Monday Roundup

U.S. Healthcare

Monday Roundup

David Ermer–CMS, FDA, HSA, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • ‘A vaccine that federal regulators approved on Monday could help make the most severe cases of a dangerous respiratory illness in infants a thing of the past. 
    • ‘The Food and Drug Administration approved the first vaccine for pregnant women to protect their babies against respiratory syncytial virus during their first six months. RSV is the leading cause of infant hospitalization in the U.S. and kills as many as 300 children under 5 years old each year. 
    • ‘Pfizer’s vaccine, called Abrysvo, gives parents another way to protect their newborns, after Sanofi’s drug Beyfortus won approval in July. The FDA earlier this year also cleared a pair of RSV shots from Pfizer and GSK to protect older adultsfrom RSV. Until now, most children had to fight off infections on their own. Only babies at high risk for severe disease are eligible for a drug from the company Sobi. 
    • “We’re sort of going from famine to feast,” said Dr. Kristin Moffitt, an infectious-disease specialist at Boston Children’s Hospital. “These are huge game changers for what has typically been the most common cause of hospitalization for young infants in the U.S.” 
  • Health Payer Intelligence relates,
    • “CMS has released draft guidance detailing a new program allowing Medicare beneficiaries to pay out-of-pocket Part D costs in monthly installments.
    • “The Medicare Prescription Payment Plan is required under the Inflation Reduction Act and will take effect in 2025.
    • “The program mandates Medicare Part D plan sponsors to offer Part D beneficiaries the option to pay their out-of-pocket costs for prescription drugs monthly over a year instead of at the point of sale. Part D sponsors must pay the pharmacy the out-of-pocket cost-sharing beneficiaries would have paid if they were not in the program. Sponsors will then bill beneficiaries monthly for the cost-sharing.
    • “The program is available to all Medicare Part D beneficiaries, but CMS indicated that those incurring high out-of-pocket costs earlier in the plan year are more likely to benefit from the payment plan. The agency will develop tools to help beneficiaries decide if the program will be helpful.
    • “While the program will not reduce beneficiaries’ overall out-of-pocket costs, spreading the costs throughout the year can help ease some cost-sharing burden, CMS said. Additionally, beneficiaries will owe $0 upfront when picking up medication at the pharmacy.”

From the public health front,

  • Health Leaders Media tells us,
    • “Innovation in pediatric healthcare often focuses on the tiniest of factors affecting the tiniest of patients. And Tanja Gruber, MD, PhD, says research around the makeup and functions of the gene are enabling care providers to get a better idea of how to tackle cancer.
    • “HealthLeaders recently sat down—virtually—with Gruber, chief of pediatric hematology, oncology, and stem cell transplantation at Stanford Medicine Children’s Health to discuss innovative ideas like immunotherapy, stem cell transplants, gene therapy, and gene editing, and how they’re helping to improve outcomes for millions of children.”
    • Check it out.
  • Per the Washington Post,
    • In a study presented at the annual meeting of the American Society for Nutrition, researchers found that men who had adopted all eight habits by middle age lived 24 years longer than men whose lifestyle included few or none of the habits. Women’s life expectancy increased by 23 years for those who had adopted the eight habits compared with women who had not.
    • The study was based on data from nearly 720,000 U.S. veterans 40 and older, which is considered a nationally representative sample. Described by the researchers as “therapeutic lifestyle factors,” the eight key habits were:
      • Not smoking.
      • Being physically active.
      • Managing stress.
      • Eating a healthy diet.
      • Having good sleep hygiene.
      • Avoiding binge drinking.
      • Not being addicted to opioids.
      • Having positive social relationships.

From the U.S. healthcare business front,

  • STAT News informs us,
    • “To much of the public, the promise of telehealth is all about convenience — get the prescription you need quickly, and get it delivered right to your door. But as digital health companies build out their weight loss businesses, capitalizing on the popularity of drugs like Wegovy and Ozempic, they’re courting a very different audience: payers and employers who have a vested interest in preventing quick scripts.
    • “Payers are reeling as they try to figure out how to sustainably cover GLP-1 receptor agonists, a class of remarkably effective but expensive obesity and type 2 diabetes drugs. So in the last six months, digital health companies, including Teladoc, Found, Hello Alpha, and Calibrate, have advanced enterprise products that pair virtual visits and prescriptions with lifestyle coaching. Their hope is that more and more payers and employers will offer their programs as a way to support lasting weight loss and metabolic health — or even require them if patients want their drugs reimbursed.”

From the human resources front,

  • CFO reports,
    • [A]ccording to a study released on Monday, a newer type of account — “lifestyle spending accounts,” or LSAs — has quickly become the most common employer-funded perquisite. (Unlike FSAs and HSAs, LSAs are categorized as perks because they’re funded solely by employers and are considered taxable income for employees.) * * *
    • LSAs differ from HSAs and FSAs in another key respect — employees can use them for many types of spending needs, as determined by the employer. These could include health-related purchases such as gym memberships, nutritionists, and health-care coaching, as well as spending on, for example, learning and development, family activities, commuting, pets, or charitable giving.
  • HR Morning identifies “five ways to help employees who are mental health caregivers.” Aren’t we all mental health caregivers to some extent?

Weekend update

David Ermer–CDC, Congress, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

From Washington, DC

  • Congress remains on its State/district work break, with one hearing scheduled to be held in Guam.
  • The Centers for Disease Control reminds us that August is National Immunization Awareness Month by pointing out its immunization guidance website.

From the public health front,

  • Fortune Well discusses skin cancer prevention and identifies “five nutrients that ‘help keep brains in top condition at all ages,’ researchers say.
    •  Lycopene: An antioxidant that could help protect cells from damage, lycopene gives some fruits and vegetables—like tomatoes, watermelon, red oranges, pink grapefruits, apricots, and guavas—their red hue.
    • Retinol: A form of Vitamin A that helps the immune system work properly, retinol helps you see in dim lighting and keeps skin healthy. It’s found in foods like cheese, eggs, oily fish, milk, yogurt, and liver. The body can convert beta-carotene into retinol, so indirect sources include yellow, red, and green leafy vegetables like spinach, carrots, sweet potatoes, and red peppers, as well as yellow fruits like mangos, papaya, and apricots.
    • Lutein: Often referred to as the “eye vitamin,” lutein is thought to protect eye tissue from sun damage. You can find it in foods like egg yolks, spinach, kale, corn, orange peppers, kiwis, grapes, zucchini, and squash.
    • Zeaxanthin: An antioxidant, zeaxanthin is known to protect eye tissues from the sun. It’s found in eggs, oranges, grapes, corn, goji berries, mango, and orange peppers.
    • Vitamin E: Also an antioxidant, Vitamin E keeps free radicals in check, improves immune function, and can prevent clots from forming in the arteries of the heart. It can be found in plant-based oils, nuts, seeds, fruits, and vegetables like sunflower oil, soybean oil, almonds, peanuts, spinach, pumpkin, red bell peppers, asparagus, mangoes, and avocados.
  • CNN reports
    • “As rates of sexually transmitted infections continue to skyrocket across the United States, a growing number of physicians are prescribing a commonly used antibiotic as a way to prevent chlamydia, gonorrhea and syphilis infections in gay and bisexual men and transgender women.
    • “Doxycycline is a class of medications traditionally used to treat bacterial STIs after someone has been infected. Yet recent research suggests that one 200mg dose of the drug can be effective in preventing such infections among men who have sex with men if taken within 72 hours after unprotected sex.
    • “This approach, called doxyPEP, has garnered so much attention that the US Centers for Disease Control and Prevention is expected to post draft guidance for public comment in the next several weeks on how healthcare workers may deploy the preventative treatment, such as how many pills should go into a prescription or which people could benefit most from the drug.”
  • NPR Shots explains how to keep your home’s air clean.
    • Maximize fresh air.
    • Control the source of pollutants.
    • Purify the air.
  • The Wall Street Journal points out seven exercises to improve your hands’ grip.
    • As we age, a firm handshake implies far more than confidence.
    • A strong grip is a great proxy for longevity. Feeble handgrip strength has been shown to be a better predictor of adverse health events like cardiovascular disease and stroke than systolic blood pressure.
    • Your grip involves everything from your forearm muscles to the muscles in your hands, all of which allow us to move our finger joints. A strong grip allows us to hold securely on to things, such as the railing of a staircase, and open stubborn jars of peanut butter or pickles. 

From the U.S. healthcare business front,

  • Fierce Healthcare reports
    • Cigna has launched a new tool that will allow its members to use their smartphones to check for dental health issues, including gum disease and cavities.
    • The insurer announced Thursday morning that the online service, which is backed by Dental.com, will be available for free. It offers guided steps for members to take five photos of their teeth and mouth, which will be analyzed by the SmartScan technology. A Cigna network dentist will then review the scans.
    • The tool will provide members with an oral health score as well as personalized dental care tips. It will also identify any concerns and connect the user with either virtual or in-person follow-ups for treatment.
    • The program is available starting [August 17] to more than 16.5 million Cigna members in employer-sponsored or Affordable Care Act exchange plans, the insurer said.

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Federal Times says,
    • “Members of Congress are urging the Office of Personnel Management to ensure providers of its health insurance program do not exclude same-sex couples and single individuals from seeking the same artificial reproductive procedures that other federal employees do.”
  • The FEHBlog believes that this expresssed concern misunderstands OPM’s 2024 call letter and technical guidance which focus on fertility coverage and requires carriers to cover artificial insemination, which is typically used by same-sex couples and single individuals.
  • KFF tells us,
  • “A new proposal from the Centers for Medicare & Medicaid Services * * * would authorize Medicare payments to health care professionals to train informal caregivers who manage medications, assist loved ones with activities such as toileting and dressing, and oversee the use of medical equipment. * * *
  • “Several details of CMS’ proposal have yet to be finalized. Notably, CMS has asked for public comments on who should be considered a family caregiver for the purposes of training and how often training should be delivered.
  • “If you’d like to let CMS know what you think about its caregiving training proposal, you can comment on the CMS siteuntil 5 p.m. ET on Sept. 11. The expectation is that Medicare will start paying for caregiver training next year, and caregivers should start asking for it then.”

From the public health front,

  • The Centers for Disease Control announced the availability of flu shots for the 2022-23 flu season and offers flu shot finder tool.
  • Beckers Hospital Review informs us
    • “Health officials have started monitoring BA.2.86 — a highly mutated version of the COVID-19 virus. Not much is known yet about the newly detected lineage, though its large number of mutations has prompted the World Health Organization and CDC to begin tracking the strain. 
    • “The World Health Organization added BA.2.86, dubbed “Pirola” on social media by scientists closely tracking evolutionary changes in the virus, to its list of variants under monitoring Aug. 17. Shortly after, the CDC also said it has started tracking the lineage. 
    • “CDC is gathering more information and will share more about this lineage as we learn it,” the agency said on the social media platform X, formerly known as Twitter. So far, BA.2.86 has been detected in Israel, Denmark, the U.S. and the U.K. So far, only six cases of the new strain have been identified, with the single U.S. case detected in Michigan.” 
  • STAT News discusses the low rates of lung cancer screening in the U.S. notwithstanding the fact that lung cancer is the deadliest cancer in our country.
  • The National Institutes of Health informs us
    • “Past-year use of marijuana and hallucinogens by adults 35 to 50 years old continued a long-term upward trajectory to reach all-time highs in 2022, according to the Monitoring the Future (MTF) panel study, an annual survey of substance use behaviors and attitudes of adults 19 to 60 years old. Among younger adults aged 19 to 30, reports of past-year marijuana and hallucinogen use as well as marijuana and nicotine vaping significantly increased in the past five years, with marijuana use and vaping at their highest historic levels for this age group in 2022. The MTF study is funded by the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, and is conducted by scientists at the University of Michigan’s Institute for Social Research, Ann Arbor.
    • “While binge drinking has generally declined for the past 10 years among younger adults, adults aged 35 to 50 in 2022 reported the highest prevalence of binge drinking ever recorded for this age group, which also represents a significant past-year, five-year, and 10-year increase.
    • “Substance use is not limited to teens and young adults, and these data help us understand how people use drugs across the lifespan,” said NIDA director, Nora Volkow, M.D. “Understanding these trends is a first step, and it is crucial that research continues to illuminate how substance use and related health impacts may change over time. We want to ensure that people from the earliest to the latest stages in adulthood are equipped with up-to-date knowledge to help inform decisions related to substance use.”

From the medical research front,

  • STAT News relates that “An innovative eye stem cell transplant could help restore vision in people with chemical injuries”
  • Medscape dives into the issue of whether artificial kidneys can replace dialysis.

From the Rx coverage front,

  • The Institute for Clincical and Economic Research reminds us
    • “ICER’s 2022 obesity management Final Evidence Report included subcutaneous semaglutide (Wegovy, Novo Nordisk), liraglutide (Saxenda, Novo Nordisk), phentermine/topiramate (Qsymia, Vivus Pharmaceuticals), and bupropion/naltrexone (Contrave, Currax Pharma). We found that semaglutide used for weight loss would achieve common thresholds for cost-effectiveness if priced between $7,500 – $9,800 per year. The current annual estimated net price is over $13,000.
    • “The Financial Times quoted ICER’s Chief Medical Officer, David Rind, MD:
      • “At current prices, ICER estimated that only 0.1 percent could be treated within five years without ‘major budget disruptions’ for the insurers. ‘The options are to move money away from other healthcare, raise premiums, or taxes if you’re the government, or manufacturers could lower the price to a cost-effective price and still make enormous amounts of money because enormous numbers of patients want this,’ Rind says.” 

From the U.S. healthcare business front

  • Forbes reports,
    • “Blue Shield of California said Thursday it will soon work with several companies to manage the prescriptions of its nearly 5 million health plan members, including Amazon Pharmacy, Cuban’s company and a fast-growing pharmacy benefit manager known as Abarca, which will “pay prescription drug claims.” Financial terms of the arrangement were not disclosed.
    • “But CVS Caremark will continue to provide specialty pharmacy services for Blue Shield “members with complex conditions, including education and high-touch patient support,” the health plan said.
    • “And it’s the specialty pharmacy business that may be a bigger deal to CVS and patients looking for a better deal on their costliest medicines.”
  • Per MedCity News,
    • “Fee-for-services payment models in the primary care ecosystem are doing a poor job of keeping Americans healthy and reducing the nation’s massive amount of healthcare spending, two CEOs of primary care companies said during a recent webinar. They argued that stakeholders in the primary care space need to come together to support more value-based care arrangements to reduce costs, advance population health and improve the patient experience.”
  • Per Healthcare Dive,
    • Rochester, Minnesota-based Mayo Clinic on Thursday reported increased operating revenue and income year over year in its second quarter earnings, driven by higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 10.8% year over year, and $300 million in operating income. Operating expenses rose 7.5% compared to the prior-year period, totaling nearly $4.2 billion, though the cost of salaries and benefits increased at a slower rate this quarter compared with last year.
    • The earnings mark the second consecutive quarter of increased operating margins for Mayo, as the health system attempts to turn around after a rocky 2022 when its operating profit was cut in half.

Thursday Miscellany

David Ermer–Medical / Rx research, No Surprises Act, Rx coverage, SDOH, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Federal News Network says,
    • “The largest payroll provider for federal employees is at risk, and if there aren’t improvements soon, hundreds of thousands of employees could see the impacts immediately.
    • “The National Finance Center, an agency housed in the Agriculture Department, is struggling with legacy IT systems, limited funding, low staffing — and even building maintenance issues. In a new nine-month study, the National Academy of Public Administration said NFC must take immediate action or else risk being unable to provide payroll services to more than 170 agency customers, spanning some 650,000 federal employees.
    • “It is unthinkable that the U.S. government could find itself in a position where it could not pay a sizeable portion of the federal workforce — but it could happen, at least in the short term,” the NAPA report, published earlier this month, said.”
  • Ruh-roh.
  • In other puzzling news, Healthcare Dive informs us that a committee advising Congress on how to avoid surprise billing with ground ambulance charges decided against using the No Surprises Act IDR process but does not appear to have a good alternative. The committee meets again in October and plans to submit its report to Congress later this year.

From the U.S. healthcare business front,

  • The Wall Street Journal lets us know,
    • “A major health insurer says it will jettison the complicated system that Americans use to pay for drugs and create something that aims to be better, with partners including Amazon.com and the entrepreneur Mark Cuban.
    • “Blue Shield of California said it is dropping CVS Health’s Caremark, the pharmacy-benefit manager it currently uses, which negotiates drug prices and wraps in other services such as a mail-order pharmacy.
    • “Instead, Blue Shield, a nonprofit health plan with about 4.8 million members, will work with a selection of companies that each perform a designated function. Amazon will offer at-home drug delivery. Cuban said Mark Cuban Cost Plus Drug Company will provide access to low-cost medications, including through retail pharmacies. Another company, Abarca, will process drug claims.
    • “Blue Shield said that working with its partners, it aims to negotiate prices with pharmaceutical makers in a way that is different from the typical approach—with a simple net price structure that is supposed to eliminate rebates and hidden fees. 
    • “Blue Shield executives said that with one company handling many aspects of how drugs are procured through the system, it is often hard to track the flow of payments accurately.”
  • Health Payer Intelligence also discusses this new unbundled PBM arrangement and related developments.
  • The Segal Co. points out,
    • “The average stop-loss coverage premium increase is 8.4 percent for the nearly 250 health plans in Segal’s national medical stop-loss database’s 2023 dataset.
    • “The average includes groups that increased specific stop-loss deductible levels and/or aggregating specific stop-loss deductibles resulting in an overall reduced rate action. The average premium increase for groups that maintained similar specific stop-loss benefit levels as the prior year is 13.4 percent.”
  • Fierce Healthcare notes
    • “Tech company HealthEdge polled more than 2,800 insured people to delve into their attitudes toward their health plan and where they think payers can improve the experience.
    • “The survey asked respondents what they think insurers should be doing to improve satisfaction. Five steps ranked highest:
      • “Offer members incentives and/or rewards for healthy behaviors.
      • “Ensure they can easily access their medical records.
      • “Connect them to providers who offer care based on their preferences and personal traits.
      • “Provide high-quality customer service.
      • “Deploy tools and information that members can use to avoid high-cost care.”
  • From the miscellany department,
  • MedPage Today tells us,
    • “Few people with early Alzheimer’s disease met eligibility criteria for the new anti-amyloid monoclonal antibody treatments lecanemab (Leqembi) and aducanumab (Aduhelm), cross-sectional data from the Mayo Clinic Study of Aging showed.
    • “Of 237 people with mild cognitive impairment or mild dementia and increased brain amyloid on PET, clinical trial inclusion and exclusion criteria narrowed the number who would qualify for a lecanemab trial to 19 or 8% of the cohort, reported Maria Vassilaki, MD, Ph.D., of the Mayo Clinic in Rochester, Minnesota, and co-authors. * * *
    • “Our study results show only a small percentage of people with early Alzheimer’s disease may be eligible to receive treatment, mostly due to chronic health conditions and brain scan abnormalities common in older adults,” Vassilaki said in a statement.”
  • Fierce Healthcare relates,
    • “Kaiser Permanente has launched a multichannel support center to better address the social needs of members and nonmembers.
    • “The Community Support Hub is a self-service online directory of community resources. It also includes a call center for referral assistance. The solution will enable Kaiser to have more touch points with patients and better address the overall health of its communities.
    • “Many people need more than high-quality medical care to stay healthy, which is why we’re continuing to support our members beyond clinical walls to seamlessly connect them to the community resources they need to live healthy, thriving lives,” Bechara Choucair, M.D., senior vice president and chief health officer, said in a press release.
    • “If you’re not a KP member, your friend is, your neighbor is,” Vice President of Social Health Anand Shah, M.D., told Fierce Healthcare. In effect, there is no distinction between a member and a community. “You can’t have one without the other.” 
  • BioPharma Dive reports,
    • A drug combination involving Gilead’s antibody medicine Trodelvy shrank or eliminated tumors in just over half of the lung cancer patients who received it in a closely watched Phase 2 trial, according to data released ahead of a medical meeting next month. The findings suggest Trodelvy, currently approved to treat breast and bladder cancers, may be active against lung tumors as well.
    • The study, EVOKE-02, is testing several regimens of Trodelvy and Merck & Co.’s immunotherapy Keytruda with or without chemotherapy in patients newly diagnosed with advanced non-small cell lung cancer. Full results were inadvertently published Wednesday, weeks before the data will be presented at the World Conference on Lung Cancer.

Midweek Update

David Ermer–Congress, COVID-19, Government Contracting, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Manasvita S on Unsplash

From Washington DC,

  • Govexec informs us,
    • “The House and Senate appeared headed for a short-term spending deal when lawmakers return to Washington following the August recess, with leaders from both chambers suggesting they are pursuing that path to avoid a shutdown in October. 
    • “The continuing resolution would keep agencies funded at their current levels through early December, House Speaker Kevin McCarthy, R-Calif., told his caucus this week. Senate Majority Leader Chuck Schumer, D-N.Y., said on Wednesday he met with McCarthy a few weeks ago, and the two leaders agreed to pass a stopgap that would last “a few months.” 
    • “I thought that was a good sign,” Schumer told MSNBC. 
    • “Separately on Tuesday, Schumer said the short-term measure would allow lawmakers to come together on full-year appropriations.”
  • Federal News Network says,
    • For the second year in a row, the General Services Administration announced an increase to per diem lodging rates for federal employees.
    • Starting Oct. 1, base daily traveling allowances for feds will increase to $166 from $157 last year. That increase is thanks to an uptick in the standard per diem lodging rate for the Continental United States (CONUS), which will increase from $98 to $107. GSA did not make any changes to the per diem tiers for meals and incidental expenses. Those will remain in the range of $59 to $79, with the standard rate remaining at $59. * * *
    • GSA also offers a calculator tool to let feds search by city, state, zip code or map to figure out the exact amount of their per diem.
  • The Federal Acquisition Regulation cost principles apply these per diems to official travel by FEHB experience-rated carriers.

From the public health front,

  • The Washington Post reports,
    • Most cancers in the United States are found in people age 65 and older, but a new study shows a concerning trend: Cancer among younger Americans, particularly women, is on the rise, with gastrointestinal, endocrine and breast cancers climbing at the fastest rates.
    • A study published Wednesday in JAMA Network Open showed that while cancers among older adults have declined, cancers among people younger than 50 have increased slightly overall, with the largest increases among those aged 30 to 39.
    • “This is a population that has had less focus in cancer research, and their numbers are getting bigger, so it’s important to do more research to understand why this is happening,” said Paul Oberstein, director of the Gastrointestinal Medical Oncology Program at NYU Langone’s Perlmutter Cancer Center, who was not involved in the study.
  • STAT News points out
    • “Cancer patients, doctors, and patient advocates alike are struggling with the wide-ranging effects of the ongoing chemotherapy drug shortages. The platinum-based drugs carboplatin and cisplatin have been hard to keep in stock for months now, affecting most U.S. cancer centers: 93% have reported carboplatin shortages, and 70% have reported shortages of cisplatin.
    • “While patients with various types of cancer have been impacted by the shortages, those with ovarian cancer are among the groups most affected — both because the disease is relatively common, with women having a 1 in 78 chance of getting it in their lifetime, and because the drugs that are most effective in treating it are the ones now in short supply.
    • “While there are alternatives to the use of platinum drugs to treat ovarian cancer, none of them work quite as well. Carboplatin, in particular — in combination with the chemotherapy drug paclitaxel — has remained unchallenged as the go-to for ovarian cancer, in particular when the treatment could be curative rather than palliative.
  • Forbes relates
    • “New Covid omicron subvariant EG.5, or “Eris,” is now the dominant strain in the U.S., surpassing XBB.1.16 (or “Arcturus”), according to new data from the Centers for Disease Control and Prevention.
    • “EG.5 made up 17.3% of all cases in the two-week period from July 23 to August 5, a large jump from the 0.4% of cases it made up between April 30 and May 13.
    • “The World Health Organization classified EG.5 as a “variant of interest” Wednesday, which is a step below a variant of concern—WHO previously labeled it a “variant under monitoring” on July 19.
    • “While EG.5 may cause an increase in cases, WHO said it poses a low risk to public health in comparison to other omicron offspring because there’s no evidence it causes more severe cases.
    • “It is a recombinant strain—the result of two Covid variants combining during the replication process, which can occur if a person is infected with two variants at the same time—of the omicron family and a descendant of another strain labeled XBB.1.9.2.
    • “EG.5 has an extra mutation on its spike called mutation 465, which is present in about 35% of coronavirus sequences worldwide—a lot of the XBB variants have mutation 465, though experts don’t know what comes with the mutation.”

From the judicial front,

  • The Wall Street Journal reports,
    • “A federal appeals panel ruled that the Food and Drug Administration improperly expanded access to the widely used abortion pill mifepristone over the last seven years but left in place the drug’s original approval, teeing up the issue for review by the Supreme Court. 
    • “The ruling by a three-judge panel of the New Orleans-based Fifth U.S. Circuit Court of Appeals is the latest twist in a case that has at times threatened to pull the pill from the market nationwide.
    • “The appeals panel said pill opponents who sued the FDA had likely waited too long to challenge the drug’s original approval in 2000, and it also left in place the agency’s 2019 approval of the generic version of the pill. But the court said the FDA failed to properly scrutinize changes that eased access to mifepristone in recent years, such as allowing the drug to be administered without an in-person visit with a medical provider. * * *
    • “The appeals court decision doesn’t have immediate practical consequences because the Supreme Court in April issued an order allowing current broad levels of access to mifepristone while litigation proceeds. That is likely to ensure availability for months.”

From the U.S. healthcare business front,

  • Per Forbes
    • “Demand for nurse practitioners and primary care physicians is escalating along with their compensation as retailers from Amazon and CVS Health to Walmart and Walgreens build primary care clinics across the country.
    • “A new report from AMN Healthcare shows nurse practitioners—not doctors—topped the staffing company’s list of “most requested search engagements for the third consecutive year,” according to an annual report released Monday from AMN Healthcare’s Physician Solutions division, formerly known as Merritt Hawkins.
    • “Demand for NPs is being driven by a growing number of ‘convenient care’ providers, including retail clinics, urgent care centers and telemedicine platforms, which employ large numbers of NPs,” the report said.”
  • Beckers Hospital Review notes,
    • “Ozempic might find itself in CMS’ hands soon.
    • “Sales of the Type 2 diabetes drug in the U.S. have reached more than $3 billion so far in 2023, according to an Aug. 10 quarterly report from the drug’s maker, Novo Nordisk. CMS might try to influence the company to lower the medication’s cost, which sits at about $1,000 per month.
    • “In August 2022, President Joe Biden signed the Inflation Reduction Act, which gave Medicare Parts B and D negotiation powers for costly drugs with no generic or biosimilar competition. CMS said it will reveal by Sept. 1 which are the first 10 drugs that will see price negotiations, which are effective in 2026. This allowance will add more drugs each year. 
    • “Researchers from the Washington, D.C.-based West Health Policy Center and the University of California San Diego predicted Ozempic would be chosen for these negotiations in 2027 — when it passes 10 years on the market, one of the rules of the Inflation Reduction Act provision — according to a study published in March.”
  • Business Insurance adds,
    • “The U.S. Department of Justice has contested the Chamber of Commerce’s move to block the Medicare drug price negotiation program, stating the Chamber lacks the standing for the lawsuit and that halting the program would be detrimental to the public, The Hill reports. The Chamber had previously filed for an injunction against the program, citing potential harm to businesses and patients.”
  • Fierce Healthcare identifies “22 health systems that are charging for certain patient-provider electronic messages as of Aug. 16.” These systems are trying to squeeze the last golden egg out of the goose, in the FEHBlog’s opinion.

 

Tuesday Tidbits

David Ermer–CDC, Congress, COVID-19, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC —

  • Roll Call reports,
    • “House Republicans are planning to take up a short-term stopgap funding measure next month to avoid a partial government shutdown, Speaker Kevin McCarthy, R-Calif., told members of his conference during a Monday night call, sources familiar with the conversation said. 
    • “The continuing resolution is expected to extend current funding until early December, giving lawmakers a few extra months past the Sept. 30 deadline to complete fiscal 2024 appropriations. McCarthy said Monday that he did not want to have a continuing resolution run up to the Christmas recess, sources said. 
    • “The speaker’s announcement, which came as little surprise, served as an acknowledgment that the clock had run out for completing appropriations on time for the fiscal year that begins Oct. 1.”
  • Govexec says,
    • “Although President Biden and congressional appropriators appear to be in accord on the White House’s plan to grant federal employees their largest annual raise in more than two decades in 2024, there is still work to be done to make it a reality.
    • “Biden first proposed an average 5.2% pay increase for civilian federal workers and members of the military next year when he unveiled his fiscal 2024 budget plan. That figure marks the highest annual pay increase federal employees have seen since President Carter authorized a 9.1% raise in 1980.
    • “And although the administration and Senate Democrats have been butting heads with GOP appropriators in the House on a variety of funding issues in recent months, neither the House nor the Senate have included language in their respective spending packages to overrule the pay raise plan.”
  • The article explains the legal steps that the President must take this year to implement his pay raise plan.
  • Federal News Network informs us,
    • “In another effort to try to usher young talent into the federal workforce, the Office of Personnel Management is proposing changes to decade-old parameters for the Pathways Program.
    • “The new proposed regulations from OPM, in part, look to expand eligibility for the recent graduates’ Pathways Program, to include individuals who may not have a college degree, but who have completed different “technical education programs.” By counting experience in the Peace Corps, AmeriCorps, Job Corps and the Registered Apprenticeship Program, OPM said it hopes to make the program overall more inclusive, and help agencies attract a broader, more diverse pool of early-career applicants.”
  • Fierce Healthcare tells us,
    • “The Centers for Medicare & Medicaid Services (CMS) recently published new changes to further advance health equity and increase participation under the ACO REACH model.
    • “National Association of ACOs President and CEO Clif Gaus said the changes will “satisfy many concerns and stabilize future participation.” * * *
    • “Currently, there are 132 participants under ACO REACH, a value-based care model that began in January and replaced the Direct Contracting Model. The new model pushes providers to form accountable care organizations, or ACOs, for fee-for-service Medicare enrollees, and allows for providers to take on more financial risk. Participants are required to implement a health equity plan identifying disparities in care.”
  • A STAT News explains,
    • “The Inflation Reduction Act passed and signed into law a year ago attempts to deal with high drug prices paid by the U.S. government, allowing Medicare to negotiate the prices of some medicines after they have been on the market for years. (Industry would say it’s not negotiation but price-fixing.) But while the IRA is desperately needed — branded medicines cost 2.4 times more in the U.S. than in other developed countries, according to the RAND Corporation — there are ways in which it makes the situation worse.
    • “Here is the problem. The process of testing new experimental medicines takes a long time, sometimes a decade or more, and it is much longer for some objectives, such as preventing heart attacks, than others, like slightly extending the lives of terminal cancer patients.
    • “If one got to design a drug-pricing system from a blank slate, allowing drug prices to spike and then be cut after a few years would look less than ideal. It would be far better to set a lower price at the outset and not raise it but to allow a company to sell a drug for longer so the manufacturer has an incentive to fully study the benefits and risks of its medicines. * * *
    • “There are alternative models of how the drug pricing system can work. Take vaccines, for instance. They are not made nearly as expensive as, say, cancer drugs. But, in most cases, drug companies can trust that the market for them will be long and stable.
    • “This brings us back to the cancer drug shortage. All of the medicines in shortage are treatments that are generic, made into commodities by Hatch-Waxman. This problem could be changed if, say, hospitals were in a position to pay more to manufacturers who were seen as having a more stable supply.
    • “All of it is a reminder that the health care system in the U.S. is a Rube Goldberg machine created by past decisions that were made as much out of expediency as sober planning. The IRA, in particular, is another one of these decisions, pushed through a partisan Congress after the pharmaceutical lobby spent decades avoiding real change. It’s not surprising that a bill that has to be ushered in along partisan lines is not fully thought out or that many of the details are left to bureaucrats.
    • “At some point, we might want to actually design something sensible. Until then, we’d be better served by being more conscious of the mess we’re in.”

From the public health front —

  • Medscape points out,
    • “The newest version of the COVID-19 vaccine will be available by the end of September, according to the CDC. 
    • “The updated vaccine still needs final sign-offs from the FDA and the CDC.
    • “We anticipate that they are going to be available for most folks by the third or fourth week of September,” Director Mandy Cohen, MD, MPH, said on a podcast last week hosted by former White House COVID adviser Andy Slavitt. “We are likely to see this as a recommendation as an annual COVID shot, just as we have an annual flu shot. I think that will give folks more clarity on whether they should get one or not.”
    • “For people who are considering now whether they should get the currently available COVID vaccine or wait until the new one comes out, Cohen said that depends on a person’s individual risk. People who are 65 or older or who have multiple health conditions should go ahead and get the currently available shot if it’s been more than 6 to 8 months since their last dose. For all other people, it’s OK to wait for the new version.”
  • AHA News adds,
    • “Receiving a COVID-19 mRNA vaccine or booster during pregnancy can benefit pregnant people and their newborn infants, according to findings from a federally funded study published in Vaccine. The study looked at 167 pregnant people who received a primary or booster vaccine, which generated antibodies that crossed to the cord blood and likely conferred some protection in their newborns. Participants who received a booster dose had substantially more antibodies in their own blood and in their cord blood, suggesting that boosting increased their newborns’ immune defenses against COVID-19.
  • STAT News reports
    • “Every year, doctors get better tools to fight cancer. Engineered cancer-killing cells, immunotherapies, targeted drugs, and more are helping clinicians cure more patients. Increasingly, though, oncologists are trying to use less radiation, long one of the main pillars of cancer therapy. In some cases, they are even keeping certain patients with low-risk tumors off radiation entirely.
    • “We are in an era of radiation omission or de-escalation,” said Corey Speers, vice chair of radiation oncology at the University Hospitals Seidman Cancer Center and Case Western Reserve University. “Radiation is perhaps one of the most precise and most effective cancer therapies we have, so it will always play an important role in cancer management, but there are situations now on an individual patient basis where radiation may not be needed.”
  • MedPage Today notes that “Incident dementia was tied to exposure to fine particulate matter, especially air pollution from wildfires and agriculture, an observational study of 28,000 adults over age 50 suggested.”

From the judicial front,

  • A unanimous panel of the U.S. Court of Appeals for the 10th Circuit ruled today that ERISA and Medicare Part D preempt certain provisions of an Oklahoma PBM reform law that purport to apply to contracts between PBMs and ERISA and Part D plans. The opinion is helpful to the FEHB Program because the “relates to” clause in the ERISA state law preemption clause, 29 U.S.C. Sec. 1144, is read. analogously or “in pari materia” with the “relates to” clause in the FEHB Act’s state law preemption clause, 5 U.S.C. Sec. 8902(m)(1). Hopefully, this new precedent will pick up steam for ERISA and FEHB preemption of state laws, which do help control premiums.

From the Rx coverage front,

  • Healthcare Dive relates
    • “Amazon on Tuesday added more than 15 new manufacturer-sponsored coupons for insulin brands and diabetes care products to its online pharmacy.
    • “The additions bring Amazon’s manufacturer coupons that are automatically applied during check-out for eligible customers to 36.
    • “The new coupons include some of the most commonly prescribed products from drugmakers including Novo Nordisk, Eli Lilly and Sanofi, including insulin vials, pens and continuous glucose monitors, according to a blog post on Amazon’s website.
  • BioPharma Dive calls attention to
    • “Radiopharmaceuticals for cancer: Making radiation precise
    • “More than a dozen startups are developing drugs that deliver a dose of radiation directly to tumors. Here’s where they stand, and why their progress is worth watching.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans informs us,
    • “U.S. corporate employers project a median healthcare cost increase of 7% for 2024, according to International Foundation of Employee Benefit Plans survey results. The 7% increase is on pace with cost trends projected last year in a similar survey conducted by the International Foundation.
    • “Plan sponsors shared their thoughts on the primary reasons contributing to a rise in medical plan costs for 2024. The top four responses are:
      • 22%—Utilization due to chronic health conditions (up from last year)
      • 19%—Catastrophic claims (same percentage as last year)
      • 16%—Specialty/costly prescription drugs/cell and gene therapy (new in the top four this year)
      • 14%—Medical provider costs (up from last year).
      • The effects of the pandemic appear to be waning as only 4% of responding employers indicated that the primary reason for cost increases is utilization due to delayed preventive/elective care during the pandemic (down from 12% last year).”
    • These factors will be largely offset by Medicare savings for those FEHB plans that are offering Medicare Part D plans for 2024, in the FEHBlog’s view.
  • Health Payer Intelligence explains,
    • “How Payers Are Reducing Prior Authorizations, Limiting Care Disruptions
    • “To limit patient care disruptions, payers have reduced prior authorization requirements for genetic testing, cataract surgeries, and physical therapy.”
  • and reports
    • “Payers prefer to utilize claims and administration platforms from vendors that are efficient, manage multiple business lines, and can meet their complex needs, according to a KLAS report.
    • “The Payer Claims & Administration Platforms 2023 report includes KLAS Decision Insights data and KLAS performance data, which reflects information about vendors and feedback from healthcare organizations.
    • “Among 28 payer organizations, 14 considered using HealthEdge’s claims and administration solutions. The vendor received an overall performance score of 76.5 on a 100-point scale. Twelve organizations considered using Cognizant, which received a score of 74.7.”
  • Healthcare Dive relates
    • “More than three years after the onset of the COVID-19 pandemic, only 1% of primary care clinicians surveyed by the Larry A. Green Center and the Primary Care Collaborative believe their practice has fully recovered from its impacts, and 61% characterize U.S. primary care as “crumbling.”
    • “Nearly 80% of respondents felt the current workforce is undersized to meet patient needs, and just 19% of clinicians report their practices are fully staffed.
    • “The results are emblematic of a “larger national crisis,” and policymakers must act to reinforce primary care, said Rebecca Etz, co-director of the Larry A. Green Center, in a statement. “ … It is not a matter of if, but when there will be another pandemic … If we don’t act soon, primary care won’t be there when it happens.”

Monday Roundup

David Ermer–COVID-19, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington DC,

  • The Department of Health and Human Services “announced two awards totaling $2 million under “the Leading Edge Acceleration Projects in Health Information Technology (LEAP in Health IT) funding opportunity. LEAP in Health IT awardees seek to create methods and tools to improve care delivery, advance research capabilities, and address emerging challenges related to interoperable health IT.”

From the public health front,

  • Medscape takes a look at the current state of Covid.
    • Cautious optimism and a call to remain vigilant seem like the consensus at the moment. While the numbers remain low so far, and the uptick in new cases and hospitalizations are relatively small compared to past scenarios, “It makes sense to boost our anti-Omicron antibody levels with immunizations before fall and winter,” Anne Liu, MD, an allergy, immunology, and infectious disease specialist at Stanford University, said.
    • “It’s just advisable for everyone — especially those who are at higher risk for hospitalization or death — to be aware,” Bernard Camins, MD, an infectious disease specialist at Mount Sinai Hospital in New York City, said, “so they can form their own decisions to participate in activities that may put them at risk for contracting COVID-19.”
  • MedPage Today says,
    • “Reassuringly, a history of oral contraceptive use had no deleterious effects on cardiovascular disease (CVD) and survival over long-term follow-up, a U.K. Biobank study showed. * * *
    • “These findings provide significant public health insights and may facilitate a shift in public perception because OC [oral contraceptive] use is common in women of reproductive age, and previously negative publicity exists about the safety of OC use,” Huijie Zhang, MD, Ph.D, of Nanfang Hospital, Southern Medical University, in Guangdong, China, and colleagues wrote in the Journal of the American Heart Association.”
  • Fierce Healthcare says,
    • “CareFirst BlueCross BlueShield is joining forces with Ryse Health, a company that specializes in providing in-person and virtual care for patients with uncontrolled Type 2 diabetes, in hopes of driving better long-term outcomes.”
    • “CareFirst officials said they believe the effort will help improve care by better pinpointing what they need most.”
    • “This partnership with Ryse is unique from our perspective because it’s one of the first ways in which we’ve been able to create a longitudinal value-based program that is complementing the broader value-based program efforts that the organization has,” Nathan Coffey, CareFirst’s manager of payment transformation, told Fierce Healthcare.
    • “But there’s been a gap, not just with us, but across the industry where you have a lot of discrete care programs for specialists, but having that longitudinal tie that amplifies the impact of those larger population health programs—that’s harder to create,” Coffey said.”

From the telehealth front —

  • mHealth Intelligence reports
    • “Despite the boom in telehealth use during the COVID-19 pandemic, Americans and healthcare workers largely agree that in-person care is higher quality, more efficient, and more affordable than virtual care, a new survey shows.
    • “Conducted by Morning Consult, the survey polled 1,006 healthcare workers from May 5 to May 18 and 2,202 United States adults from July 21 to July 23.
    • “But patient perceptions regarding telehealth may be changing. The survey shows that only 6 percent of US adults prefer virtual care versus 53 percent who prefer in-person care.
    • “This preference for in-person care was evident across all age groups. Generation Z displayed the highest preference for virtual care, with 9 percent of survey respondents in this group saying they preferred virtual care. However, 49 percent of Gen Z patients preferred in-person care. Similarly, while only 8 percent of Millennials said they preferred virtual care, 43 percent preferred in-person care. * * *
    • “On the other hand, hybrid care proved relatively popular across age groups. About 30 percent of Gen Z patients, 40 percent of Millennials, 37 percent of Gen X patients, and 31 percent of Baby Boomers said they preferred a hybrid healthcare model that includes both in-person and virtual care.”

From the U.S healthcare business front,

  • Healthcare Dive informs us,
    • Religiously affiliated hospital giant AdventHealth is suing cost management firm MultiPlan, alleging the company works with health insurers to systematically underpay for out-of-network medical claims.
    • AdventHealth alleges providers have lost at least $19 billion per year as a direct result of MultiPlan’s anticompetitive agreements with major payers, including UnitedHealth, Aetna, Elevance, Centene, Cigna, Humana and a number of Blue Cross Blue Shield insurers.
    • MultiPlan called the lawsuit, which was filed last week in the U.S. District Court for the Southern District of New York, meritless in a statement.
  • From what the FEHBlog knows about Multiplan arrangements, he agrees with Multiplan’s take.

Following up on yesterday’s lede article, the FEHBlog tracked down the American Society of Anesthesiologist’s warning about the relationship between the use of GLP-1 drugs and aspiration while under anesthesia.

“ASA’s Task Force on Preoperative Fasting suggests the following for patients taking GLP-1 agonists for type 2 diabetes or weight loss who are having elective procedures. It is also calling for further research to be done regarding GLP-1 agonist medications and anesthesia.

“Day or week prior to the procedure:

  • Hold GLP-1 agonists on the day of the procedure/surgery for patients who take the medication daily.
  • Hold GLP-1 agonists a week prior to the procedure/surgery for patients who take the medication weekly.
  • Consider consulting with an endocrinologist for guidance in patients who are taking GLP-1 agonists for diabetes management to help control their condition and prevent hyperglycemia (high blood sugar).

“Day of the procedure:

  • Consider delaying the procedure if the patient is experiencing GI symptoms such as severe nausea/vomiting/retching, abdominal bloating or abdominal pain and discuss the concerns of potential risk of regurgitation and aspiration with the proceduralist or surgeon and the patient.
  • Continue with the procedure if the patient has no GI symptoms and the GLP-1 agonist medications have been held as advised. 
  • If the patient has no GI symptoms, but the GLP-1 agonist medications were not held, use precautions based on the assumption the patient has a “full stomach” or consider using ultrasound to evaluate the stomach contents. If the stomach is empty, proceed as usual. If the stomach is full or if the gastric ultrasound is inconclusive or not possible, consider delaying the procedure or proceed using full stomach precautions. Discuss the potential risk of regurgitation and aspiration of gastric contents with the proceduralist or surgeon and the patient.

“Full stomach precautions also should be used in patients who need urgent or emergency surgery.”

https://www.asahq.org/about-asa/newsroom/news-releases/2023/06/patients-taking-popular-medications-for-diabetes-and-weight-loss-should-stop-before-elective-surgery

Weekend update

David Ermer–CDC, Congress, Medical / Rx research, Mental health care, Rx coverage, SDOH, Telehealth, U.S. Healthcare–
Photo by Dane Deaner on Unsplash

The lede item necessarily is this Fortune Well warning dated August 13

  • “Patients who take blockbuster drugs like Wegovy or Ozempic for weight loss may face life-threatening complications if they need surgery or other procedures that require empty stomachs for anesthesia. This summer’s guidance to halt the medication for up to a week may not go far enough, either.
  • “Some anesthesiologists in the U.S. and Canada say they’ve seen growing numbers of patients on the weight-loss drugs who inhaled food and liquid into their lungs while sedated because their stomachs were still full — even after following standard instructions to stop eating for six to eight hours in advance.”
  • The drugs can slow digestion so much that it puts patients at increased risk for the problem called pulmonary aspiration, which can cause dangerous lung damage, infections and even death, said Dr. Ion Hobai, an anesthesiologist at Massachusetts General Hospital in Boston.
  • “This is such a serious sort of potential complication that everybody who takes this drug should know about it,” said Hobai, who was among the first to flag the issue.

From the healthcare policy front —

  • Congress is on a State/District work break this week. There are no out-of-town hearings scheduled.
  • NPR Shots predicts that a recently proposed rule will improve hospital price transparency. Fingers crossed.

From the public health front –

  • Fortune Well identifies and explains the four daily habits of “truly happy” people.
  • The Drug Enforcement Administration’s public education website explains the dangers of
    • “Xylazine – often called “tranq” – is a drug adulterant that DEA has detected in a growing number of overdose deaths, despite the FDA authorizing it only for veterinary use.
    • “Illicitly-used xylazine is most often reported in combinations with two or more substances present, such as fentanyl, cocaine, or heroin, and can increase the potential for these drugs to cause fatal overdoses.”
  • Cardiovascular Business points out that,
    • “The U.S. Food and Drug Administration (FDA) has announced that Datascope, a subsidiary of Getinge, is recalling certain Cardiosave intra-aortic balloon pumps (IABPs) due to a risk that the devices could stop working unexpectedly. This is a Class I recall, which means the FDA believes using one of these IABPs “may cause serious injuries or death.” 
    • “These devices are designed to provide temporary support to a patient’s left ventricle. Electrical failures have caused some of them to turn off with no warning, however, putting the patient’s health at immediate risk. 
    • “Using an affected pump may cause serious adverse health events, including unstable blood pressure, injury (for example: inadequate blood supply or a vital organ injury), and death,” according to the FDA’s advisory.”
    • This is the fourth cardiac care device to be recalled in 2023.
  • mHealth Intelligence says that “Using survey data on patient attitudes toward mental health services and depression screening, a new study indicated that Black American Women are comfortable with using voice or video calls to communicate with mental health providers.”
  • Patient Engagement HIT informs us,
    • Only a fifth of the nearly 2.5 million adults with opioid use disorder received medication for the disease 2021, leaving millions without access to addiction treatment, according to new data from the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC).
    • The report, published as a research note in JAMA Network Open, also showed sociodemographic health disparities in opioid use disorder treatment access, with Black people, women, individuals who were unemployed, and those in non-metropolitan areas being less likely to receive treatment.
    • The study looked particularly at medication-assisted treatment, or MAT, which is considered the gold standard in OUD therapy. Drugs like buprenorphine, methadone, and naltrexone have all proven effective for OUD treatment.

In early medical/drug research news,

  • Precision Vaccinations reports
    • While the U.S. government has recently licensed monoclonal antibody therapies (LEQEMBI®), anti-amyloid vaccines may offer a convenient, affordable, and accessible means of preventing and treating Alzheimer’s Disease (AD).
    • The Lancet’s eBioMedicine recently published a paper that concludes that an immunotherapeutic vaccine candidate targeting toxic forms of aggregated beta-amyloid in the brain to treat and prevent AD.
    • Published on July 29, 2023, this research paper concludes Vaxxinity, Inc. UB-311 is an active immunotherapy, “was safe and well-tolerated,” with early clinical data demonstrating a trend for slowing cognitive decline in mild Alzheimer’s disease (AD).
    • And UB-311 could offer multiple competitive advantages over licensed passive immunotherapies, including less frequent dosing, a more convenient mode of administration, improved accessibility, and cost-effectiveness.

From the U.S. healthcare business front,

  • Healthcare Dive reports
    • “Federal spending on Medicare Advantage bonus payments has risen every year since 2015, and will reach at least $12.8 billion this year — an increase of nearly 30% from 2022, according a new KFF analysis.
    • “Rapid growth in bonus payments has implications for Medicare spending and beneficiary premiums, especially since spending on the bonuses has grown faster than MA enrollment overall, researchers said.
    • “UnitedHealthcare — the biggest MA insurer — will receive the largest total payments at $3.9 billion. Kaiser Permanente has the highest per-enrollee bonuses at $523.”
  • and
    • “The Department of Justice is requesting more data from Amedisys regarding its proposed $3.3 billion acquisition by UnitedHealth, a move that will push back the timeline of the deal.
    • “The home health and hospice provider disclosed in a filing with the SEC on Thursday that it received a second request for information from regulators on August 4 regarding the merger.
    • “UnitedHealth announced plans to acquire Amedisys in June, after the Louisiana-based provider reneged on an existing merger agreement with Option Care Health.”

Friday Factoids

David Ermer–No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The AMA News says,
    • “The Centers for Medicare & Medicaid Services today released a FAQ explaining how it will handle the administrative fee for out-of-network providers and group health plans that initiate payment disputes under the No Surprises Act’s independent dispute resolution process on or after Aug. 3, when a federal judge vacated nationwide a six-fold increase in the fee. According to the FAQ, the fee for disputes initiated on or after Aug. 3 or unpaid before Aug. 3 will return to $50 per party until the Departments of Health and Human Services [HHS}, Labor, and the Treasury set a new fee amount.
    • “The judge also vacated nationwide the department’s restrictions on batching related claims in a single payment dispute. In response to the ruling, CMS has suspended the IDR process, including the ability to initiate new disputes. The agency said the departments intend to reopen the portal for new disputes soon and will notify interested parties at that time.”
  • Bear in mind that the independent dispute resolution entities will continue to charge $400 to $500 per party on top of the government’s fee.

From the Rx coverage front —

  • KFF Health News notes
    • Basics — “Leqembi [the recently approved Alzheimer’s Disease infused drug] is very effective at removing amyloid plaques (a protein that clumps between neurons) from people’s brains. But it doesn’t reverse cognitive decline or prevent future deterioration.”
    • Benefits — Research suggests that patients notice a “clinically meaningful” change in cognitive performance — a noticeable alteration in their ability to think, remember, and perform daily tasks — when scores rise at least 1 point on an 18-point scale used to measure Leqembi’s impact. But the change detected after 18 months for patients taking this medication was only 0.45%.
    • Side Effects — The drugmaker reported 17% of patients taking Leqembi experienced swelling in the brain and 13% had brain bleeds. Most of these side effects occurred during the first three months of treatment and were resolved without serious consequences four months later. In slightly more than 1 in 4 cases, there were also infusion-related side effects — chills, aches, nausea, vomiting, a spike or drop in blood pressure, and more. A little-discussed side effect is a reduction in brain volume associated with Leqembi and other anti-amyloid therapies. “We don’t know what this will mean to patients long term, and that’s concerning,” Alberto Espay, a professor of neurology at the University of Cincinnati College of Medicine said.
    • Not all patients will qualify. “I’m very carefully selecting the patients I think will be appropriate, focusing on people with mild cognitive symptoms who are otherwise healthy,” said Erik Musiek, an associate professor of neurology at the Washington University School of Medicine in St. Louis.
    • Costs could be considerable. Costs for Leqembi are difficult to calculate since Medicare officials haven’t announced what the government [Part B] will pay for services. But the University of Southern California estimates that a year’s worth of care, including the $26,500 cost of the medication, could total about $90,000, according to Schneider. A separate analysis by the Institute for Clinical and Economic Review suggests that all the medical services necessary to administer the drug, monitor patients, and undertake needed testing could total an average of $82,500 yearly on top of Leqembi’s direct cost.
  • Medscape informs us,
    • “A novel triple agonist to receptors for three nutrient-stimulated hormones led to weight loss as high as 24% among people with overweight or obesity but who did not have type 2 diabetes when used at the highest tested dose for 48 weeks. The results are from a phase 2 study of retatrutide that was published in The New England Journal of Medicine on August 9.
    • “This level of weight loss is “unprecedented” for a medication administered for 48 weeks, commented Mary-Elizabeth Patti, MD in an editorial that accompanied the report.
    • “The findings “offer further optimism…that effective pharmacologic management of obesity and related disorders is possible,” writes Patti, a principal investigator at the Joslin Diabetes Center in Boston.”
  • BioPharma Dive reports,
    • The Food and Drug Administration has conditionally approved a new medicine for multiple myeloma, offering patients with hard-to-treat forms of the blood cancer another therapy option.
    • “The medicine, which was developed by Johnson & Johnson and will be sold under the brand name Talvey, is what’s known as a bispecific antibody. A first of its kind, Talvey binds to both “CD3,” a protein found on T cells, and “GPRC5D,” a protein found on malignant blood plasma cells, bringing the two together so the immune system has a better shot at identifying and fighting cancer.
    • “The FDA based its decision on a clinical trial that enrolled multiple myeloma patients whose disease persisted after at least four other therapies. The trial found just under three-quarters of participants responded in some way to J&J’s drug, with roughly a third going into remission. Regulators have requested additional testing to confirm the benefits of Talvey and to keep it on the market.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Healthcare merger and acquisition activity hit a three-year low in the second quarter of this year, according to a report by accounting firm and consultancy KPMG. 
    • “The analysis tallied 245 deals in the second quarter of 2023, a decrease of 7% compared to the same period last year and a 41% decline from the second quarter in 2021. 
    • “Ongoing financial pressures — like potential interest rate hikes, political divisions and uncertainty about valuations of acquisition targets — could keep M&A low in the second half of the year. But some of those headwinds are expected to lighten up as sell-side valuations continue to contract and companies look to divest non-core assets, giving deal-making a boost during the first half of 2024, the report noted.”
  • Fierce Healthcare tells us
    • “While major payers issued warnings to investors ahead of second-quarter earnings about rising utilization rates, patients returning to deferred services did not prevent these companies from turning a profit.
    • “UnitedHealth Group led the way yet again in profitability for the second quarter as well as the first half of 2023, according to company earnings reports. The healthcare giant posted $5.5 billion in profit for the quarter and $11.1 billion through the first six months of the year.
    • “By comparison, the next-highest company for second-quarter profit was CVS Health at $1.9 billion. CVS also reported the second-highest profit for the first half of 2023 with $4 billion, according to the filings.
    • “UnitedHealth also tops the list for revenue in the second quarter and first sixth months of the year. The company reported $92.9 billion in second-quarter revenue and $184.8 billion in midyear revenue.”
  • The AHA News reports on its President Rick Pollack’s views on controlling medical consumer debt. Of course, Mr. Pollack does not mention lowering healthcare prices which is a straight line to debt reduction. Rather, he focuses on adding administrative burdens to health insurers and plans and reducing consumer choice of health plans.

Midweek update

David Ermer–COVID-19 vaccine, Medicare, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From the public health and Rx coverage front —

  • Think Advisor informs us
    • “Executives from life insurance, health insurance and annuity issuers have spent their second-quarter earnings calls telling securities analysts about an open secret: The U.S. death rate is still noticeably higher than it was before 2020, when the COVID-19 pandemic began.
    • “Some executives emphasized that COVID-19 had little effect on earnings because their companies had prepared for COVID-19 to linger, not because the effects have gone away.
    • “But John Gallina, Elevance CFO, said costs related to COVID-19 and the pandemic’s impact are a headwind.
    • “When you combine COVID and non-COVID cost, the overall cost of the health care system is more expensive than if COVID had never occurred,” Gallina said. “We’ve seen it, we’ve priced for it and we’ve factored it into our expectations. But COVID is not gone. It still exists. It’s just no longer the big significant driving force that it had been for the past several years.”
  • KFF Health News says,
    • “[M]ultiple studies show that firefighters, both military and civilian, have been diagnosed with testicular cancer at higher rates than people in most other occupations, often pointing to the presence of perfluoroalkyl and polyfluoroalkyl substances, or PFAS, in the foam.
    • “But the link between PFAS and testicular cancer among service members was never directly proven — until now.
    • “A new federal study for the first time shows a direct association between PFOS, a PFAS chemical, found in the blood of thousands of military personnel and testicular cancer. * * *
    • “The Department of Veterans Affairs does not recommend blood testing for PFAS, stating on its website that “blood tests cannot be linked to current or future health conditions or guide medical treatment decisions.”
    • “But that could change soon. Rep. Dan Kildee (D-Mich.), co-chair of the congressional PFAS Task Force, in June introduced the Veterans Exposed to Toxic PFAS Act, which would require the VA to treat conditions linked to exposure and provide disability benefits for those affected, including for testicular cancer.
    • “The last thing [veterans] and their families need to go through is to fight with VA to get access to benefits we promised them when they put that uniform on,” Kildee said.”
  • Reuters reports,
    • “U.S. psychiatrists are increasingly prescribing the popular weight-loss drug Wegovy to patients who gain weight from medicines used to treat mental disorders, such as schizophrenia or bipolar disorder, according to Reuters interviews with ten prescribers across the country.
    • “Many antipsychotic drugs and mood stabilizers can cause patients to gain significant weight and contribute to diabetes and heart disease, the leading cause of death among adults with schizophrenia.”
  • The New York Times provides us with information about who should get the flu, Covid and R.S.V. vaccines, and when this fall.

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “The average U.S. physician earns $350,000 a year. Top doctors pull in 10 times that.
    • “When those simple data points were first presented in 2020, a small subset of physicians came unglued on the microblogging site formerly known as Twitter, slinging personal insults and at least one deeply unflattering photo illustration of an economist.
    • “We couldn’t understand why. The figures are nigh-on unimpeachable. They come from a working paper, newly updated, that analyzes more than 10 million tax records from 965,000 physicians over 13 years. The talented economist-authors also went to extreme lengths to protect filers’ privacy, as is standard for this type of research.
    • “By accounting for all streams of income, they revealed that doctors make more than anyone thought — and more than any other occupation we’ve measured. In the prime earning years of 40 to 55, the average physician made $405,000in 2017 — almost all of it (94 percent) from wages. Doctors in the top 10 percent averaged $1.3 million. And those in the top 1 percent averaged an astounding $4 million, though most of that (85 percent) came from business income or capital gains.”
  • Fierce Healthcare relates,
    • “Hospitals nationwide charge payers more than double for healthcare services covered under commercial plans than they do for the same insurer’s Medicare Advantage (MA) plans, according to a recent Johns Hopkins analysis of hospitals’ published pricing data.
    • “The work, published this week in Health Affairs, reviewed more than 200,000 unique combinations of hospitals, insurers, settings and services for which a commercial and an MA price were available for direct comparison. In total, it included pricing data from 2,434 hospitals and 118 insurers collected in September 2022.
    • “Commercial prices were, on average, between $600 and $707 more expensive than MA prices, or 2.1 to 2.2 times more expensive.
    • “The dollar gap for prices was widest within the surgery and medicine service category where median commercial prices were nearly $800 more expensive than the charges for MA plans ($1,702 versus $928), 1.8 times higher. The median price increases were consistent across the other three reviewed service categories: imaging ($490 versus $191, 2.6 times higher), lab tests ($32 versus $12, 2.7 times higher) and ED visits ($519 versus $262, 2.0 times higher).”
  • Beckers Hospital Review points out the payer mix of largest for profit health systems based on their second-quarter earnings reports.
  • BioPharma Dive reports on the latest biotech M&A deals as the market begins to pick up.

From the miscellany department,

  • AHA News reminds us that “Health care providers must comply with the HIPAA rules with respect to telehealth effective Aug. 9 at 11:59 p.m., when the 90-day enforcement discretion period announced in April expires.” 
  • MedPage Today notes
    • “A new blood test from Quest Diagnostics has Alzheimer’s experts concerned.
    • “The Quest AD-Detect test, which consumers can now purchase from home without visiting a doctor, measures amyloid-beta 42 and amyloid-beta 40 in blood to provide an amyloid-beta 42/40 ratio. In theory, the ratio may help identify the risk of developing Alzheimer’s disease. In practice, the value of the Quest test is unknown.
    • “The test has not been cleared or approved by FDA.”