75D301-25-R-73216 Amend 0003 (04.01.25).pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE PAGE OF PAGES

1 160

2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

04/01/2025

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE 8219 7. ADMINISTERED BY (If other than Item 6) CODE Centers for Disease Control and Prevention Chamblee Campus Building 102, MS S102-4 4770 Buford Hwy Atlanta, GA 30341-3717

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

X

9A. AMENDMENT OF SOLICITATION NO.

75D301-25-R-73216

9B. DATED (See Item 11)

01/16/2025

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (See Item 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers __ is extended, X is not extended. Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning _1_ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

See page 2 for description of the modification.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA

BY ___________________________________________

(Signature of Contracting Officer)

16C. DATE SIGNED

NSN 7540-01-152-8070 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE 30-105 Prescribed by GSA

FAR (48 CFR) 53.243

ITEM 10A.

75D301-25-R-73216 Amendment 0003

Block 14 continuation page.

The purpose of this modification is to:

(a) Performance Work Statement (PWS).

(1) Delete footnote #62 in Section 4.4.1, NYMA EPN Adoption and Expansion, pertaining to the availability of Attachment ATT016, WTC Health Program Provider Agreement Terms and Conditions.

(2) Delete footnote #63 in Section 4.4.2, Nationwide Provider Network (NPN) Network Development, pertaining to the availability of Attachment ATT016, WTC Health Program Provider Agreement Terms and Conditions.

(3) Delete footnote #81 in Table 7 (Attachments to the Performance Work Statement) in Section 9, Reference Materials, pertaining to the availability of Attachment ATT016, WTC Health Program Provider Agreement Terms and Conditions.

(4) Revise Section 4.4.3, Provider Enrollment and Credentialing, to include provisions for the termination of Provider Agreements.

(5) Revise a reference in Section 8.1 from HHSAR 352.239-74 to HHSAR 352.239-79.

(6) Revise the description for Attachment ATT020, Business Associate Agreement, in Table 7 (Attachments to the Performance Work Statement) in Section 9, Reference Materials.

(b) Section C.

(1) Delete HHSAR 352.224-70, Privacy Act, from Section C1.

(2) Revise Section C7, HHSAR 352.224-71, Confidential Information.

(3) Revise Section C8, HHSAR 352.239-79, Information and Communication Technology

Accessibility.

(c) Section D.

(1) Attach Attachment ATT016, WTC Health Program Provider Agreement Terms and Conditions, to the RFP. Please note: This attachment will be provided to each prospective offeror that has already completed and returned to CDC Attachment ATT104, Offeror Non-Disclosure Agreement (NDA).

See footnote #86 regarding the process for obtaining non-public attachments.

(2) Delete footnote #87 pertaining to the availability of Attachment ATT016, WTC Health Program Provider Agreement Terms and Conditions.

(d) Section E.

(1) Delete HHSAR 352.239-73, Electronic Information and Technology Accessibility Notice, from Section E1.

(2) Revise the dates for the virtual session to June 17, 2025, through June 26, 2025, in Section E3(e)(4) and Section E3(i)(2).

(3) Increase the maximum page limit for Volume 2 from 20 pages to 30 pages in Section E3(i)(1)(ii).

(4) Clarify that the Volume 7 appendix is excepted from the font and page specifications that apply to Volume 7 in Section E3(i)(1)(vii).

(5) Clarify the assumptions to be used in pricing the ad hoc all-member and targeted letters in Section

E3(i)(1)(viii)(A)(1)(g).

(6) Add the requirement for a signed Business Associate Agreement to Part B (Administrative information) of Volume 8 in Section E3(i)(1)(viii)(B)(10)(h).

(7) Correct terminology used in the Volume 9 instructions in Section E3(i)(1)(ix)(D).

(8) Add the link to the virtual session booking site in Section E3(i)(2).

(9) Clarify what will be evaluated for the past performance factor in Section E4(a)(2).

(10) Clarify that the price factor will be evaluated using Volume 8, Part A (Pricing) in Section E4(a)(3).

(11) Add Section E11, HHSAR 352.239-78, Information and Communication Technology Accessibility

Notice.

All other terms and conditions remain unchanged.

Additionally, please find attached an updated version of Attachment ATT110, Questions and Answers (revised 04.01.25).

Performance Work Statement

Title: World Trade Center Health Program Third-Party Administrator

Table 1. Periods of performance.

Period/phase Dates

Base/Transition-In Period 10/30/2025 – 10/29/2026

Option Period 1 (12 months)

Start of Healthcare Delivery (SHCD)

Dual Operations phase following the Transition-In Period (1 month)

Sustainment phase (11 months)

10/30/2026 – 10/29/2027

10/30/2026

10/30/2026 – 11/29/2026

11/30/2026 – 10/29/2027 Option Period 2 (Sustainment phase) (12 months) 10/30/2027 – 10/29/2028

Option Period 3 (Sustainment phase) (12 months) 10/30/2028 – 10/29/2029

Option Period 4 (Sustainment phase) (12 months) 10/30/2029 – 10/29/2030

Option Period 5 (Sustainment phase) (12 months) 10/30/2030 – 10/29/2031

Option Period 6 (Sustainment phase) (12 months) 10/30/2031 – 10/29/2032

Option Period 7 (Sustainment phase) (12 months) 10/30/2032 – 10/29/2033

Option Period 8 (Sustainment phase) (12 months) 10/30/2033 – 10/29/2034

Transition-Out Period (12 months) (overlaps Option Periods 8 and 9) 9/30/2034 – 9/29/2035

Option Period 9 (Sustainment phase) (11 months) 10/30/2034 – 9/29/2035

Transition-Out Dual Operations Period (1 month) 9/30/2035 – 10/29/2035

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 Public Law No. 118-31, codified at 42 U.S.C. §§ 300mm - 300mm-64.49 In addition to the statutory requirements for the Program codified in 42 U.S.C. §§ 300mm – 300mm-64, 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.50

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 are comprised 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. Program enrollment and certification decisions are carried out by Program enrollment and certification specialists within NIOSH, at the direction of the

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

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

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

Administrator. The Zadroga Act establishes Program responsibilities for enrolling, initially evaluating, medically monitoring, treating, and reimbursing 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 provided to members residing in the New York Metropolitan Area (NYMA), as defined in 42 C.F.R. § 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.” The TPA Contractor 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 (to include dental) claims. The data maintained by the TPA Contractor to carry out these responsibilities 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 ATT001, which is incorporated by reference herein as if fully set forth herein.

Section 1.1 – Other Program Contractors

The following is a non-exhaustive list of Program contractors, and related definitions,51 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.52 High-level descriptions of how the different contractors work together and their distinct roles, responsibilities, and systems are expanded upon in Attachment ATT002, which is incorporated by reference herein as if fully set forth herein.

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 but not limited to receiving data from the TPA Contractor, CCEs, and NPN; developing initial health evaluation, monitoring, and treatment protocols for WTC-related health conditions; and coordinating outreach activities. There are currently three DCs contracted with the Program, serving the Fire Department of the City of New York (FDNY), General Responder, and Survivor populations.

Health Program Evaluation (HPE) Contractor: A vendor providing consulting services for data analytics to

51 The definitions provided herein are included for ease of understanding this Performance Work Statement; they are not official definitions of the various contractors and their roles in the Program. Official definitions may be found in the Zadroga Act, as amended, codified at 42 U.S.C. §§ 300mm – 300mm-64, and Program regulations in 42 C.F.R.

pt. 88.

52 An additional key entity that the TPA Contractor is responsible for engaging with is the claims payment contractor. See Section 4.6.2. The Program’s relationship with the claims payment contractor is governed through an interagency agreement with the Centers for Medicare and Medicaid Services (CMS).

support strategic planning and program evaluation.

Health Program Support (HPS): The incumbent vendor to this Contract 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.

Nationwide Provider Network (NPN) Contractor: The vendor who is currently contracted to facilitate access to WTC-related care for members residing outside of the NYMA. Tasks of the NPN Contractor include managing the Nationwide Provider Network (defined below), customer service, and care coordination. During the Transition-In Period of this Contract, the NPN Contractor will cease administration of the Nationwide Provider Network, and the TPA Contractor shall become responsible for establishing and managing the Nationwide Provider Network. 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” will be used to refer to the nationwide provider network itself.

National Program Administrator (NPA): A vendor that ensures provision of medical monitoring, diagnosis, certification, treatment services, case management, and benefits counseling for members residing outside of the NYMA. Monitoring and treatment services are conducted through referrals to providers within the NPN. This role is like that of the CCEs and is currently fulfilled by the NPN Contractor. The National Program Administrator will be the name of the contract succeeding the current NPN Contractor contract; the contract name is changing to be more descriptive of the work and reduce confusion, as the network administration shifts to the TPA.

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 which provides comprehensive pharmacy services to the 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, pharmacy claims adjudication, formulary management, pharmacy network management, and clinical reviews.

SECTION 2 – PURPOSE/OBJECTIVE

The primary purposes of this Contract are to:

1. Maximize member access to and utilization of Program benefits within the boundaries of the 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, maintain all systems, and otherwise satisfy all responsibilities and requirements herein in accordance with Title XXXIII of the Public Health Service Act (codifying the Zadroga Act, 42 U.S.C. §§ 300mm – 300mm-64), 42 C.F.R. pt. 88, the Privacy Act (5 U.S.C. § 552a), the Health Insurance

Portability and Accountability Act of 1996 (HIPAA), as modified (Pub. L. 104–191; 42 U.S.C. § 1320d and the corresponding implementing regulations at 45 C.F.R. pts. 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 and aligns with the Program mission and vision. The TPA Contractor will not be responsible for underwriting the cost of care; details on how claims will be paid can be found in Section 4.6.2.

Tasks to be performed are detailed in the following Functional Area Sections:

4.1 Transition-Related Services;

4.2 Contract Management;

4.3 Member Services;

4.4 Provider Network Management;

4.5 Medical Benefit Administration and Policy;

4.6 Claims Processing;

4.7 Data and Business Information Management; and

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 on October 30, 2026, 12 months after the award/effective date. The TPA Contractor shall have an Introductory Call with the COR within seven calendar days53 after the award/effective 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/effective date.

The Kickoff Meeting will occur in-person at the Program’s offices 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, Sections 8.3.1 and 8.3.3 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 both deliverables.

Section 4.1.2 – Transition-In

The TPA Contractor shall collaborate with the Program and other Program contractors to ensure a successful Transition-In is completed in the required timeframe. Transition-In begins upon the award/effective date and includes the development and testing and validation of the TPA Contractor’s systems and operations. Transition-In ends 12 months after the award/effective date. 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

53 Calendar day, as used in this Performance Work Statement unless otherwise specified, includes weekends and holidays. For deliverable due dates that fall on a weekend or a federal holiday, the due date is the next business day (Monday through Friday, excluding federal holidays). Federal holidays are defined in 5 U.S.C. § 6103.

the TPA Contractor. Systems and processes shall be developed and tested, and all required services shall be fully operational to implement SHCD – meaning that the TPA Contractor has the resources, systems, data, and other information necessary to perform the full scope of work as defined in Section 3 – twelve months after the award/effective 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 in writing with the Program. During the Transition-In Period, the TPA Contractor shall perform the following tasks:

1. Contract Management – Track the 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, assess the accuracy of the EPN network provider file and load it into the TPA Contractor’s system(s), develop a new NPN, update and manage EPN and NPN provider network data, and perform all other responsibilities detailed in Section 4.4. The TPA Contractor shall be ready to manage the NPN by the SHCD date, after fully transitioning this task from the NPA.

4. Medical Benefit Administration and Policy – 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 payer requirements and edits including incorporation of business rules into an automated claims processing 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 and/or NPN contractors 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 in-progress 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 TPRs, 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 interim and final 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 TPA Contractor’s Transition-In team shall support this 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. 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 ATT003, which is incorporated by reference herein as if fully set forth herein. 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 Kickoff 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 Performance Work Statement (PWS). 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 and mail/document center operations; and the secure self-service portals are fully operational. The TPA Contractor shall provide all training documents provided to its staff for Program review and approval, in accordance with Section 4.2.6. 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 EPN provider file and availability of EPN and NPN Provider Directory, to include any newly recruited providers. The TPA Contractor shall provide written documentation attesting to completion of the EPN network absorption and NPN development. 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 Sections 4.2 through 4.8 below and the QASP in Attachment ATT003. 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 Program 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 System Testing Results to the Program incrementally throughout the Transition-In Period in accordance with the Transition-In Plan, with all System Testing Results delivered to the Program no later than 90 calendar days prior to SHCD. This document(s) shall provide a summary of all testing completed since the award/effective 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. Testing results are to be delivered incrementally throughout the Transition-In Period in accordance with the Transition-In Plan. Individual tests deemed unsuccessful by the TPA Contractor or the Program, in accordance with the success criteria contained in the Transition-In Plan, shall be remediated and re-run within seven calendar days of identification. If the Program finds unsuccessful testing that affect multiple, interrelated testing scenarios, the TPA Contractor shall submit a detailed mitigation and revised testing plan within 14 calendar days from the identification, by the Program, of the unsuccessful testing affecting multiple, interrelated testing scenarios.

The TPA Contractor shall move into a final Acceptance and Performance Testing (APT) phase after all feature, module, 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 45 calendar days prior to SHCD and be successfully completed at least 15 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 seven calendar days of identification.

Section 4.1.4 – Dual Operations following Transition-In

The first 30 days following the Transition-In Period is a “Dual Operations” phase during which both the incumbent HPS contractor and the TPA Contractor will be delivering Program support services simultaneously. The Dual Operations phase following the Transition-In Period is part of Option Period 1. Specifically, the HPS contractor will perform claims runout activities, adjudicating WTC-related medical claims received prior to SHCD. The TPA Contractor will receive, process, and adjudicate all medical claims received on or after SHCD. The HPS contractor may also perform other support activities, if agreed upon between the Program, the HPS contractor, and the TPA Contractor; however, all public-facing interactions (e.g., call center) shall be performed or coordinated by the TPA Contractor during Dual Operations. The TPA Contractor shall minimize disruption of Program operations and services during the Dual Operations.

Dual Operations starts at SHCD and will last up to 30 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 medical claims with dates of receipt on or after the SHCD, while the incumbent HPS contractor processes incoming medical claims with dates of receipt prior to the SHCD. The TPA Contractor shall coordinate with the incumbent HPS contractor to update members’ claims history during this concurrent processing phase and ensure consistent messaging to relevant stakeholders, including members, providers, Program staff, and other Program contractors, throughout Dual Operations.

The TPA Contractor shall assume processing for all incoming and in-progress medical claims regardless of date received beginning no later than the 31st calendar day after the SHCD. The TPA Contractor shall use historical Program claims data and/or otherwise obtain 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 the Dual Operations phase following the Transition-In Period, the TPA Contractor shall move into the Sustainment phase of this Contract. The Sustainment phase is defined as the operational time between the end of Dual Operations phase following the Transition-In Period, and the end of Option Period 9 (if exercised), where the TPA Contractor performs and is solely responsible for all tasks required under this Contract.

The TPA Contractor shall perform at the expected levels defined by the PWS and the QASP starting at SHCD.

Section 4.1.6 – Transition-Out (including Transition-Out Dual Operations)

If and once exercised, the TPA 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 TPA 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 entity’s(ies’) 12-month Transition-In period, the TPA Contractor will transfer duties and responsibilities to a Program appointed designee, whether a government entity, one or more successor contractors, or a mix of both. At the end of the Transition-Out Period, the Government intends to exercise a 30-day Transition-Out Dual Operations Period. The Transition-Out Dual Operations Period may be exercised by the Government at any time, provided that the Government gives the TPA Contractor a preliminary written notice of its intent no less than 60 days prior to the start of the Transition-Out Dual Operations Period. During the Transition-Out Dual Operations Period, the TPA Contractor shall continue to provide limited services after SHCD of the successor contractor(s) or other Program appointed designee, as described below.

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 PWS and the QASP. The TPA Contractor shall cooperate fully with the Program and the successor contractor(s) or other Program appointed designee during the Transition-Out Period, to facilitate an orderly transfer of Program functions and operations to the successor contractor(s) or other Program appointed designee. The TPA Contractor shall minimize disruption of Program operations and services during the Transition-Out Period.

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 Period. 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) or other Program appointed designee, maintain operational standards, and complete all Transition-Out tasks successfully—within a risk management framework. The Transition-Out Plan shall include a Transition-Out Master Schedule (TOMS). 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(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) or other Program appointed designee;

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 Period begins;

3. 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 TPA Contractor over the life of this Contract along with full support in the reconciliation of the inventory as needed;

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

5. Attend meetings to transfer information, processes, and Program data; mitigate transition risks and issues;

and report status of transition tasks;

6. Communicate final dates of usage of current systems and processes, in accordance with the successor contractor(s)' or other Program appointed designee’s transition-in, and assist in communicating transition details to stakeholders, including but not limited to members, providers, Program staff, and other Program contractors;

7. Ramp down operations (as appropriate);

8. 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;

9. Execute all required “system decommissioning” tasks, including destruction of all non-public or other protected data from Contractor-owned systems, and certify execution. See Section 10.12.7; and

10. Continue to perform the Sustainment phase of this Contract, in accordance with the tasks of the exercised option period(s) on-going at the time of the Transition-Out Period.

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 in-process medical 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) that is part of the Transition-Out Plan. The TPA Contractor shall ensure all handoffs are completed by SHCD of the successor contractor or other Program appointed designee, unless otherwise agreed upon between the Program, the TPA Contractor, and the successor contractor(s) or other Program appointed designee.

During the 30-day Transition-Out Dual Operations Period, which the Government intends to exercise following the 12-month Transition-Out Period and after the Sustainment phase of this Contract ends, but which may nevertheless be exercised by the Government at any time, the TPA Contractor will continue to provide limited services after SHCD of the successor contractor(s) or other Program appointed designee. The TPA Contractor shall:

1. Perform claims runout activities, processing all medical claims with dates received prior to the successor contractor(s)’ or other Program appointed designee’s SHCD;

2. Provide medical claims processing updates to the Program and successor contractor(s) or other Program appointed designee with each claims processing cycle to update the member profile and provide a status update on the open medical claims inventory;

3. Maintain sufficient customer service capabilities and staffing levels to properly respond to the successor contractor(s)’ or other Program appointed designee’s inquiries related to medical claims processing during this period; and

4. Transfer all open medical claims inventory remaining at the end of the 30 calendar days to the successor contractor(s) or other Program appointed designee.

The TPA Contractor shall also work with the Program Information Security Officer (ISO) and COR to transfer all existing Program records and data (including but not limited to member data, provider network(s) 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 Period begins, with updates provided on a cadence as defined by the Program thereafter. The data transfer shall be performed in a manner and format that enables the Program to map all Program data from the TPA Contractor’s system(s) to the replacement system(s) of the Government or a successor contractor(s) or other Program appointed designee. This includes all data and data-related documentation as listed in Section 4.7.6, as well as:

1. High-level, functional business process flows and 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) or other Program appointed designee.

Section 4.2 – Contract Management

The TPA Contractor shall effectively manage this Contract in accordance with the TPA Contractor’s proposal and Contract Management Plan (CMP). See Section 8.3.3. The TPA Contractor shall perform the following tasks:

1. Coordinate with the 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 this 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 10.

4. Implement a Change Control Process per Section 4.2.2.

5. Implement processes for identification, tracking, mitigation, and escalation of risks and issues as codified in the CMP.

6. Collaborate with Program stakeholders, as directed and overseen by the Program.

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

8. Oversee all subcontractors to ensure quality of subcontractor performance and compliance with all Program requirements.

All the TPA Contractor’s processes and workflows shall be documented in an Operations Manual, due 60 calendar days prior to SHCD. See Section 8.3.4. 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, in accordance with Sections 8.3.5 and 8.3.6, respectively.

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, Dual Operations, 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 this 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 this Contract in coordination with Program staff and other Program contractors.