From Washington, DC

• The Wall Street Journal reports
  • “Nursing homes will have to maintain minimum staffing levels under a Biden administration proposal despite furious lobbying from the industry, which says it will be too onerous amid a continuing labor shortage.
  • “Biden administration officials said the first-ever national staffing rule would require nursing homes that participate in Medicare and Medicaid to provide a minimum of 0.55 hours of care from a registered nurse per resident a day, and 2.45 hours of care from a nurse aide per resident a day. A registered nurse would be required to be on-site at all times and nursing-home care assessments would be strengthened under the proposal.
  • “The Centers for Medicare and Medicaid Services estimates that about 75% of nursing homes would have to strengthen staffing in their facilities under the proposal. The proposed staffing standard exceeds those existing in nearly all states.”

• and
  • “The Federal Trade Commission said Friday it had agreed to end its legal challenge of drugmaker  Amgen’s $27.8 billion deal to buy  Horizon Therapeutics, averting a trial that was to have started this month.
  • “The pact also dismisses the antitrust claims of six states that joined the FTC in May seeking to block the deal over concerns that Amgen would illegally bundle its products with Horizon’s medicines for thyroid eye disease and gout. Amgen agreed in the proposed settlement not to bundle the Horizon treatments and swore off conditional rebates or other tactics that could entrench the monopoly position of Horizon’s products.”

• HHS Secretary Xavier Berra made a statement recognizing National Suicide Awareness Month.
  • “The Biden-Harris Administration is deeply committed to tackling the mental health crisis facing America, particularly the alarming rates of suicide. Recognizing the urgency of this issue, SAMHSA continues to support the Suicide Prevention Resource Center and consistently invests millions in suicide prevention initiatives. In fact, SAMHSA will award nearly $12 million to the Zero Suicide in Health Systems program next week. This ambitious program aims to comprehensively integrate the Zero Suicide intervention and prevention model across various health systems with the express aim of reducing suicide ideation, suicide attempts, and deaths due to suicide.
  • “But no program exemplifies our work to prevent suicide better than 988, the three-digit Suicide & Crisis Lifeline, which HHS launched in collaboration with the states in 2022. The Biden-Harris Administration has invested close to $1 billion in 988, and, thanks to 988, Americans are now connected with trained counselors who offer real support in times of crisis. Since the July 2022 launch, 988 has received more than 5.5 million calls, texts, and chats, and this July, text and chat were made available in Spanish.”

• Per Fierce Healthcare,
  • Enforcement of information blocking penalties for health IT entities [went] into effect on Friday, opening the door to penalties of up to $1 million per violation.
  • The breakdown of how exactly the Department of Health and Human Services (HHS) Office of Inspector General (OIG) will prioritize what it expects to be a deluge of information-blocking complaints was posted by the regulator in late June.

From the public health front,

• The Wall Street Journal discusses “Covid This Fall: What’s the Same, What’s Different and What to Know.”

• The Hill adds
  • “COVID-19 hospitalizations have steadily increased over the past few weeks, reaching 15,067 for the week ending Aug. 19 — an 18.8 percent increase from the week prior, according to CDC data. But at this time last year, the U.S. averaged over 84,000 hospitalizations per week. More than 96 percent of U.S. counties are experiencing low COVID-19 hospitalization levels, at less than 10 new COVID-19 hospital admissions per 100,00 people.”

• Per Beckers Hospital Review,
  • “The CDC updated its risk assessment on distant omicron relative BA.2.86 on Aug. 30, saying the strain — which has concerned experts over the large number of mutations it carries — has been detected in at least four states. 
  • “CDC continues to track the presence of the BA.2.86 [COVID-19] variant,” the update said. “Since CDC’s initial risk assessment, this variant has been identified in additional countries from both human and wastewater specimens.” 
  • “In the U.S., BA.2.86 cases have been detected in Virginia, Michigan, Ohio and New York either through human samples or wastewater samples. Separately, Houston Methodist in an Aug. 31 statement emailed to Becker’s said it has identified Texas’ first reported instance of BA.2.86 through genomic sequencing. The hospital’s COVID-19 sequencing team continues to sequence all positive specimens.” 

• The New York Times Morning column provides an overview of Fall 2023 Covid, flu and now RSV vaccines. Of note, at least to the FEHBlog,
  • “This year’s flu vaccine shots are now available at drugstores, hospitals, doctor’s offices and elsewhere. You may want to wait until late September or October to get one, though. The heaviest parts of flu season tend to occur between December and February. If you wait, the shot’s protection against severe illness will still be near its strongest level during those months.”

From the U.S. healthcare business front,

• Healthcare Dive relates,
  • “Walgreens chief executive Rosalind Brewer is stepping down as CEO and a member of the board effective immediately, the retail pharmacy giant announced Friday.
  • “Brewer’s departure comes less than three years after she joined the Illinois-based retailer. The parting was a mutual decision between Brewer and Walgreens’ board, according to a release. Walgreens’ lead independent director Ginger Graham will serve as interim CEO while the company looks for a permanent replacement.”

• STAT News discusses the “curious case of J&J’s Stelara, the unluckiest drug on Medicare’s list” of ten drugs subject to CMS “price negotiation.” Bad beat.