PBM_RFI_20240404.docx

WTC HEALTH PROGRAM

RFI 75D301-24-RFI-PBM

World Trade Center Health Program Request for Information

CDC WORLD TRADE CENTER (WTC) HEALTH PROGRAM PHARMACY BENEFITS MANAGEMENT

REQUEST FOR INFORMATION

75D301-24-RFI-PBM

RESPONSE DUE DATE:

12 PM Eastern, May 2, 2024

Title: CDC World Trade Center (WTC) Health Program Pharmacy Benefits Management

This Request for Information (RFI) is issued solely for information and planning purposes and is not a solicitation for proposals, proposal abstracts, or quotations. Release of this RFI shall not be construed as a commitment to procure items or services. Responses are not offers and cannot be accepted by the Government to form a binding contract. The Government will not pay for any information or administrative cost incurred in response to this RFI; all associated costs with responding to this RFI is solely at the respondent’s expense. Respondents should indicate which information in their response they consider to be proprietary. Responses will assist the Government in the development of its acquisition strategy, including the determination of small business capabilities and interest in any possible future acquisition.

I. Purpose The World Trade Center (WTC) Health Program requests information from Pharmacy Benefits Managers to identify and provide insight into:

1) Benefits and drawbacks of various pricing mechanisms, especially within the context of keeping prices competitive throughout a potential 10-year contract and in the landscape of increasing regulatory pressures on PBM reform.

2) Emerging and existing technical and operational solutions that can be leveraged to optimize efficiency of pharmacy benefits management and/or member health outcomes.

II. Background The WTC Health Program was established by Title I of the James Zadroga 9/11 Health and Compensation Act of 2010, 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). All references to the Administrator in this document mean the Director of the National Institute for Occupational Safety and Health (NIOSH) within the Centers for Disease Control and Prevention (CDC), or his or her designee. Information on the WTC Health Program is available at http://www.cdc.gov/wtc. High-level Program statistics can be found at https://www.cdc.gov/wtc/ataglance.html.

The WTC Health Program provides monitoring, screening, and treatment (medical and pharmacy) to 9/11 Responders and Survivors. Specifically, the WTC Health Program is a limited benefit health plan, meaning that treatment is covered for only specified health condition(s) resulting from exposure to airborne toxins, hazards, or other adverse conditions arising from the September 11, 2001, terrorist attacks. An internal provider enrolled with the WTC Health Program must diagnose a member with a WTC-related health condition and determine that it is related to the member’s 9/11 exposure. The determination must then be certified by the WTC Health Program for the member to receive treatment. An enrolled member must meet certain exposure, latency, and symptom-onset requirements for their health condition to be certified. A range of conditions are covered, such as mental health, aero-digestive, and cancer. There are currently eight (8) Clinical Centers of Excellence (CCEs) in the New York City (NYC) metropolitan area, and one Nationwide Provider Network (NPN) that administer the 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 drugs are covered only for certified WTC conditions, while also not impeding access, within appropriate limits.

As a limited benefit health plan 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. 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. As the average age of Responders is around 61 and average age of Survivors is around 64, the uniqueness and complexity of the WTC Health Program requires deep expertise, age-related competence, and patience in communicating with WTC Health Program’s aging members the nuances with their health insurance, as well as coordinating payer order in the case of Survivors.

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 prior authorization (PA) criteria, and point-of-sale (POS) 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 WTC-related conditions and rules of the Zadroga Act. Technologies needing specific customization include solutions such as real-time pharmacy benefits checks, prescriber network status checks, 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 benefits (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. The WTC Health Program had approximately 35,000 unique members utilize the pharmacy benefit, and approximately 24,000 pharmacy prior authorizations adjudicated in 2023.

III. Information Requested The WTC Health Program is interested in receiving comments and relevant, evidence-based information addressing each of the areas listed below.

1. Cost Control The WTC Health Program intends to solicit a 10-year Pharmacy Benefits Management (PBM) contract. Recognizing the fluidity of the market, the WTC Health Program seeks information and cost/benefit analyses on available pricing methods and formulas that will provide the PBM sufficient resources to meet established performance standards, while allowing the WTC Health Program to pay the lowest overall cost. In response to this RFI:

a. Describe how your company would ensure drug prices and plan cost remain competitive for the WTC Health Program throughout a potential 10-year contract.

b. Describe the methods and means by which your company serves as a 100% passthrough, fully transparent and fiduciary PBM to your health plan sponsors. Describe your company’s suggested pricing model to serve as a 100% passthrough, fully transparent and fiduciary PBM. If your company is not a fiduciary PBM, describe specifically the benefits to the Government your company can provide that are only possible through the traditional model, and describe the long-term outlook of this model over a 10-year contract in consideration of ongoing and increasing regulatory pressures on PBM reform. PBM reform is happening at both the state and federal level. Some states have already enacted their reform laws over the past several years, such as West Virginia[footnoteRef:2] and Georgia[footnoteRef:3], while others such as New York[footnoteRef:4] are currently undergoing their new proposed PBM reform legislation changes, and even others such as Florida[footnoteRef:5] have just recently implemented their own PBM reform legislation. Pressure has been mounting as well on the federal level[footnoteRef:6]. In general, the goals of these regulatory reforms are increased member choice, increased access to pharmacies, increased PBM transparency, and increased control on PBM pricing tactics. [2: See West Virginia Legislature, at: https://www.wvlegislature.gov/Bill_Status/bills_text.cfm?billdoc=HB2263%20SUB%20ENR.htm&yr=2021&sesstype=RS&i=2263#.] [3: See Rules and Regulations of the State of Georgia, at: https://rules.sos.ga.gov/gac/120-2-97.] [4: See New York State Department of Financial Services Proposed, at: https://www.dfs.ny.gov/system/files/documents/2023/08/rp_ins_a3reg219_a1reg224_226_227_228_229_text.pdf.] [5: See Florida Senate Legislature, at: https://www.flsenate.gov/Session/Bill/2023/1550/BillText/er/PDF.] [6: See United States Senate Committee on Finance, at: https://www.finance.senate.gov/chairmans-news/wyden-crapo-call-for-swift-passage-of-bipartisan-pbm-reforms.]

c. Identify and describe mechanisms available, including if your company integrates with any third party/subcontractor, or other creative solutions to perform automatic pricing comparisons to ensure that the WTC Health Program always pays the lowest available for any given drug through “lesser-of” logic for claims at the point-of-sale (POS), including application of POS rebates. Detail whether your company’s solutions are compatible with scenarios when other health insurance plans require a Brand drug to be dispensed in the case of coordination of benefits (COB) and when the WTC Health Program requires the generic. If applicable, identify differences (either required or recommended) in approach for retail, home delivery, and specialty pharmacy pricing comparisons.

2. System Customization As a limited benefit health plan 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. The WTC Health Program requires customizable automation and PA bypass technology to leverage ICD codes, various lookback rules, prior claim history, quantity limits, and other potential qualifiers in accordance with WTC Health Program requirements. Additional technologies needing specific customization include solutions such as real-time pharmacy benefits checks, prescriber network status checks, ePA capabilities, smart/automation technologies, any e-prescribing software interfaces, formulary search tools, formulary and PA criteria, subrogation technology, any reports and reporting dashboards, call center phone trees and automated voice response systems, COB adjudication that allows for restrictions which 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, such as for eligibility information and prescription management. In response to this RFI:

a. For Responder claims, explain whether your application can store information from prior claims that were determined to be eligible for billing under a member’s primary insurance and use that information to block, reject, or count towards any lookback/step therapy rules for a subsequent claim billed to the WTC Health Program. If this kind of application does not exist yet, please explain.

b. For Survivor claims, describe your company’s system functionalities and procedures for processing COB prescription claims, whereby the WTC Health Program serves as the payer of last resort and thus is billed only after all other upstream prescription benefit plans are billed first, including private and commercial insurance, Tricare, Medicare, and Medicaid. What process would be used for exceptions to this policy (e.g., a survivor does not have primary insurance, or primary insurance does not allow for COB)?

c. Some of WTC Health Program’s CCEs/NPN may operate their own retail and specialty pharmacy establishments. Describe whether your company could incorporate any aspect of the 340B Drug Pricing Program to the WTC Health Program, and how this integration would help the WTC Health Program achieve a greater level of cost savings. If this type of 340B Drug Pricing integration is not available, please explain.

d. Describe the extent your company can customize your technical solutions to allow the WTC Health Program to leverage industry best practices and enterprise vendor solutions, while also accommodating the WTC Health Program-specific requirements mentioned above. If any of the above WTC Health Program needs cannot be met, please explain why and provide your company’s proposed solutions instead.

e. Describe the process and timeframes for developing, testing, and implementing ongoing changes to your company’s technical solutions, after initial system go-live.

f. Explain if your company can provide a fully operable test environment for all electronic platforms and portals the WTC Health Program and its members and clients are expected to use, such that the test environment acts, appears, and behaves exactly like what the live environment operations would be.

3. Continuous Improvement The WTC Health Program is committed to achieving efficient and member-centered administrative and clinical healthcare services and outcomes, and seeks innovation and continuous improvement through both process re-engineering and new technologies. Specific areas of interest include decreasing manual interventions in PA processing, increasing medication adherence, and increasing successful coordination of benefits. In response to this RFI:

a. Describe how your company would ensure continuous improvement and help the WTC Health Program benefit from changes in the industry and provide examples of your company’s performance in this area.

b. Describe how your company performs data analytics to identify potential fraud, waste, and abuse, and/or to inform future coverage determination recommendations or process improvements to your health plan sponsors. Provide examples of your company’s performance in this area.

4. Communications The WTC Health Program PBM works with 8 Clinical Centers of Excellence (CCEs) and 1 Nationwide Provider Network (NPN) to coordinate pharmacy care for WTC Health Program members in all US states and territories. In response to this RFI:

a. Describe how your company identifies issues (e.g., network change, drug shortages) and when and how you communicate such issues (and their operational resolutions) to various audiences (e.g., clients, providers, and members). Identify and describe any differences in approach for issues involving an individual versus a group of individuals. Please address both network changes and drug shortages, and also detail these communications plans as pertained to home delivery and specialty pharmacies.

b. Describe your company’s experience with communicating with older individuals (55+) about their pharmacy benefits and changes to coverage, and how that approach differs from communications with younger individuals. The WTC Health Program population is aging; the average age of Responders is around 61, while the average age of Survivors is around 64.

c. Describe your company’s capabilities in developing and mailing general and member specific letters, such as prescription benefit cards, prior authorization outcomes letters, brand to generic letters, and other types of member communications.

5. Customer Care Services and Pharmacy Network The WTC Health Program PBM provides extensive customer call center capabilities that support all US states and territories, and provides all labor, materials, technologies, equipment, and contractual agreements and capabilities to manage pharmacy benefits administration services to include customer care and maintaining a pharmacy network. In response to this RFI:

a. Describe whether your company’s internal customer service representatives from different service departments (e.g., for members, pharmacies, providers, and clients) all directly collaborate with each other in resolving member or prescription issues, instead of asking the member to be the middle person and relaying a message.

b. Describe how your company prepares and adjusts to pharmacy closure and walk-out/strike pressures, and how your company still ensures member access.

6. Clinical Services and Utilization Management The WTC Health Program PBM provides clinical services such as formulary management and utilization management, and provides all labor, materials, technologies, equipment, and contractual agreements and capabilities to manage pharmacy benefits clinical services such as reviewing and adjudicating drug-specific PAs, performing various utilization management activities, customizing formulary and drug criteria based on WTC Health Program requirements, and participating in the data collection, analysis, preparation, content creation, and making select presentations in the World Trade Center Health Program Pharmacy and Therapeutics (P&T) Forums. In response to this RFI:

Describe how your company uses utilization and pharmacoeconomics data that lead to cost containment for your health plan sponsors, such as removal of wasteful drugs from the formulary, and leveraging cost/dose optimization, high-cost generic interchange, and specialty medication utilization programs. If available, provide examples of your company’s performance in these areas.

7. Reporting The WTC Health Program PBM provides extensive reporting capabilities that support the WTC Health Program and its clients (CCEs/NPN), and provides all labor, materials, technologies, equipment, and contractual agreements and capabilities to manage pharmacy benefits administration services to include standard and custom reporting. In response to this RFI:

a. Detail your company’s standard and custom reporting availabilities, and real-time, client-facing, interactive and perpetual reporting dashboard capabilities. Describe how often the data is refreshed/updated, and the degree to which filters and adjustments can be made by your company’s health plan sponsors to visualize different trends, such as by different drug classes, by top spends, by brands or generics, by different member groups, and by specific clinics or practices. Provide examples of current reporting dashboards and reporting your company offers to your health plan sponsors.

b. Describe your company’s capability to provide all claims data reporting down to the claims level, by detailing your company’s ability to comply with all of the following WTC Health Program requirements:

(1) All claims from all reporting platforms must indicate which prescriber/prescribing entity (e.g., CCE/NPN) the member is with, and whether the drug is designated as a cancer or non-cancer drug.

(2) Zero-balance due claims are disallowed as a part of any claims reporting, PBM performance, and pricing/performance guarantees

(3) All claims data shall at a minimum include:

i. listed average wholesale price (AWP) on the date of service (DOS),

ii. discounted AWP,

iii. Maximum Allowable Cost (MAC) on the DOS,

iv. Usual and Customary (U&C) price on the DOS,

v. plan cost,

vi. reimbursed amount back to the pharmacy,

vii. manufacturer-derived revenue,

viii. which prescriber/prescribing entity (e.g., CCE/NPN) the claim is associated with, and

ix. whether the claim was for a cancer drug or non-cancer drug.

c. Describe your company’s capability of reporting cost savings data based off the actual contracted pricing rates with your health plan sponsor (aka what the health plan actually pays), and not the U&C price.

d. Describe your company’s capability of reporting utilization metrics related to online platforms/applications that the WTC Health Program and its members, providers, and clients are expected to use. For example, if clients are expected to reference various guidance documents or process forms on the PBM’s online resource portal, then metrics to analyze how often these various documents are opened and from which CCEs/NPN should be available.

e. Describe your company’s ability to provide reporting support to the WTC Health Program and its clients (all 8 CCEs and the NPN). Include details on any data analytics support, reports customizing support, data visualization requests, and custom report templates that could be utilized by the WTC Health Program and its clients.

IV. Instructions for Submission

1. Page limit: fifteen (15) single-spaced pages with a minimum 10-point Times New Roman font, to address every set of questions (1, 2, 3, 4, 5, 6, and 7) listed in Section III. Information Requested. (Note: any pictorial examples or attachments provided in support of descriptive responses do not count towards this page limit.)

2. Questions Due By: April 12, 2024 at 12pm Eastern

3. Interested parties should respond to this RFI with a white paper by 12 PM Eastern on May 2, 2024, to Michael Baron at lpc0@cdc.gov. Please include “WTC Health Program | RFI 75D301-24-RFI-PBM” in the subject line.

4. Page 1 of the white paper shall include the chart below, completed by your organization:

Company Name

Company Address

Unique Entity ID (UEI)

Primary Point of Contact Name

Primary Point of Contact Email

Primary Point of Contact Phone Number

Business Type (large business, small business, nonprofit, minority- or woman-owned, etc.)

GSA or other Federal Schedule Awards

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, part of the Centers for Disease Control and Prevention image1.jpeg image2.jpeg