75D301-21-R-71805 Revised 04-19-2021.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.

75D301-21-R-71805

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

04/15/2021

6. REQUISITION/PURCHASE NO.

0000HCCP-2021-51438

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 2:00pformtext until local time

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See SECTION C.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:

(770) 488-2949

C. E-MAIL ADDRESS

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 C.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 & Implementation (06/17/2021 – 06/16/2022) Items:

Base Period

All work to be performed in accordance with the performance work statement 1 Years

All work to be performed in accordance with the performance work statement This is a time & material line item.

1 Job

All work to be performed in accordance with the performance work statement This is a time & material line item.

*The period of performance of CLINs 000101 and 000102 is estimated to be a maximum of 6 months; Offerors are encouraged to propose a period of performance based on their own estimate.

Option Period 1 (06/17/2022 – 06/16/2023) Items:

1 Years

Option Period 2 (06/17/2023 – 06/16/2024) Items:

1 Years

Option Period 3 (06/17/2024 – 06/16/2025) Items:

1 Years

Option Period 4 (06/17/2025 – 06/16/2026) Items:

1 Years

B.1 The dates for each period of performance are estimates, and may be revised based on the solicitation and pre-award timeline.

B.2 Pharmacy Benefits Management CLIN Type

The CLIN type (FFP, T&M, or Unfunded Cost Savings Recovery Fee) of the Pharmacy Benefit Management CLINs (0001, 1001, 2001, 3001, and 4001) will be determined by which contract type the awarded offeror proposes.

SECTION C - Description/Specification/Work Statement

SECTION C.1 – BACKGROUND

On January 2, 2011, the President signed Public Law No. 111-347, the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act). Title I of the Zadroga Act amended the Public Health Service Act to add Title XXXIII establishing the World Trade Center (WTC) Health Program within the Department of Health and Human Services (HHS). Title I is codified at 42 U.S.C. §§ 300mm – 300mm-61. The Zadroga Act was amended in 2015 by Public Law No. 114-113 to provide authority and funding and for the WTC Health Program to continue through 2090 and further amended in 2019 by Public Law. No 116-59. The Zadroga Act, as amended, can be found at: https://uscode.house.gov/view.xhtml?path=/prelim@title42/chapter6A/subchapter31&edition=prelim. In addition to the statutory requirements for the Program codified in 42 U.S.C. §§ 300mm – 300mm-61, the WTC Program Administrator has also promulgated regulations governing the administration of the Program at 42 C.F.R. pt. 88.

As of June 30, 2020, the WTC Health Program had 105,272 members enrolled, including 79,001 general responders and 26,271 survivors. Current WTC Health Program statistics and reports can be found at https://www.cdc.gov/wtc/ataglance.html#enrollmentWTC.

The WTC Health Program is administered by the National Institute for Occupational Safety and Health (NIOSH), part of the Centers for Disease Control and Prevention (CDC), a component of HHS, and provides monitoring and treatment for survivors and responders (referred to as members) of the 9/11 terrorist attacks in New York City (NYC), the Pentagon, and near Shanksville, Pennsylvania. The WTC Health Program is a limited health benefit program, meaning that treatment is only available for specific covered health condition(s) for which exposure to airborne toxins, any other hazard, or any other adverse condition resulting from the September 11, 2001, terrorist attacks has been determined to be substantially likely to be a significant factor in aggravating, contributing to, or causing the illness or health condition in an individual member. In order to receive treatment, members must be both enrolled in the Program and certified for a qualifying condition(s). Both program eligibility and certification decisions are made by the NIOSH/WTC Health Program enrollment and certification specialists within NIOSH. This data is maintained by the Health Program Support (HPS) contractor and transferred to the pharmacy benefits manager (PBM) based on a pre-determined schedule. 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.

Care is administered to members in the New York Metropolitan Area (NYMA) through the Clinical Centers of Excellence (CCEs), and to members outside the NYMA through a Nationwide Provider Network (NPN), all of which are managed by contracts with the Program. In addition to these contracts, the Program also contracts with an HPS vendor that processes medical claims, manages the Program’s HPS call center, processes enrollment and certification applications, manages the provider network, and maintains eligibility data for the Program.

This contract will assume all the PBM services currently being provided to the WTC Health Program and add new PBM services. In supporting the WTC Health Program, the PBM shall work closely with NIOSH/WTC Health Program and regularly communicate and interact with other Program contractors including the CCEs, the NPN, the Data Centers, the Health Program Evaluation (HPE) vendor, and the HPS vendor.

In 2019, the WTC Health Program pharmacy claims expenditures were $111,677,009.80 with 416,288 total pharmacy transactions and 27,345 members utilizing pharmacy benefits. There is significant home delivery use within the program with home delivery penetration at 40.31% in 2019.

The current PBM specializes in workers’ compensation benefits, and the pharmacy benefits are operationally administered similarly to workers’ compensation by requiring the point-of-sale decisions to be routed externally to the CCEs/NPN. Under this new contract, the PBM shall develop processes and utilize technology to manage all point-of-sale edits internally, and the CCE/NPN and providers will be responsible for submitting prior authorization (PA) requests.

The WTC Health Program oversees all pharmacy operations and develops pharmacy program policies. The Program leads a quarterly Pharmacy and Therapeutics (P&T) Forum where clinical decisions are presented to stakeholders regarding drug coverage and coverage changes. The PBM supports this process; however, NIOSH/WTC Health Program makes all formulary decisions. The Program currently uses five formularies to manage members based on their certified condition(s). The Program intends to utilize automated solutions in the next contract to manage prescriptions based on a member’s condition/diagnosis.

The Program manages multiple contractors whose responsibilities affect pharmacy operations. Standard Operating Procedures (SOPs) for pharmacy benefits are developed by the Program and PBM. The Program resolves escalated member issues. The Program conducts and oversees all quality assurance activities related to prescription processing, member service, and other types of processes.

For more detailed information on the pharmacy program’s current policies and procedures, please visit the WTC Health Program Administrative Manual, Chapter 12: Pharmacy Benefits: https://www.cdc.gov/wtc/ppm.html#pharmacy.

SECTION C.1.1 – 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.

Average Wholesale Price (AWP): The average wholesale price of a prescription drug published and updated by Medi-Span. The AWP price will be based on the actual 11-digit NDC of the package size dispensed on the date dispensed. Supplier will use the NDC of the original packaging manufacturer rather than a repackaged NDC.

Brand Drugs: a prescription drug that is protected by a patent, supplied by one company and marketed under the manufacturer’s brand name or a multi-source brand product which was once a Brand product.

Drugs with a Medi-Span code of “M”, “N”, and “O” will be considered brands.

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

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

Certification: A determination by the Program that a member’s health condition is included on the List of WTC-Related Health Conditions and 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.

Clinical Center of Excellence (CCE): A NYMA-based medical facility that, in accordance with the Zadroga Act, operates under an individual contractual relationship with NIOSH/WTC Health Program to provide medical monitoring, diagnosis, and treatment services for members in the NY metropolitan area. Members are assigned a CCE which is responsible for coordinating their care under the WTC Health Program. There are currently seven CCEs contracted with the Program: one for the survivor population and six for the responder population.

Drug Utilization Review (DUR): An authorized, structured, ongoing review of prescribing, dispensing, and use of medication. DUR encompasses a drug review against predetermined criteria that results in changes to drug therapy when these criteria are not met. Can be prospective, concurrent, or retrospective.

Formulary: A list of drugs for which coverage is provided. Products not on the formulary require approval by the Program based on medical necessity. The Program maintains five unique closed formularies and coverage is limited based on certified conditions.

Fraud: Any of the following:

· Knowingly submitting, or causing to be submitted, false claims or making misrepresentations of fact to obtain a Federal health care payment for which no entitlement would otherwise exist;

· Knowingly soliciting, receiving, offering, or paying remuneration (e.g., kickbacks, bribes, or rebates) to induce or reward referrals for items or services reimbursed by Federal health care programs;

· Making prohibited referrals for certain designated health services.

Generic Drugs: Any drug that is not a Brand. A drug with a Medi-Span code of “Y” on the date dispensed will be considered a generic.

Go-Live Date: Set date where the PBM is fully operational, independent, and available for use following the implementation period.

Maximum Allowable Cost (MAC) List: Limited to one list of generic and brand drugs, supplies, and devices subject to MAC pricing schedules. The source of the MAC list will be disclosed to the client.

Member: An individual enrolled in the WTC Health Program as a responder, eligible family member of an

Fire Department of the City of New York (FDNY) responder, certified-eligible survivor, or screening-eligible survivor.

Multi-source Brand Drug: A drug product manufactured by more than one company or source; commonly used to describe a brand drug for which generic equivalents are available.

Nationwide Provider Network (NPN): A nationwide network of health care providers across the country administered by a central entity under contract with the Program to provide WTC-related health care for Program members who live outside the NY Metropolitan Area.

Personally Identifiable Information (PII): Information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other information that is linked or linkable to a specific individual.

Prior Authorization (PA): PA is required for certain drugs that are subject to a point of sale block at the pharmacy because there are specific eligibility criteria that must be met before they are adjudicated through the WTC Health Program. The PBM adjudication system will maintain multiple, closed formularies and will allow the separate formularies to have unique PA criteria for the same drug. When a member tries to a fill a prescription for a drug requiring PA, the pharmacist will receive a rejection at the point of sale that says, “medication requires PA.” Reasons that medications require a PA are step therapy, multi-use/certification specific drugs, high cost, high fraud/waste/abuse potential, brand/generic, over-the-counter, and non-formulary. PA approval may be granted on a per-drug basis for a member after PA criteria is met and the claim will be assigned a PA authorization number for the pharmacy to enter to adjudicate the claim.

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.

Rebates: All manufacturer revenue, manufacturer administrative fees, discounts, or remuneration of any kind received by PBM pursuant to a contract with a pharmaceutical manufacturer and directly attributable to the utilization of certain covered benefits by members of the client.

Responder: A worker or volunteer who provided rescue, recovery, debris cleanup, or related support services on or in the aftermath of the September 11, 2001, terrorist attacks for certain amounts of time between September 11, 2001 and July 31, 2002. There are three groups of responders in the WTC Health Program: FDNY Responders (and surviving FDNY family members); WTC General Responders (including NYPD); and Pentagon and Shanksville, PA Responders.

Single-Source Generic Drug: A drug given a period of exclusivity after a brand drug patent expires where the generic drug manufacturer has submitted an accepted Abbreviated New Drug Application (ANDA) and there is product availability in the marketplace.

Specialty Drug: A drug with two or more of the following characteristics:

o Is a biotech or biological drug;

o Is produced through DNA technology or biological processes;

o Is a complex therapy for a complex disease;

o Has a high cost, with a negotiated price equal to or greater than $670 per month;

o Requires special handling, shipping, and/or storage;

o Requires frequent monitoring or specialized patient training;

o Has limited distribution.

Survivor: An individual who was present in the dust or dust cloud on September 11, 2001; or who lived, worked, or attended school, childcare, or adult daycare in the NYC Disaster Area for a certain amount of time between September 11, 2001 and July 31, 2002.

U&C Price (U&C): The minimum every-day price charged by a non-participating pharmacy or a participating pharmacy for a covered product in a cash or uninsured transaction on the date such drug is dispensed.

Waste: Failure to control costs or regulated payment associated with federal program funding that results in taxpayers not receiving reasonable value for their money in connection with any government-funded activities due to an inappropriate act or omission by payers with control over or access to government resources. Importantly, waste relates primarily to mismanagement, inappropriate actions, or inadequate oversight.

Wholesale Acquisition Cost (WAC): The wholesale acquisition cost pricing data for a given pharmaceutical product, as published by Medi-Span.

SECTION C.2 – PURPOSE

The project objective of this contract is to provide comprehensive pharmacy services to the WTC Health Program for filling prescriptions at retail and mail-order pharmacies, with controls on formularies, members, and prescribers. PBM services include:

1. Authorization interfaces for prescribers;

2. Closed-panel physician maintenance;

3. Contract management;

4. Maintenance of an extensive retail and mail-order pharmacy networks;

5. Coordination of benefits (COB);

6. Discount/rebate negotiation;

7. Drug Utilization Review (DUR);

8. Electronic prescription claims adjudication;

9. Electronic tools for benefit manipulation and reporting;

10. Electronic prescribing;

11. Eligibility maintenance;

12. Formulary administration;

13. Specialty pharmacy services for complex cases (e.g. cancer);

14. Pharmacy claims auditing;

15. Quality Assurance (QA) controls to prevent unauthorized prescriptions:

16. Web portal for members and providers

17. Pharmacy and Therapeutics (P&T) clinical support

The WTC Health Program is a federally funded, limited health benefits program and therefore must comply with all federal regulations and requirements, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations.

SECTION C.3 – SCOPE OF WORK

The PBM shall operationalize a prescription benefit by ensuring members are able to receive only medications appropriate for their certified condition(s). The PBM shall also ensure that prescriptions adjudicated through the Program meet all Program eligibility and clinical requirements. As a part of this requirement, the WTC Health Program has established a P&T Forum which the PBM shall support and actively participate in. The PBM shall manage the formularies and prescription benefits using advanced and continually improved industry standards (e.g., a secure online service). The PBM shall provide these services with the goals of minimizing drug costs to the WTC Health Program, improving member health, and providing superior member service. The PBM shall manage the contract to ensure that subcontracts, staffing, reporting, security, deliverables, repositories, and Quality Assurance (QA) staff and services meet the requirements of the contract.

SECTION C.4 – TASKS TO BE PERFORMED

The PBM must possess the knowledge, capability, and resources to effectively provide PBM services in accordance with all federal, state, and any other applicable laws; regulations; policies; and the WTC Health Program requirements.

The PBM awarded the contract under the associated request for proposals (RFP) will be responsible for cooperating with the WTC Health Program and the incumbent PBM during an implementation period in order to become the PBM responsible for completing all required services.

The PBM shall provide competent and qualified staff to work on the scope of services under the contract. The PBM shall be responsible for ensuring the accuracy, timeliness, and completion of all tasks assigned under the resulting contract.

At a summary level, these tasks include:

1. Implementation Services

2. Administrative Services

3. Clinical Management Services

4. Transition of Data and Information Turnover

5. Optional/Additional Services SECTION C.4.1 – Implementation Services

The PBM shall have a six-month implementation period to stand up and implement all services required by this SOW. The PBM shall submit a revised Implementation Plan and submit it to the WTC Health Program for approval within 30 calendar days of the contract award. Once the plan has been approved, any material changes to the plan must be documented and presented in conjunction with the monthly progress report. The Implementation Plan shall:

1. Assign dedicated PBM staff to the implementation;

2. Define project management plans for implementing all tasks and deliverables in accordance with this SOW;

3. Establish the staff utilized under the contract, including subcontractors, with clearly defined roles and responsibilities. The PBM’s Implementation Plan shall include the proposed labor mix of personnel who will be responsible for implementing this requirement, including the identification of key personnel and the percentage of their time devoted to the contract.

The PBM shall work with the WTC Health Program and the incumbent PBM to facilitate the implementation and transfer all aspects of the pharmacy benefit program. The PBM shall provide the Program the following standard implementation services:

SECTION C.4.1.1 - Meeting participation The PBM shall participate in a kick-off meeting either virtually or in-person with WTC Health Program personnel once the contract has been awarded. The PBM shall conduct project implementation status meetings with appropriate WTC Health Program staff thereafter on an agreed-upon schedule (e.g., weekly).

SECTION C.4.1.2 - Implementation credit The PBM shall provide an implementation credit to the WTC Health Program to offset the Program’s expenses associated with the implementation and ongoing services. In no case will the WTC Health Program be required to repay all or a portion of the used or unused implementation credit. The PBM shall track such services and provide an update in the mid-year report of current utilization and the remaining balance, if any, of the implementation credit. Any remaining balance will not expire and will be available for use during the term of this contract.

SECTION C.4.1.3 - Establish necessary data/file transfers Implement system programming for data/file transfers including data collection, data mapping, and file transfers to and from the WTC Health Program, Program contractors, and the PBM. If the PBM requires file mapping and/or subsequent mapping updates, this service will be provided by the PBM at no additional cost to the Program. Data may include, but not be limited to, drug claims file, prescriber file, eligibility file, and PA review file. All file transfer processes must be tested for accuracy and be in place 30 days before the implementation date.

SECTION C.4.1.4 - Establish the retail pharmacy network The PBM’s retail network must meet all requirements listed under SECTION C.4.2.3.1. In addition, the PBM shall provide an updated list of participating pharmacies in its network and make lists of these pharmacies available to the Program and members. The PBM shall provide the WTC Health Program with a disruption report comparing all pharmacies that filled prescriptions under the WTC Health Program for the previous twelve (12) months under the incumbent’s contract to the new PBM’s network. These will require at least a 99% match. For members whose pharmacies are not included in the new network, the PBM shall either enroll those pharmacies into their network or facilitate the members’ transfers to in-network pharmacies near them.

SECTION C.4.1.5 - Establish mail-order and specialty pharmacy services The PBM shall implement a mail-order service program as outlined in SECTION C.4.2.3.2. In addition, the PBM shall develop an implementation plan for members using the current mail-order and specialty pharmacy service program, if necessary, that ensures limited disruption.

SECTION C.4.1.6 - System programming The PBM shall program all systems required by the SOW to operationalize the pharmacy benefit. The PBM must perform comprehensive systems testing and QA audits, with results reported to the WTC Health Program at least 30 calendar days prior to the “Go-Live” date. These systems must include:

1. Adjudications system including programming formularies, adjudication rules, drug utilization review edits, point of sale edits, and member eligibility;

2. Web-based PA platforms for providers;

3. An internal PBM system that coordinates and adjudicates clinical decision processes and procedures for PA approval/denial/exceptions

4. External prescription management portals;

5. E-prescribing platforms (e.g., SureScripts);

6. Data-reporting systems;

7. Web-based portals for members (e.g., mail-order pharmacy, PBM Member Benefits).

SECTION C.4.1.7 - Member communications The PBM shall develop welcome packets that include identification cards (“ID cards”) and mail these to current members. The PBM must ensure that 99% of all ID cards and supplemental materials for members are mailed no later than 10 business days prior to the “Go-Live” date, upon receipt of a clean and accurate eligibility file. The PBM must also establish a process for sending cards no later than 5 business days to newly enrolled and certified members thereafter. ID cards will be distributed only to members who are enrolled in the Program and have an active certification for a covered condition.

The PBM shall be responsible for the cost of producing ID cards and priority-mail shipping.

SECTION C.4.1.8 - Member services The PBM shall establish member services, including set-up of the member-service phone line, training of member-service staff regarding the WTC Health Program, development of processes related to various member-service issues, and call scripting/guidance for member-service staff. The WTC Health Program Pharmacy Benefits Unit must approve all training activities/materials used.

SECTION C.4.1.9 - Training The PBM’s Account Services Team shall provide onsite and/or virtual training for new operational processes and systems to the WTC Health Program personnel, CCE/NPN staff, and other stakeholders during the implementation period.

SECTION C.4.1.10 - Implementation Audit The PBM must complete an audit to evaluate all processes and systems necessary to operationalize the benefit at least 15 calendar days prior to the “Go-Live” date. Implementation audit results will be shared with the Program as part of the Weekly Service Log and Agenda (SECTION C.7).

SECTION C.4.2 – Administrative Services The PBM shall develop and maintain an Operations Manual that includes descriptions of all contract-related services, processes, and activities of the SOW. The PBM shall also develop Standard Operating Procedures (SOPs) to be included in the Operations Manual, including, internal procedures for WTC Health Program personnel and procedures for the CCEs/NPN and other stakeholders, if applicable. The SOPs will be used to meet the objectives outlined in this SOW and provide the requisite security and process support for the WTC Health Program.

SECTION C.4.2.1 – Member and Provider Eligibility Administration Member Eligibility

The PBM shall load and maintain member eligibility files daily (or upon another agreed-upon schedule) with 100% accuracy upon receipt of clean data files. Member benefit eligibility information shall include member ID number, name, address, date of birth, CCE/NPN assignment, formulary assignment, certification ICD 10/9/11 codes; survivors’ information will also include and Coordination of Benefit (COB) information. Prescriptions will be accurately processed based on the members’ benefit eligibility. The PBM’s system will allow WTC Health Program staff (and their designees, such as CCE staff) to make real-time updates to member eligibility information within the member profile or through a phone call to the client service center.

Prescriber Eligibility

The PBM shall maintain a closed prescriber network, including any individual licensed to write prescriptions, and load and maintain prescriber files with 100% accuracy upon receipt of clean data files. The PBM shall have the ability to manage separate prescriber files for each CCE/NPN.

SECTION C.4.2.2 – Pharmacy Network Administration

The PBM shall have a pharmacy network that covers all US states and territories and includes mail order and specialty pharmacies. The PBM shall state in their proposal the number of pharmacies in their nationwide network. When automatic refills are provided, the PBM must ensure that prescriptions are being utilized as part of current therapy and not filled solely because of the existence of a refill. The PBM must require that automatic refills be opted into and not required or automatically assigned to WTC Health Program prescriptions through both retail and mail order pharmacies. The PBM shall ensure that its network pharmacies have the capability to accept electronic prescriptions from WTC Health Program authorized prescribers. The PBM shall assess the pharmacy saturation and provide pharmacy network status updates in the monthly reports.

SECTION C.4.2.2.1 – Retail Pharmacy Operations The PBM shall have a national pharmacy network that covers all US states and territories and includes all major retailers. At a minimum, the retail pharmacy network will contain at least 65,000 pharmacies nationwide and ensure:

a) More than 98% of members in the NYMA (the combined statistical areas comprising the Bridgeport-Stamford-Norwalk, CT Metropolitan Statistical Area; Kingston, NY Metropolitan Statistical Area; New Haven-Milford, CT Metropolitan Statistical Area; New York-Northern New Jersey-Long Island, NY-NJ-PA Metropolitan Statistical Area; Poughkeepsie-Newburgh-Middletown, NY Metropolitan Statistical Area; Torrington, CT Micropolitan Statistical Area; Trenton-Ewing, NJ Metropolitan Statistical Area) will have at least one (1) participating retail pharmacy within three (3) miles of their home zip code;

b) More than 98% of suburban and rural members outside the areas described above will have at least one (1) participating pharmacy within 10 miles of their home.

The PBM shall have a preferred network option and 90-day-at-retail contracts with select network pharmacies for greater price discounts.

The PBM may not enact any changes to the pharmacy network that will cause disruption to members without written approval from the WTC Health Program 90 days prior to the prospective change.

SECTION C.4.2.2.2 – Mail-Order Pharmacy and Specialty Operations The PBM’s pharmacy network shall include a mail-order pharmacy that allows members to refill prescriptions via mail, phone, or the Internet and have their prescriptions delivered to their home or other designated location. The PBM’s mail-order and specialty pharmacy operations will have fulfillment centers in more than one geographic location to permit continuous operations in the event of a local disaster or business disruption. The PBM shall provide specialty pharmacy services to deliver specialty medications to members.

Mail order and specialty pharmacy services shall include:

a) Prescription shipment via the lowest-cost carriers (e.g., United States Postal Service). The mail-order facility will cover the cost of shipping the medication without any additional upcharges;

b) Overnight delivery, as required, to the member’s home or prescriber’s office, with no additional charge for shipping;

c) Proper handling, packaging, and inclusion of member instructions for drugs requiring refrigeration or special storage;

d) Inclusion of education material, including a welcome brochure, medication information, and general resources for members;

e) Inclusion of necessary ancillary supplies (e.g., syringes, alcohol swabs, and sharps containers);

f) 24-hour access call center for members seeking information on mail order and specialty pharmacy services, including access to pharmacist for medication inquiries;

g) 24-hour access to clinical pharmacists who can address specialty medication questions or urgent concerns. These clinical pharmacists will also monitor for member compliance with the medication dosing regimen, supplies required, changes to dosage or frequency, and possible side effects.

h) If the PBM’s specialty pharmacy is unable to provide limited distribution drugs, they must be able to provide an alternative source for members such as an affiliated specialty pharmacy.

i) During the specialty medication ordering process, the pharmacy will coordinate delivery using processes that eliminate potential waste and provide guidance to members regarding medication administration and storage.

j) Provide a member web portal for mail order as outlined in SECTION C.4.2.5.4.

The PBM may not enact any changes to mail-order pharmacy or specialty operations that will cause disruption to members without written approval from the WTC Health Program six (6) months prior to the prospective change.

SECTION C.4.2.3 – Pharmacy Adjudication System The PBM shall provide real-time electronic claims adjudication system conforming to the National Council for Prescription Drug Programs (NCPDP) standards. Prescriptions must be billed using the 11-digit National Drug Code (NDC). Submitted claims will be evaluated for appropriate format and values. The PBM system must evaluate and manage claims using standard NCPDP point-of-sale edits as described further in SECTION C.4.3.2. The adjudication platform will seamlessly integrate and automate the WTC Health Program’s eligibility information, provider network information, formulary and business rules including the following requirements:

a) The adjudication system will have a minimum availability of 99.5% or greater, 24 hours per day, 7 days per week apart from scheduled downtime not to exceed 2 hours per week.

b) 95% of all claims will be adjudicated within 10 business days and 99% of all claims will be adjudicated within 20 business days.

c) Redundant adjudication system processing capacity will be maintained in the event of a local disaster or business disruption.

d) The PBM shall provide a paper claims process whereby members can submit for reimbursement retroactively.

e) The system will integrate all member prescription claims for retail, mail, specialty, and paper claims submitted.

f) The system will accept electronic transfer of eligibility data and provider network data in a format indicated by WTC Health Program and mutually acceptable to the PBM. The system will verify claims against provider and beneficiary eligibility based on the most current data from the WTC Health Program. The system will allow for real-time updates to member eligibility and provider status.

g) Ability to implement administrative rules (hard and soft edits) at the point of sale.

h) The system will allow for customizable messaging to pharmacies at the point of sale in alignment with NCPDP guidelines.

i) Formulary: The PBM adjudication system will maintain multiple, closed formularies and apply members’ pharmacy claims based on their eligibility. For more on formulary management see SECTION C.4.3.1.

a. If/when a member changes formulary assignment, the system will subject all prescriptions to the adjudication rules in the newly assigned formulary.

b. Formulary and/or system changes will be applied to prescriptions that were already approved in the system (e.g. if a PA is removed from a drug on the formulary, and a member previously had a PA for that drug approved, the system will not require renewals in their profile after the formulary change).

c. The PBM’s adjudication system will allow separate formularies to have different PA levels for the same drug.

j) COB: COB is a key aspect of the WTC Health Program prescription benefit for the survivor population. The adjudication system must –

a. Accept historical and other updated information on any health insurance the member has for the purposes of COB with the members eligibility file in a format mutually acceptable to the PBM and WTC Health Program.

b. Allow for the eligibility files to indicate known WTC Health Program member COB information and place point of sale edits to ensure survivor’s primary insurance to be billed first for the drug claim and the Program to be billed as the payer-of-last-resort.

c. Maintain member specific COB intelligence for utilization against future prescription claims transactions to route primary and secondary claims or portions of the claims to the appropriate benefit.

d. Verify when members have other insurance coverage on file, deny the claim at the point of service with an NCPDP 41 - Submit Bill to Other Processor or Primary Payor error message that includes all necessary information for the pharmacy to bill the primary carrier, including carrier code, carrier name, BIN, and policy number.

e. Allow WTC Health Program staff to make real-time updates to member COB information within the member profile.

f. Allow members to submit manual COB claims for reimbursement.

k) Dispense as Written (DAW): The PBM shall agree that multi-source brand products will only be dispensed pursuant to an appropriate DAW code. In the case a multi-source brand drug is dispensed absent the request of the physician (DAW=1), the Program will be charged the contracted generic rate and the claim will be included in the generic discount reconciliation. This includes claims billed using DAW 3, 4, and 5 where the pharmacist and/or pharmacy have indicated the generic to brand conversion. Member (DAW=2) will reject at all points of service when there is a generic equivalent available.

l) Administrative fees will be applied to paid claims only and will not include reversals or denied claims.

m) The PBM shall inform the WTC Health Program of any significant modifications to the claims’ adjudication planned or anticipated a minimum of six (6) months prior to the anticipated change. This excludes routine updates.

n) The PBM system will incorporate the use of member certification information using International Classification of Diseases (ICD)-9/10/11 diagnosis codes into the member eligibility file.

o) The PBM system will match diagnosis code to formulary drugs during adjudication to automate PAs based on disease conditions.

p) Specific drugs will be excluded/included based on prescriber specialty.

q) The PBM shall provide tools to streamline and automate the override and authorization process.

r) The PBM shall incorporate and automate the use of member diagnoses in the adjudication process for point of sale requirements. The system must automate approvals for drugs that require a PA based on certified condition when they match the members’ certified conditions on file, as determined by the Program. The WTC Health Program will provide member certification using the appropriate ICD-9/10/11 diagnosis codes in the member eligibility file.

SECTION C.4.2.4 – Systems and Data The Program requires all system functions as described below. Some of these systems may be combined based on the PBM’s resources.

SECTION C.4.2.4.1 – Client-Facing Prescription Management Web Portal

The PBM shall maintain a client facing web portal for program staff, including NIOSH personnel, contractors, and the CCEs/NPN that allows access to member information and prescription transaction information in real time for the purposes of managing a member’s treatment. The portal will support and provide the following functions:

a) The system will allow the WTC Health Program staff (and their designees such as CCE staff) to make real-time updates to physician eligibility information within the physician profile or through a phone call to the support service center.

b) The system will allow the WTC Health Program staff (and their designees such as CCE staff) to make real time updates to member eligibility information within the members profile or through a phone call to the support service center.

c) The system will show pharmacy transaction status in real time as well as access to prescription history reports

d) The system will allow the WTC Health Program staff (and their designees) to make real time decisions on prescriptions

e) The system will allow for customized user access as determined by the Program.

f) The PBM shall provide program training to WTC Health Program staff and stakeholders as required/determined by the Program (systems, processes, etc.)

SECTION C.4.2.4.2 – Physician-Facing Electronic Prior Authorization Web Portal The PBM shall provide a PA web platform that securely and electronically transmits PA requests and approvals among pharmacies, providers, and the PBM. If the user is federal employee, the access to the system will be through their HSPD-12 Card.

SECTION C.4.2.4.3 – E-Prescribing Software

The PBM shall utilize electronic tools and interfaces that allow program prescribers using e-prescribing software to confirm member eligibility and formulary requirements for a prescription prior to sending the prescription to the network pharmacy (e.g., Surescripts). The system must work in real time and be compatible with most e-prescribing systems. The PBM must also ensure that formulary and member information is updated in real-time when eligibility or formulary changes are made.

SECTION C.4.2.4.4 – Member-Facing Mail-Order Pharmacy Web Portal The PBM shall provide members with a home delivery web portal and mobile application, at least 30 calendar days prior to the “Go-Live” date, that will allow members to:

1. Enroll in home delivery

2. Order refills

3. Request new prescriptions

4. Enroll, maintain, or discontinue auto refill

5. Check order status

6. Track shipping

7. Manage medication reminders

8. Sign-up for paperless communications

9. Change Shipping address

10. Update email address and phone numbers

11. Activate text messages and/or email notifications

12. Search medication information

SECTION C.4.2.4.5 – Portal Access to Pharmacy-Related Data

The PBM shall provide access to a web-based portal to the WTC Health Program, the CCEs, the NPN, and other stakeholders, that provides access to the Program’s pharmacy-related data. This portal’s functions shall include the ability to provide historical reports, custom reports, and reports that compare/trend utilization data from multiple time periods utilizing business intelligence software tools. If the user is federal employee, the access to the system will be through their HSPD-12 Card. The portal will have the capability to extract the data below.

1. Brand and Generic Utilization Summary

2. Member Service Statistics

3. Days’ Supply

4. Direct Member Utilization

5. Drug Utilization and Cost

6. Formulary Compliance

7. CCE/NPN Utilization Summary

8. Mail-order Service Utilization

9. PA Utilization

10. Pharmacy Provider Utilization Summary

11. Top N Therapeutic Classes by Cost*

12. Top N Drugs by Cost*

13. Top N Members by Costs *

14. Top N Pharmacies by total cost and Ingredient Cost*

15. Top N Prescribers by Ingredient Cost*

16. Total Transactions Processed

17. Utilization Summary

18. Drug Detail

19. Member Detail

20. Pharmacy Detail

21. Prescriber Detail

22. Top N Prescriber*

23. Top N Drug*

24. Top N Member*

25. Top N Pharmacy*I told

26. General Performance Statistics

27. General Member Comparison

28. General Medical Group Utilization Summary

29. General Formulary Management

30. Detailed Claim-Level Rebate Remittance

31. PBM Earnings After Cost Disbursement

* “Top N” reports allow the user to select the number of records captured in the report.

SECTION C.4.2.4.6 – Member Pharmacy Benefits Management (PBM) Website

The PBM shall provide the following member portal tools available via desktop and/or mobile application to facilitate member communications and enhance the effective utilization of the prescription benefit. The website should be customizable for the WTC Health Program including adding logos and content and at least 30 calendar days prior to the “Go-Live” date.

a) Personalized prescription benefit information

b) PA information

c) Search for in network pharmacies

d) Access program information and alerts

e) Prescription claims history

f) Refill reminders

g) Online formularies (updated quarterly; SECTION C.4.3.1)

h) Network pharmacy locator

i) Flu-shot reminders

j) PA renewal reminders

k) Prescription Take Back Day

SECTION C.4.2.4.7 – Pharmacy Resource Webpage The PBM must provide a secure webpage, at least 30 calendar days prior to the “Go-Live” date, that provides resources and program information in a user-friendly format for the CCEs/NPN, NIOSH/WTC Health Program staff, and other Program support staff including -

a) Access and download documents such as commonly used forms, SOPs/Operations Manuals, and the latest formularies.

b) Access to training and educational materials developed by the Program or provided by the PBM.

c) Stay apprised of the latest drug news and FDA updates and WTC Health Program updates.

d) Obtain information about mail order and specialty medication services.

SECTION C.4.2.5 – Call Center

The PBM shall provide a service center (call center/helpdesk/support) with knowledgeable and accessible representatives that are well trained in the specifics of the WTC Health Program. The call center must provide accurate and timely information to members, prescribers, pharmacies, CCE/NPN staff, and the WTC Health Program staff and be able to resolve issues quickly which is vital to the success of the Program. The PBM shall provide the following call center operational features:

a) Furnish a dedicated toll-free number exclusive to WTC Health Program for incoming service calls, including telephone technology for the hearing impaired and multi-lingual support. The dedicated call center for pharmacies, members, and account management must be staffed 24 hours / 7-days per week/ 365 days per year.

b) Interactive Voice Response (IVR) system messaging that is exclusive to WTC Health Program member services.

c) Management of call scripting/messaging.

d) Service call centers located in more than one geographic region to permit continuous operations in the event of a local disaster or business disruption.

e) Minimum live contact hours of 5am – 9pm ET with 24 hour on-call emergency messaging for returned calls within 4 hours.

f) Warm transfer call routing capability for members so they do not have to disconnect from the original call to call separate service bureaus.

g) Average Speed of Answer within 20 seconds or less.

h) Call Abandonment rate of less than 2% of calls.

i) First Call Resolution Rate of 98%.

j) Written member inquiries will be answered within ten business days of receipt.

k) Provide service support for claims.

The PBM shall maintain call logs, notes, documentation, and reporting. A call activity summary will be provided no less than quarterly to provide trend analysis and outliers. In addition, the PBM shall coordinate bi-monthly calls with the WTC Health Program to perform a call audit where calls are listened to for quality assurance. The audit will review for quality, accuracy, and courtesy. Coaching opportunities for Call Center staff will be identified as well as improvements in language and processes. Upon request, PBM shall provide digital recordings of phone calls within two (2) business days of request.

The Call Center staff supporting the WTC…