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United States Government Accountability Office: GAO: 

Report to the Ranking Member, Committee on Homeland Security and 
Governmental Affairs, U.S. Senate: 

July 2014: 

World Trade Center Health Program: 

Approach Used to Add Cancers to List of Covered Conditions Was 
Reasonable, but Could Be Improved: 

GAO-14-606: 

GAO Highlights: 

Highlights of GAO-14-606, a report to the Ranking Member, Committee on 
Homeland Security and Governmental Affairs, U.S. Senate. 

Why GAO Did This Study: 

The WTCHP provides health benefits to eligible responders and 
survivors of the September 11, 2001, attacks. In September 2012, the 
WTCHP added 60 types of cancer to the list of covered conditions. The 
VCF—-which provides financial compensation to eligible individuals—- 
uses the WTCHP list as a basis for eligibility. GAO was asked to 
review the WTCHP Administrator's approach to add cancers and the 
effects of the additions on the WTCHP and VCF. This report (1) 
describes and assesses the approach for adding cancers to the list of 
covered conditions, (2) describes the effects the addition has had on 
the WTCHP, and (3) describes the effects the addition has had on the 
VCF. GAO reviewed relevant laws and documents, interviewed WTCHP 
officials, and convened a meeting of experts with the assistance of 
the Institute of Medicine. GAO examined data for services paid by the 
WTCHP from October 2012 through March 2014, and VCF claims data as of 
March 31, 2014. 

What GAO Found: 

The Administrator of the World Trade Center Health Program (WTCHP)-—a 
program of the Department of Health and Human Services (HHS)-—used a 
hazard-based, multiple-method approach to determine whether to add 
cancers to the WTCHP list of covered conditions for which treatment 
may be provided at no cost to an enrollee. Experts who participated in 
a meeting held by GAO indicated that the Administrator's approach was 
reasonable but could be improved. 

* According to these experts, a hazard-based approach focuses on 
identifying whether particular “hazards”—-sources of potential harm—- 
are associated with certain health conditions, and does not attempt to 
quantify the risks of developing those health conditions. The 
Administrator's approach used four methods to determine whether there 
was an association between a September 11 exposure and a specific 
cancer, and thus, whether to add that cancer to the list.

* The experts considered the approach reasonable given the WTCHP 
certification process for enrollees to obtain coverage for treatment 
for a condition on the list, the lack of data related to exposure 
levels and risks, and the use of similar approaches by previous 
federal compensation programs.

* The experts indicated the approach could have been communicated more 
clearly. For example, the description of the approach in rulemaking 
did not clearly articulate how decisions would be made when evidence 
under one method supported adding a cancer type to the list, and 
evidence under a different method did not. The Administrator noted 
that this omission was an oversight. Since the Administrator plans to 
use the same approach in future cancer-related decision making, the 
absence of a clear description can lead to questions about the 
credibility and equity of the program.

* According to the experts, an independent peer review process similar 
to that used in other federal compensation programs could improve the 
approach. According to the Administrator, this was not feasible due to 
time constraints imposed by law. A process through which an 
independent party assesses the validity of the information upon which 
decisions are being made and that rationales for decisions are clearly 
described could help ensure the credibility of the Administrator's 
approach. 

WTCHP spending (claims paid) directly attributable to the addition of 
cancers to the list of covered conditions accounted for 6.5 percent of 
its total spending on services from October 2012 (when cancers were 
added) through March 2014. The addition of cancers to the list led to 
the need for a third-party administrator to help the program provide 
uninterrupted cancer-related services to enrollees who had been 
receiving care outside of the program. WTCHP and other officials 
reported that the addition of cancers has helped ensure enrollees have 
access to high-quality cancer care, which may contribute to better 
health outcomes, but required increased WTCHP staff to accommodate the 
program's growing scope. 

The effects on the Department of Justice's September 11th Victim 
Compensation Fund (VCF) of adding cancers to the list of covered 
conditions are not yet known because there have been a small number of 
compensation decisions. Of the 502 compensation decisions made as of 
March 31, 2014, only 39 were for claimants with cancer, either alone 
or in combination with other conditions. 

What GAO Recommends: 

GAO recommends that, to help ensure future decisions are equitable and 
credible, HHS direct the WTCHP Administrator to communicate clearly 
the approach used for determining whether to add conditions to its 
list, and include an independent peer review in the approach, seeking 
authority to extend time frames if necessary. HHS supports these 
recommendations, but noted concerns with including a peer review given 
statutory time frames. GAO acknowledges the time constraints by 
recommending HHS seek authority to extend the time frames if necessary. 

View [hyperlink, http://www.gao.gov/products/GAO-14-606]. For more 
information, contact Debra Draper at (202) 512-7114 or draperd@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

Experts Indicated That the WTCHP Administrator's Hazard-Based Approach 
Was Reasonable, but Could Be Improved: 

Addition of Cancers to the List of Covered Conditions Accounted for a 
Small Portion of Spending and Led to the Need for a Third-Party 
Administrator: 

The Effects on the VCF of Adding Cancers to the List of Covered 
Conditions Are Not Yet Known: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Composition of the World Trade Center Health Program 
Scientific/Technical Advisory Committee: 

Appendix II: List of Participants in GAO's Expert Meeting Hosted by 
the Institute of Medicine, October 21, 2013: 

Appendix III: Cancers Added to the WTCHP List of Covered Conditions: 

Appendix IV: Comments from the Department of Health and Human Services: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: World Trade Center Health Program (WTCHP) Contracts for the 
Provision of Services: 

Table 2: World Trade Center Health Program (WTCHP) Claims Paid, from 
October 2012 through March 2014: 

Table 3: Spending for World Trade Center Health Program (WTCHP) 
Clinical Center of Excellence (CCE) Subcontracts with HealthSmart to 
Provide Cancer-Related Services, from October 2012 through March 2014: 

Table 4: Status of September 11th Victim Compensation Fund (VCF) 
Claimant Submissions and Compensation Decisions as of March 31, 2014: 

Figure: 

Figure 1: World Trade Center Health Program (WTCHP) Administrator's 
Stated Approach to Determining Whether to Add Cancers to the Program's 
List of Covered Conditions, as Published in the September 12, 2012, 
Final Rule: 

Abbreviations: 

CCE: Clinical Center of Excellence: 

CDC: Centers for Disease Control and Prevention: 

DOJ: Department of Justice: 

HHS: Department of Health and Human Services: 

IOM: Institute of Medicine: 

NPN: Nationwide Provider Network: 

NIH: National Institutes of Health: 

NIOSH: National Institute for Occupational Safety and Health: 

STAC: Scientific/Technical Advisory Committee: 

VCF: September 11th Victim Compensation Fund: 

WTC: World Trade Center: 

WTCHP: World Trade Center Health Program: 

Zadroga Act: James Zadroga 9/11 Health and Compensation Act of 2010: 

[End of section] 

United States Government Accountability Office: GAO:
441 G St. N.W. 
Washington, DC 20548: 

July 23, 2014: 

The Honorable Tom Coburn, M.D. 
Ranking Member: 
Committee on Homeland Security and Governmental Affairs: United States 
Senate: 

Dear Dr. Coburn: 

The September 11, 2001, attacks caused great loss of life and directly 
affected the long-term physical and mental health of many exposed to 
the event. In particular, in the New York City area, the collapse of 
the World Trade Center (WTC) and the burning of adjacent buildings 
produced a dense dust and smoke cloud containing toxic compounds. 
Responders and survivors[Footnote 1] exposed to these and other 
hazards experienced a wide range of physical and emotional trauma 
following the attacks, and many continue to experience problems or 
have been newly diagnosed.[Footnote 2] However, determining the exact 
relationships between exposure to specific substances from the attacks 
and particular health conditions has been challenging.[Footnote 3]

In light of health problems among responders and survivors following 
the September 11 attacks, the President signed the James Zadroga 9/11 
Health and Compensation Act of 2010 (Zadroga Act) on January 2, 2011. 
[Footnote 4] The act (1) established the World Trade Center Health 
Program (WTCHP) to provide, beginning July 1, 2011, medical monitoring 
and treatment benefits to responders and survivors enrolled in the 
program,[Footnote 5] and (2) reactivated the September 11th Victim 
Compensation Fund (VCF) to provide expanded compensation to 
individuals who suffered physical harm as a result of the attacks. 
[Footnote 6] The act appropriated amounts not to exceed about $1.6 
billion to support the WTCHP for the last quarter of fiscal year 2011 
and for fiscal years 2012 through 2016,[Footnote 7] and about $2.8 
billion for the VCF's period of reactivation (Oct. 3, 2011, through 
Oct. 3, 2016).[Footnote 8] The WTCHP is administered by the Centers 
for Disease Control and Prevention (CDC), an agency within the 
Department of Health and Human Services (HHS); specifically, the WTCHP 
Administrator is the director of CDC's National Institute for 
Occupational Safety and Health (NIOSH). The Department of Justice 
(DOJ) administers the VCF.

The Zadroga Act established a WTCHP list of covered conditions for 
which treatment may be provided at no cost to a WTCHP enrollee if the 
program determines that exposure to the September 11 attacks was 
"substantially likely to be a significant factor in aggravating, 
contributing to, or causing" the enrollee's condition.[Footnote 9] The 
list included certain aerodigestive disorders,[Footnote 10] 
musculoskeletal disorders, and mental health conditions. The WTCHP 
Administrator is authorized to consider the addition of other 
conditions to the list and must respond to petitions that request the 
addition of conditions to the list.[Footnote 11] The Special Master of 
the VCF decided to rely on the medical judgment of the WTCHP and use 
its list of covered conditions as the basis for determining 
eligibility for VCF compensation.[Footnote 12]

In response to a September 2011 petition from members of Congress to 
consider the addition of cancer to the list of covered conditions, the 
WTCHP Administrator created an approach for determining whether 
conditions should be added.[Footnote 13] Although the Zadroga Act 
required the Administrator to respond to petitions to add conditions 
to the list within a specific time frame, it did not prescribe a 
particular approach for determining whether conditions should be 
added.[Footnote 14] As a result of his review of evidence, in 
September 2012, the Administrator expanded the list to include 60 
types of cancer.[Footnote 15] Coverage for these cancer types became 
effective October 12, 2012; treatment received after that date has 
been covered for enrollees with these types of cancers so long as the 
WTCHP determines that exposure to the September 11 attacks is 
"substantially likely" to be a significant factor in the development 
of their cancers. Furthermore, prospective VCF claimants with a cancer 
added to the list and associated with exposure to the September 11 
attack sites have been eligible, since October 12, 2012, to seek VCF 
compensation for related financial loss.

In light of the WTCHP Administrator's decision in September 2012 to 
add 60 types of cancer to the list, you asked us to review the 
Administrator's approach, and the potential effects of the additions 
on the WTCHP and VCF. In this report, we (1) describe and assess the 
Administrator's approach to determining whether to add certain cancers 
to the list of covered conditions; (2) describe effects that the 
addition of cancers to the list has had on the WTCHP; and (3) describe 
effects that the addition of cancers to the list has had on the VCF.

To describe and assess the Administrator's approach, we analyzed the 
Zadroga Act and 2012 proposed and final rulemaking adding cancers to 
the list of covered conditions,[Footnote 16] and reviewed federal 
standards for internal controls.[Footnote 17] Among other things, the 
proposed and final rulemaking described the Administrator's approach 
and his decision to expand the list to include 60 types of cancer in 
2012. We reviewed HHS documents such as correspondence between the 
Administrator and members of the WTCHP Scientific/Technical Advisory 
Committee (STAC)--an advisory committee established by the Zadroga 
Act.[Footnote 18] To clarify the Administrator's approach, we 
interviewed HHS officials, including the WTCHP Administrator, and the 
STAC chairperson. We also reviewed reports from Institute of Medicine 
(IOM) committees charged with assisting other federal compensation 
programs similarly assess whether specific exposures were associated 
with certain health outcomes that may have been experienced by those 
programs' targeted populations.[Footnote 19] We reviewed these IOM 
reports to identify approaches commonly used to assess available 
evidence, and interviewed IOM officials responsible for directing 
these committees to clarify these approaches. In addition, we convened 
a meeting of relevant experts, with the assistance of IOM, to help us 
characterize and assess the Administrator's approach, including any 
potential areas for improvement. As we did not seek to achieve 
consensus among experts participating in this meeting, statements from 
these experts do not reflect the opinions of all meeting participants, 
unless otherwise noted. We worked with staff at IOM to identify 
experts and a moderator to participate; generally, selecting experts 
based on their areas of expertise, which included environmental 
medicine, epidemiology, occupational health, and other areas.[Footnote 
20] (See appendix II for a list of experts who participated.) We also 
conducted follow-up interviews with some of the participating experts 
to clarify points discussed during the meeting.

To describe effects that the addition of cancers to the list has had 
on the WTCHP, we analyzed WTCHP enrollment and spending data (based on 
paid claims) for services for cancer and noncancer conditions for four 
groups of enrollees: (1) those with coverage for treatment for cancer 
conditions only, (2) those with coverage for treatment for noncancer 
conditions only, (3) those with coverage for treatment for both cancer 
and noncancer conditions, and (4) those being monitored, but who had 
not received coverage for treatment for any condition.[Footnote 21] 
The WTCHP spending data captured claims for services paid by the 
program from October 2012 through March 2014. To identify program 
spending that resulted from the addition of cancers to the list, we 
analyzed the spending data for each of the four groups of enrollees 
based on (1) the types of services they received--specifically, 
monitoring or treatment for cancer and noncancer conditions; and (2) 
the date of enrollment for individual enrollees (before or after 
October 12, 2012, the date the addition of cancers to the list became 
effective). For purposes of this report, monitoring includes initial 
health and diagnostic evaluations, screening tests, and monitoring 
exams. We reviewed the Zadroga Act, including funding appropriated by 
the act. We also reviewed 2012 proposed and final rulemaking that 
added 60 cancers to the list and included estimates of future costs 
and benefits resulting from these additions. In addition, we conducted 
interviews with officials associated with the program, including 
members of the WTCHP Responder and Survivor Steering committees. 
[Footnote 22] We also reviewed previous GAO reports for background on 
the WTCHP and earlier programs for WTC responders and survivors. 
[Footnote 23]

To describe effects on the VCF of the addition of cancers to the list, 
we reviewed data obtained from VCF officials for three claimant 
groups: (1) claimants with cancer only, (2) claimants with noncancer 
conditions only, and (3) claimants with both cancer and noncancer 
conditions. The VCF data captured registrations, submitted claims 
(including eligibility and compensation forms), eligibility decisions, 
and VCF compensation decisions and calculations as of March 31, 2014. 
We reviewed the Zadroga Act, including VCF requirements and funding 
for the program, and applicable rulemaking, which describes the VCF 
program and potential effects resulting from the addition of cancers. 
[Footnote 24] We also interviewed VCF officials and reviewed VCF 
documents that describe program eligibility, processes for submitting 
claims, and key deadlines.[Footnote 25]

We assessed the reliability of WTCHP and VCF data we received by 
reviewing related documentation, performing data reliability checks 
(such as examining the data for missing values), and interviewing 
WTCHP and VCF officials. After taking these steps, we determined that 
the data we used were sufficiently reliable for the purposes of our 
report.

We conducted this performance audit from May 2013 to July 2014 in 
accordance with generally accepted government auditing standards. 
Those standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe 
that the evidence obtained provides a reasonable basis for our 
findings and conclusions based on our audit objectives.

Background: 

The Zadroga Act established the WTCHP to provide medical monitoring 
and treatment benefits, and reactivated the VCF to provide financial 
compensation to eligible individuals.

WTCHP: 

As of March 31, 2014, there were 67,783 WTCHP enrollees, including 
responders and survivors from the WTC attack site and responders from 
the Pentagon and Shanksville, Pennsylvania, attack sites.[Footnote 26] 
Monitoring, for the purposes of this report, includes initial health 
and diagnostic evaluations, screening tests, and monitoring exams. 
[Footnote 27] Treatment provided by the WTCHP must be deemed medically 
necessary, and in accordance with the WTCHP's medical treatment 
protocols.[Footnote 28] WTCHP services are provided to enrollees at no 
cost, through contracts with Clinical Centers of Excellence (CCE) in 
the New York metropolitan area and the Nationwide Provider Network 
(NPN) for those who reside outside of the New York metropolitan area. 
[Footnote 29]

Under the Zadroga Act, the Administrator may publish a rule to add 
conditions to the list of covered conditions at his discretion. If the 
Administrator receives a written petition requesting the addition of a 
condition to the list, the law specifies certain time frames in which 
he must respond to that petition. Specifically, upon receipt of a 
petition to add a health condition to the list, the Administrator is 
required to respond within 60 days in one of four specified ways: (1) 
request a recommendation of the STAC; (2) publish a proposed rule in 
the Federal Register to add the condition; (3) publish in the Federal 
Register a determination not to publish such a rule; or (4) publish in 
the Federal Register a determination that insufficient evidence exists 
to take any such action.[Footnote 30] If the Administrator chooses to 
request a recommendation of the STAC, the STAC has up to 180 days to 
provide it,[Footnote 31] and the Administrator has up to 60 days, 
following the receipt of the STAC's recommendation, to publish a 
decision on whether to add the condition in the Federal Register. 
Therefore, when a recommendation from the STAC is requested for a 
review based on a petition, up to 300 days may elapse from the time 
the Administrator receives the petition to when he publishes a 
response in the Federal Register. In response to the September 2011 
written petition from members of Congress to add coverage for cancer, 
the Administrator requested a recommendation from the STAC,[Footnote 
32] which, in March 2012, provided its recommendation to add certain 
types of cancers to the list.[Footnote 33] The Administrator then 
conducted his own assessment of available scientific evidence, 
including an assessment of the STAC's recommendation.

To obtain coverage for treatment for a condition included on the list, 
a WTCHP enrollee must obtain a determination from a CCE or NPN 
physician, and a certification from the WTCHP. Specifically, a 
physician must determine that (1) the condition for which the enrollee 
seeks coverage is on the list; and (2) exposure to airborne toxins, 
other hazards, or adverse conditions resulting from the September 11 
attacks is "substantially likely to be a significant factor in 
aggravating, contributing to, or causing the condition."[Footnote 34] 
The WTCHP then reviews the physician's determination and certifies 
that the enrollee satisfactorily meets the exposure assessment and 
symptom requirements. Once an enrollee's condition has been certified 
for coverage, a WTCHP provider can be reimbursed for treatment 
services provided for that specific health condition.

The Zadroga Act established the WTCHP Fund and made appropriations to 
that fund for the federal share of expenditures for the last calendar 
quarter of fiscal year 2011, as well as for each of fiscal years 2012 
through 2016, totaling a maximum of about $1.6 billion.[Footnote 35] 
As of March 31, 2014, cumulative WTCHP obligations totaled about $0.8 
billion. About one-half of that amount ($450.9 million) was obligated 
to pay for claims from the CCEs and the NPN. The remaining amount 
($326.2 million) was obligated for CCE and NPN infrastructure, 
education and outreach, the STAC, data centers, and other activities. 
Claims paid from October 2012 (when cancers were added to the list) 
through March 2014 totaled about $140.7 million. In addition, the 
estimated costs of the CCE and NPN contracts for the 5-year period 
ranged from about $5.9 million to nearly $55.0 million. (See table 1.) 

Table 1: World Trade Center Health Program (WTCHP) Contracts for the 
Provision of Services: 

WTCHP contracted entity: Clinical Center of Excellence (CCE); 

Icahn School of Medicine at Mount Sinai; Period of performance[A]: 
07/01/2011 - 06/30/2016; Estimated cost[B: $54,965,150.

State University of New York (Stony Brook); Period of performance[A]: 
07/01/2011 - 06/30/2016; Estimated cost[B: $24,267,708.

Fire Department of New York City; 
Period of performance[A]: 07/01/2011 - 06/30/2016; Estimated cost[B: 
$39,784,900.

New York University School of Medicine; Period of performance[A]: 
07/01/2011 - 06/30/2016; Estimated cost[B: $5,858,523.

Rutgers University; 
Period of performance[A]: 07/01/2011 - 06/30/2016; Estimated cost[B: 
$7,751,271.

North Shore Long Island Jewish Health System; Period of 
performance[A]: 07/01/2011 - 06/30/2016; Estimated cost[B: $8,545,829.

New York City Health and Hospitals Corporation; Period of 
performance[A]: 09/29/2011 - 06/30/2016; Estimated cost[B: $14,569,904.

WTCHP contracted entity: Nationwide Provider Network (NPN): 

Logistics Health, Inc.[C]; 
Period of performance[A]: 09/30/2010 - 09/29/2015; Estimated cost[B: 
$25,544,423.

Source: Centers for Disease Control and Prevention. GAO-14-606. 

[A] According to CDC officials, the CCE contracts were awarded for 1 
year with 4 option years. While the end date for the last option year 
is June 30, 2016 (3 months before program funding expires), CDC 
officials stated that the contracts may be extended as long as the 
maximum amount of the awards have not been expended.

[B] The contract costs are estimated because the contracted entities 
are reimbursed by the WTCHP following service delivery.

[C] The NPN is operated by Logistics Health, Inc., which subcontracts 
with health systems, such as UnitedHealthcare, to provide services to 
enrollees, according to WTCHP officials. 

[End of table] 

VCF: 

Rules reactivating the VCF under the Zadroga Act became effective 
October 3, 2011.[Footnote 36] The VCF provides compensation for 
personal injury or death resulting from traumatic physical injuries, 
physical health conditions, or diseases considered to have occurred as 
a result of the September 11 attacks or debris removal.

An individual must register with the VCF within 2 years of diagnosis 
with a covered condition, but not later than October 3, 2016.[Footnote 
37] Individuals with an existing condition have 2 years from the date 
the condition is added to the WTCHP list to register with the VCF; all 
registrations must be submitted by October 3, 2016. As such, 
individuals who were diagnosed with a cancer added to the list on 
October 12, 2012, are required to register by October 12, 2014. To 
file a VCF claim, an individual must submit completed eligibility and 
compensation claim forms, including information that demonstrates a 
physical health condition included in the WTCHP list resulted from the 
September 11 attacks, by October 3, 2016.[Footnote 38] Although there 
had been over 60,000 individual registrations with the VCF as of March 
31, 2014, most claimants had not submitted eligibility or compensation 
forms as of that date.

The Zadroga Act capped funding for VCF compensation at nearly $2.8 
billion, which covers both claims and administrative costs. Of that 
amount, $875 million (31 percent) is available for payments during the 
VCF's first 5 years after its reactivation (from Oct. 3, 2011, through 
Oct. 3, 2016). The act required the VCF to set a rate for prorating 
payments during the first 5 years to ensure that every eligible 
claimant received a payment during that period. In January 2013, the 
VCF set a proration amount of 10 percent of total compensation 
calculations for those first 5 years. In the VCF's sixth year (from 
Oct. 3, 2016, through Oct. 3, 2017), the program will make payments 
based on the remaining funds. After all payments are made, the VCF 
shall be permanently closed.

Experts Indicated That the WTCHP Administrator's Hazard-Based Approach 
Was Reasonable, but Could Be Improved: 

In determining whether to add cancers to the list of covered 
conditions, the Administrator used a hazard-based, multiple method 
approach. Experts who participated in our meeting indicated that this 
approach was reasonable. However, the approach could be improved, as 
it was not clearly communicated and did not include an independent 
peer review.

The Administrator Used a Hazard-Based, Multiple-Method Approach to 
Determine Whether to Add Cancers to the List: 

The WTCHP Administrator used a hazard-based, multiple-method 
approach-- rather than a risk-based approach--to determine whether to 
add certain types of cancer to the list. The Zadroga Act does not 
prescribe a specific methodology for assessing evidence to determine 
whether to add new conditions to the list. According to experts who 
participated in our meeting,[Footnote 39] a hazard-based approach 
focuses on identifying whether particular "hazards"--sources of 
potential harm-- are associated with certain health conditions, and 
does not attempt to quantify the risks or likelihood of developing 
those health conditions as would a risk-based approach. Under the 
Administrator's hazard-based approach, types of cancer found to be 
associated with exposures to the September 11 attack sites were added 
to the list. In contrast, a risk- based approach would have involved 
determining whether the risk of a specific type of cancer from the 
September 11 exposures was high or low as a result of quantified 
levels and durations of exposure, and would have added only those 
cancers where risk was determined to be high.

The Administrator's hazard-based approach used four methods to 
determine whether there was an association between a September 11 
exposure and a particular cancer that warranted adding that cancer to 
the list. According to the approach described in rulemaking,[Footnote 
40] the Administrator may have added a cancer to the list in the 
following circumstances: 

* Method 1: Data from published, peer-reviewed epidemiologic studies 
in the September 11 exposed population supported a causal association 
between September 11 exposures and the cancer type.

* Method 2: Multiple published epidemiologic studies supported a 
causal association between the cancer and a condition already on the 
list (such as esophageal cancer and gastroesophageal reflux disease). 
[Footnote 41]

* Method 3: A hazard identified at the September 11 attack sites in 
peer-reviewed studies was identified by the National Toxicology 
Program to be (or reasonably anticipated to be) a human 
carcinogen,[Footnote 42] and the International Agency for Research on 
Cancer determined that there was at least limited evidence that the 
hazard causes the cancer.[Footnote 43]

* Method 4: The STAC provided a reasonable basis to add a cancer to 
the list based on its review of scientific and medical evidence. 
[Footnote 44]

The Administrator characterized his hazard-based, multiple-method 
approach as a hierarchy in 2012 rulemaking. To determine whether to 
add a particular type of cancer, the Administrator said he began his 
review by assessing evidence under Method 1, which he considered to be 
the strongest type of evidence. If a cancer did not meet the criteria 
to be added to the list under Method 1, the Administrator considered 
evidence under Methods 2, 3, or 4, which he considered to be less 
rigorous forms of evidence. The Administrator told us that when 
evidence that supported the addition of a cancer was available under a 
method higher in the hierarchy, he did not consider evidence under the 
methods lower in the hierarchy. (See fig. 1 for a flowchart of the 
approach presented in the 2012 rulemaking adding cancers to the list.) 

Figure 1: World Trade Center Health Program (WTCHP) Administrator's 
Stated Approach to Determining Whether to Add Cancers to the Program's 
List of Covered Conditions, as Published in the September 12, 2012, 
Final Rule: 

[Refer PDF for image: process illustration] 

Method 1: 

Start: 

1. How many epidemiologic studies of 9/11-exposed populations have 
been published? 
None: go to Method 2; 
One: go to #2; 
More than one: go to #3. 

2. Are there cancer types significantly increased over appropriate 
reference population? 
Yes: Include cancer type; 
No: go to Method 2. 

3. Assess: strength of association, consistency, biological gradient, 
plausibility, and coherence of findings; Weight of evidence does not 
support: go to Method 2; Weight of evidence supports: Include cancer 
type. 

Method 2: 

4. Are there published medical studies supporting a relationship 
between WTC-related health condition and cancer type? No: go to Method 
3; 
Yes: go to #5. 

5. Assess: nature of association, plausability, and consistency of 
findings: Include cancer type; 
Weight of evidence does not support: go to Method 3. 

Method 3: 

6. Is a 9/11 agent reported in a published, peer-reviewed exposure 
assessment? 
Yes: go to #7; 
No: go to #8. 

7. Do NTP and IARC categorize 9/11 agent as a carcinogen?[A] Yes: 
Include cancer type. 
No: go to Method 4. 

Method 4: 

8. Does the STAC provide a reasonable basis for inclusion?[B] Yes: 
Include cancer type; 
No: Do not include cancer type. 

Source: Federal Register and GAO. GAO-14-606. 

Notes: This figure, with the exception of the figure notes, has been 
taken in its entirety from the World Trade Center Health Program; 
Addition of Certain Types of Cancer to the List of WTC-Related Health 
Conditions (Final Rule) published on September 12, 2012. See 77 Fed 
Reg. 56143 (Sept. 12, 2012). 

To evaluate whether the epidemiologic studies reviewed under Methods 1 
and 2 supported a causal association between the cancer type and 
either September 11 exposures or another condition on the list, the 
Administrator used criteria established by epidemiologist Austin 
Bradford Hill (known as the Bradford Hill criteria), commonly used to 
assess relationships between exposure and health outcomes. The 
Administrator described the use of specific Bradford Hill criteria 
under certain circumstances in his approach (for example, when only 
one epidemiologic study was available) in World Trade Center Health 
Program; Addition of Certain Types of Cancer to the List of WTC- 
Related Health Conditions (Notice of Proposed Rulemaking). See 77 Fed. 
Reg. 35578, 35580 (June 13, 2012) (preamble, III.D.2. and III.D.3.) 

[A] NTP refers to the National Toxicology Program, which is an 
interagency program of the Department of Health and Human Services 
established to provide information about potentially toxic substances. 
IARC refers to the International Agency for Research on Cancer, which 
is the World Health Organization's agency that promotes international 
collaboration in cancer research.

[B] STAC refers to the WTCHP Scientific/Technical Advisory Committee, 
an advisory committee established by the Administrator to, among other 
things, review scientific and medical evidence and make 
recommendations on the addition of eligibility criteria and covered 
health conditions. 

[End of figure] 

Of the 60 types of cancers that the Administrator added to the list, 
53 were added using Method 3, 6 using Method 4, and 1 using Method 2. 
No cancers were added based on Method 1. (See text box, below, for 
examples of how two cancers were added to the list and appendix III 
for a list of cancers added to the list by method.) 

Text box: 

Examples of the World Trade Center Health Program (WTCHP) 
Administrator's Application of the Hazard-Based, Multiple-Method 
Approach: 

Example 1: Esophageal Cancer:

Method 1: The Administrator considered adding the cancer to the WTCHP 
list of covered conditions under Method 1; however, no evidence was 
available under this method to support its addition. 

Method 2: The Administrator then assessed scientific information that 
supported a causal relationship between esophageal cancer and 
gastroesophageal reflux disease--the latter, a condition already on 
the WTCHP list--and determined that the information was sufficient to 
add the cancer. 

Methods 3 and 4: According to the Administrator, the consideration of 
these less rigorous methods was not needed given the evidence 
available under Method 2. 

Decision: Add esophageal cancer based on evidence considered under 
Method 2. 

Example 2: Thyroid Cancer: 

Method 1: Epidemiologic evidence demonstrated an association between 
September 11 exposures for New York City firefighters and thyroid 
cancer. However, the Administrator reported in proposed rulemaking 
that he would not add the cancer under Method 1 as that association 
was not significantly higher than for firefighters with the cancer who 
were not exposed to the September 11 attack site. 

Methods 2 and 3: No evidence was available under these methods to 
support adding the cancer. 

Method 4: The Administrator found that the WTCHP Scientific/Technical 
Advisory Committee (STAC) provided a "reasonable basis" for including 
thyroid cancer; the STAC reviewed the same evidence the Administrator 
reviewed under Method 1. 

Decision: Add thyroid cancer based on evidence considered under Method 
4. 

Source: GAO summary of information from the Federal Register and WTCHP 
officials. GAO-14-606. 

[End of text box] 

In deciding on the approach to use, the Administrator reported trying 
to strike a balance between the program's need to provide timely 
health care services to affected September 11 responders and 
survivors, and the limited availability of scientific information. He 
reported considering an alternative approach that would have presumed 
September 11 exposures could have resulted in the development of any 
and all types of cancer. However, he decided against such an approach 
because it would not require any scientific evidence as a basis for 
determinations. Alternatively, the Administrator considered an 
approach that would have relied only on epidemiologic studies that 
demonstrated an association between September 11 exposure and the 
development of a type of cancer. He ultimately decided against such an 
approach because epidemiological studies linking conditions with 
September 11 exposure may not yet have been published, due to the long 
latency period for certain cancers. Waiting for such studies could 
prevent coverage for some responders and survivors with conditions 
that may have been related to September 11 exposures, according to the 
Administrator.

Experts at our meeting indicated that the Administrator's decision to 
use a hazard-based, multiple-method approach resulted in a high degree 
of inclusivity, allowing more types of cancers to be added to the list 
than other approaches might have allowed. According to these experts, 
this high degree of inclusivity could result in individuals with 
cancers not related to September 11 exposures seeking coverage from 
the WTCHP program for these cancers, while a lower degree of 
inclusivity, which would have resulted from using a risk-based 
approach, could have meant some individuals with cancers related to 
September 11 exposures would not have been able to obtain coverage.

Experts Indicated That the Administrator's Approach Was Reasonable: 

According to experts participating in our meeting, the Administrator's 
approach was reasonable. Both hazard-based and risk-based approaches 
can be used for determining associations between exposures and health 
outcomes, according to these experts. They indicated that the 
Administrator's use of a hazard-based, multiple-method approach was 
reasonable given the certification process and data constraints for 
the WTCHP, and the use of similar approaches by other federal 
compensation programs. Specifically, they indicated the following: 

* Certification process. Experts highlighted the fact that an 
applicant must obtain certification to receive coverage for treatment, 
and as part of this process provide information comparable to that 
used in a risk-based approach, adding some of the benefit of that type 
of approach.[Footnote 45] The Administrator explained that the 
information reviewed during the certification process includes 
assessing WTCHP enrollees' time period of exposure, duration of 
exposure, temporal sequence of symptoms, and activities that caused 
the exposure. In addition, qualitative exposure assessments are 
performed to determine whether enrollees have met the requirements 
needed for certification that their condition be covered.

* Data Constraints. Experts told us that developing a risk-based 
approach would have been less feasible than developing a hazard-based 
approach. Specifically, a risk-based approach would have required data 
on levels of exposures to specific hazards among individuals, but such 
data (for example, epidemiologic studies regarding cancer risk in the 
exposed population) was lacking. This point was confirmed by the 
Administrator who told us that using a risk-based approach would have 
been challenging due to the lack of data on individual exposures 
following the attacks, especially in the immediate aftermath of the 
attacks when exposures were at their highest. According to experts, 
the multiple-method approach was reasonable because of limitations in 
available data due to the length of cancer latency and the relatively 
short period of time that had elapsed between the attacks and the 
Administrator's review.

* Use of Similar Approaches. Other federal compensation programs, such 
as those for Gulf War Veterans, used a similar hazard-based or 
multiple-method approach to assess the available, often limited, data 
about relationships between exposures and health outcomes, according 
to the experts. For example, under the Persian Gulf War Veterans Act, 
the Secretary of Veterans Affairs was required to use the National 
Academy of Sciences to determine whether certain health conditions had 
a relationship with specific war-related exposures;[Footnote 46] the 
Academy performed this task through committees convened by its IOM. 
The IOM committees used a similar hazard-based approach as the 
Administrator, and did not consider the magnitude of the risk as would 
have been done with a risk-based approach.[Footnote 47] IOM officials 
responsible for directing these committees also told us that the 
Administrator's approach was reasonable given the limitations of the 
available evidence, due in part to cancer latency.

Administrator's Approach Was Not Communicated Clearly and Did Not 
Include Independent Peer Review: 

Although experts participating in our meeting considered the 
Administrator's approach reasonable, they indicated that the approach 
could have been communicated more clearly to strengthen the 
credibility of the process. According to these experts, the approach 
was not clearly described in 2012 proposed and final rulemaking. 
Specifically, the Administrator did not clearly communicate the 
approach when there was negative evidence (information that supported 
not adding a cancer) under one method and positive evidence 
(information that supported adding a cancer) under a different method. 
The approach described in the flowchart and text in 2012 rulemaking 
(see figure 1) suggested that if there was positive evidence under a 
given method (for example, Method 3), the Administrator would add the 
cancer to the list and cease assessing evidence; he would not consider 
negative evidence found under methods higher in the hierarchy (Methods 
1 or 2), or any evidence under methods lower in the hierarchy (Method 
4) in making his decision of whether to add that cancer to the list. 
The Administrator told us, however, that in the case of prostate 
cancer, negative evidence under Methods 1 and 4 led to his decision 
not to add prostate cancer during rulemaking in 2012,[Footnote 48] 
even though there was positive evidence under Method 3.[Footnote 49] 
He agreed that the process for decision making when there was negative 
evidence under a method higher in the hierarchy and positive evidence 
under a method lower in the hierarchy was not expressed in the 
flowchart or text included in 2012 proposed and final rulemaking. He 
acknowledged that it was an oversight not to have included this 
information. Further, according to the Administrator, decisions to add 
a condition to the list could be reconsidered with new evidence; 
[Footnote 50] however, the approach outlined in 2012 rulemaking did 
not clearly communicate how he would assess such new evidence, for 
example from future studies, against existing evidence.

Information about decision making should be adequately communicated to 
external stakeholders, such as Congress and the public, according to 
Standards for Internal Control in the Federal Government.[Footnote 51] 
Additionally, clear communication is particularly important as the 
Administrator plans to use the same approach to make future 
determinations on potential additions of cancer to the list.[Footnote 
52] In the absence of a clearly communicated description, the approach 
may not be consistently applied during such future decision making, 
which could raise questions not only about the approach's credibility, 
but also equity for program enrollees.

In addition to improvements regarding communication, the 
Administrator's approach could be improved by the use of an 
independent peer review process, according to experts who participated 
in the meeting we convened. This peer review process would include, 
for example, an evaluation of scientific and technical evidence by 
independent experts to assess the validity and credibility of the 
information upon which decisions are being made. Experts participating 
in our meeting noted that independent peer review has been used to 
review conclusions made by IOM committees assessing scientific 
evidence related to exposures and health outcomes for other federal 
compensation programs. In these instances, peer reviewers independent 
of the IOM committee provided feedback on matters such as whether the 
specific evidence assessed by the committee was appropriate, what 
additional evidence should be assessed, and if aspects of the 
committee's report could be more clearly described.[Footnote 53] 
According to IOM officials responsible for directing these committees, 
independent peer review helps ensure that a committee's assessment of 
scientific evidence is accurate and as effective in relaying its 
conclusions as possible. This assurance enhances the credibility of 
the final product by ensuring that the conclusions are scientifically 
based and appropriately portrayed, according to IOM officials. 
[Footnote 54]

While the Administrator agreed that independent peer review was 
important, he told us that, due to time constraints, he did not use it 
in his approach for the 2012 decisions.[Footnote 55] Specifically, he 
told us that although he supported the use of independent peer review 
in all NIOSH programs, he did not consider implementing such a process 
feasible given the time limitations in place under the Zadroga Act for 
responding to petitions and receiving a recommendation from the STAC. 
According to the act, when a recommendation from the STAC is requested 
for a review based on a petition, up to 300 days may elapse from the 
time the Administrator receives the petition to when he publishes a 
response in the Federal Register. The Administrator told us that the 
time limits imposed by the Zadroga Act for the review of petitions and 
responses to STAC recommendations, in addition to the time needed for 
administrative processes, are very restrictive and provide little time 
for scientific analysis and decision-making processes. However, 
without an independent peer review process through which an 
independent party has determined that the evidence assessed was 
appropriate and that the rationales for decisions made were clearly 
described, there may be questions around the transparency of the 
process and whether the decisions made were appropriate.

Addition of Cancers to the List of Covered Conditions Accounted for a 
Small Portion of Spending and Led to the Need for a Third-Party 
Administrator: 

WTCHP spending on services (claims paid) directly attributable to the 
addition of cancers to the list of covered conditions accounted for 
6.5 percent of total spending on services from October 2012 (the month 
when cancers were added) through March 2014. The addition of cancers 
also led to the need for a third-party administrator to facilitate 
uninterrupted care for enrollees with cancer. WTCHP officials and 
others reported that the addition of cancers has helped ensure access 
to high-quality cancer care for enrollees, but also required increased 
staff to accommodate the program's growing scope.

WTCHP Spending on Services Directly Attributable to the Addition of 
Cancers Totaled 6.5 Percent of Spending on Services from October 2012 
through March 2014: 

WTCHP spending on services provided to enrollees that was directly 
attributable to the addition of cancers to the list totaled $9.1 
million, 6.5 percent of the $140.7 million in total spending on 
services from October 2012 through March 2014. The $9.1 million in 
spending included: about $1.9 million on cancer monitoring for 
enrollees, regardless of whether they were diagnosed with any of the 
conditions on the list; and $7.2 million on cancer treatment for 
enrollees who had cancer certifications.[Footnote 56] Enrollees who 
received these cancer monitoring and treatment services may have 
joined the program before or after cancer coverage became effective 
(Oct. 12, 2012).

In addition to the spending directly attributable to the addition of 
cancers, an additional $2.2 million spent on enrollees who joined the 
program on or after October 12, 2012 (1.5 percent of total spending on 
services from October 2012 through March 2014) also may have resulted 
from the addition of cancers. Enrollees who joined the program after 
October 12, 2012, may have joined as a result of the addition of 
cancers to the list, even if they only received services for noncancer 
conditions. The $2.2 million in spending included about $1.6 million 
on noncancer monitoring for these enrollees. It also included about 
$0.6 million on noncancer treatment for enrollees who had 
certifications for noncancer conditions only. (See table 2.) 

Table 2: World Trade Center Health Program (WTCHP) Claims Paid, from 
October 2012 through March 2014: 

WTCHP spending resulting from addition of cancers: 

Service type: Monitoring for cancer; Enrollment date: Any; 
Certification[A]: None or any; 
Number of Enrollees[B]: 1,880 to 1,949[E]; Spending[C]: $1,932,217; 
Average per enrollee: $991 to $1,028[F]; Percentage of total 
spending[D]: 1.37%.

Service type: Treatment for cancer; Enrollment date: Any; 
Certification[A]: Cancer; 
Number of Enrollees[B]: 581; 
Spending[C]: $7,169,097; 
Average per enrollee: $12,339; 
Percentage of total spending[D]: 5.09%.

Total: 
Spending[C]: $9,101,314; 
Percentage of total spending[D]: 6.47%.

WTCHP spending possibly resulting from addition of cancers[G]: 

Service type: Monitoring for noncancer condition; Enrollment date: On 
or after 10/12/12; Certification[A]: None or any; 
Number of Enrollees[B]: 1,314 to 2,088[E]; Spending[C]: $1,584,635; 
Average per enrollee: $759 to $1,206[F]; Percentage of total 
spending[D]: 1.13%.

Service type: Treatment for noncancer condition; Enrollment date: On 
or after 10/12/12; Certification[A]: Noncancer; 
Number of Enrollees[B]: 455; 
Spending[C]: $566,646; 
Average per enrollee: $1,245; 
Percentage of total spending[D]: 0.40%.

Total: 
Spending[C]: $2,151,281; 
Percentage of total spending[D]: 1.53%.

WTCHP spending not resulting from addition of cancers: 

Service type: Monitoring for noncancer condition; Enrollment date: 
Before 10/12/12; 
Certification[A]: None or any; 
Number of Enrollees[B]: 30,202 to 47,844[E]; Spending[C]: $33,097,436; 
Average per enrollee: $692 to $1,096[F]; Percentage of total 
spending[D]: 23.52%.

Service type: Treatment for noncancer condition; Enrollment date: 
Before 10/12/12; 
Certification[A]: Noncancer; 
Number of Enrollees[B]: 20,420; 
Spending[C]: $96,371,096; 
Average per enrollee (dollars): $4,719; Percentage of total 
spending[D]: 68.48%.

Total: 
Spending[C]: $129,468,532; 
Percentage of total spending[D]: 92.00%.

Overall spending from October 2012 through March 2014: Spending[C]: 
$140,721,127; 
Percentage of total spending[D]: 100.00%.

Source: GAO analysis of data from the Centers for Disease Control and 
Prevention. GAO-14-606. 

Notes: The data in this table represent WTCHP claims paid from October 
2012 (the month when cancers were added to the WTCHP list of covered 
conditions) through March 2014. Monitoring includes initial health and 
diagnostic evaluations, screening tests, and monitoring exams.

[A] To obtain coverage for treatment for a condition included on the 
list, a WTCHP enrollee must obtain a determination from a WTCHP- 
affiliated physician and a certification from the WTCHP. Specifically, 
a physician must first determine that (1) the condition for which the 
enrollee seeks coverage is on the list; and (2) exposure to airborne 
toxins, other hazards, or adverse conditions resulting from the 
September 11 attacks is "substantially likely to be a significant 
factor in aggravating, contributing to, or causing the condition." The 
WTCHP then must review the physician's determination and certify that 
the enrollee satisfactorily meets the exposure assessment and symptom 
requirements. In some cases, an enrollee may receive coverage for 
treatment without having a certification. This may occur when the 
enrollee is transitioning into the program and requires immediate care 
for a condition that a physician believes will result in a 
certification.

[B] The number of enrollees represents individuals that received the 
specified type of service. While most enrollees had certifications for 
the treatment services received, some enrollees who required immediate 
care received treatment without having certifications. In addition, 
enrollees may receive multiple types of services, so the number of 
enrollees who received services cannot be added to determine the total 
number of enrollees in the WTCHP who received services. For example, 
an enrollee with a certification for cancer only may have received 
monitoring for cancer, monitoring for noncancer conditions, and 
treatment for cancer, and as a result, the enrollee is represented in 
the enrollee counts for all three types of services.

[C] While most spending for treatment was provided to enrollees who 
had certifications for such treatment, some spending for treatment was 
for enrollees who required immediate care, and thus did not have 
certifications for that treatment.

[D] Percentages for spending on each type of service were calculated 
based on the WTCHP's total spending on services after cancers were 
added to the list, which totaled about $140.7 million.

[E] Enrollees may have received multiple types of monitoring services, 
and the data we received did not provide an unduplicated count of 
enrollees who received any monitoring service. Therefore, this range 
represents the minimum and maximum number of enrollees who received 
monitoring services.

[F] Enrollees may have received multiple types of monitoring services 
and the data we received did not provide an unduplicated count of 
enrollees who received any monitoring service. Thus, these figures 
represent the possible range of average spending per enrollee based on 
the minimum and maximum numbers of enrollees who received monitoring 
services.

[G] Because this group of enrollees joined the WTHCP on or after 
October 12, 2012, it is possible that they sought services as a result 
of the addition of cancers to the list of covered conditions. 

[End of table] 

Addition of Cancers to the List Led to the Need for a Third-Party 
Administrator: 

WTCHP officials reported that the addition of cancers to the list led 
to the need for a third-party administrator to help the program 
provide uninterrupted cancer-related services to enrollees who had 
been receiving care outside of the program. Cancer care for any 
individual (regardless of WTCHP enrollment) requires the provision of 
services by multiple physicians, such as oncologists, surgeons, 
infectious disease specialists, and nephrologists, according to a 
WTCHP Responder Steering Committee member and a CCE official. 
Initially, to ensure uninterrupted access to services for enrollees 
already receiving cancer services from physicians outside the CCEs or 
NPN, the CCEs and NPN credentialed such physicians on a case-by-case 
basis, which, according to a WTCHP Responder Steering Committee 
member, was an unwieldy process and risked delaying the certification 
and treatment of enrollees.[Footnote 57] Furthermore, the program 
needed to establish a separate billing arrangement for each physician, 
and doing so risked delaying the payment of claims.

To facilitate uninterrupted care for its enrollees with cancer, each 
of the WTCHP's seven CCEs subcontracted with HealthSmart--a third- 
party administrator that could provide enrollees with access to cancer 
services by developing a broad network of providers.[Footnote 58] 
WTCHP spending for these subcontracts totaled $2.2 million from 
October 2012 through March 2014, which fell well below the combined 
maximum amounts negotiated for each contract.[Footnote 59] (See table 
3.) According to a WTCHP Responder Steering Committee member and a CCE 
official, HealthSmart recruits providers to join a network, or makes 
other case-by-case arrangements with providers, so that WTCHP 
enrollees have the option of continuing to receive cancer services 
from physicians outside of the CCEs without interruption. In addition 
to providing access to providers, HealthSmart also provides enrollees 
with case management services and access to a 24/7 nurse triage line. 
Additionally, it processes claims for services provided through its 
network, and performs network credentialing and contracting as needed. 
WTCHP officials told us they were not aware of any enrollees who were 
unable to receive needed cancer-related services through the WTCHP.

Table 3: Spending for World Trade Center Health Program (WTCHP) 
Clinical Center of Excellence (CCE) Subcontracts with HealthSmart to 
Provide Cancer-Related Services, from October 2012 through March 2014: 

CCE: $Icahn School of Medicine at Mount Sinai; Negotiated maximum 
annual cost for subcontract: $1,639,450; Spending: $1,031,757.

CCE: $State University of New York (Stony Brook); Negotiated maximum 
annual cost for subcontract: $1,857,462; Spending: $172,100.

CCE: $Fire Department of New York City; Negotiated maximum annual cost 
for subcontract: $1,574,662; Spending: $373,648.

CCE: $New York University School of Medicine; Negotiated maximum 
annual cost for subcontract: $279,289; Spending: $48,498.

CCE: $Rutgers University; 
Negotiated maximum annual cost for subcontract: $1,096,945; Spending: 
$158,788.

CCE: $North Shore Long Island Jewish Health System; Negotiated maximum 
annual cost for subcontract: $984,498; Spending: $60,671.

CCE: $New York City Health and Hospitals Corporation; Negotiated 
maximum annual cost for subcontract: $1,328,571; Spending: $338,309.

CCE: $Total; 
Negotiated maximum annual cost for subcontract: $8,760,877; Spending: 
$2,183,771.

Source: GAO summary of information from the Centers for Disease 
Control and Prevention. GAO-14-606. 

Notes: WTCHP benefits are provided at no cost to WTCHP enrollees in 
the New York metropolitan area through contracts with CCEs. To 
facilitate uninterrupted care for its enrollees with cancer, each of 
the CCEs subcontracted with HealthSmart--a third-party administrator 
that could provide enrollees with access to cancer services by 
developing a broad network of providers. The dollar amounts shown in 
the table represent the maximum annual cost for these subcontracts and 
actual spending for the first year-and-a-half of the WTCHP's coverage 
of certain types of cancer. According to WTCHP officials, the 
subcontracts include fixed costs that may be related to both cancer 
and noncancer services and cannot be attributed specifically to cancer. 

[End of table] 

The Addition of Cancers Has Helped Ensure Access to High-Quality 
Cancer Care, but Required Increased Staff to Implement Program Changes: 

Officials we spoke with reported that the addition of cancers to the 
list has helped ensure that enrollees have access to high-quality 
cancer care, which may contribute to better health outcomes. In 
particular, the WTCHP has provided access to high-quality cancer care 
because providers affiliated with the CCEs have experience treating 
cancer patients and are well suited for monitoring recurrences and 
complications, according to officials associated with the WTCHP. In 
addition, officials noted that the network established by HealthSmart 
on behalf of the CCEs includes physicians that specialize in cancer 
care and provide high-quality services.

WTCHP officials and others also reported that the addition of cancers 
has helped ensure access to high-quality cancer care because the 
program developed cancer-related policies and procedures using 
appropriate guidance. The WTCHP implemented a cancer treatment 
plan,[Footnote 60] and prescription drug formulary,[Footnote 61] 
allowing providers who participate in the WTCHP the ability to provide 
medically necessary treatment, including medications, according to the 
National Comprehensive Cancer Network's Clinical Practice Guidelines 
in Oncology.[Footnote 62] In addition, physicians have provided colon 
and breast cancer screenings for members who meet certain criteria as 
recommended by the U.S. Preventive Services Task Force.[Footnote 63] 
According to officials associated with the WTCHP, access to high- 
quality care, including cancer-related monitoring that could result in 
early detection of the disease, may contribute to better health 
outcomes for enrollees who otherwise would not have had access to such 
services.

Although WTCHP officials and others reported that the addition of 
cancers has helped ensure access to high-quality care, they reported 
that these additions also led to the need for dedicating significant 
amounts of staff time, and for hiring new staff. According to WTCHP 
officials, a CCE official, and a WTCHP Responder Steering Committee 
member, after cancers were added to the list, NIOSH and the CCEs 
needed to dedicate a large amount of staff time to develop and 
implement policies and procedures that would address the needs of 
enrollees seeking cancer services. For example, NIOSH had to hire a 
consultant to help evaluate whether certain procedures were medically 
necessary for cancer treatment and the CCEs had to increase the amount 
of staff time dedicated to: 

* providing case management services to enrollees;

* educating affiliated physicians regarding WTCHP coverage rules;

* facilitating cancer diagnostic services for enrollees immediately 
after "red flag" symptoms are identified, particularly for cancer 
types that need frequent follow-up services (such as colon cancer and 
thyroid cancer);

* responding to end of life issues affecting enrollees and their 
families; and: 

* reviewing the most up-to-date guidelines on screening for certain 
cancer types (such as colon cancer and breast cancer), and working 
with NIOSH to develop WTCHP screening protocols.

A WTCHP Responder Steering Committee member told us the program may 
encounter future challenges as enrollment increases as a result of the 
addition of cancers, including increased wait times and an increased 
rate of spending. The member said that program enrollment is likely to 
increase significantly, which could result in extended wait times to 
obtain appointments for enrollees seeking non-urgent services. The 
member added that there had been no observable effects yet, but that 
wait times may soon increase as the program anticipates a large influx 
of enrollees as responders and survivors seek certifications from the 
WTCHP in order to document their VCF eligibility.[Footnote 64] The 
member also expressed concern about the finite funding for the WTCHP, 
and said that the cost of treating cancer is expected to be higher 
than the cost of treating other serious conditions such as certain 
lung diseases. CDC forecast that the annual cost of adding cancers to 
the list could range from about $12.5 million to $33.3 million; 
however, this estimate was made before verifiable data on the cancer 
status of WTCHP enrollees were available.[Footnote 65] As of January 
2014, CDC had yet to revise the estimate to include fiscal year 2013 
spending and enrollment data.

The Effects on the VCF of Adding Cancers to the List of Covered 
Conditions Are Not Yet Known: 

The effects on the VCF of adding cancers to the WTCHP list of covered 
conditions are not yet known because there have been only a small 
number of compensation decisions. As of March 31, 2014, there were 502 
VCF compensation decisions, totaling $194.6 million, while 5,587 
claimants had been found eligible to receive compensation.[Footnote 
66] The number of compensation decisions is limited in part because 
many of the forms submitted by claimants did not contain sufficient 
information. Specifically, as of March 31, 2014, only 1,237 claimants 
(22.1 percent of the 5,587 eligible claimants) had submitted both 
eligibility and compensation forms that VCF determined to be 
actionable for compensation decisions.

Further adding to the challenge of determining the effects on the VCF 
of adding cancers to the list, few of the compensation decisions to 
date have been for claimants with cancer, either alone or in 
combination with other conditions. Specifically, of the 502 
compensation decisions, only 39 were for claimants with cancer; 
compensation calculations for these individuals totaled $15.6 million 
(8.0 percent of the $194.6 million calculated for all compensation 
decisions).[Footnote 67] The remaining 463 compensation decisions were 
for claimants who had a noncancer condition only, and totaled $179.0 
million (92.0 percent of the total $194.6 million). (See table 4) 

Table 4: Status of September 11th Victim Compensation Fund (VCF) 
Claimant Submissions and Compensation Decisions as of March 31, 2014: 

Claimants with cancer only: 
Eligible claimants[A]: 161; 
Claimants who submitted both eligibility and compensation forms[B]: 
Incomplete: 84; 
Actionable for compensation decision: 31; Compensation decisions[C]: 
39; 
Compensation calculations[C]: $15,564,797; Average calculated 
compensation per claimant[C] $399,097.

Claimants with both cancer and noncancer conditions: Eligible 
claimants[A]: 461; 
Claimants who submitted both eligibility and compensation forms[B]: 
Incomplete: 242; 
Actionable for compensation decision: 138; Compensation decisions[C]: 
39; 
Compensation calculations[C]: $15,564,797; Average calculated 
compensation per claimant[C] $399,097.

Claimants with noncancer conditions only: Eligible claimants[A]: 4,965; 
Claimants who submitted both eligibility and compensation forms[B]: 
Incomplete: 2,017; 
Actionable for compensation decision: 1,068; Compensation 
decisions[C]: 463; 
Compensation calculations[C]: $179,043,919; Average calculated 
compensation per claimant[C]: $386,704.

Total" 
Eligible claimants[A]: 5,587; 
Claimants who submitted both eligibility and compensation forms[B]: 
Incomplete: 2,343; 
Actionable for compensation decision: 1,237; Compensation 
decisions[C]: 502; 
Compensation calculations[C]: $194,608,716; Average calculated 
compensation per claimant[C]: $387,667.

Source: GAO analysis of data from the Department of Justice (DOJ). 
GAO- 14-606. 

Notes: The VCF is a federally funded program, administered by DOJ, 
that provides compensation to individuals who suffered physical harm, 
or relatives of individuals who were killed, as a result of the 
September 11 attacks.

[A] To be considered eligible for compensation, an individual must 
register with the VCF and submit a completed eligibility form that 
includes information demonstrating that his or her physical health 
condition resulted from the September 11 attacks. The numbers of 
claimants in this column represent claimants for whom VCF had approved 
eligibility as of March 31, 2014.

[B] To be considered for compensation from the VCF, claimants must 
submit eligibility forms that show their conditions were related to or 
affected by the September 11 attacks, and compensation forms that 
document expenses related to their condition(s). Claimants' 
eligibility and compensation forms are considered incomplete, and 
require follow up, if they are missing information. VCF officials 
consider forms to be actionable for compensation decisions when forms 
contain sufficient information to make a decision about the claimant's 
eligibility, and to calculate compensation. For example, the 
eligibility forms must demonstrate that the claimant has a physical 
health condition covered by the VCF that resulted from exposure to the 
September 11 attacks, and the compensation forms must include 
documentation (such as a W-2 form) to substantiate lost income.

[C] Due to the limited number of decisions made, we combined data on 
compensation decisions for claimants with both cancer and noncancer 
conditions, and claimants with cancer only, to protect claimants' 
privacy. As of March 31, 2014, VCF had made more compensation 
decisions for claimants with both cancer and noncancer conditions than 
decisions for claimants with cancer only. Similarly, the total amount 
of compensation calculations was higher for claimants with both cancer 
and noncancer conditions than for claimants with cancer only. 

[End of table] 

VCF officials indicated that the amount set for prorating initial VCF 
payments accounted for the cancers that have been added to the list. 
The Zadroga Act required VCF to set a proration amount to ensure that 
every eligible claimant received a payment during the first 5 years of 
the program's reactivation. VCF officials told us that in setting this 
proration amount at 10 percent, the program took into account all 
September 11-related physical injuries covered by the VCF, including 
the 60 cancers added to the list.[Footnote 68] As of March 31, 2014, 
VCF had issued initial prorated payments to 310 of the 502 claimants 
who received compensation decisions from the VCF, totaling $13.0 
million.[Footnote 69] Final payments will be sent to claimants in Year 
6 of the program based on remaining funds.[Footnote 70]

Officials stated that no significant administrative changes to the VCF 
resulted specifically from the addition of cancers to the list. 
Although the VCF added 44 new staff members in fiscal year 2013, VCF 
officials reported that these staff members were hired as a result of 
the overall increase in eligibility and compensation forms, and 
related documentation submitted by claimants. As of March 31, 2014, 
the number of claimants who had submitted eligibility and compensation 
forms for which cancer was the only condition was low (3.2 percent), 
and had not required the need for additional staff. They said the 
remaining claims that included cancer were from claimants who also had 
noncancer conditions that likely would have led to a claim regardless 
of the addition of cancer coverage.

Conclusions: 

For responders and survivors who suffered serious health problems as a 
result of September 11 exposures, the WTCHP and VCF may be important 
sources of needed health-care services or financial assistance, 
respectively. Among other factors, eligibility for these programs is 
contingent on an individual having a covered health condition for 
which exposure to the September 11 attacks was "substantially likely 
to be a significant factor in aggravating, contributing to, or 
causing." Consequently, it is important to ensure that additions to 
the list of covered conditions are made in a transparent and credible 
manner. Although experts participating in the meeting we convened 
indicated that the WTCHP Administrator's approach to determining 
whether to add cancers to the list was reasonable, they also indicated 
that the approach was not communicated clearly and lacked an 
independent peer review. Standards for internal control also state 
that administrative decisions should be clearly communicated. The lack 
of a clearly communicated approach could result in difficulty 
replicating the approach during future decision making, which may 
affect the equity and credibility of the overall process. In addition, 
the WTCHP missed an important opportunity to validate its approach by 
not using an independent peer review process to, among other things, 
assess the validity and credibility of the information upon which 
decisions were being made, as has been used by other federal 
compensation programs making similar coverage decisions. The time 
constraints imposed by the Zadroga Act may preclude the inclusion of 
such a process; however, the addition of an independent peer review 
process may help ensure the credibility of the Administrator's 
approach, which is especially important to the extent that he plans to 
use the same or a similar approach for future coverage decisions.

Recommendations for Executive Action: 

To help ensure that future decisions related to adding conditions to 
the WTCHP list of covered conditions are equitable and credible, we 
recommend that the Secretary of HHS direct the WTCHP Administrator to 
take the following actions: 

* communicate clearly, through rulemaking or other means, the approach 
for decision making related to the addition of covered conditions to 
the list, including a clear delineation of the relationship between 
methods when conflicting evidence is available.

* include an independent peer review in the approach for adding to the 
list of covered conditions, seeking authority to extend time frames if 
necessary.

Agency Comments and Our Evaluation: 

We provided a draft of this report to HHS and DOJ for their review, 
and HHS provided written comments (see app. IV). HHS supports our 
recommendation to clearly communicate the WTCHP's approach for 
decision making related to the addition of covered conditions to the 
list. In its written comments, HHS indicated that, since the 
publication of rulemaking on the decision to add cancers, the WTCHP 
published a policy document on its website that further clarified the 
approach. However, neither the policy document nor the 2012 proposed 
and final rulemaking fully describe the approach used by the 
Administrator. Specifically, these documents indicate that if any of 
the methods provide evidence to support adding a cancer to the list, 
the cancer will be added. As noted in the report, the Administrator 
told us that, despite having evidence under Method 3 supporting the 
addition of prostate cancer to the list, he decided not to add this 
cancer during 2012 rulemaking because of negative evidence under 
Methods 1 and 4. Thus, we continue to believe that a complete 
description of the process is needed to ensure that the approach is 
consistently applied during future decision making.

In regard to our recommendation on the inclusion of an independent 
peer review process, HHS indicated that it supports the intent of the 
recommendation, but noted concerns about the implementation of such a 
process given statutory time restrictions. Specifically, HHS explained 
that if the WTCHP Administrator receives a petition to add a health 
condition to the list, the Administrator must take one of four actions 
within 60 days of receipt of the petition. Our report provides a 
detailed description of the time frames imposed by the Zadroga Act 
when responding to a petition requesting the addition of a condition 
to the list. The report also acknowledges that these statutory time 
frames may preclude the inclusion of a peer review process in the 
approach. However, we continue to believe that the inclusion of an 
independent peer review process is important to ensure that future 
decisions related to the addition of conditions to the list are 
equitable and credible, which is why our recommendation accounts for 
the possibility that HHS may need to seek a legislative change-- 
namely, to extend these time frames--to include a peer review process 
in the approach.

HHS and DOJ both provided technical comments, which we incorporated as 
appropriate.

As agreed with your office, unless you publicly announce the contents 
of this report earlier, we plan no further distribution until 30 days 
from the report date. At that time, we will send copies of this report 
to the Secretary of Health and Human Services and the Attorney General 
of the Department of Justice, and other interested parties. In 
addition, the report will be available at no charge on GAO's Web site 
at [hyperlink, http://www.gao.gov].

If you or your staff have any questions about this report, please 
contact me at (202) 512-7114 or at draperd@gao.gov. Contact points for 
our Office of Congressional Relations and Office of Public Affairs can 
be found on the last page of this report. Other major contributors to 
this report are listed in appendix V.

Sincerely yours, 

Signed by: 

Debra A. Draper: 
Director, Health Care: 

[End of section] 

Appendix I: Composition of the World Trade Center Health Program 
Scientific/Technical Advisory Committee: 

The World Trade Center Health Program (WTCHP) Scientific/Technical 
Advisory Committee (STAC) is an advisory committee established 
pursuant to the law[Footnote 71] to, among other things, review 
scientific and medical evidence and make recommendations to the 
program Administrator on eligibility criteria, and the addition of 
covered health conditions. The law required the Administrator to 
appoint the members of the STAC and include at least: 

* four occupational physicians, at least two of whom have experience 
treating World Trade Center (WTC) rescue and recovery workers;

* one physician with expertise in pulmonary medicine;

* two environmental medicine or environmental health specialists;

* one industrial hygienist;

* one toxicologist;

* one epidemiologist;

* one mental health professional;

* two representatives of WTC responders; and: 

* two representatives of certified-eligible WTC survivors.

The WTCHP Administrator first solicited nominations to serve on the 
STAC in June 2011 through an announcement in the Federal Register. 
[Footnote 72] According to the Administrator, since this primarily 
resulted in responses from individuals in the New York City region, 
WTCHP and other officials from the Centers for Disease Control and 
Prevention also contacted additional individuals outside of the New 
York City region to expand the geographic diversity of the STAC 
membership. The Administrator also told us that he added a third 
representative of WTC responders to ensure that the different types of 
responder groups were represented on the committee. The Administrator 
also added a third representative for the survivors to ensure equal 
representation between the responder and survivor groups. 

[End of section] 

Appendix II: List of Participants in GAO's Expert Meeting Hosted by 
the Institute of Medicine, October 21, 2013: 

Name: A. John Bailer, PhD; 
Title and Affiliation: University Distinguished Professor and Chair, 
Department of Statistics; Miami University; Oxford, OH.

Name: David H. Garabrant, MD, MPH; Title and Affiliation: Professor 
Emeritus, Environmental Health Sciences; Emeritus Professor of 
Occupational Medicine and Epidemiology; The University of Michigan 
School of Public Health; Ann Arbor, MI.

Name: Jack R. Harkema, DVM, PhD, DACVP; Title and Affiliation: 
University Distinguished Professor, College of Veterinary Medicine; 
Michigan State University; East Lansing, MI.

Name: Rogene Henderson, PhD, DABT Moderator; Title and Affiliation: 
Senior Scientist Emeritus; Lovelace Respiratory Research Institute; 
Albuquerque, NM.

Name: Petros Koutrakis, PhD; 
Title and Affiliation: Professor of Environmental Sciences; Director 
of the Environmental Chemistry Lab, Exposure, Epidemiology & Risk 
Program; Harvard School of Public Health; Boston, MA.

Name: Daniel Kreswki, PhD, MHA; 
Title and Affiliation: NSERC Chair in Risk Science; Professor and 
Director, McLaughlin Centre for Population Health and Risk Assessment; 
University of Ottawa; Ottawa, Ontario, Canada.

Name: Dorothy E. Patton, PhD, JD; 
Title and Affiliation: (Retired) Former Director, Office of Science 
Policy; U.S. Environmental Protection Agency; Washington, DC.

Name: Charles Poole, ScD, MPH; 
Title and Affiliation: Associate Professor, Department of 
Epidemiology; Gillings School of Global Public Health, University of 
North Carolina; Chapel Hill, NC.

Name: Alvaro Puga, PhD; 
Title and Affiliation: Professor of Molecular Biology and 
Environmental Health; Associate Director, Superfund Basic Research 
Program; University of Cincinnati Medical Center; Cincinnati, OH.

Name: Kenneth S. Ramos, MD, PhD, PharmB; Title and Affiliation: 
Distinguished University Professor; University of Louisville Health 
Sciences Center; Louisville, KY.

Name: Carrie A. Redlich, MD, MPH; 
Title and Affiliation: Professor of Medicine, Pulmonary Section & 
Occupational and Environmental Medicine; Program Director, Yale 
Occupational and Environmental Medicine Program; Yale University 
School of Medicine; 
New Haven, CT.

Name: Steven D. Stellman, PhD, MPH; Title and Affiliation: Professor 
of Clinical Epidemiology; Mailman School of Public Health, Columbia 
University; New York, NY.

Source: GAO. GAO-14-606. 

[End of table] 

[End of section] 

Appendix III: Cancers Added to the WTCHP List of Covered Conditions: 

In determining whether to add cancer, to the WTCHP list of covered 
conditions, in September 2012, the WTCHP Administrator developed a 
four-method approach. Following that approach, the Administrator may 
have added a cancer to the list in the following circumstances: 

* Method 1: epidemiologic studies in the September 11-exposed 
population supported a causal association between September 11 
exposures and the cancer type;

* Method 2: there were established causal associations between the 
cancer and a condition already on the list;

* Method 3: a hazard identified at the September 11 attack sites was 
identified by the National Toxicology Program to be (or reasonably 
anticipated to be) a human carcinogen, and the International Agency 
for Research on Cancer determined that there is at least limited 
evidence that the hazard causes the cancer; and: 

* Method 4: The STAC provided a reasonable basis to add a cancer to 
the list based on its review of scientific and medical evidence.

Of the 60 types of cancers that the WTCHP Administrator added to the 
list in September 2012,[Footnote 73] 53 were added using Method 3, 6 
using Method 4, and 1 using Method 2. No cancers were added based on 
Method 1.

Method 1: 

No cancer types added under method: 

Method 2: 

1. Malignant neoplasm of the esophagus: 

Method 3: 

1. Malignant neoplasm of lip: 

2. Malignant neoplasm of base of tongue: 

3. Malignant neoplasms of other and unspecified parts of tongue: 

4. Malignant neoplasm of parotid gland: 

5. Malignant neoplasm of other and unspecified major salivary glands: 

6. Malignant neoplasm of floor of mouth: 

7. Malignant neoplasm of gum: 

8. Malignant neoplasm of palate: 

9. Malignant neoplasm of other and unspecified parts of mouth: 

10. Malignant neoplasm of tonsil: 

11. Malignant neoplasm of oropharynx: 

12. Malignant neoplasm of nasopharynx: 

13. Malignant neoplasm of piriform sinus: 

14. Malignant neoplasm of hypopharynx: 

15. Malignant neoplasms of other and ill-defined conditions in the 
lip, oral cavity, and pharynx: 

16. Malignant neoplasm of nasal cavity: 

17. Malignant neoplasm of accessory sinuses: 

18. Malignant neoplasm of larynx: 

19. Malignant neoplasm of the stomach: 

20. Malignant neoplasm of colon: 

21. Malignant neoplasm of rectosigmoid junction: 

22. Malignant neoplasm of rectum: 

23. Malignant neoplasm of other and ill-defined digestive organs: 

24. Malignant neoplasm of liver and intrahepatic bile duct: 

25. Malignant neoplasm of retroperitoneum and peritoneum: 

26. Malignant neoplasm of trachea: 

27. Malignant neoplasm of the bronchus and lung: 

28. Malignant neoplasm of heart, mediastinum and pleura: 

29. Malignant neoplasm of other ill-defined sites in the respiratory 
system and intrathoracic organs: 

30. Mesothelioma: 

31. Malignant neoplasm of peripheral nerves and autonomic nervous 
system: 

32. Malignant neoplasm of other connective and soft tissue: 

33. Other malignant neoplasms of skin: 

34. Malignant neoplasm of scrotum: 

35. Malignant neoplasm of ovary: 

36. Malignant neoplasm of bladder: 

37. Malignant neoplasm of the kidney: 

38. Malignant neoplasm of the renal pelvis: 

39. Malignant neoplasm of ureter: 

40. Malignant neoplasm of other and unspecified urinary organs: 

41. Hodgkin's disease: 

42. Follicular [nodular] non-Hodgkin lymphoma: 

43. Diffuse non-Hodgkin lymphoma: 

44. Peripheral and cutaneous T-cell lymphomas: 

45. Other and unspecified types of non-Hodgkin lymphoma: 

46. Malignant immunoproliferative diseases: 

47. Multiple myeloma and malignant plasma cell neoplasms: 

48. Lymphoid leukemia: 

49. Myeloid leukemia: 

50. Monocytic leukemia: 

51. Other leukemias of specified cell type: 

52. Leukemia of unspecified cell type: 

53. Other and unspecified malignant neoplasms of lymphoid, 
hematopoietic and related tissue: 

Method 4: 

1. Malignant melanoma of skin: 

2. Malignant neoplasm of the breast[Footnote 74]

3. Malignant neoplasm of eye and orbit: 

4. Malignant neoplasm of thyroid gland: 

5. Childhood Cancers: 

6. Rare Cancers[Footnote 75] 

[End of section] 

Appendix IV: Comments from the Department of Health and Human Services: 

Department of Health and Human Services:	 Office of The 
Secretary:	
Assistant Secretary for Legislation: Washington, DC 20201: 

July 9, 2014: 

Debra A. Draper: 
Director, Health Care:
U.S. Government Accountability Office: 441 G Street NW Washington, DC 
20548: 

Dear Ms. Draper: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled, "World Trade Center Health Program: Approach 
Used to Add Cancers to List of Covered Conditions Was Reasonable, but 
Could Be Improved" (GAO-14-606). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's Draft Report Entitled: World 
Trade Center Health Program: Approached Used To Add Cancers To List Of 
Covered Conditions Was Reasonable, But Could Be Improved (GAO-14-606): 

The Department appreciates the opportunity to review and comment on 
this draft report. 

GAO Recommendation: 

Communicate clearly, through rulemaking or other means, the approach 
for decisionmaking related to the addition of covered conditions to 
the list, including a clear delineation of the relationship between 
methods when conflicting evidence is available. 

HHS Response: 

HHS supports this recommendation. Since the publication of the rule, 
which added certain types of cancers to the List of World Trade Center 
(WTC)-Related Health Conditions (List), the World Trade Center Health 
Program (WTCHP) has published a policy on its website, and 
disseminated the policy to stakeholders, which clarifies the Program's 
decisionmaking. The Policy and Procedures for Adding Types of Cancer 
To the List of WTC-Related Health Conditions clearly states, "If a 
review of the evidence demonstrates fulfillment of at least one of the 
four methods... the Administrator will publish in the Federal Register 
a Notice of Proposed Rulemaking (NPRM) to add the type of cancer to 
the List." The policy also clearly states, "If a review of the 
evidence does not demonstrate fulfillment of at least one of the four 
methods described in IV.A. above and does demonstrate that 9/11 
exposures are not causally related to the type of cancer, the 
Administrator will publish in the Federal Register a determination not 
to propose a rule and the basis for such determination." This policy 
is consistent with how the WTCHP made its decisions in the cancer rule 
and with how it will do so in the event of future decisions regarding 
cancer conditions. The Policy and Procedures for Adding Types of 
Cancer To the List of WTC-Related Health Conditions is available at: 
[hyperlink, http://www.cdc.gov/wtc/policies.html. 

GAO Recommendation:
 
Include and independent peer review in the approach for adding to the 
list of covered conditions, seeking authority to extend time frames if 
necessary. 

HHS Response: 

HHS supports the intent of the recommendation, but has concerns about 
the implementation of such an action given the statutory time 
restrictions placed on the WTCHP Administrator with regard to 
publishing a NPRM. HHS does not think the draft report provides enough 
detail about the statutory time restrictions that are specified for 
the petition process nor does it acknowledge that "seeking authority 
to extend time frames" is not a simple administrative action but would 
require Congress to amend the statute. If the WTCHP Administrator 
decides to add a health condition to the List at his own discretion, 
there are no statutory time restrictions for the publication of a 
NPRM. However, if the WTCHP receives a petition to add a health 
condition to the List, the Administrator must take one of the 
following four actions within 60 days of receipt of the petition: 

I. Request a recommendation from the WTCHP Scientific/Technical 
Advisory Committee (STAC); 

2. Publish a NPRM in the Federal Register to add a health condition; 

3. Publish in the Federal Register the determination not to publish a 
NPRM and the basis for the determination; or; 

4. Publish in the Federal Register a determination that insufficient 
evidence exists to take one of actions (1) — (3). 

If the Administrator requests a recommendation from the STAC, the 
WTCHP has only 60 days from the date it receives the STAC's 
recommendation to publish a determination in the Federal Register. 
Therefore, the 60 days would have to include the consideration and 
review of the STAC's recommendation and, if the Administrator 
determines to propose the addition of a health condition, the writing, 
revision, clearance, and publication of a NPRM. Due to the 
administrative requirements for clearance and publication of a NPRM, a 
60-day time frame mandated by the statute is already quite limiting, 
without the added time needed to organize, hold, and consider the 
input from an independent peer review. 

If the Administrator does not request a recommendation from the STAC, 
but determines to publish a NPRM for the petitioned health condition, 
the WTCHP has only 60 days from the date the petition was received to 
publish the NPRM. Therefore, the 60 days would have to include the 
Administrator's own review of the evidence for adding the health 
condition to the List, as well as the writing, revision, clearance, 
and publication of a NPRM. As mentioned above, due to the 
administrative requirements for clearance and publication of a NPRM, a 
60-day time frame mandated by the statute is already quite limiting 
without the added time needed to organize, hold, and consider the 
input from an independent peer review. 

In summary, CDC concurs with GAO's recommendation for clear 
communication of the WTC Health Program's approach for dccisionmaking 
related to the addition of health conditions to the List. However, 
while CDC understands the potential value input from an independent 
peer review would provide, CDC does not think that the statutory time 
restrictions related to the petition process allow for such a review. 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Debra A. Draper, (202) 512-7114 or draperd@gao.gov: 

Staff Acknowledgments: 

In addition to the contact named above, Helene Toiv, Assistant 
Director; Michelle B. Rosenberg, Assistant Director; Jennie Apter; 
Hernán Bozzolo; Toni Harrison; Emily Ryan; Walter Vance; and George 
Bogart made key contributions to this report.

[End of section] 

Footnotes: 

[1] Responders include individuals who performed rescue, recovery, 
demolition, debris cleanup, law enforcement, or other related services 
at the WTC, Pentagon, and Shanksville, Pennsylvania, disaster sites. 
Survivors include individuals who were not responders, but who were, 
for example, (1) present on September 11, 2001, in the New York City 
disaster area--specifically, the area of Manhattan south of Houston 
Street, including the WTC attack site, and any block in Brooklyn 
within a 1.5 mile radius of the WTC attack site--in the dust or dust 
cloud, or (2) who worked, resided, or attended school, child care, or 
adult day care in the New York City disaster area for at least 4 days 
during the 4-month period after the attacks, or at least 30 days 
during the 11-month period after the attacks.

[2] See for example, GAO, September 11: HHS Needs to Develop a Plan 
That Incorporates Lessons from the Responder Health Programs, 
[hyperlink, http://www.gao.gov/products/GAO-08-610] (Washington, D.C.: 
May 30, 2008), p. 9, for details on some of the problems responders 
and survivors experienced following the attacks. In addition, research 
findings related to September 11 health effects are listed at 
[hyperlink, http://www.cdc.gov/wtc/wtcresearch.html] (accessed Mar. 
17, 2014).

[3] For example, challenges to conducting definitive scientific 
analysis on the relationship between exposure to the attacks and 
particular health conditions include: (1) lack of exposure 
measurements for individuals, especially during the early stages of 
the September 11 attacks, when exposures were most intense, and (2) 
the length of time between exposure and detection (sometimes years or 
decades) of some conditions, including certain types of cancer. The 
latency (time between exposure and detection) of some conditions may 
mean that those conditions may not be captured in epidemiologic 
studies of the affected population, even when they could be related to 
exposure to the attacks.

[4] Pub. L. No. 111-347, 124 Stat. 3623.

[5] Pub. L. No. 111-347, tit. I, 124 Stat. 3624 (adding Title XXXIII 
to the Public Health Service Act) (codified at 42 U.S.C. §§ 300mm et 
seq.).

[6] Pub. L. No. 111-347, tit. II, 124 Stat. 3659 (amending various 
provisions of the Air Transportation Safety and System Stabilization 
Act, Pub. L. No. 107-42, 115 Stat. 230 (2001)) (codified at 49 U.S.C. 
§ 40101 note). The VCF previously provided compensation to eligible 
claimants from December 21, 2001, through December 21, 2003. See Pub. 
L. No. 107-42, § 405(a)(3), 115 Stat. 238 (codified at 49 U.S.C. § 
40101 note).

[7] Pub. L. No. 111-347, 124 Stat. 3657 (adding § 3351 to the Public 
Health Service Act) (codified at 42 U.S.C. 300mm-61).

[8] Pub. L. No. 111-347, §205, 124 Stat. 3664 (amending Pub. L. No. 
107-42 § 406) (codified at 49 U.S.C. § 40101 note). The fund will be 
open through October 3, 2017 to process and pay claims.

[9] Pub. L. No. 111-347, 124 Stat. 3639, 3652 (adding §§ 3312 and 3322 
to the Public Health Service Act) (codified at 42 U.S.C. §§ 300mm-22 
and 300mm-32).

[10] Aerodigestive disorders include, but are not limited to, asthma, 
chronic cough syndrome, and gastroesophageal reflux disorder.

[11] See Pub. L. No. 111-347, 124 Stat. 3642, 3652 (adding Public 
Health Service Act §§ 3312(a)(6) and 3322(b)(3)) (codified at 42 
U.S.C. §§ 300mm-22(a)(6) and 300mm-32(b)(3)). In addition, the 
Administrator was required to conduct an initial review of available 
scientific and medical evidence within 180 days of enactment to 
determine if cancer or types of cancer should be added to the list. 
For the initial review, the Administrator gathered information from 
peer-reviewed studies on exposure and cancer resulting from the 
September 11 attacks, findings and recommendations from various 
programs that gathered information from WTC responders, and 
information obtained from the public. In July 2011, the Administrator 
published a report stating there was insufficient evidence available 
to propose a rule to add any type of cancer to the list. He noted that 
he would consider any emerging findings about exposures and cancer in 
responders and survivors in subsequent periodic reviews. See 
Department of Health and Human Services (National Institute for 
Occupational Safety and Health), First Periodic Review of Scientific 
and Medical Evidence Related to Cancer for the World Trade Center 
Health Program, Publication Number 2011-197 (Washington, D.C.: July 
2011).

[12] 76 Fed. Reg. 54112, 54114 (Aug. 31, 2011) (preamble, I.(b).) 
(discussion of presumptively covered conditions). The VCF's use of the 
WTCHP list of covered conditions became effective October 3, 2011. The 
VCF does not provide compensation for mental health conditions because 
it is authorized only to provide compensation related to physical 
conditions. See Pub. L. No. 111-347, § 202(c)(2), 124 Stat. 3661 
(amending 49 U.S.C. § 40101 note).

[13] NIOSH published the petition on its website: [hyperlink, 
http://www.cdc.gov/wtc/received.html] (accessed July 9, 2014).

[14] See Pub. L. No. 111-347, 124 Stat. 3642 (adding Public Health 
Service Act § 3312(a)(6)) (codified at 42 U.S.C. § 300mm-22(a)(6)). 

[15] World Trade Center Health Program; Addition of Certain Types of 
Cancer to the List of WTC-Related Health Conditions (Final Rule), 77 
Fed. Reg. 56138, 56158 (Sept. 12, 2012) (codified at 42 C.F.R. § 88.1 
(2013)). In subsequent rulemaking, the Administrator expanded the list 
of covered conditions to include prostate cancer effective October 21, 
2013, and amended the definition of "rare cancers" and reversed a 
policy pertaining to certain rare cancers, resulting in four specific 
types of cancers becoming eligible for coverage effective February 18, 
2014: malignant neoplasms of the brain, the cervix uteri, the 
pancreas, and the testis. The Administrator grouped the types of 
cancers that were added to the list into 24 broad categories. See 78 
Fed Reg. 57505, 57522 (Sept. 19, 2013) (prostate cancer); 79 Fed. Reg. 
9100, 9117 (Feb. 18, 2014) (malignant neoplasms of the brain, the 
cervix uteri, the pancreas, and the testis) (both rules codified at 42 
C.F.R. 88.1).

[16] See World Trade Center Health Program; Addition of Certain Types 
of Cancer to the List of WTC-Related Health Conditions (Notice of 
Proposed Rulemaking), 77 Fed Reg. 33574 (June 13, 2012); and 77 Fed 
Reg. 56138 (Sept. 12, 2012).

[17] See GAO, Standards for Internal Control in the Federal 
Government, [hyperlink, 
http://www.gao.gov/products/GAO/AIMD-00-21.3.1] (Washington, D.C.: 
November 1999), and its supplemental guide, Internal Control 
Management and Evaluation Tool, [hyperlink, 
http://www.gao.gov/products/GAO-01-1008G] (Washington, D.C.: August 
2001).

[18] The WTCHP STAC is an advisory committee established by the 
Administrator to, among other things, review scientific and medical 
evidence and make recommendations on the addition of eligibility 
criteria and covered health conditions. Members of the STAC include 
scientific and medical professionals with expertise in occupational 
medicine and environmental health (among other specialties), and at 
least two WTC responder representatives and two WTC survivor 
representatives. See Pub. L. No. 111-347, 124 Stat. 3627 (adding 
Public Health Service Act § 3302) (codified at 42 U.S.C. § 300mm-1). 
(For additional information on the STAC, see appendix I.)

[19] IOM is a component of the National Academy of Sciences, a 
private, nonprofit organization charged by Congress with providing 
independent, objective advice on matters related to science and 
technology. Statutes directed agencies administering certain federal 
compensation programs, including those for veterans of the Vietnam War 
and Gulf War, to use the National Academy of Sciences to create study 
committees of experts to assess whether specific exposures are 
associated with certain health outcomes. IOM is the arm of the 
National Academy of Sciences that directs such study committees. The 
committees publish their results in reports provided to the agency 
administering the federal compensation program, and to the general 
public.

[20] To ensure that experts represented a broad range of views and 
interests and that we fully understood those interests, we required 
that experts complete conflict-of-interest forms, which we reviewed 
before the expert meeting.

[21] WTCHP enrollees who joined the program after October 12, 2012, 
may have joined as a result of the addition of cancers to the list 
regardless of whether they received coverage for the treatment of 
cancer.

[22] The steering committees were intended for the purpose of 
receiving input from affected stakeholders and facilitating the 
coordination of monitoring and treatment programs for enrolled WTC 
responders and survivors.

[23] See, for example, [hyperlink, 
http://www.gao.gov/products/GAO-08-610] and GAO, September 11: HHS 
Needs to Ensure the Availability of Health Screening and Monitoring 
for All Responders, [hyperlink, 
http://www.gao.gov/products/GAO-07-892] (Washington, D.C.: July 23, 
2007).

[24] See 76 Fed. Reg. 36027 (June 21, 2011) and 76 Fed. Reg. 54112 
(Aug. 31, 2011) (codified at 28 C.F.R. part 104).

[25] The VCF publishes such documents on its website: [hyperlink, 
http://www.vcf.gov]. (accessed May 6, 2014).

[26] Although the name of the program refers specifically to the WTC, 
responders from all three September 11, 2001, attack sites may be 
eligible to join the program. The vast majority of enrollees are 
responders from the WTC site.

[27] Responders enrolled in the WTCHP are automatically eligible to 
receive periodic monitoring exams for conditions on the list, and to 
determine whether a condition should be attributed to the September 11 
attacks and, as such, may be the basis for WTCHP treatment benefits. 
Survivors are eligible to receive an initial health evaluation from 
the program to determine treatment and monitoring benefits.

[28] Treatment could include services of physicians and other health- 
care providers, diagnostic and laboratory tests, prescription drugs, 
inpatient and outpatient hospital services, and other medically 
necessary treatment.

[29] As of May 2014, the contracted CCEs were Icahn School of Medicine 
at Mount Sinai, New York University School of Medicine, North Shore 
Long Island Jewish Health System, State University of New York (Stony 
Brook), Rutgers University, the Fire Department of New York City, and 
the New York City Health and Hospitals Corporation. The NPN is 
operated by Logistics Health, Inc., which subcontracts with systems, 
such as UnitedHealthcare, to provide services to enrollees, according 
to WTCHP officials.

[30] See Pub. L. No. 111-347, 124 Stat. 3642 (adding § 3312(a)(6) to 
the Public Health Service Act) (codified at 42 U.S.C. § 300mm-22(a)(6)).

[31] The law requires the STAC to provide its recommendation no later 
than 60 days after the Administrator's request, or by a date specified 
by the Administrator, which may not exceed 180 days from the date of 
the request.

[32] The Administrator requested that the STAC provide a scientific 
basis for any recommendations to add cancer, or a type of cancer, to 
the list of covered conditions. Specifically, he requested the STAC 
provide a description of the scientific or technical evidence it 
relied on, a description of the quality of the data supporting the 
recommendation, and a description of the methods used to formulate its 
recommendations. See "Letter from John Howard, M.D., Administrator, 
World Trade Center Health Program, to Elizabeth Ward, Ph.D., Chair, 
World Trade Center Health Program Scientific/Technical Advisory 
Committee," October 5, 2011, accessed March 14, 2013, [hyperlink, 
http://www.cdc.gov/niosh/docket/archive/pdfs/NIOSH-248/0248-100511- 
letter.pdf].

[33] See "WTCHP STAC letter from Elizabeth Ward, Chair, to John 
Howard, MD, WTCHP Administrator," March 31, 2012, accessed April 8, 
2013, [hyperlink, 
http://www.cdc.gov/niosh/topics/wtc/stacpetition001.html].

[34] Pub. L. No. 111-347, 124 Stat. 3643 (adding § 3312(b)(1)(A) to 
the Public Health Service Act) (codified at 42 U.S.C. § 300mm- 
22(b)(1)(A)).

[35] The Zadroga Act specified that the federal share of funding for 
the WTCHP was to be the lesser of either 90 percent of expenditures 
for a year, or an amount specified for that year. The amount provided 
for fiscal year 2016 is limited to any unexpended funds remaining 
available from fiscal years 2011 through 2015. Federal payments are 
conditioned on New York City agreeing to contribute 10 percent of the 
program's costs through fiscal year 2015 and one-ninth of any federal 
spending in fiscal year 2016.

[36] The VCF previously provided compensation to eligible claimants 
from December 21, 2001, through December 21, 2003. During its 2 years 
of operation, the VCF distributed over $7.0 billion in compensation.

[37] Claimants who, prior to October 3, 2011, had been diagnosed with 
conditions that were eligible for compensation by the VCF when the 
program was reactivated, were required to register by October 3, 2013.

[38] A claimant may amend a submitted compensation form if the 
claimant is diagnosed with a covered health condition after the form 
was submitted. In addition, claimants may modify submitted claims 
under other circumstances. For example, if the covered health 
condition substantially worsened, resulting in damages or losses that 
were not previously compensated, the claimant may amend the claim. 
Thus, claimants who submitted claims prior to October 12, 2012, can 
amend their claims if they were diagnosed with a type of cancer that 
since has been added to the list.

[39] As we did not seek to achieve consensus among experts 
participating in the meeting we convened, statements from these 
experts do not reflect the opinions of all meeting participants, 
unless otherwise noted.

[40] See 77 Fed. Reg. 35580 (June 13, 2012) (preamble, III.D.3.); 77 
Fed. Reg. 56142 (Sept. 12, 2012) (preamble, IV.). The approach was 
also described in a WTCHP policy memorandum. See World Trade Center 
Health Program, Policy and Procedures for Adding Types of Cancer to 
the List of WTC-Related Health Conditions, May 14, 2014, accessed May 
19, 2014, [hyperlink, 
http://www.cdc.gov/wtc/pdfs/WTCHPPPAddingCancerConditions14May2014.pdf].

[41] To evaluate whether the epidemiologic studies reviewed under 
Methods 1 and 2 supported causal associations between particular 
cancer types and either September 11 exposures or another condition 
already on the list, the Administrator used criteria established by 
epidemiologist Austin Bradford Hill (known as the Bradford Hill 
criteria), commonly used to assess relationships between exposure and 
health outcomes. See Austin Bradford Hill. "The Environment and 
Disease: Association or Causation?" Proceedings of the Royal Society 
of Medicine, 58: 295-300 (1965). The Administrator described the use 
of specific Bradford Hill criteria under certain circumstances in his 
approach (for example, when only one epidemiologic study was 
available) in 2012 rulemaking. See 77 Fed. Reg. 35578, 35580 (June 13, 
2012) (preamble, III.D.2. and III.D.3.).

[42] The National Toxicology Program is an interagency program of HHS 
established to provide information to health regulatory and research 
agencies, scientific and medical communities, and the public, about 
potentially toxic substances. For additional information on its 
classifications of carcinogenicity, see National Toxicology Program, 
Listing Criteria, accessed April 25, 2014, [hyperlink, 
http://ntp.niehs.nih.gov/?objectid=47B37760-F1F6-975E-7C15022B9C93B5A6].

[43] The International Agency for Research on Cancer is the World 
Health Organization's agency that promotes internal collaboration in 
cancer research. For additional information on its classifications, 
see International Agency for Research on Cancer, Agents Classified by 
the IARC Monographs, Volumes 1-109, accessed April 25, 2014, 
[hyperlink, http://monographs.iarc.fr/ENG/Classification/index.php].

[44] To make its recommendation regarding the addition of cancers to 
the list, the STAC reviewed the same types of sources used by the 
Administrator--that is, epidemiologic studies, studies on causal 
associations between a cancer type and a condition on the list, and 
information from the International Agency for Research on Cancer and 
the National Toxicology Program. The STAC, however, did not report 
using specific criteria to assess whether the epidemiologic evidence 
reviewed supported a causal association between September 11 exposures 
and a cancer type, but did document its rationale for adding certain 
types of cancer in a letter to the Administrator.

[45] Specifically, the WTCHP certification process calls for 
physicians to use information about individuals' specific exposures to 
the September 11 sites, and duration of those exposures, to determine 
whether those individuals' cancers are substantially likely to be 
related to the September 11 attacks.

[46] Pub. L. No. 105-277, title XVI, 112 Stat. 2681, 2681-742 (1998).

[47] See Institute of Medicine of the National Academies, Gulf War and 
Health, Volume 8: Update of Health Effects of Servicing in the Gulf 
War (Washington, D.C., 2010).

[48] The STAC voted not to recommend adding prostate cancer to the 
list following its review of evidence in 2012, which we considered to 
be a form of negative evidence.

[49] Subsequently, in 2013, the Administrator received a petition from 
the Patrolmen's Benevolent Association--a union representing New York 
City police officers--requesting the addition of prostate cancers to 
the list. In response to this petition, the Administrator reviewed 
available evidence using his four-method approach, including 
additional evidence under Method 1 and the same existing evidence 
under Method 3 that he had reviewed before. While the additional 
evidence under Method 1 was inconclusive, the Administrator ultimately 
determined that, based on evidence under Method 3, prostate cancer 
would be added to the list. See 78 Fed. Reg. 57506 (Sept. 19, 2013) 
(preamble.IV.).

[50] The Administrator noted in the 2012 proposed rule that he would 
review any future studies with epidemiologic evidence on site-specific 
cancers, such as thyroid and melanoma cancers, implying that decisions 
may be reconsidered in the future. Thyroid and melanoma cancers were 
added to the list in 2012 under Method 4.

[51] Standards for Internal Control also states that government 
processes, including administrative decisions, such as those made 
during rulemaking, should be clearly documented.See [hyperlink, 
http://www.gao.gov/products/GAO/AIMD-00-21.3.1] and [hyperlink, 
http://www.gao.gov/products/GAO-01-1008G].

[52] See World Trade Center Health Program, Policy and Procedures for 
Adding Types of Cancer to the List of WTC-Related Health Conditions, 
May 14, 2014, accessed May 19, 2014, [hyperlink, 
http://www.cdc.gov/wtc/pdfs/WTCHPPPAddingCancerConditions14May2014.pdf].

[53] According to IOM officials, independent peer reviewers are 
selected based on their familiarity with the subject(s) addressed by 
the committee and conduct their evaluation of the report independent 
of the committee; however, the reviewers themselves may be 
stakeholders or those with known opinions on the subject.

[54] The National Academies. "Consensus Reports," Report Review 
Committee Guidelines for Review, accessed February 7, 2014, [hyperlink, 
http://www.nationalacademies.org/xpedio/groups/nasite/documents/webpage/
na_067076.pdf].

[55] The Administrator told us that, at HHS's request, officials from 
the National Institutes of Health (NIH) reviewed the proposed rule, 
which describes the Administrator's approach and decision to add 
cancer to the list. While the Administrator told us that he viewed 
NIH's review as a form of independent peer review, he indicated that 
he did not know what NIH's review consisted of, because the request 
for the review was handled by HHS. NIH's input to the Administrator 
was limited to a memo, in which it commented on the approach's 
appropriateness as a policy decision. NIH did not comment on whether 
it assessed the appropriateness of specific evidence, or ways in which 
the Administrator could more clearly describe his assessment in 
rulemaking documents, key items that would be included in an 
independent peer review process.

[56] The WTCHP issued these certifications to enrollees when the 
program determined that September 11 exposure was substantially likely 
to be a significant factor in aggravating, contributing to, or causing 
cancer.

[57] Credentialing is the process of reviewing a health professional's 
credentials, training, experience, demonstrated ability, practice 
history, and medical certification or license, to determine if 
clinical privileges to practice in a particular setting are to be 
granted.

[58] According to WTCHP officials, CDC did not establish a single 
contract between the agency and a third-party administrator because of 
time constraints. They said that to meet the immediate need of program 
enrollees with cancer, each CCE needed to establish a separate 
subcontract.

[59] Each CCE negotiated a maximum dollar amount for subcontracted 
services that could be billed by the third-party administrator for the 
first year of cancer coverage. According to WTCHP officials, the 
subcontracts include fixed costs that may be related to both cancer 
and noncancer services and cannot be attributed specifically to cancer.

[60] According to WTCHP officials, a cancer treatment plan is used for 
claims adjudication, and allows an enrollee with a cancer 
certification to receive certain prescription drugs and other benefits.

[61] A formulary is a list of medications, grouped by therapeutic 
class, that a health care system's providers are expected to use when 
prescribing medications.

[62] The National Comprehensive Cancer Network is a nonprofit alliance 
of 25 cancer centers that develops resources for stakeholders in the 
health care delivery system, including the Clinical Practice 
Guidelines in Oncology, which document evidence-based, consensus- 
driven management to ensure that all patients receive preventive, 
diagnostic, treatment, and supportive services that are most likely to 
lead to optimal outcomes.

[63] The U.S. Preventive Services Task Force is an independent panel 
of nonfederal experts in prevention and evidence-based medicine that 
makes recommendations to primary care clinicians on clinical 
preventive services. The task force reviews evidence from randomized 
control trials and other studies documenting the effectiveness of 
clinical preventive services. It then issues recommendations for 
providers and may include guidance on the sex and age groups most 
likely to benefit from the service, as well as the interval of the 
service.

[64] In addition, a WTCHP Responder Steering Committee member noted 
that a large influx of enrollees due to the addition of cancers could 
result in the program reaching WTCHP enrollment limits established by 
the Zadroga Act (85,000 responders and 30,000 survivors), but it is 
too early to determine the likelihood of this occurring. Reaching 
enrollment limits could exacerbate any existing delays in wait times 
for WTCHP enrollees and it could leave responders and survivors who 
are not enrolled in the program without access to needed services.

[65] CDC included the estimated range in September 2012 final 
rulemaking and identified important limitations. CDC did not have data 
on the cancer status of responders and survivors who had not yet 
enrolled in the WTCHP. A WTCHP Responder Steering Committee member 
noted that information using actual WTCHP data to estimate the range 
would be needed for CDC to produce a useful forecast.

[66] The $194.6 million in VCF compensation calculations represents 
about 22.2 percent of the $875 million in VCF funding available for 
the first 5 years after the program's reactivation.

[67] Due to the limited number of decisions made, we combined data on 
compensation decisions for claimants with both cancer and noncancer 
conditions, and claimants with cancer only, to protect claimants' 
privacy. As of March 31, 2014, VCF had made more compensation 
decisions for claimants with both cancer and noncancer conditions than 
decisions for claimants with cancer only. Similarly, the total amount 
of compensation calculations was higher for claimants with both cancer 
and noncancer conditions than for claimants with cancer only.

[68] Because prostate cancer was added to the list on October 21, 
2013, this cancer was not included in the proration analysis; however, 
the VCF determined that the addition of prostate cancer likely would 
not have a material effect on the proration percentage.

[69] Specifically, VCF issued prorated payments to 21 of the 39 
claimants with cancer (for a total of $871,442, or $41,497 per 
claimant) and 289 of the 463 claimants with only noncancer conditions 
(for a total of $12,154,569, or $42,057 per claimant).

[70] In light of the uncertainty of the number of potential claimants, 
the VCF must prorate the initial payments to ensure that all eligible 
claimants receive an equal percentage of their calculated compensation 
as an initial payment within the first 5 years of the program's 
reactivation.

[71] Pub. L. No. 111-347, 124 Stat. 3627 (adding Public Health Service 
Act § 3302) (codified at 42 U.S.C. 300mm-1). This provision of law 
provides that the STAC shall be established subject to the Federal 
Advisory Committee Act, which contains broad requirements for balance, 
independence, and transparency. See 5 U.S.C. App. 2.

[72] 76 Fed, Reg. 36926 (June 23, 2011).

[73] Coverage for the treatment and monitoring of these 60 cancers 
added to the list went into effect on October 12, 2012. See World 
Trade Center Health Program; Addition of Certain Types of Cancer to 
the List of WTC-Related Health Conditions (Final Rule), 77 Fed Reg. 
56158 (Sept. 12, 2012) (codified at 42 C.F.R. § 88.1 (2013)). In 
subsequent rulemaking the Administrator expanded the list of covered 
conditions to include prostate cancer effective October 21, 2013, and 
amended the definition of "rare cancers" and reversed a policy 
pertaining to certain rare cancers, resulting in four specific types 
of cancers becoming eligible for coverage effective February 18, 2014: 
malignant neoplasms of the brain, the cervix uteri, the pancreas, and 
the testis. The Administrator grouped the types of cancers that were 
added to the list into 24 broad categories. See 78 Fed Reg. 57505, 
57522 (Sept. 19, 2013) (prostate cancer); 79 Fed. Reg. 9100, 9117 
(Feb. 18, 2014) (malignant neoplasms of the brain, the cervix uteri, 
the pancreas, and the testis) (both rules codified at 42 C.F.R. 88.1).

[74] The basis for adding malignant neoplasm of the breast was changed 
to Method 3 in April 2013 (See 78 Fed Reg. 22794, 22795 (Apr. 17, 2013).

[75] The Administrator amended the definition of "rare cancers" and 
reversed a policy pertaining to certain rare cancers, resulting in 
four specific types of cancers becoming eligible for coverage 
effective February 18, 2014: malignant neoplasms of the brain, the 
cervix uteri, the pancreas, and the testis. See 79 Fed. Reg. 9100, 
9117 (Feb. 18, 2014) (malignant neoplasms of the brain, the cervix 
uteri, the pancreas, and the testis) (codified at 42 C.F.R. 88.1). 

[End of section] 

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