FEHBlog

Tuesday Tidbits

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

October 10 is World Mental Health Day. The International Foundation of Employee Benefit Plans offers six steps toward addressing mental health in the workplace.

From Washington, DC,

  • The Foundation provides some basics on the final rule on imposing civil monetary penalties for violations of Medicare reporting requirements imposed on group health plans, including FEHB plans, and others. The new rule, which was released today, takes effect one year from its publication in the Federal Register.
  • Govexec tells us,
    • “The Biden administration on Monday has begun the queue of new regions to add to the federal government’s map where federal workers are entitled to higher pay for 2025, approving a recommendation to add Clallam and Jefferson counties in Washington state to the existing Seattle-Tacoma, Washington, locality pay area.
    • “The Office of Personnel Management on Monday published the President’s Pay Agent’s annual report on locality pay, the practice by which the federal government supplements its compensation to employees under the General Schedule to address pay disparities between federal workers and their private sector counterparts in a given region.
    • “In this year’s report, the pay agent, which is made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and Acting Labor Secretary Julie Su and acts upon the recommendations of a panel of political appointees and labor leaders, approved one change to the map of locality pay regions in the form of adding Clallam and Jefferson counties to the Seattle-Tacoma locality pay area. But federal employees in line for an additional pay raise from the decision will have to wait; OPM first must craft and publish regulations implementing the pay agent’s decision, which won’t be in place until the 2025 pay raise at the earliest.”

From the public health and medical research front,

  • MedPage Today reports,
    • “A multilevel primary care intervention that included automated electronic health record (EHR) reminders and patient outreach/navigation improved timely follow-up of overdue abnormal cancer screening test results, a cluster randomized trial showed.
    • “Among nearly 12,000 patients with an abnormal screening test result for colorectal, cervical, breast, or lung cancer, completion of follow-up testing within 120 days of study enrollment was significantly higher with EHR reminders, patient outreach, and patient navigation (31.4%) and EHR reminders and patient outreach (31.0%) compared with only EHR reminders (22.7%), and usual care (22.9%), reported Steven J. Atlas, MD, MPH, of Massachusetts General Hospital in Boston, and colleagues.”
  • The NIH Director’s Blog discusses “Taking a Deep Dive into the Alzheimer’s Brain in Search of Understanding and New Targets.”
  • The Wall Street Journal informs us,

    • Getting tested for Alzheimer’s disease could one day be as easy as checking your eyesight.

    • RetiSpec has developed an artificial intelligence algorithm that it says can analyze results from an eye scanner and detect signs of Alzheimer’s 20 years before symptoms develop. The tool is part of broader work by startups and researchers to harness AI to unlock the mysteries of a disease that afflicts more than seven million Americans. 

  • Per Medscape,
    • “Damaged mitochondrial DNA (mtDNA) initiates and spreads Parkinson’s disease (PD) pathology, potentially opening new avenues for early diagnosis, disease monitoring, and drug development.
    • “While defects in mitochondrial functions and in mitochondrial DNA have been implicated in PD in the past, the current study demonstrates “for the first time how damaged mitochondrial DNA can underlie the mechanisms of PD initiation and spread in brain,” lead investigator Shohreh Issazadeh-Navikas, PhD, with the University of Copenhagen, Denmark, told Medscape Medical News. 
    • “This has direct implication for clinical diagnosis” ― if damaged mtDNA can be detected in blood, it could serve as an early biomarker for disease, she explained.
    • “The study was published online October 2 in Molecular Psychiatry.”

From the U.S. healthcare business front,

  • Healthcare Dive shares information from the HLTH conference in Las Vegas.
    • “Microsoft announced a slew of new data and artificial intelligence offerings in the healthcare sector on Tuesday, including new generative AI models meant to help ameliorate administrative burden on clinicians.
    • “Microsoft’s cloud division Azure is releasing new capabilities meant to free up information for clinicians. Those include patient timelines, which use generative AI to extract specific elements from unstructured data — like medication information in an electronic health record — and organize them chronologically to give a full view of a patient’s history. Another functionality, called clinical report simplification, uses generative AI to simplify clinical jargon so patients can better understand medical information.
    • “The launches tie in with Microsoft’s ethos of developing high-impact but low-risk use cases for AI in healthcare, said David Rhew, Microsoft’s global chief medical officer and vice president of healthcare, in an interview at the HLTH conference in Las Vegas, where the offerings were announced.”
  • and
    • “Walgreens plans to launch telehealth visits on its website later this month, as the retail pharmacy giant continues its strategic pivot to healthcare services.
    • “Walgreens Virtual Healthcare will offer on-demand virtual consultations with providers for common medical needs and medication prescriptions.
    • “Walgreens is adding direct-to-consumer virtual care because “our goal is to be the most convenient health and wellness destination, whether you’re physically in our stores or virtually in our stores,” said Tracey Brown, Walgreens’ chief customer officer and president of retail, while debuting the new offering at the HLTH conference in Las Vegas on Monday.”
  • and
    • “Cigna’s health services division Evernorth has acquired the technology and clinical capabilities of asynchronous telehealth provider Bright.md for an undisclosed amount, the company announced on Tuesday at the HLTH conference in Las Vegas.
    • “Evernorth’s telehealth business MDLive plans to start offering asynchronous care using the new capabilities within its virtual urgent care platform in 2024, and eventually expand asynchronous care to chronic disease management and wellness visits.
    • “A spokesperson for the company said it was too early to share a specific timeline for the launch in virtual urgent care and the expansion to more clinical areas. Currently, more than 43 million people have access to MDLive virtual urgent care through their health plans and employers, Cigna says.”
  • Healthcare Finance points out,
    • “Aetna is modifying its commercial policy to no longer cover certain telemedicine services starting on Dec. 1, the company said in a statement.
    • “This is for audio-only and asynchronous text-based visits that were expanded under the public health emergency, the CVS subsidiary said. 
    • “The modifications are in line with the industry as a result of the expected PHE ending in May 2023,” Aetna said. “Telemedicine services that remain covered for Aetna Commercial plan sponsors are actually more extensive than what was provided pre-pandemic because of the access and value these services clearly bring to our members and providers.” 
    • “According to Aetna, currently covered telehealth services include routine care, sick visits, urgent care through walk-in clinics, prescription refills and behavioral health services.”
  • Reuters lets us know,
    • “The number of U.S. employers who cover obesity medications, including Wegovy from Novo Nordisk that belongs to a class of GLP-1 drugs, could nearly double next year, according to a survey. The survey of 502 employers by Accolade, a company that provides healthcare programs for employers, and research firm Savanta said 43% of the employers it polled could cover GLP-1 drugs in 2024 compared to 25% that cover them now.”
    • It will be helpful to the FEHB if other employers join the FEHB in covering these drugs.

Monday Roundup

David Ermer–Generative AI, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Happy Columbus Day / Indigenous Peoples’ Day

In anticipation of my residential move to Texas, which occurred in April 2022, the FEHBlog applied to waive into the Texas bar. My application was approved on June 30, 2022. (The FEHBlog remains a member of the DC Bar.)

The FEHBlog then became acquainted with the Texas Bar’s continuing legal education requirement. Last year, I took a 15-hour televised course on eldercare. This year, I am attending the Texas Health Law Conference in downtown Austin.

The FEHBlog had lunch today (by happenstance) with a lawyer who told me that he represents a rural hospital near Odessa. The hospital has twelve beds. Beckers Hospital Review points out 2023 Texas hospital closings and bankruptcies.

There was a provider-oriented session on the No Surprises Act. The speakers quipped that the law is no balance billing law with surprises for providers. At least the speakers agree with the FEHBlog that the law is helping patients.

From the public health front,

  • Healthcare Finance tells us that telehealth may be the solution to the chronic illness problem plaguing a large part of our country, as reported by the Washington Post last week.
    • “More patients with chronic disease. Fewer providers to take care of them. An aging population. SDOH barriers. Telemedicine and remote patient monitoring are essential tools to help manage these healthcare hurdles, an expert says.”
  • The Hill adds,
    • “The Biden administration on Friday extended flexibilities regarding controlled substances to be prescribed via telemedicine. 
    • “The Drug Enforcement Administration (DEA) said in a notice it would allow providers to continue using telemedicine to prescribe certain controlled substances through the end of 2024.”  
  • NBC News reports,
    • “The coronavirus isn’t the only pathogen that can cause symptoms that last months, or even years after an initial infection is overcome, a new study published Friday in The Lancet’s eClinicalMedicine suggests. 
    • “In an analysis of data from 10,171 U.K. adults, the researchers found evidence of a “long cold” syndrome that can follow infection with a variety of common respiratory viruses, including common cold viruses and influenza.
    • “While some of the symptoms of long Covid and long colds overlapped, the study noted that people with long Covid were more likely to continue to experience lightheadedness, dizziness and problems with taste and smell; lingering long cold symptoms were more likely to include coughing, stomach pain and diarrhea. 
    • “Experts said the new research could help shine a light on the types of long-lasting symptoms that come after recovery from an illness, including chronic fatigue syndrome.”
  • Fierce Healthcare discusses how payers are tackling the food insecurity issue in our country.
  • Cardiovascular Business lets us know,
    • “The American Heart Association (AHA) has developed a brand new strategy for the prevention and management of cardiovascular disease (CVD). 
    • “This updated approach highlights the close relationship CVD has with three other significant health conditions: kidney disease, type 2 diabetes (T2D) and obesity. Patients with CVD, for example, often face a heightened risk of developing kidney disease, T2D or obesity. The opposite can also be true—patients with any of those three conditions may face a heightened risk of developing CVD. 
    • “With these close connections in mind, the AHA has defined a new health condition: cardiovascular-kidney-metabolic (CKM) syndrome. CKM syndrome involves nearly every major organ in the body, the group said in a new statement, though its biggest impact is on a patient’s cardiovascular system. 
    • “Anyone who has CVD, or even faces a risk of developing CVD in the future, may have CKM syndrome. By educating physicians and patients alike on the way these different conditions interact with one another and implementing a screening strategy for CKM syndrome, the AHA believes it can help patients get the care they need to live longer, healthier lives.”  

From the U.S. healthcare business front,

  • The Wall Street Journal informs us,
    • “The biopharmaceutical company on Sunday said that it had entered into a definitive merger agreement with Mirati under which it would pay $58.00 per share in cash. Mirati stockholders will also receive one non-tradeable contingent value right per share, potentially worth $12.00 per share in cash.
    • “Mirati’s board unanimously approved the transaction. * * *
    • “The acquisition of Mirati will add the Krazati lung cancer medicine to Bristol Myers Squibb’s commercial portfolio. It also includes access to clinical assets that Bristol Myers Squibb said would complement its oncology pipeline.”

The other business news comes from the HLTH conference ongoing in Las Vegas, NV.

  • Per Healthcare Dive,
    • “Venture capital firm General Catalyst plans to buy an unnamed health system to act as a proving ground for new technology to improve hospital operations and patient care. 
    • “The impending purchase is part of a new health business being spun out by General Catalyst, called the Health Assurance Transformation Corporation, or HATCo, General Catalyst managing director Hemant Taneja and former Intermountain CEO (and new HATCo CEO) Marc Harrison said Sunday at the HLTH conference in Las Vegas.
    • “Harrison and Taneja did not share details on what health system General Catalyst would be looking to acquire, when an acquisition could happen or how much the VC firm plans to spend.”
  • Per Fierce Healthcare,
    • Here’s an overview of the second day of the conference and moreover
    • “Headway, a startup that connects patients with mental health providers covered by insurance, picked up $125 million in fresh funding to build out its provider network to all 50 states. * * *
    • “This latest round of capital will go toward investing in technology and tools to help mental health providers grow their practice, Andrew Adams, co-founder and CEO, wrote in a blog post.
    • “We have plans to make Headway available to individuals seeking care in all 50 states and the District of Columbia very soon and will be building products to help providers deliver care across state lines in 2024. We’re also further investing in ensuring patients have a simplified experience understanding their insurance benefits and changes, with excellent visibility, support, and accuracy,” Adams wrote.”
  • and
    • “Main Street Health focuses exclusively in rural communities and partners with primary care clinics in these regions by placing a health navigator in each facility. The navigator then assists with care coordination, including reaching out to patients about preventive screenings, contacting them with medication reminders, scheduling primary care visits following a hospital discharge and providing support for social needs.
    • “The company currently operates in 18 states by partnering with more than 900 clinics. The expansion brings its total footprint to 26 states. The average clinic working with Main Street Health is based in a town with between 3,000 and 5,000 people and includes 2.5 providers, according to an announcement.
    • “Value-based care company Main Street Health is charting an expansion into eight additional states as it banks more than $315 million in new capital.”

Weekend update

David Ermer–Congress, COVID-19, COVID-19 vaccine, Generative AI, HSA, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Senate is on State work break this week, while the House of Representatives is focusing on electing a new Speaker on Wednesday October 11.
  • The Motley Fool tells us,
    • “The most important day of the year for the more than 66 million people who receive a Social Security benefit each month is nearly here. This coming Thursday, Oct. 12, 2023, at 08:30, a.m., ET, the Social Security Administration (SSA) will announce the 2024 cost-of-living adjustment (COLA). * * *
    • “Suffice it to say, the 2024 Social Security COLA isn’t going to be anywhere close to [2023’s historic] 8.7%. It will, however, be an above-average boost to benefits.
    • “According to the latest estimate from Mary Johnson, senior Social Security policy analyst at The Senior Citizens League (TSCL), a nonpartisan senior advocacy group focused on advancing issues important to seniors, the program’s COLA is expected to hit 3.2% for 2024. Over the past 20 years, Social Security’s COLA has averaged just 2.6%.”  

From the public health front,

  • The Washington Post informs us,
    • “In a sobering analysis, researchers warn that those who’ve had childhood cancer are highly likely to face physical and mental health challenges later in life, with 95 percent developing a “significant health problem” related to their cancer or treatment by age 45.”In a sobering analysis, researchers warn that those who’ve had childhood cancer are highly likely to face physical and mental health challenges later in life, with 95 percent developing a “significant health problem” related to their cancer or treatment by age 45.
    • “The researchers reviewed 73 studies, including 39 cohort studies that followed patients over time. Publishing their findings in JAMA, they said approximately 15,000 children and adolescents through age 19 are diagnosed with cancer every year and that 85 percent of children now live five years or more beyond their diagnosis. That’s compared with just 58 percent in the 1970s, according to the American Cancer Society.
    • “The research documented a variety of concerns for young cancer survivors, ranging from subsequent hormone issues to reproductive health challenges, problems with muscles and bones, cognitive impairment and more.”
  • The New York Times lets us know,
    • “A new study has an encouraging message for Americans who shy away from Covid shots because of worries about side effects: The chills, fatigue, headache and malaise that can follow vaccination may be signs of a vigorous immune response.
    • “People who had those side effects after the second dose of a Covid vaccine had more antibodies against the coronavirus at one month and six months after the shot, compared with those who did not have symptoms, according to the new study. Increases in skin temperature and heart rate also signaled higher antibody levels”
  • MedPage Today explains why utilizing artificial intelligence may reduce maternal and infant mortality.
    • “For example, “One of the biggest threats to maternal and infant health is the unmet needs within the social determinants of health, which often directly influence mothers’ ability to access healthcare services. If a pregnant woman doesn’t have access to reliable transportation to get her to and from the doctor or lives a significant distance from one, AI can measure how that might impact health outcomes for her and her unborn child. Then, it can flag it for her doctor or health plan so they can help solve these issues before they cause larger problems.
    • “The result? Reduced racial disparities for maternal health, fewer preterm births and neonatal intensive care unit (NICU) admissions, and shorter NICU stays.” 
  • Medscape reports,
    • “Once weekly glucagon-like peptide 1 receptor agonist (GLP-1 RA) semaglutide (Ozempic, Novo Nordisk) significantly improved A1clevel and body weight for up to 3 years in a large cohort of adults with type 2 diabetes, show real-world data from Israel.
    • “Treatment with semaglutide was associated with reductions in both A1c (-0.77%; P < .001) and body weight (-4.7 kg; P < .001) at 6 months of treatment. These reductions were maintained for up to 3 years and, in particular, in those patients with higher adherence to the therapy.
    • “Avraham Karasik, MD, from the Institute of Research and Innovation at Maccabi Health Services, Tel Aviv, Israel, led the study and presented the work as a poster at this year’s annual meeting of the European Association for the Study of Diabetes (EASD).”

From the U.S. healthcare business front

  • Forbes reports
    • “Uber Health is partnering with UnitedHealth Group’s Optum health services business to make paying for ancillary benefits like ride share and product delivery easier for seniors via the Uber app.
    • “Health plan benefit cards, including health spending account (HSA) and flexible spending (FSA) cards, can be added as a form of payment within the Uber app,” Optum and Uber said in statement released Sunday during HLTH 2023 in Las Vegas. “This payment option can then be used to cover eligible expenses, including health related rides (like non- emergency doctor visits), over-the-counter items and healthy food.”
  • Per Healthcare Dive,
    • “Rite Aid on Wednesday said it has failed to meet the New York Stock Exchange’s continued listing standards. The retailer is no longer in compliance with NYSE standards on minimum stock price and market capitalization. The NYSE listing standards require a $1.00 average closing share price over a 30 trading-day period. 
    • “As of midday Thursday, Rite Aid’s stock was trading at about 50 cents on the NYSE. Rite Aid now has 10 business days to formally confirm if it will seek to regain compliance and six months to do so. But the company said it, “can provide no assurances that it will be able to regain compliance with the NYSE’s continued listing standards.”
    • “News that Rite Aid faces delisting comes weeks after reports emerged that the company, which has $3.3 billion in debt, may seek to close up to 500 of its 2,200 locations as part of a possible Chapter 11 bankruptcy filing.”

Cybersecurity Saturday

David Ermer–Cybersecurity–

From the cybersecurity policy front,

  • The Federal Employees Health Benefits Program has two sets of regulations — OPM’s rules found at 5 CFR Part 890 and because federal procurement contracts create FEHB plans, the Federal Acquisition Regulation (FAR) at 48 CFR Chap. 1 and OPM’s implementing FEHB Acquisition Regulation (FEHBAR)found at 48 CFR Chap. 16. It’s worth noting that the FAR was first issued forty years ago.
  • The Holland and Knight law firm discusses two proposed FAR cybersecurity rules published on October 3, 2023. The first one (FAR Case No. 2021-17) captioned “Cyber Threat and Incident Reporting and Information Sharing will apply to the FEHB Program as it generally imposes obligations on federal contractors. The other rule (FAR Case No. 2021-19 captioned “Standardizing Cybersecurity Requirements for Unclassified Federal Information Systems” will not apply to the FEHB because carrier systems are not federal information systems. The public comment deadline for the two proposed rules is December 4, 2023.  
  • The National Security Agency announced on October 5, 2023,
    • “The National Security Agency (NSA) and the Cybersecurity and Infrastructure Security Agency (CISA) are releasing a joint Cybersecurity Advisory (CSA) highlighting the top ten most common cybersecurity misconfigurations found in large organizations’ networks. The CSA details tactics, techniques, and procedures (TTPs) that cyber actors could use to compromise these networks, as well as mitigations to defend against this threat. * * *
    • “As indicated in the CSA, these most common misconfigurations illustrate a trend of systemic weaknesses in several large organizations and the importance of software manufacturers embracing secure-by-design principles to reduce the risk of compromise.
    • “Some of the misconfigurations mentioned in the CSA include default configurations of software and applications, weak or misconfigured multifactor authentication (MFA) methods, and unrestricted code execution.
    • “NSA and CISA encourage network defenders and software manufacturers to implement the recommendations found within the Mitigations section of this advisory to reduce the risk of compromise. The agencies also recommend network owners and operators examine their networks for similar misconfigurations even when running other software not specifically mentioned in the advisory.”
  • The Cybersecurity and Infrastructure Security Agency (CISA) announced on October 4, 2023,
    • “CISA and the National Security Agency (NSA) published Identity and Access Management: Developer and Vendor Challenges, authored by the Enduring Security Framework (ESF), a CISA- and NSA-led working panel that includes a public-private cross-sector partnership. ESF aims to address risks that threaten critical infrastructure and national security systems.
    • “This publication, which follows ESF’s Identity and Access Management Recommended Best Practices Guide for Administrators, assesses and addresses challenges developers and technology manufacturers face in identity and access management (IAM). The guidance specifically addresses technology gaps that limit the adoption and secure employment of multifactor authentication (MFA) and single sign-on (SSO) technologies within organizations.
    • “Although the publication primarily addresses challenges facing large organizations, it also provides recommendations applicable to smaller organizations. CISA encourages cybersecurity defenders to review this guidance and to speak to their software vendors about implementing its recommendations.”
  • The Health Sector Cybersecurity Coordination Center (HC3) released on October 4, 2023, a sector alert about securing remote access and management software.
    • “Cybersecurity and law enforcement agencies such as CISA, MS-ISAC, CIS, and the FBI have been reporting on increased misuse of remote access software to target organizations and critical infrastructure sectors.
    • “For implications to the Healthcare and Public Health (HPH) sector, remote access solutions keep healthcare professionals connected while also providing increased flexibility and convenience. But the same solutions used to operate, maintain, and secure healthcare systems and networks can also be turned against their own infrastructure. Mitigating the risk associated with them is not as simple as deploying a patch or reconfiguring an application.”
  • The Health Sector Council released an updated Health Industry Cybersecurity Supply Chain Risk Management Guide – Version 2023 (HIC-SCRiM-v2)
    • The HIC-SCRiM is a toolkit for small to mid-sized healthcare institutions to better ensure the security of the products and services they procure through an enterprise supply chain cybersecurity risk management program.

From the cybersecurity breaches and vulnerabilities front,

  • HC3 announced on October 6, 2023,
    • “Cisco recently released an update that fixes a critical vulnerability in their Emergency Responder communications platform, a system that is utilized in the health sector. The exploitation of this vulnerability allows for a cyberattacker to completely compromise a vulnerable system and then utilize it for further cyberattacks across an enterprise network. HC3 recommends healthcare organizations identify vulnerable systems in their infrastructure and prioritize the implementation of this update.”
  • HC3 posted its report on September vulnerabilities of interest to the health sector on October 5, 2023.
    • In September 2023, vulnerabilities to the health sector have been released that require attention. This includes the monthly Patch Tuesday vulnerabilities released by several vendors on the second Tuesday of each month, along with mitigation steps and patches. Vulnerabilities for September are from Microsoft, Google/Android, Cisco, Apple, Mozilla, SAP, Fortinet, VMWare, Progress Software, and Adobe.
    • A vulnerability is given the classification as a zero-day when it is actively exploited with no fix available or if it is publicly disclosed.
    • HC3 recommends patching all vulnerabilities with special consideration to the risk management posture of the organization.
  • CISA added one known exploited vulnerability to its catalog on October 2, another one on October 3, two more on October 4 (and deleted five catalog entries) and three more on October 5, 2023.

From the cybersecurity defenses front,

  • Cybersecurity Dive discusses what to consider when choosing cybersecurity providers.
  • Dark Reading proposes “five steps [by which] organizations can develop stronger security practices and make the inevitable breaches inconsequential.
  • An ISACA expert explains how to comply with multiple security standards and frameworks.
  • Another ISACA expert discusses common privacy dark patterns and ways to improve digital trust.

Friday Factoids

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 6 reopened the No Surprises Act’s Independent Dispute Resolution [IDR] portal to out-of-network providers and group health plans initiating new single payment disputes under the No Surprises Act’s independent dispute resolution process, including single disputes involving bundled payment arrangements. The agency also released new guidance for processing these disputes.
    • “New and in-progress batched disputes and new air ambulance disputes remain temporarily suspended while the Departments of Health and Human Services, Labor and the Treasury update their guidance and operations to align with recent court orders, including an Aug. 24 ruling that set aside certain regulations implementing the IDR process and an Aug. 3 ruling that vacated nationwide a federal fee increase and batching rule for the process.”
  • In that regard, the federal regulators issued ACA FAQ 62 today, which focuses on No Surprises Act issues.
  • What’s more, a No Surprises Act IDR operations proposed rule is still undergoing review at OMB’s Office of Information and Regulatory Affairs.
  • BioPharma Dive informs us,
    • “The National Institutes of Health on Thursday said it will provide funding for three clinical trials of experimental ALS drugs, part of a broader push by the federal government to support the development of treatments for rare neurodegenerative diseases. * * *
    • “Until recently, the FDA had approved just two main medicines for the disease. Clinical testing had shown the drugs respectively offered modest benefits on function and survival.
    • “But in the last year or so, two more treatment options received nods from the FDA. Amylyx Pharmaceuticals’ Relyvrio is now cleared for the broad ALS population, while Biogen’s Qalsody is specifically for the small portion of patients who have mutations in a gene called SOD1.”
  • Per Pharmaceutical Technology,
    • “The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders. * * *
    • “FDA Center for Drug Evaluation and Research Substance Use and Behavioral Health deputy center director Marta Sokolowska said: “Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps. 
    • “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as the development of evidence-based treatments for stimulant use disorder.”
  • Federal News Network points out,
    • “The Office of Personnel Management’s retirement claims backlog saw some improvement in September. OPM cut its backlog by 2,111 claims, hitting a new six-year low point in its overall inventory. OPM received 6,768 claims in September, and managed to process 8,879, shrinking the backlog to the lowest it has been in six years: 15,852.”
  • The Wall Street Journal reports,
    • “The U.S. Postal Service wants to raise the price of a stamp in what would be the third increase in a year.
    • “The postal service proposed a price of 68 cents, up 3% from the current price of 66 cents. If approved by the Postal Regulatory Commission, the price increase would go into effect on Jan. 21. 
    • “The agency raised stamp prices to 63 cents from 60 cents in January 2023. Six months later, the price of a stamp went up again, by 3 cents.”

From the public health and research front,

  • Medscape notes,
    • “Around 4 million Americans received the updated COVID-19 shots in September, according to the U.S. Department of Health and Human Services (HHS), even as some people have found it difficult to book vaccination appointments or find the vaccines at no cost.”
  • NBC News reports,
    • “People who take popular drugs for weight loss, such as Ozempic or Wegovy, may be at an increased risk of severe stomach problems, research published Thursday in the Journal of the American Medical Association finds.
    • “The brief report is the first study of its kind, the researchers say, to establish a link between the use of such drugs, called GLP-1 agonists, for weight loss and the risk of such gastrointestinal conditions. GLP-1 agonists include semaglutide — the drug found in Ozempic and Wegovy — and liraglutide, the drug used in Saxenda. Both drugs are made by Novo Nordisk. 
    • “Although rare, the incidence of these adverse events can happen. I’ve seen it happen,” said lead author Mohit Sodhi, a medical student at the University of British Columbia Faculty of Medicine in Vancouver. “People should know what they’re getting into.” 
  • Get a load of this good news. Per ALM Benefits Pro,
    • “World Mental Health Day is right around the corner and this year, there’s good news to share. The mental health of U.S. employees is finally on the rise nearly three years after the pandemic. A new study shared by Leapsome, a people enablement platform based in Germany, found that 88% of U.S. employees rate their mental health as being good or very good. 
    • “The massive improvements in mental health took place largely over the past year, with 47% of U.S. workers reporting that their mental health had improved within the last 12 months, according to the study.”
  • STAT News notes,
    • “The grand plan for Moderna’s future in respiratory viruses is to market a single shot that would protect against Covid-19, influenza, and RSV, using the scalability of mRNA to craft a first-of-its-kind product. And the first step — establishing the promise of its combination flu and Covid vaccine — is moving on as planned.
    • “Yesterday Moderna said its combo shot measured up to established flu and Covid vaccines in generating immune responses against each virus. The next step is to take that combination to Phase 3, which could lead to approval by 2025. At the same time, Moderna is awaiting FDA approval for its RSV vaccine and testing a combination that would protect against all three viruses.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Amgen on Friday closed its $27.8 billion acquisition of Horizon Therapeutics, about one month after securing clearance from U.S. antitrust regulators who had challenged the deal.
    • “With the acquisition’s completion, Amgen gains access to 12 drugs that had combined sales of $1.8 billion over the first six months of 2023. The company said it will update its sales guidance for the rest of the year when it reports third-quarter earnings.
    • “The deal is the largest in Amgen’s history, surpassing in dollar terms the 2001 buyout of Immunex. That acquisition gave Amgen Enbrel, a long-lasting blockbuster that, like several of its other major drugs, could lose market exclusivity in the coming years. That looming patent cliff has pushed the company to restock its pipeline via dealmaking.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare’s Surest, which axes deductibles and provides upfront pricing data to members, is the fastest growing product among its commercial plan lineup. And a new analysis offers a look as to why.
    • “The insurance giant released Thursday an Impact Study examining some of the results Surest has seen to date and notes that members enrolled in these plans had 6% fewer emergency department visits and 13% fewer inpatient hospital admissions compared to those who were not enrolled in a Surest plan at the same employer.
    • “In addition, members enrolled in Surest plans had a 20% increase in visits to a physician and a 9% jump in preventive physical exams compared to those in other commercial plans.”
  • and
    • “Cigna’s Evernorth is launching a new, value-based care management program for its behavioral health network.
    • “The company said in an announcement that this marks a key step in collaboration with providers as the industry pushes for standardized benchmarks in behavioral health. About 44,000 providers will participate in the program at launch, according to Evernorth.
    • “Ultimately, if payers and providers align on how to measure success in treatment, it will drive better care, lower costs, and lead to improvements in collaboration. It should also ease administrative burdens for providers, according to the announcement, as at present they use a wide array of measures across multiple payers.”

Thursday Miscellany

David Ermer–ACA, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • STAT News reports
    • The shortage of cancer drugs is not going away, but it may be easing slightly, a new national survey suggests. Based on questions posed to 29 of its 33 member hospitals, the National Comprehensive Cancer Network said Thursday that 86% of those cancer centers are experiencing a shortage of at least one type of generic chemotherapy drug, down from 90% in May.
  • and adds
    • One of the top health care committees in the Senate is assembling ideas for bipartisan legislation to address drug shortages, three Senate aides and three lobbyists told STAT.
    • The talks, led by Senate Finance Chair Ron Wyden (D-Ore.) and ranking member Mike Crapo (R-Idaho) are in the early days, but they could move the debate over drug shortage reforms into a new phase. The committee has jurisdiction over Medicare and Medicaid payment policies for hospitals. Other committees that have tried tackling the issue have jurisdiction mostly over the Food and Drug Administration.
  • Two law firms dive into regulatory issues that have puzzled the FEHBlog recently:
  • Miller and Chevalier makes the following observation about the recent federal court decision vacating an HHS rule permitting health plans to use manufacturer copay assistance accumulators. These accumulators prevent the manufacturer coupons from being counted toward out-of-pocket maximums.
    • “Following this ruling, it is unclear what rules will govern the use of co-pay accumulator programs. The prior agency rule, under which plans and issuers were allowed to exclude manufacturer co-pay assistance payments from deductible and out-of-pocket maximum calculations only if a generic drug was available and only to the extent permitted by state law, may be reinstated, but it suffers from the same issues that led the court to vacate the 2020 rule. The government may move for reconsideration of the court’s ruling or for a stay of the ruling, pending an appeal, and an appeal is expected. Further guidance from HHS and CMS is likely forthcoming in the interim. It should be noted that state laws prohibiting co-pay accumulator programs could be susceptible to ERISA pre-emption challenges, and the related guidance may spawn collateral litigation.” 
  • Proskauer explains how the ACA regulators used FAQ 61 to “press play” on the Transparency in Coverage Rule’s Prescription Drug Machine-Readable File Requirement.
    • “Prescription drug machine-readable file: Having concluded that the prescription drug machine-readable file requirement is sufficiently different from the separate CAA prescription drug reporting obligation, the Departments rescinded their prior delayed enforcement policy. The Departments state they intend to release future technical guidance with an implementation timeline that “sufficiently accounts” for prior reliance by plan sponsors on the deferred enforcement policy, suggesting that plan sponsors may have some lead time to gather the necessary information to post the file.
    • “In-network rate machine-readable file: Going forward, the Departments state they intend to exercise enforcement discretion on a case-by-case basis with respect to the requirement that in-network rates be expressed as dollar amounts for items and services covered by arrangements that make it difficult to express the cost as a dollar amount prior to receipt of the item or service.  Because the Departments do not mention future guidance or an implementation guideline, it appears that the revocation of this enforcement safe harbor is immediate.”
  • The Congressional Budget Office issued a call for new research in the area of obesity. In this regard, the Wall Street Journal observes
    • “Big food companies and investors are watching as Ozempic and other similar weight-loss drugs flow to millions of people, upending America’s diet industry and raising new questions about how consumers will eat. 
    • “Executives at food manufacturers from  Campbell Soup to Conagra Brands said they are fielding questions from investors about the drugs’ potential impact as internal teams start to assess consumer behavior and brainstorm ways to respond.
    • “The drugs, which suppress patients’ appetites, have exploded in popularity in the U.S., straining manufacturing capacity. 
    • “Morgan Stanley has projected that 24 million people, or nearly 7% of the U.S. population, will be taking such medications in 2035. 
    • “Those people could cut their daily calorie consumption by as much as 30%, according to the firm, which surveyed over 300 patients. For a person on a 2,000-calorie diet, that could mean eliminating a one-ounce bag of salted potato chips, a bottle of soda and more each day.”
  • Govexec points out,
    • “The Office of Personnel Management on Wednesday reminded federal agencies of recent changes to how to monitor and collect data on the usage of workplace flexibilities like telework and remote work, as the Biden administration prepares to increase in-person work across the federal government this fall.”

From the public health and research front,

  • NBC News tells us,
    • “So-called “good” HDL cholesterol may not be as healthy as experts once thought, a new study suggests. 
    • “The new study, published Wednesday in Neurology, found that having either high or low levels of high-density lipoprotein, or HDL, cholesterol, may increase the risk of dementia in older adults. It’s more evidence showing that keeping HDL cholesterol within a certain range is important for cardiovascular and brain health.  
    • “The relationship between HDL cholesterol and dementia is more complex than we previously thought,” said the study’s lead author, Erin Ferguson, a doctoral student studying epidemiology at the University of California San Francisco. “While the magnitude of this relationship is relatively small, it’s important,”
    • “The results show a correlation between HDL cholesterol and dementia, but do not prove that low or high levels of the lipid directly caused dementia.”
  • The Washington Post reports
    • “Using a host of high-tech tools to simulate brain development in a lab dish, Stanford University researchers have discovered several dozen genes that interfere with crucial steps in the process and may lead to autism, a spectrum of disorders that affects about one in every 36 Americans, impairing their ability to communicate and interact with others.
    • “The results of a decade of work, the findings published in the journal Nature may one day pave the way for scientists to design treatments that allow these phases of brain development to proceed unimpaired.”
  • Health Payer Intelligence points out
    • “Mortality rates among women and children grew between 2018 and 2021, emphasizing the importance of prioritizing preventive care and public health interventions, a report from the United Health Foundation shared.
    • “The America’s Health Rankings 2023 Women and Children Report analyzed data on 122 healthcare measures from 34 data sources. The findings reflect outcomes among women between 18 and 44 and children across the United States.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Froedtert Health plans to acquire full ownership of insurer Network Health from Ascension Wisconsin, the Milwaukee-based health system announced Tuesday. 
    • “The system agreed to buy the remaining 50% stake in the payer, which offers commercial and Medicare plans in 23 counties throughout the state, from Ascension Wisconsin. Froedtert originally acquired its stake in the company in 2014.
    • “Terms of the deal weren’t disclosed, and the health systems said a closing date will be determined after regulatory review and approval.”
  • and
    • “U.S.-based digital health startups raised $2.5 billion across 119 deals in the third quarter this year, marking the second-lowest quarter of funding since the fourth quarter in 2019, according to a report by consultancy and venture capital firm Rock Health.                    “Digital health startups have raised $8.6 billion in 365 deals so far this year, a little more than half of 2022’s total. The results cement a move toward decreased funding compared with pandemic boom years, the report found.                                                                                       “While funding and deal count has fallen significantly, trends have now stabilized for several quarters in a new normal for the digital health sector

Midweek update

David Ermer–Congress, Medical / Rx research, Mental health care, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Several prominent Republicans jumped into the race for House speaker and pledged to unite their splintered party, a day after Kevin McCarthy was ousted in a vote orchestrated by hard-line conservatives, setting up a crowded race for the gavel.
    • “House Majority Leader Steve Scalise, the No. 2 House Republican, announced his candidacy, as did Ohio Rep. Jim Jordan, chairman of the House Judiciary Committee and a founding member of the conservative House Freedom Caucus. A third member, Oklahoma Rep. Kevin Hern, told the Texas delegation that he planned to run as well as he laid the groundwork for a campaign.
    • “The House is effectively paralyzed until it picks a new speaker, raising the stakes for a successful vote next week. Members are hoping to avoid a replay of the 15 rounds of ballots in January to elect McCarthy. Major legislative fights, including Ukraine aid and border security, remain unresolved, and the next speaker will control the floor on both of those hot-button issues as well as a spending showdown with Democrats in mid-November.”
  • The Assistant Secretary of Labor for Employee Benefits Security created a blog post on mental health parity.
    • “We’re proposing new regulations, committing unprecedented resources to bringing plans into compliance with the law, and reaching out to communities across the United States to ensure that more of America’s workers and families understand their rights and are better able to exercise them, including by contacting us for help when they need it.
    • “We are determined to make sure these workers and beneficiaries get their due. For example, our enforcement program has required plans to address discriminatory practices by:
      • “eliminating blanket pre-authorization requirements for mental health benefits;
      • “ensuring comparable coverage of nutrition counseling for people with eating disorders applied behavioral analysis therapy to treat autism, and medication-assisted treatment for opioid use disorders, and
      • “eliminating special gatekeepers for mental health and substance use disorder treatment.
  • The FEHBlog is on board with mental health parity. However, he would prefer a proposed rule that sets forth clear requirements like the ones stated above rather than a convoluted process for confirming parity status.
  • Federal News Network informs us,
    • “In an effort to expand new personnel vetting procedures well beyond national security positions, agencies will soon have to begin implementing “continuous vetting” requirements for a larger subset of the federal workforce.
    • “The Office of Personnel Management is now directing agencies to ramp up preparations to start continuous vetting (CV) procedures for employees in “non-sensitive public trust positions,” beginning in fiscal 2024.
    • “OPM defines this section of the workforce as positions in both high and moderate risk levels. These include jobs involving, for instance, policymaking, public safety and health, law enforcement, fiduciary responsibilities or “other duties demanding a significant degree of public trust,” OPM said.”

From the FEHB front,

  • Govexec offers a closer look at 2024 FEHB premiums.

From the public health and research front,

  • BioPharma Dive tells us,
    • “Moderna on Wednesday announced what it described as positive data from an early-stage study of its experimental messenger RNA-based combination vaccine for COVID-19 and influenza.
    • “Moderna said the vaccine spurred similar or stronger immune responses against all four influenza strains compared to one of two flu vaccines and to its Spikevax COVID booster in older adults. Most side effects were mild in severity, the company said.
    • “The company plans to begin a Phase 3 study of the vaccine candidate later this year, and is targeting regulatory approval in 2025.”
  • STAT News lets us know
    • “The Hermitage, Pennsylvania resident has vasculitis, a genetic disease that inflames the blood vessels and stops blood from flowing to the legs. She had already lost her left leg below the knee after a sunburn on the tip of her toe got progressively worse. She was determined to keep her right one. * * *
    • “She went to Mehdi Shishehbor, an interventional cardiologist at University Hospitals in Cleveland, for help. Traditional surgical methods had failed to save her left leg, so he offered her an investigational treatment from a company called LimFlow. The device employed an old surgical technique: using a stent to connect the blocked artery to an open vein, thus allowing blood to flow through and heal injuries. Previously, that type of surgery was risky and invasive, as it involved cutting a patient’s leg open. LimFlow allows doctors to perform the surgery percutaneously via a catheter inserted in the bottom of the foot.
    • “The procedure, performed around three years ago, ultimately saved Elford’s leg. LimFlow hopes to save many more after the Food and Drug Administration approved its device last month. * * *
    • “It’s a tool in the fight to end the amputation epidemic, which disproportionately impacts Black patients — though experts cautioned to STAT that this is limited to a small subset of people with PAD and that expanding screenings to catch the disease early is the most important measure. It’s also unclear whether the most vulnerable patients will be able to access this procedure and whether it will be able to help patients retain legs in the long-term.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly’s diabetes division head, Mike Mason, will retire at the end of 2023 after four years in the position. The company veteran will be replaced by immunology chief Patrik Jonsson in one of several executive changes the Indianapolis-based drugmaker announced Wednesday.
    • “The shake-ups, which also affect leadership in research, corporate affairs and customer service, come as Lilly’s newest diabetes drug, Mounjaro, is set for rapid growth with an expected Food and Drug Administration approval as a weight loss treatment.”
  • Per the American Hospital Association News,
    • “Median operating margins for nonprofit hospitals declined to 0.2% in fiscal year 2022 as labor costs and staffing shortages drive a “labordemic” expected to persist into 2024, according to the latest Fitch Ratings report, adding to a growing body of evidence that describes hospitals’ rocky recovery.”

Tuesday’s Tidbits

David Ermer–Congress, COVID-19, COVID-19 vaccine, Medicare, NIH, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

From Washington, DC, comes an outcome that the FEHBlog didn’t expect.

  • The Washington Post reports,
    • “Rep. Kevin McCarthy (R-Calif.), after being removed as House speaker Tuesday, told fellow Republican lawmakers that he won’t seek the position again. The vote to remove him was the first such action in congressional history. McCarthy’s ouster was sought by hard-right members of his own party. McCarthy was removed by a 216-210 vote, with eight Republicans joining all Democrats in favor of the removal. The move puts the House in uncharted territory as it searches for a leader.
    • “Following McCarthy’s ouster, Rep. Patrick T. McHenry (R-N.C.) was designated as speaker pro tempore. He presided over the chamber briefly before calling a recess to allow Republicans and Democrats to meet privately.
    • “The House will take no further votes this week. Republicans are expected to hold a speaker candidate forum Tuesday, according to sources familiar with the plans who spoke on the condition of anonymity to discuss private deliberations.
  • The Wall Street Journal informs us
    • “Americans will soon be able to choose a third option in the updated Covid-19 booster-shot campaign.
    • “The Food and Drug Administration on Tuesday authorized the use of Novavax‘s Covid-19 shot in people age 12 and older. The shot has been updated to target a strain of the coronavirus that was circulating earlier this year, which health authorities say could help protect people through the fall and winter.
    • “The Centers for Disease Control and Prevention’s recommendation last month that most people receive updated booster shots applies to all updated boosters cleared by the FDA, now including Novavax’s, a CDC spokesman said. 
    • The recommendation clears the way for the vaccine to become available in pharmacies and other vaccination sites.
    • “Novavax said it priced the updated vaccine at $130 a dose, but most people are expected to be able to get it with no out-of-pocket cost.
    • “The company said it has millions of doses that will start to become available in the coming days. The shots will be offered at more than 13,000 sites around the U.S., including retail pharmacies and physician offices.”

From the public health front,

  • On Saturday, the FEHBlog made an appointment with a local chain pharmacy to get the new Covid booster. Later that day, he received a message from the pharmacy canceling the appointment because the booster was no longer available. Medscape points out that the FEHBlog’s experience was not unusual. The following posts put the FEHBlog’s problem in perspective though. There is good news if you can get to the end of this section.
  • The Washington Post has bad news about American life expectancy.
    • “Sickness and death are scarring entire communities in much of the country. The geographical footprint of early death is vast: In a quarter of the nation’s counties, mostly in the South and Midwest, working-age people are dying at a higher rate than 40 years ago, The Post found. The trail of death is so prevalent that a person could go from Virginia to Louisiana, and then up to Kansas, by traveling entirely within counties where death rates are higher than they were when Jimmy Carter was president.”
    • The FEHBlog thinks you don’t need a moonshot to address this problem. Connect people with primary care physicians early in their adult lives.
  • AHRQ’s Medical Expenditure Panel Survey lets us know,
    • “In 2020, about 1 of every 12 adults aged 18 and older received any heart disease treatment. The percentage of adults who received any heart disease treatment was highest among those aged 65 and older, higher among non-Hispanic Whites than among other racial/ethnic groups, and also higher among those in poor/low-income families than those in middle- or high-income families.
    • “Annual healthcare expenditures for the treatment of heart disease for adults in the civilian noninstitutionalized population totaled $114.9 billion in 2020 (a mean of $5,540 per adult treated for heart disease).
    • “Inpatient hospital care accounted for the largest proportion of annual medical spending for heart disease.
    • “Medicare and private health insurance combined paid about four-fifths of the medical spending for heart disease.”
  • Per Fierce Healthcare,
    • “About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.”About 8 in 10 women say they are delaying care until their symptoms worsen or affect their daily lives, and 43% have recently missed a day or more of work due to health issues.
    • “These health trends are bad for women and also for their employers.
    • “Primary care provider Parsley Health commissioned a survey of 1,200 full-time employed, insured women ages 18 to 60 to uncover their top health concerns and care challenges. The biggest takeaway? For many women, their healthcare needs have been left behind by a system that has largely ignored the broad, intersecting and complex health needs women experience across their lifetimes, Robin Berzin, M.D., founder and CEO of Parsley Health, said during an exclusive interview to review the survey results.”
  • The National Institutes of Health Directors notes,
    • “Chronic pain is an often-debilitating health condition and serious public health concern, affecting more than 50 million Americans. The opioid and overdose crisis, which stems from inadequate pain treatment, continues to have a devastating impact on families and communities across the country. To combat both challenges, we urgently need new ways to treat acute and chronic pain effectively without the many downsides of opioids.
    • “While there are already multiple classes of non-opioid pain medications and other approaches to manage pain, unfortunately none have proved as effective as opioids when it comes to pain relief. So, I’m encouraged to see that an NIH-funded team now has preclinical evidence of a promising alternative target for pain-relieving medicines in the brain.
    • “Rather than activating opioid receptors, the new approach targets receptors for a nerve messenger known as acetylcholine in a portion of the brain involved in pain control. Based on findings from animal models, it appears that treatments targeting acetylcholine could offer pain relief even in people who have reduced responsiveness to opioids. Their findings suggest that the treatment approach has the potential to remain effective in combatting pain long-term and with limited risk for withdrawal symptoms or addiction. * * *
    • “Finding treatments to modify acetylcholine levels or target acetylcholine receptors may therefore offer a means to treat pain and prevent it from becoming chronic. Encouragingly, drugs acting on these receptors already have been tested for use in people for treating other health conditions. It will now be important to learn whether these existing therapeutics or others like them may act as highly effective, non-addictive painkillers, with important implications for alleviating chronic pain.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Eli Lilly is making a bet on radiopharmaceutical drugs for cancer, announcing Tuesday a deal to buy Point Biopharma and its pipeline of experimental therapies for approximately $1.4 billion.
    • “Per acquisition terms, Lilly will pay $12.50 per Point share, a premium of about 87% to what the biotechnology company’s stock closed at Monday. The companies expect their deal to close “near the end” of this year.
    • “Based in Lilly’s home base of Indianapolis, Point specializes in radiopharmaceuticals, which pair a radioisotope with a targeting compound that delivers radiation directly into tumor cells. Recent improvements in manufacturing and supplying the complex treatments have boosted investment in the field, drawing interest from large pharma companies like Lilly as well as new drug startups.”
  • Healthcare Dive informs us,
    • “Growing expenses outpaced operating revenue at Trinity Health during its 2023 fiscal year ended June 30. The hospital system reported operating revenue of $21.6 billion on total expenses of $21.9 billion.
    • “Acquisitions for the Livonia, Michigan-based healthcare system added both $1.6 billion in revenue and $1.7 billion in operational expenses, according to the results released on Friday. The revenue gains were partially offset by the divestiture of St. Francis Medical Center in December 2022.
    • “Labor expenses continue to plague the hospital operator, which called contract rates “unprecedented” last year. Labor costs rose approximately 7.7% this year to $12 billion compared with $11.1 billion in the year prior. Contract labor accounted for $933 million compared with $626 million in 2022.”

Monday Roundup

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

From Washington, DC

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

From the public health front,

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

From the awards front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–Congress, SCOTUS, U.S. Healthcare–

From Washington, DC

  • Roll Call reports
    • “President Joe Biden signed a short-term spending bill to avert a partial government shutdown starting Sunday after a dramatic turn of events Saturday that saw the House quickly pivot to bipartisanship.
    • “Hours before the midnight deadline, the Senate voted 88-9 to clear the House-passed, 48-day funding patch, which generally mirrors the Senate version except for one major omission: There’s no military or economic aid for Ukraine, unlike the Senate bill, which had $6 billion.
    • “Democrats grumbled about that and called on the House to bring a separate Ukraine aid bill to the floor. But ultimately, there was no stomach to allow a government shutdown over the lack of Ukraine money, which lawmakers on both sides of the aisle said would be forthcoming in a separate package.”
  • The new deadline is November 17, the Friday before Thanksgiving. Bear in mind that the debt ceiling act incentivizes passing all twelve appropriations bills by the end of the calendar year.
  • Axios adds
    • Rep. Matt Gaetz (R-Fla.) wants to remove House Speaker Kevin McCarthy (R-Calif.) for working across the aisle to stop a government shutdown — but some Democrats are not on board.
    • Why it matters: As Axios has previously reported, Gaetz will likely need the vast majority of Democrats to vote with him, barring an unprecedented GOP uprising against McCarthy.
    • Driving the news: Gaetz said during an appearance on CNN’s “State of the Union” on Sunday that he planned to file a motion to vacate against McCarthy this week.
    • McCarthy responded in a CBS News interview that he will “survive,” calling Gaetz’s effort “personal.”
    • What they’re saying: “I’m not going to follow Matt Gaetz to Peter Luger’s Steakhouse,” said Rep. Steve Cohen (D-Tenn.), a member of the Progressive Caucus.
      • Cohen said McCarthy “shouldn’t be put out” for putting a bipartisan stopgap funding bill on the floor: “He did the right thing … and I’ll definitely vote not to vacate. I expect a good number of Democrats will as well.”
      • “Every time we work together, he loses his mind,” Rep. Greg Landsman (D-Ohio) said of Gaetz in a statement, adding: “This is all about TV appearances for him … just let us govern.”
      • “I see almost no way that Matt gets most of the Dems,” said one senior House Democrat, speaking on the condition of anonymity. “Many will vote present if they don’t vote No on [House Minority Leader Hakeem Jeffries’] recommendation.”
  • The U.S. Supreme Court begins its new October 2023 term tomorrow. The SCOTUS blog tells about the cases the Court will consider in the next two weeks.

In health news,

  • The Wall Street Journal reports,
    • “Hundreds of children die or are left severely injured around the country each year after they are rushed to hospital emergency rooms that are poorly prepared to treat them.
    • “Only about 14% of emergency departments nationwide have been certified as ready to treat kids, or are children’s hospitals specializing in treating young patients, The Wall Street Journal found.
    • “Many emergency doctors don’t treat enough children to be able to spot life-threatening illnesses obscured by run-of-the-mill symptoms, or conditions more common in kids. Some E.R. staff default to drug doses and protocols meant for adults and either don’t have or don’t know where to find child-size gear in a crisis.
    • “Doctors, health authorities and policy makers have known—and warned—of these failures for decades. Research in recent years has quantified the lack of readiness and number of child deaths that could have been avoided, and pointed to basic steps for solving the problem.
    • “Yet most hospitals haven’t taken action, according to the Journal’s investigation of certification levels in all 50 states, reviews of medical records and interviews with doctors, health officials and researchers.”
  • The Journal helpfully “put together the first comprehensive list of hospitals nationwide that have received state certification of some level of readiness for pediatric emergencies. The tally also includes certain children’s hospitals and certain pediatric trauma centers, which specialize in caring for kids.”