Department of Health and Human Services November 17, 2021 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is amending its select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS- CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. HHS/CDC intends to regulate this agent and to require the regulated entity to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.

The Office of Head Start, Administration for Children and Families (ACF), is proposing to collect data for a new evaluation of a trauma-informed care program that will include a small randomized controlled trial across 10 sites within Head Start Region V. The goals of the project are to identify the implementation supports and methods needed to enable teachers to effectively implement Trauma-Informed Care in early care and education programs, and to evaluate its outcomes. Information collected will be used to inform ongoing training and technical assistance (TTA) work provided by the Head Start Centers, particularly decisions regarding allocation of TTA resources. More generally, results may inform OHS guidance around social-emotional programming.

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2022 under Medicare's Hospital Insurance Program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2022, the inpatient hospital deductible will be $1,556. The daily coinsurance amounts for CY 2022 will be: $389 for the 61st through 90th day of hospitalization in a benefit period; $778 for lifetime reserve days; and $194.50 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.

This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $152,000,000 (total costs) for up to two years to Vibrant Emotional Health for the 988 National Suicide Prevention Lifeline Expansion for Behavioral Health Crisis Response (Lifeline Expansion). Under this cooperative agreement, Vibrant Emotional Health will improve and expand the national Lifeline backup centers, text/chat centers, and Spanish language crisis centers to: (1) Respond, intervene, and provide follow- up to individuals experiencing a behavioral health crisis by recruiting and training additional behavioral health staff; (2) support and expand services for populations at high risk of suicide; and (3) develop the infrastructure needed to meet the increased service demand requirements anticipated with the FCC's national launch of 988 in July 2022. It is expected that this program will: (1) Increase response rates for national Lifeline backup centers, text/chat centers, and Spanish language crisis centers; (2) increase the workforce capacity of the national Lifeline backup centers, text/chat centers, and Spanish language crisis centers; and (3) improve the oversight and standardization of outcomes of the Lifeline. With this award, Vibrant Emotional Health will directly support the much needed expansion of the behavioral health workforce for all designated national Lifeline backup centers, text/chat centers, and Spanish language crisis centers to ensure the Network can meet or exceed established metrics; provide direct support to increase the workforce at national Lifeline back-up centers, text/chat centers, and Spanish language crisis centers to expand the implementation of follow-up protocols; expand and enhance core Lifeline network functions; expand and facilitate timely and ongoing communication with the existing network of backup and text/chat centers to minimize wait time and maximize call connectivity; expand the ability of backup and text/chat centers to respond to sudden and large spikes in call volume immediately following a public service announcement, disaster, or other type of traumatic event; expand collaboration with backup and text/chat centers to ensure they have sufficient policies and procedures for the training and supervision of center staff in caller engagement, risk assessment, intervention, and linkage to appropriate services; develop and implement a quality improvement plan focusing on policies, first contact, assessment, referral, and access to local care to ensure there is a comprehensive and coordinated response to individuals at imminent risk for suicide; develop and implement a plan to support backup call centers, text/chat centers, and the Spanish language sub-network in accessing mobile crisis services and coordinating with 911 throughout the United States; provide technical assistance to states and crisis centers in communicating and aligning 988 implementation plans, including the ability to meet Key Performance Indicator expectations; establish interoperability with the VA infrastructure and operations to ensure veterans, service members, and families can access at the VA through authorized 988 phone and text services; and expand the Lifeline network by incorporating additional centers or developing formal agreements with service providers for populations at higher risk of suicide for the expansion of services, training, referrals, facilitated transfers and other approaches to link individuals in crisis with the most person centered and culturally appropriate responses. This is not a formal request for application. Assistance will be provided only to Vibrant Emotional Health based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: Lifeline Expansion. Assistance Listing Number: 93.243. Authority: Section 520E-3 of the Public Health Service Act, as amended; and Section 9005 of the 21st Century Cures Act. Justification: Eligibility for this award is limited to the Mental Health Association of New York City, Inc. (DBA Vibrant Emotional Health). Vibrant Emotional Health is the current Lifeline system administrator and this award funds a rapid expansion of the ongoing Lifeline services to meet the anticipated demands of the FCC's 988 launch before July 2022. Since 2005, Vibrant Emotional Health has provided oversight and management of the Suicide Prevention Lifeline and its local call centers, backup centers, and chat/text functions with a network of over 180 centers in all fifty states. This longstanding history has positioned Vibrant Emotional Health as the best suited organization as the only identified organization with the required experience and national reach to work with the backup centers and chat/text organizations with expansion of their workforce and development of the infrastructure that is needed for the launch of 988 in July 2022. Vibrant Emotional Health's history, experience, and ongoing communications with these centers are critical given the time sensitivity of the need for sufficient capacity to be in place by July 2022. Several external evaluations have reinforced the evidence of effectiveness of Lifeline services through oversight of the Lifeline by Vibrant Emotional Health. The Federal Communication Commission has ordered that by July 16, 2022 every cell phone, land line and voice over internet provider in the United States must make 988 operational and this date of implementation is also a requirement in the National Suicide Hotline Designation Act. Given the anticipated significantly increased contact volumes with the universal availability of 988, a rapid upgrading of Lifeline capacity is required by July 2022. It would not be possible for any other organization to establish the relationships with crisis centers that Vibrant Emotional Health has built over the last 15 years by July 2022, running the risk of significant numbers of unanswered calls, chats, and texts. In addition, if these funds were awarded to another organization, oversight of the expanded backup and chat/text centers would be fragmented and the network would run the risk of inefficiencies and adverse outcomes to individuals in crisis during the period when the demand for Lifeline is expected to surge with the launch of 988. Coordination, quality monitoring, and rapid response would be compromised. Vibrant Emotional Health also has extensive engagement with the Department of Veterans Affairs Veterans Crisis Line (VCL) that helps ensure call connectivity between Vibrant Emotional Health and VCL, backup services, and engagement across the Lifeline local crisis centers on Veteran identification, care, and linkage to the VA. Vibrant Emotional Health has long been recognized throughout the nation for its state-of-art technology-enabled services, community wellness programs, and advocacy and education work and is uniquely qualified to carry-out the requirements of this funding opportunity.