Midweek Update

NIH

Midweek Update

David Ermer–ACA, Congress, COVID treatment, Federal employment benefits, Medical / Rx research, NIH, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • The Wall Street Journal reports,
    • “GOP Rep. Jim Jordan failed again to win enough votes to be elected House speaker, as divisions hardened for House Republicans, with some lawmakers pursuing new paths to break the impasse that has paralyzed the chamber.
    • “More than two weeks after former House Speaker Kevin McCarthy (R., Calif.) was ousted, Republicans remained gripped in a fierce internal struggle over his successor. Jordan said he would keep up his campaign, but pushed off any further voting until Thursday at the earliest as mounting GOP defections on his second ballot left Republicans snarled into warring factions over what should happen next.”
  • The Federal Times informs us that the Senate is considering a bipartisan bill to improve benefits for the families of federal employees who die on the job.
  • Govexec tells us,
    • “A bipartisan trio of Senators hope to advance new legislation aimed at improving and “streamlining” federal agencies’ customer service across platforms, in part by adopting practices already employed in the private sector.
    • “Customer service at agencies that interact with members of the public has been top of mind for lawmakers and administration officials in recent years. During the height of the COVID-19 pandemic, that attention was on electronic means like phone and the Internet, while over the last 18 months, the focus turned toward in-person service as well as backlogs that cropped up over the course of the pandemic.
    • “The Improving Government Services Act (S. 2866), introduced by Sens. Gary Peters, D-Mich., James Lankford, R-Okla., and John Cornyn, R-Texas, last month but publicized Tuesday, tasks federal agencies that provide services to members of the public to develop annual customer experience action plans and submit them both to the director of the Office of Management and Budget and Congress. The Senate Homeland Security and Governmental Affairs Committee is slated to consider the bill next week.”
  • MedPage Today discusses today’s confirmation hearing for the President’s nominee to be NIH Director, Dr. Monica Bertagnolli.
    • “In laying out her vision for the agency, a key theme for Bertagnolli was equity. “NIH can and must support research that is equitable and accessible to all populations,” she said, stressing the need to diversify clinical trials.”
  • The Internal Revenue Service announced, “The applicable dollar amount that must be used to calculate the [PCORI] fee imposed by sections 4375 and 4376 for policy years and plan years that end on or after October 1, 2023, and before October 1, 2024, is $3.22. This is the per belly button fee that FEHB plans will owe for the current 2023 plan year next July 31, 2024.
  • HHS Office for Civil Rights issued “Resources for Health Care Providers and Patients to Help Educate Patients about Telehealth and the Privacy and Security of Protected Health Information.”
  • AHIP posted its helpful comments on the proposed mental health parity rule changes. The public comment deadline was yesterday.
  • Fedsmith offers its guidance on the upcoming Federal Employee Benefits Open Season.

From the public health front,

  • STAT News reports,
    • Treatments like Ozempic, Wegovy, and Mounjaro have been hailed for showing 15% to over 20% weight loss in trials, but those are just averages. In reality, there are big variations in how much weight people lose on the therapies, and it’s unclear what explains those differences.
    • “One way researchers are trying to figure this out is by focusing on genes.
    • “The variability is so wide that we want to understand what predicts response,” said Lee Kaplan, chief of obesity medicine at the Geisel School of Medicine at Dartmouth. Since genetics is a significant reason people develop obesity, and since early data also show that genetics may contribute to how people respond to bariatric surgery, “that would argue that there’s probably going to be a genetic contribution” to the amount of weight loss people experience on obesity drugs.”
  • Beckers Hospital Review discusses what the closure of various Walgreen’s and Rite Aid drug stores means for healthcare.
    • “The closures also disproportionately affect Black and Latino city neighborhoods, as well as rural areas, according to Serena Guo, MD, PhD, an assistant professor at the Gainesville-based University of Florida College of Pharmacy. 
    • “Closure has the potential to worsen disparities in access to pharmacies,” Dr. Guo told MarketWatch.”
  • The National Institutes of Health announced,
    • “Starting buprenorphine treatment for opioid use disorder through telehealth was associated with an increased likelihood of staying in treatment longer compared to starting treatment in a non-telehealth setting, according to a new study analyzing Medicaid data from 2019-2020 in Kentucky and Ohio. Published in JAMA Network Open, these findings(link is external) add to a growing body of evidence demonstrating positive outcomes associated with the use of telemedicine for treatment of opioid use disorder.
    • “In Kentucky, 48% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 44% of those who started treatment in non-telehealth settings. In Ohio, 32% of those who started buprenorphine treatment via telehealth remained in treatment for 90 continuous days, compared to 28% of those who started treatment in non-telehealth settings.”
  • HealthDay points out,
    • “Researchers have identified a link between attention-deficit/hyperactivity disorder (ADHD) in adults and dementia.
    • “The risk of dementia is three times higher in adults with ADHD, according to a large study of Israelis who were followed for 17 years.
    • “More research is needed to verify the findings and understand the link.”
  • The Wall Street Journal reports,
    • “Pfizer will price a course of its Covid-19 drug Paxlovid at nearly $1,400 when commercial sales begin later this year, more than double what the U.S. government has paid.
    • “Pfizer told the pharmacies and clinics that will dispense Paxlovid, in a letter dated Wednesday that was viewed by The Wall Street Journal, that a five-day course of the antiviral will list for $1,390. The U.S. government had paid $529.
    • “Health plans will probably pay much less than the list price for the pills, and most patients will have a small or no out-of-pocket cost because Pfizer is expected to offer price discounts and help patients with their out-of-pocket charges.
    • “Pfizer has already faced criticism from doctors and patient advocates that raising the price will limit patient access. Disclosure of the list price will probably fuel further criticism.”

From the U.S. healthcare business front,

  • KFF reports,
    • “Amid rising inflation, annual family premiums for employer-sponsored health insurance climbed 7% on average this year to reach $23,968, a sharp departure from virtually no growth in premiums last year, the 2023 benchmark KFF Employer Health Benefits Survey finds.
    • “On average, workers this year contribute $6,575 annually toward the cost of family premium, up nearly $500 from 2022, with employers paying the rest. Future increases may be on the horizon, as nearly a quarter (23%) of employers say they will increase workers’ contributions in the next two years.
    • “Workers at firms with fewer than 200 workers on average contribute nearly $2,500 more toward family premiums than those at larger firms ($8,334 vs. $5,889). In fact, a quarter of covered workers at small firms pay at least $12,000 annually in premiums for family coverage.
    • “This year’s 7% increase in average premiums is similar to the year-over-year rise in workers’ wages (5.2%) and inflation (5.8%). Over the past five years, premiums rose 22%, in line with wages (27%) and inflation (21%).”
  • Per WXYZ.com (Detroit MI),
    • “Henry Ford Health and Ascension Michigan have signed an agreement to enter into a joint venture, the latest merger between health systems in Michigan.
    • “According to the health systems, Ascensions Southeast Michigan and Genesys healthcare facilities will join with Henry Ford’s. * * *
    • According to the companies, the combined organization would employ around 50,000 team members at more than 550 sites of care across the area.”
  • Healthcare Dive adds,
    • “Thirty-nine percent of mergers and acquisitions announced in the third quarter included a hospital or health system that cited financial distress as a driver for deal, according to a report by Kaufman Hall. 
    • “Though M&A activity is continuing to trend back to pre-pandemic levels, the number of hospitals in distress shows the financial strain of the past two years, the report said. Eighteen transactions were announced in the third quarter, compared with just seven in the same period in 2021 and 10 during the third quarter in 2022.
    • “Increased costs, both for labor and other expenses, has been a significant challenge for smaller and medium-sized health systems. Now, more large systems — with annual revenue of $1 billion or more — are pointing to financial concerns as their reason for dealmaking, according to Kaufman.”
  • Beckers Payer Issues notes,
    • “In the third quarter, we completed a strategic review of our operations, assets, and investments to enhance operating efficiency, refine the focus of our investments in innovation and optimize our physical footprint,” the company wrote. “This resulted in a net charge of $697 million, comprised of the write-off of certain information technology assets and contract exit costs, a reduction in staff including the relocation of certain job functions, and the impairment of assets associated with the closure or partial closure of data centers and offices.”
    • “Elevance Health posted $1.3 billion in net income during the third quarter, a nearly 20% decrease compared to the same period last year, according to the company’s earnings report published Oct. 18.
  • and
    • “Consumers’ overall satisfaction with health insurers is up 4% over 2023, according to a report from the American Customer Satisfaction Index published Oct. 17. 
    • “Customer satisfaction with insurers reached a score of 76 out of 100, the highest in the index’s history, according to the report.” 
  • Per Fierce Healthcare,
    • “Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday.
    • “The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said.
    • “Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December.
    • “Delivery of medications via drone will be offered in College Station initially and will expand to additional cities in the coming years, an Amazon Pharmacy spokesperson said. The announcement was made this week as part of Amazon’s Delivering the Future event in Seattle focused on its latest innovations.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, NIH, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC, comes an outcome that the FEHBlog didn’t expect.

  • The Washington Post reports,
    • “Rep. Kevin McCarthy (R-Calif.), after being removed as House speaker Tuesday, told fellow Republican lawmakers that he won’t seek the position again. The vote to remove him was the first such action in congressional history. McCarthy’s ouster was sought by hard-right members of his own party. McCarthy was removed by a 216-210 vote, with eight Republicans joining all Democrats in favor of the removal. The move puts the House in uncharted territory as it searches for a leader.
    • “Following McCarthy’s ouster, Rep. Patrick T. McHenry (R-N.C.) was designated as speaker pro tempore. He presided over the chamber briefly before calling a recess to allow Republicans and Democrats to meet privately.
    • “The House will take no further votes this week. Republicans are expected to hold a speaker candidate forum Tuesday, according to sources familiar with the plans who spoke on the condition of anonymity to discuss private deliberations.
  • The Wall Street Journal informs us
    • “Americans will soon be able to choose a third option in the updated Covid-19 booster-shot campaign.
    • “The Food and Drug Administration on Tuesday authorized the use of Novavax‘s Covid-19 shot in people age 12 and older. The shot has been updated to target a strain of the coronavirus that was circulating earlier this year, which health authorities say could help protect people through the fall and winter.
    • “The Centers for Disease Control and Prevention’s recommendation last month that most people receive updated booster shots applies to all updated boosters cleared by the FDA, now including Novavax’s, a CDC spokesman said. 
    • The recommendation clears the way for the vaccine to become available in pharmacies and other vaccination sites.
    • “Novavax said it priced the updated vaccine at $130 a dose, but most people are expected to be able to get it with no out-of-pocket cost.
    • “The company said it has millions of doses that will start to become available in the coming days. The shots will be offered at more than 13,000 sites around the U.S., including retail pharmacies and physician offices.”

From the public health front,

  • On Saturday, the FEHBlog made an appointment with a local chain pharmacy to get the new Covid booster. Later that day, he received a message from the pharmacy canceling the appointment because the booster was no longer available. Medscape points out that the FEHBlog’s experience was not unusual. The following posts put the FEHBlog’s problem in perspective though. There is good news if you can get to the end of this section.
  • The Washington Post has bad news about American life expectancy.
    • “Sickness and death are scarring entire communities in much of the country. The geographical footprint of early death is vast: In a quarter of the nation’s counties, mostly in the South and Midwest, working-age people are dying at a higher rate than 40 years ago, The Post found. The trail of death is so prevalent that a person could go from Virginia to Louisiana, and then up to Kansas, by traveling entirely within counties where death rates are higher than they were when Jimmy Carter was president.”
    • The FEHBlog thinks you don’t need a moonshot to address this problem. Connect people with primary care physicians early in their adult lives.
  • AHRQ’s Medical Expenditure Panel Survey lets us know,
    • “In 2020, about 1 of every 12 adults aged 18 and older received any heart disease treatment. The percentage of adults who received any heart disease treatment was highest among those aged 65 and older, higher among non-Hispanic Whites than among other racial/ethnic groups, and also higher among those in poor/low-income families than those in middle- or high-income families.
    • “Annual healthcare expenditures for the treatment of heart disease for adults in the civilian noninstitutionalized population totaled $114.9 billion in 2020 (a mean of $5,540 per adult treated for heart disease).
    • “Inpatient hospital care accounted for the largest proportion of annual medical spending for heart disease.
    • “Medicare and private health insurance combined paid about four-fifths of the medical spending for heart disease.”
  • Per Fierce Healthcare,
    • “About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.”About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.
    • “These health trends are bad for women and also for their employers.
    • “Primary care provider Parsley Health commissioned a survey of 1,200 full-time employed, insured women ages 18 to 60 to uncover their top health concerns and care challenges. The biggest takeaway? For many women, their healthcare needs have been left behind by a system that has largely ignored the broad, intersecting and complex health needs women experience across their lifetimes, Robin Berzin, M.D., founder and CEO of Parsley Health, said during an exclusive interview to review the survey results.”
  • The National Institutes of Health Directors notes,
    • “Chronic pain is an often-debilitating health condition and serious public health concern, affecting more than 50 million Americans. The opioid and overdose crisis, which stems from inadequate pain treatment, continues to have a devastating impact on families and communities across the country. To combat both challenges, we urgently need new ways to treat acute and chronic pain effectively without the many downsides of opioids.
    • “While there are already multiple classes of non-opioid pain medications and other approaches to manage pain, unfortunately none have proved as effective as opioids when it comes to pain relief. So, I’m encouraged to see that an NIH-funded team now has preclinical evidence of a promising alternative target for pain-relieving medicines in the brain.
    • “Rather than activating opioid receptors, the new approach targets receptors for a nerve messenger known as acetylcholine in a portion of the brain involved in pain control. Based on findings from animal models, it appears that treatments targeting acetylcholine could offer pain relief even in people who have reduced responsiveness to opioids. Their findings suggest that the treatment approach has the potential to remain effective in combatting pain long-term and with limited risk for withdrawal symptoms or addiction. * * *
    • “Finding treatments to modify acetylcholine levels or target acetylcholine receptors may therefore offer a means to treat pain and prevent it from becoming chronic. Encouragingly, drugs acting on these receptors already have been tested for use in people for treating other health conditions. It will now be important to learn whether these existing therapeutics or others like them may act as highly effective, non-addictive painkillers, with important implications for alleviating chronic pain.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly is making a bet on radiopharmaceutical drugs for cancer, announcing Tuesday a deal to buy Point Biopharma and its pipeline of experimental therapies for approximately $1.4 billion.
    • “Per acquisition terms, Lilly will pay $12.50 per Point share, a premium of about 87% to what the biotechnology company’s stock closed at Monday. The companies expect their deal to close “near the end” of this year.
    • “Based in Lilly’s home base of Indianapolis, Point specializes in radiopharmaceuticals, which pair a radioisotope with a targeting compound that delivers radiation directly into tumor cells. Recent improvements in manufacturing and supplying the complex treatments have boosted investment in the field, drawing interest from large pharma companies like Lilly as well as new drug startups.”
  • Healthcare Dive informs us,
    • “Growing expenses outpaced operating revenue at Trinity Health during its 2023 fiscal year ended June 30. The hospital system reported operating revenue of $21.6 billion on total expenses of $21.9 billion.
    • “Acquisitions for the Livonia, Michigan-based healthcare system added both $1.6 billion in revenue and $1.7 billion in operational expenses, according to the results released on Friday. The revenue gains were partially offset by the divestiture of St. Francis Medical Center in December 2022.
    • “Labor expenses continue to plague the hospital operator, which called contract rates “unprecedented” last year. Labor costs rose approximately 7.7% this year to $12 billion compared with $11.1 billion in the year prior. Contract labor accounted for $933 million compared with $626 million in 2022.”

Thursday Miscellany and Friday Factoids

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, Mental health care, NIH, No Surprises Act, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The FEHBlog failed to hit publish last night, so Thursday Miscellany was not emailed Friday morning. To correct the problem, Friday Factoids will follow Thursday September 21’s post. Lo siento

From Washington, DC,

  • The Hill reports
    • “Faced with the House stalemate over a government stopgap funding bill, Senate Majority Leader Chuck Schumer (D-N.Y.) on Thursday set up a path for the Senate to move first on a bill to fund the government beyond Sept. 30.  
    • “Schumer filed cloture on a motion to proceed to H.R. 3935, the House-passed bill to reauthorize the Federal Aviation Administration (FAA), which could serve as a legislative vehicle to pass a continuing resolution to fund the government through the Senate.   * * *
    • “Senators will spend next week debating and voting on the legislation in hopes of sending it to the House by Wednesday or Thursday of next week.”  
  • Roll Call adds
    • “The [new] plan [from the House of Representatives] is to ready more of the chamber’s 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a firm negotiating position for talks with the bigger-spending Senate.”
  • Yesterday, the Affordable Care Act regulators extended the public comment deadline for the proposed mental health parity rule revisions from October 2 to October 17, 2023.
  • Today, the Centers for Medicare and Medicaid Services posted a new announcement on its No Surprises Act website:
    • “Effective September 21, 2023, the Departments have directed certified IDR entities to resume processing all single and bundled disputes already submitted to the IDR portal and assigned to a certified IDR entity.  The ability to initiate new disputes involving air ambulance items or services as well as batched disputes for air ambulance and non-air ambulance items and services is currently unavailable. IDR portal functionalities related to previously initiated batched disputes are also unavailable. Disputing parties should continue to engage in open negotiation according to the required timeframes.”
  • CMS also updated its website with No Surprises Act rules and fact sheets.
  • Also today, the U.S. Office of Personnel Management
    • “released the Federal Workforce Competency Initiative (FWCI) General Competencies and Competency Models for a broad set of occupational series. The FWCI is a governmentwide effort led by OPM that updates a selection of general competencies from OPM’s MOSAIC (Multipurpose Occupational Systems Analysis Inventory—Closed-Ended) studies.  
    • “The FWCI competencies provide a common language for 214 occupational series. OPM has published 80 occupation-specific competency models representing work governmentwide that may be used for selection, evaluation, and training activities. The FWCI is a resource for agencies to leverage in their skills-based hiring practices. 
    • “OPM will continue to support agencies and collect critical data that strengthens our workforce and enables us to deliver services for the American people,” said OPM Director Kiran Ahuja. “This update to the Federal Workforce Competency Initiative will help agencies hire the talent they need and expand opportunities for positions that do not require certain degrees.” 
  • The Equal Employment Opportunity Commission posted its new strategic enforcement plan for 2024 through 2028.

From the public health front,

  • The American Medical Association identifies eight things doctors wish their patients knew about the flu shot.
  • The Washington Post reports,
    • “Poor oral hygiene is associated with an increased risk for myriad health problems, including heart disease, diabetes, cancer, rheumatoid arthritis and early death. The state of our teeth and gums, though, may be vital for our well-being beyond the mouth and body.
    • “Emerging evidence suggests that what goes on in our mouth can affect what goes on in our brain — and may even potentially affect our risk for dementia.
    • “People should really be aware that oral health is really important,” said Anita Visser, professor in geriatric dentistry at the University of Groningen in the Netherlands.”
  • Per a CVS Health press release,
    • “A recent CVS Health®/Harris Poll survey of Americans 18 years and older found that nearly one in five (18%) U.S. adults say they were plagued with suicidal thoughts in the past year.  
    • “Other key findings from the survey include:
      • “More than a third of younger adults aged 18-34 (36%) say they had moments in the past year where they contemplated suicide.
      • “An overwhelming nine in ten (89%) U.S. adults deem suicide prevention efforts a major priority in our society.
      • “However, less than a third (32%) strongly agree they can recognize the warning signs of someone potentially at risk, and only four in ten (43%) are strongly aware of resources that offer support and information on suicide prevention.
      • “Nearly eight in ten (77%) U.S. adults believe healthcare providers have a crucial role in suicide prevention, and there is an opportunity for providers to have more discussions about suicide with patients.”

From the U.S. healthcare business front

  • Per Healthcare Dive,
    • “The Federal Trade Commission is suing anesthesia provider U.S. Anesthesia Partners and private equity firm Welsh, Carson, Anderson and Stowe, alleging the two colluded to consolidate anesthesiology practices in Texas, driving up prices to boost their profits.
    • “Welsh Carson created USAP in 2012 before acquiring over a dozen anesthesia providers over the next decade to create a single dominant provider in the state, regulators allege. The PE firm and USAP also made price-setting agreements with independent anesthesiology practices while sidelining a potential competitor by striking a deal to keep them out of USAP’s market, the FTC said.
    • “The complaint filed Thursday in federal district court says the actions have cost Texans “tens of millions of dollars” more each year in anesthesiology services.”
  • MedCity News offers insights on value-based care from an executive at the HealthPartners HMO in Minnesota. “The commercial market has struggled to adopt value-based care, but HealthPartners has had some success, according to Mark Hansberry, senior vice president and chief marketing officer of the company. During a conference, he shared five rules for scaling value-based care, including creating trust and providing real-time data.”
  • Beckers Hospital Review tells us,
    • “Nearly 1,900 U.S. physicians have applied to become certified in obesity medicine — a record number — according to data from the American Board of Obesity Medicine. 
    • “In October, 1,889 physicians will take the exam to become certified in the specialty area. That’s up from 1,001 exam candidates in 2020, marking an 88.7 percent jump. Physicians’ growing interest in the certification comes amid booming patient demand for GLP-1 receptor agonist drugs such as Ozempic and Wegovy. As of August, 2023, sales for Ozempic in the U.S. topped $3 billion. 
    • “More than 6,700 physicians are certified in obesity medicine, a certification that first became available in 2012. For the upcoming exam in October, 38 percent of exam candidates are internal medicine physicians and 30 percent family medicine. To sit for the exam, physicians must have completed a minimum of 60 continuing medical education credits on the topic of obesity.” 
  • The FEHBlog notes that if you build it, they will come.
  • Fierce Healthcare looks inside Walgreens’ pharmacy and primary care model.
  • The Wall Street Journal reports,
    • “Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal.
    • “The Food and Drug Administration inspected the Clayton, N.C., plant in July and issued a report saying that Novo Nordisk had failed to investigate the cause thoroughly and that the plant’s microbial controls were deficient.  
    • “The plant makes the drug ingredient semaglutide, which is used in the diabetes pill Rybelsus. Semaglutide is also the main ingredient in Novo Nordisk’s popular injections Ozempic and Wegovy, but the company said the semaglutide for those products isn’t made at the same plant.
    • “The Danish company said the Clayton plant is still running and producing for the market and wouldn’t share details of its interactions with the FDA.
    • “The agency said Thursday that based on Novo’s responses to its inspection findings, the FDA isn’t aware of ongoing compliance issues that raise any concerns about the quality of drugs made at the plant.”

Friday, September 23, 2023 Post

From Washington DC,

  • Senator Chuck Grassley (R Iowa) announced
    • “A bipartisan bill led by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to improve access to lifesaving organ donations became law today. The Securing the U.S. Organ Procurement and Transplantation Network Act will improve the management of the U.S. organ donation system by breaking up the contract for the Organ Procurement and Transplantation Network (OPTN) and encouraging participation from competent and transparent contractors. U.S. Sens. Ben Cardin (D-Md.), Todd Young (R-Ind.) and Bill Cassidy (R-La.) are original cosponsors of the legislation.”
  • The Wall Street Journal reports,
    • “The collapse this week of efforts to pass spending bills through the House has ignited a long-shot push to head off a government shutdown, with a bipartisan group of senators floating legislation that provides carrots and sticks to force lawmakers to reach a deal.
    • “The lawmakers’ novel approach would aim to ensure Congress completes its work on all 12 appropriations bills needed to fund the government, without the threat of a shutdown that would furlough hundreds of thousands of federal workers and leave government contractors unpaid. Major government functions will stop on Oct. 1 at 12:01 a.m. unless Congress acts.
    • “The bill, co-sponsored by Sens. James Lankford (R., Okla.) and Maggie Hassan (D., N.H.), would set in motion 14-day continuing resolutions, which keep the government funded at the prior year’s levels, while Congress works exclusively on passing appropriations bills.” 
  • Bloomberg points out
    • “The threat of a massive tax is enough to push drugmakers such as Boehringer Ingelheim Pharmaceuticals, Inc. and Novartis AG to comply with the Biden administration’s landmark drug pricing law and negotiate with Medicare.
    • “Companies who manufacture the first 10 drugs selected to negotiate prices with Medicare have until Oct. 1 to officially agree to enter price talks. Under the Inflation Reduction Act, those who refuse to comply with the negotiations must pay a tax starting at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.”
  • That’s a lot of leverage.
  • The Consumer Financial Protection Bureau has “announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals under consideration that would help families financially recover from medical crises, stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often plagued with inaccuracies and mistakes.” In the FEHBlog’s view, this approach is bound to backfire as lenders lose faith in credit reports.

From the public health and medical research front,

  • MedPage Today informs us
    • “Nearly half of U.S. states had an adult obesity prevalence at or above 35% in 2022, according to CDC.
    • “The 22 states that met this mark — a small jump from the 19 states just the year prior — included Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin.”
  • and
    • The CDC’s advisors on Friday recommended a maternal respiratory syncytial virus (RSV) vaccine to protect infants from serious infections.
    • By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks gestation to prevent lower respiratory tract RSV infection in infants.
    • After decades without an option for protecting most infants against the annual respiratory scourge, providers now have two options: the maternal vaccine and the monoclonal antibody nirsevimab (Beyfortus), which the ACIP last month recommended for all infants younger than 8 months born during or entering their first RSV season.
  • STAT News adds, “The recommendation was accepted by CDC Director Mandy Cohen shortly after the conclusion of the panel’s meeting.”
  • Per BioPharma Dive,
    • “A new cancer drug developed by Daiichi Sankyo and AstraZeneca met one of its two main goals in a breast cancer trial, helping patients who had progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, the companies said Friday.
    • “The trial tested the drug, known as datopotamab deruxtecan, in HER2-low or -negative patients whose tumors were sensitive to hormone treatments before their cancer returned. AstraZeneca and Daiichi didn’t release detailed data and stated that the trial hadn’t gone on long enough to tell if patients given their treatment lived longer overall, the trial’s other main goal.
    • “The data suggest the companies’ drug could present a threat to Gilead’s similarly acting medicine Trodelvy, which gained approval in a similar setting earlier this year. HR-positive, HER2-negative breast cancer is the most common form of the disease.”
  • and
    • “A combination of cancer drugs from Seagen and Merck & Co. has shown early success in a large clinical trial, results that help confirm the pairing’s ability to treat a wide range of bladder cancer patients.”
  • The National Institutes of Health announced
    • “A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 people at research sites around the world. It is supported by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in partnership with NIH’s National Center for Advancing Translational Sciences (NCATS).
    • “Immune modulators—treatments for modifying the immune system to better respond to disease or illness—are lifesaving for certain hospitalized COVID-19 patients. However, the optimal timing for administering the medicines to achieve the best outcomes has not been defined.”
  • The Wall Street Journal poses ten questions about experimental drugs that can be made available to seriously ill patients.

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Catholic healthcare giant CommonSpirit Health has reported a $1.4 billion operating loss (-4.1% operating margin) and a net loss of $259 million for its 2023 fiscal year, which ended June 30, according to financial statements released Thursday.
    • “The nonprofit, which currently operates 145 hospitals across 24 states, had logged a $1.3 billion operating loss (-3.8% operating margin) and a $1.8 billion deficit of revenues over expenses during its prior fiscal year.
    • “This time around, the organization enjoyed patient volumes that “reached pre-pandemic levels in many of the health system’s markets” but was dragged by “private and government reimbursements [that] did not keep pace with increased costs of providing care to patients,” CommonSpirit said in a release accompanying the latest financial filings. The most recent year’s operating performance also included a $160 million adverse impact from a fall 2022 cybersecurity breach that affected numerous locations.”
  • Healthcare Dive tells us,

    • The CMS is poised to crack down further on health insurers in the Medicare Advantage program, according to new comments from a top agency official.

    • MA plans — which now cover more than half of Medicare beneficiaries — have faced rising criticism over care denials and access, along with improper coding practices that inflate the program’s cost.

    • “You will see CMS in the future be a much tougher payer and much tougher regulator to ensure that, for every beneficiary and taxpayer who pay more for it, the value is there, the service is there and beneficiaries have full information for the choices that they’re making,” CMS Deputy Administrator Jon Blum said Thursday at the National Association of ACOs’ fall conference in Washington, D.C.

Midweek update

David Ermer–CDC, Congress, COVID-19 testing, FDA, Generative AI, Medical / Rx research, NIH, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Roll Call informs us
    • House Republicans appeared to be moving closer to an agreement Wednesday on an opening bid for stopgap funding legislation that would keep the lights on at federal agencies beyond Sept. 30 and pave the way for their chamber to take up its full-year appropriations bills.
    • At least a handful of conservative holdouts still maintained their opposition as of Wednesday night, which would be enough to sink a revised bill unless GOP leaders are able to change some minds in the next few days. Speaker Kevin McCarthy, R-Calif., is expected to keep the chamber in session on Saturday if necessary.
    • Even if GOP leaders’ new effort is successful, however, it was starting to look more like a bid to reopen the government after a brief shutdown, given the deadline is 10 days away and the Senate is likely to ping-pong a much different bill back to the House.
  • The FEHBlog notes that it would not be unusual for Congress to pass a brief continuing resolution next week to allow for the passage of a longer continuing resolution, thereby side stepping the partial government shutdown.
  • Fierce Healthcare offers details on the House Ways and Means Committee’s No Surprises Act hearing, while Healthcare Dive shares details on the House Oversight and Accountability’s PBM reform hearing. Both hearings were held yesterday.
  • Speaking of the No Surprises Act, the ACA regulators released a proposed rule increasing the government’s NSA arbitration fee from $50 per party to $150 per party next year. The FEHBlog has no idea why the government doesn’t ladder the fee based on the amount in dispute. The government also increased the maximum fee independent dispute resolution entities can charge the parties.
  • MedCity News informs us
    • “FDA Approves GSK Myelofibrosis Med That Has Edge Over Others in Drug Class 
    • “FDA approval of GSK’s Ojjaara in myelofibrosis introduces a new competitor to blockbuster Incyte drug Jakafi. Ojjaara was part of GSK’s $1.9 billion acquisition of Sierra Oncology last year.”
  • and
    • “FDA Rejects ARS Pharma’s Nasal Spray Alternative to Injectable Epinephrine 
    • “ARS Pharmaceuticals frames its intranasal epinephrine spray as a needle-free alternative to products such as EpiPen. Though this spray won the backing of an FDA advisory committee, the agency is now requiring that ARS Pharma run another study to support a regulatory submission.”

From the public health and medical research fronts,

  • STAT News reports,
    • “The federal government is again offering free Covid-19 tests to Americans, providing a fifth round of free tests in part to meet current needs and in part to stimulate a domestic testing industry that has struggled with cratering demand for rapid diagnostics.
    • “The measure, announced Wednesday, will see rapid tests released from the Strategic National Stockpile. In addition, 12 domestic test manufacturers will receive investments totaling $600 million to help “warm-base” the U.S. capacity for rapid test production, both for Covid and future disease threats. * * *
    • “Households will be entitled to receive four free rapid tests apiece, with ordering at COVIDtests.gov opening on Sept. 25. O’Connell said test shipments are expected to start on Oct. 2.”
  • The FEHBlog thinks that the government is fighting the last pandemic. Why not incent the production of the FDA-approved (last February) at-home tests for Covid or the flu, not just Covid?
  • In any event, the Wall Street Journal points out
    • “Don’t throw out that seemingly outdated at-home rapid Covid-19 test just yet. It may still be good. 
    • “The Food and Drug Administration has been extending expiration dates for some authorized at-home, over-the-counter Covid test kits, meaning some unused tests may still be viable. The agency’s updated list of expiration dates may be useful to those reaching for their stash of Covid-19 tests amid new variants and a recent bump in cases and hospitalizations.”
  • The National Institutes of Health announced,
    • “A trial of a preventive HIV vaccine candidate has begun enrollment in the United States and South Africa. The Phase 1 trial will evaluate a novel vaccine known as VIR-1388 for its safety and ability to induce an HIV-specific immune response in people. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has provided scientific and financial support throughout the lifecycle of this HIV vaccine concept and is contributing funding for this study.”
  • Per NBC News,
    • “Is morning the best time of day to exercise? Research published Tuesday in the journal Obesity finds that early morning activity — between 7 a.m. and 9 a.m. — could help with weight loss. 
    • “My cautious suggestion from this study is that if we choose to exercise in the early morning before we eat, we can potentially lose more weight compared to exercise at other times of the day,” said lead researcher Tongyu Ma, a research assistant professor at The Hong Kong Polytechnic University.”

From the U.S. healthcare business front,

  • Healthcare Dive tells us
    • “Ochsner Health is launching a pilot program this month that will use generative artificial intelligence to draft “simple” messages to patients.
    • “About a hundred clinicians across the New Orleans-based health system will participate in the first phase of the program, where AI will prepare responses to patient questions unrelated to diagnoses or clinical judgments. The messages will be reviewed and edited by providers before being sent to patients, according to a news release. 
    • “Ochsner is part of an early adopter group of Microsoft’s Azure OpenAI Service, which integrates with the Epic electronic health record. The health system will test the messaging feature over three phases this fall, and Ochsner will collect patient feedback to improve the system.” 
  • Per Fierce Healthcare,
    • “Making sense of mountains of data continues to be an often elusive goal for most of the healthcare system, but Cambia Health Solutions said it hopes its latest effort will allow it to better corral useable information.
    • “Cambia and Abacus Insights, a data management company that tacklesthe challenge of making healthcare networks interoperable, launched a new data aggregating system that processes information for about 3.4 million members across four Blues plans. 
    • “According to an Abacus case study (PDF), “Cambia recognized that to deliver care orchestrated around the unique needs of each individual, data must be actionable. To be actionable, case study data must be understandable, usable, timely, and have clinical utility.”

Midweek update

David Ermer–FDA, Generative AI, Medical / Rx research, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC,

  • “Today, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra declared a Public Health Emergency (PHE) for the state of Florida to address the health impacts of Hurricane Idalia and the Administration for Strategic Preparedness and Response (ASPR) deployed approximately 68 emergency response personnel to the state. At President Biden’s direction, HHS is aiding impacted communities through the Administration’s whole-of-government response effort.”
  • The Society for Human Resource Management informs us,
    • “The Department of Labor (DOL) has proposed an increase to the Fair Labor Standards Act’s (FLSA’s) annual salary-level threshold to $55,068 from $35,568 for white-collar exemptions to overtime requirements. The department also is proposing automatic increases every three years to the overtime threshold. * * * *
    • “To be exempt from overtime under the FLSA’s “white-collar” executive, administrative and professional exemptions, employees must be paid a salary of at least the threshold amount and meet certain duties tests. If they are paid less or do not meet the tests, they must be paid 1 and a half times their regular hourly rate for hours worked in excess of 40 in a workweek. * * *
    • “Under the new rule, approximately 300,000 more manufacturing workers would be entitled to overtime pay, the Labor Department reports. A similar number of retail workers would be eligible, along with 180,000 hospitality and leisure workers, and 600,000 in the health care and social services sector.” 
  • MedCity News relates,
    • “A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and positioning the therapy to achieve its blockbuster expectations.
    • “The drug, Reblozyl, treats myelodysplastic syndromes (MDS), a group of cancers in which the immature blood cells in bone marrow do not mature to become healthy blood cells. In 2020, the FDA approved Reblozyl as a second-line treatment for the anemia resulting from MDS. The FDA decision announced late Monday makes it a first-line therapy.”
  • The National Institutes of Health announced,
    • “In a study of 152 deceased athletes less than 30 years old who were exposed to repeated head injury through contact sports, brain examination demonstrated that 63 (41%) had chronic traumatic encephalopathy (CTE), a degenerative brain disorder associated with exposure to head trauma. Neuropsychological symptoms were severe in both those with and without evidence of CTE. Suicide was the most common cause of death in both groups, followed by unintentional overdose.
    • “Among the brain donors found to have CTE, 71% had played contact sports at a non-professional level (youth, high school, or college competition). Common sports included American football, ice hockey, soccer, rugby, and wrestling. The study, published in JAMA Neurology, confirms that CTE can occur even in young athletes exposed to repetitive head impacts. The research was supported in part by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.” 

From the public health, medical research and Rx coverage fronts,

  • STAT News reports,
    • “The first Alzheimer’s therapy to clearly slow cognitive decline, approved in the United States last month, lifted the hope of patients and their families. But creating access to the program is a painfully slow process, even in Massachusetts, where large hospital systems have been preparing for months to administer the much-anticipated medicine.
    • “Thousands of patients are stuck on waiting lists across the state and nationally as hospitals struggle to ramp up infusion centers and monitoring processes for the drug, called Leqembi, while neurologists grapple with workforce and capacity constraints. * * *
    • “Hospitals say the backlog is temporary, reflecting the challenge of building from scratch a treatment infrastructure for new Alzheimer’s drugs. Leqembi, developed by Biogen and its Japanese partner, Eisai, was the first such treatment to be green-lighted by the Food and Drug Administration. The agency will evaluate a second therapy, Eli Lilly’s donanemab, later this year.”
  • and
    • “KRAS, one of the most common genetic mutations in cancer, has been one of the most tantalizing oncogenic targets for drug developers since its discovery four decades ago. An altered KRAS gene can drive cells to divide uncontrollably, propelling them down the path towards malignancy. But for most of the last four decades, any attempt to target KRAS failed, leading many researchers to doom the protein as “undruggable.”
    • “In the last few years, that attitude has sharply turned around. In 2013, Kevan Shokat, a biologist at the University of California, San Francisco, discovered a key chemical vulnerability in a specific subset of mutant oncogenic KRAS that made it possible to design small molecules that would bind to the protein. This discovery catalyzed a frenzy of drug development around KRAS inhibitors, which eventually led to the first approved KRAS drugs in the last couple of years. Those successes are now driving a new wave of early-stage innovation around the target.
    • “It broke the code for us, for KRAS,” said Ravi Salgia, chair of medical oncology and therapeutics research at the City of Hope. “That gives us more hope to say we’ve spent more than 30 years studying it. Now, great breakthroughs have occurred. Let’s keep going forward.”
    • “That includes work around new small molecules for other subsets of mutant KRAS as well as immunotherapy approaches for targeting the oncogene. These therapies could potentially treat a wide range of different KRAS-mutant cancers including lung, pancreas, and colorectal cancers.”
  • CNN tells us,
    • “A group of novel synthetic opioids emerging in illicit drugs in the United States may be more powerful than fentanyl, 1,000 times more potent than morphine, and may even require more doses of the medication naloxone to reverse an overdose, a new study suggests.
    • “Nitazenes are a synthetic opioid, like fentanyl, although the two drugs are not structurally related. In the small study published Tuesday in the journal JAMA Network Open most of the patients who overdosed on nitazenes received two or more doses of the opioid overdose reversal drug naloxone, whereas most patients who overdosed on fentanyl received only a single dose of naloxone.
    • “Clinicians should be aware of these opioids in the drug supply so they are adequately prepared to care for these patients and anticipate needing to use multiple doses of naloxone,” the researchers, from the Icahn School of Medicine at Mount Sinai in New York, Lehigh Valley Health Network based in Pennsylvania, and other US institutions, wrote in the study. “In addition, to date there has been a lack of bystander education on repeat naloxone dosing.”

From the U.S. healthcare business front,

  • Per Healthcare Dive, and the FEHBlog agrees,
    • “Ensuring workers can find and access high-quality providers is key to tamping down healthcare costs and improving outcomes in the employer-sponsored insurer market, according to a study by Morgan Health and Embold Health published in NEJM Catalyst. 
    • “Employers can now access more data on the quality of care provided by clinicians, so they should take a larger role in health plan network design and steer workers toward higher-performing providers, according to the report. 
    • “Clinician quality can drive poor outcomes, missed treatments and unnecessary care, the report said. For example, among the top 10% of about 800 cardiologists in Ohio by quality rank, an average of 73% of patients with coronary artery disease were taking cholesterol-lowering statins regularly, compared with only 39% for the bottom 10% of clinicians.” 
  • The Wall Street Journal reports
    • “In a male-dominated industry, female surgeons spend more time in the operating room, and their patients endure fewer postoperative complications.
    • “That’s the conclusion of two research studies published Wednesday in JAMA Surgery. Researchers found better outcomes for patients treated by female surgeons in the sweeping reviews of millions of procedures in Canada and Sweden. 
    • “In the first study, 17 researchers in the U.S. and Canada followed the outcomes for 1.2 million patients in Canada undergoing common surgeries between 2007 and 2020.
    • “The study authors found that at both 90 days and one year following surgery, patients treated by female surgeons were less likely to experience adverse postoperative issues, including death. The outcome differences were modest, but consistent.”
  • Fierce Healthcare relates,
    • “Earlier this year, Anthem Blue Cross and Blue Shield unveiled a new virtual-first plan that harnesses artificial intelligence to streamline health services for members, the insurer announced.
    • “Now, it’s making that plan available in several additional states beginning Jan. 1. Large group fully insured or self-funding employer clients in Connecticut and Virginia can select Anthem Link Virtual First plans, which harness the power of the insurer’s Sydney app to connect members with benefits details, cost transparency information and more around the clock.
    • “Stephanie DuBois, a spokesperson for Anthem Blue Cross and Blue Shield in Connecticut, told Fierce Healthcare in an email that the plans first became available to large group self-insured employers in California, Missouri and New York as well as large group self-funded and fully insured employers in Georgia starting in July.
    • “Members can access Anthem Link Virtual First plans through Sydney Health, which is a digital member engagement platform that includes access to benefits, tools, resources and provider care 24/7,” DuBois said. “Sydney Health also offers an AI-driven symptom checker that intuitively uses the information members provide to narrow down millions of medical data points and assess specific symptoms before seeing a doctor.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Generative AI, NIH, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Mount Rushmore

From Washington, DC —

  • STAT News reports
    • “Senators on the Finance Committee on Wednesday nearly unanimously passed a bill to clamp down on drug middlemen but kicked the can down the road on some of the more challenging policies.
    • “The bill would offer some more transparency into the business practices of pharmacy benefit managers, ensure PBMs aren’t skimming off of the money they send to insurers, prohibit them from overcharging insurers, and ensure certain fees in the Medicare program aren’t tied to a drug’s price.”
  • From the Senate Finance Committee, “click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • The House Ways and Means Committee relates,
    • “Congresswoman Nicole Malliotakis, a member of the House Committee on Ways and Means, today announced her legislation, the Protecting Patients from Middlemen Act, passed out of the full committee and will be included in the committee’s Health Care Price Transparency Act of 2023.
    • “Specifically, Malliotakis’ legislation, which was introduced in partnership with Rep. Brad Wenstrup (OH-02), would prohibit prescription drug plans and Pharmacy Benefit Managers (PBMs) in Medicare Part D or Medicare Advantage from charging patients more in drug cost-sharing that the net price of the drug.”
  • AHA News tells us,
    • “The House Ways and Means Committee July 26 voted 25-16 to pass the Health Care Price Transparency Act (H.R. 4822), legislation that would impose additional site-neutral payment cuts and regulatory burdens on off-campus hospital outpatient departments, impose additional Medicare sequester cuts on hospitals, and codify and make changes to hospital price transparency regulations. * * *
    • “In other action today, the committee voted 23-17 to pass the Providers and Payers COMPETE Act (H.R. 3284), AHA-opposed legislation that would impose new regulatory responsibilities on the Department of Health and Human Services regarding consolidation.”
  • Federal News Network informs us,
    • “Federal retirees, and employees looking to retire, have some new resources to help them through the often long and thorny retirement process.
    • “A new series of video tutorials from the Office of Personnel Management lays out, step by step, a couple of key items on the federal retirement to-do list.
    • “With the three new videos, OPM said it hopes to reduce the number of errors from federal retirees when trying to log in to manage their online retirement accounts. And in theory, the videos should also help reduce wait times at retirement services call centers, OPM said, now that more detailed information is readily available to feds who get caught up in some of the early steps of the process.”
  • Forbes reports
    • “The FDA has approved Octapharma’s drug Balfaxar, which is used by patients who require surgery but have seen a reduction in blood clotting factors due to being treated with the blood thinner warfarin.” 

From the public health front —

  • Employee Benefits News offers expert views on the current state of Covid.
  • The National Institutes of Health announced
    • “Researchers have found that people with obstructive sleep apnea have an increased cardiovascular risk due to reduced blood oxygen levels, largely explained by interrupted breathing. Obstructive sleep apnea has long been associated with an increased risk of cardiovascular issues, including heart attack, stroke, and death, but the findings from this study, partially supported by the National Institutes of Health and published in the American Journal of Respiratory and Critical Care Medicine, show the mechanism mostly responsible for the link.
    • “These findings will help better characterize high-risk versions of obstructive sleep apnea,” said Ali Azarbarzin, Ph.D., a study author and director of the Sleep Apnea Health Outcomes Research Group at Brigham and Women’s Hospital and Harvard Medical School, Boston. “We think that including a higher-risk version of obstructive sleep apnea in a randomized clinical trial would hopefully show that treating sleep apnea could help prevent future cardiovascular outcomes.”
  • Medscape considers where exercise boosts cognition.
  • Fierce Healthcare lets us know,
    • “One in three counties in the U.S. is considered a maternal healthcare desert.
    • “Since that statistic was dropped back in October 2022 by March of Dimes, care in corners of the country has only continued to dry up. In response to the crisis, providers are using every seed in their seed bag and looking to “multimodal” technology strategies to predict health emergencies before they happen.
    • “Those multimodal approaches combine telehealth, remote patient monitoring (RPM) and text messages to identify high-risk patients. High blood pressure monitoring and hypertension screening are currently recommended for pregnant patients by the U.S. Preventive Services Task Force, as heart disease and stroke are two of the leading causes of maternal mortality.
    • “Lucienne Ide, M.D., is the CEO of the digital health company Rimidi. She sees the country teetering on an inflection point.
      • “We’re at this fork in the road of looking at what we could do with technology, identifying high-risk women and getting them into the programs where we’re proactively and earlier identifying something dangerous and doing something about it,” Ide told Fierce Healthcare.
      • “But the alternate narrative is really, really bad, and it’s going to get worse. It’s not like, ‘Here we are today, and we could do better.’ No, here we are today, and it’s going to get worse, but we can actually do better,” she said.

From the U.S. healthcare business front —

  • Per Fierce Healthcare,
    • “As hospitals acquire ambulatory care centers, consumers are more likely to be forced to pay outpatient facility fees for routine care traditionally covered by physician offices at lower costs.
    • “These new costs, appearing seemingly out of nowhere to the average consumer through out-of-pocket spending and premium increases, can add up to hundreds or thousands of dollars in additional expenses for a patient, according to a report from Georgetown University’s Center on Health Insurance Reforms.
    • “Outpatient facility fees cover a hospital’s operational expenses. But when hospitals acquire physician practices, that usually generates another outpatient facility bill, eventually passing on the cost to the patient. Consumers are often unaware that they are now responsible for an extra cost.”
  • Healio reports that the growth of telehealth in cancer care continued after the initial surge during the COVID-19 pandemic.
  • Per Healthcare Dive, the path toward reducing physician burnout is widening.
    • “Amazon has become the latest tech giant to announce a clinical documentation service that allows providers to automatically create medical notes using generative AI.
    • “The Amazon Web Services tool announced Wednesday, called HealthScribe, allows providers to build clinical applications that use speech recognition and generative AI to create transcripts of patient visits, identify key details and create summaries that can be entered into an electronic health record.
    • “HealthScribe is being previewed for two specialties: general medicine and orthopedics. An Amazon spokesperson said AWS could expand to additional specialties based on client feedback. HealthScribe costs users a set amount per second of audio processed each month.”

Thursday Miscellany

David Ermer–ACA, Congress, COVID-19, COVID-19 vaccine, Electronic health records, Medical / Rx research, NIH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC —

  • Govexec informs us
    • “The Senate continues to advance spending bills without controversy and with bipartisan support, offering hope that lawmakers will avoid a lapse in appropriations this fall. 
    • “The [Senate Appropriations Committee] has now approved eight of the 12 annual must-pass spending measures, most of which have won unanimous approval. Sen. Patty Murray, D-Wash., who chairs the appropriations committee, announced Thursday her panel would hold votes on the final four funding packages next week. Murray said ahead of Thursday’s votes that she was focusing on passing bills “that can actually be signed into law.”  * * *
    • “The House Appropriations Committee has approved 10 of the 12 spending bills, all largely along party-line votes. House Speaker Kevin McCarthy, R-Calif., said on Wednesday he planned to bring those to the House floor soon, adding his intention was to have the process complete before current funding expires on Sept. 30. Without commenting on the vast differences between the two sets of bills, McCarthy called it “a positive” that the Senate was already moving its spending measures.”
  • The Affordable Care Act regulators issued a letter encouraging employers and other plan sponsors to extend the special employer-sponsored health plan enrollment period for employees who lost Medicaid or CHIP coverage for themselves or family members beyond the sixty days required by law.  
  • The Department of Health and Human Services released guidance “to clarify the prohibition at 45 CFR § 162.412(b) that a health plan may not require a healthcare provider that has been assigned an NPI to obtain an additional NPI.” However, “it does not prohibit a health plan from requiring that a subpart that does not have a unique NPI obtain a unique NPI as a condition of enrollment with the health plan.”
  • The American Academy of Actuaries posted its annual report outlining the factors likely to drive premium changes in the individual and small group insurance markets for the next plan year, in this case, 2024. 

From the public health front —

  • MedPage Today informs us,
    • “A second booster with an mRNA bivalent vaccine offered the best protection against severe COVID-19 due to the Omicron BA.5 variant in older adults, and protection appeared to wane less than with the monovalent shot, a large retrospective study out of Italy showed.”
  • The National Institutes of Health announced
    • “Omega-3 fatty acids, which are abundant in fish and fish oil supplements, appear promising for maintaining lung health, according to new evidence from a large, multi-faceted study in healthy adults supported by the National Institutes of Health. The study provides the strongest evidence to date of this association and underscores the importance of including omega-3 fatty acids in the diet, especially given that many Americans do not meet current guidelines. Funded largely by the National Heart, Lung, and Blood Institute (NHLBI), part of NIH, the study results were published in the American Journal of Respiratory and Critical Care Medicine.” 
  • Cigna Healthcare offers five tips for healthier sleep.

From the EHR interoperability front, check out this fascinating Computer World update

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.
  • Beckers Hospital Review tells us,
    • “Severe winds from an EF-3 tornado on July 19 crushed a North Carolina Pfizer manufacturing plant that made nearly 25 percent of the drugmaker’s sterile injectables used by U.S. hospitals. 
    • “The facility manufactured and stored injectable drugs, and 50,000 pallets of therapies were destroyed by wind and rain, according to local news outlets, NBC affiliate WRAL and CBS affiliate WNCN. 
    • “At 1.4 million square feet, the facility was one of the largest sterile injectable plants in the world, according to Pfizer’s website. The site made nearly 400 million products every year, including solutions of anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers.
    • “The tornado touched down in Rocky Mount, N.C., at 12:36 p.m., according to a tweet from the county’s government.
    • “Pfizer said there are no reports of workers with serious injuries.” 
  • The Wall Street Journal reports,
    • “A surge in heart procedures and higher demand for cold and flu medicines helped Johnson & Johnson report solid gains in revenue and profit for the second quarter.
    • “J&J’s quarterly earnings are regarded as a bellwether for healthcare because the company has large pharmaceutical, medical-device and consumer-health divisions. The overall improvement in J&J’s results suggests an easing of some of the challenges that have dogged health-product makers in recent years: supply-chain constraints, hospital staffing shortages and Covid-19 pandemic restrictions. “You now have hospital staffing much more on a routine cadence,” J&J Chief Financial Officer Joseph Wolk said in an interview Thursday.” 
  • Healthcare Dive adds,
    • “Abbott on Thursday posted a decline in second-quarter net earnings as demand for its COVID-19 testing supplies continued to wane, but the company raised the outlook for its base business on higher sales of its medical devices and nutrition products.
    • “Excluding COVID-19 tests, organic sales exceeded the company’s expectations with a nearly 12% increase in the quarter.”
  • The Society for Human Resource Management explores the limited impact that the Supreme Court’s affirmative action in education decision may have on employer affirmative action and diversity, equity, inclusion, and accessibility programs.

Tuesday Tidbits

David Ermer–CDC, Medical / Rx research, Mental health care, NIH, Rx coverage, SCOTUS, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • The U.S. Supreme Court released three more opinions this morning. The Wall Street Journal reports
    • “The Supreme Court rejected a bid by Norfolk Southern to limit its state-court liability in states where it does relatively little business, ruling Tuesday that states can require companies to submit to their courts’ jurisdiction as a condition of doing business within their borders.
    • “While the case involved a long-pending workplace lawsuit filed by a retired railway employee from Virginia, Justice Neil Gorsuch, writing for a 5-4 majority of the justices, linked the issue to a Norfolk Southern train’s Feb. 3 derailment in East Palestine, Ohio.”
  • The Supreme Court has pending seven more decisions from its October 2022 term. The next decision day will be Thursday morning.
  • Beckers Hospital Review tells us,
    • “The Federal Trade Commission has proposed changes to the premerger notification form in addition to premerger notification rules implementing the Hart-Scott-Rodino Act, which requires organizations to report large transactions to the FTC and Justice Department for antitrust review.
    • “The HSR Act and its implementing rules related to mergers and acquisitions involve completing HSR Forms and waiting a specified period of time before completing the transaction.
    • “The proposed HSR changes would help the agencies to more effectively screen transactions for potential competition issues within the waiting period, which is generally 30 days. The FTC said that this competition review is important to identify deals that require in-depth investigations to determine whether they would violate antitrust laws and, if so, to seek to block the proposed transaction.”
  • HHS Inspector General announced posting
    • “its final rule implementing information blocking penalties. The final rule establishes the statutory penalties created by the 21st Century Cures Act. If OIG determines that an individual or entity has committed information blocking, they may be subject up to a $1 million penalty per violation.
    • “The final rule does not impose new information blocking requirements. OIG incorporated regulations published by the Office of the National Coordinator for Health Information Technology (ONC) as the basis for enforcing information blocking penalties. For more information on ONC’s information blocking regulations see: Information Blocking.
    • “To report complaints about information blocking, please visit the ONC Information Blocking Portal or the OIG Hotline.”
  • HR Dive points out the steps that covered employers to take to comply with the Pregnant Workers Fairness Act, which took effect today.

From the public health front —

  • The Washington Post reports,
    • “For the first time in two decades, malaria infections have been confirmed in people who did not travel outside the United States, leading federal health authorities to warn about the potential for transmission of the mosquito-born disease within the nation’s borders.
    • “Four people in Sarasota County, Fla., and one in Cameron County, Tex., were confirmed as having been infected between late May and late June through local transmission. All have gotten treatment and are recovering as health officials watch for additional cases, the Centers for Disease Control and Prevention said.
    • “Although the potentially fatal disease was once endemic, it was declared eliminated in the United States in 1951. About 2,000 people are diagnosed with malaria in the nation each year, but those cases have involved trips abroad. For a handful who came down with the disease in recent months, that was not the case.
    • “The risk of getting malaria in the United States “remains extremely low,” the CDC said. Still, experts said Americans should be aware of the possibility and take steps to prevent mosquito bites.”
  • The CDC discusses a recent study examining the health impact of widening the age range eligible for cost-free in-network diabetes type 2 testing.
  • The Health and Human Services Department “released a report showcasing evidence-based interventions to support physical activity among adults ages 65 years and older. By the year 2030, 1 in every 5 Americans will be age 65 or over. More than 85 percent of older adults currently have at least 1 chronic health condition. The growing population of older adults can gain substantial health benefits and prevent or manage chronic disease by engaging in physical activity.”

From the Rx coverage front —

  • Health Affairs lets us know that
    • “Using Medicare claims, we documented US prescribing patterns for originator biologic trastuzumab (Herceptin), a targeted cancer therapy, and five biosimilar entrants since 2019. The first biosimilar captured a dominant share, but over time, average sales prices of all products declined, and later entrants became dominant in some states. Despite strong brand loyalty to the first biosimilar, competitive pressure increased with subsequent entrants.”
  • Beckers Hospital Review relates
    • “With about a dozen cancer drugs on back order and no clear end to the shortages, the American Society of Clinical Oncology and the Society of Gynecologic Oncology recently advised clinicians to ration chemotherapy supplies. 
    • “The updated guidelines recommend curbing or halting pharmaceutical treatment for patients with “recurrent, agent-resistant cancers” — which means saving therapies for patients with a better chance of surviving. 
    • “The national cancer care group also recommended extending the time between treatments when appropriate; lessening waste by “optimizing vial size, dose rounding and using multi-use vials”; and providing support services to patients and clinicians experiencing “shortage-related distress.”
    • “Two cancer drugs in shortage that treat multiple cancers and cost about $20 per vial, cisplatin and carboplatin, have been in shortage for months. One of the main suppliers for the drugs ended operations in late 2022 after FDA investigators found numerous quality infractions and ruined reporting documents. In another inspection, the agency found more quality issues, which could further delay expected recovery. 
    • “The FDA allowed a China-based drug company to produce and import cisplatin, and the agency is working to boost carboplatin supplies.”

From the studies front —

  • The National Institutes of Health announced
    • “In people with Alzheimer’s disease, the underlying changes in the brain associated with dementia typically begin many years—or even decades—before a diagnosis. While pinpointing the exact causes of Alzheimer’s remains a major research challenge, they likely involve a combination of genetic, environmental, and lifestyle factors. Now an NIH-funded study elucidates the role of another likely culprit that you may not have considered: the human gut microbiome, the trillions of diverse bacteria and other microbes that live primarily in our intestines.
    • “Earlier studies had showed that the gut microbiomes of people with symptomatic Alzheimer’s disease differ from those of healthy people with normal cognition [2]. What this new work advances is that these differences arise early on in people who will develop Alzheimer’s, even before any obvious symptoms appear.
    • “The science still has a ways to go before we’ll know if specific dietary changes can alter the gut microbiome and modify its influence on the brain in the right ways. But what’s exciting about this finding is it raises the possibility that doctors one day could test a patient’s stool sample to determine if what’s present from their gut microbiome correlates with greater early risk for Alzheimer’s dementia. Such a test would help doctors detect Alzheimer’s earlier and intervene sooner to slow or ideally even halt its advance.”
  • Fierce Healthcare informs us
    • “Medicare Advantage (MA) beneficiaries given home-delivered meals in the four weeks after being discharged from a hospital were not only less likely to be readmitted within 30 days, they were also less likely to die, according to a study in JAMA Health Forum.
    • “The 2018 Chronic Care Act gave MA plans greater leverage to address the social determinants of healthcare. In addition to giving insurers an impetus for launching dietary programs, the act also covers transportation for beneficiaries and other at-home services.
    • “The study states that “nearly three-quarters of MA plans offered meals as a supplemental benefit in 2022, mostly driven by expectations of downstream cost savings based on findings from earlier observational studies of community-based nutrition programs, and desires to maintain market parity in an increasingly competitive MA space.
    • “Beginning in January 2021, Kaiser Permanente Southern California (KPSC) began offering home-delivered meals to eligible MA enrollees. The comparative cohort study in JAMA Health Forum examines data from 4,032 KPSC MA enrollees who’d been hospitalized for heart failure and 7,944 who’d been hospitalized for other reasons after they’d been discharged from Jan. 1, 2021, to Jan. 31, 2022. The data come from 15 hospitals in the KPSC network.”

In U.S. healthcare business news —

  • Healthcare Dive reports
    • “Walgreens missed Wall Street earnings expectations in its third fiscal quarter and cut its 2023 outlook, citing macro factors including a weak respiratory season and falling demand for COVID-19 tests and vaccines.
    • “The pharmacy chain did beat the Street’s revenue expectations with a topline of $35.4 billion, up 9% year over year, thanks in part to its expanding U.S. Healthcare segment, which includes value-based medical group VillageMD.”

Midweek update

David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC —

  • The Wall Street Journal reports,
    • “The House passed a sweeping bill that suspends the federal government’s $31.4 trillion debt ceiling in exchange for spending cuts, as Republican Speaker Kevin McCarthy muscled through a deal struck with President Biden to avert a looming government default.
    • “The 314-117 vote relied on support from both Republicans and Democrats. Passage of the deal sends the measure to the Senate, where leaders have promised quick action, and Biden has said he is eager to sign the measure into law. Treasury Secretary Janet Yellen has said the government could run out of the cash it needs on June 5 to pay its bills on time and warned of severe economic damage and market disruptions unless Congress acts.
    • “The House vote marks the culmination of a hard-fought debate in the chamber, where Republicans were intent on using the debt ceiling as leverage to deeply cut deficit spending and roll back many of Biden’s signature initiatives—but ended up settling for more modest changes.
    • “The outcome showed, for now, that McCarthy has the power to deliver high-stakes deals with Democrats while still keeping his job, and bolstered Biden’s reputation as a deal maker who was willing to find a middle ground with Republicans.”
  • Healthcare Dive provides details on the healthcare provisions in the bill (HR 3746).
  • STAT News tells us
    • “As Congress considers wide-ranging reforms to pharmacy benefit managers, a top executive at CVS Health, which owns one of the largest PBMs in the country, said the company would find ways to maintain its level of profit if those reforms to things like drug rebates went into effect.
    • “There’s other ways in the economic model that we can adjust to if one of those things changes,” Shawn Guertin, CVS’ chief financial officer, said at an industry conference Wednesday. “The other important part of this, if some of these things change, it could lead to higher costs for employers and health plans.”
  • If the FEHBP’s experience with transparent prescription drug pricing is any guide, the reforms under consideration will not lower costs for employers and health plans. For example, OPM mandated full transparency of manufacturer rebates and 100% distribution of those rebates to the health plans, causing higher administrative expenses for FEHB plans. Presumably, the larger rebates and higher administrative expenses wash. OPM also mandates triennial RFP processes for PBM contracts which do produce savings.

Speaking of FEHBP, Govexec brings us up to date on Postal Service Health Benefits Program implementation. The article illustrates the support that carriers and the Postal Services, among other agencies, are providing OPM with this project. All of the major Postal unions are FEHB carriers.

Today is the deadline for FEHB carriers to submit their 2024 benefit and rate proposals to OPM. Fierce Healthcare discusses a Mercer survey of employer expectations for 2024 premiums.

From the public health front —

  • Kaiser Family Foundation News points out that medical debt is materially higher in the Diabetes Belt found in the southeastern U.S. “The CDC says the Diabetes Belt consists of 644 mostly Southern counties where rates of the disease are high. NPR found that more than half of the counties have high levels of medical debt in collections — meaning at least 1 in 5 people are affected.”
  • Healio relates
    • Compared with reoffering colonoscopy and fecal immunochemical test alone, offering a blood test as a secondary option resulted in a nearly twofold increase in colorectal cancer screening in veterans who had declined first-line screening. 
    • “We know screening prevents colorectal cancer, but participation in screening is suboptimal,” Peter S. Liang, MD, MPH, assistant professor of medicine and population health at NYU Langone Health, told Healio. “Compared to widely used screening modalities such as colonoscopy and stool-based testing, a blood test has certain advantages: It is noninvasive, can be done at point of care and does not require self-collection.”
  • Leapfrog Group calls attention to its newly released 2023 maternity care report.
  • STAT News explains why new cancer patients need navigation support
    • [P]eople * * * in this suspected peri-diagnostic period (the time between a positive finding on a screening test and leading up to a formal diagnosis and treatment) are not looking for specific answers so much as they are seeking general support.
    • Patients want a trusted person to help provide a general overview of the journey ahead. They want someone to help them through the structural and logistical challenges of our cumbersome and sometimes unresponsive health systems. They would like triage on whether their case is common enough that they can access high-quality, convenient, and accessible community care, or whether their diagnosis warrants the specialized care available at large academic medical centers. They want guidance on what sorts of questions to ask their care team. They want to know if they should pursue second opinions, and if so, how to go about getting insurance approval or the mechanics of how to actually secure an appointment.
  • Medscape reports
    • “About 10% of people infected with Omicron reported having long COVID, a lower percentage than estimated for people infected with earlier strains of the coronavirus, says a study published in The Journal of the American Medical Association.”

From the Rx coverage front —

  • The Hill reports
    • “The Food and Drug Administration (FDA) on Wednesday approved Pfizer’s vaccine to prevent the respiratory disease RSV in older adults, the company announced.
    • The approval of Pfizer’s Abrysvo marks the second authorized RSV shot for older adults in the U.S. this month, after GlaxoSmithKline won approval for its rival shot, Arexvy. “
  • Medscape informs us
    • Sotagliflozin, a novel agent that inhibits sodium-glucose cotransporter (SGLT) 1 as well as SGLT2, received marketing approval from the US Food and Drug Administration (FDA) on May 26 for reducing the risk for cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in patients with heart failure, and also for preventing these same events in patients with type 2 diabetes, chronic kidney disease (CKD), and other cardiovascular disease risk factors.
    • This puts sotagliflozin in direct competition with two SGLT2 inhibitors, dapagliflozin (Farxiga) and empagliflozin (Jardiance), that already have indications for preventing heart failure hospitalizations in patients with heart failure as well as approvals for type 2 diabetes and preservation of renal function.
    • Officials at Lexicon Pharmaceuticals, the company that developed and will market sotagliflozin under the trade name Inpefa, said in a press release that they expect US sales of the agent to begin before the end of June 2023. The release also highlighted that the approval broadly covered use in patients with heart failure across the full range of both reduced and preserved left ventricular ejection fractions.
    • Lexicon officials also said that the company will focus on marketing sotagliflozin for preventing near-term rehospitalizations of patients discharged after an episode of acute heart failure decompensation.

From the U.S. healthcare business front —

  • Beckers Hospital Review reports
    • “The median year-to-date operating margin index for hospitals slightly improved in April to 0 percent, according to Kaufman Hall. 
    • “The neutral margin marks a slight improvement from the -0.3 percent recorded in March, according to Kaufman Hall’s latest “National Flash Hospital Report” — based on data from more than 900 hospitals.
    • “Hospitals saw increased bad debt and charity care and decreased inpatient and outpatient volumes in April, which Kaufman Hall experts correlate to the winding down of the COVID-19 Public Health Emergency, which ended May 11.” 
  • Healthcare Dive tells us
    • “Nonprofit hospital and health plan operator Kaiser Permanente announced Tuesday that it was committing $10 million to safety-net hospital and regional operator Denver Health, as the facility struggles with “unprecedented financial challenges” including increased expenses and a rise in uninsured patients.
    • “Denver Health provides care for around 30% of the city’s population — including the largest percentage of uninsured patients. The system has struggled with a rise in costs and a surge in sicker patients, with expenses totaling $1.3 billion for Denver Health in fiscal year 2022.
    • “The announcement comes as both nonprofit and for-profit hospitals across the country struggle with negative margins and pent-up financial challenges stemming from the COVID-19 pandemic, including persistent heightened contract labor costs, inflationary pressures and unfavorable payer mixes.”

From the miscellany department —

  • Bloomberg updates us on the promising hunt for a breast cancer vaccine.
  • MedCity News relates
    • About 65% of Americans believe that employer-sponsored insurance provides them with “financial peace of mind,” a new survey shows.
    • The AHIP report, published Wednesday, was conducted by Locust Street Group from April 17 to April 25 as part of AHIP’s Coverage@Work campaign, which aims to gather insights on Americans’ thoughts on employer-sponsored coverage. It included responses from 1,000 U.S. consumers with employer-sponsored coverage.
  • Beckers Payer Issues ranks the States by Medicare Advantage enrollment.
  • The Society for Human Resource Management reports
    • “In a memo released May 30, National Labor Relations Board (NLRB) General Counsel Jennifer Abruzzo announced that noncompete agreements violate the National Labor Relations Act (NLRA). The announcement, which applies to nonunionized and unionized employers, may result in unfair labor practice charges for any employer that uses noncompetes, said Thomas Payne, an attorney with Barnes & Thornburg in Indianapolis.
    • “However, a manager’s or supervisor’s noncompete would seemingly be unaffected by the memo because the NLRA applies only to nonmanagerial, nonsupervisory staff, said James Redeker, an attorney with Duane Morris in Philadelphia.  Managers and supervisors are the most likely to have noncompetes, he noted.”

Thursday Miscellany

David Ermer–Congress, COVID treatment, COVID-19, Electronic health records, FDA, Medical / Rx research, NIH, Rx coverage–
Photo by Josh Mills on Unsplash

From Washington, DC, —

  • The New York Times reports
    • “Top White House officials and Republican lawmakers were closing in on Thursday on a deal that would raise the debt limit for two years while capping federal spending on everything but the military and veterans for the same period. Officials were racing to cement an agreement in time to avert a federal default that is projected in just one week.
    • “The deal taking shape would allow Republicans to say that they were reducing some federal spending — even as spending on the military and veterans’ programs would continue to grow — and allow Democrats to say they had spared most domestic programs from significant cuts.
    • “Negotiators from both sides were talking into the evening and beginning to draft legislative text, though some details remained in flux.”
  • The Wall Street Journal adds
    • “The Treasury Department is preparing to change how the U.S. processes federal agencies’ payments if the debt ceiling is breached, dusting off a contingency plan crafted after the 2011 borrowing-limit standoff, people familiar with the matter said.
    • “Just days away from becoming unable to pay all of the government’s bills on time unless Congress raises the debt limit, Treasury officials have been quietly laying the groundwork for potentially delaying some payments after June 1.
    • “Under the backup plan created for a debt-limit breach, federal agencies would submit payments to the Treasury Department no sooner than the day before they are due, the people familiar with the talks said. That would represent a change from the current system, in which agencies may submit payment files well before their due dates. The Treasury Department processes them on a rolling basis, often ahead of the deadlines. Some payments are already sent to the department one day early, one person said. 
    • “The plan would enable the Treasury to make daily decisions about whether it can pay all of the government’s bills the next day.”
  • Back to the New York Times,
    • “The [U.S.] House of Representatives passed legislation on Thursday that would make permanent harsh criminal penalties and strict controls on fentanyl-related drugs, with scores of Democrats joining nearly all Republicans in a vote that reflected the political challenges of tackling what both parties consider America’s most pressing drug crisis.
    • “The bill, approved by a vote of 289 to 133, would permanently list fentanyl-related drugs as Schedule I controlled substances, a designation that mandates severe prison sentences for highly addictive, nonmedicinal chemicals, and which is now set to expire at the end of 2024.
    • “The bipartisan vote reflected agreement among Republicans and a solid bloc of Democrats that stiffening penalties for fentanyl-related drugs is a necessary component of the federal response to the crisis. According to the Centers for Disease Control and Prevention, there were roughly 75,000 synthetic opioid overdose deaths in 2022, with fentanyl being a main culprit.”
  • Federal News Network informs us
    • “With many agencies’ return-to-office plans still uncertain, Republicans on the House Oversight and Accountability Committee want to take matters into their own hands.
    • “GOP committee leaders changed their strategy for trying to get more federal telework data, now reaching out directly to agency heads. In a series of 25 letters, the lawmakers asked for up-to-date  numbers of teleworking federal employees, after saying the Biden administration was “not adequately tracking the specific levels of telework.”
    • “The Biden administration “has not provided current data about the specific amount of telework occurring within federal agencies or across the entire federal workforce. Furthermore, it has provided no objective evidence concerning the impact of elevated telework on agency performance — including any deleterious impacts,” lawmakers said in the letters, published May 18.”

From the Rx coverage front —

  • Today the Food and Drug Administration granted full marketing approval to Paxlovid, the Covid treatment pill, which in the FEHBlog’s opinion, brought us to the end of the pandemic. Here’s a link to a MedPage Today report on this FDA action
  • The Institute for Clinical and Economic Research released “a Final Evidence Report assessing the comparative clinical effectiveness and value of resmetirom (Madrigal Pharmaceuticals, Inc.) and obeticholic acid (Ocaliva®, Intercept Pharmaceuticals, Inc.) for non-alcoholic steatohepatitis (NASH).”
    • “Independent appraisal committee narrowly voted that currently available evidence for resmetirom is adequate to demonstrate a net health benefit over lifestyle management, whereas current evidence for obeticholic acid was deemed inadequate to demonstrate a net health benefit —
    • “ICER analyses suggest resmetirom would achieve common thresholds for cost-effectiveness if priced between $39,600 – $50,100 per year assuming that short-term effects on liver fibrosis translate into longer-term reductions in cirrhosis; under the same assumptions, obeticholic acid would achieve common thresholds for cost-effectiveness if priced between $32,600 – $40,400 per year.
    • “Payers should develop coverage criteria based on non-invasive testing to foster equitable access to early detection and treatment across diverse communities.
  • BioPharma Dive tells us
    • “Apellis Pharmaceuticals on Thursday became the latest drugmaker to give up on a potential treatment for amyotrophic lateral sclerosis, a neurodegenerative disorder that has frustrated researchers for decades.
    • “The decision came after a Phase 2 trial showed no benefit for the drug, known as systemic pegcetacoplan, compared with a placebo. It failed to meet the primary endpoint, measured by a statistical tool called the Combined Assessment of Function and Survival, as well as secondary goals assessing overall function, survival, lung function and muscle strength.
    • “The final results weren’t a total surprise; an independent board monitoring the study had already advised the company not to start a second, “open-label” part of the trial that would have offered the medicine to all participants after the initial 52-week research period. Apellis executives had also signaled to analysts that the trial had a low chance of success.”

From the miscellany department —

  • The National Institutes of Health announced
    • “Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant.
    • The study, published in JAMA, is coordinated through the NIH’s Researching COVID to Enhance Recovery initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward potential treatments for long COVID, which affects the health and well-being of millions of Americans.
  • The New York Times discusses the miraculous case of a paralyzed man who has begun to walk again thanks to brain and spine “implants that provided a “digital bridge” between his brain and his spinal cord, bypassing injured sections” of his body.
  • HealthDay relates
    • “Older Americans are increasingly likely to log into “patient portals” to access their health care information — but confidence levels vary. 
    • “About 78% of people aged 50 to 80 now use at least one patient portal, according to the new University of Michigan (U-M) National Poll on Healthy Aging. 
    • “Five years ago, just 51% in this age range used patient portals, the researchers said. 
    • “The poll also found that 55% of those who used patient portals had done so in the past month. About 49% had accounts on more than one portal. 
    • “This surge is partly due to the increase in use of telehealth visits, said Denise Anthony, the U-M School of Public Health professor who worked on the poll.
    • “This change makes access to secure portals even more important for older adults who want to see their doctors and other health care providers virtually. It also makes the disparities we found in our poll even more troubling,” Anthony said in a Michigan Medicine news release. 
    • “Older adults with annual household incomes below $60,000, and those who were Black or Hispanic, had lower rates of portal use. These groups were also less likely to say they’re comfortable using a portal.”
  • The Washington Post reports
    • “U.S. authorities have seized increasing quantities of illegal ketamine, according to new research, a trend that coincides with the psychedelic drug’s rising popularity as a treatment for mental health ailments.
    • “The number of ketamine seizures by federal, state and local law enforcement in the United States increased from 55 in 2017 to 247 in 2022, while the total weight increased by more than 1,000 percent over that time, according to a letter published Wednesday in JAMA Psychiatry. Most of the ketamine was in powder form, which could raise the risk of being adulterated with deadly drugs such as fentanyl.”