Section C - SurvivorCCE_PWS_20March2025.pdf

Performance Work Statement World Trade Center Health Program Survivor Clinical Center of Excellence

Period of performance of this contract: July 01, 2025 to June 30, 2030. This anticipated period of performance consists of a base year and four option years.

Base Period: July 01, 2025 to June 30, 2026 Option Period One: July 01, 2026 to June 30, 2027 Option Period Two: July 01, 2027 to June 30, 2028 Option Period Three: July 01, 2028 to June 30, 2029 Option Period Four: July 01, 2029 to June 30, 2030

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, and in 2023 by Public Law No. 118- 31, and the National Defense Authorization Act of 2024, codified at 42 USC 300mm-300mm-64 .1 In addition to the statutory requirements for the Program codified in 42 USC 300mm – 300mm-64, the Administrator of the WTC Health Program has also promulgated regulations governing the administration of the Program at 42 CFR 88. As of March 2024, the Program had 132,530 members enrolled, including 44,516 Survivors; of these members, 27,069 Survivors live in the New York Metropolitan Area (NYMA), as defined in 42 CFR 88.1.2

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, screening, 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,3 and an enrolled member must meet certain exposure, latency, and symptom-onset requirements for their health condition to be certified. 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 for the limited benefit plan.

1 The Zadroga Act, as amended, can be found at:

https://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter6A/subchapter31&edition=prelim.

2 Current Program statistics and reports can be found at https://www.cdc.gov/wtc/atcxicxiaglance.html#enrollmentWTC.

3 See 42 CFR 88.15 for the complete List of WTC-Related Health Conditions (List) at https://www.ecfr.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.15.

https://uscode.house.gov/view.xhtml?path=/prelim%40title42/chapter6A/subchapter31&edition=prelim https://www.cdc.gov/wtc/atcxicxiaglance.html#enrollmentWTC.

https://www.ecfr.gov/current/title-42/chapter-I/subchapter-G/part-88/section-88.15

Monitoring and treatment are administered to members residing in NYMA by Clinical Centers of Excellence (CCEs) and to members residing outside of the NYMA through the Nationwide Provider Network (NPN) Contractor. The Government also contracts with a Pharmacy Benefits Manager (PBM) to administer prescription benefits in the Program and a Health Program Support/Third-Party Administrator (HPS/TPA) Contractor to receive and process enrollment and certification applications for NIOSH decision-making, maintain the Program’s provider network(s), administer Program benefits, and process medical claims for payment.

There are currently eight CCEs in NYMA. One CCE serves WTC Responders affiliated with the Fire Department of the City of New York (FDNY), five CCEs serve General WTC Responders, and two CCEs serve Survivors. The CCEs/NPN provide medical monitoring, diagnosis, and treatment services to members for certified WTC-related health conditions. Treatment services may include physician visits, test procedures, medical devices, pharmacy benefits, case management, care coordination, health education, and social benefits counseling. The CCEs and NPN work as a clinical consortium with cohort-specific, standardized medical monitoring protocols; shared diagnostic and treatment guidelines; and multiple opportunities for communication with WTC Health Program staff and each other to calibrate medical and member benefits across practice sites. The CCEs and NPN are actively engaged with stakeholder groups and other interested parties of the New York City community to discuss program policies and ensure awareness of emerging issues. Key terms are described, and acronyms are expanded upon in Attachment 001.

Section 1.1 – Membership Categories WTC Health Program members are categorized into two primary membership categories: Responders and Survivors. To enroll in the Program, Survivors and Responders must meet certain eligibility criteria described in the Zadroga Act. The WTC Health Program has promulgated regulations implementing the Zadroga Act that govern the administration of the Program at 42 CFR 88.

Responders include workers or volunteers who provided rescue, recovery, debris cleanup, and related support services on or in the aftermath of the September 11, 2001, terrorist attacks at the World Trade Center, the Pentagon, or the aircraft crash site near Shanksville, PA.

Survivors include persons who were present in the New York City (NYC) Disaster Area in the dust or dust cloud on September 11, 2001, or who worked, resided, or attended school, childcare, or adult daycare in the NYC Disaster Area for a certain period following the September 11, 2001, terrorist attacks.

WTC Responder – affiliated with the Fire Department of the City of New York (FDNY) (“FDNY Responder”) An individual (active or retired) who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites (including Ground Zero, Staten Island Landfill, and the New York City Chief Medical Examiner’s Office). As of March 2024, there are 17,059 FDNY Responder members.

WTC Responder – FDNY Family Member (“FDNY Family”) A surviving immediate family member of an FDNY member (whether fire or emergency personnel, active or retired) who was killed at the World Trade Center site on September 11, 2001, and received any treatment for a WTC-related mental health condition on or before September 1, 2008. As of March 2024, there are 667 FDNY Family members.

WTC Responder – not affiliated with FDNY (Non-FDNY Responder) (“General Responder”) An individual who worked or volunteered onsite in rescue, recovery, demolition, debris cleanup, or related support services in lower Manhattan (south of Canal St.), the Staten Island Landfill, or the barge-loading piers; a member of the Police Department of New York City (active or retired) or a member of the Port Authority Police of the Port Authority of New York and New Jersey (active or retired) who participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.), including Ground Zero, the Staten Island Landfill, or the barge loading piers; an employee of the Office of the Chief Medical Examiner of New York City involved in the examination and handling of human remains from the World Trade Center attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff; a worker in the Port Authority Trans-Hudson Corporation Tunnel; or a vehicle-maintenance worker who was exposed to debris from the former World Trade Center while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks. As of March 2024, there are 70,955 General Responder members.

Pentagon and Shanksville, PA Responders Fire or police department employees (fire or emergency personnel, active or retired), Department of Defense or other Federal agency employees and contractors, members of the regular or reserve uniformed services, recovery, or cleanup contractor workers, or volunteers, who performed rescue, recovery, demolition, debris cleanup, or other related services after the terrorist-related aircraft crashes on September 11, 2001, at the Pentagon in Arlington, VA, or in Shanksville, PA. As of March 2024, there are 1,161 Pentagon Responder and 143 Shanksville Responder members.

WTC Survivor An individual present in the New York City Disaster Area in the dust or dust cloud on September 11, 2001; an individual who lived, worked, or went to school, childcare, or adult daycare in lower Manhattan south of Houston Street and certain parts of Brooklyn; certain cleanup and maintenance workers in the New York City Disaster Area;

and certain residents and individuals whose place of employment were deemed eligible to receive certain grants from the Lower Manhattan Development Corporation.

Upon enrollment, Survivors are “screening-eligible” for an initial health evaluation. Any such individuals who are then certified for a covered health condition are “certified-eligible” for medical monitoring and treatment pursuant to § 88.12(b) of the Regulations.4 Survivors are required to carry other health insurance (OHI) – through which coordination of benefits (COB) is required (the Zadroga Act does not require COB for Responders). As of March 2024, there are 44,516 Survivor members.

Section 1.2 – Selected Roles and Business Associates The following is a non-exclusive list of other WTC Health Program contractors with which the Contractor may be expected to engage while carrying out Program services and functions. Unless otherwise specified, references to “other Program contractors” shall mean one or more of the contractors listed below.

Clinical Center of Excellence (CCE): A NYMA-based medical facility that, in accordance with the Zadroga Act, operates under an individual contractual relationship with the WTC Health Program to provide medical monitoring, diagnosis, certification, treatment services, case management, and benefits counseling for members in the NYMA.

Members residing in NYMA or otherwise electing care through a CCE are assigned a CCE that is responsible for coordinating their care under the WTC Health Program. The Zadroga Act defines a CCE as “a Center that demonstrates to the satisfaction of the Administrator that the Center—(i) uses an integrated, centralized health care provider approach to create a comprehensive suite of health services under this title that are accessible to enrolled WTC Responders, screening-eligible WTC Survivors, or certified-eligible WTC Survivors; (ii) has experience in caring for WTC Responders and screening-eligible WTC Survivors or includes health care providers who have been trained pursuant to section 3313(c);5 (iii) 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 (iv) meets such other requirements as specified by the Administrator.”

Comprehensive Cost Avoidance (CCA) Contractor: A vendor that implements comprehensive cost avoidance functions, including recovering of funds from workers’ compensation programs and other

4 https://www.cdc.gov/wtc/regulations2.html.

5 See Administrative Manual Chapter 3, Section 10 at: https://www.cdc.gov/wtc/ppm.html#certification_appeals.

https://www.cdc.gov/wtc/regulations2.html https://www.cdc.gov/wtc/regulations2.html https://www.cdc.gov/wtc/ppm.html#certification_appeals health insurance (OHI) where the Program overpaid; facilitating Coordination of Benefits; and verifying member demographic information to improve efficiency and control healthcare costs without compromising quality of care. The Survivor CCE Contractor is not anticipated to have a direct relationship with the CCA.

Data Center (DC): A vendor that supports various functions, including receiving data from the CCEs, NPN, and HPS/TPA Contractor; 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 that provides consulting services for data analytics to support strategic planning and program evaluation. The Survivor CCE Contractor is not anticipated to have a direct relationship with the HPE Contractor.

Health Program Support/Third Party Administrator (HPS/TPA) Contractor: A vendor that performs various Program functions, including processing member enrollment and certification applications, managing the customer-service call center, managing the provider network, administering benefit plans, processing medical claims, maintaining the member database, and coordinating member communications.

Nationwide Provider Network (NPN) Administrator: A vendor that administers the Nationwide Provider Network—a nationwide network of healthcare providers that provides WTC-related healthcare, including initial health evaluation, monitoring, and treatment benefits to enrolled WTC Responders, screening-eligible Survivors, and certified-eligible Survivors who live outside the NYMA, and processes claims submitted by these providers for Program-authorized services.

Outreach and Education (O&E) Contractor: A vendor that supports recruitment for potential members (both Responders and Survivors) by developing culturally and linguistically appropriate educational materials and conducting various outreach efforts. The Survivor CCE Contractor is not anticipated to have a direct relationship with the O&E Contractor.

Pharmacy Benefits Manager (PBM): A vendor that 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 purpose of this solicitation is to secure the services of one or more Clinical Center(s) of Excellence (CCE) to serve WTC Health Program Survivors living inside the NYMA, responsible for the following tasks, as described in the Zadroga Act (42 USC 300mm-4):

(A) For the provision of monitoring and treatment benefits and initial health evaluation benefits under subtitle B of the Zadroga Act;

(B) For the provision of outreach and retention activities to individuals eligible for such monitoring and treatment benefits, for initial health evaluation benefits, and for follow-up to individuals who are enrolled in the monitoring program;

(C) For the provision of counseling for benefits under subtitle B of the Zadroga Act, with respect to WTC-related health conditions, for individuals eligible for such benefits;

(D) For the provision of counseling for benefits for WTC-related health conditions that may be available under workers’ compensation or other benefit programs for work-related injuries or illnesses, health insurance, disability insurance, or other insurance plans or through public or private social service agencies, and assisting eligible individuals in applying for such benefits;

(E) For the provision of translational and interpretive services for program participants who are not English language proficient; and

(F) For the collection and reporting of data, including claims data, in accordance with section 3304 [of the Zadroga Act].6

To note, a single entity may serve both Survivor and Responder members; however, the tasks noted herein are specific requirements for administering Program benefits to Survivor members. An entity that serves both Survivor and Responder members would need to be able to identify Survivor and Responder members and tailor care according to the membership category and its associated allowable benefits and requirements.

SECTION 3 – SCOPE OF WORK

The Survivor CCE contractor, referred to herein as “the Contractor,” shall operationalize a Clinical Center of Excellence to ensure eligible Survivor members receive monitoring and treatment only for appropriately certified condition(s). The Contractor is responsible for an up-to-date understanding of and compliance with the Zadroga Act and the Program’s implementing regulations, including any amendments, as well as the Program’s policies, standard operating procedures, technical and medical guidance documents, and WTC Health Program Administrative Manual. The Contractor shall manage the CCE using advanced and continually improving industry standards.

The 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;

42USC 1320d and the corresponding implementing HIPAA regulations at 45 CFR 160, 162, and 164), Program policies, Technical Guidance Documents (TGDs), Patient Protection and Affordable Care Act, and all other applicable federal statutes and regulations, at all times. All tasks shall be completed in the timeframes required, unless the Contractor can provide a good and compelling reason for an extension. The determination to grant an extension will be made at the sole discretion of the Contracting Officer (CO) and/or Contracting Officer’s Representative (COR).

The Contractor shall manage the CCE in a way that aligns with advanced and continually improving industry standards and best business practices. The Contractor shall provide these services with the goals of minimizing costs to the WTC Health Program, improving member health, and providing superior and clinically excellent member services. The Contractor shall manage the contract to ensure that subcontracts, staffing, reporting, security, deliverables, repositories, and services meet the requirements of the contract.

At a summary level, these tasks include:

• Contract management and implementation services

• Quality assurance to prevent unauthorized services and potential fraud, waste, and abuse

• Member services and outreach to current members

6 Currently, the WTC Health Program has been able to facilitate the process more efficiently by having the HPS/TPA contractor exchange data with the Data Centers (DCs) who then coordinate with the CCE(s). The current process handles new enrollees, changes in demographic data of current members, and transfers between CCEs or to/from the NPN. The HPS/TPA contractor also provides original and amended claims data to CCEs and DCs.

While CCEs do not need to be responsible for all data exchanges with their corresponding DC, the CCE must provide updates to member demographic information to their DC and be able to ingest updates to member demographic information from their DC.

• Program communications

• Benefit management (certification requests, prior authorizations, care coordination, case management)

• Administration of healthcare services (monitoring, screening, and treatment)

• Electronic submission of claims for services rendered

• Coordination of Benefits (COB) with Other Health Insurance (OHI)

• Collection of clinical and operational data

• Maintenance of up-to-date member records

SECTION 4 – TASKS TO BE PERFORMED

The Contractor must possess the knowledge, capability, and resources to effectively provide services to manage the CCE in accordance with all federal, state, and any other applicable laws, regulations, policies, procedures, and WTC Health Program requirements. The applicable CCE contract requirements set forth by the Zadroga Act are excerpted below and further detailed throughout the Performance of Work Statement (PWS):

1. Establish a formal mechanism for consulting with and receiving input from representatives of eligible populations receiving monitoring and treatment benefits under subtitle B from such Center.

2. Coordinate monitoring and treatment benefits under part B [of the Zadroga Act] with routine medical care provided for the treatment of conditions other than WTC-related health conditions.

3. Collect and report to the corresponding Data Center data, including claims data, in accordance with section 300mm–3(b) of the Zadroga Act.

4. Have in place safeguards against fraud that are satisfactory to the Administrator, in consultation with the Inspector General of HHS.

5. Treat or refer for treatment all individuals who are enrolled certified-eligible WTC Survivors with respect to such Center who present themselves for treatment of a WTC-related health condition.

6. Have in place safeguards, consistent with section 300mm–3(d) of the Zadroga Act, to ensure the confidentiality of an individual's Protected Health Information (PHI), including requiring that such information not be disclosed to the individual's employer without the authorization of the individual.

7. Use amounts paid under subsection (c)(1) of 42 USC 300mm-4 only for costs incurred in carrying out the activities described in subsection (a), other than those described in subsection (a)(1)(A).

8. Utilize healthcare providers with occupational and environmental medicine expertise to conduct physical and mental health assessments, in accordance with protocols developed under subsection (a)(2)(A)(ii) of 42 USC 300mm-4.

9. Conduct outreach and education activities in appropriate languages to educate potential and current members on Program benefits and to facilitate member participation.

10. Meet all the other applicable requirements of the Zadroga Act, including regulations implementing such requirements. 7

Section 4.1 – Transition-Related Services

The 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 as soon as possible, within 12 months of the award start date.

Section 4.1.1 – Kickoff Meeting The Contractor shall have an introductory call with the COR within seven calendar days after the award start date to establish dates, location, and an agenda for an in-person Kickoff Meeting where the Contractor shall present their plan to meet all contractual requirements. The Contractor shall finalize the Kickoff Meeting Agenda and deliver it to

7 See 42 USC 300mm-4(b)(1)(B) the COR seven calendar days prior to the Kickoff Meeting. The Contractor shall create a Kickoff Presentation that summarizes the Contractor’s technical solutions and how all contract functions shall be fulfilled and operationalized within contract parameters; a draft Kickoff Presentation shall be published alongside 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 start date at one of the Program’s offices in Washington, DC; Cincinnati, OH; Atlanta, GA; or New York, NY. The Contractor shall take and distribute Meeting Minutes in accordance with Section 4.2.2. The Contractor shall also develop, execute, and maintain detailed written documentation of the 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 Contractor’s proposal and are due within 14 calendar days after the Kickoff Meeting. The 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 Contractor shall collaborate with the Program andother Program contractors, including the incumbent Survivor CCE contractor (if applicable), to ensure a successful Transition-In is completed in the required timeframe.

Transition-In begins upon the award start date and includes the tailoring, testing and validation of the Contractor’s systems and operations to meet Program needs. All required services shall be fully operational to implement SHCD within twelve months of the award start date—meaning that the Contractor has the resources, systems, data, and other information necessary to perform the full scope of work detailed herein.

The Transition-In shall cause minimal disruption to customer service and other benefits/services provided by the incumbent Survivor CCE contractor. The Contractor shall ensure that the Contractor’s activities during Transition-In have minimal detrimental impact to the member experience and trigger minimal changes to other Program contractor systems and processes, unless agreed upon with the Program.

During the Transition-In period, the 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. Staffing Requirements – Establish a well-trained, knowledgeable, qualified workforce capable of meeting all requirements of the contract, in accordance with Section 4.3.

3. Stakeholder Engagement – Implement the Transition-In Communications Plan that successfully communicates relevant information to affected stakeholders, in accordance with Section 4.4.

4. Member Services – Implement solutions for member management, engagement, and participation, transition of transfer processing, COB facilitation, and all other responsibilities detailed in Section 4.5.

5. Health Benefit Administration – Implement solutions for medical and pharmacy benefit administration, including monitoring, diagnostics, screening, treatment, and all other responsibilities detailed in Section 4.6.

6. Comprehensive Care Management – Implement solutions for coordinating care including prior authorizations, referrals, case management, utilization management, and all other responsibilities detailed in Section 4.7.

7. Claims Submission and Payment – Implement solutions for submitting and/or reviewing claims for allowable services, medical necessity review, coordination of benefits, and other responsibilities detailed in Section 4.8.

8. Data Collection, Management, and Reporting – 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 4.9.

The Contractor shall coordinate with the Program and the incumbent(s) to minimize the quantity of risks associated with services that have been initiated but have not been fully resolved, including member certification requests, clinic transfers, and open member issues.

The Contractor shall establish transition meetings with the Program every two weeks during the Transition-In period; ad hoc meetings shall be scheduled as necessary per request of the COR where the Contractor shall present a Transition-In Progress Report (TIPR) (Section 8.3.2). The TIPR shall summarize the status of Transition-In activities, highlighting items that may require Program input or support to prevent impacts on transition cost, project timeline, or key milestones.

The Contractor shall generate and submit TIPRs, including an up-to-date copy of the TIMS, Risk, Assumptions, Issues and Decisions (RAID) Log (Section 4.2.3), and Data Dictionary every two weeks throughout Transition-In, starting 30 calendar days after the Kickoff Meeting. The TIPR and TIMS shall only be delivered during the Transition-In period, through SHCD. The RAID Log shall continue to be delivered throughout the duration of the contract, to be submitted with the Monthly Progress Report (MPR) after SHCD.

An interim Transition-In Summary Report documenting the actual Transition-In activities shall be delivered 90 calendar days after SHCD, with a final report due 180 calendar days after SHCD. The reports 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 calendar days before it is due.

The Contractor’s Transition-In team shall support the contract until the final Transition-In Summary Report is accepted.

Section 4.1.3– Readiness for SHCD The Contractor shall execute the Transition-In Plan to establish readiness for SHCD as described in this section. To be deemed “ready,” all services and systems shall be fully operational in such a manner that the performance standards established in the Quality Assurance Surveillance Plan (QASP) will be achievable immediately by SHCD.

See Attachment 002. 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 Contractor and the Program. The Contractor shall schedule a System Readiness Kickoff Meeting with the Program within 15 calendar days after the Kickoff Meeting to review requirements and strategy for establishing connectivity with Program and other Program contractor systems.

The Contractor shall demonstrate readiness for SHCD by verifying capabilities, including:

1. Contract Management – The Contractor is able to track the status of transition activities, tasks, and outcomes to ensure alignment with the TIMS and agreed-upon readiness criteria, in accordance with Section 4.2.

a. The Contractor can manage the contract and meet all regulatory, CDC, and Program requirements, as well as internal Contractor policies and procedures, including the Contract Management Plan (CMP) (Section 8.3.3) and Operations Manual (Section 8.3.4).

b. The Contractor can establish and implement change control, risk and issue management, and quality assurance processes to accurately address any variance from the baseline plan to ensure that required tasks are being performed and required contract deliverables are being submitted on time.

c. The Contractor can effectively and accurately interact and engage with Program stakeholders.

d. The Contractor can develop and manage budgets for all work performed and has submitted accurate and timely invoices via the established channels.

2. Staffing Requirements – The Contractor has established a well-trained, knowledgeable, qualified workforce capable of efficiently meeting all requirements of the contract, in accordance with Section 4.3.

a. The Contractor has selected Key Personnel and individuals to fill leadership roles to support Key Personnel.

b. The Contractor has sufficient resources, including relevant subcontractors, to meet contract requirements in the required timeframes and to the expected performance levels outlined in the

QASP.

c. The Contractor has ensured that training materials have been reviewed and approved by the Program.

d. The Contractor has established that all staff have received the required and appropriate training specific to their role and can demonstrate the technical expertise to meet contract requirements.

e. The Contractor can maintain records of training such that training can be reported.

3. Stakeholder Engagement and Communications – The Contractor has developed and implemented a strategy for communicating relevant information to stakeholders to ensure that individuals involved in or affected by the Contractor’s activities understand their role and have a seamless Program experience, and the Communications Plan has been approved, in accordance with Section 4.4.

a. The Contractor has demonstrated ability to successfully distribute timely and accurate member communications through multiple communication methods (e.g., by phone, by mail).

b. All communications products to be implemented within the first three months of SHCD are approved by the Program and ready for timely and accurate distribution.

c. The Contractor can maintain regular contact with all members to keep them informed on Program updates, provide appointment reminders and appointment follow-up communication, and coordinate with the Program to tailor and disseminate standard member communications.

d. The Contractor can disseminate all communications products in appropriate content, language, and dissemination method to target the intended audience(s).

4. Member Services – The Contractor has developed and implemented solutions for member management, engagement, and participation; transfer processing; COB facilitation; and all other responsibilities detailed in Section 4.5.

a. The Contractor has established mechanisms for member contact through phone calls, written correspondence, member self-service portal, and/or other means in their preferred language, and receive timely and accurate responses during established hours of operation.

b. The Contractor can engage with newly enrolled and newly transferred members timely.

c. The Contractor can schedule and track initial health evaluations and annual monitoring exams ensuring member engagement, participation, and timely access to Program benefits.

d. The Contractor can facilitate COB.

e. The Contractor can appropriately respond if a member becomes violent, aggressive, and/or threatening, including submitting required Program documentation, when applicable.

f. The Contractor can facilitate, track, and report on benefits counseling, including benefits counseling on Program-specific benefits, social benefits, workers’ compensation, and other healthcare benefits.

g. The Contractor can maintain and update the member record such that it is accurate, secure, and readily accessible.

h. The Contractor can notify the Program of potential fraud, waste, and abuse, following the Program’s fraud reporting policies and procedures.

5. Health Benefit Administration – The Contractor has implemented solutions for medical and pharmacy benefit administration, including monitoring, diagnostics, screening, treatment, and all other responsibilities detailed in Section 4.6. 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.

a. The Contractor can complete initial health evaluations for screening-eligible Survivors and annual monitoring exams for certified-eligible Survivors in accordance with Program requirements.

b. The Contractor can provide and/or refer eligible members for timely diagnostic and treatment services, including cancer screenings, in accordance with Program requirements, medical necessity, and COB. The Contractor can provide or refer eligible members to telehealth services, when indicated.

c. The Contractor can identify members with conditions meeting certification eligibility criteria and submit accurate and timely certification requests to the Program. The Contractor has established and approved processes to handle identified conditions that do not meet certification criteria, including appropriate referrals and secondary review, when applicable.

d. The Contractor can ensure appropriate treatment and provide oversight of member medical and pharmacy benefit utilization ensuring compliance with medical necessity; state, local, and federal law; clinical best practices; benefit eligibility; and all Program requirements.

e. The Contractor can provide disability evaluations for members upon request by the Program on behalf of the September 11th Victim Compensation Fund (VCF).

6. Comprehensive Care Management – The Contractor has developed and implemented solutions for coordinating care, including prior authorizations, referrals, case management, utilization management, and all other responsibilities in accordance with Section 4.7.

a. The Contractor can provide case management for active members, where appropriate, as clinically indicated through member outreach and medical monitoring.

b. The Contractor can request prior authorization, including coordinating with the member’s primary insurance, and ensure compliance with Program requirements.

c. Billing and rendering providers are enrolled and credentialed with the CCE Provider Network.

d. The Contractor can conduct utilization management (UM) and maintain documentation securely.

e. The Contractor can complete utilization review for non-emergency inpatient services (i.e., overnight stay), and can notify the Program timely.

7. Claims Submission and Payment– The Contractor has developed and implemented solutions for submitting claims for allowable services, medical necessity review, coordination of benefits, and other responsibilities detailed in Section 4.8.

a. The Contractor can submit claims accurately and timely via Electronic Data Interchange (EDI) and can receive payments disbursed via Electronic Funds Transfer (EFT).

b. The Contractor can ensure that all internal provider claims submitted to the WTC Health Program are for allowable and medically necessary services as outlined in the Program Codebook (provided on award), in line with medical necessity requirements.

c. The Contractor can coordinate benefits for all Survivor members, where appropriate.

8. Data Collection, Management, and Reporting – The Contractor has developed a comprehensive approach to managing member data, claims and billing records, administrative and health records, all other data and information that comprise WTC Health Program records, and all other responsibilities detailed in Section 4.9.

a. The Contractor has successfully completed comprehensive systems testing and quality assurance/quality control reviews prior to SHCD in alignment with the Contractor’s approved Data and Information Management (DIM) Plan, which shall be submitted 30 calendar days after the Kickoff Meeting with plans and results reported to the WTC Health Program. Testing includes, but is not limited to, ensuring that the member record can be maintained and updated, data can be collected and reported/exchanged timely and accurately, and all other functions that are required to be performed by the Contractor in order to complete the required services.

b. The Contractor’s systems are integrated with each other and with the Program and other Program contractors, where relevant, to centralize and streamline access and control for secured data exchanges.

c. Data conversion and migration plan are successfully executed, bidirectional data exchanges are established and operational, all systems are configured and compliant to support Program operations, system access is granted to critical staff, and analytical platforms and data repositories are available for Program staff use.

The Contractor shall demonstrate readiness for SHCD no later than 30 calendar days prior to SHCD. The Contractor has discretion over specific testing and validation review activities, methodologies, accuracy/timeliness thresholds, and procedures. The Program shall verify the Contractor's validation process, which must be structured to meet or exceed Program performance standards as outlined in the QASP.

If the Program identifies unsuccessful tests and/or deficiencies in the Contractor’s ability to perform the required services, the Contractor shall submit a detailed mitigation and revised testing/implementation plan on an agreed-upon timeline. Timeline for mitigation will be dependent on the timeframe of identification relative to SHCD, the scope of the deficiency, and the potential impact to the Contractor’s ability to perform the required services.

Section 4.1.4 – Sustainment The Start of Healthcare Delivery (SHCD) is the date at which the Sustainment phase of the contract begins. This is the contract phase wherein the Contractor performs and is solely responsible for all tasks required under this contract, as listed in Section 4.2, and onwards.

The Contractor shall perform at the expected levels defined by the PWS and the QASP (Attachment 002) starting at SHCD under this Contract, through the start of healthcare delivery of the successor contractor.

Section 4.1.5 – Transition-Out If and once exercised, the Contractor shall perform the Transition-out Period simultaneous to the Sustainment phase.

The Government may exercise the Transition-Out Period 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 Transition-In, the Contractor shall transfer duties and responsibilities to a Program-appointed designee, whether a government entity, another contractor, or a mix of both.

The 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 as defined by the PWS and QASP. The Contractor shall cooperate fully with the Program and the successor contractor during the Transition-Out period, to facilitate an orderly transfer of Program functions and operations to the successor contractor. The Contractor shall ensure continuity of services during this period of transition, with the priority of minimal disruption of services to members receiving care and providers delivering care.

The Contractor shall submit a Transition-Out Plan 30 calendar days after the Transition-Out Contract Line Item Number (CLIN) is exercised, detailing all activities necessary for the Contractor to provide Program data and information to the successor contractor, maintain operational standards, and completing all Transition-Out tasks successfully—within a risk management framework. The Contractor shall implement the plan and perform all Transition-Out activities listed below. The Contractor shall revise this plan throughout the Transition-Out period to provide information and lessons learned. The Contractor shall incorporate additional feedback provided by the Program and collaborate with the successor contractor to ensure alignment of the Contractor’s Transition-Out Plan with the successor’s Transition-In Plan.

During the Transition-Out period, the Contractor shall:

1. Maintain continuity of operations through the transition period;

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

3. 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 Period begins;

4. If Government Furnished Property or Contractor-Acquired Property is added to this contract, provide a current, validated inventory of all Government-owned assets used by the 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 ofthe Transition- Out Plan with the successor’s Transition-In Plan (if applicable), and convene regular meetings to provide regular updates on Transition-Out activities to the Program;

6. Attend meetings to transfer information, processes, and Program 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's Transition-In, and assist in communicating transition details to stakeholders, including but not limited to members, Program staff and other Program contractors;

8. Adapt to reductions in operational volume as appropriate;

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

10. At the expiration of the contract and after confirmation of Program receipt of data delivery, destroy all

Program data from the Contractor's systems aside from data that is required to be maintained in accordance with records retention requirements in Section 4.8.3, security requirements listed in Section 10, and other applicable laws and regulations;

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

12. Continue to perform the Sustainment phase of this contract, in accordance with the tasks of the exercised option period(s) ongoing at the time of the Transition-Out Period.

The Contractor shall coordinate with the Program and any successor(s) to minimize the quantity of risks associated with services that have been initiated but have not been fully resolved, including member certification requests, clinic transfers, and open member issues. The 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 Contractor shall ensure all handoffs are completed by SHCD of the successor contractor, unless otherwise agreed upon between the Program, the Contractor, and the successor.

The Contractor shall also work with the WTC Health Program Information Security Officer (ISO) and COR to transfer all Program records and data (including but not limited to member demographic, monitoring, and treatment data and process and policy guidance materials) to the Program and/or successor contractor(s) within 14 calendar days after the Transition-Out Period begins, with updates provided in accordance with the approved schedule. The data transfer shall be performed in a manner and format that enables the Program and/or the successor contractor(s) to map all data from the Contractor’s system(s) to the replacement system(s) of the Government or a successor contractor. This includes all data and data-related documentation as listed in Section 4.9.6, 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;

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

Section 4.1.5.1 - Claims Runout The final phase of Transition-Out is a period of “Claims Runout” during which the Contractor and the successor contractor will be submitting claims simultaneously. Claims runout starts at SHCD for the successor contractor and continues for no fewer than six months, through the end of the contract.

During this time, the Contractor shall not render any healthcare services to members. The Contractor shall submit all claims for services rendered by the Contractor’s internal providers for dates of service prior to the successor contractor’s SHCD. The Contractor shall also continue to review external provider claims for medical necessity through this claims runout period for dates of service prior to the successor contractor’s SHCD.

All claims for dates of service prior to SHCD that are not submitted by the end of the contract will continue to be paid for a total of 18 months after the date of service (per Timely Filing Guidelines); however, the successor contractor will be responsible for medical necessity review for all claims received on or after the end of this contract. Any claims submitted with dates of service on or after SHCD shall be submitted and/or reviewed by the successor contractor.

Section 4.2 – Contract Management

The Contractor shall effectively manage the contract in accordance with the Contractor’s proposal and the Contract Management Plan (CMP), initially delivered 14 calendar days after the Kickoff Meeting. The Contractor shall perform the following tasks:

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

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

3. Implement a change control process (documented in the Operations Manual) to address any variance from the baseline plan established during Transition-In and the contract per Section 4.2.1.

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

5. Collaborate with Program…