2.PBMSourcesSought_3Year_Final_Sam.Gov.pdf

World Trade Center Health Program

Sources Sought

CDC WORLD TRADE CENTER

(WTC) HEALTH PROGRAM

PHARMACY BENEFITS

MANAGER

SOURCES SOUGHT

75D301-25-SS-

524292

RESPONSE DUE

DATE: February 14, WTC HEALTH PROGRAM

75D301-25-SS-524292

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

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

The Centers for Disease Control and Prevention (CDC) is issuing this sources sought notice as a means of conducting market research to identify parties having an interest in and the resources to support this requirement for the operationalization of a three-year Pharmacy Benefits Manager to administer pharmacy benefits for a limited health care benefit program (the WTC Health Program). The Program anticipates a transition-in (implementation) period not to exceed 12 months, plus one year of full operations post-go-live, with a transition-out period not to exceed 12 months in the final option period (third contract year). The result of this market research will contribute to determining the method of procurement. The applicable North American Industry Classification System (NAICS) code assigned to this procurement is 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds.

There is no solicitation at this time. This request for capability information does not constitute a request for proposals or quotes. Submission of any information in response to this market survey is purely voluntary; the Government assumes no financial responsibility for any costs incurred.

Program 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.

https://www.cdc.gov/wtc/laws.html https://www.cdc.gov/wtc/about.html https://www.cdc.gov/wtc/ataglance.html

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, 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

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, 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, 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.

Submission Details Please review each section and questions below, and tailor your responses and capability statements addressing the particulars of this effort (see attached draft PWS), with appropriate documentation supporting claims of organizational and staff capability. The response must address at a minimum the following items below.

A. System Customization As a limited benefit health plan that is only authorized to cover “medically necessary” treatment related to certified WTC-related health conditions, the WTC Health Program has unique formularies with custom drug criteria, as well as unique prior authorization (PA) criteria. One example of this is a drug on our standard formulary may be covered for one member but not for another member despite being on the same standard formulary. 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 dashboard visualizing, 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 prescriptions management. In response to this Sources Sought, please answer each of the following prompts:

1. Service Implementation: How would you ensure full implementation of system customization, as detailed above, within the transition-in year of this 3-year contract?

2. Transition-In Capabilities: What is your approach to transitioning into a new PBM contract that requires significant system customizations and technological builds, and how long would it take to achieve full operational readiness? Please provide examples of successfully completed transitions under one (1) year.

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health,

3. Transition-Out Capabilities: How would you manage transitioning out of the contract at the end of three (3) years while ensuring continuity of care and effective data transfer to the next vendor? Will your company be able to transfer data and logic of customized builds used to meet the WTC Health Program’s benefit design to a successor PBM so that they can replicate the customizations logic required for the WTC Health Program?

4. Specific Technical Capabilities (Experience in PBM Services):

a. Detail can your company utilize Medi-Span to load drug indicators and drug cost data? The WTC Health Program utilizes Medi-Span as the source of truth for brand/generic determinations and drug costs.

b. For therapeutic classifications, can your company utilize First Data Bank (FDB)’s 3-character codes to obtain the most specific drug classifications? If not, what does your company use to pull therapeutic category data?

c. 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.

d. 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 for survivors 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)?

e. How does your company work with ePA platforms to ensure specific pharmacy benefit formularies and rules are integrated in the ePA software? Can your company get ePA platforms to correctly display drug formulary information down to the specific health plan’s formularies? If this kind of application does not exist yet, please explain.

f. What is your company’s involvement and role in performing subrogation? What technologies do you leverage for the subrogation process?

g. Does your company prospectively identify what primary/other health insurance (OHI) members have? If so, please describe the process for how this works in your company, and how this obtained OHI is communicated to pharmacies and your health plan sponsors.

h. 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.

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health,

i. 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.

j. 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 operational environment would be.

5. Key Challenges: What challenges do you anticipate in ensuring full implementation of the above WTC Health Program needs for a 3-year contract, and how would your organization address them?

B. Customer Care Services, Pharmacy Network, and Communications The current 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 Sources Sought, please answer each of the following prompts:

1. Specific Technical Capabilities (Experience in PBM Services):

a. Describe how 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, and to what extent they refrain from asking the member to be the middle person to advocate for themselves or to relay a message.

b. How does your company adjust to pharmacy closures and pharmacy walk-outs/strike pressures while still ensuring member access?

c. How does your company communicate network changes, drug shortages, and other issues along with action plans and resolutions to various audiences, (e.g., clients, providers, and members)?

d. Describe your company’s capabilities in developing, customizing with your health plan sponsors, 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.

2. Service Implementation:

a. Continuity of Care: What measures would you implement to ensure uninterrupted member services during the transition-in period? What about the transition-out period?

b. Resource Allocation: Do you have the necessary personnel, infrastructure, and resources to deliver high-quality PBM call center services, communications, and

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, pharmacy network management within the first year of transitioning in, and for the remaining two years of the 3-year contract?

3. Key Challenges: What challenges do you anticipate in ensuring full implementation of viable call centers, an operational communication plan, and an effective pharmacy network within the first year of a 3-year contract? How would your organization address these challenges?

C. Clinical Services and Utilization Management The current 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 Sources Sought, please answer each of the following prompts:

1. Specific Technical Capabilities (Experience in PBM Services):

a. How does your company leverage utilization and pharmacoeconomics data that lead to cost containment for your health plan sponsors? Please provide specific examples.

b. Detail your company’s strategy and involvement in the removal of wasteful drugs from the formulary, performing cost/dose optimization, performing high-cost generic interchange, and administering specialty medication utilization programs. How successful or not successful have your strategies in these areas been, and why?

2. As mentioned in Section A – System Customization, the WTC Health Program’s formularies along with drug criteria and automation require tremendous customization, therefore the systems architecture/engineer/pharmacy IT side of your company needs to be extremely agile and work very closely or be integrated with your clinical services team.

a. Resource Allocation: Do you have the necessary personnel, infrastructure, and resources to deliver high-quality PBM clinical, formulary, and utilization management services for the entire duration of the 3-year contract?

b. Key Challenges: What challenges do you anticipate in performing the above WTC Health Program clinical services and utilization management needs for a 3-year contract, and how would your organization address them?

D. Reporting The current WTC Health Program PBM provides extensive reporting capabilities that support the WTC Health Program and its clients (CCEs, NPN, HPS/TPA, HPE, DCs), and provides all labor, materials, technologies, equipment, and contractual agreements and capabilities to manage

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, pharmacy benefits administration services to include standard and custom reporting. In response to this Sources Sought, please answer each of the following prompts:

1. Specific Technical Capabilities (Experience in PBM Services):

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 (if any of the below is not possible, please explain why):

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

ii. Zero-balance due claims are disallowed as a part of any claims reporting, PBM performance, and pricing/performance guarantees; and

iii. All claims data shall at a minimum include:

1. date of service (DOS),

2. listed average wholesale price (AWP) on the DOS,

3. discounted AWP,

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

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

6. plan cost,

7. reimbursed amount back to the pharmacy,

8. manufacturer-derived revenue,

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

10. 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 sponsor actually pays), and not the U&C price or AWP.

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, The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, then the associated 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 training and support to the WTC Health Program and its clients (CCEs, NPN, HPE, DCs). 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.

2. Capacity to Meet Requirements: Can you fully meet the claims reporting requirements summarized within the transition-in year and for the remaining two years of the 3-year contract, including reporting all claims data down to the minimum level specified in subsection D. 1. b.?

E. Cost Control The WTC Health Program seeks to administer its pharmacy benefit effectively while paying the lowest overall cost, with the acknowledgement that PBMs need to make money. In response to this Sources Sought, please answer each of the following prompts:

1. Experience in PBM Services:

a. 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 detail how your company has been preparing for and adjusting to PBM reform legislation and laws. Specifically, these regulatory reforms have been targeting increased PBM transparency on pricing tactics, curbing exorbitant PBM profits, while trying to provide more help to members, pharmacies, and health plan sponsors.

b. What is your company’s average annual Earnings After Cash Disbursement (EACD) for a pharmacy benefit managed by your company that is comparable to the WTC Health Program’s complexity and membership size?

c. What is your company’s average per utilizing member per month for a pharmacy benefit managed by your company that is comparable to or even older than the WTC Health Program’s membership? The WTC Health Program population is aging; the average age of Responders is around 61, while the average age of Survivors is around 64.

d. 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 COB scenarios when other health insurance plans

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, require a Brand drug to be dispensed but 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.

F. Interest/Wrap-Up

1. If you were able to answer in detail all the sections above, please indicate if you are interested and able to perform PBM services under this three-year contract. If interested, please explain how your organization is uniquely suited to succeed under these conditions.

2. Risk Mitigation: What risk mitigation strategies would you implement to ensure a successful 3-year contract execution, including transitions in and out?

3. Only interested and capable vendors—please note the following and provide:

a. Your company profile to include number of employees, annual revenue history, office locations, DUNs number, etc.

b. The contract type is anticipated to be blended Firm Fixed Price CLINs for the

Implementation and Transition Out while Time & Materials with a Per Member Per Month (PMPM) CLIN. PMPM tasks have a fixed rate and ceiling, with a total cost based on the number of members utilizing pharmacy benefits. If you believe this contract type may not be feasible, please provide an alternative contract type along a justification for your recommendation.

c. If you have a suggested optimal CLIN structure for the contract, that you consider suitable, kindly provide it along with your reasoning in your response to this notice.

d. Please include in your response your ability to meet the requirements in the Facility and Safeguarding requirements.

e. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

f. Please note that under a Small-Business Set-Aside, in accordance with FAR 52.219- 14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Provide an explanation of your company’s ability to perform at least 50% of the tasking described based on the above mentioned Program Background and Required Capabilities.

3) The anticipated NAICS for this requirement is 524292 - Pharmacy Benefit Management and Other Third Party Administration of Insurance and Pension Funds. If your company believes another NAICS would be more appropriate, please provide that NAICS and the rationale for the recommendation.

The Government will evaluate market information to ascertain potential market capacity to 1) provide services consistent in scope and scale with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; and 3) implement a successful project management plan that includes:

The World Trade Center Health Program is administered by the National Institute for Occupational Safety and Health, compliance with program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation.

Based on the responses to this sources sought notice/market research, this requirement may be set-aside for small businesses or procured through full and open competition.

Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

Submission Instructions: Interested parties who consider themselves qualified to perform the above-listed services are invited to submit a response to this Sources Sought Notice by 5:00 pm ET February 14, 2025. All responses under this Sources Sought Notice must be emailed to Contract Specialist, Laurie Presley at xnp0@cdc.gov. Please include “WTC Health Program | 75D301-25-SS-524292” in the subject line. If you have any questions concerning this opportunity, please contact the Contract Specialist.

mailto:xnp0@cdc.gov