Thursday Miscellany

No Surprises Act

Thursday Miscellany

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

From Washington, DC,

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

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Midweek Update

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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


 

Tuesday Tidbits

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

From Washington, DC,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Post Thanksgiving Extra

David Ermer–No Surprises Act, Rx coverage, Telehealth, U.S. Healthcare–

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

David Ermer–ACA, Congress, COVID-19, FDA, Federal employment benefits, Medical / Rx research, No Surprises Act, OPM, Rx coverage, U.S. Healthcare–
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

David Ermer–CDC, CMS, Congress, Electronic health records, Federal employment benefits, Medicare, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
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

David Ermer–COVID treatment, COVID-19, Electronic health records, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–
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.

Monday Roundup

David Ermer–Generative AI, Mental health care, No Surprises Act, Telehealth, U.S. Healthcare–
Photo by Sven Read on Unsplash

Happy Columbus Day / Indigenous Peoples’ Day

In anticipation of my residential move to Texas, which occurred in April 2022, the FEHBlog applied to waive into the Texas bar. My application was approved on June 30, 2022. (The FEHBlog remains a member of the DC Bar.)

The FEHBlog then became acquainted with the Texas Bar’s continuing legal education requirement. Last year, I took a 15-hour televised course on eldercare. This year, I am attending the Texas Health Law Conference in downtown Austin.

The FEHBlog had lunch today (by happenstance) with a lawyer who told me that he represents a rural hospital near Odessa. The hospital has twelve beds. Beckers Hospital Review points out 2023 Texas hospital closings and bankruptcies.

There was a provider-oriented session on the No Surprises Act. The speakers quipped that the law is no balance billing law with surprises for providers. At least the speakers agree with the FEHBlog that the law is helping patients.

From the public health front,

  • Healthcare Finance tells us that telehealth may be the solution to the chronic illness problem plaguing a large part of our country, as reported by the Washington Post last week.
    • “More patients with chronic disease. Fewer providers to take care of them. An aging population. SDOH barriers. Telemedicine and remote patient monitoring are essential tools to help manage these healthcare hurdles, an expert says.”
  • The Hill adds,
    • “The Biden administration on Friday extended flexibilities regarding controlled substances to be prescribed via telemedicine. 
    • “The Drug Enforcement Administration (DEA) said in a notice it would allow providers to continue using telemedicine to prescribe certain controlled substances through the end of 2024.”  
  • NBC News reports,
    • “The coronavirus isn’t the only pathogen that can cause symptoms that last months, or even years after an initial infection is overcome, a new study published Friday in The Lancet’s eClinicalMedicine suggests. 
    • “In an analysis of data from 10,171 U.K. adults, the researchers found evidence of a “long cold” syndrome that can follow infection with a variety of common respiratory viruses, including common cold viruses and influenza.
    • “While some of the symptoms of long Covid and long colds overlapped, the study noted that people with long Covid were more likely to continue to experience lightheadedness, dizziness and problems with taste and smell; lingering long cold symptoms were more likely to include coughing, stomach pain and diarrhea. 
    • “Experts said the new research could help shine a light on the types of long-lasting symptoms that come after recovery from an illness, including chronic fatigue syndrome.”
  • Fierce Healthcare discusses how payers are tackling the food insecurity issue in our country.
  • Cardiovascular Business lets us know,
    • “The American Heart Association (AHA) has developed a brand new strategy for the prevention and management of cardiovascular disease (CVD). 
    • “This updated approach highlights the close relationship CVD has with three other significant health conditions: kidney disease, type 2 diabetes (T2D) and obesity. Patients with CVD, for example, often face a heightened risk of developing kidney disease, T2D or obesity. The opposite can also be true—patients with any of those three conditions may face a heightened risk of developing CVD. 
    • “With these close connections in mind, the AHA has defined a new health condition: cardiovascular-kidney-metabolic (CKM) syndrome. CKM syndrome involves nearly every major organ in the body, the group said in a new statement, though its biggest impact is on a patient’s cardiovascular system. 
    • “Anyone who has CVD, or even faces a risk of developing CVD in the future, may have CKM syndrome. By educating physicians and patients alike on the way these different conditions interact with one another and implementing a screening strategy for CKM syndrome, the AHA believes it can help patients get the care they need to live longer, healthier lives.”  

From the U.S. healthcare business front,

  • The Wall Street Journal informs us,
    • “The biopharmaceutical company on Sunday said that it had entered into a definitive merger agreement with Mirati under which it would pay $58.00 per share in cash. Mirati stockholders will also receive one non-tradeable contingent value right per share, potentially worth $12.00 per share in cash.
    • “Mirati’s board unanimously approved the transaction. * * *
    • “The acquisition of Mirati will add the Krazati lung cancer medicine to Bristol Myers Squibb’s commercial portfolio. It also includes access to clinical assets that Bristol Myers Squibb said would complement its oncology pipeline.”

The other business news comes from the HLTH conference ongoing in Las Vegas, NV.

  • Per Healthcare Dive,
    • “Venture capital firm General Catalyst plans to buy an unnamed health system to act as a proving ground for new technology to improve hospital operations and patient care. 
    • “The impending purchase is part of a new health business being spun out by General Catalyst, called the Health Assurance Transformation Corporation, or HATCo, General Catalyst managing director Hemant Taneja and former Intermountain CEO (and new HATCo CEO) Marc Harrison said Sunday at the HLTH conference in Las Vegas.
    • “Harrison and Taneja did not share details on what health system General Catalyst would be looking to acquire, when an acquisition could happen or how much the VC firm plans to spend.”
  • Per Fierce Healthcare,
    • Here’s an overview of the second day of the conference and moreover
    • “Headway, a startup that connects patients with mental health providers covered by insurance, picked up $125 million in fresh funding to build out its provider network to all 50 states. * * *
    • “This latest round of capital will go toward investing in technology and tools to help mental health providers grow their practice, Andrew Adams, co-founder and CEO, wrote in a blog post.
    • “We have plans to make Headway available to individuals seeking care in all 50 states and the District of Columbia very soon and will be building products to help providers deliver care across state lines in 2024. We’re also further investing in ensuring patients have a simplified experience understanding their insurance benefits and changes, with excellent visibility, support, and accuracy,” Adams wrote.”
  • and
    • “Main Street Health focuses exclusively in rural communities and partners with primary care clinics in these regions by placing a health navigator in each facility. The navigator then assists with care coordination, including reaching out to patients about preventive screenings, contacting them with medication reminders, scheduling primary care visits following a hospital discharge and providing support for social needs.
    • “The company currently operates in 18 states by partnering with more than 900 clinics. The expansion brings its total footprint to 26 states. The average clinic working with Main Street Health is based in a town with between 3,000 and 5,000 people and includes 2.5 providers, according to an announcement.
    • “Value-based care company Main Street Health is charting an expansion into eight additional states as it banks more than $315 million in new capital.”

Friday Factoids

David Ermer–Congress, COVID-19 vaccine, Federal employment benefits, Medical / Rx research, Mental health care, No Surprises Act, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The American Hospital Association News tells us,
    • “The Centers for Medicare & Medicaid Services Oct. 6 reopened the No Surprises Act’s Independent Dispute Resolution [IDR] portal to out-of-network providers and group health plans initiating new single payment disputes under the No Surprises Act’s independent dispute resolution process, including single disputes involving bundled payment arrangements. The agency also released new guidance for processing these disputes.
    • “New and in-progress batched disputes and new air ambulance disputes remain temporarily suspended while the Departments of Health and Human Services, Labor and the Treasury update their guidance and operations to align with recent court orders, including an Aug. 24 ruling that set aside certain regulations implementing the IDR process and an Aug. 3 ruling that vacated nationwide a federal fee increase and batching rule for the process.”
  • In that regard, the federal regulators issued ACA FAQ 62 today, which focuses on No Surprises Act issues.
  • What’s more, a No Surprises Act IDR operations proposed rule is still undergoing review at OMB’s Office of Information and Regulatory Affairs.
  • BioPharma Dive informs us,
    • “The National Institutes of Health on Thursday said it will provide funding for three clinical trials of experimental ALS drugs, part of a broader push by the federal government to support the development of treatments for rare neurodegenerative diseases. * * *
    • “Until recently, the FDA had approved just two main medicines for the disease. Clinical testing had shown the drugs respectively offered modest benefits on function and survival.
    • “But in the last year or so, two more treatment options received nods from the FDA. Amylyx Pharmaceuticals’ Relyvrio is now cleared for the broad ALS population, while Biogen’s Qalsody is specifically for the small portion of patients who have mutations in a gene called SOD1.”
  • Per Pharmaceutical Technology,
    • “The US Food and Drug Administration (FDA) has issued a draft guidance to aid sponsors in developing biologics and drugs for stimulant use disorders. * * *
    • “FDA Center for Drug Evaluation and Research Substance Use and Behavioral Health deputy center director Marta Sokolowska said: “Currently there is no FDA-approved medication for stimulant use disorder. When finalized, we hope that the guidance will support the development of novel therapies that are critically needed to address treatment gaps. 
    • “The guidance is one of the actions within the agency’s Overdose Prevention Framework, which includes appropriate prescribing of prescription stimulants as well as the development of evidence-based treatments for stimulant use disorder.”
  • Federal News Network points out,
    • “The Office of Personnel Management’s retirement claims backlog saw some improvement in September. OPM cut its backlog by 2,111 claims, hitting a new six-year low point in its overall inventory. OPM received 6,768 claims in September, and managed to process 8,879, shrinking the backlog to the lowest it has been in six years: 15,852.”
  • The Wall Street Journal reports,
    • “The U.S. Postal Service wants to raise the price of a stamp in what would be the third increase in a year.
    • “The postal service proposed a price of 68 cents, up 3% from the current price of 66 cents. If approved by the Postal Regulatory Commission, the price increase would go into effect on Jan. 21. 
    • “The agency raised stamp prices to 63 cents from 60 cents in January 2023. Six months later, the price of a stamp went up again, by 3 cents.”

From the public health and research front,

  • Medscape notes,
    • “Around 4 million Americans received the updated COVID-19 shots in September, according to the U.S. Department of Health and Human Services (HHS), even as some people have found it difficult to book vaccination appointments or find the vaccines at no cost.”
  • NBC News reports,
    • “People who take popular drugs for weight loss, such as Ozempic or Wegovy, may be at an increased risk of severe stomach problems, research published Thursday in the Journal of the American Medical Association finds.
    • “The brief report is the first study of its kind, the researchers say, to establish a link between the use of such drugs, called GLP-1 agonists, for weight loss and the risk of such gastrointestinal conditions. GLP-1 agonists include semaglutide — the drug found in Ozempic and Wegovy — and liraglutide, the drug used in Saxenda. Both drugs are made by Novo Nordisk. 
    • “Although rare, the incidence of these adverse events can happen. I’ve seen it happen,” said lead author Mohit Sodhi, a medical student at the University of British Columbia Faculty of Medicine in Vancouver. “People should know what they’re getting into.” 
  • Get a load of this good news. Per ALM Benefits Pro,
    • “World Mental Health Day is right around the corner and this year, there’s good news to share. The mental health of U.S. employees is finally on the rise nearly three years after the pandemic. A new study shared by Leapsome, a people enablement platform based in Germany, found that 88% of U.S. employees rate their mental health as being good or very good. 
    • “The massive improvements in mental health took place largely over the past year, with 47% of U.S. workers reporting that their mental health had improved within the last 12 months, according to the study.”
  • STAT News notes,
    • “The grand plan for Moderna’s future in respiratory viruses is to market a single shot that would protect against Covid-19, influenza, and RSV, using the scalability of mRNA to craft a first-of-its-kind product. And the first step — establishing the promise of its combination flu and Covid vaccine — is moving on as planned.
    • “Yesterday Moderna said its combo shot measured up to established flu and Covid vaccines in generating immune responses against each virus. The next step is to take that combination to Phase 3, which could lead to approval by 2025. At the same time, Moderna is awaiting FDA approval for its RSV vaccine and testing a combination that would protect against all three viruses.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Amgen on Friday closed its $27.8 billion acquisition of Horizon Therapeutics, about one month after securing clearance from U.S. antitrust regulators who had challenged the deal.
    • “With the acquisition’s completion, Amgen gains access to 12 drugs that had combined sales of $1.8 billion over the first six months of 2023. The company said it will update its sales guidance for the rest of the year when it reports third-quarter earnings.
    • “The deal is the largest in Amgen’s history, surpassing in dollar terms the 2001 buyout of Immunex. That acquisition gave Amgen Enbrel, a long-lasting blockbuster that, like several of its other major drugs, could lose market exclusivity in the coming years. That looming patent cliff has pushed the company to restock its pipeline via dealmaking.”
  • Per Fierce Healthcare,
    • “UnitedHealthcare’s Surest, which axes deductibles and provides upfront pricing data to members, is the fastest growing product among its commercial plan lineup. And a new analysis offers a look as to why.
    • “The insurance giant released Thursday an Impact Study examining some of the results Surest has seen to date and notes that members enrolled in these plans had 6% fewer emergency department visits and 13% fewer inpatient hospital admissions compared to those who were not enrolled in a Surest plan at the same employer.
    • “In addition, members enrolled in Surest plans had a 20% increase in visits to a physician and a 9% jump in preventive physical exams compared to those in other commercial plans.”
  • and
    • “Cigna’s Evernorth is launching a new, value-based care management program for its behavioral health network.
    • “The company said in an announcement that this marks a key step in collaboration with providers as the industry pushes for standardized benchmarks in behavioral health. About 44,000 providers will participate in the program at launch, according to Evernorth.
    • “Ultimately, if payers and providers align on how to measure success in treatment, it will drive better care, lower costs, and lead to improvements in collaboration. It should also ease administrative burdens for providers, according to the announcement, as at present they use a wide array of measures across multiple payers.”

Thursday Miscellany and Friday Factoids

David Ermer–CDC, CMS, Congress, Medical / Rx research, Medicare, Mental health care, NIH, No Surprises Act, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

The FEHBlog failed to hit publish last night, so Thursday Miscellany was not emailed Friday morning. To correct the problem, Friday Factoids will follow Thursday September 21’s post. Lo siento

From Washington, DC,

  • The Hill reports
    • “Faced with the House stalemate over a government stopgap funding bill, Senate Majority Leader Chuck Schumer (D-N.Y.) on Thursday set up a path for the Senate to move first on a bill to fund the government beyond Sept. 30.  
    • “Schumer filed cloture on a motion to proceed to H.R. 3935, the House-passed bill to reauthorize the Federal Aviation Administration (FAA), which could serve as a legislative vehicle to pass a continuing resolution to fund the government through the Senate.   * * *
    • “Senators will spend next week debating and voting on the legislation in hopes of sending it to the House by Wednesday or Thursday of next week.”  
  • Roll Call adds
    • “The [new] plan [from the House of Representatives] is to ready more of the chamber’s 11 remaining full-year appropriations bills for votes, focusing on passing those to establish a firm negotiating position for talks with the bigger-spending Senate.”
  • Yesterday, the Affordable Care Act regulators extended the public comment deadline for the proposed mental health parity rule revisions from October 2 to October 17, 2023.
  • Today, the Centers for Medicare and Medicaid Services posted a new announcement on its No Surprises Act website:
    • “Effective September 21, 2023, the Departments have directed certified IDR entities to resume processing all single and bundled disputes already submitted to the IDR portal and assigned to a certified IDR entity.  The ability to initiate new disputes involving air ambulance items or services as well as batched disputes for air ambulance and non-air ambulance items and services is currently unavailable. IDR portal functionalities related to previously initiated batched disputes are also unavailable. Disputing parties should continue to engage in open negotiation according to the required timeframes.”
  • CMS also updated its website with No Surprises Act rules and fact sheets.
  • Also today, the U.S. Office of Personnel Management
    • “released the Federal Workforce Competency Initiative (FWCI) General Competencies and Competency Models for a broad set of occupational series. The FWCI is a governmentwide effort led by OPM that updates a selection of general competencies from OPM’s MOSAIC (Multipurpose Occupational Systems Analysis Inventory—Closed-Ended) studies.  
    • “The FWCI competencies provide a common language for 214 occupational series. OPM has published 80 occupation-specific competency models representing work governmentwide that may be used for selection, evaluation, and training activities. The FWCI is a resource for agencies to leverage in their skills-based hiring practices. 
    • “OPM will continue to support agencies and collect critical data that strengthens our workforce and enables us to deliver services for the American people,” said OPM Director Kiran Ahuja. “This update to the Federal Workforce Competency Initiative will help agencies hire the talent they need and expand opportunities for positions that do not require certain degrees.” 
  • The Equal Employment Opportunity Commission posted its new strategic enforcement plan for 2024 through 2028.

From the public health front,

  • The American Medical Association identifies eight things doctors wish their patients knew about the flu shot.
  • The Washington Post reports,
    • “Poor oral hygiene is associated with an increased risk for myriad health problems, including heart disease, diabetes, cancer, rheumatoid arthritis and early death. The state of our teeth and gums, though, may be vital for our well-being beyond the mouth and body.
    • “Emerging evidence suggests that what goes on in our mouth can affect what goes on in our brain — and may even potentially affect our risk for dementia.
    • “People should really be aware that oral health is really important,” said Anita Visser, professor in geriatric dentistry at the University of Groningen in the Netherlands.”
  • Per a CVS Health press release,
    • “A recent CVS Health®/Harris Poll survey of Americans 18 years and older found that nearly one in five (18%) U.S. adults say they were plagued with suicidal thoughts in the past year.  
    • “Other key findings from the survey include:
      • “More than a third of younger adults aged 18-34 (36%) say they had moments in the past year where they contemplated suicide.
      • “An overwhelming nine in ten (89%) U.S. adults deem suicide prevention efforts a major priority in our society.
      • “However, less than a third (32%) strongly agree they can recognize the warning signs of someone potentially at risk, and only four in ten (43%) are strongly aware of resources that offer support and information on suicide prevention.
      • “Nearly eight in ten (77%) U.S. adults believe healthcare providers have a crucial role in suicide prevention, and there is an opportunity for providers to have more discussions about suicide with patients.”

From the U.S. healthcare business front

  • Per Healthcare Dive,
    • “The Federal Trade Commission is suing anesthesia provider U.S. Anesthesia Partners and private equity firm Welsh, Carson, Anderson and Stowe, alleging the two colluded to consolidate anesthesiology practices in Texas, driving up prices to boost their profits.
    • “Welsh Carson created USAP in 2012 before acquiring over a dozen anesthesia providers over the next decade to create a single dominant provider in the state, regulators allege. The PE firm and USAP also made price-setting agreements with independent anesthesiology practices while sidelining a potential competitor by striking a deal to keep them out of USAP’s market, the FTC said.
    • “The complaint filed Thursday in federal district court says the actions have cost Texans “tens of millions of dollars” more each year in anesthesiology services.”
  • MedCity News offers insights on value-based care from an executive at the HealthPartners HMO in Minnesota. “The commercial market has struggled to adopt value-based care, but HealthPartners has had some success, according to Mark Hansberry, senior vice president and chief marketing officer of the company. During a conference, he shared five rules for scaling value-based care, including creating trust and providing real-time data.”
  • Beckers Hospital Review tells us,
    • “Nearly 1,900 U.S. physicians have applied to become certified in obesity medicine — a record number — according to data from the American Board of Obesity Medicine. 
    • “In October, 1,889 physicians will take the exam to become certified in the specialty area. That’s up from 1,001 exam candidates in 2020, marking an 88.7 percent jump. Physicians’ growing interest in the certification comes amid booming patient demand for GLP-1 receptor agonist drugs such as Ozempic and Wegovy. As of August, 2023, sales for Ozempic in the U.S. topped $3 billion. 
    • “More than 6,700 physicians are certified in obesity medicine, a certification that first became available in 2012. For the upcoming exam in October, 38 percent of exam candidates are internal medicine physicians and 30 percent family medicine. To sit for the exam, physicians must have completed a minimum of 60 continuing medical education credits on the topic of obesity.” 
  • The FEHBlog notes that if you build it, they will come.
  • Fierce Healthcare looks inside Walgreens’ pharmacy and primary care model.
  • The Wall Street Journal reports,
    • “Novo Nordisk found bacteria in batches of the main ingredient for a diabetes pill that is a cousin to popular diabetes and weight-loss drugs and was made at a North Carolina plant earlier this year, according to a federal inspection report reviewed by The Wall Street Journal.
    • “The Food and Drug Administration inspected the Clayton, N.C., plant in July and issued a report saying that Novo Nordisk had failed to investigate the cause thoroughly and that the plant’s microbial controls were deficient.  
    • “The plant makes the drug ingredient semaglutide, which is used in the diabetes pill Rybelsus. Semaglutide is also the main ingredient in Novo Nordisk’s popular injections Ozempic and Wegovy, but the company said the semaglutide for those products isn’t made at the same plant.
    • “The Danish company said the Clayton plant is still running and producing for the market and wouldn’t share details of its interactions with the FDA.
    • “The agency said Thursday that based on Novo’s responses to its inspection findings, the FDA isn’t aware of ongoing compliance issues that raise any concerns about the quality of drugs made at the plant.”

Friday, September 23, 2023 Post

From Washington DC,

  • Senator Chuck Grassley (R Iowa) announced
    • “A bipartisan bill led by Sens. Chuck Grassley (R-Iowa) and Ron Wyden (D-Ore.) to improve access to lifesaving organ donations became law today. The Securing the U.S. Organ Procurement and Transplantation Network Act will improve the management of the U.S. organ donation system by breaking up the contract for the Organ Procurement and Transplantation Network (OPTN) and encouraging participation from competent and transparent contractors. U.S. Sens. Ben Cardin (D-Md.), Todd Young (R-Ind.) and Bill Cassidy (R-La.) are original cosponsors of the legislation.”
  • The Wall Street Journal reports,
    • “The collapse this week of efforts to pass spending bills through the House has ignited a long-shot push to head off a government shutdown, with a bipartisan group of senators floating legislation that provides carrots and sticks to force lawmakers to reach a deal.
    • “The lawmakers’ novel approach would aim to ensure Congress completes its work on all 12 appropriations bills needed to fund the government, without the threat of a shutdown that would furlough hundreds of thousands of federal workers and leave government contractors unpaid. Major government functions will stop on Oct. 1 at 12:01 a.m. unless Congress acts.
    • “The bill, co-sponsored by Sens. James Lankford (R., Okla.) and Maggie Hassan (D., N.H.), would set in motion 14-day continuing resolutions, which keep the government funded at the prior year’s levels, while Congress works exclusively on passing appropriations bills.” 
  • Bloomberg points out
    • “The threat of a massive tax is enough to push drugmakers such as Boehringer Ingelheim Pharmaceuticals, Inc. and Novartis AG to comply with the Biden administration’s landmark drug pricing law and negotiate with Medicare.
    • “Companies who manufacture the first 10 drugs selected to negotiate prices with Medicare have until Oct. 1 to officially agree to enter price talks. Under the Inflation Reduction Act, those who refuse to comply with the negotiations must pay a tax starting at 65% of the US sales of a product. The fines would increase by 10% every quarter, with a maximum of 95%.”
  • That’s a lot of leverage.
  • The Consumer Financial Protection Bureau has “announced it is beginning a rulemaking process to remove medical bills from Americans’ credit reports. The CFPB outlined proposals under consideration that would help families financially recover from medical crises, stop debt collectors from coercing people into paying bills they may not even owe, and ensure that creditors are not relying on data that is often plagued with inaccuracies and mistakes.” In the FEHBlog’s view, this approach is bound to backfire as lenders lose faith in credit reports.

From the public health and medical research front,

  • MedPage Today informs us
    • “Nearly half of U.S. states had an adult obesity prevalence at or above 35% in 2022, according to CDC.
    • “The 22 states that met this mark — a small jump from the 19 states just the year prior — included Alabama, Arkansas, Delaware, Georgia, Indiana, Iowa, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Dakota, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Virginia, West Virginia, and Wisconsin.”
  • and
    • The CDC’s advisors on Friday recommended a maternal respiratory syncytial virus (RSV) vaccine to protect infants from serious infections.
    • By an 11-1 vote, the Advisory Committee on Immunization Practices (ACIP) recommended that pregnant women receive a single dose of Pfizer’s prefusion F protein (RSVpreF) vaccine (Abrysvo) at 32 to 36 weeks gestation to prevent lower respiratory tract RSV infection in infants.
    • After decades without an option for protecting most infants against the annual respiratory scourge, providers now have two options: the maternal vaccine and the monoclonal antibody nirsevimab (Beyfortus), which the ACIP last month recommended for all infants younger than 8 months born during or entering their first RSV season.
  • STAT News adds, “The recommendation was accepted by CDC Director Mandy Cohen shortly after the conclusion of the panel’s meeting.”
  • Per BioPharma Dive,
    • “A new cancer drug developed by Daiichi Sankyo and AstraZeneca met one of its two main goals in a breast cancer trial, helping patients who had progressed on earlier-line treatments live longer than those receiving chemotherapy without their disease getting worse, the companies said Friday.
    • “The trial tested the drug, known as datopotamab deruxtecan, in HER2-low or -negative patients whose tumors were sensitive to hormone treatments before their cancer returned. AstraZeneca and Daiichi didn’t release detailed data and stated that the trial hadn’t gone on long enough to tell if patients given their treatment lived longer overall, the trial’s other main goal.
    • “The data suggest the companies’ drug could present a threat to Gilead’s similarly acting medicine Trodelvy, which gained approval in a similar setting earlier this year. HR-positive, HER2-negative breast cancer is the most common form of the disease.”
  • and
    • “A combination of cancer drugs from Seagen and Merck & Co. has shown early success in a large clinical trial, results that help confirm the pairing’s ability to treat a wide range of bladder cancer patients.”
  • The National Institutes of Health announced
    • “A clinical trial has launched to test whether early intensive immune modulation for hospitalized COVID-19 patients with relatively mild illness is beneficial. The placebo-controlled study, part of the global clinical trials consortium known as Strategies and Treatments for Respiratory Infections and Viral Emergencies (STRIVE), will enroll approximately 1,500 people at research sites around the world. It is supported by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) in partnership with NIH’s National Center for Advancing Translational Sciences (NCATS).
    • “Immune modulators—treatments for modifying the immune system to better respond to disease or illness—are lifesaving for certain hospitalized COVID-19 patients. However, the optimal timing for administering the medicines to achieve the best outcomes has not been defined.”
  • The Wall Street Journal poses ten questions about experimental drugs that can be made available to seriously ill patients.

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Catholic healthcare giant CommonSpirit Health has reported a $1.4 billion operating loss (-4.1% operating margin) and a net loss of $259 million for its 2023 fiscal year, which ended June 30, according to financial statements released Thursday.
    • “The nonprofit, which currently operates 145 hospitals across 24 states, had logged a $1.3 billion operating loss (-3.8% operating margin) and a $1.8 billion deficit of revenues over expenses during its prior fiscal year.
    • “This time around, the organization enjoyed patient volumes that “reached pre-pandemic levels in many of the health system’s markets” but was dragged by “private and government reimbursements [that] did not keep pace with increased costs of providing care to patients,” CommonSpirit said in a release accompanying the latest financial filings. The most recent year’s operating performance also included a $160 million adverse impact from a fall 2022 cybersecurity breach that affected numerous locations.”
  • Healthcare Dive tells us,

    • The CMS is poised to crack down further on health insurers in the Medicare Advantage program, according to new comments from a top agency official.

    • MA plans — which now cover more than half of Medicare beneficiaries — have faced rising criticism over care denials and access, along with improper coding practices that inflate the program’s cost.

    • “You will see CMS in the future be a much tougher payer and much tougher regulator to ensure that, for every beneficiary and taxpayer who pay more for it, the value is there, the service is there and beneficiaries have full information for the choices that they’re making,” CMS Deputy Administrator Jon Blum said Thursday at the National Association of ACOs’ fall conference in Washington, D.C.