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AMENDED POSTING: Date: April 9, 2020 Reason: Post Responses to Questions and Extend Deadline Date for Responses to May 4, 2020 Request for Information (RFI) Number: 75D301-20-R-67926 TITLE: Request fo... AMENDED POSTING: Date: April 9, 2020 Reason: Post Responses to Questions and Extend Deadline Date for Responses to May 4, 2020 Request for Information (RFI) Number: 75D301-20-R-67926 TITLE: Request for Information – WTCHP Pharmacy Benefits Manager (PBM) SYNOPSIS This is a request for information to gain additional information to supplement the Request for Information (RFI) that was issued by the World Trade Center (WTC) Health Program in October of 2019 (RFI 75D301-20-R-67830). It is not a solicitation for proposals, proposal abstracts, or quotations. Release of this information should not be construed as a commitment to procure items discussed or to incur costs for which reimbursement would be required or sought. WTC Health Program is encouraging vendors of all sizes (large and small business entities) to respond to this RF including all those that have responded previously. WTC Health Program also encourages all interested respondents to review The WTCHP Administrative Manual located at https://www.cdc.gov/wtc/ppm.html prior to constructing their responses to the RFI. This detailed information in conjunction with the written synopsis provides a detailed overview of the essential elements of the current benefit and could be helpful to the vendors in developing RFI responses tailored to the requirements of the program. The purpose of this notice is to identify: Potential Pharmacy Benefits Manager (PBM) pricing structures to increase transparency as well as control and reduce costs for the WTC Health Program; PBM services for administering and operationalizing the WTC Health Program pharmacy benefits; and Potential clinical benefits that PBMs may be able to provide to help improve cost saving measures and formulary management. BACKGROUND On January 2, 2011, the President signed into law the James Zadroga 9/11 Health and Compensation Act of 2010 (Zadroga Act). 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 December 31, 2019, there are a total of 77,752 responders and 24,297 survivors enrolled in the Program. In order to enroll in the Program, survivors and responders must meet certain criteria described in the Zadroga Act (https://www.cdc.gov/wtc/laws.html). The WTC Health Program is a limited benefit program, meaning that treatment is only covered for health condition for which exposure to airborne toxins, hazards, or any other adverse conditions resulting from the September 11, 2001, terrorist attacks. There is a list of applicable WTC-related health conditions that must be diagnosed by a WTCHP provider and certified by the Program in order for the member to receive treatment. In order 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 mental health, aero-digestive, and cancer. There are currently seven (7) Clinical Centers of Excellence in the NYC metro area, and one Nationwide Provider Network that administer the benefits to Members. The complex limited structure of the Program poses a unique challenge when managing a member’s pharmacy benefits. The 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. Current PBM Services The current Pharmacy Benefits Manager (PBM) specializes in worker’s compensation benefits, and the pharmacy benefits are operationally administered in a way that is similar to worker’s compensation. The PBM is responsible for adjudicating pharmacy claims, implementing the pharmacy formulary and point of sale edits, and providing customer service to stakeholders. They also provide and manage the retail pharmacy network, which must be abundant in all 50 states and US territories, as well as a home delivery/mail-order and specialty drug pharmacy. In 2019, the WTC Health Program pharmacy claims expenditures were $111,677,009.80 with 416,288 total claims and 27,345 members utilizing pharmacy benefits. There is significant home delivery use within the program with home delivery penetration at 40.31% in 2019. The PBM provides an external pharmacy adjudication web portal that shows prescriptions processed in real time and routes point of sale edits to the appropriate party, such as the CCE/NPN staff, PBM clinical or customer service team, or CDC. The Program works closely with the PBM to manage operations and processes related to pharmacy benefits and adjudication rules. The PBM also provides some clinical staff to consult on formulary decisions and prior authorizations. The Program is interested in exploring different models for administering and managing the pharmacy benefit as noted in questions below. The PBM also provides a pharmacy claims data system that allows stakeholders to run a variety of reports on pharmacy claims for quality assurance purposes including data analysis for clinical reviews, cost analysis, program and formulary decisions. In addition, the PBM provides quality assurance and fraud, waste, and abuse reports monthly, quarterly, and ad hoc. These include recommendations for cost savings. PBM staff provide general support to the WTC Health Program for clinical, operational, and customer service projects and daily requests. The PBM is also responsible for all customer service related to pharmacy for both members, pharmacies, and CCE/NPN clinical staff. The PBM operates a call center specific to the WTC Health Program. Additionally, the PBM is responsible for distribution of pharmacy cards, and other types of communications developed in conjunction with the WTC Health Program. WTC Health Program Interaction Role and Responsibilities The WTC Health Program oversees all pharmacy operations and develops pharmacy program policies. The Program leads a Pharmacy and Therapeutics Forum quarterly where clinical decisions are presented to stakeholders regarding drug coverage and coverage changes. This is done with the support of the PBM. This process includes implementation of policy changes such as communication to Members. The Program also manages multiple contractors that impact pharmacy. Standard Operating Procedures for pharmacy benefits are also developed by the Program and PBM. Member issues, when escalated, are brought to the Program for resolution. The WTC Health Program conducts and overseas all quality assurance activities related to prescription processing, customer service, and other types of processes. For additional information please consult the World Trade Center Health Program Administrative Manual. REQUESTED INFORMATION Question 1: The WTCHP currently utilizes a Workers’ Compensation-type model whereby members must be pre-certified for a covered medical condition to access prescription benefits under the WTCHP. Prescription benefits are only allowed for a members’ certified condition. This certification occurs through member visits to the Clinical Centers of Excellence (CCEs) and, once established, becomes part of the members’ eligibility records. There are currently five different formularies assigned to members based on their eligibility and certified conditions. Members may be eligible for one or more formularies. Describe Workers’ Compensation-type prescription benefit programs you have or currently administer and the programs’ features. Describe how your firm would operationalize a limited health-prescription benefit by ensuring members are only able to receive medications appropriate for their certified condition (based on formulary requirements established by the WTCHP) through the Program. What process would be utilized for authorizing prescriptions, prior authorizations, and other types of formulary restrictions? Explain whether your eligibility systems allow for real-time updates of member information such as eligibility status and linkage to approved closed formularies. What applications are available for prescription management and eligibility information? Explain whether and how these applications may be accessed and utilized by: Your internal customer support center representatives. External WTCHP administrative staff. External CCE staff. If external access to the applications are available, what forms of training for the utilization of these applications are available? Question 2: WTCHP is open to other overall administrative models whereby the PBM could provide oversight and operational process control in validating that the medications’ criteria have been met (member certification, eligibility, formulary requirements) to allow coverage of medications. Describe how your firm would internalize, standardize, and operationalize prescription coverage validation for the WTCHP to ensure eligibility and clinical requirements have been met for access to a medication. Describe the channels (i.e. WEB portals, user interfaces, support desk) available to CCEs and/or WTCHP to submit member information to your firm to complete a validation. Explain to what extent the Program’s existing formularies could be integrated into your existing formularies and whether there would be limitations in maintaining the Program’s current customized formularies. Of the functions in a through c above, explain if there are any operational aspects that your firm could not internalize and would have to be maintained by WTCHP. Detail which of the above functions would be performed internally under your existing operations and which of these functions would be outsourced to an outside entity. Question 3: Coordination of Benefits (COB) is a key aspect of the WTCHP prescription benefit in which our responder member classification has a primary benefit under the program and our survivor member classification has a payer-of-last-resort benefit under the program. a. Describe your system’s functionality and your procedures for processing COB prescription claims, whereby the member’s primary insurance is billed first, and the WTC Health Program would be billed as the payer-of-last-resort insurance at the point of sale (in the case of the survivor member classification). What process would be used for exceptions to this policy (i.e. someone does not have primary insurance, or primary insurance does not allow for COB)? b. Detail the information/data and data format required to maintain this COB information. c. Explain how often this information may be updated or refreshed within your system. d. 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 or reject a subsequent claim with the same or similar criteria. e. Explain whether you have the current capability to update member COB information within your platform in real-time and whether these applications may be accessed and utilized by: Your internal customer support center representatives. External WTCHP administrative staff. External CCE staff. f. If external access to the applications are available, what forms of training for the utilization of these applications are available? g. Detail any additional services you provide to facilitate coordination of benefits for those members that do have primary insurance on record to assist them in the utilization of that insurance to obtain their prescription. Question 4: WTCHP maintains a closed panel of approved physicians that also have designations for the conditions they are approved to treat under the program. Describe your system’s functionality and your procedures for maintaining a closed panel of physicians and information detailing the conditions and the associated formulary drugs they are permitted to prescribe. Detail the information/data and data format required to maintain this information. Explain how often this information may be updated or refreshed within your system. Explain whether you have the current capability to update physician information within your platform in real-time and whether these applications may be accessed and utilized by: Your internal customer support center representatives. External WTCHP administrative staff. External CCE staff. If external access to the applications are available, what forms of training for the utilization of these applications are available? Question 5: WTCHP maintains five specific drug formularies containing medications that members are eligible for based on their certified medical health conditions. In some instances, these formularies contain the same drug products, but different utilization management criteria for these products from formulary to formulary. Describe your formulary management process and ability to administer client specific formularies that are tied to member eligibility under a certified condition. Detail the process that would be utilized to update the formularies with additions and deletions of medications over time. Explain how and whether the formularies with differing utilization management criteria assigned to the same drug from formulary to formulary can be administered within your programming and the edits that would apply to such drug claims through your claim’s adjudication process. Describe the Pharmacy and Therapeutics support such as new drug reviews, therapeutic class reviews, and recommendations your firm could provide to the program. Explain how restrictive formularies could benefit the program in terms of cost-savings generated through generic steerage, preferred/limited manufacturer products within therapeutic class categories, prior authorization, step therapy, and pharmaceutical manufacturer rebates. Question 6: Communications with the network pharmacy providers (i.e. retail, mail service, specialty) regarding member eligibility, COB, drug coverage, utilization management (quantity limitations, step therapy, and prior authorization), and physician eligibility via messaging through the pharmacy claims adjudication platform is an important aspect of providing the benefit. The ability to provide timely overrides to rejected claims is also a key functionality desired to minimize disruption in service to WTCHP members. Detail whether and what types of custom messaging may be provided through your claims adjudication platform to address the unique program circumstances or issues that may be causing a claim to reject so that pharmacy personnel may troubleshoot an issue and/or provide information to the program’s members to assist in the resolution of the rejected claim. Describe the types of edit override capabilities that may be made available at the pharmacy to permit a rejected claim to be processed. Describe the authorization processes that could be utilized to permit a rejected claim to process. Explain whether the current capability exists to override edits and adjust authorizations within your platform in real-time and whether these applications may be accessed and utilized by: Your internal customer support center representatives. External WTCHP administrative staff. External CCE staff. If external access to the applications are available, what forms of training for the utilization of these applications are available? Question 7: A customer service center (call center/helpdesk) with knowledgeable representatives that are well trained in the specifics of the WTCHP; that are accessible; can provide accurate and timely information to members, physicians, pharmacies, CCE staff and WTCHP staff; and can resolve issues quickly is vital to the success of the program. Describe the features of your customer service center along with its hours of availability and the systems, applications, and other features that would benefit WTCHP. Detail the training requirements and ongoing training that your customer service representatives would receive for new programs such as WTCHP. Explain whether you are able to provide a unique dedicated customer service center phone number for WTCHP members, providers, physicians, and staff that would identify to the customer service representatives that a WTCHP associated user is calling. Explain whether you are able to provide a dedicated automated voice response system message chain that has customized instructions specific to WTCHP associated users and the benefit design when the call enters the system from a dedicated phone number? Explain whether a provider could call a customer service center in advance of writing a prescription for a member to determine whether the provider is eligible to write the prescription for the medication desired, whether the member is eligible for coverage, and whether there are any formulary restrictions for the medication. When a program member calls the customer service center for mail order or specialty pharmacy services, explain whether the center can perform a warm transfer of the call to the desired entity. Question 8: The utilization of e-prescribing platforms to transmit prescriptions from physicians to pharmacies can greatly enhance the efficiency of the prescription benefit by ensuring an eligible member receives an approved formulary medication from a physician that is eligible to prescribe the medication and any benefit design requirements are met prior to the adjudication attempt of the prescription by the pharmacy. Describe the e-prescribing strategy, tools, and interface your firm would recommend and utilize and detail how they would be used to confirm the physician and member eligibility and the coverage of the prescription medication within the transfer protocol of the prescription to a network pharmacy. Explain the forms of training and resources you would make available to WTCHP CCEs and physician providers in the instruction and use of e-prescribing to transmit prescriptions to network pharmacies. Question 9: Mail service pharmacy and specialty pharmacy options are important for member convenience, clinical service, and program cost savings. Provide an overview of your mail service and specialty pharmacy capabilities. Discuss whether your mail service and your specialty pharmacies are wholly owned or your firm partners with other vendors to provide these services. Discuss how utilization of these services in conjunction with the design of the prescription benefit can lead to cost savings in overall prescription drug spending. Explain whether you are able to provide a unique dedicated mail order and/or specialty pharmacy phone number(s) for WTCHP members, providers, physicians, and staff that would identify to the mail order and/or specialty pharmacy service representatives that a WTCHP user is calling. Explain whether you are able to provide a dedicated automated voice response system message chain when the mail order and/or specialty pharmacy is called directly that has customized instructions specific to WTCHP users and the benefit design when the call enters the system from a dedicated phone number? Question 10: Ease of use of the benefit for our members is an important goal for the program. Explain whether you can provide Web addresses/Web portals that are specific and customized to the program for general prescription benefit information, mail service pharmacy ordering, and specialty pharmacy ordering. Describe the mobile/tablet applications that are available to members, the type of information that can be accessed through the apps, and the member action that can be achieved through these apps such as pharmacy locators, formularies, and ordering. Question 11: Providing the WTCHP benefit to our respondent and survivor members by the most cost-advantageous methodology is essential to the mandate of this program. Discuss whether and how you have implemented Federal Supply Schedule (FSS) pricing for qualified Federal clients and the comparative impact this had to the overall cost of the benefit, such as the percent of annual drug spending improvement including and any savings generated relative to other price options. Explain how you would implement FSS pricing within the structure of the WTCHP prescription benefit. Discuss other price methodologies you make available for prescription benefit services, for example, prices and discounts pegged to price bases such as Average Wholesale Price (AWP), National Average Drug Acquisition Cost (NADAC), and/or Wholesale Acquisition Cost (WAC). Explain the advantages to the WTCHP of a traditional pricing model as well as a transparent pricing model. Explain the price methodology you recommend to WTCHP based on your understanding of the program. (Please detail the reasons and rationale that supports your recommendation). Explain how your firm includes and/or prices administrative costs for the processing of claims eligible for COB into the overall cost of services. Several of the CCEs operate retail pharmacy establishments. Discuss whether there may be aspects of the Program that could benefit from the 340B Drug Pricing Program and whether your firm could integrate this into the WTCHP benefit to achieve a greater level of cost savings for the Program. Question 12: Reliable and dependable account services will be necessary to assist in quality assurance monitoring, problem resolution, and program improvement. Discuss the role your account services representative would take in serving WTCHP. Would you provide a clinical account service representative in addition to the account services representative and if so, what roles would they take and what value could they add to the program? Explain whether these representatives would be available to spend time with WTCHP personnel to receive background training, meet with staff at the CCEs/NPN, and participate in meetings regarding benefit performance and process improvements as a standard part of serving the program. In addition to account services and clinical representative support, detail any other specialized support personnel that your firm provides to its accounts such as a liaison for home delivery services and for specialty pharmacy services, data analysts, physicians or other medical personnel, training specialists, and also discuss when higher-level management is available for critical support and time-sensitive problem resolution. Question 13: Reporting capabilities and functionality for monitoring the program is important in the continuous improvement of the program performance for our members. Please describe your data systems and reporting capabilities for drug utilization and cost projections. Detail whether you provide standard reporting and what would be included. Describe your client accessible portals and user interfaces including the frequency data is loaded into these applications. Describe if your user interfaces allow client users the ability to customize the report information and data formatting. Question 14: Controlling for potential fraud, waste, and abuse (FWA) within the benefit is an important goal of the program. Detail your FWA detection and prevention strategies and programs you utilize to control for potential gaming of the benefit. Which of these programs would be included within the provision of benefits for WTCHP? Question 15: Communication services to members are a requirement of the program. Explain the capability of your firm to provide communication services, such as development and mailing of pharmacy cards and other types of member communications? INSTRUCTIONS Questions about the RFI are due by 9AM EST on April 3, 2020, via email to Lauren Peel at ijt9@cdc.gov. Interested parties are requested to respond to this RFI with a white paper. White papers are due by 9AM EST on April 27, 2020, to Lauren Peel at ijt9@cdc.gov. White papers should list each question identified above and provide the accompanying response immediately following. Interested parties may provide a general corporate capabilities statement in addition to your white paper. Please do not submit a capabilities statement without an accompanying white paper. Capabilities statements should be limited to two (2) pages. Section 1 of the white paper shall provide administrative information, including: Company Name, mailing address, phone number, and name and contact information of designated point of contact; DUNS; Business type (small, large, 8(a), women-owned, etc.); Relevant NAICS code proposed for any contract that may follow; and Participation in a GSA Schedule or other government-wide vehicle that may be applicable for this requirement.