JA - Kaiser Registry - RFP-NIH-NIAAA-2021 - Signed.pdf

Justification for Other than Full and Open Competition

“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/NIH/NICHD

b. Sponsoring organization. NIAAA/Division of Medications Development

c. Project Officer information.

Project Officer name. Megan Ryan

Mailing address. 6700 Rockledge Drive, Rm 1324, Bethesda, MD 20892

E-mail address. Mryan1@mail.nih.gov

Telephone number. 3014434225

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

a. Acquisition purpose and objectives. The purpose of this J&A is to award a base plus 4 options to develop a registry of patients with diagnosis of AUD or alcohol misuse by leveraging comprehensive proprietary electronic health record (EHR)-based data within Kaiser Permanente Northern California (KPNC) and use this registry to evaluate the full course of alcohol problems, longitudinally and comprehensively, including early identification, initiation and engagement in treatment (including psychiatry, addiction medicine, and pharmacotherapy), and long-term outcomes (e.g., drinking, physical and mental well-being), which are critical to understanding recovery.

b. Project background. Alcohol Use Disorder (AUD) is a devastating disease, resulting in a myriad of medical, psychological, social, and economic problems. Approximately 14.4 million Americans have a diagnosable AUD, causing 88,000 deaths annually and costing the United States (US) society more than $249 billion dollars. Globally, alcohol misuse was the fifth leading risk factor for premature death and disability in 2010.

Because of the heterogeneity of AUD, not all behavioral and pharmacological therapies are effective in every patient and in every circumstance. Instead, a menu of medications—each of which shows efficacy in certain groups of patients—might offer the best option.

Clinicians would then have a wide variety of medications and behavioral therapies from which to choose and could target those drugs that are most effective to each individual patient—in short, precision medicine.

A large body of evidence has demonstrated the effectiveness of current treatments for AUD. However, there is a dearth of evidence about what happens after an individual completes treatment successfully, a period commonly referred to as recovery. To move this important area of research forward and guide the provision of AUD treatment, NIAAA recently developed a definition that describes recovery as a process through which an individual pursues both remission from AUD and cessation from heavy drinking. The definition is as follows: “Recovery is a process through which an individual pursues both remission from AUD and cessation from heavy drinking. An individual may be considered “recovered” if both remission from AUD and cessation from heavy drinking are achieved and maintained over time. For those experiencing alcohol-related functional impairment and other adverse consequences, recovery is often marked by the fulfillment of basic needs, enhancements in social support and spirituality, and improvements in physical and mental health, quality of life, and other dimensions of well-being.

Continued improvement in these domains may, in turn, promote sustained recovery.”

Although there are many treatment sites across the United States to treat AUD, there is little follow-up with the patients after they complete short-term, circumscribed treatment programs (< 90 days). Unlike other diseases (e.g., cancer), there is no established AUD treatment registry to follow patients.

The purpose of this contract is to develop a registry of patients with diagnosis of AUD or alcohol misuse by leveraging comprehensive, proprietary electronic health record (EHR)-based data within Kaiser Permanente Northern California (KPNC). KPNC is an integrated health care system that provides primary and specialty care (including addiction medicine and psychiatry) internally and has a mature, fully developed EHR system, Kaiser Permanente HealthConnect™, that stores data collected throughout the full course of patient care since 2005.

Longitudinal, multi-dimensional patient-level data can be obtained (including health service utilization, diagnoses, medications, laboratory tests, and responses to health questionnaires), providing a unique opportunity to study the onset and progression of alcohol problems, care provided during all phases (i.e., follow-up, management, continuity of care), and long-term outcomes such as recovery. The registry has the ability to evaluate the full course of alcohol problems, longitudinally and comprehensively, including early identification, initiation and engagement in treatment (including psychiatry, addiction medicine, and pharmacotherapy), and long-term outcomes (e.g., drinking, physical and mental well-being), which are critical to understanding recovery.

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

a. Project title. KPNC Alcohol Registry to evaluate and inform alcohol treatment and recovery

b. Project description. Please see attached SOW.

Requirement type.

X 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.

X New requirement Follow-on Other (specify): ______________________

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________

X 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 X Term form

Acquisition identification number. RFP-NIH-NIAAA-2021-8

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

Period of Performance Amount

$145,3856/15/2021-6/14/2022

6/15/2022-6/14/2023 $149,555

$153,851

$158,277

6/15/2023-6/14/2024

6/15/2024-6/14/2025

6/15/2025-6/14/2026 $162,832

Total dollar value: $769,900

Performance Period: Base plus 4-year options – 6/15/2021 through 6/14/2026 (estimated)

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

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.

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).

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). Kaiser Foundation Research Institute, Kaiser Division of Research, 1800 Harrison Street FL 16, Oakland, CA 946123433

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

NIAAA requires Kaiser to provide a registry of their AUD patients from the Kaiser patient EMR system and follow registry participants during the course of the contract period for the purposes of studying AUD/alcohol misuse and recovery after treatment. This dataset is unique in that Kaiser includes sufficient granularity of alcohol consumption data so as to allow computation of all necessary drinking outcomes. Moreover, the database is longitudinal allowing for analysis of long-term health outcomes over time. This is a unique, national database and no other organization known to NIAAA possesses the volume and numbers of patient records with the required drinking data and repeated long-term healthcare follow-ups. The Program Office performed market research through discussions with industry and internet searches, and found no other sources where 1) drinking data are collected as part of primary care practice; 2) patients are followed longitudinally over a period of at least 3 years; 3) physical health data from Electronic Medical Records are linked with the drinking data; 4) the PI has IRB approval to conduct the necessary statistical analysis; the

5) the number of patients in the registry exceeds 500,000 patients; and 6) the patients are from an insured population.

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.

This effort is only being solicited from a single source due to the unique nature of the requirement. Kaiser is the only entity that has the registry in question. A presolicitation notice was posted on February 22, 2021, with a response date of March 9, 2021. No responses were received for the presolicitation notice.

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

The anticipated cost is determined by the Contracting Officer to be fair and reasonable. The estimated cost is based on experience with similar efforts in the past at the National Institute on Alcohol Abuse and Alcoholism. Those costs are based in large part on labor costs

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 Government has interfaced with industry in the past in order to find data sources that would support research in the field of alcohol research. This includes discussions at conferences, grant opportunities, journal submissions, etc. NIAAA has found that the Kaiser data set is uniquely able to meet the research needs of the institute, due to its granularity and its longitudinal nature.

While other data sources may be available, there are none that meet the unique nature of the Kaiser registry which is necessary to continue ongoing research with the data in question. A presolicitation notice was posted on February 22, 2021, with a response date of March 9, 2021. No responses were received for the presolicitation notice.

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

NIAAA has worked with Kaiser in the past to make use of the data they possess, and Kaiser has been found to be a conscientious partner to the Government.

They have been highly collaborative with NIAAA investigators and have been good stewards of federal funding that they have received in the past.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other sources have expressed an interest, in writing, in the proposed acquisition.

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.

There is currently no plan to acquire the same type of data or services. The proprietary and unique source of the registry data require that competition be curtailed.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Contracting Officer’s Representative (COR)

Megan Ryan, M.B.A.

COR Level III

COR’s Immediate Supervisor

Patricia Powell, Ph.D.

NIAAA Deputy Director

Head of the Sponsoring Program

Office

Raye Z. Litten, Ph.D.

Division of Medications Development

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Jeremy White, Contracting Officer

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

1.25.2020

Chief of the Contracting

Office

Olga Acosta, Director, NICHD Office of Acquisitions

Head of the Contracting

Activity

FOR

Diane Frasier, Director, OALM

Dr. Sheryl K. Brining, Director, ORIS, Office of Extramural Research, OD, NIH