FDA Issues Digital Health Newsletter
The United States Food and Drug Administration (FDA) has issued its digital health newsletter, which can be read below.
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Lance's Corner
The FDA established a docket for public comment on the inaugural Digital Health Advisory Committee meeting to be held November 20-21, 2024, in Gaithersburg, Maryland. Interested persons may present data, information, or views orally or in writing, on issues pending before the advisory committee. Comments received on or before November 1, 2024, will be provided to the advisory committee. For more information about submitting comments, please see the 
The FDA published a 
On September 6, 2024, the FDA updated the list of medical devices that incorporate augmented reality (AR) and virtual reality (VR). With this update, the FDA has authorized 69 medical devices that incorporate AR/VR. 
Have you used the 
The Digital Health Center of Excellence is continuing to build a dynamic team that is at the forefront of advancing medical science, creating new opportunities, and providing a regulatory environment that brings safe and effective digital health technologies to market. We are seeking candidates for multiple positions with a variety of experiences in AI, generative AI, and data science to serve as digital health specialists. Our innovative thinking and patient-centric digital health specialists assist CDRH and the FDA in developing new and enhancing existing strategies and regulatory policies focused on digital health technologies. Our digital health specialists develop and utilize methodologies and protocols to assess the quality, predictability, and performance of digital health technologies, such as medical devices with AI technologies, wearables, patient monitoring devices, and sensor-based digital health technologies.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.
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:
- Accommodation and Compliance: Long COVID
- One-on-One Accommodation Consultations
- Long COVID and the ADA
- Accommodating Employees with COVID-19 or Long COVID
- Does Long COVID Impact Men and Women Differently?
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.
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.
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.
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.
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.
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.
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:
View the Statistical Chart
Engage with the Interactive Map
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 ReportView 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)
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
https://www.cms.gov/training-education/medicare-learning-network/newsletter/2024-03-14-mlnc
