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.

Improved Social and Behavioral Scores Following IVIG Therapy Suggest a Neuroimmune Etiology in Some Children with Autism

In the largest case series of children with autism spectrum disorder (ASD) treated with IVIG, researchers identified brain-targeted autoantibodies in children with ASD.

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).

CMS Final Rule Updates 2019 Medicare Payment Rates and Wage Index for Hospices

The Centers for Medicare and Medicaid Services (CMS) has issued a final rule that updates the 2019 Medicare payment rates and wage index for hospices servicing Medicare beneficiaries.

CMS Launches Medicare Advantage Qualifying Payment Arrangement Incentive Demonstration

The Centers for Medicare and Medicaid Services is launching the Medicare Advantage Qualifying Payment Arrangement Incentive demonstration.

Cinryze Approved for Preventing Pediatric Angioedema Attacks

The U.S. Food and Drug Administration (FDA) has approved Shire’s Cinryze (C1 esterase inhibitor [human]) to prevent angioedema attacks in children 6 years and older with hereditary angioedema.

Second JAK Inhibitor Drug for RA Approved by FDA

The U.S. Food and Drug Administration (FDA) has approved Incyte Corp.’s Olumiant (baricitinib) 2 mg once-daily oral medication to treat adults with moderately to severe active rheumatoid arthritis.

FDA Approves Marijuana-Based Drug for Seizures

The U.S. Food and Drug Administration has approved the first prescription drug made from marijuana.

FDA Approves Diagnostic Test for Lupus and ANCA-Associated Vasculitis

The U.S. Food and Drug Administration has approved new automated diagnostic tests for lupus and ANCA-associated vasculitis.