JA NCI-- NCCRD 7-22NN--Redacted.pdf

an analytic resource for future CCDI priorities. The Contractor shall deploy their software to an NCI-approved cloud-based environment.

The NCI under the CCDI is focusing on building data infrastructures to support research that focuses on childhood cancer patients. These patients have experienced complexities in their care and outcomes that are significantly different than for adults. These include long term sequelae of treatment, high risk for second primary cancers, and psycho-social challenges. Further because they are so young and often mobile, it is especially challenging to track these patients from a surveillance perspective. This Programmatic CCDI related requirement complements, enhances, and supports efforts aligned with the ongoing STAR Act of 2018 (Public Law No. 115-180) that was enacted to maximize discovery, and accelerate development and availability, of promising childhood cancer treatments.

b. Project background. DCCPS is one (1) of the six (6) Divisions of the National Cancer Institute. It generates new knowledge and seeks to ensure that the products of cancer control research are effectively applied in all segments of the population. Childhood cancer patients comprise a special and understudied population of cancer patients. Approximately 16,000 childhood cancer patients are diagnosed in the United States annually, compared with the

1.7 million new cancer cases diagnosed each year. Due to their rare nature, it has been challenging to collect substantial and vital information on a large scale to study and understand the needs for this unique population of cancer patients.

The NCI launched the Childhood Cancer Data Initiative (CCDI) in 2019 to collect, analyze, and share data to address the burden of cancer in children, adolescents, and young adults. The NCI Board of Scientific Advisors affirmed CCDI priorities for this 10-year initiative in a June 2020 report.1 The NCCR is a critical component of the CCDI. Currently, cancer registries in the United States hold structured information on every cancer case, including childhood cancers, within their respective catchment areas. The NCCR consists of population-based cancer data from 18 Surveillance, Epidemiology and End Result (SEER) registries across the US (California (Greater Bay, Greater California, Los Angeles), Connecticut, Georgia, Hawaii, Idaho, Illinois, Iowa, Kentucky, Louisiana, Massachusetts, New Jersey, New Mexico, New York, Seattle, Texas, Utah) and 5 Centers for Disease Control (CDC) National Program of Cancer Registries (NPCR) (Florida, Michigan, Ohio, Pennsylvania, Tennessee, Wisconsin) for children diagnosed under age 20 since 1995, with the goal to expand to all 50 states, capture all patients with cancer diagnosed before age 40, and provide annual updates. The initial participation of 23 registries covers 66% of the US population. Registries report data in SEER2 and North American

1 https://deainfo.nci.nih.gov/advisory/bsa/sub-cmte/CCDI/CCDI%20BSA%20WG%20Report Final%20061620.pdf 2 https://seer.cancer.gov/tools/submission.html

Association of Central Cancer Registries (NAACCR)3 formats. For childhood cancer patients and survivors, data on late effects, recurrence, subsequent primary cancers, and follow-up are critically important to capture at a national level to ensure data completeness. Patients frequently travel for care and survivors mature and leave their original state of residence at the time of initial diagnosis and treatment. Additionally, childhood cancer survivors experience a wide sequalae of long-term outcomes as a direct result of their cancer and cancer treatment and require proactive health screenings over their lifetimes.

The NCCR can enhance registry data by incorporating data on genomic and tumor characterization, claims, social determinants of health, longitudinal treatment and outcomes, pharmacy and claims information, and comorbidities.

The NCCR will bring together key information on every childhood cancer patient regardless of where or when they receive care and will support research about childhood cancer patients and survivors. Access to external healthcare data will help improve scientific opportunities, enable cancer surveillance to rapidly adapt to emerging issues in pediatric oncology care, and support research that will improve the health and wellbeing of childhood cancer survivors. The implementation of an NCCR data platform activity is in in close alignment with the NCI’s CCDI and a high priority for the NCI.

SRP has made significant progress in securing registry data submissions in the NCCR’s first two years and creating public-facing analytic tools (https://nccrexplorer.ccdi.cancer.gov/) and statistical reports (https://nccrexplorer.ccdi.cancer.gov/about/nccr.html) using de-identified registry data in 2021. The next major step for the NCCR is to supplement registry data with external data sources and integrate with the wider cancer data ecosystem in a modern data platform. The NCCR Data Platform will hold de-identified registry data, securely link patients using privacy-preserving methods to external data sources, provide secure governance workflow components to manage data access and approvals, allow users to conduct cohort discovery and use other features to understand data availability, connect to other data resources in the childhood cancer data ecosystem, and support analytical tools.

These data are rapidly needed to support NCI’s CCDI analytic projects, NIH data sharing priorities, and to support future planning efforts for CCDI priorities.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. National Childhood Cancer Registry (NCCR) Data Platform

b. Project description. Statement of Work (SOW) .

Requirement type.

Research & development (R&D)

3 https://www.naaccr.org/call-for-data/

R & D support services Support services (non-R&D) Supplies/equipment

X Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

X New requirement Follow-on:

Other (specify): ______________________

Proposed contract/order type.

X Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials

Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________ Completion Form Term form

Acquisition identification number.

c. Total estimated dollar value and performance/delivery period. Total estimated dollar value= for the ultimate period of performance consisting of one (1) base year base period ( ) with one (1) Term Option period . This requirement would be funded from FY 2022 CCDI funds that support the ongoing STAR Act of 2018.

4. Identification of the statutory authority permitting other than full and open competition.

Check the applicable block below based on the acquisition circumstance.

This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation

(FAR) 6.302- __.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

This acquisition is conducted under the authority of FAR 13.501(a)(1) in accordance with 41 U.S.C. 1901.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

HealthVerity, Inc.

1818 Market St LOBBY 6 Philadelphia, PA 19103-3602 Phone: (215) 499-8499

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The need of SRP is to ensure that pediatric cancer data is collected in a timely and secure fashion. SRP is mandated to release cancer data to the public. These data are used to supplement and enhance the completeness and value of the registry data to better support a broader set of longitudinal, national research activities. In order to efficiently link and consolidate data from this wide set of heterogeneous data sources, a central privacy-preserving record linkage process is required to improve the accuracy of linkages from external data owners in compliance with HIPAA and subsequently enable interoperability with their data. The ability to integrate these data with registry data through a common data platform improves their quality and increases the efficiency of this process for both the government and external partner organizations. Finally, managing the governance of multiple data sources in a common platform is a complex workflow that requires integration of search, query, reporting, notifications, and request and approval routings to multiple data owners.

As a result of the Market Research conducted, HealthVerity, Inc. was determined to be the only source to have the capabilities and expertise to fulfill this urgent requirement through their Census technology (privacy-preserving probabilistic record linkage-PPRL), Marketplace solution (normalized, licensed external data sources and governance process to request access), and an existing data platform. No other vendor has all components ready to implement in an NCI-environment nor can other vendors provide multiple real world data sources. Engaging other vendors to conduct new, custom development of these components and seek out licensed data for the NCI will incur substantially increased effort, risk, and cost to the NCI that cannot be recovered through competition and create unacceptable delays in fulfilling the NCI’s requirements for CCDI and NCCR.

The unique, innovative, and proprietary components required by the NCCR include and are only provided by HealthVerity in a single solution include:

1. Real World Data Marketplace: HIPAA-compliant, normalized, high-volume data from multiple, real-world sources involved in pediatric cancer care and long-term follow-up, including medical claims, pharmacy data, electronic medical records, laboratories, hospital chargemaster data, patient demographics and social determinants of health, and consumer data.

2. Governance: Ability to visualize the intersection of de-identified patients across all participating data sources, search against that data, query the data show the overlap of unique patients in a search across all sources.

Ability for users to request access to the platform and discrete data sources and for data owners and NCI to approve access requests.

3. Privacy-preserving probabilistic record linkage: Proprietary de-identification and matching technology that relies on PII and PHI at the source systems to enable downstream de-identified record linkage and interoperability in their Marketplace.

To date, the proposed source is the only Vendor that can satisfy the Government’s requirements because it has:

Real World Data Marketplace o HealthVerity has over 75 data sources capturing 330 million unique patients and over 150 billion de-identified transactions.

Marketplace is currently used by over 350 users across 162 companies and organizations.

o The HealthVerity platform allows users to search across multiple data sources aligned to common data models with common searchable concepts such as ICD-9, ICD-10, NDC, CPT, HCPCs, and LOINC and filter on concepts such as Gender, Age, BMI, and specific Data Types (i.e., Genomics).

Governance o The HealthVerity platform includes a governance component compliant with federal privacy, confidentiality, and security requirements that allows users and data owners to maximize intra-organizational collaboration in the acquisition, use, release, and analysis of data, structured queries, and reports.

Privacy-preserving probabilistic record linkage o HealthVerity has existing software technology for PPRL used by

SRP-funded registries and real-world data providers.

These components are already available in an existing data platform solution that also supports functionality critical for efficient and secure data sharing:

o Allows users to create cohorts and visualize key characteristics of patients and data sources in epidemiologic profiles.

o Ability to host NCI registry data in NCI-approved cloud storage with confidential, private tiles to visualize the intersection of de-identified patients in registry data and datasets in the HealthVerity Marketplace.

o Ability to update interface and technology solutions to be hosted in an NCI-approved environment and for NCI-specific requirements.

The consequences of a different source being selected are significant:

The current ability to conduct privacy-preserving linkages with registry data and real world, external healthcare data would not be possible with a different source. The NCCR’s progress would be delayed and at risk as SRP cannot receive any data without these privacy-preserving approaches. In the absence of licensed data that relies on PPRL from PII and PHI held by the original, authorized data owner would stop, other key activities that support CCDI beyond SRP and with the extramural research community could not continue.

Given the length of time required to establish legal agreements with multiple data providers in the HealthVerity Marketplace, it is likely that data transmission would be severely delayed or paused until a new contractor would form new relationships and agreements with the same data providers.

Any other source would be unable to have all the data provider agreements in place at the same time further increasing the delay.

The risk of disruption extends beyond SRP:

Other programs within the NCI and CCDI would be impacted such as CRDC and the ability to release harmonized data such as those from NCI-supported Cancer Center supplements.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a SAM.gov notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. A pre-solicitation notice was posted on SAM.gov on May 18, 2022 with a response date of May 31, 2022, 3:00PM ET. Two (2) responses were received via email The Contracting Officer’s Representative (COR) for the requirement reviewed the received capability statements and completed an assessment form for each. The COR found that the capability statement each did not sufficiently demonstrate that the organization met the technical requirements presented in the SAM.gov notice. The HHS Small Business Office approved the market research conducted, stated in section 8 below, on 06/22/2022.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. An award will be made only if, during negotiations, it is shown that the anticipated cost to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The COR, in conjunction with Subject Matter Experts, via extensive experience and knowledge of the market, has determined that a single vendor is source capable of performing the requirements needed to provide these services. The NCI staff has stayed abreast of published literature in the area of healthcare technology, as well as through internet searches and exchanges with the cancer surveillance community and healthcare data technology providers. The COR has a clear understanding of resources available for this requirement, no other vendor has the unique expertise and capabilities to perform the required work.

stated above, the Vendor has established the expertise, resources, and infrastructure necessary to provide these requirements. There is a single provider that meets all the components needed for the NCCR Data Platform in a commercially-available software: privacy-preserving patient matching technology that enables interoperability with already licensed external data sources, a data governance workflow process to manage data requests, cohort discovery and search features along with data storage, exchange, and management.

SRP issued RFI on SAM.gov and received 19 responses in 2021. SRP conducted a 5-person technical review panel to evaluate responses

. SRP software evaluations s to explore requirements and features of: HealthVerity, LabKey, CAVATICA (Seven Bridges), Analysis, Visualization, and Informatics Lab-space (AnVIL), Rare Disease Clinical Research Network Data Management Coordinating Center (DMCC) (5U2CTR002818) at Cincinnati Children’s Hospital Medical Center and the University of Cincinnati, NCI’s Precision Medicine Analysis and Coordinating Center (PMACC) software that enables real-time clinical trial enrollment for Children’s Oncology Group (COG), Observational Health Data Sciences and Informatics (OHDSI), National COVID Cohort Collaborative (N3C), and the All of Us software suite.

As a result of reviewing the RFI responses, HealthVerity demonstrated that it met the minimum Government requirement, and currently has all the components needed to implement the NCCR Data Platform. Minimal customization changes associated with deploying their commercial software in a private, FISMA-Moderate, NCI-approved cloud environment will be required to meet cost efficiency requirements and provide rapid deployment to enable data sharing to external researchers quickly – a major goal of the CCDI implementation plan.

PPRL technology and interoperability of licensed data to the NCI SEER Program related to use real-world data to study SARS-CoV-2 serologic testing on risk of reinfection related to linkage of Medicaid claims data (e.g., treatment, comorbidities and health care utilization on pediatric patients with Medicaid insurance benefits) for NCCR registries

This effort would leverage PPRL technology currently under contract to SRP and expand NCI’s capabilities to provide fully interoperable, HIPAA-compliant external data. HealthVerity is also with an existing governance technology to manage approvals and access to linked data in the marketplace.

As stated above, a pre-solicitation notice was posted on SAM.gov for this requirement.

Please refer to section #6 of this document for the outcome of that posting.

9. Any other facts supporting the use of other than full and open competition.

Not applicable.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. A pre-solicitation notice was posted on SAM.gov on May 18, 2022 with a response date of May 31, 2022, 3:00PM ET. Two (2) responses were received via email The Contracting Officer’s Representative (COR) for the requirement reviewed the received capability statements and completed an assessment form for each. The COR found that capability statement each did not sufficiently demonstrate that the organization met the technical requirements presented in the SAM.gov notice.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. Based on the acquisition history presented for this developing Programmatic requirement, it is anticipated that a subsequent acquisition likely will be needed. Currently, the Vendor identified above is the only available Vendor as stated above. Also, any future procurements will continue to be supported by sources sought notices and/or presolicitation notices posted on the federal-wide point of entry for contracting opportunities, and the NCI will continue to review any responses received.

a pre-solicitation notice was posted on SAM.gov. Please refer to section #6 of this document for the outcome of that posting.