Notice of Intent to sole source - Data Claims and EHR.pdf

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT

PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) intends to award a purchase order without providing for full and open competition to OPTUMINSIGHT, INC.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 541715 with a Size Standard of 1,000.

REGULATORY AUTHORITY

The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2024-07 effective August 29, 2024.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13- Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 1901 – Simplified Acquisition Procedures.

DESCRIPTION OF REQUIREMENT

Background

The mission of the National Institutes of Health (NIH) is to seek fundamental knowledge about the nature and behaviors of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability.

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science- based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases and to improve people’s health and quality of life.

NIDDK's Division of Digestive Diseases and Nutrition (DDN) has responsibility for managing programs in basic and clinical research, as well as training and career development, related to liver and biliary diseases; pancreatic diseases; gastrointestinal diseases, including neuroendocrinology, motility, immunology, absorption, and transport in the gastrointestinal tract; nutrient metabolism; obesity, weight control, bariatric surgery; nutrition research, and eating disorders. NIDDK published two reports on the burden of digestive diseases in the United States in 1994, 2008, and a new edition is underway.

The current Burden of Digestive Diseases in the United States report will include pertinent information on the frequency, health impact, and cost of major digestive diseases and covered health conditions. A primary purpose of the Burden Report is to provide critical information to assess the state-of-the-science in digestive diseases and the related NIH research portfolio, with a view toward identifying areas of research challenges and opportunities to guide the NIDDK leadership –along with the investigative and lay communities– in pursuing important research avenues to combating digestive diseases. Considerable strides in digestive diseases, nutrition, and obesity research are being made on an ongoing basis in community-based and national surveys, and a continual update that compiles these data will be needed.

NIDDK requires ongoing access to healthcare claims data to support the research and analysis of national disease and condition trends that result in the creation of journal publications and epidemiological reports that NIDDK is uniquely positioned to and, in the case of Digestive Diseases, congressionally mandated to publish. NIDDK requires that key information on diseases of interest to NIDDK are reported by race/ethnicity-by-gender stratification. Market research performed indicates that currently only one provider of patient claims data from private insurance markets has a wide national pool of data reliably available by race/ethnicity.

SCOPE

The scope of this contract is to provide access to healthcare claims data and electronic health records (EHR) to support the research and analysis of national disease and condition trends that result in the creation of journal publications and epidemiological reports.

TECHNICAL REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services and qualified personnel not otherwise provided by the Government as needed to perform the Statement of Work below. Specifically, the Contractor shall provide a license to access a national pool of patient claims data with common clinical data elements for the Division of Digestive Diseases and Nutrition (DDN) within NIDDK and its epidemiology support contractor. Relevant claims data elements include but are not limited to the data represented in Table 1 below.

Race/ethnicity is a critical data element as minority populations are disproportionately affected by the diseases and conditions under the purview of NIDDK’s mission.

These data must be as complete as possible with demographic data including age, gender, race/ethnicity (with as minimal missing data as possible). All ages, including pediatrics (age<18 years), must be provided if available. All data must include information based on claims or other fields to indicate comorbid conditions of interest (diabetes, hypertension, kidney disease, digestive diseases, among others; at minimum any conditions coded within claims and/or electronic health records, e.g., data using those systems cited in Table 1) when available. At least fifteen years of data must be provided (if available), and that data structured to allow longitudinal follow up of individual patients over time. However, data sets provided must not include personally identifiable information (PII) but must contain anonymized, individual level identifiers to link various data sets longitudinally as needed.

Medical, pharmacy, and lab test data must be included, data must include laboratory values, medication use, vital signs data (height, weight, blood pressure, others as available), costs of care, and provider notes in a natural language searchable fashion, as well as structured, longitudinal data (review of systems, physical examination, etc.)

where possible, and Socioeconomic data (household and individual median income) if available. Data must include ZIP code, aggregate median household income, highest level of education achieved, and current employment status.

Table 1.

National Patient Claims Data Elements

Individual Data Medical Claims Data

Pharmacy Claims Data

Lab test results data

Inpatient Confinement Data

Provider Data

Member identifier Member identifier Member identifier

Member identifier

Admit and discharge dates

Credential

Plan Provider identifier Provider identifier

Lab test name Admit and discharge diagnoses

Affiliations

Sex/Gender Procedures (CPT- 4, Revenue Codes, ICD-9, ICD-10)

Drug dispensed

(NDC)

LOINC codes Length of stay State

Age Diagnosis (ICD-9-

CM, ICD-10,

DRG)

Generic name Result (numeric and text)

Diagnosis (ICD-9-CM, ICD-10 –CM, DRG)

Provider notes

Dates of eligibility Admission and discharge dates

Quantity and date

Procedures (CPT-4, Revenue Codes, ICD-9, ICD-10)

Specialty

Family identifier Admit types and channels dispensed Facility detail Years of experience

Health exchange Denied claims Drug strength Standard pricing Race

Zip Code Date and place of service

Days supply Vital Signs (height, weight, blood pressure, etc.)

Gender

Education Standard pricing Dollar amounts Site of Care (ICU, Ward, ED, short stay, other)

Employment Comorbid conditions (diabetes, high blood pressure, kidney disease, digestive diseases etc.)

Standard pricing

Socioeconomic

Race

Ethnicity

Income

Education

Marital status

12/29

UPDATES, SUPPORT, AND TRAINING

The Contractor shall provide data updates, customer service support, and training. The Contractor shall provide customer support via phone and email to facilitate data use by

NIDDK.

1. Updates. The Contractor shall provide updated data, such as the most recent data and new patients for the same population as the original data or with the most current population available, for each contract year and ad hoc updates (e.g. quarterly) when available.

2. Customer Service Support. The Contractor shall provide standard technical support for the Data and Database Builder, during normal business/support hours. Technical support shall include at a minimum:

• Data definitions and coding conventions of Data, Data delivery, formatting, and quality assurance.

• Interpretation of Data dictionary elements consistent with Data user training.

• Questions covering definition and implementation of inclusion / exclusion criteria

(e.g., when querying data for project-specific extracts).

3. Training. The Contractor shall provide:

a. a one-time 2-4 hour training session for users at a site determined by NIDDK

b. one (1) webinar-based training session per year upon written request. The webinar- based training session shall be at least two (2) hours in length.

INTELLECTUAL PROPERTY

The Contractor shall be solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials need to perform the project. Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the Contractor any proprietary rights, including intellectual property rights, or any materials needed by the Contractor to perform the project. The Contractor is required to report to the U.S. government all inventions made in the performance of the project, as specified inn FAR 52.227-11 (Bayh-Dole Act).

PURCHASE ORDER TYPE

This purchase order will be a Firm Fixed Price.

PERIOD OF PERFORMANCE

The period of performance for this requirement is:

Base Period: 09/27/2024 – 09/26/2025

INSPECTION AND ACCEPTANCE

Invoices will be reviewed and approved by the Government.

PROJECT OFFICER

The following Project Officer(s) will represent the Government for the purpose of this Purchase Order:

Project Officer: TBD

The Project Officer is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this Purchase Order; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this Purchase Order. Only the Contracting Officer has authority to:

(1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this Purchase Order; or

(5) otherwise change any terms and conditions of this Purchase Order.

CLOSING STATEMENT

This is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.”

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by Monday, September 16, 2024 12:00 P.M. EST.

Responses must be submitted via email to Ijada Fields, Contract Specialist at ijada.fields@nih.gov and Kimesha Leake, Contracting Officer at kimesha.leake@nih.gov.

“All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.”