Happy Groundhog Day

FDA

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.

Monday Roundup

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports,
    • “Key congressional negotiators have reached an agreement on how to divvy up funding for the fiscal 2024 spending bills, clearing a major threshold that will allow appropriators to finalize those measures. 
    • “The deal, confirmed by a source familiar with talks, was hammered out after weeks of negotiations between Sen. Patty Murray, D-Wash., and Rep. Kay Granger, R-Texas, who respectively chair the Senate and House Appropriations Committees, and establishes how much money will be allocated to each of the 12 bills Congress must pass to fund government each year. With those allocations set, lawmakers can now complete their work of setting line-by-line funding for every program and office in agencies across government.”
  • Federal News Network tells us,
    • “The Office of Personnel Management is issuing a final rule to bar the government from considering a person’s current or past pay when determining their salary for federal employment. Administration officials said this step will help limit pay discrimination and ensure compensation is based on an applicant’s skills, experience and expertise.
    • “A similar proposal will offer protections to those employed by federal contractors.
    • “The Federal Acquisition Regulatory Council is issuing a proposal to prohibit federal contractors and subcontractors from seeking and considering information about a job applicant’s compensation history when hiring or setting pay for anyone who works on a government contract.
    • “The proposal also requires contractors and subcontractors to disclose salary ranges in job postings.
    • “Administration officials said the proposal would help federal contractors recruit, diversify and retain talent, improve job satisfaction and performance and reduce turnover.”
  • The Department of Health and Human Services is holding a virtual summit this Wednesday January 31 “for policymakers, advocates, researchers, and a wide variety of stakeholders with equities in the Food is Medicine space to engage in a substantive conversation about why food is medicine is important, what actions are being taken to promote this concept, and what stakeholders can do to bolster this work.”
  • The Centers for Medicare and Medicaid Services informs us about
    • “Increased participation in CMS’ accountable care organization (ACO) initiatives in 2024, which will increase the quality of care for more people with Medicare. Of note, CMS is announcing that 19 newly formed accountable care organizations (ACOs) in the Medicare Shared Savings Program (Shared Savings Program) are participating in a new, permanent payment option beginning in 2024 that is enabling these ACOs to receive more than $20 million in advance investment payments (AIPs) for caring for underserved populations. An additional 50 ACOs are new to the program in 2024, and 71 ACOs renewed their participation, bringing the total to 480 ACOs now participating in the Shared Savings Program, the largest ACO program in the country. CMS also announced that 245 organizations are continuing their participation in two CMS Innovation Center models — ACO Realizing Equity, Access, and Community Health (ACO REACH) and the Kidney Care Choices (KCC) models.”
  • Bloomberg reports,
    • “Justice Department investigators are scrutinizing the healthcare industry’s use of AI embedded in patient records that prompts doctors to recommend treatments.
    • “Prosecutors have started subpoenaing pharmaceuticals and digital health companies to learn more about generative technology’s role in facilitating anti-kickback and false claims violations, said three sources familiar with the matter. It comes as electronic health record vendors are integrating more sophisticated artificial intelligence tools to match patients with particular drugs and devices.
    • “It’s unclear how advanced the cases are and where they fit in the Biden administration’s initiative to spur innovation in healthcare AI while regulating to promote safeguards. Two of the sources—speaking anonymously to discuss ongoing investigations—said DOJ attorneys are asking general questions suggesting they still may be formulating a strategy.”
  • Per Healthcare Dive,
    • “Federal legislation holding patients blameless for surprise medical charges prevented more than 10 million unexpected bills in the first nine months of 2023, according to a new analysis by health insurance groups.
    • “The survey of U.S. payers from AHIP and the Blue Cross Blue Shield Association also highlighted a “growing and troubling trend” — an increasing number of claims going through the payment negotiation process set up by the No Surprises Act.
    • “Regulators forecast that 17,000 claims would go through that process, called independent dispute resolution, each year. However, AHIP and BCBSA estimate almost 670,000 claims were submitted to IDRbetween January and September 2023 alone.”
  • Per BioPharma Dive,
    • “Philips has agreed to stop selling new sleep therapy devices or other respiratory care products in the U.S., roughly two-and-a-half years after launching its massive recall of related products, the company said Monday. 
    • “The company agreed to the action as part of a consent decree it is entering into with the U.S. Department of Justice, representing the Food and Drug Administration. Philips has been negotiating the decree in light of the quality problems that led to its recall of more than 15 million sleep therapy and respiratory care devices. The decree is now being finalized ahead of its submission to a U.S. court for approval.
    • “Philips shared details of the agreement as part of its fourth-quarter earnings call.”

From the public health and medical research front,

  • ABC News reports,
    • “The Centers for Disease Control and Prevention (CDC) is warning clinicians to remain on alert for measles cases due to a growing number of infections.
    • “Between Dec. 1, 2023, and Jan. 23, 2024, there have been 23 confirmed cases of measles including seven cases from international travelers and two outbreaks with five or more infections each, according to an email sent this week.
    • “Cases have been reported in Pennsylvania, New Jersey, Delaware and the Washington, D.C. area so far.
    • “Most of these cases were among children and adolescents who had not been vaccinated against measles, despite being eligible.
    • “According to the CDC, most measles cases in the U.S. occur when unvaccinated or partially vaccinated Americans travel internationally, contract the disease and then spread it to those who are unvaccinated upon their return.”
  • Bloomberg offers background on the effective measles vaccine.
    • “The measles, mumps and rubella combined vaccine is so effective that in the US, thanks to a widely accepted vaccine campaign, measles was declared eliminated in 2000.
    • “But the disease has made a comeback. A now-discredited studypublished in the journal The Lancet in 1998 suggested that the MMR vaccine was linked to autism. This is not true, but some parents became reluctant to immunize their children. Dahl’s letter about the measles vaccine has had an online revival multiple times in the past decade, as measles spread repeatedly in children who’d never gotten their shots.
    • “The disease is flaring up again now, this time in Europe, where the World Health Organization waved a warning flag last week. The region reported more than 40,000 cases between January and November of last year, compared to 942 in 2022. The havoc the Covid-19 pandemic wreaked on basic preventative care is partly to blame.”
  • The National Institutes of Health provides us with an emotional wellness tookit.
  • MedPage Today points out,
    • A multiparametric blood test for prostate cancer showed potential to avoid more than half of unnecessary biopsies without sacrificing accuracy, a large prospective study showed.
    • In a comparison against the current PSA testing standard of ≥4 ng/mL, the Stockholm3 biomarker, which incorporates a PSA cutoff of 15 ng/mL with other proteins and genomic information, would have spared 56% of men from biopsies for grade group (GG) 1 or benign disease. The standard PSA cutoff would have avoided 19% of unnecessary biopsies, decreasing to 10% with a cutoff of ≥3 ng/mL.
    • Sensitivity, specificity, and predictive values with the multicomponent test either approximated or surpassed those achieved with conventional PSA testing, reported Scott Eggener, MD, of the University of Chicago, at the Genitourinary Cancers Symposium

From the U.S. healthcare business front,

  • Health Payer Intelligence notes,
    • “UnitedHealth Group saw revenue growth of over 14 percent in 2023, while adding 1.7 million new consumers to its Medicare and commercial offerings, executives shared during the UnitedHealth Group Fourth Quarter and Full Year 2023 Earnings Conference Call.
    • “Last year was a “year of balanced, sustainable growth for UnitedHealth Group,” according to Andrew Witty, CEO of UnitedHealth Group.”
  • Beckers Payer Issues lets us know,
    • “Though Medicare Advantage enrollment keeps climbing, the program may not have the profitability it once did for insurers. 
    • “In a January analysis shared with Becker’s, Moody’s analysts wrote that the program “seems to be losing some of its luster,” facing a significant increase in medical costs and lower reimbursement rates from CMS. 
    • “Earnings in Medicare Advantage shrunk by 2.1% among the insurers Moody’s rated from 2019 to 2022, despite premiums and members growing by 40% in the same time period.”
  • and
    • After a called-off merger between Humana and Cigna, executives at both companies say the companies are focused on staying on their existing courses. 
    • Neither company has directly addressed the called-off merger, but they have each fielded questions from investors on the outlook for the future. 
  • Beckers Hospital Review explains how the Ozempic boom affects hospital pharmacies.

Weekend Update

David Ermer–Congress, FDA, Medical / Rx research, Medicare, U.S. Healthcare–

From Washington DC

  • The House of Representatives and the Senate continue to meet on Capitol Hill this week for Committee meetings and floor business. For your information, here’s an interesting meeting:
    • House Energy and Commerce Subcommittee on Health
    • Wednesday January 31, 2024 10:00 AM (EST) | 2123 Rayburn House Office Building, Washington, D.C.
    • Hearing: Health Care Spending in the United States: Unsustainable for Patients, Employers, and Taxpayers
    • Meeting Details
  • Fortune Well discusses the Medicare income adjusted premiums known as IRMAA. In the FEHBlog’s view, the best course is to pay the IRMAA premium because the Medicare Part B is worth the temporary surcharge.

From the public health and medical research front,

  • Medscape discusses research on a urine test that can diagnose lung cancer.
    • “Lung cancer is the deadliest cancer in the world, largely because so many patients are diagnosed late.
    • “Screening more patients could help, yet screening rates remain critically low. In the United States, only about 6% of eligible people get screened , according to the American Lung Association. Contrast that with screening rates for breast, cervical, and colorectal cancer, which all top 70%.
    • “But what if lung cancer detection was as simple as taking a puff on an inhaler and following up with a urine test?
    • “Researchers at the Massachusetts Institute of Technology (MIT), Cambridge, Massachusetts, have developed nanosensors that target lung cancer proteins and can be delivered via inhaler or nebulizer, according to research published this month in Science Advances. If the sensors spot these proteins, they produce a signal in the urine that can be detected with a paper test strip.
    • “It’s a more complex version of a pregnancy test, but it’s very simple to use,” said Qian Zhong, PhD, an MIT researcher and co-lead author of the study.”
  • The American Medical Association reports
    • ‘While the 2018 physical activity guidelines recommend that adults engage in at least 150 to 300 minutes per week of moderate exercise, 75 to 150 minutes each week of vigorous movement or an equivalent combination of both intensities, it turns out that if adults do more than the recommended amount, it can lower their risk of death. Moderate physical activity is defined as walking, weightlifting and lower-intensity exercise. Meanwhile, vigorous exercise is categorized as running, bicycling and swimming.’ 
  • The American Medical Association points out what doctors wish their patient knew about which cold medicines work.

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Cognoa, maker of the first FDA-approved autism diagnostic tool, announced Highmark has signed on as its first commercial payer partner. 
    • “The tool, Canvas Dx, will now be reimbursed for commercial Highmark members. It aims to enable earlier and more equitable access to diagnosis for children and families without specialists. The tool leverages AI to empower doctors to quickly and accurately diagnose developmental risk without bias, the company claims.
    • “The contract should be seen as “model medical policy,” Dennis Wall, Ph.D., autism researcher and founder of Cognoa, told Fierce Healthcare. Wall hopes the coverage will be replicated across other payers. Highmark will cover the full price, including the total cost of CanvasDx and the time it takes for a provider to administer it.” 
  • STAT News tells us,
    • “At least, as of yesterday [January 25], in terms of market value. Eli Lilly, which has more than doubled in value since 2022, is now worth about $600 billion, eclipsing Elon Musk’s electric car company, which has fallen about 25% since the start of the year.
    • “There’s only so much one can read into the fates of two completely unrelated companies, but here’s a thought: For years, biotech specialists have pointed out that if generalist investors reallocated even 2% of their tech investments into the drug industry, it would make a massive difference for the comparatively small pond that is biotech.
    • “Through that lens, Lilly overtaking Tesla, to the extent it has any meaning at all, points to a future in which fund managers consider treating obesity and Alzheimer’s disease to be a better use of capital than making cars that sometimes don’t work when it’s cold, which would benefit biotech as a whole.”

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.” 

Midweek Update

David Ermer–ACA, FDA, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The Department of Health and Human Services announced that
    • “21.3 million people selected an Affordable Care Act Health Insurance Marketplace plan during the 2024 Open Enrollment Period. Total plan selections include more than five million people — about a fourth — who are new to the Marketplaces and 16 million people who renewed their coverage. Notably, open enrollment continues in four states and Washington, D.C., through January 31.
    • “For decades, when it came to federal programs we could depend on to keep Americans covered, three were always top of mind — Medicare, Medicaid, and Social Security, but now it’s crystal clear that we need to add a fourth — the Affordable Care Act,” said HHS Secretary Xavier Becerra. “Once again, a record-breaking number of Americans have signed up for affordable health care coverage through the Affordable Care Act’s Marketplace, and now they and their families have the peace of mind that comes with coverage. The ACA continues to be a successful, popular, and important federal program to millions of people and their families. As we celebrate the success of this most recent enrollment effort, HHS will double down on the Biden-Harris Administration’s efforts to increase access to quality care and lower costs.”
  • The Peterson-KFF Health System Tracker identifies “Health Cost and Affordability Policy Issues and Trends to Watch in 2024.”

From the public health and medical research front,

  • Beckers Hospital Review informs us,
    • “After discontinuing the use of semaglutide and liraglutide weight-loss medications, a majority of patients were able to maintain the same weight they were at when halting the use — or even continued to lose additional weight after one year, a new study revealed. 
    • “The research, published Jan. 23 in Epic Research, focused on the outcomes of 20,274 patients who were prescribed semaglutide and 17,733 patients prescribed liraglutide, who lost at least five pounds while taking it. 
    • “Sustained weight loss slightly differed for the drugs — 56.2% of patients prescribed semaglutide kept the weight off one year after discontinuation of the drug, while that same outcome was 55.7% of patients who took liraglutide.
    • “While the majority were able to maintain their weight or shed additional pounds, some did not, and the outcomes differed by medication type. 
    • “One year after discontinuation of semaglutide medications, 17.7% regained all the weight they had lost while on the medication, and some even gained additional weight. For liraglutide, 18.7% entirely regained their weight one year after halting use.
  • Medpage Today tells us,
    • “Infants born to unvaccinated mothers who had COVID-19 during pregnancy were at high risk for developing neonatal respiratory distress, the longitudinal, cohort COMP study found.
    • “The odds of developing respiratory distress were threefold higher (OR 3.06, 95% CI 1.08-10.21) in infants born to unvaccinated mothers diagnosed with COVID-19 while pregnant compared with COVID-exposed infants born to COVID-vaccinated mothers, Mary Catherine Cambou, MD, of the University of California Los Angeles (UCLA), and colleagues reported in Nature Communications.
    • “This was not something we were expecting to see, as none of the babies were diagnosed with COVID-19 themselves,” co-author Karin Nielsen-Saines, MD, also from UCLA, told MedPage Today in an email. “We also noted that respiratory distress was not transient and lasted several days.”
    • “However, when pregnant participants had received at least one mRNA vaccine dose prior to SARS-CoV-2 infection, the odds of their infants developing neonatal respiratory distress dropped to 0.33 (95% CI 0.10-0.96) — a 67% decline, the authors pointed out.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health have found overactivation in many brain regions, including the frontal and parietal lobes and the amygdala, in unmedicated children with anxiety disorders. They also showed that treatment with cognitive behavioral therapy (CBT) led to improvements in clinical symptoms and brain functioning. The findings illuminate the brain mechanisms underlying the acute effects of CBT to treat one of the most common mental disorders. The study, published in the American Journal of Psychiatry, was led by researchers at NIH’s National Institute of Mental Health (NIMH). 
    • “The findings can help our understanding of how and for which children CBT works, a critical first step in personalizing anxiety care and improving clinical outcomes,” said senior author Melissa Brotman, Ph.D., Chief of the Neuroscience and Novel Therapeutics Unitin the NIMH Intramural Research Program. * * *
    • “This study provide evidence—in a large group of unmedicated youth with anxiety disorders—of altered brain circuitry underlying treatment effects of CBT. The findings could, in time, be used to enhance treatment outcomes by targeting brain circuits linked to clinical improvement. This is particularly important for the subset of children who did not significantly improve after short-term CBT.
    • “The next step for this research is to understand which children are most likely to respond. Are there factors we can assess before treatment begins to make the most informed decisions about who should get which treatment and when? Answering these questions would further translate our research findings into clinical practice,” said Brotman.”
  • BioPharma Dive reports,
    • “An 11-year-old boy who was born deaf can hear after receiving an experimental gene therapy, developer Eli Lilly reported on Tuesday.
    • “The boy, identified as Aissam Dam by The New York Times, was the first participant treated in a small study Lilly is running to test the therapy, which is designed to correct a particular type of inherited hearing loss.
    • “While only from one person, the result is a striking example of gene therapy’s potential. According to Lilly, Dam experienced restored hearing across sound frequencies within a month of treatment. In some frequencies, Dam’s hearing was within the normal range at day 30, Lilly said.
    • “Lilly plans to present full data from Dam, as well as a second participant in its study, at a medical conference in early February.”

From the U.S. healthcare business front,

  • Healthcare Dive lets us know,
    • “Elevance Health raked in $6 billion in profit last year on revenue of more than $171 billion — a better performance than Wall Street expected, given that high medical costs have been dogging payers.
    • “The payer beat analysts’ consensus expectations for earnings and revenue in the fourth quarter of 2023, with a topline of $42.7 billion, up 7% year over year. Elevance’s fourth-quarter profit of $831 million was down, however, by 5% year over year.
    • “Elevance chalked its revenue growth up to higher premiums and growth in its pharmacy benefit manager CarelonRx. Analysts said the Indianapolis, Indiana-based payer also benefited from better-than-expected medical costs and higher investment income in the quarter.” 
  • and
    • “Walgreens is considering a sale of its specialty pharmacy business Shields Health Solutions as the struggling retail chain attempts to improve its halting finances, according to a Bloomberg report. 
    • “Shields could be valued at more than $4 billion in a sale, and a deal might appeal to private equity firms or healthcare companies, Bloomberg said, citing sources familiar.
    • “Walgreens is in the midst of a shift to focus on delivering healthcare services to payer, provider and pharmaceutical clients. But the company’s U.S. Healthcare division — which Shields is a part of — isn’t currently profitable.” 
  • and
    • “HCA Healthcare’s outpatient surgery operator Surgery Ventures has acquired majority interests in two ambulatory surgical centers in North Texas, the for-profit hospital operator announced on Monday.
    • “The centers are now affiliated with HCA subsidiary Medical City Healthcare, which runs 19 hospitals and 15 surgery centers in the region.
    • “The purchase comes after HCA, one of the largest hospital operators in the country, has made other recent acquisitions in Texas, which is one of the chain’s largest markets.” 
  • Per BioPhama Dive,
    • “Johnson & Johnson CEO Joaquin Duato sold 2023 as a “remarkable year” on an earnings call with investors Tuesday. But the pharmaceutical giant faces looming difficulties that hang over its performance, including incoming biosimilar competition to its blockbuster immune drug Stelara and a $700 million settlement over claims the company’s talc product caused cancer.
    • “As far as last year goes, J&J narrowly beat Wall Street’s expectations with $85.2 billion in revenue. Pharma sales grow 9.5% in the fourth quarter compared to the same period the year before. Cancer treatments and immunology medicines like Stelara made up the bulk of that revenue.
    • “As one of the largest pharma companies and often the first in the sector to report earnings each quarter, J&J is often considered a sort of bellwether for the industry.”
  • and
    • “Novo Nordisk is adding yet another prospect to its obesity drug pipeline, this time from a biotech company spun out of Harvard University and Zurich University. · EraCal Therapeutics tests compounds in larval zebrafish in a bid to trigger behavioral changes related to appetite while minimizing other effects in the body. The Swiss startup says it’s seen early success in mice and may be able to produce a drug that helps people lose weight without the side effects sometimes seen with current treatments. ·
    • “As part of the deal announced Tuesday, EraCal is eligible for payments worth as much as 235 million euros, or about $256 million, as well as royalties if a product reaches the market. The total includes an unspecified amount of money up front, as well as future payments tied to developmental and commercial milestones.”
  • North Carolina Public Radio reports
    • “The board that oversees the North Carolina State Health Plan will face a heavy decision Thursday when it considers dropping coverage of weight loss medications like Wegovy. * * *
    • “The State Health Plan is the health insurance plan for more than 740,000 teachers, state employees, retirees, and their dependents. It’s a massive health plan that paid more than $4 billion in claims last fiscal year, according to plan data.
    • “But even at that size, the high costs of these GLP-1 medications take an outsized bite of the pie. In 2023, the 24,750 people with prescriptions of Wegovy, Saxenda, and Zepbound cost the plan $102 million after rebates. In 2024, CVS Caremark, the plan’s pharmacy benefits manager, warned those rebates might lessen or go away completely, something that could push total costs north of $170 million. For context, as recently as 2019-20, the plan paid less than $790 million for all pharmacy claims for the entire fiscal year.”
  • Bolton consulting group identifies seven key employee benefit trends for this year.

Tuesday Tidbits

David Ermer–ACA, AHRQ, Congress, FDA, Federal employment benefits, OPM, Rx coverage, Telehealth, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Senator Chuck Grassley (R Iowa) announced that he and
    • Maria Cantwell (D-Wash.) are leading 12 of their colleagues in urging the Federal Trade Commission (FTC) to complete its investigation into the health care industry’s most powerful prescription drug middlemen. The bipartisan senators are also requesting a status update on the investigation, which has now been open for over 18 months.
    • “We support the [FTC’s] issuance of a Section 6(b) order and conducting a timely study of pharmacy benefits managers’ (PBM) business practices,” the senators wrote in their letter to FTC Chair Lina Khan. “With the FTC’s inquiry reaching its year-and-a-half mark, we urge the FTC to complete the study without delay. In the interim, we believe it is important to know the status of the study and therefore ask the FTC to issue a progress report.”  ***
    • Read the full letter HERE.
  • The Department of Health and Human Services informs us,
    • “On January 12th, U.S. Secretary of Health Xavier Becerra spoke with Canadian Health Minister Mark Holland regarding the recent announcement on commercial drug importation from Canada by U.S. states. During the call, they agreed to continue to discuss mechanisms and strategize on finding solutions to combat increasing drug prices to ensure that both Americans and Canadians have access to an affordable and stable drug supply.  Secretary Becerra and Minister Holland committed to keeping in close contact to ensure a mutually beneficial path forward.”
  • and
    • “On Monday, January 22, HHS and Pfizer leadership met virtually with health care provider groups, including the American Medical Association, American Academy of Family Physicians, and others – highlighting the pathways for a smooth transition of oral antivirals for COVID-19, including Paxlovid, to the commercial market and the importance of provider education and clear communication to consumers.
    • “During the call, HHS leadership reminded providers that no patient should be forced to pay the full out-of-pocket cost to access Paxlovid, regardless of their insurance status. Providers should take steps to ensure patients understand the full range of options when it comes to accessing these life-saving treatments and anyone who is facing difficulties at the pharmacy counter should be directed to the PAXCESS patient assistance program (PAP).”
  • Federal Manager tells us,
    • “The results from the fiscal year (FY) 2023 Human Capital Reviews show that Chief Human Capital Officers (CHCOs) want more resources, are making strides in implementing diversity, equity, inclusion, and accessibility (DEIA), and plan to use data more heavily in the future.
    • “The annual reviews probed CHCOs opinions in four areas: Workforce planning and analysis, Implementation of Executive Order 14035 (Advancing Diversity, Equity, Inclusion, and Accessibility), evaluation of system development, and innovation.”
  • Reg Jones, writing in FedWeek, discusses 2024 FEHB premiums and coverage.
  • BioPharma Dive points out,
    • “The makers of CAR-T cell therapies will need to warn about the risk of new blood cancer, the Food and Drug Administration said, following a review of reports involving so-called T cell malignancies following their use.
    • “In Jan. 19 letters to the manufacturers of six CAR-T therapies, the FDA said the prescribing information will need to include boxed warnings, the strongest type. In communication with industry executives, FDA officials have said they believe the benefits of these treatments, which are approved for types of lymphoma, leukemia and multiple myeloma, outweigh their risks.
    • “Since the FDA’s review began in late November, academic researchers have been probing the issue, too. One cell therapy advocacy group noted how the rate of 20 cases of T cell malignancies in roughly 34,000 CAR-T treated patients “is notably lower than that reported for more conventional alternative treatments.” The organization called for more studies to determine if some patients are at higher risk than others.”
  • The U.S. Preventive Services Task Force “concluded that the current evidence is insufficient to assess the balance of benefits and harms of screening for speech and language delay and disorders in children 5 years or younger.” The USPSTF previously gave the same recommendation to this service in 2015.

From the public health and medical research front,

  • Phrma, the drug manufacturer trade association, announced,
    • “2023 marked a five-year high for the number of new treatments and vaccines developed by the biopharmaceutical industry and approved by the U.S. Food and Drug Administration (FDA). According to new information from the FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), 71 novel treatments and vaccines were approved last year for people facing various cancers, certain rare diseases and more. Each new treatment represents new hope and progress for patients and their loved ones.”
  • CNN reports,
    • “Testing a person’s blood for a type of protein called phosphorylated tau, or p-tau, could be used to screen for Alzheimer’s disease with “high accuracy,” even before symptoms begin to show, a new study suggests.
    • “The study involved testing blood for a key biomarker of Alzheimer’s called p-tau217, which increases at the same time as other damaging proteins — beta amyloid and tau — build up in the brains of people with the disease. Currently, to identify the buildup of beta amyloid and tau in the brain, patients undergo a brain scan or spinal tap, which often can be inaccessible and costly.
    • “But this simple blood test was found to be up to 96% accurate in identifying elevated levels of beta amyloid and up to 97% accurate in identifying tau, according to the study published Monday in the journal JAMA Neurology.
    • “What was impressive with these results is that the blood test was just as accurate as advanced testing like cerebrospinal fluid tests and brain scans at showing Alzheimer’s disease pathology in the brain,” Nicholas Ashton, a professor of neurochemistry at the University of Gothenburg in Sweden and one of the study’s lead authors, said in an email.”
  • The Washington Post adds, “For some Alzheimer’s patients, vision problems may be an early warning. A large study brings fresh attention to a lesser-known variant of the disease called posterior cortical atrophy.”
  • The AP reports,
    • “New York City intends to wipe out more than $2 billion in medical debt for up to 500,000 residents, tackling a top cause of personal bankruptcy, Mayor Eric Adams announced Monday.
    • The city is working with RIP Medical Debt, a nonprofit that buys medical debt in bulk from hospitals and debt collectors for pennies on the dollar. The group targets the debt of people with low incomes or financial hardships and then forgives the amounts.
    • Under the program, the city will spend $18 million over three years.”

From the U.S. health care business front,

  • Beckers Hospital Review shares the latest HeathGrades top hospital lists.
    • “Healthgrades has recognized 250 hospitals nationwide for exceptional care via its “America’s Best Hospitals” awards, released Jan. 23.
    • “Three lists feature America’s 50, 100 and 250 best hospitals, which represent the top 1 percent, 2 percent and 5 percent of hospitals in the nation, respectively.”
  • STAT News reports,
    • “Steward Health Care, a for-profit health system that serves thousands of patients in Eastern Massachusetts, is in such grave financial distress that it may be unable to continue operating some facilities, according to public records and people with knowledge of the situation. The fast-moving crisis has left regulators racing to prevent the massive layoffs and erosion of care that could come if hospital services were to suddenly cease.
    • “Steward runs nine Massachusetts hospitals, mostly in Boston suburbs and underserved cities from the Merrimack Valley to the South Coast. But the national operator has shown escalating financial difficulties for at least the past three years, according to public records. This month, Steward’s landlord revealed in a news release that the health system hadn’t been paying its full rent for months and would contemplate selling off hospitals nationally.”
  • Healthcare Dive adds,
    • “Hospital Sisters Health System will close two hospitals and some health centers in Western Wisconsin following prolonged financial stress, the nonprofit system said Monday.
    • “HSHS will close St. Joseph’s Hospital and Sacred Heart Hospital around the end of the first quarter this year. The system also plans to close all the medical centers it operates in the region in partnership with multispecialty group Prevea Health by April 21, according to a release.
    • “The closures, which will impact roughly 1,400 HSHS and Prevea employees, will fully exit the faith-based heath system from the Western Wisconsin region.”
  • BioPharma Dive lets us know,
    • “Sanofi on Tuesday said it will acquire San Diego biotechnology company Inhibrx in a complex deal that could be worth up to $2.2 billion.
    • “The focus of the deal is an experimental drug Inhibrx is developing for a rare lung disease known as alpha-1 antitrypsin deficiency. Sanofi will acquire the drug via a buyout of Inhibrx following the spinout of the biotech’s other assets and employees into a new publicly traded company that will inherit the Inhibrx name.”
  • MedTech Dive notes that “Orthopedics leaders watch procedure backlog, new technologies in 2024. J&J, Medtronic and Smith & Nephew executives and orthopedic surgeons said they expect more procedures to move outpatient, while questions about pricing and procedure backlogs loom over the space.”
  • Per Beckers Hospital Review,
    • “Optum Perks, a prescription discount provider, has launched a new telehealth service that provides affordable healthcare and prescription treatments for conditions such as acne, cough and high blood pressure.
    • “The new service, with a starting cost of $25, allows patients to receive care at any time and can give them access to birth control, cold or flu medication and medication refills, without the need for scheduling or video chat, according to a Jan. 23 news release from Optum Perks. Optum Perks is part of RVO Health, a joint venture between Optum and Red Ventures.” 
  • Per Fierce Healthcare,
    • “Bitewell, a food-as-medicine company, has launched a new digital food “farmacy” to encourage members to buy healthy groceries and pre-made meals.
    • “The online store personalizes the food shopping experience based on members’ health conditions and goals. Members can access the offering through a participating health plan, wellness program or provider.
    • “Kelly’s Choice, a nutrition and health platform offering coaching and workplace wellness, is among the partners who will begin sponsoring Bitewell food farmacy memberships this month.”