Thursday Miscellany

Rx coverage

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.

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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


 

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Friday Factoid

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

 

Tuesday Tidbits

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. health care business front,

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

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front

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

From the U.S. healthcare business front,

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

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.

Friday Factoids

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

From Washington, DC

  • Roll Call reports,
    • “Speaker Mike Johnson reiterated support Friday for the fiscal 2024 spending agreement he negotiated in the face of opposition from members of the House Freedom Caucus, who’ve been lobbying him to toss the deal. 
    • “Johnson, R-La., told reporters that while he is seeking feedback from across his conference, he is committed to the “strong” deal he negotiated with Senate Majority Leader Charles E. Schumer, D-N.Y.
    • “Our topline agreement remains; we are getting our next steps together, and we are working toward a robust appropriations process,” he said.”  * * *
    • “Next week, Congress will face a more pressing Jan. 19 spending deadline for agencies covered under four of the 12 annual appropriations bills. Schumer took the first procedural step needed for a stopgap spending bill Thursday, filing cloture on the motion to proceed to a shell vehicle. 
    • “The Senate’s continuing resolution is expected to last until March, sources familiar with the talks say. But while Johnson has said he is “not ruling out” the need for another continuing resolution, he has not yet said definitively whether or not he would support one. 
    • “And that stopgap measure will be essential to keep the government open, as Senate Appropriations Chair Patty Murray, D-Wash., and House Appropriations Chairwoman Kay Granger, R-Texas, are continuing to negotiate over the final subcommittee allocations, also known as 302(b)s. 
    • “Negotiators will need about a month to wrap up their work after those allocations are finalized, House Appropriations ranking member Rosa DeLauro, D-Conn., said Friday. “
  • Govexec tells us,
    • “The Office of Personnel Management made some of its best progress at reducing the number of pending retirement applications from federal workers last year, reducing the backlog by 34% in 2023 and breaking multiple recent records in the process.
    • “Long a source of frustration for the governmental HR agency, lawmakers and retirees alike, OPM’s inventory of pending retirement claims has been plagued by delays due to the still largely paper-based nature of federal employment records, staffing issues and other challenges. The COVID-19 pandemic exacerbated many of these issues, as the backlog climbed to a high of more than 36,000 pending claims in March 2022.
    • “But OPM moved on multiple fronts last year to improve the process. The agency released its long-awaited IT strategic plan, which includes plans to develop a “digital retirement system,” complete with electronic records and an online retirement application process.
    • “And officials launched a series of short-term fixes aimed at shoring up the current system, including a guide for retirees to follow as they navigate the retirement process, as well as staffing up and coordinating more actively with federal agencies to prepare for the annual wave of new retirement claims that occurs between January and March.”
  • Federal News Network informs us,
    • “The Postal Service says its competitive package business is growing, following its busy year-end holiday season.
    • “USPS says it delivered 130 million more packages in the “peak” first quarter of fiscal 2024, a nearly 7% increase, compared to the same period last year.
    • “USPS delivered more than 1.9 billion packages in the first quarter of fiscal 2023, which covers October through the end of December.
    • “Postmaster General Louis DeJoy, in a video message to employees, said growing the package business is the key to turning around the Postal Service’s long-term financial problems.”
  • KFF analyzes the Food and Drug Administration’s recent decision to allow Florida to import prescription drugs from Canada.
  • Per Fierce Healthcare, AHIP, among others, expressed opposition to the provision in the proposed 2025 Notice of Benefit and Payment Parameters Notice, reducing the number of non-standardized plans that an Affordable Care Act plan carrier can offer from four to two.
    • “AHIP is particularly concerned about the impact of non-standardized plan limits on issuers’ ability to offer broad networks for consumers that want access to a variety of providers and specialists, which is often a key factor in plan selection for those with chronic health conditions,” the lobbying group wrote in comments on the proposed rule.”
  • The U.S. Preventive Services Task Force offers a report on its 2023 accomplishments.

From the public health and medical research front,

  • Becker’s Hospital Review provides three updates on the predominant Omicron strain JN.1.
    • “Disease severity: New findings from a study led by researchers at the Ohio State University indicate BA.2.86 and its close relative, JN.1, may be linked to an increase in disease severity. The research focused on mutations in the spike protein of BA.2.86 and found it can infect human cells that line the lower lung, which is a feature linked to severe symptoms. Researchers emphasized additional research is needed to confirm the findings, since the study used pseudoviruses. 
    • “But from our past experience, we know that infectivity in human epithelial cell lines provides very important information,” Shan-Lu Liu, MD, Ph.D., senior study author and virology professor at OSU, said in a news release. “The concern is whether or not this variant, as well as its descendants including JN.1, will have an increased tendency to infect human lung epithelial cells similar to the parental virus that launched the pandemic in 2020.” 
    • “In late December, the WHO classified JN.1 as a “variant of interest” due to its rapid spread. At the time, the agency said the overall risk to public health posed by the strain remains low, since updated vaccines continue to offer protection against severe illness. The CDC published its latest update on JN.1 Jan. 5, stating, “At this time, there is no evidence JN.1 causes more severe disease.” 
  • The Centers for Disease Control points out,
    • “As seasonal flu activity remains elevated nationally, CDC is tracking when, where and what influenza viruses are spreading and their impact on the public’s health. So far this season, the most commonly reported influenza viruses are type A(H1N1) and type B viruses. According to CDC research, this could mean more severe outcomes among people who are hospitalized with flu.”
  • Here’s a link to the CDC’s latest Fluview report.
    • “Seasonal influenza activity remains elevated in most parts of the country.
    • “After several weeks of increases in key flu indicators, a single week of decrease has 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 baseline1 nationally since November and is above baseline in all 10 HHS Regions.
    • “The number of weekly flu hospital admissions decreased slightly.”
  • The CDC also announced,
    • “On October 23, 2023, the Centers for Disease Control and Prevention (CDC) issued Health Alert Network (HAN) Health Advisory 499 to provide guidance for prioritization of nirsevimab given the limited supply. Nirsevimab (Beyfortus, Sanofi and AstraZeneca) is a long-acting monoclonal antibody immunization recommended for preventing RSV-associated lower respiratory tract disease in young children.
    • Given the recent increase in nirsevimab supply and the manufacturers’ plan to release an additional 230,000 doses in January, the CDC advises healthcare providers to return to recommendations put forward by the CDC and the Advisory Committee on Immunization Practices (ACIP) on the use of nirsevimab in young children. Infants and children recommended to receive nirsevimab should be immunized as quickly as possible. Healthcare providers should not reserve nirsevimab doses for infants born later in the season when RSV circulation and risk for exposure to RSV may be lower. RSV activity remains elevated nationwide and is continuing to increase in many parts of the country, though decreased activity has been observed in the Southeast.” 
  • Fierce Healthcare reports,
    • “Though prescriptions for antiviral influenza medications have declined somewhat since 2023, perhaps indicating that the United States might be less encumbered by the flu than in recent record-breaking years, healthcare providers still find themselves battling a surge above historic norms, according to data by the Evernorth Research Institute.
    • “Researchers there examined pharmacy claims for more than 32 million people during current and past flu seasons and found an increasing prevalence of antiviral medication prescriptions since Thanksgiving 2023, though that’s tapered off slightly recently. More individuals experience flu symptoms severe enough to send them to physicians’ offices for prescriptions, and most of many of those forced to do so did not get the flu vaccination. Evernorth, a Cigna subsidiary, tries to develop cost-effective delivery systems for pharmacy benefits.
    • “Urvashi Patel, M.D., vice president of the Evernorth Research Institute, told Fierce Healthcare in an email that “since the shift to remote work from the pandemic, many employees who used to get their flu vaccines at the office are no longer able to. This may change as more workers continue to return to the office, but it’s likely a contributor to lower vaccination rates.”
  • The Wall Street Journal shares an employee’s favorable experience with the powerful weight loss drug Mounjaro.
  • Health Day provides the following study notes:
    • “U.S. doctors are prescribing antifungal creams to patients with skin complaints at rates so high they could be contributing to the rise of drug-resistant infections, new research shows.
    • “These are “severe antimicrobial-resistant superficial fungal infections, which have recently been detected in the United States,” noted a team led by Jeremy Gold, a researcher at the U.S. Centers for Disease Control and Prevention.
    • “One of the biggest emerging threats: Drug-resistant forms of ringworm (a form of dermatophytosis).”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “UnitedHealth was slammed with medical costs as it closed out 2023. The health insurance behemoth still managed to exceed Wall Street’s financial expectations.
    • “UnitedHealth posted a medical loss ratio of 85% in the fourth quarter — its highest MLR since the COVID-19 pandemic began early 2020.
    • “MLR is a metric of how much payers shell out to cover their members’ medical expenses. Payers tried to shake the effects of higher medical costs all last year as patients who delayed healthcare during the pandemic returned to doctor’s offices.
    • “The bulk of higher costs in the fourth quarter was driven by more seniors using outpatient services, a trend that first appeared in the second quarter of 2023, said UnitedHealth CEO Andrew Witty on a Friday morning call with investors.”
  • Beckers Hospital Review offers an interview with Mayo Health System President “Prathibha Varkey, MBBS, [who] is excited about the future of healthcare,” and an analysis of nurse practitioner pay by specialty.
  • The Washington Post offers an interview with the American Medical Association President Jesse Ehrenfeld, MD.
  • Mercer Consulting offers guidance on network strategies to optimize patient care and save while its sister company, Oliver Wyman, peers into the crystal ball concerning the state of healthcare in 2035.
  • Beckers Payer Issues offers a look at ten updates to the 2024 Medicare Advantage landscape.
  • MedCity News discusses seven JP Morgan Conference news items that you don’t want to miss.
  • BioPharma Dive poses five questions facing the pharmaceutical industry this year. “Many drugmakers hope to compete with Novo and Lilly in obesity, while others seek to win oncology’s next era. Meanwhile, a contentious drug pricing law looms.”
  • Drug Channels shares a guest post titled “Repairing the Patient Journey: How Pharma Can Fix the Obvious–and Not So Obvious–Breaking Points of Nonadherence.”
  • The Wall Street Journal reports,
    • “CVS Health plans to close dozens of pharmacies inside Target stores at a time when pharmacy chains are struggling to grow retail profits.
    • “CVS will close the pharmacies between February and April this year, said a company spokeswoman. The closures are part of CVS’s efforts to pare down its retail footprint “based on our evaluation of changes in population, consumer buying patterns and future health needs,” she said. * * *
    • “CVS has operated pharmacies inside Target stores since late 2015 when it bought the business from the retailer for around $1.9 billion. It has pharmacies in around 1,800 of Target’s more than 1,950 U.S. stores. A Target spokeswoman declined to comment. The latest round of closures account for a small percentage of CVS’s pharmacies at Target stores.” 
  • Per Fierce Healthcare,
    • “Artificial intelligence was dominating CES 2024 this week. From assistive speech tools to pet wearables to AI-enabled pillows to prevent snoring, the majority of companies exhibiting at CES boasted the use of the technology as part of their products.
    • “Digital health companies at the show also are putting AI to use from Intuition Robotics’ AI-enabled ElliQ care companion robot to hearing eyewear.
    • “Amid all this hype, entrepreneur and investor Mark Cuban believes AI will be transformative for healthcare.
    • “There are two types of companies in the world — those who are great at AI and everyone else and either you know how to use it to your advantage or you’re in trouble,” he said during a digital health panel at CES on Thursday.
    • “He added, “I don’t think it will be dominated by five or six big models. I think there will be millions of models. I think we’ll find every company will have a model, every vertical will have its own model, individuals will have their own models, doctors have their own models, and trying to get to the point where it’s more democratic so that specific verticals will be used within healthcare is going to be an evolution and I don’t think we’ve figured all that out.”
  • Healthcare Dive adds
    • “Generative artificial intelligence can be used to pull social determinants of health data, like housing or employment status, from clinician notes to identify patients who need additional support, according to a new study.
    • “Large language models trained by researchers could identify 93.8% of patients with adverse social determinants of health, while official diagnostic codes include that data in only 2% of cases. 
    • “The finely tuned models were also less likely than OpenAI’s GPT-4 to change their determination when demographic information like race or gender was added. Algorithmic bias is a major concern for AI use in healthcare, amid fears the technology could worsen health inequities.” 

Tuesday Tidbits

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

From Washington, DC,

  • Govexec updates us on FY 2024 appropriations actions on Capitol Hill.
  • Roll Call tells us,
    • “A consistent drip of members announcing they will not seek reelection combined with a desire to portray Capitol Hill as a toxic place everyone wants to flee can create a narrative that there’s a mass exodus underway from the House. 
    • “But that’s not the real story, at least not yet. 
    • “Up to this point, 38 House members have decided not to seek another term. Indiana Republicans Greg Pence and Larry Buschon and Colorado Republican Doug Lamborn were the latest to announce, just in the last few days. Overall, that’s just a few more than average, and that’s with an asterisk. * * *
    • “In order to make comparisons across cycles, the tally does not include resignations (or expulsions) because those seats will be filled by Election Day and will have new incumbents likely running in the regular election. So the 38 does not include the seats of former Reps. George Santos of New York and Kevin McCarthy of California and soon-to-be former Reps. Bill Johnson of Ohio and Brian Higgins of New York.
    • “North Carolina Democrats Kathy Manning, Wiley Nickel, and Jeff Jackson are included in the 38, but they likely would have run for reelection if Republicans hadn’t redrawn their districts to make them virtually unwinnable for a Democrat. Without redistricting forcing their hands, the number of members not seeking reelection would be remarkably average.”
  • The Hill reports,
    • “Sen. Bernie Sanders (I-Vt.) and a group of Senate Democrats on Monday announced an investigation into the high costs of asthma inhalers.
    • “Sanders, chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee, sent letters to the CEOs of the four biggest manufacturers of inhalers sold in the United States — AstraZeneca, Boehringer Ingelheim (BI), GlaxoSmithKline (GSK) and Teva — demanding information and documents on internal strategic communications, patient assistance programs and the costs involved in the manufacturing of inhalers.”
  • American Hospital Association News reports,
    • “The Department of Health and Human Services’ Office for Civil Rights Jan. 9 released a final rule that partially rescinds a sweeping 2019 rule that was held unlawful by three federal district courts. The new rule restores the longstanding process for enforcing federal conscience laws, and strengthens protections against conscience and religious discrimination. 
    • “The AHA last year submitted comments supporting the Administration’s approach, adding that conscience protections for health care professionals “are longstanding and deeply rooted in our health care delivery system.”
  • HR Dive notes,
    • “The U.S. Department of Labor announced Tuesday a final rule revising its interpretation of the Fair Labor Standards Act’s classification provision to determine whether a worker may be considered an independent contractor.
    • “The final rule largely tracks the agency’s October 2022 proposed rule. It retains the multifactor, “totality-of-the-circumstances” framework for analyzing independent contractors’ status included in that proposal.
    • “Under this framework, DOL will consider six nonexhaustive factors when examining the relationship between a worker and a potential employer:
      • Worker’s opportunity for profit or loss.
      • Investments made by the worker and the employer.
      • Degree of permanence of the work relationship.
      • Nature and degree of control over performance of the work.
      • Extent to which the work performed is an integral part of the employer’s business.
      • Use of the worker’s skill and initiative.
    • “The rule will be published in the Federal Register on Wednesday, Jan. 10, and is slated to take effect March 11, officials said.”

From the public health and medical research front,

  • The National Institutes of Health announced,
    • “Researchers have discovered that a protein called phosphorylated α-synuclein, which is associated with several neurodegenerative diseases such as Parkinson’s disease and Lewy body dementia, is also involved in the normal processes of how neurons communicate with each other in a healthy brain. The research, published in Neuron, was funded in part by the National Institute of Neurological Disorders and Stroke (NINDS), a part of the National Institutes of Health.   
    • “Phosphorylation is a process where a phosphate ion is added to a specific amino acid, or building block, of a protein, in this case the protein α-synuclein. This addition can change the shape of that protein, causing it to change its level of activity. Most studies of phosphorylated α-synuclein have studied its role in certain neurological disorders such as Parkinson’s disease and Lewy body dementia, where it builds up in protein clumps called Lewy bodies. These clumps are thought to be toxic to neurons, and one of the prevailing hypotheses is that the phosphorylation of the protein α-synuclein triggers these diseases.
    • “In most studies to date, the mere presence of α-synuclein phosphorylation is assumed to be a marker for pathology for certain disorders, like Parkinson’s and Lewy Body dementias,” said Beth-Anne Sieber, Ph.D., program director, NINDS. “Recently, there has been considerable interest in developing drugs that prevent α-synuclein phosphorylation as a way of treating these disorders. These findings challenge the current hypotheses about how these disorders may originate in the brain and may give insight into how we might better treat them.”
  • The Hill reports,
    • “The American Red Cross sounded the alarm Sunday over a severe blood shortage facing the U.S. as the number of donors dropped to the lowest levels in two decades. 
    • “The Red Cross said in an announcement that the number of people donating blood in the U.S. dropped 40 percent over the last 20 years, which can majorly disrupt those needing emergency blood transfusions and other operations. The organization added there was a 7,000-unit shortfall in blood donations between Christmas Day and New Year’s Day alone.  * * *
    • “The organization is urging people to sign up to donate blood and are encouraging people to do so by working with the NFL, which is offering a chance to win a trip for two people to Super Bowl LVIII in Las Vegas.
    • “The organization said anyone who signs up to donate blood in January will be automatically entered for a chance to win.”
  • Healio points out,
    • “Two doses of the recombinant zoster vaccine provided strong protection over 4 years, even in patients taking corticosteroids who are at higher risk for herpes zoster, also known as shingles, according to researchers.
    • “Currently, the CDC recommends that adults aged 50 years and older receive two doses of the recombinant zoster vaccine (RZV) separated by a period of 2 to 6 months.”
  • and
    • “Rates of HPV vaccine initiation before age 13 increased among boys and girls from 2018 to 2021.
    • “Rates of HPV vaccine series completion also increased but remained below 40% in both groups.”

From the U.S. healthcare business front

  • Beckers Payer Issues points out,
    • “Aetna President Brian Kane said CVS Health is still in the “early innings” of integrating the payer into the company, the Hartford Business Journal reported Jan. 8.
    • CVS Health acquired Aetna in 2018. Mr. Kane told the news outlet that Aetna’s integration into the company was slowed by the COVID-19 pandemic. He said significant changes are likely in the next five years and that there will be a “really tight ecosystem between payer, provider and pharmacy.”
    • He said the key to the integration will be leveraging CVS Health’s “various businesses and technology platforms to improve patient care and lower costs.” 
  • Per BioPharma Dive,
    • “Over the span of five months, biotechnology startup Aiolos Bio launched, raised initial funding from venture investors and negotiated a $1 billion buyout by GSK.
    • “The acquisition, announced by GSK on Tuesday, marks a rapid return on investment for Aiolos’ blue-chip backers, which included Atlas Venture and Bain Capital Life Sciences. They could receive up to $400 million more if certain regulatory milestones are met.
    • “Based in San Francisco and London, Aiolos was founded last year around an experimental antibody for treating asthma that the company licensed in August from China’s Jiangsu Hengrui Pharmaceuticals. The biologic drug, dubbed AIO-001, shares a target with Amgen and AstraZeneca’s approved medicine Tezspire, but Aiolos claims its version could be given less frequently.”
  • Beckers Hospital Review lets us know,
    • “Stephen Dorner, MD, chief clinical and innovation officer of Mass General Brigham Healthcare at Home, told Becker’s that the more home-based care models are scaled, the more opportunity there is to move the needle and flatten the curve of healthcare costs in the U.S.  
    • “Boston-based Mass General Brigham, which runs one of the largest home hospital programs in the country, has had more than 2,500 home hospital admissions since January 2022, saving 13,300 acute care facility-based bed days. 
    • “But, the journey first began with two pilot programs launched in 2017, evolving through iterative processes to identify sustainable models. By 2019, the health system began to recognize the strategic importance of the home-based care model, and prioritized refining best practices and modifying them for scalability.
    • “The core strategies, according to Dr. Dorner, involved transforming manual processes into standardized workflows and focusing on translating strong clinical practices from traditional facilities to home-based care without sterilizing the comfort of the home environment.”
  • Healthcare Dive adds,
    • “Medicare patients treated in acute hospital-at-home programs had low levels of mortality and rarely needed to return to facilities for care, according to a new study published in Annals of Internal Medicine. 
    • “Researchers found that 0.5% of patients in the study died while receiving acute care in their homes, while 6.2% had to go back to the hospital for at least 24 hours.
    • “The results could help make the case to continue supporting hospital-level care delivered at home, researchers said. A waiver that expanded the programs at the height of the COVID-19 pandemic is set to expire at the end of the year.”
  • and
    • “Most nonprofit hospitals and health systems had enough cash on hand to cover operating expenses for an extended period of time in 2022, according to a new analysis from KFF.
    • “On average, hospitals and systems reported having 218 days of cash on hand in 2022 — S&P Global Ratings generally considers 218 days to be a “very strong” level of cash, according to the report. Nearly three-quarters of nonprofit hospitals had “strong” levels of cash on hand, while about one in 10 had “vulnerable” or “highly vulnerable” levels of cash on hand.
    • “The metric, which estimates the number of days that an entity could cover their cash expenses using available reserves, offers nuance to reports that show struggling nonprofit hospitals, the authors wrote. Though hospitals broadly reported negative operating margins in 2022, the KFF study said many had a “large financial cushion” as of 2022 to help weather challenges.”
  • Drug Channels discusses 2024 developments among the big three prescription benefit managers.

Thursday Miscellany

David Ermer–AHRQ, CDC, COVID treatment, COVID-19, FDA, Medical / Rx research, Obesity, OPM, Rx coverage, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Govexec informs us,
    • “Published last month, OPM’s annual report to Congress covers the 2022 fiscal year, which ended in September 2022, meaning it covers a period of time when agencies were developing and beginning implementation of re-entry plans after a two-year period of maximum telework during the COVID-19 pandemic, but before the Biden administration’s concerted push beginning last spring to increase “meaningful in-person work” across government.
    • “In a message accompanying the report, OPM Director Kiran Ahuja acknowledged that the snapshot of telework as represented by the data may not be current, given the shift in the last year toward more in-person work, but she stressed that changes made this year will improve agencies’ data collection and OPM’s analysis going forward.
    • “With COVID-19 no longer the primary driver in workforce decisions, federal agencies are closely examining the balance of in-person and virtual work to maximize mission delivery—including making increases to meaningful in-person work while also utilizing flexible work arrangements as a strategic tool to enhance organizational performance,” she wrote. “To support this work, OPM has been engaging with agencies to improve the quality of government-wide and agency-specific telework data. OPM anticipates that future reports will reflect these improvements.”
  • HHS’s Agency for Healthcare Research and Quality issued a report about the value of respectful maternity care.
  • BioPharma Dive points out five Food and Drug Administration decisions to watch out for this first quarter of 2024.
    • “The agency could approve a closely watched Alzheimer’s disease drug, as well as what could be the first medicine for a prevalent liver disease and a new kind of cancer therapy. Also on deck are verdicts for a drug at the heart of a multibillion dollar buyout and a linchpin asset for one biotech’s oncology plans.”

From the public health and medical research front,

  • The New York Times reports,
    • “As Covid rises again, killing about 1,500 Americans each week, medical researchers are trying to understand why so few people are taking Paxlovid, a medicine that is stunningly effective in preventing severe illness and death from the disease.
    • “A study of a million high-risk people with Covid found that only about 15 percent who were eligible for the drug took it. If instead half of the eligible patients in the United States had gotten Paxlovid during the time period of the research, 48,000 deaths could have been prevented, the authors of the study, conducted by the National Institutes of Health, concluded.
    • “It’s not because people don’t know about the drug — most do — but the reluctance seems to come from doctors worried about interactions with other drugs and people wary of a possible rebound case or the metallic aftertaste.” * * *
    • “Reasons for not prescribing or taking it have varied: Doctors balk at the long list of medications not to be mixed with Paxlovid, including common drugs meant to lower blood pressure or prevent blood clots. Patients tend to complain about the drug’s metallic aftertaste. Many wave off the drug in the early days of Covid, when symptoms tend to be mildest, bypassing the chance to limit early viral growth. * * *
    • “Federal officials still have more than one million free doses out to pharmacies, and the medication will be free through 2024 for Medicaid and Medicare patients. But in recent weeks, officials have handed distribution of the drug off to Pfizer, which has priced it at about $1,400 per course, though private insurers are expected to cover some portion of the price and Pfizer is offering co-payment assistance.“
  • Fierce BioTech tells us,
    • “Researchers at Roche have developed a novel antibiotic with the ability to fight a dangerous drug-resistant bacteria that kills in up to 60% of infections.
    • “In a pair of articles published Jan. 3 in Nature, Roche and Harvard University scientists described how they developed a new antibiotic that is effective against carbapenem-resistant acinetobacter baumannii—also known as CRAB—in mice. The drug, zosurabalpin, works by interrupting construction of the bacteria’s outer membrane.
    • “The ongoing research into zosurabalpin, as well as a second novel class of antibiotics being developed by Roche in human clinical studies, will help uncover new biology about the construction of bacterial membranes,” Michael Lobritz, M.D., Ph.D., global head of infectious diseases at Roche Pharma Research & Early Development, said in a statement provided to Nature. “Our goal is to contribute new innovations to overcome antimicrobial resistance, one of the biggest infectious disease challenges to public health.”
    • “CRAB is a common culprit in hospital-acquired sepsis and other infections, and is at the top of the list of both the World Health Organization’s and the Centers for Disease Control’s “priority pathogens” for which new drugs are urgently needed.” 

From the U.S. healthcare business front,

  • BioPharma Dive points out,
    • “Eli Lilly wants to make it easier for people to access its medicines for obesity, diabetes and migraine, announcing Thursday the launch of a website designed to support home delivery of drugs like its in-demand weight loss treatment Zepbound.
    • “The company’s new service, dubbed LillyDirect, relies on online pharmacy providers like Eversana and Truepill to deliver prescribed Lilly medicines. A website provides access to telehealth services through which people can consult with an independent physician. If prescribed a Lilly medicine, LillyDirect is also meant to help patients more easily access the company’s savings cards.
    • “LillyDirect currently supports 14 of the pharmaceutical company’s medicines, 12 of which are various formulations and types on insulin. Notably, the service also offers Zepbound, which the FDA approved for weight loss in November, and Lilly’s migraine medicine Emgality.”
  • Reuters reports
    • “CVS Health (CVS.N) said on Wednesday it will remove AbbVie’s (ABBV.N) blockbuster rheumatoid arthritis drug Humira from some of its lists of preferred drugs for reimbursement as of April 1, and will recommend biosimilar versions of the medicine instead.
    • “CVS said Hyrimoz and an unbranded version of Humira, both from Swiss drugmaker Sandoz (SDZ.S), will be covered across all its formularies, while branded and unbranded near copies of the drug from India’s Biocon (BION.NS) will be covered on some reimbursement lists.
    • “CVS also announced that AbbVie and CVS-owned company Cordavis, which launched in August, will produce a co-branded version of Humira that will be made available to customers in the second quarter of this year. While most biosimilars are near copies of the branded drug, the Cordavis version will be identical to Humira in its formulation, CVS said.”
  • Healthcare Dive notes,
    • “Walgreens beat Wall Street expectations on earnings per share and revenue in its first quarter, as the pharmacy giant continues to push through “growing pains” amid its shift to healthcare services, according to CEO Tim Wentworth.
    • “The chain’s U.S. Healthcare segment posted sales of $1.9 billion compared with $989 million in the prior-year period, boosted by primary care chain VillageMD’s acquisition of Summit Health and growth in other business units. But the segment still reported a $96 million adjusted operating loss, compared with a $152 million loss last year. 
    • “Walgreens is nearly halfway through its plan to close 60 VillageMD clinics as the provider focuses on density in “high opportunity” markets, Wentworth said during an earnings call.” 
  • The Wall Street Journal reports,
    • “Health insurance companies say they want to offer more services directly to customers. But that requires dropping the cumbersome technology that has defined the industry in favor of the smartphone-app experience users have come to expect.
    • “Kaiser Permanente Chief Digital Officer Nari Gopala said he is working to remove friction from the company’s digital-pharmacy experience, including introducing prescription-refill reminders. “The experience itself is like what you’re used to as a consumer in other industries, like how you order your coffee or groceries,” Gopala said.
    • “Kaiser, an integrated health system with insurance and hospital components, is one of a number of firms revamping technology in the hopes of encouraging more people to get their medications through the mail rather than picking them up in retail pharmacies.”
  • United Healthcare discusses, “Recently launched initiatives by Optum Rx enable more than 26,000 in-network community and independent pharmacies with expanded support to strengthen access to care and improve outcomes for the patients they serve.”
  • Beckers Hospital Review lets us know,
    • “Since launching in January 2021 with about 100 generics, Mark Cuban Cost Plus Drug Co. now offers more than 2,000 drugs, including about a dozen brand-name medications. 
    • “The company has also grown to offer discounted drug prices through more than 4,000 affiliated pharmacies, including those in Kroger and Meijer grocery stores. 
    • “Cost Plus Drugs is targeting inflated drug prices through multiple lenses. It markets medications at their acquisition cost and adds a $5 shipping fee, a $5 pharmacy labor fee and a 15% markup. Other pharmaceutical companies are taking notice of the transparency marketing effect. 
    • “The company’s conservative drug pricing model is buttressed with a “yes, and” approach to its collaborations and partnerships, which include four pharmacy benefit managers. 
    • “In recent months, Cost Plus Drugs has struck collaboration deals with an elderly care business, two fertility health companies, a digital health company and a mail-order pharmacy.” 
  • Per Fierce Healthcare,
    • “A “pivotal year for price transparency” closed out with most—but not all—of the healthcare industry publishing their data publicly and at a higher quality, price transparency data startup Turquoise Health wrote in a state-of-the-industry report released Thursday.
    • “Across a total of 6,357 hospitals, 5,763 (90.7%) posted a machine-readable file (MRF) with at least some necessary service rates in 2023. This was an increase of 562 hospitals over the end of 2022, with Turquoise noting that most of the additions “were individual hospitals, often with unique MRF formats.”
    • “Turquoise gave 2,634 of the hospitals posting MRFs a five-star rating for publishing “a complete MRF that contains cash, list and negotiated rates for a significant quantity of items and services,” the group wrote. That list of top scorers grew 24% from the end of 2022, and now represent more than half of the total hospital field. * * *
    • “The number of payers publishing their data has grown from an initial 67 back in July 2022 to 170 in January 2023, and now to 205 as of November 2023, according to the report. Turquoise also noted that “the quality and breadth of their files have also improved” over the past several months — welcome news for researchers and other stakeholders who previously critiqued payers’ unwieldy data releases.”