Midweek Update

U.S. Healthcare

Midweek Update

David Ermer–CDC, Congress, COVID-19, FDA, Medicare, Mental health care, No Surprises Act, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Senate Finance Committee announced,
    • Senate Finance Committee Chairman Ron Wyden, D-Ore., will convene a committee hearing on Tuesday, December 5, 2023 titled “Drug Shortages: Examining Supply Challenges, Impacts, and Policy Solutions from a Federal Health Program Perspective.” The hearing will take place at 10:00 a.m. in Room 215 of the Dirksen Senate Office Building.
  • The American Hospital Association News notes,
    • “The House Energy and Commerce Subcommittee on Health Nov. 29 held a hearing  to explore how medical devices and hospitals are using artificial intelligence and what Congress should consider as AI in health care evolves.”
  • BioPharma Dive reports,
    • “The Food and Drug Administration’s top scientist Namandjé Bumpus will assume the role of principal deputy commissioner when longtime agency leader Janet Woodcock retires from that role in early 2024, according to an announcement Thursday.
    • “Among Bumpus’ priorities when she assumes the role will be “creating a new model” for the FDA’s Office of Regulatory Affairs, the branch that conducts inspections, monitors drug imports, and issues recalls, market withdrawals and safety alerts, Commissioner Robert Califf said in a memo to agency staff.”
  • Sequoia reminds us,
    • “Beginning in 2024, group health plans and carriers will be required to include all covered items and services in their self-service internet-based price comparison tool, as required under the Transparency in Coverage (TIC) Final Rules.
    • “As background, plans must provide participants and beneficiaries with out-of-pocket cost estimates via a user-friendly online self-service tool (and by paper upon request). The intent of this requirement is to provide individuals with real-time cost-sharing information to support making informed health care decisions. Implemented in two phases, the first phase of the price comparison tool required the first 500 items and services (as defined by the DOL) to be published in the tool effective for plan years beginning on or after January 1, 2023, and the second phase will require all other services covered by the plan to be included in the tool effective for plan years beginning on or after January 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control announced,
    • “CDC’s National Center for Health Statistics released two reports today examining provisional mortality data from 2022. While analysis shows the number and rate of suicides increased for the second year in a row from, overall life expectancy at birth increased by just over a year. This increase regains some of the 2.4 years of life expectancy lost between 2019 and 2021.
    • “The findings are featured in two new reports, “Provisional Life Expectancy Estimates for 2022” and “Provisional Estimates of Suicide by Demographic Characteristics: United States, 2022. * * *
    • “The increase of 1.1 years in life expectancy from 2021 to 2022 primarily resulted from decreases in mortality due to COVID-19, heart disease, unintentional injuries, cancer, and homicide. Declines in COVID-19 mortality accounted for approximately 84% of the increase in life expectancy. * * *
    • “The percentage increase in the number of suicides was greater for females (4%) than males (2%), but the provisional 2022 suicide number for males (39,255) was nearly four times that of females (10,194).”
  • Health Day points out,
    • “The prevalence of a highly mutated COVID variant has tripled in the past two weeks, new government data shows.
    • “Now, nearly 1 in 10 new COVID cases are fueled by the BA.2.86 variant, the U.S. Centers for Disease Control and Prevention reported Monday.
    • “The variant is spreading the fastest in the Northeast: Just over 13% of cases in the New York and New Jersey region are blamed on BA.2.86. * * *
    • “So far, preliminary data on the variant suggests it does not trigger more severe illness than previous variants, the WHO said in a recent risk evaluation, but the international agency still noted a recent and “substantial rise” in BA.2.86 cases.
    • “The CDC also noted that BA.2.86 variant poses a “low” public health risk.”
  • and
    • “Personal trainers can help people increase their strength and their fitness.
    • “Could a “brain coach” be just as useful in preventing Alzheimer’s’ disease?
    • “A new study suggests that personalized health and lifestyle changes can delay or even prevent memory loss for older adults at high risk of Alzheimer’s or dementia.
    • “People who received personal coaching experienced a 74% boost in their thinking and memory tests compared with those who didn’t receive such attention.
    • “This is the first personalized intervention, focusing on multiple areas of cognition, in which risk factor targets are based on a participant’s risk profile, preferences and priorities, which we think may be more effective than a one-size-fits-all approach,” said co-lead researcher Dr. Kristine Yaffe, vice chair of research in psychiatry at the University of California, San Francisco (UCSF).”
  • Healio informs us,
    • “One in four adults relied solely on medications to manage chronic pain, highlighting an opportunity to increase use of nonpharmacologic therapies, particularly in men, older adults and those with public insurance, according to researchers.
    • “Findings from this study contribute important information about use of over-the-counter pain relievers, prescriptions nonopioids and exercise, which were found to be some of the most common pain management therapies used by adults with chronic pain,” Stephanie Michaela Rikard, PhD, a health scientist at the CDC, told Healio.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Cigna and Humana are in talks for a combination that would create a new powerhouse in the health insurance industry.
    • “The companies are discussing a stock and cash deal that could be finalized by the end of the year, assuming the talks don’t fall apart, according to people familiar with the matter.”
  • and
    • “A law designed to protect patients from surprise medical bills is contributing to the financial distress of some medical-service providers, which say lengthy billing disputes and payment delays with insurers are hurting their ability to stay afloat. 
    • “The No Surprises Act, which took effect last year, aims to protect patients from surprise medical bills from out-of-network healthcare providers when there are disagreements over reimbursements between insurers and providers. Previously, providers often billed patients to make up for the amounts insurers were unwilling to pay. 
    • “Numerous healthcare businesses, some owned by private equity, said the legislation is contributing to delays and reductions in payments by insurance companies, hurting their cash flows and earnings. A handful of major healthcare-service providers already have filed for chapter 11 protection this year, specifically naming the law as a major reason for their bankruptcies. These include physician-staffing companies Envision Healthcare and American Physician Partners as well as helicopter-ambulance operator Air Methods.”
  • and
    • “There are five tech companies valued at over $1 trillion. In healthcare, the closest contender is  Eli Lilly. 
    • .”This year it became the first big pharmaceutical to surpass a market capitalization of $500 billion thanks to the popularity of its obesity and diabetes medications and, to a lesser extent, its experimental Alzheimer’s drug. But hanging over Lilly and rival  Novo Nordisk is a reality that puts the brakes on big pharma’s ascent: the patent cliff.
    • “There are several reasons why there isn’t a big pharma company in the trillion-dollar club, but the boom-and-bust nature of drug development is high on the list. Unlike Apple, which hypothetically can make huge margins off the iPhone for perpetuity, U.S. drug companies have a limited period from which to profit from their innovation. As their patents expire and generic competitors enter the market, sales plunge. Pharma executives, overly focused on short-term growth, don’t often prepare their companies for that.”
  • FEHBlog notes on the Journal articles,
    • Cigna and Humana are undoubtedly aware of the firebreathing nature of anti-trust enforcers in the federal government. Cigna is focused on the commercial market while Humana currently is pulling out of that market to focus on government business. Time will tell.
    • Out-of-network doctors and air ambulance companies flying the pirate flag can avoid No Surprises Act problems by joining health plan networks.
    • Lilly’s recent growth has been impressive.
  • Reuters tells us,
    • “UnitedHealth Group on Tuesday forecast 2024 profit broadly in line with Wall Street expectations, indicating that medical costs are likely to remain elevated for the health insurance giant.
    • “The healthcare sector has this year seen a recovery in demand, especially among older patients who started returning to doctors’ clinics and hospitals for procedures they had delayed during the COVID-19 pandemic.”
  • Healthcare Dive adds,
    • “Healthcare insurers could get a slight respite from rising medical costs next year. Global costs are expected to rise 9.9% year over year in 2024, down from a 10.7% increase in 2023, according to a new survey from consultancy WTW released on Tuesday.
    • “However, that decline might not last long. Nearly three-fifths of insurers surveyed anticipate higher medical cost growth over the next three years as new medical technologies, overuse of care and members’ poor health habits drive increased spend.
    • “Many insurers told WTW they are leaning on deductibles, contracted provider networks and telehealth options to manage costs. Others are excluding coverage for healthcare such as fertility treatments or gender re-affirming care.”
  • Beckers Hospital CFO Report identifies the states with the most rural hospital closures.
    • “Since 2005, 104 rural hospitals have closed and more than 600 additional rural hospitals — 30% of all rural hospitals in the U.S. — are at risk of closing in the near future, according to the Center for Healthcare Quality and Payment Reform.”
  • Beckers Hospital Review calls attention to this development,
    • “Mayo Clinic’s board of trustees has given the green light to an initiative dubbed “Bold. Forward. Unbound.,” which involves a $5 billion redesign of Mayo Clinic’s downtown Rochester, Minn., campus. 
    • “The redesign will introduce new facilities that incorporate innovative care approaches and digital technologies, according to a Nov. 28 news release from Mayo, with a pivotal element of these being specialized “neighborhoods.” According to the health system, the neighborhood concept will offer patients a centralized location for all required services related to their specific condition, eliminating the need for navigating between different departments.”
  • Per Fierce Healthcare,
    • “Accountable care organizations do not positively influence treatment and outcomes for chronic mental health conditions for Medicare patients, according to a study in Health Affairs.
    • “For patients newly enrolled in ACOs, they saw no improvements in their depression and anxiety symptoms after one year. These patients were also 24% less likely to have their depression or anxiety treated than patients unenrolled in ACOs, and 9.8% less likely to have an evaluation and management visit for depression or anxiety with a primary care clinician.
    • “Since mental health conditions in Medicare patients are often underdiagnosed and undertreated, some have suspected that mental health illnesses are ideal conditions for ACOs to handle, but the study found that there were no significant differences in any other measures of mental health treatment.”
  • Beckers Hospital Review also names the winners of Forbes 30 under 30 in healthcare for 2024.


 

Tuesday Tidbits

David Ermer–ACA, FDA, No Surprises Act, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • This morning, the federal government filed a notice appealing to the D.C. Circuit the HIV and Hepatitis Foundation’s successful challenge to the Trump administration’s co-pay accumulator rule.
  • Yesterday, the federal government moved for the district court to modify its decision to state that the Trump administration rule would remain effective until the ACA regulators reconsidered it in compliance with the court’s order. The plaintiffs reportedly oppose the government’s motion. 
  • The ACA regulators issued
  • The FAQs concern the claims batching limitations under the No Surprises Act and the update to CLAS requirements that health plans, including FEHB plans must use in certain plan publications. The FEHBlog noticed that the ACA regulators have added new languages to CLAS requirements. The CLAS changes will take effect for the 2025 plan year.
  • The American Hospital Association News adds,
    • In response to recent court decisions that set aside certain regulations implementing the No Surprises Act’s Independent Dispute Resolution process, the Centers for Medicare & Medicaid Services Nov. 28 released [ACA] FAQs [63] explaining how certified IDR entities may determine whether a dispute is appropriately batched and clarifying certain other provisions and its policy for extending existing IDR deadlines once the federal IDR portal reopens to all batched disputes and single disputes involving air ambulance services. CMS also rescheduled to Nov. 30 at 3 p.m. ET its webinar to review the FAQs for health care providers and insurers submitting batched or air ambulance claims. To attend the webinar, register here.
  • Get a load of this other AHA News item,
    • A bipartisan group of House members Nov. 28 introduced AHA-supported legislation that would prohibit health insurers from charging fees for standard electronic fund transfers to pay health care providers for services. Commercial insurers often automatically charge health care providers a percentage-based fee for EFT payments. 
    • FEHBlog note — EFT transactions are not free. If the entire cost is shifted onto the insurer, then premiums go up.

From the public health and medical research front,

  • BioPharma Dive informs us,
    • “The Food and Drug Adminsitration is investigating whether CAR-T cell therapies like Novartis’ Kymriah or Gilead’s Yescarta are linked to the risk of new blood cancers after receiving reports of so-called T cell malignancies in people who have received the treatments.
    • “In a statement Tuesday, the agency said it’s weighing “the need for regulatory action” in response to the reports, which came from both clinical testing and safety monitoring tied to commercial use. The identified risk is applicable to all approved CAR-T therapies, although the agency noted that “the overall benefits of these products continue to outweigh their potential risks for their approved uses.”
  • The Wall Street Journal reports,
    • “The U.S. Food and Drug Administration warned of an emerging safety issue involving a continuous positive airway pressure, or CPAP, machine made by Philips.
    • “The FDA issued a safety communication about thermal issues with the Philips Respironics’ DreamStation 2 CPAP machines, which are used to treat forms of sleep apnea, and recommended patients monitor machines.
    • “The agency said it had received reports of issues such as fire, smoke, burns and other signs of overheating. The FDA said it is in discussions with the company about strategies to address the safety issue.”
  • The Washington Post points out,
    • “Scientists have discovered a new type of stem cell in the spine that appears crucial to resolving a long-standing mystery: why far more cancer cells spread to the spine than to other bones in the body.
    • “When breast, lung and prostate cancers metastasize to multiple bones in the body, three to five times more cancer winds up in the spine than in the lower and upper limbs. Scientists have known of this disparity for decades, but the reason for it has remained unclear.
    • “One theory held that differences in blood flow might be the cause. But the new findings suggest an alternative that could have implications for cancer care, spine fusion surgery and osteoporosis, a bone-weakening disease that afflicts about 10 million Americans.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “releasing a Draft Evidence Report assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. This preliminary draft marks the midpoint of ICER’s eight-month process of assessing these treatments, and the findings within this document should not be interpreted to be ICER’s final conclusions.“
  • The ICER announcement also explains how to submit public comments and participate in virtual public meeting on February 9, 2024.

From the U.S. healthcare business front,

  • The Business Group on Health issued a report on nine healthcare cost trends to watch in 2024.
  • Beckers Hospital Review tells us,
    • “Hospitals’ median operating margin was 1.2% through October, marking the third straight month with the same year-to-date median and signaling growing stability.  
    • “The latest figure comes from Kaufman Hall’s November “National Hospital Flash Report,” which is based on data from more than 1,300 hospitals. 
    • “Kaufman Hall said the 1.2% year-to-date median operating margin for October reflects “continued stabilization” among hospitals. In the first 10 months of 2023, hospitals’ net operating revenue per calendar day was up 6%, and total expense per calendar day was up 4% compared to the same time period in 2022.”

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.”

Thanksgiving Weekend Update

David Ermer–CDC, Congress, COVID-19, Medicare, OPM, U.S. Healthcare–

We are halfway through the Federal Employee Benefits Open Season, which will end on December 11.

The Senate and the House of Representatives will be engaged in Committee business and floor voting this week.

Axios brings us a dental coverage update for Affordable Care Act plans and Medicare. Of note, Axios tells us that “earlier this month, the Biden administration expanded all Medicare beneficiaries’ access to dental services when they’re necessary for other medical care, like cancer treatment.”

From the public health front,

  • Axios reports
    • “The big picture: In the two years since Omicron emerged, it has continued to rank as the predominant strain in the U.S., and its subvariants are now driving most of the country’s coronavirus infections.
    • “State of play: COVID-19 is circulating in every country and remains a threat, Maria Van Kerkhove, the WHO’s technical lead on COVID-19, said in an update Tuesday.
      • “Infection from the variants now in circulation can cause anything from asymptomatic infection to severe disease, pneumonia and death, she explained.”Infection from the variants now in circulation can cause anything from asymptomatic infection to severe disease, pneumonia and death, she explained.
      • “Luckily, she added, most people are experiencing less severe symptoms because they have population-level immunity from vaccination, prior infection, or both.
    • “Zoom in: Case rates are not as high as this summer, but experts expect they may rise during the winter as they have the past three years, given colder weather that drives people indoors and holiday gatherings.”
  • The Wall Street Journal adds,
    • “Flu and RSV killed thousands of people on their own during typical winters before the pandemic. Covid isn’t killing people as it once did, but it remains the deadliest of the three—in part because it is more active year-round. 
    • “The Centers for Disease Control and Prevention predicts hospitalizations this year will be about the same as last year: well above pre-pandemic levels. Even a milder season with the three viruses circulating together would likely mean more hospitalizations than a severe season of just flu and RSV, said Jason Asher, who directs a CDC forecasting department.
    • “More illness means more disruptions to life and work. The flu alone is responsible for billions of dollars in medical and economic costs and millions of lost workdays. Covid has added to worker absences in recent winters.  * * *
    • “There’s one more virus out there for you to get,” said Justin Lessler, an infectious disease epidemiologist at the University of North Carolina. “Your risk of getting sick has probably gone up.”

From the U.S. healthcare business front,

  • The Washington Post reports,
    • “About half of all people are in hospice at the end of their lives, but more than 25 percent of hospice patients enroll in the final week, according to 2021 data from the Medicare Payment Advisory Commission, which advises Congress on Medicare issues.
    • “Others among the 1.7 million Medicare patients who used hospice that year availed themselves of its services for much longer. That is reflected in data that reveal the dual nature of hospice: The median stay is only 17 days, meaning half of patients were in hospice less than 17 days and half longer than that. But the average is 92 days, which shows that some patients were in hospice for many months.”
  • The Wall Street Journal points out,
    • A healthcare hiring boom is helping offset weaker job growth in other areas of the softening U.S. economy, boosting its chances of skirting a recession.
    • The industry could serve as a strong job generator for years to come as an aging population and Covid-19 fuel widespread worker shortages and greater needs for healthcare services. 
    • Healthcare providers—including hospitals, clinics, pharmacies and doctors’ offices—accounted for 30% of U.S. job gains in the six months through October, though less than 11% of the country’s total employment, Labor Department figures show. 
    • “As behavior returns to normal—as kids go back to germ-factory indoor play spaces and daycare centers, and as people schedule elective procedures and catch up on routine scans delayed during the height of the pandemic—providers are having to staff up to keep up with demand,” said Julia Pollak, chief economist at Ziprecruiter.”

Post Thanksgiving Extra

David Ermer–No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

The FEHBlog noted his plan on Wednesday to hold off on future posts until Cybersecurity Saturday. A pleasant Thanksgiving holiday resulted in the FEHBlog preparing this Friday Extra.

From Washington, DC,

  • CMS issued a No Surprises Act toolkit for consumer advocates.
  • Federal News Network tells us,
    • “As it’s the middle of open season, those eligible have until Dec. 12 to enroll or make changes to their plans under TRICARE – the Defense Department’s healthcare system – for 2024.
    • “The two main plans eligible for enrollment are TRICARE Prime, which includes the U.S. Family Health Plan, and TRICARE Select. TRICARE Open Season does not apply to its premium plans – TRICARE Young Adult, TRICARE Reserve Select and TRICARE Retired Reserve. TRICARE Open Season also does not apply to those who are eligible for Medicare or those using TRICARE For Life. It also does not apply to active duty service members. These groups do not have to do anything during the Open Season.
    • “Open Season is an opportunity for you to evaluate the health care coverage that your family has and to see if you need to change plans or if you want to stay in the current plan that you’re in,” Zelle Zim, who’s on TRICARE’s policy and programs team, said at a TRICARE event on Wednesday. “You also have the opportunity to enroll in a new plan during TRICARE Open Season.”

In public health and medical research news,

  • Healthcare Dive informs us,
    • “Rates of completion for high-risk diagnostic tests and referrals were lower when ordered during a telehealth visit compared with an in-person appointment, according to a study published in JAMA Network Open. 
    • “For telehealth orders, 43% were completed during the designated time frame compared with 58% of tests and referrals requested during in-person appointments, and 57% of those ordered without any visit at all. 
    • “Failure to get tests or complete referrals is a leading cause of diagnostic errors, and safety risks can be a particular concern in primary care due to the large number of potential diagnoses, researchers said.” 
  • STAT News points out,
    • “Overdose deaths among pregnant or postpartum people skyrocketed between 2018 and 2021, according to new research published Wednesday in JAMA Psychiatry.
    • “The study, conducted by the National Institute on Drug Abuse (NIDA) and the National Institutes of Health, compared the incidence of maternal deaths for overdose of commonly misused psychotropic drugs (such as heroin and other opioids, including synthetic ones, or cocaine) among girls and women aged 10 to 44.
    • “The spike in overdose deaths was especially high among women ages 35 to 44. In 2018, the rate was 4.9 overdose maternal deaths per 100,000 mothers with a live birth; in 2021, the rate was 15.8 per 100,000. The rate of overdose death for all age groups also increased significantly, from 6.9 per 100,000 mothers in the first half of 2018 to 12.2 in the second half of 2021.”
  • Beckers Hospital Review reports, “There’s been a slight slowdown in reports of new drug shortages before the winter holiday season, but six medications recently entered the list of ongoing shortages, which includes about 300 drugs.” Becker’s article lists those six drugs.

From the U.S. healthcare business front,

  • Beckers Payer Issues notes that Blue Cross licensees are “diving into” direct healthcare delivery. “BCBS plans have spent 2023 reorganizing to better compete with larger insurers through corporate restructuring, M&A or the launch of healthcare delivery subsidiaries.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit management giant Optum Rx is aiming to address maternal and fetal health by leaning on the power of independent pharmacies.
    • “The Road to Healthy Baby program launched earlier this year in three states—Louisiana, Michigan and New Mexico—and offers pregnant patients prenatal checkups and vitamins at an independent pharmacy. The initiative is part of a broader push by the PBM that seeks to harness the power of these pharmacies.
    • “Through the program, a pregnant person who maintains their prenatal vitamins across three prescriptions or a 90-day supply will receive a care kit with key items that help during pregnancy and after the baby is born.
    • “Optum has also deployed grants to local diaper banks to ensure new mothers have access to necessary supplies. Katie McCarey, vice president of pharmacy strategy and product innovation at Optum Rx, told Fierce Healthcare that the company has found in some markets that new mothers often have just one or two diapers available each day for their babies.”
  • and
    • “UPMC’s operations dipped into the red this quarter as volumes and their associated care delivery costs and insurance claims continue to climb.
    • “The Pittsburgh-based integrated nonprofit system reported Tuesday a $191 million operating loss (-2.8% operating margin) and a $421.8 million change in net assets (without donor restrictions) for the three months ended Sept. 30. During the same time a year prior, UPMC had logged a $114.5 million operating income (1.8% operating margin) and $272.6 million drop in its net assets (without donor restrictions).
    • “The organization is now sitting at a $176.5 million operating loss (-0.9%) year to date despite its strong start to 2023. Its bottom line reflects a $244.7 million net decline over nine months.
    • “In a release announcing the financial results, UPMC Executive Vice President and Chief Financial Officer stressed that the system is “staying to true its commitments” surrounding capital investments ($517 million year to date) despite industry-wide workforce challenges and other headwinds.”
  • Healthcare Dive highlights five major healthcare company bankruptcy filings in 2023. “Bankruptcies have spiked this year as federal COVID-19 funding lapsed and heightened interest rates, regulatory changes and labor shortages squeezed the sector.”

Happy Thanksgiving!

David Ermer–Congress, COVID-19 testing, Federal employment benefits, Generative AI, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Priscilla Du Preez 🇨🇦 on Unsplash

Following this post, The FEHBlog will reappear on Saturday for Cybersecurity Saturday. The FEHBlog wishes his readers a Happy Thanksgiving.

From Washington DC

  • Thanks to Bloomberg, the FEHBlog learned about this Congressional Research Service report on FY 2024 USPS Appropriations. To wit,
    • “On September 30, 2023, Congress passed the Continuing Appropriations Act, 2024 and Other Extensions Act (H.R. 5860; P.L. 118-15), which provides continuing FY2024 appropriations to federal agencies through November 17,
    • “Section 126 of the act increases the rate of funding for the Office of Personnel Management (OPM) to approximately $219.1 million, which is about $28.3 million above its FY2023 funding.
    • “The additional OPM funding is provided for the implementation of the Postal Service Health Benefits Program (PSHBP), a new health benefit program for eligible postal employees and retirees. Under the PSRA, OPM is required to establish and administer the PSHBP.”
  • FEHBlog note — The Postal Service also is on the financial hook for funding implementation of the PSHBP.
  • STAT News reports,
    • “Senate Democrats, led by Sen. Bernie Sanders (I-Vt.), on Tuesday mounted a public pressure campaign to get the executives of Merck, Johnson & Johnson, and Bristol Myers Squibb to testify in a January hearing on why the United States pays more for prescription drugs than other countries.
    • “All three companies have sued the Biden administration over the new Medicare drug price negotiation that congressional Democrats passed last year. Bristol Myers Squibb’s blood thinner Eliquis; Johnson & Johnson’s blood thinner Xarelto, anti-inflammatory medicine Stelara, and blood cancer treatment Imbruvica; and Merck’s diabetes drug Januvia were selected as part of the first 10 drugs to go through the negotiation process.
    • “It’s unclear whether the executives will agree to testify at the hearing, which is titled “Why “Does the United States Pay, By Far, The Highest Prices In The World For Prescription Drugs?” Sanders also put out a fundraising email just before the letter was announced, with the subject line: “The greed of the pharmaceutical industry is out of control.” It featured an op-ed he wrote for the Guardian Monday.”

In FEHB Open Season and federal retirement news,

  • Fedweek provides Reg Jones’ observations on FEHBP and Medicare Parts A and B. The Federal Times offers articles titled “A Procrastinator’s Checklist for Choosing Open Season Benefits” and “What’s driving rate hikes for federal employee health premiums?”
  • The second Federal Times article is a topic that the FEHBlog follows throughout the year. In that regard, Mercer Consulting released the following survey findings last week:
    • “Mercer, a business of Marsh McLennan (NYSE: MMC), released the findings of its 2023 National Survey of Employer-Sponsored Health Plans, which found the average per-employee cost of employer-sponsored health insurance rose by 5.2% in 2023 to reach $15,797. * * *
    • “In 2022, cost rose by 3.2%, well below general inflation, which averaged 8% that year. Because healthcare providers typically have multi-year contracts with health plans, employers did not feel the full brunt of inflation last year. “Rather, inflation-driven cost increases are phasing in as contracts are renewed,” says Sunit Patel, Chief Health Actuary, Mercer. The survey shows employers project another sharp increase of 5.2% for 2024.
    • “It may take another couple of years for price increases stemming from higher healthcare sector wages and medical supply costs to be felt across all health plans,” Mr. Patel says.
    • “At the same time, inflation is only one factor behind this year’s higher cost increases. In 2023, spending on prescription drugs rose sharply. “While the effects of inflation may be relatively short-lived, new and ongoing developments in the pharmaceutical market seem likely to have a longer-term impact on health benefit cost.”
  • The Federal Times adds,
    • “Federal employees’ retirement applications take almost twice as long to process when they contain errors, leading to further delays in processing and dispensing annuities, according to a watchdog report published Monday.
    • “The Office of Personnel Management’s inspector general found that “healthy” application packages took on average 53 days to process, and “unhealthy” ones containing errors took more than 108 days, according to a random sample of applications the inspector general studied.
    • “That discrepancy needs be reflected in the data OPM reports monthly to accurately monitor whether retirement processing is improving, the IG report said.
    • “The lack of transparency for healthy versus unhealthy ‘incomplete’ application packages limits the quality of information being provided to external parties as the main cause for why Retirement Services has not met its goal for processing retirement application packages within 60 days,” according to the report.”

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “Hospital and public health officials are urging people to take precautions and be mindful of where they seek care to limit capacity strain on emergency departments as respiratory virus activity heats up heading into the holiday season. 
    • “Since early September, COVID-19 metrics had mostly been trending downward or remained flat. Now they are on the rise again, though they remain far below levels seen in previous surges. There were 16,239 new admissions for the week ending Nov. 11, up 8.6% from the previous week. 
    • “Meanwhile, most of the country is seeing an uptick of flu and respiratory syncytial virus cases. Hospitalizations associated with the two infections are also ticking up, particularly among children and older adults. 
    • “The more concerning thing is the severity of some of the illness,” Hany Atallah, MD, chief medical officer Jackson Memorial Hospital in Miami, told ABC affiliate WPLG. “And we are also seeing some patients come in with more than one viral infection, so they may have RSV and flu, for example. We’re constantly trying to follow the science and encourage people to get vaccines.” 
  • The Wall Street Journal points out,
    • “Ozempic, Wegovy and their counterparts have exploded in popularity over the past year, earning billions for the drugs’ makers, transforming the American approach to weight-loss, and sparking widespread cultural discussion in a country that is already obsessed with weight. 
    • “That conversation lands on Thanksgiving tables this week, where some people say the drugs have boosted their confidence around food, and others say they are worried about facing questions about what they’re eating, what they’re not eating, and changes in their appearance.
    • “It’s a hot topic, and people have a lot of judgments,” says Dr. Gauri Khurana, a psychiatrist in private practice in New York City and a clinical instructor at Yale University who has prescribed the medications and helped patients manage them. * * *
    • “Doctors advise people to listen to their bodies—not their family members—when it comes to serving sizes. A balanced plate that gives priority to protein and high-fiber foods over carbohydrates and fatty foods, which tend to sit in the stomach and exacerbate the medication’s effects of delayed gastric emptying, can help patients avoid filling up too quickly or feeling nauseous.”
  • The New York Times reports,
    • “Just in time for the holiday season, the Biden administration is offering Americans a fresh round of free at-home coronavirus tests through the Postal Service.
    • “The administration revived the dormant program in September, announcing then that households could order four free tests through a federal website, covidtests.gov.
    • “Beginning Monday, households may order an additional four tests. Households that have not placed an order since the program resumed can submit two orders, for eight tests in total.”
  • The University of Minnesota informs us,
    • “A new survey of 158 hospital executives, conducted by the Sepsis Alliance, found that 90% see antimicrobial resistance (AMR) as a threat, and 88% think the problem is getting worse. The survey, conducted by Sage Growth Partners on behalf of the Sepsis Alliance, also dug into executives’ views on other related AMR issues. An 11-page report on the findings was published on the Sepsis Alliance websiteon November 17.
    • “Another top concern is the public’s lack of knowledge about AMR, with 59% of executives saying that public education of clinicians as well as patients is the largest barrier to antibiotic stewardship. Respondents recommend public service announcements covering the need for early treatment, the importance of completing treatment, and storing the drugs properly.”

From the U.S. healthcare business front,

  • Healthcare Dive asks “Where are all the nurses? Hospitals, advocates disagree on crisis; Hospitals and nursing unions disagree about what’s driving sluggish application rates for open registered nurse positions — a lack of qualified candidates or a lack of interest.”
  • BioPharma Dive notes,
    • “Roche’s Genentech unit is partnering with computing giant Nvidia in a multiyear deal that highlights the pharmaceutical industry’s growing hopes of using artificial intelligence to speed up the process of designing and developing new drugs. 
    • “By collaborating with Nvidia, Genentech expects to “significantly enhance” its existing AI research and potentially improve on the chip designer’s own software, such as its “BioNemo” platform for drug discovery. 
    • “Our teams will be continuously exchanging expertise on the advancement of science and the state-of-the-art methods emerging in accelerated computing, AI and simulation across this entire drug discovery process,” said Kimberly Powell, vice president of healthcare at Nvidia, in a briefing with reporters.” 

Monday Roundup

David Ermer–CDC, COVID-19, COVID-19 vaccine, Generative AI, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC (note the FEHBlog is back in Texas after a productive week in DC)

  • The Society for Human Resource Management tells us,
    • “The National Labor Relations Board (NLRB) announced it will extend the effective date of its joint employer rule to Feb. 26, 2024, to facilitate resolution of legal challenges to the rule.
    • “The NLRB released the final rule on Oct. 26 with an implementation date of Dec. 26. The rule was published in the Federal Register on Oct. 27.
    • “U.S. Sen. Bill Cassidy, R-La., sent a letter informing the NLRB that it was out of compliance with the Congressional Review Act’s 60-day threshold rule, which mandates that the implementation of all major federal rules must be delayed 60 days from when they are received by Congress.
  • The Internal Revenue Service posted for public comment a draft version of the 2024 Employers’ Tax Guide to Fringe Benefits.

From the public health and medical research front,

  • The Associate Press reports,
    • “The U.S. flu season is underway, with at least seven states reporting high levels of illnesses and cases rising in other parts of the country, health officials say.
    • “The Centers for Disease Control and Prevention posted new flu data on Friday, showing very high activity last week in Louisiana, and high activity in Alabama, Florida, Georgia, Mississippi, New Mexico and South Carolina. It was also high in the District of Columbia and Puerto Rico, the U.S. territory where health officials declared an influenza epidemic earlier this month. * * *
    • “Traditionally, the winter flu season ramps up in December or January. But it took off in October last year, and is making a November entrance this year.”
  • STAT News offers its observations on this development.
    • “The early signals from influenza suggest the virus is settling back into the seasonal pattern it followed — to the degree the always mercurial bug follows any pattern — before the pandemic, said Alicia Budd, team lead for domestic flu surveillance at the Centers for Disease Control and Prevention. “All I can say is at this point we are at a pretty typical point in flu activity,” she told STAT.
    • “Overall, the signs to date appear to portend a winter more like what we knew before the arrival of Covid, said Megan Culler Freeman, an assistant professor of pediatrics specializing in infectious diseases at the University of Pittsburgh.
    • “Last year as early as August, children’s hospitals across the country were full to the gills … because there were so many children with respiratory distress,” Freeman said. “And I would say that this season is starting to feel a lot more normal. Only now, as we’re getting into November — even towards mid- to late- November — we’re starting to see more of our winter volume starting to begin. * * *
    • “The scientific consensus is still out about whether Covid will be a seasonal virus, transmitting primarily during cold-and-flu season. Many experts think it is heading that way, but hasn’t yet settled into that pattern.”
  • The American Medical Association explains what doctors wish their patients knew about diabetes 2. Check it out.
  • KFF informs us,
    • “Research suggests that the Novavax [Covid] vaccine is about as safe and effective as the mRNA shots. Its main disadvantage is arriving late to the scene. Vaccine uptake has plummeted since the first shots became widely available in 2021. Nearly 70% of people got the primary vaccines, compared with fewer than 20% opting for the mRNA covid boosters released last year. Numbers have dwindled further: As of Oct. 17, only 5% of people in the United States had gotten the latest covid vaccines, according to the Department of Health and Human Services.
    • “Daniel Park, an epidemiologist at George Washington University, said low rates might improve if people who felt lousy after their last mRNA shots gave Novavax a try. It protects against severe illness, but researchers struggle to specify just how effective this and other vaccines are, at this point, because studies have gotten tricky to conduct: New coronavirus variants continuously emerge, and people have fluctuating levels of immunity from previous vaccines and infections.
    • “Still, a recent study in Italy suggests that Novavax is comparable to mRNA vaccines. It remained more than 50% effective at preventing symptomatic covid four months after vaccination. Some data suggests that mixing and matching different types of vaccines confers stronger protection — although other studies have found no benefit. 
    • “Given all this, Park held out for the Novavax vaccine on account of its potentially milder side effects. “Between a demanding full-time job and two young kids at home, I wanted to stay operational,” he said. His arm was sore, but he didn’t have the 24-hour malaise accompanying his last mRNA shot.”

From the U.S. healthcare business front,

  • MedCity News notes,
    • “Eli Lilly’s cardiometabolic drug portfolio is expanding with newly approved therapies. To meet demand for those therapies and additional products to come, the company is building a new $2.5 billion manufacturing site in Germany.
    • “Construction on the new plant is on track to begin next year. Lilly expects the site will start operations in 2027, becoming its sixth manufacturing site in Europe. The company said it has invested more than $11 billion in its global manufacturing capabilities in the past three years to support the production of medicines across its portfolio.
    • “Some of Lilly’s capital investments have been closer to the Indianapolis-based drugmaker’s home. Last year, the company committed more than $2 billion to two new facilities in Lebanon, Indiana for the manufacturing of existing products and future ones, the company said in its annual report. Lilly also invested more than $1 billion in a new facility in Concord, North Carolina, for the manufacturing of injectable products and devices. Earlier this year, Lilly pledged to spend an additional $450 million to expand capacity at a site in Research Triangle Park that also makes injectable products, including new blockbuster medicine Mounjaro.”
  • Healthcare Dive points out,
    • “AstraZeneca’s new health-tech business, Evinova, launched Monday, with several big-name partnerships already in place and a goal to “better meet the needs of healthcare professionals, regulators and patients.”
    • “Evinova’s main focus will be helping to optimize their clinical trials for biotechnology companies, pharmaceutical firms and CROs, or contract research organizations, in an effort to reduce the time and costs associated with developing new medicines.
    • “Two CROs, Parexel and Fortrea, have agreed to offer Evinova’s digital health solutions to their customers. Evinova is also collaborating with Accenture and Amazon Web Services to “accelerate industry adoption and sustain and expand the global reach of its digital products.”
  • Per Fierce Healthcare,
    • “The financial outlook for major health plans is stable in the face of notable potential headwinds heading into the end of the year, according to a new report from Moody’s Investors Service.
    • “The Moody’s analysis said earnings in the third quarter were on par with reports from the second quarter and that the industry’s stability is in line with expectations. However, the researchers said they were expecting payers to face different challenges as 2023 got underway.
    • “A notable trend that emerged in the second quarter was increased utilization in Medicare Advantage (MA), which peaked in the second quarter thanks to a boost in outpatient care. While the trend did stabilize in the third quarter, “it did not get better,” the Moody’s analysts wrote.
    • “Centene was the lone exception, and it reported a lower medical loss ratio for MA in the third quarter of 2023 compared to the prior-year quarter, according to the report.”
  • and
    • “As the industry continues to debate the promise and risks of artificial intelligence in healthcare, patients are bullish on the potential for generative AI to improve access and even lower healthcare costs.
    • “More than half (53%) of U.S. consumers believe generative AI could improve access issues and shorten wait times for medical care, according to a survey by Deloitte’s Center for Health Solutions. A little less than half of consumers (46%) say it has the potential to make healthcare more affordable.”

Friday Factoids

David Ermer–CDC, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, OPM, SDOH, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • President Biden on Friday named W. Kimryn Rathmell to be the next director of the National Cancer Institute, where the prominent researcher will help oversee several White House-backed initiatives intended to reduce cancer deaths and accelerate clinical breakthroughs.
    • Rathmell, an expert in kidney cancer, is the chair of medicine at Vanderbilt University Medical Center in Nashville. The Stanford University-trained physician and scientist has been a member of the National Cancer Institute’s board of scientific advisers since 2018, providing guidance to the institute’s leaders on its scientific research and operations. Rathmell’s new role as head of the cancer institute, which the White House said would begin in December, does not require Senate confirmation.
  • Federal News Network tells us,
    • “The Office of Personnel Management faces a tight deadline to set up a new health insurance marketplace for Postal Service employees and retirees to enroll in new plans, starting next year.
    • “Now OPM is addressing watchdog concerns about whether the IT infrastructure supporting this new USPS marketplace is following federal cybersecurity requirements.
    • “OPM’s Office of Inspector General, in a flash audit released Friday, raised concerns about the cybersecurity steps OPM took before launching the IT systems that will run the Postal Service Health Benefits (PSHB) Program.”
  • Govexec tells us,
    • The Office of Personnel Management this week proposed new regulations delegating its authority to waive the caps on recruitment and relocation incentive payments to federal employees and job candidates to the agencies themselves, a move the federal government’s HR agency says will ease administrative burdens and accelerate the hiring process. * * *
    • “Under the new process, each agency would be required to designate an official who would be tasked with reviewing and adjudicating waiver requests. Additionally, the new regulations would eliminate the minimum service period required to receive an incentive payment. Currently set at six months, OPM argued that removal of the minimum time period would allow short-term, yet still difficult to fill positions such as paid internships to become eligible for recruitment and relocation incentives.
    • “Retention incentive payments would not change under the regulatory proposal, as OPM reported that such changes would require the passage of legislation by Congress.”
  • The Government Accountability Office issued a report on the composition of the federal workforce.
    • “The federal government aims to hire and promote a workforce that reflects the diversity of the U.S. population.
    • “We looked at a decade of federal employment trends. For example, from 2011-2021 there were minor changes in the representation of historically disadvantaged racial groups—like Black or African American and Asians—in the federal workforce. But several of these groups made gains in senior executive service positions.
    • “The percentage of Hispanic federal workers also increased. But in FY 2021, Hispanic individuals made up 10% of the federal workforce, even though they represented 18% of the civilian labor force.”
  • Reuters reports,
    • “The U.S. Centers for Disease Control and Prevention said on Thursday it has expedited the release of more than 77,000 additional doses of Sanofi (SASY.PA) and AstraZeneca’s (AZN.L) respiratory syncytial virus (RSV) drug Beyfortus.
    • “The additional doses, which the CDC said will be distributed immediately to physicians and hospitals, will help improve the availability of the drug at a time when a surge in cases of the disease is outpacing supply.
    • “Beyfortus was approved earlier this year to prevent the disease in infants and toddlers.
    • “CDC said the agency, along with the U.S. Food and Drug Administration, will continue to be in close contact with the manufacturers to ensure availability of additional doses through the end of this year and early 2024 to meet the demand.”

In FEHB News, Federal News Network offers a lengthy and informative exchange with Kevin Moss from Consumer Checkbook.

From the public health and medical research front,

  • STAT News points out,
    • “Flu activity in many parts of the United States is starting to rise more rapidly, signaling that flu season is on the horizon, the Centers for Disease Control and Prevention reported Friday.
    • “With Americans set to travel for Thanksgiving gatherings next week, people who’ve been waiting to get a flu shot should think about acting now, Alicia Budd, the CDC’s team lead for domestic flu surveillance, told STAT.
    • “Really what we’re seeing is a more sharp increase in activity, week over week, and we know from experience when that happens often times we are entering into that period of even more increased activity,” Budd said. “It’s a great time for people to get vaccinated, if they’ve been holding off.”
  • ABC News states,
    • An estimated 36 million adults in the United States have received the updated COVID-19 vaccine as of Monday according to new data from the federal government.  Additionally, about 3.5 million children have also gotten the updated shot, according to the survey, which is a sample size of the U.S. population, from the Centers for Disease Control and Prevention. This is roughly equal to the number of Americans who had received the bivalent booster — which was targeted against different COVID variants — by this time last year.
  • The Wall Street Journal reports,
    • “The Food and Drug Administration said it is screening cinnamon shipments from several countries as part of its investigation of illnesses potentially linked to pouches of cinnamon-flavored applesauce.
    • “The federal agency said this week it believes the cinnamon used in these products could be the source of lead contamination. There have been 34 reports of lead-related illnesses potentially tied to the recalled products. 
    • “The FDA, which has been investigating the lead illnesses since October, said they are potentially linked to contaminated children’s fruit puree and applesauce pouches. WanaBana,  Weis Markets and Schnucks brands have recalled cinnamon-flavored fruit puree and applesauce pouches.”
  • CNN reports,
    • “The rate of premature birth in the United States remains high, especially in the southern region of the country, according to the infant and maternal health nonprofit March of Dimes.
    • “The group’s annual “report card” on US maternal and infant health, released Thursday, says that the nation’s preterm birth rate – the rate of babies born before 37 weeks gestation – was 10.4% in 2022, down only 1% from 2021’s rate, which was the highest in more than a decade.
    • “We went from 10.5% to 10.4%. It’s flat,” said Dr. Elizabeth Cherot, president and chief executive officer of March of Dimes. “A slight change is just not big enough in that direction.”
  • Per NBC News,
    • The rate of child and teen cancer deaths in the U.S. fell 24% from 2001 to 2021, according to a CDC report released Thursday. The report looked at death rates, for Black, Hispanic and non-Hispanic whit youths up to 19 years old. These groups comprised 92% of all youth cancer deaths in 2021, the report noted.
  • Per STAT News, while Wegovy and Zepbound ride high, interest in weight loss drugs that preserve muscle is surging.
    • [B]iotech startups are hoping to use those [earlier Johns Hopkins] findings to create what they believe will be better weight loss medications. In the last several months, multiple companies have disclosed they are testing drugs that preserve or grow muscle while reducing fat, as shown in the updated STAT Obesity Drug Tracker. They hope that their drugs, possibly when used in conjunction with existing obesity treatments, will result in healthier weight loss.

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • Rochester, Minnesota-based Mayo Clinic reported increased year-over-year operating revenue and income in its third-quarter earnings, on higher outpatient visits and surgical cases.
    • The nonprofit posted $4.5 billion in operating revenue, up 8.2% year over year, and $302 million in operating income. Operating expenses rose 4.8% year over year, totaling nearly $4.2 billion.
    • The earnings mark the third quarter Mayo has posted net income after the operator struggled last year. The health system reported profits last year that were half its 2021 returns, after contract labor expenses increased 37% year over year. 
  • and
    • For-profit operator Tenet Healthcare has agreed to sell three of its hospitals in South Carolina for about $2.4 billion in cash to Winston-Salem, North Carolina-based Novant Health. 
    • Proceeds from the deal, which is expected to close in the first quarter in 2024, will primarily go toward paying debt, Tenet said in a news release. 
    • Under the agreement, Dallas-based Tenet’s financial services subsidiary Conifer Health Solutions will also provide revenue cycle management for the hospitals and their related operations under an expanded 15-year contract. 
  • and
    • CommonSpirit Health reported a $441 million operating loss in the first quarter of the 2024 fiscal year on increased expenses.
    • The system expects a California assistance fund — due to be approved later this fall — to offset its operational losses slightly. However, CommonSpirit’s net loss ballooned to $738 million in the quarter as investments faltered, compared to a $413 million loss same time last year, according to its earnings report filed Wednesday
    • In the report, CommonSpirit also outlined plans to expand its ambulatory care footprint next year after a string of recent outpatient acquisitions in multiple states, despite liquidity concerns.

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.”

Tuesday Tidbits

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

From Washington, DC,

  • The New York Times reports,
    • “The House passed legislation on Tuesday to keep federal funding flowing into early 2024, after Democrats stepped in to rescue a plan opposed by many Republicans to avert a government shutdown at the end of the week.
    • “A coalition of Democrats and mainstream Republicans overcame the opposition of G.O.P. conservatives to approve the bill under special expedited procedures that required a supermajority. That approach, hatched by Speaker Mike Johnson, amounted to a gamble that a substantial number of Democrats would rally to help pass a package that Mr. Johnson’s own party was unwilling to back.
    • “The vote was 336 to 95, clearing the two-thirds threshold required for passage. In the end, 209 Democrats and 127 Republicans joined to pass the bill. Ninety-three Republicans opposed it, as did two Democrats.
    • “Senator Chuck Schumer of New York, the majority leader, told reporters that he wanted the Senate to vote on the bill “as soon as possible.”
  • The American Academy of Pediatrics News announced,
    • “The advisory was issued after the Food and Drug Administration (FDA) received 22 reports of high blood lead levels (BLLs) in children who consumed recalled fruit pouches that contain high levels of lead. The recall includes WanaBana brand apple cinnamon fruit puree pouches, Schnucks brand cinnamon applesauce pouches and Weis brand cinnamon applesauce pouches.”
  • ICD Monitor points out that “the new Healthcare Common Procedural Coding System (HCPCS) codes were released on Nov. 6. These codes include supplies, medications, implants, surgeries, etc. The latest release contained 553 changes and updates to the coding system . . . .
  • The Acting NIH Director Lawrence Tabak released his farewell issue of the NIH Directors blog.
    • “I congratulate Dr. Monica Bertagnolli as she takes the helm as the next permanent NIH director. Dr. Bertagnolli—an outstanding physician scientist—is a strong leader who will bring fresh, bold new ideas to NIH and the biomedical research enterprise. I know she’ll be in good hands thanks to the outstanding staff across NIH and the leadership in the Department of Health and Human Services. I look forward to supporting her efforts and continuing to ensure that NIH research optimizes health for all people.”

From the public health and medical research front,

  • MedPage Today informs us that early detection is the key to longer survival rates for people afflicted with pancreatic cancer.
  • NPR tells us,
    • “If your hearing begins to decline, your risk of falling may rise.
    • “Research shows older adults with mild hearing loss are at a greater risk — more than double — of falling. Though it’s not exactly clear how hearing loss increases the risk, it’s known that falls are the top cause of death from injury among people 65 and older.
    • “Now, new evidence shows that restoring hearing through the use of hearing aids may be protective, especially when people wear them consistently. That’s according to a study published this summer in the Journal of the American Geriatrics Society.”
  • The Wall Street Journal reports,
    • “Millions of adults struggle for years with chronic low-back pain—a disabling ailment that has no easy fix.
    • “Common causes include injury, arthritis and degenerative changes in the spine. It tends to start at midlife with the natural wear and tear of aging. But often there is no clearly identifiable physical cause, leaving patients to veer from one ineffective treatment to another—including highly addictive prescription opioids.
    • “Now, researchers are working on personalized treatment plans that can address physical, emotional and psychological traits in individual patients that influence the pain they are experiencing. Physical therapy, exercise, diet and lifestyle choices often play a role. Some research is also looking at ways to retrain the brain to think differently about pain.
    • “To be sure, low-back pain can be a sign of something life-threatening, such as cancer, or a severe spine condition that requires surgery. As a result, chronic low-back pain needs to be fully evaluated. But once “red flags” are eliminated, doctors need a more precise way to determine what will work for individual patients, says Dr. Matt Mauck, a researcher and pain-medicine physician at the University of North Carolina Chapel Hill’s UNC Pain Management Center.”
  • The Institute for Clinical and Economic Review “posted its revised Evidence Report assessing the comparative clinical effectiveness and value of sotatercept (Merck & Co) for pulmonary arterial hypertension (PAH).”
    • “This Evidence Report will be reviewed at a virtual public meeting of the Midwest CEPAC (Midwest CEPAC) on December 1, 2023. The Midwest CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

From the U.S. healthcare business front,

  • The International Foundation of Employee Benefit Plans announced,
    • “A new survey report from the International Foundation of Employee Benefit Plans reveals U.S. employer coverage and considerations surrounding glucagon-like peptide-1 (GLP-1) drugs, which have historically been used to treat diabetes. These drugs were also found to cause weight loss and have been subsequently used to treat obesity.
    • “Among survey respondents, 76% provide GLP-1 drug coverage for diabetes, 27% provide coverage for weight loss, and 13% are considering covering for weight loss.
    • “In 2023, the average representation of GLP-1 drugs used for weight loss in employers’ total annual claims was 6.9%, according to survey respondents. Those who are covering GLP-1 drugs are relying heavily on utilization management (79%) to control costs. A less common approach (32%) is step therapy. Fourteen percent of employers have no cost control mechanism in place.
    • “Though GLP-1 drugs have a high price tag, they currently represent only 6.9% of annual claims, according to survey respondents,” said Julie Stich, CEBS, Vice President of Content at the International Foundation. “Employers can take this information into account when designing long-and short-term benefit strategies.”
  • Bloomberg reports,
    • “Cigna Group is taking a page from billionaire Mark Cuban’s playbook to sell medicines for a set markup, the latest sign that companies that manage drug benefits are responding to pressure from upstart competitors.
    • “Next year Cigna’s Express Scripts subsidiary will offer employers and health plans the option to pay pharmacies up to 15% above their wholesale costs, plus an extra fee for dispensing the medicines. Employers now typically pay pharmacies based on an average discount, which can result in them paying more for drugs than a pharmacy charges.”
  • Reuters notes,
    • “Elevance Health (ELV.N) and Cigna Group’s (CI.N) Express Scripts unit on Monday settled the last pending claim in a long-running contract dispute, clearing the way for Elevance to appeal the dismissal of its $14.8 billion lawsuit accusing Express Scripts of overcharging it for prescription drugs.”
  • The Albany Times-Union reports that Empire Blue Cross is changing its name to Anthem Blue Cross.
    • “The company retains the Blue Cross Blue Shield name and remains part of the Blue Cross Blue Shield Association, which serves one in three insured Americans. * * *
    • “Empire joined Anthem in 2006, and the new name represents the next stage in the company’s journey to merge with the national brand, benefiting from combined resources and capabilities of its parent company and affiliates, company executives said.”
  • Per Fierce Healthcare,
    • “BeMe, a digital behavioral health app aimed at teenagers, has inked several partnerships with major payers, including $1.5 million in investment from Blue Cross and Blue Shield of Kansas (BCBSKS).
    • “Through the investment, BeMe’s platform will be made available to 20,000 teenagers across the Sunflower State. Executives said in an announcement that tools like BeMe will become increasingly critical as youth mental health issues continue to worsen.”