Midweek Update

CDC

Midweek Update

David Ermer–CDC, Congress, FDA, Medical / Rx research, Medicare, Mental health care, NIH, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today lauded committee passage of the Better Mental Health Care, Lower Drug Cost, and Extenders Act, which was reported out of committee 26-0.” 
  • “The legislation expands mental health care and substance use disorder services under Medicaid and Medicare, reduces prescription drug costs for seniors at the pharmacy counter, extends essential Medicaid and Medicare provisions that will expire this year, and increases Medicare payments to support physicians and other providers. * * *
  • “Click here for more information on the legislation, including a description of the Chairman’s Mark and a section-by-section summary.”
  • Fierce Healthcare adds,
    • “Under the Senate Finance proposal, the $8 billion in cuts to hospitals through the Medicaid disproportionate share hospital (DSH) payments will be eliminated, saving providers $16 billion over the next two years, according to the mark released earlier this week.
    • “Hopefully in further discussion Senators will decide not to pursue so-called ‘site neutral’ policies,” said Federation of American Hospitals President and CEO Chip Kahn in a statement. “This is no time for hospital cuts – particularly for struggling hospitals serving rural America. This ‘one-size-fits-all’ policy will ultimately threaten service resulting in limits on access to care for seniors and others who are better served receiving necessary treatment in the hospital. “
    • “The draft also includes decreasing physician reimbursements by 1.25%, a reduction from larger cuts that could better appease physician interest groups.”
  • STAT News reports
    • “Eli Lilly’s blockbuster drug tirzepatide, sold as Mounjaro for type 2 diabetes [and nicknamed the Godzilla of GLP-1 drugs], has been cleared to treat obesity, making it the second in a highly effective class of weight loss medications to enter the market.
    • “The Food and Drug Administration’s long-awaited approval of the injectable drug, which will be marketed under the name Zepbound for obesity, is a milestone for Lilly. It also introduces stiff competition for Novo Nordisk, which has had to limit starter doses of its obesity treatment Wegovy due to ongoing shortages. * * *
    • “Lilly will sell Zepbound at a list price of $1,059.87 per month, about the same price as Mounjaro and about 20% lower than the price of Novo’s Wegovy. Lilly is also introducing a savings card program for people with commercial insurance.
    • “Lilly expects the drug to be available in American pharmacies after Thanksgiving. In an effort to prevent future shortages, the company plans to have roughly doubled its manufacturing capacity by the end of the year, CEO David Ricks said on a conference call with reporters. Only about 5 million people in the U.S. receive any form of GLP-1 treatment, Ricks said, but there are roughly 50 million Americans who would be eligible for Zepbound and who have commercial insurance that covers obesity treatments.
    • “We know with such an effective medication there’ll be a lot of demand,” Ricks said. “We’re stepping up to that challenge and hope to fulfill it in the coming years.”
  • Ka-ching!!
  • Per an EEOC news release,
    • “The U.S. Equal Employment Opportunity Commission (EEOC) today released three reports focusing on different groups of women in the federal government: American Indian and Alaska Native (AIAN) women, African American women, and Hispanic women and Latinas.
    • “The reports examined fiscal year (FY) 2020 data to compare the participation, retention, advancement, and pay of each group of women to three different groups: the total federal workforce, all women, and men of the same ethnicity or race. Results show that employment outcomes for these three groups of women were not equal to the comparison groups. Understanding the challenges these groups of women face in the federal workplace can help agencies better address these inequalities.”

From the public health and research front,

  • The Wall Street Journal reports that children in mental health crises have been surging into hospital emergency rooms.
    • “Broadly, children’s demand for emergency mental-health services has eased from the pandemic’s extreme highs, according to an analysis of records across more than 1,100 hospitals by the research arm of Epic Systems, a medical record software company. Still, the rates remain elevated. 
    • “For adults, the data on trips to emergency departments for psychiatric reasons during the pandemic is limited, but doctors say they are more used to seeing such cases. E.R.s aren’t accustomed to seeing large numbers of children in psychiatric crisis—and many are ill-equipped to handle them.”
  • STAT News reports,
    • “The radiopharmaceutical world is now approaching critical mass. There are currently around 75 such startups in the U.S., several of which have raised sizable financing rounds this year. In September, RayzeBio managed to complete an IPO — rare amid an industry slump — raising $358 million. Bayer has made a few acquisitions in the field. And last month, pharmaceutical giant Eli Lilly jumped in, acquiring Point Biopharma and its Phase 3 radiopharmaceutical treatment for prostate cancer for $1.4 billion.
    • “Investors and executives are optimistic these investments will pay off not just for venture capitalists, but for cancer patients. But just how much they can benefit the field remains to be seen. To achieve anything, radiopharmaceutical companies must hurriedly address supply and production challenges — issues that have handicapped other promising areas of oncology drug development.”
  • and
    • Vaccines work well to prevent cancers caused by the human papillomavirus (HPV). So well, in fact, that it may be time to review HPV screening protocols, according to the somewhat provocative conclusion of a new study examining the occurrence of genital HPV types eight years after immunization, published Wednesday in Cell Host & Microbe.
  • and
    • “In American health care, overtreatment is common. Recently though, there has been a subtle shift in the opposite direction. It’s possible that “less is more” is catching on.
    • “Now, some providers are asking what the line between necessary and unnecessary really is. The results are encouraging, suggesting that, in some cases, it may be possible to achieve the same health outcomes with less treatment — and fewer side effects, too.
    • “This shift is particularly noticeable in cancer care.”
  • Here is a link to the National Cancer Institute’s latest research update.
  • Gallup announced
    • “U.S. workers are optimistic that employer-sponsored wellness initiatives could enhance their wellbeing, according to data from the Bentley-Gallup Business in Society Report. When asked to rate the potential impact of six wellness initiatives on wellbeing, the top three most positively rated (based on combined extremely and somewhat positive ratings) are employers offering a four-day workweek option (77%), providing mental health days (74%) and limiting the amount of work employees are expected to perform outside of work hours (73%).”
  • Becker’s Payer Issues tells us,
    • “Increasing Medicare Advantage enrollment in rural areas did not increase rural hospitals’ financial distress or risk of closing, a study published Nov. 3 in the American Journal of Managed Care found. 
    • “Researchers studied rural hospitals in 14 states from 2008 to 2019. Medicare Advantage enrollment in rural hospital counties increased from 14.3% of Medicare beneficiaries in 2008 to 28.4% in 2019. The percentage of Medicare inpatient stays paid for by MA plans increased from 6.5% in 2008 to 20.6% in 2019. 
    • “The researchers found that when Medicare Advantage penetration increased by 1% in a county, hospitals’ financial stability increased slightly, and they experienced a 5% reduction in risk of closing. 
    • “One in 5 of the hospitals studied treated no Medicare Advantage patients during the study period.” 

From the U.S. healthcare business front,

  • The Segal Company highlights fraud, waste, and abuse trends in this fourth quarter of 2023.
  • Healthcare Dive provides the biggest takeaways from health insurers’ third-quarter earnings.
  • KFF offers
    • “One new analysis shows that the typical beneficiary has a choice of 43 Medicare Advantage plans as an alternative to traditional Medicare for 2024. That is the same number available as in 2023, but more than double the number of plans offered in 2018, which shows how this market is attractive to both enrollees and insurers.
    • “In addition, the typical person covered under traditional Medicare can choose among 21 Medicare stand-alone prescription drug plans (PDPs), the second analysis shows. The number of PDP options for 2024 is lower and the number of Medicare Advantage prescription drug plan (MA-PD) options is higher than in any other year since Part D started, reflecting the broader trend toward Medicare Advantage.”
  • Fierce Healthcare informs us,
    • “A recent federal district court ruling against the office overseeing the 340B Drug Pricing Program has opened the doors for hospitals to more broadly claim discounts, healthcare legal experts say.
    • “The decision in Genesis Healthcare, Inc. v. Becerra, handed down Friday by the U.S. District Court of South Carolina, establishes that “at least some of [the] interpretative policies surrounding the 340B definition of the patient are inconsistent with the 340B statute,” Anil Shankar, a partner at Foley & Lardner, told Fierce Healthcare.
    • “This is a stunning decision that will have the attention of every 340B stakeholder,” he said. “… This creates new opportunities for 340B-covered entities to purchase 340B for their patients and suggests that [the Health Resources and Services Administration’s (HRSA’s)] audit processes will need to change.”
  • and
    • “Building on its One Medical deal, Amazon is now offering a One Medical for Prime membership, including 24/7 virtual care, for $9 per month, or $99 a year. That’s $100 less than the standard One Medical membership fee, according to the company.
    • “Prime members can add up to five additional memberships, each for just $6 a month, or $66 annually.
    • “The One Medical for Prime membership fee covers unlimited access to 24/7 virtual care nationwide, including video chats with licensed providers and access to an in-app “Treat Me Now” feature that lets users get fast care for common concerns like cold and flu, skin issues, allergies, urinary tract infections.”

Tuesday Tidbits

David Ermer–CDC, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Roll Call informs us,
    • “House Republicans are aiming to reach a consensus this week on a stopgap funding measure that would get a vote next week before the current continuing resolution runs out on Nov. 17.
    • “During a Monday night leadership meeting, Speaker Mike Johnson, R-La., floated a “laddered CR” that would extend funding for four bills through Dec. 7 and the rest through Jan. 19. Johnson said Tuesday after meeting with the GOP conference that a stopgap bill running into January “with certain stipulations” is also on the table.
    • “The new speaker said he would be revealing his spending plan “in short order” but did not share any details Tuesday morning after House Republicans met to discuss the options. However, Senate Democrats are pushing for a stopgap measure into early December, with Dec. 8 as the preferred end date, according to sources familiar with the consideration.”
  • The Washington Post reports,
    • “The Senate on Tuesday voted 62 to 36 to confirm cancer surgeon Monica M. Bertagnolli as the director of the National Institutes of Health, ensuring that America’s flagship biomedical agency will have a permanent leader following a months-long dispute involving a key senator that threatened to derail her nomination.
    • “Bertagnolli will be the second woman ever to lead the nearly $48 billion agency, which plays a central role in the U.S. scientific agenda by funding grants to hundreds of thousands of researchers, overseeing clinical trials on its Maryland campus and supporting other endeavors to develop drugs and therapeutics.”
  • The U.S. Preventive Services Task Force gave brand new “inconclusive” recommendations to the following services:
    • The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries or periodontal-related disease, in adults.
    • The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of routine screening performed by primary care clinicians for oral health conditions, including dental caries, in children and adolescents aged 5 to 17 years.
  • Federal News Network points out,
    • “In October, 6,924 new [federal and postal retirement] claims were filed, an increase of 156 more than September. OPM also processed fewer retirement claims last month. The agency said it processed 6,098 claims, a  2,781 drop from the previous month.
    • “Initial retirement cases in October completed in less than 60 days on average took 42 days to process, up 2 days from the previous month, while initial cases that were processed in more than 60 days on average took 113 days.  That’s a 9 day improvement from September.
    • “Along with the increase of the claims backlog, the monthly average processing time in days grew from 70 to 73. But there is some good news: The fiscal year-to-date average processing time in days decreased from 77 to 73 days in October.”

In FEHBP news,

  • Per the Federal Times,
    • “Millions of federal employees and their family members will be able to shop for health benefits beginning Monday. 
    • “Open enrollment, spanning for four weeks, could overlap with a government shutdown if Congress fails to extend the current continuing resolution or pass a spending package by next Friday. More than a month into fiscal 2024, the government is still operating on last year’s funding levels after Congress passed a last-minute stopgap bill on Sept. 30.
    • “As the name implies, a shutdown means that many agency offices close and employees whose work is outside of national security, health and “life or death” services are sent home without pay. However, the office that oversees the Federal Employee Health Benefits program and open season is funded by a trust that does not rely on annual appropriations.
    • “There are sufficient amounts in these trust funds to operate them throughout the duration of any lapse in appropriations,” according to the White House’s Office of Personnel Management.
    • “Thus, employees will be able to participate in open season in the event of a shutdown. And coverage will not lapse during this time either, either for medical or dental and vision.”
  • Federal News Network considers, in consultation with Kevin Moss from Consumers’ Checkbook, “six reasons feds why should take a look [at available FEHB plans] during Open Season this year.”

From the public health and research front,

  • The American Hospital Association News tells us,
    • “Over 3,700 babies were born with syphilis in 2022, 32% more than in 2021 and 10 times more than in 2012, the Centers for Disease Control and Prevention reported Nov. 7. Almost 9 in 10 cases last year could have been prevented with timely testing and adequate treatment, the agency said, and urged emergency departments, syringe service programs, prisons/jails and maternal and child health programs to use rapid syphilis testing and treatment during pregnancy and other settings to consider immediate treatment if a patient tests positive and faces obstacles to ongoing care.
    • “The congenital syphilis crisis in the United States has skyrocketed at a heartbreaking rate,” said CDC Chief Medical Officer Debra Houry, M.D. “New actions are needed to prevent more family tragedies. We’re calling on healthcare providers, public health systems, and communities to take additional steps to connect mothers and babies with the care they need.” 
  • The National Institutes of Health announced,
    • “In a small study, researchers at the National Institutes of Health have found that positron emission tomography (PET) scans of the heart may identify people who will go on to develop Parkinson’s disease or Lewy body dementia among those at-risk for these diseases. The findings, published in the Journal of Clinical Investigation and led by scientists at the National Institute of Neurological Disorders and Stroke (NINDS), part of NIH, may advance efforts to detect the earliest changes that years later lead to Parkinson’s disease and Lewy body dementia.
    • “In 34 people with Parkinson’s disease risk factors, researchers conducted PET scans of the heart to gain insight into levels of the neurotransmitter norepinephrine. They found that the scans could distinguish individuals who would later be diagnosed with Parkinson’s or Lewy body dementia—both are brain diseases caused by abnormal deposits of the protein alpha-synuclein that form clumps known as Lewy bodies. The research was conducted at the NIH Clinical Center, currently the only location for F-dopamine PET scanning.”
  • The Wall Street Journal reports on ways to control sugar consumption
    • People assume they can build up the willpower to completely avoid sweets or restrict them to tiny amounts, but cutting them out increases the chances of overeating later, says Dr. Judson Brewer, a neuroscientist and psychiatrist at Brown University and author of a forthcoming book about eating habits. 
    • “Willpower is more myth than muscle,” says Brewer.
    • “Unsurprisingly, a fully permissive approach to sugar won’t work for kids, says Crystal Karges, a San Diego-based dietitian who works with families. Still, she doesn’t encourage restriction. One strategy she suggests is to offer sweets alongside regular meals in order to normalize the treats. 
    • “Brewer, the neuroscientist, suggests another alternative to restricting yourself: Find your “pleasure plateau.” Rather than cutting out treats entirely, train yourself to pay close attention to how a treat is tasting as you eat it and note when you stop enjoying the taste of it. 
    • “Practicing attentive eating or mindfulness over time can help your body feel the rewards of limiting sugar consumption, which can be anything from having more energy to fewer cravings to weight loss, Brewer says. 
    • “Keeping your home well-stocked with healthy snacks, alongside indulgent treats, is helpful. In her own home, [University of Minnesota professor Dianne] Neumark-Sztainer says roughly 70% of the food options are nutritious and lack added sugar, including whole grains, fruits and vegetables. 
    • “She doesn’t recommend most people count the amount of sugar they eat each day, which can increase anxiety. “Try to look at the whole picture and not to make a big deal about it,” she says.”

From the U.S. healthcare business front,

  • Per STAT News,
    • “Sage Therapeutics set the price of Zurzuvae, its recently approved treatment for postpartum depression, at $15,900 for a 14-day course of therapy. The once-daily pill will be launched in December, co-marketed with Biogen. 
    • “Eisai reported sales of 300 million yen ($2 million) for Leqembi, its treatment for Alzheimer’s disease, in the company’s fiscal second quarter. Approximately 800 people were receiving treatment with Leqembi as of Oct. 27, the company said.” 
  • Beckers Payer Issues ranks the major health insurers by third-quarter medical loss ratios.
  • Per Healthcare Dive,
    • “E-prescribing giant Surescripts has acquired ActiveRADAR, a company that aims to find cheaper medication alternatives.
    • “ActiveRADAR, formerly known as RxTE Health, evaluates drugs in 165 therapeutic categories to identify clinical equivalents, then uses health plan-specific data to determine alternative medications that could reduce costs for employers and patients, according to the company.
    • “The deal, announced on Monday, makes ActiveRADAR a wholly owned subsidiary of Surescripts, according to a company spokesperson. Terms of the deal weren’t disclosed.”
  • Forbes offers “Five considerations for health plan leaders using AI-enabled prior authorization and utilization management.”

Friday Factoids

David Ermer–CDC, CMS, Congress, Electronic health records, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Department of Health and Human Services discusses its efforts to support rural healthcare.
  • Today, the proposed No Surprises Act regulation that would change current Independent Dispute Resolution processes was published in the Federal Register. OPM’s proposed FEHB rules changes are described on page 75,808 and may be found on page 75,851.
  • The Centers for Medicare and Medicaid Service issued FAQs on its new final rule imposing civil monetary penalties on Section 111 reporting violations. The rule, which impacts FEHB carriers, becomes enforceable on October 11, 2024.
  • Congressman Gerry Connolly (D VA) released a “statement in support of the Office of Personnel Management’s (OPM) expansion of infertility coverage benefits for Federal Employee Health Benefits (FEHB) program enrollees.” The FEHBlog is pleased to read about Congressman Connolly’s support.
  • The Office of the National Coordinator of Health Information Technology created a blog post titled “Coming in Hot! TEFCA Will Soon Be Live and Add Support for FHIR-Based Exchange.” The post indicates that this critically important electronic health record key to data sharing will be going live soon.
    • “Our TEFCA timelines will remain aggressive and ambitious as ONC and the RCE help support the industry to usher in a new era of data exchange for the United States.
    • “For more information on TEFCA in general, please check out the RCE resources and sign up for the RCE newsletter and monthly public calls.”
  • Govexec reports, “The Office of Personnel Management on Friday announced new plans aimed at helping the federal government’s HR agency better weather the annual surge of retirement applications from departing federal employees that occurs each winter.” Good luck.
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission opened its 2022 EEO-1 Component 1 data collection Oct. 31. Reports must be submitted by Dec. 5, the agency said in a news release. 
    • “The EEO-1 Component 1 report is a mandatory demographic data report the EEOC requires from all private-sector employers with 100 or more employees, and from certain federal contractors.
    • “EEOC’s Office of Enterprise Data and Analytics released a booklet to help filers complete the process. It has also provided a Filer Support Team Message Center and other resources, the agency said.”

From the public health front,

  • The Centers for Disease Control posted its inaugural issue of FluSight for the current flu season. Here’s the kickoff forecast.
  • Health Payer Intelligence explains how public and private payers cover healthcare for the LGBTQ+ community.
  • The Institute for Clinical and Economic Research published
    • “its third annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report |Supplemental Materials) within US commercial insurance and the Veterans Health Administration. The analysis found that major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions. However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients.” 
  • Beckers Hospital Review shares CMS statistics on emergency department wait times across our country.
  • The Wall Street Journal gives advice on how to avoid the gloom associated with turning the clock to standard time this weekend.
    • “Daylight hours affect our brain chemistry. As days grow shorter, light receptors in the eyes receive less light and send a signal to the brain about what chemicals to produce, says Lina Begdache, associate professor of health and wellness studies at Binghamton University. 
    • “Our brains begin producing more melatonin—the sleep-related hormone—and less serotonin, which enhances mood and controls appetite. When the brain starts making more melatonin at 4 p.m. due to the earlier dusk, people can feel prematurely sluggish, which can affect mood, diet, exercise and sleep patterns.  
    • “Focusing on improving one area that is affected by the time change, such as exercise, can help the others and might be more doable than trying to improve everything at once, says Begdache, the associate health and wellness studies professor.  * * *
    • “If you improve your diet, you’re more likely to exercise more. And if you exercise more, you’re more likely to sleep better,” says Begdache, who led a 2021 study on mental well-being and seasonal changes. “
  • The FEHBlog personally likes having more sunlight in the morning.

From the U.S. healthcare business front,

  • Here’s a link to the American Medical Association’s reaction to the 2024 Medicare Part B pay cut announced this week. The pay cut is a wash for FEHB carriers because the cut applicable to Medicare prime annuitants will be offset by price increases for younger members. The big problem is that the cut will drive more doctors out of Medicare Part B. When the FEHBlog, who is on traditional Medicare, lived inside the Beltway, his primary care doctor joined the crowd of local PCPs who had dropped out of Medicare. When the FEHBlog moved to Texas last year, he had no problem finding a PCP who takes Medicare, and what’s more, his PCP participates in an accountable care organization. Access to affordable healthcare and dental care is better in central Texas than inside the Beltway, at least for now. The FEHBlog agrees with the AMA that Congress needs to step up.
  • BioPharma Dive informs us,
    • “Moderna on Thursday shifted its revenue forecast for the year to “at least” $6 billion from a previous range of between $6 billion to $8 billion, a change it said reflected COVID-19 vaccination trends in the U.S.
    • “The biotechnology company also disclosed third-quarter earnings showing a net loss of $3.6 billion, driven mainly by non-cash charges of $3.1 billion related to a “manufacturing resizing” and a tax charge. Shares slumped 6% Thursday on the news but traded up Friday morning.
    • “Moderna said it plans to break even in 2026 through “disciplined investment” and launches for new products like its mRNA flu and respiratory syncytial virus vaccines as well as a combination flu and COVID shot.”
  • MedTech Dive shares medtech executives’ views on the new GLP-1 obesity drugs.
    • “Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
    • “The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector.
    • “Fears that medications such as Ozempic, Mounjaro and Wegovy, which are used for diabetes and weight loss, will eventually reshape treatment for a variety of diseases have driven the most severe correction in the medtech sector since the onset of COVID-19, wiping out about $370 billion in market capitalization, according to Mizuho analyst Anthony Petrone.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, FDA, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson said Thursday that Republicans are considering a new approach to stopgap funding that would extend pieces of current appropriations for different time periods, effectively setting up a series of funding cliffs while avoiding a single deadline that could trigger a partial government shutdown for all agencies.
    • “With current funding for the entire government set to expire on Nov. 17, Johnson has proposed a CR to extend funding through Jan. 15, though that date is the federal Martin Luther King Day holiday. But the Louisiana Republican said at a press conference some GOP members raised the idea of a “laddered CR” to extend funding on a piecemeal basis.”
  • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released a discussion draft including policies aimed at expanding mental health care under Medicaid and Medicare and reducing prescription drug costs for seniors at the pharmacy counter. The package also includes essential Medicaid and Medicare provisions that will expire this year, as well as changes to Medicare payment to support physicians and other professionals. The Committee intends to advance these legislative proposals, in addition to pharmacy benefit manager (PBM) reforms previously passed out of the Committee in July, and pursue full Senate passage and enactment. As part of that process, the Committee intends to hold a markup on Wednesday, November 8 at 10 a.m. In keeping with Finance Committee rules, the Chairman’s Mark will be released 48 hours in advance of the markup.”
  • It was a very busy day for the Centers for Medicare and Medicaid Services. We learned from the American Hospital Association that
    • The Centers for Medicare & Medicaid Services Nov. 2 issued a final rule that increases Medicare hospital outpatient prospective payment system rates by a net 3.1% in calendar year 2024 compared to 2023. This includes a 3.3% market basket update, offset by a 0.2% cut for productivity.
    • In a statement shared with the media, AHA Executive Vice President Stacey Hughes said “The AHA is concerned that CMS has again finalized an inadequate update to hospital payments. Today’s increase for outpatient hospitals of only 3.1% comes in spite of persistent financial headwinds facing the field. Most hospitals across the country continue to operate on negative or very thin margins that make providing care and investing in their workforce very challenging day to day. Hospitals’ and health systems’ ability to continue caring for patients and providing essential services for their communities may be in jeopardy, which is why the AHA is urging Congress for additional support by the end of the year.” 
    • The rule also finalizes several changes to the hospital price transparency rule, including requiring a new standard format with an additional data element and a completeness and accuracy affirmation statement. CMS also makes updates to streamline the enforcement process. Compliance dates for the changes range from Jan. 1, 2024, to Jan. 1, 2025. Most formatting changes take effect July 1, 2024.
  • and
    • “Following last year’s unanimous Supreme Court decision in favor of the AHA and others, the Department of Health and Human Services Nov. 2 issued a final rule outlining the agency’s remedy for the unlawful payment cuts to certain hospitals that participate in the 340B Drug Pricing Program. 
    • “HHS’ final rule contains two central components. First, HHS will repay 340B hospitals that were unlawfully underpaid from 2018 to 2022 in a single lump sum payment. The final rule contains the calculations of the amounts owed to the approximately 1,600 affected 340B covered entity hospitals. Second, HHS finalizes a policy to recoup funds from those hospitals that received increased rates for non-drug services from 2018 to 2022. HHS will recoup these funds by adjusting the outpatient prospective payment system conversion factor by minus 0.5% starting in calendar year 2026 (one year later than HHS had originally proposed and as AHA advocated), making this adjustment until the full amount is offset, which the department estimates to be 16 years.
    • “In a statement shared with the media, AHA President and CEO Rick Pollack said, “Following years of litigation and a unanimous Supreme Court win, the AHA is very pleased that 340B hospitals finally will be reimbursed in full for what HHS unlawfully withheld from them for five years. The one-time, lump-sum repayment hospitals will soon receive will help them to continue providing high-quality care to their patients and communities. However, HHS made a grievous mistake in choosing to claw back billions of dollars from America’s hospitals, especially those that serve rural, low-income and other vulnerable communities. HHS decided to ignore hundreds of comments from hospitals and other providers explaining why this Medicare cut is both illegal and unwise. The AHA will continue to review this rule and consider all available options going forward.”
  • and
    • “The Centers for Medicare & Medicaid Services Nov. 2 released its calendar year 2024 final rule for the physician fee schedule. The rule will cut the conversion factor by 3.4%, to $32.74 in CY 2024, as compared to $33.89 in CY 2023. This reflects the expiration of the 2.5% statutory payment increase for CY 2023; a 1.25% statutory payment increase for 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a budget-neutrality adjustment. 
    • “As urged by the AHA, CMS addressed the fact that on Jan. 1 practitioners who render telehealth services from home would have been required to report their home address on enrollment and claims forms. The agency delayed this provision until Jan. 1, 2025, and solicits comments on the issue for future rulemaking.
    • “In addition, the agency finalized a revised definition of the substantive portion of a split (or shared) visit. Specifically, for CY 2024, for purposes of Medicare billing, the definition of “substantive portion” means more than half of the total time spent by the physician and non-physician practitioner performing the split (or shared) visit or a substantive part of the medical decision-making.
    • “CMS finalized its proposals to advance access to behavioral health services. First, CMS will implement regulations as directed by the Consolidated Appropriations Act of 2023 to create a new benefit category for marriage and family therapists and mental health counselors under Part B, who will be eligible to provide telehealth services and behavioral health integration services. CMS also established new payment codes for mobile psychotherapy for crisis services as required by the CAA. Separately, the agency will apply an adjustment to psychotherapy services payments billed with a new increased complexity code and will increase the payment rate for the substance use disorder bundle.”
  • What’s more, AHA News reports,
    • “The AHA, joined by the Texas Hospital Association, Texas Health Resources, and United Regional Health Care System, Nov. 2 sued the federal government to bar enforcement of an unlawful, harmful and counterproductive rule that has upended hospitals’ and health systems’ ability to share health care information with the communities they serve, analyze their own websites to enhance accessibility, and improve public health.  * * *  
    • “Today’s lawsuit challenges a “Bulletin” issued by HHS’ Office for Civil Rights. The December 2022 “Bulletin” restricts hospitals from using standard third-party web technologies that capture IP addresses on portions of hospitals’ public-facing webpages that address health conditions or health care providers. For example, under HHS’ new rule, if someone visited a hospital website on behalf of her elderly neighbor to learn more about Alzheimer’s disease, a hospital’s use of any third-party technology that captures an IP address from that visit would expose that hospital to federal enforcement actions and significant civil penalties.”  
  • The U.S. Office of Personnel Management announced “the recipients of the 2023 Presidential Rank Awards (PRA) chosen by President Joe Biden. The PRAs are one of the most prestigious awards in the career civil service, recognizing the important contributions of public servants across the federal government.” Congratulations to the recipients.   

In FEHB news, FedWeek discusses the relationship between FEHBP and FEDVIP plans.

  • “FEDVIP is the “secondary” payer to any benefits provided under an FEHB plan. If you are enrolled in both FEDVIP and FEHB, you must provide your FEHB enrollment information during the FEDVIP enrollment process (which takes place online, on www.benefeds.com). It’s a good idea to provide your FEHB information to the medical office that is providing the dental or vision services under FEDVIP.
  • “Also, if you change your FEHB health plan during the year, you need to notify BENEFEDS immediately. If you fail to provide this information, payment of claims will be delayed.”

From the public health and research front,

  • The U.S. Preventive Services Task Force released its final research plan for “Healthy Diet, Physical Activity, and/or Weight Loss to Prevent Cardiovascular Disease in Adults: Behavioral Counseling Interventions.”
  • The NIH Director’s Blog discusses “How Double-Stranded RNA Protects the Brain Against Infection While Making Damaging Neuroinflammation More Likely.”
    • “The findings show how this tricky balance between susceptibility to infection and inflammation in the brain works in both health and disease. It also leads to the tantalizing suggestion that treatments targeting these various players or others in the same pathways may offer new ways of treating brain infections or neuroinflammatory conditions, by boosting or dampening dsRNA levels and the associated immune responses. As a next step, the researchers report that they’re pursuing studies to explore the role of dsRNA-triggered immune responses in ALS and Alzheimer’s, as well as in neuropsychiatric symptoms sometimes seen in people with lupus.”
  • The Food and Drug Administration released
    • “data from the 2023 National Youth Tobacco Survey (NYTS) on tobacco product use among U.S. youth. The findings, which were collected between March and June 2023, show that 10% of U.S. middle and high school students (2.8 million youth) reported current use of any tobacco product.
    • “Among U.S. high school students, current overall tobacco product use declined during 2022-2023 (16.5% to 12.6%). This decline was primarily attributable to reduced e-cigarette use (14.1% to 10%), which translates to 580,000 fewer high school students who reported current use of e-cigarettes in 2023. Among high school students, declines in current use were also observed during 2022-2023 for cigars and overall combustible tobacco smoking, representing all-time lows.”
    • “It’s encouraging to see this substantial decline in e-cigarette use among high schoolers within the past year, which is a win for public health,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “But we can’t rest on our laurels. There’s more work to be done to build on this progress.”  

From the U.S. healthcare business front

  • Per Healthcare Dive
    • “Cigna has hiked its membership expectations for 2023. The health insurer previously expected to lose commercial members in the back half of the year, prepping for an economic downturn that might cause Americans to lose their jobs — and subsequently, their insurance.
    • “But the expected economic downturn has yet to materialize, leading Cigna to say on Thursday it expects to add at least 1.6 million members this year, up 200,000 lives from previous forecasts.
    • “We’ve not seen the disenrollment levels we incorporated into our prior outlook,” said CFO Brian Evanko on a Thursday call with investors. Cigna also raised its revenue and adjusted earnings per share outlook for 2023, after releasing third-quarter earnings.”
  • and
    • “Amwell posted a growing net loss in the third quarter as the telehealth firm notched another hefty goodwill impairment charge.
    • “The Boston-based company’s losses reached $137.1 million — a 94% increase from the same period in 2022 —  including $78.9 million in impairment charges linked to sustained decreases in its share price and market capitalization. Revenue declined 11% year over year to $61.9 million. 
    • “But a recent contract with the Department of Defense’s Health Agency that aims to digitize the military healthcare system “fortifies our path to profitability,” expanding Amwell’s reach within the public sector, CEO Ido Schoenberg said on a call with investors Wednesday.”
  • BioPharma Dive adds
    • “Novo Nordisk and Eli Lilly on Thursday reported strong sales growth for their rival GLP-1 metabolic disease drugs, setting up a 2024 showdown as the latter company’s latest product Mounjaro nears approval as a weight-loss rival to Novo’s Wegovy.
    • “Both companies cautioned about potential supply constraints, however. Wegovy still has limited availability at the starter dose, and Lilly CEO David Ricks said there is a need to increase manufacturing capacity “pretty dramatically from the current levels.
    • “Wegovy sales jumped nearly five-fold to 21.7 billion Danish krone, or about $3.1 billion, through the first nine months of this year, according to Novo. Sales of Ozempic, which is approved as a diabetes drug but used off-label in weight loss, were 65.7 billion krone, a 58% rise. * * *
    • “Lilly on Thursday revealed equally promising sales numbers for Mounjaro, which is so far approved only as a blood sugar-lowering agent for people with Type 2 diabetes. Sales of the dual-acting drug were $3 billion for the first nine months of 2023, which will be its first full year on the market. It is now Lilly’s second-biggest seller after another GLP-1 drug called Trulicity, sales of which have declined as Mounjaro’s have grown.
    • “A Food and Drug Administration decision on approving Mounjaro, known also as tirzepatide, in obesity should come by the end of 2023 * * *.”
  • The Wall Street Journal points out
    • “Both Lilly and Denmarks Novo Nordisk, which makes Ozempic and its sister drug Wegovy, are struggling to meet skyrocketing demand for their medications. There is no quick fix for that given the complexity of building out manufacturing capacity for the injections. Both companies are investing billions of dollars a year to try to catch up. * * *
    • “Keeping up with demand requires investments in factories that take years to build. Morgan Stanley analysts recently forecast the global anti-obesity market would be worth $77 billion by 2030. Mounjaro, Ozempic and Wegovy are injectables, which are complex to manufacture. Some oral medications currently in clinical trials, such as Lilly’s orforglipron, are smaller molecules, which are simpler to make. Supply constraints may only be truly remedied whenorals come to the market, the analysts said.”

Midweek Update

David Ermer–CDC, CMS, Congress, COVID-19 testing, Federal employment benefits, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • Roll Call tells us, “The Senate on Wednesday voted 82-15 to pass the first three of its fiscal 2024 appropriations bills in a “minibus” as the House tees up votes this week on three of its remaining seven fiscal 2024 appropriations bills.”
    • The minibus included “the fiscal 2024 Military Construction-VA, Agriculture, and Transportation-HUD appropriations bills.” 
  • The Centers for Medicare and Medicaid Services issued its “calendar year 2024 Home Health Prospective Payment System (HH PPS) Rate Update final rule.”
  • Per Fierce Healthcare, the rule
    • increases the 2024 home health payments by 0.8%, or $140 million.
    • “The $140 million increase in estimated payments for CY 2024 reflects the effects of the CY 2024 home health payment update percentage of 3% ($525 million increase), an estimated 2.6% decrease that reflects the effects of the permanent behavioral assumption adjustment ($455 million) and an estimated 0.4% increase that reflects the effects of an updated FDL ($70 million increase),” the unpublished rule said.
    • “CMS expects increasing the rate will bring home health payments in line with statutory payment authority.”
  • BioPharma Dive informs us,
    • “An experimental sickle cell disease treatment made with CRISPR technology is one step closer to approval in the U.S., following a meeting Tuesday in which advisers to the Food and Drug Administration seemed generally comfortable with its safety.
    • “Made up of scientists and physicians, the advisory panel spent hours discussing highly technical questions around how best to assess the risk that CRISPR — the gene editing technique often likened to a pair of scissors — might make unwanted, or “off-target,” cuts to DNA.
    • “Ultimately, the panel appeared convinced that Vertex Pharmaceuticals, which developed the sickle cell treatment, had done enough to show the therapy is safe, although they pointed to several avenues for further study.”
  • Reuters adds, “Analysts have been optimistic the therapy, which is a first-of-its-kind product to reach the FDA for review, will win the health regulator’s nod by Dec. 8.”
  • On a related note, an article in Health Affairs Scholar prognosticates,
    • “Despite the potential of gene therapy to transform the lives of patients with rare genetic diseases, serious concern has been raised about the financing of the high up-front costs for such treatments and about the ability of the employer-sponsored insurance system in the United States, particularly in small firms, to pay for discoveries of this type. In this paper, we provide a conceptual framework and empirical evidence to support the proposition that, at present, private group insurance financing of cost-effective gene therapies is not only feasible and competitively necessary in the labor market for employers, regardless of group size, but also that, currently, the number of US workers in small firms who might be stressed by very high-priced claims is a tiny fraction of the group market for genetic treatments. The current system of employer-paid self-insurance supplemented by stop-loss coverage should be able to facilitate the use of new cost-effective gene therapies. Other alternative methods of financing that have been proposed may not be urgently needed. There are, however, some concerns about the long-term resilience of this system if stop-loss premiums continue to have high growth.”
  • The Society for Human Resource Management reminds us,
    • “Employers are required to use the latest version of Form I-9 beginning today.
    • “The new form from U.S. Citizenship and Immigration Services has been available for use since August but becomes mandatory for all employers as of Nov. 1. 
    • “The new I-9 does not make any new changes to employer or employee obligations involved in the verification of work authorization. Cosmetic changes include the reduction of Sections 1 and 2 to a single page, slight revisions to the Lists of Acceptable Documents, and a new box that eligible employers must check if the employee’s documents were examined remotely under the newly authorized alternative procedure for qualified E-Verify employers.”

In FEHB news, as we approach the Open Season,

  • FedSmith offers its perspective on factors to consider when selecting an FEHB plan during Open Season.
  • FedWeek offers retired OPM executive Reg Jones’s views on the upcoming Open Season.
  • The Federal Times highlights the fine points of fertility coverage in 2024 FEHB plans.

From the public health and research front,

  • The Centers for Disease Control reminds us,
    • Every U.S. household can order 4 more free COVID-19 self-tests. 
    • Self-tests (also called at-home tests and over-the-counter tests) are one of several tools that protect you and others by reducing the chances of spreading COVID-19.
    • Self-tests can be taken at home or anywhere, are easy to use, and produce rapid results.
    • You can place an order 
      • Online at COVIDTests.gov
      • By calling 1-800-232-0233 (TTY 1-888-720-7489)
      • By calling or emailing the Disability Information and Access Line (DIAL) at 1-888-677-1199 or DIAL@usaginganddisability.org (for people with disabilities)
  • The Washington Post reports,
    • “Dying from heart failure and ineligible for a human heart transplant, Lawrence Faucette knew that the last chance he had at extending his life was to receive a heart transplanted from a pig. The 58-year-old man said from his Baltimore hospital bed in September that he was “hoping for the absolute best,” but understood that he was the second person in the world to undergo the procedure — and the highly experimental surgery did not guarantee that he would get more time with his wife and two sons.
    • “We’re going to do the best we can,” he said in a video posted by the University of Maryland School of Medicine. “Now at least I have hope. And now I have a chance.”
    • “Faucette died Monday, nearly six weeks after the surgery, becoming the second patient to die after receiving a genetically modified pig heart, medical school officials announced Tuesday.”
  • RIP, Mr. Faucette.
  • The Wall Street Journal reports,
    • “The rate of babies dying in the U.S. increased significantly for the first time in two decades, raising new alarms about maternal-infant health in America.
    • “The nation’s infant mortality rate rose 3% from 2021 to 2022, reversing a decadeslong overall decline, the Centers for Disease Control and Prevention said Wednesday. The rate increased from 5.44 infant deaths for every 1,000 births to 5.6 in 2022, a statistically significant uptick. * * *
    • “The death rate increased significantly for babies born to American Indian and Alaska Native women, babies born to white women, babies born to women ages 25 to 29 years, male babies and preterm babies.
    • “Changes in the rates for other groups weren’t significant, though the agency’s data showed that mortality rates among racial groups in the U.S. remain wide. The rate for babies born to Black mothers was more than double that of white mothers.”
  • STAT New calls attention to the fact that
    • “Most lung cancer screening guidelines hinge on how much people smoked tobacco and when they last smoked, but the American Cancer Society now says it doesn’t matter how long ago they quit. On Wednesday, the ACS released guidance recommending that anyone with a significant smoking history get an annual low-dose CT scan for lung cancer.
    • “The new guidelines also expand the age range for lung cancer screening to 50 through 80, instead of 55 through 74, and lower the smoking history requirement from 30 cigarette pack years to 20 pack years or more. That means the equivalent of a pack a day for 20 years, which includes two packs a day for 10 years or four packs a day for five years. Most private insurance plans are required to cover screening guidelines with an A or B-grade recommendation from the U.S. Preventive Services Task Force, though some organizations do follow ACS guidelines.
    • “These recommendations bring the ACS’ new age range and smoking history requirements in line with that of the task force’s lung cancer guidelines, which were updated in 2021. However, the task force still only extends lung cancer screening eligibility to patients who quit smoking within the last 15 years. 
    • One of the main reasons the ACS wanted to strike the years-since-quit requirement from their guidelines was that many former smokers are still at high risk for lung cancer regardless of when they quit smoking. “The more we dug into the data, the more we saw there was no real evidence for that criterion,” said Robert Smith, the senior vice president of early detection science at the American Cancer Society.”
  • The Lown Institute issued a report on unnecessary heart stent procedures in the U.S.
    • “Every seven minutes, a Medicare patient receives an unnecessary coronary stent at a U.S. hospital, a new report finds. The Lown Institute, an independent think tank, examined the overuse of percutaneous coronary interventions (coronary stent or balloon angioplasty) at 1,733 general hospital inpatient and outpatient facilities and found more than 229,000 procedures met the criteria for overuse.
    • “While coronary stents can be lifesaving for someone having a heart attack, years of research shows that stents for stable heart disease provide no benefit over optimal medication therapy. Across all hospitals, Lown estimates that more than one in five stents were placed unnecessarily in Medicare patients from 2019 to 2021, at a cost of $2.44 billion.
    • “When physicians continue a practice despite the evidence against it, it becomes more dangerous than useful,” said Dr. Vikas Saini, a cardiologist and president of the Lown Institute. “The overuse of stents is incredibly wasteful and puts hundreds of thousands of patients in harm’s way.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • CVS Health beat Wall Street expectations for earnings and revenue in the third quarter, as growth in pharmacy benefits offset higher spending in its health insurance segment.
    • The Rhode Island-based healthcare behemoth continues to wrangle with headwinds including higher-than-expected healthcare utilization, a pharmacist strike and lost bonus payments in Medicare Advantage.
    • As a result, interim CFO Tom Cowhey cautioned investors on a Wednesday morning call to expect 2024 earnings at the low end of the company’s guidance.
  • and
    • “Humana reported growing medical costs in its insurance segment during the third quarter as a result of increased medical utilization among Medicare Advantage members and higher-than-anticipated COVID-19 admissions.
    • “The payer expects higher levels of utilization to continue for the remainder of the year, and is now forecasting its 2023 medical loss ratio (MLR) will outpace prior guidance. Humana is projecting an MLR of 87.5% for 2023, up from the 86.6% to 87.3% range it previously expected.
    • “Humana’s shares slid following the earnings release Wednesday, despite the insurer beating Wall Street expectations on revenue of $26.4 billion and profit of $1.1 billion.
  • Forbes reports that biopharma giant “GSK shares rose on Wednesday after the pharma giant upgraded its profit guidance for the second time this year amid booming demand for its new vaccine for respiratory syncytial virus (RSV).”

Tuesday’s Tidbits

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

From Washington, DC,

  • The Department of Health and Human Services announced,
    • “Take Action for Adolescents: A Call to Action for Adolescent Health and Well-Being a new effort to promote collaboration and spur action to improve the health and well-being of adolescents across the U.S.
    • “Young people today are facing significant challenges to their health and well-being,” said Admiral Rachel Levine, M.D., Assistant Secretary for Health. “We are committed to working closely with our allies and partners across the country to support improvements in adolescent health and well-being.”
    • “It is critical that we take action for adolescents now,” said Jessica Swafford Marcella, Deputy Assistant Secretary for Population Affairs. “This new Call to Action and accompanying toolkit will inspire collaborative efforts across youth-serving sectors to build a healthier future for America’s young people.”
    • “Take Action for Adolescents outlines a vision, key principles, eight goals, and a set of initial action steps. It is research-based and was developed with extensive input from adult and youth allies and partners, including nationally recognized adolescent health experts. It is accompanied by a Take Action Toolkit with tips and resources to spur collaboration in states and communities.” * * *
    • The Office of Population Affairs’ Take Action for Adolescents webpage features a suite of resources that are easy to download and share.
  • The Food and Drug Administration announced approving
    • “Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana, like Stelara, is approved to treat the following indications: 
      • “Adult patients with:
        • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy;
        • active psoriatic arthritis;
        • moderately to severely active Crohn’s disease; and
        • moderately to severely active ulcerative colitis.
      • “Pediatric patients 6 years of age and older with:
        • moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and 
        • active psoriatic arthritis.
    • “Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.”
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez announced a proposed rule to improve retirement benefit security under ERISA.

From the public health front,

  • The Wall Street Journal reports,
    • “There’s some good news about flu season this year. Doctors and scientists don’t expect the worst. 
    • “The flu season in the Southern Hemisphere, where the cold-weather illness period wraps up as we head into ours, often serves as a harbinger of what’s to come for us. There, cases picked up a little earlier than usual in some countries but didn’t result in an especially large number of hospitalizations and deaths, say public health experts and doctors.
    • “Also encouraging: The components in this year’s flu vaccine are a good match to the predominant strain so far.” 
  • U.S. News and World Report tells us,
    • “COVID-19 hospitalizations in the U.S. remained relatively steady week over week following five weeks of larger declines, according to data from the Centers for Disease Control and Prevention.
    • “The U.S. tallied about 16,200 new hospitalizations of people with COVID-19 over the seven days ending Oct. 21, according to provisional data – only 40 hospitalizations less than the total for the previous week and effectively pausing a downward trend that began after hospitalizations totaled close to 21,000 during the week ending Sept. 9. Hospitalizations dipped to a low point of approximately 6,300 in late June before starting to trend back up.
    • “Relative to population, data points to 4.9 new COVID-19 hospital admissions per 100,000 people for the week through Oct. 21. Among states and territories, Montana saw the highest rate over the week at 10 per 100,000. West Virginia (8.3), the District of Columbia (8.1), and Colorado (7.6) had the next-highest rates. Compared with the week prior, Mississippi had the highest percentage increase in its COVID-19 hospitalization rate at 45%, followed by Kansas(41%), Indiana (40%) and Iowa (32%).
    • “Among patients visiting a subset of emergency departments, data indicates 1.3% were diagnosed with COVID-19 nationally – a rate down about 5% from the week before. New Mexico(3.1%), Colorado (2.4%) and Arizona (2.3%) saw the highest rates.”
  • MedPage Today informs us that
    • The CDC released new recommendations for hepatitis C virus (HCV) screening among perinatally exposed infants and children.
    • The four new recommendations are detailed in the MMWR Recommendations and Reports.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Tenet Healthcare beat Wall Street expectations on revenue in the third quarter due to cost control measures and sustained revenue growth at its facilities. 
    • “The for-profit operator’s ambulatory care and hospital segments both experienced volume growth, with both divisions’ earnings coming in “well above” Tenet’s expectations, said CFO Dan Cancelmi during a call with investors on Monday.
    • “Executives raised the lower end of Tenet’s full-year revenue guidance. The operator now expects to capture between $20.3 billion and $20.5 billion this year.”
  • Per Fierce Pharma,
    • “For Pfizer, several years of pandemic megaprofits have soured as overstocked COVID-19 drugs and vaccines take a major toll on the drug behemoth’s financials.
    • “In the third quarter of 2023, Pfizer recorded $5.6 billion in coronavirus-related inventory write-offs and other charges, plus a $4.2 billion revenue reversal tied to the planned return of some 7.9 million Paxlovid doses from the U.S. government.
    • “Concerning the inventory write-offs, $4.7 billion of the sum is tied to Pfizer’s antiviral Paxlovid, with the remaining $900 million stemming from the company’s BioNTech-partnered mRNA vaccine Comirnaty, Pfizer said Tuesday.”
  • Here’s a link to Pfizer’s third-quarter report.
  • Beckers Payer Issues informs us,
    • Employers are looking to deductible-free health plans as employees report increasing concerns about the cost of healthcare, according to Mercer’s 2023-2024 “Inside Employees’ Minds” survey. 
    • The survey, published Oct. 30, interviewed 4,505 full-time employees in the United States, working for organizations with more than 250 employees. 
    • In 2023, 15% of organizations are offering some employees no-cost health plans, and 18% are using salary-based contributions. 
    • Around 4 in 10 employers offer a medical plan with low or no deductible. 
    • Plans with no deductibles are growing in popularity — UnitedHealthcare’s fastest-growing commercial plans have no annual deductibles, COO Dirk McMahon told investors Oct. 30. 
    • “UnitedHealthcare members in these offerings are receiving more preventive care, while paying about 50% less out of pocket, compared to people enrolled in traditional offerings, and their employers can reduce the total cost of care with an average savings of 11%,” Mr. McMahon said. 
    • According to Mercer’s survey, 79% of workers making between $60,000 and $100,000 each year say they can afford the healthcare their family needs without hardship, compared to 51% of workers making less than $30,000 annually. 
    • See the full report here. 
  • Beckers Health IT identifies 121 unicorns (companies with at least a one billion dollar valuation) operating in the healthcare space.
  • KFF tells us what to watch for in the eleventh Affordable Care Act open enrollment period, which begins tomorrow. Here’s an interesting tidbit from that article:
    • Private health plans must permit young adults the option of remaining covered as a dependent under their parent’s policy until they turn age 26. Starting in 2024, though, federal Marketplace health plans will officially not be allowed to terminate coverage for young adult dependents mid-year on their 26th birthday. Instead, they will have to continue the dependent coverage through the end of the calendar year. The federal Marketplace has already been keeping these individuals on the plan until the end of the year, and then automatically enrolling them in their own exchange coverage the following year, but this rule codifies that practice.

Weekend update

David Ermer–CDC, Congress, COVID-19, Mental health care, U.S. Healthcare, Uncategorized–
Thanks to ACK15 for sharing their work on Unsplash.

From Washington, DC,

  • The federal marketplace open enrollment period for Affordable Care Act coverage will open on November 1. This enrollment opportunity closes on December 15.
  • The Wall Street Journal reports, “Insurers spar With Biden Administration over coverage for mental-health care; New requirements aim to reduce out-of-pocket costs for treatment; insurers cite a shortage of mental-health providers.” Per the Journal,
    • “A landmark law, the Mental Health Parity and Addiction Equity Act of 2008, helped curtail arbitrary annual limits imposed by insurers on mental-health coverage. Insurers aren’t supposed to put such limits on mental-health visits if they don’t also have similar limits on doctor visits for a chronic condition like asthma. They also aren’t supposed to impose higher copayments and deductibles or more restrictive prior authorization requirements for mental health care.
    • “But the promise of out-of-pocket parity remains far more elusive. The reasons are complex: There is a shortage of mental health clinicians, with an estimated 350 individuals for every one mental-health provider, according to Mental Health America.”
  • The legal issue is that the law requires parity in quantitative treatment limits (QTL), which health plan compliance with the law has created. The regulators, however, created a separate nonquantitative treatment limitation category, which includes network adequacy, prior authorization, and many, many other factors. The regulators in the proposed rule demand that the QTL parity factors be applied to all NQTLs. That is an infeasible, pointless task, in the FEHBlog’s opinion. The regulators need to try again.
  • On a related note, the Washington Post informs us,
    • “Beginning in January, Medicare [Part B], for the first time, will allow marriage and family therapists and mental health counselors to provide services. This cadre of more than 400,000 professionals makes up more than 40 percent of the licensed mental health workforce and is especially critical in rural areas.
    • “Medicare is also adding up to 19 hours a week of intensive outpatient care as a benefit, improving navigation and peer-support services for those with severe mental illness, and expanding mobile crisis services that can treat people in their homes or on the streets.”

From the public health front,

  • NBC News notes,
    • “A new Covid variant has become dominant in the U.S., but relatively few people have thus far gotten the new shots that could offer some protection against it.
    • “The variant, called HV.1, replaced EG.5 as the country’s most prevalent this week, according to data released Friday by the Centers for Disease Control and Prevention.
    • “The two variants are genetically similar versions of omicron.
    • “HV.1 makes up around 25% of Covid cases now, up from around 1% at the beginning of August. EG.5, meanwhile, represents nearly 22% of cases, down from 24% at the start of the month.
    • “Both are descendants of the XBB variant. The updated Covid vaccines from Pfizer and Moderna, which became available last month, target a different XBB descendant, called XBB.1.5.
    • “But disease experts say the new shots should offer cross-protection against the currently dominant strains. Dr. Scott Roberts, an infectious disease specialist at Yale Medicine, said that although the vaccine is not a “perfect match” for HV.1, “it’s still a good match because it’s still within the same family of variants.”
  • WTOP, a news radio station in Washington DC, reports,
    • “We’ve already been receiving warnings from the CDC that there are RSV cases in the Southeast, which is kind of an indication to us that it’s going to be moving our way soon,” said Dr. Christine Ashburn, a pediatrician with Kaiser Permanente’s Mid Atlantic Group.
    • “While an increase in RSV cases could be coming soon,  Ashburn says she doesn’t think it’ll be as bad as last year, which saw hospital systems across the region — and the country — overrun with cases in infants. * * *
    • “Ashburn says looking for early signs of this illness in infants and small children is key.
    • “Watch for fast, rapid breathing,” she said. “Sometimes in babies, you’ll even see the area around their chest sinking in as they’re breathing.”
    • “She also said flared nostrils, prolonged fever, and even rhythmic grunting — or any signs of respiratory distress — are signs your baby is struggling to get air.
    • “If you think your child could be suffering from RSV, it’s imperative you make an appointment with your health care provider,” she said.
    • “Dr. Ashburn said she’s also optimistic about a new antibody treatment for RSV, AstraZeneca’s Beyfortus™ (or nirsevimab, generically), which is designed to help prevent and mitigate the illness’s effects.”
  • Vox adds
    • Demand for Beyfortus currently exceeds supply. But as the need for the drug becomes more predictable, and as other monoclonal RSV antibodies in development make it onto the market, we can expect supply to better meet that demand. 
    • It’s more complicated to fix the fragmented US health care system that creates big barriers to Beyfortus access for some kids, [Dr. Sean] O’Leary [a pediatric infectious disease specialist at the University of Colorado’s medical school] said. That system is structured such that many pediatricians have to take huge financial risks to keep Beyfortus in stock. For patients who get care at those practices, access will likely be a little touch-and-go until demand also stabilizes and pediatricians can better forecast how much to stock. * * *
    • One dose costs a doctor’s office nearly $500 — and as a totally novel immunization, its popularity was hard to forecast. “For a medium-sized practice, they might have to spend $250,000 to cover their [privately insured”] patient population,” O’Leary said. “And that is not money they have lying around.”
    • “It’s not that pediatricians and family docs don’t want to do the right thing,” he added — but the financial risk of just keeping Beyfortus on the shelves is a barrier.
  • However, according to a 2018 survey about vaccine financing billing practices at medical practices serving adults
    • Of 242 practices approached, 43% (n=104) completed the survey. Reported payment levels and perceived profit varied by payer type. Only for preferred provider organizations did a plurality of respondents report profiting on adult vaccination services. Over half of respondents reported losing money vaccinating adult Medicaid beneficiaries. One-quarter to one-third of respondents reported not knowing about Medicare Part D payment levels for vaccine purchase and vaccine administration, respectively. Few respondents reported negotiating with manufacturers or insurance plans on vaccine purchase prices or payments for vaccination.
  • FEHBlog note: It’s no wonder that chain pharmacies are the principal distributors of vaccines.

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “AbbVie Inc. raised its profit outlook for this year and next as demand for newer biologic drugs helped fill the gap left by falling Humira sales, but investors were disappointed as Botox sales missed estimates.
    • “Adjusted earnings will be $11.19 to $11.23 a share this year, up from the earlier range of $10.86 to $11.06, AbbVie said Friday in a statement. Profit for 2024 will be at least $11 a share, up from the earlier view of at least $10.70, the drugmaker said.
    • “However, sales of Botox, Juvaderm and other aesthetics products were $1.24 billion, missing the average sales estimate by about $100 million. Shares of the North Chicago, Illinois-based drugmaker dropped as much as 5.6% at the New York market open, their biggest intraday loss since April.”
  • Reuters points out,
    • “Healthcare companies who profit from treating obese and overweight patients are trying to convince investors that powerful new weight-loss drugs won’t shrink their businesses.
    • “The global market for obesity drugs could reach as much as $100 billion within a decade due to the effectiveness of Novo Nordisk’s (NOVOb.CO) Wegovy and similar medicines.
    • “Such forecasts have prompted a sell-off in a wide range of companies from makers of bariatric surgery devices to companies whose products address the health issues created by excess weight, from diabetes to sleep apnea.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Govexec tells us,
    • “The Senate Homeland Security and Governmental Affairs Committee on Wednesday voted to advance a pair of measures aimed at improving federal employees’ death benefits and agency customer service more broadly.
    • “The Honoring Civil Servants Killed in the Line of Duty Act (S. 3029); sponsored by Sens. Kyrsten Sinema, I-Ariz., Bill Hagerty, R-Tenn., Alex Padilla, D-Calif., and Josh Hawley, R-Mo.; would increase the amount of money the family of a federal worker who died of injuries sustained while on the job for the first time since 1997. Death gratuity payments would increase from the current $10,000 to $100,000, while the amount the federal government covers for funeral expenses would increase from $800 to $8,800. * * *
    • “The committee also voted 10-1 to advance legislation aimed at improving public-facing federal agencies’ customer service. The Improving Government Services Act (S. 2866), introduced by Committee Chairman Gary Peters, D-Mich., and Sens. James Lankford, R-Okla., and John Cornyn, R-Texas, would require agencies that provide services to members of the public to develop annual customer service action plans that outline strategies to adopt “human-centered” practices that reduce administrative burdens as well as practices already employed in the private sector like online services and call-back functions at call centers.”
  • The House Budget Committee announced,
    • “Its Health Care Task Force (HCTF) hit the ground running with its inaugural Member roundtable. This roundtable brought together Director Phillip Swagel of the nonpartisan Congressional Budget Office (CBO), independent experts, and stakeholders to discuss CBO’s methods for analyzing policies that impact drug development in the United States, including the Inflation Reduction Act (IRA).
    • “Led by Rep. Michael Burgess M.D. (R-TX), the HCTF Member roundtable examined potential refinements and improvements to CBO’s drug development model to ensure future analysis is capturing additional factors and subsequent real-world effects of policies impacting medical innovation in the United States.
    • Health Care Task Force Chairman Michael Burgess (R-TX) published an op-ed in the Washington Times sharing the Task Force’s goals with the American people ahead of today’s roundtable.
  • MedPage Today informs us,
    • “By a 14-0 vote, the [Centers for Disease Control’s] Advisory Committee on Immunization Practices (ACIP) recommended the two-dose Jynneos vaccine for mpox prevention in adults at risk for infection, which typically passes through close skin-to-skin contact, including sex. * * *
    • “Groups considered at-risk for mpox include men who have sex with men (MSM) and transgender or nonbinary people who in the past 6 months have had a new diagnosis of a sexually transmitted disease, multiple sex partners, engaged in sex work, or who had sex in association with a large public event in a region where mpox is circulating. Also people who anticipate exposure to those risks and the partners of these individuals.
    • “The committee also voted 10-4 in favor of recommending the newly approved pentavalent meningococcal vaccine (Penbraya) when both the MenACWY and bivalent MenB vaccines are indicated at the same visit. It’s the first vaccine to provide protection against the five meningococcal serogroups (A, B, C, W, and Y; MenABCWY) responsible for most cases of invasive meningococcal diseases globally.
    • “The pentavalent vaccine gained approval earlier this month for individuals ages 10 to 25 years, based on phase III trial data in previously unvaccinated individuals that showed non-inferior immune responses and comparable safety with MenABCWY when compared with vaccination with the MenACWY (Menveo) and MenB (Trumenba) vaccines.
    • “While meningitis is rare in the U.S., mortality is 10% to 15%. Most cases occur among children younger than 1 year, adolescents and young adults ages 16 to 23, and adults older than 85.”
  • HR Dive reports,
    • “The National Labor Relations Board published Thursday a rule updating the standard for determining when multiple employers may be considered joint employers under the National Labor Relations Act.
    • “NLRB’s new joint employer rule retains much of the same details from its 2022 proposed rule, specifying that an entity may be considered a joint employer of another employer’s employees if the two share or codetermine essential terms and conditions of employment. Per the rule, joint employers may possess or exercise direct or indirect control over one or more essential terms and conditions of employment.
    • “Changes from the proposed rule include an exhaustive list of seven categories of employment terms or conditions that the board will consider essential for the purposes of its joint employer analysis, as well as a description of those it will consider “irrelevant” for such analysis. The final rule also addresses joint employers’ bargaining obligations. The rule is scheduled to be published in the Federal Register tomorrow; it will take effect 60 days after that.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • “Contract negotiations between payers and providers are becoming more public, and the number of communities affected across the country is growing, according to data published Oct. 25 by FTI Consulting.
    • “Notably, disputes reported in the media during the third quarter involved Medicare Advantage plans more than ever previously recorded, standing at 15 total.
    • “In whole numbers, it may not be shocking, but each of these disputes can affect a few thousand to tens of thousands of people, so it’s significant,” Adam Broder, managing director of FTI’s strategic communications segment, told Becker’s. “Medicare Advantage is being scrutinized by federal regulators, and I think these disputes are a mirror of that on the local level with some hospitals feeling the pinch.”
  • The FEHBlog notes the number of Medicare Advantage plan disputes should be hardly surprising as those plan’s premiums, etc., are constrained by CMS.
  • Per Fierce Healthcare,
    • “Payers’ “increasingly aggressive behavior,” a spike in physician expenses and recruitment are front of mind for executives at Universal Health Services (UHS).
    • “The King of Prussia, Pennsylvania-based for-profit system came out slightly ahead of analyst estimates this quarter with a $167 million profit ($2.55 per diluted share).
    • “Much of the success came from a continued rise in patient volumes, particularly on the acute care side of the business where patients are seeking care after delaying procedures during the pandemic, Chief Financial Officer Steve Filton told investors during a Thursday morning earnings call. 
    • “While key to the company’s 6.8% year-over-year increase in net revenues, that recaptured care was largely lower acuity services that held same-facility revenue per adjusted admission to a “somewhat more muted” 0.4% year-over-year increase, Filton explained.
    • “That trend isn’t expected to last much longer. “Over time, we would expect our volumes to moderate a little bit, but also our revenue per adjusted admission to come up,” Filton told investors.” 
  • Per Healthcare Dive,
    • “Community Health Systems missed Wall Street expectations for earnings per share in its third quarter earnings this week, despite rising patient admissions and efforts to control labor expenses.
    • “The operator posted a net loss of $91 million in the third quarter, compared to net loss of $42 million from the prior year period. [For-profit CHS, which spans 76 owned or leased affiliate hospitals and more than 1,000 sites of care, has been in the red for the past three quarters.] 
    • “The losses come even as same facility admissions, which rose 3.7% year over year, reached their highest levels since the fourth quarter of 2019, CHS CEO Tim Hingtgen said during a Thursday morning call with investors.”

In judicial news,

  • Reuters reports,
    • “A U.S. appeals court has rejected legal challenges to a $2.67 billion settlement that resolves civil antitrust claims that Blue Cross Blue Shield Association and member plans conspired to drive up health insurance costs.
    • “A three-judge panel of the 11th U.S. Circuit Court of Appeals unanimously upheld Alabama-based U.S. District Judge R. David Proctor’s August 2022 approval of the settlement, which followed nearly a decade of litigation involving allegations from individual policyholders, businesses and others.
    • “The appeals court’s order on Wednesday spurned challenges to the insurance subscribers’ deal from Home Depot and others. One objector fought the $667 million in legal fees and expenses that are part of the settlement.
    • “Writing for the panel, Chief Circuit Judge William Pryor said Home Depot had not persuaded the court that the settlement would harm the power of antitrust enforcers or others to bring claims against Blue Cross Blue Shield in the future.”

Monday Roundup

David Ermer–CDC, Congress, COVID-19, COVID-19 vaccine, FDA, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The New York Times reports,
    • “After days of warnings, [Rep. Matt] Gaetz [(R FL)] rose Monday evening [on the floor of the House of Representatives] to bring up a resolution declaring the speakership vacant. That started a process that would force a vote within days on whether to keep Mr. McCarthy in his post. * * *
    • “Under House rules, Mr. McCarthy and his leadership team will need to address the motion within two legislative days — though they could do so sooner.”
  • Roll Call adds,
    • “The Senate will adjourn earlier than planned this week, with no session on Thursday, to allow members to travel to California and pay their respects to the late Sen. Dianne Feinstein. * * *
    • “On Sunday, California Gov. Gavin Newsom appointed Laphonza Butler to fill the remainder of Feinstein’s term. Butler recently led the abortion rights campaign group EMILY’s List and spent 20 years as president of SEIU Local 2015, a home care workers union in California.
    • “Butler will serve until a replacement is elected in a still-unscheduled special election. Three House Democrats — Barbara Lee, Katie Porter and Adam B. Schiff — are running in the March primary for the full, six-year term and can also run in the special election.
    • “Butler is scheduled to be sworn in by Harris on Tuesday. She will become the first openly gay Black woman to serve in the Senate.”
  • Last Thursday, U.S. District Judge John Bates vacated a Trump-era Affordable Care Act rule permitting health plans, including FEHB plans, to use copay assistance accumulators. These accumulators prevent manufacturer assistance used to pay cost-sharing for expensive drugs from counting towards out-of-pocket maximums. While that outcome seems reasonable to the FEHBlog, Judge Bates takes the opposite view in his opinion. The federal government, which is the defendant in the case, has the right to appeal this final judgment.
  • The Institute for Clinical and Economic Research published a “Special Report on Eliquis and Xarelto Submitted to CMS as Part of Public Comment Process on Medicare Drug Price Negotiations.” The report “evaluate[es] the evidence on apixaban (Eliquis®, Bristol-Myers Squibb) and rivaroxaban (Xarelto®, Bayer) for the treatment of nonvalvular atrial fibrillation (NVAF).”
  • BioPharma Dive identifies five Food and Drug Administration to watch for in the fourth quarter of 2023. “By the end of the year, the regulator will decide on new genetic treatments for sickle cell, expanded use of Alnylam’s Onpattro and an inflammatory disease drug from Pfizer.”

From the public health front,

  • MedPage Today informs us
    • “Maternal COVID vaccination in pregnancy protected young infants against Omicron-associated hospitalization, but few women actually receive the vaccine during pregnancy, according to new data from the CDC.
    • “At least one maternal vaccine dose had an effectiveness of 54% (95% CI 32-68) against COVID-related hospitalization among infants younger than 3 months of age, and an effectiveness of 35% (95% CI 15-51) for infants younger than 6 months, reported researchers led by Regina Simeone, Ph.D., of CDC’s National Center for Immunization and Respiratory Diseases in Atlanta, in the Morbidity and Mortality Weekly Report. * * *
    • “Looking at the COVID shot specifically, women were nine times more likely to receive a bivalent booster if a provider recommended it (63.2% vs 6.8% when a provider did not).”
  • The American Medical Association offers “What doctors wish patients knew about managing anxiety disorders.”
  • STAT News points out,
    • “In a guidance document published Monday in the Federal Register, the CDC is seeking input on its proposal that health providers offer gay and bisexual men who have sex with men, as well as transgendered women, access to a common antibiotic, doxycycline, that they could take after having had unprotected sex to lower their risk of acquiring chlamydia, gonorrhea, or syphilis. Doxycycline is in the tetracycline family of antibiotics.
    • “Studies have show the so-called “doxy PEP” regime — a single, 200-milligram dose taken no later than 72 hours after unprotected sex — can reduce acquisition of chlamydia and syphilis by nearly 80%, and gonorrhea by about 50%. PEP is short for post-exposure prophylaxis.
    • “Doxy PEP is moving STI prevention efforts into the 21st century,” Jonathan Mermin, director of CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, said in a statement. “We need game-changing innovations to turn the STI epidemic around, and this is a major step in the right direction.”

From the awards front,

  • The Wall Street Journal reports
    • “Katalin Karikó and Drew Weissman won the Nobel Prize in medicine on Monday for an idea that pushed them to the fringes of the scientific establishment before it saved millions of lives during the pandemic. 
    • “Karikó, a molecular biologist, and Weissman, an immunologist, realized during a chance encounter at a University of Pennsylvania a photocopy machine in the 1990s that they could combine their work exploring messenger RNA’s potential in drugs or vaccines. 
    • “Their collaboration was met with skepticism by their colleagues and indifference in the scientific community. Karikó struggled to secure funding for her work. Penn demoted her and sent her to work in an office on the outskirts of campus. 
    • “People wondered, ‘What the hell is wrong with her,’ there must be some reason she’s not on the faculty,” Karikó has said.
    • “Years later, as drugmakers raced to develop vaccines against COVID-19, it was mRNA technology that powered widely used shots from Pfizer–BioNTech and Moderna. The Nobel committee credited Karikó’s and Weissman’s work with saving millions of lives.
    • “The laureates contributed to the unprecedented rate of vaccine development during one of the greatest threats to human health in modern times,” the committee said in awarding Karikó, 68, and Weissman, 64, the annual prize in physiology or medicine. Karikó is the 13th woman among 227 people to win the prize.”
    • Bravo.
  • Fierce Healthcare announced its Fierce 50.
    • “The Fierce 50 goes beyond surface-level accolades to delve deep into the monumental impact 50 exceptional individuals and organizations have on the lives of patients. It shines a spotlight on the visionaries and trailblazers who have pioneered groundbreaking therapies, overhauled patient care models, and spearheaded innovative approaches to address the most pressing challenges in biopharma and healthcare.”

From the U.S. healthcare business front,

  • Beckers Hospital CFO Report tells us,
    • “Hospital margins are moving in the right direction, as the median year-to-date operating margin improved in August to 1.1 percent, according to Kaufman Hall. 
    • “August’s median of 1.1 percent marked an upswing from the 0.9 percent median margin recorded in July, according to Kaufman Hall’s latest “National Hospital Flash Report” — based on data from more than 1,300 hospitals.
    • “Increased revenue offset hospitals’ increased supply and drug expenses in August. Decreased reliance on contract labor helped labor expenses decline on a volume-adjusted basis, while average lengths of stay also fell, by 4 percent month over month.”

Tuesday Tidbits

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

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democratic and Republican leaders unveiled their plan to avoid a government shutdown, releasing legislation to extend funding through Nov. 17 while also providing about $6 billion apiece for Ukraine and for disaster relief.
    • “The proposal—the only bipartisan approach currently being pursued by congressional leaders—marks a contrast with House Speaker Kevin McCarthy’s plan to extend government funding on the condition that Congress also enact strict border-security measures. The Senate plan was released as the chamber prepared a vote to open debate on the measure, while the House was preparing to vote to advance four full-year funding bills.”
  • Roll Call adds
    • “House Republicans finally paved the way for consideration of more fiscal 2024 appropriations bills, setting up a busy week in which the chamber is set to consider four separate spending measures. And that’s not counting the one bill they have to pass this week in order to stop a partial government shutdown.
    • After several tries to get the Defense bill on the floor, the House adopted a rule to take up that legislation plus three others — Homeland Security, Agriculture and State-Foreign Operations.”
  • The Centers for Medicare and Medicaid Services announced
    • “that average premiums, benefits, and plan choices for Medicare Advantage and the Medicare Part D prescription drug program will remain stable in 2024. Improvements adopted in the 2024 Rate Announcement, as well as the 2024 Medicare Advantage and Part D Final Rule, such as increased beneficiary protections around marketing and prior authorization and increased access to behavioral health, support this stability. CMS is committed to ensuring these programs work for people enrolled in Medicare, that benefits remain strong and stable, and that payments to plans are accurate.
    • “Additionally, thanks to the Inflation Reduction Act, people with Medicare Part D prescription drug coverage will continue to have improved and more affordable benefits, including a $35 cost-sharing limit on a month’s supply of each covered insulin product, recommended adult vaccines at no cost, and additional savings on their Medicare Part D drug coverage costs in 2024. These savings include the expansion of the Low-Income Subsidy (LIS) program, also called Extra Help, which helps eligible enrollees afford their premiums and cost-sharing, as well as a cap on out-of-pocket costs for millions of people with very high drug costs in the catastrophic phase of the Part D benefit.
    • “CMS is releasing this key information, including 2024 premiums and deductibles for Medicare Advantage and Medicare Part D prescription drug plans, ahead of the upcoming Medicare Open Enrollment, beginning October 15, 2023, to help people with Medicare determine the best Medicare coverage option for their health care needs.”
  • The National Institutes of Health announced its Targeted Challenge to revolutionize technology to treat genetic diseases.
  • NIH also “designated people with disabilities as a population with health disparities for research supported by the National Institutes of Health.” 
  • The Centers for Disease Control called attention to its quick Pre-Diabetes Test.

From the public health front,

  • NBC News reports,
    • “More than three years into the pandemic, the millions of people who have suffered from long Covid finally have scientific proof that their condition is real. 
    • “Scientists have found clear differences in the blood of people with long Covid — a key first step in the development of a test to diagnose the illness. 
    • “The findings, published Monday in the journal Nature, also offer clues into what could be causing the elusive condition that has perplexed doctors worldwide and left millions with ongoing fatigue, trouble with memory and other debilitating symptoms.”
  • MedPage Today tells us,
    • “Long COVID in the U.S. is rare among children and has affected roughly one in 14 adults, according to a pair of data briefs from the CDC’s National Center for Health Statistics (NCHS).
    • “Overall, in 2022, an estimated 1.3% of children in the U.S. ever had long COVID, and 0.5% currently had long COVID, reported Anjel Vahratian, PhD, MPH, of the NCHS, and colleagues.
    • “As for adults, an estimated 6.9% ever had long COVID, and 3.4% currently had long COVID that year, said Dzifa Adjaye-Gbewonyo, Ph.D., MPH, of the NCHS, and colleagues.
  • Deloitte released a report concluding
    • “Out-of-pocket health care costs for employed women in the United States are estimated to be $15 billion higher per year than for employed men, exacerbating gender wage disparities. And this financial burden on women persists even when excluding maternity-related services.”
    • The report offers possible remedies to employers and health plans.

From the U.S. healthcare business front,

  • Per Fierce Healthcare
    • “In the aftermath of a devastating summer tornado at Pfizer’s Rocky Mount injectables plant in North Carolina, manufacturing has largely resumed. Still, the company expects supply shortfalls for some drugs produced at the plant to stretch into next year.
    • “The “majority” of the Rocky Mount facility’s manufacturing lines have restarted, Pfizer said in a Monday release. What’s more, Pfizer has launched an additional line in the site’s new sterile injectable manufacturing area, dubbed R3, the company added.
    • “The “expedited restart” comes ahead of Pfizer’s previously stated timeline. Late last month, Pfizer said it intended to restart manufacturing at the plant the fourth quarter of 2023.
    • “Pfizer is restarting production in phases, with full production across the site’s three manufacturing suites expected to come back online by the end of the year.”
  • Beckers Hospital Review adds
    • “As the supply of two staple cancer drugs rebounds after months of scarcity, two medications used in pediatric cancer patients have fallen into shortage, NBC News reported Sept. 25. 
    • “The shortages of cisplatin and carboplatin are easing, but methotrexate access remains in flux, and supply levels of vinblastine and dacarbazine are worsening. 
    • “Vinblastine is approved to treat Hodgkin lymphoma, non-Hodgkin lymphoma, Kaposi sarcoma, and breast and testicular cancer; dacarbazine is used for melanoma and Hodgkin lymphoma. Both are in shortage, and pediatric providers are worried because there are few alternatives.”
  • Healthcare Dive reports
    • “Elevance Health and Blue Cross Blue Shield of Louisiana have paused their $2.5 billion merger following criticism from state regulators that it could reduce competition and raise healthcare costs in the state.
    • “Political pressure has been building to delay the deal, with Louisiana Attorney General Jeff Landry calling for a stay in the approval process last week.
    • “Elevance and BCBSLA said they’re withdrawing the merger to “provide more time for key stakeholders to understand the benefits this transaction will provide” in a statement to Healthcare Dive.”
  • Axios shares private employer ideas on how to improve health benefits for their employees.