38914 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 

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. 

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 erulemaking portal at http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• E-mail: NIOSH Docket Officer, 

nioshdocket@cdc.gov. Include ‘‘RIN 

0920–AA44’’ and ‘‘42 CFR 88’’ in the 

subject line of the message. 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

Instructions: All submissions received 

must include the agency name and 

docket number or Regulation Identifier 

Number (RIN) for this rulemaking. All 

comments will be posted without 

change to 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 

wtcpublicinput@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

This preamble is organized as follows: 

I. Public Participation 

II. Background 

A. WTC Medical Monitoring and 

Treatment Program and Environmental 

Health Center Community Program 

History 

B. WTC Health Program Statutory 

Authority 

C. Implementation of the WTC Health 

Program 

III. Issuance of an Interim Final Rule With 

Immediate Effective Date 

IV. Summary of Interim Final Rule 

V. Regulatory Assessment Requirements 

A. Executive Order 12866 and Executive 

Order 13563 

B. Regulatory Flexibility Act 

C. Paperwork Reduction Act 

D. Small Business Regulatory Enforcement 

Fairness Act 

E. Unfunded Mandates Reform Act of 1995 

F. Executive Order 12988 (Civil Justice) 

G. Executive Order 13132 (Federalism) 

H. Executive Order 13045 (Protection of 

Children From Environmental Health 

Risks and Safety Risks) 

I. Executive Order 13211 (Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use) 

J. Plain Writing Act of 2010 

I. Public Participation 

Interested persons or organizations 

are invited to participate in this 

rulemaking by submitting written views, 

opinions, recommendations, and data. 

Comments received, including 

attachments and other supporting 

materials, are part of the public record 

and subject to public disclosure. Do not 

include any information in your 

comment or supporting materials that 

you consider confidential or 

inappropriate for public disclosure. 

HHS will consider those submissions 

and may revise the final rule as 

appropriate. 

Comments are invited on any topic 

related to this interim final rule. In 

addition, HHS invites comments 

specifically on the following questions 

related to this rulemaking: 

1. The PHS Act requires ‘‘1 day’’ of 

presence for a number of eligibility 

criteria for firefighters and related 

personnel (see § 88.4(a)(1) of the interim 

final rule text), members of the New 

York City Police Department (see 

§ 88.4((a)(2)(ii)), and vehicle 

maintenance-workers (see § 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 


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Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 38915 

1Title 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. 

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. 

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, 

§ 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 § 3306 of Title XXXIII of the 

PHS Act, the WTC Program 

Administrator is responsible for a 

program to enroll qualified firefighters 

and related personnel, law enforcement 

officers, and rescue, recovery and 

cleanup workers who responded to the 

New York City, Pentagon, and 

Shanksville, PA disaster sites; screen 

and certify qualified survivors of the 

New York City attacks; and to establish 

a nationwide system of healthcare 

providers to provide monitoring and 

treatment to those individuals found 

eligible. The WTC Program 

Administrator is also required to 

promulgate regulations to determine 

medical necessity with respect to 


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38916 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 

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 § 88.3 of the interim final rule, or 

who meets the eligibility criteria in 

§ 88.4) must fill out an application form 

indicating that he or she meets certain 

eligibility criteria described in § 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 § 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 certifiedeligible 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 § 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 WTCrelated health conditions, is substantially 

likely to be a significant factor in aggravating, 

contributing to, or causing the illness or 

condition (Title XXXIII, § 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 


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


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38918 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 

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, 

§ 3311 of the PHS Act, for WTC 

responders who have received medical 

monitoring and treatment benefits from 

the MMTP program. Under § 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 § 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, vehiclemaintenance 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 § 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 

§ 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 (§ 3311(a)(4), 

§ 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 

§ 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 


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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 screeningeligible survivors can become certifiedeligible 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, § 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 § 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 screeningeligible or certified-eligible survivor. 

The WTC Program Administrator will 

evaluate applications for screeningeligible status on a first-come, firstserved 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 § 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 screeningeligible. 

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 WTCrelated 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 screeningeligible 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 § 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 


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2U.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. 

certification. Paragraph (b) establishes 

that the physician must provide 

documentation that a health condition 

medically associated with a WTCrelated 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 § 88.12. If the 

WTC Program Administrator determines 

that a diagnosed condition is a WTCrelated 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 WTCrelated 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 screeningeligible or certified-eligible survivor 

may appeal the decision pursuant to the 

process in § 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 WTCrelated health condition is pending, 

unless treatment is necessary for a 

medical emergency. As established by 

§ 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 workrelated 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. 


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

only) 

FY 2012 FY 2013 FY 2014 FY 2015 

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 


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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 nonadditive 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 Enrollees (Low & High Estimates) 58,000 ....................

59,064 ....................

58,000 

63,319 

58,000 

67,574 

58,000 

71,829 

58,000 

76,084 

Initial Health Evaluation 

New Enrollees ............................................................................................. 0 .............................

1,064 ......................

0 

4,255 

0 

4,255 

0 

4,255 

0 

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 ....................

10,875 ....................

43,500 

44,298 

43,500 

47,489 

43,500 

50,681 

43,500 

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 ......................

4,282 ......................

16,820 

18,363 

16,820 

19,596 

16,820 

20,830 

16,820 

22,064 

Total Undiscounted Cost of Medical Treatment: 

Low Estimate = $3,461 per person ...................................................... $14.55 .................... $58.21 $58.21 $58.21 $58.21 

High Estimate = $3,710 per person ..................................................... $15.89 .................... $68.13 $72.70 $77.28 $81.86 


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Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 38923 

TABLE 2—SUMMARY OF MEDICAL MONITORING AND TREATMENT AND CLINICAL CENTERS OF EXCELLENCE

INFRASTRUCTURE COST CALCULATIONS—Continued 

[In $ millions] 

FY 2011 

(4th qtr) FY 2012 FY 2013 FY 2014 FY 2015 

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) ..

+ $3.60 (non-add) ..

$15.40 $15.40 $15.40 $15.40 

High Estimate ....................................................................................... $19.67 (obligated) ..

+ $6.56 (non-add) ..

$28.22 $28.22 $28.22 $28.22 

• 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 


jlentini on DSK4TPTVN1PROD with RULES3
38924 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 

TABLE 3—ESTIMATED PREVALENCE OF WTC-RELATED HEALTH CONDITIONS AMONG ENROLLED/CERTIFIED WTC HEALTH

PROGRAM RESPONDERS AND SURVIVORS—Continued 

[High range only] 

2011 2012 2013 2014 2015 

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 and vapors ....................... 78 335 357 380 402 

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 


jlentini on DSK4TPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 38925 

3Paltiel 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. 

4Briggs 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. 

5Ragab 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. 

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. 

• 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. 

• 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 healthrelated 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. 

• 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 


jlentini on DSK4TPTVN1PROD with RULES3
38926 Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 

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. 8Nacasch 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. 9Foa 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. 

10Mancino 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. 

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. 

• 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. 

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

Health condition 

Total 

undiscounted 

QALYs gained 

by treatment 

(mid-range 

estimates) 

Present value 

of QALYs 

gained by 

treatment 

discounted at 

3% 

Present Value 

of QALYs 

gained by 

treatment 

discounted at 

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 

(low/high) Year dollar Discount rate (%) 

Period 

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 


jlentini on DSK4TPTVN1PROD with RULES3
Federal Register / Vol. 76, No. 127 / Friday, July 1, 2011 / Rules and Regulations 38927 

TABLE 5—ACCOUNTING STATEMENT: ANNUALIZED COSTS AND SELECT HEALTH BENEFITS OF THE WTC HEALTH

PROGRAM—Continued 

Estimate range 

(low/high) Year dollar Discount rate (%) 

Period 

covered 

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 

$106.70–$139.93 

2011 

........................

7 

3 

5 

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 


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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 § 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 omb@cdc.gov. 

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, § 3311 and § 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. 


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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 screeningeligible 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 WTCrelated 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 § 88.12, 

‘‘Physician’s Determination of WTCRelated 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 § 88.12 and § 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 

§ 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. 

Section Title Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

Total burden 

(in hours) 

88.3 ........ Eligibility—currently identified responders; .................................. 290 1 10/60 48 

88.7 ........ Eligibility—currently identified survivors.

88.5 ........ Application process—status as a WTC responder (FDNY) ........ 189 1 30/60 95 

88.5 ........ Application process—status as a WTC responder (general) ...... 2,979 1 30/60 1,490 

88.9 ........ Application process—status as a WTC survivor ......................... 1,560 1 15/60 390 

88.11 ...... Appeals regarding eligibility determinations—responders and 

survivors.

47 1 30/60 24 

88.12 ...... Physician’s determination of health conditions in WTC responders and certified-eligible survivors [physician reporting].2,300 14 30/60 16,100 

88.15 ...... Appeals regarding treatment ....................................................... 588 1 30/60 294 

88.15 ...... Appeals regarding certification of health conditions .................... 30 1 30/60 15 

88.16 ...... Reimbursement for medically necessary treatment, monitoring, 

initial health evaluations.

200 1 15/60 50 


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Section Title Number of 

respondents 

Responses 

per 

respondent 

Average 

burden per 

response 

Total burden 

(in hours) 

Outpatient prescription pharmaceuticals ..................................... 150 261 1/60 653 

Travel expenses .......................................................................... 10 1 10/60 2 

Total ...................................................................................................... ........................ ........................ ........................ * 19,111 

* The physician reimbursement claim under § 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 WTCrelated 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. 

§ 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 WTCrelated 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 


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monitoring and treatment under 

§ 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 WTCrelated health condition. 

Initial health evaluation means 

assessment of one or more symptoms 

that may be associated with a WTCrelated health condition and includes a 

medical and exposure history, a 

physical examination, and additional 

medical testing as needed to evaluate 

whether the individual has a WTCrelated health condition and is eligible 

for treatment under the WTC Health 

Program. 

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 WTCrelated 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 WTCrelated 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 certifiedeligible survivors who live outside the 

New York metropolitan area. 

New York City disaster area means an 

area within New York City that is the 

area of Manhattan that is south of 

Houston Street and any block in 

Brooklyn that is wholly or partially 

contained within a 1.5-mile radius of 

the former World Trade Center complex. 

New York metropolitan area means 

the combined statistical areas 

comprising the Bridgeport-StamfordNorwalk, CT Metropolitan Statistical 

Area; Kingston, NY Metropolitan 

Statistical Area; New Haven-Milford, CT 

Metropolitan Statistical Area; New 

York-Northern New Jersey-Long Island, 

NY–NJ–PA Metropolitan Statistical 

Area; Poughkeepsie-NewburghMiddletown, NY Metropolitan 

Statistical Area; Torrington, CT 

Micropolitan Statistical Area; TrentonEwing, 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 


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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 WTCrelated health condition and meets the 

eligibility criteria for a survivor 

specified in § 88.8 of this part. 

September 11, 2001, terrorist attacks 

means the terrorist attacks that occurred 

on September 11, 2001, in New York 

City, at Shanksville, Pennsylvania, and 

at the Pentagon, and includes the 

aftermath of such attacks. 

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 WTCrelated 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 § 88.3 or who 

meets the eligibility criteria in § 88.4. 

§ 88.2 General provisions. 

(a) Designated representative. (1) An 

applicant, enrolled responder, 

screening-eligible survivor, or certifiedeligible 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, screeningeligible 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 certifiedeligible survivor is a minor, a parent or 

guardian may act on his or her behalf. 

(b) [Reserved] 

§ 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. 

§ 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 § 88.3 of this part 

may apply for enrollment in the WTC 

Health Program on or after July 1, 2011. 

Such individuals must meet the criteria 

in one of the following categories to be 

considered eligible for enrollment: 

(1) Firefighters and related personnel 

must meet the criteria specified in 

paragraph (a)(1)(i) or (ii) of this section: 

(i) The individual was an active or 

retired member of the Fire Department, 

City of New York (whether firefighter or 

emergency personnel), and participated 

at least 1 day in the rescue and recovery 

effort at any of the former World Trade 

Center sites (including Ground Zero, the 

Staten Island Landfill, or the New York 

City Chief Medical Examiner’s Office), 

during the period beginning on 

September 11, 2001, and ending on July 

31, 2002; or 

(ii) The individual is: 

(A) A surviving immediate family 

member of an individual who was an 

active or retired member of the Fire 

Department, City of New York (whether 

firefighter or emergency personnel), 

who was killed at Ground Zero on 

September 11, 2001, and 

(B) Received any treatment for a WTCrelated mental health condition on or 

before September 1, 2008. 

(2) Law enforcement officers and 

WTC rescue, recovery, and cleanup 

workers must meet the criteria specified 

in paragraph (a)(2)(i) or (ii) of this 

section: 

(i) The individual worked or 

volunteered onsite in rescue, recovery, 

debris cleanup, or related support 

services in lower Manhattan (south of 

Canal Street), the Staten Island Landfill, 

or the barge loading piers, for at least: 

(A) 4 hours during the period 

beginning on September 11, 2001, and 

ending on September 14, 2001; or 


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(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. 

§ 88.5 Application process—status as a 

WTC responder. 

(a) An application to the WTC Health 

Program based on the criteria in § 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 § 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 § 88.4. 

(b) The application and supporting 

documentation shall be submitted to the 

WTC Program Administrator for 

consideration. 

§ 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 § 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 § 88.3 and § 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 § 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. 

§ 88.7 Eligibility—currently identified 

survivors. 

(a) Survivors who have been 

identified as eligible for medical 

treatment and monitoring as of January 

2, 2011, are considered certified-eligible 

in the WTC Health Program. 

(1) No individual who is determined 

to be a positive match to the terrorist 

watch list maintained by the Federal 

government will be considered to be a 

certified-eligible survivor in the WTC 

Health Program. 

(2) [Reserved] 

(b) Survivors identified as certifiedeligible under this section are not 

required to submit an application to the 

WTC Health Program. 

§ 88.8 Eligibility criteria—status as a WTC 

survivor. 

(a) Criteria for status as a screeningeligible survivor. An individual who is 

not a WTC responder, claims symptoms 

of a WTC-related health condition, and 

who has not been previously identified 

as eligible under § 88.7 may apply to the 

WTC 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 


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(B) 30 days during the period 

beginning on September 11, 2001, and 

ending on July 31, 2002. 

(iii) The screening applicant worked 

as a cleanup worker or performed 

maintenance work in the New York City 

disaster area during the period 

beginning on September 11, 2001, and 

ending on January 10, 2002, and had 

extensive exposure to WTC dust as a 

result of such work. 

(iv) The screening applicant: 

(A) Was deemed eligible to receive a 

grant from the Lower Manhattan 

Development Corporation Residential 

Grant Program; 

(B) Possessed a lease for a residence 

or purchased a residence in the New 

York City disaster area; and 

(C) Resided in such residence during 

the period beginning on September 11, 

2001, and ending on May 31, 2003. 

(v) The screening applicant is 

an individual whose place of 

employment— 

(A) At any time during the period 

beginning on September 11, 2001, and 

ending on May 31, 2003, was in the 

New York City disaster area; and 

(B) Was deemed eligible to receive a 

grant from the Lower Manhattan 

Development Corporation WTC Small 

Firms Attraction and Retention Act 

program or other government incentive 

program designed to revitalize the lower 

Manhattan economy after the September 

11, 2001, terrorist attacks. 

(2) [Reserved] 

(b) Criteria for status as a certifiedeligible survivor. Survivors who have 

been determined to have screeningeligible status under § 88.10(a), may 

seek status as a certified-eligible 

survivor. Status as a certified-eligible 

survivor is based on a certification by 

the WTC 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. 

§ 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 § 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 

§ 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 screeningeligible survivor’s initial health 

evaluation (see § 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. 

§ 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 § 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 § 88.8(a). 

(2) The WTC Program Administrator 

may deny screening-eligible survivor 

status if the numerical limitation on 

certified-eligible survivors in 

§ 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 § 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 WTCrelated health condition, the physician 

shall promptly transmit to the WTC 

Program Administrator his or her 

determination, consistent with the 

requirements of § 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 certifiedeligible status if he or she determines 

that the screening-eligible survivor does 

not have a WTC-related health 

condition as determined pursuant to 

§§ 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 § 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 


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available evidence, that sufficient funds 

are available under the WTC Health 

Program Fund to provide treatment and 

monitoring only for individuals who 

have already been certified as certifiedeligible survivors at that time. 

(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 screeningeligible survivor’s health condition, the 

screening-eligible survivor may appeal 

the WTC Program Administrator’s 

decision to deny certification, as 

provided under § 88.15. 

§ 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. 

§ 88.12 Physician’s determination of WTCrelated 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 WTCrelated 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. 

§ 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 certifiedeligible 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 § 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 certifiedeligible 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 § 88.15. 

(c) Treatment pending certification. 

While certification is pending, 

authorization for treatment of a WTCrelated 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. 

§ 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. 

§ 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, screeningeligible survivor denied status as a 

certified-eligible survivor, certifiedeligible 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 


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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. 

§ 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 WTCrelated 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 WTCrelated 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 certifiedeligible 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 


jlentini on DSK4TPTVN1PROD with RULES3