75D301-22-R-72142 Revision 06-28-2022.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-22-R-72142

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

6/28/2022

6. REQUISITION/PURCHASE NO.

0000HCCP-2022-62044

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and handcarried, in the depository located in CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Eric C Lyons

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

C. E-MAIL ADDRESS

kpy2@cdc.gov

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs

Base Period (09/29/2022 – 09/28/2023) Items:

All work performed within accordance of the Performance Work Statement.

1 Years

Option Period 1 (09/29/2023 – 09/28/2024) Items:

1 Years

Option Period 2 (09/29/2024 – 09/28/2025) Items:

1 Years

Option Period 3 (09/29/2025 – 09/28/2026) Items:

1 Years

Option Period 4 (09/29/2026 – 09/28/2027) Items:

1 Years

Option Period 5 (09/29/2027 – 09/28/2028) Items:

1 Years

Option Period 6 (09/29/2028 – 09/28/2029) Items:

1 Years

Option Period 7 (09/29/2029 – 09/28/2030) Items:

1 Years

*If transition is necessary.

B.1 Travel

If proposing any travel costs please include an additional line item for each period of performance with the travel costs.

B.2 Lifestyle Medicine (Optional to Propose)

If proposing to provide services for lifestyle medicine, please include an additional line item for each period of performance with a firm fixed price, per member per month price. It is estimated that 5% of members would participate in Lifestyle Medicine.

Section C - Description/Specification/Work Statement

SECTION 1.0 – BACKGROUND

The James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act) was signed into law on January 2, 2011; the Act was subsequently reauthorized through 2090. Pub. L. 111-347, as amended by Pub. L. 114-113 and Pub. L. 116-59; codified at 42 U.S.C. §§ 300mm – 300mm-61. The Zadroga Act established the World Trade Center (WTC) Health Program within the Department of Health and Human Services’ Centers for Disease Control and Prevention (CDC) to provide medical monitoring, screening, and treatment for responders and survivors of the September 11, 2001, terrorist attacks. In this Performance Work Statement (PWS) where “Section” or “Subsection” numbers are specified, those sections refer to the appropriate Section or Subsection Numbers of the Zadroga Act.

The WTC Health Program (“Program”) is a limited benefit health program, meaning that treatment is covered for only specified health condition(s) resulting from exposure to airborne toxins, hazards, or other adverse conditions arising from the September 11, 2001, terrorist attacks. An internal provider enrolled with the WTC Health Program must diagnose a member with a covered health condition and determine that it is related to the member’s 9/11 exposure and the determination must then be certified by the Program for the member to receive treatment. An enrolled member must meet certain exposure, latency, and symptom-onset requirements for their health condition to be certified. Program eligibility and certification decisions are made by the WTC Health Program enrollment and certification specialists, respectively. A range of conditions are covered including mental health, aerodigestive disorders, and cancer; see 42 C.F.R. § 88.15 for the complete List of WTC-Related Health Conditions (List).

The Clinical Centers of Excellence (CCEs) and Nationwide Provider Network (NPN) provide treatment and medical monitoring for over 125,000 Program members, while the WTC Health Program administers Program policy, makes eligibility and certification decisions, and covers the costs associated with treatment and monitoring. The Zadroga Act encompasses myriad Program administration and performance responsibilities including those pertaining to enrollment, initial evaluation, medical monitoring, and care management of covered health conditions for eligible individuals through diagnostic and treatment services.

In Spring 2011, the CDC entered contracts with Clinical Centers of Excellence the following tasks, as excerpted from the Zadroga Act (42 USC §300mm-4):

(A) for the provision of monitoring and treatment benefits and initial health evaluation benefits under part 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 part 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

There are currently seven (7) CCEs and one Short-term Survivor Clinic (SSC) in the New York Metropolitan Area that administer benefits to members. One CCE serves WTC Responders affiliated with the Fire Department of the City of New York (FDNY), five CCEs serve General WTC Responders, and one CCE and the SSC serve WTC Survivors. As of September 2021, there were a total of 82,331 responders and 31,972 survivors enrolled in the Program; of these members, 24,855 live outside of the New York City Metropolitan Area and are served by the Nationwide Provider Network (NPN). The CCEs/NPN medical monitoring examinations, diagnosis, and treatment services for the WTC-related health conditions. 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.

The WTC Health Program is a federally funded, limited health benefit program and, therefore, must comply with all federal regulations and requirements, including the 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).

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

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

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

WTC Responder - affiliated with the Fire Department of the City of New York (FDNY) (“FDNY Responder”)

An individual (active or retired) who participated at least one day in the rescue and recovery effort at any of the former World Trade Center sites (including Ground Zero, Staten Island Landfill, and the New York City Chief Medical Examiner’s Office). As of October 31, 2021, there are 17,041 FDNY Responder members.

WTC Responder - FDNY Family Member (“FDNY Family”)

A surviving immediate family member of a member of an FDNY member (whether fire or emergency personnel, active or retired) who was killed at the World Trade Center site on September 11, 2001 and received any treatment for a WTC-related mental health condition on or before September 1, 2008. As of November 17, 2021 there are 49 FDNY Family members.

WTC Responder - not affiliated with FDNY (Non-FDNY Responder) (“General Responder”)

An individual who worked or volunteered onsite in rescue, recovery, demolition, debris cleanup, or related support services in lower Manhattan (south of Canal St.), the Staten Island Landfill, or the barge-loading piers; a member of the Police Department of New York City (active or retired) or a member of the Port Authority Police of the Port Authority of New York and New Jersey (active or retired) who participated onsite in rescue, recovery, debris cleanup, or related services in lower Manhattan (south of Canal St.), including Ground Zero, the Staten Island Landfill, or the barge loading piers; an employee of the Office of the Chief Medical Examiner of New York City involved in the examination and handling of human remains from the World Trade Center attacks, or other morgue worker who performed similar post-September 11 functions for such Office staff; a worker in the Port Authority Trans-Hudson Corporation Tunnel; or a vehicle-maintenance worker who was exposed to debris from the former World Trade Center while retrieving, driving, cleaning, repairing, and maintaining vehicles contaminated by airborne toxins from the September 11, 2001, terrorist attacks. See 42 CFR 88.1, 88.3, 88.4. As of October 31, 2021, there are 65,533 General Responder members.

Pentagon and Shanksville, PA Responders

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. See 42 CFR 88.1. As of October 31, 2021, there are 1,019 Pentagon Responder and 98 Shanksville Responder members.

WTC Survivor

An individual present in the New York City Disaster Area in the dust or dust cloud on September 11, 2001; an individual who lived, worked, went to school, childcare, or adult daycare in lower Manhattan south of Houston Street and certain parts of Brooklyn; certain cleanup and maintenance workers in the New York City Disaster Area; and certain residents and individuals whose place of employment were deemed eligible to receive certain grants from the Lower Manhattan Development Corporation. See 42 CFR 88.1. As of October 31, 2021, there are 32,379 Survivor members.

Upon enrollment, survivors are “screening-eligible” for an initial health evaluation. Any such individuals who are then certified for a covered health condition are “certified-eligible” for medical monitoring and treatment pursuant to § 88.12(b) of the Regulations (https://www.cdc.gov/wtc/regulations2.html). In contrast to responders, survivors are required to carry other health insurance (OHI) – through which coordination of benefits (COB) is required.

SECTION 1.2 – Definitions

Abuse: Practices that may directly or indirectly result in unnecessary costs to the Program; includes any practice that does not provide patients with medically necessary services or meet professionally recognized standards of care. Examples include:

· Billing for services that were not medically necessary;

· Charging excessively for services or supplies;

· Coding and billing for one hour when the visit was only 15 minutes.

Adjunct Condition: Conditions that may be treated under the Program without certification because they are deemed medically necessary to effectively treat a certified WTC-Related Health Condition or certified Health Condition Medically Associated with a WTC-Related Health Condition.

Business Days: All days excluding Saturdays, Sundays, and designated federal holidays.

Calendar Days: All days including Saturdays, Sundays, and designated federal holidays.

Certification: A Program review of a health condition in a particular member for the purpose of identification and approval of a WTC-related health condition included on the List of WTC-Related Health Conditions in 42 CFR § 88.15, or a health condition medically associated with a WTC-related health condition. For a health condition to be certified as WTC-related by the Program, a provider must determine that the member’s 9/11 exposures are substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition such that the health condition is eligible for treatment by the Program. The WTC Health Program reviews and makes decisions to approve or deny requests for certification.

Program members receive coverage only for services deemed medically necessary to treat certified conditions. Certifications become part of the Member’s record to authorize treatment from the effective date. See 42 CFR 88.1, 88.18.

Clinical Center of Excellence (CCE): A New York metropolitan area (NYMA)-based medical facility that, in accordance with the Zadroga Act and program regulations, operates under an individual contractual relationship with the WTC Health Program to provide medical monitoring, diagnosis, and treatment services for members in the NYMA. Members in the NYMA have the option to choose their CCE; if they do not choose a CCE in a set amount of time, they are automatically assigned to the CCE closest to them. Their CCE is responsible for coordinating their care under the WTC Health Program. There are currently eight CCEs contracted with the Program, two for the survivor population and six for the responder population. See 42 CFR 88.1.

CCE-affiliated Network Providers (Internal Provider): Internal providers within the CCE located in the NYMA under the umbrella of a CCE, who have established a relationship within the CCE. These providers use internal CCE systems and staff for administrative support such as claims processing and provide care to WTC Health Program Members under the direct oversight of the CCE Medical Director.

Coordination of Benefits (COB): Where a WTC Health Program Survivor member has a WTC-related health condition or health condition medically associated with a WTC-related health condition, the WTC Health Program Survivor member’s public or private health insurance plan is the primary payer. The WTC Health Program will seek to coordinate benefits among all appropriate entities in the same manner and to the same extent as required by Section 1862(b) of the Social Security Act (Medicare as Secondary Payer) 42 U.S.C. § 300mm-41(c)(1) and 42 U.S.C. § 1395y(b)(2) for medical treatment claims (exclusions: initial health evaluations, monitoring, screening, and diagnostics). The WTC Health Program will pay costs not reimbursed by the public or private health insurance plan due to the application of deductibles, co-payments, co-insurance, other cost sharing arrangements, or payment caps up to and in accordance with the rates described in WTC Health Program Regulations § 88.22(b).

Minimum Essential Coverage: All members with certified WTC-related health condition(s) or (a) health condition(s) medically associated with a WTC-related health condition which are not work-related are required to have minimum essential health insurance coverage at the time the claimed treatment services were rendered or must be identified as exempt from having minimal essential coverage.

Work-Related: 42 U.S.C. § 300mm-41(e) states: “…a WTC-related health condition shall be treated as a condition that is work-related if – (1) the condition is diagnosed in an enrolled WTC responder, or in an individual who qualifies as a certified-eligible WTC survivor on the basis of being a rescue, recovery, or cleanup worker; or (2) with respect to a condition that individual has filed and had established a claim under a workers’ compensation law or plan of the United States or a State, or other work-related injury or illness benefit plan of the employer of such individual.”

External Providers: The external provider network comprises healthcare providers (both individuals and groups) of all specialties throughout the NYMA that do not operate within the CCE. These providers have agreed to the Programs Terms and Conditions to provide medical services for members.

Fraud: An intentional deception or misrepresentation made by a person with the knowledge that the deception could result in some unauthorized benefit to him or some other person. It includes any act that constitutes fraud under applicable Federal or State law. Examples include:

· Providing false statements on an enrollment application to obtain coverage or concealing information about past medical history/preexisting conditions.

· Failing to report other insurance or to disclose claims that were a result of an injury unrelated to 9/11 exposure.

· Billing for services that were not rendered including upcoding and unbundling or providing services that are not medically necessary.

Health Conditions Medically Associated with a WTC-Related Health Condition (MAC): A condition that results from the treatment or progression of a WTC-related health condition. “Results from” means that the relationship linking the medically associated health condition with the WTC-related health condition occurs without the influence of an intermediary health condition or event, and that the linkage has been well-established by published, peer-reviewed scientific literature. Once certified, health conditions medically associated with a WTC-Related Health Condition are eligible for treatment covered by the Program.

Initial Health Evaluation (IHE): The assessment of one or more symptoms that may be associated with a WTC-related health condition and includes a medical and exposure history, a physical examination, and additional medical testing as needed to evaluate whether the individual has a WTC-related health condition or health condition medically associated to a certified WTC-related health condition and is eligible for treatment under the WTC Health Program. See 42 CFR 88.1.

Medical Coverage Determination (MCD): The Medical Coverage Determination is an administrative tool which provides coverage information for specific services, along with qualifying criteria for coverage, and instructions for authorization.

Medically Necessary Treatment: The provision of services to a WTC Health Program member by physicians and other health care providers, including diagnostic and laboratory tests, prescription drugs, inpatient and outpatient hospital services, and other care that is appropriate, to manage, ameliorate, or cure a WTC-related health condition or a health condition medically associated with a WTC-related health condition, and which conforms to medical treatment protocols developed by the Program and/or by Data Centers, with input from the CCEs, and approved by the Administrator of the WTC Health Program. For purposes of this document, medical necessity is the review of documentation to ensure treatment rendered or to be rendered is considered medically necessary treatment.

Medical Policy: Establishes guidelines for determining what medical services, procedures, and supplies are medically necessary for the treatment or monitoring of qualifying conditions and therefore eligible for coverage. Medical policy is grounded in best and most current scientific evidence and is updated to reflect changes in such evidence. For the purposes of the Program, medical policy indicates what services shall be covered for each of the Program’s qualifying WTC-Related Health Conditions, Health Conditions Medically Associated with a WTC-Related Health Condition, and Adjunct Conditions (i.e., is an acute or chronic health condition co-occurring with a certified WTC-related health condition, that, if left untreated, would interfere with reasonable treatment (i.e. manage, ameliorate, or cure) of a certified WTC-related health condition. Medical policy may be housed in the Program’s codebook, public website, Administrative Manual, and other related Program documents. Medical policy is subject to change, and compliance with such changes is required.

Monitoring: Periodic physical and mental health assessment of a WTC responder or certified-eligible survivor in relation to exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks and which includes a medical and exposure history, a physical examination and additional medical testing as needed for surveillance or to evaluate symptom(s) to determine whether the individual has a WTC-related health condition. Generally, a WTC responder or certified-eligible survivor receives annual physical and mental health assessments.

Nationwide Provider Network (NPN): A nationwide network of health care providers throughout the United States administered by a central entity under contract with the Program to provide WTC-related health care, including initial health evaluation, monitoring, and treatment, for Program members who live outside the NYMA. See 42 CFR 88.1.

Other Health Insurance (OHI): Another health insurance policy held by a Program member, whether public or private, including group health, government, or workers’ compensation insurance. For survivors, members are required to maintain OHI and their treatment claims must first be billed to their OHI before being billed to the Program (See COB definition).

Outreach and Education: A service provided by the contractor to ensure prospective members have information they need about the WTC Health Program and how to apply. This phrase is sometimes also used to describe outreach to engage existing members as part of retention efforts.

Percentage of Effort: The percentage of time the person will be working on the defined duties for the WTC CCE.

Personally Identifiable Information (PII): Any information about an individual maintained by an agency that includes (1) any information that can be used to distinguish or trace an individual's identity, such as name, social security number, date and place of birth, mother's maiden name, or biometric records; or (2) any other information that is linked or linkable to an individual, such as medical, educational, financial, and employment information.

Prior Authorization (PA): A PA is required for certain services that require specific criteria be met before coverage can be approved. Service specific requirements can be found in the WTC Health Program medical policies and the Administrative Manual.

Protected Health Information (PHI): Individually identifiable health information (health information, including demographic information, collected from an individual and created or received by a health care provider, health plan, employer, or health care clearinghouse that relates to the individual’s past, present, or future mental or physical health condition, provision of health care, or payment for care and which identifies the individual or is reasonably believed to make the individual identifiable) that is transmitted by electronic media, maintained in electronic media, or transmitted or maintained in any other form or medium. PHI excludes individually identifiable health information in certain education records, certain student medical records, employment records held by a covered entity in its role as employer, and records regarding a person who has been deceased for more than 50 years. See 45 CFR 160.103.

Retention: Actions taken by the CCEs to maintain contact with members and promote continued participation by active members and encourage inactive members to participate in the Program.

Technical Guidance Document (TGD): A technical guidance document (TGD) is an official communication from the WTC Health Program Contracting Officer Representative (COR) and the WTC Health Program. It advises the contractor on how to implement or interpret certain contractual obligations. TGDs are included as part of the WTC Health Program Procedures and any relevant TGDs that are not included as an attachment will be provided upon award.

Treatment Pending Certification: Should only be used in clinically urgent and time-sensitive situations. Refers to treatment provided for WTC-Related Health Conditions or Health Conditions Medically Associated with a WTC-Related Health Condition while certification is awaiting adjudication. In order for a CCE or NPN to provide treatment pending certification for a health condition, the condition must be eligible for treatment by the Program and a certification request must have been submitted to the Program but not yet adjudicated. The Program members sometimes require urgent or otherwise time-sensitive care for conditions pending certification and such cases may be covered by the Program if all requirements are met. As directed by Program regulations, authorization for treatment of a WTC-Related Health Conditions or a Health Condition Medically Associated with a WTC-Related Health Condition must be obtained from the Program before treatment is provided, except for the provision of treatment for a medical emergency.

Utilization Management (UM): The evaluation of the medical necessity, appropriateness, and efficiency of the use of health care services, procedures, and facilities under the provisions of the applicable health benefits plan.

Utilization Management – Concurrent Review (CCR): a method of reviewing patient care and services during a hospital stay to validate the necessity of care and to explore alternatives to inpatient care. It is also a form of utilization review that tracks the consumption of resources and the progress of patients while being treated. CCR involves review of necessity decisions made while the patient is currently in an acute or post-acute setting (CCR may also be referred to as “Urgent Concurrent”).

Utilization Management -- Continued Stay Review (CSR): type of review used to determine that each day of the hospital stay is necessary, and that care is being rendered at the appropriate level. It takes place during a patient’s hospitalization for care. CSR is conducted concurrently (as is CCR); however, it applies to non-Diagnosis Related Grouping (DRG) facilities in which the status of each day of a hospital stay is addressed separately. DRG facilities may only require an initial review in which the determination would apply to the entire hospital stay.

Utilization Management -- Prospective Review: The review of medical necessity for the performance of services or scheduled procedures before admission, procedure, or course of treatment.

Utilization Management -- Retrospective Review: Medical necessity review after treatment is provided.

Waste: Failure to control costs or regulated payments due to an inappropriate act or omission by payers with control over or access to government resources. Waste relates primarily to mismanagement, inappropriate actions, or inadequate oversight. Examples include:

· Poor execution or lack of widespread adoption of best practices, such as effective preventive care practices or patient safety best practices;

· Unnecessary hospital readmissions, avoidable complications, and declines in functional status, especially for the chronically ill;

· Use of higher-priced services that have negligible or no health benefits over less expensive alternatives;

· Writing high-cost prescriptions over less expensive but equivalent generic prescriptions.

WTC Health Program (“ Program”): The program established by Title XXXIII of the Public Health Service Act, as amended, 42 U.S.C. 300mm to 300mm-61 (codifying Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 , Pub. L. 111-347, as amended by Pub. L. 114-113 and Pub. L. 116-59), to provide medical monitoring and treatment benefits for eligible responders to the September 11, 2001, terrorist attacks and initial health evaluation, monitoring, and treatment benefits for residents and other building occupants and area workers in New York City who were directly impacted and adversely affected by such attacks. See 42 CFR 88.1.

WTC Health Program Member: Any person that has been enrolled in the WTC Health Program including responders, FDNY family members, or survivors. See 42 CFR 88.1.

WTC-Related Health Condition: An illness or health condition for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks, based on an examination by a medical professional with expertise in treating or diagnosing the health conditions in the List of WTC-Related Health Conditions, is substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition, including a mental health condition. Only those conditions on the List of WTC-Related Health Conditions codified in 42 CFR 88.15 may be considered WTC-related health conditions. See 42 CFR 88.1.WTC-related Health Conditions must be certified by the WTC Health Program to receive treatment for that condition.

SECTION 1.3 – Selected Roles and Business Associates

The following is a non-exclusive list of other WTC Health Program contractors and business associates with which the CCE may be expected to engage while carrying out Program services and functions.

Clinical Center of Excellence (CCE): A NYMA-based medical facility that, in accordance with the Zadroga Act, operates under an individual contractual relationship with the WTC Health Program to provide medical monitoring, diagnosis, certification, treatment services, case management, and benefits counseling for members in the NY metropolitan area. Members residing in NYMA or otherwise electing care through a CCE are assigned a CCE which is responsible for coordinating their care under the WTC Health Program. The Zadroga Act defines a CCE as “a Center that demonstrates to the satisfaction of the Administrator that the Center—(i) uses an integrated, centralized health care provider approach to create a comprehensive suite of health services under this title that are accessible to enrolled WTC responders, screening-eligible WTC survivors, or certified-eligible WTC survivors; (ii) has experience in caring for WTC responders and screening-eligible WTC survivors or includes health care providers who have been trained pursuant to section 3313(c);

(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.” See Zadroga Act Section 3305(b)(1)(A).

Comprehensive Cost Avoidance (CCA) Contractor: A vendor contracted with the Program who performs comprehensive cost avoidance functions including recovery of funds from workers compensation programs and other health insurance (OHI) where the Program overpaid. The contractor also provides support in facilitating coordination of benefits processes and verifying member demographic information for the purposes of improving efficiency and controlling costs.

Data Center (DC): There are currently three DCs under contract with the WTC Health Program to support various functions, including receiving data from the CCEs, NPN, and HPS/TPA Contractor; developing examination, monitoring, and treatment protocols; establishing provider credentialing criteria; and coordinating outreach activities. See 42 CFR 88.1.

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

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

Nationwide Provider Network (NPN): A vendor under contract to service as the nationwide network of health care providers throughout the United States administered by a central entity under contract with the Program to provide WTC-related health care, including initial health evaluation, monitoring, and treatment, for Program members who live outside the NYMA.

Outreach Partner: Vendor who supports recruitment for responders and survivors by developing culturally and linguistically appropriate educational materials and conducting various outreach efforts.

Pharmacy Benefits Manager (PBM): A vendor contracted with the Program that administers the pharmacy benefits by providing the pharmacy customer call center, claims adjudication, formulary management, pharmacy network, and clinical reviews.

SECTION 2.0 – PURPOSE

The purpose of this contract is to secure the services of multiple entities to serve as the Clinical Centers of Excellence (CCEs) for eligible members living inside the New York metropolitan area (NYMA), consistent with the requirements of the Zadroga Act. The potential contractors shall indicate in their proposals the selected member category they propose to serve: FDNY Responders and FDNY Family Members, Non-FDNY Responders (General Responders), or Survivors (Section 1.1). as well as the region of intended geographic coverage area. The Pentagon/Shanksville, PA Responders are served by the NPN contractor.

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).”

SECTION 3.0 – SCOPE OF WORK

The CCE contractor shall operationalize a Clinical Center of Excellence to ensure eligible members receive monitoring and treatment only for appropriately certified condition(s). The CCE contractor is responsible for an up-to-date understanding of and compliance with the Zadroga Act and the Program’s implementing regulations, including any amendments, as well as the Program’s policies, standard operating procedures, technical and medical guidance documents, and WTC Health Program Administrative Manual. The CCE contractor shall manage the CCE using advanced and continually improving industry standards. The CCE contractor shall provide these services with the goals of minimizing costs to the WTC Health Program, improving member health, and providing superior and clinically excellent member services. The CCE contractor shall manage the contract to ensure that subcontracts, staffing, reporting, security, deliverables, repositories, and services meet the requirements of the contract.

At a summary level these tasks include:

· Contract Management and Implementation Services

· Quality Assurance Controls to prevent unauthorized services and FWA

· Member Services and Outreach to current members

· Care Coordination and Case Management

· Program Communications

· Administering healthcare services (monitoring, screening, and treatment) and submitting claims for services provided

· Coordination of benefits with OHI (for the survivor member category, only)

· Collect clinical and operational data

· Maintain up-to-date member records

SECTION 4.0 – TASKS TO BE PERFORMED

The CCE contractor must possess the knowledge, capability, and resources to effectively provide services to manage the CCE in accordance with all federal, state, and any other applicable laws; regulations; policies; procedures; and WTC Health Program requirements. The requirements set forth by the legislation are excerpted below and further detailed throughout the PWS:

(i) Establish a formal mechanism for consulting with and receiving input from representatives of eligible populations receiving monitoring and treatment benefits under part B from such Center.

(ii) Coordinate monitoring and treatment benefits under part B with routine medical care provided for the treatment of conditions other than WTC-related health conditions.

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

(iv) Have in place safeguards against fraud that are satisfactory to the Administrator, in consultation with the Inspector General of the Department of Health and Human Services.

(v) Treat or refer for treatment all individuals who are enrolled WTC responders or certified-eligible WTC survivors with respect to such Center who present themselves for treatment of a WTC-related health condition.

(vi) Have in place safeguards, consistent with section 300mm–3(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.

(vii) Use amounts paid under subsection (c)(1) only for costs incurred in carrying out the activities described in subsection (a), other than those described in subsection (a)(1)(A).

(viii) Utilize health care providers with occupational and environmental medicine expertise to conduct physical and mental health assessments, in accordance with protocols developed under subsection (a)(2)(A)(ii).

(ix) Communicate with WTC responders and screening-eligible and certified-eligible WTC survivors in appropriate languages and conduct outreach activities with relevant stakeholder worker or community associations.

(x) Meet all the other applicable requirements of the Zadroga Act including regulations, policies and procedures, and the WTC Health Program Administrative Manual.

SECTION 4.1 – Contract Management

The CCE contractor shall participate in a kick-off meeting in-person with WTC Health Program personnel within 15 days of the contract start date. The CCE contractor must coordinate with the COR and CO to establish dates, location, and agenda for the kickoff meeting. The contractor must take meeting minutes, which must be provided to WTC Health Program five (5) business days after the conclusion of the meeting. The CCE contractor shall conduct status meetings with appropriate WTC Health Program staff thereafter on an agreed-upon schedule (e.g., weekly).

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. The Contractor shall engage with the WTC Health Program business owners throughout implementation and sustainment on issues that prioritize:

· Quality Assurance and continuous performance improvement

· Risk and issue management

· Change Control Activities

SECTION 4.1.1 – Training

The CCE contractor shall provide training for new operational processes and systems to the CCE staff to ensure cohesive and quality benefits and ensure understanding of the limited-health benefit plan and ensure sufficient knowledge to fulfill the requirements of this contract. The CCE contractor shall also provide training to WTC Health Program staff. Generally,

1) Internal Contractor and subcontractor staff need to be trained on both Contractor and Program systems and processes. Training related to the Contractor’s systems and associated processes are to occur at no charge to the Government.

2) Internal Contractor and subcontract staff shall complete applicable required HIPAA, CDC, Program, and Program contractor (HPS/TPA, PBM, etc.) trainings aligned to their roles and responsibilities. These trainings and any other trainings conducted on the Program’s systems and associated processes may be billed to the Program.

3) Program personnel and any other users of the Contractor’s systems (if any) need to be trained on Contractor systems and processes, as applicable. Such trainings may be billed to the Program.

The CCE contractor must implement a security awareness and training program for all members of its workforce at least annually and must provide HIPAA training to all members of its workforce at least annually and to new members of the workforce within a reasonable time after joining the CCE contractor. The CCE contractor shall work with the Program to review provider education materials for accuracy.

The CCE contractor must require contractor and subcontractor staff to attend (virtually, in person, or by recorded video) the WTC Health Program Administrative Overview Training within the following timeframes:

1. All CCE contractor key personnel within 3 months of award

2. CCE contractor staff identified as holding key functions within 3 months award

3. All CCE contractor clinical staff and other support staff within 6 months of contract award

4. Throughout the life of the contract, all new CCE contractor staff within 3 months of onboarding

CCE contractor key staff and clinical staff shall remain up to date on research findings funded by the Program and best practices that are established from those findings and other sources available to key and medical staff.

The CCE contractor shall train staff to respond in an emergency or a difficult situation when a conflict or violent event occurs, to ensure the health and safety of staff and members. The CCE contractor shall follow any WTC Health Program policy that deals with such situations.

SECTION 4.1.1.1 – Training Reporting

All training administered and/or attended by the CCE Contractor shall be tracked and reported as part of the monthly report. Information in the training report should include: description of the training, objectives/purpose, names of staff members who attended, duration of any necessary travel (beyond local transit).

SECTION 4.1.2 – Staffing Requirements

The CCE shall communicate to the Program, within 3 business days, when the status changes for a staff member with access to any Program systems so that the Program can remove system access accordingly.

In cases where it becomes necessary to replace someone holding a position listed as “Key Personnel,” the CCE Contractor shall establish a succession plan to be submitted to the Program for review. The CCE will also provide the Program the resume of another staff person of equal or greater experience for review and approval. The physicians who will be conducting the medical monitoring assessments, physical examinations, and providing WTC-related treatment must be board certified in and experienced in occupational medicine, internal medicine,and/or preferred specialties. The CCE shall properly instruct the participating CCE providers about the potential exposures and health outcomes that have been associated with the WTC attack and the conditions and services covered by the WTC Health Program.

The CCE will provide an efficient multi-and interdisciplinary team of personnel at all operational levels with advanced technical expertise, health service experience, and other appropriate skills to perform the required services to meet the requirements in this PWS. 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, a health service administration manager, multiple billing/coding and claims specialists, and other staff necessary to support program management and operations such as quality assurance, provider network, and analytics (See Minimum Vendor Qualifications and Level of Effort). The CCE contractor shall provide a well-defined and cost-effective mix of specialists that are knowledgeable in Federal Health Care Delivery Policies and Procedures.

The CCE contractor and its staff shall be 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.

SECTION 4.1.2.1 – Staffing Report and Wages Report

The CCE shall provide a quarterly reconciled staffing report (Attachment J.19) that contains a staffing list that aligns to the accepted proposal and the approved change requests and describes staffing changes with termination and hiring dates, percentage of effort, activity codes, salaries, and new and unfilled positions. Each quarter, the CCE must submit a reconciliation staffing report within 15 days after the end of each quarter. Changes to proposed staffing plans must be submitted to the Program on a CR form detailing the impact to budget and justification for the change. Approval by the Program is required prior to implementation.

SECTION 4.1.3 – Coordination and Participation

The CCE contractor (and subcontractors) are required to participate in meetings as requested to provide intellectual input and ensure collaboration with the WTC Health Program, NPN, DCs, PBM, and other contractors and stakeholders to the WTC Health Program. “Key Personnel”, including Medical Director, Program Administrator, and staff responsible for key functions, are required to participate in the Responder Steering Committee Meetings, Survivor Steering Committee Meetings, Medical Forum call, Data Center outreach calls, Pharmacy and Therapeutics forum, and…