Monday Roundup

Rx coverage

Monday Roundup

David Ermer–Congress, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, the Wall Street Journal reports

“President Biden and House Speaker Kevin McCarthy (R., Calif.) opened a high-stakes meeting on Monday evening, as negotiators worked to get back on track on reaching a debt-ceiling deal that could pass both the Republican-led House and Democratic-led Senate by the end of the month. 

“Central to the talks is setting a top-line spending level for the next year and deciding how long to lift the debt ceiling until having to raise it again. The two sides are aiming to reach a deal by June 1, when the Treasury Department estimates the U.S. could run out of money to pay all of its bills, leading to a first-ever default. Treasury Secretary Janet Yellen repeated that estimate Monday.”

About 90 minutes later, Politico adds, “President Joe Biden and Speaker Kevin McCarthy ended their one-on-one meeting Monday [with a “better tone” yet] still short of a deal to avoid a U.S. debt default that could come as soon as June 1.”

From the Rx coverage front —

  • STAT News informs us,
    • “An oral version of semaglutide, the drug marketed as Ozempic and Wegovy, led to dramatic weight loss in a trial enrolling people with obesity, manufacturer Novo Nordisk said Monday, data that could bolster what is already a blockbuster medicine.
    • “In the study, which enrolled nearly 700 adults classified as overweight or obese, patients treated with a daily semaglutide tablet lost 15.1% of their body weight over the course of 17 months, while those on placebo lost 2.4%, Novo Nordisk said. The result is comparable to weekly injections of Wegovy, which in an earlier study led to 14.9% weight loss over the same period of time. In both studies, the most common side effects were gastrointestinal distress, with the majority of cases graded mild or moderate, the company said.
    • “Novo Nordisk said it plans to submit oral semaglutide for U.S. and E.U. approvals later this year. A lower-dose version of the drug is already approved as a treatment for type 2 diabetes under the brand name Rybelsus.”
  • Reuters tells us,
    • “Taking Novo Nordisk’s new obesity drug may help reduce the risk of heart disease as well as boosting weight loss, according to new research from the United States.
    • “After a year of taking semaglutide, marketed as Wegovy, patients’ risk of suffering from conditions like a heart attack or a stroke over the next ten years dropped to 6.3% from 7.6% when measured by a commonly used calculator, researchers at the Mayo Clinic found.
    • “The results, which were presented this week at the European Congress on Obesity in Dublin, are among the first indication that the weight loss induced by the new GLP-1 agonist drugs like Wegovy also brings heart health benefits – something scientists expected, but do not yet have much comprehensive data to prove.
    • “The study was only done among 93 patients, and the researchers said that more and larger studies were needed to see if the risk reduction score actually meant less illness and death long-term.
    • “Novo is expected to release results from its 5-year SELECT trial looking into the health impact of its injectable drug, particularly around heart disease, later this year. Investors, governments and insurers alike are keenly watching the data.
  • FiercePharma offers a special report about the most expensive drugs in our country.

From the U.S. healthcare business front —

  • Fierce Healthcare relates
    • Found, a company that offers an evidence-based weight loss management program for consumers, is launching a new platform that aims to help employers manage services and cost for workers struggling with weight, including GLP-1 drugs like Ozempic and Wegovy.
    • With medication-assisted obesity care in the headlines, Found for Business offers employers a solution that’s based on clinical best practices and is cost-effective and medication-agnostic. Found’s approach combines virtual clinical care with personalized medication regimens and behavioral health change, according to an announcement
  • Healthcare Dive reports
    • HCA Healthcare, one of the nation’s largest for-profit health systems, has agreed to acquire 41 urgent care centers in Texas.
    • The deal includes 19 FastMed and 22 MedPost clinics in Dallas, Austin, San Antonio, Houston and El Paso, HCA said Thursday.
    • Terms of the deal were not disclosed, but the buy is expected to close this summer, according to the operator.

In federal employee benefits news

  • OPM released “the OPM Retirement Quick Guide, a three-page guide to voluntary retirement that walks federal employees through what to expect as a retirement application is processed and benefits are determined, including helping employees estimate when they can expect to receive their interim and first annuity payments. OPM Retirement Services (RS) developed the guide in partnership with the Lab at OPM, using human-centered design principles.” 
  • Federal News Network discusses “OPM’s new approach to modernizing retirement services [which] is all about small bites.”

Friday Factoids

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

From Washington, DC. Roll Call informs us,

“Top negotiators for President Joe Biden and Speaker Kevin McCarthy resumed talks Friday evening to lift the nation’s borrowing cap, ending a “pause” put in place hours earlier when Republicans expressed frustration with the White House position.

“After a nearly daylong setback, White House Counselor Steve Ricchetti, White House budget director Shalanda Young, Rep. Garret Graves, R-La., and House Financial Services Chairman Patrick T. McHenry, R-N.C., resumed talks at the Capitol shortly after 6 p.m.”

From the public health front —

  • Reuters reports
    • “The U.S. Centers for Disease Control and Prevention is urging people at high risk of mpox to get two doses of Bavarian Nordic’s (BAVA.CO) Jynneos vaccine, based on new evidence from a U.S. study showing that the regimen is more effective at preventing infection than one shot.
    • “The study, published on Thursday, offered some of the first evidence on the efficacy of the Jynneos vaccine, which was deployed last year during a global outbreak of mpox that affected more than 30,000 people in the United States.”
  • and
    • “A World Health Organization (WHO) advisory group on Thursday recommended that this year’s COVID-19 booster shots be updated to target one of the currently dominant XBB variants.
    • “New formulations should aim to produce antibody responses to the XBB.1.5 or XBB.1.16 variants, the advisory group said, adding that other formulations or platforms that achieve neutralizing antibody responses against XBB lineages could also be considered.
    • “The group suggested no longer including the original COVID-19 strain in future vaccines, based on data that the original virus no longer circulates in human beings and shots targeting the strain produce “undetectable or very low levels of neutralizing antibodies” against currently circulating variants.
    • “COVID-19 vaccine makers like Pfizer/BioNtech (PFE.N), , Moderna Inc (MRNA.O) and Novavax Inc (NVAX.O) are already developing versions of their respective vaccines targeting XBB.1.5 and other currently circulating strains.
    • “The U.S. Food and Drug Administration is also set to hold a meeting of outside experts in June to discuss the strain compositions of COVID-19 shots for later this year; vaccine manufacturers will be expected to update their shots once the strains are selected.”
  • CNBC reports
    • “NIH is enrolling patients in an early-stage clinical trial to test a universal flu vaccine based on mRNA technology.
    • “The technology is behind Moderna’s and Pfizer’s widely used Covid vaccines.
    • “Scientists hope the vaccine will protect against a wide variety of flu strains and provide long-term immunity so people do not have to receive a shot every year.” 
  • Health Payer Intelligence reminds us that the Affordable Care Act requires health plans to cover four categories of preventive services without cost-sharing when delivered in-network, not just U.S. Preventive Services Task Force Grades A and B recommendations. In addition,
    • “(1) Payers have to cover routine immunizations per the recommendations of the Advisory Committee on Immunization Practices (ACIP), a federal immunization committee. ACIP recommendations are finalized when adopted by the director of the Centers for Disease Control and Prevention (CDC). * * *
    • “(2) The ACA rules around covering preventive care services for women are based on USPSTF and ACIP recommendations. But they also consider Health Resources and Services Administration (HRSA) guidelines, which draw from the Women’s Preventive Services Initiative (WPSI) standards. To comply with the requirements of preventive care services for women, payers must fully cover well-woman visits, breastfeeding support, and screening and counseling related to intimate partner violence and other conditions and circumstances. Contraceptives approved, granted, or cleared by the Food and Drug Administration (FDA) are also covered. * * *
    • “(3) ACA preventive care coverage also encompasses services for children. These requirements are based on HRSA’s Bright Futures Project. They include well-child visits, immunizations, screenings, behavioral and developmental assessments, and more. As of May 2023, the immunization list covered conditions including but not limited to HPV, hepatitis A and B, rubella, influenza, and tetanus.” * * *
  • The Department of Health and Human Services “and the non-profit organization Baby2Baby announced a new pilot program to distribute a one-time only Newborn Supply Kit made up of essential goods and critical maternal health items to new mothers and their infants. * * * HS and Baby2Baby will first distribute 3,000 of the Newborn Supply Kits across Arkansas, Louisiana, and New Mexico – three states experiencing deep levels of family poverty – via hospitals and community-based partner organizations. Any mother giving birth during pilot implementation at one of the partner sites will be eligible to receive a kit. * * * HHS also launched a new website, www.hhs.gov/newbaby, that includes information across all Federal agencies for families on health, feeding, sleeping, child development and programmatic information.”

From the FDA front —

  • Biopharma Dive tells us
    • “A panel of Food and Drug Administration advisers on Thursday backed maternal use of Pfizer’s RSV vaccine for protecting young infants, but recommended its early use be closely monitored to confirm study safety data.
    • “The panel of outside advisers voted 14-0 that Pfizer’s vaccine, called Abrysvo, was effective in protecting infants from infections caused by respiratory syncytial virus, or RSV, when given to their mothers during pregnancy.
    • “Despite some concerns around the shot’s potential risk, they agreed in a 10-4 vote that Pfizer’s data showed it to be generally safe. The FDA, which usually follows the advice of its advisers, is expected to decide whether to approve maternal use of the shot by August. Separately, its use in older adults is due for a decision this month.”
  • MedCity News relates
    • “The inflammatory bowel disorder Crohn’s disease can be treated by several different biologic drugs administered as injections or infusions. The FDA just approved the first daily pill for the chronic condition.
    • “Rinvoq, a blockbuster AbbVie drug already approved for multiple autoimmune and inflammatory disorders, is now approved as a treatment for moderately to severely active Crohn’s disease. The decision announced Thursday specifically covers the treatment of adults whose disease has not been adequately managed by tumor necrosis factors inhibitors, a class of biologic drugs currently used to treat the disorder.”
  • “Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes. These two devices, along with a compatible FDA-cleared integrated continuous glucose monitor (iCGM), will form a new system called the iLet Bionic Pancreas. This new automated insulin dosing (AID) system uses an algorithm to determine and command insulin delivery.”

From the Rx coverage front

  • Healio tells us,
    • “Of adolescents with obesity receiving semaglutide in the STEP TEENS trial, 44.9% improved to overweight or normal weight.
    • “The odds of improving body mass index category with semaglutide were 23 times higher than placebo.”
  • STAT News adds.
    • Novo Nordisk is pausing ads for its obesity drug Wegovy as it struggles to keep up with surging demand, the latest hurdle in its rollout of the weight loss drug.
    • “To avoid stimulating further demand for this medicine, we’re pausing some key Wegovy promotional efforts,” the Danish drugmaker said in an emailed statement. “We are pausing all local television advertising and postponing planned national television advertising for Wegovy. We are also assessing our promotional efforts to healthcare professionals and adjusting accordingly.” The news was earlier reported by Endpoints.
  • Medscape informs us,
    • “Drug shortages in the United States hit a 10-year high in the first quarter of 2023, according to data from the American Society of Health-System Pharmacists (ASHP). Among the top five drug classes affected by shortages are chemotherapy drugs used in the treatment of cancer, many of which do not have alternatives.
    • “The shortage of certain cancer drugs has become a serious and life-threatening issue for cancer patients across the country,” said Karen E. Knudsen, MBA, PhD, chief executive officer of the American Cancer Society (ACS) and its advocacy affiliate, the American Cancer Society Cancer Action Network (ACS CAN), in a statement. “I have heard from patients and practitioners who are directly experiencing the impact of these shortages.”
    • “As of earlier this month, there were 15 oncology drugs on the official US Food and Drug Administration (FDA) drug shortage list. The other top drug classes on shortage include drugs used for central nervous system (CNS) disorders,  antimicrobials, fluids and electrolytes, and hormones.” * * *
    • “Drug shortages in the United States have been a chronic problem for more than two decades, waxing and waning in intensity. In March, a hearing on drug shortages held by the Senate Committee on Homeland Security and Governmental Affairs noted that since 2001, the number of new drug shortages has ranged between 58 (in 2004) and 267 (in 2011). The trend toward new drug shortages declined from 2018 through 2021, but then rose to 160 in 2022.”

From the U.S. healthcare business front —

  • MedCity News points out,
    • “If you enter a drugstore in any major American city, there’s a good chance you might see a retail health clinic. In the past decade or so, healthcare stakeholders have gone back and forth as to whether these clinics will have a significant impact on healthcare delivery in the U.S. But a new report reveals that retail clinics are solidifying their position as a major force in the U.S. healthcare system.
    • “Retail clinic claims volumes have shot up by 200% in the past five years, according to the report, which was released Thursday by analytics company Definitive Healthcare. 
    • Claims growth for these clinics, which are usually located in stores like Walmart, CVS and Walgreens, have greatly outpaced growth in claims for urgent care centers, emergency departments and physician practices. Urgent care center claims grew by 70% in the past five years. Meanwhile, emergency room usage dropped by 1%, and primary care office claims declined by 13%.
    • As of this year, there are more than 1,800 active retail clinics across 44 states. Most of these are in major metropolitan areas, with just 2% of clinics located in rural areas. The report argued that this paucity stems from the same factors that have produced care deserts in rural America — mainly low population density and difficulty attracting workers.
    • The report also revealed that about half of all retail clinics are concentrated in the following seven highly populated states: California, Georgia, Illinois, Florida, Ohio, Tennessee and Texas.

Midweek update

David Ermer–Congress, End of the PHE, NE, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington DC, Roll Call informs us,

“Negotiators tapped by President Joe Biden and Speaker Kevin McCarthy to hash out a debt limit compromise were racing against the clock Wednesday to get some principles down on paper that could be written into legislative text in time for votes as early as next week.

“Both the president and his chief GOP counterpart on Capitol Hill said they thought a deal was possible. Biden is scheduled to return Sunday from his trip to Japan for the G-7 summit, telling reporters at the White House on Wednesday he’d be back for “final negotiations” and that he’d hold a press conference upon his return.

“I’m confident that we will get the agreement on the budget, that America will not default,” Biden said. “Every leader in the room understands the consequences if we fail to pay our bills.”

The FEHBlog offers less encouraging news from the public health front —

  • The Wall Street Journal reports
    • “For decades, advances in healthcare and safety steadily drove down death rates among American children. In an alarming reversal, rates have now risen to the highest level in nearly 15 years, particularly driven by homicides, drug overdoses, car accidents and suicides.
    • “The uptick among younger Americans accelerated in 2020. Though Covid-19 itself wasn’t a major cause of death for young people, researchers say social disruption caused by the pandemic exacerbated public-health problems, including worsening anxiety and depression. Greater access to firearms, dangerous driving and more lethal narcotics also helped push up death rates.
    • “Between 2019 and 2020, the overall mortality rate for ages 1 to 19 rose by 10.7%, and increased by an additional 8.3% the following year, according to an analysis of federal death statistics led by Steven Woolf, director emeritus of the Center on Society and Health at Virginia Commonwealth University, published in JAMA in March. That’s the highest increase for two consecutive years in the half-century that the government has publicly tracked such figures, according to Woolf’s analysis. * * *
    • “Many public-health experts say they don’t think the end of the pandemic will reverse the rise in death rates among young people. Rivara predicts these problems will continue due to persistent issues around mental health and the accessibility of guns.
    • “[Dr. Elizabeth] Wolf said demand for child and adolescent psychiatric services still outstrips supply in her Richmond, Va., office. Patients are on months long waiting lists to see a psychiatrist that accepts insurance.”  
  • Digging deeper, the Journal informs us,
    • “Overdose deaths in the U.S. edged higher in 2022, a federal estimate showed, marking only the second time drugs killed more than 100,000 people in a year. 
    • “The Centers for Disease Control and Prevention on Wednesday released a provisional count of overdose deaths last year that indicated the toll of the fentanyl crisis leveling off after two years of surges during the Covid-19 pandemic. The CDC counted 109,680 overdose deaths in 2022 compared with 109,179 deaths from a similar 2021 projection. For overdose deaths to hover at such a high level demonstrates how fentanyl’s ubiquity and potency continue to threaten the lives of illicit drug users. 
    • “I’m glad to see us not get worse, but it’s hard to celebrate,” said Dr. Chad Brummett, an anesthesiologist and co-director of the Opioid Research Institute at the University of Michigan.”
  • STAT News adds
    • “More than a quarter of American adults are depressed, a 10% surge from nearly a decade ago, according to the latest Gallup survey.
    • “The data come as the Biden administration tries to overhaul mental health care costs and boost the number of health care workers licensed to practice behavioral health care. Congress in this year’s budget also allotted hundreds of millions of dollars to mental health care grants and programs, many of them trained on children or substance misuse.”
  • On a related note
    • McKinsey Consulting explores how virtual hospitals could offer respites to overwhelmed health systems.
    • Health Affairs Forefront discusses approaches to integrating behavioral health with primary care.
    • Employee Benefits News identifies three coverage categories that can reduce healthcare disparities and lower costs — 1) Colon cancer screening (Hey OPM, the article suggests giving a free day off to employees who undergo screening colonoscopies); 2) Basic dental care, and 3) fertility coverage.

From the Rx coverage front, the New York Times reports,

“Thousands of patients are facing delays in getting treatments for cancer and other life-threatening diseases, with drug shortages in the United States approaching record levels.

“Hospitals are scouring shelves for supplies of a drug that reverses lead poisoning and for a sterile fluid needed to stop the heart for bypass surgery. Some antibiotics are still scarce following the winter flu season when doctors and patients frantically chased medicines for ailments like strep throat. Even children’s Tylenol was hard to find.

“Hundreds of drugs are on the list of medications in short supply in the United States, as officials grapple with an opaque and sometimes interrupted supply chain, quality and financial issues that are leading to manufacturing shutdowns.

“The shortages are so acute that they are commanding the attention of the White House and Congress, which are examining the underlying causes of the faltering generic drug market, which accounts for about 90 percent of domestic prescriptions.”

No bueno.

From the human resources front, HR Dive relates,

  • “Employers cannot automatically revoke reasonable accommodations related to COVID-19, despite the dissolution of the “public health emergency” status for the pandemic, the U.S. Equal Employment Opportunity Commission cautioned employers Monday. “Employers may evaluate accommodations granted during the public health emergency, and, in consultation with the employee, assess whether there continues to be a need for reasonable accommodation based on individualized circumstances,” the agency said. 
  • “The warning came as EEOC announced updates to its technical guidance, “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws,” including additional accommodation examples and tips for preventing COVID-related harassment.
  • “The EEOC highlighted that accommodations include low-cost or free measures, such as uninterrupted work time, a quiet workspace or noise-canceling headphones to facilitate that.”

Monday Roundup

David Ermer–AHRQ, Congress, FDA, Federal employment benefits, HSA, Rx coverage, SDOH–
Photo by Sven Read on Unsplash

From Washington DC —

  • The Wall Street Journal reports,
    • “Time isn’t on Washington’s side.
    • “With the U.S. facing a potentially economy-shaking default as soon as next month, logistical hurdles, disagreements on the scope of any talks, a tight legislative calendar and a late start are complicating negotiations over raising the debt ceiling.
    • “President Biden said Monday that the next meeting with congressional leaders will come Tuesday, while responding “no” when asked if there were updates regarding the talks with Republicans. House Speaker Kevin McCarthy (R., Calif.) said that the two sides remain “far apart” and that he would like a deal to be done by this weekend.” * * *
    • “A second meeting with the president and congressional leaders that was originally set to take place on Friday was postponed until early this week. The House and Senate are scheduled to be in session simultaneously for just one more week this month, and Mr. Biden is set to travel overseas for a Group of Seven meeting. Moreover, Republican leaders have so far rejected any short-term debt deal to buy more time.”
  • According to the White House’s briefing room,
    • “President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.”  

From the litigation front, the American Hospital Association informs us

“The U.S. Court of Appeals for the 5th Circuit today temporarily restored an Affordable Care Act requirement that most health plans cover certain preventive services without cost sharing. The 5th Circuit ordered that this requirement remain in effect for everyone (except the few health plans challenging the requirement) until it issues a final decision in the case, which is expected later this year. A federal judge in Texas recently vacated the requirement nationwide, prompting the Department of Health and Human Services and plaintiff to appeal the decision and seek this temporary stay.”

From the public health front —

  • HealthDay tells us,
    • “Older Americans are dying of falls at more than double the rate of 20 years ago — with women, men and all racial groups showing increases, according to a new study.
    • “In 2020, the study found, just over 36,500 Americans age 65 and up died of a fall-related injury. That was up from roughly 10,100 deaths in 1999.
    • “Adjusted for age, those numbers translated into a more than twofold increase in the rate of fall-related deaths among older Americans: from 29 per 100,000 in 1999, to 69 per 100,000 in 2020.” * * *
    • The National Council on Aging has a tool for older adults to check their risk of falls.

From the Rx coverage front —

  • MPR relates
    • “The Food and Drug Administration’s (FDA) Pulmonary-Allergy Drug Advisory Committee voted 16:6 in favor for adults, and 17:5 in favor for children (<18 years of age and ≥30kg), that available data support a favorable benefit-risk assessment for neffy® in the treatment of severe allergic reaction (Type 1), including anaphylaxis, for adults and children who weigh more than 30kg. * * *
    • “While not bound to the committee’s recommendations, the FDA does take them into consideration when making final decisions on approval. If approved, neffy would be the first needle-free epinephrine product to treat severe allergic reaction. A decision is expected by mid-2023.”
  • The Institute for Clinical and Economic Review (ICER) announced today that it will assess the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension.
  • The Wall Street Journal delves into “How to Get Your Health Insurance to Cover Ozempic and Other Drugs Used for Weight Loss; Tips for checking whether your health plan will pay for a prescription and then getting authorization.”
  • Per Hub International,
    • “CMS recently released its updated Medicare Part D guidelines that can be used by group health plan sponsors to determine whether their plans’ prescription drug coverage is creditable for 2024 and to update the information needed for required Part D disclosures to eligible individuals and to CMS.
    • “To help determine whether prescription drug coverage is creditable, CMS has released the following 2024 parameters for the standard Medicare Part D prescription drug benefit:
      • Deductible: $545 (up from $505 in 2023);
      • Initial coverage limit: $5,030 (up from $4,660);
      • Out-of-pocket threshold: $8,000 (up from $7,400);
      • Total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are not eligible for the coverage gap discount program: $11,477.39 (up from $10,516.25 in 2023); and
      • Estimated total covered Part D spending at the out-of-pocket expense threshold for beneficiaries who are eligible for the coverage gap discount program: $12,447.11 (up from $11,206.28).”

From the artificial intelligence front —

  • This week’s episode of the Econtalk podcast features an artificial intelligence discussion between host Russ Roberts and his guest Tyler Cowen. Russ Roberts suggests using ChatGPT to formulate questions for your doctor or your parents’ or your kids’ doctors.
  • Bloomberg examines the use of AI by drug manufacturers.
  • Medcity News looks into the use of AI by pharmacists and PBMs.

From the miscellany department —

  • Fierce Healthcare points out, “Million-dollar claims per million covered employees rose 15% in the past year and 45% from 2019 to 2022, according to a report by Sun Life, a life and disability insurance company.”
  • EHR Intelligence reports,
    • “The Health IT End-Users Alliance has released a consensus statement regarding collecting and using social determinants of health (SDOH) data to support health equity.
    • “The Alliance brings together health information professionals, physicians, hospitals, and other front-line healthcare providers to advance end-user perspectives in health IT policy and standards development.
    • “The statement calls for additional efforts to standardize and increase the uniform collection and reporting of SDOH. The group also calls for more training on collecting this data, better use of appropriate tools and processes to manage and share SDOH, and ongoing research to support these efforts.”
  • Employee Benefit News notes, “Thirteen FSA and HSA-eligible expenses that may surprise you.”

Friday Factoids

David Ermer–CDC, COVID-19, End of the PHE, NE, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

Today marks the final issue of the CDC’s weekly interpretative review of its Covid statistics. The final issue advises

“The latest updates to CDC’s COVID Data Tracker reflect these changes. The homepage has a new look, and there are also new landing pages for hospitalizations, emergency department (ED) visits, and death data, as well as visualizations of trends and maps. Several pages have also been retired, but COVID Data Tracker has a page with links to archived data and visualizations.

“These are the most notable changes to COVID Data Tracker:

  • Hospital admission rates and the percentage of COVID-19 deaths among all deaths are now the primary surveillance metrics.
  • COVID-19 hospital admission levels replace COVID-19 Community Levels (CCLs) as the main indicator of county trends. COVID-19 hospital admission levels are comparable with CCLs.
  • Provisional death certificate data from the National Vital Statistics System (NVSS) will become the primary source for mortality surveillance, replacing aggregate death counts.
  • Aggregate case and death count reporting has been discontinued.
  • ED visit data will serve as an early indicator of COVID-19 activity.”

The Wall Street Journal reports on the ongoing struggles of people afflicted with long Covid.

From the public health front –

  • In recognition of Mothers’ Day this weekend, the CDC encourages pregnant women to get a flu shot (not the nasal flu vaccine spray).
  • MedPage Today tells us that “The CDC reported that the nation’s first-ever cases of treatment-resistant ringworm were identified in New York City. (Morbidity and Mortality Weekly Report)
  • The Department of Health and Human Services celebrated “the first anniversary of the National Maternal Mental Health Hotline. Since being launched on Mother’s Day 2022 by the Health Resources and Services Administration (HRSA), the hotline’s professional counselors have provided emotional support, resources, and referrals to almost 12,000 pregnant and postpartum individuals struggling with mental health concerns, and their loved ones.  Additionally, HRSA is introducing an updated, more user-friendly toll-free number for the Hotline: 1-833-TLC-MAMA (1-833-852-6262).”

From the Rx coverage front —

  • The Food and Drug Administration announced “approving Veozah (fezolinetant), an oral medication for the treatment of moderate to severe vasomotor symptoms, or hot flashes, caused by menopause. Veozah is the first neurokinin 3 (NK3) receptor antagonist approved by the FDA to treat moderate to severe hot flashes from menopause. It works by binding to and blocking the activities of the NK3 receptor, which plays a role in the brain’s regulation of body temperature.”
  • Mercer Consulting offers advice to employers and health plans on how to help employees and members address drug shortages.
  • Biopharma Dive reports
    • “A group of Food and Drug Administration advisers narrowly supported approving what could be the first gene therapy for Duchenne muscular dystrophy in a meeting Friday, clearing the way for the agency to make a closely watched decision later this month.
    • “By an 8-6 vote, the panel recommended that the treatment, developed by biotechnology company Sarepta Therapeutics, be granted an “accelerated” approval. The close vote reflected a daylong back-and-forth over the treatment, and whether the protein it’s designed to produce in the body — called microdystrophin — is reasonably likely to benefit people with Duchenne who can still walk. * * *
    • “The FDA usually follows the advice of its advisory committees, but isn’t required to do so. The agency is set to make its decision by May 29.
    • “While far from unanimous, the panel’s recommendation could make that decision easier, and marks an important moment for a Duchenne patient community that has long advocated for gene therapy.”

From the federal employee benefits front, NARFE informs us that.

  • “Effective May 1, 2023, the US Office of Personnel Management (OPM) extended its contract with John Hancock to provide insurance coverage to all Federal Long Term Care Insurance Program (FLTCIP) enrollees. Although OPM solicited multiple bids, John Hancock remained the sole bidder. The program administrator, Long Term Care Partners LLC, has mailed notice of this action to enrollees.  
  • “Per the extended contract, most enrollees should expect to face a premium increase effective January 1, 2024. In September 2023, each enrollee will be offered personalized options that will include accepting the premium rate increase to maintain current coverage or to reduce coverage to reduce the impact of any increase. OPM indicated that premium increases would be phased in over three years for some options.  
  • No additional information on the premium increases or personalized options is available currently.” 

From the bravery department, Govexec points out that the National Association of Letter Carriers named two dozen letter carriers were named as heroes of the year for taking life-saving actions on the job. Bravo!

From the healthcare spending front, Fierce Healthcare informs us

  • “The anti-dementia medication lecanemab will come with an extraordinarily high price tag if the Centers for Medicare & Medicaid Services (CMS) decides to cover it, according to a research letter in JAMA Internal Medicine.
  • “Researchers at RAND estimate that covering the drug and other associated services could add between $2 billion and $5 billion in annual Medicare costs. This could also lead to “substantial out-of-pocket costs for beneficiaries lacking supplemental coverage,” the researchers said.
  • :Those out-of-pocket costs could be as much as one-fifth of the annual income for a Medicare beneficiary, according to the study. The medication, developed by Eisai and Biogen, costs $26,500 a year, including treatment add-ons such as imaging.”

Whoa, Nelly. Thank heavens OPM is allowing FEHB carrier to offer Medicare Part D EGWPs next year.

Thursday Miscellany

David Ermer–Congress, COVID-19, End of the PHE, NE, FDA, Medical / Rx research, Rx coverage–

From Washington DC —

Photo by Josh Mills on Unsplash
  • The Secretary of Health and Human Services issued a statement on the end of the Covid health emergency which occurred today.
    • Govexec and the Society for Human Resource Management respectively discuss the impact of this event on federal agencies and employers generally.
      • SHRM notes, “President Biden in April ended the pandemic national emergency weeks earlier than expected—but the premature ending won’t shift the deadlines spelled out in the administration’s guidance from March, including the extended deadline for special enrollment in health plans. * * * July 10 will also mark the end of some COBRA-related relief, under which employees were allowed extra time to pay their COBRA premiums or to decide whether they wanted to use the coverage.”
  • The Wall Street Journal reports
    • “A highly anticipated meeting scheduled for Friday between President Biden and congressional leaders to chart a path forward on lifting the debt ceiling was postponed until next week, officials said.
    • “The delay will give White House and congressional staff more time to make progress in their closed-door spending talks, the officials said, adding that one of the lawmakers was unable to attend the meeting Friday because of a scheduling conflict.
  • STAT News informs us
    • “The Senate health committee on Thursday passed a package of bills aimed at speeding generic drug competition and reining in drug middlemen business practices. But they failed to pass an ambitious reform to the pharmacy benefit manager sector, despite strong bipartisan support for it.
    • “Chairman Bernie Sanders (I-Vt.) is pursuing the drug pricing reforms at the behest of Senate Majority Leader Chuck Schumer (D-N.Y.), who wants to hold a floor vote on an even bigger package of health bills later this year. The markup came just a day after the same panel held a major hearing on PBM and drugmakers’ role in high insulin prices.
    • “It’s not clear when the Senate would take up that package, and while the package is bipartisan, it’s not clear whether it has enough support among House Republicans to pass in that chamber. There are a few, tamer PBM bills that the House Energy and Commerce Committee is expected to mark up on May 17, but there is no indication that Senate and House lawmakers are coordinating on PBM legislation.
    • “The committee passed 18 to 3 a bill that would ban PBMs from using so-called spread pricing. It would also require that the middlemen disclose rebates, fees, and other payments they receive and to pass them on to the insurers for whom they negotiate those concessions. * * * The committee included an amendment from Sen. Tina Smith (D-Minn.), that would let patients appeal insurer decisions to make them try cheaper drugs before getting more expensive drugs.”

From the public health front, Healio tells us that “Overweight and obese BMI during adulthood appeared associated with increased risk for colorectal cancer and non colorectal gastrointestinal cancers, according to study results published in JAMA Network Open.” The FEHBlog does not think that the new generation of obesity-reduction drugs needs publicity, but there you go.

From the Rx coverage and more front, the FDA announced

  • “the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s disease. This is the first FDA-approved treatment option for this indication.”
    • Medpage Today adds, “Brexpiprazole’s labelopens in a new tab or window will continue to carry a boxed warning about the risk of increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. The warning further stipulates that the drug is not approved for patients with dementia-related psychosis who are not experiencing agitation associated with Alzheimer’s dementia.”
  • and “finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures.”
  • Beckers Hospital Review points out “The Biden administration has been taking action to address the prescription drug supply shortage, which has caused upheaval both for patients and providers, according to a May 10 Bloomberg report.”

From the medical research front —

  • STAT News reports
    • “Home to billions of cells that form trillions of connections, the human brain isn’t just the body’s most important organ; it’s also the hardest to study. But an international team of scientists using cutting-edge stem cell technology has devised a new way to better understand the brain’s cellular cleanup crew — and its connection to neurological disease.
    • “Researchers coaxed stem cells to grow into microglia, immune cells that roam the brain searching for signs of damage and that monitor and maintain neuronal connections. They then added microglia to brain organoids, tiny 3D structures of neurons that mimic some aspects of brain function, and transplanted these microglia-containing “mini-brains” into mice. Doing so caused microglia to look and behave much more like they would in a human brain compared to previous lab experiments conducted in a dish.
    • “The authors also found early hints that they could use these transplanted organoids to study disease, including the role that microglia might play in autism. Microglia in brain organoids derived from people with autism had larger cell bodies than cells from controls and had an overabundance of small cellular extensions associated with an active, inflammatory state researchers believe may contribute to the disorder.”
    • “The findings, published on Thursday in the journal Cell, are the result of a collaboration between scientists from San Diego to Germany to Israel. The study raises the possibility of using transplanted organoids to understand the complex crosstalk between neurons and immune cells across a range of diseases, and to perhaps one day use this system to test potential treatments.”
  • The Washington Post adds
    • “A skin patch being developed by a French pharmaceutical company to treat peanut allergy is showing promise in toddlers, according to a peer-reviewed study published Wednesday.
    • “The “peanut patch” outperformed a placebo in “desensitizing children to peanuts and increasing the peanut dose that triggered allergic symptoms,” said the study, which was funded by the company DBV Technologies and published in the New England Journal of Medicine.”

Midweek Update

David Ermer–Congress, End of the PHE, NE, NCQA, NIH, OPM, Rx coverage, Telehealth, Uncategorized–
Photo by Michele Orallo on Unsplash

From Capitol Hill —

Roll Call reports

  • “The White House and congressional leaders are discussing the duration of appropriations caps and a debt limit raise as staff talks get underway in advance of the next principals meeting on Friday.
  • “A two-year appropriations deal is under consideration, according to sources familiar with the talks, along the lines of three separate laws since 2015 that were paired with suspensions of the debt limit. 
  • “The White House and top Democrats are pushing for two years of debt limit breathing room, as in the 2019 deal cut with former President Donald Trump. That law contained two years of spending caps, which Speaker Kevin McCarthy pointed out as far back as January.
  • “Such an arrangement would, in theory, remove the threat of fiscal cliffs facing lawmakers and the economy until after the 2024 elections.”

Fierce Healthcare tells us,

  • “The Senate Health, Education, Labor and Pensions (HELP) Committee convened the heads of three big pharmas—Eli Lilly CEO David Ricks, Novo Nordisk CEO Lars Fruergaard Jørgensen and Sanofi CEO Paul Hudson—as well as the top brass at the three largest PBMs—CVS Health Executive Vice President and President of Pharmacy Services David Joyner, Express Scripts President Adam Kautzner and OptumRx CEO Heather Cianfrocco.
  • “The legislation on the docket for the HELP Committee aims to inject transparency into the pharmaceutical supply chain as well as increase access to generics. PBM reforms on the table include eliminating spread pricing models as well as clawbacks from pharmacies. * * *
  • “The HELP Committee will convene Thursday to mark up four bills that target drug pricing. Sanders said that while these measures are a priority, there’s more work to be done in addressing this issue. He added that issues with affording drugs are a broader part of the ongoing challenges around affordability in healthcare.”

Tomorrow is the last day of the Covid public health emergency, and today the Department of Health and Human Services posted a fact sheet on how the end of the PHE affects telehealth.

From the Rx coverage front, the Wall Street Journal points out

  • “Advisers to the Food and Drug Administration recommended making an oral contraceptive available without a prescription for the first time, potentially widening access to birth control for women across the country. 
  • “The panel of FDA advisers voted 17 to 0 on Wednesday that there was enough evidence for the agency to approve the medication’s sale over-the-counter. The FDA, which is expected to make a final decision this summer, doesn’t have to follow the expert panel’s advice, though it often does.
  • “The FDA approved the pill, called Opill, for prescription use in 1973. HRA Pharma, owned by Perrigo, a Dublin-based generic drugmaker, submitted its application to make Opill available over-the-counter last July. 
  • “The advisory panel said the benefits of making oral contraceptives available over-the-counter outweighed the risks.”

The cost curve is pointing down.

From the medical research front, the National Institutes of Health updates us on multiple mRNA vaccines that show promise for treating HPV-Related cancers.

From the healthcare quality front, NCQA informs us

  • “We launched our Race and Ethnicity Stratification Learning Network.
  • “The network is a free, interactive, online tool that offers data and best practices to help health plans improve how they collect race and ethnicity data on enrollees.
  • Improving data collection of race and ethnicity data is vital to improving health equity.
  • “The data available in this new resource summarize the care of 20 million people enrolled in 14 health plans that reported results on 5 HEDIS measures, stratified by race and ethnicity.
  • “Best practices we identify come from NCQA’s qualitative interviews of key staff at plans in the learning network.
  • “A report groups our findings in three areas.”

Check it out.

From the federal employment front, the Office of Personnel Management announced

  • released proposed regulations that would prohibit the use of previous salary history in setting pay for federal employment offers. Under the new proposed regulations, federal agencies would not be able to consider an applicant’s salary history when setting pay for new federal employees in the General Schedule pay system, Prevailing Rate pay system, Administrative Appeals Judge pay system, and Administrative Law Judge pay system.  
  • “These proposed regulations are a major step forward that will help make the federal government a national leader in pay equity,” said OPM Director Kiran Ahuja. “Relying on a candidate’s previous salary history can exacerbate preexisting inequality and disproportionally impact women and workers of color. With these proposed regulations, the Biden-Harris Administration is setting the standard and demonstrating to the nation that we mean business when it comes to equality, fairness, and attracting the best talent.” 

Midweek Update

David Ermer–Congress, Medical / Rx research, Patient safety, Rx coverage, U.S. Healthcare–

From Washington, DC, the Wall Street Journal reports

  • “The Biden administration and Capitol Hill leaders are scrambling to avoid a first-ever government default that could arrive as soon as June 1, taking potential alternative strategies more seriously after months of deadlock over raising the country’s borrowing limit.  
  • “Publicly, both Republicans and Democrats are still sticking to their demands as the clock ticks. GOP lawmakers are seeking to force cuts to federal spending in exchange for supporting raising the debt limit, while Democrats continue to call for a debt-limit increase without any other policy conditions.
  • “Privately, though, Biden administration officials and lawmakers have started to weigh potential alternatives to their negotiating position, including a short-term increase in the borrowing limit that would buy them time to find a compromise, according to people familiar with the matter. Biden administration officials are also taking a fresh look at experimental ways the U.S. could potentially keep paying the government’s bills even if Congress doesn’t raise the debt limit, the people said.” 

From the Rx coverage front —

MedPage Today informs us,

  • “The FDA has approved the first-ever vaccine for respiratory syncytial virus (RSV), the agency announced on Wednesday.
  • “Marketed under the trade name of Arexvy, the adjuvanted RSV prefusion F protein-based vaccine is specifically indicated for preventing lower respiratory tract infections in adults 60 and over.
  • “Until now, no vaccine has existed to protect against RSV infection, a common scourge both for young children and older adults.  * * *
  • “GSK said the vaccine would be available ahead of the 2023/2024 RSV season, and that the CDC’s Advisory Committee on Immunization Practices will weigh in on the RSV vaccine’s appropriate use in June.”

Beckers Pay Issues points out,

  • “Payers are anticipating the cost of expensive new gene therapy drugs to be a significant issue in the coming years, according to a survey from the Pharmaceutical Strategy Group. 
  • “The survey, published May 1, asked 182 benefits leaders at employers and health plans about their organization’s specialty drug benefit design. 
  • “Read the full report here. “

From the drug research front, the Wall Street Journal reports

  • “An experimental Eli Lilly drug slowed cognitive and functional decline for people with early-stage Alzheimer’s disease in a new study that signals drugmakers are turning a corner in long-running efforts to find meaningful treatments for the memory-robbing disease.
  • “Based on the new data, Lilly said Wednesday it plans to apply this quarter to the U.S. Food and Drug Administration for approval to market the drug, setting up a potential agency decision later in 2023 or in 2024. * * *
  • “Researchers designed Lilly’s drug donanemab and Leqembi, from Eisai and Biogen, to work by targeting and reducing amyloid, a substance that forms plaque in the brain and is a prime suspect in fueling the worsening of Alzheimer’s. * * *
  • “In the study of more than 1,730 patients, the [intravenously administered] drug slowed patients’ decline by 35% compared with people who received a placebo over 18 months of treatment, Lilly said. Researchers gave the drug to elderly people who testing indicated were in the early stages of Alzheimer’s. * * *
  • “The findings could bolster donanemab’s appeal to some doctors and patients when compared with Eisai and Biogen’s Leqembi, according to analysts.
  • “Leqembi slowed Alzheimer’s patients’ decline by 27% versus a placebo over 18 months in a separate study, though there were differences in the studies that make direct comparisons difficult.
  • “Yet Leqembi’s safety profile might give it an advantage over donanemab with other doctors and patients, analysts said.”

From the U.S. healthcare business front, Healthcare Dive informs us that “CVS [Health] lowers 2023 earnings outlook on Oak Street, Signify deal costs.”

  • “Despite lowering 2023 earnings guidance by 20 cents to a range of $8.50 to $8.70 per share, “we remain committed to achieving the $9 and $10 targets for 2024 and 2025,” CFO Shawn Guertin said on a Wednesday earnings call.”

From the patient safety front, the Leapfrog Group released

  • “the spring 2023 Leapfrog Hospital Safety Grade. An analysis found the average risk of three healthcare-associated infections (HAIs)— including Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSI) and catheter-associated urinary tract infections (CAUTI)—spiked to a 5-year high in hospitals during the COVID-19 pandemic.” 
  • “Additional highlights from the spring 2023 Safety Grades include:
  • “Twenty-nine percent of hospitals received an “A,” 26% received a “B,” 39% received a “C,” 6% received a “D,” and less than 1% received an “F.”
  • “The top ten states with the highest percentages of “A” hospitals are: New Jersey, Idaho, Utah, Pennsylvania, Connecticut, North Carolina, South Carolina, Colorado, Virginia and Massachusetts.
  • “There were no “A” hospitals in Delaware, the District of Columbia or North Dakota.

Monday Roundup

David Ermer–CMS, Congress, End of the PHE, NE, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, The Wall Street Journal reports

  • “Treasury Secretary Janet Yellen said the U.S. government could become unable to pay all of its bills on time as soon as June 1 if Congress doesn’t first raise the debt limit.
  • “President Biden on Monday invited the top Republicans and Democrats on Capitol Hill to meet next week to discuss raising the country’s roughly $31.4 trillion borrowing limit, the White House said soon after Ms. Yellen’s warning. 
  • “The new estimate released Monday sets a shorter timeline than forecasters had previously expected, putting the U.S. potentially just weeks away from the first default on the U.S. debt. Republicans and Democrats have been debating how to raise the debt ceiling for months, but they have so far made little progress toward reaching an agreement.  * * *
  • “Ms. Yellen said the Treasury’s latest projection was still uncertain. The Treasury could ultimately be able to pay the nation’s bills for several weeks beyond early June, she said. The Treasury tends to be conservative when communicating projected deadlines for possible default.
  • “It is impossible to predict with certainty the exact date when Treasury will be unable to pay the government’s bills,” Ms. Yellen wrote in a letter to House Speaker Kevin McCarthy (R., Calif.).” 

In public health emergency (PHE) news,

  • Govexec informs us “The White House announced on Monday it’s officially ending the COVID-19 vaccine mandates for federal employees and contractors when the public health emergency ends on May 11.”
  • The Centers for Disease Control issued public fact sheets on post-PHE coverage for over-the-counter Covid tests. OPM’s end of PHE guidance requires carriers to continue coverage of these items but allows cost sharing.

From the public health front —

  • The National Institutes of Health announced
    • “Researchers have found the “Eat, Sleep, Console” (ESC) care approach to be more effective than using the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess and manage opioid-exposed newborns, according to a national, randomized controlled clinical trial funded by the National Institutes of Health. Newborns cared for with ESC were medically ready for discharge approximately 6.7 days earlier and 63% less likely to receive medication as part of their treatment, compared to newborns cared for with FNAST. ESC prioritizes non-pharmacologic approaches to care, such as a low-stimulation environment, swaddling, skin-to-skin contact and breastfeeding. ESC also encourages parental involvement in the care and assessment of their infants. These findings are based on the hospital outcomes of a large and geographically diverse group of opioid-exposed infants. A two-year follow-up study of a subset of infants is ongoing. The current findings are published in the New England Journal of Medicine.
    • “Medical care for newborns who were exposed to opioids during pregnancy varies widely across hospitals,” said Diana W. Bianchi, M.D., director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which co-led the study with the NIH Environmental Influences on Child Health Outcomes (ECHO) Program. “These findings are an important step toward standard, evidence-based guidance for the care of these infants.”
  • The McKinsey Health Institute evaluates the impact of tech and social media on Gen Z mental health.
    • “Much like many relationships a person might have between ages 18 and 24, the relationship a young person has with social media can be complicated. No matter where they live, respondents in a new global survey said social media usage can lead to a fear of missing out (FOMO) or poor body image, but it also can help with social connections and self-expression.”

From the Rx coverage front, STAT News tells us,

  • “It’s hard to imagine now, but there was a time when obesity was a desert for drug development. Now that drugs originally conceived to control diabetes appear to be such sweeping successes in weight loss, competitors may soon crowd the field. Some candidates may move beyond the current class of GLP-1-based drugs, which mimic the hormone that helps regulate insulin and hunger. 
  • “STAT’s Elaine Chen and Allison DeAngelis explore novel approaches still in development, including some that don’t induce muscle loss, unlike the GLP-1 drugs, and some that mirror the effect of bariatric surgery. Still, among roughly 80 obesity treatments in development, more than half are GLP-1-based, according to tallies by STAT and analysts at TD Cowen. And combination treatments may be the future. Read more.“

From the U.S. healthcare business front,

  • Beckers Hospital Review points out that “Nursing shortages are easing for some hospitals after falling pay from temp agencies and new hospital perks drive more nurses back into permanent positions, The Wall Street Journal reported May 1.”
  • Beckers Payer Issues relates “Molina Healthcare reported double-digit growth in net income since the same period last year and raised its year-end earnings guidance, according to the company’s first-quarter earnings posted April 26.”
  • According to BioPharma Dive
    • “Japanese drugmaker Astellas Pharma on Sunday agreed to acquire Iveric Bio for about $5.9 billion, betting that a medicine the biotechnology company has developed for a common type of vision loss can help it build an eye drug business. * * *
    • “The deal hands Astellas a drug called Zimura that Iveric is studying as a treatment for a form of vision loss known as geographic atrophy. Iveric’s drug already succeeded in a pair of Phase 3 trials and is currently being reviewed by U.S. regulators. A decision is expected by Aug. 19.
    • “Pharmaceutical companies have increasingly turned to dealmaking to help offset patent losses that are soon expected for many of the industry’s top-selling drugs. Over the last two months, drugmakers have spent roughly $65 billion in total on buyouts, led by Pfizer’s $43 billion acquisition of cancer biotech Seagen, according to BioPharma Dive data.”

Friday Factoids

David Ermer–CDC, Congress, COVID-19, FDA, Mental health care, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Sincerely Media on Unsplash

From the public health front —

  • Here are links to the CDC’s Covid Daily Tracker and its Fluview. It turns out that the CDC is planning one more issue of its Covid statistics review on May 12. All signs continue to support ending the PHE on May 11.
  • ABC News reports on the latest results of the Youth Risk Behavior Survey, published Thursday by the Centers for Disease Control and Prevention.
  • The GAO issued a report on government efforts to curb antibiotic resistance. The Wall Street Journal adds
    • A bipartisan group of U.S. senators and representatives introduced legislation aimed at encouraging drugmakers to develop antibiotics and antifungal drugs to address a growing public health threat. 
    • Bills that lawmakers proposed in the House and Senate on Thursday would commit $6 billion to purchasing new drugs to treat drug-resistant bacteria and fungi that federal officials designate as critically important targets. 
    • Nearly three million people in the U.S. are infected each year with bacteria immune to many antibiotics, the Centers for Disease Control and Prevention said. Some 35,000 of them die. The manufacturers of some promising antibiotics have gone bankrupt because sales of drugs needed only in emergencies are small, public-health experts said. Many big pharmaceutical companies got out of the antibiotic business years ago. 
  • The Hill tells us,
    • A record-low number of adults reported cigarette use in 2022, while reported usage of electronic cigarettes rose among adults. 
    • Preliminary survey results from the Centers for Disease Control and Prevention (CDC) found just 11 percent of American adults — or about 1 in 9 — reported they are smokers, which is a drop from 12.5 percent reported in 2020 and 2021. 
    • The new data, which is based on responses from 27,000 adults, captured an uptick in e-cigarette use among adults, from 4.5 percent who reported use in 2021 to 6 percent in 2022.
  • Fierce Pharma informs us.
    • With its next-generation pneumococcal vaccine, Pfizer has been playing catch-up with Merck in the indication’s key age group—infants. Thursday, Pfizer got to the finish line 10 months after its rival, but with a shot that offers more protection.
    • The FDA approval of Prevnar 20 covers children ages 6 weeks to 17 years and gives Pfizer a chance to continue to control a market it has dominated for two decades.
    • Prevnar 20 is Pfizer’s follow-on to Prevnar 13, offering protection against seven additional serotypes. Merck’s next-gen shot, Vaxneuvance, is a 15-valent vaccine.
    • In the U.S., the seven additional serotypes covered by Prevnar 20 have shown to be associated with antibiotic resistance and heightened disease severity, according to Pfizer. In children five and younger, the seven serotypes account for 37% of the incidence of pneumococcal disease.
  • STAT News points out
    • “To equip both clinicians and patients with the tools to prevent these [maternal health] tragedies, a group of experts * * * have developed a new, evidence-based preventive care plan for those who are at moderate to high risk of preeclampsia, a pregnancy complication that can drive blood pressure dangerously high and is a leading cause of maternal and infant deaths. The care plan, published Friday in the American Journal of Obstetrics and Gynecology, recommends a range of interventions to lower a patient’s risk, including at-home blood pressure checks, treatments like low-dose aspirin, and continuing to take any other needed heart medication, which people are often wary to do when pregnant. The plan also includes lifestyle recommendations for patients like eating a Mediterranean diet, exercising, and getting at least 7 hours of sleep per night.”

From the U.S. healthcare business front —

  • BioPharma Dive report
    • “AbbVie withstood the first months of U.S. copycat competition to its lucrative arthritis drug Humira about as Wall Street had expected, conceding on price to maintain insurance coverage in response to Amgen launching the country’s first biosimilar rival in January.
    • “U.S. Humira sales totaled nearly $3 billion, a decline of 26% from the same period one year ago and just over analysts’ consensus forecasts. AbbVie executives told investors on a Thursday conference call that most of that impact was driven by price changes.
    • “Amgen, which recorded $51 million in U.S. revenue for its biosimilar Amjevita, is selling its Humira rival at two different prices: a 5% discount to Humira’s nearly $90,000 annual list price, and a 55% discount. The approach is meant to address the unique demands of the U.S. healthcare system, in which insurers rely on manufacturers providing rebates off of a drug’s sticker price.”
  • Becker’s Health IT provides more details about this week’s Kaiser Permanente deal with Geisinger, while Beckers ASC Review explores Optum’s physician acquisition strategy.