Tuesday Tidbits

AHRQ

Tuesday Tidbits

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

From Washington, DC,

  • This morning, the Federal Trade Commission released an interim staff report on its ongoing investigation of prescription benefit managers. The report was favorably received by Senators Wyden and Grassley. Healthcare Dive summarizes the report here.
  • The FEHBlog recalls when around 2009 the State of New York went after UnitedHealthcare for offering a for profit service that provided usual, reasonable and customary rates for out-of-network providers. In a legal settlement, UnitedHealthcare transferred the service to a new not-for-profit company called Fair Health. Meanwhile most health plans had switched to the Medicare Part RBRVS pricing as base for its UCR reimbursements. Nevertheless, Fair Health is still around.
  • Today, the American Hospital Association News tells us,
    • “An op-ed published July 9 in Modern Healthcare written by AHA President and CEO Rick Pollack and Catholic Health Association President and CEO Sr. Mary Haddad discusses why nonprofit hospitals need positive margins. The commentary piece seeks to add important context and education to the conversation around nonprofit hospitals’ community benefit, tax-exempt status and other issues, arguing that positive margins are necessary to maintain basic services and advance care for all patients and communities 24/7. “Barely making ends meet or operating at a financial loss should never be the goal or an acceptable status quo for any nonprofit healthcare organization,” Pollack and Haddad write. “It’s not just bad economics; it also impedes institutions’ ability to deliver services and improve health outcomes.”
  • If the regulators are considering taking a page out of the Fair Health playbook, consider this finding from a USC-Brookings report issued last September:
    • “Pre-tax operating margins for the three largest PBMs averaged a bit more than 4% of their revenues in 2022. Since PBMs’ revenues encompass both the administrative fees charged to PBMs and payers’ net payments for claims, this implies that even completely eliminating PBMs’ margins [a no-no] would only modestly reduce payers’ drug-related costs. Achieving larger reductions would require reducing the revenue captured by pharmacies or, particularly, manufacturers. Ultimately, the amount of revenue that manufacturers capture depends principally on the extent of intellectual property protections related to drugs and whether and how the prices that drug manufacturers receive are regulated.”
  • The healthcare industry is complex, to say the least, and there are no simple answers.

From the public health and medical research front,

  • “Did you know that the U.S. Preventive Services Task Force (Task Force) has a free app called Prevention TaskForce? This app can help healthcare professionals identify which screenings, counseling interventions, and preventive medications are right for their patients. It includes all current Task Force recommendations and can be searched by specific patient characteristics, such as age, sex/gender, and selected behavioral risk factors. Download the app, on mobile or desktop, to find the preventive services that can help keep your patients healthy.”
    • “For more information and to download the app, click here.”
  • STAT News reports,
    • “In a long-awaited study, patients in Australia will soon receive an IV infusion designed to transform their own immune cells into swarms of cancer-fighting drones.
    • “The trial, announced on Tuesday by Interius Biotherapeutics, will be the first to test what’s known technically as in vivo CAR-T therapy. Researchers have long hoped the approach could provide a potentially cheaper, safer, and more scalable version of the cell therapies that are curative for some blood cancer patients but remain out of reach for many. 
    • “Interius received regulatory clearance on June 28 and will dose up to 30 patients, beginning in the fall. It beat out several competitors, including one with over $1 billion in funding, to the first-in-human trial.  
    • “There are absolutely people alive out there today that would not have been without the CAR technology,” said Dora Mitchell, Interius’ senior vice president for operations. But the therapy is still only delivered in some places in the U.S. and Europe and almost nowhere else. “The vision that catalyzed the formation of Interius was: can we bring this to the masses?”
  • Healio informs us,
    • “There is insignificant evidence to support recommendations that children with autism will benefit from intensive interventions, according to the results of a meta-analysis published in JAMA Pediatrics.
    • “One of the study’s authors told Healio that in reviewing standard intervention recommendations for autism in children, she found that one recommended that children receive at least 20 hours or up to 40 hours of intensive intervention per week.
    • “This recommendation originated initially from a quasi-experimental study conducted in the ’80s that, although remarkable for the time, was flawed,” Micheal P. Sandbank, PhD, director of The Brain and Language Lab at the University of Texas at Austin, told Healio. “There have been additional studies since then, but most were quasi-experimental and compared intensive intervention with different uncontrolled supports, failing to isolate the effect of intensity specifically from the effect of providing a systematic and comprehensive intervention approach.”
  • The Washington Post explains what to know about six popular home tests for urinary tract infections, menopause, allergies, colon cancer, A1c blood sugar and thyroid conditions.

From the U.S. healthcare business front,

  • Beckers Hospital CFO report informs us,
    • “Average hospital margins year to date remained steadfast in May at 3.8%, according to Kaufman Hall’s “National Hospital Flash Report,” released July 9.
    • “Hospital financial performance remained relatively unchanged during the month of May, and the rate of change slowed for margins and other key performance indicators, which reflects stabilization,” wrote Erik Swanson, senior vice president at Kaufman Hall.
    • “The stabilization is a positive sign for hospitals after ending the year with average margins at 1.9%. The average hospital margin shot up in January to 4.6% and then decreased slightly in February and March.
    • “From April to May, the monthly average operating margin index dipped from 4.2% to 3.7%. Operating margins increased 23% year to date over the same period last year.”
  • BioPharma Dive reports,
    • “Pfizer’s top scientist Mikael Dolsten is stepping down after leading the drugmaker’s research and development for the past 15 years, a period that includes Pfizer’s remarkable success developing a COVID-19 vaccine but ends with the company at a crossroads.
    • “On Tuesday, Pfizer said it has begun searching for a successor to Dolsten, who in 2010 became chief scientific officer as well as R&D head. The process is expected to last “probably through early next year,” Pfizer said.
    • “Dolsten will help with the search and continue to serve in his current position until a successor is in place and “any necessary transition is complete,” according to Pfizer.”

Monday Roundup

David Ermer–AHRQ, CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call lets us know,
    • “Senate Appropriations Committee leaders have agreed to add $34.5 billion in emergency spending to their fiscal 2025 bills on top of levels agreed to in last year’s debt limit negotiations, sources familiar with the talks said Monday. 
    • “Under the pact between Senate Appropriations Chair Patty Murray, D-Wash., and ranking member Susan Collins, R-Maine, defense accounts would receive an extra $21 billion in emergency spending while nondefense programs would get $13.5 billion.” 
  • Taking a gander at reginfo.gov led the FEHBlog to discover that on July 1, the final version of the simply infeasible federal mental health parity rule changes was submitted to OIRA for its review.
  • In yesterday’s post, the FEHBlog called attention to the new CMS GUIDE program. The post noted that program details would be released in early July. What do you know? Those details were posted today. The American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services July 8 announced over 400 participants in a new model focused on improving dementia care. The Guiding an Improved Dementia Experience (GUIDE) Model began July 1 and seeks to reduce strain on unpaid caregivers as well as offer care coordination and management, caregiver education and support, and respite services. CMS will also test an alternative payment for participants delivering key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. People with dementia and their caregivers will have access to a care navigator to help them access services and support, including clinical services and non-clinical services such as meals and transportation through community-based organizations.”
  • The HHS Inspector General posted an impact brief on Medicare Advantage program fraud involving its risk adjustment program. The Wall Street Journal published an article the same type of fraud today.
  • STAT News informs us,
    • “The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills — and at least $1 billion in royalties may be at stake.
    • “At issue is a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
    • “The U.S. Centers for Disease Control, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company refused to reach a licensing agreement despite several attempts to strike a deal.” * * *
    • “U.S. District Court Judge Maryellen Noreika narrowed the Gilead victory last March when she set aside the jury finding that CDC patents were not infringed. So the appeal filed by the U.S. Department of Justice — on behalf of HHS — refers to the only portion of the jury finding that remains, which is that the patents were invalid.”
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.” * * *
    • “Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.”
  • Govexec tells us,
    • “The Office of Personnel Management lost a small modicum of ground in its fight to reduce the backlog of pending retirement claims from federal employees as the agency’s backlog of cases inched back over 15,000.
    • “In June, OPM received 6,919 new retirement requests from departing federal workers, a slight increase over the 6,751 claims it received the previous month. But the agency’s pace in processing those claims fell precipitously, completing only 5,614 claims last month compared to the 8,793 it processed in May.
    • “That deficit led to OPM’s overall backlog of pending claims to climb from 14,035—an eight-year low—in May to 15,340 at the end of June. Consequently, the monthly average processing time for a retirement application ticked up four days, from 60 in May to 64 last month, though measured since the beginning of fiscal 2024, the average processing time has remained static at 61 days for four months running.”
  • The U.S. Preventive Services Task Force is celebrating its 40th anniversary. The FEHBlog is reminded that the FEHB Act will be 65 years old on September 28, 2024.

From the public health and medical research front,

  • The New York Times reports,
    • “The process for diagnosing a child with autism heavily relies on a parent’s description of their child’s behavior and a professional’s observations. It leaves plenty of room for human error.
    • “Parents’ concerns may skew how they answer questionnaires. Providers may hold biases, leading them to underdiagnose certain groups. Children may show widely varying symptoms, depending on factors like culture and gender.
    • “A study published Monday in Nature Microbiology bolsters a growing body of research that suggests an unlikely path to more objective autism diagnoses: the gut microbiome.
    • “After analyzing more than 1,600 stool samples from children ages 1 to 13, researchers found several distinct biological “markers” in the samples of autistic children. Unique traces of gut bacteria, fungi, viruses and more could one day be the basis of a diagnostic tool, said Qi Su, a researcher at the Chinese University of Hong Kong and a lead author of the study.”
  • The American Medical Association tells us what doctors wish their patient knew about heat stroke.
  • The Wall Street Journal discusses the right and wrong ways for people to snack.
    • “America is a nation of snackers. A lot of us are doing it wrong. 
    • “Noshing outside of traditional mealtimes isn’t inherently bad. A snack can stave off hunger, boost energy, provide important nutrients and keep us from overeating later. But snacking can also lead us to eat extra calories and overdo it on sodium, added sugars and saturated fats, which can raise our risk of heart disease and obesity. 
    • “How to snack better? Reach for food combinations that keep you fuller longer: Pair carbs like apple slices with protein and fats, like peanut butter. Or try yogurt with berries. Then plan your snack times, and watch out for the minefield that is evening snacking.”
  • The Washington Post and Consumer Reports offer information about “an aggressive tick species spreading across the U.S. Lone star ticks don’t spread Lyme disease, but they can transmit other serious diseases and are linked to a mysterious meat allergy. And the threat is growing.”
    • “Lone star ticks have long been firmly established in the Southeastern United States. In recent decades, however, their numbers have been increasing in Midwestern and Northeastern states. Between 2017 and 2021, according to CDC data, nearly half of reported ehrlichiosis cases were in five states: Arkansas, Missouri, New York, North Carolina and Tennessee.”
  • The CDC has posted FAQs on infertility. “This page has definitions and frequently asked questions related to infertility. It has important information about infertility, including common misconceptions, risk factors, and treatment options.”
  • Beckers Hospital Review points out,
    • “GLP-1 drugs such as Ozempic and Wegovy may lower the risk of developing certain obesity-related cancers, according to a new study from researchers at Case Western Reserve University in Cleveland. 
    • “Researchers found people with type 2 diabetes who were being treated with the medications were significantly less likely to develop 10 of 13 obesity-associated cancers than those taking insulin, according to the findings published July 5 in JAMA Network Open. The retrospective study is based on an analysis of the medical records of over 1.6 million type 2 diabetes patients from 2005 to 2018.
    • “The risk was reduced by more than half for gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma. Esophageal, colorectal, endometrial, ovarian, multiple myeloma and kidney were among the other cancers for which there was a significant risk reduction. The study did not find a difference in cancer risk reduction among those treated with GLP-1s compared with those taking metformin, an older diabetes drug. 
    • “In an interview with Bloomberg, Arif Kamal, MD, chief patient officer at the American Cancer Society and who was not involved in the research, called the new evidence on GLP-1s “compelling.”
  • Per Fierce Pharma,
    • “In examining the electronic records of more than 18,000 overweight or obese adults in the United States, health data analytics company Truveta found that Lilly’s tirzepatide helped patients lose more weight than Novo’s semaglutide, with the effects growing over time.
    • “Results of the study, which looked at data from May of 2022 and September of 2023, were published Monday in the JAMA Internal Medicine monthly review.
    • “”After use of tirzepatide for three months, patients lost an average of 5.9% of their body weight compared to 3.6% for semaglutide. Over a year’s time, those on tirzepatide lost an average of 15.3% of their body weight compared to 8.3% for semaglutide users.
    • Additionally, tirzepatide patients were much more likely to lose 15% of their body weight than those using semaglutide. While 42% of those on tirzepatide reached the benchmark after one year of treatment, only 18% of those on semaglutide could say the same. 
    • “Lilly’s tirzepatide is the active ingredient found in its diabetes product Mounjaro and its obesity treatment Zepbound, while Novo’s semaglutide is the compound used to make its diabetes blockbuster Ozempic and its obesity follow-on Wegovy.
    • “Importantly, the Truveta study looked at the drugs that are approved for diabetes. The authors noted that “future studies are needed to compare versions labeled for weight loss.”
  • Per an NIH press release,
    • “A series of experiments with highly pathogenic H5N1 avian influenza (HPAI H5N1) viruses circulating in infected U.S. dairy cattle found that viruses derived from lactating dairy cattle induced severe disease in mice and ferrets when administered via intranasal inoculation. The virus from the H5N1-infected cows bound to both avian (bird) and human-type cellular receptors, but, importantly, did not transmit efficiently among ferrets exposed via respiratory droplets. The findings, published in Nature, suggest that bovine (cow) HPAI H5N1 viruses may differ from previous HPAI H5N1 viruses and that these viruses may possess features that could facilitate infection and transmission among mammals. However, they currently do not appear capable of efficient respiratory transmission between animals or people.”
  • MedPage Today lets us know,
    • “Extended-release 7-day injectable buprenorphine was safe and tolerable for most patients who had minimal-to-mild opioid withdrawal, a nonrandomized trial found.
    • “Among 100 adult patients with minimal-to-mild opioid withdrawal scores who were given a 24-mg dose of extended-release buprenorphine, only 10 people (10%, 95% CI 4.9%-17.6%) saw a 5-point or greater jump in withdrawal symptoms within 4 hours of injection, reported Gail D’Onofrio, MD, of the Yale School of Medicine in New Haven, CT, and colleagues.” * * *
    • “The study examined whether patients with untreated opioid use disorder (OUD) and minimal-to-mild withdrawal could tolerate a 7-day dose of buprenorphine. Patients with OUD typically aren’t treated with medication until they are in significant withdrawal, due to fear of precipitated withdrawal. For that reason, “[n]o one has ever even attempted to give buprenorphine in that [0 to 7] range,” D’Onofrio said.” * * *
    • “[This is a real game-changer for emergency physicians and clinicians, even in the clinic, who would be able to induce people on buprenorphine much earlier than they previously could have,” D’Onofrio said.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY has agreed to buy biopharmaceutical company Morphic Holding MORF for $3.2 billion in a deal that bolsters the drugmaker’s immunology pipeline.
    • “Eli Lilly on Monday said it would pay $57 a share for Morphic, a 79% premium to Friday’s closing price of $31.84 for the Waltham, Mass., company.
    • “Morphic is developing therapies for the treatment of serious chronic diseases, with a lead program targeting the inflammatory bowel diseases ulcerative colitis and Crohn’s disease.
    • “Eli Lilly late last year won U.S. Food and Drug Administration approval of its Omvoh treatment for moderately to severely active ulcerative colitis in adults.
    • “Indianapolis-based Eli Lilly said it expects to complete the acquisition, which isn’t subject to any financing conditions, in the third quarter.”
  • Modern Healthcare relates,
    • “More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
    • “Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.” * * *
    • “The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.”
  • Per Fierce Healthcare,
    • “A recent proposal to report prior authorization to insurance plans through CPT codes was withdrawn at the eleventh hour when its physician advocate made an unexpected discovery: For certain codes and in very narrow circumstances, the prior auth requirements were already in place.
    • “Alex Shteynshlyuger, M.D., director of urology with New York Urology Specialists, had previously brought forward a time-based proposal that would ensure physicians are compensated for time spent on prior auth claims. He believed the changes would also reduce the number of claim requirements imposed by plans and limit the amount of appeals and could lead to better patient outcomes.
    • “Following the proposal, however, the American Medical Association (AMA) informed Shteynshlyuger that prior authorization is already explicitly mentioned in official procedure descriptions for half a dozen CPT codes. This required Shteynshlyuger to withdraw the proposal so he could revise and resubmit at a later date.
    • “Each CPT code includes a short description detailing the type of visit or examination. Longer descriptions—where the prior auth mentions were contained—are also stored in databases that can be purchased, but those are rarely encountered.
    • “As a matter of fact, I’ve never seen the long description in my lifetime,” said Shteynshlyuger.”
  • and
    • “Nearly 5 million fewer people delayed care from 2019 to 2022, a study from the Urban Institute with funding from the Robert Wood Johnson Foundation revealed.
    • “The study shows 4.75 million non-elderly Americans skipped necessary medical care, dropping from 12.1% to 9.7% in 2022.
    • “For families below 138% of the federal poverty line, there was a 27% reduction in cost barriers. A 19% reduction was evident for families between 138% and 249% of the federal poverty line.
    • “Researchers say these outcomes are a direct result of the Medicaid continuous coverage requirements and enhanced tax credits.
    • “Our findings show significant improvements in health insurance coverage and healthcare access under federal and state policy changes enacted during the public health emergency,” said Michael Karpman, principal research associate at the Urban Institute, in a statement. “The continued unwinding of the Medicaid continuous coverage requirement and the potential expiration of enhanced Marketplace subsidies after 2025 could make these gains in coverage and access difficult to sustain.”

Tuesday Tidbits

David Ermer–AHRQ, CDC, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • KFF Health News reports,
    • “U.S. Surgeon General Vivek Murthy declared firearm violence a public health crisis, as gun deaths and injuries punctuate daily life in America.
    • “On nearly every day of 2024 so far, a burst of gunfire has hit at least four people somewhere in the country. Some days, communities have endured four or five such shootings.
    • “The nation’s top doctor called on policymakers to consider gun safety measures such as bans on assault weapons and high-capacity ammunition magazines and universal background checks for all firearm purchases. His advisory also urges a “significant increase” in funding for research on gun injuries and deaths, as well as greater access to mental health care and trauma-informed resources for people who have experienced firearm violence.”
  • NPR discusses what the declaration will do.
  • The U.S. Public Health Service Task Force issued a draft recommendation today which “concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for food insecurity on health outcomes in the primary care setting.” The public comment period ends on July 22, 2024.
  • Reg Jones, writing in FedWeek, explains “Earning, Accumulating and Using Sick Leave in the Federal Government.”

From the public health and medical research front,

  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention warned clinicians, health authorities and the public Tuesday about an increased risk for dengue virus infections in the United States because of the record-breaking global incidence of the mosquito-borne viral disease.
    • “In the first six months of 2024, countries in the Americas have reported more than 9.7 million dengue cases, twice as many as in all of 2023, exceeding the highest number ever recorded in a single year, the CDC said in a health advisory. Puerto Rico declared a public health emergency because of the unusually high number of cases reported in the winter and spring, the dry season, when dengue cases are typically low.
    • “Since January, 745 dengue cases have been identified among U.S. travelers who became infected abroad, the agency said. Dengue cases typically increase during the warmest months that are yet to come. Last year, there were 1,829 travel-associated cases in the U.S. * * *
    • “With increased global and domestic incidence of dengue, the CDC is urging health-care providers to be on the lookout for dengue among people with fever who have been in areas with dengue transmission within 14 days of the start of illness. Infants, pregnant people, adults over 65 years old and people with certain medical conditions are at increased risk for severe dengue.”
  • Beckers Hospital Review lets us know,
    • “Teva Pharmaceuticals is launching the first authorized generic of Victoza, the first generic GLP-1 product available in the United States.
    • “By launching an authorized generic for Victoza (liraglutide injection 1.8mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, SVP, Head of U.S. Commercial Generics at Teva, said in a June 24 news release.”
  • Highlighting the importance of a generic GLP-1 product is this Wall Street Journal article reporting that
    • “Blockbuster obesity drug Wegovy has been approved in China, opening the door for maker Novo Nordisk to begin selling it in the world’s second-largest economy, where the appetite for similar treatments is surging. * * *
    • “Novo Nordisk’s Ozempic drug—which contains the same semaglutide active ingredient as Wegovy—was approved to treat diabetes in China in 2021. Sales of the drug in the country more than doubled on year in 2023, reaching 4.82 billion Danish kroner ($693.6 million).
    • “Demand for weight-loss drugs is surging in China, where the proportion of overweight and obese adults reached almost 51% in 2022, creating a frenzy among local manufacturers to develop their own versions of the popular treatments, especially as Novo Nordisk’s semaglutide patent expires there in 2026, which will pave the way for generic versions.”
  • MedPage Today notes,
    • “Disrupted circadian rhythms in cognitively normal adults were tied to higher subsequent amyloid-beta levels, prospective data showed.
    • “Higher daily variability at baseline — an indicator of fragmented 24-hour activity rhythms — was associated with higher PET amyloid burden 8 years later (β=0.15, P=0.02) after adjusting for age, sex, APOE4 status, and other factors, according to Julia Neitzel, PhD, of Erasmus University Medical Center in Rotterdam, the Netherlands, and co-authors. * * *
    • “Considerable interest surrounds the role of sleep dysfunction in the development of Alzheimer’s disease and dementia,” observed Matthew Pase, PhD, of Monash University in Victoria, Australia, who wasn’t involved with the study.
    • “If poor sleep contributes to dementia, improving sleep symptomatology could be one strategy to lower dementia risk,” he told MedPage Today.
  • NPR discusses why “Your gut microbes may influence how you handle stress.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “The University of Alabama System’s board of trustees unanimously approved an agreement to acquire Ascension St. Vincent’s Health System.
    • “Birmingham-based UAB will assume ownership of all Ascension St. Vincent’s care sites under the agreement, announced June 25. The transaction still needs approval from federal regulators and the Catholic Church. UAB and Ascension expect the $450 million deal to close in the fall of 2024, according to the Shelby County Reporter.
  • and
    • identifies the twenty most socially responsible hospitals in the U.S., per Lown Institute. Duke Regional Hospital, in Durham, NC, leads the pack.
  • Per Fierce Pharma,
    • “Physicians don’t mind patients choosing at-home testing options over coming in for an in-person clinic visit—in fact, they overwhelmingly support it, according to the results of a new survey.
    • “Ixlayer’s report this week is based on a poll of more than 140 U.S. physicians representing a variety of specialties. All together, nearly 90% agreed that at-home tests are more convenient to many patients and can improve access to diagnostic care, and almost as many said they believe offering at-home testing options can help speed up diagnoses and, ultimately, improve patient outcomes.
    • “There is a large subset of my patients where making routine office visits is difficult, either complicated by age, travel time, costs, or time constraints. So I see having a convenient, at-home solution as a plus for improving medical care,” one of the survey’s respondents said.
    • “The overwhelming majority of the doctors surveyed, 91% of the group, said they were open to providing at-home testing kits to their patients, and 80% agreed that the remote tests could support or even enhance the healthcare system’s existing workflows.

Friday Factoids

David Ermer–AHRQ, CDC, Congress, Employee Wellness Programs, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • STAT News reports,
    • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
    • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
    • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
    • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
  • BioPharma Dive informs us,
    • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
    • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
    • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
    • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
    • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
  • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
  • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
  • The political ball is in the Biden Administration’s court.

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Health Day lets us know,
    • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
    • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
    • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
    • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
    • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
  • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
  • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
    • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
    • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
    • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
    • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
  • Per Healthcare Dive,
    • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
    • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
    • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
  • and
    • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
    • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
    • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
  • Per Fierce Healthcare,
    • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
    • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
    • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
    • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
  • HR Dive offers five stories on the rise of wellness benefits.

Tuesday Tidbits

David Ermer–ACA, AHRQ, FDA, Medical / Rx research, Medicare, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “The rate of uninsured Americans is expected to rise over the next decade, largely erasing coronavirus pandemic-era gains as subsidies for plans in the Affordable Care Act marketplaces and policy stipulations keeping low-income people on Medicaid expire, according to new projections from the Congressional Budget Office.
    • “This year, just 7.7% of Americans, or 26 million people, are uninsured, according to the CBO. In comparison, 10.3% or 33.2 million Americans were uninsured in 2019.
    • “Yet an estimated 1.7 million people — mostly working-age adults — will become uninsured on average every year until the uninsured rate swells to 8.9% in 2034, the CBO projects.”
  • Modern Healthcare reports,
    • “Novant Health ended its 16-month pursuit of a $320 million deal to acquire two North Carolina hospitals from Community Health Systems after a federal appellate court on Tuesday dealt it a harsh blow.
    • “The U.S. Court of Appeals for the Fourth Circuit hit Novant’s proposed acquisition of Mooresville-based Lake Norman Regional Medical Center when a panel voted 2-1 to grant the Federal Trade Commission’s motion to stop that proposal pending appeal. Lake Norman Regional Medical Center was one of two hospitals Novant sought to purchase from Community Health Systems, along with Statesville-based Davis Regional Medical Center.
    • “A Novant spokesperson said the health system doesn’t see a way to finalize the deal given the FTC’s “continued roadblocks.” Winston-Salem, North Carolina-based Novant announced plans in February 2023 to acquire the two hospitals from Franklin, Tennessee-based Community Health Systems.”
  • Beckers Hospital Review tells us,
    • “Spending on drugs purchased at discounted 340B prices across all participating facilities went up 19% annually between 2010 and 2021, according to a June 17 report from the Congressional Budget Office. 
    • “Established by Congress in 1992, the 340B drug pricing program allows qualifying hospitals and clinics that treat low-income and uninsured patients to purchase some drugs at a discounted rate of between 25% and 50% off their normal price.
    • “Enrollment in the 340B program has drastically increased in recent years, driving up spending and also leading to more disputes between covered entities who need to obtain affordable medications for uninsured or underinsured patients and drugmakers who need to protect company profits and resources. 
    • “Cancer drugs, anti-infective agents, and immunosuppressants accounted for 70% of total 340B spending in 2021 — up from 58% in 2010 — according to data from the Health Resources and Service Administration, which was analyzed by the Congressional Budget Office.” 
  • The U.S. Preventive Services Task Force today gave a B grade to a recommended that clinicians provide or refer children and adolescents 6 years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.
  • STAT News adds,
    • “On Tuesday, the United States Preventive Services Task Force issued recommendations encouraging clinicians to provide or refer children and adolescents 6 years or older with a high body mass index to comprehensive, intensive behavioral interventions. That counters last year’s recommendation by the American Academy of Pediatrics to consider obesity drugs for kids 12 and older whose weight tops growth charts, along with encouraging better nutrition, physical activity, and behavioral therapy from age 6 on up. 
    • “The USPSTF called evidence on the benefits of pharmacotherapy “inadequate” due to the small number of studies and limited data on long-term treatment harms, asserting that at least two years of follow-up are needed to gauge the long-term outcomes of drug therapy. That assessment would go beyond BMI to include metabolic health and psychosocial functioning, among other impacts. 
    • “Wanda Nicholson, task force chair and senior associate dean of diversity and inclusion at the George Washington University School of Public Health, said the evidence is clear to support high-intensity behavioral interventions to help children and adolescents lose weight and gain better quality of life. It’s less than clear for the four drugs discussed in the task force’s analysis of current research, she said. The drugs are semaglutide (sold as Wegovy for weight loss/Ozempic for diabetes), liraglutide (Saxenda/Victoza), orlistat (Xenical, Alli), and phentermine/topiramate (Qsymia). * * *
    • “A child’s BMI — a measure many view as flawed — is considered high if it’s at or above the 95th percentile for age or sex. Nearly 20% of U.S. children fall into that category. The prevalence of high BMI rises with age and is higher among Hispanic/Latino, Native American/Alaska Native, and non-Hispanic Black children and adolescents and among children from lower-income families. The dissonance between the USPSTF’s and the AAP’s positions does not address criticism voiced last year over whether the focus on weight instead of health is misplaced. * * *
    • “USPSTF guidance from 2017 focused on screening before intervention, but the new statement instead moves directly to behavioral methods to promote a healthy weight while stopping short of suggesting GLP-1 drugs such as Wegovy. It’s a recognition that screening has become a routine part of primary care.
    • “Those intensive behavioral interventions, intended to help children achieve a healthy weight while improving their quality of life, entail 26 or more hours over one year with a health professional. That might mean physical activity, support for weight-related behavior change, and information about healthy eating.”
  • MedPage Today also discusses today’s USPSTF recommendationj.

From the public health and medical reseaarch front,

  • The International Foundation of Employee Benefit Plans offers guidance on designing the best oncology benefits.
  • The National Cancer Institute posted its latest research highlights.
  • Beckers Hospital Review points out,
    • “Many physicians in obesity medicine have observed a trend among their patients: Those with obesity begin taking a weight loss drug like Wegovy, and their other chronic conditions improve or clear up entirely. “Many physicians in obesity medicine have observed a trend among their patients: Those with obesity begin taking a weight loss drug like Wegovy, and their other chronic conditions improve or clear up entirely. 
    • “As a result, some physicians are embracing an “obesity first” approach in which they treat obesity first with drugs approved for that purpose, anticipating other related conditions, such as high blood pressure and arthritis, will also improve as patients begin to lose weight, according to  a June 19 report from The New York Times. 
    • “We are treating the medical condition of obesity and its related complications at the same time,” Stefie Deeds, MD, an internist and obesity medicine specialist at a private practice in Seattle, told the Times. Dr. Deeds is also an assistant professor at the University School of Washington in Seattle. 
    • “The approach marks a shift from traditional medical practice in which patients with obesity are prescribed a number of medications to treat conditions that often accompany obesity, and advised to make diet and exercise changes. In some cases, patients are happy to be taking a single drug, experts said. 
    • “But there’s no firm consensus that this approach works, and not all physicians are on board. A primary care physician told the Times he leans toward an “obesity last” approach in which he starts by treating obesity-related conditions with drugs known to work for those conditions. If related conditions didn’t improve, only then would he discuss obesity drugs with patients.” 
  • MedPage Today notes, “Adding financial incentives to meal incentive therapies for for teens with severe obesity helped improve weight and body fat, but not cardiometabolic risk factors, a randomized study found.”
  • Per BioPharma Dive,
    • “Intra-Cellular Therapies plans to seek clearance to sell its medicine Caplyta for patients with depression after a second-late stage study of the drug succeeded. 
    • “Caplyta, also known as lumateperone, is currently approved for patients suffering from schizophrenia and depressive episodes associated with bipolar disorder. Intra-Cellular now wants to add major depressive disorder to the list.
    • T”he latest study followed 480 patients already medicated to treat depression. Patients who randomly received Caplyta as an add-on to existing therapy showed a significantly better response on scales that measure depression symptoms compared with participants who received a placebo, Intra-Cellular said Tuesday.”
  • The Washington Post reports for what it’s worth.
    • “Sedentary coffee drinkers had a 24 percent reduced risk of mortality compared with those who sat for more than six hours and didn’t drink coffee, according to the lead author of a study published recently in the journal BMC Public Health.”
    • “The finding, which was not part of the original article, was calculated at The Washington Post’s request and provided by Huimin Zhou, a researcher at the Medical College of Soochow University’s School of Public Health in China and the lead author of the study on coffee and health.”

From the U.S. healthcare business front,

  • MedTech Dive relates,
    • “Boston Scientific has agreed to acquire Silk Road Medical, a maker of stroke prevention devices, for $27.50 per share in cash, or an equity value of about $1.26 billion, the companies said Tuesday.
    • “Silk Road’s products are the only commercially available devices for use during a minimally invasive procedure called transcarotid artery revascularization (TCAR) to treat patients with carotid artery disease, according to Boston Scientific.
    • “We view the deal as largely inexpensive for Boston yet meaningful enough to move the needle on growth in the peripheral interventions business,” J.P. Morgan analyst Robbie Marcus said in a note to clients.”
  • Per Fierce Healthcare,
  • and
    • “Insured patients are often better off buying their generic prescriptions through their health insurance benefits than through Mark Cuban Cost Plus Drug Company, though those without insurance could find cost savings in over a quarter of their pharmacy fills, according to a study published Friday in JAMA Health Forum.
    • “Across a sample of nearly 844 million prescription pharmacy fills logged among 124 generic drugs in 2019, researchers found that nearly 100 million (11.8%) would have reduced out-of-pocket spending for patients if they had been acquired through the billionaire-backed manufacturer and distributor.”

Tuesday Tidbits

David Ermer–AHRQ, Congress, FDA, Generative AI, Medical / Rx research, Medicare, OPM, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Chief Healthcare Executive lets us know,
    • Telehealth advocates have said this year represents the Super Bowl for virtual healthcare, and the game is about at halftime.
    • On the upside, telehealth leaders remain confident that Congress will approve legislation that would allow health systems and providers to continue offering virtual care and hospital-at-home programs.
    • But lawmakers may not act until late in the fourth quarter [in other words, the expected lame duck session following the November’s national election].
  • Roll Call informs us,
    • “The Supreme Court will decide a dispute about hospital reimbursement rates under Medicare, with hundreds of hospitals arguing the government had shorted them for treating low-income patients.
    • More than 200 hospitals in more than 30 states, led by Advocate Christ Medical Center in Illinois, have asked the justices to overturn a lower court ruling that allows the Department of Health and Human Services to reimburse a lower rate for treating a high proportion of low-income patients. The dispute, which the hospitals said could affect more than $4 billion in federal funds, hinges on how to determine which patients count toward that reimbursement rate and follows a 2022 Supreme Court decision over the same program.
    • The justices announced Monday that they would decide the case, which means oral arguments and a decision would come in the next term that starts in October.
  • Federal News Network tells us,
    • “The Chief Human Capital Officers (CHCO) Council has a new face taking the lead to collaborate on human capital initiatives and strategies across government.”
    • “Colleen Heller-Stein, formerly deputy CHCO at the Treasury Department, has stepped in as executive director of the CHCO Council, Federal News Network has learned. The senior-level position within the Office of Personnel Management leads agency CHCOs and other human capital leaders to innovate on best practices for managing the recruitment and retention of the federal workforce.
    • “Heller-Stein is the first career federal executive to serve in the CHCO Council leadership role. She took over the position a few weeks ago from Latonia Page, who had been working as acting executive director of the CHCO Council since September 2023. Prior to Page’s time on the job, Margot Conrad — currently deputy chief of staff at OPM — served as the council’s executive director for about two and a half years.”‘

From the public health and medical research front,

  • KFF expresses concern about the general unavailability of bird flu tests.
    • “A recent rule that gives the FDA more oversight of lab-developed tests may bog down authorization. In a statement to KFF Health News, the FDA said that, for now, it may allow tests to proceed without a full approval process. The CDC did not respond to requests for comment.”
    • “But the American Clinical Laboratory Association has asked the FDA and the CDC for clarity on the new rule. “It’s slowing things down because it’s adding to the confusion about what is allowable,” said Susan Van Meter, president of the diagnostic laboratory trade group.
    • “Labcorp, Quest Diagnostics, and other major testing companies are in the best position to manage a surge in testing demand because they can process hundreds per day, rather than dozens. But that would require adapting testing processes for their specialized equipment, a process that consumes time and money, said Matthew Binnicker, director of clinical virology at the Mayo Clinic.
    • “There’s only been a handful of H5N1 cases in humans the last few years,” he said, “so it’s hard for them to invest millions when we don’t know the future.”
  • The Wall Street Journal offers guidance on how people can improve the deathbed experiences of loved ones.
  • Beckers Hospital Review points out,
    • “Baltimore-based Johns Hopkins School of Nursing is addressing community needs by taking primary care door to door, NPR reported June 11.
    • “The Neighborhood Nursing pilot program consists of a team of nurses and community health workers that make weekly visits to three apartment buildings in Johnston Square, a predominantly Black disadvantaged neighborhood. The visits are free to patients and are not dependent on health status, income or what type of insurance, if any, they have. Visits are done in people’s homes, senior centers, lobbies, libraries and anywhere else people can be found. 
    • “In the time it has run, Neighborhood Nursing has successfully helped patients receive care and has expedited physicians’ appointments as needed. However, the greatest challenge is funding.”
  • Per Healio,
    • “From 2010 to 2021, most high and moderate risk factors for preeclampsia increased in the U.S.
    • “Multifetal gestation and nulliparity were the only preeclampsia risk factors to decrease during this period.”
  • Per BioPharma Dive,
    • “Pharmaceutical companies employ many different strategies when building their cancer drug pipelines, but one recent commonality among them is a belief in the future of targeted therapies known as antibody-drug conjugates.
    • “Many of the leading cancer drugmakers have at least one or two antibody-drug conjugates, or ADCs, in development. Others, such as Pfizer, Johnson & Johnson and Merck & Co., have used buyouts or partnerships to build an ADC portfolio.
    • “One of the best-selling ADCs on the market is AstraZeneca and Daiichi Sankyo’s Enhertu, which brought in combined sales of $2.5 billion in 2023, almost double the year before. The two companies formed a $7 billion alliance around Enhertu in 2019 and since then, the drug has secured multiple approvals and changed the way some breast cancers are treated.
    • “Over that time, AstraZeneca has made ADCs a more substantial part of its overall pipeline alongside radiopharmaceuticals and immunotherapies, giving the company many potential combinations to work with, said Carlos Doti, vice president and head of medical affairs for its U.S. oncology division.”

From the U.S. healthcare business front,

  • Beckers Payer Issues notes,
    • “CMS must recalculate the Medicare Advantage star ratings for Anthem Blue Cross Blue Shield of Georgia, a federal judge ruled June 10. 
    • “The judge ruled partially in favor of Elevance Health, which sued to challenge CMS’ star ratings methodology in December. The insurer sought new ratings for several of its subsidiaries, but the judge ruled CMS needs to recalculate ratings only for BCBS of Georgia. 
    • “Elevance’s challenge focused on CMS’ use of the Tukey method, a change announced by CMS in a 2020 final rule and implemented in 2024 star ratings. The method removes extreme outliers from measure scores to prevent outliers from affecting all MA contracts, making it more difficult for plans to earn a high star rating. In 2022, a final star ratings rule from CMS did not mention the new change, which the agency added back in the 2023 rule, citing an inadvertent removal. 
    • “CMS also limits scoring changes to 5% annually. In the lawsuit, Elevance said CMS should have factored in those limits before adding the Tukey change back in 2023 versus the other way around.
    • “Randolph Moss, a judge for the U.S. District Court in Washington, D.C, ruled CMS violated the Administrative Procedure Act in applying the Tukey methodology. However, Mr. Moss ruled Elevance proved the Tukey method affected the star rating only for BCBS of Georgia and not the other plans for which it sought revised ratings.” 
  • This opinion and last week’s Scan Health opinion may wind up before the U.S. Court of Appeals for the D.C. Circuit.
  • Per Healthcare Dive,
    • “Just three days before bankrupt Steward Health Care was set to run out of funds, the health system said it’s struck a deal to capture $225 million of additional debtor-in-possession financing to keep its operations afloat during Chapter 11 proceedings.
    • “The funds come from Steward’s FILO lenders, which include private credit lenders Sound Point Capital and Brigade Agency Services, as well as Chamberlain Commercial Funding, according to a press release shared with Healthcare Dive. 
    • “Steward will present the deal — which the system says is sufficient to finance operations prior to its July asset sales — for approval in bankruptcy court later this week.”
  • According to BioPharma Dive,
    • “Approval of Eli Lilly’s experimental Alzheimer’s disease drug donanemab would help drive sales of Eisai and Biogen’s rival medicine Leqembi, analysts wrote after a Food and Drug Administration panel on Monday supported clearance of donanemab.
    • “A rising tide lifts all boats, in our view,” wrote Myles Minter, an analyst at William Blair, in a client note. Donanemab works similarly to Leqembi by eliminating from the brain a toxic protein called amyloid that scientists see as linked to Alzheimer’s progression.”
  • McKinsey & Co. discusses the ongoing digital transformation in healthcare.
  • The International Foundation of Employee Benefit Plans shares useful insights on the final rules amending the Fair Labor Standards Act that take effect on July 1.

Midweek Update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The House Appropriations Committee tells us, “Today, the House Appropriations Financial Services and General Government Subcommittee met to consider its Fiscal Year 2025 bill. The measure was approved by the Subcommittee.”
  • This bill provides appropriations for OPM and the FEHBP. The Committee summary of the bill describes its OPM appropriations as follows —
    • “Provides $477 million for the Office of Personnel Management (OPM), which is $31.4 million below the FY25 Budget Request and $29.1 million above the FY24 enacted level.”
  • Govexec informs us,
    • “Senate Democrats have vowed to move quickly on legislation protecting Americans’ access to in vitro fertilization and other forms of assistive reproductive technology, including a provision expanding federal workers’ access to those treatments as part of the government’s employer-sponsored health insurance program.
    • “On Monday, Sens. Tammy Duckworth, D-Ill., Patty Murray, D-Wash., and Cory Booker, D-N.J., introduced the Right to IVF Act, a repackaging of three separate previously introduced bills on reproductive health services.
    • “Included is the Family Building FEHB Fairness Act, first introduced last year by Duckworth, which would require the Federal Employees Health Benefits Program to cover additional costs associated with IVF, and would expand coverage to all types of assisted reproductive technology, such as gamete and zygote intrafallopian transfer.”
  • Govexec also pointed out this OPM Inspector General brief that summarizes OPM OIG recommendations that have been open for more than six months as of March 31, 2024. The FEHBlog understands why the FEHB open recommendations remain outstanding
  • Healthcare Dive lets us know,
    • “Congress appears to be inching toward injecting more transparency into a controversial program that forces drugmakers to give safety-net hospitals steep discounts on drugs.
    • “It would be a win for pharmaceutical manufacturers, which have long lobbied that hospitals be required to account for their savings in the 340B program — or that it be overhauled entirely.
    • “The latter appears unlikely, after lawmakers on both sides of the aisle expressed blanket support for 340B during a House Oversight and Investigations subcommittee hearing on Tuesday. However, members said they approved of more oversight to try and stop financial gaming in the program.
    • “Though “we’re all in support of 340B … I think nearly all of us agree that the status quo is not acceptable,” said Rep. Larry Bucshon, R-Ind.”
  • Yesterday, the U.S. Preventive Services Task Force released a final recommendation concerning “Falls Prevention in Community-Dwelling Older Adults: Interventions.” Its recommendations align with the recommendations currently in force.
  • Thompson Reuters Practical Law relates,
    • “In litigation under the No Surprises Act (NSA), a district court concluded that there is no cause of action for health providers to enforce awards involving surprise billing disputes under the NSA’s independent dispute resolution (IDR) process (Guardian Flight LLC & Med-Trans Corp. v. Health Care Serv. Corp., (N.D. Tex. May 30, 2024)).”
  • The American Hospital Association News shares the organization’s “comments [submitted’ June 5 on the Centers for Medicare & Medicaid Services’ inpatient prospective payment system proposed rule for fiscal year 2025, expressing support for several provisions, including certain policies supporting low-volume and Medicare-dependent hospitals, and several aspects of CMS’ quality-related proposals. However, AHA raised concerns about the rule’s proposed payment updates.”

From the public health and medical research front,

  • CNN reports,
    • “About 61% of US adults will have cardiovascular disease by 2050, new research from the American Heart Association predicts. The biggest driver of this trend will be the large number of people who have or will develop high blood pressure, which makes them much more likely to develop dangerous problems like a heart attack or stroke.
    • “Other cardiovascular problems include heart attacks, arrhythmias like atrial fibrillation or a-fib, heart failure and congenital heart disease. * * *
    • In the research published Tuesday, the association predicts that 45 million adults will have some form of cardiovascular disease – excluding high blood pressure – or will have a stroke in 2050, up from 28 million in 2020.
  • The New York Times reports,
    • One of the nation’s premier medical advisory organizations has weighed in on long Covid with a 265-page report that recognizes the seriousness and persistence of the condition for millions of Americans.
    • More than four years since the start of the coronavirus pandemic, long Covid continues to damage many people’s ability to function, according to the National Academies of Sciences, Engineering and Medicine, a nongovernmental institution that advises federal agencies on science and medicine.
  • and
    • “A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.
    • “The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.
    • “In the coming weeks, the F.D.A. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant.
    • “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.”
  • Per Biopharma Dive,
    • “A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.”A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.
    • “Data presented at the American Society of Clinical Oncology annual meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.
    • “The researchers are now comparing the saliva test to several screening methods such as fast MRI scans and prostate-specific antigen (PSA) blood tests to determine the best approach.”
  • and
    • “Eli Lilly’s drug tirzepatide — sold as Zepbound for obesity — continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the study’s success earlier this year, but the full data will provide a more complete view of tirzepatide’s potential. The abstract’s release comes one day after Viking Therapeutics released trial data for its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug.”
  • The Institute for Clinical and Economic Research “today posted a Protocol outlining how it will conduct the fourth annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. These standards were developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies.”
  • Per MedPage Today,
    • “The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).”The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).
    • “Healthcare providers should discuss and offer doxy PEP to people in these populations with a history of at least one bacterial STI — specifically syphilis, chlamydia, gonorrhea — in the last 12 months, Lindley Barbee, MD, of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, and colleagues wrote in Morbidity and Mortality Weekly Report.”
    • “Doxy PEP represents the first new STI prevention tool in decades, at a time when innovation in the nation’s fight against STIs is desperately needed,” said Barbee in a CDC statement.
  • The National Institutes of Health announced,
    • “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”
  • The Washington Post reports, “Male birth control gel shows promise in early-stage clinical trials. “A National Institutes of Health official said the findings marked a milestone, even if the product is probably years away.”

From the U.S. healthcare business front,

  • KFF informs us,
    • The Medical Loss Ratio (MLR) provision of the Affordable Care Act (ACA) limits the amount of premium income that insurers can keep for administration, marketing, and profits. Insurers that fail to meet the applicable MLR threshold are required to pay back excess profits or margins in the form of rebates to individuals and employers that purchased coverage.
    • In the individual and small group markets, insurers must spend at least 80% of their premium income on health care claims and quality improvement efforts, leaving the remaining 20% for administration, marketing expenses, and profit. The MLR threshold is higher for large group insurers, which must spend at least 85% of their premium income on health care claims and quality improvement efforts. MLR rebates are based on a 3-year average, meaning that rebates issued in 2024 will be calculated using insurers’ financial data in 2021, 2022 and 2023 and will go to people and businesses who bought health coverage in 2023.
    • This analysis, using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, finds that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2024. Since the ACA began requiring insurers to issue these rebates in 2012, a total of $11.8 billion in rebates have already been issued to individuals and employers, and this analysis suggests the 2012-2024 total will rise to about $13 billion when rebates are issued later this year.
  • TechTarget calls our attention to the fact that “As providers seek to advance patient-centered care, many behavioral health organizations are turning to their EHR vendors to support integrated care models, according to a KLAS report.” Yippee.
  • Beckers Hospital Review lets us know,
    • “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. 
    • “The sales will be conducted in two rounds. The first round, which includes the health system’s physician group, Stewardship Health, and all Steward hospitals excluding its Florida facilities and some of the Texas hospitals, will have a bid deadline of June 24 and a first sale hearing July 11.
    • “The second round includes Steward’s Florida hospitals and four of its Texas facilities, with a bid deadline of Aug. 12 and a sale hearing of Aug. 22.”
  • Beckers Payer Issues tells us about the payers that landed on the 2024 Fortune 500.

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, FDA, Medicare, Mental health care, NCQA, No Surprises Act, Obesity, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Bloomberg News reports,
    • “Federal agencies are aiming to issue final regulations this year that aim to make the arbitration process more efficient for No Surprises Act health care payment disputes, an IRS official said.
    • “The regulations are a priority for the Treasury, Labor, and Health and Human Services departments, said IRS Office of Chief Counsel Senior Technician Reviewer Kevin Knopf during a Thursday panel at the Federal Bar Association’s Insurance Tax Seminar.
    • “The proposed rules aim to reduce certain administrative fees tied to participating in an independent dispute resolution system that arbitrates clashes between medical providers and health insurers over payments. They also aim to clarify requirements to prove that a dispute is eligible for the dispute resolution process.” 
  • The Department of Health and Human Services (“HHS”) announced,
    • “Today, on National Heat Awareness Day, the U.S. Department of Health and Human Services (HHS) is launching a new tool to help communities prepare for extreme heat and prevent heat-related illness, especially among those most at risk. The Heat and Health Index (HHI) is the first nationwide tool to provide heat-health outcome information at the ZIP code level. The HHI will help state and local officials identify communities, at the zip code level, most likely to experience negative health outcomes from heat, ensure that outreach and medical aid reach the people who need it most, and help decision-makers prioritize community resilience investments.”
  • The National Committee for Quality Assurance released a fact sheet about Mental Health Awareness Month, which ended today.
  • HHS’s Agency for Health Research and Quality tells us,
    • “As we round out Older Americans Month, it is crucial that we continue to recognize the significant contributions of older adults and the urgent need to transform and improve their healthcare. Our current system is ill-equipped to meet the complex needs of older adults, who often contend with multiple chronic conditions. This inadequacy leads to fragmented and sub-optimal care, resulting in poor health outcomes, avoidable adverse events, hospitalizations, institutionalization, and increased costs. 
    • “To meet these challenges, AHRQ remains committed to using its research capabilities to build the evidence base and identify solutions ready for action. To do so, the agency has released a Special Emphasis Notice to announce its strong interest in funding health services research to improve care quality for older adults.  Research proposals for enhancing service access, delivery, organization, and equitable distribution are welcome. In particular, AHRQ seeks research to address critical questions related to the development, implementation, evaluation, and scalability of person-centered models of care to optimize older adults’ physical and mental health, functional status, and overall well-being.” 
  • BioPharma Dive informs us,
    • The Food and Drug Administration on Friday approved a third vaccine for respiratory syncytial virus, clearing a shot from biotechnology company Moderna one year after granting a green light to vaccines from GSK and Pfizer.
    • The vaccine, dubbed mResvia, is for the prevention of disease caused by respiratory syncytial virus, or RSV, in adults 60 years of age and older. Experts from the Centers for Disease Control and Prevention are expected to meet next month to provide recommendations on the shot’s use. Moderna had said it expects the vaccine to be available in time for the fall immunization season in the U.S.
  • The Centers for Disease Control (CDC) adds,
    • “The RSV vaccine is not currently an annual vaccine, meaning people do not need to get a dose every RSV season. Currently, CDC recommends only a single dose of RSV vaccine for adults ages 60 and older, using shared clinical decision-making. Additional surveillance and evaluation activities are ongoing to determine whether older adults might benefit from receiving additional RSV vaccines in the future. So far, RSV vaccines appear to provide some protection for at least two RSV seasons.”

From the public health and medical research front,

  • HHS posted a “Fact Sheet: In Response to H5N1, HHS and USDA Focus on Protecting Farmworkers.” For more information on the ongoing response, please visit FDA, CDC, and USDA’s ongoing H5N1 update pages.
  • STAT News reports,
    • “There are a lot of reasons why updated data on Pfizer’s Lorbrena, a treatment for non-small cell lung cancer, might not seem to be a big deal. The results are an update on the clinical trial that resulted in the Food and Drug Administration granting Lorbrena full approval in 2021, so in a sense they are not even that new. For Pfizer investors, Lorbrena isn’t that big a deal, either. The medicine, for patients whose lung tumors have particular genetic mutations, generated only $575 million last year — an amount that is up 57% from the year prior, but that still constitutes only 1% of the drug giant’s annual sales.
    • “But there is one number that makes the Lorbrena data quite eye-catching: In the updated data, the daily pill decreased the risk that cancer would progress or that a patient would die by 81% over five years.
    • “That’s a stunning number, especially when one considers that Lorbrena was not being compared to an inert placebo but to Xalkori, another Pfizer targeted cancer drug.
    • “Put a different way, 60% of the patients who received Lorbrena were alive and had not seen their tumors progress in the five years of the study, compared to 8% who received Xalkori.
    • “The data are being presented at the annual meeting of the American Society of Clinical Oncology and published in the Journal of Clinical Oncology.“
  • BioPharma Dive informs us,
    • “People with chronic myeloid leukemia, a simmering cancer of the bone marrow, are often treated with one of several targeted drugs that, over the past two decades, have helped to substantially prolong survival from the disease.
    • “Study results revealed Friday suggest that Scemblix, the newest of those therapies, can be both safer and more effective, potentially supporting wider use of it as an initial treatment. The results are from a late-stage clinical trial run by Scemblix’s maker, Novartis, and will be presented at the American Society of Clinical Oncology’s annual meeting.
    • “In the trial, dubbed ASC4FIRST, Scemblix led to treatment responses in significantly more participants than did other targeted drugs, which included the mainstay therapy Gleevec as well as more recently introduced medicines. Additionally, more people given Novartis’ drug experienced what’s called a “deep molecular response,” which over time can be considered a remission and allow treatment to be stopped.
    • “Study researchers also reported “markedly favorable safety and tolerability” for Scemblix, compared to Gleevec and the other so-called kinase inhibitors it was tested against.”
  • Medscape notes,
    • A personalized diet, created by integrating microbiome analysis with artificial intelligence (AI) algorithms, is a promising approach to the management of irritable bowel syndrome(IBS) symptoms, leading to enhanced symptom relief and greater gut microbiome diversity than a standard low–fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet, new research suggests.
  • and
    • “About 9 out of 10 people will have a genetic difference in their DNA that can impact how they respond to common medications,” said Emily J. Cicali, PharmD, a clinical associate at the University of Florida College of Pharmacy, Gainesville, Florida.
    • “Cicali is the clinical director of UF Health’s MyRx, a virtual program that gives Florida and New Jersey residents access to pharmacogenetic (PGx) tests plus expert interpretation by the health system’s pharmacists. Genetic factors are thought to contribute to about 25% or more of inappropriate drug responses or adverse events, said Kristin Wiisanen, PharmD, dean of the College of Pharmacy at Rosalind Franklin University of Medicine and Science in North Chicago, Illinois.
    • “Pharmacogenetics helps consumers avoid drugs that may not work well for them or could cause serious adverse events. It’s personalized medicine,” Cicali said.
    • “Through a cheek swab or blood sample, the MyRx program — and a growing number of health system programs, doctors’ offices, and home tests available across the United States — gives consumers a window on inherited gene variants that can affect how their body activates, metabolizes, and clears away medications from a long list of widely used drugs.”
  • The Wall Street Journal recounts the experiences of readers months after stopping GLP-1 drug treatment.

From the U.S. healthcare business front,

  • The Employee Benefit Research Institute relates.
    • According to findings of the Employee Benefit Research Institute (EBRI)/Greenwald Research Consumer Engagement in Health Care Survey, most plan enrollees are satisfied with their health plan, but high-deductible health plan (HDHP) enrollees are less likely to be extremely or very satisfied than traditional plan enrollees.
    • HDHP and traditional plan enrollees are both satisfied with the quality of care received and choice of doctors.
    • Differences in overall satisfaction may be driven by cost sharing. HDHP enrollees are less likely than traditional plan enrollees to be extremely/very satisfied with out-of-pocket expenses for prescription drugs and other health care services.
  • Beckers Hospital Review reports,
    • “The Justice Department has rejected bankrupt Dallas-based Steward Health Care’s suggested auction timeline for its physician group Stewardship Health to be sold to UnitedHealth Group’s subsidiary Optum. 
    • “In a May 28 bankruptcy court filing, obtained by Becker’s, Brian Boynton, principal deputy attorney general for the justice department, detailed how the debtor-in-possession financial deal between Steward and its landlord Medical Properties Trust interferes with the health system’s “obligation to comply with the United States’ antitrust review” of the Stewardship Health, Optum deal and should not be approved.”
  • and calls attention to an American Hospital Association report identifying the inpatient and outpatient services that are biggest money losers for hospitals.
  • Healthcare Dive points out,
    • “Most of the nation’s leading nonprofit healthcare providers reported progress toward financial recovery during earnings for the quarter ended March 31.
    • “However, improvements varied widely by health system, and the industry at large has a long way to go before it is back to profitability levels enjoyed pre-pandemic — if it fully rebounds at all, analysts told Healthcare Dive.
    • “Nonprofits struggled with cost challenges, confirming reports from analysts at credit rating agencies Moody’s Ratings and Fitch Ratings that predicted expenses, particularly labor costs, would continue to vex providers in 2024.
    • “Analysts also expected this year to bring a bifurcated financial recovery for the sector, where health systems that could successfully contain costs would recover more quickly.
    • “With early financial data now in for 2024, that expectation appears to be playing out.”

Thursday Miscellany

David Ermer–AHRQ, CDC, Congress, FDA, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Hill informs us,
    • “Blockbuster weight-loss drug Wegovy could bankrupt the U.S. health care system unless the price drops, according to a staff report released Wednesday from the office of Senate Health Committee Chair Bernie Sanders (I-Vt.). 
    • “Unless prices dramatically decline, Wegovy and weight loss drugs could push Americans to spend $1 trillion per year on prescription drugs, the report concluded.
    • “Pricing drugs based on their value cannot serve as a blank check, or the sole determinant for how we understand what to pay for essential goods,” the report stated. As important as these drugs are, they will not do any good for the millions of patients who cannot afford them.” 
    • “The report ups the pressure from Sanders on Danish drugmaker Novo Nordisk to lower the price of Wegovy and Ozempic.”
  • The good Senator has a point here. Drug manufacturers need a dose or two of price reasonableness.
  • STAT News reports,
    • “A House subcommittee on Thursday advanced legislation that would extend some pandemic-era telehealth policies in Medicare for two years, bringing the panel’s approach in line with another committee.
    • “During the pandemic, Congress extended flexibilities that changed what kinds of care Medicare beneficiaries could receive over telehealth and where. Originally, the House Energy and Commerce health subcommittee had considered a bill that would have enacted the policies permanently, but amended the legislation Thursday to pare it down to a two-year extension. The bill passed to the full committee unanimously on a 21-0 vote.
    • “The approach is in line with that of another panel, the House Ways and Means Committee, which passed a two-year extension earlier this month. Both bills include similar provisions that would pay for the extension in part through reforms to the way in which pharmacy middlemen operate.”
  • American Hospital Association News shares,
    • “The AHA shared a series of proposals to strengthen rural health care with the Senate Finance Committee for a hearing May 16 titled, “Rural Health Care: Supporting Lives and Improving Communities.” The proposals include policies promoting flexible payment options; ensuring fair, timely and adequate reimbursement; bolstering the workforce; and improving maternal health. During the hearing, several members focused on access to obstetric services and augmenting the number of medical residency slots awarded to rural hospitals. Jeremy P. Davis, MHA, president and CEO of AHA-member Grande Ronde Hospital in La Grande, Ore., and other health care leaders and policy researchers testified.”
  • The Department of Health and Human Services celebrates the Administration’s mental healthcare accomplishments.
  • The New York Times reports,
    • “The Food and Drug Administration on Thursday approved an innovative new treatment for patients with a form of lung cancer. It is to be used only by patients who have exhausted all other options to treat small cell lung cancer, and have a life expectancy of four to five months. * * *
    • “Each year, about 35,000 Americans are diagnosed with small cell lung cancer and face a grim prognosis. The cancer usually has spread beyond the lung by the time it is detected. * * *
    • “The drug tarlatamab, or Imdelltra, made by the company Amgen, tripled patients’ life expectancy, giving them a median survival of 14 months after they took the drug. Forty percent of those who got the drug responded.
    • “After decades with no real advances in treatments for small cell lung cancer, tarlatamab offers the first real hope, said Dr. Anish Thomas, a lung cancer specialist at the federal National Cancer Institute who was not involved in the trial.
    • “I feel it’s a light after a long time,” he added.”
  • Tammy Flanagan, writing in Govexec, discusses FEHB annuitant reactions to Part D EGWP offerings in various FEHB plans for 2024.
  • Federal News Network notes,
    • After a couple years of uncertainty, satisfaction among federal employees is beginning to rise at many agencies.
    • In a preview of the latest Best Places to Work in the Federal Government rankings, out of the top 10 agencies in each of the four categories — large, midsize and small agencies, as well as agency subcomponents — prioritizing employee engagement was the common thread, the Partnership for Public Service said.
    • “At a time when our nation faces both critical challenges and exciting opportunities at home and abroad, an engaged federal workforce is vitally important,” Max Stier, president and CEO of the Partnership for Public Service, said in a statement. “The top-ranked agencies have excelled at keeping their workforces engaged and motivated and, as a result, they are well positioned to deliver results for the public.” * * *
    • “The Environmental Protection Agency, Energy Department, Office of Personnel Management and National Credit Union Administration all moved up in the rankings and increased their overall scores.” 
  • The CDC is promoting its new and improved website.

From the public health and medical research front,

  • The New York Times informs us,
    • “With Pride events scheduled worldwide over the coming weeks, U.S. officials are bracing for a return of mpox, the infectious disease formerly called monkeypox that struck tens of thousands of gay and bisexual men worldwide in 2022. A combination of behavioral changes and vaccination quelled that outbreak, but a majority of those at risk have not yet been immunized.
    • “On Thursday, the Centers for Disease Control and Prevention warned of a deadlier version of mpox that is ravaging the Democratic Republic of Congo and urged people at risk to be vaccinated as soon as possible. No cases of that subtype have been identified outside Africa so far. But the escalating epidemic in Congo nevertheless poses a global threat, just as infections in Nigeria set off the 2022 outbreak, experts said.
    • “This is a very important example of how an infection anywhere is potentially an infection everywhere, and why we need to continue to improve disease surveillance globally,” said Anne Rimoin, an epidemiologist at the University of California, Los Angeles. * * *
    • “The C.D.C. is focusing on encouraging Americans at highest risk to become vaccinated before the virus resurges. The agency’s outreach efforts include engaging with advocacy groups and social media influencers who have broad appeal among the L.G.B.T.Q. community. In December, the agency urged clinicians to remain alert for possible cases in travelers from Congo.”
  • and
    • “Heart disease, diabetes and kidney disease are among the most common chronic illnesses in the United States — and they’re all closely connected.
    • “Adults with diabetes are twice as likely to have heart disease or a stroke compared with those who don’t have diabetes. People with diabetes — Type 1 and Type 2 — are also at risk of developing kidney disease. And when the kidneys don’t work well, a person’s heart has to work even harder to pump blood to them, which can then lead to heart disease.
    • “The three illnesses overlap so much that last year the American Heart Association coined the term cardiovascular-kidney-metabolic syndrome to describe patients who have two or more of these diseases, or are at risk of developing them. A new studysuggests that nearly 90 percent of American adults already show some early signs of these connected conditions.
    • “While only 15 percent of Americans meet the criteria for advanced stages of C.K.M. syndrome, meaning they have been diagnosed with diabetes, heart disease or kidney disease or are at high risk of developing them, the numbers are still “astronomically higher than expected,” said Dr. Rahul Aggarwal, a cardiology fellow at Brigham and Women’s Hospital in Boston and co-author of the study.
    • “The research suggests that people should pay attention to shared risk factors for these diseases early on — including excess body fat, uncontrolled blood sugar, high blood pressure and high cholesterol or triglyceride levels.”
  • BioPharma Dive points out,
    • “An experimental Roche drug helped people with obesity lose an average of nearly 19% of their body weight over six months, after adjusting for placebo, in an early-stage trial, the company said Thursday.
    • “Roche is awaiting additional data from a study of the drug, called CT-388, in people with diabetes as well as obesity. It also didn’t provide specifics on the drug’s side effect profile. CT-388 is currently only in a Phase 1 program involving 96 people. Larger and longer trials are needed before the company can ask the Food and Drug Administration for approval.
    • “Roche acquired CT-388 through a $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to capture a share of a market estimated to be worth more than $100 billion annually by early next decade.”
  • and
    • “A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.”A once-weekly form of insulin being developed by Eli Lilly proved just as effective at controlling blood sugar in adults with diabetes as commonly used daily injections, according to results from two clinical trials that were released by the drugmaker Thursday.
    • “Lilly is betting that its experimental drug, dubbed insulin efsitora alfa, could provide a longer-lasting and more convenient option than daily treatment for managing diabetes. 
    • “With efsitora, we have an opportunity to provide an innovative once-weekly solution that safely achieves and maintains A1C control, reduces treatment burden of traditional daily injections and potentially improves adherence for people with diabetes,” said Jeff Emmick, a senior vice president of product development for Lilly, in a statement on the trial results.” 
  • The National Institutes of Health Director, in her blog, discusses “Speeding the Diagnosis of Rare Genetic Disorders with the Help of Artificial Intelligence.”
  • The National Institutes of Health announced,
    • “People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.”People were more likely to develop a type of treatment-resistant hypertension when they experienced adverse effects of economic and social conditions that influence individual and group differences in health status, known as social determinants of health. Additionally, this risk was higher among Black American adults than white American adults, according to a study funded by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.
    • “Factors linked to this increased risk included having less than a high school education; a household income less than $35,000; not seeing a friend or relative in the past month; not having someone to care for them if ill or disabled; lack of health insurance; living in a disadvantaged neighborhood; and living in a state with low public health infrastructure. Apparent treatment-resistant hypertension is defined as the need to take three or more types of anti-high blood pressure medication daily and is associated with an increased risk for stroke, coronary heart disease, heart failure, and all-cause mortality.”
  • The U.S. Preventive Services Task Force released a final research plan for “Unhealthy Alcohol Use in Adolescents and Adults: Screening and Behavioral Counseling Interventions.”
  • Beckers Hospital Review alerts us,
    • “In 2023, patient falls were once again the most common sentinel event reported by healthcare organizations, according to a May 15 report from The Joint Commission.
    • “The Joint Commission defines a sentinel event as a patient safety event that results in death, permanent harm, severe temporary harm or intervention required to sustain life.
    • “The accrediting body received 1,411 reports of sentinel events in 2023, on par with the volume reported in 2022. Only a small portion of all sentinel events are reported to The Joint Commission, meaning conclusions about the events’ frequency and long-term trends should not be drawn from the dataset, the organization said.
    • “In total, 96% of healthcare organizations voluntarily reported sentinel events. About 18% of events were associated with patient death, 8% with permanent harm or loss of function, 57% with severe temporary harm and 12% with unexpected additional care or extended healthcare stays.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “One reason U.S. inflation is still high: Increases in prices for procedures to prop open clogged arteries, provide intensive care for newborns and biopsy breasts.
    • “Hospitals didn’t raise prices as early in the pandemic as supermarkets, retailers and restaurants. But they have been making up ground since then. Their increases have contributed to stubbornly high inflation readings from the consumer-price index, which in April increased 3.4% from a year ago. 
    • “Hospital prices specifically jumped 7.7% last month from a year ago, the highest increase in any month since October 2010, the Labor Department said Wednesday. * * *
    • Economists said they expect higher hospital inflation to persist as recent years’ labor-market disruption continues to ripple through wages and health-insurance contracts. 
    • “We’re not expecting much slowing,” said Alan Detmeister, an economist for UBS. “This was a very large shock that we saw in the healthcare industry over Covid, and it takes years for those to pass through to the prices.”
    • Hospital price increases are responsible for about 23% of the growth in U.S. health spending each year, on average, according to an analysis by federal actuaries for the Journal. Health-insurance premiums last year shot up at the fastest rate in a decade. 
    • Premiums rise with health spending. Public employees in California saw premiums increase 11% this year, largely because of rising prices, which alone raised their premiums by 8%, said the California Public Employees’ Retirement System. 
  • Healthcare Finance adds,
    • The Centers for Medicare and Medicaid Services’ January [2024] expansion of the two-midnight rule to include Medicare Advantage plans has contributed to higher inpatient volumes and revenue growth in the first quarter of the year, according to a Strata Decision Technology report.
    • This is because inpatient services have higher reimbursement levels compared to outpatient services and the two-midnight rule concerns inpatient care.
  • Per Fierce Healthcare,
    • “Though held in check by inflation, Cleveland Clinic’s first-quarter operations trickled past last year’s tally thanks to a jump in volumes and revenues.
    • The nonprofit system reported this week a $50.2 million operating gain (1.3% operating margin), as opposed to the prior year’s $32.3 million (0.9% operating margin). Operating revenues rose 10.2% year over year to nearly $3.9 billion while operating expenses followed close behind with a 9.8% increase.
    • “Cleveland Clinic enjoyed “strong demand for both inpatient and outpatient services” during the quarter, management wrote in commentary on its operations. Compared to the prior year, acute admissions rose 6.7%, total surgical cases by 3.7% and outpatient evaluation and management visits by 3.9%.
    • “The system’s 9.4% increase in net patient service revenue was also boosted by rate increases among Cleveland Clinic’s managed care contracts that went into effect with the new year. Additionally, management wrote, “over the last few years, the system initiated national, regional and local revenue management projects designed to improve patient access throughout the system while striving to ensure the safety of patients, caregivers and visitors.”
  • According to Healthcare Dive,
    • “[Philadelphia based] Jefferson Health and [Allentown, PA, based] Lehigh Valley Health Network signed a definitive agreement Wednesday to merge. The health systems expect the deal to close later this summer, pending regulatory approval, according to a press release. Deal terms were not disclosed.”
  • Fierce Healthcare adds,
    • “UnitedHealth Group’s investments in affordable housing have topped $1 billion, with the program a keystone in its overarching strategy to address health equity and disparities.
    • “The company has made investments in housing since 2011 and, in that time, has supported the development of affordable and mixed income units across 31 states and the District of Columbia, creating more than 25,000 homes for people and families who face housing insecurity.
    • “The investments include direct funding from the company as well as those made through Low-Income Housing Investment Tax Credits and Community Reinvestment Act loans, UnitedHealth said. The company has backed both new development and rehabilitation for older locations in urban, suburban and rural markets. * * *
    • “UnitedHealth is tracking the health benefits of these investments and spent two years measuring outcomes against a baseline set by Stewards of Affordable Housing for the Future and the National Affordable Housing Trust. It found that people living in the properties it backed were more likely to receive annual checkups, with 95% having one in the past year.
    • “In addition, residents living in these locations reported better mental health compared to low-income individuals across the country.”

OPM Director Resigns

David Ermer–AHRQ, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, Mental health care, OPM, Rx coverage, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • Federal News Network reports,
    • Kiran Ahuja, director of the Office of Personnel Management, will be stepping down from her position in early May, OPM announced Tuesday. * * *
    • Ahuja decided to leave the position due to ongoing health concerns and a recent death in the family, an agency spokesperson said. Once Ahuja vacates her position as the top-most OPM official in the coming weeks, OPM Deputy Director Rob Shriver will begin serving as acting director. * * *
    • “Kiran leaves an incredible legacy as a strong and indefatigable champion of the 2.2 million public servants in the federal workforce,” OPM’s Shriver said in a statement. “Under Kiran’s leadership, OPM has bounced back stronger than ever and partnered with agencies across government to better serve the American people. Kiran represents the very best of the Biden-Harris administration, and I am honored to call her a dear colleague and friend.”
  • Here are links to today’s relevant House of Representatives Committee hearings — one “Examining Health Sector Cybersecurity in the Wake of the Change Healthcare Attack” and the other “ERISA’s 50th Anniversary: the Path to Higher Quality, Lower Cost Health Care.”
  • STAT News reports,
    • “President Joe Biden’s administration will help 50 countries identify and respond to infectious diseases, with the goal of preventing pandemics like the Covid-19 outbreak that suddenly halted normal life around the globe in 2020.
    • “U.S. government officials will offer support in the countries, most of them located in Africa and Asia, to develop better testing, surveillance, communication, and preparedness for such outbreaks in those countries.
    • “The strategy will help “prevent, detect and effectively respond to biological threats wherever they emerge,” Biden said in a statement Tuesday.
    • “The Global Health Security Strategy, the president said, aims to protect people worldwide and “will make the United States stronger, safer, and healthier than ever before at this critical moment.”
  • The Congressional Budget Office issued a report about past performance and future directions of Medicare Accountable Care Organizations.
  • One Digital tells us,
    • “The 2023 EEO-1 Component 1 data collection window opens on April 30, 2024 and ends June 4, 2024. Private-sector employers with 100 or more employees or federal contractors with 50 or more employees must submit workforce demographic data. The EEO-1 Component 1 report is a mandatory annual data collection. Covered employers must submit data by job category and sex and race or ethnicity to the Equal Employment Opportunity Commission (EEOC). Updates to the data collection will be posted to the EEOC’s dedicated EEO-1 Component 1 website.
    • “The 2023 EEO-1 Component 1 Instruction Booklet and 2023 EEO-1 Component 1 Data File Upload Specifications are available on the EEOC’s dedicated EEO-1 Component 1 website. Employers must file their information through the EEO-1 Component 1 Online Filing System (OFS) either through manual data entry or data file upload. The EEO-1 Component 1 online Filer Support Message Center (i.e., filer help desk) will also be available on Tuesday, April 30, 2024, to assist filers with any questions they may have regarding the 2023 collection.”

From the public health and medical research front,

  • Value Penguin lets us know,
    • “Some much-needed good news for U.S. citizens: Between the first quarters of 2021 and 2023, the national age-adjusted death rate fell by 17.7%, according to the latest ValuePenguin study.
    • “Our study also looked at death rates by cause and the leading causes by state. Perhaps unsurprisingly given increased vaccination access and herd immunity, COVID-19 deaths fell most precipitously over that time. Deaths from most other causes showed a decline, too.”
  • HHS’s Agency for Healthcare Quality and Research released a Medical Expenditure Panel Survey with the following highlights
    • “In 2021, the top 1 percent of the population ranked by their healthcare expenditures accounted for 24 percent of total healthcare expenditures, while the bottom 50 percent accounted for less than 3 percent.
    • “Persons in the top 1 percent expenditure tier had an average of $166,980 in healthcare expenditures in 2021, nearly $30,000 higher than in 2019 or 2018. In 2020, persons in the top 1 percent expenditure tier had average expenditures that were more than $20,000 higher than in 2019 or 2018.
    • “Persons aged 65 and older and non-Hispanic Whites were disproportionately represented in the top expenditure tiers. 
    • “Inpatient stays accounted for about 26 percent of healthcare expenses for persons in the top 5 percent expenditure tier.
    • “More than three-quarters of aggregate expenses for persons in the top 5 percent expenditure tier were paid for by private insurance or Medicare.
    • “Among adults in the top 5 percent expenditure tier, 78.1 percent had two or more priority conditions.”
  • MedPage Today relates,
    • “Independent reviewers confirmed a causal relationship between the first mRNA COVID-19 vaccines and myocarditis, and also determined that, more broadly, intramuscular shots can cause a series of shoulder injuries.
    • “At the same time, the National Academies of Sciences, Engineering, and Medicine (NASEM) committee rejected a causal relationship between the Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273 (Comirnaty and Spikevax, respectively) mRNA COVID vaccines and female infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with thrombocytopenia syndrome (TTS), and myocardial infarction.”
  • According to the University of Minnesota’s CIDRAP,
    • “A study yesterday in JAMA Internal Medicine demonstrates that 22% of hospitalized adults aged 50 years or older with respiratory syncytial virus (RSV) infection experienced an acute cardiac event—most frequently acute heart failure (16%). Moreover, 1 in 12 of infected patients (8.5%) had no documented underlying cardiovascular disease.
    • “RSV is associated with annual totals of up to 160,000 US hospitalizations, 10,000 deaths, and $4 billion in direct healthcare costs among adults age 65 years or older.
    • “Despite evidence of considerable RSV-associated morbidity, mortality, and health care expenditure, the potential severity of RSV infection in adults has historically been underappreciated by public health professionals and clinicians,” the authors write. RSV is rarely tested for in the clinical settings, and symptoms usually mirror other respiratory diseases, they add.” 
  • and
    • “New research conducted at US primary and urgent care sites shows that antibiotics didn’t provide any benefit for patients with a cough caused by an acute lower respiratory tract infection (LRTI).
    • “In fact, the findings, published yesterday in the Journal of General Internal Medicine, show that receipt of an antibiotic was associated with a small but significant increase in the duration of cough overall compared with those who didn’t receive an antibiotic. Even for those patients with a confirmed bacterial infection, the time until illness resolution was the same whether or not the patients received an antibiotic.
    • “Patients who received an antibiotic also had a higher overall disease severity over the entire course of their illness compared with those who didn’t.
    • “The study authors say the results of the Enhancing Antibiotic Stewardship in Primary Care (EAST-PC) study, which is the largest observational study to date on LRTIs in US primary and urgent care settings, are yet another indication that clinicians should be more prudent about using antibiotics for LRTIs.”
  • BioPharma Dive informs us,
    • “An antipsychotic drug from Intra-Cellular Therapies appears to also work as an add-on therapy for depression, according to clinical trial results the New York-based biotechnology company released Tuesday.
    • “The large trial enrolled almost 500 patients with major depression and hit its main goal as well as “key secondary endpoints,” the company said in a statement. It found that, over a six-week period, depressive symptoms significantly declined in study volunteers given Intra-Cellular’s drug plus antidepressants compared to those given a placebo and antidepressants.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth estimates costs from the Change Healthcare cyberattack could reach $1.6 billion this year, executives said on Tuesday. However, the managed care giant maintained its full-year earnings guidance, suggesting the financial fallout from the attack on the massive claims clearinghouse may be less serious than feared.
    • “The hit comes from direct response efforts like recovering Change’s clearinghouse platform and paying higher medical costs after its insurance arm suspended some utilization management processes, in addition to the loss of Change’s revenue.
    • “In the first quarter alone, the cyberattack cost UnitedHealth $872 million, according to financial results posted Tuesday.”
  • Beckers Payer Issues adds,
    • “Rising medical cost trends aren’t going down, but they are stabilizing, UnitedHealth Group executives say. 
    • “CEO Andrew Witty told investors April 16 that pent-up demand and increased health system capacity following the COVID-19 pandemic drove rising costs through 2023, but the trend was a “one-off.” 
    • “We don’t see anything like that. We see much more stabilization. We haven’t seen a step-down from that trend, but we certainly see that kind of sustained activity without aggressive acceleration,” Mr. Witty said. 
    • “Every major insurer reported rising costs in the Medicare Advantage population in the last months of 2023. While a few insurers, including Humana and CVS Health, cut their 2024 earnings guidance based on the trend, UnitedHealth Group maintained it can weather the storm. 
    • “The company reported its first-quarter earnings April 16. UnitedHealthcare’s medical loss ratio was 84.3% in the first quarter, compared to 82.2% the year prior and down from 85% in the fourth quarter of 2023.”
  • and
    • “UnitedHealth Group plans to bring Change Healthcare back stronger than it was before it suffered the largest cyberattack in the history of the U.S. healthcare system. 
    • “On an April 16 call with investors, UnitedHealth Group CEO Andrew Witty said it is “important for the country” that UnitedHealth Group owns Change. 
    • “Without UnitedHealth Group owning Change Healthcare, this attack likely would still have happened. It would have left Change Healthcare, I think, extremely challenged to come back,” Mr. Witty said. “Because it is a part of UnitedHealth Group, we’ve been able to bring it back. We’re going to bring it back much stronger than it was before.” 
  • Medscape offers a slideshow on 2023 physician compensation.
  • Beckers Payer Issues notes,
    • “Elevance Health will enter a partnership with private equity firm Clayton, Dubilier & Rice to develop advanced primary care models. 
    • “The joint effort will operate across multiple states and commercial, individual, Medicare and Medicaid markets, according to an April 15 news release. The payer-agnostic platform will serve more than 1 million members, the companies said. 
    • “The deal is financed primarily “through a combination of cash and our equity interest in certain care delivery and enablement assets of Carelon Health,” according to the news release. The two companies did not disclose the financial terms of the deal, and it is not expected to have a material impact on Elevance’s 2024 earnings. 
    • “The partnership will bring together two CD&R assets, digital platform Apree Health and Florida-based provider group Millennium Physician Group, and Carelon Health. Several Carelon Health clinics, part of Elevance Health, will provide care to members with chronic and complex conditions.” 
  • Beckers Hospital Review lets us know,
    • “About nine months after the FDA fully approved an Alzheimer’s drug for the first time, the medicine is trudging through insurance barriers and hesitations from potential patients, the Chicago Tribune reported April 12. * * *
    • “One of its manufacturers, Eisai, predicted 10,000 patients would begin treatment by the end of March. Eisai executives have since backed away from that forecast, but they say sales are increasing, according to the Tribune. 
    • “CMS covers Leqembi, and so do about 75% of commercial plans in the U.S., a spokesperson for the drugmaker said. But, for the upwards of 6 million Americans who are diagnosed with Alzheimer’s disease, the medication has not made a splash as patients worry about side effects and contraindications.”
  • and
    • “Multiple April bankruptcy court filings revealed that Camp Hill, Pa.-based Rite Aid has plans to shutter 53 additional locations across nine states after it filed for Chapter 11 bankruptcy and shared it will close 154 locations last October. 
    • “The “notice of additional closing stores” filings, obtained by Becker’s, revealed the stores are located in Pennsylvania, New Jersey, New York, Ohio, California, Massachusetts, Michigan, Virginia and Maryland.”