News

Novavax Receives FDA Emergency Use Approval for Protein-based COVID-19 Vaccine

• On August 30, the FDA announced it has granted emergency use authorization of an updated Novavax COVID-19 vaccine for individuals 12 years of age and older that targets recent variants using a protein-based formula. This is the only non-mRNA vaccine option against COVID-19 available in the U.S. However, this vaccine targets a less recent variant compared to the mRNA vaccines from Pfizer and Moderna, which were approved on August 22. The CDC’s Advisory Committee on Immunization has officially recommended a booster shot given the significant summer wave of COVID-19 infections. The committee hopes that Novavax’s protein-based vaccine option will help bolster vaccination rates among individuals hesitant of mRNA vaccines (Inside Health Policy, August 30).

CMS Awards $100M to Navigators for Open Enrollment

• CMS announced awards for $100 million in grants to navigators to assist with the upcoming Marketplace Open Enrollment. CMS awarded grants to 44 organizations whose navigators provide assistance in finding health insurance coverage in states that utilize the Federally-facilitated Marketplace (FFM), Healthcare.gov. The 2024 Navigator cooperative agreement awards were awarded for a five-year period of performance, which runs from August 27, 2024, through August 26, 2029. The cooperative agreement award amounts listed below under each awardee cover the first 12-month budget period (August 27, 2024, to August 26, 2025) (CMS, September 3; Fierce Healthcare, August 30; Modern Healthcare, August 26).

CMS Set to Reinstate Mandatory Respiratory Illness Reporting Within Hospitals

• Beginning November 1, CMS is reinstating the COVID-19, influenza and respiratory syncytial virus data reporting as part of hospitals’ condition of participation (CoP). This decision follows the agency’s prior decision to suspend hospital data reporting requirements on May 1. The FY2025 Hospital Inpatient Prospective Payment System (IPPS), which was released on August 1, reiterates the need for this type of reporting to obtain vital information on a local, regional and national level, and how it could potentially cause implications within the realm of patient care and public health mitigation. Patient advocacy groups like the American Hospital Association (AHA) believe that the mandatory reinstatement is inconsistent with the purpose of CoPs. The AHA approved of CMS’ prior decision to suspend these requirements as hospitals continue to deal with staffing shortages and financial pressures. The AHA is pushing for a voluntary reporting system that would utilize the pre-existing National Health Care Safety Network (NHSN) platform, with streamlined reporting fields (Inside Health Policy, August 26).

CMS Publishes Latest Enrollment Numbers for Medicare, Medicaid, and the Children’s Health Insurance Program (CHIP)

• On August 30, CMS released the most recent enrollment numbers for Medicare, Medicaid, and CHIP. As of May 2024, enrollment in Medicare increased by 122,882 since the last report to 67.41 million. Medicaid/CHIP enrollment decreased by 840,795 for a total of 80.85 million enrollees. Of the 80.85 million individuals, 7.06 million are enrolled in CHIP. There are also more than eight million individuals that are full-benefit dually eligible for Medicare and Medicaid and are counted in both program totals (Medicaid.gov, August 30).

Federal Infectious Disease Requirements in Nursing Homes Need Additional Reform Says the Association for Professionals in Infection Control and Epidemiology (APIC)

• APIC stakeholders believe that until the Office of the Inspector General (OIG) requires a full-time infection preventionist in nursing homes, along with other changes, infection control reforms will not be successful at getting nearly 25% of nursing homes into compliance with federal requirements. The OIG report studied 100 for-profit nursing homes in 31 states between July 1, 2021, through June 30, 2022. 76 of these facilities complied with federal regulations, but 17 facilities did not have an infection preventionist with specialized training and seven facilities did not have a preventionist designated at all. The American Health Care Association (AHCA) and the National Center for Assisted Living (NCAL) believe that the OIG report is inaccurate because CMS data shows that less than 2% of providers have been cited for infection preventionist issues since 2021. While APIC supports the two recommendations given by OIG to have CMS follow-up with nursing homes that might be out of compliance to ensure corrective actions and to require state survey agencies to focus on preventionist training, APIC believes additional measures need to be taken to ensure compliance (Inside Health Policy, August 27).

Federal Litigation

HHS Withdraws Their Appeal on AHA Third-Party Tracking Case

• On August 29, the HHS withdrew its appeal to overturn a ruling from June that determined HHS overstepped its authority when it prevented providers from using certain third-party tracking technologies. on hospital websites. The HHS had originally filed an appeal notice on August 19 with the U.S. Fifth Circuit Court of Appeals, which was withdrawn only 10 days after with consent from AHA (Modern Healthcare, August 29; Fierce Healthcare, August 29).