88.4(a)(1)(ii), may be enrolled at any 
time.
    (A) The WTC Program Administrator may determine, 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.
    (B) [Reserved]
    (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 determined to be eligible for the WTC Health Program.
    (d) Notification of enrollment determination.
    (1) Applicants who meet the current eligibility criteria for WTC 
responders in Sec.  88.4 and are qualified shall be notified in writing 
by the WTC Program Administrator of the enrollment decision within 60 
calendar days of the date of receipt of the application.
    (2) If the WTC Program Administrator determines that an applicant 
is denied enrollment, the applicant will be notified in writing and 
provided an explanation, as appropriate for the determination to deny 
enrollment. The notification will inform the applicant of the right to 
appeal the initial denial of eligibility and provide instructions on 
how to file an appeal.


Sec.  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 required to submit an application to the WTC Health Program.


Sec.  88.8  Eligibility criteria--status as a WTC survivor.

    (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 Program Administrator on 
or after July 1, 2011, for a determination of eligibility for an 
initial health evaluation.
    (1) The WTC Program Administrator 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

[[Page 38934]]

    (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 employ 
ment--
    (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 
Program Administrator 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 Program Administrator will maintain a list of 
screening-eligible and certified-eligible survivors.


Sec.  88.9  Application process--status as a WTC survivor.

    (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) shall 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 shall 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 shall attest, under 
penalty of perjury, that he or she meets the criteria specified in 
Sec.  88.8.
    (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.  88.10(e)), the WTC Program Administrator 
certifies the diagnosis of a WTC-related health condition, then the 
survivor will also obtain status as a certified-eligible survivor.


Sec.  88.10  Enrollment determination--status as a WTC survivor.

    (a) Screening-eligible survivor status determination. (1) The WTC 
Program Administrator will determine if the applicant meets the 
screening-eligibility criteria pursuant to Sec.  88.8(a), and notify 
the applicant in writing (or by e-mail if an e-mail address is provided 
by the applicant) of any deficiencies in the application or the 
supporting documentation.
    (b) Denial of screening-eligible status. (1) The WTC Program 
Administrator may deny screening-eligible status if the applicant is 
ineligible under the criteria specified in Sec.  88.8(a).
    (2) The WTC Program Administrator may deny screening-eligible 
survivor status if the numerical limitation on certified-eligible 
survivors in Sec.  88.10(f)(2) 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.
    (c) Notification of screening-eligible status determination. (1) An 
individual who applies under the eligibility criteria in Sec.  88.8(a) 
will be notified of his or her status as a screening-eligible survivor 
within 60 days of the date of transmission of the application.
    (2) If the WTC Program Administrator determines that an applicant 
is denied enrollment, the applicant shall be notified in writing and 
provided an explanation, as appropriate for the determination to deny 
enrollment. The notification shall inform the applicant of the right to 
appeal the initial denial of eligibility and provide instructions on 
how to file an appeal.
    (d) Initial health evaluation for screening-eligible survivors. (1) 
A WTC Health Program Clinical Center of Excellence or a member of the 
nationwide network provider will provide the screening-eligible 
survivor an initial health evaluation to determine if the individual 
has a WTC-related health condition and is eligible for follow-up 
monitoring and treatment benefits under the WTC Health Program.
    (2) 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.
    (3) If the physician diagnoses the screening-eligible survivor with 
a WTC-related health condition, the physician shall promptly transmit 
to the WTC Program Administrator his or her determination, consistent 
with the requirements of Sec.  88.12(a).
    (e) Certified-eligible survivor status determination. (1) The WTC 
Program Administrator will prioritize certifications in the order in 
which they are received.
    (2) The WTC Program Administrator will review the physician's 
determination, render a decision regarding certification of the 
individual's diagnosed WTC-related health condition, and provide 
written notice of the decision and the reason for the decision.
    (3) If the individual's condition is certified as a WTC-related 
health condition, the individual will also be certified as a certified-
eligible survivor.
    (f) Denial of certified-eligible survivor status. (1) The WTC 
Program Administrator will deny certified-eligible status if he or she 
determines that the screening-eligible survivor does not have a WTC-
related health condition as determined pursuant to Sec. Sec.  88.12 and 
88.13 of this part.
    (2) The WTC Program Administrator may deny certified-eligible 
survivor status of an otherwise eligible and qualified screening-
eligible survivor if the WTC Program Administrator determines that 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 of this part, may be determined to certified-eligible 
survivors at any time.
    (A) The WTC Program Administrator may determine, based on the best

[[Page 38935]]

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.
    (B) [Reserved]
    (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 a certified-eligible survivor in the WTC Health Program.
    (g) Notification of certified-eligible status determination. (1) An 
individual who is certified by the WTC Program Administrator as a 
certified-eligible survivor will be notified in writing by the WTC 
Program Administrator.
    (2) If the WTC Program Administrator denies certification of the 
screening-eligible survivor's health condition, the screening-eligible 
survivor may appeal the WTC Program Administrator's decision to deny 
certification, as provided under Sec.  88.15.


Sec.  88.11  Appeals regarding eligibility determinations--responders 
and survivors.

    (a) An individual or his or her designated representative may 
appeal a denial of enrollment as a WTC responder or a denial of a 
determination of status as a screening-eligible survivor by sending a 
written letter to the WTC Program Administrator at the address 
specified in the notice of denial.
    (1) The letter shall be sent within 60 days of the date of the WTC 
Program Administrator's notification letter, and shall state the 
reasons why the individual believes the denial was incorrect and may 
include relevant new evidence not previously considered by the WTC 
Program Administrator.
    (2) Where the denial is based on information from the terrorist 
watch list, the appeal will be forwarded to the appropriate Federal 
agency.
    (b) The WTC Program Administrator will designate a Federal official 
independent of the WTC Health Program to review the appeal. The Federal 
official will issue a final decision after receipt and review.
    (c) The WTC Program Administrator may reopen and reconsider a 
denial at any time.


Sec.  88.12  Physician's determination of WTC-related health 
conditions.

    (a) A physician in a Clinical Center of Excellence or a member of 
the nationwide provider network shall promptly transmit to the WTC 
Program Administrator a diagnosis and the basis for the diagnosis of a 
WTC-related health condition or health condition medically associated 
with a WTC-related health condition. The physician's diagnosis shall 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 shall 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.  88.13  WTC Program Administrator's certification of health 
conditions.

    (a) WTC-related health condition. (1) The WTC Program Administrator 
will review each physician determination, render a decision regarding 
certification, and notify the WTC responder, screening-eligible 
survivor, or certified-eligible survivor of the WTC Program 
Administrator's decision and the reason for the decision in writing.
    (2) If certification is denied, the WTC responder, screening-
eligible survivor, or certified-eligible survivor may appeal the WTC 
Program Administrator's decision to deny certification, as provided 
under Sec.  88.15.
    (b) Health condition medically associated with a WTC-related health 
condition. (1) The WTC Program Administrator will review each physician 
determination, render a decision regarding certification, and notify 
the WTC responder or certified-eligible survivor in writing of the WTC 
Program Administrator's decision and the reason for the decision.
    (i) In the course of review, the WTC Program Administrator may seek 
a recommendation about certification from a physician panel with 
appropriate expertise for the condition.
    (ii) [Reserved]
    (2) If certification is denied, the WTC responder or certified-
eligible survivor may appeal the WTC Program Administrator's decision 
to deny certification, as provided under Sec.  88.15.
    (c) Treatment pending certification. While certification is 
pending, authorization for treatment of a WTC-related health condition 
or a health condition medically associated with a WTC-related health 
condition shall be obtained from the WTC Program Administrator before 
treatment is provided, except for the provision of treatment for a 
medical emergency.


Sec.  88.14  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 and approved by the 
WTC Program Administrator.


Sec.  88.15  Appeals regarding treatment.

    (a) Individuals may appeal the following decisions made by the WTC 
Program Administrator: not to certify a health condition as a WTC-
related condition; not to certify a health condition as medically 
associated with a WTC-related health condition; or not to authorize 
treatment due to a determination by the WTC Program Administrator about 
medical necessity for a certified WTC-related health condition.
    (1) A WTC responder, screening-eligible survivor denied status as a 
certified-eligible survivor, certified-eligible survivor, or designated 
representative may appeal a determination by the WTC Program 
Administrator denying certification of the individual's health 
condition for coverage under the WTC Health Program or a determination 
that treatment will not be authorized as medically necessary.
    (2) Appeal shall be made in writing, describe the reason(s) why the 
individual believes the determination is incorrect, and be postmarked 
within 60 calendar days of the date of the WTC Program Administrator's 
letter notifying the individual of the WTC Program Administrator's 
adverse determination. No new documentation will be considered in the 
appeal process that was not available to the WTC Program Administrator 
at the time of his or her initial determination.
    (b) Review of appeal. (1) The WTC Program Administrator will 
appoint a Federal official to conduct the appeal.
    (2) The Federal official may convene one or more qualified experts, 
independent of the WTC Health Program, to review the WTC Program 
Administrator's initial determination. The expert reviewers shall base 
their review and recommendation on the documentation available to the 
WTC Program Administrator when the initial determination was made. The 
reviewers

[[Page 38936]]

shall submit their findings to the Federal official.
    (3) The Federal official shall review the expert reviewers' 
findings and make a final determination, which will be sent to the WTC 
Program Administrator and the individual who filed the appeal. No 
further requests for review of this final determination will be 
considered.
    (c) At any time, the WTC Program Administrator may reopen a final 
determination (pursuant to paragraph (b)(2) of this section) and may 
affirm, vacate, or modify such final determination in any manner he or 
she deems appropriate.


Sec.  88.16  Reimbursement for medically necessary treatment, 
outpatient prescription pharmaceuticals, monitoring, initial health 
evaluations, and travel expenses.

    (a) Medically necessary treatment and outpatient prescription 
pharmaceuticals. (1) The costs of providing medically necessary 
treatment or services for a WTC-related health condition or a health 
condition medically associated with a WTC-related health condition by a 
Clinical Center of Excellence or by a member of the nationwide provider 
network will be reimbursed according to the payment rates that apply to 
the provision of such treatment and services by the facility under the 
Federal Employees Compensation Act (5 U.S.C. 8101 et seq., 20 CFR Part 
20).
    (i) The WTC Program Administrator will reimburse a Clinical Center 
of Excellence or a member of the nationwide provider network for 
treatment not covered under the Federal Employees Compensation Act 
pursuant to the applicable Medicare fee for service rate, as determined 
appropriate by the WTC Program Administrator.
    (ii) [Reserved]
    (2) 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 Program Administrator under a 
contract with one or more pharmaceutical providers.
    (b) Monitoring and initial health evaluations. (1) Payment for the 
costs of providing monitoring and initial health evaluations to a WTC 
responder, screening-eligible survivor, or certified-eligible survivor 
by a Clinical Center of Excellence or a member of the nationwide 
provider network will be reimbursed according to the payment rates that 
would apply to the provision of such treatment and services under the 
Federal Employees Compensation Act (5 U.S.C. 8101 et seq., 20 CFR Part 
20).
    (c) Review of claims for reimbursement for medically necessary 
treatment. (1) Each claim for reimbursement for treatment will be 
reviewed by the WTC Program Administrator.
    (2) If the WTC Program Administrator determines that the treatment 
is not medically necessary, reimbursement will be withheld by the WTC 
Program Administrator.
    (d) Transportation and travel expenses. The WTC Program 
Administrator may provide for necessary and reasonable transportation 
and expenses incident to the securing of medically necessary treatment 
through the nationwide provider network, involving travel of more than 
250 miles.

    Dated: May 6, 2011.
Kathleen Sebelius,
Secretary, Department of Health and Human Services.
[FR Doc. 2011-16488 Filed 6-29-11; 8:45 am]
BILLING CODE 4163-18-P