Monday Roundup

CMS

Monday Roundup

David Ermer–CDC, CMS, Medical / Rx research, Medicare, Mental health care, NIH, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Govexec reports
    • “Weeks following the news that Office of Personnel Management Director Kiran Ahuja would step down, agency Deputy Director Rob Shriver has been appointed acting director of the federal government’s dedicated HR agency.
    • “Shriver announced the news in a post on LinkedIn. * * *
    • “According to the Vacancies Act, Shriver may serve as acting OPM director for 210 days, or until Dec. 2. If he is ultimately nominated to succeed Ahuja on a permanent basis, he likely will be able to remain in the acting director role during the Senate confirmation process, thanks to his service as her “first assistant” in a Senate-confirmed position.”
  • Federal News Network tells us,
    • “Highlighting the work federal employees and other civil servants perform, and especially noting their efforts in administrating pandemic recovery programs, President Joe Biden expressed his appreciation for public servants across the country. In keeping with tradition, the White House issued a proclamation that May 5 will mark the beginning of Public Service Recognition Week.
    • “PSRW is traditionally celebrated the first full week of May. Many federally-focused organizations, including the National Active and Retired Federal Employees Association, show appreciation for public servants during the month of May.”
  • Govexec adds,
    • “Sammie Tafoya, a foreign service officer assigned to Haiti, said she didn’t know what the State Department was when her African history professor encouraged her to apply to work there. 
    • “Whenever I wrote for his class, he said…‘I think what you are looking for — the idea of being able to push change and to be able to write to inform the people that have power to make policies — there’s actually an agency for that. It’s the State Department. It’s the Foreign Service,’” she said. 
    • “Tafoya is one of 25 finalists announced Monday for the Partnership for Public Service’s 2024 Service to America Medals. Nicknamed the Sammies after the award’s namesake, Samuel J. Heyman, who founded the nonpartisan organization, the program has been around since 2002 and honors excellence and innovation in the career federal service. 
    • “The finalists will be recognized at a reception on Thursday, and winners will be announced ahead of an awards ceremony on Sept. 11 at the Kennedy Center.  * * *
    • “A full list can be found here.” 
  • The Society for Human Resource Management informs us,
    • “On May 3, President Joe Biden vetoed a resolution to overturn the National Labor Relations Board’s (NLRB’s) joint employer rule. However, the rule has been blocked by a federal district court in Texas, and litigation might continue.
    • “Overcoming the veto by a two-thirds majority vote in the Senate and House of Representatives is unlikely. The resolution passed the House by a 206-177 vote on Jan. 12 and cleared the Senate by a 50-48 vote on April 10. SHRM had urged Biden not to veto the measure.”

From the public health and medical research front,

  • The New York Time reports,
    • “Scientists are proposing a new way of understanding the genetics of Alzheimer’s that would mean that up to a fifth of patients would be considered to have a genetically caused form of the disease.
    • “Currently, the vast majority of Alzheimer’s cases do not have a clearly identified cause. The new designation, proposed in a studypublished Monday, could broaden the scope of efforts to develop treatments, including gene therapy, and affect the design of clinical trials.
    • “It could also mean that hundreds of thousands of people in the United States alone could, if they chose, receive a diagnosis of Alzheimer’s before developing any symptoms of cognitive decline, although there currently are no treatments for people at that stage.
    • “The new classification would make this type of Alzheimer’s one of the most common genetic disorders in the world, medical experts said.”
  • and
    • “A new study, published Saturday in The Journal of the American Medical Association, revealed growing disparities in child death rates across racial and ethnic groups. Black and Native American youths ages 1 to 19 died at significantly higher rates than white youths — predominantly from injuries such as car accidents, homicides and suicides.
    • “Dr. Coleen Cunningham, chair of pediatrics at the University of California, Irvine, and the pediatrician in chief at Children’s Hospital of Orange County, who was not involved in the study, said the detailed analysis of the disparities documented “a sad and growing American tragedy.”
    • “Almost all are preventable,” she said, “if we make it a priority.”
  • The Wall Street Journal discusses efforts in the U.S. to eliminate cervical cancer using the HPV vaccine.
    • “Doctors are rallying around an audacious goal: eliminating a cancer for the first time. 
    • “Cervical cancer rates in the U.S. have dropped by more than half since the 1970s. Pap tests enable doctors to purge precancerous cells, and a vaccine approved in 2006 has protected a generation of women against human papillomavirus, a sexually transmitted infection that causes more than 90% of cervical cancers. 
    • “With this evidence that the disease is preventable, groups that have worked for decades to end polio and malaria are turning to cervical cancer, plotting to take cases down to null. The World Health Organization is urging countries to boost vaccination, screening and treatment. Doctors in the U.S. are working on a national plan.” 
  • Beckers Hospital Review lets us know,
    • “A 12-year-old boy is the first commercial patient in the world to receive an FDA-approved gene therapy for sickle cell disease, The New York Times reported May 6.
    • “Kendric Cromer is a 12-year-old boy from the suburbs of Washington, D.C., and the first to receive Lyfgenia, a gene therapy treatment created by Somerville, Mass.-based Bluebird Bio. Kendric’s treatment, which costs about $3.1 million, is covered by his family’s insurance. He underwent the first part of treatment at Washington, D.C.-based Children’s National Hospital, in which physicians removed his bone marrow stem cells, which Bluebird will genetically modify for his treatment. The modified cells will be returned in three months.
    • “The FDA gave two companies authorization to sell gene therapy to people with sickle cell disease, a genetic disorder that affects roughly 100,000 people, most of them Black. 
    • “Bluebird estimates it can only treat 85 to 105 patients each year with sickle cell or beta thalassemia, who can receive a similar gene therapy. Children’s National, meanwhile, said it can accept only 10 gene therapy patients a year.”
  • The American Medical Association points out “What doctors wish patients knew about osteoporosis.”
  • The National Institute for Mental Health updated its website about coping with traumatic events.
  • The Washington Post notes, Ultrasound technology is used in many ways. Addiction is the next frontier. The use of the high-frequency sound waves is also being adapted to treat Alzheimer’s disease, tumors and psychiatric disorders.

From the U.S. healthcare business front,

  • Fierce Healthcare offers a look at how “major payers fared in a Q1 dragged by a cyberattack, MA challenges,” and Beckers Payer Issues ranks major payers by first quarter 2023 and 2024 medical loss ratios.
  • Beckers Payer Issues discusses major Medicare Advantage insurer plans for 2025.
  • Healthcare Dive reports,
    • “Dallas-based Steward Health Care, the largest physician-led hospital operator in the country, filed for Chapter 11 bankruptcy this morning in the U.S. Bankruptcy Court for the Southern District of Texas, following months of financial struggles including missed payments to its landlord and vendors.
    • “Steward operates more than 30 hospitals across eight states, according to a spokesperson for the company. The filing marks the largest provider bankruptcy in decades, according to Laura Coordes, professor of law at the Sandra Day O’Connor College of Law at Arizona State University.” 

Friday Factoids

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, No Surprises Act, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • A Senate Finance Committee tells us,
    • “U.S. Senate Finance Committee Ranking Member Mike Crapo (R-Idaho) and Chair Ron Wyden (D-Oregon) released a legislative proposal to address persistent economic problems leading to shortages of generic medicines plaguing America’s health care system, including chemotherapy drugs and ADHD medications. * * *
    • “The proposal, released as a discussion draft, would establish a new program in Medicare for hospitals and physicians to incentivize transparent, reliable, and resilient purchasing practices across supply-chain participants, including by driving health care providers, intermediaries (such as group purchasing organizations, or GPOs) and drug manufacturers to meet ambitious, proactive standards in securing a sustainable, high-quality supply of essential medicines for patients from all walks of life. * * *
    • “A one-page summary of the discussion draft can be found here.
    • “A section-by-section summary can be found here.
    • “The legislative text can be found here.”
  • STAT News reports,
    • “Members of Congress appear poised to advance another short-term [two year] extension of pandemic-era telehealth flexibilities instead of permanently addressing the issue, seven sources familiar with the talks said.
    • “During the Covid-19 pandemic, lawmakers allowed Medicare patients to access telehealth services in more places and with a greater variety of providers than before, but some of those flexibilities are set to expire at the end of the year. The expiration is expected to be an impetus for a broader health care package in December, when other public health programs also run out. * * *
    • “The House Ways & Means Committee is planning to mark up a two-year telehealth policy extension next week, per five sources familiar with the planning. Politico first reported the markup. According to two sources, the markup will contain entirely new language than is in the dozen or so bills that have been circulated so far.”
  • The U.S. Office of Personnel Management’s final Postal Service Health Benefits Program (PSHBP) implementation rule appeared in the Federal Register’s Public Inspection list today. The final rule will be published in the Federal Register on Monday May 6.
    • “OPM is making several changes between the interim final rule and this final rule:
      • “In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as ofJanuary 1, 2025” includes events that occur on January 1, 2025.”
      • In § 890.1604, OPM is clarifying the requirements to enroll in Medicare Part B by expressly providing that the exceptions referring to events occurring “as of January 1, 2025” includes events that occur on January 1, 2025.
      • “Section 890.1604(c) is reserved in anticipation of future rulemaking. [FEHBlog note — This provision creates exceptions from the Medicare Part B enrollment mandate for certain PSHBP enrollees and family members.]
      • “In § 890.1604(e), OPM is clarifying that a Postal Service annuitant or their family member who is required to be enrolled in Medicare Part B must promptly notify OPM or the Postal Service, in writing, if they choose not to enroll in or to disenroll from Medicare Part B.
      • “In § 890.1604, OPM is removing reference to the Postal Service as the entity to receive documentation of overseas residency to qualify for an exception to the Part B enrollment requirement.
      • “In § 890.1606(e), OPM is correcting a typographical error by removing the word “the” before “January 1 of the next year.”
  • A proposed follow-up PSHBP rule is pending review at OMB’s Office of Information and Regulatory Affairs. OPM further explains in the preamble.
    • “Topics OPM plans to address in more detail in the proposed rule include: reconsideration of initial decisions concerning PSHB eligibility; application of the Medicare Part B requirement and associated exceptions in specific scenarios; allocation of Reserves credits; calendar year alignment of government contribution requirements; financial reporting and actuarial calculations; premium payment prioritization from the Postal Service Retiree Health Benefits Fund; and Medicare Part D integration.” 
  • CMS also released a No Surprises Act user guide for resubmission of certain IDR cases.
    • “This user guide provides an overview of the “Notice of IDR Initiation – Resubmission” web form and the steps for successfully completing and submitting the web form. This user guide is intended to assist parties who have submitted a dispute through the Federal Independent Dispute Resolution (IDR) process and received an email from Auto-Reply-FederalIDRQuestions@cms.hhs.gov with a link to the “Notice of IDR Initiation – Resubmission” web form.
    • “The “Notice of IDR Initiation – Resubmission” web form will be sent to the initiating party if the certified IDR entity’s eligibility review of a dispute determines that one or more of the dispute line items must be resubmitted because it was improperly batched or bundled. The initiating party must complete the “Notice of IDR Initiation – Resubmission” web form by the deadline specified in the email. The non-initiating party will not need to take any action.”

From the public health and medical research front,

  • The Centers for Disease Control informs us on May 3:
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare continues to decrease across most areas of the country. This week, no jurisdictions experienced moderate, high, or very high activity. Last week one jurisdiction experienced moderate activity. No jurisdictions experienced high or very high activity.
    • “Nationally, emergency department visits with diagnosed influenza are decreasing. Emergency department visits with COVID-19 and RSV remain stable at low levels.
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week.
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.”
  • NBC News reports,
    • “New research suggests patients with an average risk of colon cancer may only need to undergo a colonoscopy screening every 15 years instead of the recommended 10. 
    • “Swedish researchers found that waiting an extra five years after a first negative colonoscopy carried about the same risk of later having a colorectal diagnosis or dying from the disease as getting screened every 10 years. Extending screening time could reduce “unnecessary invasive examinations,” according to the study published Thursday in JAMA Oncology.  * * *
    • “In an editorial accompanying the new study, gastroenterologists suggested that future screening guidelines may safely be prolonged for some people, noting that “15 has the potential to be the new 10.” * * *
    • “We do not have enough gastroenterology doctors to do a colonoscopy every 10 years in everyone over 50,” said Dr. Otis Brawley, the Bloomberg distinguished professor of oncology and epidemiology at Johns Hopkins University, who was not associated with the new research. * * *. 
    • “Employing cheaper, less invasive screening methods 10 to 15 years after a negative colonoscopy could greatly reduce the number of missed screenings, said the study’s lead author, Dr. Mahdi Fallah, head of the Risk Adapted Cancer Prevention Group at the German Cancer Research Center in Heidelberg. 
    • “The best screening test is the one that is actually done. So, if a test like colonoscopy is unaffordable for a person, an alternative cheaper valid test is much better than no test at all,” said Fallah, who is also a visiting professor in the department of clinical sciences at Lund University in Sweden.”
  • The Institute for Clinical and Economic Review announced on May 2,
    • “[We] will assess the comparative clinical effectiveness and value of tabelecleucel (“tab-cel”, Pierre Fabre) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD).
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in November 2024, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.“

From the U.S. healthcare business front,

  • Kaufmann Hall announced on May 2,
    • “[Hospital m]argins and volumes declined slightly in March, which may signal more challenges ahead. Hospital outpatient revenue also fell 5%, reflecting the competitive challenges of providing outpatient care.
    • “The median Kaufman Hall Calendar Year-To-Date Operating Margin Index reflecting actual margins for the month of March was 3.9%.
    • “The April issue of the National Hospital Flash Report covers these and other key performance metrics.
  • and
    • “Overall labor expenses and revenue continue to rise, and Q1 2024 data show that labor represented 84% of total expenses. The median investment/subsidy per provider increased 2% compared to Q1 2023.
    • “The [Q1] Physician Flash Report features the most up-to-date industry trends drawn from the same data physician groups use to track their finances and operations.”
  • Beckers Hospital Review compares Spring 2024 Leapfrog Hospital Safety Grades against CMS Star ratings for hospitals receiving high and low Leapfrog grades.
  • BioPharma Dive notes,
    • “Amgen shares soared by double digits Friday following its announcement an obesity drug it’s developing has shown enough promise to warrant advancing into late-stage testing.
    • “On an earnings call with analysts Thursday, CEO Robert Bradway said the company is “confident” in the drug’s “differentiated profile” following an internal review of interim Phase 2 study results. Full data are expected by the end of the year and should support a subsequent move into Phase 3 trials, executives said.
    • “Yet Amgen’s drug is likely at least two years away from regulators’ desks, by which time Eli Lilly and Novo Nordisk may already have successors to their weight loss medicines Wegovy and Zepbound. It will take even more time to accumulate data to prove the drug can protect heart health, a key claim for convincing commercial and federal insurers to reimburse for treatment.”
  • Healthcare Dive lets us know,
    • “Walgreens has inked a clinical trial deal with major German drugmaker Boehringer Ingelheim.
    • “Under the deal, Walgreens will find candidates who are overweight or have obesity or diabetes and connect them with a Phase III clinical trial for Boehringer’s GLP-1 drug survodutide, according to a release.
    • “Walgreens launched its clinical trials business in 2022 as part of the company’s broader pivot to health services. Since then, Walgreens has notched more than 35 clinical trials deals with life sciences companies, according to a spokesperson.”

Thursday Miscellany

David Ermer–CMS, Congress, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • The Washington Post reports,
    • “Congressional leaders unveiled Thursday a $275 million bill to boost federal research, physician training and public awareness about menopause, a campaign led by prominent female lawmakers and boosted by the star power of actor Halle Berry.
    • “The bipartisan Senate bill, the Advancing Menopause Care and Mid-Life Women’s Health Act, is led by Sen. Patty Murray (D-Wash.), chair of the Senate Appropriations Committee, and has support from Sens. Lisa Murkowski (R-Alaska), Tammy Baldwin (D-Wis.), Susan Collins (R-Maine) and other lawmakers. The legislation has been championed by Berry, who has discussed her experience with menopause-related misdiagnoses and joined female senators at a news conference Thursday at the U.S. Capitol.”
  • The Wall Street Journal lets us know,
    • “Drunken-driving deaths in the U.S. have risen to levels not seen in nearly two decades, federal data show, a major setback to long-running road-safety efforts.
    • “At the same time, arrests for driving under the influence have plummeted, as police grapple with challenges like hiring woes and heightened concern around traffic stops. 
    • “We are really stuck in some quicksand,” said James Fell, who has been studying impaired driving since 1967 and is a principal research scientist at NORC at the University of Chicago, a nonpartisan research organization.
    • “About 13,500 people died in alcohol impairment-related crashes in 2022, according to data released in April by the National Highway Traffic Safety Administration. That is 33% above 2019’s toll and on par with 2021’s. The last time so many people died as a result of accidents involving intoxicated drivers was in 2006.”
  • The Society for Human Resource Management notes,
    • “Compensation growth kicked up more than expected in the first quarter of the year in another sign of persistent inflation.
    • “Workers were paid 1.2 percent more in the first three months of 2024 than in the fourth quarter of 2023, according to the Employment Cost Index (ECI), released April 30 by the U.S. Bureau of Labor Statistics (BLS). That’s up from the 0.9 percent climb in the fourth quarter of 2023. Wages and salaries increased 1.1 percent, as did benefits costs, from December 2023. Many economists forecasted that the ECI would rise 1 percent.
    • “Year over year, compensation costs—including pay and benefits— in the U.S. for civilian workers rose 4.2 percent, an uptick from the 4.1 percent year-over-year rise in the final quarter of 2023. Meanwhile, compensation for state and local government workers is up 4.8 percent.
    • “Wages and salaries grew 4.4 percent for the 12-month period ending in March 2024 and rose 5 percent for the 12-month period ending in March 2023, according to the BLS. Benefits costs grew 3.7 percent over the year and rose 4.5 percent for the 12-month period ending in March 2023.”

From the public health and medical research front,

  • NBC News reports,
    • “The number of women dying while pregnant is returning to pre-pandemic levels following a worrisome 2021 spike, a new report from the Centers for Disease Control and Prevention shows.
    • “In 2022, 817 U.S. women died either while pregnant or soon after giving birth, down from 1,205 the previous year.
    • “If you look at 2021, we had such a sharp increase as we were really still in the pandemic and still dealing with disruptions of care, the fear of coming into the healthcare space and the inability to access care during that time,” said Dr. Veronica Gillispie-Bell, an OB-GYN at Ochsner Medical Center in Kenner, Louisiana. She was not involved in the new report, which was published Thursday by the CDC’s National Center for Health Statistics.”
  • mHealth Intelligence tells us,
    • “Telehealth-based interventions can help lower the risk of readmissions and emergency department (ED) visits after abdominal surgery, according to new research published in JAMA Network Open.
    • “The study notes that amid the digital healthcare boom of the COVID-19 pandemic, telehealth technologies were applied in areas where they were previously not used, including surgery. Though the use of telehealth in surgery is growing, the study authors noted that there is little research on how telehealth utilization affects patient safety in abdominal surgery.
    • “Thus, the researchers conducted a systematic review and meta-analysis to evaluate whether telehealth-based interventions reduce complications, readmissions, and postoperative ED visits among abdominal surgery patients. They searched PubMed, Cochrane Library, and Web of Science databases from inception through February 2023 to identify randomized clinical trials (RCTs) and nonrandomized studies that compared perioperative telehealth interventions with usual care and reported at least one patient safety outcome.”

From the U.S. healthcare business front,

  • Healthcare Dive informs us,
    • “Cigna has written off more than half of its multibillion-dollar investment in VillageMD amid the declining value of the primary care chain.
    • “Cigna invested $2.5 billion into VillageMD in late 2022, with the goal of accelerating value-based care arrangements for employer clients by tying VillageMD’s physician network with Cigna’s health services business, Evernorth — hopefully reaping profits from shared savings as a result.
    • “But on Thursday, Cigna wrote off $1.8 billion of that investment, citing VillageMD’s lackluster growth after its majority owner Walgreens elected to close underperforming clinics. The writedown drove Cigna’s shareholder earnings down to a net loss of almost $300 million, compared to profit of $1.3 billion in the same time last year.”
  • Per BioPharma Dive,
    • “Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine.”Sales of Novo Nordisk’s obesity drug Wegovy slowed over the first three months of 2024, compared to the fourth quarter last year, as lower realized prices and continued supply constraints curbed growth from the in-demand medicine.
    • “Still, the $1.3 billion in first quarter sales Novo reported for Wegovy was twice the total in the first quarter of 2023. The company has been working to boost supply and, in January, gradually started increasing the number of Wegovy “starter” doses.
    • “Wegovy gained competition last November with the U.S. approval of Eli Lilly’s Zepbound, which brought in $517 million in sales in its first quarter on the market. Citing data from analytics company Iqvia, Novo said that, while new prescriptions of Zepbound are tracking slightly ahead of Wegovy, its drug has larger market share.”
  • and
    • “Pfizer’s rare disease drug Vyndaqel may be its least well known blockbuster medicine. The pharmaceutical company’s COVID-19 vaccine became a household name during the pandemic, while its other top-sellers for blood clots, breast cancer and pneumococcal infections are routinely and widely advertised on TV.
    • “Yet during the first quarter, it was Vyndaqel that outperformed expectations, delivering sales that substantially exceeded Wall Street forecasts. The drug, which treats the cardiac form of a rare disease called transthyretin amyloidosis, brought in $1.1 billion between January and March, 25% higher than the consensus estimate of just over $900 million.”
  • MedCity News considers whether “Walmart’s decision to shutter its healthcare division reflects just how difficult it is to achieve profitability in the primary care and telehealth markets. Experts think retailers simply aren’t prepared to handle the bevy of challenges that come along with delivering healthcare — but could this news also be a sign of the system being broken?”
  • Bloomberg tells us,
    • “Amid the GLP-1 craze, companies including Quest Diagnostics and Labcorp are offering a suite of blood tests intended to help doctors decide if drugs like Wegovy and Zepbound are the right choice for their patients. So far, business is booming.”

Monday Roundup

David Ermer–CMS, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • American Hospital News reports
    • “The Centers for Medicare & Medicaid Services April 22 finalized minimum staffing requirements for nursing homes that participate in Medicare and Medicaid. As proposed in September, the final rule will require nursing homes to provide a minimum of 3.48 hours of nursing care per resident day, including 0.55 hours of care from a registered nurse per resident day and at least 2.45 hours of care from a nurse aide per resident day, as well as 24/7 onsite RN services. CMS slightly expanded the opportunity for facilities to seek exemptions from the requirements from its original proposal. AHA had urged CMS not to finalize the proposal but instead develop more patient- and workforce-centered approaches focused on ensuring a continual process of safe staffing in nursing facilities.”
  • KFF adds
    • “KFF estimates that 19% of nursing facilities would meet the minimum HPRD staffing standards under full implementation of the final rule with their current staffing levels (Figure 1). Nearly 60% of facilities would meet the interim requirement of an overall requirement of 3.48 HPRD, but fewer facilities would meet the RN and nurse aide provisions that are required when the rule is fully implemented (49% and 30% respectively; data not shown).”
  • HHS’s Office for Civil Rights announced a final amendment to the HIPAA Privacy rule concerning reproductive health. The final rule
    • “Prohibits the use or disclosure of PHI when it is sought to investigate or impose liability on individuals, health care providers, or others who seek, obtain, provide, or facilitate reproductive health care that is lawful under the circumstances in which such health care is provided, or to identify persons for such activities.
    • “Requires a regulated health care provider, health plan, clearinghouse, or their business associates, to obtain a signed attestation that certain requests for PHI potentially related to reproductive health care are not for these prohibited purposes.
    • “Requires regulated health care providers, health plans, and clearinghouses to modify their Notice of Privacy Practices to support reproductive health care privacy.
    • “The Final Rule may be viewed here – PDF.
    • “View The Final Rule Fact Sheet here.”
  • AHA News adds,
    • “The rule will take effect 60 days after publication in the Federal Register and require covered entities to comply within 240 days. As requested by the AHA, OCR plans to issue a model attestation form before the compliance date.”
  • HHS’s Office of the National Coordinator of Health IT announced that
    • “Common Agreement Version 2.0 (CA v2.0) has been released. The Common Agreement establishes the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other – all under commonly agreed-to rules-of-the-road. The seven designated Qualified Health Information Networks™ (QHINs™) under the Trusted Exchange Framework and Common Agreement℠ (TEFCA℠) can now adopt and begin implementing the new version. Also published today is the Participant and Subparticipant Terms of Participation, which sets forth the requirements that each Participant and Subparticipant must agree to and comply with to participate in TEFCA.”Common Agreement Version 2.0 (CA v2.0) has been released.
    • “The Common Agreement establishes the technical infrastructure model and governing approach for different health information networks and their users to securely share clinical information with each other – all under commonly agreed-to rules-of-the-road. The seven designated Qualified Health Information Networks™ (QHINs™) under the Trusted Exchange Framework and Common Agreement℠ (TEFCA℠) can now adopt and begin implementing the new version. Also published today is the Participant and Subparticipant Terms of Participation, which sets forth the requirements that each Participant and Subparticipant must agree to and comply with to participate in TEFCA.
    • ?Notably, CA v2.0 includes enhancements and updates to require support for Fast Healthcare Interoperability Resources® (FHIR®) Application Programming Interface (API) exchange, which will allow TEFCA Participants and Subparticipants to more easily exchange information directly between themselves and will enable individuals to more easily access their own health care information using apps of their choice via TEFCA. These enhancements and updates mark a huge step forward for TEFCA as it meets the promise of seamless nationwide exchange at scale. Visit HealthIT.gov to view a list of key concepts that have evolved from Common Agreement v1.1 to v2.0.”
  • Federal News Network shared the results of survey of federal employee attitudes toward the push to return to office.
    • “Of the 6,300 survey respondents, about 30% said they work entirely remotely, 6% work entirely in-person and 64% were working on a hybrid schedule — a mix of in-person work and telework.
    • “Over half of employees said senior leadership at their agency had not clearly explained the purpose of returning to the office. More than a third were in strong disagreement.”
  • From MedTech Dive,
    • “The Food and Drug Administration approved Lumicell’s breast cancer imaging tool, the company said Thursday.
    • “Lumicell developed the Lumisystem imaging technology to enable surgeons to detect residual cancer in the breast cavity after performing a lumpectomy to remove the tumor.
    • “An FDA advisory committee voted in March that the benefits of Lumisystem outweigh the risks, with one expert predicting the system will have the biggest impact on surgeons who have higher re-excision rates.”

From the public health and medical research front,

  • The New York Times asks and considers,
    • Bird Flu Is Infecting More Mammals. What Does That Mean for Us?
    • H5N1, an avian flu virus, has killed tens of thousands of marine mammals, and infiltrated American livestock for the first time. Scientists are working quickly to assess how it is evolving and how much of a risk it poses to humans. * * *
    • “I never let my kids go to a state fair or animal farm, I’m one of those parents,” Dr. Lakdawala said. “And it’s mostly because I know that the number of interactions that we increase with animals, the more opportunities there are.”
    • “Should H5N1 adapt to people, federal officials will need to work together and with their international counterparts. Nationalism, competition and bureaucracy can all slow down the exchange of information that is crucial in a developing outbreak.
    • “In some ways, the current spread among dairy cows is an opportunity to practice the drill, said Rick Bright, the chief executive of Bright Global Health, a consulting company that focuses on improving responses to public health emergencies. But the U.S. Agriculture Department is requiring only voluntary testing of cows, and is not as timely and transparent with its findings as it should be, he said.
    • “Dr. Rosemary Sifford, the department’s chief veterinarian, said the staff there were working hard to share information as quickly as they can. “This is considered an emerging disease,” she said.
    • “Government leaders are typically cautious, wanting to see more data. But “given the rapid speed at which this can spread and the devastating illness that it can cause if our leaders are hesitant and don’t pull the right triggers at the right time, we will be caught flat-footed once again,” Dr. Bright said.
    • “If we don’t give it the panic but we give it the respect and due diligence,” he added, alluding to the virus, “I believe we can manage it.”
  • MedPage Today discusses the ready availability of human vaccines for the H5H1 avian flu virus should the need arise.
  • Precision Vaccinations reminds us,
    • “In April 2024, the United States observes the 15th Annual Oral Cancer Awareness Month, which emphasizes the significance of preventing human papillomavirus (HPV)- related oral cancers [with HPV vaccines].
  • HealthDay tells us,
    • “The right diet may be the best medicine for easing the painful symptoms of irritable bowel syndrome (IBS), new research shows. 
    • “In the study, two different eating plans beat standard medications in treating the debilitating symptoms of the gastrointestinal disease. One diet was low in “FODMAPs,” a group of sugars and carbohydrates found in dairy, wheat and certain fruits and vegetables, while the second was a low-carb regimen high in fiber but low in all other carbohydrates.
    • “Published April 19 in the journal Lancet Gastroenterology and Hepatology, the findings suggest that patients should first try dietary changes before moving to drugs for relief.”
  • MedScape informs us,
    • “A new three-phase screening protocol that incorporates a PSA test, a four-kallikrein panel, and an MRI scan appears to improve the prostate cancer detection rate among men invited to participate in a single screening compared with those not invited, according to preliminary findings from the Finnish ProScreen randomized clinical trial.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “UnitedHealth’s results beat Wall Street expectations on an adjusted basis, with the company noting that overall care patterns in the first quarter were“consistent with the company’s expectations.” Nothing to worry about here, executives repeatedly told investors, who promptly sent UnitedHealth’s stock soaring and hospital shares tanking. Then on Thursday, Elevance offered more relief, saying that costs were running as expected while raising its full-year earnings guidance.
    • “Various monthly surveys are also showing a moderation in hospital volumes. TD Cowen’s survey, for instance, found that 305 hospitals reported only 1% year-over-year revenue growth in March, which was far weaker than 11% growth in February. Analysts led by TD Cowen’s Gary Taylor suggested that we could be at the start of a reversal of hospitals’ outperformance over managed care companies. 
    • “Investors will find out more this week as providers including Universal Health and HCA Healthcare, two large hospital chains, report earnings. HCA might still deliver solid results, as improvements in labor cost pressures and pricing should still positively influence earnings, notes UBS analyst A.J. Rice. 
    • And in any case, stabilization of healthcare utilization isn’t the same as a sharp drop-off. UnitedHealth and Elevance earnings may have signaled to investors that their views on providers were perhaps a bit too rosy, but they didn’t exactly demonstrate that cost pressures have eased. UnitedHealth noted that while it was no longer seeing the “aggressive acceleration” in medical utilization the industry saw in 2023, it hasn’t yet seen a major “step down.”
  • Per Fierce Healthcare,
    • “UnitedHealth Group provided an update late Monday on its analysis of the data accessed in the cyberattack on Change Healthcare, and said it identified files that contain personal and health information.
    • “The company said that the personal health information (PHI) and personally identifiable information (PII) found in the files “could cover a substantial proportion of people in America.” However, UHG said it has not yet uncovered evidence that full medical histories or doctors’ charts were among what was stolen.
    • “UnitedHealth added that with the complexity of the review, it will likely take months of further analysis to identify and notify impacted customers. In the meantime, it’s offering two years of credit monitoring and identity theft protection to anyone who has been effected by the breach.
    • “In addition, the company has also offered to make notifications and conduct required administrative steps on behalf of providers and customers.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb is turning to a manufacturing startup to help produce cancer cell therapies faster, announcing Monday a partnership with the South San Francisco, California-based Cellares.
    • “The deal, which reserves Cellares’ production capacity for Bristol Myers’ use, is worth up to $380 million in upfront and milestone payments. Cellares will handle technology transfer of certain Bristol Myers cell therapies to its automated manufacturing platform, dubbed the Cell Shuttle.
    • :Bristol Myers currently sells two so-called CAR-T cell therapies, Breyanzi for lymphoma and Abecma for multiple myeloma, and has several others in development. In a statement, Lynelle Hoch, head of the pharmaceutical company’s cell therapy unit, said the Cellares deal would help it meet demand for CAR-T therapies “now and in the future.”

Thursday Miscellany

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Medical / Rx research, Medicare, NIH, OPM, Patient safety, Telehealth, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC

  • This morning, the Senate Finance Committee held a hearing to “discuss how to update and strengthen Medicare’s guarantee of high-quality health benefits for the next generation of America’s seniors.”
  • Healthcare Dive informs us,
    • “Lawmakers lauded the benefits of telehealth during a hearing Wednesday, but House members also raised questions about cost, quality and access that still need to be answered as a year-end deadline looms.
    • “As a December deadline draws closer, legislators are working to hash out details about extending or making pandemic-era telehealth flexibilities in Medicare permanent. 
    • “During an hours-long House Energy and Commerce subcommittee hearing, lawmakers considered 15 different legislative proposals surrounding telehelath access, noting changes in Medicare will impact decisions of private insurers.
    • “There’s an urgent need to extend these flexibilities because it’s going to run out,” said Rep. Anna Eshoo, D-Calif. “We need to take action on this.” 
  • STAT News adds,
    • “More than a quarter of outpatient antibiotics are inappropriately prescribed, and telehealth could exacerbate the problem: Studies have suggested that virtual visits, on average, result in more antibiotic prescribing than in-person visits. But not all telehealth is created equal — and research is beginning to untangle which approaches are more likely to result in unnecessary antibiotics. In turn, national telehealth guidelines and standards are fighting back by prioritizing safe and effective virtual prescribing practices.
    • “It’s hard to draw conclusions about antibiotic prescribing via telehealth because it comes in so many flavors, said Guillermo Sanchez, a physician assistant and epidemiologist with the office of antibiotic stewardship at the Centers for Disease Control and Prevention. Telemedicine can be provided by direct-to-consumer companies in one-off visits or by large, integrated health systems; via message, phone, or video.
    • “In a recent literature review, Sanchez and his colleagues found studies showing antibiotics were prescribed similarly in virtual and in-person appointments, as well as research that showed higher prescribing in virtual visits — especially for upper respiratory infections that rarely need antibiotics.
    • “But one thing is clear: There’s plenty of room for improvement.”
  • American Hospital Association News tells us,
    • “The Centers for Disease Control and Prevention April 11 updated its strategy to improve data exchange with health care organizations and other public health authorities to better detect and monitor public health threats. Among other priorities for 2024-2025, the strategy calls for using the Office of the National Coordinator for Health Information Technology’s Trusted Exchange Framework and Common Agreement to enable faster sharing of data between health care and public health; expanding core data sources to detect and monitor threats, including wastewater, hospitalization and hospital bed capacity; and prioritizing data to address health disparities and promote health equity.”
  • STAT News reports,
    • “Medicare for the first time has estimated that a new Alzheimer’s treatment could cost the program billions of dollars by next year — well beyond what Wall Street or even the drug’s manufacturer has projected — according to a document obtained by STAT.
    • “Medicare’s actuaries expect the drug Leqembi, made by the Japanese drugmaker Eisai and sold in partnership with Biogen, to cost the traditional Medicare program around $550 million in 2024, and the entire Medicare program $3.5 billion in 2025, a spokesperson for the Centers for Medicare and Medicaid Services confirmed to STAT. That projection forecasts a large increase in uptake over the next year and a half.
    • “The estimate was buried in a new CMS document that addressed questions about next year’s payments for Medicare Advantage plans, which cover more than 33 million people and serve as the alternative to the traditional Medicare program.
    • “I think CMS’ estimates demonstrate an incredible demand for Alzheimer’s treatments and possibly suggest broader use than I think was originally conceived,” said Ameet Sarpatwari, an assistant professor of medicine at Harvard Medical School who studies pharmaceutical costs and outcomes. “That raises the question: What are we, as taxpayers, willing to spend on this drug with limited resources?”
  • The U.S. Office of Personnel Management announced,
    • “The U.S. Office of Personnel Management (OPM) issued a final rule today on the Pathways Programs designed to significantly expand opportunities for early career talent in the federal government. The final rule is one of the most significant actions the federal government has taken since the program’s inception 14 years ago. Updates include expanding skills-based hiring through qualifying career programs, raising the ceiling for starting salaries for recent graduates, and easing the path for interns to be converted into permanent positions, including lowering the number of hours required to convert and expanding the time given to agencies to complete such a conversion.  
    • “In addition, OPM will soon release new web-based guidance, an updated Pathways Program Handbook, an updated Pathways Toolkit for federal managers and supervisors, and will host a series of webinars and office hours targeted at HR professionals, hiring managers, educational institutions, and other key stakeholders.”  

From the public health and medical research front,

  • MedPage Today tells us,
    • “The hunt for a signal of excess sudden cardiac deaths among young people after COVID-19 vaccination left Oregon health officials empty-handed, they reported.
    • “Investigators searched death certificates for Oregon residents 16-30 years old who died from cardiac or undetermined causes of death from June 2021 to December 2022 and tried to match these deaths with mandatory statewide records of mRNA COVID vaccination, according to Juventila Liko, MD, and Paul Cieslak, MD, both of the Oregon Health Authority’s Public Health Division in Portland, in the CDC’s Morbidity and Mortality Weekly Report.”
  • The NIH Director in her blog lets us know,
    • “Colorectal cancer is a leading cause of death from cancer in the United States. We know that risk of colorectal cancer goes up with age, certain coexisting health conditions, family history, smoking, alcohol use, and other factors. Researchers are also trying to learn more about what leads colorectal cancer to grow and spread. Now, findings from a new study supported in part by NIH add to evidence that colorectal tumor growth may be driven by a surprising bad actor: a microbe that’s normally found in the mouth.
    • :The findings, reported in Nature, suggest that a subtype of the bacterium Fusobacterium nucleatum has distinct genetic properties that may allow it to withstand acidic conditions in the stomach, infect colorectal tumors, and potentially drive their growth, which may lead to poorer patient outcomes. The discoveries suggest that the microbe could eventually be used as a target for detecting and treating colorectal cancer.”
  • Beckers Hospital Review points out,
    • “The number of ongoing drug shortages in the U.S. is at its highest since 2001 — when the American Society of Health-System Pharmacists began tracking data. There are now 323 medications in low supply. 
    • “The reasons for 3 in 5 shortages are unknown, the ASHP said in a report released April 11. Supply and demand are cited for 14% of shortages, manufacturing problems for 12%, business decisions for 12% and raw material issues for 2%. 
    • “Basic and life-saving products are in short supply, including oxytocin, Rho(D) immune globulin, standard of care chemotherapy, pain and sedation medications and ADHD [attention-deficit/hyperactivity disorder] medications,” the ASHP said. 
    • “The top five drug classes in shortages are central nervous system agents, antimicrobials, hormone agents, chemotherapies, and fluid and electrolyte therapies.” 
  • Mercer Consulting alerts us,
    • “Are you ready for the 75-year plus workforce? That’s the question Dr. Charlotte Yeh from AARP Services Inc. asked our webcast participants when she sat down with Mercer’s Kate Brown to discuss how longevity is changing workforce demographics.
    • “In the last 100 years, the 65+ age group has grown five times faster than the rest of the population. What’s even more surprising are projections that people aged 75+ will constitute the fastest-growing age band in the civilian workforce between now and 2030! As an employer, are you prepared for these changing demographics?
    • “In this conversation, Dr. Yeh debunks common myths about older workers – including their inability to use technology to perform essential job functions. In fact, studies show that age-diverse workforces contribute to increased revenue and profit margins – perhaps not surprising given that people 50 and older, contribute $8.3 trillion dollars to the economy. At the same time, working later in life can provide seniors with purpose and social connections, both essential to health and happiness.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Hospitals and health systems have kicked off the calendar year with a flurry of merger and acquisition deals reflecting several different strategic trends driving providers in 2024.
    • “Twenty transactions were unveiled in the first quarter, marking the highest volume of dealmaking Kaufman Hall’s seen within the sector since 2020, according to a report from the healthcare consulting firm released Thursday.
    • “The deals involved organizations of varying sizes and types, the firm wrote, and appeared motivated by a combination of new and old health system trends — for instance, smaller community systems flocking to larger organizations with stable finances, or portfolio realignments among for-profit and non-profit systems alike.”
  • According to Beckers Hospital Review,
    • “Less than 20% of the nation’s hospitals were recognized for excellent patient safety ratings and the highest level of adherence to federal price transparency rules. 
    • “On April 9, the Health Transformation Alliance, The Leapfrog Group and Turquoise Health honored 472 hospitals across 42 states. Each of the organizations received a Leapfrog “A” safety rating and the highest price transparency score from Turquoise Health. 
    • “We encourage all hospitals to look to these industry leaders in both patient safety and price transparency as a model for how to provide patient-centered, high-quality care,” Robert Andrews, CEO of Health Transformation Alliance, said in a news release. “In following their example and commitment to safety and price transparency, we believe the healthcare industry can collectively strive towards better health outcomes for all.”

From the legal news front,

  • Biopharma Dive reports,
    • “The U.S. Department of Justice on Wednesday accused Regeneron of defrauding Medicare by knowingly inflating the average sales price for its top-selling eye drug Eylea.
    • “In a lawsuit filed in U.S. District Court in Massachusetts, prosecutors alleged Regeneron failed to disclose hundreds of millions of dollars in price concessions given to drug distributors in the form of credit card fee reimbursements. As a result, they said, the average sales price for Eylea, which Medicare uses to set payment to doctors, was higher than it should have been.
    • “Regeneron’s tactics also gave it an unfair competitive advantage over rivals, the Justice Department said. Eye clinics were able to get Regeneron’s drug for the discounted cash price while at the same time reaping the benefits of credit card rewards such as “cash back.” At some practices, doctors took turns using their personal credit cards to buy the drug, the lawsuit said. * * *
    • “In a statement to BioPharma Dive, Regeneron said it believes the allegations are “without merit” and show a “fundamental misunderstanding of drug price reporting standards.” The company added that it will defend itself in court.” 
  • The U.S. Attorney for the Southern District of Florida announced,
    • “On April 10, a substance abuse facility owner was sentenced to four years in federal prison, followed by three years of supervised release, and ordered to pay $4,444,417.65 in restitution, for defrauding the Federal Employees Health Benefits Program (FEHBP) of over $4 million. The sentence comes after the defendant entered a guilty plea in February.
    • “Joseph Toro, 39, of Jupiter, Florida, owned and operated Reawakenings Wellness Center (RWC), a substance abuse facility that treated patients, including FEHBP beneficiaries, from 2013 until January 2018, when RWC was evicted from their location in Miramar, Florida. After the RWC eviction, Toro continued to submit FEHBP insurance claims, using personal identifying information of former RWC patients, for substance abuse treatment that was never provided. To do so, he called the FEHBP hotline, impersonated former patients, and changed their mailing addresses to addresses that he controlled so he could obtain the fraudulent insurance reimbursement checks. For over a year, Toro submitted fraudulent claims on behalf of 29 former RWC patients for over $6.7 million in substance abuse treatment that he knew RWC never provided. As a result of Toro’s fraudulent claims, he obtained nearly $4.2 million in proceeds from the FEHBP. Toro also applied for and obtained a $150,000 Economic Injury Disaster Loan (EIDL) from the U.S. Small Business Administration (SBA) during the COVID-19 pandemic. That application misrepresented that RWC had five employees and grossed over $1.4 million in 2019, when in truth RWC had shut down years prior.”

Midweek Update

David Ermer–CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Govexec tells us,
  • “The House Oversight and Accountability Committee on Wednesday advanced legislation [HR 7868] aimed at preventing improper payments in the employer-sponsored health insurance program for federal workers, as well as to ensure roughly 1,200 U.S. Customs and Border Protection officers receive the enhanced retirement benefits they were promised. * * *
  • “Rep. Jamie Raskin, D-Md., the committee’s ranking member, sought unsuccessfully to amend the bill to include language that would authorize additional funding go to OPM to cover the cost of the audit, but Committee Chairman James Comer, R-Ky., expressed a willingness to amend the bill before it reaches the House floor authorizing a specific dollar figure, based on analysis from the Congressional Budget Office. The CBO does not “score” legislation until it has advanced out of committee.”
  • A client of the FEHBlog called to his attention today this April 1, 2024, Centers for Medicare and Medicaid Services (CMS) Part D instruction which calmed the FEHBlog’s nerves about the 2025 notice of creditable coverage which FEHB plans must issue:
    • “Creditable Coverage
    • “Consistent with IRA changes, we are revising the regulatory definition of creditable coverage at § 423.56(b) to reflect that discounts paid under the Manufacturer Discount Program are not taken into account when determining actuarial value. Given various concerns raised by commenters and the significant changes to the Part D benefit for CY 2025 as a result of the redesign, CMS will continue to permit use of the creditable coverage simplified determination methodology, without modification to the existing parameters, for CY 2025 for non-EGWP group health plan sponsors not applying for the retiree drug subsidy under section 1860D-22(a) of the Act. The Final Program Instructions also specify that CMS will re-evaluate the continued use of the existing simplified determination methodology or establish a revised one for CY 2026 in future guidance.”
  • The FEHBlog loves simplicity.  
  • Fierce Healthcare informs us,
    • “The Biden administration is proposing a 2.6% increase for inpatient hospitals’ payments for the coming fiscal year, a $3.3 billion increase over the current year’s payout, as well as other policy adjustments intended to shore up surgical care coordination, drug supply, emergency preparedness monitoring, maternal health and care for the underserved.
    • “The potential updates came under Centers for Medicare & Medicaid Services (CMS)’s proposed Inpatient Prospective Payment Systems (IPPS) rule and the Long-Term Care Hospital pay rule, which were unveiled Wednesday afternoon.
    • “Hospitals that participate in the IPPS Quality Reporting Program and meaningfully use electronic records are projected to get a 2.6% increase to payments for fiscal year 2025, which begins in October. The pay raise is based on a projected hospital market basket update of 3%, which is reduced by a projected 0.4 percentage point productivity adjustment, according to a release on the rule.
    • “Long-term care hospitals are looking at a proposed 2.8% pay increase, which is a 1.6% or $41 million bump over the current year. This is “primarily due to the proposed update to the rate partially offset by a projected decrease in high-cost outlier payments in FY 2025 compared to FY 2024,” CMS wrote in a release.”
  • The Washington Post reports,
    • “The Environmental Protection Agency has finalized the nation’s first drinking water standard for “forever chemicals,” a group of persistent human-made chemicals that can pose a health risk to people at even the smallest detectable levels of exposure.
    • “The new rules are part of the Biden administration’s efforts to limit pollution from these per- and polyfluoroalkyl substances, or PFAS, which can persist in the environment for centuries. Exposure to PFAS has been linked to an increased risk of certain types of cancer, low birth weights, high cholesterol, and negative effects on the liver, thyroid and immune system.
    • “EPA officials estimate that the federal rule will reduce PFAS exposure in drinking water for about 100 million people.
    • “This is the first time the EPA has set a drinking water standard for a new contaminant since 1996. Some states — including Maine, Massachusetts, New Jersey and Washington — have already passed drinking water standards for certain PFAS.”
  • Govexec explains employer-sponsored dental benefits for federal employees and annuitants.
  • Reg Jones, writing in Fedweek, discusses “Extended Health Insurance Benefits for Children of Deceased Federal Employees and Retirees.”

From the public health and medical research front,

  • STAT News tells us,
    • “Cancer vaccines have traveled a potholed road over the last decade. But as researchers from different companies and academic institutions presented promising early data at the American Association for Cancer Research annual meeting in San Diego this week, experts said there’s a collective feeling of turning a corner.
    • “There’s a lot more interest in vaccines” now that the technology is improving, said Roy Herbst, chief of medical oncology at Yale Cancer Center.”
  • MedPage Today informs us that “Taking acetaminophen (Tylenol) during pregnancy was not associated with the development of autism or attention deficit-hyperactivity disorder (ADHD) in children, a large Swedish nationwide cohort study found.”
  • The National Institutes of Health informs us,
    • “Researchers at the National Institutes of Health applied artificial intelligence (AI) to a technique that produces high-resolution images of cells in the eye. They report that with AI, imaging is 100 times faster and improves image contrast 3.5-fold. The advance, they say, will provide researchers with a better tool to evaluate age-related macular degeneration (AMD) and other retinal diseases.
    • “Artificial intelligence helps overcome a key limitation of imaging cells in the retina, which is time,” said Johnny Tam, Ph.D., who leads the Clinical and Translational Imaging Section at NIH’s National Eye Institute.”
  • Per a Neurovalens press release,
    • “Modius Stress becomes company’s second product cleared for use in US 
    • “Neurovalens, a global leader in non-invasive neuro-technology, has received medical device clearance from the US Food & Drug Administration (FDA) to treat anxiety with its Modius Stress device.
    • “Based in Belfast, Neurovalens is a health-tech company that specialises in combining neuroscience and technology to tackle a range of global health challenges. 
    • “The company’s medical devices have been designed to deliver non-invasive electrical stimulation to key areas of the brain and nervous system without the need for surgically implanted electrodes. 
    • “Modius Stress is designed to treat anxiety by delivering a small and safe electrical pulse to the head for a period of 30 minutes before bed, during which users can do other activities, such as watching TV or reading.”  
  • Per a Bristol Myers Squibb press release,
    • “Bristol Myers Squibb (NYSE: BMY) today announced new interim results from the Phase 3 EMERGENT-4 open-label extension trial evaluating the long-term efficacy, safety and tolerability of KarXT (xanomeline-trospium) in adults with schizophrenia. Long-term efficacy data from the trial were presented in a poster titled, “Maintenance of Efficacy of KarXT (Xanomeline and Trospium) in Schizophrenia” (Poster F264) at the Annual Congress of the Schizophrenia International Research Society (SIRS) being held April 3-7, 2024, in Florence, Italy.
    • “We are pleased to see a continued and consistent meaningful reduction in symptoms of schizophrenia across 52-weeks in an outpatient setting, beyond what was seen in the short-term, in-patient five-week trials (EMERGENT-2 and EMERGENT-3),” said Roland Chen, MD, senior vice president and head, Immunology, Cardiovascular and Neuroscience development, Bristol Myers Squibb. “We look forward to continued conversations with the FDA and to sharing additional data from the EMERGENT program later this year.”

From the U.S. healthcare business front,

  • BioPharma Dive reports,
    • “Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash.”Vertex Pharmaceuticals on Wednesday said it would buy biotechnology company Alpine Immune Sciences and its experimental kidney disease drug for $65 per share, or approximately $4.9 billion in cash.
    • “Through the deal, which the companies expect to close in the second quarter, Vertex will gain access to povetacicept, a therapy for IgA nephropathy, or IgAN. The drug is set to enter Phase 3 testing by the end of the year. 
    • “The acquisition is the largest in Vertex’s 35-year history and comes as the company works to expand into kidney disease treatment.”
  • Beckers Hospital Review relates,
    • “Three pharmacy benefit managers accounted for nearly 80% of all prescription claims handled in 2023, according to an April 9 report from the Drug Channels Institute.
    • “To compile the list, Drug Channels analyzed estimated total equivalent prescription claims managed across the industry in 2023. CVS Caremark, Express Scripts and OptumRX managed 79% of prescription claims last year, the same percentage as in 2022.” 
  • Beckers Payer Issues lets us know,
    • “AHIP, the American Medical Association and the National Association of ACOs have released a playbook of voluntary best practices for value-based care payment arrangements. 
    • “National Association of ACOs President and CEO Clif Gaus said that in the past decade, value-based care has grown from “almost nothing to an undeniably significant aspect of our health system,” according to a joint April 10 news release from the organizations. 
    • “This iteration of the playbook synthesizes what we’ve learned over the last decade plus, so that payers, physicians, hospitals and ACOs can implement payment and delivery models that improve outcomes and lower costs,” Dr. Gaus said.” 

Friday Factoids

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

From Washington, DC

  • Healthcare Dive informs us
    • “The Senate continued to probe the impact of private equity on healthcare delivery this week, launching both an inquiry into PE’s emergency department management practices and holding a subcommittee field hearing on “corporate greed” and PE’s impact on patient care.
    • “The field hearing and request for information come as private equity has increased its investment in healthcare. As of January, more than a quarter of the nation’s rural hospitals and 460 total hospitals in the U.S. were owned by private equity firms, according to a tracker produced by nonprofit watchdog, the Private Equity Stakeholder Project. 
    • “PE-backed physician staffing groups operate nearly one-third of emergency departments across the country, according to letters sent Monday to some of the nation’s largest private equity companies by Sen. Gary Peters, D-Mich., and chair of the Senate’s Homeland Security Committee. * * *
    • “PE firms acquire assets and then seek to sell them for profit, typically within a three- to five-year time frame. The investors may also have limited direct knowledge of healthcare, and the funds are subject to fewer regulations than public companies, according to a 2023 report from the CommonWealth Fund. As a result, the firms tend to have fewer patient-centric guardrails in place compared to traditional healthcare owners and investors.”
  • Fierce Healthcare tells us,
    • “Centers for Medicare & Medicaid Services finalized a host of actions ranging from broker compensation, health equity, mental health, supplemental benefits and biosimiliars, in the Contract Year 2025 Medicare Advantage and Part D final rule Thursday night.
    • “Technical experts and industry execs warned the changes will be consequential for MA plans.
    • “Yesterday’s 2025 Final Rule was one of the more impactful that I can recall in my two-plus decades in the industry,” said Sean Libby, president at BeneLynk. “It is clear that MA plans need a roadmap for health related social needs and health equity.”
    • “It is difficult to put words to the extent and impact of changes codified today,” saidMelissa Newton Smith, senior advisor for Oliver Wyman. “Every MA leadership team needs to be thoughtfully redesigning your stars and quality approach in order to earn quality bonus payments in 2025.”
    • “The primary winners are behavioral health providers, namely Arcadia Healthcare and Universal Health Systems,” said global strategy firm Capstone in a new analysis.
  • Per BioPharma Dive,
    • “The Food and Drug Administration has cleared Bristol Myers Squibb and 2seventy Bio’s multiple myeloma cell therapy for earlier use treating the blood cancer, approving the CAR-T medicine for patients who have previously received at least two previous drug regimens.
    • “The OK comes three weeks after a panel of FDA advisers agreed the benefit of earlier treatment outweighed the risks, including a concern raised by agency reviewers over data indicating an elevated risk of death among treated study participants in the first year of the companies’ main trial.
    • “Overall, trial results showed the CAR-T therapy, Abecma, reduced the risk of disease progression or death by about half, compared to standard regimens. Bristol Myers cited patient crossover from the control arm to treatment as confounding survival data, while the advisory panel noted complications with the “bridging” therapy used prior to CAR-T treatment.”
  • Fierce BioTech lets us know,
    • “As new cancer vaccines—led by Moderna and Merck’s mRNA-4157—near pivotal trial readouts, the FDA’s vaccines czar Peter Marks, M.D., Ph.D., said the agency is ready to review the shots despite AI-related unknowns.
    • “We are ready to review—we’re open for business,” Marks, director of the FDA’s Center for Biologics Evaluation and Research, said of cancer vaccines at the 2024 World Vaccine Congress (WVC).
    • “We have therapeutic cancer vaccines coming in; I think we would review them very much like we could review potentially a CAR-T cell or other therapeutic products,” Marks said.”
  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Validation data to support the EUA of this test was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The test can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.”
  • The Washington Post reports,
    • “A group of public health experts and scientists is calling on the Food and Drug Administration to rescind its controversial approval of a DNA test that promises to predict genetic risk of opioid addiction.
    • “In a letter sent to the agency on Thursday, 31 experts in genetics, addiction, psychiatry and medical-device regulation called the approval of AvertD a mistake that relied on faulty science and puts patients at risk. The group sent a separate letter to the Centers for Medicare and Medicaid Services urging the agency, which oversees government health insurance programs, to deny coverage for the prescription-only test.
    • “The Washington Post last month highlighted concerns about the test’sreliability and the unintended consequences of false results. The letters said a negative test could give patients a false sense of security, or lead doctors to “refrain from prescribing opioids to patients who test positive, even in situations where opioids are beneficial.”
  • MedTech Dive lets us know,
    • “Smiths Medical is recalling more than 2,900 emergency ventilators in the U.S. after receiving reports of a fault linked to eight serious injuries, the Food and Drug Administration said Thursday.
    • “The fault can cause patients to receive the wrong amount of ventilation or too little oxygen, as well as a complete or partial airway obstruction. The FDA categorized the event as a Class I recall because of the risk of serious injury or death.
    • “Smiths Medical, which has faced a series of regulatory actions in recent years, told customers to continue using the Pneupac Parapac Plus 300 and 310 Ventilator Kits but to take precautions.”

From the public health and medical research front,

  • The Centers for Disease Control announced today,
    • “The amount of respiratory illness (fever plus cough or sore throat) causing people to seek healthcare remains elevated nationally but is decreasing across many areas of the country. This week, 6 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high activity the previous week. No jurisdictions experienced very high activity. 
    • “Nationally, emergency department visits with diagnosed COVID-19, influenza, and RSV are decreasing.   
    • “Nationally, COVID-19, influenza, and RSV test positivity decreased compared to the previous week. 
    • “Nationally, the COVID-19 wastewater viral activity level, which reflects both symptomatic and asymptomatic infections, remains low.
  • STAT News reports,
    • “The Centers for Disease Control and Prevention urged medical practitioners on Friday to be on the lookout for people who might have contracted H5N1 bird flu from cows. The agency also urged state health departments to rapidly assess any suspected human cases, and recommended that dairy farms with confirmed or suspected outbreaks require workers to use personal protective equipment.
    • “The recommendations were outlined in a health alert network advisory, or HAN in CDC parlance. The advisory is in response to the outbreak of H5N1 avian influenza in at least 16 dairy herds in six states across the country, which has led to at least one human infection so far.
    • “Health care providers should ask themselves “Could this be an H5N1 infection?” if they are faced with a patient with what CDC called a relevant exposure history — for instance, someone who works with dairy cows or lives with someone who works with dairy cows.”
  • Medscape notes,
    • “Cognitive assessments administered via a smartphone app are a reliable and valid way to detect frontotemporal dementia (FTD) in high-risk individuals, new research showed.
    • “Cognitive tests administered remotely on the phone “showed similar findings as our gold standard in-clinic cognitive tests and brain imaging,” study investigator Adam M. Staffaroni, PhD, with the Memory and Aging Center, University of California San Francisco, told Medscape Medical News.
    • “We also provided evidence that these assessments may be useful for detecting early symptoms of the disease at a level that is on par, or perhaps slightly better, than our gold standard in-person tests,” Staffaroni said.
    • “The study was published online on April 1 in JAMA Network Open.

From the U.S. healthcare business front,

  • CNBC reports,
    • “CVS Health on Thursday said its drug plans will cover the first over-the-counter birth control pill in the U.S. at no cost for many health plan sponsors, a decision that could open the door for more people to prevent unintended pregnancies without a prescription. 
    • “The company’s pharmacy benefit manager, CVS Caremark, said the pill will be added to its preventive services oral contraceptives list and will be covered at zero cost for many sponsors. The drug, known as Opill from Perrigo, was available at pharmacies starting April 1, according to a pharmacy update from CVS Caremark dated last week and viewed by CNBC.
    • “Pharmacy benefit managers, or PBMs, maintain lists of drugs covered by health insurance plans and negotiate drug discounts with manufacturers. At most stores, Opill has a retail price of $19.99 for a one-month supply and $49.99 for a three-month supply.” 
    • FEHBlog note — Smart move, CVS Health.
  • The President of the Institute for Clinical and Economic Review comments,
    • “Yesterday Amylyx announced it would remove Relyvrio, a treatment for amyotrophic lateral sclerosis (ALS), from the market. The drug was originally approved in 2022 based on a small phase II trial, well ahead of the conclusion of its phase III trial. The results of that phase III trial were reported last month and unfortunately, the therapy failed to provide any benefit to patients. Historically, a failed trial following FDA approval has not resulted in an automatic revocation of FDA approval or withdrawal of the drug from the market, and post-marketing trial requirements are not consistently used to assess the regulatory status of all approved products. Despite this hole in regulation, Amylyx made the responsible decision to discontinue this drug, and is being rightly lauded for the choice. 
    • “Of course, everyone hopes that treatments approved early with limited evidence will prove effective. But when they don’t, this is how it is supposed to play out: patients get early access to a potentially promising treatment, and then when all the data come in and the benefits fall short, the manufacturer removes the drug from the market. What’s missing from this story though is price: since 2022, the health system paid a steep price for a drug with no proven benefit to patients. When ICER reviewed Relyvrio (prior to FDA approval), we recommended that the manufacturer consider setting the launch price, “close to the cost of production until the benefits of treatment can be adequately evaluated.” Amylyx priced the drug at $158,000 per year, far beyond ICER’s recommended price of $9,100 to $30,700 per year, a price range based on the benefits shown in the small phase II trial. The fact is, that when our health care system allows pricing of treatments far above any reasonable alignment with the benefits they have demonstrated for patients, we do real harm to unseen people in the health care system. Costs increase for everyone without making anyone healthier. And as costs increase, more people forgo care or drop their health insurance all together. 
    • “Even though the story played out as planned this time, the system can be improved to protect all patients and ensure affordability for everyone.”
  • BioPharma Dive relates,
    • “Johnson & Johnson has agreed to acquire Shockwave Medical for approximately $13.1 billion, the companies announced Friday morning. The deal values Shockwave at $335 per share.
    • “J&J said in a statement that Shockwave will expand its “cardiovascular portfolio into two of the highest-growth, innovation-oriented segments of cardiovascular intervention – coronary artery disease and peripheral artery disease.”
    • “Both companies’ boards have approved the transaction, and J&J expects the deal to close in mid-2024.”
  • and
    • “Boehringer Ingelheim is laying off staff in response to sluggish adoption of its Humira biosimilar Cyltezo, a company spokesperson confirmed to BioPharma Dive. Stat first reported the news Thursday.
    • “The German company said it will trim its customer-facing teams in favor of a hybrid in-person and virtual sales model by June 30, but didn’t specify how many jobs are affected. Pharmacy benefit managers, or PBMs, have kept Humira on their coverage lists, resulting in cheaper copycats like Cyltezo falling below their “anticipated potential,” the spokesperson said.
      • “Humira, a blockbuster immune disease drug sold by AbbVie, began facing biosimilar competition in the U.S. last year. Launched in July,Cyltezo is one of more than half a dozen Humira biosimilars now available, but holds an advantage due to its “interchangeable” designation, which allows pharmacists to substitute it for Humira.”
  • Per Healthcare Dive,
    • “Teladoc Health’s long-time chief executive officer Jason Gorevic is leaving the virtual care giant effective immediately, the company said Friday.
    • “Gorevic has been CEO since 2009 and oversaw a period of exponential growth for Teladoc during the COVID-19 telehealth boom. However, he’s departing after the telehealth company struggled to sustain that momentum as the pandemic waned. Teladoc’s stock has sunk significantly since early 2021, and recently hit an eight-year low.
    • “The leadership change is probably coming at the right time, as the company focuses on a longer-term profit growth strategy, Leerink Partners analysts Michael Cherny, Daniel Clark and Ahmed Muhammad wrote in a Friday note.”
  • and
    • “Telehealth company Amwell is in trouble with the New York Stock Exchange for its stock price trading below the minimum standard for listing.
    • “Amwell was a high-flying stock during COVID-19, as the value of telehealth companies soared due to demand for virtually provided medical care. The price of Amwell’s shares peaked at $42.80 in January 2021. However, for the past 30 days, Amwell’s shares have closed at less than $1, sparking a warning notice from the NYSE.
    • “NYSE rules give Amwell six months to regain compliance. In a Thursday release, Amwell said it plans to effect a reverse stock split — when existing shares are consolidated into fewer but more valuable shares, boosting a company’s stock price. Amwell’s board and shareholders will vote on the proposal at an annual meeting later this year.” 
  • In this regard, the FEHBlog heard a health system executive comment at the ABA’s Health Law Section’s Emerging Healthcare Law Issues conference —
    • While the amount of telehealth services has returned a little higher than pre-pandemic 2019 levels, telehealth vendors that hang on will be a lifesaver in the looming physician shortage crisis.

Thursday Miscellany

David Ermer–CMS, FDA, Medical / Rx research, Medicare, Mental health care, OPM, U.S. Healthcare, Uncategorized–

From Washington, DC,

  • Per an HHS press release,
    • Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), is finalizing policies that continue to strengthen enrollee protections and guardrails to ensure Medicare Advantage and Medicare Part D (Part D) prescription drug plans best meet the needs of people with Medicare. The Contract Year (CY) 2025 Medicare Advantage and Part D final rule builds on existing CMS policies to promote competition, increase access to care, including important behavioral health services, and protect individuals from inappropriate marketing and prior authorization. * * *
    • [For example,] CMS is finalizing greater flexibility for Part D plans to substitute, more quickly, lower cost biosimilar biological products (biosimilars) for their reference products so that enrollees may have faster access to equally effective, but potentially more affordable, drug treatment options. * * *
    • View a fact sheet on the final rule at cms.gov/newsroom.
  • From the AHA News,
    • “Primary care providers who commit to practicing two years in a health professional shortage area can initially receive up to $75,000 in loan repayment under the National Health Service Corps Loan Repayment Program, $25,000 more than previously and the first significant increase in 30 years, the Health Resources and Services Administration announced April 4. Participants who extend their service beyond two years can receive additional funding under the program. HRSA also will offer up to $5,000 in additional loan repayment to participants who can demonstrate fluency in Spanish and commit to practice in a high-need area serving patients with limited English proficiency.”
  • The International Foundation of Employee Benefit Plans lets us know,
    • “The Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act (MHPAEA) requires group health plans that provide mental health or substance use disorder (MH/SUD) benefits to offer parity between coverage of physical health conditions and mental health conditions. The Department of Labor (DOL) Employee Benefits Security Administration (EBSA) enforces MHPAEA and reports annually to Congress on how agency investigators are working with plan sponsors and administrators to bring them into compliance.
    • “Recent DOL reports on MHPAEA enforcement indicate several pitfalls that self-funded plan sponsors and their administrative service providers should avoid in order to be compliant with mental health parity rules. A new priority in the 2023 report was impermissible exclusions of key treatments for MH/SUD.
    • One-Minute Summary
      • Recognize that autism spectrum disorder, opioid use disorder and eating disorders are mental health conditionsand therefore treatment of these disorders are mental health benefits covered by mental health parity laws.
      • Blanket exclusions of ABA therapy for autism spectrum disorder, nutritional counseling for eating disorders, and medication-assisted treatment (MAT) and medications for opioid use disorder (MOUD) are impermissible.
      • Methods that participants use to access care should be in parity. Prior authorization, gatekeepers such as EAP referrals and telehealth are impermissible barriers to access mental health benefits.
  • Per an OPM press release,
    • In the first week of the Biden-Harris Administration, President Biden revoked an Executive Order issued by the previous Administration that risked altering our country’s long-standing merit-based civil service system, by creating new excepted service schedule, known as “Schedule F,” and directing agencies to move potentially large swathes of career employees into this new excepted service status. This attempt would have stripped career civil servants of their civil service protections that ensure that decisions to hire and fire are based on merit, not political considerations.  
    • The [OPM] final rule [released today] advances these important policy goals by:  
      • Clarifying that the status and civil service protections an employee has accrued cannot be taken away by an involuntary move from the competitive service to the excepted service, or from one excepted service schedule to another. Once a career civil servant earns protections, that employee retains them unless waived voluntarily.  
      • Clarifying that the phrase “confidential, policy determining, policymaking, or policy-advocating” positions—a term of art to describe positions that lack civil service protections—means noncareer, political appointments. This rule prevents that exception from being misapplied to career civil servants.  
      • Establishing procedural requirements for moving positions from the competitive service to the excepted service and within the excepted service. This change both creates transparency and establishes an appeals process for federal employees when any such movement is involuntary and characterized as stripping employees of their civil service protections.   

From the public health and medical research front,

  • The Society for Human Resources Management tells us,
    • “Anxiety has skyrocketed in recent years, now becoming the top mental health issue plaguing workers, new data shows.
    • “An analysis of more than 300,000 U.S. cases from mental health provider ComPsych found that nearly a quarter of people (24 percent) who reached out to ComPsych for mental health assistance in 2023 did so to get help with anxiety.
    • “That makes anxiety the No. 1 presenting issue reported by U.S. workers, topping depression, stress, relationship issues, family issues, addiction and grief, ComPsych said.”
  • MedPage Today notes,
    • New U.S. hepatitis C infections dropped slightly in 2022, a surprising improvement after more than a decade of steady increasesopens in a new tab or window, federal health officials said Wednesday.
    • Experts are not sure whether the 6% decline is a statistical blip or the start of a downward trend. Seeing 2023 and 2024 data, when it’s available, will help public health officials understand what’s going on, said Daniel Raymond, director of policy at the National Viral Hepatitis Roundtable, an advocacy organization.
    • “We’ve had a decade of bad news … I am cautiously encouraged,” he said. “You always want to hope something like this is real, and a potential sign that the tide has turned.”
  • STAT News reports,
    • “The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective for diabetes and obesity, but is also showing early potential to help with conditions involving the brain, like mental health disorders, Alzheimer’s, and even, as new study results suggest — Parkinson’s disease.
    • “In a Phase 2 trial, patients with early Parkinson’s disease taking an older GLP-1 diabetes drug called lixisenatide experienced no worsening of motor symptoms over a year, in contrast to patients on placebo who did, according to the study, published Wednesday in the New England Journal of Medicine.
    • “The difference between the groups — as measured by a test looking at someone’s tremors and rigidity — was small, almost but not quite reaching what is deemed to be a clinically significant difference. Still, the authors said they were encouraged that patients on the drug did not get worse, and the findings add to a growing body of research that suggests this class of medications holds potential as a new way of addressing Parkinson’s, a slow-moving, debilitating disorder that currently lacks any treatments that can halt disease progression.”
  • and
    • “Moderna may be best known for its Covid-19 vaccine, but since its start, it’s always been set on developing therapies.
    • “It’s run into some hurdles as it’s pioneered turning mRNA — the strand of genetic material that’s at the heart of Moderna’s approach — into medicines. But the company’s vision of making cells into their own drug factories is showing signs of progress.
    • “On Wednesday, scientists reported interim results from an early study of Moderna’s most advanced rare-disease therapy, a treatment for propionic acidemia, a metabolic condition in which the body makes defective versions of enzymes that are required to break down fats and proteins. While the study primarily focused on safety and testing different doses, some patients — most of the participants were children — saw a reduction in the life-threatening metabolic emergencies that can crop up with the disease.
    • “And while most patients reported such side effects as fever and vomiting, they broadly wanted to stay on the drug even after the trial period wrapped up, according to the study, published in the journal Nature.”

From the U.S. healthcare business front,

  • American Hospital Association News informs us,
    • “Almost half of rural hospitals had negative total margins in 2022 and negative patient care margins both before and after the COVID-19 pandemic, according to a report prepared for the AHA by faculty at the Virginia Commonwealth University College of Health Professions. When provider relief funds are excluded from margins, the average total margin for rural hospitals was lower in 2022, the most recent year with data available, than in any year since 2017.” 
  • Mercer Consulting looks at the performance of exclusive provider organizations.
    • “We’re seeing growing adoption of network configurations that differ from the traditional broad PPO network. This might mean eliminating out-of-network benefits, offering a plan with a narrow network of high-performing providers, or both. According to our Survey on Health and Benefit Strategies for 2024, 24% of large employers (those with 500 or more employees) now offer a medical plan option with a High-Performance Network curated by a carrier. Most often, these are plans offered by a national carrier in which the providers are a subset of the carrier’s larger Preferred Provider Organization network and are selected based on quality and cost metrics. A few independent provider networks (for example, Centivo and Imagine Health) have gained some traction as well. The largest employers are moving the fastest – 38% of companies with 20,000 or more employees offer some type of high-performance network.” 
  • Healthcare Dive reports,
    • “Walmart is pushing back expansion plans for its health center superstores, as retail giants struggle to right-size their primary care networks.
    • “The company plans to open 22 health centers this year, according to a Walmart spokesperson. Previously, the retail giant said it would open more than 30 locations in 2024.
    • “Walmart plans to open 18 centers in Texas and another four in the Kansas City metro area, the spokesperson said. The clinic openings will start this month in Houston, and run throughout the fall.”
  • According to BioPharma Dive,
    • “Amylyx Pharmaceuticals is pulling from market one of the few approved treatments for ALS.
    • “Rarely do drugmakers voluntarily withdraw products. In Amylyx’s case, the decision comes just weeks after a large clinical trial meant to confirm the benefits of its medicine instead found it no better than a placebo at slowing the fatal, nerve-destroying disease.
    • “Starting Thursday, the medicine, which is sold as Relyvrio in the U.S. and Albrioza in Canada, will no longer be available for new patients. Those who are taking it and wish to continue may enter a free drug program. Additionally, a phase of that large trial that allows participants to continue on Relyvrio remains ongoing.”
  • MedTech Dive points out,
    • “The Food and Drug Administration granted de novo clearance to an AI tool to help clinicians predict and diagnose sepsis, the first time the agency has authorized such a tool.
    • “The Sepsis Immunoscore software, developed by Chicago-based Prenosis, provides a risk score for clinicians on a patient having or developing sepsis within 24 hours. The score is based on 22 parameters, including respiratory rate, blood pressure and white blood cell count. 
    • “Hospitals already use early sepsis detection tools, despite lacking FDA review. The agency clarified in a final guidance in 2022 that clinical decision support software that provides a risk score or probability of a condition should be regulated as a medical device.”

Midweek Update

David Ermer–CDC, CMS, FDA, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The President, joined by Sen. Bernie Sanders (I Vt) made remarks on the success of their efforts to lower the cost of medicine inhalers.
  • MedPage today tells us that the CDC Director, Dr. Mandy Cohen, spoke at the World Vaccine Congress.
    • “Although the risk to humans is very low, the case of the Texas farmworker apparently contracting pathogenic avian influenza A (H5N1) from a cow illustrates the importance of data collection, CDC Director Mandy Cohen, MD, MPH, said Tuesday.
    • “We need to continue to invest in data, in lab capacity, in our ability to respond to health threats, and we need a talented workforce,” Cohen said here at the World Vaccine Congress. In the realm of modernizing data collection, she added, “We cannot solve problems we don’t see.”
  • The Washington Post adds,
    • “Officials have said the risk to human health remains low. But the CDC has warned that people with unprotected exposure to infected birds or other animals, including livestock, are at greater risk of infection.
    • “People should also avoid uncooked or undercooked food, unpasteurized milk and raw cheese, according to the CDC. Cooking eggs or poultry to an internal temperature of about 165 degrees Fahrenheit generally “kills bacteria and viruses, including bird flu viruses,” it says. Backyard chickens or pet chickens are at risk if they come in contact with wild birds carrying the virus.
    • “Human symptoms of bird flu include eye redness, fever, coughing, sore throat, muscle or body aches, headaches, fatigue, shortness of breath or difficulty breathing. Diarrhea, nausea, vomiting or seizures are less common, the CDC said.”
  • Per an FDA press release,
    • Today, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP).
    • “The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in the FDA’s Center for Drug Evaluation and Research. “The FDA will continue our important work in this area as part of our efforts to protect the public health.”
  • Per a National Safety Council press release,
    • Driving is the leading cause of work-related death each year in the United States, with nearly 40% of deaths on the job occurring on American roads according to the U.S. Bureau of Labor Statistics. A major contributing factor to road deaths each year, including work-related fatalities, is distracted driving, which takes thousands of lives on the country’s roads annually and leaves even more people seriously injured. 
    • To address this heartbreaking reality and the need for key stakeholders to come together on these intersecting safety topics, the Occupational Safety and Health Administrationand the National Safety Council are convening a panel discussion on the critical role employers play in roadway safety, Roadway Safety is Workplace Safety: The Need to Eliminate Distracted Driving, on April 10 during Distracted Driving Awareness Month.  * * *
    • The event takes place at the U.S. Department of Labor at 2:30 p.m. (ET) April 10. It is open to the public. Register to attend in person or virtually.

From the public health and medical research front,

  • The New York Times reports,
    • “The first patient to receive a kidney transplanted from a genetically modified pig has fared so well that he was discharged from the hospital on Wednesday, just two weeks after the groundbreaking surgery.
    • “The transplant and its encouraging outcome represent a remarkable moment in medicine, scientists say, possibly heralding an era of cross-species organ transplantation [or xenotransplant].
    • “Two previous organ transplants from genetically modified pigs failed. Both patients received hearts, and both died a few weeks later. In one patient, there were signs that the immune system had rejected the organ, a constant risk.
    • “But the kidney transplanted into Richard Slayman, 62, is producing urine, removing waste products from the blood, balancing the body’s fluids and carrying out other key functions, according to his doctors at Massachusetts General Hospital. * * *
    • “Whether Mr. Slayman’s body will eventually reject the transplanted organ is still unknown, Dr. Klassen noted. And there are other hurdles: A successful operation would have to be replicated in numerous patients and studied in clinical trials before xenotransplants become widely available.”
  • Health Day lets us know,
    • “Research offers a new reason to avoid vaping: It may raise your heart failure risk
    • “People who vaped had a 19% higher odds for the debilitating disease
    • “The risk held even after accounting for other heart risk factors or substance use.”
  • Medscape tells us,
    • “Nontraditional risk factors such as migraine and autoimmune diseases have a significantly greater effect on stroke risk in young adults than traditional risk factors such as hypertension, high cholesterol, and tobacco use, new research showed.
    • “The findings may offer insight into the increased incidence of stroke in adults under age 45, which has more than doubled in the past 20 years in high-income countries, while incidence in those over 45 has decreased.
    • “Investigators believe the findings are important because most conventional prevention efforts focus on traditional risk factors.
    • “The younger they are at the time of stroke, the more likely their stroke is due to a nontraditional risk factor,” lead author Michelle Leppert, MD, an assistant professor of neurology at the University of Colorado School of Medicine, Aurora, Colorado, said in a news release.
    • “The findings were published online on March 26, 2024, in Circulation: Cardiovascular Quality and Outcomes.”

From the U.S. healthcare business front,

  • MedCity News highlights health plan industry association concerns about Monday’s Medicare Advantage rate announcement.
  • Per Biopharma Dive,
    • “Genmab said Wednesday it’s agreed to pay $1.8 billion for ProfoundBio, gaining access to the biotechnology startup’s technology for developing antibody-drug conjugates, or ADCs.
    • “ProfoundBio’s portfolio includes Rina-S, a newer type of ADC it claims to be a potentially best-in-class medicine. The drug is designed to target tumors that express a protein called folate receptor alpha and is currently in Phase 2 testing for ovarian cancer and certain other types of solid tumors. 
    • “The all-cash transaction is expected to close by the end of June. The Danish drugmaker said the purchase will result in extra expenses this year as the company takes on responsibility for developing Rina-S and other ProfoundBio experimental medicines. It expects to update investors on its financial outlook upon releasing second-quarter earnings.”
  • MedPage Today informs us,
    • “More than $12 billion in payments were made from industry to physicians from 2013 to 2022, an analysis of payment data showed.
    • “Over this time period, 85,087,744 payments with a total value of $12.13 billion were made by industry to 826,313 physicians, with 93.8% of these payments associated with one or more marketed medical products, reported Andrew Foy, MD, of the Penn State Milton S. Hershey Medical Center in Hershey, Pennsylvania, and colleagues in a JAMAopens in a new tab or window research letter. * * *
    • “The top three drugs related to industry payments in the U.S. during the study period were rivaroxaban (Xarelto), apixaban (Eliquis), and adalimumab (Humira), with $176.34 million, $102.62 million, and $100.17 million in associated payments, respectively. The top medical devices related to industry payments were the da Vinci Surgical System, Mako SmartRobotics, and CoreValve Evolut, with $307.52 million, $50.13 million, and $44.79 million in associated payments, respectively.
    • “Top-paid specialties included orthopedic surgery, which received a total of $1.36 billion, neurology and psychiatry at $1.32 billion, and cardiology at $1.29 billion. Pediatric surgery and trauma surgery received the lowest sum of payments.
    • “Within each specialty, payments to the median physician ranged from $0 to $2,339, while the mean amount paid to the top 0.1% of physicians ranged from $194,933 for hospitalists to $4,826,944 for orthopedic surgeons. * * *
    • “The Physician Payments Sunshine Act established OpenPayments, a national repository of industry payments to physicians run by the Centers for Medicare & Medicaid Services.”
  • Per Fierce Healthcare,
    • “CVS Health is aiming to bolster the pharmacy workforce with new scholarship and tuition assistance programs for people looking to enter the field.
    • “The company’s new PharmD assistance program will be available to all graduates who intern with CVS as of April 30, according to an announcement, and they’re eligible to apply for an award of up to $20,000 applicable to their final year of tuition. 
    • “CVS said it plans to grow the program in the fall and will make it available to interns in their last two years of pharmacy training, offering up to $20,000 toward each of those years while they intern for the company. The program will also provide participants opportunities throughout the year to “obtain valuable experience before starting their post-graduate professional career in pharmacy,” CVS said.”

Tuesday Tidbits

David Ermer–ACA, CMS, FDA, Generative AI, Medical / Rx research, Obesity, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Per HHS press releases
    • Today, the Biden-Harris Administration, through the U.S. Department of Health and Human Services (HHS)’s Centers for Medicare & Medicaid Services (CMS), announced policies for the Affordable Care Act Marketplaces that make it easier for low-income people to enroll in coverage, provides states the ability to increase access to routine adult dental services, and sets network adequacy standards for the time and distance people travel for appointments with in-network providers. Finally, the rule will standardize certain operations across the Marketplaces to increase reliability and consistency for consumers. The 2025 [ACA] Notice of Benefit and Payment Parameters final rule builds on the Administration’s previous work expanding access to quality, affordable health care and raising standards for Marketplace plans nationwide.
  • and
    • Today, the U.S. Department of Health and Human Services’ (HHS) Office of the Assistant Secretary for Planning and Evaluation (ASPE) released new research showing how key Inflation Reduction Act provisions will lower costs for women enrolled in Medicare, including nearly 30 million women enrolled in Part D. Also, today, HHS announced that the Centers for Medicare & Medicaid Services (CMS) responded to counteroffers from all manufacturers participating in Medicare drug price negotiations – which the Inflation Reduction Act made possible – and invited them to participate in further discussions.
  • and
    • Today, the U.S. Department of Health and Human Services (HHS) released a white paper highlighting steps HHS has taken to prevent and mitigate drug shortages and proposing additional solutions for policymakers to consider. Drug shortages have occurred in the nation’s health care system for several decades, largely due to market failures and misaligned incentives. With today’s white paper, HHS offers solutions and stands ready to work with Congress to ensure no patient faces the devastating consequences of drug shortages or goes without needed medicines.
  • With respect to the 2025 Notice of Benefit and Payment Parameters, here is a link to the CMS fact sheet and a related ACA FAQ 66.
    • “FAQ 66 puts large group market plans (all FEHB plans are large market plans) and self funder ERISA plans on notice that the regulators will be subjecting these plans and the small group and individual market plans to a new rule applying the prohibition against lifetime and annual dollar limits to prescription drugs classified as essential health benefits.  
    • “Under the law, large group market and self funded ERISA plans must select a state benchmark to apply this limit to essential health benefits other than prescription drugs. For 2025, the EHB prescription drugs also must be considered.” 
  • CMS posted the Final 2025 Actuarial Value Calculator Methodology.
  • CMS also issued an update to its Section 111 Group Health Plan User Guide. The update seeks to prevent overlapping drug records.

From the public health and medical research front,

  • Health Affairs Forefront gives us access to “The CMS Innovation Center’s Strategy To Support Person-Centered, Value-Based Specialty Care: 2024 Update.”
  • STAT News reports,
    • “An AI algorithm to detect heart failure, embedded in a digital stethoscope, earned clearance from the Food and Drug Administration on Tuesday. The goal is to help primary care doctors more easily identify the often-hidden condition.
    • “The stethoscope is the result of a collaboration between Mayo Clinic researchers, who built the algorithm, and the startup Eko Health, which built the hardware. Mayo Clinic is an investor in Eko, which has raised $128 million over the past six years. Eko’s stethoscopes currently use two predictive AI algorithms: one for atrial fibrillation and one for structural heart murmur. The difference with heart failure, though, is how much more difficult it is for doctors to catch. 
    • Nearly 6.5 million Americans have heart failure, meaning their hearts are unable to pump blood properly. The illness is typically visible via heart ultrasounds, or echocardiograms, but these tests are expensive. Catching the condition early and non-invasively at a primary care checkup could save lives. 
    • “We’re moving from what’s human visible to what’s almost human invisible,” said Connor Landgraf, CEO of Eko Health. “The signals that we’re identifying in the heart sounds in an ECG are so subtle that humans wouldn’t even be able to pick them up.”
  • Beckers Hospital Review tells us,
    • “Among nearly 1 million patients who underwent upper or lower endoscopy procedures, those prescribed GLP-1s, such as Ozempic or Wegovy, were 33% more likely to experience aspiration pneumonia than other patients. 
    • “This finding was detailed in a study conducted by researchers at Los Angeles-based Cedars-Sinai. The risk of GLP-1 patients aspirating and regurgitating under anesthesia was first addressed in June 2023, when the American Society of Anesthesiologists recommended halting a patient’s last dose before an elective surgery. 
    • “The recommendation was based on anecdotal evidence at the time, and physicians across the U.S. soon implemented new perioperative workflows. Now, data from January 2018 through December 2020 shows an association between GLP-1 use and aspiration pneumonia, or pneumonia caused by foreign objects entering the lungs, according to a Cedars-Sinai news release.
    • “The researchers considered other variables that could affect surgery outcomes, the release said. Results were published March 27 in Gastroenterology.”
  • MedPage Today lets us know,
    • “A few simple interventions boosted flu vaccine uptake for patients waiting at the emergency department [ED], according to the cluster-randomized, controlled PROFLUVAXED trial.
    • “People in ED waiting areas who consented to view a 3-minute video with a scripted message, read a one-page flyer, and have a short discussion with an ED clinician about the flu vaccine had a 30-day follow-up vaccination rate of 41% versus 15% among patients that received no messaging about the vaccine.
    • “Even just asking people in the ED “Would you accept the influenza vaccine in the emergency department today if your doctor asked you to get it?” resulted in a 30-day vaccination rate of 32%, Robert Rodriguez, MD, of the University of California San Francisco, and colleagues reported in NEJM Evidence.”
  • The Washington Post and Consumer Reports discuss “What to know about 6 important blood tests for your health.”

From the U.S. healthcare business front,

  • Fierce Healthcare informs us,
    • “Kaiser Permanente’s Risant Health has closed its acquisition of Geisinger Health, notching the first step on its ambitious plan to form a multisystem, multiregional value-based care organization.
    • “Oakland, California-based Kaiser Permanente announced the deal alongside the formation of Risant Health and its broader strategy nearly a year ago. The acquisition has been approved by state and federal regulatory agencies and closed March 31, Kaiser Permanente said in a Tuesday release.
    • “Danville, Pennsylvania-based Geisinger, which runs 10 hospitals, was highlighted as an ideal inaugural partner for the budding value-based care platform due to the system’s experience running a roughly 600,000-member health plan.
    • “Through Risant Health, we will leverage our industry-leading expertise and innovation to increase the country’s access to high-quality and evidence-based health care, which we know improves care quality and the patient and member experience,” Kaiser Permanente CEO Greg A. Adams, who is also the board chair of Risant Health, said in Tuesday’s announcement. “We will also learn and benefit from Geisinger and the additional health systems that become part of Risant Health in the future, to help them grow in new ways, be more affordable and bring value-based care to more people.”
    • “Jaewon Ryu, M.D., Geisinger’s president and CEO since 2019, is now stepping into the role of Risant Health CEO, according to the announcement. Terry Gilliland, M.D., will fill Ryu’s post at Geisinger once the transition is complete.”
  • and
    • “Intermountain Health shuttered Saltzer Health, a multispecialty group the system acquired less than four years ago, after it failed to find a buyer for the provider.
    • “Based in southwest Idaho, Saltzer Health had been one of the state’s oldest and largest primary care groups. in operation for 63 years, the company had 450 employees and clinicians spread across 11 locations.” 
  • Per Biopharma Dive,
    • “Abbott said Tuesday it received the Food and Drug Administration’s approval to market a transcatheter device for repairing the tricuspid valve in patients who are unable to withstand open-heart surgery.
    • “The go-ahead from the FDA paves the way for Abbott’s Triclip repair system to compete in the U.S. against Edwards Lifesciences’ recently approved transcatheter tricuspid valve replacement device, Evoque.
    • “Triclip uses the same clip-based technology to treat tricuspid regurgitation as Abbott’s Mitraclip for mitral valve regurgitation, a device the company has credited with driving double-digit growth in its structural heart business.”
  • USA Today reports,
    • “Costco and its low-cost health care partner are expanding into weight-loss management.
    • “Costco will begin offering its members in the U.S. access to a weight loss program through Sesame, a health care marketplace, Sesame exclusively told USA TODAY. The service, which will cost $179 every three months, is scheduled to become available April 2.”
  • Medical Economist notes,
    • “Data exchange, or interoperability, among electronic health records (EHRs) is getting easier but still has a long way to go before primary care doctors are completely satisfied with it, a new study concludes. * * *
    • “Broken down by information type, the highest level of satisfaction—34%– was ability to receive lab reports from external organizations. The lowest level—21%—was for information on preventive care. Overall, 11% said they were not at all satisfied with at least half the information types they received, about 25% reported they were very satisfied with at least half the information types and 11% were very satisfied with all the information types.
    • “Fewer than one in ten (8%) said information from EHR developers different from their own was very easy to use, compared with 38% who said data from the same EHR developer was very easy to use.
    • “The authors say their findings highlight the need for different initiatives to improve interoperability depending on the challenges faced by different physician populations. For example, physicians serving vulnerable populations said they often lack the resources to address patients’ social needs, and thus could benefit from initiatives making it easier for them to join an exchange network.”
    • “Taken together,” they conclude, “these data suggest a need for diverse and targeted approaches to complete progress toward universal, high-value interoperability.”