Thursday Miscellany

CMS

Thursday Miscellany

David Ermer–CMS, Congress, COVID-19, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Politico reports,
    • “The House cleared a stopgap spending bill on Thursday afternoon that officially keeps federal agencies funded through early March, sending the measure to President Joe Biden’s desk. * * *
    • “With parts of the government now funded through March 1 and March 8, leading appropriators have a tremendous amount of work to do in just a matter of weeks. ***
    • “Haggling over the broader spending bills can’t begin in earnest, however, until leading appropriators lock down a deal on funding totals for all 12 of them. It’s a critical next step that has consumed the last couple weeks for Senate Appropriations Committee Chair Patty Murray (D-Wash.) and her House counterpart, Chair Kay Granger (R-Texas).”
  • The American Hospital News informs us,
    • “The Departments of Health and Human Services, Labor, and the Treasury will reopen the public comment period for their proposed rule to improve the No Surprises Act independent dispute resolution process for 14 days beginning Jan. 22 to provide additional time for interested parties to comment.”
  • The Center for Medicare and Medicaid Services announced the Innovation in Behavioral Health (IBH) Model.
    • IBH is focused on improving quality of care and behavioral and physical health outcomes for Medicaid and Medicare populations with moderate to severe mental health conditions and substance use disorder (SUD). Medicare and Medicaid populations experience disproportionately high rates of mental health conditions and/or substance use disorders (SUD), and as a result are more likely to experience poor health outcomes and experiences, like frequent visits to the emergency department and hospitalizations, or premature death. 
    • The IBH Model seeks to bridge the gap between behavioral and physical health; practice participants under the IBH Model will screen and assess patients for select health conditions, as well as mental health conditions and/or SUD, in community-based behavioral health practices. IBH is a state-based model, led by state Medicaid Agencies, with a goal of aligning payment between Medicaid and Medicare for integrated services.
    • CMS will release a Notice of Funding Opportunity (NOFO) in Spring 2024, and up to eight states will be selected to participate. The model will launch in Fall 2024 and run for eight years.
  • The Department of Health and Human Services also issued a fact sheet about steps taken over the last year to expand access to behavioral health by integrating behavioral health with primary care and other physical health and community settings.
  • The U.S. Preventive Services Task Force posted a draft research plan concerning “BRCA-Related Cancer: Risk Assessment, Genetic Counseling, and Genetic Testing” for public comment. The public comment deadline is February 14, 2024.

From the public health and medical research front

  • The Kaiser Family Foundation discusses the two healthcare cost crises facing our country.
    • “The cost of health care isn’t a single problem, it’s a multi-dimensional one. That’s one reason we often talk past each other about healthcare costs; we’re talking about different problems. There’s national health spending, consumer out-of-pocket costs, federal health spending (mostly for Medicare and Medicaid), state health spending (mostly Medicaid), employer premiums, and the cost problem currently in vogue—getting better “value” for the health care dollar. Like a Venn diagram with sets that don’t always overlap, each of these are different challenges that often have different and sometimes conflicting solutions. We work on all of these dimensions of health care costs at KFF, but two health cost problems stand out as legitimate health policy crises: Affordability, especially for people who are sick and need a lot of healthcare, and national health spending (the subject of the CMS annual report).”
  • STAT News reports,
    • Mental health care in the United States is in crisis. As the need for care surges — a longstanding trend exacerbated by the Covid-19 pandemic — the demand for therapists far outstrips the supply. In national surveys, more than one in five U.S. adults suffer from mental illness, yet almost half of those in need report receiving no care. People struggling with mental health challenges often spend months on a wait list despite needing immediate care. Others simply can’t afford it. And getting care is even harder for people living in rural areas and people of color. * * *
    • In the face of these issues, there’s growing interest in the use of lay counselors. One scientific journal recently announced a call for papers for a special issue on the subject. In its executive summary for a recent population health summit, the APA [American Psychological Association] declared that the “exclusive reliance on trained mental health care providers when there are severe gaps in support for training of a mental health workforce has left millions untreated.” A number of recent research articles suggest addressing the gap by innovating on the traditional model of mental health treatment, including where and how it is provided and who provides it.
    • Lynn Bufka, associate chief of practice transformation and quality at the APA, believes that an expanded approach to providing mental health care is essential to meet the current need. “We clearly cannot meet the need for mental health services in this country with the existing workforce,” she said. “We’re going have to consider those kinds of models and options in order to get to where we need to be in this country.”
  • STAT New also delves into whether recent scientific findings may lead to a test for long Covid.
    • “Long Covid has long eluded scientists looking for its cause. Not knowing what triggers its persistent and distressing symptoms makes the condition challenging to treat; it’s hard to even say definitively who has it. New research published Thursday in Science has identified proteins present in the blood of people with long Covid that could point the way to a much-needed diagnostic test and possibly to future therapeutic targets.
    • “Scientists at the University of Zurich discovered high levels of proteins involved in the complement system — an important part of the immune system bridging innate and adaptive responses — that were disrupted in people with long Covid symptoms, but not in those who got better after the initial Covid-19 infection or in those who had recovered from long Covid symptoms after six months. The team also found damaged red blood cells and platelets as well as signs of harm to the endothelial cells that line blood vessels.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Drugmakers kicked off 2024 by raising the list prices for Ozempic, Mounjaro and dozens of other widely used medicines. Companies including the maker of Ozempic, and Eli Lilly , which sells Mounjaro, raised list prices on 775 brand-name drugs during the first half of January, according to an analysis for The Wall Street Journal by 46brooklyn Research, a nonprofit drug-pricing analytics group. 
    • “The drugmakers raised prices of their medicines by a median 4.5%, though the prices of some drugs rose by around 10% or higher, according to the research group. The median increase is higher than the rate of inflation, which ticked up to 3.4% in December. * * *
    • “Among the notable increases: The price for Ozempic, a diabetes treatment that many people are taking to lose weight, went up by 3.5% to nearly $970 for a month’s supply. Mounjaro, a diabetes drug in the same class that is also widely used for weight loss, climbed 4.5% to almost $1,070 a month.”
  • Healthcare Dive identifies “Top healthcare trends in 2024; Here’s what industry experts see coming down the pike for hospitals, insurers and digital health companies this year.” The article summarizes Healthcare Dive’s 2024 trend reports from the past few weeks.
  • Healthcare Dive also informs us,
    • “Humana is the latest victim of elevated medical costs in the fourth quarter. The health insurer on Thursday lowered its 2023 profit outlook after members utilized more healthcare than expected as the year drew to a close.
    • “Humana now expects $26.09 in adjusted earnings per share for full-year 2023, according to a financial filing. That’s down from its prior guidance of at least $28.25.
    • “Humana also lowered its expectations for growth in the lucrative Medicare Advantage program. The insurer now expects to increase MA membership 1.8% this year. Previously, Humana said it would outstrip expected industry growth of 6% to 8%.”
  • CVS Health posted a report highlighting opportunities for the future of community pharmacies.

Midweek update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Congressional leaders struck a cautiously optimistic tone Wednesday on reaching a deal combining tighter border security with aid for Ukraine, as they emerged from meeting with President Biden at the White House.
    • “House Speaker Mike Johnson (R., La.) said the hour-and-20-minute sit down was “productive” while reiterating Republicans’ demand that changing border law was a condition for further funding Kyiv, which is one piece of a stalled $110.5 billion foreign-aid package championed by Biden.”
  • and
    • “The Biden administration on Wednesday finalized requirements to streamline the process for doctors and patients seeking health insurance approval for medical care and treatments.
    • “The rule aims to shorten the timeline for the so-called prior authorization process to as little as 72 hours for many of the tens of millions of people who get their health insurance through Medicare Advantage, Medicaid or an Affordable Care Act health plan by automating some of the processing of the requests.
    • “Plans would also have to share more information with doctors about the status of decisions and information on denials, with a turnaround time of seven calendar days for non-urgent requests.”
  • Here is a link to the CMS fact sheet on the final rule.
    • “Impacted payers must implement certain operational provisions, generally beginning January 1, 2026. In response to public comment on the proposed rule, impacted payers have until compliance dates, generally beginning January 1, 2027, to meet the API development and enhancement requirements in this final rule. The exact compliance dates vary by the type of payer.”
  • STAT News reports that the federal government dismissed its appeal of a D.C. district court decision vacating a Trump Administration rule favoring use of copay accumulators by health plans. “Insurers can still use the copay accumulators when patients use brand drugs that do have generic competition.”
  • MedPage Today tells us,
    • “The FDA cleared an artificial-intelligence (AI)-powered device designed to non-invasively detect skin cancer in the primary care setting, the agency announced on Tuesday.
    • “Developer DermaSensor said the device uses AI-powered spectroscopy technology to non-invasively evaluate cellular and subcellular characteristics of a lesion for any of the three common skin cancers — melanoma, basal cell carcinoma, and squamous cell carcinoma. The wireless, handheld device then provides a result in real time using an FDA-cleared algorithm.”
  • MedTech Dive informs us,
    • “The Food and Drug Administration issued an alert for patients and healthcare providers about the risks associated with an Exactech shoulder replacement device after the company “declined to initiate a voluntary recall.”
    • “FDA officials advised healthcare professionals against implanting Equinoxe Shoulder Systems packaged in defective bags because of a risk of oxidation that can accelerate device wear or failure. The issue could lead to patients needing additional surgery to replace or correct devices.
    • “Exactech recalled other orthopedic devices in 2021 and 2022, initially because of excessive and premature wear of unknown cause, and later because it found a problem with its packaging.”

From the public health and medical research front,

  • Beckers Hospital Review points out 35 states where respiratory illness levels remain high or very high, according to the Centers for Disease Control.
  • The Wall Street Journal lets us know,
    • “Americans are living longer, but spending less time in good health.
    • “The estimated average proportion of life spent in good health declined to 83.6% in 2021, down from 85.8% in 1990, according to an analysis of the latest data from the Institute for Health Metrics and Evaluation’s Global Burden of Disease study, a research effort based at the University of Washington.
    • “The decrease of time spent in good health is partly because medical advances are catching and treating diseases that once would have killed us. But it is also because of the rising prevalence, often among younger people, of conditions such as obesity, diabetes and substance-use disorders.
    • “Declining health takes a deep physical and emotional toll on patients and their caregivers. There are also broad ramifications on society, including rising health costs that eat into household budgets, as well as more people who want to work but can’t.
    • “The period of life spent not healthy is getting larger and larger and the implications of that are enormous,” says Dr. John Rowe, a professor of health policy and aging at Columbia University. “70 is the new 80.”
  • Beckers Hospital Review adds,
    • “The expected increase in new cancer diagnoses this year is record-setting, even as overall cancer mortality is expected to continue its decline, the American Cancer Society said in its latest report.
    • “The report was based on the most recent data on population-based cancer occurrences and outcomes collected by central cancer registries through 2020 and mortality data from the National Center of Health Statistics through 2021.
    • “The projected number of new diagnoses tops 2 million for the first time, with an increase in six out of 10 top cancers. Notably, colorectal cancer new cases have shifted mortality patterns in adults younger than 50 and have moved up from being the fourth leading cause of cancer death to the first in men and second in women.”
  • AHRQ announced the following study result:
    • “Diagnostic errors can result in significant morbidity and mortality. This large cohort study reviewed the health records of 2,428 adult inpatients who were transferred to the intensive care unit (ICU) and/or died in the hospital to estimate frequency, cause, and harms of diagnostic errors. Nearly a quarter (23.0%) of patients in the cohort experienced a diagnostic error, and 6.6% of patients who died had a diagnostic error. Delays in ordering and interpreting tests and problems with clinical assessment were the most common contributing factors resulting in transfer to ICU and/or death.”
  • According to Healio,
    • “Rates of long COVID were similar between groups of people who received Paxlovid and those who do not.
    • “COVID-19 rebound is not linked to an overall risk for long COVID.”
  • Per Beckers Payer Issues,
    • “RSV vaccinations brought more older adults to their primary care offices in the last months of 2023, one factor behind rising medical costs in Medicare Advantage, UnitedHealth Group executives said. 
    • “Andrew Witty, CEO of UnitedHealth Group, told investors on a Jan. 12 call that more visits to primary care providers for RSV vaccines led to increased medical service costs in other areas for the Medicare population. 
    • “To be clear, all of that is good news for healthcare. These are seniors, many of whom had not been to the office in a long time,” Mr. Witty said. “They’ve come back in now, got vaccinated, and physicians have picked up on other things.” 

From the U.S. healthcare business front,

  • Healthcare Dive notes,
    • “Cigna announced a slew of leadership updates on Wednesday, including an expansion of chief financial officer Brian Evanko’s role.
    • “Evanko will continue to hold the CFO position, and he’ll also serve as president and CEO of the company’s Cigna Healthcare division, its benefits business, which includes the U.S. Commercial and U.S. Government segments.”  
  • Per Beckers Payer Issues,
    • “Humana plans to lay off a small portion of its workforce, the Louisville Courier-Journal reported Jan. 16. 
    • “Humana did announce some limited workforce reductions last week,” a Humana spokesperson told Becker’s Jan. 16. “The impacted positions represented a small percentage of our total workforce and were geographically dispersed across multiple locations.”
  • Forbes reports,
    • “Three months ago, venture capital firm General Catalyst announced an unusual move: The creation of an entirely new company that would someday acquire a multi-billion dollar health system that could serve as a proving ground for new technologies.
    • “On Wednesday, that company – the Healthcare Assurance Transformation Corporation, or HATCo – revealed its intended target: Akron, Ohio-based Summa Health, a nonprofit three-hospital system and health insurer.”
  • Medical Economics notes,
    • “This year promises to be a Super Bowl of telehealth, according to plans by the American Telemedicine Association (ATA).
    • “The year 2024 has at least two major factors that could be hugely influential for telehealth, according to the organization and its affiliated ATA Action advocacy nonprofit.
    • “It’s a presidential election year, and it will bring the end of the telehealth flexibilities that Congress enacted by during the COVID-19 pandemic and continued after the end of the public health emergency. Those need to remain in place, said Kyle Zebley, ATA senior vice president for public policy and ATA Action executive director.
    • “With Congress back in session, the clock officially starts counting down,” Zebley said in a news release this month. “It’s time for the administration and our congressional leaders to take permanent action to ensure patients across the country have access to safe, affordable, and effective health care where and when they need it and provide certainty to beneficiaries and our nation’s health care providers. That would be a win-win.”
  • The Brookings Institution offers a report assessing early experience with arbitration under the No Surprises Act.

Monday Roundup

David Ermer–CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Roll Call offers a preview of Congress’s actions over the next month, after which point the first session of this 118th Congress will come to a close.
  • Bloomberg provides an update on ongoing efforts to revamp the Nation’s organ transplant system. Here are the highlights:
    • “First contract bid solicitations from HHS expected this fall, and
    • “Multiple vendors to run transplant system for first time.”
  • The Centers for Medicare and Medicaid Services published in today’s Federal Register corrections to its Section 111 reporting civil monetary penalty rule which was issued on October 11, 2023. CMS asserts that the corrections fix “typographical and technical errors in the final rule, and it does not make substantive changes to the policies or the implementing regulations that were adopted in the final rule.”
  • The Department of Health and Human Services announced,
    • “As part of the inaugural meeting of the White House Council on Supply Chain Resilience, President Biden and Secretary of Health and Human Services Xavier Becerra today announced new efforts to bolster the domestic supply chain for essential medicines and medical countermeasures.
    • “President Biden will issue a Presidential Determination broadening HHS’ authorities under Title III of the Defense Production Act (DPA) to enable investment in domestic manufacturing of essential medicines, medical countermeasures, and other critical inputs that have been deemed by the President as essential to the national defense. In addition, HHS will designate a new Supply Chain Resilience and Shortage Coordinator for efforts to strengthen the resilience of critical medical product and food supply chains, and to address related shortages.”
  • The Food and Drug Administration announced,
    • “approv[ing] Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype of soft tissue sarcomas.
    • “Desmoid tumors are non-cancerous but can be locally aggressive. The tumors may invade into surrounding structures and organs, resulting in pain, issues with being able to move, and decreased quality of life. Although surgical removal has historically been the treatment of choice, there is a high risk that the tumor will return or that other health challenges will occur after removal; therefore, systemic therapies (cancer treatment targeting the entire body) are being increasingly evaluated in clinical trials.” 
  • The HHS Inspector General concluded that “The Risk of Misuse and Diversion of Buprenorphine for Opioid Use Disorder in Medicare Part D Continues to Appear Low: 2022.”
  • Govexec tells us,
    • “The U.S. Postal Service is planning to hire just 10,000 temporary employees during the current holiday season as part of a new approach that management has acknowledged comes with some risks. 
    • “The seasonal hiring marks a 64% reduction from the employees brought on in 2022 during what USPS calls its “peak season” when the agency made 28,000 temporary hires. The agency had said it would bring on just 20,000 seasonal workers that year, but a recent USPS inspector general report found it reached a higher tally. 
    • “This will mark the second consecutive year in which the Postal Service significantly reduces its seasonal hiring. In 2021, USPS added 45,000 non-permanent staff for the holiday rush. Postmaster General Louis DeJoy has said additions to the permanent, career workforce has lessened the need for such a surge. In the last two years, the agency has converted 150,000 employees from part-time workers to full-time, career personnel.”
  • Federal News Network informs us,
    • “Participants in [OPM’s] Thrift Savings Plan felt less content with the TSP this year, according to the latest results of the Federal Retirement Thrift Investment Board’s annual satisfaction survey.
    • “Currently, 82% of TSP participants are satisfied with the plan, compared with an 87% satisfaction rate in 2022, the board’s survey of tens of thousands of TSP participants showed.
    • “The slumping satisfaction scores may not come as a surprise after the TSP’s tumultuous transition to a new recordkeeper in June 2022. The 2023 survey, conducted between March and May of this year, was the first time the major update was reflected in the annual participant satisfaction survey.”

From the public health and medical research front,

  • Precision Vaccinations points out,
    • “The World Health Organization (WHO) today reported that the multi-country mpox outbreak continues at a low transmission level in the European Region and the Americas.
    • “The 30th WHO Situation Report, published on November 25, 2023, offers insights regarding the latest epidemiology and a particular focus on the ongoing and evolving epidemiology of mpox in the Democratic Republic of the Congo (DRC).
    • “The WHO confirmed that from January 2022 through October 31, 2023, a cumulative total of 91,788 laboratory-confirmed cases of mpox, including 167 deaths, have been reported from 116 countries/territories/areas.
    • “The countries that have reported the highest cumulative number of mpox cases are the United States (30,771), Brazil (10,967), and Spain (7,647).”
  • Healio notes,
    • “Eating disorder claims in the United States rose 65% as a percentage of all medical claims over the last 5 years, according to a report from FAIR Health, a health care claims repository.
    • “Researchers at FAIR Health evaluated more than 43 billion private health care claims records to investigate trends in eating disorders from 2018 to 2022 based on regional and national levels, demographic and socioeconomic factors and other health conditions. * * *
    • “Key takeaways:
      • “Patients aged 14 to 18 years accounted for most eating disorder claims in 2022.
      • “Overall, 72% of patients with eating disorders were diagnosed with at least one co-occurring mental illness.”
  • Beckers Hospital Review lets us know,
    • “Eli Lilly’s Mounjaro helped patients lose weight more effectively than Novo Nordisk’s Ozempic, according to a preprint study that included more than 40,000 patients. 
    • “The research evaluated 41,223 EHRs of overweight or obese patients taking Mounjaro (tirzepatide) or Ozempic (semaglutide) for Type 2 diabetes. The cohort was restricted to patients with available weight data and those who had not received a glucagon-like peptide-1 receptor agonist prior to May 2022.
    • “Although about 77% of the patients took Ozempic, those who took Mounjaro “were significantly more likely to achieve 5%, 10% and 15% weight loss and experience larger reductions in weight at 3, 6, and 12 months,” the study found.
    • “Truveta, a healthcare data company that collects EHR information from more than 30 systems, conducted the research. It is the first real-world comparative effectiveness study between Mounjaro and Ozempic, Truveta said in a Nov. 27 news release.” 
  • STAT News reports,
    • “The inflammation-targeting therapy Dupixent succeeded in a Phase 3 trial in patients with the chronic lung disease COPD, its developers said Monday, results that could propel the blockbuster medicine into a massive new market.
    • “Dupixent, which is jointly developed by Sanofi and Regeneron Pharmaceuticals, has already racked up approvals for several indications, including asthma, atopic dermatitis, and eosinophilic esophagitis. If approved for COPD, it would be the first biologic treatment for the condition.
    • “The trial, dubbed Notus, was the second Phase 3 trial for Dupixent in COPD, with the companies announcing similarly positive results from the Boreas trial earlier this year. The full data from Boreas were published in the New England Journal of Medicine.”

From the U.S. healthcare business front,

  • Employee Benefit News offers tips on PBM contracting.
  • Per Fierce Healthcare,
    • “Mark Cuban Cost Plus Drug Company has inked its latest partnership, joining forces with Expion Health to address the rising cost of specialty drugs.
    • “Cost Plus Drugs’ pricing model will integrate into Expion’s dynamic pricing technology, harnessing the power of both for speciality medications. Expion’s tool and Cost Plus Drugs’ approach together “equips payers with a sophisticated tool for navigating this modern landscape,” the companies said in the announcement.”
  • and
    • “Ayble Health, a digital health platform for patients with chronic gastrointestinal conditions, has announced a new collaboration with the Mayo Clinic.
    • “Ayble is working with the Mayo Clinic Complex Care Program to offer a hybrid care model that matches patients with the appropriate virtual and in-person care based on acuity and need.
    • “By matching the right care for a patient at the right time, the two hope to improve outcomes and costs for digestive diseases. The collaboration is available for large employers and health plans.” 
  • MedCity News calls to our attention,
    • “AI startup Hoppr teamed up with AWS to launch a new foundation model to help bring more generative AI solutions into medical imaging, the companies announced on Sunday at RSNA 2023, the annual radiology and medical imaging conference in Chicago.
    • “The new product, named Grace, is a B2B model designed to help application developers build better AI solutions for medical images — and to build them more quickly. Along with the launch of Grace, Hoppr also announced that it received “a multi-million dollar investment” from Health2047, the American Medical Association’s venture studio.”
  • Per Healthcare Dive,
  • “Advocate Health’s financial performance dipped in the third quarter despite rising patient volumes as the major nonprofit health system navigated higher expenses and declining investment returns.
  • “The operator reported a nine-month operating income of $79.4 million, down from the $85.7 million Advocate recorded through the first half of the year.
  • “Advocate’s investment income also took a hit, falling more than a third from midyear. Overall, the nonprofit’s bottom line dropped to $721.2 million, 28% lower than midyear. * * *
  • “Formed out of a merger between Illinois-based Advocate Aurora Health and North Carolina-based Atrium Health last year, the health system is comprised of three divisions: Advocate Aurora Health, Atrium Health’s Charlotte-Mecklenburg Hospital Authority and Atrium Health Wake Forest Baptist. Together, the divisions operate more than a thousand care sites, including 67 hospitals.”

Midweek update

David Ermer–CMS, Congress, FDA, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Washington Post reports,
    • “The Senate passed legislation Wednesday to extend funding for federal agencies, sending the bill to avert a government shutdown to President Biden’s desk just days before the weekend deadline.
    • “The bill, which passed by an 87-11 vote, represents a marked de-escalation between congressional Democrats and new House Speaker Mike Johnson (R-La.). Without the new spending measure, called a continuing resolution or CR, the government would have shut down just after midnight Saturday, forcing federal workers — including military members and airport security agents — to work without pay or go on furlough on the eve of the Thanksgiving holiday.”
  • Roll Call informs us,
    • “House lawmakers left town Wednesday for Thanksgiving after a GOP revolt that led to defeat of the rule for floor debate on the final two pieces of legislation the chamber was scheduled to consider.
    • “Nineteen Republicans voted against the rule for the fiscal 2024 Commerce-Justice-Science spending bill and separate legislation dealing with frozen Iranian assets.
    • “Combined with all Democrats voting “no,” the measure was rejected on a 198-225 vote, leaving the House with no further business to attend to after dispensing with a series of pending amendments to the fiscal 2024 Labor-HHS-Education appropriations bill.”
  • The Department of Health and Human Services announced,
    • “taking the next step in working to ensure greater access to the life-saving services that it provides for people with Limited English Proficiency (LEP) and people with disabilities. In releasing the HHS Language Access Plan, HHS joins agencies across the federal government in prioritizing communication in services to the public. Today’s action supports President Biden’s Executive Orders to advance racial equity and support for underserved communities, which aims to improve access to benefits and services across the Administration, including for people with LEP.”
  • and
    • On November 15, 2023, the Centers for Medicare & Medicaid Services (CMS) placed on display at the Federal Registera final rule that will implement portions of section 6101 of the Affordable Care Act, requiring the disclosure of certain ownership, managerial, and other information regarding Medicare skilled nursing facilities (SNFs) and Medicaid nursing facilities, commonly known as nursing homes. It also defines the terms private equity company and real estate investment trust, about which information must be disclosed on Form CMS-855A, the Medicare enrollment application. This final rule continues a series of initiatives the Biden-Harris Administration announced in February 2022[1], designed to improve care and accountability at such facilities.
  • Per Govexec,
    • “The U.S. Postal Service lost $6.5 billion in fiscal 2023 despite initial projections it would break even for the year, and leadership cautioned the agency will once again be in the red in fiscal 2024. 
    • “Looking at only the parts of the operation that USPS leadership considers within its control, losses spiked to $2.3 billion compared to just $500 million in fiscal 2022 and a controllable profit of $1.5 billion in fiscal 2021. At the start of fiscal 2023, USPS forecasted a $4 billion loss. The negative financial numbers occurred despite the Postal Service growing its total revenue by $500 million. 
    • “Postal leadership attributed much of the losses—about $5.6 billion—to two factors: ongoing inflation and a miscalculation of what it must statutorily contribute toward its pension fund. Postmaster General Louis DeJoy also noted USPS is incurring upfront costs as it updates its network as part of his 10-year Delivering for America plan.” 
  • The Food and Drug Administration announced,
    • granting marketing authorization to LetsGetChecked for the Simple 2 Test. This is the first diagnostic test for chlamydia and gonorrhea with at-home sample collection to be granted marketing authorization. Prior to today’s authorization, the only cleared tests for either condition were used with samples collected at the point of care, such as a doctor’s office. The Simple 2 Test is available over-the-counter (OTC) and is intended for use in adult patients ages 18 years and older. It is the first FDA-authorized test with at-home sample collection for any sexually-transmitted disease other than HIV.

In Open Season news, Reg Jones discusses the FEDVIP and FSAFeds offerings in Fedweek.

From the public health and medical research front,

  • STAT News reports from London,
    • Clinical trials have shown that lifestyle programs — which include diet, exercise, and behavioral coaching — can help people in danger of developing type 2 diabetes from tipping into a diagnosis of the condition. But there’s been a nagging question of whether such intensive regimens work in the real world.
    • A study published Wednesday backs up the idea that they can. Researchers behind the work relied on novel statistical approaches to analyze millions of records from England’s National Health Service and found that participants in the NHS’s Diabetes Prevention Program saw improvements in risk factors for type 2 diabetes, indicating that patients can benefit from such initiatives even outside the confines of a controlled experiment.
  • The Washington Post points out,
    • “Lung cancer survival rates have increased over the past five years, but serious disparities remain among Black and Latino communities, according to the American Lung Association’s 2023 “State of Lung Cancer” report released Tuesday.
    • “The report highlights the need for better messaging about screening for lung cancer, which is still the nation’s leading cause of cancer-related deaths. The disease claims more than 120,000 lives each year, according to the American Cancer Society, in part because it is most often diagnosed at later stages when the cancer is harder to treat.
    • “The national survival rate for lung cancer jumped nearly five percentage points, from 21.7 to 26.6 percent, over the last five years, said report author Zach Jump, the national senior director of epidemiology, statistics and research at the American Lung Association.”
  • KFF lets us know,
    • “The U.S. spends huge amounts of money on health care that does little or nothing to help patients, and may even harm them. In Colorado, a new analysis shows that the number of tests and treatments conducted for which the risks and costs exceed the benefits has barely budged despite a decade-long attempt to tamp down on such care.
    • “The state — including the government, insurers, and patients themselves — spent $134 million last year on what is called low-value care, according to the report by the Center for Improving Value in Health Care, a Denver nonprofit that collects billing data from health plans across Colorado. The top low-value items in terms of spending in each of the past three years were prescriptions for opiates, prescriptions for multiple antipsychotics, and screenings for vitamin D deficiency, according to the analysis.”
  • McKinsey and Company discusses how
    • “Clinical factors are responsible for just 20 percent of individuals’ health outcomes; the remainder can be attributed to factors such as health-related social needs (HRSNs).1 Increasing recognition of the impact of these needs on consumers’ health and livelihoods is driving momentum across the healthcare ecosystem to integrate health and social care, creating opportunities for healthcare entities to design consumer-centric models of care tailored to individual needs and preferences.
    • This article synthesizes insights gleaned from a survey of more than 5,000 US consumers that highlights how HRSNs are evolving; their potential impact on healthcare use, preferences, and outcomes; and actions healthcare entities may consider to effectively support consumers’ needs.”
  • The Wall Street Journal reports,
    • “Researchers are coming up with new ways to make medical studies less white.
    • “They are building trust in groups long ignored by science and working with doctors and patients of color to design better studies. They are opening research sites in more diverse communities and providing stipends to help people participating in their studies pay for gas and child care.
    • “The efforts are starting to work: More people of color are participating in medical research. That is good news for everyone. Data from clinical trials—used to approve drugs and train artificial intelligence on medical decision-making—until recently failed to include swaths of the population. In the future, more diverse data sets will lead to better treatments and prevention of diseases in people of different backgrounds.
    • “Without diversity, we lose the ability to address fundamental problems that lead to suffering and loss of life,” said Dr. Carol Horowitz, director of Mount Sinai’s Institute for Health Equity Research.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Amazon’s One Medical inked a major partnership with Health Transformation Alliance, expanding access to its primary care services to 67 employers and nearly 5 million employees.
    • “HTA is a collective of large U.S. employers, and its member companies include Coca-Cola, American Express, Marriott, Boeing and Intel.
    • “Employers are grappling with rising healthcare costs and expect health benefit expenses to climb 5.4% in 2024, according to Mercer.
    • “HTA, on behalf of its member companies, saw an opportunity to partner with One Medical to provide access to high-quality primary care services while also addressing inefficiencies and costs in the healthcare system, according to HTA CEO Robert Andrews.”
  • BioPharma Dive reports,
    • “Gilead is expanding its collaboration with cancer cell therapy developer Arcellx, announcing Wednesday that subsidiary Kite Pharma has used an option to license a second experimental drug. The partners will also broaden their collaboration on a cell therapy that was the subject of the initial partnership.
    • “Per deal terms, Gilead will buy $200 million of Arcellx shares, giving it a 13% stake, as well as pay an $85 million cash fee. Arcellx will be owed undisclosed payments on achievement of development milestones “to offset prespecified development costs,” according to Gilead.
    • “Last year, Gilead paid $225 million upfront and made a $100 million investment in Arcellx to secure access to the first drug in the collaboration, a type of cancer treatment called CAR-T therapy, which engineers a patient’s own immune cells to attack tumors.”
  • Health Payer Intelligence notes,
    • “Members with diabetes spend between $3,300 and $4,600 per year in out-of-pocket costs for chronic disease management, including lost wages, according to a new report from GoodRx Health.
    • “These out-of-pocket cost estimates accounted for health insurance coverage but still represented 6 to 8 percent of the typical yearly wage in the US.
    • “The researchers addressed the cost of managing diabetes separately from the cost of complications. They used data from the Medical Expenditure Panel Survey (MEPS) for 2021 and prices across online diabetes medical device suppliers to assess healthcare spending among patients with diabetes.”

Monday Roundup

David Ermer–CMS, Congress, Medical / Rx research, Medicare, OPM, Patient safety, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Bloomberg reports,
    • “House lawmakers worked over the weekend on a stopgap measure needed to fund the US government beyond a Nov. 17 deadline, Speaker Mike Johnson said.
    • “While Johnson didn’t mention the proposed length of the extension in a Fox News Sunday interview, he has floated a Jan. 15 timeline since being elected speaker in October.
    • “The extension “would allow us time” to continue the appropriations process, which involves bringing 12 spending bills to the House floor for passage, the Louisiana Republican said.”
  • The FEHBlog watched the House Rules Committee pass a rule on the financial services and general government appropriations bill (HR 4664), which means that the bill will be brought to the House floor this week.
  • From the other side of Capitol Hill,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today released the Chairman’s Mark of a legislative package to expand mental health care and substance use disorder services under Medicaid and Medicare, reduce prescription drug costs for seniors at the pharmacy counter, extend essential Medicaid and Medicare provisions that will expire this year, and increase Medicare payments to support physicians and other providers.
    • “The Committee will hold a markup on the legislation on Wednesday, November 8, at 10 a.m.
    • “The Chairman’s Mark can be found here. A section by section can be found here. A CBO analysis can be found here.
    • “Amendments and additional information will be posted here on Tuesday, November 7, after 12 p.m.”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) released governmentwide results of the 2023 OPM Federal Employee Viewpoint Survey (FEVS) today. The OPM FEVS is the largest annual survey of government employees in the world that tracks how federal employees view their current work environment, including workforce management, policies, and new initiatives. OPM FEVS is an unmatched government data asset that collects employee feedback from more than 80 executive agencies to assist in driving improvement and supporting the workforce to serve the American people.   
    • “This year’s Federal Employee Viewpoint Survey highlights that federal employees remain remarkably resilient, increasingly engaged, and value diversity, equity, inclusion, and accessibility in the workplace,” said Kiran Ahuja, Director of the Office of Personnel Management. “These encouraging results provide opportunities for agencies to build momentum and support their workforce to leverage workplace flexibilities, continue advancing DEIA, and remain motivated to continue delivering for the American people.”  
  • The Centers for Medicare and Medicaid Services proposed a new Medicare Advantage Program rule that covers multiple topics.
  • Health Payer Intelligence adds,
    • “Medicare Advantage beneficiaries experience higher quality care and better health outcomes than fee-for-service beneficiaries, according to a report from Harvard and Inovalon.
    • “Researchers used Inovalon’s claims data to assess care quality for people enrolled in Medicare Advantage and those with Medicare fee-for-service between 2015 and 2019.”
  • Healthcare Dive reports,
    • “Healthcare employment growth fell across the board during the COVID-19 pandemic. Some sectors have had more difficulty rebounding than others, according to a new study — especially skilled nursing facilities, which face a controversial federal push for more staffing.
    • “Employment in hospitals increased 0.4% per quarter before the pandemic, but that growth rate shrunk to 0.03% during COVID-19, according to the study published in JAMA. By comparison, employment at skilled nursing facilities was already declining before COVID, dropping at a rate of 0.2% per quarter. During the pandemic, the rate of job losses accelerated to 1.1%.
    • “The Biden administration is seeking to impose mandatory nursing staffing minimums at skilled nursing facilities, or SNFs. The nursing home industry largely opposes the rule, arguing there are not enough workers available to meet the staffing mandate.” 

From the public health and research front,

  • The FEHBlog took the RSV vaccine today. The pharmacist who administered the injection told him the RSV vaccine are expected to be a once-every-decade experience for adults like the Tdap vaccine.
  • American Hospital News informs us,
    • “The more than 11,000 patients who received care during the first 16 months of the Acute Hospital Care at Home initiative had a low mortality rate and minimal complications related to escalations back to the brick-and-mortar hospital, according to a study reported Friday in JAMA Health Forum. CMS launched the initiative in November 2021 to address the COVID-19 public health emergency and concerns about hospital bed capacity. The Consolidated Appropriations Act of 2023 extended the CMS initiative through December 2024.
    • “The law also requires hospitals to provide additional data to CMS to monitor the quality of care, and for CMS to undertake a comprehensive study of the AHCAH initiative by September 30, 2024,” the authors note. “This study, data review, and additional monitoring will be important for identifying best practices that support safe and effective inpatient-level care delivered in the home environment.”
  • Per Fierce Healthcare,
    • “U.S. hospitals made gains to reduce healthcare-acquired infections (HAIs) but saw patient experiences further deteriorate in the latest release of an independent watchdog’s twice-yearly safety report.
    • “According to The Leapfrog Group, the sector has significantly reduced the incidences of Methicillin-resistant Staphylococcus aureus (MRSA), central line-associated bloodstream infections (CLABSIs) and catheter-associated urinary tract infections (CAUTIs) after reaching five-year highs during the COVID-19 pandemic.
    • “Specifically, 66% of the almost 3,000 general hospitals polled by the group improved their performance on at least one of the three HAIs. Nineteen percent improved across all three of the infection measures, while 16% either worsened or made no improvement.
    • “Now that we have pre- and post-pandemic data for patient safety measures, we are encouraged by the improvement in infections and applaud hospitals for reversing the disturbing infection spike we saw during the pandemic,” Leah Binder, president and CEO of The Leapfrog Group, said in a release.”
  • Here is a link to the Leapfrog Group report.
  • Beckers Hospital Review adds, “A comparison of data from CMS and The Leapfrog Group suggests that a hospital’s strong performance in one national quality rating system does not necessarily mean it will be a top performer in another.”
  • The New York Times Magazine gives us a story about the use of bariatric surgery on teenagers.

From the U.S. healthcare business front,

  • Reuters reports,
    • “Cigna is working with an investment bank to evaluate options for its Medicare Advantage business, which could fetch several billions of dollars in a potential divestment, the sources said.
    • “The discussions with interested parties, including other companies and private equity firms, are at an early stage, and Cigna may decide to keep the business, the sources added, requesting anonymity because the matter is confidential.”
  • Per Beckers Hospital Review,
    • “Oakland, Calif.-based Kaiser Permanente reported $156 million in operating income (0.6% margin) for the third quarter, up from a $75 million operating loss (-0.3% margin) in the third quarter of 2022. 
    • “For the three months ended Sept. 30, Kaiser’s health plan, hospitals and their respective subsidiaries posted $24.9 billion in revenue and $24.7 billion in expenses, compared to $24.3 billion and $24.3 billion, respectively, in the same period of the prior year. 
    • “Net income for the third quarter was $239 million, up from a net loss of $1.5 billion in the third quarter of 2022.”
  • and
    • “As operating margins inch upward, hospitals are trending to profitability. But their performance still isn’t at pre-pandemic levels. 
    • “For the first three quarters of 2023, hospital operating margins were up 19% and operating EBIDA was up 11% compared to the same period last year, according to Kaufman Hall’s October National Hospital Flash Report. Net operating revenue per calendar day saw a 6% increase and even inpatient revenue was up 3%. Compared to 2020, year-to-date operating margins in September were down 2% and operating EBIDA margins were down 9%.”

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).”

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.”

Tuesday Tidbits

David Ermer–CMS, Congress, FDA, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • “House Majority Whip Tom Emmer (R., Minn.) dropped his bid to serve as House speaker just hours after he was narrowly elected as the Republican nominee, as stiff resistance from hard-right conservatives reinforced by former President Donald Trump sank the party’s latest pick to run the chamber.
    • “His withdrawal put the Republicans back to square one for the fourth time, three weeks after hard-liners engineered the ouster of former Speaker Kevin McCarthy (R., Calif.). Republicans regrouped again late Tuesday to map out their next steps, assembling another slate of candidates and holding a fresh forum in the evening. A new vote was expected Tuesday evening.”
  • The Hill offers a potpourri of articles on this situation.
  • The American Hospital Association News informs us,
    • “The Centers for Disease Control and Prevention Oct. 23 released interim guidance for clinicians with limited access to the monoclonal antibody nirsevimab, recently approved to prevent respiratory syncytial virus in children aged 2 and under. The guidance calls for prioritizing 100 milligram doses of the treatment for infants under 6 months old and infants at high risk for severe disease due to underlying health conditions, among other recommendations.”
  • STAT News tells us,
    • “Infertility has a new definition in the U.S. — one that could make a big difference to would-be parents who are single or LGBTQ+.
    • “Last week, the American Society for Reproductive Medicine (ASRM) issued an expanded description of the condition, stating that infertility involves “the need for medical intervention, including, but not limited to, the use of donor gametes or donor embryos in order to achieve a successful pregnancy either as an individual or with a partner.”
  • It’s worth adding that for 2024, OPM adopted a broad definition of fertility coverage for the FEHBP to serve this purpose.
  • Also from STAT News,
    • “People eligible to use the only needle-free flu vaccine available in the United States may be able, next year, to give it to themselves or to eligible children at home.
    • “AstraZeneca, which makes the vaccine FluMist, announced Tuesday it has submitted to the Food and Drug Administration a supplemental biologics license application that would allow for self-administration of the vaccine by people ages 18 through 49, and would allow people 18 and older to give the vaccine to eligible children. FluMist is only licensed for use in children and adults from the age of 2 to 49 years old.”
    • “The application, which the FDA is considering, would not mean there would effectively be over-the-counter sales of FluMist, Lisa Glasser, head of AstraZeneca’s U.S. medical affairs for vaccines and immune therapies, told STAT in an interview. Rather, the vaccine, which must be stored at refrigerator temperatures, would be ordered and delivered under appropriate temperature controls, after consultation with a medical professional.
    • “Glasser said the program, if approved, would not replace the option of getting FluMist in a doctor’s office or at a pharmacy, but would be another alternative for busy families. “It is meant to enhance the ability to access influenza vaccination,” she said. “That’s the goal.”

From the public health and medical research front,

  • The NIH Directors blog points out,
    • When NIH launched The BRAIN Initiative® a decade ago, one of many ambitious goals was to develop innovative technologies for profiling single cells to create an open-access reference atlas cataloguing the human brain’s many parts. The ultimate goal wasn’t to produce a single, static reference map, but rather to capture a dynamic view of how the brain’s many cells of varied types are wired to work together in the healthy brain and how this picture may shift in those with neurological and mental health disorders.
    • So I’m now thrilled to report the publication of an impressive collection of work from hundreds of scientists in the BRAIN Initiative Cell Census Network (BICCN), detailed in more than 20 papers in Science, Science Advances, and Science Translational Medicine.1 Among many revelations, this unprecedented, international effort has characterized more than 3,000 human brain cell types. To put this into some perspective, consider that the human lung contains 61 cell types.2 The work has also begun to uncover normal variation in the brains of individual people, some of the features that distinguish various disease states, and distinctions among key parts of the human brain and those of our closely related primate cousins. * * *
    • All the data represented in this work has been made publicly accessible online  for further study. Meanwhile, the effort to build a more finely detailed picture of even more brain cell types and, with it, a more complete understanding of human brain circuitry and how it can go awry continues in the BRAIN Initiative Cell Atlas Network (BICAN). As impressive as this latest installment is—in our quest to understand the human brain, brain disorders, and their treatment—we have much to look forward to in the years ahead.”
  • Per STAT News,
    • “Since the Apple Watch was unveiled in 2014, it has been trumpeted not only as a high tech fashion accessory, but also as a way for people to track their own health and fitness. It has evolved as a popular cardio tool for such uses as heart rate monitoring, recording your ECG, and measuring the oxygen saturation of your blood.
    • “But now, after nearly a decade of development, the Apple Watch is being leveraged on an entirely new health frontier: Parkinson’s disease, the degenerative brain disorder that affects more than a half million Americans.
    • “While there is no cure for Parkinson’s and treatment options can be daunting, people with the disease can now turn to technology spawned by the Apple Watch to take an active role in their care much as continuous glucose monitors have helped people manage diabetes better. Over the past year, the Food and Drug Administration has cleared three Apple Watch apps from independent developers to track symptoms associated with Parkinson’s that can help inform treatment decisions for people and their doctors.”
  • and
    • “If you had to pinpoint one subject that stood out at this year’s European Society for Medical Oncology meeting, a massive conference with thousands of people from 140-some countries and 2,500 studies presented, it would be a burgeoning type of cancer treatment called antibody-drug conjugates (ADC)
    • “The conference opened to the news that Merck had signed one of the biggest licensing deals in industry history — worth up to $22 billion — to partner on three of the compounds from ADC specialist Daiichi Sankyo. GSK followed up with an ADC licensing announcement of its own (if a much smaller one). Multiple ADC studies were presented at the meeting’s top sessions. ADCs were, in short, the belle of the cancer research ball.
    • “The thing is, ADCs are actually quite an old approach.
    • “The industry’s been putting ADCs into the clinic for 20 years, and it’s only recently that we’ve really had a breakthrough here,” Susan Galbraith, who leads AstraZeneca’s cancer work, told STAT.
    • “ADCs are designed to deliver chemotherapy directly to tumors, possibly one day replacing the blunt-force toxic therapies that have been the backbone of cancer care for generations. The idea is that these finely crafted shipments can pack the punch of chemo while minimizing side effects. Experts are still scrutinizing the safety profiles of ADCs — they come with their own side effect concerns, and trials have included some patient deaths — but some studies are showing that patients can tolerate ADCs better than traditional chemo.”

From the U.S. healthcare business front,

  • Beckers Hospital Review provides us with a link to Healthgrades’s latest rankings of specialty hospitals.
  • Moreover, Beckers Hospital Review reports,
    • “Since launching in 2018, hospital-owned Civica Rx works with about a third of the nation’s hospitals and manufactures 80 drugs facing shortages, NBC affiliate KSL-TV reported Oct. 22. 
    • “Seven health systems formed the pharmaceutical company after struggling for years with recurring drug shortages. The first goal was to make 14 generics constantly in short supply for hospitals, and 19 systems were founding members. 
    • “Now, some governments and hundreds of hospitals are buying from Civica Rx. 
    • “Dan Liljenquist, the chief strategy officer for Salt Lake City-based Intermountain Health, volunteer board chair of Civica Rx and a former Utah senator, told KSL-TV Civica Rx plans to scale up operations at its Petersburg, Va.-based manufacturing plant.” 
  • and
    • “Pittsburgh-based UPMC said it has entered into an integration and affiliation agreement with Washington (Pa.) Health System, according to an Oct. 23 filing.
    • “The two signed a letter of intent in June regarding the partnership. Unions have criticized the move, saying it would harm both patients and workers.
    • “UPMC will appoint about one-third of the Washington Health board directors and the system will be renamed UPMC Washington, according to the filing.
    • “The proposed transaction still has to meet regulatory and closing conditions.”
  • Per Healthcare Dive,
    • “Centene raised its 2023 outlook on Tuesday after the health insurer handily beat Wall Street expectations for earnings and revenue in its third quarter, helped by lower medical costs.
    • “Centene reported a medical loss ratio — a marker of spending on patient care — of 87%, down from the year prior. On a call with investors Tuesday morning, executives chalked the lower medical spending up to significantly more members in Affordable Care Act marketplace plans, who generally require less expensive care than members in Medicaid and Medicare. Centene grew marketplace membership 76% year over year.
    • “The ongoing effect of Medicaid redeterminations — now almost halfway complete — on membership numbers and care acuity continues to track to Centene’s expectations, CEO Sarah London said on the call. Centene still expects to lose roughly two million members once redeterminations are complete.”
  • Per Fierce Healthcare,
    • “Teladoc’s third-quarter revenue grew 8% to reach $660 million, boosted by solid performance in its chronic condition management business and steady membership growth as the company now touts 90 million users.
    • “The telehealth giant, which has been in operation for 20 years, also narrowed its losses this past quarter to a net loss of $57 million, or 35 cents per share, compared to a net loss of $73.5 million, or 45 cents per share, for the third quarter of 2022.” 
  • and
    • “Elevance Health’s CarelonRx is the latest pharmacy benefit manager to put biosimilars for popular drug Humira on its formulary, the company said this week.
    • “Beginning Dec. 1, adalimumab-adbm will be added to each of its commercial formularies, according to a blog post from CarelonRx. Cyltezo will also be added to certain formularies, and both will be offered at parity with Humira.
    • “Humira has been the bestselling drug in the U.S. for a decade, and PBMs have long awaited biosimilar products to challenge the drug’s dominance in the market. Drugs that treat inflammatory conditions, like Humira, represent a growing piece of overall drug spend.
    • “Other key PBMs, including Express Scripts and Optum, have taken similar steps. CVS Health launched a new subsidiary, called Cordavis, earlier this year that aims to work alongside drugmakers to bring additional biosimilars to market, with the first product a Humira biosimilar in collaboration with Sandoz.”