CMS to Strengthen and Enhance Oversight and Transparency of Medicare Accrediting Organizations
CMS takes steps to enhance and strengthen its oversight and quality transparency of accrediting organizations.
New Hemophilia A Treatment Approved by FDA
The U.S. Food and Drug Administration (FDA) has approved Bayer’s Jivi (BAY94-9027) as a preventive treatment for bleeding in hemophilia A.
Cervical Cancer Vaccines Safe and Effective in Girls and Women
A study that examined data from more than 73,000 girls and women shows vaccines designed to prevent infection with human papillomavirus (HPV) are effective in protecting against precancerous cervical lesions in women, particularly in those vaccinated between age 15 and 26 years.
Single-Dose Flu Drug Given Priority Review by FDA
Genentech’s baloxavir marboxil, an experimental, single-dose flu drug, has been given priority review by the U.S. Food and Drug Administration (FDA).
Neonatal Fc Receptor Antagonist Efgartigimod Sustainably Reduces Circulating IgG Level in Humans
Investigators from the Belgian biotechnology company argenx and U.S. collaborators conducted a PhaseI clinical study to assess a novel modified antibody Fc fragment (efgartigimod) that reduces the circulating IgG level by blocking neonatal Fc receptor-mediated IgG recycling.
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.
