Lance's Corner

FDA Issues Comprehensive Regulatory Update

May 20, 2024

The United States Food and Drug Administration (FDA) has issued its weekly comprehensive regulatory update, which can be read below.

The latest from FDA

UpdatesPublic health emergency response and other updates from FDA since our last MCMi email include:
More FDA press announcements

HPAI response updates 

Highly pathogenic avian influenza (H5N1) in dairy cows  

Updates on Highly Pathogenic Avian Influenza (HPAI) in dairy cows
In a May 10 update, FDA confirmed that all 297 samples from FDA’s national survey of retail dairy products were found to be negative for viable highly pathogenic H5N1 avian influenza (H5N1 HPAI) virus. On May 20, for continued transparency, FDA provided additional information on our retail sample survey.
While FDA collected the 297 samples at retail locations in 17 states, these retail samples represent products produced at 132 processing locations in 38 states. Retail samples were collected between April 18-22, 2024, and represent a snapshot in time. This testing did not detect any live, infectious virus.

Learn more from FDA and our federal partners:
Consumer information on milk safety from FDA:

NIH and FDA seek comment

Draft glossary of clinical research terms related to innovative clinical trial design

Open book representing a glossary
On May 6, 2024, FDA and NIH published a request for information (RFI) seeking public comments on a proposed glossary of clinical research terminology. This glossary is intended to facilitate communication within the clinical research community by helping establish a common vocabulary to more uniformly characterize clinical research. FDA and NIH identified and developed definitions for 37 terms related to innovative clinical study designs. The public comment period will be open through June 24, 2024.

Emergency Use Authorization (EUA) updates

Emergency Use Authorization (EUA)

Recent new EUAs

Additional information about these EUAs can be found at: In Vitro Diagnostics EUAs - Antigen Diagnostic Tests for SARS-CoV-2 
  • 5/7/2024: iHealth COVID-19/Flu A&B Rapid Test (iHealth Labs, Inc.)
  • 4/30/2024: WELLlife COVID-19 / Influenza A&B Home Test (Wondfo USA Co., Ltd.) 
  • 4/19/2024: WELLlife COVID-19 / Influenza A&B Test (Wondfo USA Co., Ltd.) 
  • 4/5/2024: CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test (CorDx, Inc.) 
  • 4/3/2024: QuickFinder COVID-19/Flu Antigen Self Test (OSANG LLC) 

EUA quick links

Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens - July 30 - August 1, 2024

 

Events

More events: FDA Meetings, Conferences and Workshops

Information for industry and health care providers

Guidance and updates for industry

On May 9, 2024, FDA issued the final guidance: Remanufacturing of Medical Devices as part of ongoing efforts to help distinguish between remanufacturing and servicing. This guidance clarifies whether activities performed on devices are likely "remanufacturing," which differs from servicing activities such as maintenance and repair. This clarification is intended to help ensure consistency and a better understanding of the regulatory requirements applicable to remanufacturers. Additionally, the guidance recommends information to be included in the labeling of reusable medical devices to help ensure their continued quality and safety during servicing. On June 27, 2024, FDA will host a webinar for those interested in learning more about the final guidance.  
Compass representing FDA guidance
Expiration Date Extension

Expiration date extension

You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions. Recent extension:
Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

In case you missed it

COVID-19 resources 112px
Quick COVID-19 resources
Frequently Asked Questions
What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ.

Hand sanitizer safety alert
List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 650 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.

Q&A with FDA podcast (CE available)
Q&A with FDA podcast
In this podcast series, FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about drug shortages, expanded access, avoiding medication scams, and much 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