RFI for Decentralized Healthcare.pdf

Title: RFI for Decentralized Clinical Studies Healthcare Delivery Network

Disclaimer

Pursuant under Federal Acquisition Regulation (FAR) Part 10, the intent for this Request for Information

(RFI) / Sources Sought is to conduct market research. This is NOT a solicitation for proposals, proposal abstracts, or quotation. This announcement does not constitute an Invitation for Bids (IFB), Request for

Quote (RFQ), or a Request for Proposal (RFP), and it should not be construed as a commitment of any kind by the Government to issue a formal solicitation or ultimately award a contract. Responses to this notice cannot be accepted as offers. The sole purpose of the RFI is to assist the Agency in crafting the appropriate solicitation and shall be used for information purposes only. Any proprietary information will be protected, if appropriately marked.

The information provided is entirely voluntary and will not impact the ability to submit on future requirements. The RFI is for planning purposes and shall not be considered a Broad Agency

Announcement.

The Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS), is issuing this Request for Information (RFI) to collect feedback from organizations at the forefront of implementing decentralized healthcare delivery and clinical study models that incorporate virtual and remote care. These organizations include, but are not limited to, telemedicine, urgent care, direct to patient testing, integrated payor-providers, and retail pharmacy. BARDA is seeking to substantially improve its ability to respond to future public health emergencies (PHEs) by better utilizing novel healthcare delivery models to: develop drugs and devices, including medical countermeasures (MCMs), designed for use in more distributed settings (e.g., retail pharmacies, the home); assess effectiveness and utility in those distributed settings; implement novel technologies and understand the impact on real-world patient outcomes; and ultimately reach more patients during a PHE, for both testing and use of MCMs.

Information collected from this RFI will serve as continued market research for the development of a potential future program within BARDA’s Division of Research, Innovation and Ventures (DRIVe) to support the establishment of a decentralized clinical studies and healthcare delivery network.

BACKGROUND: The COVID-19 pandemic both demonstrated and accelerated the need for rapid assessment and accessibility of MCMs during PHEs. Patients now increasingly access healthcare providers in settings away from hospitals and outpatient clinics (e.g., retail, telemedicine, wearables) including at home. This creates a wealth of opportunity for improving access to care, especially for

Americans without immediate access to primary care physicians. The rapid evaluation of MCMs relies on recruiting, enrolling, and retaining a diverse set of patients. With this shift in care settings, relying alone on traditional hospital-based care models or other centralized models for conducting clinical studies and/or distributing MCMs, may become inadequate, especially considering preparedness for future pandemics. Some of these challenges were apparent during COVID-19. Many MCM developers of both drugs and devices had difficulty identifying, enrolling, and retaining patients for clinical trials as well as making their products available to the right individuals at the right time.

BARDA DRIVe has identified an opportunity to establish a network of organizations focused on implementing decentralized clinical trials and healthcare delivery models across multiple settings. This network could allow for experimental clinical studies, observational studies, and piloting of new interventional care models relevant to PHEs and pandemic preparedness. In addition, providing a network for testing medical products across multiple settings may help de-risk the path to market and accelerate the product pipeline.

Through this RFI, BARDA DRIVe is seeking to explore the trend towards healthcare decentralization and to determine whether BARDA’s interests align with commercial capabilities in decentralized healthcare delivery and clinical study models. Specifically, we envision that such a network could benefit the development and validation process for products/technologies intended for remote use and allow for agility of product/technology development and delivery of care during a PHE. In addition, potential network benefits include, but are not limited, to:

• reaching patients in the clinical settings for which they would like to receive care (i.e., outside of the hospital)

• increasing access, patient participation and diversity

• improving timing and accessibility of patient touch points for delivery of care

• enhancing continuity and temporal access of data collection across the care continuum

• supporting data collection from a broader range of sources including patient generated and patient reported data to better evaluate real-world patient outcomes

• enabling more robust clinical studies representative of real-world patient outcomes

CAPABILITIES OF INTEREST:

BARDA has preliminarily identified capabilities and characteristics thought to be relevant to an individual organization (and their associated partners), participating within such a future network, including:

• Rapid access to, or ability to operate via pharmacies, retail locations, telemedicine platforms, the home, and other non-hospital settings;

• Ability to reach patients facing physical and temporal barriers to care such as proximity/location, cost, time to scheduling appointments/receiving care, and/or other limitations that make an office visit difficult;

• Ability to reach diverse patient populations, including: underserved and at-risk populations;

those without a primary care physician (PCP); those without insurance; and other factors that limit regular interaction with the healthcare system;

• Ability to implement existing or new products and tools (e.g., wearables, at-home/POC diagnostics, digital therapeutics);

• Ability to pilot new models of care (e.g., delivery of services, delivery decision support, process of care, care coordination) including pressure-testing changes in clinical processes/workflow and collecting user feedback;

• Ability to conduct an array of clinical studies including but not limited to traditional research and development clinical trials for products seeking regulatory approval, clearance or licensure, quality improvement or other pragmatic clinical studies which may monitor patients and capture clinical and real-world data continuously or in near real-time that provide value for developers, the U.S. government (USG), patients, providers, and payors and that improve the quality of care (i.e., not limited to studies designed for regulator decision-making by FDA);

• Ability to track patients and collect longitudinal data throughout the care continuum (e.g., healthy patients before they become sick, while sick/hospitalized, and post-illness);

• Ability to address challenges that exist with centralized clinical study design and reduce or eliminate hurdles with patient identification, recruitment, enrollment and follow up appointments typically associated with traditional clinical study sites.

STUDY AREAS OF INTEREST:

The following clinical study areas represent three potential functions of the network:

Area 1: Validate technologies in real-world environments: Evaluate the clinical performance and/or utility of specific medical countermeasures (e.g., therapeutics, vaccines, drugs, devices, digital health tools), technologies or approaches, developed and marketed, or in development, as identified by BARDA. These studies will largely involve prospective clinical study design, execution, data collection and evaluation in decentralized settings outside the hospital, as defined above.

Area 2: Leverage health data for new insights: Analyze data from the normal course of care/treatment being implemented with existing technological capabilities and care models.

This would include the ability to collect and mine real-world data to identify potential challenges and /or opportunities for future care delivery/medical countermeasure development. Study designs may be prospective or retrospective with the aim of testing and/or generating hypotheses. Data can also be collected over longer timeframes and in real-world settings which can offer a broader understanding of disease etiology, progression, and patient outcomes.

Area 3: Test new healthcare delivery models: Evaluate new technologies and models of care relevant to PHE response in decentralized care settings outside the hospital, as defined above.

This will involve prospective study design, implementation, data collection and evaluation based on piloting new clinical workflows that may not be in existence before study start to determine feasibility.

RESPONSE REQUESTED ON THE FOLLOWING QUESTIONS:

BARDA encourages input from a variety of organizations, including, but not limited to: urgent care centers; pharmacies and other retail establishments involved in decentralized healthcare delivery or services; direct to patient testing companies; technology developers for providers of telehealth, remote exams and monitoring; and organizations providing a hybrid of in-person and telehealth care. Small businesses and first‐time government contractors are also strongly encouraged to provide input. Input from traditional provider groups or healthcare systems that rely primarily on office visits; clinical trial networks/CROS that rely on in-person visits and/or referral from primary care physicians or have defined clinical sites (i.e., centralized models) that have interest in expanding into decentralized care would also be of interest. It is important to note that care provided in the hospital setting alone is not the target of interest for the RFI, though information from the hospital setting along with the ability to provide information prior to and/or after hospitalization would be of interest.

BARDA is soliciting input from organizations with relevant knowledge and experience. Interested organizations are invited to respond to the questions below and submit at: RFI Submission Link. In the submission form you will not be able to save your work and return to edit, so it is recommended that you have prepared answers for all the questions at the time of submission. In the event you are unable to access the form please email responses to the questions to HI3@hhs.gov.

https://forms.office.com/Pages/ResponsePage.aspx?id=6t2K1VNQgEqEmbpNlEkQ33soYV3cJmVGv4hg3Y8cIEFUOEdNQTg1UTlRT0dVVDZFRVZTUUxMSlVTQi4u mailto:HI3@hhs.gov

All questions marked with an asterisk (*) are required.

Administrative Information:

1. Name of Organization*:

2. Street address of Organization*:

3. City of Organization*:

4. State of Organization*:

5. Zip code of Organization*:

6. Point of Contact (POC) name and title*:

7. POC email*:

8. Is the following information provided by your organization considered proprietary information?

(Y/N) *

Technical Questions:

Referring to the Capabilities of Interest and Study Areas of Interest listed above, please provide your organization’s perspective and experience by answering the following questions. If you would like to share any supporting documents, you may send them to HI3@hhs.gov, using the subject line “RFI Documents-Company Name”. Please include the name and e-mail address of the POC along with the submission.

9. Please specify the number of states in each region (as designated by the U.S. Census Bureau) that your organization operates in: * https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf

The above photo is courtesy of the U.S. Census Bureau and can be retrieved here.

i. New England:

ii. Middle Atlantic:

iii. East North Central:

iv. West North Central:

v. South Atlantic:

vi. East South Central:

vii. West South Central:

viii. Mountain

ix. Pacific

10. In which of the following non-hospital settings does your organization currently operate or could rapidly access? (select all that apply): *

i. Retail locations

ii. Pharmacies

iii. Telemedicine platforms

iv. The home

v. None of the above

vi. ‘Other’ (write in an additional answer)

11. Please describe your organization’s current patient/user base including size and represented populations (e.g., age, race, ethnicity, biological sex, health risk factors, social determinants of health):

12. How does your organization address potential barriers to patient access such as proximity to care, cost, time to care, office hours, and/or physical limitations that make an office visit difficult?

13. What is your organization’s approach to reaching diverse patient populations, including:

underserved populations, at-risk populations, and those who may not have regular interaction with the healthcare system due to lack of a PCP, lack of insurance or other factors?

14. Please describe your organization’s capabilities to track patients and collect longitudinal data in different care settings (e.g., outside hospital, within hospital, specialized care), particularly as is applies to BARDA’s interests in infection or injury throughout the care continuum (i.e., healthy patients prior to illness, during illness/hospitalization, and post-illness).

15. Please indicate the Study Areas of Interest where your organization has experience: (select all that apply): *

i. Area 1: Validate technologies in real-world environments

ii. Area 2: Leverage health data for new insights

iii. Area 3: Test new healthcare delivery models

16. Please indicate the specific types of studies that your organization is capable of conducting:

(select all that apply) *

i. Clinical trials for premarket regulatory approval/clearance/licensure

ii. Postmarket observational studies https://www2.census.gov/geo/pdfs/maps-data/maps/reference/us_regdiv.pdf

iii. Postmarket clinical studies

iv. Pragmatic trials

v. Healthcare quality research

vi. Comparative effectiveness

vii. Outcomes research

viii. Health services studies

ix. Other

17. Please provide examples of any relevant studies, products, or data analytics relevant to your previous answers. If you would like to include any supporting figures/documents, you may send them to HI3@hhs.gov, using the subject line “RFI Documents-Company Name”. Please include the name and e-mail address of the POC along with the submission.

18. How has the organization addressed study challenges, typically associated with centralized care/trial models, such as patient identification, recruitment, enrollment, and follow-up?

19. For Study Area 3 (Test new healthcare delivery models), if capability to conduct these types of studies exist in your organization, please explain ability to: (a) incorporate existing or new products and tools (e.g., wearables, at-home/POC diagnostics, digital therapeutics) into care delivery, or distribute for care and (b) pilot new models of care (e.g., delivery of services, delivery decision support, process of care, care coordination) including pressure-testing changes in clinical processes/workflow and collecting user feedback.

20. Please indicate which Study Areas of Interest may present challenges for your organization to conduct (select all that apply): *

i. Area 1: Validate technologies in real-world environments

ii. Area 2: Leverage health data for new insights

iii. Area 3: Test new healthcare delivery models

iv. Organization would not have challenges with any of the study areas

21. Please describe these challenges, if any.

22. Are there additional resources or capabilities not listed in the Capabilities of Interest section that will be needed to conduct the three Study Areas of Interest?

23. Are there any questions and/or feedback on the proposed decentralized network and associated Study Areas of Interest? Are there any potential challenges (e.g., financial, technological, legal) or additional opportunities not captured in the above descriptions, you would like to highlight?

24. Please indicate whether or not your organization has experience partnering or teaming with others to conduct clinical studies, such as those described in the Study Areas of Interest?*

i. If so, would you consider your organization a lead/ prime on conducting these types of studies or a subcontractor that would need to partner with others?

ii. Is your organization amenable to partnering?

25. Does your organization meet the requirements for working with, collecting, or handling specimens defined as Federal select agents? Do you have access to laboratories that can utilize Biosafety Level 2, 3 or 4?

https://www.selectagents.gov/sat/list.htm?CDC_AA_refVal=https%3A%2F%2Fwww.selectagents.gov%2FSelectAgentsandToxinsList.html

Business Questions:

26. What is your perspective on granting the Government access/rights to the decentralized network functions as described above, on a preferential basis (“priority access”) in the event of a declared PHE?

27. What is the likelihood that your organization would be interested in and available to respond to a potential future solicitation addressing the types of clinical studies described in this RFI?

28. Please list your North American Industry Classification System (NAICS) codes. If you have more than one, please separate with a comma: *

29. Does your organization SAM registration include NAICS 541714? (Y/N) *

30. Based on your answer to the above, is the total number of employees for your organization less than 1,000? (Y/N/Not Applicable) *

31. Based on your answer to the above, which of the following apply to your organization? (select all that apply): *

i. Small business (FAR 19.102)

ii. Small disadvantaged business (FAR 19.304)

iii. Service-disabled, Veteran-owned small business (FAR 19.14)

iv. 8(a) Small disadvantaged business (FAR 19.8)

v. HUBZone small business (FAR 19.13)

vi. Woman-Owned small business (FAR 19.15)

vii. Involved in the HHS Mentor/Protégé program

viii. Does not apply

32. If you are registered in SAM, please provide your SAM UEI and CAGE Code, if available.

Otherwise, please enter “N/A”: *

33. Does your organization currently provide or has your organization provided the same or similar services to other organizations, the Federal Government, both, or neither? *

34. If your organization has provided services to the Federal Government, please indicate the following: Contract Number, Contract Type, Procuring Agency, Contract Value, and Service Provided. Otherwise, please enter “N/A” *

35. Please identify any Study Areas of Interest or Capabilities of Interest that your organization believes should be broken out exclusively for Small Business.

36. Has your company's accounting system been deemed adequate for determining costs by a cognizant contract administration office (CAO), pursuant to FAR 42.302(a)(12)? (Y/N) *

37. If you answered no to the above, would your organization agree to disclose cost accounting practices (i.e., accumulated and reported cost) to a cognizant CAO for a determination of adequacy for a contract award, pursuant to FAR Part 16? (Y/N/Not Applicable) * https://www.census.gov/naics/

38. What types (provisional, final, predetermined or carry forward) and categories (Facilities, Administration, or Other) of indirect costs, and range of fees would your organization customarily report or specifically charge for this type of work/project?

39. What would be the typical time required by your organization to submit a proposal in response to a USG proposal request if a previous contract/agreement was already established (e.g., IDIQ) on orders relevant to the Study Areas of Interest described above?

i. 1-2 weeks

ii. 2-3 weeks

iii. +3 weeks

iv. Other

40. Which of these contract types would your organization prefer or have previous experience with for the same or similar type of service as described above in the Study Areas of Interest? (select all that apply): *

i. Cost plus fixed fee

ii. Cost plus incentive fee

iii. Firm Fixed Price

iv. Cost-sharing contracts

v. Other

THIS INFORMATION IS REQUESTED FOR INFORMATION GATHERING PURPOSES ONLY. NO SOLICITATION CURRENTLY EXISTS. This is not a request for proposals and does not commit the Government to issue a solicitation, make any contract award, nor pay any costs associated with responding to this announcement. All submitted information shall remain with the Government and will not be returned.

BARDA will use this information to guide decisions and potential future solicitation plans regarding the Decentralized Clinical Studies Healthcare Delivery Network as well as to establish a contact list of potential industry participants for future outreach. Please note that contractors performing advisory and assistance services to support BARDA will have access to any submission under this RFI.

HHS BARDA DRIVe Resource Mailbox for this RFI: HI3@hhs.gov