From Washington, DC,

• STAT News reports
  • The shortage of cancer drugs is not going away, but it may be easing slightly, a new national survey suggests. Based on questions posed to 29 of its 33 member hospitals, the National Comprehensive Cancer Network said Thursday that 86% of those cancer centers are experiencing a shortage of at least one type of generic chemotherapy drug, down from 90% in May.
• and adds
  • One of the top health care committees in the Senate is assembling ideas for bipartisan legislation to address drug shortages, three Senate aides and three lobbyists told STAT.
  • The talks, led by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) are in the early days, but they could move the debate over drug shortage reforms into a new phase. The committee has jurisdiction over Medicare and Medicaid payment policies for hospitals. Other committees that have tried tackling the issue have jurisdiction mostly over the Food and Drug Administration.

• Two law firms dive into regulatory issues that have puzzled the FEHBlog recently:

• Miller and Chevalier makes the following observation about the recent federal court decision vacating an HHS rule permitting health plans to use manufacturer copay assistance accumulators. These accumulators prevent the manufacturer coupons from being counted toward out-of-pocket maximums.
  • “Following this ruling, it is unclear what rules will govern the use of co-pay accumulator programs. The prior agency rule, under which plans and issuers were allowed to exclude manufacturer co-pay assistance payments from deductible and out-of-pocket maximum calculations only if a generic drug was available and only to the extent permitted by state law, may be reinstated, but it suffers from the same issues that led the court to vacate the 2020 rule. The government may move for reconsideration of the court’s ruling or for a stay of the ruling, pending an appeal, and an appeal is expected. Further guidance from HHS and CMS is likely forthcoming in the interim. It should be noted that state laws prohibiting co-pay accumulator programs could be susceptible to ERISA pre-emption challenges, and the related guidance may spawn collateral litigation.” 

• Proskauer explains how the ACA regulators used FAQ 61 to “press play” on the Transparency in Coverage Rule’s Prescription Drug Machine-Readable File Requirement.
  • “Prescription drug machine-readable file: Having concluded that the prescription drug machine-readable file requirement is sufficiently different from the separate CAA prescription drug reporting obligation, the Departments rescinded their prior delayed enforcement policy. The Departments state they intend to release future technical guidance with an implementation timeline that “sufficiently accounts” for prior reliance by plan sponsors on the deferred enforcement policy, suggesting that plan sponsors may have some lead time to gather the necessary information to post the file.
  • “In-network rate machine-readable file: Going forward, the Departments state they intend to exercise enforcement discretion on a case-by-case basis with respect to the requirement that in-network rates be expressed as dollar amounts for items and services covered by arrangements that make it difficult to express the cost as a dollar amount prior to receipt of the item or service.  Because the Departments do not mention future guidance or an implementation guideline, it appears that the revocation of this enforcement safe harbor is immediate.”

• The Congressional Budget Office issued a call for new research in the area of obesity. In this regard, the Wall Street Journal observes
  • “Big food companies and investors are watching as Ozempic and other similar weight-loss drugs flow to millions of people, upending America’s diet industry and raising new questions about how consumers will eat. 
  • “Executives at food manufacturers from  Campbell Soup to Conagra Brands said they are fielding questions from investors about the drugs’ potential impact as internal teams start to assess consumer behavior and brainstorm ways to respond.
  • “The drugs, which suppress patients’ appetites, have exploded in popularity in the U.S., straining manufacturing capacity. 
  • “Morgan Stanley has projected that 24 million people, or nearly 7% of the U.S. population, will be taking such medications in 2035. 
  • “Those people could cut their daily calorie consumption by as much as 30%, according to the firm, which surveyed over 300 patients. For a person on a 2,000-calorie diet, that could mean eliminating a one-ounce bag of salted potato chips, a bottle of soda and more each day.”

• Govexec points out,
  • “The Office of Personnel Management on Wednesday reminded federal agencies of recent changes to how to monitor and collect data on the usage of workplace flexibilities like telework and remote work, as the Biden administration prepares to increase in-person work across the federal government this fall.”

From the public health and research front,

• NBC News tells us,
  • “So-called “good” HDL cholesterol may not be as healthy as experts once thought, a new study suggests. 
  • “The new study, published Wednesday in Neurology, found that having either high or low levels of high-density lipoprotein, or HDL, cholesterol, may increase the risk of dementia in older adults. It’s more evidence showing that keeping HDL cholesterol within a certain range is important for cardiovascular and brain health.  
  • “The relationship between HDL cholesterol and dementia is more complex than we previously thought,” said the study’s lead author, Erin Ferguson, a doctoral student studying epidemiology at the University of California San Francisco. “While the magnitude of this relationship is relatively small, it’s important,”
  • “The results show a correlation between HDL cholesterol and dementia, but do not prove that low or high levels of the lipid directly caused dementia.”

• The Washington Post reports
  • “Using a host of high-tech tools to simulate brain development in a lab dish, Stanford University researchers have discovered several dozen genes that interfere with crucial steps in the process and may lead to autism, a spectrum of disorders that affects about one in every 36 Americans, impairing their ability to communicate and interact with others.
  • “The results of a decade of work, the findings published in the journal Nature may one day pave the way for scientists to design treatments that allow these phases of brain development to proceed unimpaired.”

• Health Payer Intelligence points out
  • “Mortality rates among women and children grew between 2018 and 2021, emphasizing the importance of prioritizing preventive care and public health interventions, a report from the United Health Foundation shared.
  • “The America’s Health Rankings 2023 Women and Children Report analyzed data on 122 healthcare measures from 34 data sources. The findings reflect outcomes among women between 18 and 44 and children across the United States.”

From the U.S. healthcare business front,

• Per Healthcare Dive,
  • “Froedtert Health plans to acquire full ownership of insurer Network Health from Ascension Wisconsin, the Milwaukee-based health system announced Tuesday. 
  • “The system agreed to buy the remaining 50% stake in the payer, which offers commercial and Medicare plans in 23 counties throughout the state, from Ascension Wisconsin. Froedtert originally acquired its stake in the company in 2014.
  • “Terms of the deal weren’t disclosed, and the health systems said a closing date will be determined after regulatory review and approval.”
• and
  • “U.S.-based digital health startups raised $2.5 billion across 119 deals in the third quarter this year, marking the second-lowest quarter of funding since the fourth quarter in 2019, according to a report by consultancy and venture capital firm Rock Health.                    “Digital health startups have raised $8.6 billion in 365 deals so far this year, a little more than half of 2022’s total. The results cement a move toward decreased funding compared with pandemic boom years, the report found.                                                                                       “While funding and deal count has fallen significantly, trends have now stabilized for several quarters in a new normal for the digital health sector