75N91019Q00078-_J_A_FINAL_Redacted.pdf

Justification and Approval for Sole Source Acquisition for Commercial Items for Acquisitions Over the Simplified Acquisition Threshold

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS/ National Institutes of Health (NIH)

b. Sponsoring organization.

National Cancer Institute (NCI)/Division of Cancer Control and Population Sciences (DCCPS)/Surveillance Research Program (SRP)

c. Contracting Officer’s Representative (COR) information.

Name.

Mailing address. 9609 Medical Center Dr.

Rockville, MD 20850

E-mail address.

Telephone number.

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives.

The primary objective of this project is to maintain the weekly submission of medical claims data from oncologists and oncology practices (providers) that have previously provided consent, and which follow cancer reporting guidelines according to their respective states (Georgia, Kentucky, Louisiana, New Mexico, Iowa, and Utah). These claims are crucial to obtain detailed treatment information for new cancer cases, to assess longitudinal treatment as well as progression, recurrence and to more rapidly ascertain cancer cases. To obtain longitudinal treatment information, as well as recurrence and progression it is crucial to obtain a very long series of claims for each individual cancer patient and maintain consistency on the cancer patients being covered.

A second objective is to onboard new providers with the capability to transmit claims data within the existing SEER areas, as well as in additional states/areas covered by cancer registration.

b. Project background.

Healthcare providers in all 50 states are required by law to report new cases of cancer to their state’s cancer registries. The National Cancer Institute’s (NCI’s) Surveillance, Epidemiology, and End Results (SEER) Program, collects data on each and every cancer patient in SEER covered areas. This data includes demographics, a description of their cancer, limited initial treatment information, and patient follow-up including cause of death for deceased patients. In the past the main source of registry data came from Hospitals. With the increasing complexity of cancer care and delivery systems, patients are being increasingly treated exclusively at physicians’ offices.

Thus, for SEER to continue capturing all cancer cases and their treatment information SEER is interested in obtaining other sources of data such as claims data from oncology practices. Oncology practice claims has proven to be a rich source of information on detailed systemic therapy, including agents, doses administration dates etc.

Beginning in 2015, the NCI SEER Program began supporting the procurement of oncology practice claims data for six (6) SEER central cancer registries (see related contracts listed below), from Unlimited Technology Systems, LLC. Unlimited Technology Systems provides healthcare information systems to a national community of oncology practices. In addition to obtaining cancer treatment information for cases recently diagnosed, SEER is interested in evaluating the long history of claims to assess longitudinal treatment as well as progression and/or cancer recurrence. To do this, it is crucial to have a very long series of longitudinal claims on the same cancer patient. The SEER Program has already obtained claims for a substantial number of SEER cancer patients for the years 2013-2017 in Georgia, Kentucky, Louisiana, New Mexico, New Jersey, and Utah from oncology practices and oncologists, referenced here as providers. These providers process their claims using Unlimited Systems Technology. Therefore, Unlimited Systems Technology is the only vendor that has access to this exact subset of claims data.

Further, the Unlimited providers have previously provided consent to Unlimited Systems Technology to send claims to the respective central cancer registries to fulfil their obligation in reporting cancer cases.

These claims are currently being used by SEER registries to ascertain new cancer cases more rapidly as the claims are received weekly, to capture systemic therapy and to ascertain follow-up information in terms of vital status of cancer patients. The SEER Program is interested in continuing to support the transmission of claims data for practices which have been set up to do so over these past years, as well as to support the expansion of this capability, for additional providers within the SEER regions, or new states/areas covered by cancer registration that the Program identifies as important to obtain claims data information. This project is critical for SEER to remain relevant and advance cancer surveillance and research.

Related Contracts:

HHSN261201300015I Emory University HHSN261201300013I University of Kentucky HHSN261201300016I Louisiana State University Health Sci. Center HHSN261201300010I University of New Mexico HHSN261201300021I Rutgers, the State University of New Jersey HHSN261201300017I University of Utah

HHSN261201800649P Unlimited Technology Systems (awarded 2018;

and onboarded Iowa)

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

a. Project title.

Electronic Capture of Cancer Claims Data for SEER Program

b. Project description.

See attached Statement of Work.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on (list of prior contracts above) Other (specify): ______________________

Proposed contract/order type.

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. 75N91019Q00078

c. Total estimated dollar value and performance/delivery period.

Base Period (Year 1): Period of Performance is 09/07/2019 – 09/06/2020 with the Independent Government Estimate of (for 1-400 providers at , and onboarding of four (4) new practices at each).

Base Period Optional Additional Services (to be exercised during Period of Performance of Base Period): Independent Government Estimate of

(This option can be exercised up to four (4) times at each)

Term Option Period #1 (Year 2): Period of Performance is 09/07/2020 – 09/06/2021 with the Independent Government Estimate of:

(for 1-400 providers at , and onboarding of four (4) new practices at each).

OR (To be determined by the Government prior to exercising Term Option Period 1)

(for 1-500 providers at , and onboarding of four (4) new practices at each)

OR (To be determined by the Government prior to exercising Term Option Period 1)

(for 1-600 providers at , and onboarding of four (4) new practices at each)

Term Option Period #1 Optional Additional Services (to be exercised during Period of Performance of Term Option Period #1): Independent Government Estimate of (This option can be exercised up to four (4) times at each)

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

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- __modified to reflect that the procedures in FAR subpart 13.5.

This acquisition is conducted under the authority of FAR subpart 13.5 in accordance with 41 U.S.C. 1901. No other requirement and/or type of service will satisfy the agency need.

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).

Unlimited Technology Systems, LLC 5905 E Galbraith Rd. Ste 8000 Cincinnati, OH, 45249

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

The SEER program is interested in evaluating the long history of claims data to assess longitudinal treatment as well as progression and/or cancer recurrence. To do this, it is crucial to have a very long series of longitudinal claims data for the same cancer patient. The SEER program has previously obtained this claims data from oncologist providers and oncology practices as shown in the following table:

SEER Area Number of Oncology Practices

(Providers)

Medical Oncologists

Georgia 6 95 Iowa 3 57 Kentucky 1 2 Louisiana 1 3 New Mexico 1 20 Utah 2 29

The above providers process their oncology claims using Unlimited Technology Systems.

Unlimited Technology Systems is the only provider with the specific oncology provider network that has access to the current subset of claims data for the same cancer patients.

Obtaining this claims data for the same cancer patients is necessary to maintain the consistency of the longitudinal claims data that are reported to the SEER registries. Award of this contract to any other provider would result in access to a different network of oncology providers. This would compromise the consistency of longitudinal claims data by providing this data for a different group of cancer patients. Thus, it is reasonable for the NCI to conclude that its needs for this unique subset of provider claims data for the same cancer patients can only be satisfied by Unlimited Technology Systems.

Further, Unlimited Technology Systems has expended effort under related NCI contracts working with their network of providers to obtain consent to send this claims data to the respective SEER registries. In addition to obtaining consent, Unlimited Technology Systems expended effort under related NCI contracts working to establish the technical infrastructure required to transmit the data between the providers and SEER registries. Subsequently, it is likely that award to any other source would result in substantial duplication of cost to the Government that is not expected to be recovered through competition and result in unacceptable delays in fulfilling the NCI’s requirements

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps 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 FedBizOpps.gov on July 9, 2019 with a response date of July 19, 2019; 3:00PM ET. Only one (1) response was received via email on July 17, 2019 in response to the Pre-solicitation notice from Cliexa. The Contracting Officer’s Representative (COR) for the requirement reviewed the received capability statement and completed an assessment form for it. The COR found the capability statement did not sufficiently demonstrate that the organization met the technical requirements presented in the FBO notice.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

The NCI Contracting Officer will consider the Independent Government Estimate and previous purchases as a determining factor for reasonableness. A final determination will be conducted prior to the award of this contract.

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 NCI staff has stayed abreast of published literature in the area of healthcare technology, as well as through internet searches and exchanges at meetings with the cancer surveillance community. The COR has a clear understanding of resources available for this requirement, and to her knowledge, no other vendor has the unique expertise and capabilities to perform the required work. Furthermore, no vendors expressed ability to provide required services during prior year contract establishment.

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 FedBizOpps.gov on July 9, 2019 with a response date of July 19, 2019; 3:00PM ET. Only one (1) response was received via email on July 17, 2019 in response to the Pre-solicitation notice from Cliexa. The Contracting Officer’s Representative (COR) for the requirement reviewed the received capability statement and completed an assessment form for it. The COR found the capability statement did not sufficiently demonstrate that the organization met the technical requirements presented in the FBO 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. NCI anticipates the needs to be met successfully with this fulfillment of this requirement. In the event that additional service is required, the NCI Program Office and the and Contracting Officer will conduct market research to determine if the current state of technology has advanced and to determine if there are others sources available that can provide the services required.