Monday Roundup

Monday Roundup

Photo by Sven Read on Unsplash

From Washington, DC,

  • The New York Times reports,
    • “The prospects for passing legislation to speed military aid to Ukraine this year are fading, as Republicans balk at striking a quick deal on immigration policy changes they have demanded in exchange for allowing the bill to move forward.
    • “After a weekend of intensive bipartisan border talks yielded progress but no breakthrough, Senator Chuck Schumer, Democrat of New York and the majority leader, acknowledged on Monday that negotiators were still far from completing a deal.
    • “It’s going to take some more time to get it done,” he said on the Senate floor on Monday afternoon, laying out plans for the week that made no mention of any votes on the aid package for Ukraine.”
  • Govexec tells us that “The Senate on Monday voted 50-11 to confirm former Maryland Gov. Martin O’Malley as commissioner of the Social Security Administration, ending a drought of more than two years in which the embattled agency lacked a permanent leader at the helm.”
  • Fierce Healthcare informs us,
    • “The Biden administration on Monday released amended fees related to independent dispute resolution under the No Surprises Act.
    • “In the amended final rule, CMS said it will instead set an administrative fee of $115 for disputes that are subject to the rule. A separate rule, which is up for comment until Jan. 2, adjusts the fees for disputes initiated after Jan. 1, 2025. * * *
    • “In addition, CMS outlined ranges for certified IDR entity fees, which the arbiters charge for determinations. Under the rule, the agency finalized a range of between $200 and $840 for a single determination and between $268 and $1,173 for batch rulings.
    • “These fees are also set annually, and IDRs can request to update them once each year, which the feds must approve.”
    • The rule takes effect on January 20, 2023.

From the public health and medical research front,

  • STAT News points out,
    • “As more data emerges that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms.
    • “A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss.
    • “In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.
    • “Though the researchers only studied mice, and didn’t look at how much the reduced inflammation translates to actual health benefits, they detailed a previously unknown mechanism of GLP-1 drugs that may help explain their effects on organs throughout the body.
    • “This is a new model for the anti-inflammatory actions of GLP-1” drugs, said Daniel Drucker, senior author of the study and a senior scientist at the Lunenfeld-Tanenbaum Research Institute.”
  • JAMA Pediatrics provides good news:
    • Question  Is maternal influenza vaccination during pregnancy associated with a reduction in influenza-associated hospitalizations and emergency department (ED) visits in infants younger than 6 months?
    • Findings  In this case-control study of 3764 infants younger than 6 months, maternal vaccination was associated with a reduction in influenza-associated hospitalizations and ED visits in infants. Vaccine effectiveness was highest among hospitalized infants, those younger than 3 months, and those born to mothers vaccinated in the third trimester.
    • Meaning  The findings in this study indicate that maternal influenza vaccination during pregnancy provided important protection for the infant in the first few months of life before infants are eligible for vaccination.”
  • The American Medical Association shares what doctors wish their patients knew about social drivers of health.

From the U.S. healthcare business front,

  • Bloomberg reports
    • “We’re seeing wide price variation even in the same hospitals on the same day based upon the negotiated prices by the differing health insurance carriers or health plans,” said Cynthia Fisher, founder and chairman of the philanthropic group Patient Rights Advocate, , which provides free price data for nearly all of the more than 6,000 hospitals in the US. “For the employers, this is eye-opening.”
    • “Patient Rights Advocate on Dec. 11 introduced a hospital pricing search tool for the public. The organization pointed to prices for an injection of cancer drug Rituximab at Rush University Medical Center in Chicago that ranged from $899.33 for the Cigna Basic/Premier medical plan for Rush employees administered through Allegiance Benefit Plan Management Inc. by the Cigna Group, to $9,260.13 for the Cigna One Health HMO.
    • “If they’re able to offer it at a tenth of the price, why should one employer pay 10 times more?” Fisher said.
    • “Cigna didn’t respond to a request for comment, and a spokesman for Rush said the hospital wasn’t “in a position to speak to something that specific so rapidly.”
    • “Being able to easily compare prices will protect health plans from billing errors and fraud by hospitals and insurers, Fisher said. “The employers and unions that design health plans will be able to benefit from being well-informed about their choices and decisions to seek the best quality of care at the lowest possible prices,” she said.
  • Beckers Hospital Review identifies the thirteen out of twenty most popular prescription drugs that are in shortage and the 25 largest health systems by number of physicians.
  • Healthcare IT News calls attention to the fact that “Now that telemedicine is mainstream, artificial intelligence is helping healthcare providers with imperatives such as patient triage. Early results are promising.”
  • According to Reuters,
    • “High cost, logistical issues and the prospect of potential treatment advances are holding back adoption of the first gene therapies for hemophilia, experts said this week during the American Society of Hematology’s (ASH) annual meeting.
    • “Experimental options discussed at the San Diego meeting included personalized treatments and next-generation gene therapies, many still in the earliest stages of testing.”
  • Benefits Pro lets us know about a “Cigna report [that] outlines the benefits, challenges of value-based care. The Cigna paper suggests that physicians, patients, and health plans tend to recognize the good aspects of VBC, but that change has been slow nonetheless in the private sector.”
  • Per Fierce Healthcare,
    • “Kroger is piloting value-based primary care clinics as it joins a growing list of retailers looking to cash in on the booming sector of senior-focused medical care.
    • “The grocery chain has teamed up with Better Health Group, a provider network, to shift some of its in-store clinics, called The Little Clinic, into primary care centers for seniors, in addition to offering regular services.
    • “Better Health Group is rolling out the value-based model at eight of Kroger’s Altanta-area stores.
    • “The clinics today provide a full range of services from your acute, convenient care to primary care-like functions. About 60% of patients that we see in the clinic don’t have an assigned or designated primary care provider. So, there’s a huge opportunity just in general to serve patients and provide longitudinal care,” said Jim Kirby, chief commercial officer for Kroger Health, in an interview with Fierce Healthcare.”

Friday Factoids

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From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Departments of Health and Human Services, Labor, and the Treasury Dec. 15 reopened the federal independent dispute resolution portal to process all dispute types, including previously initiated batched disputes, new batched disputes, and new single disputes involving air ambulance services. The departments also have extended the applicable deadlines to initiate new batched disputes and new single disputes involving air ambulance services, resubmit disputes determined by certified IDR entities to be improperly batched, and select or reselect a certified IDR entity. For details, see the [lengthy] announcement
  • In Department of Health and Human Services news,
  • and
    • “A paper published today in JAMA Network Open addresses the use of healthcare algorithms and provides the healthcare community with guiding principles to avoid repeating errors that have tainted the use of algorithms in other sectors. * * *
    • “The paper, Guiding Principles to Address the Impact of Algorithm Bias on Racial and Ethnic Disparities in Health and Health Care, may be found in JAMA Network Open is available here. The journal also links to an accompanying podcast interview of panel co-chairs Marshall Chin, MD, MPH, and Lucila Ohno-Machado, MD, PhD, MBA. The final EPC report, Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare, can be found here.”

In Food and Drug Administration news,

  • From Bio-Pharma Dive,
    • “The Food and Drug Administration on Thursday broadened use of a drug Merck & Co. acquired in a $1 billion buyout four years ago, clearing Welireg for use in people whose kidney tumors have progressed following treatment with two other types of medicines. 
    • “Approval was based on a trial that compared Welireg to an older therapy called everolimus. Merck’s drug reduced the risk of cancer progression or death by 25% compared with everolimus and shrank or eliminated tumors in 22% of people who received it. Welireg hasn’t yet proven it can help kidney cancer patients live longer, however. 
    • “Merck inherited Welireg when it bought biotechnology company Peloton Therapeutics. Since then, the drug’s been cleared for use in a rare condition called von Hippel-Lindau disease and now kidney cancer. Merck is studying its potential in other settings as well.”
  • From MedTech Dive,
    • “Glaukos Corporation received Food and Drug Administration approval for a drug-releasing implant that is designed to reduce intraocular pressure in patients with ocular hypertension or open-angle glaucoma. The implant was approved for single administration per eye.
    • “The device continuously delivers a formulation of travoprost, an established treatment for high pressure in the eye, to provide patients with an alternative to eye drops and remove the risk that noncompliance with the treatment regimen will affect outcomes.
    • “Glaukos failed to secure approval for repeat dosing but plans to work with the FDA to change the label. The wholesale acquisition cost (WAC) is $13,950 per dose, or implant, well above analysts’ expectations. William Blair analysts estimated the price would fall in a range of from $3,000 to $4,000 per implant, while BTIG analysts said they modeled a price of $5,000.”
  • and
    • “Medtronic has gained the first approval from the Food and Drug Administration for a pulsed field ablation (PFA) system to treat atrial fibrillation (AFib), pulling ahead of other medtech companies in the race to bring the technology to the U.S. market.
    • “The treatment approach has garnered attention as a safer alternative to radiofrequency and cryoablation techniques for addressing the abnormal heart rhythm, and Boston Scientific and Johnson & Johnson are pursuing the market.
    • “Medtronic, in announcing the FDA’s approval for its PulseSelect PFA system, said the device has demonstrated a 0.7% safety event rate and clinical success rates of 80% in both paroxysmal and persistent AFib patients.”

From the public health and medical research front,

  • The New York Times offers readers’ perspectives on its article about the high and climbing number of pedestrian deaths occurring at night. “Readers share concerns like headlight glare, streetlight design and the aging of American motorists.”
  • HealthDay informs us,
    • “Diabetes drugs, including Ozempic, do not appear to increase the risk of birth defects
    • “Babies born of moms using drugs to control their type 2 diabetes had no greater risk of birth defects than those whose moms used insulin.
    • “Diabetes medications have grown in popularity over the past decade, particularly those in Ozempic’s class.”
  • The Director of the National Institute of Diabetes and Digestive and Kidney Diseases posted his Winter 2023 report.
  • Per Medscape,
    • “Living in food deserts and food swamps — areas with no access to healthy food, and areas with a plethora of unhealthy food options — may raise the risk of dying from postmenopausal breast cancer, a novel ecological study has found. 
    • “Food deserts and food swamps are both bad, but it’s worse in food swamps,” Malcolm Bevel, PhD, MSPH, with Augusta University in Georgia, told Medscape Medical News
    • “He presented his research here at the San Antonio Breast Cancer Symposium (SABCS) 2023.” 

From the U.S. healthcare business front,

  • KFF unveiled its updated
    • Health Spending Explorer, an interactive tool that allows users to explore trends in health spending by federal and local governments, insurers, nursing care, hospital, and other service providers, and consumers.
    • “The tool captures just-released 2022 data from the federal government, when national health expenditures totaled nearly $4.5 trillion. Overall spending rose 4.1% in 2022, with almost all categories of health spending experiencing growth. This rise was muted by lower federal public health spending related to the pandemic. Meanwhile, consumers’ out-of-pocket costs rose 6.6%, a large but less dramatic increase than in 2021.”
  • The Health Care Cost Institute reports,
    • “Healthcare spending continues to grow, and prices are the primary driver. Without addressing high and growing prices, efforts to make care more affordable will not be successful. One way to understand what is going on with prices in employer-sponsored insurance (ESI) is to compare negotiated rates paid in that market to Medicare payments for the same services. New analysis from the Health Care Cost Institute finds that, in 2021, ESI payments for outpatient services were, on average, 287 percent higher than Medicare payments.”
  • Beckers Hospital Review identifies the 25 largest health systems in the U.S. by number of beds, and provides the reasons for fourteen hospital closures.
  • Using the American Medical Association’s health insurance market concentration report, Beckers Payer Issues identifies the cities with the most competitive Medicare Advantage markets.
  • Reuters reports,
    • “Bluebird bio (BLUE.O) said on Thursday a large insurer had agreed to cover its newly approved sickle cell disease gene therapy, easing some investor worries about resistance from other payers over the high price of the treatment.
    • “Bluebird’s treatment, Lyfgenia, was approved along with another gene therapy Casgevy from partners Vertex Pharmaceuticals (VRTX.O) and CRISPR Therapeutics (CRSP.BN).
    • “Bluebird’s price of $3.1 million is nearly $1 million higher than its rival, despite Lyfgenia having a serious safety warning about blood cancer risk. That had raised concerns over whether it would get enough coverage from insurers versus its rival.”
  • and
    • “Drugmaker Novo Nordisk paid U.S. medical professionals at least $25.8 million over a decade in fees and expenses related to its weight-loss drugs, a Reuters analysis found. It concentrated that money on an elite group of obesity specialists who advocate giving its powerful and expensive drugs to tens of millions of Americans.”
  • The Employee Benefit Research Institute factors health savings accounts into the retirement funding picture for Americans.
  • Per Fierce Healthcare,
    • “Two months ago, Elevance Health and Blue Cross and Blue Shield of Louisiana hit the pause button on a potential $2.5 billion merger in the midst of regulatory scrutiny.
    • “The insurers brought the deal back to life this week, though, with BCBSLA filing an updated application on Thursday seeking to reorganize as a for-profit, which would allow it to be purchased by Elevance Health. Per the New Orleans Times-Picayune, many of the plan’s initial proposals remain, but BCBSLA has made changes to the planned nonprofit foundation that will roll out should it be finalized.
    • “The newspaper reported that the Accelerate Louisiana Initiative will receive 91% of the proceeds from the merger.
    • “In a joint statement to Fierce Healthcare, the companies said that the new “filing reflects the input and vision of our communities to ensure that we deliver on these commitments.”
  • and
    • “While its merger with Humana may have fallen through for now, Cigna is attracting plenty of interest for the rumored sale of its Medicare Advantage business, Bloomberg reported.
    • Sources close to the matter told the outlet that Health Care Service Corp. and Elevance Health are “competing” to scoop up the MA segment. Cigna is expecting that the final bids will be submitted next week, according to the report.
    • “Cigna’s Medicare Advantage unit could sell for more than $3 billion, according to Bloomberg. The article noted that talks with HCSC and Elevance Health may not ultimately lead to a sale.
    • “That Cigna was shopping for a potential buyer for its MA business was first reported in early November by Reuters. That report mentioned that Cigna could ultimately elect to hang on to the MA unit if it didn’t find an appealing deal.
  • The Institute for Clinical and Economic Review listed their top ten stories of 2023.

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The Hill reports,
    • “Congress is struggling to lock down a deal on government funding with just days until lawmakers are set to leave town for the rest of the year, as both chambers appear to have given up on passing their own spending bills.
    • “Lawmakers had been hopeful leadership would strike a deal last week on an overall top-line level for government funding in fiscal 2024 as part of the annual appropriations process. But as negotiations continue, lawmakers say leadership is cutting it close. Congress is staring down a shutdown deadline next month, with little legislative time on the calendar.” 
  • Healthcare Dive explains the features of the Lowers Costs, More Transparency bill passed last night by the House of Representatives. The wide bi-partisan margin supporting the bill gives it more likelihood of success in the Senate.
  • American Hospital Association News tells us,
    • “The House Dec. 12 voted 386-37 to pass AHA-supported legislation (H.R. 4531) that would reauthorize key SUPPORT Act programs for patients with substance use disorder and permanently extend required Medicaid coverage for medication-assisted treatments. The Senate Health, Education, Labor & Pensions Committee today advanced its own SUPPORT Act reauthorization bill (S. 3393).”
  • Healthcare Dive informs us,
    • “Nationwide health data exchange under TEFCA, the Trusted Exchange Framework and Common Agreement, is now operational, the HHS’ Office of the National Coordinator for Health Information Technology announced on Tuesday.
    • “Five Qualified Health Information Networks, or QHINs, completed the onboarding process and are ready for data exchange: eHealth Exchange, Epic Nexus, Health Gorilla, KONZA and MedAllies.
    • “The go-live marks a significant milestone that’s been years in the making, HHS leaders said at a signing event. “I feel like we’re watching the Big Bang occur in 2023,” said Secretary Xavier Becerra.”
  • Yippee! Now, true interoperability begins. Bye, bye fax machines.
  • HHS also announced,
    • “release[ing] HHS’s National Plan to Address Alzheimer’s Disease: 2023 Update – PDF. The National Plan is a roadmap of strategies and actions of how HHS and its partners can accelerate research, expand treatments, improve care, support people living with dementia and their caregivers, and encourage action to reduce risk factors. It highlights the progress made in 2023, which was an historic year for the treatment of Alzheimer’s disease and related dementias (ADRD) and care for people with this condition.”
  • The U.S. Preventive Services Task Force is proposing to retain its Grade B recommendation that
    • “Clinicians provide or refer children and adolescents age six years or older with a high body mass index (BMI) (≥95th percentile for age and sex) to comprehensive, intensive behavioral interventions.”
    • The public comment period is open until January 16, 2024.
  • MedPage adds that
    • “To reap the “moderate net benefit,” kids should have 26 or more contact hours with the behavioral interventions for up to a year, [the USPSTF] advised.
    • “USPSTF fell short of recommending pharmacologic therapy, citing a lack of evidence. This did not mean the group recommended against this type of treatment; however, behavioral interventions should be the primary effective intervention for kids’ weight loss, the task force said.”
  • The CDC offers five healthy eating tips for the holidays.
  • The GAO issued a report on the rocky implementation of the No Surprises Act’s independent dispute resolution process.

From the public health and medical research front,

  • Beckers Hospital Review points out the fifteen states (and New York City), up from ten the previous week, with the highest rates of respiratory disease.
    • “Two states — Louisiana and South Carolina — reported “very high” respiratory virus activity levels. Thirteen states — Alabama, California, Colorado, Florida, Georgia, Mississippi, Nevada, New Jersey, New Mexico, North Carolina, Tennessee, Texas and Wyoming — and New York City reported “high” activity levels, which are a measure of the weekly percentage of visits to an outpatient healthcare provider or emergency department for fever and cough or sore throat.” 
  • Per STAT News,
    • “The sickle cell community has for the past few days been buzzing with news of the first-ever approved gene therapies for the devastating disease. Meanwhile, researchers at the American Society of Hematology meeting on Tuesday are reporting advances in a less expensive and more established strategy proven to cure patients: bone marrow transplant.
    • “This approach has been around for decades but required patients to have a well-matched donor and endure a hefty dose of chemotherapy, ruling out transplant as an option for the vast majority of patients. In a mid-stage trial, however, researchers said sickle cell patients who were given a gentler course of chemo and an infusion of half-matched cells fared well: They had less pain, and 95% of participants were alive two years after transplant and only 7% of recipients experienced a severe reaction caused by transplanted immune cells attacking their new home.”
  • and
    • “One of the toughest subtypes of acute leukemia involves a genetic alteration in the KMT2A gene. Many cancers with this genetic alteration end up relapsing or don’t respond to treatment, but new data presented at the annual American Society of Hematology meeting offer hope of a new targeted therapy for these patients.
    • “The study, called the Phase 2 Augment-101 trial, tested Syndax’s revumenib in patients with relapsed or refractory leukemia with these KMT2A genetic rearrangements. Overall, about 63% of the patients responded to the treatment, with many able to receive a potentially curative stem cell transplant later on, which is often the ultimate goal for patients with relapsed or refractory patients, said Ibrahim Aldoss, a hematologist-oncologist at City of Hope and the study’s presenter, in an interview.”
  • The New York Times asks why since 2009 pedestrian deaths at night continue climb?
    • “[P]ut together, it’s clear that there’s been a particularly American mix of technological and social changes over the past decade and a half. And they have all come on top of a road system and an ingrained culture that prioritizes speed over safety. Whatever has happened over this time has reversed years of progress on daytime pedestrian fatalities, too, leading to a modest increase in deaths. Nighttime, however, has the potential to amplify so many of these new risks.
    • “A transportation system that’s safer by design — as in many European countries — might better absorb any one of these dangers. Distracted drivers are safer at lower speeds. People out at night are safer with well-lit crosswalks.”
  • The New York Times furthermore reports,
    • Zepbound, the newly approved weight loss drug, hit the market this month. People seeking out the medication may have to stay on it for the foreseeable future — potentially, for the rest of their lives — if they want to keep the weight off, new research confirms.
    • “A study published Monday followed 670 people who had taken tirzepatide, the compound in Zepbound and the diabetes drug Mounjaro, for 36 weeks. Eli Lilly, the company that makes both drugs, funded the study. Tirzepatide regulates insulin levels and slows down the emptying of the stomach. It also acts on areas of the brain that control hunger and appetite. As a result, people can lose significant weight: On average, the study participants lost around 20 percent of their body weight during that time.
    • “After that, half of the participants continued to take a high dose of tirzepatide for a year while the other half received a placebo shot. Those in the study also underwent lifestyle counseling, ensuring that they were eating fewer calories and exercising regularly.
    • “People who continued taking tirzepatide for an additional year lost, on average, another 5.5 percent of their body weight. Those who were switched to the placebo, however, gained 14 percent of their body weight on average. Those on the placebo also tended to have higher cholesterol, blood sugar and blood pressure than they did while taking tirzepatide, said Dr. Louis Aronne, the lead author on the study and the director for the Comprehensive Weight Control Center at Weill Cornell Medicine.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Optum Rx is launching a new weight management program aimed at improving outcomes and addressing affordability.
    • “The cost of GLP-1 drugs amid continued high demand is a key focus for pharmacy benefit managers and plan sponsors, especially as individual therapies can top $10,000 per year. Through the Optum Rx Weight Engage program, the PBM is aiming to support employers and other clients in designing benefits for their membership.
    • “The team will review the client’s goals to build a tailored program that will deploy clinical solutions as well as patient monitoring and motivation and support tools, the company said. Members can connect to an obesity management specialist who will direct them to the appropriate clinical services.”
  • Healthcare Dive reports,
    • “Healthcare prices typically rise faster than inflation, but 2023 may have bucked that trend.
    • “The cost of shoppable medical services at hospitals increased 2% in the first three quarters of the year, according to new data from Turquoise Health released Tuesday. That’s in line with the 1.9% overall growth of the economy.
    • “The findings — some of the first from new price transparency data disclosing the once-secret negotiated rates between health insurers and providers — illustrate how overall economic inflation could be catching up to faster health cost growth.”
  • STAT News notes,
    • “In its latest bid to police the pharmaceutical industry, the U.S. Federal Trade Commission sought to block Sanofi from licensing a Pompe disease treatment made by another drug company. And in response, Sanofi is ending the deal.
    • “Sanofi sought the rights to the medication from Maze Therapeutics, but the regulator argued the deal — valued at $775 million — would eliminate a “nascent competitor” that could, otherwise, challenge the monopoly Sanofi has in the market for Pompe disease treatments, according to an FTC statement. The agency had filed a complaint in a federal court in Boston and also planned to seek a preliminary injunction.”
  • BioPharma Dive adds,
    • “The scuttled deal came on the same day that the regulator gave final clearance to Pfizer’s $43 billion acquisition of Seagen, which had faced close scrutiny from the antitrust regulator. To ease the FTC’s concerns, Pfizer has agreed to donate royalties from sales of the cancer drug Bavencio to the American Association for Cancer Research.”
  • Beckers Hospital Review points out six innovative hospitals.
  • According to BioPharma Dive,
    • “AstraZeneca on Tuesday reached a deal to acquire vaccine developer Icosavax in a deal worth up to $1.1 billion. 
    • “Per deal terms, AstraZeneca will acquire Icosavax’s shares at $15 apiece, and could add another $5 per share to the buyout if certain milestones and sales targets are met. The upfront payment from AstraZeneca represents an equity value of about $838 million and a premium of about 43% to Icosavax’s closing price on Monday. The acquisition would reach $1.1 billion if AstraZeneca eventually makes the future payouts, which are known as “contingent value rights.”  
    • “Icosavax has been developing an experimental shot that simultaneously targets respiratory syncytial virus and human metapneumovirus, another lung infection. The biotech released Phase 2 study results on Tuesday showing the vaccine spurred an immune response against both viruses without causing any serious adverse events. AstraZeneca will now take over late-stage development, and, if successful, commercialization.”  

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC,

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

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

Photo by Manasvita S on Unsplash

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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


 

Tuesday Tidbits

Photo by Patrick Fore on Unsplash

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Post Thanksgiving Extra

The FEHBlog noted his plan on Wednesday to hold off on future posts until Cybersecurity Saturday. A pleasant Thanksgiving holiday resulted in the FEHBlog preparing this Friday Extra.

From Washington, DC,

  • CMS issued a No Surprises Act toolkit for consumer advocates.
  • Federal News Network tells us,
    • “As it’s the middle of open season, those eligible have until Dec. 12 to enroll or make changes to their plans under TRICARE – the Defense Department’s healthcare system – for 2024.
    • “The two main plans eligible for enrollment are TRICARE Prime, which includes the U.S. Family Health Plan, and TRICARE Select. TRICARE Open Season does not apply to its premium plans – TRICARE Young Adult, TRICARE Reserve Select and TRICARE Retired Reserve. TRICARE Open Season also does not apply to those who are eligible for Medicare or those using TRICARE For Life. It also does not apply to active duty service members. These groups do not have to do anything during the Open Season.
    • “Open Season is an opportunity for you to evaluate the health care coverage that your family has and to see if you need to change plans or if you want to stay in the current plan that you’re in,” Zelle Zim, who’s on TRICARE’s policy and programs team, said at a TRICARE event on Wednesday. “You also have the opportunity to enroll in a new plan during TRICARE Open Season.”

In public health and medical research news,

  • Healthcare Dive informs us,
    • “Rates of completion for high-risk diagnostic tests and referrals were lower when ordered during a telehealth visit compared with an in-person appointment, according to a study published in JAMA Network Open. 
    • “For telehealth orders, 43% were completed during the designated time frame compared with 58% of tests and referrals requested during in-person appointments, and 57% of those ordered without any visit at all. 
    • “Failure to get tests or complete referrals is a leading cause of diagnostic errors, and safety risks can be a particular concern in primary care due to the large number of potential diagnoses, researchers said.” 
  • STAT News points out,
    • “Overdose deaths among pregnant or postpartum people skyrocketed between 2018 and 2021, according to new research published Wednesday in JAMA Psychiatry.
    • “The study, conducted by the National Institute on Drug Abuse (NIDA) and the National Institutes of Health, compared the incidence of maternal deaths for overdose of commonly misused psychotropic drugs (such as heroin and other opioids, including synthetic ones, or cocaine) among girls and women aged 10 to 44.
    • “The spike in overdose deaths was especially high among women ages 35 to 44. In 2018, the rate was 4.9 overdose maternal deaths per 100,000 mothers with a live birth; in 2021, the rate was 15.8 per 100,000. The rate of overdose death for all age groups also increased significantly, from 6.9 per 100,000 mothers in the first half of 2018 to 12.2 in the second half of 2021.”
  • Beckers Hospital Review reports, “There’s been a slight slowdown in reports of new drug shortages before the winter holiday season, but six medications recently entered the list of ongoing shortages, which includes about 300 drugs.” Becker’s article lists those six drugs.

From the U.S. healthcare business front,

  • Beckers Payer Issues notes that Blue Cross licensees are “diving into” direct healthcare delivery. “BCBS plans have spent 2023 reorganizing to better compete with larger insurers through corporate restructuring, M&A or the launch of healthcare delivery subsidiaries.”
  • Per Fierce Healthcare,
    • “Pharmacy benefit management giant Optum Rx is aiming to address maternal and fetal health by leaning on the power of independent pharmacies.
    • “The Road to Healthy Baby program launched earlier this year in three states—Louisiana, Michigan and New Mexico—and offers pregnant patients prenatal checkups and vitamins at an independent pharmacy. The initiative is part of a broader push by the PBM that seeks to harness the power of these pharmacies.
    • “Through the program, a pregnant person who maintains their prenatal vitamins across three prescriptions or a 90-day supply will receive a care kit with key items that help during pregnancy and after the baby is born.
    • “Optum has also deployed grants to local diaper banks to ensure new mothers have access to necessary supplies. Katie McCarey, vice president of pharmacy strategy and product innovation at Optum Rx, told Fierce Healthcare that the company has found in some markets that new mothers often have just one or two diapers available each day for their babies.”
  • and
    • “UPMC’s operations dipped into the red this quarter as volumes and their associated care delivery costs and insurance claims continue to climb.
    • “The Pittsburgh-based integrated nonprofit system reported Tuesday a $191 million operating loss (-2.8% operating margin) and a $421.8 million change in net assets (without donor restrictions) for the three months ended Sept. 30. During the same time a year prior, UPMC had logged a $114.5 million operating income (1.8% operating margin) and $272.6 million drop in its net assets (without donor restrictions).
    • “The organization is now sitting at a $176.5 million operating loss (-0.9%) year to date despite its strong start to 2023. Its bottom line reflects a $244.7 million net decline over nine months.
    • “In a release announcing the financial results, UPMC Executive Vice President and Chief Financial Officer stressed that the system is “staying to true its commitments” surrounding capital investments ($517 million year to date) despite industry-wide workforce challenges and other headwinds.”
  • Healthcare Dive highlights five major healthcare company bankruptcy filings in 2023. “Bankruptcies have spiked this year as federal COVID-19 funding lapsed and heightened interest rates, regulatory changes and labor shortages squeezed the sector.”

Thursday Miscellany

Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Republicans yanked another fiscal 2024 spending bill before a final vote scheduled for Thursday morning, leaving them empty-handed for the week and stuck at seven out of 12 annual appropriations bills passed.
    • “The $25 billion Financial Services bill [which funds OPM and the FEHBP] ran into trouble with GOP moderates over language that would block the District of Columbia from implementing its 2014 law preventing employment discrimination based on reproductive health decisions, including taking birth control or having an abortion.
    • “The simple analogy is they didn’t have the votes. Shocking,” said Rep. Ryan Zinke, R-Mont., who backs the bill. “Monday, we’ll see if we can have a consensus over the weekend for those people that have a problem with what I think is a very straightforward bill.”
    • “Another issue which contributed to the measure’s demise Thursday, according to a source familiar with the decision, was conservative opposition to allowing the General Services Administration to implement its plan to build a new FBI headquarters in Greenbelt, Md.”
  • As Rosanna Rosannadana would say, “If it’s not one thing, it’s another.”
  • The Society for Human Resource Management informs us,
    • Employees can funnel an extra $150 into their health flexible spending accounts (FSAs) next year, the IRS announced Nov. 9.
    • “The annual contribution limit is rising to $3,200 in 2024, up from $3,050 in 2023. The hike is still significant, although it’s a smaller boost than the $200 hike seen this year.
    • “If the employer’s plan permits the carryover of unused health FSA amounts, employees can carry over up to $640 in 2024. That’s up $30 over the 2023 carryover amount, which is $610.”
  • Here’s a link to the IRS’s complete list of 2024 inflation adjustments to tax items.
  • STAT News tells us that the Ground Ambulance Committee created by the No Surprises Act wants to cap the cost-sharing for people who use ground ambulances at $100 per trip. The catch is that they have difficulty deciding how much health plans should pay for ground ambulance services.
    • “Some experts say a Medicare benchmark is the simplest administrative solution. Medicare’s payment system for ambulances is outdated, but it’s based on some measure of costs. But that shift would result in a lot of upheaval, especially for ambulance providers that currently are able to bill and collect large sums of money from the biggest insurance companies. * * *
    • “Early next year, the federal ambulance committee will deliver its recommendations to Congress. Key lawmakers have not shown a lot of interest in taking up surprise billing again because it requires a lot of political capital to confront the ambulance and insurance industries.”

In FEHBP news,

  • FedSmith offers its strategy for approaching the FEHB open season which begins next Monday.
  • FedWeek discusses coordinating benefits between FEHB plans and Medicare. The best resource is OPM’s chart found in Section 9 of every FEHB plan’s brochure.

From the public health and research front,

  • The Wall Street Journal reports,
    • “A team of New York surgeons has performed the world’s first whole-eye transplant on a human, a breakthrough that could change vision treatments even though the patient hasn’t regained sight in the grafted eye. 
    • “In the six months since the eye surgery was performed, in conjunction with a partial face transplant, the 46-year-old patient has shown promising signs of health in the eye, the surgical team at NYU Langone Health said Thursday. 
    • “The grafted eye is maintaining normal ocular pressure and has direct blood flow to the retina, the area at the back of the eye that receives light and sends images to the brain. It isn’t known if the patient will regain his sight, but the transplant is still a significant accomplishment, according to Dr. Eduardo D. Rodriguez, director of the Face Transplant Program at NYU Langone.  
    • “We’ve made one major step forward and have paved the way for the next chapter to restore vision,” Rodriguez said. Rodriguez led the May surgery, which lasted 21 hours and included more than 140 surgeons, nurses and other healthcare professionals.” 
  • The Food and Drug Administration announced,
    • “approving Adzynma, the first recombinant (genetically engineered) protein product indicated for prophylactic (preventive) or on demand enzyme replacement therapy (ERT) in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura (cTTP), a rare and life-threatening blood clotting disorder.”
  • and
    • “approving Ixchiq, the first chikungunya vaccine. Ixchiq is approved for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
    • “The chikungunya virus is primarily transmitted to people through the bite of an infected mosquito. Chikungunya is an emerging global health threat with at least 5 million cases of chikungunya virus infection reported during the past 15 years. The highest risk of infection is in tropical and subtropical regions of Africa, Southeast Asia, and parts of the Americas where chikungunya virus-carrying mosquitos are endemic. However, chikungunya virus has spread to new geographical areas causing a rise in global prevalence of the disease.” 
  • and
    • clearing for marketing the first over-the-counter (OTC) antigen test for COVID-19. ACON Laboratories’ Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18. Today’s announcement follows clearance of a molecular home test earlier this year.
  • Per Beckers Hospital Review,
    • “Pneumonia patients who took an antibiotic that’s typically reserved as an alternative were less likely to develop Clostridioides difficile infections compared to those taking the recommended drug, according to a study from Veterans Affairs Hospitals. 
    • “The retrospective study analyzed 156,107 patients treated for pneumonia at a VA hospital between 2009 and 2022. Overall, less than 1% of pneumonia patients were diagnosed with a C. diff infection, but among those who had C. diff in the year before contracting pneumonia, 12% developed a new C. diff infection associated with their antibiotic treatment. 
    • “Clinical guidelines recommend azithromycin, and nearly 9 in 10 of the patient cohort received the drug. Of the 13% who received doxycycline, the alternative antibiotic, the drug was associated with reducing C. diff infections by 45%. 
    • “The researchers concluded that, if Legionella pneumonia can be ruled out, clinicians might consider doxycycline as a first-line treatment over azithromycin.”
  • The Wall Street Journal notes,
    • “There is hope for those of us who live (and sleep) in the real world: Getting less than 8 hours of shut-eye a night doesn’t mean you’re doomed to an early grave.
    • “A recent study looking at sleep and longevity found that sleep “regularity”—going to bed and waking up at consistent times with few mid-slumber interruptions—matters more than how long you sleep. Sleeping six hours every night on a consistent schedule was associated with a lower risk of early death than sleeping eight hours with very irregular habits.
    • “The study adds to a growing understanding of the links between sleep and longevity. Research in recent years has shown not only how important sleep is for health and lifespan, but also that the duration of sleep isn’t the only thing that matters.”

From the U.S. healthcare business front,

  • Healthcare Dive points out,
    • “For-profit hospital operators strained by physician fees, payer relations in the third quarter of 2023. Except for HCA, the biggest U.S. health systems all reported lower year-over-year profits in the third quarter.”
  • and
    • “More than 85,000 Kaiser Permanente healthcare workers have a new four-year contract with the nonprofit system after union members overwhelmingly voted to ratify a compromise reached in October following months of labor negotiations and a high-profile strike.”
  • and
    • “Virgin Pulse announced on Thursday it closed its merger with third-party health plan administrator HealthComp. Private equity firms New Mountain Capital and Marlin Equity Partners are new majority and minority owners of the company, respectively, according to a release.”
  • Per Fierce Healthcare,
    • “Optum Rx is shifting eight different insulin products to its preferred formulary in a bid to address affordability, the company said Thursday.
    • “The product selection includes all rapid-acting and short-acting insulin products and some long-acting insulins, according to the announcement. It includes insulins manufactured by Sanofi, Novo Nordisk and Eli Lilly.
    • “Optum’s Tier 1 includes the lowest cash prices that its members will pay, the company said.”
  • and
    • A BCBSA study concludes that the Affordable Care Act’s risk adjustment system works, notwithstanding noteworthy failures.
  • The Wall Street Journal reports,
    • AstraZeneca raised its full-year guidance for core earnings per share and total revenue excluding Covid-19 medicines despite a lower third-quarter profit that missed forecasts after booking a tax charge compared with a credit for the comparable period.
    • “The Anglo-Swedish pharmaceutical giant said Thursday that it expects core earnings per share to increase by a low double-digit percentage compared with previous guidance of a high single-digit to low double-digit percentage increase.
    • “Total revenue excluding COVID-19 medicines is now expected to increase by a low-teens percentage at constant-exchange rates compared with previous expectations of low double-digit percentage growth.
    • “Total revenue is expected to increase by a mid-single-digit percentage compared with previous guidance of low-to-mid single-digit, it said.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Department of Health and Human Services discusses its efforts to support rural healthcare.
  • Today, the proposed No Surprises Act regulation that would change current Independent Dispute Resolution processes was published in the Federal Register. OPM’s proposed FEHB rules changes are described on page 75,808 and may be found on page 75,851.
  • The Centers for Medicare and Medicaid Service issued FAQs on its new final rule imposing civil monetary penalties on Section 111 reporting violations. The rule, which impacts FEHB carriers, becomes enforceable on October 11, 2024.
  • Congressman Gerry Connolly (D VA) released a “statement in support of the Office of Personnel Management’s (OPM) expansion of infertility coverage benefits for Federal Employee Health Benefits (FEHB) program enrollees.” The FEHBlog is pleased to read about Congressman Connolly’s support.
  • The Office of the National Coordinator of Health Information Technology created a blog post titled “Coming in Hot! TEFCA Will Soon Be Live and Add Support for FHIR-Based Exchange.” The post indicates that this critically important electronic health record key to data sharing will be going live soon.
    • “Our TEFCA timelines will remain aggressive and ambitious as ONC and the RCE help support the industry to usher in a new era of data exchange for the United States.
    • “For more information on TEFCA in general, please check out the RCE resources and sign up for the RCE newsletter and monthly public calls.”
  • Govexec reports, “The Office of Personnel Management on Friday announced new plans aimed at helping the federal government’s HR agency better weather the annual surge of retirement applications from departing federal employees that occurs each winter.” Good luck.
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission opened its 2022 EEO-1 Component 1 data collection Oct. 31. Reports must be submitted by Dec. 5, the agency said in a news release
    • “The EEO-1 Component 1 report is a mandatory demographic data report the EEOC requires from all private-sector employers with 100 or more employees, and from certain federal contractors.
    • “EEOC’s Office of Enterprise Data and Analytics released a booklet to help filers complete the process. It has also provided a Filer Support Team Message Center and other resources, the agency said.”

From the public health front,

  • The Centers for Disease Control posted its inaugural issue of FluSight for the current flu season. Here’s the kickoff forecast.
  • Health Payer Intelligence explains how public and private payers cover healthcare for the LGBTQ+ community.
  • The Institute for Clinical and Economic Research published
    • “its third annual “Barriers to Fair Access” assessment of prescription drug coverage policies (Report |Supplemental Materials) within US commercial insurance and the Veterans Health Administration. The analysis found that major payer coverage policies for 18 drugs often met fair access criteria for cost sharing, clinical eligibility, step therapy, and provider restrictions. However, the report’s findings suggest that major improvements are needed in the transparency of coverage policy information for consumers and in detailing out-of-pocket costs for patients.” 
  • Beckers Hospital Review shares CMS statistics on emergency department wait times across our country.
  • The Wall Street Journal gives advice on how to avoid the gloom associated with turning the clock to standard time this weekend.
    • “Daylight hours affect our brain chemistry. As days grow shorter, light receptors in the eyes receive less light and send a signal to the brain about what chemicals to produce, says Lina Begdache, associate professor of health and wellness studies at Binghamton University. 
    • “Our brains begin producing more melatonin—the sleep-related hormone—and less serotonin, which enhances mood and controls appetite. When the brain starts making more melatonin at 4 p.m. due to the earlier dusk, people can feel prematurely sluggish, which can affect mood, diet, exercise and sleep patterns.  
    • “Focusing on improving one area that is affected by the time change, such as exercise, can help the others and might be more doable than trying to improve everything at once, says Begdache, the associate health and wellness studies professor.  * * *
    • “If you improve your diet, you’re more likely to exercise more. And if you exercise more, you’re more likely to sleep better,” says Begdache, who led a 2021 study on mental well-being and seasonal changes. “
  • The FEHBlog personally likes having more sunlight in the morning.

From the U.S. healthcare business front,

  • Here’s a link to the American Medical Association’s reaction to the 2024 Medicare Part B pay cut announced this week. The pay cut is a wash for FEHB carriers because the cut applicable to Medicare prime annuitants will be offset by price increases for younger members. The big problem is that the cut will drive more doctors out of Medicare Part B. When the FEHBlog, who is on traditional Medicare, lived inside the Beltway, his primary care doctor joined the crowd of local PCPs who had dropped out of Medicare. When the FEHBlog moved to Texas last year, he had no problem finding a PCP who takes Medicare, and what’s more, his PCP participates in an accountable care organization. Access to affordable healthcare and dental care is better in central Texas than inside the Beltway, at least for now. The FEHBlog agrees with the AMA that Congress needs to step up.
  • BioPharma Dive informs us,
    • “Moderna on Thursday shifted its revenue forecast for the year to “at least” $6 billion from a previous range of between $6 billion to $8 billion, a change it said reflected COVID-19 vaccination trends in the U.S.
    • “The biotechnology company also disclosed third-quarter earnings showing a net loss of $3.6 billion, driven mainly by non-cash charges of $3.1 billion related to a “manufacturing resizing” and a tax charge. Shares slumped 6% Thursday on the news but traded up Friday morning.
    • “Moderna said it plans to break even in 2026 through “disciplined investment” and launches for new products like its mRNA flu and respiratory syncytial virus vaccines as well as a combination flu and COVID shot.”
  • MedTech Dive shares medtech executives’ views on the new GLP-1 obesity drugs.
    • “Strong patient interest in GLP-1 drugs to treat obesity has prompted medtech companies to take a hard look at the potential impact on demand for procedures like bariatric surgery and products such as glucose monitors and sleep apnea devices.
    • “The potential threat to medical device sales has spooked investors, who have sold shares in companies across the sector.
    • “Fears that medications such as Ozempic, Mounjaro and Wegovy, which are used for diabetes and weight loss, will eventually reshape treatment for a variety of diseases have driven the most severe correction in the medtech sector since the onset of COVID-19, wiping out about $370 billion in market capitalization, according to Mizuho analyst Anthony Petrone.”

Friday Factoids

Photo by Sincerely Media on Unsplash

From Washington, DC

  • The American Medical Association News informs us,
    • “The Departments of Health and Human Services, Labor and the Treasury Oct. 27 issued a proposed rule intended to improve how the No Surprises Act independent dispute resolution process functions in response to feedback and challenges shared by stakeholders. The public will have 60 days to submit comments. The rule would require plans to include claim adjustment reason codes and remittance advice remark codes, among other new information, with the initial payment or notice of payment denial for certain items and services subject to the NSA protections. The rule proposes changes to the batching requirements so that Items and services could be batched in the same payment determination if they are: furnished to a single patient on one or more consecutive dates of service and billed on the same claim form (a single patient encounter); billed under the same service code or a comparable code under a different procedural code system; or anesthesiology, radiology, pathology and laboratory items and services billed under service codes belonging to the same Category I CPT code section, as specified in the agencies’ guidance. Batched items would be limited to 25 items or services in a single dispute. Lastly, the proposed rule would amend certain requirements related to the open negotiation period preceding the IDR process, the initiation of the process, the dispute eligibility review, and the payment and collection of administrative fees and certified IDR entity fees.”
  • The proposed rule will be published in the Federal Register next Friday, November 3, and the proposal creates a sixty-day public comment period.
  • Here’s a link to the government’s fact sheet on the proposed rule.
  • The FEHBlog noticed that the proposed rule would run open negotiations through the government’s IDR portal, which will increase the government’s administrative costs. It strikes the FEHBlog that the proposed rule could have established a process for the open negotiation for the parties to follow. The proposed rule will require health plan system changes, which is always expensive.
  • Also today, the Department of Health and Human Services wrote to stakeholders, including health plans, reminding them the cost of Paxlovid and other Covid drugs is shifting from the government to the private sector beginning on November 1.
  • STAT News reports,
    • “The Food and Drug Administration on Thursday approved an Eli Lilly drug that takes a new approach to treating ulcerative colitis, a chronic inflammatory disease that can cause intense gastrointestinal pain and distress.
    • “The therapy, dubbed Omvoh, is an antibody that blocks IL-23p19, an immune signaling molecule that plays a key role in sustaining the disease. It’s the first treatment to target this particular pathway in ulcerative colitis. The drug’s approval comes after two late-stage trials found that patients taking Omvoh showed a significant improvement in symptoms after both three months and a year compared with those given a placebo, and that the therapy had minimal side effects.
    • “Omvoh’s list price will be $9,593 per month for intravenous delivery and $10,360 per dose injected beneath the skin. A company spokesperson told STAT that patients who have the drug covered by commercial insurance may pay as little as $5 per month for up to 30 months.”

From the public health front,

  • Health Payer Intelligence points out,
    • “Americans are feeling more optimistic about their well-being than last year, but financial concerns and mental health challenges are still negatively impacting their health, according to a report from The Cigna Group.
    • “The second annual Vitality in America study reflects responses from 10,000 adults collected in June 2023 by Morning Consult. The study uses the Evernorth Vitality Index, a subjective measure of health and well-being, to assess Americans’ experiences with personal health, finances, and job satisfaction.
    • “Almost half of respondents said they look forward to each new day, up from 43 percent in 2022. However, fewer adults said they prioritize their physical health (39 percent), feel capable of managing their emotions (45 percent), and can financially support themselves (40 percent).
    • “The top driver of stress among US adults was finances (40 percent), followed by housing conditions (25 percent), work (25 percent), family or social relationships (25 percent), and health (24 percent).”
  • Per Fierce Healthcare,
    • “More patients are accessing their medical records online via patient portals or apps and are doing so more often than in years past, according to the Office of the National Coordinator for Health IT (ONC).
    • “From 2020 to 2022, the portion of U.S. adults who reported being offered access to their medical records by a provider or insurer increased 24% to about 3 in 5, the office wrote in a recent data brief. The percentage who said they were offered access and used it jumped 50% during the same period, from 38% to 57%, according to ONC.
    • “Together these findings demonstrate increased patient demand for and use of online health information by individuals in recent years,” the office wrote in the brief, citing data from the 6,252-respondent 2022 Health Information National Trends Survey.
    • “Patients who were offered access to their online medical records also used them more frequently—54% reported accessing their records at least three times during 2022, compared to 38% in 2020 and 26% in 2017.”
  • Healthcare IT News notes,
    • “The emergence of telehealth during the COVID-19 pandemic and the resulting surge in the adoption of telemedicine are helping address patients’ needs without major signs of safety concerns, according to a study by Kaiser Permanente.
    • “The study, published in the Annals of Internal Medicine, analyzed more than 1.5 million adult patients at Kaiser Permanente Northern California in 2021, and compared treatment and follow-up visits among primary care telemedicine (video and telephone) and in-person office visits.
    • “Of the 2,357,598 primary care visits analyzed, just over half (50.8%) utilized telemedicine, which broke down to just under 20% composed of video visits and 31.3% telephone visits.
    • “The findings indicate that medication prescriptions were lower for video and telephone visits at 38.4% and 34.6%, respectively, compared to in-person visits at 46.8%. Additionally, follow-up appointments within seven days were less frequent for in-person visits (1.3%) compared to video (6.2%) and telephone (7.6%) visits.”
  • Per Medscape,
    • “Among the 3188 people with type 2 diabetes who were adherent to their tirzepatide (Mounjaro, Lilly) regimen in four pivotal trials of the agent, a quarter achieved at least a 15% cut from their baseline body weight after 40–42 weeks of treatment, and researchers found seven baseline variables that were significantly linked with a higher incidence of this level of weight loss.
    • “These findings help inform which people with type 2 diabetes are most likely to achieve greater body weight reduction with improved cardiometabolic risk factors with tirzepatide,” say the authors.”
  • HR Dive offers advice to employers about how to extend a helping hand to employees in their first trimester of pregnancy.

From the U.S. healthcare business front,

  • Mercer Consulting offers plan design advice to self-fund health plan sponsors. For example,
    • “Commit to affordable plan designs. One of the biggest reasons people delay care is because they can’t afford to pay for care. Encourage use of preventive care and chronic condition management. 
    • “Provide advocacy support to help plan members get to the most appropriate care and setting. 
    • “Review the emerging spectrum of virtual care for options to help rein in costs while making care more accessible and affordable to plan members. 
    • “Now is the time to consider the long list of network options that exist in the market today and could result in cost savings.   
    • “If you haven’t explored reference-based pricing, you might want to do so. The protections offered by the No Surprises Act make this a more attractive and less risky option for plan members. 
    • “Make mental health a priority. People with medical conditions often have mental health needs. People with mental health needs often develop medical conditions. It is an investment you can’t afford to overlook. 
    • “Focus on pharmacy. Prescription drug costs are a top driver of medical plan cost increases mostly associated with new drugs and the cost of specialty drugs.” 
  • The Wall Street Journal reports,
    • Big Pharma is almost finished with the cough and cold medicine business.
    • French drug giant  Sanofi said Friday it plans to spin off its consumer-health business, which includes well-known brands like allergy medicine Allegra and the pain treatments IcyHot and Aspercreme.
    • — to hive off a division selling over-the-counter medicines and other retail products to focus on more commercially lucrative but scientifically riskier prescription drugs.
    • Once the split is completed as early as the fourth quarter of next year, there will be just one consumer-health business left under the umbrella of a big drugmaker parent. Germany’s Bayer will be the largest drugmaker with such a business. 
    • Sanofi and its rivals have made the moves in the hunt for higher margins and faster sales growth. “It allows Sanofi to become a pure-play biopharma company. We’ll be more agile and more focused in our areas of key areas of strength,” Chief Executive Paul Hudson said.
    • Yet the companies lose the crutch of a reliable source of cash flow and now face more pressure to hit on breakthrough medicines with large sales potential.