Friday Factoids

COVID-19

Friday Factoids

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

From Washington, DC

  • The U.S. Office of Personnel Management released its call letter for benefit and rate proposals for 2025 FEHB and Postal Service Health Benefit (PSHB) plans. Not surprisingly, the 2025 call letter focuses on the launch of the PSHB Program on January 1, 2025. The next step will be for OPM to issue its technical guidance. The benefit and rate proposals are due on May 31, 2024.
  • Fierce Healthcare reports,
    • “A bipartisan group of senators announced Friday that it is working on new legislation for “long-term reforms” to physician payments under Medicare and other program changes.
    • “In a joint release, U.S. Sens. Catherine Cortez Masto, D-Nevada; Marsha Blackburn, R-Tennessee; John Barrasso, R-Wyoming; Debbie Stabenow, D-Michigan; Mark Warner, D-Virginia; and Minority Whip John Thune, R-South Dakota said they have formed a “Medicare payment reform working group.”
    • “The lawmakers plan to proposes changes to the physician fee schedule and “make necessary updates” to 2015’s Medicare Access and CHIP Reauthorization Act (MACRA), they said, and “in the coming weeks” will be seeking feedback from stakeholders.”
  • The Department of Health and Human Services announced,
    • “On Thursday, February 8, 2024, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra addressed the National Press Club in Washington, D.C. for its historic Headliners Luncheon.
    • “During his address, he urged the nation to shift from an “illness-care system” to a “wellness-care system.” He also highlighted the Biden-Harris Administration’s work to increase access to quality, affordable health care, lower health care costs, including the cost of prescription drugs, and protect access to reproductive health care.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • What CDC knows
      • BA.2.87.1, a new variant of SARS-CoV-2, the virus that causes COVID-19, was identified in South Africa by the National Institute for Communicable Diseases. CDC is closely tracking this variant because of the large number of mutations when compared to previous variants. At this time, BA.2.87.1 has not been identified in clinical specimens outside South Africa. Because this is a newly emerging variant, there is not as much additional data about its potential impact. So far, the public health risk for this new variant appears low.
    • What CDC is doing
      • CDC continues to track the appearance and spread of new variants around the world through genomic surveillance. CDC is working closely with partners in South Africa to gather the latest information on BA.2.87.1. CDC and its partners are continually assessing potential impacts to vaccines, tests, and treatments.
    • Keep reading: CDC Tracks New SARS-CoV-2 Variant, BA.2.87.1
  • Here is a link to the CDC’s Covid Data Tracker.
  • ABC News adds,
    • “The flu virus is hanging on in the U.S., intensifying in some areas of the country after weeks of an apparent national decline. 
    • “Centers for Disease Control and Prevention data released Friday showed a continued national drop in flu hospitalizations, but other indicators were up — including the number of states with high or very high levels for respiratory illnesses.
    • ““Nationally, we can say we’ve peaked, but on a regional level it varies,” said the CDC’s Alicia Budd. “A couple of regions haven’t peaked yet.”
  • MedPage Today lets us know,
    • “The CDC has published its first comprehensive laboratory recommendations for syphilis testing.
    • “Published in the Morbidity and Mortality Weekly Reportopens in a new tab or window, the new recommendations include approaches for laboratory-based tests, point-of-care tests, sample processing, and how laboratories should report test results to clinicians and health departments.
    • “The recommendations are primarily for clinical laboratory or disease control personnel, but also for clinicians to understand how to collect and process specimens, interpret test results, and counsel and treat patients, according to CDC researchers led by John Papp, PhD, of the agency’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention in Atlanta.”
  • Mercer Consulting suggests that rising cancer rates call for a comprehensive strategy.
    • “A comprehensive cancer strategy includes both support for employees as they cope with the physical and emotional stresses of a cancer diagnosis, and effective care management to help ensure the patient receives quality care quickly in the most appropriate setting — which can lead to better outcomes and better use of healthcare dollars. Just over a third of large employers (34%) provide a specialized cancer care management program. These programs assist with care coordination, support compliance with treatment regimens, find applicable clinical trials, and connect families to local community resources and to other solutions the employer offers.  
    • “Centers of Excellence or site-of-care navigation programs, offered by 24% of large employers, help ensure that members are treated by quality providers with relevant experience and expertise. Hotlines, caregiver and family advocacy services, and financial planning services can help employees and their families deal with the day-to-day challenges of the cancer journey.”
  • Milliman Consulting offers some use cases for AI in healthcare and their implications for health insurers.
  • Per BioPharma Dive,
    • Takeda Pharmaceutical plans to quickly begin late-stage testing of an experimental drug for narcolepsy, which, if successful, could help the company enter what Wall Street analysts see as a multibillion-dollar market.
    • There are two kinds of narcolepsy, with a key difference being that “Type 1” can involve a sudden loss of muscle control. Takeda has been testing its drug, known as TAK-861, as a potential treatment for both, and on Friday disclosed high-level results from a pair of studies that each focused on one type.
    • “Takeda said the Type 1 trial, which evaluated 112 patients, found those given its drug as opposed to a placebo experienced statistically significant and “clinically meaningful” improvements in wakefulness at the eight-week mark. The company now intends to begin Phase 3 trials in the first half of its fiscal year, which begins April 1.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Primary care providers Indianapolis-based Marathon Health and Denver-based Everside Health completed their merger on Thursday, and will operate as Marathon Health.
    • “The Marathon executive team — CEO Jeff Wells and executive chairman Ben Evans — will stay intact post-merger, while Everside Health CEO Chris Miller will depart the company, according to a company spokesperson. Marathon declined to disclose financial details of the deal.
    • “The new Marathon Health will have a physical presence in 41 states at 680 health centers and provide virtual healthcare in all 50 states.” 
  • and
    • “One Medical is closing several offices and moving its chief financial officer to a role focused on growth as Amazon attempts to reallocate internal resources to cut costs.
    • “One Medical plans to close offices in New York City, Minneapolis and St. Petersburg, Florida, by the end of February, according to an internal email obtained by Business Insider. The company will also downsize its San Francisco office space to one floor.
    • “An Amazon spokesperson confirmed the changes to Healthcare Dive and said the company is reducing its investment in corporate office space given many One Medical corporate employees work remotely.”
  • MedTech Dive informs us,
    • “Fresenius Medical Care has received 510(k) clearance for its high-volume hemodiafiltration dialysis therapy system, the company said Thursday.
    • “The device, the 5008X Hemodialysis System, uses both diffusion and convection to remove waste products from the blood of kidney disease patients. Using diffusion, the standard mechanism for hemodialysis, and convection is intended to improve the removal of larger waste products.
    • “Fresenius plans to start a broad market launch next year and push to establish hemodiafiltration, which is already widely used in Europe, as the new standard of care in the U.S.”
  • Health Payer Intelligence points out “KLAS Report Reveals Top-Performing Vendors for Payer Services. The top-performing vendors varied across payer services, with Zelis ranking high for payment accuracy and integrity and ZeOmega succeeding in care management.”

Midweek update

David Ermer–CDC, CMS, COVID-19, Generative AI, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Department of Health and Human Services informs us,
    • “On Monday, February 5, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra met virtually with pharmacy CEOs, including Walgreens, CVS, Walmart, and pharmacy leaders, to discuss COVID-19 therapeutics commercialization. Secretary Becerra reconvened pharmacy leaders as a follow-up to his larger meeting with pharmacies, pharmacy benefit managers, and insurers on January 9, 2024.
    • “During the call, Secretary Becerra made it clear that no patient should be charged hundreds of dollars for Paxlovid at the pharmacy counter – stressing the importance of pharmacist education and clear communication to patients. Secretary Becerra re-iterated the Biden-Harris Administration’s commitment to equitable access to COVID-19 therapeutics, reminded pharmacy leaders of the pathways for access that HHS negotiated with Pfizer, and made it clear that HHS would continue to engage with pharmacist leadership as needed.
    • “While HHS is no longer managing the distribution of COVID-19 therapeutics since they transitioned to the commercial market, the Biden-Harris Administration has been closely monitoring the therapeutics commercialization process and remains committed to equitable access to lifesaving COVID-19 therapeutics, including Paxlovid. Thanks to the pathwaysthat HHS negotiated with Pfizer, all individuals on Medicare and Medicaid can receive Paxlovid for free through 2024 and individuals who are uninsured can receive Paxlovid for free through 2028. * * *
    • “To learn more about Paxlovid access, go to Pfizer’s PAXCESS Website“
  • Health Payer Intelligence points out a KFF study on how various types of payer cover COVID-19 tests, treatments and vaccines post-public health emergency.
  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services yesterday released FAQs clarifying coverage criteria and utilization management requirements for Medicare Advantage plans under its final rule for calendar year 2024, which includes provisions intended to increase program oversight and create better alignment between MA and Traditional Medicare. Topics addressed by the FAQs include medical necessity determinations; algorithms and artificial intelligence; internal coverage criteria; post-acute care; the two-midnight benchmark for inpatient admission criteria; prior authorization; and enforcement.”
  • STAT News adds,
    • “In recent months, the federal government has repeatedly told Medicare Advantage insurers that they cannot use artificial intelligence or algorithms to deny medical services the government routinely covers.
    • “But in finalizing a rule to that effect, it also stepped into a thicket of questions from insurers about a technology that is especially difficult to pin down: What is AI? Can it be used at all to make decisions about the coverage of older patients? If so, how?
    • “This week, the federal agency that oversees Medicare sought to boil it all down into a simple directive: Put the circumstances of the individual patient first, and your algorithm second.
    • “An algorithm that determines coverage based on a larger data set instead of the individual patient’s medical history, the physician’s recommendations, or clinical notes would not be compliant” with federal regulations, the government wrote in a memo to Medicare Advantage insurers on Tuesday.”
  • Health plans were using algorithms in claims processing long before AI exploded on the scene. On a related note, Health IT Analytics explores the benefits of predictive analytics in healthcare.
  • The FEHBlog noticed this entry on the OMB Office of Information and Regulatory Affairs website.
AGENCY: OPMRIN: 3206-AO43Status: Pending ReviewRequest EO Meeting
TITLE: Postal Service Reform Act; Establishment of the Postal Service Health Benefits Program 
STAGE: Final RuleSECTION 3(f)(1) SIGNIFICANT: No
** RECEIVED DATE: 02/06/2024LEGAL DEADLINE: None  
From Reginfo.gov
  • This notice pertains to OPM’s effort to finalize the interim final rule establishing the Postal Service Health Benefits Program issued April 6, 2023. OIRA review is the last step in the regulatory process before publication of this “final, final” rule in the Federal Register. OPM had project publishing that rule this month.
  • Drug Channels discusses
    • the latest National Health Expenditure (NHE) data, which measures all U.S. spending on healthcare.
    • As you will see, retail and mail prescription drug spending remain a consistently small share of the $4.5 trillion that we spend on U.S. healthcare. 
    • And contrary to what you might read, drug spending growth was *not* driven by purportedly “skyrocketing” drug prices. In reality, nearly all drug spending growth occurred due to growth in the number of people treated, prescriptions dispensed, and other nonprice factors.

From the public health and medical research,

  • The Washington Post offers an opinion piece by former CDC Director Thomas Frieden about the public health importance of treating hypertension.
  • The Post also provides background on stomach cancer, the disease that cause country singer Toby’s Keith’s death earlier this week.
  • The National Institutes of Health announced,
    • In a recent study of the brain’s waste drainage system, researchers from Washington University in St. Louis, collaborating with investigators at the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institute of Health (NIH), discovered a direct connection between the brain and its tough protective covering, the dura mater. These links may allow waste fluid to leave the brain while also exposing the brain to immune cells and other signals coming from the dura. This challenges the conventional wisdom which has suggested that the brain is cut off from its surroundings by a series of protective barriers, keeping it safe from dangerous chemicals and toxins lurking in the environment.
    • “Waste fluid moves from the brain into the body much like how sewage leaves our homes,” said NINDS’s Daniel S. Reich, M.D., Ph.D. “In this study, we asked the question of what happens once the ‘drain pipes’ leave the ‘house’—in this case, the brain—and connect up with the city sewer system within the body.” Reich’s group worked jointly with the lab of Jonathan Kipnis, Ph.D., a professor at Washington University in St. Louis. * * *
    • Together, the labs found a “cuff” of cells that surround blood vessels as they pass through the arachnoid space. These areas, which they called arachnoid cuff exit (ACE) points, appear to act as areas where fluid, molecules, and even some cells can pass from the brain into the dura and vice versa, without allowing complete mixing of the two fluids. In some disorders like Alzheimer’s disease, impaired waste clearance can cause disease-causing proteins to build up. Continuing the sewer analogy, Kipnis explained the possible connection to ACE points:  
    • “If your sink is clogged, you can remove water from the sink or fix the faucet, but ultimately you need to fix the drain,” he said. “In the brain, clogs at ACE points may prevent waste from leaving. If we can find a way to clean these clogs, its possible we can protect the brain.”  
  • Medscape lets us know,
    • “Dry January has come to an end — at least for those who jumped on the trendy post-holiday no-booze wagon.
    • “The benefits of drinking less alcohol are well documented. A systematic review of 63 studies, for example, found that reducing or giving up alcohol reduced people’s risk for hospitalization, injuries, and death. The lifestyle change also improved people’s physical and mental health as well as their quality of life.
    • “When it comes to cancer risk, however, the benefits of quitting or cutting back on alcohol remain much less clear, according to a new report from the cancer agency of the World Health Organization (WHO).
    • “After reviewing dozens of studies, the International Agency for Research on Cancer (IARC) concluded that, for most alcohol-related cancers, there is limited evidence to support a link between eliminating or reducing alcohol consumption and lowering of cancer risk.”

From the U.S. healthcare business front,

  • Healthcare Dive relates,
    • “Citing elevated medical costs, CVS Health on Wednesday cut its 2024 outlook despite posting better revenue and earnings than Wall Street had expected in the fourth quarter.
    • “The massive healthcare conglomerate now expects to bring in at least $8.30 in adjusted earnings per share this year, compared to prior guidance of $8.50.
    • “CVS is the latest insurer to post 2024 guidance below investors’ expectations, after Humana released a disappointing earnings outlook last month.”
  • and
    • “Amazon is cutting hundreds of jobs across One Medical and Amazon Pharmacy, the company confirmed on Wednesday.
    • “The goal of the cuts is to “realign” resources to meet the divisions’ goals, Amazon Health Services SVP Neil Lindsay said in an email to staff shared with Healthcare Dive. The company is not disclosing the number of employees or what roles are being impacted by the cuts.
    • “Affected employees will receive financial support and benefit continuation, as well as the opportunity to apply for new roles at Amazon, according to Lindsay. Amazon is not on a hiring freeze and will continue to hire providers and employees for One Medical and Amazon Pharmacy.”
  • Beckers Hospital Review notes,
    • “More than a quarter of the top U.S. hospitals for patient experience fall under Providence’s umbrella, according to a new ranking from PEP Health. 
    • “The Minneapolis-based AI platform extracts behavioral insights data from patient comments shared on multiple social media and review platforms. To rank the top U.S. hospitals for patient experience in 2024, PEP Health gathered and analyzed more than 30 million online patient reviews shared between Jan. 1 and Dec. 31, 2023.  * * *
    • “On average, the top 30 scored 30% higher in continuity of care, 22% higher in attention to physical and environmental needs, and 17% higher in fast access than their peers. 
    • “Hospitals belonging to Renton, Wash.-based Providence excelled on more than half of the assessment metrics, according to PEP’s report. Although eight of the top 30 hospitals were prefixed with “Providence” — and another, Swedish Medical Center-First Hill in Seattle, is an affiliate — the system could still show improvement in communication and emotional support, per the AI company.”
  • Per BioPharma Dive,
    • “Amgen is a global pharmaceutical company worth more than $160 billion. Nine of its marketed medicines are blockbuster products by annual sales.
    • “Yet, on a Tuesday conference call discussing Amgen’s fourth quarter earnings, all Wall Street analysts wanted to talk about was an experimental drug that only just cleared the first stage of human testing.
    • “More than half of the questions asked by analysts were focused on AMG 133, a promising treatment for obesity that’s drawn attention as a potential competitor to in-demand weight loss medicines from Novo Nordisk and Eli Lilly. While Wall Street often overlooks the present to focus on the future, the intense interest in a drug years away from the market was noteworthy.”
  • Milliman has made available its
    • “sixth annual Milliman Multiemployer Health and Welfare Study, which analyzes financial disclosures for multiemployer health and welfare plans, also known as Taft-Hartley plans. This year’s report includes data for 1,226 plans covering approximately 4.6 million members as of 2021, the most recent year for which data is available. The average plan could pay about one year and three months of benefits and expenses with its net assets, a decrease of approximately one month from 2020.”

Happy Groundhog Day

David Ermer–CDC, CMS, Congress, COVID-19, FDA, NIH, Telehealth, U.S. Healthcare–

From Gobbler’s Notch, PA, NPR informs us,

  • “Punxsutawney Phil, the renowned groundhog who’s been predicting when winter will end since 1887, says things are about to warm up.
  • “Glad tidings on this Groundhog Day. An early spring is on the way,” a proclamation was read out at Gobbler’s Knob, elating a crowd of thousands of people who had weathered dark and cold to see the famous rodent.”

From Washington, DC

  • Rep. James Comer, the Chair of the House of Representatives Oversight and Accountability Committee announced that the full Committee will be marking up several bills next Tuesday at 10 am, including
    • “H.R. 6283, the Delinking Revenue from Unfair Gouging Act: Adds a new section to the Federal Employees Health Benefits Act which would make changes to Pharmacy Benefit Manager (PBM) pricing, including implementing de-linking policies and requiring a PBM to only charge a flat fee for drug placement versus letting them continue to charge a percentage of the drug.”
    • The markup will be open to the public and press [at 2154 Rayburn House Office Building”] and will be live streamed online at https://oversight.house.gov/.
  • Govexec tells us,
    • “The federal government added 11,000 jobs in January, an usually high number but in line with recent trends under the Biden administration. 
    • “Including the U.S. Postal Service, federal agencies have seen robust growth of 86,000 jobs over the last year. Not counting decennial census years when the government hires hundreds of thousands of temporary workers, total federal employment reached its highest level in at least 20 years, according to Bureau of Labor Statistics data. The last year saw the most non-census hiring of any 12-month period over the same two-decade period. 
    • “Of the 11,000 jobs gained in January, about 4,500 were for the Postal Service and 6,500 went toward the rest of federal government. Only a handful of non-census months over the last 20 years have seen such significant federal job growth. Federal employment has increased in 16 of the last 17 months.” 
  • mHealth Intelligence points out,
    • “The Department of Health and Human Services (HHS) published a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.”The Department of Health and Human Services (HHS) will publish a final rule on February 2 that significantly expands access to medications for opioid use disorder (OUD), including allowing treatment initiation through telehealth.
    • “This final rule updates certain provisions of regulations related to Opioid Treatment Program (OTP) accreditation, certification, and standards for treating OUD with medications. These are the first substantial changes to the rules governing OTPs in 20 years.”
  • Healthcare Finance delves into the 2025 Advance Notice for the Medicare Advantage and Medicare Part D Prescription Drug Programs released Wednesday.
  • The Affordable Care Act regulators issued ACA Frequently Asked Question 65 which seeks to resolve a Transparency in Coverage compliance issue.
  • “On Thursday, the FDA advised consumers in the Don’t Overuse Acetaminophen Consumer Update to be cautious not to exceed the daily maximum recommended dose of acetaminophen, which can lead to overdose and severe liver damage. Over 600 medications – both prescription and nonprescription – have acetaminophen to help relieve pain and reduce fever.”
  • The Hill reports that Perigo expects to have its Opill over the counter female contraceptive pills on pharmacy shelves in the first quarter of 2024. Perigo has not accounced Opill’s retail price, “with a spokesperson saying it is committed to making sure its product is ‘accessible to people who need it.'”

From the U.S. public health and medical research front,

  • The University of Minnesota’s CIDRAP reports,
    • “After declining trends over the past few weeks, flu activity rose in some parts of the country, while COVID-19 and respiratory syncytial virus (RSV) levels continued overall declines, according to the latest updates today from the US Centers for Disease Control and Prevention (CDC).
    • “Though flu indicators declined following the winter holidays, the CDC has said that it is watching for a second peak that sometimes occurs after the winter holidays. In its respiratory virus snapshot, the CDC said some regions are seeing rising flu indicators, especially in the Midwest and South-Central regions.
    • “Also, the percentage of respiratory samples that were positive for flu at clinical labs rose last week to 16.2%, compared to 14.2% the previous week, the CDC said in its weekly flu update. Influenza A is still dominant, with 60.4% of subtyped samples belonging to the 2009 H1N1 subtype. There were increases in the percentages of H3N2 and influenza B detections compared to the previous week.
    • “Outpatient visits for flulike illness held steady and have been above the national baseline since November. However, CDC surveillance shows a rise for one age-group: people ages 5 to 24 years.”
  • The Center for Disease Control adds,
    • “According to insurance claims data for adults 18 years and older, as of January 13, 2024, the number of flu vaccination doses given so far this season in pharmacies and medical offices is lower compared with last season by about 7 million doses (from 66 million to 59 million doses, or about a 10% percent decline). There were drops in the number of doses given in both pharmacies and medical offices this season compared with last season.”
  • The National Institutes of Health’s Director explains in her blog why “Findings in Tuberculosis Immunity Point Toward New Approaches to Treatment and Prevention.”
  • Precision Vaccinations discusses why HIV vaccine development is rekindling in 2024.
  • Mercer Consulting lets us know,
    • “Black Americans represent approximately 12% of the U.S. population but account for 40% of people with HIV. The rate of new HIV infections among Black women is 10 times that of white women and four times that of Latina women. While HIV can affect anyone regardless of sexual orientation, race, ethnicity, gender, age, or where they live, some population groups have higher rates of HIV in their communities, thus raising the risk of new infections.  
    • “Black communities have made great progress in reducing HIV. Yet racism, discrimination, and mistrust in the health care system may affect whether Black people seek or receive HIV prevention services. These issues may also reduce the likelihood of engaging in HIV treatment and care.
    • “National Black HIV AIDS Awareness Day on February 7 is an opportunity to increase HIV education, testing, community involvement, and treatment among Black communities. We encourage employers to use this as a call to action to educate your workforce about HIV, to reduce stigma and create workplaces where everyone feels they belong, as well as help make employees aware of the HIV prevention and treatment resources available to them.”
  • Fierce Healthcare adds,
    • “There are significant health disparities among people with employer coverage, but plan sponsors still have work to do to fully address those issues, according to a new analysis.
    • “The report comes from Morgan Health, the healthcare arm of banking giant JPMorgan Chase. It identifies some critical disparities in the employer-sponsored sector and suggests strategies employer can use to tackle these challenges.
  • NPR interviews an anatomy professor who explains why a person’s appendix is useful.
    • “It turns out that the appendix appears to have two related functions. The first function is supporting the immune system. The appendix has a high concentration of immune tissue, so it’s acting to help the immune system fight any bad things in the gut. 
    • “The second function that it serves is what we refer to as the safe house. So this was a hypothesis that was put forward by a team from Duke University in 2007. And they argued that the appendix may serve as a safe reservoir for the beneficial gut bacteria that we have.” 

From the U.S. healthcare business front,

  • Beckers Payer Issues reports,
    • “The Cigna Group is projecting $235 billion in revenue by the end of 2024 and recorded double-digit growth in the fourth quarter across its core lines of business at Evernorth Health Services and Cigna Healthcare, according to the company’s year-end earnings report published Feb. 2.
    • “Total revenues in the fourth quarter were $51.1 billion, up 12% year over year. Total revenues in 2023 were $195.3 billion, up 8%.
    • “In the fourth quarter, net income was more than $1 billion, down 14% from nearly $1.2 billion year over year. Year-end net income was nearly $5.2 billion, down 23% year over year. 
    • “Evernorth revenues rose 12% year over year to $40.5 billion in the fourth quarter. Operational earnings in the fourth quarter were nearly $1.5 billion, and $4.8 billion in 2023.
    • “The insurance side of the business, Cigna Healthcare, reported fourth-quarter revenues of nearly $13 billion, up 16% from the previous year. Operational income in the fourth quarter was $925 million, and $4.2 billion in 2023.
    • “The company’s medical loss ratio was 82.2% in the fourth quarter, compared to 83.8% during the same period last year. In 2023, the company’s MLR was 81.3%.”
  • Healthcare Dive adds,
    • “Cigna on Friday defended its decision to sell its Medicare division, with management telling investors the health insurer will emerge from the divestiture as a leaner and more focused organization.
    • “On a call to discuss Cigna’s fourth-quarter earnings, analysts peppered the payer’s C-suite with questions about the trajectory of its business following the sale, which some had criticized for seeming to undervalue Cigna’s Medicare lives.
    • “Cigna still likes Medicare as an expansion area, but is more interested in providing services like pharmacy benefits to other Medicare Advantage organizations than offering plans itself, according to CEO David Cordani. “We were really pleased with the nature of the transaction we were able to structure,” Cordani said on the call. ”We see it as a win-win.”
  • Per Fierce Healthcare,
    • “When Florida Blue announced this week that it’s partnering with Sanitas Medical Center in Jacksonville to deliver primary care, officials with the company considered it in keeping with a healthcare system that’s evolving from one based on volume to one based on value.
    • “The healthcare system has largely been fee-for-service,” Elana Schrader, M.D., senior vice president of Florida Blue healthcare services and president of sister company GuideWell Health, told Fierce Healthcare. “Now, we’re talking about paying for services that help us achieve better outcomes. It’s a whole new value equation. Value-based care has been around, but it’s growing and growing.
    • “She added that in the future the health plan hopes that most, if not all, of the care provided will be based on value not volume. The umbrella of what can be described as primary care at the Jacksonville center is a large one under which resides, according to a press release, “preventive and primary care, onsite pharmacy dispensing, chronic condition management, mental health services, labs and imaging, and a community use space for patient and community education and social engagement and wellness classes and activities.”
  • and
    • “Optum Perks is rolling out a new telehealth solution that aims to make it easier for patients to secure their prescriptions at a low cost.
    • “Optum Perks is a part of the RVO Health umbrella, which is jointly backed by Red Ventures and UnitedHealth Group’s Optum. Its sister, Optum Store, is also within RVO Health. Optum Perks offers prescription discounts to consumers and is building on that foundation through the new virtual platform.
    • “Users can access care on demand starting at $25 for hundreds of conditions and needs including acne, birth control, cold and flu, high blood pressure and more. It services are available for people with or without insurance.”
  • Per Healthcare Dive,
    • “Telehealth availability for mental healthcare varies widely from state to state, suggesting some patients may face “several hurdles” when booking appointments for services, according to a study published Friday in JAMA Health Forum.
    • “The analysis, conducted by nonprofit research institute Rand Corporation, found less than half of mental health treatment facilities in Mississippi and South Carolina offered telehealth care, while all facilities contacted in Delaware, Maine, New Mexico and Oregon did. Researchers were also unable to reach one in five facilities when attempting to inquire about telehealth options, the study found.” 
  • Beckers Hospital Review lists emergency department visit times by state.
    • “Patients in Washington, D.C., had the highest median time spent in the emergency department, while patients in North Dakota had the lowest, CMS data shows.
    • “The agency’s “Timely and Effective Care” dataset, updated Jan. 31, tracks the average median time patients spend in the emergency department before leaving. The measures apply to children and adults treated at hospitals paid under the Inpatient Prospective Payment System or the Outpatient Prospective Payment System, as well as those that voluntarily report data on relevant measures for Medicare patients, Medicare managed care patients and non-Medicare patients. 
    • “Data was collected from April 2022 through March 2023. Averages include data for Veterans Health Administration and Department of Defense hospitals. Learn more about the methodology here.
    • “Nationwide, the median time patients spent in the ED was 162 minutes, up from 159 minutes in the 12-month period ending in March 2022, according to CMS data. In the same period ending in 2021, this figure sat at 149 minutes.”

Thursday Miscellany

David Ermer–COVID-19 vaccine, FDA, HSA, Medical / Rx research, Medicare, Mental health care, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • STAT News reports
    • “The Biden administration is making its opening offers to pharmaceutical companies in its brand-new Medicare drug price negotiation program on Thursday, administration officials said. And that’s about all they said.
    • “The offers will not be made public unless a manufacturer chooses to publicly disclose information about the talks, a senior administration official said. Companies have until March 2 to either accept the government’s offer or propose a counteroffer. The Biden administration will publish the final prices by Sept. 1 of this year after the negotiation process ends. 
    • “The negotiated prices won’t take effect until 2026. 
    • “The first 10 drugs up for negotiation are Bristol Myers Squibb’s blood thinner Eliquis, Boehringer Ingelheim and Eli Lilly’s diabetes drug Jardiance, Johnson & Johnson’s blood thinner Xarelto, Merck’s diabetes drug Januvia, AstraZeneca’s diabetes drug Farxiga, Novartis’ heart failure treatment Entresto, Amgen’s rheumatoid arthritis drug Enbrel, Johnson & Johnson and AbbVie’s blood cancer treatment Imbruvica, J&J’s anti-inflammatory medicine Stelara, and Novo Nordisk insulins that go by names including Fiasp and NovoLog.”
  • Here is a link to PhRMA’s views on the development.
    • “The bottom line: This process is a black box that allows a few government bureaucrats to make politicized decisions about the value of medicines and with no accountability to patients or the public.”
  • BioSpace adds,
    • “A federal court in Delaware heard arguments Wednesday in a key lawsuit challenging Medicare drug-negotiation provisions of the Inflation Reduction Act (IRA). Reportsfrom inside the courtroom suggested that the judge was skeptical of the arguments raised by plaintiff AstraZeneca, though experts told BioSpace this is just an early step in what could be a protracted series of legal battles.
    • “While no ruling on AstraZeneca’s motion for summary judgment is expected for about a month, court activity will heat up over the next few weeks, as a total of 10 cases from pharma companies and groups have challenged various aspects of the IRA’s Medicare drug-pricing provisions. Other plaintiffs include Merck, Novartis, Johnson & Johnson, Bristol Myers Squibb, Boehringer Ingelheim, Novo Nordisk and the lobbying group Pharmaceutical Research and Manufacturers of America (PhRMA).

From the public health and medical research front,

  • MedPage reports,
    • “The updated 2023-2024 COVID-19 vaccine was approximately 54% effective against symptomatic SARS-CoV-2 infection in adults, and was also effective against the JN.1 variant, which became predominant in January, CDC researchers said.
    • “Overall, vaccine effectiveness against symptomatic COVID was 57% for people ages 18 to 49 years and 46% for people ages 50 and older, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.”
  • and
    • “Military personnel stationed at Camp Lejeune from 1975 to 1985 had at least a 20% higher risk for a number of cancers than those stationed elsewhere, federal health officials said Wednesdayin a long-awaited study about the North Carolina base’s contaminated drinking water.
    • “Federal health officials called the research one the largest ever done in the U.S. to assess cancer risk by comparing a group who live and worked in a polluted environment to a similar group that did not.”
  • American Hospital Association News tells us,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 updated it Overdose Prevention and Response Toolkit, which includes basic information on overdose prevention and treatment as well as specific guidance and resources for health care providers and prescribers.”
  • The Institute for Clinical and Economic Review released
    • “its revised Evidence Report assessing the comparative clinical effectiveness and value of iptacopan (Novartis) and danicopan (Alexion Pharmaceuticals) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). While important health benefits for patients were shown in clinical trials for both agents, there is uncertainty about long-term efficacy and safety. ICER’s model for iptacopan, which is already FDA-approved, using a shared-savings approach (described in more detail below), suggests that the drug would need to be priced 70% lower than the current list price to meet commonly accepted thresholds. For danicopan, which is not yet FDA-approved, ICER’s model suggests the price would need to be between $12,300 and $13,100 per year to achieve common thresholds for cost-effectiveness.
    • “This Evidence Report will be reviewed at a virtual public meeting of the California Technology Assessment Forum (CTAF) on February 16, 2024.”
  • NPR discusses aging.
    • I used to flinch at the topic of aging. Is there anything we can do about the inevitable?
    • But recently I’ve been digging into a new wave of longevity research that is making it an exciting time to be an aging human — which is all of us.
    • It turns out, we all age at varying rates. Super-agers may have great genes, but research shows our habits and routines — everything from what we eat and how we move our bodies to who we spend our time with — matter a lot, when it comes to aging well.
    • Now, the next frontier is to target the basic biology of aging and come up with new interventions to slow it down.
    • Many scientists are optimistic that we’re on the cusp of breakthroughs. Not only to help us live longer, but — more importantly — to extend the number of years we live with good health.
    • This is the goal of researchers at the Human Longevity Lab at the Northwestern University Feinberg School of Medicine. They’re recruiting study participants so they can test what kinds of interventions may slow the rate of aging.
  • The reporter describes participating in this study.
  • HealthDay informs us,
    • “Adolescent substance use is associated with psychiatric symptoms, including suicidal thoughts, according to a research letter published online Jan. 29 in JAMA Pediatrics.
    • “Brenden Tervo-Clemmens, Ph.D., from the University of Minnesota in Minneapolis, and colleagues examined associations between commonly used substances and psychiatric symptoms among adolescents in two samples: students from 36 Massachusetts high schools who completed the 2022 to 2023 Substance Use and Risk Factor (SURF) Survey and analogous self-reported items from the 2021 Youth Risk Behavior Survey (YRBS). Data were included for 15,626 SURF participants and 17,232 YRBS participants.
    • “The researchers found significant, moderate dose-dependent associations for alcohol, cannabis, and nicotine use with worse psychiatric symptoms, including suicidal thoughts in SURF and YRBS, depressive or anxiety symptoms and inattention or hyperactivity in SURF, and general mental health in YRBS.” 
  • Memory Care Business notes,
    • “A new global effort is underway to accelerate the prevention, diagnosis and management of Alzheimer’s and other forms of dementia. 
    • “The effort, dubbed the Alzheimer’s Moonshot, was announced by StartUp Health in partnership with the Alzheimer’s Drug Discovery Foundation’s Diagnostics accelerator and Gates Ventures, the private office of entrepreneur Bill Gates. 
    • “The Alzheimer’s effort is among a new series of “moonshots” from StartUp Health. The efforts also have taken aim at other health challenges, such as Type 1 diabetes, with the goal of bringing together like-minded company founders and researchers in those spaces.”
  • The Washington Post reports,
    • “An international team led by scientists at Stanford University has discovered a probable explanation for a decades-old biological mystery: why vastly more women than men suffer from autoimmune diseases such as lupus and rheumatoid arthritis.
    • “Women account for about 80 percent of the people afflicted with autoimmune diseases, a collection of more than 100 ailments that burden a combined 50 million Americans, according to the nonprofit Autoimmune Association. In simple terms, these illnesses manipulate the body’s immune system to attack healthy tissue.
    • “In a paper published Thursday in the journal Cell, researchers present new evidence that a molecule called Xist — pronounced like the word “exist” and found only in women — is a major culprit in these diseases.
    • “Better understanding of this molecule could lead to new tests that catch autoimmune diseases sooner and, in the longer term, to new and more effective treatments, researchers said.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Tenet Healthcare has disclosed a pair of new and completed hospital transactions alongside projections that next week’s 2023 financial report “will be above the high end” of its guidance.”
  • and
    • “New Jersey providers Saint Peter’s Healthcare System and Atlantic Health System have taken the first step toward a merger they said would include “significant investments” in the Catholic system’s service area.”
  • and
    • “Hospitals and health systems closed out the year on a high note with margins up more than 15% from 2022, according to Kaufman Hall.”
    • “The firm’s latest sector-wide monthly report pointed to an increase in year-to-date operating margin index, from 1.9% through November to 2.3% at the end of the year. On a single-month basis, the operating margin index rose from 3.2% to 4.6% at the same cutoffs.
    • “These improved margins indicate that hospitals and health systems are taking the necessary steps to adapt to this new environment,” Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said in a release. “While finances are approaching historic levels, today’s care and business models look very different. Organizations have had to adjust how and where they’re delivering services to better meet patient preferences.”
  • Healthcare Dive lets us know,
    • “Healthcare executives prioritize data considerations when it comes to using generative artificial intelligence, which could prevent them from successfully integrating the hot button technology, according to a report by consultancy Deloitte. 
    • “While 82% of 60 respondents rated data availability, quality and reliability as a top consideration for implementing generative AI, only 45% cited mitigating biases or patient education on the technology and its risks as their greatest considerations when implementing the technology.
    • “Data is important, but the industry needs a “robust overarching framework” that focuses equally on governance, consumer needs and worker concerns, the report’s authors wrote.”
  • STAT News reports,
    • Merck reported earnings for the fourth-quarter and 2023. On 2024 guidance, Merck said it expects sales in the range of $62.7-$64.2 billion, or a 6% increase at the midpoint. Current Street consensus is $63.5 billion. Adjusted earnings are forecast to be between $8.44 and $8.59 per share.
    • More pharma earnings from Roche and Sanofi.
  • and
    • “Novavax, the company whose corporate missteps repeatedly sidelined an effective Covid-19 vaccine, is relying on demand for booster doses to remain solvent. And the latest update isn’t exactly encouraging.
    • “The company said yesterday that it would lay off another 12% of its staff, expanding on a cost-cutting plan disclosed last year. In the end, Novavax will have reduced its workforce by about 30% compared to 2023, part of an effort to reduce its expenses in the months to come.”
  • NewFront offers guidance on correcting mistaken health savings account distributions.


 

Midweek update

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

From Washington, DC,

  • Roll Call informs us
    • “House leadership smoothed the path for consideration of a $78 billion family and business tax break deal Wednesday by committing to a floor vote as soon as next week on a separate bill to boost the state and local tax deduction cap for married couples.”
  • and later
    • “The House on Wednesday night passed a $79 billion family and business tax break bill after several days of uncertainty, teeing it up for consideration in the Senate. 
    • “The package negotiated by House Ways and Means Chairman Jason Smith, R-Mo., and Senate Finance Chair Ron Wyden, D-Ore., easily mustered the two-thirds majority needed to pass, despite GOP drama earlier in the week and previous criticism from Democrats. 
    • “It’s a strong, commonsense, bipartisan step forward in providing urgent tax relief for working families and small businesses,” Smith said on the floor ahead of the 357-70 vote. “Parents in Main Street communities across this country will see lower taxes, more opportunity and greater financial security after we pass this legislation.”
  • Here is a link to today’s hearing held by the House Energy and Commerce Committee’s Health Subcommittee about national healthcare expenditures.
  • Fierce Healthcare tells us,
    • “Medicare Advantage (MA) payments are set to decrease yet again in 2025 as the feds phase in significant changes to risk adjustment.
    • “As those overhauls begin to take effect, benchmark payments are set to decline by about 0.2% on average, according to the latest advance notice released by the Centers for Medicare & Medicaid Services (CMS).
    • “Despite this, the feds said Wednesday that payments to MA plans are expected to increase by 3.7% in 2025, a $16 billion increase over 2024. The payment rate announced today could change by the time the final rate announcement is published, no later than April 1.”
  • The CY 2025 Advance Notice may be viewed by going to: https://www.cms.gov/Medicare/Health-Plans/MedicareAdvtgSpecRateStats/Announcements-and-Documents and selecting “2025 Advance Notice.”
  • A fact sheet discussing the provisions of the CY 2025 Advance Notice, as well as frequently asked questions, can be viewed here: https://www.cms.gov/newsroom/fact-sheets/2025-medicare-advantage-and-part-d-advance-notice-fact-sheet.
  • Beckers Payer Issues adds,
    • “A bipartisan group of lawmakers is urging CMS to maintain “payment and policy” stability in Medicare Advantage. 
    • “In a letter to CMS Administrator Chiquita Brooks-LaSure, the group of 60 senators asked the agency to “consider the ongoing implementation of program reforms finalized last year and provide stability for the Medicare Advantage program in 2025.”  * * *
    • “The letter comes after two lawmakers, Sen. Elizabeth Warren and Rep. Pramila Jayapal, wrote to the agency urging more action on curbing overpayments to the program. 
    • “Read the full letter here. “
  • Today, OPM posted on the Federal Register website a proposed FEHB rule that “would allow FEHB and PSHB coverage to become effective at the beginning of the pay period that the employee in pay status has an initial opportunity to enroll. This change would occur when the employee becomes eligible for FEHB or PSHB coverage, provided an appropriate request to enroll is received by the employing office within the initial pay period that the employee becomes eligible.”
  • American Hospital News reports,
    • “The Substance Abuse and Mental Health Services Administration Jan. 31 issued a final rule that updates certain regulations for Opioid Treatment Programs and the standards for treatment of opioid use disorder. The rule makes some COVID-19-related flexibilities permanent, including take-home doses of methadone, the ability of an OTP to prescribe medication for OUD via telehealth without an initial in-person physical evaluation, and the removal of certain requirements for admission to an OTP to better align with evidence-based practice.”
  • KFF shares three charts about Medicare drug price negotiations.
  • Federal News Network reports,
    • “The Postal Service is looking to cut $5 billion from its operating costs and grow its revenue by the same amount over the next two years to overcome its long-term financial challenges.
    • “Postmaster General Louis DeJoy is telling the White House and Congress that implementing these plans is necessary to keep USPS from running out of cash in the coming years.
    • “DeJoy, in a Jan.10 letter obtained by Federal News Network, told President Joe Biden and congressional leaders that USPS is “utilizing all of the self-help tools that are available to us,” and trying to get back on track with its “break-even” goal, after years of billion-dollar net losses.
    • “It is evident that to break even and avoid running out of cash in the next several years, we must press ahead on our financial improvement initiatives over the next two years,” DeJoy wrote. “While we have already achieved historic reductions, they are simply not enough to make us financially sustainable.”

From the public health and medical research front,

  • Check out this JAMA Open article to learn why “Paxlovid Is Effective but Underused—Here’s What the Latest Research Says About Rebound and More.”
  • Per Fierce Healthcare,
    • “As artificial intelligence advances in different areas of healthcare, there are concerns that technology and AI-based chatbots will replace the human connections between patients and practitioners.
    • “But, a new study finds promising potential for AI and large language models to enhance mental health therapy at scale by being able to analyze millions of text-based counseling messages to shine a light on what works.
    • “Researchers used AI to analyze more than 20 million text conversations of counseling sessions and successfully predicted patient satisfaction and clinical outcomes, according to a study published this week in the Journal of The American Medical Association (JAMA) Open.”
  • The National Institutes of Health announced,
    • An analysis conducted by the National Institutes of Health’s National Center for Complementary and Integrative Health (NCCIH) reveals a substantial increase in the overall use of complementary health approaches by American adults from 2002 to 2022. The study, published in the Journal of the American Medical Association, highlights a surge in the adoption of complementary health approaches for pain management over the same period.
    • Researchers utilized data from the 2002, 2012, and 2022 National Health Interview Survey (NHIS) to evaluate changes in the use of seven complementary health approaches, including yoga, meditation, massage therapy, chiropractic care, acupuncture, naturopathy, and guided imagery/progressive muscle relaxation.
    • The key findings include:
      • The percentage of individuals who reported using at least one of the seven approaches increased from 19.2% in 2002 to 36.7% in 2022.
      • The use of yoga, meditation, and massage therapy experienced the most significant growth from 2002 to 2022.
      • Use of yoga increased from 5% in 2002 to 15.8% in 2022.
      • Meditation became the most used approach in 2022, with an increase from 7.5% in 2002 to 17.3% in 2022.
      • Acupuncture, increasingly covered by insurance, saw an increase from 1% in 2002 to 2.2% in 2022.
    • Additionally, the analysis showed a notable rise in the proportion of U.S. adults using complementary health approaches specifically for pain management. Among participants using any of the complementary health approaches, the percentage reporting use for pain management increased from 42.3% in 2002 to 49.2% in 2022.
    • Despite the findings, the authors acknowledge study limitations, including decreasing NHIS response rates over time, possible recall bias, cross-sectional data, and differences in survey wording.
  • and
    • “Researchers at the National Institutes of Health detected abnormal proteins in the spinal fluid of people with amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), which could help improve diagnosis of these diseases. The findings were published in Science Translational Medicine.
    • “The proteins in question are built from “cryptic” exons—abnormal portions of RNA, the cell’s instructions for how to build proteins. Cryptic exons occur when TDP-43, a protein that regulates how RNA is processed, stops functioning normally. TDP-43 dysfunction is linked to ALS, FTD, Alzheimer’s disease, and Limbic Associated TDP-43 Encephalopathy (LATE).
    • “The study showed that these mis-spliced sections of RNA can sometimes generate new proteins from the cryptic sequence. The findings advance our understanding of how cryptic exons may be involved in the dementia disease process and could help identify diseases involving TDP-43 dysfunction before symptoms appear. Currently, TDP-43 aggregates in the brain can only be detected at autopsy.”  
  • MedPage Today points out, “Getting clinicians to commit to the Choosing Wisely recommendations somewhat reduced low-value care for older adults in common scenarios, a cluster randomized trial found.”

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Nordisk has resumed shipping starter doses of its weight-loss drug Wegovy, nearly nine months after manufacturing problems forced it to restrict distribution to maintenance shots in order to ensure that people who had already started taking it could continue, the company said Wednesday.
    • “The resumption of the starter doses, which begin at 0.25 milligrams per week, comes two months after obesity rival Eli Lilly gained U.S. approval for a competing drug, Zepbound, that could threaten to eat away at Novo’s sizable lead in weight-loss treatment.”
  • The Wall Street Journal adds,
    • “Nearly every employer in the country is now grappling with how—and whether—to pay for new weight loss drugs. Needless to say, such decisions are highly important to patients struggling with obesity.
    • “But for Eli Lilly and Novo Nordisk, it actually doesn’t matter, for now, from a financial perspective. They are selling every injection they can make. It won’t change anytime soon.” ***
    • While the companies are both moving as fast as possible, expanding the manufacturing of injectables is complicated. 
    • “You’re talking about billions of pens. That’s not a trivial exercise,” says Guggenheim analyst Seamus Fernandez. “Producing pens is a very complex process that requires precision and lots of attention to safety.” 
    • “That is one reason why developing pills such as Lilly’s orforglipron, which is undergoing clinical trials, is so crucial, he adds. Figuring out how to make oral versions well-tolerated is a challenge, though.”
  • MedTech Dive tells us about the top medtech trends in 2024. “Experts said M&A, orthopedic procedure backlogs and emerging cardiac markets were among the top trends to watch in the medical device industry this year.”
  • Per Healthcare Dive,
    • “Cigna has agreed to sell its Medicare business to Health Care Service Corporation for roughly $3.7 billion, the health insurer announced Wednesday.
    • “HCSC is acquiring Cigna’s Medicare Advantage, supplemental benefits and Medicare Part D plans, along with CareAllies, a division that helps providers transition to value-based care. In total, the plans cover 3.6 million people on Medicare.
    • “The companies said they expect the deal — which includes $3.3 billion in cash and $400 million in capital Cigna expects to be freed up — to close in the first quarter of 2025, subject to regulatory approval.”
  • and
    • “Humana plans to expand its primary care network for seniors this year, as the insurer looks to lean on provider capabilities to boost its beleaguered Medicare Advantage business.
    • “In 2024, CenterWell Senior Primary Care plans to enter three new markets in North Carolina and Louisiana, and add additional centers in eight of its current markets in the U.S., the payer announced on Tuesday.
    • “Humana is one of many health insurers racing to build out a provider network to provide convenient access to primary care for its members. But for Humana, this strategy is more important than it might be for its rivals with a broader variety of plans, given Humana has made such a significant bet on Medicare Advantage, said Arielle Trzcinski, a healthcare analyst at market research firm Forrester.”
  • BioPharma Dive lets us know,
    • In 2021, the Food and Drug Administration for the first time approved a medicine meant to slow the progression of Alzheimer’s disease. Developed by partners Biogen and Eisai, the medicine, called Aduhelm, was viewed initially as a needed new treatment option by patients and a potential blockbuster product by Wall Street analysts.
    • “Now, less than three years since that approval, Biogen is fully giving up on the drug. The company said Wednesday it is handing rights to back to Aduhelm’s original developer, Neurimmune, and will redirect much of the money spent on the drug toward other Alzheimer’s therapies in its business.
    • “Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” said Christopher Viehbacher, the company’s CEO, in a statement.”
  • Per Beckers Payer Issues,
    • “The share of U.S. employees in healthcare plans funded by their employer rose from 2015 to 2021, a study published in the January issue of Health Affairs found. 
    • “In 2015, 55% of employees were enrolled in self-funded plans, compared to 60% of employees in 2021. Most of the growth occurred in states and counties with lower levels of self-funded enrollment, the study found. 
    • “Groups of rapid growth in self-funded plans were concentrated in Arkansas, New York, Northern California, Pennsylvania and Utah, the study found. 
    • “Elevance Health is the largest administrator of self-funded plans, with around 19% of the total market, according to the study. CVS Health claimed the fastest growing self-funded enrollment from 2015 to 2021. “

Tuesday Tidbits

David Ermer–CMS, COVID treatment, FDA, Obesity, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced today that
    • “Sickle cell disease (SCD) will be the first focus of the Cell and Gene Therapy (CGT) Access Model, which was initially announced in February 2023. The model is designed to improve health outcomes, increase access to cell and gene therapies, and lower health care costs for some of the nation’s most vulnerable populations. * * *
    • “Gene therapies for sickle cell disease have the potential to treat this devastating condition and transform people’s lives, offering them a chance to live healthier and potentially avoid associated health issues,” said CMS Administrator Chiquita Brooks-LaSure. “Increasing access to these promising therapies will not only help keep people healthy, but it can also lead to savings for states and taxpayers as the long-term costs of treating sickle cell disease may be avoided.” * * *
    • “For additional information see the fact sheet – PDF and CGT model page.“
  • The American Hospital Association reports,
    • “Paxlovid may no longer be distributed with an emergency use label after March 8, the Food and Drug Administration announced. Providers may dispense unexpired Paxlovid labeled for emergency use to patients through March 8, after which Paxlovid labeled for emergency use must be returned to the manufacturer or disposed of in accord with regulations, the agency said.
    • “The FDA last May approved a new drug application for Pfizer’s Paxlovid to treat adults at high risk of progressing to severe COVID-19. Paxlovid labeled under the new drug application will continue to be authorized for emergency use to treat eligible pediatric patients, the agency said.”
  • Following up on Affordable Care Act FAQ 64, the U.S. Office of Personnel Management issued today a carrier letter no. 2024-03 on contraceptive coverage and patient education.
  • Reuters reports,
    • “Pharmaceutical companies are due to receive by Thursday the U.S. government’s opening proposal for what are expected to be significant discounts on 10 of its high-cost medicines, an important step in the Medicare health program’s first ever price negotiations.
    • “Five Wall Street analysts and two investors told Reuters they expect the negotiations over prices that will go into effect in 2026 to result in cuts ranging from the statutory minimum of 25% to as much as 60% when the final numbers are set in September.
    • “The drugmakers and the government are expected to wait until then to disclose them.” * * *
    • “Pharmaceutical companies and business groups have filed more than half a dozen lawsuits to stop the negotiations from taking place, saying that they are unlawful.
    • “Drug companies say the law’s costs will hurt drug development programs and patients.”
    • “The lawsuits have not slowed the implementation timeline.”
  • Axios points out that CMS’s recent prior authorization proposed rule do not apply to prescription drug claims.
  • The Federal Acquisition Regulation Council published in the Federal Register today a proposed rule
    • “would prohibit contractors and subcontractors from seeking and considering information about job applicants’ compensation history when making employment decisions for certain positions. Under the proposed policy and the proposed regulatory amendments, contractors and subcontractors would also be required to disclose the compensation to be offered to the hired applicant in job announcements for certain positions.”
  • The public comment period ends on April 1, 2024.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “People who are suffering from severe pain but don’t want to risk addiction to an opioid are closer to a new option for treatment.
    • “Vertex Pharmaceuticals on Tuesday reported positive study results for its closely watched non-opioid painkiller. The drug lowered the moderate-to-severe acute pain reported by study volunteers, a sign it could be the first in a new class of painkiller to be approved for use.
    • “But the experimental medicine is more likely to provide an alternative to opioids, rather than supplant them, because it didn’t work better than a widely used opioid drug sold under the brand name Vicodin.
    • “Vertex said it would file for approval from the U.S. Food and Drug Administration by the middle of this year.”
  • STAT News tells us,
    • “Drugs like Ozempic and Wegovy — already game changers for diabetes and obesity — are being studied to treat an entirely different growing health problem: mental health illnesses, including depression and bipolar disorder.
    • “Early data and anecdotes suggest that this class of GLP-1 drugs could help patients feel less depressed and anxious. The treatment may also fight the decline in cognitive and executive function that many people with mental health disorders experience, like worsening memory and losing the ability to focus and plan.
    • “If further research yields positive results, it could drive even more demand for the highly popular GLP-1 treatments, which have increasingly been shown to help with problems across the body, such as heart and kidney complications. And especially if the cognitive benefits are proven out, the GLP-1 drugs would plug a critical gap in current treatments for depression, since most depression drugs help with mood, but close to none address cognitive symptoms that affect memory and attention.”
  • and
    • “The U.S. syphilis epidemic isn’t abating, with the rate of infectious cases rising 9% in 2022, according to a new federal government report on sexually transmitted diseases in adults.
    • “But there’s some unexpected good news: The rate of new gonorrhea cases fell for the first time in a decade.
    • “It’s not clear why syphilis rose 9% while gonorrhea dropped 9%, officials at the U.S. Centers for Disease Control and Prevention said, adding that it’s too soon to know whether a new downward trend is emerging for the latter.
    • “They are most focused on syphilis, which is less common than gonorrhea or chlamydia but considered more dangerous. Total cases surpassed 207,000 in 2022, the highest count in the United States since 1950, according to data released Tuesday.”
  • MedTech Dive calls attention to “four heart device trends shaping the medtech sector in 2024. Medtronic, Boston Scientific and J&J are among the medtech companies advancing treatments in cardiac care for when medicines are not enough.
  • MedCity Dive discusses “How Food as Medicine is Becoming A Core Team Capability. As the food as medicine movement grows, some payers and healthcare organizations are carving out specific roles and teams dedicated to food and nutrition. Doing so can be beneficial considering the significant impact diet can have on health outcomes.”
  • The Washington Post notes,
    • “Older adults spend an average of three weeks every year on doctor’s appointments and other health care outside their homes, according to research published in the Annals of Internal Medicine.
    • “Of those 21 “health care contact days,” 17 involve ambulatory services, such as office visits with primary-care doctors or specialists, testing and imaging, procedures, treatments and therapy. The remaining four days included time spent in an emergency room, hospital, skilled nursing facility or hospice.
    • “The study also found that about 11 percent of people 65 and over spend even more time — 50 or more days each year (nearly one day a week) — obtaining routine health care away from home. The research was based on Medicare data from a nationally representative sample of 6,619 people 65 and older.
    • “The findings represent “not only access to needed care but also substantial time, efforts and cost, especially for older adults and their care partners,” the researchers wrote.”
  • Peterson – KFF Health System Tracker offers a study comparing U.S. life expectancy to other countries.

From the U.S. healthcare business front,

  • Pfizer released its full year 2023 results and reaffirmed its full year 2024 financial guidance provided on December 13, 2023. “The fourth-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found at www.pfizer.com.”
  • Beckers Hospital Review reports,
    • “Nashville, Tenn.-based HCA Healthcare saw revenues of $17.3 billion in the fourth quarter of 2023, up from $15.5 billion over the same period in 2022, according to its financial report released Jan. 30.” 
  • and
    • “Nonprofit Hospitals’ operating margins are far below the pre-pandemic “magic number” of 3% and are in danger of a permanent reset in the 1%-2% range, according to a Jan. 29 report published by Fitch Ratings.
    • “This operating margin reset is worrying some investors, but “hospital downgrades en masse would be unlikely because many systems have built up robust balance sheets and learned to economize on capital spending to a certain degree,” Kevin Holloran, senior director and sector head at Fitch, said.

Friday Factoid

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

From Washington, DC

  • Govexec informs us,
    • “Federal agencies will have to speed up their presidential transition preparations and ensure they are prepared for extended periods without a known electoral winner under a new law introduced on Friday by a bipartisan pair of senators. 
    • “The Agency Preparation for Transitions Act, put forward by Sens. Gary Peters, D-Mich., and Susan Collins, R-Maine, aims to provide greater resources to career employees at federal agencies tasked with preparing potential future administrations. Agencies already face a slew of requirements in drafting materials and answering questions from campaign transition teams, but the new measure looks to speed up some of the established timelines for those interactions and boost communication between the White House and agency transition teams.”
  • The Department of Health and Human Services announced
    • “On December 7, the Biden-Harris Administration announced new actions to promote competition in health care, including increasing transparency in the Medicare Advantage (MA) insurance market and strengthening MA programmatic data. Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is continuing momentum in this area by releasing a Request for Information (RFI) to solicit feedback from the public on how best to enhance MA data capabilities and increase public transparency. Transparency is especially important now that MA has grown to over 50% of Medicare enrollment, and the government is expected to pay MA health insurance companies over $7 trillion over the next decade. The information solicited by this RFI will support efforts for MA plans to best meet the needs of people with Medicare, for people with Medicare to have timely access to care, to ensure that MA plans appropriately use taxpayer funds, and for the market to have healthy competition. * * *
    • The MA Data RFI can be accessed on the Federal Register’s webpage at https://www.federalregister.gov/public-inspection/current.  Comments are due on May 29, 2024.
  • MedTech Dive reports,
    • “Absolutions Med has received breakthrough designation for an abdominal wall closure device that is intended to reduce the risk of hernia. 
    • “The Food and Drug Administration designation, which Absolutions disclosed Wednesday, covers a device designed to distribute suture tension over a large area of tissue.
    • “Absolutions began testing the device, Rebuild Bioabsorbable, in cancer patients undergoing abdominal surgeries in 2022, and the company began a study in a broader population in March 2023.”
  • The Centers for Medicare and Medicaid Services made available the latest version of the Section 111 reporting user guide for group health plans and the slides from a recent webinar on the new Section 111 civil monetary penalties program that kicks in on October 11, 2024.
  • The Society Human Resource Management points out that
    • “The Department of Labor has issued guidance on emergency savings accounts linked to retirement savings plans, a new benefit available this year under a provision of the Secure 2.0 Act of 2022.
    • “Secure 2.0 amended the Employee Retirement Income Security Act (ERISA) to authorize the establishment of pension-linked emergency savings accounts (PLESAs), which are short-term savings accounts established and maintained as part of an individual’s retirement savings plan, such as a 401(k) plan. The provision creating PLESAs, Section 127, took effect on Jan. 1.
    • “The DOL guidance comes in the form of 20 frequently asked questions.”

From the public health and medical research front,

  • STAT News reports,
    • “A historic new study out of Scotland shows the real-world impact of vaccines against the human papillomavirus: The country has detected no cases of cervical cancer in women born between 1988-1996 who were fully vaccinated against HPV between the ages of 12 and 13.
    • “Many previous studies have shown that HPV vaccines are extremely effective in preventing cervical cancer. But the study, published on Monday in the Journal of the National Cancer Institute, is the first to monitor a national cohort of women over such a long time period and find no occurrence of cervical cancer.
    • “The study is super exciting. It shows that the vaccine is extremely effective,” said Kathleen Schmeler, a professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center, who was not involved in the research. “It’s obviously early. We’re just starting to see the first data of the impact of the vaccine because it takes so long from the time of the vaccine to the effects.”
    • “The results underscore the importance of working to increase uptake of the HPV vaccine in the U.S., said Schmeler. Scotland, for example, introduced routine immunization in schools in 2008, and close to 90% of students in their fourth year of secondary school (equivalent to 10th grade in the U.S.) in the 2022-2023 school year had received at least one dose of the vaccine. In the U.S., where HPV vaccines are not administered in school, uptake among adolescents ages 13 to 17 is a little over 60%.
    • “The study also points to how crucial the timing of vaccination is. “The girls that didn’t develop any cancer were vaccinated before becoming sexually active,” said Schlemer. “So we should not wait to vaccinate folks and really do it, for the guidelines, prior to becoming sexually active.”
  • The Centers for Disease Control tells us,
    • “A new CDC study has found that more recent COVID-19 hospitalizations among adults experienced fewer severe outcomes than during earlier parts of the COVID-19 pandemic, and that the proportion of severe hospital outcomes from COVID-19 became more similar to adults hospitalized with flu. Most recently, when COVID-19 Omicron variants predominated, hospitalized flu and COVID-19 patients had similar levels of intensive care unit (ICU) admissions and use of supplemental oxygen, respiratory support, and invasive mechanical ventilation. Even the risk of death as an outcome became more similar across the two diseases, with the exception of among people 18 to 49 years, who continued to experience higher in-hospital deaths from COVID-19. This study underscores the fact that both diseases have the potential to be dangerous and that both warrant the compliance with CDC prevention and treatment recommendations.
    • “The study, published in Open Forum Infectious Diseases, analyzed a subset of adult hospitalizations with COVID-19 or flu that were recorded in one surveillance system to compare clinical outcomes and other characteristics between the two groups. People who were hospitalized with COVID-19 were additionally sorted into groups depending on the predominant COVID-19 variant circulating at the time. The most recent COVID-19 Omicron BA.5-predominant period was compared to flu outcomes during the 2021-2022 season.”
  • MedPage Today offers a transcript of an interview with Dr. Paul Paul Offit, MD, on “the history of the MMR vaccine and the lasting legacy of COVID.”
  • Precision Vaccinations lets us know,
    • “In 2023, the U.S. Food and Drug Administration (FDA) approved one respiratory syncytial virus (RSV) vaccine and an updated monoclonal antibody therapy to prevent respiratory disease in very young children.
    • “Given these were new options, health officials did not know which product pregnant women would prefer during the 2023-2024 RSV season.
    • “According to new data published by the U.S. Centers for Disease Control and Prevention (CDC) on January 23, 2024, the winner has been Beyfortus™ (Nirsevimab).”
  • The JAMA Open Network explains,
    • Question  What are the long-term trends in breast cancer incidence among women aged 20 to 49 years?
    • Findings  In this population-based, cross-sectional study using data from Surveillance, Epidemiology, and End Results, age-standardized, age-cohort–adjusted, and age-period–adjusted breast cancer incidence rates increased over the past 20 years among different races in different age groups. Incidence rates for estrogen receptor (ER)-positive, stage I, and stage IV tumors increased, while rates decreased for ER-negative, stage II, and stage III tumors.
    • Meaning  These results suggest that understanding factors driving differential trends in incidence rates for different age groups by race and ER-positive status should provide insights into breast cancer prevention in young women.

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Nonprofit hospital operating margins soared last year, increasing 20% January to November 2023 as compared to the same period in 2022, according to Kaufman Hall’s “National Hospital Flash Report,” published Jan. 9. 
    • “Operating EBITDA jumped 15% year over year in November and was up 9% for the first 11 months of the year compared to 2022.
    • “Hospitals with 500-plus beds also did particularly well. On average their operating margin was up 59.3% year over year for November, and operating EBITDA margin was : up 20.5%, according to Kaufman Hall.”
  • and
    • Boston-based Tufts Medicine reported a $171 million operating loss in the fiscal year ending Sept. 30, a 57% improvement on the $399 million loss it posted in the previous year, according to financial documents published Jan. 26. 
    • Year over year, revenue increased 14.4% to $2.6 billion while expenses grew by 3.8% to $2.8 billion. Under expenses, salaries and wages increased 6.4% to $1.3 billion and employee benefits were up 6% to $260.5 million.
    • After accounting for the performance of its investment portfolio and other nonoperating items, Tufts ended the 12-month period with an overall gain of $1.6 million, a significant improvement on the $530.4 million net loss recorded in the prior year. 
  • Per Healthcare Dive,
    • “Healthcare bankruptcies spiked in 2023 to the highest level in the past five years, according to a report released Thursday by healthcare restructuring advisory firm Gibbins Advisors.
    • “The analysis included Chapter 11 bankruptcies for companies with liabilities of at least $10 million. Gibbins Advisors found 79 such bankruptcies last year — more than three times the level seen in 2021.
    • “The number of filings dropped from the third to the fourth quarter, but total case volume could remain high in 2024 as the market continues to be “very challenging” for providers, said Tyler Brasher, a director at Gibbins Advisors, in a statement.”
  • Mercer Consulting shared its views on managing prescription drug benefits.

 

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington DC,

  • Healthcare Dive reports,
    • “A group of bipartisan senators on Wednesday reintroduced a bill that aims to remove barriers to telemental healthcare for Medicarebeneficiaries.
    • “The legislation, introduced by Sens. Bill Cassidy, R-La., Tina Smith, D-Minn., John Thune, R-S.D., and Ben Cardin, D-Md., would remove requirements that telemental health patients see an in-person provider within six months of receiving services via telehealth.
    • “The senators warned the “arbitrary” requirement that patients be seen in-person will limit access to needed care, particularly in rural areas.”
  • The Senate Finance Committee lets us know,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and Ranking Member Mike Crapo, R-Idaho, today announced their commitment to working on bipartisan health care legislation to prevent and mitigate shortages of critical generic drugs used by patients and providers in the United States.
    • “In a white paper released today, Wyden and Crapo outline concerns raised by experts at a hearing held in the Finance Committee on December 5, 2023, as well as areas of interest and ideas the Committee is exploring to address the factors contributing to shortages through modifications to the Medicare and Medicaid programs. * * *
    • The white paper can be found here.
  • and
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Finance Committee Members Chris Coons (D-Delaware), Tom Carper (D-Delaware) and Thom Tillis (R-North Carolina), along with ten of their colleagues, wrote today to President Biden urging him to reject the proposal before the World Trade Organization (WTO) that would waive intellectual property (IP) protections for COVID-19 diagnostics and therapeutics.  Waiving protections afforded by the WTO Agreement on Trade-Related Aspects of IP Rights (TRIPS) could have unintended consequences for the development of new treatments for dangerous diseases, while doing little to improve access to medicine.”
  • HHS’s Human Resource & Services Administration tells us,
    • “Today, Health Resources and Services Administration (HRSA) Administrator Carole Johnson, joined by Rep. Lauren Underwood (D-IL), co-chair of the Black Maternal Health Caucus, launched a year-long Enhancing Maternal Health Initiative. The initiative will strengthen, expand, and accelerate HRSA’s maternal health work to address maternal mortality and maternal health disparities in partnership with mothers, grantees, community organizations, and state and local health officials across the country.
    • “The kick-off event at the Kaiser Family Foundation in Washington, DC, convened HRSA maternal health grantees from 11 states and the District of Columbia, as well as key national organizations and experts, providers, and individuals with lived experience. Attendees shared personal perspectives on maternal health care and support, the innovative ways HRSA grantees are making an impact on maternal health, and how they are addressing maternal mental health. * * * For more information on HRSA’s maternal health work, visit: www.hrsa.gov/maternal-health.”
  • The Government Accountability Office issued a report on OPM’s paid parental leave program.
    • “Starting October 1, 2020, most federal civilian employees became eligible to take up to 12 weeks of paid parental leave for the arrival of a new child whether by birth, adoption, or foster care.
    • “The Office of Personnel Management’s government-wide data showed that most federal employees were aware of the benefit, and the number of employees who took paid parental leave generally aligned with OPM’s initial estimates.
    • “However, OPM’s webpage for federal leave policies is outdated and doesn’t include information about the benefit. We recommended that OPM update guidance on its webpage to help ensure employees better understand their eligibility.”
  • FedWeek explains how to weigh the options if separating from a spouse before federal employee retirement eligibility.
  • Per Healthcare Dive,
    • “The Federal Trade Commission sued to block Novant Health’s $320 million acquisition of two North Carolina hospitals from Community Health Systems on Thursday, alleging the deal threatens to raise consumer prices and reduces incentives to provide quality care.
    • “The antitrust agency said the proposed deal, which was first announced in February of last year, would reduce competition in the region and “increase annual healthcare costs by several million dollars.”
    • “In response to the lawsuit, a representative from Winston-Salem, North Carolina-based Novant said the nonprofit system would “pursue available legal responses to the FTC’s flawed position.”
  • Per BioPharma Dive,
    • “The Food and Drug Administration this week convened a group of experts to discuss ways to develop new drugs for preventing spontaneous early births, a major health concern for which there are no good treatments.
    • “At the two-day workshop led by the FDA and and the Duke-Margolis Center for Health Policy, experts in maternal and fetal health, as well as advocates, discussed challenges to developing a medicine for preterm births, which affect 1 in every 10 babies in the U.S. and can jeopardize their health.”
  • Per MedTech Dive,
    • “Abbott received approval from the Food and Drug Administration for a rechargeable deep brain stimulation (DBS) system.
    • “Abbott claimed in the Thursday announcement its device, called Liberta RC, is the world’s smallest and has the longest charge of any DBS technology on the market. The company says the device only needs to be recharged 10 times per year under standard settings for most users. 
    • “Earlier this month, Medtronic also received approval for a new DBS system called Percept RC, which has sensing technology to track patients’ response to treatment.”

From the public health and medical research front,

  • HCPLive alerts us,
    • “Despite being the leading cause of death in the US for more than a century, more than half of the respondents to a 2023 survey conducted on behalf of the American Heart Association (AHA) failed to identify heart disease as the leading killer of US adults, according to the AHA’s 2024 Heart Disease and Stroke Statistics report.
    • “Data from the report, which is created annually by the AHA and National Institutes of Health to spotlight the impact of heart disease and stroke in the US and abroad, highlight a lack of awareness surrounding the impact of cardiovascular disease, with additional statistics paint a picture where 51% failed to identify heart disease as the leading cause of death, but also spotlights how advances in care and education have caused death rates from cardiovascular disease to decline by 60% in the last 75 years.”
  • The Society for Human Resource Management offers advice on “a number of policies and strategies employers might want to turn to during this coronavirus and flu surge.”
  • Beckers Hospital Review informs us,
    • “The CDC has rejected findings from Ohio State University researchers that the JN.1 coronavirus variant is more severe than previous strains.
    • “While JN.1 currently accounts for almost 86% of current COVID-19 cases in the U.S., the CDC published a statement Jan. 22 saying that the agency has found “no evidence that it causes more severe disease,” adding that vaccines are still expected to increase protection against the variant as well.
    • “The Ohio State University research, published Jan. 8 in Cell, had focused on two subvariants: BA.2.86 and JN.1. Their study found that it “appears to have increased infectivity of human lung epithelial cells compared to all omicron variants…(which) raises a potential concern about whether or not this virus is more pathogenic,” Shan-Lu Liu, MD, PhD, senior author the study and a virology professor at OSU stated in a news release about the research.  
    • “Since JN.1 is an offspring of BA.2.86, OSU researchers found it had similar results.
    • “While the CDC does not align with this research, the agency did state it “is contributing to the spread of COVID-19 this winter.”
  • STAT News reports,
    • “Building off of some landmark discoveries published last year, researchers have mapped out the biological underpinnings of Parkinson’s disease, creating a framework for medicines that might treat the root of the disease rather than just its symptoms.
    • “Their work, published in the Lancet Neurology, stages Parkinson’s based on the accumulation of a misfolded protein called alpha-synuclein. Funded by the Michael J. Fox Foundation for Parkinson’s Research, the work expands on a 2023 publication that validated an alpha-synuclein diagnostic for the disease.
    • “The new framework still has some gaps, but the researchers believe they’ve set out a path that will allow scientists to discover and rigorously test treatments aimed at the biological causes of Parkinson’s, providing a reliable measure of disease severity that might accelerate the process of drug development.”
  • The Institute for Clinical and Economic Review posted,
    •  “its revised Evidence Repor assessing the comparative clinical effectiveness and value of xanomeline tartrate/trospium chloride (KarXT, Karuna Therapeutics) for the treatment of schizophrenia. 
    • “Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves,” said ICER’s Chief Medical Officer, David Rind, MD. “Among the important side effects of current treatments is weight gain leading to metabolic syndrome. This, in turn, places patients at risk for cardiovascular events and death. KarXT has a novel mechanism of action and, at least in the short run, does not seem to cause weight gain. This may lead to major health benefits compared with existing treatments, however current evidence on benefits and harms is limited.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC (New England CEPAC) on February 9, 2024. The New England 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.”
  • Healio calls our attention to these study findings:
    • “Adults who lose weight in the year after being diagnosed with type 2 diabetes are more likely to achieve diabetes remission.
    • “Weight regain after remission increases the risk for returning to hyperglycemia.” 

From the U.S. healthcare business front,

  • The Raleigh (NC) News and Observer reports,
    • “Facing unsustainable costs, the NC State Health Plan’s board of trustees voted to end all plan coverage of popular weight-loss drugs beginning April 1. Board members met Thursday afternoon to consider options for how the plan could deal with rising costs. In October, the board imposed a moratorium on new prescriptions for one of the drugs, Wegovy, when made solely for weight-loss purposes. The moratorium began Jan. 1. At the conclusion of the lengthy meeting, the board voted 4-3 to exclude all coverage of obesity GLP-1 medications on April 1.
    • This will end coverage for plan members who were grandfathered in and already taking the medications as well. Usage of Wegovy, Saxenda and other drugs by plan members has increased significantly in recent years, as have costs incurred by the plan. The plan spent a projected $102 million on these drugs in 2023, or 10% of its roughly $1 billion in net pharmacy spending last year.
  • It stuns the FEHBlog that Novo Nordisk and Eli Lilly continue to raise prices for their GLP-1 drugs when they have blockbuster aales.
  • The American Hospital News notes,
    • “Hospitals and health systems are prioritizing preserving access to care for patients in rural America, including via access points like hospital outpatient departments that provide essential services for rural and low-income communities, according to a new AHA report released Jan. 25. The report details how hospitals have been a lifeline for struggling rural physician practices helping to keep their doors open, and HOPDs have remained convenient, high-quality access points for rural patients with more complex care needs. Among other findings, hospitals were two and a half times more likely to acquire physician practices in rural areas than other entities, including commercial insurers which are overwhelmingly focuse”d on larger and more profitable markets.”
  • Healthcare Dive points out,
    • “Humana on Thursday released a profit outlook for 2024 that fell well short of Wall Street’s already-diminished expectations, as the health insurer continues to be plagued by high medical spending on seniors.
    • “The Louisville, Kentucky-based payer expects to bring in $16 in adjusted earnings per share in 2024 — a whopping $13 short of analysts’ consensus expectations. In comparison, Humana brought in $26.09 in adjusted earnings per share this year.
    • “Humana also rescinded its earnings target for 2025. The health insurer’s stock plunged 15% in morning trade Thursday following the results.”
  • and
    • “Cleveland Clinic executives applauded the operator’s financial rebound in an annual State of the Clinic address, but signaled it would continue lean operations to chase sustained profitability.
    • “We sustain and advance Cleveland Clinic’s mission by serving patients and managing our resources,” said Tom Mihaljevic, Cleveland Clinic CEO and president, during the Wednesday address. “It is possible to use fewer resources while touching more lives.”
    • “Cleveland Clinic exceeded its revenue projections for 2023, drawing in over $14 billion in revenue on more than 14 million annual patient interactions, according to Mihaljevic.
    • “The Ohio-based nonprofit reported an operating margin of 0.4% for the year — an improvement on the prior year’s performance, when the Clinic reported an operating margin of -1.6% on a $1.2 billion net loss.” 

The FEHBlog is back!!

David Ermer–CDC, CMS, COVID-19, HSA, Medical / Rx research, OPM, U.S. Healthcare–

On Friday, the FEHBlog flew from Austin to Washington, DC, having left his briefcase at home. As a result he did not have his laptop or his FEHBlog log in information over the weekend. He is back in action today.

From Washington, DC,

  • The White House issued a fact sheet about new actions taken by the White House Task Force on Reproductive Healthcare Access which is marking the 51st Anniversary of Roe v. Wade. Of note to the FEHB Program, the Fact Sheet discusses
    • “Strengthen[ing] Contraception Access and Affordability for Women with Private Health Insurance. The Administration is committed to ensuring that women have access to contraception—an essential component of reproductive health care that has only become more important in the wake of the Supreme Court’s decision to overturn Roe v. Wade—and reducing barriers that women face in accessing contraception prescribed by their provider. The Departments of the Treasury, Labor, and Health and Human Services (HHS) are issuing new guidance [ACA FAQ 64] to clarify standards and support expanded coverage of a broader range of FDA-approved contraceptives at no cost under the Affordable Care Act. This action builds on the progress already made by the Affordable Care Act to expand access to affordable contraception for millions of women nationwide.
    • “In addition, the Office of Personnel Management will strengthen access to contraception for federal workers, retirees, and family members by issuing guidance to insurers participating in the Federal Employee Health Benefits Program that incorporates the Departments’ guidance. OPM will also newly require insurers that participate in the Federal Employee Health Benefits Program to take additional steps to educate enrollees about their contraception benefits.”
  • You may recall that OPM issued comprehensive guidance for carriers on contraceptive coverage in Carrier Letter No. 2022-17 back in the summer of 2022.
  • The FEHBlog was surprised that new ACA FAQ 64 does not announce a decision on whether group health plans are required to cover the new over-the-counter female contraceptive Opill which is not yet reached pharmacy shelves. The FEHBlog expects that the regulators will requires that group health plans cover Opill with no cost sharing when purchased at a network pharmacy.
  • In related news, the HHS and Centers for Medicare and Medicaid Services announced:
    • “launch[ing] a series of actions to educate the public about their rights to emergency medical care and to help support efforts of hospitals to meet their obligations under the Emergency Medical Treatment and Labor Act (EMTALA). As part of this comprehensive plan, the Department will:
      • “Publish new informational resources on CMS’s website to help individuals understand their rights under EMTALA and the process for submitting a complaint if they are denied emergency medical care;
      • “Partner with hospital and provider associations to disseminate training materials on providers’ obligations under EMTALA; 
      • “Convene hospital and provider associations to discuss best practices and challenges in ensuring compliance with EMTALA; and
      • “Establish a dedicated team of HHS experts who will increase the Department’s capacity to support hospitals in complying with federal requirements under EMTALA.”
  • In sum, HHS Secretary Xavier Becerra also sent a “letter to Medicare plans, health insurance issuers, and State Medicaid and CHIP programs about upholding their [contraceptive coverage] bligations under federal law.
    • Secretary Becerra wrote: ‘From day one, the Biden-Harris Administration has made clear that women should have access to the healthcare they need, including contraception and other family planning services. I’m writing to reaffirm that access to reproductive healthcare is a core priority of the U.S. Department of Health and Human Services.’”
  • American Hospital News tells us,
    • “A Department of Veterans Affairs policy that provides free emergency suicide prevention care has helped nearly 50,000 veterans and former service members in its first year, the VA announced last week. The policy allows the agency to provide, pay for or reimburse for eligible individuals’ emergency suicide care, transportation costs and follow-up care at any VA or non-VA facility for up to 30 days of inpatient care and 90 days of outpatient care.”
  • CMS issued its latest top ten Section 111 reporting issues for group health plans.
  • Fierce Healthcare informs us,
    • “Truveta, the real-world data analysis company backed by dozens of health systems and other life sciences groups, won a multi-million-dollar contract from the Centers for Disease Control and Prevention (CDC) to assist with the agency’s research into maternal health, pediatric care and respiratory viruses, including COVID-19.
    • “The company will let the CDC tap into its collection of more than 100 million patients’ deidentified, normalized electronic health record data.
    • “The Bellevue, Washington-based collective receives the information from its 30 health system members, which include major providers like Providence, Trinity Health and Tenet Healthcare. Together, the members provide over 18% of the country’s daily clinical care.”

From the public health and medical research front,

  • U.S. New and World Report lets us know,
    • “Coronavirus hospital admissions last week decreased for the first time in more than two months, according to data from the Centers for Disease Control and Prevention. Though the number remains elevated, weekly hospitalizations fell by nearly 10% week over week.
    • “More than 32,800 new COVID-19 hospital admissions were reported over the week ending Jan. 13, and over 27,800 Americans on average each day were considered currently hospitalized due to the disease during the same time frame, according to CDC data.
    • “Despite test positivity (percentage of tests conducted that were positive), emergency department visits, and hospitalizations remaining elevated nationally, COVID-19 rates have stabilized, or in some instances decreased,” the CDC said in a post on Friday.”
  • The CDC’s Fluview from last Friday notes,
    • “Seasonal influenza activity remains elevated in most parts of the country.
    • “After several weeks of increases in key flu indicators through the end of 2023, two weeks of decreasing or stable trends nationally have been noted. CDC will continue to monitor for a second period of increased influenza activity that often occurs after the winter holidays.
    • “Outpatient respiratory illness has been above baseline nationally since November and is above baseline in all 10 HHS regions.
    • “The number of weekly flu hospital admissions has decreased slightly for two consecutive weeks.”
  • Medpage Today points out,
    • “Several recent measles outbreaks have public health officials concerned — and are drawing attention to rising childhood vaccine exemptions and renewing calls for increased measles awareness.
    • “Philadelphia’s health department confirmed nine casesof the illness as of Tuesday, which spread at local health facilities and a daycare. At least three of the infections were in unvaccinated children, according to ABC News.
    • “As of January 12, two counties in Washington state noted “3 lab-confirmed and 3 [epidemiologically]-linked measles cases have been identified among unvaccinated adults.” Delaware identified 20-30 people who were exposed to measles at the Nemours Children’s Hospital a few days earlier. * * *
    • “Katelyn Jetelina, MPH, PhD, epidemiologist and author of the “Your Local Epidemiologist” newsletter, calls the recent measles outbreaks a potential symptom of “collective amnesia” in a recent newsletter, writing, “As generations age, the memory of mid-20th-century diseases like measles fade. … Some don’t know why this disease is bad or if this vaccine is safe. This is understandable.”
  • The FEHBlog subscribes to the Your Local Epidemiologist on Substack and he finds it to be worth the money.
  • NBC News reports,
    • “After decades of good news in the fight against cervical cancer — marked by decades of steady declines in cases and deaths — a new report suggests that some women are being left behind. * * *
    • “Among women in their 30s and early 40s, incidence has been edging upward. Diagnosis of cervical cancer among women ages 30 to 44 rose almost 2% a year from 2012 to 2019.
    • “We need to make sure we are not forgetting about that generation that was a little too old for HPV vaccination,” said Jennifer Spencer, an assistant professor at the Dell Medical School at University of Texas-Austin who studies population health.
    • “Fortunately, the cancers found in 30- and 40-something women were mostly early, curable tumors, said Ahmedin Jemal, senior author of the new report and the cancer society’s senior vice president for surveillance and health equity science. About 13,800 American women are diagnosed with cervical cancer each year and 4,360 die from the disease.”

From the U.S. healthcare business front,

  • Cigna issued a report on the top healthcare trends of 2024.
  • Kaiser Health News calls our attention to the following Modern Healthcare story
    • “Blue Cross Blue Shield insurers have become the first carriers to cover multimillion-dollar new gene therapies for sickle cell disease, and other insurers and Medicaid agencies are moving to follow suit. Blue Cross’ Synergie Medication Collective has inked risk-sharing agreements with drugmaker BlueBird Bio to offer its $3.1 million Lyfgenia gene therapy treatment for sickle cell disease to some self-insured employers, as well as competitor Vertex Pharmaceuticals’ $2.2 million Casgevy treatment.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare is rolling out a new resource hub that seeks to make it easier for members to use wellness offerings while also easing the financial burden on employers.
    • “The UHC Hub features more than 20 different options, including wellbeing programs that target healthy living and more complex care management. Its network is built to make it easier for employers to find and purchase solutions and to make it simpler for consumers to engage.
    • “It’s not a secret that employers are feeling increasingly overwhelmed with the wide array of vendor options available to them. Samantha Baker, chief consumer officer for UnitedHealthcare’s commercial business, told Fierce Healthcare in an email that this is a pain point that comes up frequently in conversations with plan sponsors. * * *
    • “UnitedHealthcare said in an announcement that the hub builds on existing advocacy programs that it offers to clients, which help members in finding in-network providers, during a hospital discharge or in reviewing treatment and medication options.” 
  • Per Healthcare Dive,
    • “Intermountain-owned Saltzer Health said it will shut down if it cannot find a buyer by March 29, citing financial and economic challenges.
    • “The physician group said it’s in active negotiations with healthcare companies over the sale of some operations, and is “optimistic that a sale can be achieved,” according to a Thursday news release. 
    • “The health group, which is owned by Salt Lake City-based Intermountain Health, employs 450 people and serves approximately 100,000 annual patients across 11 Treasure Valley locations, according to a company spokesperson.”
  • BioPharma Dive explains why “With two biotech buyouts, schizophrenia drugs appear back on pharma’s radar. Deal documents suggest others besides Bristol Myers and AbbVie may be looking.”

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front

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

From the U.S. healthcare business front,

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