From Washington DC —

• Federal News Network reports,
  • “The House and Senate armed services committees each finished their work on their versions of next year’s defense authorization bill within a day of one another, with both key committees approving overall funding levels that closely match the Biden administration’s 2024 funding request of $842 billion in discretionary DoD spending.
  • “The Senate Armed Service Committee’s bill, approved behind closed doors on Friday, would authorize $844 billion next year, while the House version, debated in a public session a day earlier, would match the administration’s request.
  • “Another area of commonality: both committees endorsed the administration’s proposed pay increase for military service members, making it highly likely that they’ll receive a 2024 increase of 5.2%, the largest military pay raise since 2002.
  • “For now, the measures do not include language that would grant the administration’s request for the same pay raise for federal civilian workers. A provision to achieve that could still be added when the bills reach the House and Senate floors; however, a large faction of House Republicans is pushing an alternative plan that would make all civil servants’ pay increases “merit-based.”

• The Centers for Medicare and Medicaid Services issued,
  • “a proposed rule that proposes to update payment rates and policies and includes requests for information under the end-stage renal disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2024. This rule also proposes an update to the Acute Kidney Injury (AKI) dialysis payment rate for renal dialysis services furnished by ESRD facilities for calendar year (CY) 2024. In addition, the rule proposes to update requirements for the ESRD Quality Incentive Program (QIP).
  • “For CY 2024, CMS is proposing to increase the ESRD PPS base rate to $269.99, increasing total payments to ESRD facilities by approximately 1.6 percent. The CY 2024 ESRD PPS proposed rule also includes several proposals and requests for information related to ESRD PPS payment policies.

• The National Institutes of Health announced,
  • “The Biden-Harris Administration awarded $50 million to launch the Persistent Poverty Initiative, an initiative to alleviate the cumulative effects of persistent poverty on cancer outcomes by building research capacity, fostering cancer prevention research, and promoting the implementation of community-based programs. The Persistent Poverty Initiative is the first major program to address the structural and institutional factors of persistent poverty in the context of cancer. It is coordinated by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). These awards create five new Centers for Cancer Control Research in Persistent Poverty Areas that will advance key priorities of the Administration’s Cancer Moonshot — to reduce inequities in the structural drivers of cancer and prevent more cancers before they start by reducing tobacco use and making sure everyone has access to healthy food.”

• FedScoop informs us,
  • “Most federal government employees will receive between four and eight additional hours of leave time in 2023, the U.S. Office of Personnel Management said.
  • “The 2023 leave year ending Jan. 13, 2024, will have 27 pay periods, OPM said in a memo sent on Monday to human resource directors of U.S. government agencies. That means most federal employees will receive an additional pay period’s worth of leave in 2023, which could be four, six, or eight hours depending on their accrual rate, according to the memo.
  • “The change doesn’t apply to agencies whose first pay period was Jan. 8, 2023, as they will have 26 pay periods, the memo said. 
  • “While most federal workers will get more leave time, the maximum carryover amount for annual leave – 240 hours for most employees and 360 hours for overseas employees – won’t change, OPM said. It encouraged agencies to remind affected workers to use any time over that limit before the end of the leave year so they don’t lose it.”

From the public health front —

• CBS News tells us,
  • The Centers for Disease Control and Prevention is now separately tracking several new COVID-19 variants, the agency announced Friday, adding more Omicron descendants to an increasingly complex list of new strains that are competing nationwide. 
  • Among the new variants now being tracked by the CDC is EU.1.1, a strain first designated by scientists earlier this year over its rapid ascent in some European countries. 
  • The variant is a more distant descendant of the XBB.1.5 variant that had surged earlier this year, with a handful of more mutations to its spike protein that may be driving its spread. 
  • The CDC estimates that EU.1.1 is now 1.7% of U.S. cases nationwide but may have already reached as much as 8.7% of cases in the region spanning Colorado, Montana, North Dakota, South Dakota, Utah and Wyoming.
  • It is too early to know whether EU.1.1 will lead to new or different symptoms in the U.S.
• FEHBlog note — Reassuringly, the variants remain descendants of the late, great Omicron.

• Helio informs us,
  • “Prenatal lifestyle interventions delivered by an allied health professional, with individual delivery formats and a moderate number of sessions, decreased gestational weight gain., according to data published in JAMA Network Open.
  • “In addition, researchers observed associations with reduced gestational weight gain among physical activity and mixed behavioral interventions. 
  • “These findings suggest that future pragmatic research should focus on testing and evaluating components to inform implementation in varied antenatal care settings, including those with limited resources, to optimize population benefits for pregnant individuals and the next generation,” the researchers wrote.”

From the obesity drug front —

• STAT News reports,
  • “Almost half of Americans would be willing to spend up to $100 a month for new weight loss medicines such as Wegovy, and one-third say they would indefinitely pay whatever they can afford to get the drugs, according to a new survey by STAT and The Harris Poll.
  • “Although 47% say they would only spend the money up to a point — such as losing a certain amount of weight, or up until a special event — demand is so great that nearly one-quarter said they would pay up to $250 each month. And another 17% percent are willing to shell out as much as $500 each month. The survey, which polled 2,046 U.S. adults, was conducted earlier this month.”
• and
  • An experimental pill from Eli Lilly led to 14.7% weight loss on the highest dose in a 36-week trial, heating up the growing competition among drugmakers to develop an effective oral obesity therapy.
  • The mid-stage results for orforglipron match the estimates of 14-15% weight loss that Lilly gave in an investor call late last year. The full results, published Friday in the New England Journal of Medicine, were presented here to a packed conference room at the American Diabetes Association conference.
  • Nonetheless, an overwhelming majority — 84% — believe insurance companies should cover the injectable medicines, which carry list prices ranging from $900 to $1,300 a month.

• Meanwhile, Healthcare Dive relates,
  • “Pfizer is scrapping of one of two experimental weight-loss pills it’s been developing after spotting signs of potential safety concerns in clinical testing.  
  • “The company on Monday said the decision to stop testing of the pill, lotiglipron, was made after receiving the results from drug-drug interaction studies and observing liver enzyme elevations in early- and mid-stage tests. Patients with liver enzyme spikes, which can be signs of organ damage, didn’t have side effects or require treatment, Pfizer said.  
  • “Pfizer will now focus on its other, similar weight-loss prospect, danuglipron, which so far hasn’t had such concerns. Danuglipron is currently in Phase 2 testing in Type 2 diabetes and obesity, and could move into late-stage development by the end of the year.”  

In other Rx and medical device news

• Biopharma Dive identifies five Food and Drug Administration (FDA) decisions to watch for in this third quarter of 2023.

• Beckers Hospital Review points out
  • The FDA has given a fast-track designation to a drug designed to prevent infection from both influenza A and B strains created by San Diego-based Cidara Therapeutics, according to a June 22 news release.
  • The novel drug, CD388, is being developed alongside Janssen Pharmaceuticals primarily for flu prevention in adults who are high risk as well as for individuals for whom flu vaccines “are either ineffective or contraindicated,” the release states. 
  • The FDA’s decision could prove to be timely as early data from the flu season that is currently underway in the Southern Hemisphere is showing that both influenza A and B are both circulating.

• MedTech Dive notes
  • “Dexcom next year will introduce a continuous glucose monitor aimed at the 25 million non-insulin-using Americans with Type 2 diabetes.
  • “The CGM, which is based on the Dexcom G7, will last for 15 days, include a cash-pay option and come with software designed for the needs of people who are yet to require insulin.
  • “Dexcom’s analysis shows those patients want help understanding the effect of lifestyle on blood glucose and staying off insulin, leading the company to develop a revised set of features for the new device.” 

From the U.S. healthcare business front

• The Wall Street Journal reports
  • “UnitedHealth Group will acquire Amedisys for $101 a share, or nearly $3.29 billion, upending a prior deal for the home-health provider to combine with Option Care Health
  • “Amedisys said Monday that it has agreed to a takeover by UnitedHealth’s Optum health-services arm in which each Amedisys share will be converted into the right to $101 in cash. 
  • “Amedisys will become a wholly owned subsidiary of UnitedHealth when the transaction is completed. UnitedHealth’s UnitedHealthcare is the biggest U.S. health insurer. Its Optum business includes a sprawling network of physician groups, surgery centers and other assets.” * * *
  • “The companies didn’t provide an expected closing date on the acquisition, which still needs to be approved by regulators and Amedisys shareholders. 
  • “The combination is likely to draw close antitrust scrutiny from the Federal Trade Commission. Optum will be seeking to take over the No. 2 competitor in the home-health business after recently absorbing the No. 3 company, according to analysts. * * *
  • “When it announced its offer for Amedisys, UnitedHealth said it was confident it could secure approval for the combination, partly because of how fragmented the home-health business is.”

• Health Payer Intelligence points out
  • “What will happen to the volume and value of mergers and acquisitions in 2023? This is a question at the forefront of payers’ minds as the healthcare industry emerges from the uncertainties of the coronavirus pandemic.
  • “The twelve months ending on May 15, 2023, witnessed strong merger and acquisition volume despite various challenges, according to a report from PwC. At the end of the report’s timeframe, the volume of deals was nearly twice as high as the period of 2018 to 2020.
  • “Still, health services deals dipped slightly, dropping by four percent from 2022. Volume dropped from 1,738 in 2022 to 1,661 as of May 15, 2023.
  • “Deal values declined significantly by 15 percent. In 2022, deal value amounted to $100 billion. In the study’s timeframe, deal value totaled $85 billion. Megadeal values, specifically, have been more than halved in the last two years since 2021, a trend which might continue due to rate hikes.”