FDA Initiates Coronavirus Medical Countermeasures
The U.S. Food and Drug Administration (FDA) is taking critical actions to advance development of novel coronavirus medical countermeasures.
NIAID Awards $30 Million to Develop Tuberculosis Vaccine
The awards establish and provide up to seven years of support for three Immune Mechanisms of Protection Against Mycobacterium Tuberculosis (IMPAc-TB) Centers to elucidate the immune responses needed to protect against Mtb infection.
CMS Enacts Medicare, Medicaid and CHIP Fraud-Fighting Rules
A final rule that went into effect Nov. 4 strengthens the Centers for Medicare and Medicaid Services’ ability to stop fraud before it happens.
CMS Finalizes Rule for Programs of All-Inclusive Care for the Elderly
The Centers for Medicare and Medicaid Services (CMS) has finalized a rule to update and modernize the Programs of All-Inclusive Care for the Elderly (PACE) that reflects updates based upon best practices in caring for frail and elderly individuals.
FDA Issues Final Guidance on Biosimilar Interchangeability
The U.S. Food and Drug Administration (FDA) released guidelines on the studies companies need to conduct to show their biosimilar is interchangeable with a biologic.
CMS Finalizes Rule for Cuts to Medicaid DSH Payments
The Centers for Medicare and Medicaid Services (CMS) published a final rule for calculating state Medicaid disproportionate share hospital (DSH) cuts in the amount of $4 billion in 2020 and $8 billion for each subsequent year through 2025.
$1 Billion Grant Awarded to Fight Addiction and Chronic Pain
The National Institutes of Health (NIH) has awarded $945 million to battle addiction and chronic pain.
HHS Grants Additional Money to Expand Access to Effective Opioid Treatment
The U.S. Department of Health and Human Services released an additional $487 million to supplement first-year funding through its State Opioid Response grant program.
FDA Seeks to Enhance Clinical Trial Diversity with New Guidance
The U.S. Food and Drug Administration has issued draft guidance to overcome obstacles to increasing enrollment diversity in clinical trials.
New CMMI Direct-Contracting Pay Models Will Overhaul Fee-for-Service Models
The Centers for Medicare and Medicaid Innovation is introducing new pay models that will shift primary care from fee-for-service payments to a global fee model under which clinicians and hospitals could assume varying amounts of risk.