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The U.S. Food and Drug Administration has issued draft guidance to overcome obstacles to increasing enrollment diversity in clinical trials.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.
Grants Awarded to Fund New Clinical Trials for Products to Treat Rare Diseases
The U.S. Food and Drug Administration (FDA) has awarded 12 new clinical trial research grants to principal investigators from academia and industry totaling more than $18 million over the next four years to enhance the development of medical products for patients with rare diseases.
Revised Medical Program Integrity Manual Is a ‘Roadmap’ to LCD Process
The Centers for Medicare and Medicaid Services has revised Chapter 13 of the Medicare Program Integrity Manual to include instructions, policies and procedures that Medicare Administrative Contractors (MACs) use to administer the Medicare fee-for-service program.
Court Upholds Reimbursement Cut for 340B Drug Discount Program
The U.S. Court of Appeals for the District of Columbia upheld the reimbursement cut that took effect on Jan. 1 for drugs purchased under the 340B Drug Discount Program reimbursed under the Medicare hospital Outpatient Prospective Payment System (OPPS).
