Attachment J.1 - PWS 75D301-20-R-67985.docx

200-2011-39383

Short-term Survivor Clinical Center of Excellence (STS CCE) World Trade Center Health Program Clinical Center of Excellence Performance Work Statement

C.1 Background

Title I of Public Law No. 111-347, the James Zadroga 9/11 Health and Compensation Act of 2010 (“Zadroga Act”) amended the Public Health Service Act to add Title XXXIII, establishing the World Trade Center (WTC) Health Program as a limited federal health care program, within the Department of Health and Human Services, to provide medical monitoring and treatment for eligible Responders and Survivors of the terrorist attacks of 9/11 (Public Law 111-347, as amended by Public Law 114-113 and Public Law 116-59; codified at 42 U.S.C. §§ 300mm – 300mm-61). The Zadroga Act can be found at: http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title42-chapter6A-subchapter31&edition=prelim.

The Zadroga Act outlines a number of requirements for the WTC Health Program regarding Program administration, enrollment, initial health evaluations, medical monitoring, and medically necessary treatment of certified WTC-related health conditions for eligible individuals. Program responsibilities include the construction of a comprehensive medical and pharmaceutical benefit program consistent with a limited care model, similar in constraints to a worker compensation model, and requiring ongoing engagement with stakeholders.

The WTC Health Program promulgated regulations guiding the implementation of the Program and created policies, procedures, and benefit plans based on member category and limited to those conditions certified by the Administrator of the WTC Health Program for coverage. It also developed a business-processing component to adjudicate and pay medical and pharmacy claims from enrolled providers for allowable services authorized by Clinical Centers of Excellence (CCEs) and/or the Program. Required administrative processes included procedures for appeals related to denials of Program enrollment, health condition certification, or treatment claims.

Initial health evaluations, medical monitoring, and treatment are provided through Clinical Centers of Excellence (CCEs) for members in the New York Metropolitan Area[footnoteRef:2] and through the Nationwide Provider Network for those members beyond that area. The Zadroga Act defines a CCE as a Center that satisfactorily demonstrates that it: [2: See Section C.1.3. below.]

(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)[footnoteRef:3]; (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. [3: Section 3313(c) of the Zadroga Act relates to the provision of training and technical assistance to healthcare providers participating in the nationwide provider network. 42 U.S.C. § 300mm-23(c).]

Zadroga Act, Sec. 3305(b)(1)(A); 42 U.S.C. § 300mm-4(b)(1)(A).

The Act requires the Program to enter into contracts with CCEs to carry out the following tasks:

(A) for the provision of monitoring and treatment benefits and initial health evaluation benefits under sub-title B;

(B) for the provision of outreach 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, 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.[footnoteRef:4] [4: Section (F) refers to a requirement for the CCE. Currently the WTC Health Program has been able to facilitate the process more efficiently by providing claims data directly to the Data Centers through the health support contractor without requiring the CCEs to do so. This could change with the implementation of new contracts.]

Zadroga Act, Sec. 3305(a)(1); 42 U.S.C. § 300mm-4(a)(1).

C.1.1 Member Classification and Statistics

This Survivor CCE contractor shall serve survivor members in the New York Metropolitan Area with a physical clinic location in the financial district of New York City.

As of September 30, 2019, the WTC Health Program has 99,769 members enrolled, including 16,993 FDNY responders, 814 Pentagon / Shanksville responders, 59,097 general responders and 22,865 survivors. As of November 30, 2019, there are about 3,800 survivor active members served by the Surge Clinic, which will be transitioned to this new short-term survivor CCE (STS CCE). Monthly, an average of 60-150 new members will continue to be assigned to the STS CCE with an average of 150 – 244 initial health evaluations, 30-50 diagnostic services, 65-100 treatment services and 110-210 social and benefits counseling services., and 80-100 are in case management services.

As of September 30, 2019, of those enrolled survivor members, 12,509 are served by NYC Health + Hospitals WTC Environmental Health Center (H+H) CCE, 17,801 by the Nationwide Provider Network (NPN), and 3,759 by the Surge clinic, which will be transitioned to the STS CCE.

STS CCE members are estimated to reach 4,899 by September 2020. Current WTC Health Program statistics and reports can be found at https://www.cdc.gov/wtc/ataglance.html.

The classification of the WTC Health Program members intended to be served by this CCE is:

Enrolled WTC Survivor Individuals present in the New York City Disaster Area[footnoteRef:5] in the dust or dust cloud on September 11, 2001; an individual who lived, worked, went to school, childcare, or adult daycare in the New York City Disaster Area; 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. [5: The Zadroga Act defines the New York City Disaster Area as “the area within New York City that is (A) the area of Manhattan that is south of Houston Street; and (B) any block in Brooklyn that is wholly or partially contained within a 1.5-mile radius of the former World Trade Center site.” Sec. 3306(7); 42 U.S.C. § 300mm-5(7).]

C.1.2 Geographic Coverage

Section 3306(8) of the Zadroga Act defines the New York Metropolitan Area to be covered by CCEs as:

“An area, specified by the WTC Program Administrator, within which WTC responders and eligible WTC screening-eligible survivors who reside in such area are reasonably able to access monitoring and treatment benefits and initial health evaluation benefits under this title through a Clinical Center of Excellence described in subparagraphs (A), (B), or (C) of section 3305(b)(1).” 42 U.S.C. § 300mm-5(8). The Administrator further specified in WTC Health Program regulations that the New York Metropolitan Area is “the combined statistical areas comprising the Bridgeport-Stamford-Norwalk, CT Metropolitan Statistical Area; Kingston, NY Metropolitan Statistical Area; New Haven-Milford, CT Metropolitan Statistical Area; New York-Northern New Jersey-Long Island, NY-NJ-PA Metropolitan Statistical Area; Poughkeepsie-Newburgh-Middletown, NY Metropolitan Statistical Area; Torrington, CT Micropolitan Statistical Area; Trenton-Ewing, NJ Metropolitan Statistical Area, as defined in OMB Bulletin 10-02, December 1, 2009.” 42 C.F.R. § 88.1.

C.2 Objective

The objective of this requirement is to enter into a contract with a single short-term survivor CCE to provide services to the Survivors of the 9/11 attacks in a manner consistent with the requirements of the Zadroga Act due to nearly 400% increase in survivor member enrollment since 2011. These requirements are provided in section C.3 Scope of Work of this PWS.

C.3 Scope of Work

The scope of work for a Clinical Center of Excellence (CCE) is defined by the following requirements as defined by Section 3305 of the Zadroga Act and incorporates requirements from other parts of the Act (including Sections 3301, 3304, 3305 3312, 3322, and 3331) in addition to Program policies and procedures. The scope of work for this contract includes performance of the following requirements:

(1) Providing initial health evaluation, annual medical monitoring, diagnostic, cancer screening, and treatment benefits under Subtitle B of the Zadroga Act.

(2) Ensuring that all CCE activities (e.g., benefits counseling, health education, health care service, case management, care coordination, specialty referral and authorization, and pharmacy prescribing and authorization) align with the WTC Health Program’s Administrative Manual[footnoteRef:6]. [6: The Program’s Administrative Manual is subject to change. The interested parties shall always consult with the Administrative Manual and WTC Health Program’s shared secured records portal to obtain the latest information. ]

(3) Providing services to retain enrolled members and documenting these services.

(4) Providing case management and care coordination with participating provider network for health conditions covered by the WTC Health Program.

(5) Providing member and provider counseling for Program benefits with respect to the limited-coverage model of the Program, and coordination of care with community providers for health conditions not covered by the WTC Health Program (including pharmacy services and products).

(6) Providing 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.

(7) Providing translational and interpretive services and communication products for Program participants who are not English-language proficient.

(8) Evaluating and documenting and the quality of medical care provided to ensure it meets professionally recognized national and community practice standards.

(9) Providing diagnostic and treatment referrals for conditions covered by the Program that appropriately inform and constrain the service authorization with the limited-care model required by the Program.

(10) Providing prescriber and member oversight activities to ensure appropriate use of pharmacy benefits as described by the Program’s Administrative Manual (see footnote). This may include such things as mandatory use of generics, prospective authorization that documents medical necessity, and retrospective pharmacy-utilization review.

(11) Reviewing/approving health care claims submitted by network providers to ensure alignment with Program requirements for medical necessity and prior authorization.

(12) Establishing and maintaining a formal mechanism, including active participation in Steering Committee meetings and Program-provided trainings or conferences, for consulting with and receiving input from representatives of eligible populations receiving health care benefits from the CCE under Subtitle B of the Zadroga Act.

(13) Coordinating monitoring, cancer screening, diagnostic and treatment benefits under Subtitle B of the Zadroga Act with routine medical care provided for the treatment of conditions other than those covered by a member’s WTC Health Program benefit. This includes care coordination and case management where medical management decisions by non-participating providers may impact conditions managed by the CCE under the member’s Program benefits.

(14) Collecting data as described in Subsection (a) and reporting the data to the CCE’s corresponding Data Center (DC), to be determined, for analysis.[footnoteRef:7] [7: Section (F) refers to a requirement for the CCE, which the WTC Health Program has been able to facilitate the process more efficiently by providing claims data directly to the Data Centers without requiring the CCEs to do so.]

(15) Having in place safeguards against fraud, waste, and abuse consistent with Section 3301(d), that are satisfactory to the Administrator of the Administrator of the WTC Health Program and reporting any activities of concern to the Administrator and the Inspector General of the Department of Health and Human Services.

(16) Treating and/or referring for treatment all individuals who are certified-eligible WTC Survivors enrolled in the CCE who present themselves for treatment of a WTC-related health condition and/or medically associated WTC-related health condition as certified by the Administrator of the Administrator of the WTC Health Program.

(17) Having in place safeguards to ensure the confidentiality of an individual’s individually identifiable health information, consistent with Section 3304(d) of the Zadroga Act and HIPAA[footnoteRef:8], including requiring that such information not be disclosed to the individual’s employer without the individual’s authorization and using tools approved by the Program to transmit protected health information (PHI) and personally identifiable information (PII) (such as the WTC Health Program Web Portal). [8: Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104–191; 42 U.S.C. § 1320d), as modified, and the corresponding implementing regulations, including the Privacy, Security, Breach Notification, and Enforcement Rules (45 C.F.R. pts. 160, 162, and 164). HHS is a hybrid entity under HIPAA because it is a covered entity conducting business activities that include both covered and non-covered functions. 45 C.F.R. § 164.103. As a hybrid entity, HHS must designate any component that would “meet the definition of a covered entity or business associate if it were a separate legal entity” as a health care component; a health care component also may include a component only to the extent that it performs covered functions. 45 C.F.R. § 164.105(a)(2)(iii)(D). Accordingly, HHS has designated the WTC Health Program as a health care component of HHS and must comply with all requirements applicable to a covered entity under HIPAA.]

(18) Using amounts paid under Section 3305(c)(1) of the Zadroga Act only for costs incurred for fixed infrastructure costs as defined in Section 3305(c)(2) as costs incurred by the CCE that are not otherwise reimbursable under section 3312(c) for patient evaluation, monitoring, or treatment but which are needed to operate the CCE, but exclude costs for new construction or other capital costs.

(19) Using healthcare providers with occupational-and environmental-medicine expertise to conduct physical and psychiatric assessments, or psychological experts to conduct mental health assessments, in accordance with protocols developed by a corresponding DC under 3305(a)(2)(A)(ii) through collaboration, guidance, and approval by the Administrator of the Administrator of the WTC Health Program.

(20) Conducting retention and outreach activities that align with the Program’s strategic plan for retention and outreach and coordinating activities with the corresponding DC and the Program’s designated staff liaison.

(21) Meeting all other applicable requirements of Title, I of the Zadroga Act, as well as WTC Health Program regulations at 42 C.F.R. pt. 88, and WTC Health Program Administrative Manual,[footnoteRef:9] and Policies and Procedures and associated guidance designed to implement the WTC Health Program. [9: The Program’s Administrative Manual is subject to change. The interested parties shall always consult with the Administrative Manual and WTC Health Program to obtain the latest information.]

None of these services shall be provided by the CCEs for any person the Administrator of the WTC Health Program has not determined to be eligible for and enrolled in the WTC Health Program. If an individual who is not an enrolled member in the WTC Health Program contacts a CCE for services, the CCE shall instruct the person to contact the WTC Health Program regarding eligibility and enrollment.

The CCE shall ensure that the CCE’s Operations Manual aligns with the WTC Health Program policy and procedures, including, but not limited to, those outlined in the Administrative Manual.

While there are no research activities conducted by a CCE under this contract, data collected by the CCE will be used for analysis to improve clinical care, implementation processes, and operational efficiency. The data from the monitoring, initial health evaluations, and cancer screenings will be transmitted to the corresponding DC to be used for Program evaluation and research. In addition, the data from monitoring, initial health evaluations, and cancer screenings may be retained in an administrative data system for analytics intended to improve or evaluate operational and clinical activities. Neither the CCE nor the DC will be responsible for eligibility determinations. The eligibility determination and enrollment process will be administered by the WTC Health Program.

C.3.1 CCE Contract Management

The CCE contractor shall manage the contract to ensure that all subcontracts, staffing, reporting, security, deliverables, repositories, and quality-assurance staff and services meet the requirements of the prime contract. The CCE contractor shall implement project management objectives that focus on monitoring, controlling, and balancing the project’s three key constraints – scope, budget, and schedule – and align with the elements of the Contractor Performance Assessment Reporting System (CPARS), on an ongoing basis.

C.3.1.1 Project Management Plan

The CCE contractor shall develop and implement a Project Management Plan (PMP) which shall define appropriate technical and financial project management over all tasks and deliverable documents in accordance with this PWS. The PMP shall establish the staffing plan, project management approaches, and procedural framework for accomplishing the work required under this PWS. The PMP shall establish a transparent management baseline from which project monitoring and quality control is routinely conducted to verify adherence to the PMP and WTC Health Program protocols. The CCE’s staffing plan shall include qualifications, percentage of employment, numbers, and duties of personnel who will be responsible for implementing the CCE contract, including an identification of key personnel and members of CCE management team, with the percentage of their time to be devoted to implementation of the CCE contract requirements.

In addition to providing the Staffing Plan as part of the Project Management Plan, the CCE shall provide the quarterly reconciled staffing list that describes staff status changes, positions/roles, salaries or hourly wages, and new and unfilled positions with their starting and/or vacancy dates.

C.3.1.2 Operations Manual

The CCE contractor shall develop and maintain an Operations Manual that contains a complete set of written Standard Operating Procedures (SOPs) which guide all contract-related services, processes, and activities. The SOPs shall be used to meet the objectives outlined in the PWS and provide the requisite security and process support for the WTC Health Program to include evidentiary documentation for formal federal audits as well as Security Certification and Accreditation of contractor-provided systems for the Program. The CCE Operations Manual shall be aligned with the Administrative Manual for the WTC Health Program and the Zadroga Act, as amended. The contractor shall consult with WTC Health Program management on the latest guidance changes or to propose a change. The WTC Health Program Administrative Manual is available but may not reflect the latest changes.

For a CCE that serves Survivors member, the CCE’s Operations Manual shall provide the details of the planned coordination of benefit (COB) process that is consistent with requirements of the Zadroga Act, the WTC Health Program, the ACA, and applicable laws.

C.3.1.3 Communication Plan

The CCE contractor shall develop and maintain a comprehensive Communications Plan that will enable it to deliver appropriate messages and communicate effectively to all identified stakeholders in a consistent and timely manner. The Communications Plan shall describe all major communication activities, including mass communication with members, routine and ad hoc meetings organized by the CCE, stakeholders, and/or the WTC Health Program. The key staff, including the Medical Director, CCE Administrator, or their representatives, must attend the weekly Medical Forum call and other related meetings as required by the Administrator of the WTC Health Program, Program leadership, or the Contracting Officer’s Representative (COR) and the Contracting Officer (CO). These meetings may include other CCEs, DCs, the Health Program Support (HPS) contractor, and other contractors in the WTC Health Program; the WTC Health Program Steering Committees; and/or WTC Health Program members. A standing conference call for program management will be held between the WTC Health Program and the CCE contractor to discuss issues related to requirements implementation and CCE operations on a schedule to be agreed on by both the CCE and the COR.

In addition, the CCE shall acknowledge and provide an initial response to any written request or technical guidance from the WTC Health Program within 24 hours. A request is a written communication that specifies what is needed, why it is needed, and when it is needed, which may require the CCE to populate a Change Request (CR) or work plan to define the scope of the request and level of effort. Requests may be preceded by oral communications. The CCE contractor must inform the COR in advance if it requires more time or is unable to meet the due date. If the request or deadline is modified, an updated written request will be provided to the CCE.

The CCE contractor shall implement quality assurance measures to ensure communication process efficiency and compliance with federal privacy laws and regulations by testing any automated outputs to ensure accuracy of content and addressee before delivering materials.

The CCE shall submit co-branded material to the Program in advance of delivery or transmission for Program approval. The CCE shall retain copies of these materials for audit and quality control.

See Appendix II: Direction for Outreach, Education, and Retention Communication Initiatives and Projects for technical guidance regarding the Communications Plan.

C.3.1.4 Data Security and Continuity of Operations Plan

The CCE contractor shall develop and maintain a comprehensive Data Security and Continuity of Operations Plan. The Data Security and Continuity of Operations Plan shall outline the CCE contractor’s policies and procedures for ensuring data security, continuity of operations, and the transfer of data to the WTC Health Program. The data security and continuity of operations plan should follow HIPAA and CDC guidelines. The Data Security and Continuity of Operations Plan shall follow the requirements of a certification and accreditation process and allow for continuous monitoring as outlined by CDC’s Cybersecurity Program Office (CSPO).

The contractor should clearly describe how it would address major day-to-day disruptions to operation in the Continuity of Operations Plan beyond the scope of the IT function.

The CCE contractor shall submit draft of the CCE Contract Data Security and Continuity of Operations Plan to the WTC Health Program for review within sixty (60) days of contract award. As stipulated by HHSAR 352.222-70, the draft plan shall include identification of system of records and disposition. The system of record for this requirement is Privacy Act System Notice 09-20-0147:

(a) Identify the system(s) of records and the design, development, or operation work the Contractor is to perform and provide detailed description and point of contact (team or group) to the WTC Health Program;

(b) Specify the disposition to be made of such records upon completion of contract performance. The Contractor shall transfer all government records and all government furnished data within 30 days after the contract has ended or within the (to be) specified transition period.

(For further details, see Section C.3.9.3 for HIPAA compliance and Appendix A: Baseline Security Requirements).

C.3.1.5 Risk Management Plan

The CCE contractor shall develop and maintain a Risk Management Plan in accordance with federal guidance and CDC/NIOSH/WTC Health Program policy for a continuous-improvement approach to project performance. The Risk Management Plan shall include any potential program integrity risks and proposed strategies to reduce/mitigate these risks, particularly risks that can greatly disrupt operation of health care services.

C.3.1.6 Fraud, Waste, and Abuse Compliance Plan

The CCE contractor shall develop and maintain a Fraud, Waste and Abuse (FWA) Compliance Plan. As part of the FWA Compliance Plan, the CCE contractor shall designate executive and essential personnel to attend mandatory training in FWA detection, prevention, and reporting, and designate an officer or director in its organization with responsibility and authority for carrying out the provisions of the FWA Compliance Plan. The CCE contractor shall describe its activities to protect the integrity of the WTC Health Program by prevention, detection, and responding to suspected, potential, or actual cases of fraud, waste, or abuse as part of its ongoing quality assurance and improvement program. The activities should include fraud, compliance, and exclusions resources made available by the U.S. Department of Health and Human Services’ Office of the Inspector General, which can be found at https://oig.hhs.gov/.

C.3.1.7 Quality Assurance and Internal Audit Plan

The CCE contractor shall continue to conduct internal audit and report semi-annually for the Services and Requirements Summary Selected for Inspection (Section C.3.10) and implement the Technical Guidance for Quality Assurance and Internal Audits (see Appendix I and any subsequent updates that may follow. The CCE contractor shall update the “Quality Assurance and Internal Audit Plan” (QAP) and provide the latest version to the Program. Details of the QAP can be found in section C.3.9.1.

C.3.1.8 Cost Tracking and Invoicing

The CCE contractor shall develop and manage budgets for all work to be performed. Budget development and management includes tracking and analysis of cost, Option Year budget development, and reporting budget-related issues to the COR and the Contracting Officer.

The CCE contractor shall develop, review, and submit invoices which reflect adherence to budget/funding requirements. For a cost-reimbursable type contract, the invoice shall include standardized forms (SF-1034 & SF-1035) and other recommended elements, including a balancing sheet, by Contract Line Item Numbers (CLINs), budget snapshot, and references to support completed work.

Quarterly, the CCE shall submit a reconciliation staffing report with wages, assigned duties and hours, termination and hiring dates, and changes to proposed staffing plan and impacted budget and contract requirements.

The CCE contractor shall operate in a manner that is fully transparent, disclosing all sources of revenue and sharing all rebate dollars with the WTC Health Program based on a percentage approved by the WTC Health Program. The CCE contractor shall allow third parties to audit rebate payments and reconciliations.

The CCE contractor shall provide detailed line items and supporting documentation when other indirect costs, as defined by FAR Part 31, equal or exceed $5,000.00, and provide subcategories of these costs.

Per FAR 52.232-20 and FAR 52.323-22, the CCE contractor is required to provide a written notification at least sixty (60) days prior to when the contract is expected to exceed the obligated amount for that period of performance.

C.3.1.9 Subcontracting

The CCE contractor shall provide management and oversight of all subcontractors[footnoteRef:10] as described in FAR Parts 42 and 44. The CCE contractor shall submit the request for consent to subcontract in accordance with FAR 44, provide a summary of subcontracting effort listed in items 1, 2, 3, and 4 below and complete the newest version of the HHS Subcontracting Plan template for new and update subcontract agreement. [10: Pursuant to FAR 44.101, Definitions, a “Contractor” means “the total contractor organization or a separate entity of it, such as an affiliate, division, or plant that performs its own purchasing.” A “Subcontractor” means “any supplier, distributor, vendor, or firm that furnishes supplies or services to or for a prime contractor or another subcontractor.”]

The CCE contractor shall ensure subcontracting activities meet the contract requirements of the prime contractor and monitor the subcontractor’s compliance and performance throughout the contracting performance. The CCE contractor shall manage any required subcontracts in a manner that best fulfills the requirements of the prime contract. The CCE contractor shall ensure its subcontractors and/or their agents who require the use of or access to individually identifiable information or protected health information under the provisions of this contract comply with WTC Health Program business associate agreements and federal law, policies, and regulations, including HIPAA and CDC certification and authorization to operate requirements. The prime contractor will obtain a written assurance from each subcontractor to this effect. The CCE contractor shall notify the COR and CO in advance of placing any subcontract or modification, including submission of HHS Subcontracting Plan and summary of efforts with minimum of four required elements listed below:

A. A description of the supplies or services to be subcontracted;

B. Identification of the type of subcontract to be used;

C. Identification and selection of the proposed subcontractor;

D. A description of an oversight and quality assurance plan.

If there is a change, the CCE contractor must provide a short summary of the current subcontracting efforts within forty-five (45) days after the current option year ends for the duration of the contract and provide highlights of major changes in the monthly report.

C.3.1.10 Change Control Process

A contract change control request process allows for changes to be implemented with the mutual understanding and agreement of both the Contractor and the Government. During post-award contract management, monitoring and controlling contract changes is one of the most crucial part of contract administration, requiring extensive process integration and communication among the Contractor and Government’s project management team members. The most effective way of managing and controlling contract change requests is to integrate a contract change request management process.

The CCE contractor shall manage the contract to ensure the required services are performed and the required contract deliverables are submitted. As part of this requirement, the CCE contractor shall maintain a WTC Health Program-approved change control process to identify, record, assess, and secure approval for changes to the project. The CCE contractor and the WTC Health Program will follow the Change Request (CR) protocol and use this process to classify, prioritize, approve, or reject changes, so that implementation does not negatively impact core mission applications, functions, or live production environments. Change requests must be defined clearly and include their cost and schedule implications, to allow the WTC Health Program to make appropriate decisions. The CCE contractor shall receive prior authorization and approval of expenditures by the CO and COR.

C.3.1.11 Technical Experts Support

The CCE contractor shall identify and provide an efficient multi- and interdisciplinary team of personnel at all operational levels with advanced technical expertise, health service experience and appropriate skills set to perform services required.

The CCE contractor’s multi- and inter-disciplinary team shall include, at the minimum, mid- to high-level medical (physical and mental) and nursing professionals, licensed case managers and social workers, health service administration manager, and other staff necessary to support program management and operations (such as quality assurance, provider network, analytics, and coding and claims). The CCE contractor shall provide a well-defined and cost-effective mix of specialists in Federal Health Care Delivery Policies and Procedures, Federal Health Care Pharmacy Delivery Policies and Procedures, Case Management, Federal Health Information Technology, Federal Legislative/Regulatory Affairs as pertains to pharmacy benefits and benefit design, and Provider Education/Relations, Risk and Health Communication and show how these specialists align to Program requirements. The CCE contractor shall have exceptional expertise in standing up and operating a high-visibility federal healthcare program that requires exceptional end-user responsiveness.

The CCE contractor and its staff should be very familiar with the Zadroga Act and other related federal health laws and regulations, and maintain the knowledge and skills needed to administer a federal healthcare program.

C.3.1.12 Program Quality Improvement

The CCE contractor shall work with the WTC Health Program to facilitate and develop ongoing program quality improvements to ensure the integrity of the Program, and to address the CCE needs and WTC Health Program deficiencies regarding members, the CCEs, the DCs, the HPS contractor, and other stakeholders. The CCE contractor must address all required Quality Assurance (QA) mandates of the Zadroga Act as described in the Guidance on Developing Quality Assurance Plans and Quality Assurance Internal Audit Reports to Address Zadroga Act and CCE Contract Requirements dated November 30, 2018, and any subsequent updates that may follow, and the QAP. The CCE shall incorporate innovations and new means of providing superior care and service delivery to Program participants and stakeholders.

The WTC Health Program must be responsive to Congress, other governmental organizations, including but not limited to, the Office of Inspector General (OIG), the Government Accountability Office (GAO), HHS, and the Office of Management and Budget (OMB), and the public. As such, the CCE contractor must maintain comprehensive records and be responsive to the Program in order to complete these requests. Compliance with these requests will demonstrate that the CCE contractor is meeting Program needs and reducing Program operational risks.

The CCE contractor shall work closely with the WTC Health Program to fulfill program integrity and research requirements and make recommendations to address critical Fraud, Waste, and Abuse initiatives. This includes regularly reporting to the WTC Health Program both research and reports on potential cost-saving measures.

A qualified team of medical professionals and program managers should research and review potential quality-of-life improvement, cost-saving, and fraud, waste, and abuse control initiatives, and provide evidence-based recommendations to the WTC Health Program’s Pharmacy Unit regarding formulary requirements and drug inclusion into the formulary. The CCE contractor shall incorporate inferential data or statistics as part of measures for Program improvement, quality assurance, and fraud, waste, and abuse detection.

C.3.2 Monitoring and Initial Health Evaluations

The CCE shall administer an initial health evaluation, which is a baseline examination, for newly enrolled screening-eligible survivors. Where a survivor is certified for a WTC-related health condition and becomes a certified-eligible survivor, the CCE shall also administer annual monitoring examinations. The purpose of the monitoring exams is to: (1) provide a periodic physical and mental health assessment designed to identify acute and latent health effects that are WTC-related; (2) serve as an avenue for clinical data collection, analysis and reporting to ensure that all services provided adhere to the appropriate periodic monitoring and initial health evaluation protocols; and (3) inform the diagnosis of WTC-related health conditions that could lead to a program-covered treatment referral. The CCE contractor shall follow Program’s policy and the Administrative Manual on initial health evaluation, monitoring and certifications.

The baseline initial health evaluation includes a medical history questionnaire (occupational history, clinical history, and review of symptoms), an exposure assessment, vital signs assessment, spirometry testing, blood and urine analyses, a chest radiograph if clinically indicated, and a physical examination. For certified-eligible survivors entitled to receive annual monitoring examinations, examinations include the same components as the initial health evaluation except for the exposure assessment and the chest radiograph. Chest radiography may be conducted when indicated but not more often than every two (2) years, unless the monitoring exam indicates otherwise. If a test result indicates the presence of a WTC-related condition, or is inconclusive, the monitoring physician will refer the member for additional diagnostic testing and/or treatment. The monitoring examinations shall be conducted by qualified providers, preferably specializing in Occupational Medicine.

The method outlined below is an example of how initial health evaluation or monitoring services may be delivered.

Example:

The Medical History Questionnaire (MHQ), which is comprised of standardized assessment instruments for multiple physical and mental health conditions, may be conducted by a Registered Nurse, Licensed Practical Nurse (LPN), physician’s assistant (PA), or physician who has been trained to use the MHQ. The MHQ typically takes 45 minutes to complete. The work-up testing includes spirometry (i.e., pulmonary function test or PFT), chest radiograph (if required), and blood and urine assays.

Next a summary report is prepared for the initial health evaluation or monitoring physician. The summary report contains information from the MHQ and the work-up appointments (results from the laboratory tests, chest radiography and spirometry) plus a summary of past medical records. To complete the initial health evaluation or monitoring examination, the monitoring physician reviews the summary report, conducts a clinical interview and a physical examination, and synthesizes the clinical information for discussion of findings and treatment referrals with the program member. The CCE shall ensure that the initial health evaluation or monitoring physician has a copy of the MHQ summary report in time to review it before conducting the member’s clinical examination. The CCE shall be responsible for scheduling all components of the initial health evaluation or medical monitoring examination.

For certified-eligible survivors, medical monitoring is conducted annually. If the medical monitoring exam reveals an illness that is on the list of WTC-related health conditions and the physician determines that the condition meets the criteria for a WTC-related health condition, the physician shall transmit his determination to the Administrator of the WTC Health Program for certification. The CCE Director will provide clinical and administrative oversight for adherence to monitoring protocols, including the need for additional medical testing to confirm a diagnosis of a newly detected WTC-related health condition and/or a health condition medically associated with a given certified WTC-related health condition. The CCE will assist the member in scheduling appointments to obtain additional diagnostic evaluation as needed. Medical management of qualifying health conditions will be covered in Section 3.3 (Cancer Screening, Diagnostic, and Treatment Services).

C.3.2.1 Medical Monitoring Process

As a part of the medical monitoring evaluation process, the CCE shall accomplish the following tasks:

A. Scheduling the exam for the member with a provider in the CCE B. Summarizing prior medical records (including the initial health evaluation) and ensuring that the medical monitoring exam physician has a copy of the summary report prior to the scheduled physical exam appointment C. Performing the required lab work and a chest radiograph (if indicated) D. Performing the pulmonary function testing (PFTs) E. Ensuring that the medical monitoring physician has a summary of the Medical History Questionnaire interview, a summary of the prior treatment records, if available, and the prior medical monitoring exam records in time for the scheduled physical exam F. Reporting the results of the medical monitoring examination to the member and providing treatment promptly when results of the tests indicate urgency, pursuant to a request to authorize treatment pending certification, where appropriate. The contractor must follow Program policy on time limit on treatment pending certification and diagnostic evaluation.

G. Ensuring that medical monitoring examinations are coded correctly and that claims are submitted promptly, including conducting the Coordination of Benefits (COB) process H. CCEs serving the Survivors cohort must collect primary insurance information for medical services and pharmacy benefits and submit information and claims to the appropriate entity to ensure coordination of benefits of medical and pharmacy claims.

I. Coordinating medical testing or subspecialty evaluation for further diagnosis of suspected WTC-related health conditions with the CCE Director J. Submitting physician determinations of WTC-related health conditions or health conditions medically associated with a given WTC-related health condition to the Administrator of the WTC Health Program for certification K. Following appropriate authorization channels for treatment services (including medications) and coordinating referrals for treatment of certified conditions L. Explaining the monitoring and treatment benefits that are provided under the WTC Health Program, as well as that no treatment benefits are provided under the WTC Health Program for non-covered and/or non-certified conditions M. Providing WTC Health Program Benefits Counseling N. Providing Social Services referrals O. Performing quality assurance checks on the medical monitoring process and the appropriateness and completeness of the medical records P. Reviewing and approving all claims related to monitoring and initial health evaluations and preparing claims for processing and payment, including COB for survivor population, as directed by the Administrator of the WTC Health Program Q. Reviewing and transmitting to the DC, data from the Monitoring and Initial Health Evaluations to be used for research and analysis, as depicted in Figure C.3.2.1-A. For instance, this would include data on the number of exams conducted, people screened, and referred for treatment, and other such data as requested by the Administrator of the WTC Health Program.

R. Community referral for conditions detected that are not eligible for treatment under the WTC Health Program benefit.

S. Documenting the certification(s), prior authorizations for services (including medications), home visits and benefits counseling in a member-specific and auditable record.

T. Coordinating care for conditions that the WTC Health Program covers using an integrated case management plan for members with complex diseases.

Figure C.3.2.1-A Data flow related to initial health evaluations and monitoring examinations

CCE performs the Initial Health Examination for all Screening-Eligible Survivors and annual Monitoring Examinations for Certified-Eligible Survivors thereafter CCE transmits the results of the initial health evaluation and subsequent monitoring examinations to the corresponding Data Center CCE transmits the claims associated with monitoring, diagnostic, treatment, and ancillary services for processing and payment to the Health Program Support (HPS) contractor

HPS contractor sends claims data associated with monitoring, diagnosis, treatment, ancillary services, and medications to the Data Center and the CCE

Data Center receives health and claims data, performs analysis for reporting to the Administrator of the WTC Health Program and prepares the data to be made available for research and quality assurance and program integrity reviews according to their Data Sharing Plan

Health Data Claims

In addition, the CCE shall develop and implement procedures to handle emergency situations or manage crises that may arise during monitoring, treatment, case management, or other member interaction. The CCE shall educate and train their staff and network providers in the proper completion of paperwork, the limitations of coverage, protocol changes, and benefits counseling and shall disseminate scientific information regarding WTC exposures and related health outcomes.

When an initial health evaluation or medical monitoring exam has been completed by a provider in the CCE, the CCE shall ensure that all completed medical monitoring records are maintained by the CCE. The CCE shall be responsible for providing a letter to the member informing them of the results of the exam and tests within fifteen (15) days of completion of the exam.

Following an initial health evaluation or medical monitoring exam and based on direction from the Administrator of the WTC Health Program, the CCE shall submit a CMS1500 Form (or similar form) for reimbursement. These data shall be submitted electronically and shall, at a minimum, contain all of the data required by the CMS1500 Form. The CCEs shall have adequate financial systems for the timely submission of claims.

C.3.2.2 Medical Monitoring Protocols or Procedures

The CCE shall develop protocols or procedures for the following medical monitoring exam-related issues, working in conjunction with their respective DC and incorporate existing requirements of the Program. These protocols or procedures shall be submitted to the Administrator of the WTC Health Program for approval as a part of the CCE Operations Manual:

A. Obtaining relevant medical records for individuals previously served by a CCE;

B. Monitoring examination protocols including quality assurance components which are built upon knowledge of accepted practice guidelines;

C. Scheduling medical monitoring exams;

D. Monitoring examination delivery of service methodology;

E. Ensuring that the proper data are sent to the DC from a medical monitoring exam conducted by the CCE;

F. Ensuring that a notification (such as a letter) is sent to the member informing them of the results of the exam and tests within fifteen (15) days of the completion of the monitoring exam, initial health evaluation, or date of service;

G. Processing and submitting clean claims for all medical monitoring exam-related services;

H. Collecting and maintaining all records required for project management and reporting.

C.3.3 Cancer Screening, Diagnostic, and Treatment Services

The CCE contractor shall develop and implement procedures to provide cancer screening evaluations for lung, colorectal, breast, and cervical cancers as directed by the WTC Health Program Administrative Manual. The WTC Health Program Administrative Manual indicates which members are eligible for cancer screening. Testing included as part of the cancer screenings within Program benefits can be obtained from the Program’s codebook and treatment plans. This information must be incorporated into the CCE Operations Manual, as well as information regarding CCE procedures for member outreach to notify members of screening eligibility, documentation of service offerings, services delivered and notification of results, and treatment referral when needed.

As required by the Zadroga Act and the Program’s regulations at 42 C.F.R. pt. 88, the Administrator of the WTC Health Program shall reimburse costs for medical treatment for WTC-related health conditions at rates no higher than the Federal Employees Compensation Act (FECA) pricing for an outpatient facility and no higher than FECA or Diagnostic Related Group (DRG) pricing for an inpatient facility (DRG pricing is used by CMS to establish Medicare fee-for-service rates), or other rates established pursuant to the Act and regulation. Information on the Division of Federal Employees' Compensation of the OWCP can be found at: https://www.dol.gov/owcp/dfec/.

Diagnostic and treatment services for members shall be provided through the CCE internal WTC Health Program providers (when available) or the external network of WTC Health Program credentialed providers

As per the Zadroga Act, all treatment services must comply with an established standard for medical necessity and Program clinical guidelines.