Happy Hanukkah

U.S. Healthcare

Happy Hanukkah

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Hanukkah greeting template. Hand-drawn sketch illustration. Unsplash.

From Washington, DC,

  • The White House posted a fact sheet on the steps that the Administration is taking to lower health and prescription drug costs.
  • Following up on yesterday’s post, BioPharma Dive adds
    • The White House on Thursday took steps to pressure pharmaceutical companies to lower the price of drugs developed with federal funding, backing a plan that would enable the government to sidestep patent protections for those medicines.
    • New draft guidelines published by the National Institutes of Standards and Technology permit government agencies to consider “reasonableness of the price” when evaluating whether to invoke so-called march-in rights, which permit the government to suspend patents when federally funded inventions aren’t made available to the public.
    • The newly published framework gives agencies the power to act “if it appears that the price is extreme, unjustified, and exploitative of a health or safety need.” One example is a “sudden, steep price increase in response to a disaster,” although the initial cost of a drug when it’s launch can also be considered, the guidance said.
    • The agency is seeking further comment on its guidance — the product of an interagency review that began early this year — before publishing a final version.
  • The Senate Finance Committee leadership announced that “the Committee has reported legislation that was marked up in the committee in November. The “Better Mental Health Care, Lower-Cost Drugs, and Extenders Act” addresses a number of important health care priorities in the committee’s jurisdiction.”
    • “The final reported legislative text can be found here. A section by section summary can be found here.”
  • American Hospital News tells us,
    • “The House Energy and Commerce Committee Dec. 6 advanced 19 health care bills, including legislation (H.R. 6364) that would prevent Medicare from publicizing a telehealth provider’s home address when the provider delivers telehealth services from their home. AHA has additionally urged Congress to remove a requirement that these telehealth providers report their home address on Medicare enrollment and claims forms effective Jan. 1, 2025. 
    • “The committee also advanced H.R. 6545, as amended, which included provisions that were part of two other bills that had previously moved through the health subcommittee: H.R. 6366, to extend for one year the Geographic Practice Cost Index floor for physician work under the Medicare Physician Fee Schedule; and H.R. 6369, to extend the 3.5% incentive payment for eligible Advanced Alternative Payment Model participants for the calendar year 2026 period. AHA supports the extension, but would prefer Congress to restore the incentive payment to 5% and remove the legislation’s payment reductions for longstanding participants.”
  • MedPage Today offers insights into a December 5 Senate Finance Committee hearing on drug shortages.
  • The Government Accountability Office issued a report on “improper payments and fraud: how they are related but different.” OPM has focused FEHB carrier attention on this topic in 2023.

In federal benefit news,

  • FedWeek discusses how FEHB premiums compare for retirees versus employees.
  • Govexec reports,
    • “For the third time this year, the federal government’s backlog of pending retirement claims filed by departing federal workers hit a six-year low, as the Office of Personnel Management continues its focus on improving a process that has long pestered agencies and retirees alike.
    • “OPM reported Tuesday that its retirement backlog fell to 15,826 pending cases at the end of November. That’s the second time the inventory fell below 16,000 this year, and the third time this year that the backlog reached a six-year record low, dating back to when it briefly felt to around 14,000 in 2017. OPM’s goal is a “steady state” of 13,000 pending claims at any given time.
    • “In 2023, the retirement backlog has fallen in seven out of 11 months. Last month, the average processing time fell across multiple metrics. Measured on a monthly basis, the average processing time of a retirement claim fell from 73 days in October to 66 last month. And the average processing time so far this fiscal year—or since Oct. 1—fell from 73 at the end of last month to 69 days.”

From the public health and medical research front,

  • The Washington Post offers helpful advice on wounds that aren’t healing properly.
  • JAMA Network posts observations on GLP-1 drugs from last October’s Obesity Week meetings. Of note,
    • “Jacinda Nicklas, MD, MPH, gave a talk at the conference showing that females often respond better to newer antiobesity medications than males.
    • “Something that we’re gradually becoming more aware of over time is that GLP-1s, in general, seem to work better in females,” Nicklas, an associate professor of internal medicine at CU School of Medicine who specializes in obesity and women’s health, said in an interview with JAMA.
    • “Nicklas did not present new research, but instead combed through past studies of GLP-1 agonists. She said sex differences haven’t often been separated out in studies and that the majority of participants in the clinical trials are females.
    • “Digging into the data from the STEP trials of semaglutide, she said females had greater weight reduction than males. The same was true in a phase 2 clinical trial of retatrutide for treatment of obesity without type 2 diabetes. Participants who received the highest dose lost an average of 24% of their body weight but females lost much more: about 29% compared with about 20% for males.”
  • MedPage Today tells us that an “Alzheimer’s Blood Test Predicts Who Might Benefit Most From Anti-Amyloid Drugs — Novel two-cutoff approach may reduce need for confirmatory PET scans.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out that “U.S. News and World Report released a list December 5 recognizing hundreds of hospitals for maternity care.” Becker’s article includes that list.
  • Beckers Health IT notes,
    • “CVS is planning to release a new mobile healthcare app designed to function as a central hub for its healthcare services.
    • “The app, teased in a video at the company’s Dec. 5 investor meeting, can help consumers manage their prescriptions while providing access to informative health tips. 
    • “Some of the app’s other features include an augmented reality store navigation and a function that allows consumers to schedule appointments at CVS MinuteClinics and CVS-owned Oak Street Health. 
    • “An AI-powered chatbot will also be integrated into the app so consumers can get their questions answered.  
    • “CVS did not detail when the app would be released.”
  • The Wall Street Journal reports,
    • “Merck & Co. is ending a late-stage study of the combination of Keytruda and Lynparza in certain lung cancer patients due to an expected failure of the trial.
    • “The Rahway, N.J., drugmaker, which was evaluating Keytruda in combination with maintenance Lynparza in a Phase 3 study in patients with metastatic squamous non-small cell lung cancer, said it is stopping the trial for futility based on the recommendation of an independent data monitoring committee.”

Midweek update

David Ermer–Congress, COVID-19, Federal employment benefits, Medical / Rx research, NIH, OPM, Rx coverage, SDOH, U.S. Healthcare–
Photo by Hugo Clément on Unsplash

From Washington, DC

  • STAT New reports,
    • “The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, according to three sources familiar with the plans. It’s an early step that could have major ramifications for the American pharmaceutical industry, depending on whether and how federal officials actually use the authority.
    • “The administration will on Thursday issue a framework for the National Institutes of Health to more broadly use so-called “march-in rights” — a policy that allows it to seize patents from drugmakers whose products rely on federally funded research, according to the three people familiar with the plans. The framework will lay out when the agency might assert this authority, and endorse using a drug’s price in that determination, the sources said. * * *
    • “[T]he framework will likely include a number of conditions limiting its use, two sources said. The public — including pharmaceutical companies — will also get the chance to weigh in on the idea before it is finalized.”
    • Neverthless, the FEHBlog hears the litigation turbobillers revving up.
  • American Hospital Association News tells us,
    • “A bipartisan group of senators this week introduced the Protect Rural Seniors’ Access to Care Act, AHA-supported legislation that would prohibit the Health and Human Services Secretary from finalizing a proposed rule on minimum staffing for long-term care facilities.
    • “AHA has urged the Centers for Medicare & Medicaid Services not to finalize the rule and instead develop more patient- and workforce-centered approaches focused on ensuring a continual process of safe staffing in nursing facilities.
    • “Over 90 organizations have endorsed the bill, introduced by Sens. Deb Fischer, R-Neb., Roger Marshall, R-Kan., Jon Tester, D-Mont., James Lankford, R-Okla., Joe Manchin, D-W.Va., Roger Wicker, R-Miss., Kyrsten Sinema, I-Ariz., Susan Collins, R-Maine, and Angus King, I-Maine.
    • “Rep. Michelle Fischbach, R-Minn., introduced a House version of the bill in September.”
    •  Fingers crossed for the bill to enacted. The HHS rule is short sighted.

In FEHB Open Season news, Govexec, Federal News Network, and FedWeek offer tips for last-minute shoppers as we approach the end of the Federal Benefits Open Season next Monday. What’s more, FedWeek offers advice on protecting your survivor’s access to FEHB coverage.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Covid-19 test positivity rates increased over the summer and then stabilized earlier this fall. They have recently ticked back up, rising 1.2% for the latest week, according to the CDC’s most recent data. Emergency department visits and hospitalizations are up about 10% over the same period. 
    • “Scientists and public-health officials say that data understates the current virus spread and point to elevated levels of the virus detected in wastewater. Wastewater levels are an early warning for infections, with levels up nationally since mid-October. * * *
    • [Variant] JN.1 * * * is growing rapidly on a global level, says Jesse Bloom, a virologist and professor at Fred Hutchinson Cancer Center in Seattle. It has quickly spread in countries such as France and England. JN.1 has been detected in the U.S., though only as a blip.
    • Epidemiologist Katelyn Jetelina, a scientific adviser to the CDC and author of the “Your Local Epidemiologist” newsletter [available on Substack], says that while JN.1 isn’t growing as fast as the original Omicron in the winter of 2021-22, its current rate of growth could fuel a wave in Covid-19 cases. 
    • “If that rate continues, we should see dominance in the U.S. around Christmastime, which means that it would really jump-start a wave around New Year’s,” she says.
    • The good news, says Bloom, is that research indicates the new booster—developed to protect against the XBB variants that were dominant this summer—appears to work for the more mutated newer variants, too.
  • Here’s a link to the National Cancer Institute’s research newsletter.
  • Beckers Hospital Review informs us,
    • “More than a third of mothers — around 40 million women — are affected by lingering health issues after giving birth, according to a new study published Dec. 6 in The Lancet Global Health.
    • “However, many of the issues they report experiencing after giving birth extend long after they stop receiving postpartum care, which is where the major issues lie, according to the researchers.
    • “The authors found that after giving birth, 32% of women report low back pain, 19% experience anal incontinence, 11% experience perineal pain, 8-31% are affected by urinary incontinence, and around 11% are affected by secondary infertility issues. Mental health issues like anxiety and depression are also pervasive.”

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “Eli Lilly & Co.’s new weight-loss drug Zepbound is now available at US pharmacies, offering an alternative to rival medications like Novo Nordisk A/S’s Wegovy as supply issues persist. 
    • “Zepbound was approved by the US Food and Drug Administrationin early November as a treatment for people with obesity. Patients with a prescription from their doctor will now be able to get the drug, which was added to the list of available drugs for Express Scripts and Cigna Healthcare this month, Lilly said in a statement Tuesday.”
  • BioPharma Dive points out,
    • “AbbVie is restocking its drug pipeline in a big way, announcing Wednesday an $8.7 billion deal to buy neuroscience-focused Cerevel Therapeutics, just days after agreeing to a similar sized acquisition of the cancer biotechnology company ImmunoGen.
    • “Per the deal, AbbVie will pay $45 per share of Cerevel, which is developing medicines for schizophrenia, dementia and Parkinson’s disease. The buyout price is 22% higher than Cerevel stock’s closing price Wednesday and 73% above what shares closed at Friday, before rumors of a pending deal emerged. 
    • “Both companies’ boards of directors have agreed to the acquisition, which they expect will close sometime around the middle of next year.”
  • Per Fierce Healthcare,
    • “Elevance Health’s pharmacy benefit manager is launching a new digital pharmacy that aims to make it easier for members to track their prescriptions.
    • “CarelonRx Pharmacy will launch on Jan. 1, and members will be able to connect with pharmacists via text, chat or phone around the clock. The platform will also allow them to check the price of medications for comparison and track their prescriptions throughout the order process, similar to how a customer may follow a pizza order.
    • “The pharmacy will also use push notifications to keep members up-to-date on their prescriptions and will allow them to use text messaging to connect directly with representatives.”
  • and
    • “Many of the past year’s buzziest topics and omnipresent struggles will likely rear their heads as major talking points across 2024, per the year-ahead predictions of Deloitte’s healthcare industry heads.
    • “A disruptive pandemic, rapid digital transformation and mounting cost pressures have taken their toll on the industry’s decisionmakers, Deloitte’s healthcare sector leader Tina Wheeler and senior manager of its health solutions center Wendy Gerhardt wrote in a Wednesday outlook writeup.
    • “The pair highlighted a recent annual survey of 60 executives that found that only 3% of health system executives and 7% of health plan executives had a “positive” outlook for the coming year—down from the respective 15% and 40% of the prior year’s survey.
    • “However, there are some bright spots to consider as the industry undergoes convergence,” which the authors described as “the disruption of traditional health care stakeholders, entrance of new players like retailers and tech companies and the reassembly of a new ecosystem that creates opportunities.”
  • Health Payer Intelligence lets us know,
    • “Cardiovascular, diabetes, and obesity treatments are a critical part of women’s health, and employers can take steps to ensure that women have access to information and care related to their hearts, a flipbook from Northeast Business Group on Health (NEBGH) emphasized.
    • “With women comprising more than half of today’s workforce, employers are making women’s health and well-being a top priority, and rightfully so,” Candice Sherman, chief of executive officer of NEBGH, said in the press release.
    • “Cardiovascular disease in women is underdiagnosed and undertreated. Employers can play an important role in raising awareness and educating employees about heart disease and risk factors like diabetes and obesity as well as providing wellness and benefit programs that support women’s health. We developed this guide to give employers a tool to develop ways to improve the overall heart health of their workforce.”

Tuesday Tidbits

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

From Washington, DC

  • The Medicare open enrollment period ends on Thursday, December 7. The Federal Benefits Open Season ends next Monday, December 11. While the Affordable Care Act open enrollment period continues into next month, December 15 is the last day to enroll if you want your coverage to begin on January 1, 2024.
  • FEHB open season changes take effect on January 1, 2024, for annuitants and on January 14, 2024, for federal employees. January 14 is the beginning of the first pay period in 2024.
  • Govexec tells us,
    • “In a memo to agency heads on Friday, OPM Associate Director for Workforce Policy and Innovation Veronica Hinton announced that the government’s HR agency had added shared certification functionality to the agency-facing portion of USAJOBS through a tool called Talent Pools.
    • “The Office of Personnel Management is proud to announce a new USAJOBS feature, Talent Pools, to ‘advertise’ available shared certificates of candidates across government,” Hinton wrote. “These certificates, issued under delegated examining procedures through the Competitive Service Act or an OPM-run cross government hiring action, contain candidates who have applied to an open announcement, have been assessed and are available for agencies’ consideration.”
    • “Hinton argued that the new feature should be a boon to agency hiring managers and job applicants alike by removing unnecessary and often duplicative red tape.”
  • Federal News Network informs us,
    • “Federal employees working in cyber now have a way to develop skills, while also seeing what it’s like to work at another agency.
    • “In the hopes of boosting retention of cyber employees, the Office of Personnel Management launched a new platform Monday for agencies to advertise openings in the cyber workforce rotation program.
    • “The rotation program lets agencies offer temporary assignments to federal employees who are currently working in IT, cyber or cyber-related positions in government. Eligible employees can apply for and work at a different agency for between six months and one year before returning to their home agency.
    • “The cyber rotations will advance career opportunities and support employee engagement, satisfaction and retention,” OPM said.”
  • The U.S. Preventive Services Task Force released two draft recommendation statements for public comment.
    • “Grade B — The USPSTF recommends exercise interventions to prevent falls in community-dwelling adults age 65 years or older who are at increased risk for falls.
    • Grade C — The USPSTF recommends that clinicians individualize the decision to offer multifactorial interventions to prevent falls to community-dwelling adults age 65 years or older who are at increased risk for falls. Existing evidence indicates that the overall net benefit of routinely offering multifactorial interventions to prevent falls is small. When determining whether this service is appropriate for an individual, patients and clinicians should consider the balance of benefits and harms based on the circumstances of prior falls, presence of comorbid medical conditions, and the patient’s values and preferences.”
    • The public comment period on the draft recommendation statements and the related draft evidence reviews ends on January 8, 2024. These recommendations would continue the current grades for these recommendations, last issued in 2018.

From the public health and medical research front,

  • Per Beckers Hospital Review,
    • “Leapfrog is winding down 2023 by recognizing 132 hospitals with its Top Hospital Award, a distinction for hospitals that demonstrate the highest performance in the U.S. on quality and patient safety. 
    • “Awarded hospitals are divided into four groups: general hospitals (34), children’s hospitals (8), rural hospitals (15) and teaching hospitals (75). Methodologies for the awards in each category can be found here. Seventeen more hospitals were awarded this year compared to last.”
    • The article lists all 132 recognized hospitals by state.
  • and
    • United Health Foundation released its 2023 America’s Health Rankings Dec. 5, which analyzes the overall health of the 50 states and this year identifies a record-high and rising prevalence of chronic conditions. 
    • For the 2023 rankings, UHF analyzed 87 measures across five categories of health: social and economic factors, physical environment, behaviors, clinical care and health outcomes. This year, eight chronic conditions — arthritis, depression, diabetes, asthma, cancer, cardiovascular diseases, chronic obstructive pulmonary disease and chronic kidney disease — reached their highest levels since America’s Health Rankings began tracking these measures in 1990. 
  • STAT News reports,
    • “Given the widespread acceptance that the current flu vaccines could use improvement, are mRNA shots the answer? As the scientific world waits for published data on which to formulate conclusions, STAT spoke to influenza and vaccine experts who see some significant benefits of applying mRNA technology to the production of flu vaccine — but also some serious challenges mRNA manufacturers will face breaking into this already crowded market.” 
    • In short, it’s messy.

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “CVS Health, the nation’s largest drugstore chain, will move away from the complex formulas used to set the prices of the prescription drugs it sells, shifting to a simpler model that could upend how American pharmacies are paid. 
    • “Under the plan, CVS’s roughly 9,500 retail pharmacies will get reimbursed by pharmacy-benefit managers and other payers based on the amount that CVS paid for the drugs, in addition to a limited markup and a flat fee to cover the services involved in handling and dispensing the prescriptions. Today, pharmacies are generally paid using complex measures that aren’t directly based on what they spent to purchase specific drugs.
    • “A similar payment model, sometimes known as “cost plus,” has been promoted by entrepreneur Mark Cuban’s eponymous pharmacy company, among others, which have said it brings greater clarity and accountability to drug pricing.  * * *
    • “The company will call the payment model CostVantage. When it starts rolling out next year, the new prices will first become available to consumers paying cash for their prescriptions using an array of drug discount cards. 
    • “In 2025, the setup will be incorporated into CVS pharmacies’ contracts with pharmacy-benefit managers covering drugs paid for under employer plans.
    • “CVS will also introduce a new option for clients of its PBM, CVS Caremark, that will work in tandem with the new retail pharmacy-payment scheme. The new PBM product, called TrueCost, will be based on the net cost of drugs with defined fee structures, the company said. Employers and other clients will have the choice to use it or not.”
  • Fierce Healthcare adds,
    • “After spending nearly $20 billion to pick up Signify Health and Oak Street Health this year, CVS rebranded its health services business to “CVS Healthspire” as it plots its long-term growth strategy.
    • “During the Forbes Healthcare Summit in New York City on Monday, CVS chief executive officer Karen Lynch said Healthspire will encompass CVS’ pharmacy services business, its care delivery assets, including home health company Signify Health and Medicare-focused primary care player Oak Street Health, as well as its new Cordavis operation. Cordavis is a new segment CVS launched in August that aims to work with drugmakers to bring additional biosimilars to market.”
  • BioPharma Dive points out,
    • “Johnson & Johnson expects its pharmaceuticals division will bring to market 20 new therapies for cancer, immune and neurological diseases by 2030, an outlook that underpins the industry giant’s forecast for sales growth of between 5% and 7% through the end of the decade.
    • “Seven of those anticipated drugs have the potential to earn more than $5 billion each in peak annual sales, J&J said Tuesday as part of a business review held three months after the company split off its consumer division. The separation left J&J slimmer, but focused on its higher-margin pharmaceuticals and medical device businesses.
  • Per Healthcare Dive,
    • “Next year is set to be another “make or break” year for nonprofit hospitals as they continue to weather staffing shortages and heightened inflation, according to a report from credit ratings agency Fitch Ratings released on Tuesday.
    • “The outlook for the sector is still “deteriorating” — a rating that’s been in place since August 2022. Fitch does not forecast credit downgrades en masse in the coming year. However, downgrades and negative outlooks will likely continue to outpace upgrades and positive outlooks.
    • “The single largest differentiator in performance will be hospitals’ ability to attract and retain staff in a hypercompetitive landscape, said Kevin Holloran, Fitch senior director and sector head, in a statement.” 

Monday Roundup

David Ermer–CDC, Congress, COVID-19, Electronic health records, Employee Wellness Programs, Federal employment benefits, Medical / Rx research, Mental health care, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • STAT News informs us,
    • “The Senate health care committee will consider a sweeping bill next week meant to combat the opioid epidemic, according to four lobbyists and a congressional aide familiar with the legislation. 
    • “The proposal would reauthorize a number of programs first created by the SUPPORT Act, an addiction-focused bill that Congress first passed in 2018. Many of those programs’ authorizations expired earlier this year, however, leading addiction treatment advocates to fret that lawmakers — and specifically the committee’s chairman, Sen. Bernie Sanders (I-Vt.) — no longer view the issue as a priority.    
    • “If passed, the legislation would mark Capitol Hill’s first major action this year on the addiction crisis. Current data shows that roughly 110,000 Americans are dying of drug overdoses each year. Roughly 85,000 of those overdoses involve opioids.” 
  • The Department of Health and Human Services announced,
    • “Today, United States Surgeon General Dr. Vivek Murthy is launching the 5-for-5 Connection Challenge, calling on Americans to take five actions over five days to build more connection in their lives. Dr. Murthy recently issued this challenge to students across the country on his “We Are Made to Connect” College Tour, which concluded just last week. Now, as we enter the holiday season, the 5-for-5 Connection Challenge aims to inspire people of all ages to build, strengthen, and prioritize their relationships.
    • “For the next two weeks, from December 4th – December 15th, the Surgeon General will encourage people to take five actions over five days that express gratitude, offer support to, or ask for help from people in their lives. These types of actions are outlined in the Surgeon General’s Advisory on Our Epidemic of Loneliness – PDF as some of the ways that people can catalyze social connection. As outlined in the Advisory, social connection can advance physical, mental, and cognitive health, and it is even associated with a decreased risk of mortality.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration is evaluating the potential for plastic syringes made in China to suffer problems such as leaks and breakages.
    • “Officials began the investigation after receiving information about quality issues associated with “several Chinese manufacturers of syringes” that made them concerned that some devices “may not provide consistent and adequate quality or performance.”
    • “The FDA is advising consumers and healthcare providers to check where syringes are made and “consider using syringes not manufactured in China, if possible.” The advice applies to plastic syringes used for injecting fluids into, or withdrawing fluids from, the body.”

In FEHB Open Season news, Govexec offers helpful, last-minute advice from Kevin Moss.

From the public health and medicare research front,

  • U.S. News and World Report points out,
    • “After a period of limited change, COVID-19 activity is increasing again especially in the Midwest and Mid-Atlantic regions,” the CDC said in a report published Friday.
    • “Federal health officials are likely watching the increase given that they expect a “moderate” winter wave of coronavirus and this could be the start of it. Holiday gatherings and travel are also typically followed by an increase in coronavirus cases and hospitalizations.
    • “COVID-19 vaccination rates, meanwhile, have been disappointing for many.
    • “CDC Director Mandy Cohen told Congress this week that about 16% of Americans have gotten the updated COVID-19 vaccine.
    • “That’s not enough,” Cohen said.”
  • Beckers Hospital Review notes,
    • “So far this year, the CDC estimates there have been at least 1.8 million illnesses, 17,000 hospitalizations, and 1,100 deaths from flu in the U.S. 
    • “Influenza A continues to be the dominant strain in circulation, making up around 82% of cases, while influenza B is only accounting for around 18%. 
    • “Louisiana and South Carolina are still reporting the highest levels of flu activity in the country. 
    • “Nine states are experiencing high activity levels, but less than the two states above, including: California, New Mexico, Texas, Mississippi, Alabama, Georgia, Colorado, Florida and Tennessee. 
    • “Cases are also high in New York City and Puerto Rico.”
  • The Journal of the American Medical Association presented the following study results:
    • “Question  Is smoking still decreasing among US adults and do the trends vary by age, income, and race and ethnicity?
    • “Findings  In this cross-sectional study of 353 555 adults responding to the 2011 to 2022 National Health Interview Surveys, adults younger than 40 years had dramatic declines in smoking prevalence during the last decade, especially among those with higher incomes. In contrast, relatively slow declines were observed among adults aged 40 to 64 years, with no decrease in smoking among those 65 years or older.
    • “Meaning  These findings suggest that the precipitous decline in smoking among younger adults should be maintained, but that additional efforts are required to further reduce smoking in older adults.”
  • The American Medical Association explains “What doctors wish patients knew to improve their mental health.”
  • Per Endocrinology Advisor, “Decreased mortality risk is associated with concomitant reductions in glycated hemoglobin (HbA1c) and body weight among patients with type 2 diabetes, according to study results published in Diabetes Obesity and Metabolism.”

From the U.S. healthcare business front,

  • Fierce Healthcare profiles ten women of influence in U.S. healthcare. Check it out.
  • BioPharma Dive reports
    • “Roche on Monday agreed to acquire biotechnology company Carmot Therapeutics in a deal that bulks up the Swiss pharmaceutical giant’s pipeline with a group of weight loss drugs in early clinical testing.
    • “Roche will pay $2.7 billion upfront for the Berkeley, California-based Carmot. Roche could owe as much as $400 million more in future payments to Carmot shareholders, among them The Column Group and RA Capital, if certain milestones are met. The companies expect the acquisition to close next year.
    • “The deal hands Roche a trio of drugs in human testing for obesity, an area of pharmaceutical research that has been catalyzed by the success of weight loss medicines like Wegovy and Zepbound. Their progress has fueled a gold rush among large drugmakers, a number of which are either advancing in-house medicines or inking deals to acquire new prospects.”
  • and
    • “The Food and Drug Administration granted conditional approval to Eli Lilly’s oral cancer drug Jaypirca in two types of blood cancer, expanding its use from a rare type of lymphoma to people with leukemia and lymphoma patients who have previously received two other treatments, the company said Friday.
    • “Jaypirca is the fourth of a group of drugs called BTK inhibitors, a class that includes AbbVie and Johnson & Johnson’s Imbruvica and AstraZeneca’s Calquence. It gained approval earlier this year and posted $42 million in sales through Sept. 30.
    • “With this approval, Jaypirca can now be used in chronic lymphocytic leukemia or small lymphocytic lymphoma after patients have been treated with AbbVie and Roche’s Venclexta and another BTK inhibitor. Lilly said a Phase 3 trial meant to confirm Jaypirca’s accelerated approval has already met its primary goal.”
  • HR Dive discusses “Why EAPs go unused despite growing mental health awareness; Many factors contribute to the historic underutilization of employee assistance programs, despite their value as an access point to quality care.”
  • Medscape offers an infographic on how doctors grade their EHR systems while MedCity News explains how improved coding quality by healthcare providers can prevent denials and improve cash flow.
  • Health Payer Intelligence adds,
    • “Payers are investing in healthcare IT resources to support cost optimization and improve member experience, according to a study from EY-Parthenon and KLAS Research.
    • “As payers face operational and financial pressures, they are turning to healthcare IT solutions for help. Researchers sought to understand what strategies payers prioritize, how much they spend on healthcare IT resources, and what future investments look like.
    • “The study findings reflect responses from over 100 executives across payer entities serving commercial, Medicare, and Medicaid populations. Around 70 percent of respondents were traditional payers; the remaining were provider-sponsored, third-party administrators, and management services organizations.”
  • According to Healthcare Dive,
    • “A merger between major health insurers Cigna and Humana would go through the wringer of an intense antitrust review, but could come out finalized, experts say.
    • “Though, to receive the regulatory green light, a combined company would probably have to emerge looking different from the Cigna and Humana of today. * * *
    • “Gaining regulatory approval — especially if a challenge further ties up the process in the courts — could set a deal’s finalization back by a year or more. But, due to a lack of direct competition between the two, Cigna and Humana could be allowed to combine, creating a healthcare powerhouse with roughly $300 billion in annual revenue.”
  • and
    • “For-profit hospital chain HCA Healthcare’s Houston affiliate announced last week it completed its acquisition of 11 free-standing emergency departments from SignatureCare Emergency Centers. 
    • “HCA Houston Healthcare, which operates a network of 13 hospitals and nine outpatient surgery centers, now has 26 free-standing emergency departments in the area in addition to hospital-based emergency rooms, according to a Friday press release.
    • “The SignatureCare centers will be re-branded to HCA Houston ER 24/7. Financial terms of the deal were not disclosed.
  • and
    • “Rural hospital chain Lifepoint Health and Ascension Saint Thomas announced a joint venture last week to co-own Highpoint Health, a four-hospital system in Tennessee currently operated by Brentwood, Tennessee-based Lifepoint.
    • “The hospitals and care sites will be co-branded with Ascension Saint Thomas, but will be majority-owned and operated by Lifepoint, according to the release. The companies declined to comment on the cost of the buy-in.
    • “The health systems have partnered before. Ascension Saint Thomas partnered with Kindred Rehabilitation Services, a Lifepoint business unit, in 2022 to jointly own Ascension Saint Thomas Rehabilitation Hospital in Nashville.” 

Friday Factoids

David Ermer–AHRQ, CDC, COVID-19, Medical / Rx research, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Yesterday, OPM’s Office of Inspector General posted its Semi-annual Report to Congress for September 30, 2023. OPM has not yet posted its Management Response thereto.
  • The HHS Office of Inspector General also issued its latest Semi-annual Report to Congress.
  • Federal News Network reports that federal employees in Japan continue to experience healthcare access problems.
  • The Director of HHS’s Agency for Healthcare Research and Quality explains how the Biden Administration is tackling financial strains on healthcare consumers.

From the public health and medical research front,

  • Beckers Clinical Leadership tells us,
    • “CDC Director Mandy Cohen, MD, said the season of respiratory syncytial virus is in “full swing” as flu slowly begins and COVID-19 leads the most hospitalizations and deaths, CNN reported Nov. 30. 
    • “What to know about COVID-19, RSV and flu:
      • “COVID-19: Dr. Cohen said while COVID-19 is “relatively low,” it remains the primary reason for new respiratory admissions and deaths. In November, each week saw between 14,000 and 18,000 hospitalizations and about 1,000 deaths. 
        • “The CDC revealed a new wastewater data tracking dashboard to track local and national trends per variant, and the dashboard also tracks mpox viruses. 
        • “Between Nov. 1 and Nov. 20, the most recent CDC information available, the proportion of wastewater sites reporting high increases of SARS-CoV-2 samples grew from 22% to 32%. During the same time, the proportion of wastewater sites finding decreasing samples slimmed from 60% to 49%. 
      • RSV: “Hospitalizations for RSV have been slightly rising, with RSV accounting for 0.5% of all hospitalizations in late October and 0.8% as of Nov. 18, according to the CDC. Ten states and New York City are reporting high levels of respiratory virus activity. Louisiana and South Carolina reported “very high” respiratory virus activity levels and Alabama, California, Colorado, Florida, Georgia, Mississippi, New Mexico and Texas are seeing “high” levels.
      • Flu: “The flu season is beginning as national estimates reveal 3.9% of healthcare visits were for flu for the week ending Nov. 25, a 0.2 percentage point increase from the prior week.  Most of the U.S. is reporting an increase in flu, with hot spots appearing in the South Central, Southeast, Mountain and West Coast regions. Twenty-five states and territories are reporting minimal flu activity.
        • “Hospitalizations for flu have grown for the third consecutive week.” 
  • The Wall Street Journal reports,
    • “The Centers for Disease Control and Prevention is urging people to avoid eating certain cantaloupe products amid a salmonella outbreak that has resulted in at least two deaths in the U.S.
    • “At least 117 people across 34 states have become sick after eating contaminated cantaloupe since mid-October, according to the CDC. At least 61 people have been hospitalized and two have died in Minnesota. The federal agency said the number of people sickened by the outbreak is likely much higher.
    • “The agency said it’s particularly concerned about the outbreak because the illnesses have been severe and some have occurred in long-term-care facilities and child-care centers. Fourteen people in long-term-care facilities and seven children who attended child-care facilities have been sickened, the CDC said.”
  • STAT News informs us,
    • “Advances in treatments for congenital heart abnormalities mean more patients are living into adulthood, with over 2 million adults estimated to have the condition in the U.S. But that means more are also developing heart failure as they grow older — and many aren’t receiving proper care.
    • “A new study published this week in the Journal of the American Heart Association found that while hospitalizations of adults with congenital heart disease stayed stable from 2010 to 2020, the proportion of admissions for those who have heart failure more than doubled from 6.6% to 14%.
    • “These patients with heart failure also had worse outcomes after hospitalization, with an 86% higher risk of death, a 73% higher risk of major heart and brain complications, and a 26% higher risk of hospital readmission.
    • “The findings suggest that adults with congenital heart disease who also have heart failure are an especially high-risk population, and they may need closer monitoring and unique treatment regimens.”
  • Health Day offers these key takeaways from recent study results:
    • “Sticking to your scheduled mammograms can significantly reduce your risk of death from breast cancer
    • “Women who got all their scheduled mammograms had a 66% to 72% reduced risk of breast cancer death
    • “Regular mammograms make it more likely that breast cancers can be caught early, when they are more treatable.”
  • Mercer Consulting discusses why an end to HIV in our country is in sight and shares five ways to address HIV in the workplace.
  • The American Hospital Association News adds
    • “Nine out of 10 people receiving medical care for HIV through the Ryan White HIV/AIDS Program in 2022 were virally suppressed, meaning they cannot sexually transmit the virus if they take their HIV medication as prescribed, according to the latest annual data from the Health Resources and Services Administration program.”

From the U.S. healthcare business front,

  • EBRI posted Fast Facts about the changing nature of primary care in our country.
    • “Among users of primary care, 95–97 percent utilized it in an office setting prior to 2020, but only 86 percent did so from 2020–2021 as employees began using telemedicine (7–8 percent) and urgent care clinics (3–4 percent) with greater frequency due to the COVID-19 pandemic.
    • “There has been a consistent downward trend in the share of employees whose primary care office visits are at a general/family practice, falling from 42 percent in 2013 to 37 percent in 2021. In addition, primary care office visits at internal medicine providers have fallen from 21 percent in 2013 to 17 percent in 2021.
    • “Finally, the provision of primary care by a medical doctor has fallen from 9 percent in 2013 to 4 percent in 2021. In contrast, primary are provision by nurse practitioners and physician assistants has risen over time. The share of employees whose primary care office visits have been with a physician assistant rose from 2 percent in 2013 to 6 percent in 2021.
    • “The corresponding change for nurse practitioners has been from 4 percent in 2013 to 16 percent in 2021.”
  • BioPharma Dive lets us know,
    • “Pfizer will not advance a twice-daily dose of an experimental obesity drug into further testing after results from a mid-stage study showed high rates of gastrointestinal side effects and participant dropout. 
    • “Treatment did lead to significant weight loss compared to placebo over the course of the Phase 2b study. Placebo-adjusted reductions in body weight ranged from 8% to 13% at 32 weeks, Pfizer said in a statement Friday. Discontinuation rates were more than 50% on some drug doses, however.
    • “Moving forward, Pfizer will turn its focus to a once-daily version that’s currently being tested in a study meant to determine how the drug’s processed by the body. Data are expected in the first half of next year.”
  • Healthcare Dive reports,
    • “Community Health Systems announced on Friday it has completed the sale of three Florida hospitals to Tampa General Hospital for about $294 million in cash.
    • “The deal includes 120-bed Bravera Health Brooksville, 124-bed Bravera Health Spring Hill and 128-bed Bravera Health Seven Rivers, as well as their associated assets, physician clinic operations and outpatient services, according to a press release.
    • “The sale allows the for-profit hospital operator to “deliberately focus our resources in markets that we deem as most investable and that can produce greater growth and returns over the long term,” CHS CEO Tim Hingtgen said during a call with investors shortly after the divestiture was announced this summer.” 
  • MedCity News explains how payers can break down barriers that prevent access to value-based virtual care.
  • Per Fierce Healthcare,
    • Daniel Jones, who pens the investment newsletter Crude Value Insights, wrote in an analysis that because Cigna and Humana have fairly different focuses despite both being large health plans, there is potential that the merger could be viewed as more of a vertical deal than a horizontal one, which is less likely to stymie competition.
    • Cigna is a far smaller player in the Medicare Advantage space while Humana’s insurance business is overwhelmingly centered in MA. Humana, meanwhile, has limited reach in the commercial market, where Cigna has a far greater footprint.
  • Beckers Payer Issues adds,
    • “The sale of Cigna’s Medicare Advantage business would remove one hurdle in the company’s reported goal to merge with Humana, and Health Care Service Corp. might be part of that equation, Bloomberg reported Nov. 29.”

Thursday Miscellany

David Ermer–Congress, COVID-19, Medical / Rx research, No Surprises Act, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec tells us,
    • “A House panel on Wednesday hosted another spirited hearing over the role of telework and remote work at federal agencies, with Democrats and agency officials extolling the practices’ impact in improving productivity to skeptical GOP lawmakers.
    • “The House Oversight and Accountability Committee’s subcommittee on government operations and the federal workforce held its long-awaited second hearing on federal agencies’ “post-pandemic” telework policies. In September, the subcommittee heard testimony from HR leaders at agencies that made a “good faith effort” to comply with the panel’s information requests on telework, and Republican committee leaders suggested Wednesday’s hearing was designed to hear from agencies whose submissions were found wanting.
    • “It is difficult for me to understand why [these agencies’] responses looked like nothing more than them phoning it in,” said Subcommittee Chairman Pete Sessions, R-Texas. “This is a serious effort by the subcommittee. It has produced questions across both sides of the aisle. Either these agencies simply do not know the answers to some or all of the questions asked, or perhaps they just don’t want to share it.”
  • The American Hospital News reports,
    • The Departments of Health and Human Services, Labor and the Treasury will give healthcare providers and insurers initiating a payment dispute through Jan. 16 under the No Surprises Act’s Independent Dispute Resolution process 10 business days to select a certified IDR entity after initiating the dispute, the Centers for Medicare & Medicaid Services announced Nov 29. 
    • “Following the reopening of the Federal IDR portal on October 6, 2023, to certain new single disputes, including disputes involving bundled payment arrangements, but excluding disputes related to air ambulance services, the Departments extended the certified IDR entity selection timeline to 10 business days until November 3, 2023,” CMS explained. “Following the expiration of that extension and the return to the three-business-day timeline, numerous disputing parties have requested that the timeline temporarily return to 10 business days. Accordingly, the Departments are announcing that disputing parties will have 10 business days to select a certified IDR entity for all disputes through January 16, 2024. This extension will be provided automatically and does not require a request by disputing parties.”
  • The U.S. Preventive Services Task Force released for public comment a draft research plan for assessing the value of screening for HIV. The public comment period ends on January 3, 2024.

In FEHB Open Season news, Tammy Flanagan, writing in Govexec, discusses the Medicare Advantage plans that may FEHB carriers have integrated into their FEHB plans.

From the public health and medical research front,

  • The New York Times looks back at the Omicron variant of Covid which has been with us for two years now. While the earlier commanding Covid variants caused dangerous lower respiratory infections, Omicron causes more manageable upper respiratory infections.
  • Medscape informs us about encouraging developments that may lead to long Covid tests.
    • “[A] new preprint study suggests that the elevation of certain immune system proteins are a commonality in long COVID patients and identifying them may be an accurate way to diagnose the condition.
    • “Researchers at Cardiff University School of Medicine in Cardiff, Wales, United Kingdom, tracked 166 patients, 79 of whom had been diagnosed with long COVID and 87 who had not. All participants had recovered from a severe bout of acute COVID-19.”
  • STAT News reports,
    • “The rosiest of revenue projections for treatments like Wegovy and Zepbound rely on a future in which their use goes beyond diabetes and obesity and into Alzheimer’s disease and substance use disorders. But GLP-1 drugs’ pathway to pharmaceutical ubiquity is a little cloudier than it might seem.
    • “Take for example alcohol use disorder, or AUD. This week, a case study published in the Journal of Clinical Psychiatry reported that six patients diagnosed with AUD received Wegovy for weight loss and experienced significant reductions in their symptoms, sparking more interest in the potential of GLP-1 treatments in addiction. According to Leerink analyst David Risinger, there are at least six other mid-stage studies testing whether Novo Nordisk’s drug can treat AUD or nicotine dependence, each reading out in the coming years.
    • “The problem is that not one of those studies is sponsored by Novo, which has been noncommittal about running the costly, large-scale trials that would be required to win FDA approval in addiction. Physicians could prescribe a GLP-1 drug off-label, but manufacturers are already struggling to meet demand for patients with diabetes or obesity, leaving little supply for speculative indications.”
  • MedPage Today points out,
    • “Younger onset age of coronary heart disease was tied to higher risks of incident all-cause dementia, Alzheimer’s disease, and vascular dementia, a large prospective cohort study in Great Britain showed.
    • “Each 10-year decrease in coronary heart disease onset age was associated with a 25% increased risk of all-cause dementia, a 29% increased risk of Alzheimer’s disease, and a 22% increased risk of vascular dementia (all P<0.001), reported Fanfan Zheng, PhD, of the Chinese Academy of Medical Sciences and Peking Union Medical College in Beijing, and co-authors in the Journal of the American Heart Association.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “The United States faces a serious shortage of primary care physicians for many reasons, but one, in particular, is inescapable: compensation.
    • “Substantial disparities between what primary care physicians earn relative to specialists like orthopedists and cardiologists can weigh into medical students’ decisions about which field to choose. Plus, the system that Medicare and other health plans use to pay doctors generally places more value on doing procedures like replacing a knee or inserting a stent than on delivering the whole-person, long-term healthcare management that primary care physicians provide.
    • “As a result of those pay disparities, and the punishing workload typically faced by primary care physicians, more new doctors are becoming specialists, often leaving patients with fewer choices for primary care.
    • “There is a public out there that is dissatisfied with the lack of access to a routine source of care,” said Christopher Koller, president of the Milbank Memorial Fund, a foundation that focuses on improving population health and health equity. “That’s not going to be addressed until we pay for it.”
  • and
    • “Renton, Washington-based Providence’s operations tallied $310 million of net losses (-4.3% operating margin) during the third quarter and now sit $857.3 million in the hole (-4% operating margin) through nine months, according to filings and other financial information released this week by the nonprofit.
    • “Providence’s leadership was quick to highlight the system’s performance improvements relative to 2022, when the Catholic organization had posted a nearly $1.1 billion operating loss (-5.6% operating margin) across nine months.
    • “Rising demand, reduced length of stay, lower premium pay and better workforce retention and recruitment each helped Providence chip away at the losses, the organization wrote in an accompanying release, though lingering expense pressures and revenue roadblocks still held operations below break even.”
  • and
    • “The Cleveland Clinic logged another negative operating margin and nine figures of net losses during the three months ended Sept. 30, according to unaudited financial statements released this week.
    • “The nonprofit reported a $14.9 million operating loss (-0.4% operating margin) for the third quarter of 2023.
    • “This was an improvement over the same period in 2022, when the system logged a $28.3 million operating loss (-0.9% operating margin), and a narrow increase over the $21.4 million operating loss (-0.6% operating margin) of the immediately preceding quarter.
    • “In commentary accompanying the results, Cleveland Clinic’s management highlighted a 10.1% year-over-year rise in third-quarter operating revenue that outpaced the 9.6% bump in operating expenses.”
  • Beckers Payer Issues notes,
    • “Blue Cross Blue Shield of Arizona is looking to the payer-provider example set by Kaiser Permanente as the Phoenix-based company expands its primary care subsidiary Prosano Health Solutions, the Phoenix Business Journal reported Nov. 20.
    • “BCBSAZ opened its first Prosano facility in Maricopa County this year, with several more locations opening in the Phoenix area in 2024. Prosano launched in January for BCBSAZ employees, with 1,800 employees and their dependents enrolling. 
    • “A new health plan, the BlueSignature Prosano PPO plan, will be offered to employer groups in 2024 and provide access to the Prosano care centers. The new care centers offer access to a primary care team, behavioral health practitioners, lab services, same-day appointments, virtual options, and a selection of the most needed prescriptions. An expansion to Tucson is planned for 2025.”
  • MedPage lets us know,
    • “Optum Health now counts 90,000 doctors — some 10% of the physician workforce — as employees or affiliates, company leadership announced.
    • “The company, which is a part of UnitedHealth Group, said during an investor conference on Wednesday that it acquired or hired nearly 20,000 doctors in 2023 alone, according to reports. It also counts an additional 40,000 advanced practice clinicians among its ranks.
    • “The figures, reported by Amar Desai, MD, CEO of UnitedHealth’s Optum Health division, make Optum Health the largest employer of physicians in the U.S., and UnitedHealth is the country’s largest private health insurer.”
  • STAT News reports,
    • “AbbVie will pay $10 billion for the biotech firm Immunogen, the company said Thursday, acquiring an approved treatment for ovarian cancer and buying into a burgeoning area of oncology.
    • “Under the agreement, AbbVie will pay $31.26 per share in cash for Immunogen, a nearly 100% premium to the company’s recent trading price. Central to the deal, expected to close in the middle of next year, is Elahere, an Immunogen product that won Food and Drug Administration approval for advanced ovarian cancer in 2022.
    • “Elahere is among a surging class of cancer medicines called antibody-drug conjugates, or ADCs, which are designed to deliver a targeted dose of chemotherapy directly to tumor cells while sparing healthy tissues. AbbVie’s acquisition is the latest multibillion-dollar deal in the space, following Merck’s $22 billion agreement with ADC specialist Daiichi Sankyo and Pfizer’s $43 billion buyout of Seagen earlier this year.”

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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


 

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Monday Roundup

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Thanksgiving Weekend Update

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

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

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

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

From the public health front,

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

From the U.S. healthcare business front,

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