Thursday Miscellany

Congress

Thursday Miscellany

David Ermer–CDC, Congress, Medical / Rx research, NCQA, Obesity, U.S. Healthcare–

From Washington, DC,

  • Govexec reports,
    • [On Monday July 21, the House of Representatives passed] “the Billion Dollar Boondoggle Act, was already approved by the Senate in March. 
    • “It would require agencies to report annually to Congress about their projects that are more than five years behind schedule or are $1 billion or more over budget. 
    • “Specifically, the measure would require an explanation for the delay or cost increase as well as a justification for any award, incentive fee or other type of bonus awarded with respect to the project. 
    • “It’s a bad day for boondoggles, but a very good one for taxpayers!” bill sponsor Sen. Joni Ernst, R-Iowa, said in a statement following House passage.” 
  • and
    • “The House also cleared the GOOD Act, which would mandate agencies to post their guidance documents online in a single location on the day they are issued. 
    • “Unfortunately, agency guidance documents are difficult to find, leaving Americans and small businesses guessing, and oftentimes struggling, to comply with the law. The Guidance Out of Darkness Act rights this wrong by requiring federal agencies to be transparent about interpretations of the law through publishing guidance in an easily accessible, online location,” said House Oversight and Accountability Chairman James Comer, R-Ky., who also sponsored the bill, in a statement. “Laws should not be implemented based on guidance that’s kept in the dark.”
    • “It also would require agencies to publish previously issued guidance documents that are still in effect to the same website.”
    • This bill now goes to the Senate for consideration.
  • Govexec also informs us,
    • “The Office of Personnel Management on Thursday finalized new regulations intended to ensure that federal workers who are temporarily promoted are paid appropriately for the duration of their detail.” * * *
    • “The new rule will go into effect on Aug. 26. In a memo to agency HR directors, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton sought to reassure agencies that the new rule only applies in certain circumstances, providing an FAQ on the issue.”
  • The Washington Post tells us,
    • “A Senate committee Thursday formally opened a bipartisan investigation into Steward Health Care, the nation’s largest physician-led hospital system, and voted to subpoena the company’s CEO, alleging that Steward executives had mismanaged the system’s finances and put patient care at risk.
    • “Steward, a for-profit company that owns 31 hospitals across the country, is in bankruptcy proceedings and has been seeking to sell its hospitals. Community leaders and health workers in states served by Steward’s facilities, such as Massachusetts, have blamed Steward leaders for extravagant paydays even as hospitals struggled to meet mortgage payments and cover other expenses. The Justice Department also has been probing the company over allegations of fraud.”
    • “Senators on the Health, Education, Labor and Pensions Committee echoed those concerns Thursday and said Steward warranted a national spotlight on Capitol Hill, accusing the hospital system’s leaders of “outrageous corporate greed” that harmed access to medical services, such as spending nearly $100 million on a pair of private jets. Lawmakers on the committee have been investigating the system for months.”

From the public health and medical research front,

  • The Washington Post relates,
    • “A twice-yearly injection could help prevent HIV infections, according to the results of a new study described by medical experts as a breakthrough.
    • “In a randomized trial involving more than 5,000 young women and girls in South Africa and Uganda, none of those who received the prevention shots contracted HIV. The results were published in the New England Journal of Medicine on Wednesday.
    • “This appears to be a new breakthrough for HIV prevention. If these injections can be widely distributed at low cost, it would dramatically reduce the risk of new HIV infections worldwide,” said Sarah Palmer, co-director of the Center for Virus Research at the Westmead Institute for Medical Research in Sydney, who was not involved in the peer-reviewed study. “It is especially encouraging this research focused on young women in Africa who are so highly at-risk for HIV infection.” * * *
    • “The shots were produced by drugmaker Gilead Sciences, which funded the trial, and some of the researchers were Gilead employees. Lenacapavir, sold under the brand name Sunlenca, is approved as a treatment for HIV infections in the United States. The goal of the trial was to prove its safety and efficacy for the prevention of infection in adolescent girls and young women. A separate trial for men is underway.”
  • ‘The New York Times reports,
    • “For the more than 310,000 women diagnosed with breast cancer every year, no matter how well the treatment goes, there is always a lingering fear. Could the disease come back, even years later? And what if it comes back in the other breast? Could they protect themselves today by having a double mastectomy?
    • “A study has concluded that there is no survival advantage to having the other breast removed. Women who had a lumpectomy or a mastectomy and kept their other breast did just as well as women who had a double mastectomy, Dr. Steven Narod of Women’s College Hospital in Toronto and his colleagues reported, using U.S. data from more than 661,000 women with breast cancer on one side.
    • “In the study, published in JAMA Oncology on Thursday, the researchers added that most women did very well — the chance of cancer in the other breast was about 7 percent over 20 years.
    • “But the study’s results may not apply to women who have a gene variant, BRCA1 or BRCA2, which greatly increases their cancer risk. For the 1 in 500 American women with this variant, cancer researchers agree that it’s worth considering a double mastectomy.” * * *
    • “Dr. Angela DeMichele, a professor of medicine and co-leader of the breast cancer program at the University of Pennsylvania “says she carefully explains to patients that they have a real choice in treatment — they don’t have to have a double mastectomy.
    • “Many women, she said, assume that the more surgery they have, the more likely they are to be cured. So, they want both breasts removed.
    • “She tells them that removing the second, healthy breast does not prevent cells from their newly diagnosed cancer from spreading to other organs and to bones. “That is why chemotherapy and hormonal therapies are so important,” she tells patients. “They are designed to kill these cells.”
  • Per Beckers Hospital Review,
    • “A newly tested combination therapy showed a higher rate of survival compared to chemotherapy alone, according to a study published July 24 in The New England Journal of Medicine.
    • “Researchers from academic institutions including Mayo Clinic in Rochester, Minn., and the Dana-Farber Cancer Institute in Boston, conducted a clinical trial testing the combination therapy of blinatumomab plus chemotherapy on the survival rates of patients with B-cell precursor acute lymphoblastic leukemia.” * * *
    • “These results are encouraging and establish a new standard of treatment for people with BCP-ALL. The addition of blinatumomab to chemotherapy reduced the risk of leukemia recurrence and death by nearly 60%,” Mark Litzow, MD, lead study author and hematologist at the Mayo Clinic Comprehensive Cancer Center, said in a July 24 news release from the Mayo Clinic.” 
  • and
    • “About 28% of knee and hip replacements are performed on people younger than 55 and the trend is expected to grow, U.S. News & World Report reported July 24.
    • “By 2030, people younger than 65 are expected to account for 52% of hip replacements and 62% for total knee replacements, according to research presented at the American Academy of Orthopedics’ annual meeting in 2023. Researchers utilized data from 5,153 patients in the American Joint Replacement Registry that had a total hip arthroplasty performed between 2012 and 2020.
    • “Many of those younger adults are former athletes.”
  • The American Medical Association lets us know what doctors wish their patients knew about pink eye.
  • The Hill notes,
    • “Teen births declined 69 percent from 2000 to 2022, according to newly released federal data, but racial and ethnic disparities continue to exist.  
    • Births declined at similar rates across all races, but Black, Native American and Hispanic teenagers still had higher birth rates in 2022 than white, non-Hispanic teens, according to the data from the Centers for Disease Control and Prevention. 
  • U.S. News and World Report adds,
    • “For the first time in two decades, the infant mortality rate in the United States has risen, new government data shows.
    • “In a report released Thursday by the U.S. Centers for Disease Control and Prevention, researchers found that more than 20,500 babies died in 2022 before the age of 1. Overall, there were 5.6 infant deaths for every 1,000 live births, a 3% increase from the year before.
    • “Infant health is one of the most important public health indicators that we have,” Amanda Jean Stevenson, a demographer and assistant professor of sociology at the University of Colorado Boulder, told CNN.
    • “The fact that [infant mortality rates] are not continuing to decrease is a very big deal. Even flat infant mortality rates are not good,” she added. “We need to see these numbers going down — and fast — because they are far too high.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Hospitals are finally emerging from the pandemic’s lasting disruption to labor markets, adding nurses and other critical workers who left the market or job hopped for higher pay. 
    • “HCA Healthcare and Tenet Healthcare, two of the nation’s largest hospital and surgery-center companies, reported this week their hospitals are busy and are expected to stay that way through the year. Hiring has opened up services they had closed because of the pandemic and a tight labor market, company executives say.
    • “In totality, the strength in the hospital segment has been significant,” said Dr. Saum Sutaria, Tenet’s chief executive, on a call with analysts after the company posted its earnings this week. “We feel optimism about the demand that we see.”
  • In that regard, Healthcare Dive points out,
    • “Tenet Healthcare reported second-quarter earnings Wednesday that beat analysts’ estimates, drawing in a net income of $259 million on strong demand for outpatient services. 
    • “The Dallas-based provider raised its full-year guidance again following the results. Tenet was the only major for-profit provider to raise its full-year forecast following first-quarter earnings.
    • “Tenet now expects to bring in $3.8 billion to $4 billion in adjusted earnings before interest, taxes, depreciation and amortization — a $300 million increase over previous projections.” 
  • and
    • “Universal Health Services posted a second quarter net income of $289.2 million on Thursday and modestly revised its full-year revenue guidance up by 0.3% to 1%.
    • “However, CFO Steve Filton said on the company’s earnings call that acute care hospitals experienced a “moderation of demand” for services during the quarter, with adjusted admissions increasing 3.4% year over year and surgical growth “flattening out.” 
    • “The King of Prussia, Pennsylvania-based health system reported progress on controlling expenses — notably physician fee costs, which have plagued the system for multiple quarters. Executives called further cost controls critical to UHS’ efforts to get back to pre-pandemic operating margins.”
  • Per Beckers Hospital Review,
    • “St. Louis-based Ascension has taken another step in its effort to reorganize its portfolio — a strategy designed to enhance operating performance and ensure sustainability.
    • “The latest transaction is in the Midwest. Ontario, Calif.-based Prime Healthcare has entered into an asset purchase agreement with Ascension to acquire hospitals and care sites in Illinois.”
  • and
    • “Optum is closing clinics in multiple states and laying off 524 employees across California.
    • “According to regulatory documents filed July 18, the UnitedHealth Group company will terminate the California employees from Sept. 16 through January 2025 at clinic and administrative office locations in Hayward, Glendora, Montbello, Covina, Pasadena, Long Beach, Los Angeles, Irvine, Beaumont, Redlands, Highland, El Segundo, and Cerritos. The layoffs include some remote employees in other states.”
  • Healthcare Dive further notes,
    • “Investors came into second-quarter earnings for Molina concerned about how challenges in its core Medicaid business might affect the insurer. However, Molina exceeded Wall Street’s expectations for earnings and revenue in finances released aftermarket Wednesday.
    • “Molina reported revenue of $9.9 billion, up almost 19% year over year thanks to the insurer winning new Medicaid contracts and growing its existing businesses. Net income of $301 million was down slightly year over year due to an increase in spending on Medicaid beneficiaries, but still better than analyst forecasts.
    • “Medicaid pressures should ameliorate over the back half of the year, Molina executives told investors on a Thursday morning call. Molina is also open to additional M&A, despite coming off two recent acquisitions, and plans to stand up a new business to oversee its growth strategy in dual-eligible Medicare and Medicaid plans.”
  • Per Beckers Payer Issues,
    • “CareFirst Blue Cross Blue Shield credits a critical partnership with achieving top-tier results for Type 2 diabetes care. 
    • “CareFirst partnered with Ryse Health, a chain of clinics in the Washington, D.C. and Baltimore areas, focused exclusively on managing diabetes. CareFirst members who received care at Ryse Health clinics had, on average, scores in the 95th percentile for several HEDIS measures.
  • and
    • “UnitedHealth Group will invest $25 million for housing for veterans experiencing homelessness and low and middle-income individuals. 
    • “The grant will go to the Community Solutions Large Cities Housing Fund, a $135 million fund backed by Kaiser Permanente, Wells Fargo and other large donors. The fund directly acquires apartment units. Half of these units are reserved for individuals transitioning out of homelessness, including veterans, according to a July 24 news release.” 
  • Per BioPharma Dive,
    • “Viking Therapeutics shares soared by more than 30% early Thursday after the company told investors it’s moving an experimental obesity drug into Phase 3 testing earlier than expected and exploring more convenient dosing.
    • “The medicine, dubbed VK2735, has already shown promising results in a Phase 2 trial released in February. In that study, patients lost as much as 15% of their body weight after 13 weeks of treatment with the drug, findings that suggest Viking’s option might be a future threat to blockbuster obesity medications sold by Novo Nordisk and Eli Lilly.
    • “Analysts expected the next step would be a Phase 2b trial. But late Wednesday, Viking said it’s moving directly to Phase 3 after a meeting with Food and Drug Administration officials. The company also plans to study monthly injections for the medicine, potentially offering another advantage over the once-weekly products available now.”
  • and
    • “Roche is best known for the cancer drugs that still account for much of its drug revenue. But the Swiss pharmaceutical giant spent much of its latest quarterly earnings call fielding questions about a pair of experimental weight loss medicines that have fast become important to its future growth.
    • “Roche last year acquired those medicines in a $2.7 billion deal for biotechnology company Carmot Therapeutics. One, CT-388, is an injectable therapy, while the other, CT-996, is a pill. Since May, both have since shown the potential in early trials to spur significant weight loss, adding billions to Roche’s market value and making the company a surprise player in one of the most lucrative areas of drug research.
    • “It’s going to be a huge market,” CEO Thomas Schinecker said on a conference call. “By 2035, about 50% of the world’s population will be obese.”


Midweek update

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • At long last, the federal employee press is publicizing the Part D opt out penalty found in the proposed supplemental Postal Service Health Benefits (PSHB) Program rule.
  • Federal News Network reports, “There’s a catch in USPS insurance program for Medicare-eligible retirees. USPS annuitants who opt out of Medicare Part D will lose underlying prescription drug coverage, according to OPM’s [proposed] regulations.” Those opt out annuitants will continue to pay the full premium.
  • OPM reads the PSHB law as only offering Part D EGWP benefits to Part D eligible annuitants in the PSHBP. There is no underlying Rx coverage according to the agency’s FAQs. That statutory interpretation puts federal employees who live overseas in quite a pickle because Part D coverage is not available outside the United States.
  • In any case, it’s the FEHBlog’s legal opinion that the opt out penalty may not survive judicial review in our post-Chevron era, and because the penalty is roughly 20% of the premium, annuitants may be incented to bring a lawsuit challenging the penalty. Time will tell.
  • Govexec tells us,
    • “The Office of Personnel Management is opening a channel to provide federal employees affected by Hurricane Beryl to obtain emergency paid leave.  FEHBlog note: Beryl hit Houston TX hard.
    • “Acting OPM director Robert Shriver said in a July 19 memo that the agency had established an emergency leave transfer program, by which other federal employees may donate unused annual leave to impacted employees through the creation of agency leave banks. 
    • “Through the agency leave banks, impacted employees “who are adversely affected by a major disaster or emergency, either directly or through adversely affected family members, and who need additional time off from work” can utilize donated leave without having to use their own.” 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023.
    • “The agency said (PDF) insurers participating on the Affordable Care Act’s exchanges will pay $10.3 billion as part of the risk adjustment program. Risk adjustment state transfers as a percent of premiums declined from 2022, according to the report.
    • “This trend is likely driven by shifts in the risk pools, according to CMS, which are likely impacted by ongoing insurer expansion into new regions.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration July 24 announced it is awarding $45.1 million in grants toward various behavioral health initiatives. The funding includes $15.3 million specifically planned to support children through mental health services in schools, services for those who have experienced traumatic events, and services specific to those at risk for or with serious mental health conditions.” 
  • Roll Call reports,
    • “House leaders canceled votes scheduled for next week as the GOP majority struggles to pass its fiscal 2025 appropriations bills.
    • “The decision to scrap next week’s session came a day after Republican leaders had to yank the Energy-Water spending bill from the floor amid growing doubts they could muster enough votes to pass it with their razor-thin majority. * * *
    • “GOP leaders all week had been mulling the possibility of sending members home early rather than remain in session next week as previously scheduled. Speaker Mike Johnson, R-La., said Wednesday that the decision to cancel votes next week wasn’t a direct result of problems with the appropriations bills.
    • “It’s not related to that. We’ve had a tumultuous couple of weeks in American politics and everybody’s, to be honest, still tired from our convention, and it’s just a good time to give everybody time to go home to their districts and campaign a little bit. We’ll come back and regroup and continue to work on this.”
    • “Johnson also said funeral arrangements for Rep. Sheila Jackson Lee, D-Texas, who died last weekend after a battle with pancreatic cancer, would pose logistical challenges next week. Johnson said a lot of members would want to attend the events, to be held in Houston, which could keep members away from Washington for three days.”
  • Per a Senate press release,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and five senators today introduced a bill to apply criminal penalties to rogue insurance brokers who are changing Americans’ Affordable Care Act (ACA) marketplace plans without their knowledge or consent, and take other steps to strengthen consumer health insurance protections. * * *
    • “The one-pager is available here. A summary of the bill is available here. The bill text is available here.”

From the public health and medical research front

  • ABC News relates,
    • “So far, only 25 cases of West Nile virus have been reported in 14 states, according to data from the Centers for Disease Control and Prevention. This is lower than the 117 cases reported at the same time last year. * * *
    • “Mosquitoes typically become infected with the virus after feeding on infected birds and then spread it to humans and other animals, the federal health agency said. Cases typically begin rising in July and are highest in August and September, CDC data shows.
    • “The majority of people with the virus do not have symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting or a rash. Most symptoms disappear but weakness and fatigue may last for weeks or months.
    • “About one in 150 will develop severe disease leading to encephalitis, which is inflammation of the brain, or meningitis, which is inflammation of the membranes that surround the brain and spinal cord — both of which can lead to death. So far this year, 11 of the 25 cases have resulted in neuroinvasive disease, according to the CDC.
    • “There are currently no vaccines or specific treatments available for West Nile virus. The CDC recommends rest, fluids and over-the-counter medications. For those with severe illness, patients often need to be hospitalized and receive support treatments such as intravenous fluids.
    • “To best protect yourself, the CDC suggests using insect repellant, wearing long-sleeved shirts and pants, treating clothing and gear and taking steps to control mosquitoes. This last step includes putting screens on windows and doors, using air conditioning and emptying out containers with still water.”
  • The New York Times adds,
    • “As the bird flu outbreak in dairy cows has ballooned, officials have provided repeated reassurances: The virus typically causes mild illness in cows, they have said, and because it spreads primarily through milk, it can be curbed by taking extra precautions when moving cows and equipment.
    • “A new study, published in Nature on Tuesday, presents a more complex picture.
    • “Some farms have reported a significant spike in cow deaths, according to the paper, which investigated outbreaks on nine farms in four states. The virus, known as H5N1, was also present in more than 20 percent of nasal swabs collected from cows. And it spread widely to other species, infecting cats, raccoons and wild birds, which may have transported the virus to new locations.
    • “There’s probably multiple pathways of spread and dissemination of this virus,” said Diego Diel, a virologist at Cornell University and an author of the study. “I think it will be really difficult to control it at this point.” * * *
    • Although many infected cows did recover on their own, the researchers found, two farms reported a spike in cow deaths. On the Ohio farm, 99 cows died over the course of a three-week outbreak, a mortality rate roughly twice as high as normal.
    • “I think the potential for this virus to cause very serious disease has been downplayed a bit,” said Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, who was not involved in the new study. “That has probably hurt the response.”
    • “Still, Dr. Diel noted, the cause of these deaths remains unknown. “Whether the mortality observed in those cases was due directly to influenza or whether the influenza infection led to a secondary bacterial infection, I think that’s a question that remains to be answered,” he said.”
  • Per BioPharma Dive,
    • “An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year.
    • “The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal blood clotting. Currently, people with hemophilia A use infusions of Factor VIII to prevent bleeding episodes.
    • “In the AFFINE study, researchers followed 75 patients for at least 15 months after they received Pfizer’s therapy. Study participants had fewer bleeding episodes and higher levels of Factor VIII, compared with standard prophylactic treatment before the infusion, Pfizer said Wednesday. Only one treated patient returned to prophylactic infusions.”
  • Healio notes that “In a single-center cohort of patients with heart failure and obesity, weight-loss surgery led to improved clinical outcomes including reduced BMI and HbA1c and less reliance on diuretics, researchers reported.”
  • mHealth Intelligence reports,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Humana’s CenterWell is planning to open 23 clinics at Walmart locations in four states, the company announced Wednesday.
    • “The health clinics will operate in space that previously held Walmart’s own clinics, according to the announcement. CenterWell intends to have the locations across Florida, Georgia, Missouri and Texas fully equipped, staffed and opened by the first half of 2025.
    • “The locations will operate under both the CenterWell and Conviva brands, providing senior-focused primary care. CenterWell is the fastest-growing senior-focused primary care provider in the nation, Humana said.”
  • Per Healthcare Dive,
    • “S&P Global Ratings analysts have downgraded Walgreens Boot Alliance by two notches, to ‘BB’ from ‘BBB-’, which puts the drugstore company into speculative-grade territory.
    • ‘Analysts Diya Iyer and Hanna Zhang cited guidance for the year “notably below” their expectations, and said “material strategic changes, limited cash flow generation, and large maturities in coming years are key risks to the business.”
    • “The company is struggling in its retail business as well as its pharmacy operations, they said in a Friday client note. In the U.S., margins are taking a hit on the pharmacy side from reimbursement pressure and on the retail side from declining sales volume and higher shrink. They expect Walgreens’ S&P Global Ratings-adjusted EBITDA margin to decline more than 100 basis points this fiscal year, dipping below 5%, from 6% last year, though the company’s cost cuts will counter that somewhat.”
  • MedTech Dive points out the top five medtech deals in the first half of 2024.
  • Per HR Dive,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

    Tuesday Tidbits

    David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
    Photo by Patrick Fore on Unsplash

    From Washington, DC

    • Modern Healthcare reports,
      • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
      • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
      • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
    • Govexec lets us know,
      • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
      • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
    • Federal News Network tells us,
      • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
      • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
      • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
    • Fierce Healthcare informs us,
      • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
      • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
      • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
    • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
    • The Food and Drug Administration announced,
      • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
      • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
      • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

    From the public health and medical research front,

    • The American Hospital Association News relates,
      • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
    • Per BioPharma Dive,
      • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
      • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
      • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
    • Per National Institutes of Health press releases,
      • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
    • and
      • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
      • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
    • and
      • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
      • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
    • Per MedPage Today,
      • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
      • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
      • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
      • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
      • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
    • Modern Health points out,
      • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
      • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
      • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
      • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
    • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
      • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
      • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
      • Read more here. 
    • Behavioral Health Business discusses virtual applied behavioral therapy.
      • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
      • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
      • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”

    Weekend update

    David Ermer–CDC, Congress, Medicare, U.S. Healthcare–

    From Washington, DC,

    • The House Oversight and Accountability Committee will hold its third hearing on prescription benefit managers this Tuesday July 23 at 10 am.
    • Over the past two weeks —
      • Tammy Flanagan, writing in Govexec, offered tips on creating a smooth transition from federal employee to federal annuitant.
      • Kevin Moss, writing in the Federal Times, discusses the pros and cons of paying for both FEHB and Medicare Part B coverage. He summarizes as follows:
        • “The main reason to not consider enrolling in Part B is the cost of the extra premium. For federal annuitants that are not subject to IRMAA, adding Part B will most likely be worth it. Having Part B gives you the option to see doctors outside of the plan network and if you enroll in an FEHB plan that waives some out-of-pocket costs or consider MA plans offered by FEHB plans, you could see a reduction in your total healthcare spending.
        • “For federal annuitants that are subject to IRMAA, most of the benefits of enrolling in Part B will erode by having to pay more. This is especially true if your income places you in the second tier or higher of IRMAA and you expect that level of income throughout your retirement.”
      • The FEHBlog points out that the IRMAA tax is temporary because incomes usually subside in retirement below the IRMAA relatively high thresholds while the Medicare Part B late enrollment penalty is forever.

    From the public health and medical research front,

    • Fortune Well lets us know,
      • “As U.S. health officials investigate a fatal outbreak of listeria food poisoning, they’re advising people who are pregnant, elderly or have compromised immune systems to avoid eating sliced deli meat unless it’s recooked at home to be steaming hot.”
      • “The U.S. Centers for Disease Control and Prevention didn’t mandate a food recall as of early Saturday, because it remains unclear what specific products have been contaminated with the bacteria now blamed for two deaths and 28 hospitalizations across 12 states. This means the contaminated food may still be in circulation, and consumers should consider their personal risk level when consuming deli meats.
      • “Federal health officials warned on Friday that the number of illnesses is likely an undercount, because people who recover at home aren’t likely to be tested. For the same reason, the outbreak may have spread wider than the states where listeria infections have been reported, mostly in the Midwest and along the U.S. eastern coast.
      • “The largest number known to get sick — seven — were in New York, according to the CDC. The people who died were from Illinois and New Jersey.
      • “Of the people investigators have been able to interview, “89% reported eating meats sliced at a deli, most commonly deli-sliced turkey, liverwurst, and ham. Meats were sliced at a variety of supermarket and grocery store delis,” the CDC said.”
    • The Wall Street Journal reports,
      • “How much drinking is bad for you?
      • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
      • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
      • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
    • MedPage Today reports,
      • “U.S. health officials on Friday said a new study in Michigan suggested the bird flu virus is not causing asymptomatic infections in people, while also announcing two new human cases in Colorado.
      • “Last month, the Michigan Department of Health and Human Services launched a study of workers who were around cows sickened by the bird flu. The researchers drew blood from 35 people.
      • “One goal was to determine if there were people who never had any symptoms but did have evidence of past infections. None of the blood testing showed antibodies that would indicate infections with the highly pathogenic avian influenza (HPAI) A(H5N1) virus circulating among dairy cattle and poultry, the CDC reported on Friday.
      • “The lack of antibodies to avian influenza A(H5N1) virus suggests these people were not previously infected with an avian influenza A(H5N1) influenza virus,” the agency said. “These data are consistent with other dataopens in a new tab or window demonstrating the seroprevalence to HPAI A(H5N1), even among workers with known exposures, is low.”
      • “Many of the workers did show antibodies to seasonal flu, which was used as a control virus in the study. Researchers will continue to sample workers, and the data will be analyzed and prepared for a peer-reviewed publication, the CDC said.
    • Per Medscape,
      • “One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.
      • “When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found. * * *
      • “Dr Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs 13.1%).”

    Thursday Miscellany

    David Ermer–CDC, Congress, Federal employment benefits, Medical / Rx research, Mental health care, Obesity, OPM, Telehealth, U.S. Healthcare–
    Photo by Josh Mills on Unsplash

    From Washington, DC,

    • Modern Healthcare reports,
      • “A powerful Senate committee plans to commence a bipartisan investigation into the Steward Health Care meltdown next week.
      • “The Senate, Health, Education, Labor and Pensions Committee will convene next Thursday for a vote to officially kick off a probe into the insolvent Dallas-based health system. Steward Health Care Chair and CEO Dr. Ralph de la Torre will be subpoenaed to testify at a hearing Sept. 12, HELP Committee Chair Bernie Sanders (I-Vt.) and ranking member Dr. Bill Cassidy (R-La.) said in a news release Thursday.
      • “Given the serious harm and uncertainty Steward’s bankruptcy and financial arrangements are having on hospitals, patients and healthcare workers throughout the country, Dr. de la Torre has given us no choice but to compel him to testify at this hearing,” Sanders and Cassidy said.
      • “De la Torre declined to attend a HELP Committee hearing last month and a subcommittee session in April.
      • “We have a number of questions to ask Dr. de la Torre about the bankruptcy of Steward Health Care and the financial arrangements leading up to its insolvency. It is time for Dr. de la Torre to answer them before Congress and the American people,” Sanders and Cassidy said.
    • Federal News Network informs us,
      • “The Office of Personnel Management will soon be reopening enrollments into the government’s Flexible Spending Account program, FSAFEDS.
      • “OPM previously suspended all new enrollments in the program after a recent surge in fraudulent activity that impacted hundreds of federal employees with Flexible Spending Accounts. OPM’s inspector general said the suspension came “out of an abundance of caution,” and to try to prevent further fraud in the program.
      • “Enrollments in FSAFEDS, including any enrollments based on Qualifying Life Events (QLEs), will reopen Aug. 1, OPM wrote in an email to agency benefit officers Thursday afternoon, shared with Federal News Network. Also beginning Aug. 1, the program will transition to a “.gov” website domain, FSAFEDS.gov, rather than the current domain, FSAFEDS.com.
      • “Enrollees who missed a QLE deadline due to the pause on enrollments should still be able to make modifications once the enrollment pause is lifted, OPM said. Employees who are in that situation will have to call FSAFEDS at 877-372-3337 to request a change to the effective date for the QLE.
      • “Additionally, federal employees will be able to get reimbursed for any claims that were incurred after the effective date for the QLE, OPM said.
      • “OPM is also taking more long-term steps to address security concerns in FSAFEDS, including transitioning to Login.gov, the government’s platform for accessing government benefits and services online.”
    • Per Govexec,
      • “The Office of Personnel Management wants federal agencies to let it know how many senior executives, scientific/professionals and other senior-level personnel they estimate they will need for the next two years.
      • “OPM outlined its biennial review of agency executive allocations in a July 10 memorandum, calling on agency and department heads to examine their potential Senior Executive Service needs through fiscal 2026 and 2027 and how they may have changed. 
      • “The biennial review, which is required by statute, will give agencies until Nov. 22 to fully outline their anticipated SES needs, but they must also detail the projections of their position needs in their Senior Level and Scientific/Professional pay systems by Aug. 23. 

    From the public health and medical research front,

    • Beckers Hospital Review tells us,
      • “The highest numbers of breast and cervical cancer deaths are found mostly in southeastern states, according to new data from the “2024 State Scorecard on Women’s Health and Reproductive Care” released July 18 by The Commonwealth Fund.
      • “The analysis is based on 2021-22 data from publicly available sources. Learn more about the methodology here.
      • “Alabama, Arkansas, Delaware, the District of Columbia, Indiana, Kentucky, Louisiana, Mississippi, Missouri, Nevada, Oklahoma, Tennessee and West Virginia had 23.2 to 27.8 breast and cervical cancer deaths per 100,000 female population, the highest numbers in the country.”
    • The NIH Director, in her weekly blog, lets us know,
      • “Alzheimer’s disease is currently the seventh leading cause of death in the U.S. While your likelihood of developing Alzheimer’s-related cognitive impairment increases with age, risk for this disease and age of its onset depend on many factors, including the genes you carry. An intriguing new study suggests that having just one copy of a protective gene variant may be enough to delay cognitive impairment from this devastating disease in individuals who are otherwise genetically predisposed to developing early-onset Alzheimer’s dementia.
      • “The findings, from a study supported in part by NIH and reported in The New England Journal of Medicine, offer important insights into the genetic factors and underlying pathways involved in Alzheimer’s dementia. While much more study is needed, the findings have potential implications for treatments that could one day work like this gene variant does to delay or perhaps even prevent Alzheimer’s dementia.”
    • The Washington Post reports,
      • “If you want to increase your odds of living a long and healthy life, watch less television and become more physically active, because even a small amount of physical activity can improve overall health, according to an observational study published last month in JAMA Network Open.
      • “While there have been many studies showing that moderate to vigorous physical activity is associated with healthy aging, researchers wanted to know if light physical activity compared with sedentary behaviors also improves healthy aging, and if not, how can people’s time be reallocated.
      • “They found that replacing a sedentary behavior such as watching TV with even low-intensity activity — such as standing or walking around while cooking or washing clothes — increased one’s odds of healthy aging. And at work, replacing some of the time spent sitting with simple movements such as standing or walking around the office can improve health.
      • “These findings indicate that physical activity need not be high intensity to potentially benefit various aspects of health, which have especially important public health implications as older people tend to have limited physical ability to engage in moderate-to-vigorous physical activity,” Molin Wang, an associate professor in epidemiology at the Harvard T.H. Chan School of Public Health and an author of the study, wrote in an email.”
    • Per Medscape,
      • “An analysis based on a massive database of US electronic health records (EHRs) adds to evidence favoring the safety of glucagon-like peptide 1 (GLP-1) medications, finding no increased risk for many neurologic and psychiatric ailments when semaglutide was compared with other diabetes drugs.
      • “Riccardo De Giorgi, MD, DPhil, of the University of Oxford, Oxford, England, and colleagues published their research in eClinicalMedicine.”
    • Bloomberg informs us,
      • “Opioids. They’re a public-health pariah, leading to more than 80,000 overdose deaths a year. Patients worry they’ll get addicted to them. Doctors want nothing to do with them. And politicians of all stripes are calling for less dangerous options for treating pain.
      • “We are looking for absolutely anything that’s not an opioid,” says Seth Waldman, an anesthesiologist and director of pain management at Hospital for Special Surgery, a top orthopedic medicine center.
      • “Against that backdrop, the success of a safer painkiller would seem assured. A new drug, which Vertex Pharmaceuticals Inc. is developing, has been hailed as a scientific breakthrough because it treats pain without entering the brain, where opioids create addicts. The drug, suzetrigine, met its goal this year in pivotal trials for acute pain and is poised to become the first new class of pain medication in more than two decades.
      • “But all that may not be enough to loosen the grip opioids have on American medicine. Despite their dismal reputation, they have two powerful things going for them: They’re cheap, and they work. The number of opioid prescriptions has been cut by half over the past decade, but some 130 million are still doled out each year.” * * *
      • “Vertex is betting the nonaddictive properties of its drug will make it an attractive alternative to opioids. But it isn’t leaving anything to chance. Knowing it faces an uphill battle commercially, the company last year boosted its lobbying spending almost 50%, to more than $3 million. Vertex is pressing Congress for new policies that remove “structural impediments” blocking access to opioid alternatives, says Stuart Arbuckle, its chief operating officer.
      • “Vertex has scored at least one legislative victory: The No Pain Act, which goes into effect next year, provides an extra Medicare reimbursement to hospitals that prescribe alternatives to opioids. Another bill introduced this year in Congress would prohibit step therapy and limit how much Medicare patients pay out of pocket for non-opioids.
      • “Other types of new drugs face this cost hurdle, too. The rollout of new contraceptives or antibiotics has been hampered by insurers guiding doctors and patients to older, less pricey meds. The difference is that those generics haven’t been declared a public-health emergency.”
    • Mercer Consulting points out “four things employers need to know about summer heat.”
    • The New York Times reports,
      • “A daily dose of a widely used antibiotic [doxycycline] can prevent some infections with syphilis, gonorrhea and chlamydia, potentially a new solution to the escalating crisis of sexually transmitted infections, scientists reported on Thursday.
      • “Their study was small and must be confirmed by more research. Scientists still have to resolve significant questions, including whether S.T.I.s might become resistant to the antibiotic and what effect it could have on healthy gut bacteria in people taking it every day.
      • “The approach would be recommended primarily to people at elevated risk of sexually transmitted infections during certain periods, said Dr. Jeffrey Klausner, an infectious diseases physician at the University of Southern California who was not involved in the new work.
      • “The number of people who are really going to be offered this and take this is still very small,” he said. “In general, the more choices we have for people, the more prevention options we have, the better.”

    From the U.S. healthcare business front,

    • Per Fierce Pharma,
      • “GoodRx is joining forces with drugmaker Boehringer Ingelheim to make its Humira biosimilar adalimumab available at an affordable price.
      • “The pharmaceutical company will offer citrate-free adalimumab-admb at a cash price available only on GoodRx, according to an announcement. This will allow anyone with a prescription to obtain the drug at one of 70,000 pharmacies nationwide, even if they’re uninsured.
      • “Beginning on July 18, Boehringer and GoodRx will offer high-concentration and low-concentration formulas of the drug in auto-injectors or pre-filled syringes at a price of $550 per two pack. The companies said that this is a 92% discount compared to a Humira prescription.”
    • Per Beckers Hospital Review,
      • “The FDA is allowing Mark Cuban Cost Plus Drug Co. to temporarily import a syphilis drug that has been in shortage for more than a year. 
      • “Penicillin G benzathine injection fell into low supply in April 2023, and since then, clinicians have been rationing the product. In January, the FDA issued a temporary authorization for French drugmaker Laboratoires Delbert to import penicillin G benzathine. 
      • “On July 17, the FDA updated its post on the drug’s shortage. To address the scarcity, the agency cleared Cost Plus Drugs to import the medication from Laboratórios Atral.
      • “The Portugal-based drug company will export two presentations of Lentocilin (benzathine benzylpenicillin tetrahydrate), according to FDA documents.
      • “Cost Plus Drugs is selling this medication to healthcare businesses for less than $15, the company said in July 17 post on X.” 
    • Segal Consulting relates,
      • “The average stop-loss coverage premium increase is 9.4 percent for the nearly 240 health plans in Segal’s 2024 national medical stop-loss dataset.”
      • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 11.5 percent.”
    • Per Fierce Healthcare,
      • “Telehealth giant Teladoc is partnering with startup Brightline to extend virtual mental healthcare services for children, adolescents and their families.
      • “Through the partnership, members under the age of 18 will have access to Brightline’s behavioral health solutions through Teladoc’s virtual “front door,” the companies said.
      • “The collaboration with Brightline builds on Teladoc’s existing mental health offerings and expands access to care to members of all ages, a Teladoc spokesperson said.”
    • Beckers Hospital Review identifies seven U.S. hospitals that have received brain tumor care certification by the Joint Commission.
      • Chippenham and Johnston-Willis Hospital, Richmond, VA
      • Hackensack (N.J.) University Medical Center Hackensack
      • Jewish Hospital, Cincinnati, OH
      • Pitt County Memorial Hospital, Greenville, N.C.
      • Santa Barbara (Calif.) Cottage Hospital
      • St. Vincent Hospital and Health Care Services, Indianapolis, IN
      • Texas Health Harris Methodist Hospital – Fort Worth, TX
    • Healthcare Dive lets us know,
      • “Humana has made a minority investment in Healthpilot, a company that aims to help beneficiaries choose Medicare plans, the insurer said Wednesday. Financial terms of the deal weren’t disclosed.
      • “Healthpilot uses an artificial intelligence model to recommend Medicare Advantage, Medicare supplement and prescription drug plans based on enrollee information.
      • “Healthpilot will continue to recommend plans options from other payers following the investment, Humana said in the release. 

    Tuesday’s Tidbits

    David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare, Uncategorized–
    Photo by Patrick Fore on Unsplash

    From Washington, DC,

    • Fierce Healthcare tells us
      • “A bipartisan quartet of House representatives have introduced a bill peeling back restrictions on new or expanded physician-owned hospitals.
      • “The Physician Led and Rural Access to Quality Care Act, brought late last week, would create an exception to an Affordable Care Act’s ban that aimed to reduce conflicts of interest in care. Specifically, it would permit new physician-owned hospitals to open in rural areas that are at least 35 miles from another existing hospital or critical access hospital (or 15 miles in difficult-to-traverse areas).
      • “The new bill would also sunset a prohibition on expanding any existing physician-owned hospitals.”
      • FEHBlog note: The bill pits the American Medical Association (pro) against the American Medical Association (con).
    • Per a Department of Health and Human Services press release,
      • “Today, CMS is releasing the final part two guidance – PDF regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage, especially those most likely to benefit, are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. Notably, this payment option launches at the same time that all individuals with Medicare prescription drug coverage will begin to have their annual out-of-pocket prescription drug costs capped at $2,000, providing needed financial relief for high prescription drug costs.” * * *
      • “Today’s Medicare Prescription Payment Plan final part two guidance, which complements the final part one guidance – PDF released on February 29, is also accompanied by the release of the final Medicare Prescription Payment Plan model materials. Medicare Part D plans can use the model materials when communicating to Part D enrollees about the Medicare Prescription Payment Plan.” * * *
      • “For the fact sheet on the final part two guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-two-guidance.pdf – PDF
      • “For the updated Information Collection Request (ICR) for the Medicare Prescription Payment Plan model plan materials, please visit: https://www.cms.gov/files/zip/medicare-prescription-payment-plan-model-materials.zip
      • “For an updated implementation timeline for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/medicare-prescription-payment-plan-timeline.pdf – PDF“
    • Another HHS press release brings us up to date on improvements to the 988 mental health lifeline which was launched two years ago today.
    • Healio adds,
      • “Since the launch of the 988 Suicide & Crisis Lifeline in 2022, counselors have answered more than 10 million calls, texts and chats from people seeking help for suicidal thoughts and mental health crises, according to HHS officials.
      • “During a press conference, HHS Deputy Secretary Andrea Palm said the lifeline “has become one of the most effective first-line responses that we have to help individuals who feel alone and without options.” * * *
      • “HHS has invested nearly $1.5 billion into the lifeline, according to an agency press release. It has lines that are tailored to people who speak Spanish, veterans, American Sign Language (ASL) users and the LGBTQI+ community. Since these lines were added to the 988 lifeline in 2023, there have been about 20,000 chats and texts with Spanish speakers, more than 475,000 texts, calls and chats with LGBTQI+ individuals and approximately 20,000 videophone contacts with ASL users.
      • “Among all contacts over the past 2 years, about 1.7 million were texts, according to the release. In the past year, HHS reported a 51% increase in texts and a 34% increase in calls, with support provided by more than 200 contact centers nationwide.”
    • CMS shares the following statement from CMS Administrator Chiquita Brooks-LaSure:
      • “Remembering Gail R. Wilensky, Ph.D., a health care policy savant who knew how to work across the aisle. Her Influence and leadership can still be felt today. She was very generous to the CMS leaders who served after her, including me. My deepest condolences to her loved ones. CMS is grateful for her service to our country.”
      • FEHBlog note — Dr. Wilensky, who passed away on July 11 at age 81, served as CMS (then HCFA) Administrator for President George H. W. Bush.
    • Per the AHA News,
      • “The AHA July 16 urged the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements.” 

    From the public health and medical research front,

    • Per a press release, the Institute for Clinical and Economic Review published its Final Evidence Report on Treatment for Chronic Obstructive Pulmonary Disease 
      • “Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ensifentrine added to maintenance therapy compared to maintenance therapy alone; ICER calculated a health-benefit price benchmark (HBPB) for ensifentrine between $7,500 to $12,700 per year, and the therapy is priced at $35,400 per year.
    • The National Institutes of Health announced,
      • “In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision. Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that, for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.
      • “We’ve known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD,” said Tiarnan Keenan, M.D., Ph.D., of NIH’s National Eye Institute (NEI) and lead author of the study. “These findings support the continued use of AREDS2 supplements by people with late dry AMD.”
    • Beckers Hospital Review shares ophthalmologist organization opinions on eye conditions and Ozempic use.
      • A week after a study connected Ozempic and Wegovy to an eye condition that can cause partial blindness, two ophthalmology organizations said they have “been aware of other vision changes for some time.”
      • Changing sugar levels can affect the shape of the eye’s lens, according to the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society. Because of this, semaglutide, the active ingredient of Type 2 diabetes drug Ozempic and weight loss medication Wegovy, might lead to blurry vision. 
      • The ophthalmology groups said previous studies have also found that semaglutide can exacerbate diabetic retinopathy and macular complications. 
      • “The medical community has been aware of other vision changes with semaglutide for some time,” the organizations said in a July 8 joint statement. However, the research associating the drug to non-arteritic anterior ischemic optic neuropathy [NAION] is the first of its kind. 
      • “The condition restricts blood flow to the optic nerve, which causes sudden, painless loss of vision in one eye, the statement said. The research did not confirm a causal relationship between the medications and NAION, but it identified a potential link.: * * *
      • “The subjects in this study were either overweight or obese or had Type 2 diabetes. People who have diabetes are already at risk of NAION,” the organizations said. “Other risk factors for NAION include heart disease, history of heart attack, high blood pressure and sleep apnea” — health risks that also are tied to diabetes and obesity. 
      • “In response to the study, Novo Nordisk, the manufacturer of Ozempic and Wegovy, said it takes adverse event reports seriously. 
      • “The ophthalmology groups said they recommend patients continue taking the medications unless they experience a sudden vision loss.”  
    • The AHA News points out,
      • “Antimicrobial-resistant infections remained above pre-pandemic levels in 2022, the Centers for Disease Control and Prevention reported July 16. CDC data show that infections, which increased 20% during the pandemic compared to the pre-pandemic period — peaked in 2021.
      • “The increases in antimicrobial resistance (AR) burden seen in 2020 and 2021 are likely due in part to the impact of COVID-19, which pushed healthcare facilities, health departments and communities near their breaking points,” the agency notes. “This resulted in longer hospital stays for hospitalized patients (including those diagnosed with COVID-19), challenged the implementation of infection prevention and control practices and increased inappropriate antibiotic use.” 
      • “The AHA provides resources which promote the appropriate use of medical resources.”
    • Medscape summarized the June meeting decisions of the CDC’s Advisory Committee on Immunization Practices and identifies the five immunizations that adults need beyond Covid and the flu vaccines.
    • Medscape also discusses the use of remote trials to accelerate the testing of new long Covid treatments.

    From the U.S. healthcare business front,

    • Beckers Payer Issues and Fierce Healthcare report on UnitedHealthcare’s second quarter financial results announced today.
      • BPI – “UnitedHealth Group posted $4.2 billion in net income during the second quarter of 2024, a 23% decline year over year.
      • “The company said it has restored the majority of affected Change Healthcare services and has provided more than $9 billion in advance funding and loans to providers. The total full year impact of the breach is estimated at $1.90 to $2.05 per share, with the company raising the estimated total cost of the attack to around $2.45 billion.”
      • FH – “UnitedHealth saw an elevated medical loss ratio in Q2, and executives pointed to the Change Healthcare cyberattack as a key factor.
      • “UnitedHealthcare had an MLR of 85.1% in the second quarter, compared to 83.2% in the prior year quarter. The insurer called out multiple elements that contributed to the elevated ratio in its earnings call on Tuesday morning. For one, UHC CEO Brian Thompson said there’s a clear difference in coding intensity after the insurer ended care waivers offered following the cyberattack.
      • “Amid the cyberattack, UnitedHealth eased prior authorization and utilization management to support cash flow to providers.”
    • Beckers Hospital Review provides details on U.S. News and World Report’s latest U.S. hospital rankings by State and by specialty.
    • pwc reports,
      • “Commercial health care spending growth is estimated to grow to its highest level in 13 years, according to PwC’s newest research into annual medical cost trend. PwC’s Health Research Institute (HRI) is projecting an 8% year-on-year medical cost trend in 2025 for the Group market and 7.5% for the Individual market. This near-record trend is driven by inflationary pressure, prescription drug spending and behavioral health utilization.
      • “HRI is also restating the 2023 and 2024 medical cost trends as higher than previously reported based on the input of health plans we surveyed and their trend experience. This unfavorable trend reflects higher than expected utilization of glucagon-like peptide-1 (GLP-1) drugs as well as higher acuity (higher levels of care) inpatient and outpatient utilization. Inpatient and outpatient utilization were driven by demand from care deferred since the pandemic, which was met by newly created capacity as sites of care shifted to outpatient, professional and ambulatory care settings.
      • “The same inflationary pressure the healthcare industry has felt since 2022 is expected to persist into 2025, as providers look for margin growth and work to recoup rising operating expenses through health plan contracts. The costs of GLP-1 drugs are on a rising trajectory that impacts overall medical costs. Innovation in prescription drugs for chronic conditions and increasing use of behavioral health services are reaching a tipping point that will likely drive further cost inflation.
      • “Meanwhile, cost deflators are not enough to offset cost inflators. The growing adoption of biosimilar medications may provide some relief, while many health plans are looking inward to find opportunities across business operations to generate additional cost savings. Today’s medical cost trend is an urgent call to action for healthcare organizations to rethink their strategies to manage the total cost of care more effectively – a challenge that is inextricably linked to the broader challenge of affordability, defined by the Affordable Care Act as the percentage of a member’s household income used for healthcare expenses.”
    • FEHBlog note — OUCH!
    • MedCity News discusses the improving state of the digital health fundraising market.

    Monday Roundup

    David Ermer–CDC, Congress, COVID treatment, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Washington, DC,

    • Reuters reports,
      • “Democratic U.S. Senate aides will meet with Novo Nordisk executives on Tuesday to discuss fallout from its decision to stop selling one of its long-acting insulins in the country, two sources familiar with the meeting told Reuters.
      • “Novo Nordisk (NOVOb.CO), opens new tab will meet with the aides for Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren. In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.
      • “Novo said it has given patients enough time to switch to other options, according to a May letter seen by Reuters. The company is unaware of plans for drug manufacturers to produce a biosimilar version of the insulin, the letter said, adding Novo would not assert any patent against such a version.
      • “The sources declined to be named citing the sensitivity of the matter.”
    • STAT News lets us know,
      • “For now, the doctor groups are lobbying [Congress] in unison toward the same goal of increasing the pot of money for physician services, which stood at about $71 billion in 2022, or 16% of Medicare fee-for-service spending. A Medicare spokesperson said that number is expected to reach about $90 billion this year. Doctors would also like to get credit for saving money by keeping patients out of the hospital.
      • “Those demands would pit doctors against others in the health care system, including hospitals, because Congress typically requires that increases in Medicare spending be paid for by cuts elsewhere in the program. That’s a heavy lift. Congress has been considering equalizing certain Medicare payments between hospitals and physicians’ offices to save money, but that site-neutral policy has faltered.
      • “That’s not the only thing working against doctors. If Congress increases spending on physician services, seniors’ Medicare Part B premiums will go up, according to the nonpartisan research arm of Congress. Congress could prevent premiums from increasing, but that would add to the government tab.
      • “For those reasons, doctor lobbyists privately doubt Congress will meaningfully increase physician pay rates overall, leaving doctors to fight over how a fixed sum of money should be split up.
      • “Courtney Savage, founder of Savage Health Policy, said she sees signs of trouble ahead for specialists. Republicans and Democrats in the Senate want to boost primary care pay. Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) unveiled a plan to “improve the adequacy of pay for primary care providers in Medicare.” Two days later, Senate Finance Committee Chair Ron Wyden (D-Ore.) and the committee’s ranking Republican, Idaho’s Sen. Mike Crapo, published their plan to improve chronic care, which would likely favor primary care doctors, too.”
    • In this regard, the American Hospital News tells us,
      • The AHA July 15 commented to Sens. Sheldon Whitehouse, D-R.I., and Bill Cassidy, R-La., responding to a request for information based on the Pay PCPs Act, legislation designed to improve support and pay for primary care providers. The AHA expressed concerns that its proposed hybrid per-member-per-month and fee-for-service payment structure in the physician fee schedule for primary care could result in payment cuts, and that there may be variation in the PMPM depending on the type of provider. The bill also has language implying that there is latitude for the PMPM to not be risk-adjusted and possibly restrict what could be included in the risk adjustment, AHA said. 
      • The AHA voiced support for a provision in the legislation that would reduce beneficiary cost-sharing for primary care services by 50% under the hybrid payment model. The association also shared principles for Congress to consider when designing alternative payment models to make participation more attractive for potential participants.
    • Per Axios,
      • “The Centers for Medicare and Medicaid Services last week proposed creating three new payment codes that would allow physicians to get paid for incorporating digital therapies into patients’ mental health treatment, starting in 2025. 
      • “The codes would only apply to products approved by the Food and Drug Administration.
      • “Insurers have so far been reluctant to pay for apps, video games and other therapeutic software. There isn’t long-term data on the effectiveness, and differences in the therapies make it difficult to standardize billing.
      • “The first company to get FDA clearance for a digital therapy, Pear Therapeutics, declared bankruptcy last year after struggling to secure insurance coverage for its products.”

    From the public health and medical research front,

    • The AHA News points out,
      • “The Centers for Disease Control and Prevention July 14 announced four confirmed human cases of H5N1 bird flu among farm workers who were working at a Colorado poultry facility. The agency is also aware of a fifth presumptive-positive case, which is pending confirmation. All of the workers who tested positive reported having a mild illness, with symptoms that include conjunctivitis, eye tearing, fever, chills, coughing, sore throat and a runny nose. The CDC said they believe a risk to the public remains low.” 
    • STAT News adds,
      • The announcement of the fourth [H5N1 bird flu] case, on the eve of the July 4 holiday, led Adam Kucharski, the co-director of the Centre for Epidemic Preparedness & Response, at the London School of Hygiene and Tropical Medicine, to ask on the social platform X: “What’s the plan?”
      • Kucharski posed a bunch of hypotheticals — What if there are clusters of cases? Cases among people who haven’t had contact with cows? Cases exported to other countries? — to convey the point that a mere four years after the start of the worst pandemic since the 1918 Spanish Flu, the world does not appear to be grappling with the fact that H5 virus spreading in cows could lead to H5 virus spreading in people.
      • “What, here in 2024, is the plan for dealing with an outbreak of a potentially pandemic pathogen like H5N1?” he asked.”
    • Medscape notes,
      • “Parkinson’s disease (PD) and dementia with Lewy bodies are currently defined by clinical features, which can be heterogeneous and do not capture the presymptomatic phase of neurodegeneration.
      • “Recent advances have enabled the detection of misfolded and aggregated alpha-synuclein protein (synucleinopathy) — a key pathologic feature of these diseases — allowing for earlier and more accurate diagnosis. This has led two international research groups to propose a major shift from a clinical to a biological definition of the disease.
      • “Both groups emphasized the detection of alpha-synuclein through recently developed seed amplification assays as a key diagnostic and staging tool, although they differ in their approaches and criteria.” * * *
      • “Commenting for Medscape Medical News, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, said the principle behind the proposed classifications is where “the field needs to go.”
      • “Right now, people with Parkinson’s take too long to get a confirmed diagnosis of their disease, and despite best efforts, clinicians can get it wrong, not diagnosing people or maybe misdiagnosing people,” Beck said. “Moving to a biological basis, where we have better certainty, is going to be really important.”
    • The New York Times reports, “Families pay thousands of dollars to store their children’s stem cells with the hope of a healthier future. But the cells are rarely useful, and sometimes contaminated.” No bueno.
    • A STAT News journalist observes,
      • If you read Derek Lowe — and come on, you must read the bearded chemist who has been blogging about pharma for two decades — you’ve already thought about ibuzatrelvir, Pfizer’s potential heir to Paxlovid, which would be given as a single pill and potentially without that metallic taste.
      • “I read this eagerly, but I had another question that I asked virologist Michael Mina when he posted Derek’s article on X. How do we test it?
      • “Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.“Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.
      • “It’s very hard to prove an antiviral drug works, a problem that has long dogged Tamiflu. The benefit only shows up if people are at very high risk, or if the study is very big. Otherwise, it just appears the drug is reducing symptoms a very tiny bit.
      • “On this, David Boulware of the University of Minnesota had one perspective: Shionogi’s drug failed because regulators wanted its study to contain too few high-risk patients. But my suspicion is that getting better Covid drugs will be less a problem of chemistry than of clinical trials. This is part of why we don’t have more monoclonal antibodies against new strains. Paxlovid sales have come in higher than many analysts were expecting so far this year. Maybe that will encourage drug.” companies to solve this problem.
    • The Washington Post and Consumer Reports explain “what to do when you need medical care fast,”
      e.g., self-triage.
    • Per MedPage Today,
      • “A mammography screening decision aid with information about the benefits and harms of screening increased the percentage of average-risk women in their 40s who wanted to delay mammography, according to a national online survey.
      • “Before viewing the decision aid, 27% of women ages 39 to 49 preferred to delay screening. The decision aid raised that percentage to 38.5%, reported Laura Scherer, PhD, of the University of Colorado in Aurora, and colleagues.
      • “The survey also showed a narrower majority of women preferred to undergo mammography at their current age after viewing the decision aid (57.2% vs 67.6% beforehand) and more preferred to wait until age 50 (18% vs 8.5%).
      • “As to what information shifted their view, 37.4% of women surveyed said they found the information about overdiagnosis in the decision aid “surprising,” and 28.1% said it differed from what their doctor had told them, Scherer and colleagues reported in the Annals of Internal Medicine.
      • “While the U.S. Preventive Services Task Force (USPSTF) recommends biennial screenings starting at age 40 years — compared with a previous recommendation that screening begin at 50 — it “endorses informed choice and shared decision making at all levels of its recommendations,” Scherer’s group wrote.
      • “However, “a lack of language promoting informed choice in the guideline itself may create confusion among clinicians about whether they should discuss both screening benefits and harms with patients or instead provide only information that maximizes screening uptake,” they added.”

    From the U.S. healthcare business front,

    • AIS Daily reports,
      • “Blue Shield of California caught the attention of the industry last August when it announced a switch to a pharmacy benefits model using five vendors. While some insurers and plan sponsors have considered a similar move following Blue Shield’s revelation, benefits consultants tell AIS Health that most payers continue to have a traditional arrangement where one PBM handles all pharmacy-related activities. They add that Blue Shield’s so-called unbundled approach could be difficult to manage and may not achieve significant cost savings.”
    • Per Fierce Pharma,
      • “While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.
      • “In the July 11 report, the analysts calculate that products losing exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with Amgen, Bristol Myers Squibb and Merck facing the most exposure of their revenue.
      • “Meanwhile—citing company financial reports and data from Visible Alpha and FactSet—Morgan Stanley estimates that Big Pharma has $383.1 billion of firepower available for dealmaking. The companies sitting on the most dry powder are Johnson & Johnson, Merck and Novo Nordisk, the analysts said.
      • “We continue to see the conditions as generally favorable for bolt-on M&A as large-cap pharma companies have balance sheet capacity and a need to acquire outer-year revenue,” the Morgan Stanley team, led by Terence Flynn, Ph.D., wrote.”
    • BioPharma Dive offers a chart with “Years of expiration for principal patents protecting the top 30 pharmaceutical products by 2023 sales.”
    • Beckers Hospital Review discloses the gender breakdown of physicians across the fifty states and DC.
    • Per MedCity News, “Walgreens’ Finances Are in Dire Straits — But All Hope Is Not Lost. Walgreens’ financial performance is still rocky, but experts agree there is a good chance that CEO Tim Wentworth can lead the company to recovery. To make this happen, Walgreens will have to let go of its retail clinic dreams and focus more on making its core pharmacy business as strong as possible.”

    Weekend Update

    David Ermer–Congress, Medical / Rx research, Obesity, Rx coverage, Telehealth, U.S. Healthcare–

    From Washington, DC,

    • Fierce Healthcare discusses a Senate Special Committee on Aging hearing about healthcare price transparency held last Thursday July 11.
      • “If consumers or business departments received a major charge on their monthly statements with no pricing breakdown or itemized receipts, many would demand more information if not outright refuse to pay.
      • “But that’s not the case in healthcare, where unexpected fees billed from insurers and hospitals and multiplicative markups are delivered after the fact and with little explanation.
      • “That was the message senators heard loud and clear during a Thursday morning hearing of policy researchers and purchasers of commercial insurance for employees and union members.” * * *
      • [Ranking Member Sen. Mike} Braun [R Ind.] kept the legislative focus squarely on price transparency, highlighting a bipartisan package he brought with Sens. John Hickenlooper, D-Colorado; Bernie Sanders, I-Vermont; Chuck Grassley, R-Iowa; and Tina Smith, D-Minnesota, earlier this year.
      • That bill, the Health Care PRICE Transparency Act 2.0 [S. 1130], received the explicit support of multiple witnesses and other price transparency advocacy groups whose written comments were entered into the hearing’s record. It would impose data sharing standards, require negotiated rates and cash prices on machine-readable files rather than estimates, increase maximum annual noncompliance penalties and give group health plans the right to audit and review claims data.

    From the public health and medical research fronts,

    • MedPage Today discusses four exceptional papers from JAMA Open Forum.
      • Item 1: Smartphone App Decreases Distracted Driving
      • Item 2: Vaping and Secondhand Nicotine Exposure in Kids
      • Item 3: New Data Adds Confidence to RSV Vaccine Safety During Pregnancy
      • Item 4: Mental Health Care Access Via Telehealth Decreased After the COVID Emergency Period.
    • The Washington Post points out
      • “A study published in the journal Alcohol: Clinical & Experimental Research looked at the reasons young adults give for not drinking, which researchers say could help in crafting public health messaging aimed at reducing alcohol abuse.
      • “Researchers focused on 614 participants who took online surveys about their alcohol use from mid-February to mid-May 2022. Participants were an average of 21.5 years old, and the majority were White (64.5 percent) and male (54.2 percent). About 65 percent were college students.
      • “Among the respondents, 49.9 percent said they were moderate drinkers, with 31.5 percent reporting binge drinking five to nine drinks in a row in the prior two weeks and 18.6 percent reporting “high-intensity drinking” of 10 or more drinks on a day in the previous two weeks, researchers at the University of Michigan’s Institute for Social Research and Texas State University report. The study was funded by the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse.”
    • The Wall Street Journal warns,
      • “With their fitness-influencer endorsements and wellness sheen, energy drinks have become more appealing to women. They’ve also become a go-to for teenage girls and young women with eating disorders.  
      • “Overconsumption of low-cal, highly caffeinated energy drinks is on the rise among young women with unhealthy eating and exercise habits, say doctors at more than a dozen of the nation’s top hospitals and eating-disorder treatment centers. Taking in too much caffeine can cause serious health problems, especially for people who aren’t eating enough, doctors say.   
      • “Brands like Celsius and Alani Nu pitch themselves as fitness aids, and, in the case of Celsius, claim to boost metabolism and burn fat. Attaining a toned body, the brands’ social-media posts suggest, looks as easy as sipping a can of the sparkling sugar-free beverages before a sweat sesh.”

    From the U.S. healthcare business front,

    • Modern Healthcare reports,
      • “The rural hospital collaborative in North Dakota has secured two value-based contracts with commercial insurers and more are expected this year, building momentum for those considering similar alliances.
      • “Cibolo Health in October created the Rough Rider High-Value Network comprised of 23 critical access hospitals in North Dakota. The rural hospital advisory firm has since helped launch a similar venture in Minnesota and is in early talks to expand the model in several other states, CEO Nathan White said.
      • “The Rough Rider network inked a Medicare shared savings contract with CVS Health and a contract with Blue Cross Blue Shield of North Dakota that includes quality-based payments and shared savings, White said. Other payers are interested in Medicare Advantage and accountable care organization contracts, he added.”
    • Healthcare Dive lets us know,
      • “Geisinger will begin a $880 million expansion of its Danville, Pennsylvania-based medical center next year, with plans to include a new 11-story medical tower, the system said Tuesday.
      • “The project will include a larger emergency department, expanded intensive care units and operating suites, as well as private rooms for each patient.
      • “The Risant Health-owned nonprofit plans to execute the expansion in phases, with a target completion date of 2028.” 
    • HR Dive informs us,
      • “With the Great Resignation far in the rearview mirror, companies now are facing another challenge: what to do when employees stay.
      • “The U.S. quit rate — often used as a measure of turnover — has remained steadily at 2.2% for the past seven months, according to the Bureau of Labor Statistics’ Job Openings and Labor Turnover Summary released July 2. 
      • “The lull in employee exits is the perfect time for employers to work on succession planning and enhancing their value proposition, according to Lauren Geer, senior vice president and chief human resources officer of IAC, a holding company to media and internet brands including Dotdash Meredith, Care.com and Angi.
      • “It’s quieter now, but I don’t think we can rest on our laurels by any means or pat ourselves on the back for what a great job we’re doing retaining our employees,” Geer said. “Now’s the time to get the house in order, because I do think there’ll be a time when the employee market picks up.” 

    Friday Factoids

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

    From Washington, DC,

    • Per a Congressional press release,
      • “U.S. Sen. Chuck Grassley (R-Iowa) today applauded the enactment of the bipartisan Maternal and Child Health Stillbirth Prevention Act, a bill [(H.R. 4581)] he championed alongside U.S. Rep. Ashley Hinson (R-Iowa) and U.S. Sens. Bill Cassidy (R-La.) and Jeff Merkley (D-Ore.). The law will help curb infant mortality by enabling evidence-based stillbirth efforts to qualify for federal funding.
      • “Stillbirth prevention researchers and advocates will now have more resources to advance their work. Especially given modern medical and technological capabilities, no family should have to endure the heartbreak of a stillbirth. Many thanks to everyone – Iowa organizations in particular – who’s had a hand in advancing our commonsense bill into law. Today’s win will have a domino effect for expectant families nationwide, for years to come,” Grassley said.  
      • “Today is a huge milestone in our fight to end stillbirth, the unexpected loss of a baby after more than 20 weeks of pregnancy. I am proud to have worked with so many incredible advocates, many of whom have endured the heartbreak of stillbirth, to bring this vital legislation across the finish line and expand federal resources for stillbirth prevention. I thank President Biden for signing this bipartisan legislation into law, and I will continue my work to improve maternal health care access for more healthy moms and healthy babies,” Hinson said. “
    • Fierce Pharma lets us know,
      • “Thursday, the Senate unanimously the bipartisan Affordable Prescriptions for Patients Act [(S. 150)], which looks to limit the number of patents drugmakers can assert in litigation on individual biological products. The bill aims to fight “patent thicketing,” a tactic the branded drug industry uses to delay or thwart competition.
      • “Patent thicketing occurs when drug companies stack secondary drug patents to create a complex web of intellectual property that’s hard for generic or biosimilars developers to navigate. AbbVie, for example, was able to keep its top-selling immunology drug Humira from U.S. competition for two decades by leveraging a web of 250 patents, patient access group Patients for Affordable Drugs Now (P4ADNow) said in a press release.
      • “This long-overdue legislation would promote competition and lower prices for patients without standing in the way of innovation, and I urge my colleagues in the House to pass it as soon as possible,” bill sponsor Sen. John Cornyn, R-Texas, said in a statement. 
      • “Reining in patent thickets would create $1.8 billion in taxpayer savings over the span of a decade, the Congressional Budget Office has forecast.”
    • AXIOS reports
      • “The Biden administration on Wednesday rolled out its latest election-year initiative on women’s health, proposing standards that would require the hospital industry to invest billions in maternity care improvements to remain in Medicare. * * *
      • “Hospitals would have to keep basic resuscitation equipment available in labor and delivery rooms, document maternal health training for staff and have written policies for transferring patients to other hospitals.
      • “All hospitals offering emergency services — even if they lack an obstetrics unit — would be required to have proper protocols and supplies for emergency deliveries and other needs.
      • “Hospitals not following these standards could eventually be booted from the Medicare and Medicaid programs.”
    • The American Hospital Association News adds,
      • “An infographic released by the University of Minnesota Rural Health Research Center highlights the decline of maternity care access in rural counties across the U.S. from 2010-2022, finding that nearly 59% of rural counties did not have any hospital-based obstetric services as of 2022.
      • “Researchers categorized rural counties based on population as micropolitan (having a town of 10,000-50,000 residents) and non-core (without a town of at least 10,000 residents). They found that micropolitan counties with hospital-based obstetric care declined from about 81% in 2010 to nearly 74% in 2022. Noncore counties declined from 34% in 2010 to nearly 26% in 2022.”

    From the public health and medical research front,

    • The University of Minnesota’s CIDRAP tells us,
      • “Respiratory illness viruses as a whole remain at low levels, but many parts of the countries are experiencing consistent increases in COVID-19 activity, which has been trending upward from very low levels, the US Centers for Disease Control and Prevention (CDC) said today in its latest updates.
      • “Test positivity, emergency department (ED) visits, and hospitalizations—the main markers the CDC uses to gauge virus activity—are all rising, especially in both seniors and the western states. * * *
      • “The percentage of ED visits for COVID, considered an early indicator, rose 23.5% last week compared to the week before. Levels were higher in the West and the South than in the rest of the country.” * * *
      • “The dashboard at WastewaterSCAN a national wastewater monitoring system based at Stanford University in partnership with Emory University, shows SARS-CoV-2 detections at the high level, especially in the West, South, and East, with an upward trend over the past 21 days.
      • “In its latest variant update, posted on July 6, the CDC said the proportion of KP.3 detections continues to rise, up from 31.3% to 36.9% over the 2-week monitoring period. KP.3 is one of the JN.1 offshoots with mutations that allow it to better evade immunity from earlier infection or vaccination.” 
    • Per Fierce Pharma,
      • “Trials have already shown that Novo Nordisk’s semaglutide can cut the risk of cardiovascular events and kidney disease. Now a study from the University of Oxford indicates that the company’s semaglutide type 2 diabetes drug Ozempic can reduce the risk of dementia compared with another popular diabetes medicine.
      • “The research—which was designed to demonstrate if Ozempic could cause neurologic problems—showed instead that it produced a 48% decline in dementia when compared to Merck’s type 2 diabetes drug Januvia (sitagliptin).” * * *
      • “Prior studies have determined that diabetics have a greater risk of developing dementia. Those with type 2 diabetes are at an elevated risk for Alzheimer’s, according (PDF) to studies cited by the Alzheimer’s Association.” * * *
      • “Elsewhere, Lilly’s GLP-1/GIP therapy tirzepatide—which is the compound used to manufacture its type 2 diabetes drug Mounjaro and obesity treatment Zepbound—was recently shown to lower blood pressure. Researchers are still studying whether many of these benefits accrue from the treatment or from the weight loss they provide.”
    • The National Institutes of Health announced,
      • Using health data from almost 213,000 Americans who experienced reinfections, researchers have found that severe infections from the virus that causes COVID-19 tend to foreshadow similar severity of infection the next time a person contracts the disease. Additionally, scientists discovered that long COVID was more likely to occur after a first infection compared to a reinfection. The study, funded by the National Institutes of Health’s (NIH) Researching COVID to Enhance Recovery (RECOVER) Initiative, is published in Communications Medicine.
      • “About 27% of those with severe cases, defined as receiving hospital care for a coronavirus infection, also received hospital care for a reinfection. Adults with severe cases were more likely to have underlying health conditions and be ages 60 or older. In contrast, about 87% of those who had mild COVID cases that did not require hospital care the first time also had mild cases of reinfections.
      • “Reinfections were defined as having occurred at least two months after a first infection. They were found to occur most frequently when omicron variants were circulating in late 2021 and early 2022. Waning immunity and increased exposure to the coronavirus, including the highly-infectious variants, likely accounted for the uptick.
      • “Scientists also discovered that regardless of the variant, long COVID cases were more likely to occur after a first infection compared to a reinfection.”
    • The Wall Street Journal reports,
      • “Human lifespan has a limit and we might have reached it.
      • “S. Jay Olshansky, who studies the upper bounds of human longevity at the University of Illinois Chicago, believes people shouldn’t expect to live to 100. Most, he contends, will reach between 65-90.
      • “Biology is holding us back, Olshansky said. Human evolution favors growth and reproduction, not living to excessive ages. As people grow older, their cells and tissues accumulate damage. Breakdowns of one kind or another happen more frequently and get increasingly difficult to repair. Scientists believe there are likely many genes that affect lifespan. Aging is a complex process that isn’t well-understood.
      • “Olshansky knows his viewpoint isn’t popular. 
      • “The longevity business is booming. People are flocking to longevity meetings and taking compounds they hope will extend their lives. Investors are backing scientists researching techniques to reprogram cells to a younger state with the goal of restoring functions that diminish with age. Longevity influencers argue that if they can live long enough, scientific breakthroughs will keep them going indefinitely.” * * *
      • “Jan Vijg, chair of genetics at Albert Einstein College of Medicine in the Bronx, reached a similar conclusion from a different angle. He has studied the maximum verified age the oldest people died at in different countries. The maximum age at death increased gradually at least from the 1950s until the 1990s, when it appeared to plateau.
      • “He isn’t surprised that Jeanne Calment, a French woman who died in 1997 at 122, still holds the world record of the oldest verified age at death. There are now hundreds of millions more people who have reached old age under optimal conditions—benefiting from clean water, antibiotics, improved treatments for top killers such as heart disease and cancer, and healthier lifestyles. 
      • “If lifespan had no limit, some of those centenarians would have broken Calment’s record by now, he argued.” 
      • “It seems this is the end,” Vijg said.

    From the U.S. healthcare business front,

    • Beckers Clinical Leadership identifies the 94 emergency departments across our country that the Emergency Nurses Association has recognized “for their commitment to quality, safety and a healthy work environment.”
    • Per Fierce Pharma,
      • “Even through an onslaught of biosimilar launches that began early last year, AbbVie’s big-selling Humira has been able to retain most of its lucrative market. Still, though, the drug’s star power is on the decline.
      • “Biosimilar manufacturer Samsung Bioeps has tracked the impact of Humira biosim launches in its latest market report, finding that Humira’s slice of the market has dropped to 82%.
      • “Sandoz’ Hyrimoz, under its Cordavis co-label, is responsible for “most biosimilar gains,” according to the report. Cordavis is CVS Health’s new biosimilar subsidiary, which launched with Hyrimoz as its first product.
      • “Back in April, CVS Caremark removed branded Humira from its national commercial formularies, causing Hyrimoz prescriptions to skyrocket, analysts at Evercore ISI noted at the time. Through April 25, Hyrimoz was responsible for 82% of Humira biosimilar prescriptions, IQVIA data revealed. The successful launch has so far pushed Sandoz to revenue gains of 6% during the first quarter.”
    • The Wall Street Journal arranged for a palliative medicine doctor to write an essay about dying at home. It’s worth a look.
      • Research suggests that 70% of Americans want to die at home. More seem to be doing so, at least partly owing to the Covid-19 pandemic. In a study of where people died in 32 countries between 2012 and 2021, published in Lancet’s eClinicalMedicine in January, the authors found a rise in home deaths in most countries, including the U.S., during the pandemic, which they largely interpreted as progress.
      • The truth is more complicated. Now, 10 years into my career as a palliative medicine physician, I know that there is much more to a “good” death than its location. Presuming a home death is a success obscures important questions about the process: Did this person die comfortably? Did their caregivers have the resources and guidance they needed? Was dying at home a choice or simply the only option?

    Thursday Miscellany

    David Ermer–CDC, Congress, COVID-19, FDA, Medical / Rx research, NIH, Obesity, SDOH, Telehealth–

    From Washington, DC,

    • Govexec informs us,
      • “The Senate on Thursday made progress on advancing bipartisan spending bills for fiscal 2025, though members of both parties acknowledged significant divisions remain between the two sides. 
      • “The chamber’s Appropriations Committee approved three of the 12 annual funding measures Congress must pass each year—those funding the departments of Agriculture and Veterans Affairs, as well as the legislative branch—in unanimous, 27-0 votes. While that marked a significant step forward in the fiscal 2025 process and an accomplishment that has eluded the panel’s House counterpart—which has advanced its bills to date only along partisan lines—the Senate could not come to a bipartisan agreement on how much money to allocate for the remaining nine funding measures.”
    • and
      • “The Senate on Wednesday voted 55-37 to confirm Anne Wagner as the third member of the Federal Labor Relations Authority, finally bringing the agency’s political leadership to nearly full strength.
      • “Similar to the National Labor Relations Board’s role overseeing collective bargaining in the private sector, the FLRA governs labor-management relations at federal agencies, with a three-member board that settles unfair labor practice complaints and other disputes between unions and management.” * * *
      • “Federal employee unions rejoiced at the news that the FLRA’s board was now fully staffed. The last 18 months of deadlock between [Colleen Duffy] Kiko and FLRA Chairwoman Susan Tsui Grundmann has meant the board could only rule in noncontroversial cases.”
    • The American Hospital Association News lets us know,
      • “The Senate Committee on Health, Education, Labor and Pensions held a hearing July 11 on medical debt. The AHA submitted a statement for the hearing that highlighted how the quality of insurance coverage is a driver of medical debt, saying that coverage for many patients is either insufficient or unavailable. The AHA discussed hospital and health system efforts offering financial and other assistance, and that hospitals absorb billions of dollars in losses for patients who cannot pay their bills, mainly due to inadequate commercial insurance coverage. To address the issue, the AHA urged Congress to restrict the sale of high-deductible health plans to individuals with the ability to afford the associated cost-sharing; prohibit the sale of health-sharing ministry products and short-term limited-duration plans that go longer than 90 days; and lower the maximum out-of-pocket cost-sharing limits, among other changes.”
      • That’s nuts, and it’s worth adding that all of the witnesses, except for one, were from the creditor side. Here’s a link to the American Enterprise Institute testimony.
    • The AHA News adds,
      • “The Centers for Medicare & Medicaid Services July 10 announced there will be 133 participants representing 772 practices for its new Making Care Primary Model. Participants in this voluntary model are from Colorado, Massachusetts, Minnesota, New Jersey, New Mexico, New York, North Carolina and Washington. The model, which began July 1 and will run through 2034, seeks to improve care management and care coordination, enable primary care clinicians to partner with health care specialists, and use community-based connections to address patients’ health needs as well as their health-related social needs such as housing and nutrition.”
    • and
      • “The Centers for Medicare & Medicaid Services recently released results of an air ambulance qualifying payment amount calculations audit on Aetna Health in Texas. The report found that Aetna used practices that did not comply with federal requirements, and strongly recommended corrective actions. Specifically, the report found that Aetna failed to “properly calculate the QPA by using claim paid amounts instead of contracted rates, and counting each claim as its own contracted rate, even when the claims were for the same amounts for the same item or service and to the same provider of air ambulance services.” Aetna may also be subjected to future audits.”

    From the public health and medical research front,

    • The Washington Post reports,
      • “Research into chronic conditions affecting women is significantly lacking, and the National Institutes of Health and other agencies should do more to investigate issues that lead to worse medical treatment for women, a new report from the National Academies of Sciences, Engineering and Medicine says.
      • “Women are disproportionately affected by chronic illnesses, including Alzheimer’s disease and depression, according to the study requested by NIH’s Office of Research on Women’s Health and published Wednesday.
      • “But inadequate research in women’s health “hinders a comprehensive understanding of the impact on women” of these and other chronic illnesses, the report’s authors write. Further research is needed, particularly for Black women, who are more likely to die of a chronic illness than White women, the study says.”
    • and
      • “Nearly 1 in 10 people infected with the coronavirus during pregnancy developed long covid, according to a study published Thursday in the journal Obstetrics and Gynecology.
      • “Thursday’s study, which highlights the consequences of the virus during pregnancy, suggests long covid is more prevalent among people infected while pregnant than in the population overall. As many as 7 percent of Americans report having symptoms associated with long covid, according to a 2022 report from the Centers for Disease Control and Prevention. Some surveys suggest a far higher incidence of long covid in the general population.” * * *
      • “I was initially surprised at the prevalence of long covid in this population,” said Torri Metz, one of the study’s lead authors and a maternal-fetal medicine specialist at University of Utah Health. “It really drew my attention to the fact I need to have this on my radar when I am seeing patients.”
    • NBC News informs us,
      • “A key mystery behind one of the most common autoimmune diseases may finally have an answer.
      • “Researchers at Northwestern Medicine and Brigham and Women’s Hospital say they’ve discovered a root cause of lupus, a disease that affects hundreds of thousands of people in the U.S. 
      • “Scientists have long suspected that a person’s genetics or hormones may predispose them to lupus, and that the disease may be triggered by environmental factors like a previous viral infection or exposure to certain chemicals.
      • “Now, a study published Wednesday in the journal Nature outlines a clear pathway for how the disease likely develops, pointing to abnormalities in the immune systems of people with lupus.”
    • Neurology Advisor points out,
      • “The prevalence of stroke has increased by 14.6% from 2011 to 2022 among individuals aged 18 to 44 and 15.7% among those aged 65 and younger in the United States, according to a report published in Morbidity and Mortality Weekly Report.
      • “Researchers assessed trends in stroke prevalence between 2011 and 2022, using data from the Behavioral Risk Factor Surveillance System (BRFSS), a state-based surveillance system administered to noninstitutionalized civilian adults in the US in collaboration with the Centers for Disease Control and Prevention (CDC). * * *
      • “Age-standardized prevalence of stroke increased from 2.7% in 2011 to 2013 to 2.9% in 2020 to 2022, marking a 7.8% (95% CI, 4.9%-10.8%) increase in overall stroke prevalence. The researchers noted the highest stroke prevalence (7.7%; 95% CI, 7.5%-7.9%) among individuals aged 65 and older and the lowest prevalence (0.9%; 95% CI, 0.8%-1.0%) among individuals aged between 18 and 44 years.
      • “Stroke was observed to be highest (5.3%; 95% CI, 4.7%-5.9%) among the American Indian or Alaska Native group and lowest among the Asian group (1.6%; 95% CI, 1.2%-2.0%).
      • “With regard to educational level, individuals with a high-school diploma had the highest stroke prevalence (5.2%; 95% CI, 4.8%-5.4%) and those with a college degree or higher had the lowest stroke prevalence (1.7; 95% CI, 1.6%-1.8%).”
    • STAT News relates,
      • “Researchers from the American Cancer Society and International Agency for Research on Cancer estimate 40% of all cancer cases in the United States in people 30 and up were due to “potentially modifiable risk factors,” including cigarette smoking, physical inactivity, consumption of processed meat, viruses, excess body weight, alcohol drinking and more. Data was from 2019 in order to avoid the influence of the pandemic, when cancer diagnoses declined because of delayed care. The results were published in the American Cancer Society’s journal, CA: A Cancer Journal for Clinicians.” * * *
      • “In the study, alcohol was associated with seven cancers: oral cavity, pharynx, larynx, colorectum, and female breast, as well as squamous cell carcinoma in the esophagus, and hepatocellular carcinoma in the liver. Beyond those, “there is accumulating evidence” that alcohol can cause other cancers, such as pancreatic cancer, said lead author Farhad Islami, senior scientific director of cancer disparity research at ACS (which funded the study). 
      • “The increased risk is because of the alcohol in alcoholic beverages, not the type of beverage,” he said. A standard alcoholic beverage in the United States has about 14 grams of pure ethanol. That looks like one 12-ounce serving of 5% ABV beer, a 5-ounce serving of 12% ABV wine, 8-10 ounces of 7% ABV hard seltzer, or 1.5 ounces of 40% ABV liquor. Research suggests the higher a person’s consumption, the higher the risk of cancer.”
    • Here is a link to the NIH Director’s blog titled this week “Sequencing Technique Detects Earliest Signs of Genetic Mutations Underlying Cancer, Aging, and More”
    • The National Institutes of Health announced,
      • “Early findings from a small clinical trial provide evidence that a new cellular immunotherapy approach may be effective in treating metastatic solid tumors. In the trial, researchers from the National Institutes of Health (NIH) genetically engineered normal white blood cells, known as lymphocytes, from each patient to produce receptors that recognize and attack their specific cancer cells. These initial findings are from people with metastatic colorectal cancer who had already undergone multiple earlier treatments. The personalized immunotherapy shrank tumors in some patients and was able to keep the tumors from regrowing for up to seven months. The findings were published July 11, 2024, in Nature Medicine.” * * *
      • “Colon cancer is just one of many solid tumors the researchers are studying. The trial is still ongoing and includes patients with different types of solid cancers.
      • “It’s just the very beginning of converting normal lymphocytes into cells capable of treating the common solid cancers,” Dr. Steven A. Rosenberg, a co-leader of the study, said. “What this study shows is that it’s possible. Once you know it’s possible, you work to improve it.”
    • Here is a link to the All of Us Program’s latest Medical Minutes.

    From the U.S. healthcare business front,

    • Beckers Hospital Review tells us,
      • “As more older adults opt for Medicare Advantage plans, reimbursement fights between hospitals and insurers are increasingly centered around those contracts.
      • “According to data shared with Becker’s by FTI Consulting, there were 20 reimbursement disputes between hospitals and insurers that made headlines somewhere in the country during the second quarter, the same amount as the first quarter and slightly lower than the same period in 2023, when 24 contract disputes were reported in national or local media.
      • “Notably, a record number of Q2 disputes (15 of 20) involved Medicare Advantage plans, and 30% of disputes failed to reach a timely agreement, meaning tens of thousands of patients were left without in-network coverage. FTI has tracked media reports regarding negotiations over reimbursement rates during each quarter since early 2022.”
    • BioPharma Dive reports,
      • “On Thursday, the pharmaceutical giant [Pfizer] said it is advancing a once-daily version of an experimental and closely watched medicine called danuglipron. Pfizer based the decision on results from a small clinical trial of healthy volunteers that’s been evaluating how the body interacts with danuglipron. Studies designed to find the optimal dose of the medicine are scheduled for later this year.
      • “Umer Raffat, an analyst at the investment firm Evercore ISI, speculates that with its update Thursday, Pfizer is “likely buying time” to see more data from a backup once-daily drug it’s been developing. “Candidly, the trial that just wrapped up never answered the question on” what dose would be effective enough to compete, he wrote in a note to clients.
      • “In that backdrop, the judicious thing to do from [the] Pfizer perspective was to not overcommit — and that’s exactly what they did today,” Raffat added. They “didn’t kill [danuglipron], they said it may move forward, but not right to [Phase 3].”
    • Beckers Payer Issues adds,
      • “As insurers continue to face major financial pressures related to covering weight loss drugs, many are steering more patients toward bariatric surgery to achieve similar results.
      • “Insurance companies are seeing that they’re getting more reliable outcomes and savings in the long run if they pay for someone to have bariatric surgery,” Christine Ren Fielding, MD, told Becker’s. Dr. Ren Fielding is a professor of surgery at NYU School of Medicine, the director of the NYU Langone Weight Management Program and chief of the system’s division of bariatric surgery.
      • “If you’re a responder to appetite control caused by a GLP-1, then there’s another treatment option that will do exactly the same thing: bariatric surgery. That includes Lap-Band, sleeve gastrectomy, and gastric bypass,” she said. “Bariatric surgery is the old-fashioned way. Insurers are now putting up barriers for people who want to be covered for GLP-1s and taking down barriers for people who want to have surgery.”
    • STAT News informs us,
      • “The Food and Drug Administration rejected Novo Nordisk’s weekly insulin for the treatment of diabetes in a rare setback for the pharmaceutical giant.
      • “The agency has requests related to the manufacturing process and the use of the insulin specifically in type 1 diabetes patients, Novo said in a statement Wednesday. The company, which had submitted an application for the drug for both type 1 and type 2 patients, said it does not expect to be able to fulfill the requests this year.”