Lance's Corner

FDA Issues Sentinel Newsletter

Sep 19, 2024

The United States Food and Drug Administration (FDA) has issued its Sentinel Newsletter, which can be read below.

 
2024 ISPE Conference:
View Sentinel's Posters and Presentations Shared During This Conference
 
2024 Sentinel Webinar Series:
Learn About Various Topics and Innovative Projects from the Sentinel Program
 
16th Annual Public Workshop:
Register for the 16th Annual Sentinel Initiative Public Workshop

2024 International Society for Pharmacoepidemiology (ISPE) Posters and Presentations:

FDA colleagues including members from the Sentinel Core Team attended the 2024 ISPE Annual Meeting in Berlin, Germany last month. Sentinel work was well represented with 27 posters, presentations, and symposia shared throughout the conference. Topics presented included maternal health, COVID-19, pediatrics, EHR (electronic health records), and drug safety. Review the Sentinel posters and presentations here.

16th Annual Sentinel Initiative Public Workshop: The 16th Annual Sentinel Initiative Public Workshop is set to occur on November 7, 2024, from 9:00 AM – 4:15 PM ET. This event will be virtual and in-person at the National Press Club, Washington, District of Columbia. This workshop will serve as an opportunity for attendees to hear about recent Sentinel achievements and developments to date. Click here to register for the event.

The 2024 Sentinel Innovation and Methods Seminar Series

The Innovation and Methods Webinar Series is hosted by the Innovation Center (IC) and serves as a platform to engage with experts and innovators around topics related to the IC strategic priorities. The latest information on upcoming webinars will be made available on the Sentinel Website.
 
Follow the steps below to access the most recent and upcoming webinars series:

1.  Go to the Sentinel Initiative website homepage.
2.  On the homepage, click on the top bar menu option: News & Events.
3.  On the Meetings, Workshops, & Trainings, click on the tab located on the left vertical menu bar.
4.  The Meeting, Workshops & Trainings page displays details for a variety of events, trainings, and webinars.
5.  Access webinars information and materials within the 2024 Sentinel Innovation and Methods Seminar Series page.
 
Overview of CDER's Real World Evidence Demonstration Projects

 
 
On August 5, 2024, Dr. Bradley shared an overview of CDER's real-world demonstration projects. Aligned with the U.S. 21st Century Cures Act, FDA established a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision-making. The program is multifaceted and supports activities such as demonstration (research) projects, guidance development, internal Agency processes, external stakeholder engagement, and the Advancing Real-World Evidence initiative. This talk presents an overview of several RWE demonstration projects and describes, for select projects, how learnings directly or indirectly serve to support FDA regulatory decision-making in evaluating the effectiveness and safety of medical products.
 
Learn more >>
 
Opportunities and Challenges in the Use of Large Language Models for Post-Marketing Surveillance of Medical Products
 
On April 22, 2024, Dr. Matheny discussed some of the opportunities and challenges in using large language models (LLMs) in the conduct of post-marketing surveillance of medical products, with a focus on issues relevant to opportunities in the Sentinel Network, such as ARIA insufficiency, detection of exposures, risk factors, and outcomes, and implications for downstream analytic methods.
 

 
 
 
 
 
 
 
Learn more >>
 
Data-driven Phenotyping Algorithms for Acute Health Conditions: Applying PheNorm to COVID-19
 
 
 
On March 25, 2024, Dr. Joshua Smith presented on automated phenotyping algorithms that can reduce development time and operator dependence compared to manually developed algorithms. One such approach, PheNorm, has performed well for identifying chronic health conditions, but its performance for acute conditions is largely unknown. This presentation describes the an evaluation of PheNorm applied to symptomatic COVID-19 disease to investigate its potential feasibility for rapid phenotyping of acute health conditions. 
 

Learn more >>
 
A PRocess Guide for INferential Studies Using Healthcare Data to EvaLuate Causal Effects of Drugs (PRINCIPLED)
On February 29, 2024, Dr. Rishi Desai delivered a presentation on inferential studies using healthcare data to evaluate causal effect. The presentation introduced a stepwise process covering the range of considerations, including 1) Formulating a causal question, 2) Describing the emulation of each component of the protocol, 3) Assessing expected precision and diagnostic evaluations, 4) Planning the assessment, and 5) Completing Inferential analyses, to foster a generation of reliable and reproducible evidence.


Learn more >>

Sentinel Community Building and Outreach

Center (CBOC) Training Series

CBOC INFORMATIONAL VIDEOS
The Sentinel Community Building and Outreach Center has created informational videos to provide
on-demand resources to become more familiar with Sentinel. Click below to watch the videos.
 
MAJOR MOMENTS details the evolution of Sentinel as a national resource, starting from the Mini-Sentinel pilot in 2009 to Sentinel today.

Click here to watch the video.
 
THE SENTINEL USERBASE highlights various groups of stakeholders that can use Sentinel as a resource to inform their work.
 
 
Click here to watch the video.
 
EHR vs. CLAIMS: CBOC explores how claims and EHR data may be used to address different dimensions of a scientific question or problem. This video details the limits and strengths of each identified resource and how they both affect the outcomes of scientific studies. 

Click here to watch the video.
 
MACHINE LEARNING IN DISTRIBUTED DATA NETWORKS:This video discusses how access to larger amounts and more complex types of electronic health data in distributed data networks like the FDA Sentinel System has created a growing interest in the use of data-adaptive machine learning techniques.
 
Click here to watch the video.
Maintaining and Expanding the Reach of the Sentinel EHR and Claims Network (DI8)
 
 
 
 
 
Learn more >>
Empirical Application of the Sentinel EHR and Claims Data Partner Network to Enhance ARIA Sufficient Inferential Requests and Atypical Descriptive Requests (Use Case Package 2)


Learn more >>
Incorporate a Range of Frequently Used Engineering Features from EHRs into the Sentinel Common Data Model in the Sentinel EHR and Claims Linked Data Partner Network
 
 
 
 
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COVID-19 Pandemic-Related Changes in Healthcare Utilization Among Insured Persons in the US and its Impact on Pharmacoepidemiologic Research

 




Learn more >>
Identifying Pediatric Hypertension in Observational Data: Comparing Clinical and Claims Cohorts in Real World Data
 
 
 
 
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Research in Action Podcast: Transforming Public Health with Unstructured Data and NLP in FDA's Sentinel Initiative
 
 
 
 
Learn more >>
A Distributed Regression Analysis Application Package Using SAS
 

 

Learn more >>
A Simple Cox Approach to Estimating Risk Ratios Without Sharing Individual-Level Data in Multi-Site Studies
 
 
 
 
Learn more >>

USDOL Issues Comprehensive Employer Guidance on Long COVID

The United States Department of Labor (USDOL) has issued a comprehensive set of resources that can be accessed below for employers on dealing with Long COVID.

Supporting Employees with Long COVID: A Guide for Employers

The “Supporting Employees with Long COVID” guide from the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) and Job Accommodation Network (JAN) addresses the basics of Long COVID, including its intersection with mental health, and common workplace supports for different symptoms.  It also explores employers’ responsibilities to provide reasonable accommodations and answers frequently asked questions about Long COVID and employment, including inquiries related to telework and leave.

Download the guide

Accommodation and Compliance: Long COVID

The Long COVID Accommodation and Compliance webpage from the USDOL-funded Job Accommodation Network (JAN) helps employers and employees understand strategies for supporting workers with Long COVID.  Topics include Long COVID in the context of disability under the Americans with Disabilities Act (ADA), specific accommodation ideas based on limitations or work-related functions, common situations and solutions, and questions to consider when identifying effective accommodations for employees with Long COVID.  Find this and other Long COVID resources from JAN, below:

Long COVID, Disability and Underserved Communities: Recommendations for Employers

The research-to-practice brief “Long COVID, Disability and Underserved Communities” synthesizes an extensive review of documents, literature and data sources, conducted by the USDOL-funded Employer Assistance and Resource Network on Disability Inclusion (EARN) on the impact of Long COVID on employment, with a focus on demographic differences.  It also outlines recommended actions organizations can take to create a supportive and inclusive workplace culture for people with Long COVID, especially those with disabilities who belong to other historically underserved groups.

Read the brief

Long COVID and Disability Accommodations in the Workplace

The policy brief “Long COVID and Disability Accommodations in the Workplace” explores Long COVID’s impact on the workforce and provides examples of policy actions different states are taking to help affected people remain at work or return when ready.  It was developed by the National Conference of State Legislatures (NCSL) as part of its involvement in USDOL’s State Exchange on Employment and Disability (SEED) initiative.

Download the policy brief

Understanding and Addressing the Workplace Challenges Related to Long COVID

The report “Understanding and Addressing the Workplace Challenges Related to Long COVID” summarizes key themes and takeaways from an ePolicyWorks national online dialogue through which members of the public were invited to share their experiences and insights regarding workplace challenges posed by Long COVID.  The dialogue took place during summer 2022 and was hosted by USDOL and its agencies in collaboration with the Centers for Disease Control and Prevention and the U.S. Surgeon General.

Download the report

Working with Long COVID

The USDOL-published “Working with Long COVID” fact sheet shares strategies for supporting workers with Long COVID, including accommodations for common symptoms and resources for further guidance and assistance with specific situations.

Download the fact sheet

COVID-19: Long-Term Symptoms

This USDOL motion graphic informs workers with Long COVID that they may be entitled to temporary or long-term supports to help them stay on the job or return to work when ready, and shares where they can find related assistance.

Watch the motion graphic

A Personal Story of Long COVID and Disability Disclosure

In the podcast “A Personal Story of Long COVID and Disability Disclosure,” Pam Bingham, senior program manager for Intuit’s Diversity, Equity and Inclusion in Tech team, shares her personal experience of navigating Long COVID symptoms at work.  The segment was produced by the USDOL-funded Partnership on Employment and Accessible Technology (PEAT) as part of its ongoing “Future of Work” podcast series.

Listen to the podcast

HHS OIG Issues Annual Report on State MFCUs

Per the notice below, the Office of the Inspector General (OIG) of the United States Department of Health and Human Services (HHS) has issued its annual report on the performance of state Medicaid Fraud Control Units (MFCUs).

Medicaid Fraud Control Units Fiscal Year 2023 Annual Report (OEI-09-24-00200) 

Medicaid Fraud Control Units (MFCUs) investigate and prosecute Medicaid provider fraud and patient abuse or neglect. OIG is the Federal agency that oversees and annually approves federal funding for MFCUs through a recertification process. This new report analyzed the statistical data on annual case outcomes—such as convictions, civil settlements and judgments, and recoveries—that the 53 MFCUs submitted for Fiscal Year 2023.  New York data is as follows:

Outcomes

  • Investigations1 - 556
  • Indicted/Charged - 9
  • Convictions - 8
  • Civil Settlements/Judgments - 28
  • Recoveries2 - $73,204,518

Resources

  • MFCU Expenditures3 - $55,964,293
  • Staff on Board4 - 257

1Investigations are defined as the total number of open investigations at the end of the fiscal year.

2Recoveries are defined as the amount of money that defendants are required to pay as a result of a settlement, judgment, or prefiling settlement in criminal and civil cases and may not reflect actual collections.  Recoveries may involve cases that include participation by other Federal and State agencies.

3MFCU and Medicaid Expenditures include both State and Federal expenditures.

4Staff on Board is defined as the total number of staff employed by the Unit at the end of the fiscal year.

Read the Full Report

View the Statistical Chart

Engage with the Interactive Map

GAO Issues Report on Medicaid Managed Care Service Denials and Appeal Outcomes

The United States Government Accountability Office (GAO) has issued a report on federal use of state data on Medicaid managed care service denials and appeal outcomes.  GAO found that federal oversight is limited because it doesn't require states to report on Medicaid managed care service denials or appeal outcomes and there has not been much progress on plans to analyze and make the data publicly available.  To read the GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the first link below.  To read GAO highlights of the report on federal use of state data on Medicaid managed care service denials and appeal outcomes, use the second link below.
https://www.gao.gov/assets/d24106627.pdf  (GAO report on federal use of state data on Medicaid managed care service denials and appeal outcomes)
https://www.gao.gov/assets/d24106627_high.pdf  (GAO highlights on federal use of state data on Medicaid managed care service denials and appeal outcomes)

CMS Issues Latest Medicare Regulatory Activities Update

The Centers for Medicare and Medicaid Services (CMS) has issued its latest update on its regulatory activities in the Medicare program.  While dentistry is only minimally connected to the Medicare program, Medicare drives the majority of health care policies and insurance reimbursement policies throughout the country.  Therefore, it always pays to keep a close eye on what CMS is doing in Medicare.  To read the latest CMS update on its regulatory activities in Medicare, use the link below.
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc