1.DRAFT SOW_PBM_3Year.pdf

SECTION C - STATEMENT OF WORK

SECTION C.1 – BACKGROUND

The WTC Health Program was established by Title I of the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act), Public Law 111–347(January 2, 2011), as amended by Public Law 114–113 (December 18, 2015) and Public Law 116–59 (September 27, 2019), adding Title XXXIII to the Public Health Service (PHS) Act (codified at 42 U.S.C. 300mm to 300mm-61). The Act established with the Department of Health and Human Services a program to be known as the World Trade Center Health Program (WTC Health Program). The WTC Health Program provides medical monitoring, screening and treatment for responders and survivors of the 9/11 terrorist attacks. Responders include a worker or volunteer who provided services in the aftermath of the September 11, 2001, attacks on the World Trade Center. Survivors include persons that worked, lived, or attended school, childcare, or adult day care in the New York City disaster area, who were adversely affected by the September 11, 2001, terrorist attacks in New York City. As of October 31, 2024, there are a total of 89,874 responders and 48,624 survivors enrolled in the WTC Health Program. This represents a 3% growth in responder enrollment and a 14% increase in survivor enrollment since December 31, 2023, when the WTC Health Program had a total of 87,183 responders and 42,620 survivors enrolled. In order to enroll in the WTC Health Program, responders and survivors must meet certain criteria described in the Zadroga Act (https://www.cdc.gov/wtc/laws.html). For more information, please refer to https://www.cdc.gov/wtc/about.html, or see high-level program statistics at https://www.cdc.gov/wtc/ataglance.html.

The WTC Health Program is a limited health care benefit program, meaning that treatment is covered for only specified health condition(s) resulting from exposure to airborne toxins, hazards, or any other adverse conditions arising from the September 11, 2001, terrorist attacks. There is a list of applicable WTC-related health conditions that must be diagnosed by a WTC Health Program provider (in-network provider) and certified by the WTC Health Program in order for the member to receive treatment. To qualify for treatment, an enrolled member must meet certain exposure, latency, and symptom onset requirements for conditions. A range of conditions are covered, including but not limited to mental health, aerodigestive conditions, and cancer. There are currently eight (8) Clinical Centers of Excellence (CCEs) in the New York Metropolitan Area (NYMA), and one (1) Nationwide Provider Network (NPN) that administer Program benefits to members. The complex, limited structure of the WTC Health Program poses a unique challenge when managing a member’s pharmacy benefits. The WTC Health Program must ensure that drugs are not being covered for conditions not related to the WTC Health Program, while also not impeding access beyond appropriate limits.

As a limited health care benefit program that is only authorized to cover “medically necessary” treatment, the WTC Health Program has unique formularies with custom drug criteria, as well as unique prior authorization (PA) criteria that make the WTC Health Program unlike any other commercial plan. While the WTC Health Program serves as the primary payer for responders, for survivors the WTC Health Program serves as the payer of last resort and thus must be billed only after all other upstream prescription benefit plans are billed first, including private and commercial insurance, Tricare, Medicare, and Medicaid. Customizability of software and technology platforms are imperative in order to successfully meet the needs and requirements of the WTC Health Program, including the application of widespread custom drug criteria. Customization needs are intensive for the WTC Health Program’s pharmacy formularies and PA criteria, and point-of-sale (POS) edits along with PA automation are utilized heavily to assist with the pharmacy claims adjudication and PA review process. International Classification of Diseases (ICD) codes, various lookback rules, prior claim(s) history, quantity limits, and other potential qualifiers all are utilized and leveraged, which must be customizable to the WTC Health Program and cannot be restricted due to “enterprise”-limited solutions, as the WTC Health Program must operate and satisfy the requirements of the Zadroga Act and its corresponding implementing regulations. Technologies needing specific customization include solutions such as real-time pharmacy benefits checks, prescriber network status checks, electronic PA (ePA) capabilities, smart/automation technologies, any e-prescribing benefits, formulary search tools, formulary and PA criteria, subrogation, any reports and reporting dashboards, call center phone trees and member profile setups, coordination of benefit (COB)-related claims adjudication customizations that allow for restrictions that may be imposed by a primary plan, and any online platforms/portals that the WTC Health Program and its members and clients are expected to use.

In 2023, the WTC Health Program had approximately 475,000 paid pharmacy transactions, about one-third of which was home delivery. In 2023, the WTC Health Program had approximately 35,000 unique members utilize the pharmacy benefit, approximately 24,000 pharmacy prior authorizations, and a separate sizable amount of prior authorization-bypassed claims via successful point-of-sale automation (the approximate number of PA-bypassed claims is currently unknown, but is estimated to account for another 33-50% of pharmacy prior authorizations, https://www.cdc.gov/wtc/laws.html https://www.cdc.gov/wtc/about.html https://www.cdc.gov/wtc/ataglance.html meaning these would add to pharmacy PA volume had there been no POS automation bypass technological solution in place).

For 2024, by the end of the year the WTC Health Program is projected to have approximately 500,000 paid pharmacy transactions (about one-third still being home delivery), approximately 35,500 unique members, approximately 26,500 pharmacy PAs, and an additional 33-50% of these in the form of automated PA-bypassed claims that would otherwise also be PAs if there were no POS automation bypass.

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

“340B Claim” means: (i) claims submitted by 340B contracted pharmacies that adjudicate at a 340B price or are submitted with a submission clarification code of “20” or such equivalent codes for such Participating Pharmacies under the applicable NCPDP format (or any successor format); (ii) claims submitted by a 340B covered entity-owned or 340B contracted pharmacies which are categorized as Type 39 or Type 38 (or such equivalent codes) in the NCPDP DataQ database or otherwise identified as a 340B Claim by the dispensing pharmacy; or (iii) claims identified as a 340B Claim by a third party administrator.

“Abuse” means 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”) means 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” means 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” mean all days excluding Saturdays, Sundays, and designated federal holidays.

“Calendar Days” means all days including Saturdays, Sundays, and designated federal holidays.

“Certification” means 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)” means 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 eight CCEs contracted with the Program: two for the survivor population and six for the responder population.

“Covered Drug(s)” means those prescription drugs, supplies, Specialty Products and other items that are covered under the plan, each as indicated on the Set-Up Forms.

https://www.cdc.gov/wtc/ppm.html#pharmacy.

“Drug Utilization Review (DUR)” means 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.

“Exclusive or Limited Distribution Product” means a Specialty Product that is not generally available from most or all pharmacies but is restricted to select pharmacies as determined by a pharmaceutical manufacturer

“Formulary” means 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” means 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” mean 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” means the date where the PBM is fully operational, independent, and available for use following the implementation period.

“Maximum Allowable Cost (MAC) List” means a 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” means 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.

“Member Submitted Claim” means a paper claim submitted by a Member for Covered Drugs dispensed by a pharmacy for which the Member paid cash.

“Multi-source Brand Drug” means 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)” means 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.

“Participating Pharmacy” means any licensed retail pharmacy with which PBM or one or more of its affiliates has executed an agreement to provide Covered Drugs to Members, but shall not include any mail order or specialty pharmacy affiliated with any such Participating Pharmacy. Participating Pharmacies are independent contractors of the PBM.

“Pass-Through” means the actual ingredient cost and dispensing fee amount paid by PBM for the Prescription Drug Claim when the claim is adjudicated to the Participating Pharmacy, as set forth in the specific Participating Pharmacy remittances related to WTCHP’s claims.

“PBM Mail Pharmacy” means a pharmacy owned or operated by the PBM or one or more of its affiliates, other than a Specialty Pharmacy, where prescriptions are filled and delivered to Members via mail delivery service.

“PBM Specialty Pharmacy” means the PBM’s specialty pharmacy, or another pharmacy or home health agency owned or operated by the PBM or its affiliates that primarily dispenses Specialty Drugs. When the PBM Mail Pharmacy dispenses a Specialty Drug, it shall be considered a PBM Specialty Pharmacy hereunder.

“Personally Identifiable Information (PII)” means 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.

Pharmaceutical Agents: Defined as drugs, biological products, and medical devices under the regulatory authority of the Food and Drug Administration (32 CFR § 199.2).

The Food, Drug, & Cosmetic Act (Food Drug and Cosmetic Act. 21 USC §321) defines drugs in part, by their intended use as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

(Public Health Service Act. chapter 373, title III, §351, 58, Stat. 702, 42 USC §262 (1944).)

The term “biological product” means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component, or derivative, allergenic product, protein, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings (42 USC § 262(i)(1)).

The term “vaccine” means any substance designed to be administered to a human being for the prevention of one or more diseases (26 USC § 4132(a)(2)). Thus, vaccines are a unique class of pharmaceutical products that meet the statutory definition of both a drug and biological product.

“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)” means 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” mean all formulary-related manufacturer revenue and manufacturer administrative fees received by PBM pursuant to a contract negotiated by PBM and directly attributable to the utilization of certain covered benefits by members of the client. Rebates shall also include pharmaceutical manufacturer value applied at the point of sale. In accordance with federal laws and regulations, Rebates do not include product discounts or fees related to the procurement of prescription drug inventories by the PBM Specialty Pharmacy or the PBM Mail Pharmacy, inflation protection payments, fees received by the PBM from pharmaceutical manufacturers or pharmacies for care management or other services provided in connection with the dispensing or adjudication of products; or other fee-for-service arrangements whereby pharmaceutical manufacturers generally report the fees paid to the PBM or its wholly-owned subsidiaries for services rendered as “bona fide service fees” (collectively, “Other Pharma Revenue”).

The PBM will pay to Sponsor 100% of inflation protection payments received specific to WTCHP brand drug utilization. Inflation protection payments are separate and apart from rebates and may be subject to additional terms.

Inflation protection payments are in addition to any rebate commitment listed in the Agreement.

“Recoveries” mean any claims reversals, claims adjustments resulting in a credit back to the Program, claims reimbursements, guarantee shortfalls owed to the Program, effective rate shortfalls owed to the Program, financial recoveries identified from audits, penalties from the Contractor missing performance guarantees, and all other instances where money is owed back to the Program. Recoveries are paid back to the Program in full.

“Responder” means 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.

“Retail Pharmacy Network” means the PBM’s broadest Participating Pharmacy network, covering all 50 United States and its territories.

“Set-Up Forms” means any standard PBM document or form, which when completed by WTCHP (electronic communications from WTCHP indicating WTCHP’s approval of a Set-Up Form shall satisfy the foregoing), will describe the essential benefit elements and coverage rules adopted by WTCHP for its plan.

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 or Specialty Product” means a drug with two or more of the following characteristics:

• Is a biotech or biological drug;

• Is produced through DNA technology or biological processes;

• Is a complex therapy for a complex disease;

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

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

• Requires frequent monitoring or specialized patient training;

• Has limited distribution.

“Survivor” means 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)” means 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” means 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)” means 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 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 twelve-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 - 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.4.1.3 - 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.4.1.4 - 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 mail-order and specialty pharmacy service program, if necessary, that ensures limited disruption.

SECTION C.4.1.5 - 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.4.1.6 - 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.4.1.7 - 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.4.1.8 - 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.4.1.9 - 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 major retailers. At a minimum, the retail pharmacy network will provide 97.5% of member access in urban and suburban geographic locations, 96.5% of member access in rural locations nationwide and ensure:

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

The PBM will notify WTC Health Program and its members of any changes to the pharmacy network that will cause disruption to members 90 days prior to the prospective change; or, if the effective date of such change is less than 90 days, then as soon as reasonably practicable.

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) Expedited delivery, as required, to the member’s home or prescriber’s office, with no additional charge for shipping (e.g., refrigerated or medications requiring special handling, prescription error when applicable);

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.4.2.4.4.

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 4 hours per week.

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

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

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

e) 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.

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

g) The system will allow for customizable messaging to pharmacies at the point of sale in alignment with

NCPDP guidelines.

h) 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.

i) 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.

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.

j) 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.

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

l) 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.

m) 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.

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

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

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

q) 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 other 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.

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. 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 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) Network pharmacy locator

h) Flu-shot reminders

i) PA renewal reminders

j) 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.

e) Website analytics for NIOSH to identify volume and traffic of each link, file, and folder, to assess utilization and helpfulness of resources on the Resource Webpage.

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) The PBM Call Center is staffed for live contact 24/7/365.

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 90%.

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 every other month 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 Health Program shall:

a) Receive a minimum of 40 hours of call center training prior to taking live calls.

b) Receive a minimum of 1 hour of initial training or re-training per year in the specifics of WTC Health

Program.

c) Receive training on an ad-hoc basis as major Program changes are made. WTC Health Program Culture

Training will be a standard component of the PBM’s operations to orient new team members and…