Purpose: Independent pharmacies are important for reaching rural populations, and their participation in the ICATT program is beneficial for offering access to testing, vaccines, and therapeutics. This RFI aims to collect insights from independent pharmacy partners, including vendors, advocates, and associations that support the implementation of medical countermeasures, such as testing, vaccines, and therapeutics, in independent pharmacies. The goal of this RFI is to understand the capabilities and infrastructure required for independent pharmacies to deliver health services to under-resourced populations and communities. Current capabilities and infrastructure could include program management, regulatory compliance, IT systems for patient/data management, communication systems, and reimbursement models. The Government welcomes additional stakeholder input on infrastructure solutions to challenges faced across the above service delivery areas and state regulatory landscapes. This information will be used to develop strategies that enhance public health response capacity, improve the efficiency of medical service delivery to rural populations, and enable independent pharmacies to operate as a more cohesive group. Background: At the start of the COVID-19 pandemic, the Increasing Community Access to Testing (ICATT) program entered public-private partnerships with various national pharmacy chains, independent pharmacies, and laboratories to support community pharmacy and surge sites providing COVID-19 services for under-resourced populations. 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 Response (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. Information Requested: The Government invites comments on the following areas related to the delivery of pharmacy countermeasures (defined as vaccines, testing, and therapeutics) by independent pharmacies. Appendix A provides a working list of the capabilities and infrastructure independent pharmacies may need to support the delivery of pharmacy countermeasures. Please address challenges, facilitators, and solutions where applicable in your response. RFI Questions: 1. Capabilities and Infrastructure a) Is Appendix (A) comprehensive in describing the needed capabilities/infrastructure to provide pharmacy countermeasures (vaccines, testing, and therapeutics) to under-resourced populations/communities? If not, please provide and describe the additional capabilities and infrastructure required. b) Please provide a summary of your capabilities and infrastructure that could support strategies to enhance public health response capacity, improve the efficiency of medical service delivery to rural populations, and enable independent pharmacies to operate as a more cohesive group. 2. Existing Models and Services We are aware that several models currently exist to provide the infrastructure services listed in Appendix A for independent retail and small chain pharmacies. These services are currently provided to independent pharmacies through a wide range of organizations. a) What are the strengths and limitations of these existing models to provide the needed infrastructure to independent pharmacies for the provision of pharmacy countermeasures (defined as vaccines, testing, and therapeutics)? b) What existing models could be expanded to reach other under-resourced populations and communities who may be challenged with the traditional offerings at pharmacies (i.e., Homebound, homeless, and rural populations) Please identify additional populations and describe the gaps in reaching them. c) What challenges do independent pharmacies face in building or adopting the necessary infrastructure to expand their services to include medical health benefits, such as testing and medial assessments for the distribution of therapeutics (where authorized)? 3. Pharmacy and Medical Benefits We recognize that providing testing, vaccines, and therapeutics may require independent pharmacies to contract with private insurance providers for both pharmacy and medical benefits. a) Are contracts with insurance providers a component of the current infrastructure or are these contracts established by the independent pharmacies? b) In what ways could federal support be provided to independent pharmacies to establish contracts with insurance providers for pharmacy or medical benefits? 4. Cost Structure and Incentives for independent pharmacy participation a) Please describe potential methods for incentivizing independent pharmacy participation, beyond financial support, in the provision of pharmacy countermeasures (vaccines, testing, and therapeutics) to under-resourced populations and communities. b) What infrastructure reimbursement capabilities can be developed or expanded to provide a cost structure to incentivize independent pharmacies to adopt the delivery of additional countermeasures to under-served communities? 5. Regarding independent pharmacy participation in programs implemented through federal government contracts, a) What barriers exist to independent pharmacy participation in partnerships implemented through federal government contracts? b) What can be done to facilitate or incentivize independent pharmacy participation in such partnerships? 6. Regarding sustainability, a) Describe the infrastructure that would support a sustainable program for delivery of services (vaccines, testing, and therapeutics) at independent pharmacies in under-resourced populations and communities absent of additional financial support. Please discuss potential strategies, partnerships, infrastructure, or innovations that could support long-term sustainability in these communities. Conclusion: This RFI seeks comprehensive information to develop strategies and partnerships that will enable independent pharmacies to effectively deliver pharmacy countermeasures, thereby improving public health outcomes in under-resourced populations/communities. Your input is crucial to the success of this initiative. Additional Information and Follow-Up Based on the information received from the questions above, CDC may have additional follow up questions which include but are not limited to: 1. Federal Regulations and Reporting a) How is support provided to independent pharmacies in navigating credentialing required for the provision of pharmacy countermeasures (vaccines, testing, and therapeutics)? 2. State Regulations and Compliance a) How can fluctuating state regulatory environments be monitored or tracked to better support independent pharmacies in providing testing, vaccines, and therapeutics? b) Please outline strategies to encourage independent pharmacies to embrace changes in their scope of practice, both for those already participating and for newly onboarded pharmacies. 3. Training and Workforce Capabilities a) What infrastructure is necessary to maintain adequate pharmacy and/or medical training to staff who perform services for testing, vaccines and dispensing of therapeutics? 4. Are there HHS regions of the country that yielded higher costs related to testing and vaccination of the uninsured? If so, are the higher costs a result of elevated state regulations? 5. Which industry services have been engaged with or subcontracted with in the past that provide affordable options for testing, vaccination, and therapeutics for the uninsured for independent pharmacies? 6. Please describe any innovative technologies or approaches taken that have significantly improved the cost-effectiveness of testing, vaccines, or therapeutics. 7. Could the existing infrastructures be adapted to comply with federal and state requirements for reporting to a common data repository platform? Contact Information: For questions or further information, please contact Dawn Redman,
[email protected], (404)498-3039. A supplemental slide deck outlining the program and objectives is available upon request.