World Trade Center Health Program: Approach Used to Add Cancers to List of Covered Conditions Was Reasonable, but Could Be Improved
Published: 2014-07-23T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: 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.
section_title: What GAO Found
paragraphs: 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.
section_title: What GAO Recommends
paragraphs: 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.

section_title: Letter
paragraphs: 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 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.However, determining the exact relationships between exposure to  specific substances from the attacks and particular health conditions has  been challenging.
Pub. L. No. 111-347, 124 Stat. 3623.
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. The list included certain  aerodigestive disorders, 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. 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.
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. 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. As a result of his  review of evidence, in September 2012, the Administrator expanded the  list to include 60 types of cancer. 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, and reviewed federal standards for  internal controls. 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. 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. 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. (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.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   The WTCHP  members of the WTCHP Responder and Survivor Steering committees.  We also reviewed previous GAO reports for background on the WTCHP  and earlier programs for WTC responders and survivors.
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. We also  interviewed VCF officials and reviewed VCF documents that describe  program eligibility, processes for submitting claims, and key deadlines.
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.
subsections: section_title: Background
paragraphs: The Zadroga Act established the WTCHP to provide medical monitoring  and treatment benefits, and reactivated the VCF to provide financial  compensation to eligible individuals.
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. Monitoring,  for the purposes of this report, includes initial health and diagnostic  evaluations, screening tests, and monitoring exams. Treatment provided  by the WTCHP must be deemed medically necessary, and in accordance  with the WTCHP’s medical treatment protocols. 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.
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. If the  Administrator chooses to request a recommendation of the STAC, the  STAC has up to 180 days to provide it, 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, which, in March 2012,  provided its recommendation to add certain types of cancers to the list.  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.” 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. 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.)
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.
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.
Rules reactivating the VCF under the Zadroga Act became effective  October 3, 2011.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.
The VCF provides compensation for personal injury or  An individual must register with the VCF within 2 years of diagnosis with a  covered condition, but not later than October 3, 2016. 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. 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.
section_title: Experts Indicated That the WTCHP Administrator’s Hazard-Based Approach Was Reasonable, but Could Be Improved
paragraphs: 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.
subsections: section_title: The Administrator Used a Hazard-Based, Multiple- Method Approach to Determine Whether to Add Cancers to the List
paragraphs: 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   a hazard-based approach focuses on  participated in our meeting,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,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).
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, and the International Agency for Research on Cancer determined that there was at least limited evidence that the hazard  causes the cancer.
Method 4: The STAC provided a reasonable basis to add a cancer to  the list based on its review of scientific and medical evidence.
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.)
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.
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.).  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.  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.
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.)
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.
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.
section_title: Experts Indicated That the Administrator’s Approach Was Reasonable
paragraphs: 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. 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; 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. 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.
section_title: Administrator’s Approach Was Not Communicated Clearly and Did Not Include Independent Peer Review
paragraphs: 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 fig. 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, even  though there was positive evidence under Method 3. 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; 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. 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. 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. 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.
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.
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. 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.
section_title: 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
paragraphs: 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.
subsections: section_title: 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
paragraphs: 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. 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.)
section_title: Addition of Cancers to the List Led to the Need for a Third-Party Administrator
paragraphs: 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.Furthermore, the program needed to establish a separate billing  arrangement for each physician, and doing so risked delaying the  payment of claims.
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. which fell well below the combined maximum amounts negotiated for  each contract. (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.
section_title: The Addition of Cancers Has Helped Ensure Access to High-Quality Cancer Care, but Required Increased Staff to Implement Program Changes
paragraphs: 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, and  prescription drug formulary, 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. 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.high-quality care, including cancer-related monitoring that could result in   According to officials associated with the WTCHP, access to  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. 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.2014, CDC had yet to revise the estimate to include fiscal year 2013  spending and enrollment data.
section_title: The Effects on the VCF of Adding Cancers to the List of Covered Conditions Are Not Yet Known
paragraphs: 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. 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). 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.)
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. 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. Final payments will be  sent to claimants in Year 6 of the program based on remaining funds.
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.
section_title: Conclusions
paragraphs: 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.
section_title: Recommendations for Executive Action
paragraphs: 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.
section_title: Agency Comments and Our Evaluation
paragraphs: 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.
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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.
section_title: Appendix I: Composition of the World Trade Center Health Program Scientific/Technical Advisory Committee
paragraphs: The World Trade Center Health Program (WTCHP) Scientific/Technical  Advisory Committee (STAC) is an advisory committee established  pursuant to the law 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 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.
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.
section_title: Appendix II: List of Participants in GAO’s Expert Meeting Hosted by the Institute of Medicine, October 21, 2013
section_title: Appendix III: Cancers Added to the WTCHP List of Covered Conditions
paragraphs: 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, 53 were added using Method 3, 6 using   Method 4, and 1 using Method 2. No cancers were added based on  Method 1.
section_title: Appendix IV: Comments from the Department of Health and Human Services
section_title: Appendix V: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: 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.