World Trade Center Health Program: Improved Oversight Needed to Ensure Clinics Fully Address Mandated Quality Assurance Elements
Fast Facts
Responders and survivors of the September 11 attacks on the World Trade Center may continue to suffer related physical and mental health conditions. The WTC Health Program provides treatment for these conditions through participating clinics.
The Department of Health and Human Services administers the program. We looked at how HHS certifies eligibility for treatment, ensures accurate payments, and oversees the way that clinics monitor and improve their services (their quality assurance programs).
We found that clinics' quality assurance programs were inconsistent and suggested ways for the agency to improve its oversight of these programs.
Photograph of NYPD responders at the World Trade Center.
Highlights
What GAO Found
Certifying health conditions: The National Institute for Occupational Safety and Health (NIOSH)—an agency within the Department of Health and Human Services that administers the World Trade Center (WTC) Health Program—has developed policies, procedures, and guidance necessary for Health Program clinics and NIOSH to certify enrollees' WTC-related health conditions as being eligible for treatment. These include instructions for submitting certification paperwork, medical guidelines, and thresholds for determining whether a condition is WTC-related, and specific condition-related guidance. Medical directors of the clinics—contracted to provide health services to enrollees—noted that the guidance was clear and helpful in making determinations.
Ensuring appropriate payments: WTC Health Program clinics have implemented procedures for reviewing medical claims to help ensure appropriate payments, and NIOSH has taken steps to ensure accuracy. Each clinic uses a different claims-processing system and reviews different types of claims information, such as a patient's enrollment status. NIOSH officials noted that establishing uniform claims-review standards for the clinics would require expensive technological upgrades or other significant resources. Instead, NIOSH officials say they rely on its claims-adjudication contractor to conduct a standardized review of all claims prior to payment. A 2014 external review found the adjudication contractor's claims-review process to be robust.
Implementing a quality assurance program: NIOSH has not ensured that clinics address mandated quality assurance elements, but indicates that recently allocated funding and a new strategic plan will enhance quality assurance. Clinics are required to develop quality assurance plans that address three elements mandated by law: ensuring adherence to monitoring and treatment protocols, appropriate referrals, and prompt communication of test results. NIOSH has not systematically reviewed the plans. GAO found that some of the clinics did not include all three mandated elements, and the extent to which the plans addressed each element varied. For example, plans for two clinics addressed adherence to either monitoring protocols or treatment protocols, but not both. NIOSH officials told us they recently used allocated funding to increase staff, which will help focus on quality assurance oversight, but they have not developed a systematic process to closely review the plans or provided guidance for clinics to help ensure consistency in their plans. Without this, there is a risk that clinics are not addressing mandated elements that may provide important information about the quality of care and identify any needed improvements.
NIOSH developed a tool for reviewing clinics' quarterly audit reports and shared it with them in 2015. However, the tool does not require clinics to evaluate and report on uniform performance measures for all three mandated elements. GAO reviewed clinics' audit reports for one quarter in fiscal year 2016 and found that most clinics did not report on measures or any other information for all three mandated elements. Until NIOSH develops and requires reporting on uniform clinic performance measures that includes all mandated elements, it will be difficult for the agency to systematically identify any deficiencies and make the necessary improvements.
Why GAO Did This Study
The WTC Health Program provides health care services to eligible responders and survivors of the September 11, 2001, attacks through eight clinics. NIOSH and clinics share responsibility for several program components. The James Zadroga 9/11 Health and Compensation Reauthorization Act, which extended the program to 2090, included a provision for GAO to examine three of these components—certification of conditions for treatment coverage, actions to ensure appropriate payments, and quality assurance. This report examines (1) the development and implementation of policies, procedures, and guidance for certifying health conditions, (2) actions taken to ensure appropriate payments, and (3) the development and implementation of a quality assurance program, including mandated elements. GAO reviewed relevant legal requirements, policies and procedures, and clinic contracts. GAO also interviewed NIOSH officials, clinics, and responder and survivor committees.
Recommendations
GAO recommends that NIOSH (1) develop and implement procedures for review of clinic quality assurance plans, (2) develop guidance that specifies how mandated elements should be addressed in these plans, and (3) develop required uniform performance measures for mandated elements in quarterly audits. NIOSH agreed with GAO's recommendations.
Recommendations for Executive Action
| Agency Affected | Recommendation | Status |
|---|---|---|
| National Institute for Occupational Safety and Health | To help ensure that the WTC Health Program quality assurance (QA) program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop and implement procedures for conducting systematic reviews of each clinic's QA plan (recommendation 1). |
The National Institute for Occupational Safety and Health (NIOSH) concurred with this recommendation and have provided regular updates on its progress implementing it. On 2/13/19, NIOSH provided GAO with a copy of the guidance it created for the Clinical Centers of Excellence (CCE), National Provider Network (NPN) and Contracting Officer Representative (COR) to use when developing and reviewing quality assurance plans (QAP). This guidance was distributed to CCEs on December 3, 2018. This guidance contains milestones and procedures for receiving and reviewing initial and updated QAPs including a summary table that will allow for a standardized and systematic review across each QAP. Additionally, on 4/18/19 NIOSH noted that the CORs use a checklist to conduct their review and a cover page to document that they had completed their review. Finally, the guidance states that any changes to the QAP should be included in the CCE and NPN monthly reports. On 10/15/19, NIOSH provided examples of completed checklists that clearly demonstrate a systematic process for reviewing each CCE QAP against a consistent set of standards and providing feedback. This process will ensure that the required quality assurance elements, including the three elements mandated in the Zadroga Act, are consistently addressed in each QAP. As such, we are closing this recommendation as implemented.
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| National Institute for Occupational Safety and Health | To help ensure that the WTC Health Program QA program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop and disseminate guidance that clearly specifies how the clinics should address mandated elements in their QA plans (recommendation 2). |
The National Institute for Occupational Safety and Health (NIOSH) concurred with this recommendation and has provided regular updates on its progress implementing it. On 2/13/19, NIOSH provided GAO with a guidance document for the Clinical Centers of Excellence (CCE) and National Provider Network (NPN) to use when developing quality assurance plans (QAP). This guidance was distributed to the CCEs and the NPN on December 3, 2018. The guidance document contains 13 specific metrics with benchmarks and goals to address the 4 required Zadroga Act elements and has created specific guidance for each metric. On 4/8/19, GAO received a copy of the updated CCE Performance Work Statement which also contained key information from the guidance document. On 10/15/19, NIOSH also provided GAO with copies of the checklists they use when reviewing and providing feedback on the QAPs. The checklists have incorporated the metrics, benchmarks and goals from the guidance and show that NIOSH is using the new guidance to ensure that each CCE and the NPN is addressing each of the quality assurance elements, including the three elements in the Zadroga Act, in a consistent manner according to the distributed guidance. As such, we are closing this recommendation as implemented.
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| National Institute for Occupational Safety and Health | To help ensure that the WTC Health Program QA program addresses required QA elements, including the three elements mandated in the Zadroga Act, the Director of NIOSH should develop uniform performance measures that clinics are required to use to consistently evaluate mandated elements through their audits every quarter (recommendation 3). |
The National Institute for Occupational Safety and Health (NIOSH) concurred with this recommendation and have provided regular updates on its progress implementing it. On 2/13/19, NIOSH provided GAO with a guidance document for the Clinical Centers of Excellence (CCE) and National Provider Network (NPN) to use when developing quality assurance plans (QAP). This guidance was distributed to CCEs and the NPN on December 3, 2018. The guidance document contains 13 specific metrics with benchmarks and goals to address the 4 required Zadroga Act elements and has created specific guidance for each metric. On 4/8/19, GAO received a copy of the updated CCE Performance Work Statement which also contained key information from the guidance document. On 10/15/19, NIOSH provided GAO with additional information and documentation on the process being used to evaluate the mandated elements through NIOSH audits. NIOSH developed a checklist that contains the 13 specific metrics, benchmarks and goals from the guidance. NIOSH compares the results from the semi-annual reports against the required metrics, methodologies and benchmarks in the guidance. NIOSH provided comments to the CCEs and NPN on what was missing or what wasn't done properly in the May semi-annual report and noted that they expect substantial improvement in the November reports now that the CCEs and NPN have adequate guidance and feedback on what is expected. Through their guidance, NIOSH has developed a set of uniform measures and methodologies that allow them to consistently evaluate each semi-annual report and provide feedback for improvement, if necessary. As such, we are closing this recommendation as implemented.
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