IDIQ SOW.docx 12 30 2024 telisha.pdf

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Access to Outpatient Longitudinal Data Statement of Work

(IDIQ SOW)

Table of Contents

PART I

Section C: Description/Specifications/Scope of Work C.1 Background C.2 Program Research Goals and Objectives C.3 Scope of Work

C3.1 Requirements for Outpatient Prescription and Patient Level Drug Utilization Data C3.2 Technical Requirements and Capabilities of the Data Resources C3.3 Custom programming and analytical support (ad-hoc hours) C3.4 Onsite or Live Virtual Training Programs and Training Materials C3.5 Onsite or Live Virtual Kick-Off and Annual Meetings C3.6 Technical Support C3.7 Monthly Progress Reports C3.7 Disclosure Clearance for Aggregated Data C3.8 Clearance for Third Party Collaborations C3.9 Ad-Hoc Technical Services C4.1 Quality Assurance Surveillance Plan C4.2 Performance Evaluation Plan C4.3 Advance Understanding

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PART I

SECTION C: DESCRIPTION/SPECIFICATIONS/SCOPE OF WORK

C.1 BACKGROUND

A vital part of the U.S. Food and Drug Administration (FDA) and Center for Drug Evaluation and Research (CDER) mission is to protect the public health. Offices within CDER take a variety of approaches to meet these broad goals. For example, the mission of the Office of Surveillance and Epidemiology (OSE) is to evaluate drug risks and promote the safe use of drugs by the American people.

The statutory provisions of the Federal Food, Drug, and Cosmetic Act as amended by the Food and Drug Administration Modernization Act (FDAMA, Section 406), Title 21 Code of Federal Regulations, Section 310.305, and Title 21 Code of Federal Regulations, Section 314.80 require FDA to ensure the safety and effectiveness of regulated marketed products.

In response to reports from the Institute of Medicine (IOM), FDA is authorized by the FDA Amendments Act (FDAAA) of 2007 to expand database resources for providing advanced analyses of drug safety data to improve the quality of post-market risk/benefit analyses and enhance the ability of FDA to make timely assessments of drug safety data. In addition, a sub-section of FDAAA calls for enhanced authorities for access to disparate data sources, establish, and improve procedures to identify data trends and prescribing patterns for health care practitioners on a national-level in the outpatient setting1.

The 21st Century Cures Act which was enacted in December 2016 also contains provisions for the FDA to increase surveillance and monitoring of certain medications such as opioids, which aligns with CDER’s mission. This section of the Act encourages the use of real-world evidence in the analysis of post market surveillance data to enable the Agency to respond promptly to serious public health issues2.

The ability of FDA to respond expeditiously to the increasing number of drug safety issues is crucial to the overall public safety. Access to outpatient prescription and patient level data will complement and strengthen the utility of FDA’s Adverse Event Reporting System (FAERS) currently in place by providing estimates of the numbers of patients exposed to drugs and the numbers of prescriptions dispensed nationwide in the outpatient setting. These data provide a denominator, or context, for understanding adverse event reports; for modeling drug risk based on usage patterns; and for calculating patient-based reporting rates for drugs used in the outpatient setting.

Access to these data also increases the FDA’s ability to perform regulatory impact studies; in particular, those studies that assess the impact of risk management plans and labeling changes on

1 PUBLIC LAW 110–85—SEPT. 27, 2007

2 H.R. 34 21st Century Cures Act https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf https://www.congress.gov/114/bills/hr34/BILLS-114hr34enr.pdf

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FDA is not interested in developing this database and expects any qualified organization to own the data as well as the means to access the data.

C.2 PROGRAM RESEARCH GOALS AND OBJECTIVES

To provide FDA personnel with:

a. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of outpatient prescriptions over time.

b. Real-time, unlimited, immediate, direct, multi-user, desktop access to currently existing, commercially available, longitudinal data with the capability of providing current and historical national-level and geographical/sub-national counts of unique patients over time who received dispensed prescription drug products from outpatient settings.

c. Prescriptions, medical claims, and patient-level demographic information, in either the same or separate, linked resources. If separate linked data resources are proposed, all individuals in the patient-level data resource shall link directly to their dispensed prescription data.

d. The ability to use these data to characterize the duration of drug exposure to prescription drug products at the patient level and to examine concomitant use of drug products at the patient level.

e. The ability to use these data to analyze and describe national-level estimates of drug utilization patterns in the outpatient setting through the use of projection or other appropriate methodologies based on a nationally representative sample that are scientifically sound and transparent to FDA personnel.

f. Direct, unlimited, internet- or network-based access to all HIPAA-compliant data in a multi-user environment and in real-time.

g. The ability to download (or obtain in a timely manner using other means) large datasets as needed.

C.3 SCOPE OF WORK

The Contractor shall provide the required personnel, materials, services, facilities, and otherwise do all things required for or incidental to the performance of the work as described below.

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C3.1 Requirements for Outpatient Prescription and Patient Level Drug Utilization Data

a. Provide continuous automated access to nationally-based, outpatient prescription-level data. The data shall include historical prescription information at a national and sub-national level.

b. The prescription-level data shall be a currently existing, commercially available, HIPAA-compliant product that shall provide immediate automated access.

c. Prescription-level data shall provide the ability of analyzing current and historical aggregate national and sub-national dispensed prescription information at a minimum of monthly-level, with the ability to aggregate data by time periods specified by the user. Patient-level data shall provide the ability to analyze unique patients utilizing drug products in an outpatient setting, with the capability of stratifying by patient age and sex. Data shall have the capability of customizing patient age bands as needed.

Patient-level data shall link to prescription-level data, allowing for the assessment of new versus continuing use of drugs at the molecule level and at the drug class level.

d. The Contractor shall also provide patient-level data describing outpatient prescription drug use in individuals longitudinally. The prescription claims data and medical claims data shall provide immediate automated access with the ability to provide counts of current and historical aggregate national and sub-national drug utilization information. The longitudinal data shall include information at the medical claim and prescription claim levels with the ability of characterizing concomitant drug use and characterizing duration of drug exposure. The medical claims data shall provide immediate automated access with the ability to provide counts of current and historical aggregate national and sub-national drug utilization information.

e. The size and characteristics of the population of patients or covered lives from which the prescription- and patient-level data are derived shall be provided to FDA, since these can affect the quality and usefulness of the data provided and the validity of national projections from the data. Characteristics shall minimally include: number of individual patients or covered lives per calendar quarter; number and percent of patients or covered lives with at least two years of continuous activity; number and percent of patients or covered lives with corresponding enrollment information;

availability of enrollment/eligibility/participant inclusion information for use in data analyses; number and percentage of active patients or covered lives in populations of special interest to FDA (including children [ages ≤ 17 years], females of child-bearing age, and elderly [ages ≥ 65 years]); turnover or churn rate for participation in the data resource; the method by which patient age is obtained; geographic diversity;

patient demographics; coverage or inclusion policies relevant to pharmaceutical products under health care plans providing the majority of the data; and availability of medical claims data. The number and percent of the total population for whom clinical/medical data or data capturing the administration of drug or biologic products in the outpatient setting by healthcare professionals are available and detailed information describing how this information is linked to the pharmacy data is

5 | P a g e required. These longitudinal data shall follow uniquely identifiable individuals (using encrypted patient identifiers) and physicians over time either across or within ambulatory health care plans. Patient age and sex shall be provided. Information on race/ethnicity shall be accompanied by documentation of the origin of this information, if available.

f. Prescription data shall include the therapeutic class of drug and biologic products (including biosimilars and interchangeable biosimilars), molecule(s), active ingredient(s) (e.g., single-ingredient or combination), molecular salt (if applicable), product name (U.S. proprietary and non-proprietary), original prescribed product, substitution allowability, strength, National Drug Code (NDC), company name (manufacturer or corporation), dosage form, strength, all dates dispensed, quantity dispensed, dispensed days’ supply, prescriber specialty, and method of payment. The Contractor shall provide the ability to obtain all data elements within a single dataset extract. The Contractor shall provide a history of dataset adjustments and corrections over the past 3 years.

g. Medical claims shall include the start date and end date of the medical event, the type of medical claim (e.g., inpatient claim, outpatient facility claim), medical specialty of the practitioner(s) involved, and the following data elements as dictated by the type of medical claim: International Classification of Diseases (ICD) diagnosis code(s), admitting diagnosis code, discharge diagnosis code(s), version indicator (e.g. ICD-9, ICD-10), and procedure code(s) (e.g. CPT, HCPCS) with source indicator. Current data shall include patient-level demographic information as well as a link to a patient's current and historical prescription drug use.

h. Provide the total number of years of data available overall and the number of years available online and accessible in real-time to FDA personnel. The contractor shall have a minimum total of 10 years of data (minimum of five years of data available online and at a minimum an additional five years of historical data that is no longer online), and propose methods to obtain historical data in a timely manner. FDA’s preference is that historical datasets be available on demand and without intervention from the Contractor.

i. Provide direct access to weekly data with the capability of providing current and historical national-level and sub-national level counts of prescriptions and unique patients over time, delivered weekly with no more than an 8-day lag.

j. Provide direct access to monthly data with the capability of providing current and historical national-level and sub-national level counts of prescriptions and unique patients over time, delivered monthly with no more than a 30-day lag.

k. The online tool shall have the capability to provide data in weekly, monthly, quarterly and annual outputs.

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l. Provide a description of the Contractor’s data acquisition process for the prescription claims and medical claims data. All data flow and management procedures shall be described, including data acquisition, cleaning, and editing procedures, data de-identification procedures, specification and description of all coding systems used for diagnoses, procedures and drugs, including versions (e.g. ICD-9, ICD-10), methods for coding data, percentage of missing or incomplete information and the method of coding missing data, availability of raw/sample numbers as well as projected numbers, and the frequency with which data are updated and methods for updates.

For each health care setting, the Contractor shall estimate the proportion captured in the data source out of the entire market and provide this estimation to FDA, updated at least semi-annually. A current and complete updated data dictionary and database description shall be provided annually and as changes are made.

m. FDA requires the ability to use both the prescription-based outpatient data and patient-based outpatient data to estimate drug utilization patterns in the total U.S.

outpatient population, or in a national sub-population of interest (e.g., children [≤ 17 years], females of child-bearing age, elderly [≥ 65 years]). This shall require the use of projection or other appropriate methodologies which shall be valid, reliable, and robust with regard to drug utilization specifically. The methods of national level estimation (projection or other methodology) shall be fully disclosed.

n. Claims-level data, such as prescriptions or medical claims, shall include a de-identified patient ID for linking patients across claims and a de-identified health care practitioner ID for linking practitioners across claims.

o. The FDA has no interest in knowing the identity of any patient, provider, or health plan included in the data. It shall be solely the Contractor’s responsibility to de-identify the data for FDA use, but the methods used to de-identify the data shall be described.

C3.2 Technical Requirements and Capabilities of the Data Resources

a. The Contractor shall provide outpatient prescription longitudinal patient-level data that is currently existing and commercially available. Access to the data shall be immediate, unlimited, direct, desktop and in real-time. Direct access shall include all upgrades, enhancements, and modifications to software and data.

b. Access shall be through an existing interface and this interface shall be user-friendly, transparent and flexible enough to meet the FDA’s needs. Minimally, the interface shall provide both predefined (e.g., canned) and custom reports.

c. Full disclosure of data collection, construction, coding, and configuration are required to allow FDA staff to appropriately interpret findings and understand the construction and application of the projection or other appropriate methodology.

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d. Access to the data resources shall be accessible via a secure internet or network-based method permitting simultaneous, multi-user access through a user-friendly data query tool(s).

e. The Contractor shall provide the FDA the ability to immediately, directly download data in an automated fashion—without any intervention needed from the Contractor—in the following formats: Microsoft Excel, comma- or tab-separated file, and text delimited file. The Contractor shall provide the ability to directly download data in both a hierarchical format as well as a flat file (a file where a record contains data for each user-selected data field). For downloading datasets larger than 100 megabytes, the Contractor shall provide a manner which is compatible with FDA security procedures. The data query tool shall allow the user to download information regarding the user-selected specifications for each query, such as time period selected, drugs selected, dosage form selected, the dataset used, and the date that the query was run.

f. The Contractor shall provide FDA with a 14-day trial subscription. The Contractor shall provide a live virtual web-based training session that lasts a maximum of 2 hours at the start of the trial subscription period. The trial subscription shall include direct access, documentation, and technical support for a maximum of seven FDA users. The FDA will not pay for this subscription as access will be used solely to assess whether the contractor meets the data requirements, and not for any analyses, public disclosure, or regulatory decision making.

g. The Contractor shall specify any additional software name and version) necessary to access the data. Any software installed on FDA computers for the purposes of accessing the data shall not use keylogging or network capturing functionality to transmit any data from the FDA system. Exceptions are for login information specific to the data vendor and dataset, and procedures for querying the Contractor’s data sets, such as SQL (Structured Query Language).

h. The FDA utilizes the virtual private network (VPN) to establish a trusted, encrypted TCP/IP tunnel for accessing data from a remote location. The VPN shall be a firewall-to-firewall encrypted tunnel utilizing commercially available software and industry standard Internet Protocol Security (IPSEC) protocols. The Contractor shall conform to Section 508 standards (see Attachment 9).

i. In the event of changes to the Contractor’s business or agreements with their data suppliers, the FDA shall be notified within 5 business days of the Contractor becoming aware of such changes. This notification shall include details of the impact of these changes on data quality, data quantity, and overall data characteristics.

C3.3 Custom programming and analytical support (ad-hoc hours)

The Contractor shall provide additional analytical and programming support, to enable FDA personnel to obtain prescriptions, patients, claims and any other utilization metrics bookmark://firewall_VPN/ bookmark://firewall_VPN/ bookmark://firewall_VPN/ bookmark://firewall_VPN/ bookmark://commercially_available/ bookmark://appendix_D/

8 | P a g e not available through the online data tools. The FDA estimates a potential need of up to 200 ad-hoc hours annually. The Contractor may need to provide additional hours of ad-hoc data analyses, custom queries, or raw data preparation not available through the data tools and in increments to be determined at the Task Order level.

C3.4 Onsite or Live Virtual Training Programs and Training Materials

The Contractor shall provide training for users of the data, as well as training for FDA personnel who shall support use of the data (e.g., technical users). The Contractor shall provide a minimum of two onsite or live virtual training sessions per year as required by the FDA. Live or web-based training of FDA personnel shall be offered for any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide course outlines for all levels of training offered live virtually or on site at FDA (Silver Spring, MD) and options for additional “on-demand” sessions either in person or via web-based methods. The training shall be initiated within 30 days of award and continue throughout the duration of the contract.

C3.5 Onsite or Live Virtual Kick-Off and Annual Meetings

The Contractor shall participate in a kick-off meeting within two weeks of contract award and shall conduct an annual meeting live virtually or on-site (at the FDA’s discretion), at the FDA White Oak Campus in Silver Spring, MD. The purpose of the annual meeting is to discuss scientific issues of interest to the Agency and relevant work that the contractor has performed, as well as discussing FDA satisfaction with all deliverables.

C3.6 Technical Support

The Contractor shall provide a support package comprised of written documentation that includes technical, analytical, and clinical support throughout the length of the contract.

The support package shall include any modifications, enhancements, or upgrades to the data source.

The Contractor shall provide ongoing technical, analytical, and clinical support by phone or by e-mail during business hours (9:00 am to 5:00 pm, ET), Monday through Friday, excluding Federal holidays (available at www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/), throughout the length of the contract. This support shall be in accordance with the service levels established in the contract.

To ensure effective communication and access to needed resources, the Contractor shall have dedicated client support personnel to serve as a liaison between the FDA and the Contractor.

http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ http://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

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C3.7 Monthly Progress Reports

The Contractor shall provide Monthly Reports by 20th of each month for the previous month data detailing use of the resource by individual FDA users and type of use clearances, third party agreements, number of ad-hoc programming hours used and project title (See Attachment 6 - Example of Monthly Report) and shall include the following:

a) Number and type of data queries by individual FDA user.

b) Clearance Requests shall include type of data submitted, project title, FDA requestor, date of request, and approval date.

c) Third Party Agreement Requests shall include third party collaborator, project title, FDA principal investigator, date of request, approval date, and expiration date.

d) Ad-hoc Dataset Requests shall include the number of technical support programming hours used, project title, FDA requestor, date of request, and date received.

e) Notifications of any circumstances resulting in loss or lack of data streams, or any data enhancements or data errors that would impact access to data from the data resource(s).

f) Status update on each task worked on and deliverables submitted, any problems encountered, and suggestions for addressing problems each period.

g) If the tasks are cost reimbursable in nature, an accounting of applicable staff who worked on the tasks as well as any deviations from the original projection of hours planned vs.

actually incurred shall be required.

C3.7 Disclosure Clearance for Aggregated Data

As part of its regulatory activities, FDA requires disclosure of scientific and technical articles, study results, presentations, public health advisories, and similar works involving aggregated data to entities outside the Agency including the general public. For activities that require disclosure of aggregated data, the Contractor shall accept and adhere to FDA Data Disclosure Clearance Procedures and Form found in Appendices B and C unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by FDA. FDA shall continue to require the ability to release aggregated data through the FDA Data Disclosure Clearance process for data obtained during the contract period of performance. After Option Year 4, FDA will not require data access service, but will require the services of processing clearance requests. After option year 4, the FDA will notify the Contractor of the aggregated data release for projects initiated prior to the end of the contract and accept the Contractor’s requested revisions for a maximum of one year but will not require formal approval for release.

C3.8 Clearance for Third Party Collaborations

As part of its regulatory activities, FDA engages in collaborative research projects with third parties outside of FDA that are initiated by and conducted for the benefit of FDA.

These collaborations shall require FDA to have the ability to share project-specific aggregated or raw data with third parties for collaborative research projects. For these collaborations that require sharing of aggregated or raw data, the Contractor shall accept and adhere to the Data Disclosure Clearance Procedures and form to be found in

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Attachment 7 and Attachment 8 unless a different Data Disclosure Clearance Procedure process proposed by the Offeror is approved in advance by the FDA. These Procedures include terms and conditions for third party collaborations.

C3.9 Ad-Hoc Technical Services

The Contractor shall provide unlimited additional quantities of Services via the issuance of firm fixed priced, time and materials, or hybrid Task Orders. These technical directive orders shall be billed in accordance with the over-arching labor rates agreed upon in the pricing schedule.

The type of additional services and associated maintenance would include:

a. Validation Studies – Studies that are conducted to establish soundness or validity of a particular method used, for example to validate indications for treatment in the database using the claims data.

b. Projection Methodology Studies – Developing methods that shall allow projecting the number of prescriptions or patients based on the sample data.

c. Concomitant Drug Use Analysis – Analyses on the concomitant use of two or more drugs from the same or different therapeutic classes indicated to treat the same or different diagnosis.

d. Feasibility Studies – Studies that are conducted as initial pilot studies to determine if the scope of a study is practical, achievable, and likely to involve a large enough population size to determine a significant association or non-significance association between exposure and outcome.

e. Customized Analysis – Analyses of data that endeavor to answer a specific question that require additional tools beyond the current interface tool that is provided by the database.

f. Tool Enhancement –Expanding the tool capabilities beyond the current offering to improve data access and analysis.

g. Ability to access other outpatient data and tools that allows more granular perspective such as by geography (e.g., County, State, Metropolitan Statistical Area), and time (e.g., weekly) within the vendor’s data suite.

h. Ability to link/access additional data sources including electronic medical records within the vendor’s data suite to provide a comprehensive view of the drugs being analyzed.

C4.1 Quality Assurance Surveillance Plan

The Contractor shall provide a Quality Assurance Surveillance Plan (QASP) detailing the procedures and guidelines to ensure the required performance standards or services levels, specified in the performance evaluation plan, are met throughout the life of this contract. The QASP shall describe the systematic methods used to monitor performance, identify required documentation, and allocate resources. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

C4.2 Performance Evaluation Plan

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Performance shall be evaluated to determine whether it meets the threshold of the agreement.

When the performance threshold is not met, the FDA Contracting Officers Representative (COR) shall notify the Contract Specialist/Officer. The Contractor shall reply to all performance inquiries listed below with a resolution within 15 business days of receipt. Failure to meet the Acceptable Quality Level shall be captured as non-performance and provided to the Contracting Officer for action.

Required Service Standard Acceptable Quality Level

(AQL)

Method of Surveillance

The Contractor shall provide Disclosure Clearance and Third Party Agreement Service

The turnaround time for urgent clearance requests is 24 hours (one business day); 48 hours (two business days) for standard clearance requests; and 72 hours for third-party agreements

Standard shall be fully met at 100%

COR and FDA staff shall maintain a clearance tracking log with turnaround times

The Contractor shall provide unlimited Direct Access to Data Resource and Services

The Contractor shall notify the FDA 48 hours in advance of any circumstances resulting in loss of access to the data source due to planned downtime

The Contractor shall notify the FDA within 30 minutes (Monday-Friday, 9:00 AM – 5:00 PM

Eastern Time) from the onset of unplanned downtime with an estimate of time to restoration of access

Standard shall be fully met at 100%

COR and FDA staff shall monitor database access, notification and restoration times

The Contractor shall provide ad-hoc analyses:

custom reporting and product customization

The Contractor shall provide the FDA ad-hoc data results within 15 business days from receipt of request from FDA, or a mutually agreed upon delivery timeline for more complex analyses

Standard shall be fully met at 100%

COR and FDA staff shall monitor turnaround times of ad-hoc requests from the Contractor’s Monthly Report

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Required Service Standard Acceptable Quality Level

(AQL)

Method of Surveillance

The Contractor shall provide a resolution plan and shall include a timeline for resolving any circumstances resulting in loss of, or lack of, access to data or any data errors/loss from the database(s)

Within five business days of Contractor’s knowledge of the loss or lack of access to data or any data errors/loss from the database(s) and shall be documented in the Monthly Report

Standard shall be fully met at 100%

COR and FDA staff review of data quality (i.e., variance in data runs)

The Contractor shall guarantee timely access to outpatient prescription-and patient-level analytical datasets

The mutually agreed upon dataset parameters (max.

size, data elements) and turnaround time to be negotiated at the time of award

Standards shall be fully met for access to all prescription-and patient-analytical datasets

COR and FDA staff review of dataset quality and turnaround times

C4.3 Advance Understanding

Notwithstanding any of the above requirements, under certain circumstances, the Government may be required to share data or information it obtains under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction. If it intends to share data or information obtained under this contract with Congress, with a Federal court, or with another governmental body of competent jurisdiction, the Government shall take appropriate measures within its control to ensure that the information shall be shared in a manner intended to protect the information from public disclosure. The Contractor shall ensure the protection of the information and data they receive under this contract from unauthorized use or disclosure and shall treat the information as confidential or otherwise privileged.