CCE_PWS_11_17_16_1.pdf

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World Trade Center Health Program, Clinical Center of Excellence

Performance Work Statement

C.1 Background

On January 2, 2011, the President signed Public Law No. 111-347, the James Zadroga 9/11 Health and Compensation Act (“Zadroga Act”), providing a longer-term solution to care for the World Trade Center (WTC) responders and survivors. Title I of the Zadroga Act amended the Public Health Service Act to add Title XXXIII, which authorized the WTC Health Program as a federal health care program, within the Department of Health and Human Services, for eligible responders and survivors of the terrorist attacks of 9/11. See “James Zadroga 9/11 Health and Compensation Act of 2010,” Public Law 111-347, as amended by Public Law 114-113 (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 encompasses myriad responsibilities associated with the administration and performance needed to enroll, initially evaluate, medically monitor, and manage covered health conditions for eligible individuals through diagnostic and treatment services. 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, yet requiring the flexibility to engage with advocates and stakeholders. To align with legal requirements, the WTC Health Program promulgated regulations guiding program implementation and created member-based health benefit plans restricted to the conditions certified by the WTC Health Program Administrator for coverage. In addition, a new business processing component was developed to adjudicate and pay medical and pharmacy claims from enrolled providers for allowable services authorized by Clinical Centers of Excellence (CCEs) to manage the care of a restricted set of health conditions for eligible program members. Required administrative processes included procedures for appeals related to denials of program enrollment, health condition certification, or treatment bills. The WTC Health Program had to be operational within 6 months of the passage of the authorizing legislation - by July 1, 2011.

In Spring 2011, the CDC entered into contracts with seven Clinical Centers of Excellence (as defined in subsection (b)(1)(A)) for the following tasks:

‘‘SEC. 3305. CLINICAL CENTERS OF EXCELLENCE AND DATA CENTERS.

‘‘(a) IN GENERAL.—

‘‘(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 3304.1

As of March 31, 2016, the WTC Health Program has 74,968 members enrolled, including 16,896 FDNY responders, 49,302 general responders and 9,770 survivors. Of those members, 8,414 responders, 203 FDNY and 890 survivors

1 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.

2 | P a g e are served by the Nationwide Provider Network. The Program delivered monitoring or screening exams to an estimated 30,332 members, diagnostic services to approximately 18,850 members, and treatment services to approximately 23,283 sick or injured members between 4/1/15 and 3/31/16. Current WTC Health Program statistics and reports can be found at http://www.cdc.gov/wtc/reports_portal.html.

C.1.1 Clinical Centers of Excellence and the Nationwide Provider Network

There are currently seven Clinical Centers of Excellence (CCEs) and one Nationwide Provider Network (NPN) that provide medical monitoring examinations, diagnosis, and treatment services for the WTC-related health conditions.

One CCE serves the members affiliated with the Fire Department of the City of New York (FDNY) WTC Responders, five CCEs serve a General WTC Responder consortium, one CCE serves WTC Survivors, and the NPN serves enrolled members located elsewhere in the U.S. Treatment services include physician visits, test procedures, medical devices, pharmacy benefits, case management, care coordination, health education, and social benefits counseling. The CCEs and NPN work as a clinical consortium with cohort-specific standardized medical monitoring protocols, shared diagnostic and treatment guidelines and multiple opportunities for communication with WTC Health Program Staff and each other to calibrate medical and member benefits across practice sites. The CCEs and NPN are actively engaged with labor representatives and stakeholder members of the New York City community to discuss program policies and ensure awareness of emerging issues.

C.1.2 Member Classifications

The CCE contractor must indicate member cohort classification(s) to be served, either FDNY Responders, Non- FDNY Responders, and/or Survivors.

The Pentagon/Shanksville, PA Responders are being served by the NPN contractor.

Below are descriptions for the four (4) classifications of the WTC Health Program members being served by the CCEs and the NPN.

(1) Enrolled WTC Responders affiliated with the Fire Department of the City of New York

Approximate size: 16,520. An individual (active or retired) who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites (including Ground Zero, Staten Island Landfill, and the New York City Chief Medical Examiner’s Office), or; a surviving immediate family member of a member of the Fire Department of New York City (whether fire or emergency personnel, active or retired) who was killed at the World Trade Center site on September 11, 2001, if the family member received any treatment for a WTC-related mental health condition on or before September 1, 2008;

(2) Enrolled WTC Responders who were not affiliated with FDNY (Non-FDNY Responders)

Approximate size: 39,869. An individual who worked or volunteered onsite in rescue, recovery, demolition, debris cleanup, or related support services in lower Manhattan (south of Canal St.), the Staten Island Landfill, or the barge-loading piers; a member of the Police Department of New York City (active or retired) or a member of the Port Authority Police of the Port Authority of New York and New Jersey (active or retired) who participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.), including Ground Zero, the Staten Island Landfill, or the barge loading piers; an employee of the Office of the Chief Medical Examiner of New York City involved in the examination and handling of human remains from the World Trade Center attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff; a worker in the Port Authority Trans-Hudson Corporation Tunnel; or a vehicle-maintenance worker who was exposed to debris from the former World Trade Center while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks;

(3) Enrolled WTC Survivors Approximate size: 9,770. Individuals present in the New York City disaster area in the dust or dust cloud on September 11, 2001; an individual who lived, worked, went to school, childcare, or adult daycare in lower Manhattan south of Houston Street and certain parts of Brooklyn; certain cleanup and maintenance workers in

3 | P a g e 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; and

(4) Pentagon/Shanksville, PA Responders

Approximate size: 297. Fire or police department employees (fire or emergency personnel, active or retired);

recovery or cleanup contractor workers; or volunteers, who performed rescue, recovery, demolition, debris cleanup, or other related services after the terrorist-related aircraft crashes on September 11, 2001, at the Pentagon in Arlington VA, or in Shanksville, PA.

In this Performance Work Statement (PWS), “members” indicates responders or survivors who are assigned to a specific CCE. Also note, that where Section or Subsection Numbers are specified, those sections refer to the appropriate Section or Subsection Numbers of the Zadroga Act. The following table shows the CCE and its corresponding Data Center.

Table 1 Current Data Centers and Corresponding Clinical Centers of Excellence

CCE/NPN Members Served Corresponding Data Center

Fire Department of the City of New York (FDNY;

headquartered in Brooklyn with satellite centers at Brentwood, Fort Totten, Orange County, and Staten Island)

FDNY Responders FDNY

1. Icahn School of Medicine at Mount Sinai

2. Northwell Health System (LIJ)

3. New York University, Bellevue Hospital Center

(NYU)

4. State University of New York, Stony Brook

(SUNY)

5. Environmental and Occupational Health Sciences

Institute at Rutgers University (EOHSI)

All other Responders Icahn School of Medicine at Mount Sinai (MSSM)

New York City Health + Hospitals (Bellevue Hospital Center, Gouverneur Healthcare Services, and Elmhurst Hospital Center)

Survivors NYC HH

Logistics Health Incorporated (LHI) NPN serves survivors and responders including the Pentagon/Shanksville, PA Responders

WTC Health Program

C.1.3 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).

Within the New York Metropolitan Area, the WTC Health Program will identify CCE contractors to maximize coverage to the member populations while minimizing overlap for administrative efficiency. Offerors shall identify the population and the geographic area to be covered in their proposal.

C.2 Objective

The objective of this requirement is to enter into a contract with multiple CCEs to provide services to the responders and survivors of the 9/11 attacks in a manner that is consistent with the requirements of the Zadroga Act. These requirements are provided in section C.3 Scope of Work of the PWS.

The Zadroga Act defines a CCE as “a Center that demonstrates to the satisfaction of the Administrator that the Center—(i) uses an integrated, centralized health care provider approach to create a comprehensive suite of health services under this title that are accessible to enrolled WTC responders, screening-eligible WTC survivors, or

4 | P a g e 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);2 (iii) employs health care provider staff with expertise that includes, at a minimum, occupational medicine, environmental medicine, trauma-related psychiatry and psychology, and social benefits counseling; and (iv) meets such other requirements as specified by the Administrator.” Section 3305(b)(1)(A).3

The figure below shows a diagram of the components of the WTC Health Program that are relevant to this requirement. In addition, the Centers for Medicare & Medicaid Services (CMS) will receive claims validated by the WTC Health Program and process them through the U.S. Treasury to pay providers for services rendered.

Figure C.2.1 Components of the WTC Health Program

C.3 Scope of Work

The Scope of Work for a Clinical Center of Excellence (CCE) is defined by the following requirements as specified in the Zadroga Act:

(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 (i.e., 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 online Policy and Procedure Manual4.

(3) Providing services to facilitate active participation to support retention of enrolled members.

2 Section 3313 of the Zadroga Act addresses the national arrangement for benefits for eligible individuals outside New York, and subsection (c) relates to provision of training and technical assistance to healthcare providers participating in the network under subsection (a).

3 The James Zadroga 9/11 Health and Compensation Act of 2010, as amended, can be found at:

http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title42-chapter6A-subchapter31&edition=prelim 4 The Program’s Policy and Procedure Manual (PPM) is subject to change and currently is maintained via the Program website for ease of access.

The interested parties shall always consult with the PPM and WTC Health Program to obtain the latest information.

WTC Health Program

Program Members

(and Stakeholders)

Clinical Centers of

Excellence

Cohort-specific

Data Centers

Nationwide

Provider Network

Support Service Contracts

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(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, documenting and ensuring that professionally recognized national and community practice standards are met for the quality of medical care provided.

(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 PPM (see footnote 4). 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 bills submitted by network providers to ensure alignment with Program requirements for medical necessity and prior authorization.

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

(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 conditions 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 and reporting to the corresponding Data Center (DC) data in accordance with Section 3304(b) of the Zadroga Act.5

(15) Having in place safeguards against fraud, waste, and abuse that are satisfactory to the WTC Health Program Administrator, in consultation with the Inspector General of the Department of Health and Human Services.

(16) Treating or referring for treatment all individuals who are enrolled WTC responders or certified-eligible WTC survivors at 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 WTC Health Program Administrator.

(17) Having in place safeguards, consistent with Section 3304(d) of the Zadroga Act, to ensure the confidentiality of an individual’s individually identifiable health information, including requiring that such information not be disclosed to the individual’s employer without the authorization of the individual.

5 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.

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(18) Using amounts paid under Section 3305(c)(1) of the Zadroga Act only for costs incurred in carrying out the activities described in Section 3305(a), other than for the provision of monitoring and treatment benefits and initial health evaluation benefits under Subtitle B.

(19) Using health care 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 and guidance and approval by the WTC Health Program Administrator.

(20) Conducting retention and outreach activities that align with the Program’s strategic plan for retention and outreach, and are coordinated with the corresponding DC and the Program’s designated staff liaison.6

(21) Meeting all other applicable requirements of Title I of the Zadroga Act including regulations, policies and procedures (PPM)7 designed to implement the WTC Health Program.

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

The CCE shall ensure that the CCE’s Operations Manual is aligned with the WTC Health Program PPM.

While there are no research activities conducted by a CCE under this contract, data collected will be used for analysis to improve clinical care, process and operational efficiency. The data from the monitoring and initial health evaluations and cancer screening will be transmitted to the corresponding Data Center to be used for program evaluation and research. In addition, the data from monitoring and initial health evaluations and cancer screening 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 handled by 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 -- 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 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. The CCE contractor’s PMP shall include the proposed Staffing Plan with title, qualification, percentage of employment, numbers and duties of personnel who will be responsible for implementing the CCE Contract, including an identification of key personnel and management team with the percentage of their time to be devoted to the CCE Contract.

A draft CCE PMP shall be submitted with the offeror’s proposal. A finalized CCE PMP shall be submitted to the WTC Health Program for approval within thirty (30) days of the contract award. Once approved, any changes to the PMP shall be updated as part of the monthly report and an updated PMP shall be submitted annually at the end of each contract year for the duration of the contract.

6 WTCHP Member Services Outreach and Education Plan

7 The Program’s Policy and Procedure Manual (PPM) is subject to change and currently is maintained via the Program website for ease of access. The interested parties shall always consult with the PPM and WTC Health Program to obtain the latest information.

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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 Policy and Procedures Manual(s) for the WTC Health Program. The WTC Health Program Policy and Procedure Manual and Notices can be found at http://www.cdc.gov/wtc/ppm_portal.html.

A draft CCE Contract Operations Manual shall be submitted with the Offeror’s proposal. A finalized CCE Contract Operations Manual shall be submitted to the WTC Health Program for approval within sixty (60) days of contract award. Once approved, an updated CCE Contract Operations Manual shall be submitted, with changes indicated, to the WTC Health Program monthly for the entire duration of the contract.

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 will identify all communication activities among the CCE contractor, the WTC Health Program (including participation in the weekly Medical Forum call attended by the Medical Directors, Administrators and WTC Health Program), the CCEs, the DCs, the Health Program Support (HPS) contractor, other contractors to the WTC Health Program, the WTC Health Program Steering Committees, and WTC Health Program members. A program management conference call will be held between the WTC Health Program and the CCE contractor to discuss requirements implementation and CCE operations relevant issues on a schedule to be agreed to by both the CCE and the COR.

In addition, the CCE shall respond to any written request from the WTC Health Program within a specified timeframe. A request is a written communication that specifies what is needed, why it is needed, and when it is needed, which may include the Change Request (CR). Requests may be preceded by oral communications. The CCE must acknowledge receipt of the request in writing and add the request to a tracking form and provide status update in the monthly report and/or the program management meeting; but not doing so still requires the contractor to respond by the deadline. If there are questions about the request that result in modifying the request or extending the deadline, 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 materials are delivered.

A draft CCE Contract Communications Plan shall be submitted to the WTC Health Program for review within sixty (60) days after contract award. The offeror will have two (2) weeks to submit a finalized plan upon receipt of comments from the WTC Health Program. Once approved, an updated Contract Communications Plan shall be submitted to the WTC Health Program, with changes indicated, monthly for the entire duration of the contract.

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 standard FISMA, 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 Office of the Chief Information Officer (OCIO). A draft of the CCE Contract Data Security and Continuity of Operations Plan shall be submitted to the WTC Health Program for review within sixty (60) days of contract award.

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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 offeror 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 offeror 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. (Further details can be found in Attachment J-2, Information Technology Security and Privacy).

The offeror will have two (2) weeks to submit a finalized plan upon receipt of comments from the WTC Health Program. Once approved, an updated CCE Contract Data Security and Continuity of Operations Plan shall be submitted to the WTC Health Program, with changes indicated, monthly for the entire duration of the contract.

(For further details, see Section C.3.8.3 for HIPAA and C.14 for FISMA compliance).

C.3.1.5 Risk Management Plan

The CCE contractor shall prepare a Risk Management Plan in accordance with SEI (Software Engineering Institute) Risk Management Methods (or equivalent) 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.

A draft CCE Contract Risk Management Plan shall be submitted to the WTC Health Program for review within sixty (60) days of contract award. The offeror will have two (2) weeks to submit a finalized plan upon receipt of comments from the WTC Health Program. Once approved, an updated CCE Contract Risk Management Plan shall be submitted to the WTC Health Program, with changes indicated, monthly for the entire duration of the contract.

C.3.1.6 Fraud, Waste, and Abuse Compliance Plan

The CCE contractor shall prepare 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.

A draft CCE FWA Compliance Plan shall be submitted to the WTC Health Program for review within sixty (60) days of contract award. The offeror will have two (2) weeks to submit a finalized plan upon receipt of comments from the WTC Health Program. Once approved, an updated FWA Compliance Plan shall be submitted to the WTC Health Program, with changes indicated, monthly and open FWA issues shall be reported monthly for the entire duration of the contract.

C.3.1.7 Quality Assurance and Internal Audit Plan

The CCE contractor shall prepare a Quality Assurance and Internal Audit Plan. A draft CCE Contract Quality Assurance and Internal Audit Plan shall be submitted with the Offeror’s proposal. A finalized CCE Contract Quality Assurance and Internal Audit Plan shall be submitted to the WTC Health Program for approval within 60 days of the contract award. Once approved, an updated CCE Contract Quality Assurance and Internal Audit Plan shall be submitted to the WTC Health Program annually for the entire duration of the contract. If changes are made to the Quality Assurance and Internal Audit Plan, the changes shall be sent to the WTC Health Program within 30 days of the change. Updates to be provided monthly.

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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 monthly invoices which reflect adherence to budget/funding requirements. The invoice shall include a balance sheet.

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 $10,000.00.

C.3.1.9 Subcontracting

The CCE contractor shall provide management and oversight of all subcontractors8 as described in FAR Parts 42 and

44. This would include post-award conferences with subcontractors that involve the Contracting Officer and Contracting Officer’s Representative.

The CCE contractor shall provide a draft subcontracting plan with their proposal to include all subcontracts the offeror intends to make prior to award. Post award, the offeror will have two (2) weeks to submit a finalized plan upon receipt of comments from the WTC Health Program. The plan shall require prior approval if any changes are made throughout contract 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 FISMA, 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 the following information:

(1) A description of the supplies or services to be subcontracted

(2) Identification of the type of subcontract to be used.

(3) Identification and selection of the proposed subcontractor.

(4) A description of an oversight and quality assurance plan.

C.3.1.10 Change Control Process

The CCE contractor shall manage the contract to ensure the required services are being performed and the required contract deliverables are being 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 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 need to be defined clearly, including their cost and schedule implications, to allow the WTC Health Program to make appropriate decisions. The CCE

8 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.”

10 | P a g e contractor shall receive prior authorization and approval of expenditures by the WTC Health Program before starting any work on changes. The CRs’ status tracking must be reported in the monthly reports and any relevant issues or concerns must be discussed during the program management conference call with the COR.

C.3.1.11 Technical Experts Support

The CCE contractor shall identify and provide an efficient multi- and inter-disciplinary 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, medical (physical and mental) and nursing professionals, licensed case managers and social workers, , health service administration manager and other needed staff to support program management and operations (i.e., quality assurance, provider network, analytics, 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 Improvement

The CCE contractor shall work with the WTC Health Program to facilitate and develop ongoing program improvements that address the CCE needs of the WTC Health Program, members, the CCEs, the DCs, the HPS contractor, and other stakeholders. The CCE contractor must address all required mandates of the Zadroga Act and incorporate new innovations, and new means of providing superior care and service delivery to program participants and stakeholders. The CCE contractor shall also be mindful of the WTC Health Program’s need to be responsive to Congress and other governmental organizations and provide the means for ensuring the kind of program transparency that will demonstrate the CCE contractor is meeting program needs while containing costs 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 cost-saving initiatives, and provide evidence-based recommendations to the WTC Health Program pharmacy team 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.

A draft CCE Program Improvement Plan shall be submitted to the WTC Health Program for review within sixty

(60) days of contract award. The offeror will have two (2) weeks to submit a finalized plan upon receipt of comments from the WTC Health Program. Once approved, an updated CCE Program Improvement Plan shall be submitted to the WTC Health Program, with changes indicated, monthly for the entire duration of the contract.

C.3.1.13 Reporting (Part of administrative function)

The CCE contractor shall provide communications and reports to the WTC Health Program on the ongoing CCE Contract implementation status as well as status reports documenting program progress and risks related to program management and administration, including critical-success-factors and key-performance-indicators. In addition to the monthly updates of the Project Management Plan, the CCE contractor shall submit accurate and detailed monthly, quarterly, bi-annual and annual reports as required by this PWS.

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C.3.2 Monitoring and Initial Health Evaluations

The CCE shall provide a baseline for new enrollees and follow-up examinations to all members. 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.

A baseline (initial) exam 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. Annual follow-up monitoring examinations include the same components with the exception of the exposure assessment and the chest radiograph. Chest radiography may be conducted when indicated but not more often than every two 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 a qualified physician, preferably one specializing in Occupational Medicine.

The method outlined below is an example of how 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 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 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 participant. The CCE shall ensure that the 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 medical monitoring process.

For responders, periodic 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 WTC Health Program Administrator 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).

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

• Scheduling the exam for the member with a provider in the CCE

• Summarizing prior medical records and ensuring that the medical monitoring exam physician has a copy of the summary report prior to the scheduled physical exam appointment

• Conducting the Medical History Questionnaire interview

• Performing the required lab work and a chest radiograph (if indicated)

• Performing the pulmonary function testing (PFTs)

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• 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

• Reporting the results of the medical monitoring examination to the member

• Ensuring that medical monitoring examinations are coded correctly and that claims are submitted promptly, including Coordination of Benefits (COB) process, if appropriate

• Collect primary insurance information for pharmacy benefits and submit that information to the appropriate entity to ensure coordination of benefits of pharmacy claims when appropriate.

• Coordinating medical testing or subspecialty evaluation for further diagnosis of suspected WTC-related health conditions with the CCE Director

• Submitting physician determinations of WTC-related health conditions or health conditions medically associated with a given WTC-related health condition to the WTC Health Program Administrator for certification

• Following appropriate authorization channels for treatment services (including medications) and coordinating referrals for treatment of qualifying conditions

• 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-qualifying conditions

• Providing WTC Health Program Benefits Counseling

• Providing Social Services referrals

• Performing quality assurance checks on the medical monitoring process and the appropriateness and completeness of the medical records

• Reviewing and approving all claims related to monitoring and initial health evaluations and preparing claims for processing and payment, including COB for survivor population when applicable, as directed by the WTC Health Program Administrator

• 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. 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 WTC Health Program Administrator.

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

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

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

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Monitoring Data Flow

Figure C.3.2.1 Data flow related to monitoring examinations.

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 a 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 exam results within 15 business days of the completion of the exam.

Following a medical monitoring exam and based on direction from the WTC Health Program Administrator, 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.

CCE performs the Initial Examination and periodic Monitoring Examinations thereafter

CCE transmits the results of the initial and subsequent monitoring examinations to the corresponding

Data Center

CCE transmits to the HPS contractor the claims associated with monitoring, diagnostic, treatment, and ancillary services for processing and payment

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 WTC Health Program

Administrator 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

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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 WTC Health Program Administrator for approval as a part of the CCE Operations Manual;

• Obtaining relevant medical records for individuals previously served by a CCE

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

• Scheduling medical monitoring exams

• Monitoring examination delivery of service methodology

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

• Ensuring that a letter is sent to the member informing them of the exam results within two weeks of the completion of the monitoring exam

• Processing and submitting claims for all medical monitoring exam-related services

• 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, colon, breast, and cervical cancers following the U.S. Preventive Services Task Force recommendations. The WTC Health Program PPM 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 WTC Health Program Administrator shall reimburse costs for medical treatment for WTC-related health conditions at rates no higher than the…