Midweek Update

Midweek Update

Photo by Manasvita S on Unsplash

From Washington, DC,

  • Federal News Network builds on OPM’s March 12 press release about the Postal Service Health Benefits Program launch in January 2025.
  • STAT News calls attention to healthcare points that you might have missed in the President’s FY 2025 budget. For example,
    • “The budget proposes for the first time a change to the law that would let pharmacists fill prescriptions for brand-name biologics with biosimilars without doctor permission. The measure is part of the administration’s plan to lower drug costs. * * *
    • “Besides budget boosts for behavioral health services, research, and the 988 crisis hotline, the administration is asking Congress for legislative changes to make mental health care more accessible. Those include eliminating Medicare’s 190-day lifetime limit on psychiatric services in hospitals, which it estimates would cost the program $2.9 billion over 10 years. * * *
    • “Medicare would also have to cover three behavioral health visits without cost-sharing, a move that could cost $1.5 billion over a decade. Biden wants to extend this requirement to private insurers as well, at an estimated cost of $428 million over that time.”
  • HealthDay informs us,
    • The White House on Wednesday launched a nationwide call for more training and better access to the lifesaving opioid overdose drug naloxone.
    • Called the Challenge to Save Lives from Overdose, the initiative urges organizations and businesses to commit to train employees on how to use opioid overdose medications, to keep naloxone in emergency kits and to distribute the drug to employees and customers so they might save a life at home, work or in their communities.
    • “Today, we’re calling on organizations and businesses — big and small, public and private — across the country to help ensure all communities are ready to use this lifesaving tool to reduce opioid deaths,” the White House said in a fact sheet announcing the new initiative. “As the drug supply has gotten more dangerous and lethal, we’re asking allies to join us because we all must do our part to keep communities safe.”
  • The CDC is offering free webinars on the RxDC process on March 27 and April 3.

From the Change Healthcare situation front,

  • United Healthcare updated its Change Healthcare situation response website this afternoon.
  • The HHS Office for Civil Rights, which enforces the HIPAA Privacy and Security Rule, issued a Dear Colleague letter about the Change Healthcare situation and announced opening an investigation of UHC about cyberattack and its fallout.
  • The Congressional Research Service posted an insight report titled “The Change Healthcare Cyberattack and Response Considerations for Policymakers.’
  • The American Medical Association explained how providers can navigate the Change Healthcare situation.

From the public health and medical research front,

  • The New York Times reports,
    • “Early detection of colon cancer can prevent a majority of deaths from this disease, possibly as much as 73 percent of them. But just 50 to 75 percent of middle-aged and older adults who should be screened regularly are being tested.
    • “One reason, doctors say, is that the screening methods put many people off.
    • “There are two options for people of average risk: a colonoscopy every 10 years or a fecal test every one to three years, depending on the type of test.
    • “Or, as Dr. Folasade P. May, a gastroenterologist at UCLA Health puts it, “either you take this horrible laxative and then a doctor puts an instrument up your behind, or you have to manipulate your own poop.”
    • “But something much simpler is on the horizon: a blood test. Gastroenterologists say such tests could become part of the routine blood work that doctors order when, for example, a person comes in for an annual physical exam. * * *
    • “A study published on Wednesday in The New England Journal of Medicine found that a blood test searching for such [colon cancer] DNA called Shield and made by the company Guardant Health detected 87 percent of cancers that were at an early and curable stage. The false positive rate was 10 percent.
    • “But there is a caveat to the blood test: While it detects cancers, it misses most large polyps, finding just 13 percent of them. In contrast, the fecal test detects 43 percent and a colonoscopy finds 94 percent, Dr. Carethers said.
    • “While polyps are usually harmless, a few can turn into cancers, so doctors want to find all of them and remove them to prevent cancers from forming.”
  • The Department of Health and Human Services posted a fact sheet on in vitro fertilization across our country.
  • BioPharma Dive tells us,
    • “Merck on Wednesday announced plans to start clinical trials testing a newer version of its vaccine for human papillomavirus, or HPV, as well as a different regimen of the shot it currently sells.
    • “The trials are bids to improve upon vaccines Merck currently markets as Gardasil and Gardasil 9. One will test a shot meant to provide protection against more strains of HPV. The other will evaluate a single-dose regimen of Gardasil 9. Both studies should begin in the fourth quarter of this year. 
    • “Gardasil is approved for use against genital warts and to prevent several cancers caused by stains of HPV. The vaccine is one of Merck’s top-selling products and still growing. It generated $8.9 billion in sales in 2023, up 29% from the previous year.” 
  • STAT News informs us,
    • “For four decades, researchers and companies searched for ways to replace the broken blood-clotting genes that cause hemophilia, a multibillion dollar effort designed to turn a chronic, sometimes debilitating disease into a curable one. 
    • “But the first two gene therapies have so far been met with crickets. Only a handful of patients with hemophilia B, the rarer form of the disease, appear to have been treated worldwide since Hemgenix was approved in November 2022. After Roctavian was approved for hemophilia A last June, only three patients were treated through the rest of the year.
    • “The issue doesn’t appear to be access. Hemgenix and Roctavian, marketed by the Australian biotech CSL Behring and the San Francisco biotech BioMarin, are Malibu-mini-mansion expensive: $3.5 million and $2.9 million, respectively. But current hemophilia treatments can run over $1 million per year. So most insurers have been happy to pay the lump sum.
    • “​​You can’t blame the payers this time,” said Michael Sherman, former chief medical officer of the nonprofit insurer Harvard Pilgrim.” 
  • The National Cancer Institute posted research highlights.
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health (NIH) have discovered that symptoms of attention-deficit/hyperactivity disorder (ADHD) are tied to atypical interactions between the brain’s frontal cortex and information processing centers deep in the brain. The researchers examined more than 10,000 functional brain images of youth with ADHD and published their results in the American Journal of Psychiatry. The study was led by researchers at NIH’s National Institute of Mental Health and National Human Genome Research Institute. * * *
    • “The findings from this study help further our understanding of the brain processes contributing to ADHD symptoms—information that can help inform clinically relevant research and advancements.”
  • The Institute for Clinical and Economic Review published a “Final Evidence Report on Treatments for Paroxysmal Nocturnal Hemoglobinuria. — Independent appraisal committee voted that current evidence is not adequate to demonstrate a net health benefit for iptacopan over C5 inhibitor; committee voted that the evidence is adequate to demonstrate a net health benefit for add-on danicopan compared to C5 inhibitor alone.”
  • Medscape relates,
    • “Chronic smoking remains a major cause of premature mortality on a global scale. Despite intensified efforts to combat this scourge, a quarter of deaths among middle-aged adults in Europe and North America are attributed to it. However, over the past decades, antismoking campaigns have borne fruit, and many smokers have quit before the age of 40 years, enabling some case-control studies.
    • “Among those abstainers who made the right choice, the excess mortality attributable to smoking over a lifetime would be reduced by 90% compared with controls who continued smoking. The estimated benefit is clear, but the analysis lacks nuance. Is smoking cessation beneficial even at older ages? If so, is the effect measurable in terms of magnitude and speed of the effect? An article published online on February 8, 2024, in The New England Journal of Medicine Evidenceprovided some answers to these questions.”

From the HIMSS conference front,

  • Healthcare IT News reports “Samsung focuses on intuitive mobile tech and wearables at HIMSS24. These technologies can help cure healthcare worker burnout, patient confusion and inefficient communications between care teams, says a top exec and nurse.”
  • Forbes explains why AI is taking center stage at the conference.
    • “At the HIMSS conference in Orlando, healthcare leaders, including CIOs, CMIOs, CNIOs, and other C-suite members, were focused on AI as the central theme. They explored how healthcare organizations can better utilize their clinical data. They identified security, AI platforms, and workforce optimization as the three main areas for healthcare AI development.”
  • In related news, Health IT Analytics lets us know,
    • “Researchers from Mount Sinai have been awarded a four-year, $3 million grant from the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) to develop artificial intelligence (AI)-driven prediction models to flag risk of cardiovascular disease events in patients with obstructive sleep apnea.
    • “The American Heart Association (AHA) indicates that obstructive sleep apnea increases patients’ risk of cardiovascular disease, including coronary artery disease, hypertension and stroke. The use of continuous positive airway pressure (CPAP) machines is often prescribed to treat sleep apnea, but evidence to suggest the benefits of CPAP use in relation to cardiovascular event rates is limited.
    • “To bridge this gap, the research team will build machine learning (ML) tools to identify obstructive sleep apnea patients at high risk for atherosclerosis progression and cardiovascular events like stroke and heart attack.”

In other U.S. healthcare business news,

  • The Wall Stree Journal reports,
    • “People seeking a popular new weight-loss drug will have a new home-delivery option from a familiar name: Amazon.com.
    • Amazon Pharmacy, which has sold prescription medicines online since 2020, will now handle some of the home delivery of anti-obesity therapy Zepbound and other Eli Lilly drugs that are ordered through the drugmaker’s new direct-to-consumer service, the companies said Wednesday.
    • “The service, called LillyDirect, connects patients with telehealth services specializing in obesity that can write prescriptions for Zepbound or another weight-loss drug. The service also arranges for a prescription to be processed and mailed directly to customers.” 
  • The Society for Human Resource Management notes,
    • “According to the latest Employer Costs for Employee Compensation report, released March 13 by the U.S. Bureau of Labor Statistics (BLS), employers spent 3.8 percent more on wages and benefits in December 2023 compared to September 2023.
    • “Total employer compensation costs for private-industry workers averaged $43.11 per hour worked in December 2023. Wages and salaries averaged $30.33 per hour worked and accounted for 70.4 percent of employer costs, while benefit costs averaged $12.77 per hour worked and accounted for the remaining 29.6 percent, according to the BLS report.
    • :That’s a significant jump from the total employer compensation costs for those same workers last fall, and one indicating that despite slowing compensation growth over the past year, bigger hikes are not yet over.”

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.” 

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC

  • The Wall Street Journal reports,
    • President Biden proposed Monday a $7.3 trillion budget for the next fiscal year that would raise taxes on wealthy people and large corporations, trim the deficit and lower the costs of prescription drugs, child care and housing.
    • “The proposal isn’t expected to gain momentum in Congress, but will be a cornerstone of Biden’s re-election campaign as he looks to contrast his economic policies with those of presumed Republican presidential nominee Donald Trump. The administration has yet to reach an agreement with Congress on the budget for the current fiscal year, which began Oct. 1, and House Republicans have blasted Biden’s new proposal as reckless.
    • “The fiscal 2025 budget would cut the deficit by $3 trillion over the next decade, and it would raise taxes by a net total of $4.9 trillion, or more than 7% above what the U.S. would collect without any policy changes.” 
  • Here’s a link to the OMB page for the FY 2025 budget.
  • The Department of Health and Human Services offers a fact sheet on the budget measures impacting health insurance.
  • Govexec delves into the significant program reforms found in the budget details.
  • Federal News Network adds,
    • “For 2025, the White House is pushing for a more modest 2% federal pay raise for the roughly 1.5 million federal employees on the General Schedule.
    • “If enacted, most civilian federal employees would see the boost to their paychecks starting in the first full pay period of January 2025. Military members would receive a 4.5% raise next year, according to the budget request.
    • “The percentage adjustment would be the smallest pay raise since President Joe Biden took office. Federal employees received raises of 5.2%4.6% and 2.7%, in 2024, 2023 and 2022, respectively. In all three years, Biden’s federal pay raise proposals were finalized without intervention from Congress.
    • “The Biden administration said it opted for the smaller raise proposal for 2025 due to financial constraints agencies are expected to face over the next fiscal year.”
  • The U.S. Office of Personnel Management posted its FY 2025 Congressional Budget Justification and Annual Performance Plan. Here are OPM’s legislative proposals for FEDVIP and FEHBP/PSHBP:
    • “Expand Family Member Eligibility Under FEDVIP;
    • “Expand FEDVIP to Certain Tribal Employers;
    • “Expand FEHB to Tribal Colleges and Universities;
    • “Preempt State/Local Taxation of FEDVIP Carriers to Align with FEHB Carriers;
    • “Shorten FEDVIP Contract Terms to Allow Flexibility for New Carriers;
    • “Require Coverage of Three Primary Care Visits and Three Behavioral Health Visits Without Cost-Sharing;
    • “Limit Cost-Sharing for Insulin at $35 per Month.”
  • These proposals generally are retreads from earlier performance plans. If at first you don’t succeed, etc.

From the patient safety front,

  • HHS’s Agency for Healthcare Research and Quality reminds us that this is Patient Safety Awareness Week.
  • Fierce Healthcare tells us,
    • “Through no fault of their own, clinicians who started practicing medicine in the last several years didn’t have the same early experience as those who came before them–before the pandemic laid bare critical weaknesses in our healthcare system,” Marcus Schabacker, M.D., president and CEO of ECRI, said in a release. “ECRI’s top patient safety concern is a call to action to set new clinicians up for success through a ‘total systems safety’ approach and assess and redesign the environments in which clinicians are trained, onboarded, mentored and supported.”
    • “Among the recommendations proposed by ECRI and its affiliate, the Institute for Same Medication Practices (ISMP), in the patient safety report are new collaborative partnerships between healthcare and academic to support hands-on and simulation-based learning, as were wellness programs and adopting “a culture of safety that empowers newly trained clinicians to report safety events.”
    • “Just behind new hire challenges in ECRI’s 2024 ranking was concern that healthcare staff’s workarounds for barcode medication administration systems could lead to an increase in medication safety events.
    • “These workarounds occur when drug’s barcode can’t be scanned due to damage on a label, or when a medication hasn’t yet been added to an organization’s system, ECRI explained. This can lead to back-charting, proxy scanning, unlogged medication administration and ignored system alerts, and has historically been to blame for a majority of technology-related medication safety issues, according to the report.”
  • USAA Today reports,
    • “Beginning this year, the Centers for Medicare & Medicaid Services announced it would cover navigation services for older Americans on Medicare. The agency also established billing codes for hospitals and doctors to bill health insurance companies for navigator services.
    • “The Biden administration announced that seven large private health insurance companies have agreed to cover navigator services: Aetna, Blue Cross Blue Shield of Minnesota, Elevance Health, Health Alliance Plan, Humana, Priority Health and Select Health.
    • “In addition, 40 cancer care centers and clinics will extend navigator services to patients. The list includes high-profile cancer care centers such as Dana-Farber Cancer Institute in Boston, the Duke Cancer Institute, Northwell Health and the Mayo Clinic.
    • “This is about making sure that a growing number of Americans can get access as they need it,” Arati Prabhakar, director of the White House Office of Science and Technology Policy, told USA TODAY. “The companies that have signed up to provide insurance coverage for these services … reach 150 million Americans.”

From the Food and Drug Administration front,

  • BioPharma Dive informs us,
    • “The Food and Drug Administration has expanded the label for Novo Nordisk’s fast-selling weight loss drug Wegovy following study results that proved the medicine can protect heart health. 
    • “The agency on Friday approved use of Wegovy to reduce the risk of heart attacks, strokes or death in people with cardiovascular disease and who are either obese or overweight. The drug should be used alongside exercise and a reduced-calorie diet, the agency said. 
    • “Wegovy, part of a popular class of medicines that control blood sugar and appetite, is already approved for use in treating obesity. The drug generated about $4.5 billion in sales in 2023 despite manufacturing issues that made it difficult for the company to meet surging demand.” * * *
    • “The FDA clearance issued Friday is one step in that direction. It was based on the results of a large study, the results of which were published in The New England Journal of Medicine last year, showing that treatment with Wegovy reduced the risk of heart attack, stroke or cardiovascular death by 20% compared to a placebo.” 
  • MedTech Dive lets us know,
    • “A Food and Drug Administration advisory committee has voted that the benefits of a new agent used in Lumicell’s breast cancer imaging tool outweigh the risks.
    • “The committee, which convened last week, assessed evidence that the tool can detect residual cancer in real-time during breast conserving surgery. Detecting residual cancer during surgery could reduce the need for additional procedures.
    • “While the committee supported the risk-benefit profile of the agent, pegulicianine, by a 16-2 vote, many of the experts noted its limitations, with one panelist who voted yes saying that the “incremental benefits outweigh the small risks of anaphylaxis.”

From the public health and medical research front,

  • David Leonhardt writing in the New York Times reflects on the fourth anniversary of the beginning go of the Covid shutdown in the U.S.
  • The American Medical Association tells us what doctors wish their patient knew about sickle cell disease.
  • The Institute for Clinical and Economic Review posted a “Final Evidence Report on Treatment for Schizophrenia An independent appraisal committee voted that current evidence is not adequate to demonstrate superior net health benefits for KarXT compared to generically available aripiprazole; if long-term data confirm KarXT’s benefits and lack of weight gain, it would achieve common thresholds for cost-effectiveness if priced between $16,000 to $20,000 per year.
  • Beckers Hospital Review relates,
    • “Pfizer’s shortage of penicillin G benzathine injection, an antibiotic for syphilis and other bacterial infections, is now predicted to last until the end of 2024. 
    • “Pfizer previously said the medication’s supply would rebound by the end of June, but in a March 8 update on the FDA’s drug shortage website, the drugmaker said the estimated recovery date is the fourth quarter of 2024. 
    • “Two solutions are in limited availability and another, the 600,000 [iU]/1 mL solution, is unavailable until its next shipment in April. 
    • “The FDA first reported the supply issue in April 2023, and Pfizer then said it would end within five months. A year later, clinicians are rationing penicillin, and the U.S. is importing solutions from a France-based drugmaker as syphilis rates dramatically increase.”

From the HIMSS global conference front,

  • This week, HIMSS is holding its popular global conference in Orlando, Florida.

From the U.S. healthcare business front,

  • Fierce Healthcare discusses lobbying efforts to obtain a Congressional extension of Medicare’s hospital at home program.
  • Healthcare Dive notes,
    • “Elevance Health said on Monday it closed its deal to acquire infusion and drug therapy company Paragon Health.
    • “Under the deal, the insurer will expand Plano, Texas-based Paragon’s real estate footprint and scale up operations, according to the announcement. Paragon will operate under CarelonRx, Elevance’s pharmacy services segment.
    • “An Elevance spokesperson declined to share financial terms of the deal. However, Axios, citing sources familiar, reported the purchase would run Elevance over $1 billion.”
  • Beckers Hospital Review ranks 34 health systems by operating margin.
  • Medscape informs us,
    • “A Maryland firm that oversees the nation’s largest independent network of primary care medical practices is facing a whistleblower lawsuit alleging it cheated Medicare out of millions of dollars using billing software “rigged” to make patients appear sicker than they were.
    • “The civil suit alleges that Aledade, Inc.’s, billing apps and other software and guidance provided to doctors improperly boosted revenues by adding overstated medical diagnoses to patients’ electronic medical records.
    • “Aledade did whatever it took to make patients appear sicker than they were,” according to the suit.”
  • HR Dive reminds us,
    • “The U.S. Department of Labor’s independent contractor final rule went into effect Monday, after businesses scrambled last week to have it enjoined or halted through a preliminary injunction
    • “DOL announced the final rule in January, more than a year after it proposed changes to its evaluation of workers’ independent contractor status in October 2022. 
    • “The new “totality-of-the-circumstances” framework uses six nonexhaustive factors to determine workers’ independent contractor status, including the nature and degree of control over the work, extent to which the work performed is an integral part of the employer’s business and permanence of the arrangement. 

Weekend Update

Photo by Tomasz Filipek on Unsplash

From Washington, DC,

  • Reuters adds, “U.S. President Joe Biden will put forth his proposed U.S. spending plan [tomorrow] March 11, according to the White House Office of Management and Budget.”
  • Today, the Department of Health and Human Services posted a letter to healthcare leaders about the Change Healthcare cyberattack.
    • We urge insurance companies and other payers to:
      • Make interim payments to impacted providers. Larger payers in particular have the balance sheet stability to advance payments. Payers have the opportunity to stop-gap the cash flow concerns by stepping in with bridge payments [FEHBlog note — assuming that the payer doesn’t rely on Change Healthcare for backend claims processing.}
      • In particular, for Medicaid plans, consider making interim payments to impacted providers.
      • Ease the administrative burden on providers by simplifying electronic data interchange requirements and timelines and by accepting paper claims. 
      • Pause prior authorizations and other utilization management requirements; use all available leeway on deadlines.
  • The Washington Post further reports,
    • “Federal health officials on Saturday said they would offer emergency funding to physicians, physical therapists and other professionals that provide outpatient health care, following a cyberattack that crippled the nation’s largest processor of medical claims and left many organizations in financial distress.
    • “The Centers for Medicare and Medicaid Services also announced that it would make advance payments available to suppliers that bill through Medicare Part B, which serves a wide array of health-care organizations. Officials had previously announced a similar program to make emergency payments available for hospitals that had been ensnared by the Feb. 21 hack of Change Healthcare, a unit of UnitedHealth Group, and have struggled to get paid for more than two weeks. The emergency funds represent upfront payments made to health-care providers and suppliers based on their expected future claims. * * *
    • “It’s going to help significantly,” added Farzad Mostashari, the CEO of Aledade, the nation’s largest network of independent physician practices. Mostashari had previously warned that as many as 25 percent of physician practices were in financial distress.”

From the public health and medical research front,

  • According to the Centers for Disease Control,
    • “Activity Levels Update:
      • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 20 jurisdictions experienced high or very high activity compared to 26 jurisdictions previous week.
      • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
      • “Influenza test positivity remained stable nationally. COVID-19 and RSV test positivity decreased compared to the previous week.
      • “Nationally, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, has decreased to moderate.
    • Reported on Friday, March 8th, 2024.
  • Fortune Well offers advices on pregnancy in advance maternal age (at age 35 or older).
  • The Washington Post tells us,
    • “Tai chi, a gentle Chinese martial art involving slow movements, outperformed moderate aerobic exercise in lowering blood pressure in a recent clinical trial.
    • “An analysis, published in JAMA Network Open, tracked 342 18- to 65-year-olds with prehypertension, or blood pressure that is slightly higher than normal, between late July 2019 and mid-January 2022. * * *
    • “These findings support the important public health value of Tai Chi to promote the prevention of cardiovascular disease in populations with prehypertension,” the researchers conclude. Other research continues to explore the potential benefits of tai chi. The exercises are associated with better balance, fall reduction, and benefits for patients with conditions such as arthritis and fibromyalgia.”
  • Bloomberg discusses measles prevention practices for adults born after 1957.
    • “[Katrine Wallace, an epidemiologist at University of Illinois Chicago] says, adults are sufficiently protected from the measles if one of these four things applies to you:
      • “You had measles at some point in your life.
      • “You were born before 1957.
      • “You’ve had two doses of a measles-containing vaccine if you spend time in a high-risk setting for transmission, like schools or hospitals. 
      • Y”ou’ve had one dose of a vaccine if you don’t spend time in high-risk settings. 
      • “Kids and teens need one or two doses for protection depending on their age.” 
    • If you aren’t sure whether you’ve been vaccinated or had the measles, you can get what’s called an MMR titer test, which is available commercially at various labs for about $129, Wallace advises.
  • The Wall Street Journal delves into the development of individual body organ tests.
    • “Measuring organ age is the latest frontier in the world of biological age, the idea that your body’s physical age can be different from its chronological one. For example, a 50-year-old man hypothetically might have physical health that more closely resembles that of a 53-year-old, with, say, a 51-year-old heart and a 54-year-old brain.
    • “Knowing the age of your organs might one day help you prevent and treat disease. In theory, if you knew that your heart was aging too fast, you could take steps to ward off heart disease.
    • “Heart aging predicts future heart disease, and brain aging predicts future dementia,” says Hamilton Oh, one of the paper’s lead authors and a graduate student at Stanford.
    • “Walking into your doctor’s office and getting a simple test to determine your organ age is likely still a ways off, but the concept is gaining interest among researchers, doctors and people focused on their own longevity and health. Scientists caution that more research is needed before such a technology might be ready for mainstream use. Some also say that parts of the recent study made too many assumptions.”

From the U.S. healthcare business front,

  • The Dispatch informs us,
    • “A 2021 study published by the RAND Corporation found that, even after rebates and other discounts, U.S. prescription drug prices were, on average, nearly twice as high as those in countries including Canada, France, Germany, Japan, and the United Kingdom. A 2024 study, also conducted by the RAND Corporation for the Office of the Assistant Secretary for Planning and Evaluation, similarly found that 2022 drug prices in the U.S. were nearly three times higher than those in the 33 Organisation for Economic Co-operation and Development (OECD) countries used in the comparison.
    • “However, the study also found that, on average, unbranded generic drugs were about a third cheaper in the U.S. than in other comparison countries, meaning Americans are actually paying less for these drugs than they would elsewhere. “This finding suggests that robust price competition in U.S. unbranded generic markets continues to drive savings for consumers and health care payers relative to spending on these drugs in other countries,” the study said. Even though generic drugs make up 90 percent of U.S. prescription volume, the substantially higher cost for brand-name drugs still results in a higher average cost for all drugs in the U.S. than elsewhere, according to the report.”
  • HR Dive lets us know,
    • “Judge J. Campbell Barker of the U.S. District Court for the Eastern District of Texas vacated the National Labor Relations Board’s joint employer rule late Friday. The rule was set to go into effect Monday.
    • “The new rule would be “contrary to law” and “arbitrary and capricious,” Barker ruled. The court had been considering a legal challenge brought in November by the U.S. Chamber of Commerce, along with other business groups. 
    • “Federal agencies and employers now await a possible court decision on the U.S. Department of Labor’s independent contractor rule, also set to go in effect Monday.”

Happy International Women’s Day

Photo by Dulcey Lima on Unsplash

The International Foundation of Employee Benefit Plans celebrates International Women’s Day. “International Women’s Day is an ideal time to pause and reflect on the status of women in the workforce—both how far we’ve come and how far we still need to go to achieve true gender equality. 

Mercer Consulting adds, “Women are hugely concerned about the state of their personal finances – and too often, employers have fallen short of providing the support their people need. For too long, financial health has trailed behind physical and mental health on the list of employers’ priorities. Now is the time to act!” The article explains how to act.

From Washington, DC,

  • The Wall Street Journal reports,
    • The Senate on Friday passed a $460 billion spending bill to keep the U.S. government operating, taking a potential shutdown for several agencies off the table for the rest of the fiscal year.
    • In a 75-22 vote, Senate lawmakers approved budgets for federal agencies including the Agriculture, Justice, Transportation and Interior departments through the end of September, just hours before some agencies were scheduled to run out of money. The vote came after several nervous hours of negotiations over votes on amendments demanded by Republicans as a condition for the final vote.
    • The measure now heads to President Biden for approval.
  • Healthcare Finance News adds,
    • “A 3.34% physician payment reduction began January 1. [spending] The legislation  [includes] a prospective increase of 1.68% to Medicare physician reimbursement effective March 9, according to MGMA.
    • “Medical groups would still be left with a 1.69% reduction in reimbursement for the rest of the year.”
  • Fierce Healthcare informs us,
    • “[On Thursday night,] President Joe Biden promised the country further action on prescription drug prices, insurance coverage and reproductive care access during a State of the Union Address that doubled as an early campaign speech.
    • With a presidential election months away, the White House hasn’t held back from promoting its recent efforts on issues at the front of voters’ minds such as the cost of American healthcare and abortion. Though Biden’s address included several calls for policy support from Congress, he wasn’t shy about making his pitch directly to watching voters who could tip the scales in his office’s favor. * * *
    • “Biden asked Congress to build upon the Inflation Reduction Act (IRA) to increase the number of products subject to Medicare drug price negotiations.
    • Rather than the current 20-drug-per-year limit, Biden asked lawmakers for the authority to negotiate prices for 50 drugs a year, or “500 different drugs over the next decade,” he said.
    • “Additionally, the president called to extend the $2,000 out-of-pocket cap on prescription Medicare drugs (set to go into effect in 2025) to all private insurance.
    • “Per the fact sheets, he is also pushing for a similar expansion of another IRA requirement—that drug manufacturers pay rebates to Medicare for certain drug price increases that exceed inflation—to the commercial market. He illustrated that goal during the address by calling for Medicare’s $35-per-month cap on insulin to apply “to every American.”
  • The U.S. Office of Personnel Management issued its FEHB and PSHB technical guidance to carriers who are preparing 2025 benefit and rates proposals in response to the February 8, 2024, call letter.

From the Food and Drug Administration front,

  • BioPharma Dive reports,
    • “A large clinical trial meant to confirm the benefits of a new ALS medication has instead failed, dealing a major blow to the therapy’s developer as well as patients who had hung their hopes on it.
    • “Amylyx Pharmaceuticals disclosed Friday morning that the drug, known as Relyvrio in the U.S., didn’t meet the trial’s main or secondary goals. Though well-tolerated by participants, Relyvrio was not significantly better than a placebo at changing the trajectory of their disease.
    • “For Amylyx, the results are a monumental setback. The Massachusetts-based biotechnology company was built entirely around Relyvrio, which received approval from the Food and Drug Administration in the fall of 2022. Early sales made Amylyx profitable – a rare victory for any young drugmaker. * * * By the end of September, nearly 4,000 of the roughly 30,000 ALS patients in the U.S. were on Relyvrio, according to Amylyx’s estimates. * * *
    • “Now, the company’s future is unclear. Before Relyvrio’s approval, Amylyx co-founders Justin Klee and Joshua Cohen pledged, at the request of a top FDA official, to pull their drug from the market should confirmatory testing fail.
    • “In a statement, Amylyx said that sometime in the next eight weeks, it will share its plans for Relyvrio, which “may include voluntarily withdrawing [the drug] from the market.” The company also intends to discuss the new results with regulators, doctors and the broader amyotrophic lateral sclerosis community.
    • “In the meantime, Amylyx will pause promoting the product.”
  • STAT News tells us,
    • “In a surprise move, the Food and Drug Administration has called for a meeting of outside advisers to discuss whether an Alzheimer’s drug from Eli Lilly should be approved, even as many outsiders expected the medicine to receive regulatory clearance this month.
    • “The drug, donanemab, succeeded in its Phase 3 trial, resulting in a 35% slowing of Alzheimer’s disease progression versus placebo. But Lilly on Friday said that the FDA expects to call a meeting of an advisory committee to review the trial, saying that the agency had told the company “it wants to further understand topics related to evaluating the safety and efficacy of donanemab, including the safety results in donanemab-treated patients and the efficacy implications of the unique trial design” of the study.
    • “A date for the meeting has not been set yet.
    • “Lilly previously said a regulatory decision was expected by the end of 2023, but had already pushed that back to the first quarter of 2024. In its statement Friday, it said simply that “the timing of expected FDA action on donanemab will be delayed beyond the first quarter of 2024.”

From the public health and medical research front,

  • The Hill informs us,
    • “The rash of measles outbreaks around the country has sparked concerns that the U.S. risks losing its status as a country where the disease has been eliminated, a distinction held since 2000.
    • “As of last week, 41 measles cases have been confirmed across 15 states and New York City, according to the Centers for Disease Control and Prevention (CDC). That puts the nation already on track to surpassing the 58 total cases that were detected in 2023.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services unveiled a new Framework to accelerate smoking cessation and reduce smoking- and cessation-related disparities.  This action is part of a broader Department-wide effort to advance the Biden Cancer Moonshot goal of reducing the death rate from cancer by at least half over 25 years.
    • “Every person in America should have access to the tools and programs they need to quit smoking. And we must encourage and assist every person in America who wants to quit smoking to do so,” said Secretary Xavier Becerra. “This framework focuses on advancing equity, engaging communities, and coordinating, collaborating, and integrating evidence-based approaches across every facet of our government and society. The Biden-Harris Administration will continue these efforts until smoking is no longer the leading cause of preventable death in the United States, and the communities that remain the most vulnerable get the help they need.”
    • “The HHS Framework to Support and Accelerate Smoking Cessation – PDF provides a unifying vision and set of common goals to help drive progress towards cessation, especially in populations and communities that experience smoking- and cessation-related disparities. It is focused specifically on supporting and accelerating the cessation of combusted tobacco products, including cigarettes, cigars, little cigars, and cigarillos among people of all ages.”
  • The National Institutes of Health announced,
    • “A topical liquid, silver diamine fluoride (SDF), can stop tooth decay in young children, according to a large clinical trial funded by the National Institutes of Health. The preliminary results, published in Pediatric Dentistry, showed that 54% of cavities stopped progressing after SDF treatment, compared to 21% of those treated with a placebo. The study was funded by the National Institute of Dental and Craniofacial Research (NIDCR), part of NIH.
    • “SDF is cleared by the Food and Drug Administration for treating dental sensitivity and is used off label to treat tooth decay, also known as cavities or dental caries. It can be easily and painlessly swabbed onto cavities and has been widely used for management of tooth decay in other countries for decades. Studies suggest that the silver in SDF kills cavity-causing microbes and helps stop destruction of the tooth, while the fluoride helps to rebuild and strengthen the tooth.
    • “Current treatments for severe early childhood caries rely on restoration and tooth extraction, which can involve general anesthesia,” said lead investigator Margherita Fontana, D.D.S., Ph.D., of the University of Michigan. “These interventions are expensive, cavities often return, and anesthesia can have long-term effects on a developing brain. We didn’t really have any other options until recently — SDF is a game changer.”
  • The New York Times relates,
    • “Increasingly, doctor visits by adolescents and young adults involve mental health diagnoses, along with the prescription of psychiatric medications.
    • “That was the conclusion of a new study that found that in 2019, 17 percent of outpatient doctor visits for patients ages 13 to 24 in the United States involved a behavioral or mental health condition, including anxiety, depression, suicidal ideation, self-harm or other issues. That figure rose sharply from 2006, when just 9 percent of doctor’s visits involved psychiatric illnesses.
    • “The study, published Thursday in JAMA Network Open, also found a sharp increase in the proportion of visits involving psychiatric medications. In 2019, 22.4 percent of outpatient visits by the 13-24 age group involved the prescription of at least one psychiatric drug, up from 13 percent in 2006.”
  • The Wall Street Journal points out,
    • “More parents with young children are taking melatonin to sleep. And some of them are going to the emergency room after their children took melatoninaccidentally. 
    • “The number of children who visited emergency rooms for unsupervised melatonin consumption increased 420% from 2009-2020, federal data showed. Melatonin was implicated in some 7% of recent E.R. visits for children 5 and younger who had taken medication without supervision. 
    • “The good news: Very few of those children were hospitalized. Typically, mild drowsiness, headaches or dizziness are the worst side effects after children consume melatonin, according to America’s Poison Centers.
    • “Adults have long used melatonin, a hormone the brain produces in response to darkness, to regulate their sleep. It is sold widely as a dietary supplement.”
  • The MIT Technology Review lets us know,
    • “As a fetus grows in the womb, it sheds cells into the amniotic fluid surrounding and protecting it. Now researchers have demonstrated that they can use those cells to grow organoids, three-dimensional structures that have some of the properties of human organs—in this case kidneys, small intestines, and lungs. These organoids could give doctors even more information about how fetal organs are developing, potentially enhancing prenatal diagnoses of conditions like spina bifida.
    • “These aren’t the first organoids produced from fetal cells. Other groups have grown them from discarded fetal tissue. But this group is among the first to grow organoids from cells taken from amniotic fluid, which can be extracted without harming the fetus.
    • “The entire concept is really groundbreaking,” says Oren Pleniceanu, a stem cell biologist and head of the Kidney Research Center at Sheba Medical Center and Tel-Aviv University who has also been working on organoids from amniotic fluid. This ability to get fetal cells from the amniotic fluid, “it’s like a free biopsy,” he says. But he points out that there’s still room for improvement when it comes to describing the cells that are present. “It’s not that easy to define which cells these are,” he says.”  

From the U.S. healthcare business front,

  • Bloomberg reports,
    • “The No Surprises Act, which aims to protect patients from costly surprise medical bills is becoming “an unmitigated disaster for employers,” according to the head of the one of the largest industry groups for employer-sponsored health plans. 
    • “The trends are bad and getting significantly worse, and I really do worry that we’re going to see a trend towards much higher inflationary factors,” Shawn Gremminger, president and CEO of the National Alliance for Healthcare Purchaser Coalitions, said at a Georgetown University forum on the No Surprises Act Thursday.
    • “The law has largely protected consumers from “surprise” bills in emergencies and when they receive care from out-of-network medical providers at facilities that are in their insurance networks.
    • “But employers and health insurers that pay the bills say they are increasingly alarmed at high awards private-equity owned providers are winning in arbitration, which they say could lead to higher premiums for both employers and their enrollees, as well as higher out-of-pocket costs for consumers.”
  • How does one square this report with yesterday’s CBO report about the savings that the NSA is producing? Providers generally accept the qualifying payment amounts the No Surprises Act requires them to pay.
  • The Employee Benefit Research Institute posted an Issue Brief about “Health Savings Account Balances, Contributions, Distributions, and Other Vital Statistics: Evidence From the EBRI HSA Database”
  • Healthcare Dive offers details on UHC updates on the Change Healthcare situation.
    • Change Healthcare systems are expected to come back online starting in mid-March, about a month after a cyberattack disabled the technology firm, parent company UnitedHealth Group said Thursday
    • Electronic payments will be available beginning March 15, and electronic prescribing is fully functional as of Thursday. Change will start testing its claims network and software on March 18, with plans to restore service through that week.
    • UnitedHealth also said it would give additional financial relief to providers, including advancing funds weekly and expanding the temporary financing program it announced earlier this month.
  • Healthcare Dive also delves into Cigna’s announcement that
    • “Cigna is moving to limit how much health insurance providers and employers have to pay for pricey and in-demand obesity medications.
    • “The insurer plans to cap annual price increases for the drugs, called GLP-1 receptor agonists, at 15% for employers and plans participating in a weight loss management program offered by its pharmacy benefit manager.
    • “It’s the first financial guarantee available in the market for the drugs, according to the payer. Cigna’s health services division Evernorth, which includes PBM Express Scripts, announced the news on Thursday before the insurer’s investor day in New York City.”
  • Business Insurance adds,
    • “Cigna Group’s Evernorth Health Services is launching an outpatient behavioral health practice to integrate mental health services with medical care, Forbes reports. The new service, currently available in six states and Washington, D.C., guarantees an appointment with a clinician matching the patient’s unique goals and preferences within 72 hours. Evernorth plans a nationwide rollout by early 2025.”
  • Beckers Health IT notes,
    • “The average cost per email for patients to message their provider was $39, according to data compiled and reported by Peterson-Kaiser Family Foundation.
    • “KFF examined data from the Health Care Cost Institute on physician and outpatient claims from 2020 and 2021 for patients under the age of 65 years old with employer-sponsored insurance. Billing codes for email interactions were first introduced in 2020 amid the COVID-19 pandemic for providers to bill insurers for at least 5 minutes spent responding to patient-initiated emails.
    • “The analysis focused on email messages associated with charges. Researchers found the average claim for emailed correspondence was $39, and patients paid around $25 out of pocket, according to the report. Depending on their benefits package, some patients paid up to $40 out of pocket.”
  • Per Fierce Healthcare,
    • “Renton, Washington-based Providence closed out its year with a -4.1% operating margin and a $596 million net loss but touted “significant progress in operating performance” and an 8.7% year-over-year gain in total operating revenues outpaced by a 7.3% rise in total operating expenses.
    • “The 51-hospital Catholic system was coming off a year of heavy expenses and organizational upheaval. In 2022, it had logged a -6.4% operating margin from a $1.7 billion operating loss, which included $247 million tied to a restructuring it had launched to address spending, as well as a $2.7 billion net loss (excluding $3.4 billion tied to its split with Hoag Memorial Hospital Presbyterian).
    • “This time around, Providence whittled its operating losses down to about $1.2 billion and highlighted gains in volumes. Specifically, it saw a 4% uptick in acute adjusted admissions, a 5% increase in case-mix adjusted admissions and a 3% decline in length of stay “as access to post-acute care improved.” Non-acute volumes also grew 2% on the back of an 11% increase in outpatient surgeries and procedures.”
  • Beckers Payer Issues points out three BCBS companies reporting 2023 losses “due to ongoing trends such as rising utilization in the Medicare Advantage space and growing demand for weight loss drugs. 

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC

  • The Congressional Budget Office posted a presentation about “CBO’s Approach to Estimating the Budgetary Effects of the No Surprises Act of 2021.”
    • “This presentation describes CBO’s approach to estimating the budgetary effects of the No Surprises Act. The stated aim of the No Surprises Act was to protect patients from surprise billing. The law:
    • “Established protections for patients receiving out-of-network care,
    • “Established an arbitration process for resolving payment disputes, and
    • “Directed arbiters to consider the qualifying payment amount, defined as the median in-network rate, as the benchmark for payment (with other factors).
    • “CBO projected that reductions in prices paid to providers would reduce insurers’ costs, in turn reducing premiums by roughly 1 percent and reducing federal deficits from 2021 to 2030 by a total of $17 billion.”
  • The Internal Revenue Service warned consumers to “Beware of companies misrepresenting nutrition, wellness and general health expenses as medical care for FSAs, HSAs, HRAs and MSAs.”
  • Fedweek tells us,
    • “In a series of recent reports, the OPM inspector general’s office said it has identified misspending in the FEHB program, which adds to the cost of premiums both for the enrollees and the government, but that legal barriers prevent the program from recouping some of that amount.
    • “A report covering the last three months of 2023 is typical in noting that the FEHB program is precluded from pursuing cases under the Anti-Kickback Statute, which makes it illegal for health care providers to knowingly and willfully accept bribes or other forms of remuneration in return for activities such as patient referrals.”
  • Query me this. How can there be misspending when Congress decided in 1996 not to apply this law to the FEHBP because it is operated by commercial entities? It’s sour grapes.
  • Federal News Network informs us,
    • The Office of Personnel Management’s retirement backlog made huge improvements in claims processed for February reaching 10,025, the highest number since April 2023. OPM received  8,794 claims in February and managed to process more than 3,000 claims compared to January.
    • After seeing a large increase in the inventory backlog in January, OPM made small improvements shrinking the backlog by 1,231  to a total of 19,591 claims in February. With a slight decrease in the backlog, OPM is still over 6,000 claims above the steady goal of 13,000.
    • OPM also saw improvements for the average processing time for February,  reaching 47 days, setting a new record.

From the public health and medical research front,

  • STAT News reports good news,
    • “A new monoclonal antibody product to protect against respiratory syncytial virus was 90% effective at preventing little children from being hospitalized with RSV, according to new data from the first season it was in use.
    • The data, published Thursday in Morbidity and Mortality Weekly Report, a Centers for Disease Control and Prevention publication, looked at how well Beyfortus worked in the children whose parents managed to secure a scarce dose of the drug. These are the first real-world data showing how effective the product was in the United States.
    • “It’s basically really good news,” said Sean O’Leary, a professor of pediatrics at the University of Colorado School of Medicine and a pediatric infectious diseases specialist at Children’s Hospital Colorado. “In some clinical trials we see some level of effectiveness … but then when it’s rolled out in the real world, for any number of potential reasons, things don’t work out as well as they had in the clinical trials.”
    • “In this case, it’s great. The point estimate they came up with is even better than in the clinical trials,” said O’Leary, who was not involved in the study.
    • “AstraZeneca and Sanofi jointly developed Beyfortus, which is sold in the U.S. by Sanofi.”
  • and
    • “A pill being developed by Danish drugmaker Novo Nordisk may lead to greater weight loss than the obesity therapy Wegovy, the company reported Thursday, citing early data.
    • “In a Phase 1 trial, participants experienced an average of 13.1% weight loss after 12 weeks of taking the experimental oral medicine amycretin, according to data presented at an investor meeting. In comparison, in an earlier Phase 3 trial of the injectable drug Wegovy, people taking Wegovy lost about 6% of their body weight over the same time period. * * *
    • “Novo Nordisk isn’t the only pharma company working on a pill. An experimental pill being developed by Eli Lilly led to 14.7% weight loss in a 36-week, Phase 2 trial. Pfizer had been developing an oral medication, as well, but opted to shut down that product’s developmentdue to disappointing trial results.
    • “Many other companies are also testing oral obesity drugs, according to the STAT Obesity Drug Tracker.”

From the U.S. healthcare business front,

  • Beckers Hospital Review considers why healthcare cyberattacks last so long.
    • “The cyberattack on Change Healthcare that has caused disruptions across a wide swath of the industry has entered its third week. But why do these IT outages last so long?
    • “It’s a combination of ensuring that the hackers are no longer in the system and securing the vulnerability that allowed them to breach it in the first place, according to John Riggi, national advisor for cybersecurity and risk at the American Hospital Association.
    • “The victim must figure out how the bad guys broke into their network, where they are, throw them out and then seal that technical ‘hole,'” Mr. Riggi told Becker’s. * * *
    • “But Mr. Riggi, who spent more than two decades at the FBI, said it could take even longer to fully recover. “These disruptions could linger for several months or a year, and legacy systems that may not have been backed up or destroyed during the attack may become totally unrecoverable,” he said.”
  • United Healthcare offers a March 7 update on its Change Healthcare cyber response website.
  • Beckers Hospital Review also names ten drugs poised to be best seller this year and discussesNewsweek‘s 2024 “America’s Greatest Workplaces for Women” ranking, which includes hospitals and health systems.”
  • Business Insurance reports,
    • While inflation in the general economy has slowed since 2022, workers compensation payment growth is still at levels higher than in 2020, experts with the Workers Compensation Research Institute said Tuesday.
    • Changes in medical care utilization and mix of services continue to affect workers comp pricing, and the recent trend of health care labor shortages, especially in nursing, is also contributing to higher costs, panelists said during a session at the 2024 WCRI Issues & Research Conference.
  • The Hill relates,
    • Drugmaker Boehringer Ingelheim plans to cap the out-of-pocket costs for all its inhalers at $35 per month after coming under fire from Democratic lawmakers over pricing. 
    • The company announced Thursday that the program will start June 1. It’s aimed at patients with employer-sponsored insurance, and those who are underinsured and uninsured, meaning they likely have to pay cash. 

Midweek Update

Photo by Manasvita S on Unsplash

From Washington, DC

  • Federal News Network reports,
    • “The House passed a $460 billion package of spending bills Wednesday that would keep money flowing to key federal agencies through the remainder of the budget year. The Senate is expected to take up the legislation before a midnight Friday shutdown deadline.
    • “Lawmakers are negotiating a second package of six bills, including defense, in an effort to have all federal agencies fully funded before a March 22 deadline. In the end, total discretionary spending set by Congress is expected to come in at about $1.66 trillion for the full entire year. 
    • “A significant number of House Republicans have lined up in opposition to the spending packages, forcing House Speaker Mike Johnson, R-La., to use an expedited process to bring the bill up for a vote. That process requires two-thirds of the House to vote for the measure for it to pass.
    • “The House passed the measure by a vote of 339-85.”
  • The American Hospital Association News adds,
    • “The House March 5 voted 382-12 to pass the AHA-supported Preventing Maternal Deaths Reauthorization Act (H.R. 3838), bipartisan legislation that would reauthorize federal support for state-based committees that review pregnancy-related deaths to identify causes and make recommendations to prevent future mortalities. Passed by the House Energy and Commerce Committee last July, the bill also would require the Centers for Disease Control and Prevention to work with the Health Resources and Services Administration to disseminate best practices to prevent maternal mortality to hospitals and other health care providers.”
  • Per an HHS press release,
    • “Today, in support of President Biden’s Unity Agenda, the U.S. Department of Health and Human Services’ Health Resources and Services Administration (HRSA) announced the launch of nearly $50 million for HRSA’s Rural Opioid Treatment and Recovery Initiative and released the initiative’s funding application. Funding will support establishing and expanding comprehensive substance use disorder treatment and recovery services in rural areas, including by increasing access to medications for opioid use disorder, such as buprenorphine. Opioid use disorder is particularly concerning in rural communities and accessing treatment can be challenging due to geographic isolation, transportation barriers, and limited substance use disorder providers. This week, HRSA hosted more than 800 rural community leaders working at the grassroots level to build their communities’ capacity to turn the tide of the opioid epidemic. * * *
    • “Applications will be accepted through May 6, 2024, and the funding opportunity is posted at: https://grants.gov/search-results-detail/349409.
    • “To learn more about other programs under the Rural Communities Opioid Response Program, visit https://www.hrsa.gov/rural-health/opioid-response.”
  • Govexec tells us,
    • “Coming on the heels of debuting its new public-facing repository of high-ranking federal officials, the Office of Personnel Management released guidance last week outlining how agencies should report data to the website and how often. 
    • “The March 1 guidance details how agencies will comply with the Periodically Listing Updates to Management (PLUM) Act, which moved OPM away from maintaining the quadrennial Plum Book after this year to an annually updated website that offers information about senior agency leaders, Senior Executive Service members and other top or non-competitively appointed officials. 
    • “OPM officials launched the new website in January, phasing out the physical Plum Book that dated back to President Eisenhower’s 1952 request for a list of every position his administration would have to fill. 
    • “At the time of its launch, the PLUM reporting website possessed the names, roles and pay levels of more than 8,000 executives, with plans to grow to 10,000 with subsequent updates.”
  • The Hill notes,
    • “Alabama Gov. Kay Ivey (R) signed a bill Wednesday protecting in vitro fertilization (IVF) providers from the state Supreme Court’s recent ruling that frozen embryos are to be considered children. 
    • “The legislation, titled SB 159, will shield IVF providers from lawsuit or criminal charges over the “death or damage to an embryo,” during the IVF process. The bill passed by both the state Senate and House shortly before heading to Ivey’s desk Wednesday night.” 

From the FEHB front,

  • An expert, writing in Govexec, offers tips for federal retirees on making the decision whether or not to enroll in Medicare Part B. FEHBlog tip — Income adjusted Medicare Part B premiums usually are temporary while the Medicare Part B late enrollment penalty is forever.
  • Reg Jones, writing in FedWeek, discusses “Your Federal Benefits in Divorce.”

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

  • HR Morning offers employers guidance on how to improve employee health.
  • The National Institutes of Health announced,
    • “More than 70% of American Indian young adults aged 20-39 and 50% of American Indian teens have cholesterol levels or elevated fat in the blood that put them at risk for cardiovascular disease, suggests a study supported by the National Institutes of Health. In some cases, these levels — specifically high low-density lipoprotein (LDL) cholesterol, often thought of as “bad cholesterol,” — were linked to plaque buildup and cardiovascular events, such as heart attack and stroke.
    • “The findings, published in the Journal of the American Heart Association, came from a 19-year-review of the Strong Heart Family Study, part of the Strong Heart Study — the largest study of cardiovascular health outcomes and risk factors among American Indian adults. Researchers followed more than 1,400 participants, ages 15-39, between 2001-2003 and 2020. At the beginning of the study, 55% of participants ages 15-19 had abnormal cholesterol levels, as did 74% of those ages 20-29, and 78% of those ages 30-39.”
  • and
    • “Four children have remained free of detectable HIV for more than one year after their antiretroviral therapy (ART) was paused to see if they could achieve HIV remission, according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. The children, who acquired HIV before birth, were enrolled in a clinical trial funded by the National Institutes of Health in which an ART regimen was started within 48 hours of birth and then closely monitored for drug safety and HIV viral suppression. The outcomes reported today follow planned ART interruptions once the children met predefined virological and immunological criteria.”
    • “These findings are clear evidence that very early treatment enables unique features of the neonatal immune system to limit HIV reservoir development, which increases the prospect of HIV remission,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “The promising signals from this study are a beacon for future HIV remission science and underscore the indispensable roles of the global network of clinicians and study staff who implement pediatric HIV research with the utmost care.”
  • and
    • “Long-acting, injectable antiretroviral therapy (ART) suppressed HIV replication better than oral ART in people who had previously experienced challenges taking daily oral regimens and was found safe in adolescents with HIV viral suppression, according to two studies presented today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. Both studies were sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, in collaboration with other NIH institutes.
    • “The HIV community is just beginning to unpack the enormous potential of long-acting antiretroviral medications for HIV treatment and prevention, and we need population-specific data for everyone to benefit,” said NIAID Director Jeanne Marrazzo, M.D., M.P.H. “These findings open up new possibilities for millions of people with HIV, particularly those whose health suffers due to challenges of daily pill taking.”
  • MedPage Today lets us know,
    • “Rates of emergency surgery, serious complications, and hospital readmissions were higher among Medicare patients living in primary care shortage areas, according to a cross-sectional retrospective cohort study of data from 2015 to 2019.
    • “Medicare beneficiaries living in areas with the most severe primary care shortages had higher rates of three types of emergency surgeries compared with those living in areas with the least severe shortages (37.8% vs 29.9%; risk ratio [RR] 1.26, 95% CI 1.17-1.37, P<0.001), reported Sara Schaefer, MD, of the University of Michigan in Ann Arbor, and co-authors.
    • “Those in areas with the most severe shortages were also more likely to have serious complications (14.9% vs 11.7%; adjusted RR 1.27, 95% CI 1.12-1.44, P<0.001) and readmissions (15.7% vs 13.5%; adjusted RR 1.16, 95% CI 1.01-1.33, P=0.03), they noted in Health Affairs.
    • “However, beneficiaries in areas with the most and least severe shortages had similar rates of 30-day mortality (5.6% vs 4.8%; adjusted RR 1.17, 95% CI 0.93-1.47, P=0.17) and any complications (25.9% vs 24.5%; adjusted RR 1.05, 95% CI 0.97-1.15, P=0.21).
    • “Schaefer told MedPage Today that what surprised her most about the study was the strength of the association for the primary endpoint. Across multiple iterations of analyses, the trend remained consistent, she said.”
  • Health Day relates that according to “researchers reported March 5 in the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.”
    • “Sugary and diet drinks both appear to increase the risk of atrial fibrillation.
    • “Two liters weekly of diet drinks increased risk by 20%, and sugary drinks raised risk by 10%.
    • “Conversely, one liter weekly of unsweetened fruit or vegetable juice lowered risk by 8%.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Pittsburgh-based UPMC, a 40-hospital system, has reported a 2023 operating loss of $198.3 million (-0.7% operating margin) on revenue of $27.7 billion. 
    • “Those figures compare with a $162.1 million operating gain on revenue of $25.5 billion in 2022. Expenses in 2023, totaling $27.9 billion, were approximately 10% up on 2022. That included a 13.6% jump in insurance claims expenses. 
    • “The healthcare system’s measure of inpatient activity grew 3% over the previous year while average outpatient revenue per workday rose 10% and average physician revenue per weekday grew by 9%.”
  • Beckers Hospital Review points out four U.S. hospitals with uncertain futures.
  • Beckers Hospital Review also reports,
    • “Mark Cuban Cost Plus Drug Co. plans to begin manufacturing epinephrine and norepinephrine this week at its 22,000-square-foot drug facility in Dallas, Mr. Cuban confirmed to Becker’s on March 5. 
    • “The $11 million drug manufacturing plant, which originally planned to start operating in late 2022, will focus on producing injectable drugs that often fall into shortages. 
    • “Epinephrine is an emergency treatment for severe allergy reactions, and norepinephrine is a blood pressure medication. Injection solutions of the former have been in unsteady supply since at least 2012. Neither the FDA nor the American Society of Health-System Pharmacists list norepinephrine as a current shortage. 
    • “Next on the docket are pediatric oncology drugs, according to Fortune and Politico.” 
  • Beckers Payer Issues calls attention to the fact that
    • “Twenty-six states [listed in the BPI article] now have more than half of their Medicare enrollees in Medicare Advantage plans, according to a March 5 report from Chartis, a healthcare advisory services firm. 
    • “Nationwide, half of Medicare-eligible beneficiaries are now enrolled in Medicare Advantage plans.” 

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington DC

  • Healthcare Dive informs us,
    • “The CMS rolled out several flexibilities on Tuesday that aim to help providers’ mounting financial challenges in the wake of the cyberattack against Change Healthcare.
    • “The agency instructed Medicare administrative contractors, who process claims for the government, to expedite provider requests to switch to new clearinghouses to get around the Change outage. CMS is also encouraging Medicare Advantage plans, Part D sponsors, and Medicaid and Children’s Health Insurance Program managed care plans to relax prior authorization requirements or offer advance funding. 
    • “The agency said providers can submit requests for accelerated payment to their Medicare administrative contractors for individual consideration.”
  • Fierce Healthcare adds,
    • “Availity, another clearinghouse, is used by Humana and Elevance Health. Humana CEO Bruce Broussard said a lot of business is shifting from Change to Availity.
    • “Elevance Executive Vice President and CFO Mark Kaye noted they’ve noticed providers have been able to adapt in the days after the cyberattack.
    • “Today, we’re about down to a 10% reduction relative to normal daily volumes,” said Kaye. “Some providers are now submitting claims directly to Availity, while others have switched their clearinghouse.”
  • Axios tells us that in the wake of the CDC’s recent decision to treat Covid like other respiratory illnesses,
    • “The HHS’s free COVID test program was suspended because of the lowering case rates after the winter respiratory season, though the agency may resume it in the future as needed.
    • “Orders for free tests placed on or before Friday will be delivered, per HHS.” 
  • Per an HHS press release,
    • “The Justice Department’s Antitrust Division, Federal Trade Commission (FTC) and Department of Health and Human Services (HHS) jointly launched a cross-government public inquiry into private-equity and other corporations’ increasing control over health care.
    • “Private equity firms and other corporate owners are increasingly involved in health care system transactions and, at times, those transactions may lead to a maximizing of profits at the expense of quality care. The cross-government inquiry seeks to understand how certain health care market transactions may increase consolidation and generate profits for firms while threatening patients’ health, workers’ safety, quality of care and affordable health care for patients and taxpayers.
    • “The agencies issued a Request for Information – PDF (RFI) requesting public comment on deals conducted by health systems, private payers, private equity funds and other alternative asset managers that involve health care providers, facilities or ancillary products or services. The RFI also requests information on transactions that would not be reported to the Justice Department or FTC for antitrust review under the Hart-Scott-Rodino Antitrust Improvements Act.”
  • The Food and Drug Administration announced,
    • “Today, the U.S. Food and Drug Administration cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM). The Dexcom Stelo Glucose Biosensor System is an integrated CGM (iCGM) intended for anyone 18 years and older who does not use insulin, such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels. Importantly, this system is not for individuals with problematic hypoglycemia (low blood sugar) as the system is not designed to alert the user to this potentially dangerous condition. “
  • The Congressional Research Service issued an In Focus report about the Federal Employee Paid Parental Leave Benefit.
  • The U.S. Office of Personnel Management announced,
    • Today, the National Aeronautics and Space Administration (NASA) and the U.S. Office of Personnel Management (OPM) welcomed its new class of next generation Artemis astronauts in a ceremony at the agency’s Johnson Space Center on Tuesday. The ten astronaut graduates are now eligible for flight assignments. The agencies also announced the opening for the next round of NASA astronaut applications.  

From the public health and medical research front,

  • The Washington Post reports,
    • “The mortality rate for U.S. women with breast cancer fell an estimated 58 percent from 1975 to 2019, according to research published in JAMA that credits the decline to advances in screening and treatments.
    • “Nearly half (47 percent) of the reduction was attributed to earlier and more effective treatment of those with Stage 1, 2 or 3 breast cancer. (With staging, generally the lower the number, the less the cancer has spread.)
    • “In addition, about 25 percent of the drop was attributed to improved mammography screening and about 29 percent to better treatment of metastatic breast cancer, meaning cancer that has spread.”
  • The Wall Street Journal points out,
    • Novo Nordisk’s blockbuster weight-loss drug cuts the risk of kidney disease-related events in diabetic patients by 24%, according to a new clinical trial conducted by the Danish pharmaceutical company.
    • “Headline results from a five-year study of Semaglutide, which is marketed as Ozempic to treat diabetes, show that diabetic patients with chronic kidney disease saw a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events and death, it added.
    • “The announcement follows October’s decision to stop the trial, known as FLOW, early thanks to successful results.
    • “Last year, a separate trial of Novo Nordisk’s obesity drug Wegovy showed that it cuts the risk of heart attacks and strokes.”
  • The National Institutes of Health adds,
    • “A weekly injection of semaglutide was safe and reduced the amount of fat in the liver by 31% in people with HIV and metabolic dysfunction-associated steatotic liver disease (MASLD), according to a presentation today at the 2024 Conference on Retroviruses and Opportunistic Infections (CROI) in Denver. This is the first clinical trial of semaglutide for MASLD in people with HIV. The research was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted in the United States and Brazil by ACTG, a global clinical trials network focused on HIV and other infectious diseases. ACTG is funded by NIAID and collaborating NIH institutes. McGovern Medical School at UTHealth Houston also contributed funding for this study.
    • “Previously known as nonalcoholic fatty liver disease, MASLD is characterized by the accumulation of excess fat in the liver that is not caused by alcohol consumption or viral hepatitis. Over time, fat deposits may cause inflammation and cellular damage, and can result in cardiovascular and liver disease. MASLD also is associated with obesity, type 2 diabetes, and other metabolic disorders. It is the most common cause of chronic liver disease in the United States, and a leading reason for liver transplantation. An estimated 30-40% of people with HIV experience MASLD, slightly higher than the average among people without HIV.Semaglutide is an antidiabetic medication approved for use for the treatment of type 2 diabetes and an anti-obesity medication used for long-term weight management.”
  • Medscape relates,
    • “A new and deceptively simple advance in chronic stroke treatment could be a vibrating glove.
    • “Researchers at Stanford University and Georgia Tech have developed a wearable device that straps around the wrist and hand, delivering subtle vibrations (akin to a vibrating cellphone) that may relieve spasticity as well as or better than the standard Botox injections.
    • “The vibro-tactile stimulation can be used at home, and we’re hoping it can be relatively low cost,” said senior study author Allison Okamura, PhD, a mechanical engineer at Stanford University, Stanford, California.
    • “For now, the device is available only to clinical trial patients. But the researchers hope to get the glove into — or rather onto — more patients’ hands within a few years. A recent grant from the National Science Foundation’s Convergence Accelerator program could help pave the way to a commercial product. The team also hopes to expand access in the meantime through larger clinical trials with patients in additional locations.”
  • The New York Times reports,
    • “Determining whether someone has Alzheimer’s disease usually requires an extended diagnostic process. A doctor takes a patient’s medical history, discusses symptoms, administers verbal and visual cognitive tests.
    • “The patient may undergo a PET scan, an M.R.I. or a spinal tap — tests that detect the presence of two proteins in the brain, amyloid plaques and tau tangles, both associated with Alzheimer’s.
    • “All of that could change dramatically if new criteria proposed by an Alzheimer’s Association working group are widely adopted.
    • “Its final recommendations, expected later this year, will accelerate a shift that is already underway: from defining the disease by symptoms and behavior to defining it purely biologically — with biomarkers, substances in the body that indicate disease.
    • “The draft guidelines, Revised Criteria for Diagnosis and Staging of Alzheimer’s Disease, call for a simpler approach. That could mean a blood test to indicate the presence of amyloid. Such tests are already available in some clinics and doctors’ offices.”
    • “Someone who has biomarker evidence of amyloid in the brain has the disease, whether they’re symptomatic or not,” said Dr. Clifford R. Jack Jr., the chair of the working group and an Alzheimer’s researcher at the Mayo Clinic.
    • “The pathology exists for years before symptom onset,” he added. “That’s the science. It’s irrefutable.”

From the U.S. healthcare business front,

  • Becker’s Hospital Review lets us know,
    • “Danville, Pa.-based Geisinger appointed Terry Gilliland, MD, as the next president and CEO of Geisinger Health.
    • “Dr. Gilliland will succeed Jaewon Ryu, MD, JD, after he transitions to CEO of Risant Health, a nonprofit organization created by Kaiser Foundation Hospitals. Oakland, Calf.-based Kaiser Permanente agreed to acquire Geisinger last year as the first health system to join Risant, and the deal is waiting on regulatory approval.
    • “Geisinger’s board conducted an extensive search for Dr. Ryu’s successor.
    • “The role of leading Geisinger is unique,” said Heather Acker, chair of the Geisinger board of directors, in a news release. “It requires passion for our mission–to make better health easier for our patients and members across Pennsylvania; a drive to innovate care delivery; and a commitment to educating future caregivers. We are confident that Dr. Gilliland is the right person to lead Geisinger on our path forward.”
  • According to Fierce Healthcare,
    • “Insurance network coverage dramatically impacts whether a person remains in treatment for opioid use disorder, according to results shared by treatment provider Ophelia.
    • “A new study finds that nearly three-quarters (72.3%) of patients receiving opioid treatment through network insurance stayed in treatment for at least six months. Patients received telehealth treatment from Ophelia.”
  • Bloomberg reports,
    • “The US Department of Labor’s new worker classification rule is facing at least four lawsuits alleging the regulation is illegal, with less than a week before the new policy is set to go into effect.
    • “Freelance writers, a trucking company, and groups representing construction, financial services, and tech companies have filed four separate legal challenges in federal district court in Texas, Georgia, Tennessee, and Louisiana contending the new standard, which will make it harder for businesses to use independent contractors, violates the Administrative Procedure Act and departs from the text of the Fair Labor Standards Act. 
    • “The growing pile of lawsuits threatens to disrupt the Biden administration’s implementation of the new rule due to take effect March 11. The DOL says the regulatory update will better protect workers from misclassification, but the business community warns it could have major consequences for industries that rely on independent contractors to operate their services—like Uber Technologies Inc. and Lyft Inc., as well as the trucking, construction, and other sectors. 
    • “And the multi-district nature of the litigation also could lead to splits among the district and appellate courts, inviting potential US Supreme Court review.” 

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC

  • American Hospital Association (“AHA”) News tells us
    • The House and Senate Appropriations Committees March 3 released a package of six appropriations bills that would fund certain federal agencies through fiscal year 2024 and contains certain health care provisions of interest to hospitals. The House is expected to consider the legislation by March 6 and the Senate later this week.  
    • The health care provisions would eliminate Medicaid disproportionate share hospital cuts for FY 2024 and delay FY 2025 DSH cuts to Jan. 1, 2025; extend the Medicare-dependent hospital and enhanced low-volume hospital programs through December 2024; reduce a 3.34% physician payment cut that began Jan. 1; and extend the Community Health Centers, National Health Service Corps, and Teaching Health Centers Graduate Medical Education programs through December.
  • Govexec points out the eight biggest agency and program reforms in this package.
  • STAT News informs us that a “small group of policymakers and business people” spoke out against the three big prescription benefit manager at today’s White House listening session.
    • “The big three [pharmacy benefit managers] are everything wrong with this industry,” said Mark Cuban, who co-founded the Cost Plus Drug Company and is trying to cut out the middlemen with a website that sells mostly generic medicines directly to consumers. As part of the effort, his company is also working with smaller pharmacy benefit managers that do not rely on fees in hopes of appealing to employers.
    • “Along with Cuban, the session also featured remarks from Kentucky Gov. Andy Beshear who, as the state’s attorney general, investigated pharmacy benefit managers; Federal Trade Commission Chair Lina Khan, who is currently probing these companies; and Sandra Clarke, executive vice president and chief operating officer at Blue Shield of California, which is pursuing a new pharmacy model.”
  • The FEHBlog does not understand why the White House does not also listen to the PBMs and their supporters. Perhaps that will be the next listening session.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced today that all manufacturers participating in the first cycle of Medicare drug price negotiations have responded with counteroffers. This news comes after HHS sent initial offers on February 1, as the agency was empowered to do by President Biden’s lower cost prescription drug law, the Inflation Reduction Act. This law is a cornerstone of the Biden-Harris Administration’s efforts to lower prescription drug costs. * * *
    • “The recently launched website LowerDrugCosts.gov is a resource to help people with Medicare understand how the Inflation Reduction Act may help lower their out-of-pocket drug costs. As part of that effort, today, HHS added 50 state-by-state infographics plus DC and Puerto Rico that are accessible on LowerDrugCosts.gov by clicking on the interactive map. These new, plain language infographics are meant to assist with continuing education and outreach on the new benefits made available through the Inflation Reduction Act.”
  • Beckers Hospital Review reports,
    • “PatientRightsAdvocate.org report from Feb. 29 found that just 689 (34.5%) of 2,000 hospitals it examined were fully compliant with federal price transparency rules. 
    • “That is down from 721 (36%) that were found to be fully compliant from the organization’s last report, released in July.” 

From the Food and Drug Administration (FDA) front,

  • The AHA News relates,
    • “The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19. The OSOM Flu SARS-CoV-2 Combo Home Test is authorized for use to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens from people aged 14 and older when conducted at least twice over three days with at least 48 hours between tests. 
    • “In other news, the FDA last week recommended health care providers monitor patients with the Hintermann Series H3 Total Ankle Replacement system for potential device failure, and patients with certain implantable BioZorb breast tissue markers for potential serious complications.” 
  • eMPR notes,
    • “The Food and Drug Administration (FDA) has approved Rybrevant (amivantamab-vmjw) in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.”

From the public health and medical research front,

  • The New York Times reports,
    • “Alcohol-related liver disease is the leading cause of death from excessive drinking — and while it’s curable in the earliest stages, many people don’t realize they have it until it’s too late to reverse.
    • “Annual deaths caused by the disease are on the rise in the United States, having climbed 39 percent in recent years, according to new data from the Centers for Disease Control and Prevention. Death rates are highest in men and adults aged 50 to 64, though they are increasing more quickly among women and younger adults.
    • “People who are drinking are drinking more heavily than they were before, so I think that is the biggest factor,” said Dr. Jessica Mellinger, an assistant professor of gastroenterology and hepatology at the University of Michigan Medical School. And, she added, “we’re seeing that for the first time in this country, women are drinking as much as men.”
  • The American Medical Association tells us what doctors wish their patients knew about nutrition, which encourages patients to limit alcoholic beverage intake.
  • STAT News lets us know,
    • “Having Covid-19 increases a person’s risk of developing an autoimmune disease in the year after infection, a large study out of South Korea and Japan reports, but vaccination helps decrease that risk.
    • “Researchers used the medical records of 10 million Korean and 12 million Japanese adults to see whether those who had Covid were more likely to be diagnosed with autoimmune inflammatory rheumatic diseases, or AIRDs, in the year following infection. AIRDs include rheumatoid arthritis, systemic lupus erythematosus, Sjögren syndrome, mixed connective tissue disease, vasculitis, and other conditions. The Covid group was compared with an uninfected control group and a group of patients who had influenza during the same period from 2020 to 2022.”
  • The National Institutes of Health Director, in her blog, relates,
    • “We’re living in an especially promising time for biomedical discovery and advances in the delivery of data-driven health care for everyone. A key part of this is the tremendous progress made in applying artificial intelligence to study human health and ultimately improve clinical care in many important and sometimes surprising ways. One new example of this comes from a fascinating study, supported in part by NIH, that uses AI approaches to reveal meaningful sex differences in the way the brain works.
    • “As reported in the Proceedings of the National Academy of Sciences, researchers led by Vinod Menon  at Stanford Medicine, Stanford, CA, have built an AI model that can—nine times out of ten—tell whether the brain in question belongs to a female or male based on scans of brain activity alone. These findings not only help resolve long-term debates about whether reliable differences between sexes exist in the human brain, but they’re also a step toward improving our understanding of why some psychiatric and neurological disorders affect women and men differently.”
  • Per BioPharma Dive,
    • “The effects of an experimental medicine for a common liver disease strengthened with time in a clinical trial, giving the drug’s developer, Akero Therapeutics, a chance to rebound from a setback last year.
    • “Akero previously said the trial hit its main goal. After six months of treatment, 39% of patients with metabolic dysfunction associated steatohepatitis on a low dose of the drug and 41% on a high dose had a meaningful reduction in liver scarring and no worsening of their disease, versus 20% of placebo recipients. New results disclosed Monday show that 75% of those on a high dose and 46% on a low dose hit that mark after two years, compared to 24% of placebo patients.
    • “The most common side effects associated with treatment were mild-to-moderate cases of diarrhea, nausea and increased appetite. The 15 serious adverse events reported were “generally balanced across dose groups,” though Akero didn’t provide specifics. Three patients on the high dose stopped treatment.”

From the U.S. public health front,

  • CNBC and Fierce Healthcare bring us to date on the Change Healthcare situation. Of note,
    • “As a growing number of groups put pressure on the administration, the White House is reportedly considering short-term financial relief to support hospitals navigating the fallout of the cyberattack against Change Healthcare.
    • “The news was first reported by Politico and attributed to an anonymous senior administration official. In a series of recent meetings at the deputy level, the White House’s National Security Council reportedly discussed options that would not require support from Congress. Instead, it is exploring ways to tap into funding programs overseen by Health and Human Services, the Center for Medicare & Medicaid Services and the Department of Veterans Affairs to support healthcare organizations.
    • “This cashflow issue has been at the forefront since the beginning of last week for us,” the senior administration official told Politico. The agency is also reportedly pushing UnitedHealth Group to provide more transparency about when it can restore Change systems.
    • “The Biden administration is also considering whether to declare the hack a “significant cyber incident,” a rarely used designation that would trigger a special crisis management playbook, according to media reports.”
  • The Wall Street Journal adds these tidbits about the impending launch of Perigo’s over the counter female contraceptive pill called Opill.
    • “Dublin-based Perrigo has shipped its Opill to major U.S. retailers and expects it to be widely available by the end of the month. The company said it would sell a one-month pack for $19.99 and a three-month pack for $49.99.
    • Opill, which uses the hormone progestin to suppress ovulation, was shown to be 98% effective at preventing pregnancy when used as directed, beating out other over-the-counter methods such as condoms and spermicide. Other prescription methods that require a doctor’s visit, such as intrauterine devices, are more effective. * * *
    • “The drugmaker wouldn’t confirm which stores will carry its product, but said all major retailers and online marketplaces would sell it. Pharmacy giant Walgreens is advertising the pill as “coming soon” on its website.
    • “Perrigo will also sell its product on its website, including a six-month pack for $89.99. The company said it would ship the pills in discreet packaging to online buyers.”
  • Becker’s Hospital Review identifies twelve U.S. health systems with strong finances.
  • The FEHBlog tried to keep readers abreast of noteworthy business announcement from last week’s VIVE conference. MedCity News helpfully lists nine of them.

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec informs us,
    • “President Biden on Thursday nominated former Labor Department Secretary Marty Walsh to serve on the U.S. Postal Service board of governors, potentially giving the administration more representation in supervising the mailing agency. 
    • “Walsh, a former Democratic mayor of Boston, would fill one of two vacancies currently open on the governing board. His nomination comes at a pivotal moment for the Postal Service, which, under the leadership of Postmaster General Louis DeJoy, is in the midst of a complete overhaul of the agency’s operations, staffing and pricing strategies. It follows a call earlier this month from dozens of House Democrats who pushed Biden to fill the vacancies to ensure increased oversight of DeJoy’s reforms. * * *
    • “The former secretary’s confirmation would give Biden his sixth nominee to sit on the board that has nine presidentially appointed, Senate-confirmed slots. Lee Moak and Bill Zollars both saw their terms expire in December and their seats have been vacant ever since. Walsh would be the fourth Democrat to sit on the board, joining three Republicans and one independent. Federal statute requires no more than five members of the board be of the same party, meaning Biden could choose another Democrat to fill the remaining vacancy.” 
  • Federal News Network discusses OPM’s February 8, 2024, call letter to FEHB and PSHB carriers for 2025 FEHB and PSHB benefit and rate proposals.
  • Bloomberg tells us that a federal judge in Delaware has thrown out Astra-Zeneca’s constitutional and statutory challenge to the government drug price negotiation provisions of the Inflation Reduction Act.
    • “Because AstraZeneca’s participation in Medicare is not involuntary, AstraZeneca does not have a protected property interest in selling drugs to the Government at prices the Government will not agree to pay. Accordingly, AstraZeneca’ s due process claim fails as a matter of law,” the judge wrote.
    • “Among other cases, Connolly pointed to Dayton Area Chamber Commerce v. Becerra on how “participation in the Medicare program is a voluntary undertaking,” and neither the Inflation Reduction Act nor any other federal law requires AstraZeneca to sell its drugs to Medicare beneficiaries.” * * *
    • “AstraZeneca’s loss is another setback for the pharmaceutical industry among the lawsuits challenging the program. A federal judge in Texas dismissed Nat’l Infusion Ctr. v. Becerra for lack of jurisdiction, and a federal judge in Ohio struck down a preliminary injunction that would have halted the program.
    • “Similar suits brought by manufacturers and industry groups are pending for Johnson & Johnson, Bristol Myers Squibb & Co., Novo Nordisk A/S, Novartis AG, Merck & Co., Boehringer Ingelheim, and the Dayton Area Chamber of Commerce in Ohio.
    • “The case is AstraZeneca Pharm. LP v. Becerra , D. Del., No. 1:23-cv-00931, memorandum opinion 3/1/24 .”
  • The Wall Street Journal reports,
    • “Pharmacy chains CVS and Walgreens will begin dispensing mifepristone, commonly known as “the abortion pill, in coming weeks.
    • The two chains said Friday they received certification to dispense the pills, following a regulatory shift last year to allow bricks-and-mortar pharmacies to offer the pill with a prescription.
    • “The companies said they would distribute the pill in a way consistent with state laws—meaning it won’t be offered in states that don’t allow legal access to abortion through 10 weeks—and will begin rolling out the pill in a handful of states. Both said they wouldn’t make mifepristone available via mail order. The drug is already available via other mail-order pharmacies and telehealth platforms.”
  • According to MedTech Dive,
    • “Boston Scientific said Friday it has received Food and Drug Administration approval for a drug-coated balloon to treat coronary in-stent restenosis, a condition in which a vessel that previously received a stent narrows again due to plaque or scar tissue.
    • “Approval for the device, which received FDA’s breakthrough designation in 2021, was supported by positive results from the prospective, randomized Agent trial that enrolled 600 patients at 40 U.S. sites, the company said.
    • “We view Agent highly favorably for its statistically significant superiority in what is a difficult-to-treat and common [in-stent restenosis] patient population, which we think could enable rapid physician adoption,” BTIG analyst Marie Thibault wrote Friday in a note to clients.”

From the public health and medical research front,

  • The Centers for Disease Control relates,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare is elevated across many areas of the country. This week, 27 jurisdictions experienced high or very high activity. This number remains stable compared to last week.
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.
    • “Influenza test positivity decreased nationally but is increasing in the Central region (including Iowa, Kansas, Missouri, and Nebraska). COVID-19 and RSV test positivity decreased compared to the previous week.
    • “Nationally, COVID-19 wastewater viral activity levels, which reflect both symptomatic and asymptomatic infections, remain at high levels, particularly in the South, but are trending downward.”
  • and more specifically with regard to Covid,
    • “As the 2023-2024 fall and winter virus season ends, it’s clear that the situation surrounding COVID-19 has changed.  It is still an important health threat, but it is no longer the emergency that it once was, and its health impacts increasingly resemble those of other respiratory viral illnesses, including flu and RSV.
    • “CDC released updated Respiratory Virus Guidance in response to the decreasing risk that COVID-19 poses to the population. This updated Guidance includes strategies to protect people at highest risk of getting seriously ill and provides actionable recommendations for people with common viral respiratory illnesses, including COVID-19, flu, and RSV.
    • Keep reading: CDC’s Updated Respiratory Virus Guidance: What to do When You Are Sick.”
  • The New York Times adds,
    • Americans with Covid or other respiratory infections need not isolate for five days before returning to work or school, the Centers for Disease Control and Prevention said on Friday, a striking sign of changing attitudes toward the coronavirus.
    • People with respiratory illnesses may resume daily activities if they have been fever-free for at least 24 hours without the aid of medications and if their symptoms are improving, agency officials said. 
    • Acknowledging that people can be contagious even without symptoms, the C.D.C. urged those who end isolation to limit close contact with others, wear well-fitted masks, improve indoor air quality and practice good hygiene, like washing hands and covering coughs and sneezes, for five days.
    • The guidelines apply to Covid, influenza and respiratory syncytial virus, among other respiratory ailments, which should make it easier for people to comply, Dr. Mandy Cohen, the C.D.C.’s director, told reporters on Friday.
  • MedPage Today notes,
    • “Early estimates suggest flu shots are performing OK in the current U.S. winter flu season.
    • “The vaccines were around 40% effective in preventing adults from getting sick enough from the flu that they had to go to a doctor’s office, clinic, or hospital, health officials said during a CDC vaccines meeting Wednesday. Children who were vaccinated were roughly 60% less likely to get treatment at a doctor’s office or hospital, they noted.
    • “Officials generally are pleased if a flu vaccine is 40% to 60% effective.”
  • The National Institutes of Health announced,
    • “Researchers at the National Institutes of Health have identified antibodies targeting a hard-to-spot region of the influenza virus, shedding light on the relatively unexplored “dark side” of the neuraminidase (NA) protein head. The antibodies target a region of the NA protein that is common among many influenza viruses, including H3N2 subtype viruses, and could be a new target for countermeasures. The research, led by scientists at the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center, part of NIH, was published today in Immunity.” * * *
    • “These findings show that the NA dark side has unique, previously untapped epitopes that could be applied to the development of new vaccine and therapeutic strategies. They suggest that antibodies targeting the NA dark side could be useful in combination with antivirals or other types of antibodies for interventions against influenza, as they are effective against influenza viruses with drug-resistant mutations. The researchers also note that NA dark side targets could be included in the next generation of broadly protective vaccines against influenza.”
  • Per BioPharm Dive,
    • “Advisers to the Centers for Disease Control and Prevention are weighing updates to their recommendation older adults get vaccinated for respiratory syncytial virus, discussing changes at a meeting Thursdaythat would more forcefully encourage some individuals receive a shot.
    • “At the meeting, the Advisory Committee on Immunization Practices reviewed safety and efficacy data on RSV vaccines sold by GSK and Pfizer, as well as clinical trial data for an experimental shot from Moderna that’s nearing market.
    • “Currently, the CDC recommends adults 60 years or older discuss RSV vaccination with their physician — a process known as “shared clinical decisionmaking.” Advisers debated whether, for some individuals at higher risk, a universal recommendation would be more appropriate. They wanted more data before making a decision, however, likely at a follow-up meeting scheduled for June 26 to June 28.”

From the U.S. healthcare business front,

  • Crains Grand Rapids [Mich.] Business reports,
    • “Perrigo Co. plc expects to introduce the first oral contraceptive available in the U.S. without a physician’s prescription by mid March. 
    • “The company has “activation plans” in place to promote and drive consumer awareness of Opill at retail stores and for online sales when it goes to market, said President and CEO Patrick Lockwood-Taylor. 
    • “We expect Opill to be available to consumers in-store and online within a few weeks,” Lockwood-Taylor said during a Tuesday morning conference call to discuss Perrigo’s latest quarterly results. “You’ll find it in every store, and you’ll find it everywhere online.” 
  • Beckers Hospital Review lets us know,
    • “Cleveland Clinic posted an operating income of $64.3 million in 2023 after posting a $211.3 million loss in 2022, according to its financial report released Feb. 29. 
    • “The health system had a 0.4% operating margin for the year ended Dec. 31 after posting a -1.6% margin in 2022, according to the report. 
    • “Cleveland Clinic said the improved operating performance was driven by an 11.4% increase in operating revenues, “supported by strong patient demand for both inpatient and outpatient services, that outpaced a 9.1% increase in operating expenses in 2023 compared to 2022.”
    • “The system had a total operating revenue of $14.5 billion and total operating expenses of $13.7 billion in 2023. Cleveland Clinic said the growth in expenses was primarily driven by higher patient volumes and inflationary trends that increase salaries, wages and benefits, supply expenses and pharmaceutical costs.” 
  • According to BioPharma Dive,
    • “Pfizer believes the answer to its sliding valuation lies in oncology. 
    • “The company, which is coming off one of the worst years in its history, unveiled on Thursday a new business unit dedicated to cancer research. The division, created in the wake of Pfizer’s $43 billion buyout of Seagen last year, houses a sprawling portfolio of experimental medicines both companies discovered and acquired through deals. It also includes the marketed drugs Pfizer and Seagen have long been selling for a variety of tumor types. 
    • “Pfizer claims the pipeline it now has could produce more than eight blockbuster medicines by 2030, up from five today, and double the number of patients the company’s drugs currently treat. By then, biologic medicines should account for nearly two-thirds of its oncology revenue, up substantially from the 6% they comprise now, Pfizer said. 
    • “To achieve those goals, Pfizer will need steady sales growth and additional approvals for its currently marketed medicines. It will also need a pipeline of 16 experimental drugs across four broad areas of cancer research to come through in testing.”