Today, the United States, on behalf of the Department of Health and Human Services, filed a complaint in federal district court against Gilead Sciences, Inc. and Gilead Sciences Ireland UC (collectively, Gilead) seeking damages for Gilead’s infringement of HHS patents related to pre-exposure prophylaxis (or PrEP) for HIV prevention. Despite multiple attempts by HHS to license ...
The University of Rochester Medical Center (URMC) has agreed to pay $3 million to the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS), and take substantial corrective action to settle potential violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. URMC includes healthcare ...
This week, the Department of Health and Human Services, the American Society of Nephrology, and the National Kidney Foundation signed a memorandum of understanding to create an education, awareness, and prevention campaign regarding kidney disease, as called for in President Trump’s Executive Order on Advancing American Kidney Health. The campaign will aim to improve health ...
Today, as part of delivering on President Trump’s Executive Order on Protecting and Improving Medicare for Our Nation’s Seniors, the Centers for Medicare & Medicaid Services finalized policy changes under the Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System. HHS Secretary Alex Azar issued the following statement: “The payment changes CMS ...
Today, the Department of Health and Human Services is announcing that Dr. Ned Sharpless, who has been serving as Acting Commissioner of Food and Drugs, will be returning to his role as Director of the National Cancer Institute (NCI). The Federal Vacancies Reform Act requires that a person may not serve in an “Acting” capacity ...
Today, the Department of Health and Human Services (HHS) issued a Notice of Nonenforcement to inform the public that certain regulatory provisions in The Uniform Administrative Requirements, Cost Principles, and Audit Requirements for HHS Awards”HHS grants regulation”) will not be enforced because of serious concerns regarding the prior administration’s implementation of the Regulatory Flexibility Act, ...
On Thursday, the Centers for Medicare & Medicaid Services finalized changes to the Medicare payment rules for Durable Medical Equipment Prosthetics, Orthotics, and Supplies (DMEPOS) program, End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), and the ESRD Quality Incentive Program (QIP), delivering on President Trump’s “Advancing American Kidney Health” initiative. HHS Secretary Alex Azar issued ...
Today, the Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) announced the launch of FindTreatment.gov, a newly designed website that will help connect Americans looking for substance abuse treatment with approximately 13,000 locations across the United States. HHS Secretary Alex Azar and SAMHSA Assistant Secretary Elinore McCance-Katz issued the ...
The U.S. Department of Health and Human Services, Office for Civil Rights (HHS OCR) has successfully secured corrective action and resolved a complaint against the Florida Orthopaedic Institute (“Florida Orthopaedic”). The complaint alleged that Florida Orthopaedic unlawfully cancelled a surgery because of a patient’s HIV positive status. After HHS OCR informed Florida Orthopaedic of the ...
The U.S. Department of Health and Human Services announced today approximately $2.27 billion in Ryan White HIV/AIDS Program grants were awarded to cities, counties, states, and local community-based organizations in fiscal year (FY) 2019. This funding through the Health Resources and Services Administration (HRSA) supports a comprehensive system of HIV primary medical care, medication, and ...