Thursday Miscellany

CDC

Thursday Miscellany

David Ermer–CDC, CMS, Congress, Medical / Rx research, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington, DC

  • Think Advisor lets us know,
    • “The U.S. House of Representatives voted 211-208 on Wednesday to pass H.R. 485, the Protecting Health Care for All Patients Act of 2023.
    • “The bill would prohibit federal health programs — including Medicare, Medicaid and the Federal Employees Health Benefits Program — from using a “quality-adjusted life year” measure or similar measures when allocating resources.
    • “All Republicans who voted supported the bill, and all Democrats who voted opposed it.
    • “The bill was introduced by Rep. Cathy McMorris Rodgers, R-Ore.”
  • Roll Call reports,
    • “House Energy and Commerce Chair Cathy McMorris Rodgers, a 10-term Republican from Washington state who has been a strong advocate for people with disabilities, announced Thursday she would not seek reelection this year.
    • “It’s been the honor and privilege of my life to represent the people of Eastern Washington in Congress. They inspire me every day,’’ Rodgers said in a statement. “After much prayer and reflection, I’ve decided the time has come to serve them in new ways. I will not be running for re-election to the People’s House.”
    • “The announcement comes as Rodgers is leading negotiations with the Senate on a wide-ranging health care package that touches all parts of the industry. The legislation would implement more transparency in data and pricing for prescription drugs and other medical services.”
  • BioPharma Dive informs us,
    • “The CEOs of three major drugmakers defended the prices they charge U.S. patients in a Senate [Health Education Labor and Pensions] committee hearing Thursday, claiming Americans gain access to cutting-edge medicines months or years earlier than people in countries that pay a fraction of the U.S. costs. * * *
    • “Sen. Ben Ray Luján, D-N.M., asked the CEOs to pledge to not block entry of generics or biosimilars to the respective drugs in the spotlight when their primary patents expire, which Merck and Bristol Myers agreed to. That question in the case of Bristol Myers Squibb was focused Opdivo, its cancer immunotherapy rival to Keytruda.
    • “For Merck, Davis committed to open competition with any forthcoming biosimilars of intravenous Keytruda. But he didn’t mention the company is trying to develop and launch a subcutaneous, or under-the-skin, version that would likely extend its market advantage beyond the anticipated 2028 expiration of its main patent. Bristol Myers is also working on subcutaneous Opdivo.
    • “Questioned by Luján on settlements that have pushed the launch of biosimilar Stelara to 2025, J&J’s Duato said the price of the drug will be lower when that happens and added that prices net of rebates have dropped ahead of biosimilar competition.”
  • Bloomberg reports,
    • “The pharmaceutical industry, Trump and Obama administration officials, and others are urging the Biden administration to reconsider a controversial plan for seizing patents on a drug when its cost gets too high, claiming the approach misinterprets decades-old law and threatens the delicate pipeline that produces innovative, life-saving drugs.
    • “Over 500 comments were filed by the Feb. 6 deadline for groups and individuals to weigh in on the Biden administration’s framework for the federal government to use its march-in rights. The proposal lays out the Biden administration’s stance in a longstanding debate over whether price is a justifiable reason for the government to “march in” and take over a patent on technology developed with the help of taxpayer dollars and then license it to an outside manufacturer.
    • “The Biden plan is already drawing blowback from a broad swath of players in the innovation space. A collection of former US Patent and Trademark Office directors and other government officials under the George W. Bush, Obama, and Trump administrations wrote to warn that the proposed framework, if adopted, would prove destabilizing.”
  • Per an HHS press release
    • “The Department of Health and Human Services’ Office of Intergovernmental and External Affairs (IEA) will be hosting a stakeholder webinar TOMORROW, February 9, 2024, from 2 – 3 PM ET to provide an update on patient privacy.  
    • “Today, the U.S. Department of Health and Human Services, through its Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA), finalized modifications to the Confidentiality of Substance Use Disorder (SUD) Patient Records regulations at 42 CFR part 2 (“Part 2”), which protect the privacy of patients’ SUD treatment records. Specifically, today’s final rule increases coordination among providers treating patients for SUDs, strengthens confidentiality protections through civil enforcement, and enhances integration of behavioral health information with other medical records to improve patient health outcomes.
    • “Today’s rule was informed by the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that, among other things, required HHS to bring the Part 2 program into closer alignment with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy, Breach Notification, and Enforcement Rules.
    • “The final rule includes the following modifications to Part 2:
      • “Permits use and disclosure of Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
      • “Permits redisclosure of Part 2 records by HIPAA covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
      • “Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
      • “Expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
      • “Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
      • “Outlines new breach notification requirements applying to Part 2 records.”
    • “A fact sheet on the final rule may be found at: https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html“
    • Register in advance for this webinar: REGISTER HERE  
  • Govexec tells us,
    • “The U.S. Postal Service was $2 billion in the red in the first three months of fiscal 2024—typically its busiest and most profitable period of the year—doubling its loss from the same period in the previous year. 
    • “The accelerated losses during the holiday season continue a longstanding trend of poor financial performance for the mailing agency, but mark a troubling sign as its leadership team undertakes significant operational transformations with a promise to right the ship.
    • “In a positive development, however, USPS turned a net profit of $472 million when accounting only for the part of the ledger postal management deems within its control. That figure, which does not include fluctuations in workers’ compensation and amortized payments toward employee retirement accounts, grew from $187 million in the first quarter of the prior year.” 
  • The U.S. Office of Personnel Management announced,
    • “[t]he Finalists for this year’s Presidential Management Fellows (PMF) Program, the federal government’s premier leadership development program. In total, 825 Finalists were selected from more than 7,000 applicants from around the world. 
    • “Presidential Management Fellows are the next generation of federal government leaders,” said Kiran Ahuja, Director of OPM. “The PMF Program gives Fellows the leadership skills and exposure they need to make a difference in government and an impact within their community. Congratulations to all the 2024 PMF finalists. We cannot wait to see what you will accomplish in public service.” 

From the public health and medical research front,

  • Medscape points out,
    • “Brain fog is one of the most common, persistent complaints in patients with long COVID. It affects as many as 46% of patients who also deal with other cognitive concerns like memory loss and difficulty concentrating. 
    • “Now, researchers believe they know why. A new study has found that these symptoms may be the result of a viral-borne brain injury that may cause cognitive and mental health issues that persist for years.
    • “Researchers found that 351 patients hospitalized with severe COVID-19 had evidence of a long-term brain injury a year after contracting the SARS-CoV-2 virus. The findings were based on a series of cognitive tests, self-reported symptoms, brain scans, and biomarkers.” 
  • STAT News reports,
    • “People receiving a double dose of naloxone are no more likely to survive an opioid overdose than people receiving a standard, 4-milligram nasal spray, according to a new study.
    • “The new paper, published Thursday in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report, showed no significant difference in survival rates between people who were revived using 4- and 8-milligram sprays of naloxone, commonly known by the brand name Narcan. People receiving the smaller dose also did not require a higher total number of sprays, despite having received just half the initial amount. The researchers found only one major contrast between those receiving different dose sizes: Those who received a double dose were over 2.5 times more likely to experience severe withdrawal symptoms, like vomiting.
    • “The study comes as pharmaceutical companies continue to market expensive high-dose formulations of naloxone, arguing that amid record drug death levels resulting from potent synthetic opioids like fentanyl, it’s essential to deliver as much of the overdose-reversal medication as possible. Public health experts and harm-reduction groups have pushed back, however, charging that the companies have used Americans’ fear of fentanyl as an excuse to sell needlessly expensive naloxone products to cash-strapped public health agencies.”
  • Beckers Hospital Review reports,
    • “Patients who take Ozempic, Mounjaro and Wegovy are less likely to be diagnosed with anxiety or depression compared to those who don’t receive the popular diabetes and weight loss drugs, according to a new study. 
    • “A review of more than 4 million patient records conducted by Epic Research found that diabetic patients are less likely to have anxiety if they are taking any glucagon-like peptide-1 receptor agonist. 
    • “The researchers analyzed five different GLP-1s: tirzepatide (Mounjaro, Zepbound), semaglutide (Ozempic, Wegovy, Rybelsus), dulaglutide (Trulicity), liraglutide (Saxenda, Victoza) and exenatide (Byetta, Bydureon). 
    • “The patients taking GLP-1s for weight loss were compared with those receiving another kind of weight loss drug, and diabetic patients were compared with people not taking a GLP-1.”
  • The American Hospital Association News notes how you can “[l’earn how hospitals and health systems are improving maternal and child health outcomes in this synopsis of the latest resources from AHA’s Better Health for Mothers and Babies initiative. READ MORE.”
  • The NIH Director discusses in her blog “What’s Behind that Morning Migraine? Community-Based Study Points to Differences in Perceived Sleep Quality, Energy on the Previous Day.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • AstraZeneca sees its revenue and core earnings per share growing by double-digit percentages in 2024, the pharmaceuticals major said as it reported fourth-quarter core earnings per share below expectations on higher costs, sending the stock lower.
  • CNBC discusses how “Novo Nordisk, Eli Lilly are tackling weight loss drug supply woes.”
    • “Last week, the Danish drugmaker [Novo Nordisk] said it had more than doubled its supply of lower-dose versions of its weight loss injection Wegovy in January compared to previous months. Supply shortages forced Novo Nordisk to restrict the availability of those lower doses in the U.S. since May. 
    • “But why are those lower doses important? It’s because people are supposed to start Wegovy at a low dose and gradually increase the size over time to mitigate side effects such as nausea. So, more of those low “starter” doses means more new patients can begin treatment with Wegovy. 
    • “The company plans to “gradually” increase the overall supply of Wegovy throughout the rest of the year, executives added on the company’s fourth-quarter earnings call Wednesday.”
  • Per Healthcare Dive,
    • “UnitedHealth’s chief operating officer Dirk McMahon is retiring after more than two decades at the company.
    • “McMahon plans to retire on April 1, the payer said in a Wednesday filing with the Securities and Exchange Commission on Wednesday.
    • “UnitedHealth has yet to name a replacement for McMahon.”
  • and
    • “Walgreens has named a new head of its healthcare unit as the pharmacy chain works to improve its halting finances and shift to delivering more healthcare services.
    • “John Driscoll, the current executive vice president and president of the U.S. Healthcare segment, will be replaced by Mary Langowski, who previously held the chief executive role at chronic condition management company Solera Health. Driscoll will serve in a senior advisory role, Walgreens announced Thursday.”
  • and
    • “Molina Healthcare lost half a million Medicaid members due to redeterminations by the end of 2023, executives said Thursday.
    • “States resumed checking beneficiaries’ eligibility for the safety-net program in April following a pause during the COVID-19 public health emergency. Some 16 million Americans have been disenrolled from Medicaid to date because of the redeterminations. The process is disproportionately impacting insurers with a heavy Medicaid presence like Molina, which brings in 80% of its revenue from the program.
    • “Molina still expects to retain 40% of its Medicaid membership once redeterminations are complete. However, on Thursday the insurer raised its estimate of members gained during COVID from 800,000 to 1 million because of new business adds. That implies a net member loss of 600,000 once redeterminations are complete.” 
  • and
    • “Tenet Healthcare beat Wall Street expectations for revenue in the fourth quarter of 2023 on continued cost control measures and sustained demand for services, particularly in its ambulatory care unit, executives said during an earnings call on Thursday.
    • “CEO Saum Sutaria told investors that Tenet was entering a “new era” in which a higher proportion of its performance was generated by its ambulatory surgical business. Same-facility revenue for ambulatory services grew 9.2% during 2023, above Tenet’s long-term goal of 4% to 6% top line growth.
    • “The Dallas-based for-profit will continue a careful watch on its debt levels, executives said. The company has recently taken steps to reduce its leverage, last week finalizing the sale of three hospitals to Novant Health and announcing the sale of four additional hospitals to UCI Health.”
  • Beckers Payer Issues discusses why it appears that insurers are split in two camps over rising Medicare Advantage costs.

Midweek update

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

From Washington, DC

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

From the public health and medical research,

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

From the U.S. healthcare business front,

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

Tuesday’s Tidbits

David Ermer–CDC, Congress, FDA, Medical / Rx research, NCQA, Obesity, SDOH, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The FEHBlog listened to the House Oversight and Accountability Committee’s markup of HR 6283, the Delinking Revenue from Unfair Gouging Act. Is there such as thing as fair gouging? In any case, the FEHBlog was relieved by the amount of bipartisan opposition to the bill. However, as explained in this STAT News article, the Committee Chairman James Comer (R Ky) steered an amended version of the original bill through his Committee this morning. Like Committee members with doubts about the bill, the FEHBlog looks forward to the Congress Budget Office report on the measure.
  • The American Hospital Association (AHA) News reports
    • “In a statement submitted to the House Ways and Means Committee for a hearing Feb. 6 on chronic drug shortages, AHA recommended Congress enact legislation to diversify manufacturing sites and sources for critical pharmaceutical ingredients; support an increase in end-user and supply chain inventories for critical medications; develop a rating system for drug maker quality management processes; identify essential drugs needing more domestic manufacturing capacity; and require drug makers to disclose where their products are made and when demand for essential drugs spikes.” 
  • and
    • “The Health Resources and Services Administration Feb. 6 requested vendor proposals to support changes to governance, technology and operation of the Organ Procurement and Transplantation Network, as authorized by Congress last year. HRSA also directed the current OPTN vendor, the United Network for Organ Sharing, to standardize and update data reporting for greater accountability and equity in organ procurement and transplant practices. HRSA indicates that the scope and scale of the contract awards will be contingent on final 2024 appropriations.”
  • The Department of Health and Human Services announced,
    • releasing the National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy). As directed by the 2019 Kay Hagan Tick Act—named after the U.S. Senator who died due to complications from a tickborne illness—HHS led a four-year process with civilian agencies and defense departments to deliver this strategy. Co-led by the HHS Office of the Assistant Secretary for Health and the Centers for Disease Control and Prevention, the strategy identifies and describes federal priorities to detect, prevent, respond to, and control diseases and conditions caused by vectors in the United States.
    • “Vector-borne diseases are a global threat, with national security, economic, and health implications for the United States. As the federal government continues to proactively strengthen its response to this threat, HHS and CDC plan to develop future iterations of the VBD National Strategy with opportunities for public engagement. Read the VBD National Strategy.”
  • Beckers Hospital Review tells us,
    • “Respiratory syncytial virus vaccinations could soon extend to adults aged 50-59. 
    • “Arexvy, which was initially approved by the FDA in May 2023 for administration in adults over 60, has been granted priority review in the U.S. for use in adults ages 50-59.
    • “If approved, it will become the first RSV vaccine available for the age group, according to a Feb. 6 news release. 
    • “The FDA is slated to make a decision on the drug’s approval for the new age group by June 7.”

From the public health and medical research front,

  • Medscape informs us,
    • “Lowering the recommended age for baseline prostate-specific antigen (PSA) would reduce prostate cancer deaths by about 30% in Black men without significantly increasing the rate of overdiagnosis, according to new screening guidelines from the Prostate Cancer Foundation.
    • “Specifically, baseline PSA testing in Black men should begin at age 40-45, sooner than current guidelines recommend, and should be followed by regular screening intervals, preferably annually, at least until age 70, a multidisciplinary panel of experts and patient advocates determined based on a comprehensive literature review.”
  • Per the Food and Drug Administration,
    • On Monday, the FDA issued an outbreak advisory warning consumers not to eat, sell, or serve recalled brands of cheeses, sour creams (cremas), or yogurts manufactured by Rizo Lopez Foods, Inc. The FDA and CDC, in collaboration with state and local partners, are investigating illnesses in a multi-year, multistate outbreak of Listeria monocytogenes infections linked to queso fresco and cotija cheeses manufactured by Rizo Lopez Foods, Inc., of Modesto, California. There are 26 illnesses with 23 hospitalizations in 11 states. The firm has recalled several dairy products and has temporarily ceased the production and distribution of these products while their investigation is ongoing. The FDA’s investigation is ongoing, and the FDA will continue to update this advisory as information becomes available.”
  • Per KFF,
    • “About 1 in 5 adolescents report symptoms of anxiety or depression, according to a KFF analysis of a new federal survey of teen health.
    • “While some teens are getting mental health care, a significant share say they are not receiving the therapy they need due to costs, fear of what others will think, and/or not knowing how to get help.”
  • The American Medical Association lets us know what doctors wish their patients knew about iron deficiency.
  • Healio notes,
    • “Infants aged younger than 3 months and children with a history of prematurity experience the highest rates of hospitalization for respiratory syncytial virus, according to study findings published in Pediatrics.
    • “Last year, two new tools became available to combat RSV, the leading cause of infant hospitalization in the United States: a vaccine for pregnant people and a new monoclonal antibody.” * * *
    • “Most RSV-associated hospitalizations occurred in healthy, term infants,” Meredith L. McMorrow, MD, MPH,a researcher in the CDC’s Coronavirus and Other Respiratory Viruses Division said. “This is why allbabies need protection from either maternal RSV vaccination or nirsevimab during their first RSV season.”
  • Beckers Hospital Review offers five Ozempic updates.

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Sales of Eli Lilly’s diabetes drug Mounjaro exceeded $5 billion in 2023, its first full year on the market, the company said Tuesday, in the latest sign of surging demand for the therapy and other medicines of its kind.
    • “Mounjaro’s fast launch helped drive Lilly’s revenue last year to $34 billion, a 20% increase over 2023. Fourth quarter revenue of $9.4 billion eclipsed analysts’ consensus expectations by 5%, Leerink Partners’ David Risinger wrote in a note to clients.
    • “Lilly said Mounjaro now accounts for 27% of total prescriptions in the U.S. for injectable “incretins,” the fast-selling group of drugs that work by modulating hormones that control insulin production. Sales of an older drug in this class, Lilly’s Trulicity, fell 4% in 2023 to $7 billion, but still led Lilly’s business.
    • “The obesity drug Zepbound, which contains the same active ingredient as Mounjaro, launched in the fourth quarter and brought in sales of $176 million through Dec. 31.”
  • STAT News adds,
    • “Eli Lilly reported during its fourth-quarter earnings call that tirzepatide, which is sold commercially as Mounjaro or Zepbound, succeeded in a Phase 2 test as a treatment for the liver disease MASH. Around 74% of adults in the trial taking the drug were free of MASH after 52 weeks, compared to approximately 13% of the placebo group.”
  • Wait, there’s more from Bloomberg,
    • “Eli Lilly & Co.’s blockbuster diabetes drug Mounjaro, which is commonly used off-label for weight loss, is again in short supply due to increased demand.
    • “There will be limited availability of higher doses of the treatment through early March, according to a US Food and Drug Administration database that tracks shortages. So far, the FDA doesn’t list Mounjaro’s sister drug Zepbound, which is approved for weight loss, on its shortage list, though the two contain the same active ingredient.
    • “The company is continuing to ship all doses to wholesalers, but anticipates intermittent backorders of higher doses over the next month, a Lilly spokesperson said in an emailed statement. 
    • “We recognize this situation may cause a disruption in people’s treatment regimens and we are moving with urgency to address it,” the spokesperson said.”
  • BioPharma Dive points out
    • “The Japan-based pharmaceutical firm Eisai had hoped that, by the end of March, 10,000 patients in the U.S. would be taking its closely watched drug for Alzheimer’s disease. But that goal now seems lofty, following updates in the company’s latest earnings report.
    • “Eisai developed the drug, called Leqembi, in partnership with Biogen, and is leading its commercialization. As with an earlier Alzheimer’s therapy from the two companies, Leqembi’s launch started off slow. Yet Eisai and Biogen have argued that recent decisions from drug regulators and insurers should significantly increase both prescriptions and sales.
    • “Still, growth doesn’t appear to be coming as quickly as the companies want. Eisai recorded 1.1 billion yen, or roughly $7.4 million, in revenue from Leqembi between October and December — around half of what Wall Street analysts had generally expected, according to Michael Yee of the investment bank Jefferies.
    • The company also said Leqembi had been administered to a total of 2,000 U.S. patients as of Jan. 26, with another 8,000 or so on a waiting list. Eisai maintains the 10,000 patient milestone could be hit in a few months, though the team at Jefferies believes it might take longer “given launch dynamics have been slow to begin with.”
  • Beckers Hospital Review reports,
    • “San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.”San Francisco-based UCSF Health has signed a $100 million definitive agreement with San Francisco-based Dignity Health to take on two of its hospitals: Saint Francis Memorial Hospital and St. Mary’s Medical Center, both of which are in the city.
    • UCSF Health began acquisition talks with Dignity Health, part of Chicago-based CommonSpirit Health, for the two hospitals in July. 
    • “Under the acquisition, which UCSF Health hopes to close by this spring, the hospitals will be renamed UCSF Health Saint Francis Hospital and UCSF Health St. Mary’s Hospital, respectively, according to a Feb. 5 UCSF news release.”
  • Per Healthcare Dive,
    • “Providence will refund payments and forgive outstanding medical debt for nearly 100,000 low-income Washington residents to settle a 2022 lawsuit alleging the health system skirted its charity care obligations, according to a Thursday announcement from Washington Attorney General Bob Ferguson.
    • “The Renton, Washington-based operator will refund approximately $20 million to over 30,000 patients who were billed improperly and forgive $137 million for more than 65,000 additional patients, in what the AG called the “largest resolution of its kind in the country.”
    • “The settlement is the latest win for the AG, who has successfully brought other health systems into compliance with the state’s charity care law, which offers reduced or free medical care for approximately half of Washingtonians based on financial status.”
  • and
    • “Centene has become the second major health insurer to warn investors of an impending funding decrease in Medicare Advantage — if regulators finalize 2025 rates as proposed.
    • “New payment parameters released by the CMS last week would cause Centene’s MA rate to fall 1.3%, CFO Drew Asher said during a Tuesday morning call discussing the payer’s fourth-quarter earnings results.
    • “However, this dip is before Centene risk scores its enrollees, a process which should result in an overall increase in MA reimbursement next year, Asher said. Humana disclosed similar concerns in a filing with the Securities and Exchange Commission on Monday.”

Monday Roundup

David Ermer–AHRQ, CDC, FDA, Generative AI, Medical / Rx research, Obesity, Patient safety, SDOH, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Tomorrow at 10 am, the House Oversight and Accountability Committee will mark up several bills including the FEHB provisions in the DRUG Act, HR 6283. It’s unfortunate that the Committee did not hold a hearing on this disruptive bill. The FEHBlog will be listening to the markup.
  • The Federal Times informs us,
    • “A pair of contracts designed to improve the quality of care in Tricare’s civilian medical networks will take effect Jan. 1, 2025, according to defense officials.
    • “The contracts are moving forward following a Jan. 31 decision in the U.S. Court of Federal Claims affirming the Defense Health Agency’s choice of TriWest Healthcare Alliance as the Tricare West Region’s new manager, denying a protest lodged by incumbent contractor Health Net Federal Services last year.  * * *
    • “Humana Government Business, the incumbent contractor for Tricare’s East Region, will continue in that role under a new deal worth up to $70.8 billion.The new contracts for the two regions have a potential combined value of $136 billion over nine years.”
  • MedTech Dive lets us know
    • “FDA panel recommends new standards for pulse oximeters amid bias concerns.
    • “Studies have found that pulse oximeters overestimated oxygen saturation in people with dark skin pigmentation, resulting in delayed care.”
  • and
    • “Hologic has received regulatory clearance to sell an artificial intelligence (AI)-enabled cervical cancer screening system in the U.S. 
    • “The product, the Genius Digital Diagnostics System, creates digital images of Pap test slides and uses an AI algorithm to identify cells that cytologists and pathologists should review.
    • “Hologic’s clearance, announced on Thursday, comes days after BD partnered with Techcyte to promote a digital, AI-enabled cervical cancer screening test that is yet to come to market.”

From the public health and medical research front,

  • Beckers Hospital Review tells us,
    • “Eli Lilly’s ingredient for Type 2 diabetes medication Mounjaro and its new weight loss drug, Zepbound, significantly lowered patients’ blood pressure by up to 10.6 mmHg, according to a new study published Feb. 5. 
    • “The study recruited about 500 adult patients with a body mass index at or more than 27, or the overweight range. Compared to a placebo, tirzepatide — the active pharmaceutical ingredient of Mounjaro and Zepbound — reduced blood pressure for participants taking 5, 10 and 15 milligrams each week. The patients were not diabetic and either had normal blood pressure or high blood pressure that was under control.” 
  • STAT News reports,
    • “Amgen is trying a unique strategy with its obesity drug candidate: testing whether it can wean patients toward lower or less frequent doses over time.
    • “Very early data hints that Amgen’s candidate, called MariTide, may provide longer-lasting weight loss than highly popular obesity drugs on the market like Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound. Amgen is already seeing if that means its drug could also be dosed differently from Novo and Lilly’s products, which are costly and expected to be taken consistently for life.
    • “In an ongoing Phase 2 trial, Amgen’s researchers will first titrate participants up on MariTide, but then after some time, see if the drug can still be effective when transitioning patients to a less intensive dosing regimen, executives said in an interview.
    • “Could there be an opportunity for an induction maintenance-type of strategy for a molecule like MariTide?” said Narimon Honarpour, senior vice president of global development at Amgen, referring to a strategy used for anti-inflammatory drugs in which high, rapid doses are given at the start and then lower or less frequent doses are used for maintenance in the long run.”
  • HHS’s Agency for Healthcare Research and Quality released a rapid evidence report about deprescribing to reduce medical harms in older adults.
    • “Deprescribing has emerged as a clinical practice to reduce polypharmacy and use of potentially inappropriate medications (PIMs) and serve as a mechanism for quality improvement and increased patient safety. The purpose of this rapid response is to summarize recent literature on the use of deprescribing to improve the safety of medication use among older adults (age ≥ 65 years).”
  • CBS News reports,
    • “Preterm and early-term births in the U.S. have increased from 2014 to 2022, raising risks to babies, according to new data from the Centers for Disease Control and Prevention.
    • “Data released Wednesday from the CDC’s National Center for Health Statistics shows the preterm birth rate — meaning delivery before 37 completed weeks of pregnancy — rose 12% during that time period, while early-term birth rates, at 37 to 38 completed weeks, rose 20%. 
    • “This is compared to full-term births, which are those delivered at 39 to 40 weeks.
    • “Using data from the National Vital Statistics System, the analysis only looks at singleton births, since multiple births like twins and triplets tend to be born at earlier gestational ages, the authors note.
    • “Gestational age is a strong predictor of short- and long-term morbidity and early mortality,” the authors write. “Births delivered preterm are at the greatest risk of adverse outcomes, but risk is also elevated for early-term compared with full-term births.”
  • MedCity News points out,
    • “Mayo Clinic has entered into a collaboration with TruLite Health — Mayo is helping the Phoenix-based startup develop its software platform designed to address providers’ clinical bias. The health system said it chose to collaborate with TruLite because of the platform’s potential to mitigate health inequities and enhance patient outcomes at the point of care.”
  • Per Fierce Healthcare,
    • “Artificial intelligence can help identify easy to miss patients who might be good candidates for a palliative or hospice care referral, a recent pilot at Mass General Brigham (MGB) revealed.
    • “The results of the findings were presented Friday at the Value-Based Payment Summit.
    • “Timely end-of-life care benefits patients. Patients and their families may also be more open to a conversation about goals of care during a hospital stay, MGB said in presentation slides shown to Fierce Healthcare.” 

From the U.S. healthcare business front,

  • Per BioPharma Dive,
    • “Novo Holdings, the controlling shareholder of Danish drugmaker Novo Nordisk, will buy contract manufacturer Catalent for $16.5 billion in a take-private deal the companies announced Monday.
    • “In a related transaction, Novo Nordisk has agreed pay its parent company $11 billion to take over three Catalent plants in Italy, Belgium and Indiana to help expand production of its GLP-1 drugs Ozempic and Wegovy. Demand for the latter, which is approved in the U.S. for treating obesity, has greatly exceeded supply, forcing Novo Nordisk to restrict access.
    • “Novo Nordisk and Catalent already work together at the three sites, which employ more than 3,000 staff.”
  • and
    • “On Monday, Johnson & Johnson said one of its most closely watched experimental medicines appears to have positive effects on two autoimmune diseases, providing further support to a drug that, by the company’s estimates, could eventually generate billions of dollars in annual sales.
    • “J&J didn’t release any data, but rather said the drug hit the main goals of a mid-stage clinical trial testing it in patients with Sjögren’s disease as well as a late-stage study focused on generalized myasthenia gravis, a rare condition known in short as gMG. The company plans to present more detailed results from both studies at upcoming medical meetings, and to engage with regulators about the path to approval in gMG.”
  • Per Healthcare Dive,
    • “Cano Health filed for Chapter 11 bankruptcy late Sunday, as the beleaguered primary care chain works to bolster its financials. 
    • “The filing is part of a restructuring support agreement with the majority of its lenders. Cano said it expects to emerge from restructuring during the second quarter this year, adding that the process will help it reduce debt and allow it to search for a strategic partner or buyer.
    • “Cano also announced it reached an agreement to receive $150 million in debtor-in-possession financing to fund its operations during restructuring.”
  • and
    • “Medicare Advantage rate changes proposed by regulators last week are upsetting Humana’s funding expectations for 2025.
    • “If finalized as proposed, the MA changes will lower Humana’s benchmark funding by around 160 basis points compared to a flat rate environment, the health insurer disclosed in a filing with the Securities and Exchange Commissionon Monday.
    • “The discrepancy is because the CMS didn’t factor in persistently elevated medical costs into how it calculates rates, Humana said. However, regulators could do so in the final rule. Despite the uncertainty, the insurer reaffirmed its earnings outlook for 2025.”
  • Per Fierce Healthcare,
    • “Rural providers feel financially stable, with most planning to expand existing service lines to increase revenue, a new survey has found (PDF).
    • “The survey was conducted by accounting firm Wipfli and reached 106 rural healthcare organizations across 26 states. Respondents included a mix of critical access hospitals, rural health clinics and others.
    • “Overall, most respondents are cautiously or completely optimistic about their financial viability. About 40% said their financial stability is higher than it was a year ago, and the portion of those who think they are in a better place than they were five years ago also rose compared to 2023. Despite challenges like high inflation, dwindling COVID-19 relief funds and flat reimbursement rates, growing optimism suggests rural providers learned how to manage unpredictability during the pandemic, the report said. * * *
    • Entering 2024, rural healthcare leaders are most concerned about revenue capture, digital capabilities and people management.
  • HR Morning offers nine tips on maximizing core health benefits.
  • The Society for Human Resource Management discusses best practices for hybrid work models.

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.”

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.

Friday Factoid

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

 

Thursday Miscellany

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

From Washington DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

The FEHBlog is back!!

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

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19, FDA, No Surprises Act, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • The Wall Street Journal reports
    • “Congressional leaders struck a cautiously optimistic tone Wednesday on reaching a deal combining tighter border security with aid for Ukraine, as they emerged from meeting with President Biden at the White House.
    • “House Speaker Mike Johnson (R., La.) said the hour-and-20-minute sit down was “productive” while reiterating Republicans’ demand that changing border law was a condition for further funding Kyiv, which is one piece of a stalled $110.5 billion foreign-aid package championed by Biden.”
  • and
    • “The Biden administration on Wednesday finalized requirements to streamline the process for doctors and patients seeking health insurance approval for medical care and treatments.
    • “The rule aims to shorten the timeline for the so-called prior authorization process to as little as 72 hours for many of the tens of millions of people who get their health insurance through Medicare Advantage, Medicaid or an Affordable Care Act health plan by automating some of the processing of the requests.
    • “Plans would also have to share more information with doctors about the status of decisions and information on denials, with a turnaround time of seven calendar days for non-urgent requests.”
  • Here is a link to the CMS fact sheet on the final rule.
    • “Impacted payers must implement certain operational provisions, generally beginning January 1, 2026. In response to public comment on the proposed rule, impacted payers have until compliance dates, generally beginning January 1, 2027, to meet the API development and enhancement requirements in this final rule. The exact compliance dates vary by the type of payer.”
  • STAT News reports that the federal government dismissed its appeal of a D.C. district court decision vacating a Trump Administration rule favoring use of copay accumulators by health plans. “Insurers can still use the copay accumulators when patients use brand drugs that do have generic competition.”
  • MedPage Today tells us,
    • “The FDA cleared an artificial-intelligence (AI)-powered device designed to non-invasively detect skin cancer in the primary care setting, the agency announced on Tuesday.
    • “Developer DermaSensor said the device uses AI-powered spectroscopy technology to non-invasively evaluate cellular and subcellular characteristics of a lesion for any of the three common skin cancers — melanoma, basal cell carcinoma, and squamous cell carcinoma. The wireless, handheld device then provides a result in real time using an FDA-cleared algorithm.”
  • MedTech Dive informs us,
    • “The Food and Drug Administration issued an alert for patients and healthcare providers about the risks associated with an Exactech shoulder replacement device after the company “declined to initiate a voluntary recall.”
    • “FDA officials advised healthcare professionals against implanting Equinoxe Shoulder Systems packaged in defective bags because of a risk of oxidation that can accelerate device wear or failure. The issue could lead to patients needing additional surgery to replace or correct devices.
    • “Exactech recalled other orthopedic devices in 2021 and 2022, initially because of excessive and premature wear of unknown cause, and later because it found a problem with its packaging.”

From the public health and medical research front,

  • Beckers Hospital Review points out 35 states where respiratory illness levels remain high or very high, according to the Centers for Disease Control.
  • The Wall Street Journal lets us know,
    • “Americans are living longer, but spending less time in good health.
    • “The estimated average proportion of life spent in good health declined to 83.6% in 2021, down from 85.8% in 1990, according to an analysis of the latest data from the Institute for Health Metrics and Evaluation’s Global Burden of Disease study, a research effort based at the University of Washington.
    • “The decrease of time spent in good health is partly because medical advances are catching and treating diseases that once would have killed us. But it is also because of the rising prevalence, often among younger people, of conditions such as obesity, diabetes and substance-use disorders.
    • “Declining health takes a deep physical and emotional toll on patients and their caregivers. There are also broad ramifications on society, including rising health costs that eat into household budgets, as well as more people who want to work but can’t.
    • “The period of life spent not healthy is getting larger and larger and the implications of that are enormous,” says Dr. John Rowe, a professor of health policy and aging at Columbia University. “70 is the new 80.”
  • Beckers Hospital Review adds,
    • “The expected increase in new cancer diagnoses this year is record-setting, even as overall cancer mortality is expected to continue its decline, the American Cancer Society said in its latest report.
    • “The report was based on the most recent data on population-based cancer occurrences and outcomes collected by central cancer registries through 2020 and mortality data from the National Center of Health Statistics through 2021.
    • “The projected number of new diagnoses tops 2 million for the first time, with an increase in six out of 10 top cancers. Notably, colorectal cancer new cases have shifted mortality patterns in adults younger than 50 and have moved up from being the fourth leading cause of cancer death to the first in men and second in women.”
  • AHRQ announced the following study result:
    • “Diagnostic errors can result in significant morbidity and mortality. This large cohort study reviewed the health records of 2,428 adult inpatients who were transferred to the intensive care unit (ICU) and/or died in the hospital to estimate frequency, cause, and harms of diagnostic errors. Nearly a quarter (23.0%) of patients in the cohort experienced a diagnostic error, and 6.6% of patients who died had a diagnostic error. Delays in ordering and interpreting tests and problems with clinical assessment were the most common contributing factors resulting in transfer to ICU and/or death.”
  • According to Healio,
    • “Rates of long COVID were similar between groups of people who received Paxlovid and those who do not.
    • “COVID-19 rebound is not linked to an overall risk for long COVID.”
  • Per Beckers Payer Issues,
    • “RSV vaccinations brought more older adults to their primary care offices in the last months of 2023, one factor behind rising medical costs in Medicare Advantage, UnitedHealth Group executives said. 
    • “Andrew Witty, CEO of UnitedHealth Group, told investors on a Jan. 12 call that more visits to primary care providers for RSV vaccines led to increased medical service costs in other areas for the Medicare population. 
    • “To be clear, all of that is good news for healthcare. These are seniors, many of whom had not been to the office in a long time,” Mr. Witty said. “They’ve come back in now, got vaccinated, and physicians have picked up on other things.” 

From the U.S. healthcare business front,

  • Healthcare Dive notes,
    • “Cigna announced a slew of leadership updates on Wednesday, including an expansion of chief financial officer Brian Evanko’s role.
    • “Evanko will continue to hold the CFO position, and he’ll also serve as president and CEO of the company’s Cigna Healthcare division, its benefits business, which includes the U.S. Commercial and U.S. Government segments.”  
  • Per Beckers Payer Issues,
    • “Humana plans to lay off a small portion of its workforce, the Louisville Courier-Journal reported Jan. 16. 
    • “Humana did announce some limited workforce reductions last week,” a Humana spokesperson told Becker’s Jan. 16. “The impacted positions represented a small percentage of our total workforce and were geographically dispersed across multiple locations.”
  • Forbes reports,
    • “Three months ago, venture capital firm General Catalyst announced an unusual move: The creation of an entirely new company that would someday acquire a multi-billion dollar health system that could serve as a proving ground for new technologies.
    • “On Wednesday, that company – the Healthcare Assurance Transformation Corporation, or HATCo – revealed its intended target: Akron, Ohio-based Summa Health, a nonprofit three-hospital system and health insurer.”
  • Medical Economics notes,
    • “This year promises to be a Super Bowl of telehealth, according to plans by the American Telemedicine Association (ATA).
    • “The year 2024 has at least two major factors that could be hugely influential for telehealth, according to the organization and its affiliated ATA Action advocacy nonprofit.
    • “It’s a presidential election year, and it will bring the end of the telehealth flexibilities that Congress enacted by during the COVID-19 pandemic and continued after the end of the public health emergency. Those need to remain in place, said Kyle Zebley, ATA senior vice president for public policy and ATA Action executive director.
    • “With Congress back in session, the clock officially starts counting down,” Zebley said in a news release this month. “It’s time for the administration and our congressional leaders to take permanent action to ensure patients across the country have access to safe, affordable, and effective health care where and when they need it and provide certainty to beneficiaries and our nation’s health care providers. That would be a win-win.”
  • The Brookings Institution offers a report assessing early experience with arbitration under the No Surprises Act.