Thursday Miscellany

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.”