Amended to include Questions and Answers. Request for Information Tentative Period of Performance: June 1, 2025 – May 31, 2030 T itle: ICATT Pharmacy Services SECTION 1 – BACKGROUND At the start of the COVID-19 pandemic, the Increasing Community Access to Testing (ICATT) program contracted with pharmacies to provide community pharmacy and surge sites maintained through a public-private partnership with various national pharmacy chains, independent pharmacies, and laboratories. Since 2020, ICATT contractors have performed nearly 50,000,000 tests and administered nearly 900,000 vaccines. As the country transitioned out of the Public Health Emergency (PHE), the ICATT program integrated vaccination delivery, medical assessment, and therapeutics disbursement to create a single point of access for acute care services. The ICATT program has been re-branded as Increasing Community Access to Testing, Treatment, and Prevention (ICATT) to reflect the inclusion of disease-agnostic medical countermeasures for under-resourced populations/communities and additional support for routine public health surveillance and research. SECTION 2 – PURPOSE This procurement will provide large scale nationwide testing, assessment services, therapeutics, vaccines, sample collection and forwarding, and surge services/emergency response across the nation. The option to participate in Outreach and Education projects, as well as provide 3rd party Data Acquisition, and Distribution of Medical Countermeasures is also included. If effectively implemented, these strategies (thereafter referred to as countermeasures) will identify and track disease pathogens, minimize disease transmission, prevent outbreaks in institutional and community settings, support public health surveillance and research, and prevent the spread of disease in under-resourced populations/communities. Expansion of the ICATT program scope of services and the breadth of public health activities highlights the national importance of the public-private partnerships between the federal government and pharmacies. The government seeks partnerships with capable private contractors to develop and maintain a national model to provide countermeasures at no-cost to uninsured patients and other vulnerable populations. The Contractor must have sufficient capacity to meet the needs in communities of interest nationwide. The performance requirement is to provide pharmacy countermeasures to targeted populations and areas defined by the Federal Government, at an agreed upon price per service. SECTION 3 – SCOPE OF WORK Potential contractors would be responsible for the end-to-end program and site management of all provided services. This could include, but is not limited to, executive management, control systems, quality assurance plans and processes, reporting procedures, data management and required government reporting, patient screening, registration, physical site management, materials storage and management, specimen testing and/or shipping, and results communication. Contractors are required to participate in all tasks of Core Services and Surge Services/Emergency Response. The additional tasks are optional. Core ServicesTesting Medical Assessment Therapeutics Vaccines Sample Collection and Forwarding Surge Services/Emergency Response Data Acquisition and Analytics Outreach and Education Medical Countermeasures Distribution 1. CORE SERVICES Task A: Testing The program objectives will be achieved through providing diagnostic testing to ensure equitable access to services for under-resourced communities and to support public health surveillance and research. The government is interested in contractors capable of providing a selection of the following tests nationwide. While not all tests listed below are mandatory, the Contractor is encouraged to provide a broad mix of tests and sites to ensure resource and test manufacturing limitations do not impact contract performance. Laboratory-based testing Nucleic Acid Amplification Test (NAAT) testing Single Plex testing Multiplex testing Sequential Multiplex testing Blood spot testing Dried Wet Specialized testing Urine Blood Specialized Respiratory Samples Other bodily fluid sample types as needed Point-of-Care (POC) NAAT testing Single Plex testing Multiplex testing Point-of-Care (POC) Antigen testing Single Plex testing Multiplex testing Over the counter (OTC) test distribution (government provided) Sequencing (Diagnostic or Confirmatory) Pooled Sample Testing Task B: Medical Assessment The program objectives will be achieved through providing medical assessment to ensure equitable access to medical services for under-resourced communities. The assessment may be provided by in-house pharmacist or via telehealth options. The Contractor shall provide program management oversight for medical assessment services. The Contractor is responsible for providing appropriate personnel to conduct comprehensive medical assessments under the following terms: Prescription Eligibility Determination : The appropriate personnel shall assess patients to determine their eligibility for prescriptions based on current clinical guidelines and regulatory requirements. Test Interpretation: The appropriate personnel shall provide interpretation of diagnostic tests, ensuring that results are accurately understood and effectively communicated to the patient or their designated healthcare provider. Non-Clinical Treatment Recommendations : The appropriate personnel shall offer evidence-based, non-clinical treatment recommendations tailored to individual patient needs, adhering to recognized standards and best practices in the field. Task C: Therapeutics The program objectives will be achieved through providing access to the appropriate therapeutics to ensure equitable access to medical countermeasures in under-resourced communities. The Contractor shall provide program management for therapeutics services. Task D: Vaccines The program objectives will be achieved through providing vaccination services to ensure equitable access to services for under-resourced communities. The Contractor shall provide program management oversight for vaccine services and site operations. TASK E : Sample Collection and Forwarding The program objectives will be achieved through the Contractor's obligations to collect, handle, and forward biological samples for diagnostic purposes as per Government directives. Types of Collection could include but are not limited to collection by trained personnel, observed self-collection, and unobserved self-collection samples listed below. *Examples are provided for reference only but do not limit the use of sample type . Respiratory Swab (COVID-19 Antigen, Flu A&B) Conjunctival swab (Chlamydia) Respiratory specimen (Tuberculosis) Throat swab (Group A Strep) Blood Sample (Cholesterol, HIV, Hepatitis C, STD) MonoSpot blood test (Mononucleosis) FingerStick (A1C, Glucose) Urinalysis (UTI, STD) Skin Lesion material (Mpox) Saliva (COVID-19) The Contractor shall submit specific specimens for further characterization (e.g., genomic sequencing, culture) to state or federal laboratories, or affiliated laboratories, as identified by the Government. CLIN 0002: SURGE SERVICES AND EMERGENCY RESPONSE The program objectives will be achieved through the Contractor's provision of a comprehensive plan and capability to mobilize teams in response to a public health emergency requiring surge services or a federally declared emergency response. Surge and Emergence Response responsibilities would require: The Contractor to sustain surge and emergency response capabilities for all Core Services covered in the Contract. The Contractor to sustain the capability to deploy to disease outbreak zones, including standing up flexible off-site service options to rapidly reach government identified affected communities. CLIN 0003: DATA ACQUISITION The program objectives will be achieved by providing access to pharmacy collected data on testing, immunization, therapeutics, or other medical services provided in commercial pharmacies, laboratories, retail health clinics, or other locations. CLIN 0004 : OUTREACH AND EDUCATION The program objectives will be achieved through the Contractor's provision of Outreach and Education distribution services upon request. The Contractor shall have in place national large-scale integrated communications platform for use with information dissemination. CLIN 0005 : MEDICAL COUNTERMEASURES DISTRIBUTION The program objectives will be achieved through the Contractor's distribution of medical countermeasures as a temporary solution until state and/or federal services and programs are operational. Medical countermeasure dispensing and administration is the ability to provide medical countermeasures to partners, targeted population(s), or communities to prevent, mitigate, or treat the adverse health effects of a public health incident, including mitigation of disease spread. Questions Briefly describe the approach to managing end-to-end services for the Core Services tasks and speak to the readiness of existing systems to support the necessary infrastructure including: Capability to provide sites located in defined HHS contiguous regions. Capability to provide sites that are operational for a minimum of eight hours a day, at least 5 days per week (any day of the week). Capability to provide sites with extended hours (at least 3 hours) before 9am or after 5pm, if the demand in the areas require extended hours. Capability to provide staffing to support all hours of site operation. Capability to provide employee training in all areas of service requirements. Capability of reporting data to a federally managed system. Established process for performing insurance discovery and medical/pharmacy claims processing. When considering the proposed tasks in the Core Services, what challenges do you foresee in fulfilling the listed requirements? Are all the activities in Task A currently available? And if not, which ones are not available? If Task A capabilities are not available, could any be available under a sub- contractor relationship? Which ones? If offered, would a phased-in approach support future implementation of capabilities not currently available? Which capabilities would this apply to. The management of end-to-end services would require an existing robust administrative, quality, and operational management system to be in place. Please provide capabilities or challenges with the following expectations. An existing online patient registration/scheduling system that describes the available services and processes and applies patient screening criteria and can accommodate drive-through and walk up patients. Notifying patients of results including follow-up options. Ordering of services by a licensed healthcare practitioner where required and/or allowed. Distribution and tracking of appropriate therapeutics or treatment information. Reporting all required data to public health agencies and the federal government, and Quality system essentials including assessments, continual improvement plans, customer focus, documents and records, equipment, facilities and safety follow up, personnel competency, process management, and more. When considering Surge or Emergency response requirements, please provide examples of your experience with the following: Sustaining ongoing surge and emergency response capabilities for any of the Core Services tasks. Capability to deploy to government identified high-need areas, including standing up flexible off-site service options to rapidly reach affected communities. The potential Contract will include a CLIN for providing the distribution of medical countermeasures as a temporary stopgap in the event of an emergency. Medical countermeasures (MCMs) can include antiviral drugs, antitoxins, antibiotics, personal protective equipment, and materials designed to prevent or mitigate disease spread, illness, or injury. Please describe your current capabilities or concerns with the following: The Contractor shall have an established distribution system that can receive, store, track, distribute, and report for reimbursement. The Contractor shall distribute goods based on Government indicated areas of participating partners, targeted populations, or communities. The CDC seeks general feedback from potential vendors on the following topics and/or potential scenarios. Provide recommendations to mitigate disruption of service due to potential legislative or regulatory changes. (ie. Public Health Emergency declaration, Prep Act, or similar legislation, CLIA requirements) What current options and/or capabilities do you have to potentially provide pharmacy services to rural communities? III. Instructions: Responders to this RFI may include commercial or not-for-profit organizations, including teaming arrangements/partnerships or joint ventures. Please provide the following information on page 1 of your response: Unique Entity Identification Number Company Name Company Address Company Point of Contact, phone number and email address Type of company under North American Industry Classification System (NAICS), as validated via the SAM. Additional information on NAICS codes can be found at www.sba.gov. Any potential government contractor must be registered on the SAM located at http://www.sam.gov/index.asp General Capabilities Statements will not be accepted. Please submit a detailed responses (e.g., not standard marketing materials and general capability statements) that meet the RFI objectives. The informative nature of response is anticipated to address complex topics and possible strategies to achieving the objectives. The goal of the RFI responses is compile an enhanced understanding of strategic inputs. Product capability statements are not being sought. Do not send information that requires a non-disclosure agreement or sensitive business information. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions. Answer all questions that are relevant or most meaningful to your organization’s operations. Please denote questions that are not applicable or intentionally skipped. The page limit is not to exceed 5 pages. Responses should be single-spaced in Times New Roman 12-point font. Specify whether these responses are for USG access only by writing “[For US Government Use Only]” at end of response. Please submit your final responses to this RFI no later than (date) by 5:00 PM ET on December 15, 2024 with questions due by December 5, 2024. Submit responses electronically, with subject “RFI Response ICATT Pharmacy Services: [Company Name]” to
[email protected]. Submit general questions relating to the RFI via email to
[email protected]. All information received in response to the RFI that is marked as proprietary will be handled accordingly. IV. Disclaimer : In accordance with FAR 15.201 (e), this RFI is for market research only and does not commit the Government to issue a solicitation, make an award, or pay any costs associated with responding to this RFI. The information submitted in all responses will be utilized to help the Government further define its requirements and develop acquisition strategies. All submitted information shall remain with the Government and will not be returned.