The Food and Drug Administration’s (FDA’s) Microbiology Devices Panel will meet September 7-8 to explore whether to reclassify several types of infectious disease tests from Class III to Class II, potentially making them easier to bring to market.
The reclassification would reduce the regulatory burden for manufacturers by no longer requiring clinical trials or FDA premarket approval. Most manufacturers of diagnostic tests in Class II only need to show FDA that their new tests perform similarly to other tests already on the market.
Tests under consideration include nucleic acid and serology-based assays for diagnosing hepatitis B virus (HBV) infection or for managing HBV-infected patients. The panel also will consider serology-based assays for detecting past, recent, or current infection with human parvovirus B19. Finally, it will review assays used to help identify in vitro responses to peptide antigens associated with M. tuberculosis infection.
While the agency is not bound to take the advice of its advisory panels, it usually does.
NIH LAUNCHES TRIALS FOR LONG COVID TREATMENTS AFTER CRITICISM
The National Institutes of Health (NIH) has announced phase 2 clinical trials that will assess at least four potential treatments for long COVID, with plans to evaluate seven more treatments soon. These trials, a part of the NIH's Researching COVID to Enhance Recovery (RECOVER) initiative, aim to identify treatments for people suffering from long-term symptoms following SARS-CoV-2 infection.
RECOVER's Phase 2 clinical trials will study the impact of drugs, biologics, medical devices, and other therapies on this complex condition. The trials are designed to concurrently assess multiple treatments.
The RECOVER Initiative, a nationwide research program, seeks to understand, treat, and prevent long COVID. In its initial stages, the program conducted large-scale observational studies involving over 24,000 participants. Researchers also analyzed 60 million electronic health records and conducted over 40 pathobiology studies.
That observational approach hasn’t been well received by many patients and scientists, who criticized NIH for spending most of its funding from Congress on programs that don’t directly help patients. NIH has spent some $1 billion over nearly 3 years.
CMS TO PAY HOSPITALS 3% MORE IN 2024
The Centers for Medicare & Medicaid Services (CMS) issued a final payment rule for inpatient and long-term care hospitals that will increase operating payment rates for most hospitals by 3.1%. The rule also updates Medicare hospital quality measures that the agency says will foster safety and equity, while reducing preventable harm in the hospital setting. For example, it recognizes homelessness as an indicator of increased resource utilization.
“As part of CMS’ health equity goals, we are rewarding hospitals that deliver high-quality care to underserved populations and, for the first time, also recognizing the higher costs that hospitals incur when treating people experiencing homelessness,” said CMS Administrator Chiquita Brooks-LaSure. “With these changes, CMS is laying the foundation for a health system that delivers higher quality, more equitable, and safer care for everyone.”
However, the American Hospital Association (AHA) called the payments “woefully inadequate.” CMS “continues to finalize rate increases that are not commensurate with the near decades-high inflation and increased costs for labor, equipment, drugs and supplies that hospitals across the country are experiencing,” AHA said in a statement.
For example, CMS cut payments for hospitals that treat many of the most vulnerable patients by almost $1 billion, according to AHA. “This staggering amount is based on CMS’…estimate that the rate of uninsured will decline from 9.2% in FY 2023 to 8.3% in FY 2024. This is an inexplicable assumption.”