WTC Health Program TPA draft PWS.docx

Performance Work Statement Title: World Trade Center Health Program Third-Party Administrator

Period of performance of this contract: September 15, 2025, to September 14, 2035. This anticipated period of performance consists of a base year and 9 option years.

Option Period Three: September 15, 2028, to September 14, 2029

SECTION 1 – BACKGROUND

On January 2, 2011, the President signed Public Law No. 111-347, the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act). Title I of the Zadroga Act amended the Public Health Service Act to add Title XXXIII establishing the World Trade Center (WTC) Health Program, referred to herein as “the Program,” within the U.S. Department of Health and Human Services (HHS). The Zadroga Act was amended in 2015 by Public Law No. 114-113 to provide authority and funding and for the Program to continue through 2090 and further amended in 2019-2024 by Public Law No. 116-59, Public Law No. 117-328, Public Law No. 118-31, and the National Defense Authorization Act of 2024, codified at 42 USC 300mm-300mm-64.[footnoteRef:2] In addition to the statutory requirements for the Program codified in 42 U.S.C. §§ 300mm – 300mm-62, the WTC Program Administrator has also promulgated regulations governing the administration of the Program at 42 C.F.R. pt. 88. As of June 30, 2024, the Program has about 135,000 members enrolled, including about 88,800 responders and 46,200 survivors.[footnoteRef:3] [2: The Zadroga Act, as amended, can be found at: https://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter6A/subchapter31&edition=prelim. ] [3: Current Program statistics and reports can be found at https://www.cdc.gov/wtc/ataglance.html#enrollmentWTC.]

The Program is a limited health benefit program, meaning that treatment is only available for specific covered health condition(s) for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks has been determined to be substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition in an individual member. The Program is administered by the National Institute for Occupational Safety and Health (NIOSH), part of the Centers for Disease Control and Prevention (CDC), a component of HHS, and provides medical monitoring and treatment for Program members. Members comprise of responders to the 9/11 terrorist attacks in New York City (NYC), responders at the Pentagon and near Shanksville, Pennsylvania, and survivors in the NYC disaster area. To receive treatment for a specific health condition, members must be both enrolled in the Program and have their health condition certified as WTC-related by the Program. Only certain health conditions established by statute and the Program qualify for coverage, and the Program is therefore a limited benefit plan. Both Program enrollment and certification decisions are made by Program enrollment and certification specialists within NIOSH. The Zadroga Act establishes responsibilities associated with the administration and performance needed to enroll, initially evaluate, medically monitor, manage treatment, and reimburse services for covered health conditions. The Program contracts with vendors to carry out specific Program functions and operations of the limited benefit plan.

Monitoring and treatment are administered to members residing in the New York Metropolitan Area (NYMA), as defined in 42 CFR 88.1, by Clinical Centers of Excellence (CCEs), and to members residing outside of the NYMA through the Nationwide Provider Network (NPN) Contractor; the CCEs and NPN are administered under separate contracts in support of the Program. The Government also contracts with a Pharmacy Benefits Manager (PBM) to administer prescription benefits in the Program. In addition to these contracts, the Government also contracts with a Third-Party Administrator (TPA), the awardee of this contract and referred to herein as the “TPA Contractor,” that receives and processes enrollment and certification applications for NIOSH decision-making, maintains member demographic information, manages a call center, manages and maintains provider network(s) on behalf of the Program, administers Program benefits, and processes medical claims. The data maintained by the TPA Contractor to carry out these responsibilities is the property of the Program and may be shared with other Program contractors (e.g., CCEs, NPN, PBM, Data Centers (DCs)) on a pre-determined schedule. Key terms are described, and acronyms expanded upon in Attachment 001.

Section 1.1 – Other Program Contractors The following is a non-exhaustive list of WTC Health Program contractors, and related definitions, that the TPA Contractor shall engage with while carrying out requirements per this contract. Unless otherwise specified, references to “other Program contractors” shall mean one or more of the contractors listed below.

Clinical Center of Excellence (CCE): A center under contract with the Program that: (1) uses an integrated, centralized health care provider approach to create a comprehensive suite of health services that are accessible to enrolled WTC responders, screening-eligible survivors, or certified-eligible survivors; (2) has experience in caring for WTC responders and survivors, or includes health care providers who have received Program training; (3) employs health care provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social services counseling; and (4) meets such other requirements as specified by the Administrator of the Program. A CCE is a NYMA-based medical facility that, in accordance with the Zadroga Act, operates under an individual contractual relationship with the Program to provide medical monitoring, diagnosis, certification, treatment services, case management, and benefits counseling for members in the NYMA. Members residing in the NYMA or otherwise electing care through a CCE are assigned to a CCE that is responsible for coordinating their care under the Program. There are currently eight CCEs contracted with the Program: two for the Survivor population and six for the Responder population.

Comprehensive Cost Avoidance (CCA) Contractor: A vendor who implements a comprehensive cost avoidance, coordination of benefits, and recovery platform from pre- to post-payment processes to facilitate the ability of the Program to improve efficiency and control health care costs without compromising quality of care.

Data Center (DC): A center under contract with the Program to support various functions, including receiving data from the TPA Contractor, CCEs, and NPN; developing examination, monitoring, and treatment protocols; and coordinating outreach activities. There are currently three DCs contracted with the Program, serving the FDNY, General Responder, and Survivor populations.

Health Program Evaluation (HPE) Contractor: A vendor providing consulting services for data analytics to support strategic planning and program evaluation.

Health Program Support (HPS): The incumbent vendor who performs various Program functions, including processing member enrollment and certification applications, managing the customer-service call center, managing the NYMA External Provider Network (EPN), administering benefit plans, processing medical claims, maintaining the member database, and coordinating member communications. The TPA Contractor will be the successor to the current HPS; though contract tasks are very similar, the contract name is changing to be more descriptive of the work.

National Program Administrator (NPA): A vendor that coordinates and provides medical oversight of the healthcare provided by the NPN Network. This role is currently fulfilled by the NPN Contractor.

Nationwide Provider Network (NPN) Administrator: A vendor that establishes and manages the NPN Network. This NPN Administrator role is currently fulfilled by the NPN Contractor, though this role will be transitioned to this TPA Contractor during the transition-in period of this TPA contract.

Nationwide Provider Network (NPN) Contractor: The vendor who is currently contracted to fulfill the roles of both the NPN Administrator and the NPA.

During the transition-in period of this TPA contract, the NPN Contractor will transition the NPN Administrator tasks to the TPA Contractor and the term “NPN Administrator” in this contract will refer to the TPA Contractor. However, the successor NPN contract will remain the NPA. For clarity within the rest of this contract, “National Program Administrator (NPA)” will be used to refer to the current and successor NPN Contractor and “NPN Network” will be used to refer to the nationwide provider network itself.

Nationwide Provider Network (NPN): A nationwide network of healthcare providers that provide WTC-related health care to enrolled WTC responders, screening-eligible survivors, and certified-eligible survivors who live outside the NYMA. The provided health care includes initial health evaluation, monitoring, and treatment benefits.

Pharmacy Benefits Manager (PBM): A vendor who provides comprehensive pharmacy services to the WTC Health Program for filling prescriptions at retail and mail-order pharmacies, with controls on formularies, members, and prescribers. Pharmacy benefits are administered through a pharmacy-specific call center, claims adjudication, formulary management, pharmacy network management, and clinical reviews.

SECTION 2 – PURPOSE/OBJECTIVE

The primary purposes of this TPA contract are to:

1. Maximize member access to and utilization of Program benefits within the boundaries of the WTC Health Program’s limited health benefit plan.

2. Optimize delivery of compassionate, convenient, equitable, safe, and high-quality healthcare services.

3. Provide transparent, up-to-date, accurate, and comprehensive information to Program stakeholders (including members, providers, Program staff, and other Program contractors).

4. Deliver services focusing on quality, waste elimination, and reduction in unwarranted variation by considering the total cost of care over time and not only the cost of individual health care activities.

5. Enhance Program oversight capabilities through data collection, analysis, and visualization.

SECTION 3 – SCOPE OF WORK

The TPA Contractor shall provide Contract Management, Member Services, Provider Network Management, Medical Benefits Administration, Claims Processing, and Data and Business Information Management to support the operation and enhancement of the Program. In supporting the Program, the TPA Contractor shall coordinate with the Program and regularly communicate and interact with other Program contractors. All communications between the TPA Contractor and other Program contractors shall include the Contracting Officer’s Representative (COR) or their designee.

The TPA Contractor shall perform all tasks and maintain all systems in accordance with Title XXXIII of the Public Health Service Act (codifying the Zadroga Act, 42 USC 300mm – 300mm-64), 42 CFR 88, the Privacy Act (5 USC 552a), the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as modified (Pub. L. 104–191; 42 USC 1320d and the corresponding implementing HIPAA regulations at 45 CFR 160, 162, and 164), Program policies, and all other applicable federal statutes and regulations, at all times. All tasks shall be completed in the timeframes required.

The TPA Contractor shall manage program administration in a way that aligns with advanced and continually improving industry standards and best business practices. The TPA Contractor will not be responsible for underwriting the cost of care.

Tasks to be performed are detailed in the following sections:

4.1 Transition-Related Services;

4.2 Contract Management;

4.3 Member Services;

4.4 Provider Network Management;

4.5 Medical Benefit Administration;

4.6 Claims Processing;

4.7 Data and Business Information Management;

4.8 Regulatory Compliance.

SECTION 4 – TASKS TO BE PERFORMED

Section 4.1 – Transition-Related Services Section 4.1.1 – Kickoff Meeting The TPA Contractor shall employ the necessary resources to ensure that all services and systems are fully operational at the Start of Healthcare Delivery (SHCD). SHCD shall occur within 12 months of the award start date. The TPA Contractor shall have an introductory call with the COR within seven calendar days after the award start date to establish dates and an agenda for an in-person Kickoff Meeting where the TPA Contractor shall present their plan to meet all contractual requirements. The TPA Contractor shall finalize the agenda and deliver to the COR seven calendar days prior to the Kickoff Meeting. The TPA Contractor shall create a Kickoff Presentation that summarizes the TPA Contractor’s technical solutions and how all contract functions shall be fulfilled and operationalized within contract parameters; a draft Kickoff Presentation shall be delivered to the COR with the agenda to allow the Program time to review prior to the meeting.

The Kickoff Meeting shall occur as soon as possible but no later than 30 calendar days after the award date. The Kickoff Meeting will occur in-person at the Program’s office in Washington, DC. The TPA Contractor shall take and distribute Meeting Minutes in accordance with Section 4.2.3. The TPA Contractor shall also develop, execute, and maintain detailed written documentation of the TPA Contractor’s approach to transition-in and contract management in the Transition-In Plan and Contract Management Plan, respectively. Both plans shall be consistent with the TPA Contractor’s proposal and are due 14 calendar days after the Kickoff Meeting. The TPA Contractor shall ensure that all Program-requested changes and revisions to approaches presented in the Kickoff Meeting are addressed in these deliverables.

Section 4.1.2 – Transition-In The TPA Contractor shall collaborate with the Program, other Program contractors, and the incumbent HPS contractor to ensure a successful Transition-In is completed in the required timeframe. Transition-In begins upon the award start date, includes development, testing and validation, SHCD, and continues through the end of Dual Operations described in Section 4.1.4. The Transition-In shall cause no disruption of claims processing and Program operations, with minimal disruption of payment, customer service, and other benefits/services provided by the TPA Contractor. Systems and processes shall be developed and tested, and all required services shall be fully operational to implement SHCD within twelve months of the award start date. The TPA Contractor shall ensure that the TPA Contractor’s activities during Transition-In have minimal detrimental impact to the applicant/member experience and have minimal changes to other Program contractor systems and processes, unless agreed upon with the Program. During the Transition-In Period, the TPA Contractor shall perform the following tasks:

1. Contract Management – Track status of transition activities, tasks, and outcomes to ensure alignment with the Transition-In Master Schedule (TIMS). Deviations must be reported and addressed, in accordance with Section 4.2.

2. Member Services – Implement solutions for customer service, public-facing call center and self-service portal functionality, transition of member communications, enrollment, certification, and transfer processing, and all other responsibilities detailed in Section 4.3.

3. Provider Network Management – Implement solutions including all operations required to adopt the existing NYMA EPN, load the existing NYMA EPN provider file, assess the accuracy of the network provider file, update and manage provider network data, and perform all other responsibilities detailed in Section 4.4, including the development of the NPN. The TPA Contractor shall be ready to manage the NPN Network by the SHCD date, having fully transitioned this task from the NPA.

4. Medical Benefit Administration – Implement solutions for medical benefit administration, prior authorizations, utilization management, and all other responsibilities detailed in Section 4.5.

5. Claims Processing – Implement solutions that meet federal payor requirements and edits including incorporation of business rules into automated claims processing and adjudication system, coordination of benefits, program integrity activities, and all other responsibilities detailed in Section 4.6.

6. Data and Business Information Management – Implement solutions including data and file migration, conversion, and a comprehensive testing process that shall include industry standard quality assurance (QA) reviews and end-to-end-transactions in a way that meets requirements in Section 4.1.3. The TPA Contractor shall implement processes to establish data security, systems access, data storage and organization compliance, data integrity, continuity of operations, connectivity and information exchange, documentation, and all other responsibilities detailed in Section 4.7.

The TPA Contractor shall coordinate with the Program and the incumbent HPS contractor to minimize the quantity of risks associated with services that have been initiated but have not been fully resolved, including paper documents requiring data entry, enrollment applications, known data integrity issues, and outstanding claims. The TPA Contractor shall assume responsibility for completing these services in accordance with the TIMS.

The TPA Contractor shall establish transition meetings with the Program every two weeks where the TPA Contractor will present a Transition Progress Report (TPR); ad hoc meetings shall be scheduled as necessary per request of the COR. The TPA Contractor shall generate and submit Transition Progress Reports (TPR), including an up-to-date copy of the TIMS and Risk, Assumptions, Issues, and Decisions (RAID) Log, every two weeks starting 14 calendar days after the Kickoff Meeting through four weeks after SHCD. The TPR shall summarize the status of Transition-In activities, highlighting elements of the TIMS and the RAID Log that may require Program input or support to prevent impacts on transition cost, project timeline, or key milestones. An interim Transition-In Summary Report documenting the actual Transition-In activities shall be delivered 90 days after SHCD, with a final report due 180 calendar days after SHCD. The report shall summarize lessons learned during the implementation of each functional area; analyze issues that were realized, their root cause, and mitigation; and highlight accomplishments where risks were avoided or significantly mitigated. The Government may waive the delivery of the interim 90-day report, no later than 30 days before it is due.

Though the Government recognizes that the TPA Contractor may have distinct Transition-In and Sustainment staff, the Government prefers that the Transition-In team supports the contract until the final Transition-In Summary Report is accepted.

Section 4.1.3– Readiness for SHCD The TPA Contractor shall execute the Transition-In Plan to establish full readiness for SHCD. Readiness for SHCD shall be assessed via integrated systems testing to be conducted prior to SHCD for each functional area, as mutually agreed upon between the TPA Contractor and the Program. The TPA Contractor shall schedule a System Readiness Meeting with the Program within 15 calendar days of the Kickoff Meeting to review requirements and strategy for establishing connectivity with Program and other Program contractor systems.

The TPA Contractor shall facilitate testing sessions for all required functions to demonstrate that operations are ready for SHCD in accordance with this PWS and the Transition-In Quality Assurance Surveillance Plan (QASP) in Attachment 002. This readiness will be demonstrated by the following:

1. Member Services – successful completion of end-to-end integration testing to confirm enrollment, certification, and transfer processing, customer service and stakeholder communications, call center, mail center operations, and secure self-service portal are fully operational. The TPA Contractor shall provide all training documents provided to its staff for Program review and approval. The TPA Contractor shall provide written documentation attesting to completion of training for all enrollment, certification, and transfer processing staff. The TPA Contractor shall refer to Section 4.3. for specific guidelines on SHCD Member Services testing and deliverables.

2. Provider Network Management – successful loading of provider file and availability of provider directory, to include any newly recruited providers. The TPA Contractor shall provide written documentation attesting to completion of network absorption. The TPA Contractor shall refer to Section 4.4. for specific guidelines on SHCD Provider Network Management testing and deliverables.

3. Medical Benefit Administration – successful completion of end-to-end testing of prior authorization approval workflow and verification that assigned benefit plans reflect all medically necessary care that members are eligible for, as well as an implemented utilization management program, capable of prospective, concurrent, and retrospective utilization management. The TPA Contractor shall refer to Section 4.5 for specific guidelines on SHCD Medical Benefit Administration testing and deliverables.

4. Claims Processing – successful completion of end-to-end claims processing testing to include reimbursement and policy compliance and auto-adjudication. The TPA Contractor shall refer to Section 4.6 for specific guidelines on SHCD Claims Processing testing and deliverables.

5. Data and Business Information Management – data conversion and migration plan are successfully executed, bidirectional data exchanges with the Program and applicable other Program contractors are established and operational, all systems are configured and compliant to support program operations, system access is granted to critical staff, analytical platform and data repository is available for Program staff use. Implement solutions including data migration and conversion (where applicable). The TPA Contractor shall refer to Section 4.7 for specific guidelines on SHCD Data and Business Information testing and deliverables.

The TPA Contractor has discretion over internal testing and validation review activities, methodologies, accuracy/timeliness thresholds, and procedures. The Program shall verify the TPA Contractor's validation process, which must be structured to meet or exceed Program performance standards as outlined in the sections below. For each critical process, the baseline validation parameters shall be identified to meet required specifications. The TPA Contractor’s validation is expected to provide the necessary information to the Program to confirm, though the Government reserves the right to request additional review and validation, including roundtable exercises. Testing methodology shall be documented in the Transition-In Plan and approved by the Program prior to the commencement of testing activities.

The TPA Contractor shall include in its validation process system compatibility tests with the incumbent HPS contractor to ensure historical data is migrated accurately and verified to be usable, and with other Program contractors to ensure key data exchanges are functioning appropriately and in accordance with Program rules. The TPA Contractor shall clearly communicate and coordinate testing and validation needs with the Program, the incumbent HPS contractor, and other Program contractors. Tests shall include accessibility to records, accuracy of data, and the recipient’s ability to use the data to correctly apply Program requirements. The TPA Contractor shall complete internal testing and remediate all issues prior to delivery to the Program for acceptance.

The TPA Contractor shall submit Unit Testing Results to the Program 120 calendar days prior to SHCD. This document shall provide a summary of all testing completed since the award start date, including test scenarios used, the intended results prior to testing, and the outcomes. The test scenarios shall include all manner of scenarios, including best-case as well as complex scenarios, to ensure errors and edge cases are also handled appropriately. The TPA Contractor shall ensure that each business and technical requirement is tested. Individual tests deemed unsuccessful by the TPA Contractor or the Program shall be remediated and re-run within 7 calendar days of identification. If the Program finds any deficient testing or outcomes that affect multiple, interrelated scenarios, the TPA Contractor shall submit a detailed mitigation and revised testing plan within 14 calendar days.

The TPA Contractor shall move into a final Acceptance and Performance Testing (APT) phase after all unit and end-to-end test results have been reviewed and approved by the Program. In this phase, the TPA Contractor shall coordinate a “dry run” with the Program and other Program contractors to simulate full, end-to-end operations across the TPA Contractor’s scope of services. This “dry run” shall begin at least 60 calendar days prior to SHCD and be successfully completed at least 30 calendar days prior to SHCD. Issues identified by the TPA Contractor or the Program that have been determined by the Program to compromise a successful SHCD shall be remediated and re-run within 7 calendar days of identification.

Section 4.1.4 – Dual Operations The final phase of the Transition-In period is a period of “Dual Operations” during which both the incumbent HPS contractor and the TPA Contractor will be delivering health care services simultaneously. Dual Operations starts at SHCD and will last for up to 180 calendar days following SHCD, contingent on progress during the transition-in period and readiness of both the TPA Contractor and incumbent HPS contractor.

During Dual Operations, the TPA Contractor shall process all incoming claims with dates of service on or after the SHCD, while the incumbent HPS contractor processes incoming claims with dates of service prior to the SHCD. The TPA Contractor shall coordinate with the incumbent HPS contractor to update members’ claims history during this concurrent processing period and ensure consistent messaging to relevant stakeholders throughout Dual Operations.

The TPA Contractor shall assume processing for all incoming and outstanding claims regardless of date of service beginning no later than the 181st calendar day after the SHCD. The TPA Contractor shall use historical claims history data and or obtain any service limitation history to apply to a member’s claims information for processing, including data on members’ Initial Health Evaluation and Monitoring Exam visits.

Section 4.1.5 – Sustainment At the end of Dual Operations, the TPA Contractor shall move into the Sustainment phase of the contract. The Sustainment phase is defined as the operational time between Transition-In and Transition-Out, where the TPA Contractor performs and is solely responsible for all tasks required under this contract (except for any optional tasks not exercised).

Note that although Sustainment does not start until Transition-In (including Dual Operations) is completed, the TPA Contractor shall perform at the expected levels defined by the PWS and the Sustainment QASP (Attachment 003) starting at SHCD. Similarly, though Sustainment ends at Transition-Out, the TPA Contractor shall perform at the levels defined by the PWS and the Sustainment QASP until the start of healthcare delivery of the successor contractor(s).

Section 4.1.6 – Transition-Out The TPA Contractor shall move from the Sustainment to the 18-month Transition-Out phase of the contract when the Government exercises the Transition-Out option, which may be exercised by the Government at any time, provided that the Government gives the Contractor a preliminary written notice of its intent no less than 60 days prior to the start of the Transition-Out period. During this Transition-Out period, which will run concurrently with the successor contractor(s)’ 12-month Transition-In period and up to 6-month Dual Operations period, the TPA Contractor will transfer duties and responsibilities to a Program appointed designee, whether a government entity, another contractor, or a mix of both.

The TPA Contractor shall collaborate with the Program, other Program contractors, and the successor contractor(s), if applicable, to ensure a successful Transition-Out is completed in the required timeframe, while maintaining the expected level of performance described in the QASP. The TPA Contractor shall cooperate fully with the Program and the successor contractor(s) during the Transition-Out period, to facilitate an orderly transfer of Program functions and operations to the successor contractor(s). The TPA Contractor shall ensure the Transition-Out causes no disruption of claims processing and Program operations, with minimal disruption of payment, customer service, and other benefits/services provided to the Program.

The TPA Contractor shall submit a Transition-Out Plan within 30 calendar days after its receipt of the Government’s preliminary written notice of its intent to exercise the Transition-Out option. The Transition-Out Plan shall detail all activities necessary for the successor contractor(s) to provide Program data and information to the successor contractor(s), maintain operational standards, and completing all Transition-Out tasks successfully—within a risk management framework. The TPA Contractor shall implement the plan and perform all Transition Out activities listed below. The TPA Contractor shall revise this plan throughout the Transition-Out period to provide information and lessons learned. The TPA Contractor shall incorporate additional feedback provided by the Program and collaborate with the TPA Contractor’s successor(s) to ensure alignment of the TPA Contractor’s Transition-Out Plan with the successor contractor(s)’ Transition-In Plan.

During the Transition-Out Period, the TPA Contractor shall:

1. Maintain continuity of operations through the transition period, including the Transition-In and Dual Operations of the successor contractor(s);

2. Provide current and accurate program and system management documentation (e.g., interface library, data dictionaries, data schema, etc.), no later than 14 calendar days after the Transition-Out Option begins;

3. Transfer all Program records and data (including but not limited to member data, provider network data, claims data, and process and policy guidance materials (see Section 4.7)) to the Program or successor contractor(s) as directed by the Program 14 calendar days after the Transition-Out Option begins, with updates provided on a cadence as defined by the Program thereafter;

4. If Government Furnished Equipment is added to the contract, provide a current, validated inventory of all Government-owned assets used by the TPA Contractor over the life of the contract along with full support in the reconciliation of the inventory as needed;

5. Track the status of transition activities and milestones in a schedule to ensure alignment with the Transition-Out Plan and the successor contractor(s)’ Transition-In Plan, and convene meetings and provide updates on Transition-Out at the direction of the Program;

6. Attend meetings to transfer information, processes, and data; mitigate transition risks and issues; and report status of transition tasks;

7. Communicate final dates of usage of current systems and processes, in accordance with the successor contractor(s)' transition-in, and assist in communicating transition details to stakeholders;

8. Ramp down operations (as appropriate);

9. Ensure that duplicate files or data not required by the successor contractor(s) are stored or destroyed, in accordance with Program data security requirements;

10. Execute all required “system decommissioning” tasks, including destruction of all non-public or other protected data from Contractor-owned systems, and certify execution.

The TPA Contractor shall coordinate with the Program and any successor contractor(s) to minimize the quantity of risks associated with services that have been initiated but have not been fully resolved, including paper documents requiring data entry, enrollment applications, known data integrity issues, and outstanding claims. The TPA Contractor shall ensure that these services are tracked and communicated to relevant stakeholders and facilitate the handoff of these services to the successor contractor, in accordance with the Transition-Out Master Schedule (TOMS). The TPA Contractor shall ensure all handoffs are completed by SHCD of the successor contractor, unless otherwise agreed upon between the Program, the TPA Contractor, and the successor contractor(s).

During this Transition-Out Dual Operations, the TPA Contractor will continue to provide limited services after SHCD of the successor contractor(s). The TPA Contractor shall:

1. perform claims runout activities, processing claims with dates of service prior to the successor contractor(s)’ SHCD;

2. provide claims updates to the Program and successor contractor(s) with each claims processing cycle to update the member profile and provide a status update on the open healthcare claims inventory; and

3. maintain sufficient customer service capabilities and staffing levels to properly respond to inquiries related to claims processing during this period.

The TPA Contractor shall also work with the WTC Health Program Information Security Officer (ISO) and COR to transfer all government records, data, and other information (including process and policy guidance materials) to the Program in accordance with the approved schedule. The data transfer shall be performed in a manner and format that enables the Program to map all data from the TPA Contractor’s system(s) to the replacement system(s) of the Government or a successor contractor(s). This includes all data and data-related documentation as listed in Section 4.7.6, as well as:

1. Functional business process flows, including operational manuals, documentation of all processes to accomplish work on behalf of the Program, and sample data files; and

2. Operational information including correspondence, documentation of ongoing or outstanding issues, operations support documentation, and operational information regarding subcontractors to the successor contractor(s).

Section 4.2 – Contract Management The TPA Contractor shall effectively manage the contract in accordance with the TPA Contractor’s proposal and the Contract Management Plan (CMP). The TPA Contractor shall perform the following tasks:

1. Coordinate with COR, Program staff, and other Program contractors to oversee Transition-In, Dual Operations, Sustainment, Transition-Out and ensure continuous operation and enhancement/improvement of the Program.

2. Onboard and train all TPA Contractor staff to support Program operations throughout the lifetime of the contract. The TPA Contractor shall utilize effective retention strategies and manage staff in a way that limits degradation or disruption of services due to staffing changes.

3. Meet all Information Security requirements in accordance with Section 11.

4. Implement a Change Control Process per Section 4.2.2.

5. Implement Program-approved processes for identification, tracking, mitigation, and escalation of risks and issues.

6. Collaborate with Program stakeholders using an established process shared and approved by the Program.

7. Comply with the Business Associate Agreement, per Section 4.8.1, and document compliance mechanisms.

8. Administer the Program’s limited benefit and utilization management activities, per Section 4.5 and Section 4.6

9. Oversee all subcontractors to ensure quality of subcontractor performance.

All the TPA Contractor’s processes and workflows shall be documented in an Operations Manual, due 60 calendar days prior to SHCD. During Transition-In, the TPA Contractor shall generate and submit TPRs every two weeks starting 14 calendar days after the Kickoff Meeting through four weeks after SHCD. Upon SHCD, the TPA Contractor shall establish and maintain Monthly Progress Reports (MPR) and Quarterly Progress Reports (QPR) to track TPA Contractor progress.

Section 4.2.1 – Staffing Requirements The TPA Contractor shall establish and maintain experienced and qualified personnel to ensure that all operational areas and systems are functional and staffed sufficiently to efficiently complete Transition-In, Sustainment, and Transition-Out activities at the quality levels required in this contract.

The TPA Contractor shall identify senior-level team member(s) who possess the authority and capability to make management decisions for the TPA Contractor and obligate TPA Contractor resources within the scope of the contract. Specific Key Personnel and other leadership roles are listed below. This leadership team shall serve as primary liaison(s) for contract management and shall be prepared to address urgent concerns, regardless of the source of the concern, through the life of the contract in coordination with Program staff and other Program contractors. The TPA Contractor shall ensure that qualified individuals are available to assume these leadership roles when designated leads are on leave or otherwise unable to perform their duties. These alternate leads shall also possess the authority and capability to make management decisions for the TPA Contractor.

Fully dedicated Key Personnel, individuals assigned exclusively and full-time to the WTC Health Program, shall be appointed to serve in the following roles:

1. Account Manager: responsible for overall contract management

2. Project Manager: responsible for global project oversight; guides project execution and control through a formal documentation of project goals, objectives, scope, risks, and timelines (as captured in Transition-In Plan, CMP, TIMS, RAID Log, etc.)

Changes to Key Personnel shall require written consent by the Contracting Officer, per HHSAR 352.237-75, Key Personnel (Dec 2015).

The TPA Contractor shall identify personnel in additional leadership roles to support Key Personnel in liaising with the Program. These individuals do not need to be fully allocated to each role and can be changed at the TPA Contractor’s discretion with notice to the COR with a revised Staffing and Wages Report (Attachment 004) submitted 30 calendar days prior to any vacancy or change:

1. Transition-In Lead: responsible for overall Transition-In

2. Transition-Out Lead: responsible for overall Transition-Out

3. Communications Lead: coordinates stakeholder engagement and education to ensure plain language communications and consistency in messaging.

4. Quality Management and Improvement Lead: oversees quality monitoring, management, and improvement initiatives, per Section 4.2.7

5. Data and Analytics Lead: oversees completion of data use and interconnection security agreements, data engineering and governance, analytics, reporting and visualization, and testing and validation of system readiness, per Section 4.7

6. Member Services Lead: oversees all operational processes listed in Section 4.3, and oversees handling of member inquiries/questions, education, and engagement per Section 4.3

7. Provider Services Lead: oversees handling of provider inquiries/questions, education, and engagement per Sections 4.3 and 4.5

8. Provider Network Lead: oversees all provider enrollment activities, provider directory maintenance, and provider network adequacy, per Section 4.4

9. Claims Processing Lead: oversees claims adjudication to ensure appropriate and timely claims processing, per Section 4.6

10. HIPAA Compliance Officer: oversees development of HIPAA privacy and security policies and procedures, to ensure compliance with HIPAA statutory and regulatory requirements, per Section 4.8.1 and the BAA

11. Fraud Officer: oversees implementation of the Fraud, Waste, and Abuse (FWA) Prevention, Detection, and Reporting Plan, per Section 4.8.2

12. System Security Officer: oversees compliance and security of TPA Contractor information technology systems; ensures appropriate safeguarding of Personally Identifiable Information (PII) and Protected Health Information (PHI), per Section 11 The TPA Contractor’s staffing model and organizational structure shall consist of required personnel with relevant expertise and clearly defined roles and responsibilities. The TPA Contractor personnel shall maintain working hours in the Eastern Time Zone (ET) when most work is performed for the contract, unless otherwise approved in writing by the Government, thereby enhancing collaboration with the Program. TPA Contractor staff shall maintain standard working hours and be available to attend meetings (in person or virtually) with the Program and other Program contractors between the hours of 9:00am and 5:00pm ET, Monday through Friday, and extended hours as needed.

The TPA Contractor shall provide a quarterly reconciled Staffing and Wages Report (Attachment 004) 60 calendar days after the end of each quarter that aligns to the accepted proposal/awarded contract and any approved change requests to staffing levels. The Staffing & Wages Report shall contain an up-to-date, comprehensive list of individuals who performed work on behalf of the TPA Contractor, including subcontractors, in alignment with the invoices submitted during the reporting quarter. The report shall include the hiring date, labor category, and hourly rate for each individual, and describe any changes to staffing since the last report, including hiring date, termination date, and/or changes in tasks performed. The report shall identify the total number of approved hours for each labor category under each CLIN within the reporting quarter, clearly indicating hours worked per individual and hours worked per PWS activity code. The Government may request timesheets, resumes, and other documentation necessary to oversee level of effort and ensure individuals meet the requirements to perform work under their assigned labor category.

Section 4.2.2 – Change Control Process The TPA Contractor shall manage the contract to ensure that required services are being performed and required contract deliverables are being submitted. The TPA Contractor shall maintain a change control process to identify, record, assess, and secure approval for changes to the project (scope, budget, schedule, milestones, or level of effort) that do not align with the submitted contract proposal. The TPA Contractor shall clearly define the purpose and impact of each change and provide relevant supporting documentation to justify the request; this includes changes requested by the Program.

The TPA Contractor shall allow the Program at least 7 calendar days to review and either provide approval or denial of any Change Request (CR) or request additional information. The TPA Contractor shall maintain a Change Request Log(s) that summarizes every change request, the business justification/impact, decision, and implementation date, if approved. The Change Request Log shall be submitted with the MPR or ad hoc upon request.

The specific change control approval process and authority will be dependent on the type (e.g., process, query, database structure), cost, and stakeholders affected. The criteria for determining which changes require a Change Request to be submitted to the Program can be found in Attachment 005.

Section 4.2.3 – Project Management Throughout the lifetime of the contract, the TPA Contractor shall engage with the COR and key Program personnel in alignment with standard project management principles (i.e., Project Management Body of Knowledge [6th Edition or later]).

The TPA Contractor shall develop a Transition-In Master Schedule (TIMS) that includes a calendar-based, integrated schedule with the detailed tasks necessary to ensure successful transition execution (including Transition-In, SHCD, Dual Operations, Sustainment, and Transition-Out activities). An initial baseline TIMS shall be delivered to the Program 30 calendar days after the Kickoff Meeting with the initial TPR. The TIMS should be updated and maintained to track any deviations from the baseline TIMS; task durations shall be realistic and consider Program and the incumbent contractor’s input. The TPA Contractor shall deliver a current TIMS to the Program every two weeks with the TPR. The TPA Contractor may only re-baseline the TIMS if approved by the Program.

The TPA Contractor shall notify the COR within one business day of any change to the project schedule that alters any scheduled milestone; the notification shall be delivered to the COR in writing and shall address how the TPA Contractor plans to manage the change—to complete the delayed task and mitigate impact on dependent tasks. These risks and associated mitigation strategies shall be incorporated in the RAID Log, per Section 4.2.4.

The TPA Contractor shall coordinate and schedule project activities across various functional areas. The TPA Contractor shall deliver Meeting Agendas to the COR at least one business day before the scheduled meeting and Meeting Minutes five business days after for every meeting where the TPA Contractor is designated by the Program to be the “owner” of the meeting. The TPA Contractor is responsible for capturing all meeting minutes for meetings with the Program. Minutes shall capture—at a minimum—all decision points, takeaways, and action items (with associated assignee and estimated completion date) resulting from the meeting and shall be in a consistent format.

Section 4.2.4 – Risk and Issue Management The TPA Contractor shall, as part of risk and issue management, coordinate with the Program to establish priority, scope, and resources for managing Program risks and issues, as well as assessing and executing mitigation strategies and contingency plans. The TPA Contractor shall implement an approach to risk and issue management that incorporates identification, tracking, mitigation, and escalation of risks and issues identified across all functional areas to enable Program integration. This approach shall be documented within in the CMP. The TPA Contractor shall anticipate and prepare mitigation strategies for possible surge activities from members and providers where volumes (e.g., enrollment applications, certification requests, phone calls) exceed normal operating capacity.

The TPA Contractor shall document and report risks, assumptions, issues, and decisions to the Program via a RAID Log (Attachment 006) that catalogs all identified RAID items associated with performance of the responsibilities in this contract by the TPA Contractor or their subcontractor(s) throughout the period(s) of performance. The TPA Contractor shall also monitor its data for indicators of risks and issues affecting the Program and other Program contractors, such as an influx in provider claims appeals, and escalate first to the Program and then to other Program contractors, as appropriate. The RAID Log shall detail any milestones, progress updates, mitigation strategies, and other relevant information associated with identified RAID items.

The RAID Log shall be submitted every two weeks with the TPR during Transition-In for NIOSH review and monthly with the MPR during Sustainment and Transition-Out. The TPA Contractor shall keep in communication with the Program, including by participating in ad hoc meetings, to establish priority, scope, and resources for managing RAID items and report on mitigation strategies and contingency plans. Any issues that arise shall be transparent to both parties to prevent escalation and mitigate impact. The TPA Contractor shall notify the Program immediately of any urgent or significant risks and issues and shall make the RAID Log available to the Program within one business day upon request.

Section 4.2.5 – Stakeholder Engagement and Communications The TPA Contractor shall develop and implement a strategy for communicating relevant information to stakeholders during Transition-In, Sustainment, and Transition-Out to ensure that individuals involved in or affected by the TPA Contractor’s activities are prepared for changes in their role or their Program experience. Key stakeholders include Program staff, other Program contractors (listed in Section 1.1), applicants, members, prospective members, and providers. This communication strategy shall be documented in the TPA Contractor’s Communications Plan, due 60 calendar days after the award start date.

Generally, the TPA Contractor shall produce Communications Products that are tailored in content, language, and dissemination method to target the intended audience(s). The TPA Contractor shall ensure the accuracy, quality, and timeliness of all written and verbal communication to stakeholders. All materials shall be approved and cleared by the Program Communications Unit in accordance with TGD 020 (Attachment 007), with a final, clean copy provided to the Program. The TPA Contractor shall also provide written translational services to include Spanish, Chinese (simplified and traditional), and Polish.