What’s in today’s Policy Round Up?
- Updated CDC guidance on COVID-19 vaccine boosters and additional doses
- Call for comments on:
- Proposed rule that would prohibit payment of subminimum wages by nonprofits in the AbilityOne Program.
- HHS Strategic Plan
- FDA’s landmark proposal to improve access to hearing aid technology and proposed guidance on hearing aids and personal amplification devices
- New Department of Education resource for supporting student mental health
Updated CDC guidance on COVID-19 vaccine boosters; additional doses
CDC has now issued booster recommendations for all three COVID-19 vaccines. Booster eligibility criteria are based on which vaccine you received initially.
- If you received the Johnson & Johnson vaccine, you are eligible for a booster if you are at least 18 years old and you received your shot at least two months ago - regardless of age, disability, or other risk factors.
- If you received the Pfizer or Moderna vaccines, you are eligible for a booster if you received your second dose at least six months ago, and you are:
If you are eligible for a booster, you may choose any of the three available vaccines, regardless of which you received initially.
Finally, CDC also recommends additional doses of the COVID-19 vaccine if:
- you are moderately or severely immunocompromised, and;
- you received your second Pfizer or Moderna shot at least 28 days ago. (The additional dose guidance does not currently apply to people who received the Johnson & Johnson vaccine.)
Note: "Mix-and-match" is NOT recommended for additional dosages; people receiving an additional dose due to a compromised immune system should receive an additional dose of the same vaccine they received initially.
Input Needed: Proposed rule would prohibit payment of subminimum wages by nonprofits in the AbilityOne Program.
A proposed rule would require nonprofit agencies seeking to qualify (or maintain qualifications) under the AbilityOne program to certify that it will not pay subminimum wages using special wage certificates authorized under section 14(c) of the Fair Labor Standards Act of 1938. This would apply to employees on all contracts or subcontracts awarded, extended (other than through the exercise of an option) or renewed after the effective date of the final rule. Comments must be received by November 12. Instructions for submitting comments can be found in the Federal Register notice.
Input needed: HHS Strategic Plan
The Department of Health and Human Services is seeking public comment on its draft strategic plan, which outlines the Department’s goals for the next four years. The plan covers many issues of particular importance to people with disabilities and older adults, such as improving access to and quality of home and community-based services, reducing healthcare costs, and bolstering the healthcare workforce, so the input of the aging and disability networks is critical. Comments are due by Nov. 7.
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The draft, which ACL helped form, includes five strategic goals:
- Protect and Strengthen Equitable Access to High Quality and Affordable Health Care,
- Safeguard and Improve National and Global Health Conditions and Outcomes,
- Strengthen Social Well-being, Equity, and Economic Resilience,
- Restore Trust and Accelerate Advancements in Science and Research for All, and
- Advance Strategic Management to Build Trust, Transparency, and Accountability
Each of those goals is supported by objectives and strategies to help advance those goals over the next four years.
Input Needed: FDA Guidance on Hearing Aids and Personal Sound Amplification Products
FDA is seeking input on a proposed rule and a draft updated guidance. Comments for both are due by Jan. 18, 2022
- Proposed rule: Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. The rule creates a new category of OTC devices that would apply to some air-conduction hearing aids intended for adults age 18 and older who have perceived mild to moderate hearing loss. (Hearing aids for severe hearing loss or for users younger than age 18 would be prescription devices.) This would allow for hearing aids to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist. The rule includes additional details related to pitch, volume, and labeling requirements. See the Federal Register notice for instructions for submitting comments.
- Draft guidance: Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs). This guidance describes hearing aids and PSAPS, their uses and regulatory requirements that apply to both types of products. The draft guidance is intended to provide further clarification regarding the differences between PSAPs, which help people with normal hearing amplify sounds, and hearing aids and to inform consumers that PSAPs are not considered OTC alternatives for hearing aids. FDA’s website has the guidance and instructions for comments.
New Department of Education Resource for Supporting Student Mental Health
On October 19, the U.S. Department of Education released a new resource, Supporting Child and Student Social, Emotional, Behavioral and Mental Health, which highlights seven key challenges to providing school- or program-based mental health support education settings and provides corresponding recommendations for addressing them. This document is part of the Return to School Roadmap, which stresses the importance of supporting students' social, emotional and mental health to create a strong foundation for students' academic success. State Education Agencies and local school districts can use the resources in the American Rescue Plan's Elementary and Secondary School Emergency Relief program (ARP ESSER), as well as previous rounds of ESSER funds, to implement these recommendations and ensure students receive the support they need.
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The COVID-19 pandemic has exacerbated existing mental health challenges, and comprehensive care may have been inaccessible to those most in need. This new guidance emphasizes the importance of schools having a Multi-Tiered System of Supports that includes mental health care for students and staff alike.
The recommendations to tackle challenges are as follows:
- Prioritize wellness for every child, student, educator, and provider
- Enhance mental health literacy and reduce stigma and other barriers to access
- Implement continuum of evidence-based prevention practices
- Establish an integrated framework of educational, social, emotional, and behavioral-health support for all
- Leverage policy and funding
- Enhance workforce capacity
- Use data for decision making to promote equitable implementation and outcomes