Attach__1_NIDDK_OPTUM_Data_License_SOW_7-30_v4.pdf

STATEMENT OF WORK ATTACHMENT 1

DATED:

STATEMENT OF WORK

NIDDK Data Acquisition

RFQ NUMBER: NIH-NICHD-2019-444

1) BACKGROUND and INTRODUCTION:

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 Kidney, Urologic and Hematologic (KUH) Diseases supports basic research in normal kidney function and the diseases that impair normal function at the cellular and molecular levels, including diabetes, high blood pressure, glomerulonephritis, and polycystic kidney disease. KUH provides research funding and support for basic, translational, and clinical research studies of the kidney, urinary tract, and disorders of the blood and blood-forming organs.

Areas of research in urology include: benign prostatic hyperplasia, urinary incontinence, urinary tract infections, stones, erectile dysfunction, urologic chronic pelvic pain syndromes (including interstitial cystitis and chronic prostatitis), congenital urologic disorders, repair and regeneration of lower urinary tract organs, and normal and abnormal lower urinary tract development and physiology.

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.

2) SCOPE:

National Medical Claims Data Use License

Data about diseases under the purview of NIDDK—diabetes, digestive diseases, kidney diseases, obesity, and nutrition—have valuable, but relatively untapped, sources in the public domain.

However, to develop the national trends reports under its purview including but not limited to

Diabetes in America, the digestive diseases Burden Report, the United States Renal Data System

Annual Report and Urologic Diseases in America, NIDDK must have electronic access to a national pool of current medical claims data with race/ethnicity-by-gender stratification, among other common, clinical, demographic, and socioeconomic data elements.

3) 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 up to three (3) offices or divisions within NIDDK and its contractors. 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., using those systems cited in Table 1) when available. At least ten years or more 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 including 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

Updates, Support, and Training

The offeror shall provide data updates, customer service support, and training. The offeror shall provide customer support via phone and email to facilitate data use by NIDDK and its contractors.

1. Updates. The offeror 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 offeror 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 offeror shall provide:

a. a one-time 2-4 hour in-person 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.

A) Options

In addition to the services/quantities outlined above to be provided for the base requirement, Options(s) for additional services/quantities under the contract may be exercised at the discretion of the Government and are defined as follows:

Optional - Data Enhancements

In the base and year option years NIDDK may seek data enhancements if available including common data models and emerging standards for interoperability (e.g., FHIR-compatibility quantified, especially with any Data Quality Metrics as metadata, as offered in Sentinel, OHDSI, PCORnet, and other models). The offeror shall identify optional data enhancements as they become available over the life of the contract. Optional data enhancements shall also receive annual and ad hoc updates when new data is available and customer support to facilitate data use by NIDDK and its contractors.

For estimation purposes, provide separate line-item estimates for claims data only, vs. claims linked with EHR data. Provide separate estimates for inclusion of SNOMED, or other systems enabling standardized terminology and common data elements, or other available data enhancements.

Optional - Additional Data Access

Data access shall be granted to specified Government contractors at the request of the

Contracting Officer.

Optional - Additional Training

In the base year and each option year, the offeror shall provide up to two (2) additional in-person or webinar-based training sessions of up to two (2) hours in length

B) 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).