Policy Corner: December 4, 2020

COVID-19 Vaccine Developers Submit Request to FDA

The drug companies Pfizer and BioNTech, which have both developed a vaccine for COVID-19, have submitted a request to the U.S. Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA). A third company, Moderna, has also announced that its COVID-19 vaccine developed in partnership with the National Institutes of Health (NIH) is 94.5% effective against COVID-19 in clinical studies. If the FDA approves the vaccines, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) will hold a public meeting to review all the data and to recommend the use of the vaccine.

Should the vaccines meet approval, the ACIP has recommended that the first phase of vaccination be offered to both health care personnel and residents of long-term care facilities. Health care personnel are defined as paid and unpaid people serving in health care settings who have the potential for direct or indirect exposure to patients or infectious materials. Long-term care facility residents are defined as adults who reside in facilities that provide a variety of services, including medical and personal care, to persons who are unable to live independently.

BIAA Supports Increased Funding for Family Caregivers

The Brain Injury Association of America (BIAA) has joined 60 organizations representing all ages and disabilities to urge House and Senate Appropriators to increase funding in the fiscal year (FY) 2021 Labor, Health and Human Services (HHS), Education, and related agencies appropriations bill for the Lifespan Respite Care Program, administered by the Administration on Aging and Administration for Community Living. During this pandemic, social isolation among family caregivers has intensified. Respite providers may be their only immediate contact for relief and other critical supports. To address the growing need to support family caregivers who are the linchpin of the nation’s long-term services and supports system, organizations are requesting $10 million in FY2021, the amount included in the House-passed bill.

House and Senate Democrats Introduce the Keeping All Students Safe Act

Democrats in both the House and Senate introduced the Keeping All Students Safe Act (KASSA), H.R. 8782. The legislation would ban the use of seclusion and dangerous restraint practices (e.g., physical restraints that affect breathing, chemical restraints, etc.) in any school receiving federal taxpayer money. Additionally, KASSA would provide schools with training on evidence-based positive behavior supports and require states to monitor the law’s implementation.

BIAA Signs on to the DRRC Letter Opposing Federal Sunset Rule

BIAA signed on to the Coalition to Preserve Rehabilitation (CPR) letter to HHS Secretary Alex M. Azar opposing the Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule. In the SUNSET rule, HHS proposes to set an automatic expiration date for nearly all regulations issued by the agency, unless a detailed staff assessment determines that a regulation should be maintained. Rules would expire 10 years after their final issuance date, and HHS would have two years from the SUNSET rule’s effective date to review rules issued more than 10 years before that date and determine whether to renew them or let them expire. Annual payment update regulations for Medicare Parts A and B, such as the annual rules for the physician fee schedule and post-acute care provider settings, would be excluded from the sunset period.

CPR strongly opposes the SUNSET rule on the grounds that the proposed process is overly broad; the requirements on agency staff would be onerous and prevent important, timely regulatory work; and the blanket expiration of regulations could significantly erode the regulatory framework established over decades to protect patients, especially individuals with brain injury. In addition, a 30-day comment period is not nearly long enough to fully analyze the magnitude of the impact of this proposal. CPR encourages HHS to withdraw this rule and work toward appropriate modernization of its regulations through a more targeted process.

BIAA gratefully acknowledges the Centre for Neuro Skills and Avanir Pharmaceuticals for their support for legislative action. Click here to read past issues of Policy Corner.