Monday Roundup

OPM

Monday Roundup

David Ermer–FDA, Federal employment benefits, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • OPM has finalized a rule
    • “to expand eligibility for enrollment in the Federal Employees Dental and Vision Insurance Program (FEDVIP) to additional categories of Federal employees and certain Postal employees. This rule also updates the provisions on enrollment for active duty service members who become eligible for FEDVIP as uniformed service retirees pursuant to the National Defense Authorization Act of 2017 (fiscal year 2017 (FY17) NDAA). In addition, this rule adds exceptions to decrease an enrollment type and to cancel an enrollment for certain enrollees who may become eligible for dental and/or vision services from the Department of Veterans Affairs (VA).” 
  • Per Medscape, the Food and Drug Administration
    • “today approved quizartinib (Vanflyta) for adults with acute myeloid leukemia (AML) that carries the FLT3-ITD genetic mutation.
    • “The FDA also approved the LeukoStrat CDx FLT3 Mutation Assay to determine whether patients have this mutation.
    • “The agency granted quizartinib a first-line indication for use in combination with standard chemotherapy — cytarabine and anthracycline induction followed by cytarabine consolidation — and as maintenance monotherapy afterward, in adults whose tumors express FLT3-ITD.” * * *
    • “In a company press release, the drug’s manufacturer Daiichi Sankyo said quizartinib will be available in the US soon.”
  • Per Fierce Healthcare, the Federal Trade Commission expanded its war on prescription benefit managers by withdrawing earlier guidance that protected PBMs.

Speaking of war, STAT News reports

  • “A new lawsuit accuses Cigna of using an algorithm to automatically deny claims in bulk instead of individually reviewing each case, putting patients on the hook for bills the health insurer otherwise would have paid.
  • “The complaint filed Monday in the Eastern District of California says Cigna uses a system called PXDX to identify discrepancies between diagnoses and the tests and services it covers for those ailments. The company then allegedly denies claims in bulk without looking into each coverage request. California law requires insurers to give each claim a “thorough, fair, and objective investigation.”

For the past twenty years, health claims have been submitted and processed electronically. This is nothing new. The article adds that Cigna plans to mount a defense. The FEHBlog trusts that the court will see the light.

From the public health front,

  • MedPage Today tells us
    • “The prevalence of hepatitis C virus (HCV) infections in pregnant women increased 16-fold over a 21-year period, with associated higher risks of adverse perinatal outcomes, according to a cross-sectional study.
    • “Among more than 70 million hospital admissions for childbirth or spontaneous abortion in the U.S. from 1998 through 2018, the prevalence of HCV-positive pregnancies increased from 0.34 (95% CI 0.26-0.41) cases per 1,000 pregnancies to 5.3 (95% CI 4.9-5.7) cases per 1,000 pregnancies, reported Po-Hung (Victor) Chen, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues in JAMA Network Open. * * *
    • “Overall, our data support the recommendations for universal HCV screening with each pregnancy proposed by the Centers for Disease Control and Prevention and American College of Obstetricians and Gynecologists,” Chen and team wrote. “Perinatal care and delivery may be the initial healthcare exposure for many women. These touchpoints represent an opportunity for health care professionals to identify HCV infection and link women and their children to appropriate specialist care.”

In medical and drug research news

  • The National Institutes of Health announced,
    • “Statins, a class of cholesterol-lowering medications, may offset the high risk of cardiovascular disease in people living with HIV by more than a third, potentially preventing one in five major cardiovascular events or premature deaths in this population. People living with HIV can have a 50-100% increased risk for cardiovascular disease. The findings are published in the New England Journal of Medicine.
    • “This research suggests that statins may provide an accessible, cost-effective measure to improve the cardiovascular health and quality of life for people living with HIV,” said Gary H. Gibbons, M.D., director of the National Heart, Lung, and Blood Institute (NHLBI), a study funder. “Additional research can further expand on this effect while providing a roadmap to rapidly translate research findings into clinical practice.”
  • BioPharma Dive reports
    • “Roche will partner with Alnylam Pharmaceuticals to study a promising new treatment for high blood pressure, becoming the latest large drugmaker to commit in a big way to the often lengthy and expensive process of developing new medicines for the heart. 
    • “Through a deal announced Monday, Roche will pay Alnylam more than $300 million upfront to share rights to the experimental treatment, called zilebesiran. The Swiss pharmaceutical company will also fund the majority of the costs for a large clinical trial to test whether zilebesiran can lower the risk of dangerous cardiovascular events like heart attacks and strokes. 
    • “With this collaboration, we now can develop zilebesiran in a more robust way, allowing us to have cardiovascular outcomes data in hand at launch to ensure results relevant not only for health authorities but also for access and clinical practice in order to ultimately reach as many patients as possible,” Alnylam CEO Yvonne Greenstreet said in a statement.” 
  • BioPharma Dive adds
    • “Gilead Sciences has stopped a closely watched trial involving an experimental cancer drug the company acquired three years ago in a roughly $5 billion deal, marking the latest setback in the company’s plans to grow its oncology business.
    • “According to Gilead, a Phase 3 study testing its drug magrolimab in patients with the bone marrow cancer myelodysplastic syndrome, or MDS, was discontinued because treatment proved ineffective at an interim analysis. Safety findings were “consistent” with the drug’s profile and what’s typically observed with MDS patients, the company said late Friday. It didn’t provide details.
    • “Gilead acquired magrolimab through a buyout of biotechnology company Forty Seven. The drug is still being evaluated in two other pivotal trials in acute myeloid leukemia, with results expected next year. However, after Friday’s announcement, Wall Street analysts appear to be viewing those trials with more skepticism.”

From the U.S. healthcare business front —

  • MedCity News points out that “When asked what the key issues influencing benefits strategy are, 80% of employers said competition for talent, 67% said rising costs, 41% said a focus on inclusion and diversity and 39% said increasing mental health problems, according to a recent Willis Towers Watson survey.”
  • Fierce Healthcare relates
    • “While payers are facing headwinds going into the latter part of this year, the ongoing financial impacts of healthcare’s labor shortage will be felt in the hospital sector far longer, according to a new report from analysts at Moody’s Investors Service.
    • “The “acute” impacts of labor issues have tapered off, according to the report, but “the budgetary aftershocks will reverberate for years to come.” The analysts expect that the labor issues will pull down hospitals’ operating results through 2024, if not longer.
    • “For example, though conditions have improved, the industry’s nursing shortage is expected to extend through 2030, according to projections from the Bureau of Labor Statistics. This will force hospitals and other providers to develop and roll out new strategies that blunt the impacts, the Moody’s analysts said.
    • “Hospitals are benefiting from some expense relief as staffing has become easier and the need to use pricey contract labor has decreased,” the analysts wrote in the report. “But it will take time for improved margins to follow, and labor issues will remain an underlying sector challenge.”

Friday Factoids

David Ermer–Generative AI, HIPAA Privacy and Security Rules, HSA, OPM, Patient safety, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • Govexec tells us, “The Office of Personnel Management on Friday proposed new regulations aimed at granting federal agencies greater flexibility in selecting new federal employees during the hiring process.” The public comment deadline is September 19, 2023.
  • Federal News Network offers a table of federal government return-to-office policies.
  • The Society for Human Resource Management informs us,
    • “The U.S. Citizenship and Immigration Services (USCIS) announced Friday a new Form I-9—which has been streamlined and shortened—that employers should use beginning Aug. 1, 2023.
    • “Employers may continue to use the older Form I-9 (Rev. 10/21/19)  through Oct. 31., 2023. After that date, they will be subject to penalties if they use the older form. The new version will not be available for downloading until Aug. 1.  
    • “Additionally, the U.S. Department of Homeland Security (DHS) issued a final rule that allows the agency to create a framework under which employers could implement alternative document examination procedures, such as remote document examination. The new form subsequently has a checkbox to indicate when an employee’s Form I-9 documentation was examined using a DHS-authorized alternative procedure.
    • “At this time, the final rule only allows employers using E-Verify to use alternative verification methods.”
  • Healthcare Dive notes
    • “The Federal Trade Commission and the HHS’ Office for Civil Rights are warning hospitals and telehealth companies about embedding online tracking technologies on their websites or apps, saying the trackers risk exposing consumers’ personal health data to third parties. 
    • “The trackers, like the Meta Pixel or Google Analytics, collect identifiable information about users and could reveal information about health conditions, diagnoses, treatments, frequency of visits and more, the agencies wrote in a letter to about 130 health systems and telehealth providers.
    • “The warning marks the latest move from regulators regarding the healthcare industry’s use of tracking technologies, which monitor user behavior on websites. Sharing consumers’ health data with third parties, like advertisers, has been a recent target of FTC oversight.”

Following up on the tornado that struck a Pfizer factory in Rocky Mount, NC, STAT News reports

  • “Pfizer says a tornado that ripped through a key manufacturing plant in North Carolina does not appear to have caused “any major damage” to areas that produce medicines.
  • “The company reported most damage from the storm occurred at a warehouse that stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance personnel. As a result, it remains unclear about the extent to which destruction at the facility — which produces nearly 8% of all sterile injectables used in U.S. hospitals — will exacerbate a growing shortage of prescription drugs across the country.”

The Food and Drug Administration also issued a report on the incident.

From the medical malpractice front, STAT News points out

  • “A new study published this week in BMJ, * * * estimates that “371,000 people die every year following a misdiagnosis, and 424,000 are permanently disabled — a total of 800,000 people suffering “serious harm,” said David Newman-Toker, the lead author of the paper and a professor of neurology at Johns Hopkins School of Medicine and director of its Center for Diagnostic Excellence. Settling on an exact number is hard because many cases of misdiagnosis go undetected, he said. It could be fewer than his study identified or more — between half a million and a million — though in any event, it would be the most common cause of death or disability due to medical malpractice. 
  • “He likens the issue of misdiagnosis to an iceberg, saying cases leading to death and disability are but a small fraction of the problem. “We focused here on the serious harms, but the number of diagnostic errors that happen out there in the U.S. each year is probably somewhere on the order of magnitude of 50 to 100 million,” he said. “If you actually look, you see it’s happening all the time.” 
  • “But misdiagnoses typically don’t lead to severe consequences because, most times, people aren’t visiting the doctor with a serious condition. “The risk level just walking through the door in the doctor’s office that something horrible is going to happen to you because of a diagnostic error is actually quite low,” said Newman-Toker.”

In related news “[The American Hospital Association] AHA today released its quarterly Health Care Plan Accountability Update, featuring the latest news on AHA efforts to hold commercial health insurers accountable for policies that can delay care for patients, burden health care providers and add unnecessary costs to the health care system. READ MORE.”

From the factoid front —

  • HealthEquity suggests three ways to drive health savings account plan adoption.
  • Beckers Payer Issues points out how seven payers are using artificial intelligence.
  • MedTech Dive reports, “Intuitive Surgical posted strong robotic volume growth in the second quarter and raised its full-year procedure outlook but said patient interest in new weight-loss drugs is curbing demand for bariatric surgeries.”

Midweek Update

David Ermer–Congress, COVID-19, FDA, OPM, U.S. Healthcare–

From Washington, DC,

  • Fedweek compares the House and Senate versions of the appropriations bill that funds OPM and the FEHBP.
  • The Federal Times reports,
    • “Reproductive health advocacy groups and Democratic lawmakers are pressing the Office of Personnel Management on why some insurers offer fewer infertility treatments than they’re required to in federal employee health plans.
    • “In a letter to OPM Director Kiran Ahuja obtained by Federal Times, Rep. Gerry Connolly (D-Va.) and Sen. Tammy Duckworth (D-Ill.) said certain providers under the Federal Employee Benefits Program — which serves 8 million beneficiaries — are denying coverage of standard fertility preservation treatments. * * *
    • “For the 2023 plan year, OPM announced it was requiring all FEHB carriers to “provide coverage for standard fertility preservation procedures for … iatrogenic infertility.” Per KFF, “Iatrogenic, or medically induced, infertility refers to when a person becomes infertile due to a medical procedure done to treat another problem, most often chemotherapy or radiation for cancer.”
  • The Federal Times article contends that FEHB plans are not fully compliant with this mandate. OPM has created a process for members to ask for OPM review of claim decisions (following internal plan reconsideration). This process can work out any compliance kinks.
  • InsiderNJ adds,
    • “Today, U.S. Senator Cory Booker (D-NJ) and U.S. Representative Rosa DeLauro (D-CT) reintroduced the bicameral Access to Infertility Treatment and Care Act, legislation that would require more health insurers to provide coverage for infertility treatment, as well as fertility preservation services for individuals who undergo medically necessary procedures that may cause infertility, such as chemotherapy. * * *
    • “The full text of the bill can be found here.”
  • AHA News informs us,
    • “The Federal Trade Commission and Department of Justice July 19 released for comment through Sept. 18 updated guidance describing how the agencies review mergers and acquisitions to determine compliance with federal antitrust laws. The agencies said the document outlines 13 principles they may use when determining whether a merger is unlawfully anticompetitive and clarifies the frameworks and tools they may use when analyzing a merger with respect to each guideline. 
    • “FTC and DOJ initiated the update with a request for public input in January 2022, and plan to use the comments to update the draft before finalizing the guidelines. For more on the draft guidelines, see the agencies’ fact sheet. AHA intends to submit comments on the proposed guidelines.”
  • Washington Technology tells us,
    • “Maximus is locked in a protest fight after the U.S. Postal Service chose Deloitte Consulting for a $175 million contract to the consulting firm to build a new health benefits system.
    • “By 2025, USPS plans to move that new system for delivering health insurance benefits to its employees. USPS tasked Deloitte Consulting to build the system that would include enrollment processing, eligibility determinations, data analytics and other features, according to solicitation documents on GovTribe.
    • “Maximus filed a protest with the Government Accountability Office on Tuesday to challenge the award. The Office of Personnel Management is managing the contract on behalf of the Postal Service. * * *
    • “A decision from GAO is due Oct. 26.”
  • Cardiovascular Business points out that “The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling nearly 350,000 implantable cardiac devices due to continued issues with their ability to deliver high voltage therapy when necessary.”

From the public health front –

  • The Wall Street Journal reports,
    • “You might know a Covid-19 super-dodger who was infected with the virus but didn’t get sick. Their luck could be written in their genes. 
    • “A DNA variation that affects the immune system can boost a person’s odds of avoiding Covid-19 symptoms, a study found. The work, published Wednesday in the journal Nature, helps explain why some people infected with the virus that causes Covid-19 don’t fall ill. 
    • “The T cells of some people with the variation can find and kill the virus without having seen it before, researchers said. That is because the part of the virus their T cells home in on is similar enough to common coronaviruses they have already encountered.  
    • “There are people out there that have got strong prior immunity from their common coronavirus exposures,” said Danny Altmann, a professor of immunology at Imperial College London, who wasn’t involved in the study. The work could help researchers design better vaccines, Altmann said.” 
  • STAT News relates,
    • “Cancer drugs can burn through tumors like wildfire, killing off the vast majority of malignant cells. But a few stubborn cells often end up surviving, seeding a recurrence of the disease. The prevailing theory behind this drug resistance is built on natural selection: Among the vast and genetically diverse population of cancer cells in a tumor, some have random mutations that help these cells survive an onslaught.
    • “But this is not the full picture,” said Yogesh Goyal, a cancer researcher at Northwestern University. Goyal and his colleagues at the University of Pennsylvania demonstrated in a series of experiments that cancer cells can survive treatments just by having certain genes turned on, even if they were nearly genetically identical to cancer cells that died but had activated different genes.
    • “We think this work stands to really change how we think about therapy resistance,” said Arjun Raj, the study’s co-senior author and a bioengineer at the University of Pennsylvania.
    • “In other words, mutations alone cannot fully explain resistance to cancer therapy. Instead, researchers may need to look more closely at the assemblage of genes turned on or off at any given time in a cancer cell — what scientists call the cell’s transcriptional profile — to better understand whether it will respond to a certain drug, Goyal said.”

From the U.S. healthcare business front —

  • Healthcare Dive lets us know
    • “Elevance’s second-quarter earnings alleviated recent cost trend and utilization concerns, as the health insurer reported lower medical spending than analysts expected.
    • “The payer beat Wall Street expectations for the quarter with revenue of $43.7 billion, up 13% year over year, and profit of $1.9 billion, up 14% year over year. * * *
    • “Elevance reported a medical loss ratio of 86.4%, down 70 basis points year over year due to premium rate adjustments reflecting the post-pandemic cost of care, CFO John Gallina told investors on a Wednesday morning call.”
  • Fierce Healthcare informs us,
    • “Amar Desai, M.D., wrote in a post on LinkedIn Wednesday that he is “thrilled” to come back to the UnitedHealth Group subsidiary as the CEO of Optum Health. Desai previously spent several years in leadership roles at Optum before taking the role of president of healthcare delivery at rival CVS Health.
    • “Desai is also an associate clinical professor of medicine at the Keck School of Medicine at the University of Southern California. He previously served as president of HealthCare Partners, which was acquired in 2019 by UHG as part of DaVita Medical Group.”
  • The Society for Human Resource Management reports
    • “U.S. organizations are budgeting an average increase of 4 percent in 2024, according to consulting firm WTW, which surveyed more than 2,000 U.S. organizations for its Salary Budget Planning Survey. That number is down from the actual increase of 4.4 percent in 2023, and the 4.2 percent increase in 2022, but the projected 2024 figures remain higher than the 3.1 percent salary increase budget in 2021 as well as other increases in pre-pandemic years.”

Midweek Update

David Ermer–Congress, FDA, OPM, Rx coverage, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC —

  • Federal News Network tells us
    • “Almost 33,000 federal civilian employees are a step closer to a bigger pay raise in 2024 after the Office of Personnel Management published a proposal to establish four new locality pay areas for the General Schedule.
    • “OPM’s proposed rule, added to the Federal Register Wednesday, comes after the President’s Pay Agent in December approved recommendations from the Federal Salary Council to establish the four new locality pay areas.
    • “The four new proposed locality pay areas are:
      • Fresno-Madera-Hanford, California
      • Reno-Fernley, Nevada
      • Rochester-Batavia-Seneca Falls, New York
      • Spokane-Spokane Valley-Coeur d’Alene, Washington-Idaho.”
  • The Congressional Budget Office released its 2023 Long-Term Budget Outlook. In short,
    • “The U.S. faces a challenging fiscal outlook in the coming years, according to CBO’s projections. Measured as a percentage of GDP, large and sustained deficits lead to high and rising federal debt that exceeds any previously recorded level.”
  • Roll Call adds
    • “This month’s law suspending the debt ceiling and capping appropriations has lowered projected spending, deficits and debt over the long haul, the Congressional Budget Office said in its latest long-term budget outlook.
    • Compared to the agency’s report issued last year, overall spending and deficits are higher over the next several years in the updated forecast released Wednesday. But in part because of the spending caps in the debt limit law, estimated spending in the latter part of the 30-year projection period will be lower than the agency estimated last summer.”
  • The Justice Department announced,
    • “The Justice Department, together with federal and state law enforcement partners, announced today a strategically coordinated, two-week nationwide law enforcement action that resulted in criminal charges against 78 defendants for their alleged participation in health care fraud and opioid abuse schemes that included over $2.5 billion in alleged fraud.
    • “The defendants allegedly defrauded programs entrusted for the care of the elderly and disabled, and, in some cases, used the proceeds of the schemes to purchase luxury items, including exotic automobiles, jewelry, and yachts. In connection with the enforcement action, the Department seized or restrained millions of dollars in cash, automobiles, and real estate.  * * *
    • “Health care fraud is a complex and ever-evolving threat that negatively impacts the American people,” said Assistant Director Luis Quesada of the FBI’s Criminal Investigative Division. “Today’s nationwide coordinated law enforcement action is a testament to the tenacity of the FBI and our partners, as well as our combined efforts to pursue anyone who conspires to exploit our health care system for financial gain.”

From the public health front —

  • Beckers Payer Issues informs us,
    • “UnitedHealthcare executives recently warned of rising healthcare utilization rates as they saw a higher-than-expected number of hip replacements, knee surgeries and other elective procedures. Analysts from UBS Group AG are suggesting that pickleball could be one factor driving the higher rate of injuries, Bloomberg reported June 26. “UnitedHealthcare executives recently warned of rising healthcare utilization rates as they saw a higher-than-expected number of hip replacements, knee surgeries and other elective procedures. Analysts from UBS Group AG are suggesting that pickleball could be one factor driving the higher rate of injuries, Bloomberg reported June 26. 
    • “The firm estimates that there could be between $250 million and $500 million in medical costs attributable to pickleball injuries this year, according to the report. Analysts said that the number of pickleball players is expected to grow by 150 percent this year  to 22.3 million. They estimate about a third of the core players who play at least eight times per year are older adults.   
    • “The analysts looked at two studies regarding pickleball injuries and concluded that players go to the emergency department at a rate of about 0.27 percent, with the majority of injuries occurring among those 60 and older, according to the report. The most common injuries are strains, sprains, and fractures. The wrist and lower legs are the most likely areas to be injured. “

From the Rx coverage front —

  • The Wall Street Journal features an article titled “Ozempic Can Make You Thin, Not Necessarily Healthy; Diet and exercise still matter when you take drugs for weight loss, and not only for the reasons you expect.”
    • “For those taking these drugs, exercise is still vital to keep your heart healthy and muscles strong. Exercise lowers your risk of cardiovascular disease, cancer, Type 2 diabetes and Alzheimer’s disease, according to scientific studies. And strength-training is especially important when you lose a lot of weight quickly.
    • “People taking these drugs to lose weight also need the right foods to provide nutrients, fuel their body and keep them healthy. This approach isn’t just about eating better. It’s about eating a specific diet tailored to these drugs. If you don’t, that could lead to health problems down the road or exacerbate side effects.” 
  • STAT News reports offers a new perspective on the country’s shortage of cancer drugs, which is a big bowl of wrong.
    • “A young girl, maybe 5 or 6 years old, had come into Yoram Unguru’s clinic with acute lymphoblastic leukemia, the most common of all childhood cancers. One of the drugs needed for treatment was methotrexate. The only problem was that the drug was in short supply.
    • “Oftentimes we can cure kids of their disease, but we can’t do that without the drugs,” said Unguru, a pediatric hematologist oncologist at Children’s Hospital at Sinai in Baltimore and the Johns Hopkins School of Medicine. “It’s just so, so maddening.” * * *
    • “Methotrexate isn’t the only essential chemotherapy clinicians are having a hard time getting their hands on right now. Two other key chemotherapies, cisplatin and carboplatin, which are also generic injectable drugs, have been in shortage for the last few months. But Unguru didn’t see this particular patient recently or even in the last year. He saw her over a decade ago, when the country was facing a different methotrexate shortage back in 2012.
    • “For me, it was my first real world encounter with shortages. That was back when more of this was darker, and I had more of it on my head,” he said, gesturing to his graying beard. * * *
    • “Since then, he’s dealt with countless drug shortages in not only essential cancer medicines but many crucial generic drugs including injectables and antibiotics — nearly all of which have been around and off patent for decades. At any given time, there are dozens or hundreds of generic drugs on the Food and Drug Administration’s shortage list.
    • “These shortages are really omnipresent. In the modern era, it’s not even the new normal. It’s the normal. From 2011, they have really never gone away,” Unguru said. “It’s like Groundhog Day.”
    • “The underlying problem for this hasn’t really changed either — which is that the economics of the generic drug market drive hospitals and producers to emphasize low prices and profits rather than the reliability of the drug supply. The worst part, Unguru said, is that “these shortages are preventable. They’re absolutely preventable.”
  • Reuters relates,
    • “The U.S. Food and Drug Administration has approved Pfizer Inc’s (PFE.N) drug to treat hair loss caused by an autoimmune disease, the company said on Friday [June 23].
    • “The drug, branded as Litfulo, has been approved for people aged 12 years and older suffering from severe alopecia areata (AA), a condition where the immune system attacks hair follicles and causes hair to fall out, often in clumps.
    • “The FDA’s decision makes Litfulo the first to be allowed for the treatment of the condition in adolescents.”
  • Fierce Healthcare points out,
    • “Pharmacy benefit managers and their role in the drug supply chain have been under the microscope, and a new playbook aims to arm employers with strategies to strengthen their negotiating power.
    • “The guide, released by the National Alliance of Healthcare Purchaser Coalitions, identifies several key strategic recommendations that employers can adopt when looking to better navigate their relationship with PBMs.”

From the U.S. healthcare business front —

  • Healthcare Dive reports
    • “In May, the median year-to-date operating margin index for hospitals hit 0.3%, marking the third consecutive month of positive performance, according to a new hospital report from Kaufman Hall.
    • “Hospitals’ financial stabilization is attributable in part to patients’ increased utilization of outpatient hospital services and decreased labor costs, the consultancy found.
    • “To keep the positive momentum, hospitals should pay attention to the trend toward outpatient services, Erik Swanson, Kaufman Hall SVP of data and analytics, said in a statement, calling the shift “particularly important.”
  • Benefits Pro notes
    • “Increased investment in urgent care centers is needed as health care delivery models change and patients with non-life-threatening conditions opt for ease of access, according to a recent analysis by Colliers.
    • “The analysis notes several data points to back up its message. The Urgent Care Association found that since 2019 patient volume has spiked by 60%, while Data Bridge Market Research has predicted a compound annual growth rate of 5.35% between 2022 and 2029.”
  • STAT News explains why “After a late start, Eli Lilly has the momentum in battle for $30 billion weight loss market.”
    • “It was Novo Nordisk’s Ozempic and Wegovy that set off a new era in obesity medicine, delivering unprecedented levels of weight loss and working its way into popular culture, inescapable ads, and hundreds of thousands of medicine cabinets.
    • “But Eli Lilly has been following close behind with new treatments, and after dropping result after result from successful trials at the American Diabetes Association conference here this past weekend, the Indianapolis-based drugmaker looks to be gaining an edge over its Danish competitor in the race to supply obesity drugs.”

Tuesday’s Tidbits

David Ermer–AHRQ, CDC, FDA, Medical / Rx research, OPM, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From the public health front —

  • Health Affairs launched a new publication called Health Affairs Scholar. Health Affairs also made available its lead article in the new publication titled “Ten Health Policy Challenges for the Next Ten Years.”
  • MedPage Today reports
    • “An increase in pediatric type 2 diabetes cases that began during school closures amid the COVID-19 pandemic has not returned to baseline, according to a retrospective study.
    • “Compared with the year before COVID emerged, the number of new pediatric type 2 diabetes cases ballooned during the first year of the pandemic (March 2020 through February 2021; P=0.005), and then jumped again during the second year (March 2021 through February 2022; P=0.0006), reported Esther Bell-Sambataro, MD, of Nationwide Children’s Hospital and the Ohio State University in Columbus, during ENDO 2023opens in a new tab or window, the annual meeting of the Endocrine Society.”
  • The Food and Drug Administration adds
    • “Today, the U.S. Food and Drug Administration approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet and exercise to improve blood sugar control in children 10 years and older with type 2 diabetes. These approvals provide a new class of medicines taken by mouth to treat pediatric type 2 diabetes. Metformin, the only other oral therapy available for the treatment of children with type 2 diabetes, was first approved for pediatric use in 2000.
    • “Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, M.D., M.P.H., associate director for therapeutic review for the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes.”
  • Also from the FDA
    • “Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. 
    • “We believe this guidance and the launch of the pilot program are important steps towards addressing safety risks posed by the use of poorly performing laboratory-developed tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The pilot aims to help by making transparent performance recommendations for diagnostic tests used to select certain oncology drug treatments.”
  • The National Institutes of Health informs us
    • “A recent follow-up analysis of data from an international, National Institutes of Health-funded clinical trial suggests daily low-dose aspirin increases the risk of anemia in people age 65 years and older by approximately 20%. Given these findings, older adults on low-dose aspirin and their care providers may want to consider periodic monitoring of red blood cells or hemoglobin. Anemia in older adults is associated with functional decline, increased fatigue, disabilities, depressive symptoms, and cognition problems.
    • “Published in the Annals of Internal Medicine, scientists from the Aspirin in Reducing Events in the Elderly (ASPREE) study examined the effect of long-term low-dose aspirin use on incident anemia and the effect of aspirin on changes in hemoglobin concentration, as well as ferritin levels, as an indicator of iron deficiency. The researchers found that low-dose aspirin led to increased incident anemia in otherwise healthy older adults at enrollment, independent of major bleeding.”
  • The U.S. Preventive Services Task Force released a new recommendation — “Adults 64 years or younger, including pregnant and postpartum persons: Screen for anxiety. Grade: B” — and reissued a 2014 recommendation — “Adults, including pregnant and postpartum persons, and older adults (65 years or older): Screen for major depressive disorder (MDD). Grade: B.”
  • ICD10 Monitor alerts us
    • “The Centers for Disease Control and Prevention (CDC) released the ICD-10-CM codes for the 2024 fiscal year (FY) on Friday, June 16. This release included 395 additions, 25 deletions, and 13 revisions. The deletions are due to the expansion of the diagnosis codes. The total ICD-10-CM codes for FY 2024 is 74,044. These codes will be effective starting with Oct. 1, 2023, visits or discharges.”

From the federal employment front —

  • FedWeek tells us
    • “A hearing set for this week on three high-profile work backlogs likely will add to the pressure from House Republicans for agencies to reduce their levels of telework.
    • “The hearing in the House federal workforce subcommittee will “examine the backlogs of military and civil service personnel records requests, the Social Security Administration’s customer service line and disability claims, and passport backlogs. This hearing will also examine what steps agencies are taking to clear backlogs and provide timely service and support to the American people,” according to the panel.”
  • Govexec reports
    • “An advisory council dedicated to examining issues related to federal employee compensation issued no new recommendations for changes to the map of locality pay areas in a newly released report, instead urging quick implementation of proposals that already received a green light from the president’s pay agent.
    • “In a report dated Feb. 4 but only published by the Office of Personnel Management this month, the Federal Salary Council said none of the regions currently being studied by the Bureau of Labor Statistics regarding the pay disparity between federal workers and private sector employees currently meet the criteria to become locality pay areas.
    • “Instead, the council, which is made up of a mix of presidentially appointed federal human resources experts and representatives of unions and other federal employee organizations, focused its report on reiterating a series of recommendations approved last December by the president’s pay agent, a body made up of OPM Director Kiran Ahuja, Office of Management and Budget Director Shalanda Young and then-Labor Secretary Marty Walsh. But in order for those recommendations to be implemented, OPM must first issue regulations.
    • “In terms of discreet additions to the map of locality pay areas, the salary council urged swift action to implement the new locality pay areas of Fresno, Calif.; Reno, Nev.; and Spokane, Wash. Additionally, Dukes and Nantucket counties, Mass., would join the Boston locality pay area; Huron County, Mich., will join the Detroit locality pay area; and Pacific and San Juan counties, Wash., would be included in the Seattle locality pay area. And Greensville County and the city of Emporia in Virginia would both become part of the Richmond locality pay area.”
  • and
    • “The U.S. Postal Service is preparing layoff notices that could take effect in September, notifying staff earlier this month of the potential for workforce reductions. 
    • “USPS is allowing impacted workers to apply for lateral or downgraded positions, anticipating it can absorb the employees elsewhere. The changes will affect non-union staff in the logistics division serving in management positions. James Lloyd, a USPS director for labor relations policies and programs, said the reductions were developed “based on an evaluation of staffing criteria and manager levels” by headquarters personnel.”

From the U.S. healthcare business front —

  • HHS’s Agency for Healthcare Quality and Research released its annual update to the Compendium of U.S. Health Systems.
    • “The Compendium of U.S. Health Systems includes information on U.S. health systems, defined in this analysis to include at least one hospital and at least one group of physicians providing comprehensive care, and who are connected with each other and with the hospital through common ownership or joint management. The Compendium is updated on a regular basis, with the newest files released in June 2023:
    • “2021 Compendium (New)
    • “2020 Compendium (New)
    • “2018 Compendium“
  • Beckers Hospital Review ranks 35 health systems by revenue.
  • BioPharma Dive reports
    • “Eli Lilly has agreed to buy Dice Therapeutics for about $2.4 billion in a deal that gives the pharmaceutical giant a promising oral autoimmune disease drug in clinical testing.”
    • “Lilly will buy Dice, a young biotechnology company that went public in 2021, for $48 per share in cash, the companies announced Tuesday. The purchase price equates to a roughly 42% premium to Dice shares’ closing price Friday and about 40% above the average trading price over the last month.
    • “The deal is expected to close in the third quarter, pending regulatory clearance and the tender of a majority of Dice’s outstanding stock.”

Monday Roundup

David Ermer–Congress, COVID-19, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC —

  • Roll Call tells us “A disagreement between Speaker Kevin McCarthy and House conservatives that jammed up legislative business last week eased Monday evening, but members of the rebel bloc made clear it may not be the end of trouble for their leadership.”
  • Govexec informs us
    • “After multiple years of significant spending increases at non-defense agencies, Congress has reverted to austerity by demanding an overall freeze of discretionary funding for domestic agencies. 
    • “The pullback, agreed to as part of a deal struck by President Biden and House Republicans to meet GOP demands for raising the debt ceiling, will force agencies to make difficult decisions as they abandon some efforts to launch new programs and grow existing ones. The 2023 Fiscal Responsibility Act set only a top-level cap for non-defense spending, leaving it to Congress to establish line-by-line funding levels across government. 
    • “The impacts will look different agency to agency,” said Rachel Snyderman, a senior associate director at the Bipartisan Policy Center and former Office of Management and Budget official.”
  • Federal News Network helpfully reviews the 71 public comments submitted to OPM in response to its April 6, 2023, interim final rule implementing the Postal Service Health Benefits Program.
  • Health Payer Intelligence relates, “AHIP offered four recommendations to the Senate Finance Committee on Consolidation and Competition (the Committee) [last week] to support healthy competition and lower healthcare spending in the healthcare industry.”

From the litigation front —

  • Yahoo News reports,
    • “The Biden administration on Monday finalized a deal to preserve the federal mandate requiring U.S. health insurers to cover preventive care like cancer screenings and HIV-preventing medication at no extra cost to patients while a legal challenge continues.
    • “The agreement, first disclosed on Friday and now finalized in a filing in the New Orleans-based 5th U.S. Circuit Court of Appeals, leaves the mandate in place nationwide while the administration appeals a court order striking it down.
    • “It does allow Texas-based Braidwood Management, one of a group of businesses and individuals that sued to challenge the mandate, to stop covering pre-exposure prophylaxis (PrEP) against HIV and other preventive services for its employees for now. The administration agreed not to take any retroactive enforcement action against the company, which operates an alternative health center if the mandate is restored on appeal.”
  • STAT News adds,
    • “The U.S. Chamber of Commerce sued the federal government over its new Medicare drug-price negotiation program on Friday, arguing that Congress tried to take too much power away from the courts.
    • “The lawsuit is the second to challenge the new program, enacted by Democrats last August in the Inflation Reduction Act, within a week’s time, but relies on different legal reasoning. Merck, which makes a diabetes drug that could be subject to negotiation, sued on Tuesday.
    • “Medicare is supposed to choose the first ten drugs to be negotiated by the program by Sept. 1. The goal of the lawsuits is to slow down or stop the process from going into effect.”

From the public health front —

  • Politico relates,
    • “The FDA’s independent advisers will discuss and recommend this week which strain of SARS-CoV-2 should be included in the newest Covid booster to be rolled out ahead of fall and winter. The FDA doesn’t have to follow its advisers’ recommendations, but it often does.
    • “Since the beginning of the year, the regulatory agency has made it clear that it will shift gears to prepare for annual Covid-19 shots as the virus becomes endemic. Now that we’re four months out from the intended rollout, the FDA must select a strain that will most likely be prevalent so manufacturers can start developing vaccines.
    • “Novavax, Pfizer-BioNTech and Moderna, the companies that manufacture the three vaccines available in the U.S., need the FDA’s recommendations to begin tweaking their existing platforms. They must also conduct clinical trials to show that the updated formulas generate a similar immune response to their existing products.”
  • MedPage Today reports,
    • “Oseltamivir (Tamiflu) has not panned out for reducing the risk of influenza hospitalization, according to a large meta-analysis.
    • “Among over 6,000 flu patients across 15 studies, the 0.14-percentage point difference in hospitalization rate between those who took oseltamivir and those who did not was not significant (RR 0.77, 95% CI 0.47-1.27), Emily McDonald, MD, MSc, of McGill University Health Centre in Montreal, and colleagues reported in JAMA Internal Medicine.
    • “I wouldn’t prescribe it to an otherwise healthy person,” McDonald told MedPage Today. “There was little evidence that it would prevent you from going to the hospital.”
    • “What’s more, she added, “it’s not completely benign. It does cause uncomfortable side effects.”
  • The Wall Street Journal reports,
    • “During the pandemic, Carl Prudhomme of Alpine, Texas, got his cancer drugs mailed directly to him from his oncologist.
    • “No longer. With the end of the Covid-19 public-health emergency, independent cancer doctors can no longer send prescriptions directly to their Medicare patients—creating hurdles for some people in rural areas who say they have to travel to get their medications. Prudhomme plans to drive the 569 miles each way to his oncologist’s office in Houston every three months to pick up his drugs in person.
    • “The Centers for Medicare and Medicaid Services in September 2021 posted a list of frequently asked questions that said independent oncologists can dispense prescriptions only to a patient who is physically in the doctor’s office at the time. 
    • “Sending oral chemotherapy drugs by mail violates the Stark law, the agency said. The law bans doctors from making referrals of Medicare and Medicaid patients to other organizations or medical businesses where they have a financial stake. The restriction also applies to other independent practices, such as urology, that have an on-site dispensing pharmacy.
    • “Roughly 30% of the more than 5,000 independent oncologists in the U.S. have on-site pharmacies in their practices, according to an analysis led by the University of Pennsylvania’s Perelman School of Medicine. 
    • “The restriction was suspended during the pandemic public-health emergency. Its return has alarmed cancer doctors who are lobbying Congress and CMS to rescind the restriction, even if that means undergoing new rule-making to do so.”

From the U.S. healthcare business front —

  • Fierce Healthcare tells us,
    • “Prior authorization has been a flashpoint for providers, and, while insurers have taken steps to ease these utilization management protocols, they still play a key role as the industry shifts to value-based care.
    • “David Brailer, M.D., executive vice president and chief health officer at the Cigna Group, told Fierce Healthcare in an interview that ultimately the goal is to ensure patients are receiving the best treatment option for them.
    • “And the insurer has seen that in more advanced value-based arrangments, it can relax prior authorization and other utilization management tools, Brailer said. 
    • “That’s going to be a few years before the market shifts,” he said. “We’ve already announced that we’re starting to step down the number of prior auths that we have.”
  • STAT News relates,
    • “Novartis said on Monday it would purchase Chinook Therapeutics for $3.2 billion upfront, picking up two drugs for a chronic kidney disease that are in late-stage clinical trials.
    • “The transaction values Seattle-based Chinook at $40 a share, compared to Friday’s closing price of under $24. The agreement includes another $300 million if certain regulatory milestones are reached.”
  • Healthcare Dive points out
    • CVS Health’s decision to shut down its two-year-old clinical trials unit means less competition for the growing group of retailers in research, but the area is still nascent and potentially challenging for new entrants, experts said.
    • “It may sort of spook some pharma companies who may think that if CVS exited, maybe these other companies will also exit, and it may make them a little bit more hesitant to partner up with the retailers,” said Sari Kaganoff, general manager of consulting at Rock Health. “At the same time, there’s a lot of opportunity, we believe, for pharma companies to use retailers for clinical trials.”
    • CVS will fully exit the clinical trials business by the end of 2024, winding down the business in phases and working with trial sponsors to ensure patients continue to receive care. 

From the Rx coverage front —

  • The Wall Street Journal informs us,
    • Kristen Ireland struggled with bulimia nervosa for years, working with a therapist and taking medications for anxiety and depression.
    • It wasn’t until her psychiatrist prescribed Victoza, a diabetes medication that works much like Ozempic, Wegovy and Mounjaro, that her binges and purges faded away.
    • “I feel free now,” said Ireland, 27 years old, who manages sports-merchandise stores in Jackson Hole, Wyo. 
    • Treating eating disorders is another potential application for a class of drugs that has taken the weight-loss world by storm. The drugs, synthetic versions of the GLP-1 hormone that act on appetite centers in the brain and gut, have helped patients lose 15% of their body weight on average
    • Some studies and the experience of doctors in the field suggest they could also help people stop binge eating.
  • CBS News discusses the side effects of these new weight loss drugs.

Friday Factoids

David Ermer–Congress, COVID treatment, FDA, Federal employment benefits, OPM, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington DC

  • The Wall Street Journal reports
    • “President Biden said negotiators were closing in on a deal to cut spending and raise the $31.4 trillion debt limit, seeking to overcome final hurdles on issues regarding the budget as well as requiring more people to work to receive federal benefits.
    • “He said talks are “very close” to reaching an agreement and that he was hopeful that there could be a breakthrough as soon as later on Friday. “I hope we’ll have some clear evidence tonight, before the clock strikes 12, that we have a deal,” he said as he departed the White House for Camp David on Friday evening.
    • “Negotiators are hoping to strike a deal soon in order to set up votes on the legislation next week. The Treasury Department, which is currently using extraordinary measures to avoid exceeding the debt ceiling, estimated Friday that the government could run out of money to pay its bills if Congress doesn’t act by June 5.
    • “Treasury had previously put the deadline as early June, saying it could come as soon as June 1. Any legislation would likely take at least several days to pass both the House and Senate.
  • Govexec tells us
    • “The federal government’s HR agency on Wednesday unveiled new guidance aimed at standardizing and revitalizing employee assistance programs across the federal government, an effort officials said would prioritize employee wellness and improve productivity.
    • “Like many private sector employers, federal agencies often offer employees access to employee assistance programs, which provide services related to maintaining one’s mental and physical health, as well as resources related to substance use issues.
    • “The Office of Personnel Management, spurred by a provision of President Biden’s management agenda tasking agencies with promoting “awareness of employee well-being and [supporting] initiatives that extend beyond the workplace,” underwent a year-long effort to design a “standardized approach” to employee wellness programs, consulting with focus groups, health experts and vendors who provide assistance programs to employers.
    • “The result is a 19-page guidance document for agencies to reassess their assistance program offerings and, if necessary, expand them.
  • The FEHBlog wonders why OPM silos its various benefit programs rather than integrate them to get more bang for the buck.

From the healthcare costs front —

  • Milliman has released its 2023 Medical Index. Milliman estimates the healthcare cost for a hypothetical family of four enrolled in a hypothetical PPO plan is $31,065, a 5.6% increase over 2022.
  • The Medical Group Management Association issued its 2023 Physician Compensation and Productivity Benchmarks.
    • “Productivity remained relatively flat or only slightly increased relative to pre-pandemic benchmarks, with the biggest change in work RVUs posted in dermatology, hematology/oncology, and family medicine (without OB). 
    • “The growth in median total compensation for primary care physicians (PCPs) doubled from 2021 (2.13%) to 2022 (4.41%), but was outpaced by inflation at 7% and 6.5%, respectively. 
    • “Surgical and nonsurgical specialists saw their change in median total compensation cool slightly in 2022, dropping from 3.89% for surgical specialists in 2021 to 2.54% in 2022, and from 3.12% for nonsurgical physicians in 2021 to 2.36% in 2022. 
    • “APPs [advanced practice providers]— who saw the biggest change in median total compensation from pre-pandemic levels — saw their 2022 growth ebb slightly to 3.70%, down from 3.98% growth in 2021.” 

From the U.S. healthcare business front,

  • Beckers Hospital Review points out
    • “There are 293 rural hospitals at immediate risk of closure due to inflation, staffing shortages and other financial stress, according to the Center for Healthcare Quality & Payment Reform. 
    • “Hospitals at immediate risk of closure have lost money on patient services for multiple years, excluding 2020 during the pandemic, and aren’t likely to receive sufficient funds to cover the losses with public assistance ending, according to the report. These hospitals also have low reserves and more debt than assets.”
  • MedCity News relates
    • “The pandemic prompted a great need for technology-enabled care delivery, so the regulations surrounding reimbursement for these services were tossed out the window in 2020. Now that the public health emergency has ended, the healthcare industry has to figure out how it is going to pay for digital health services going forward.
    • “It’s clear that services like telehealth and remote patient monitoring have potential to provide value, but hospitals and digital health companies need to show payers clearer evidence of the outcomes these care modalities can produce, panelists argued during a Wednesday session at MedCity News’ INVEST conference in Chicago.” 
  • STAT News adds market perspective on the Food and Drug Administration’s full approval of Paxlovid, announced yesterday.
    • “The full approval for treating adults at high risk of progression to severe disease will help Pfizer expand its marketing campaign. U.S. officials plan to work through much of the government’s Paxlovid inventory, which is available for free at pharmacies around the country, before moving to a normal commercial market for the drug. Pfizer has sold the U.S. government nearly 24 million courses at around $530 a course, but it is not clear yet what price the company will charge.”

From the interoperability front —

  • The Pharmacy Times tells us
    • “Integrating Immunization Information Systems (IIS) vaccination records into claims data (collected by health insurers) increased the number of people identified as being vaccinated against COVID-19, according to the results of a study published in JAMA Network Open. Having accurate COVID-19 vaccination data is important for future COVID-19 vaccine studies that capture efficacy and safety, according to the study.
    • “When claims data were supplemented with IIS vaccination records, the proportion of participants with at least one vaccine dose rose from 32.8% to 48.1%. And when IIS vaccine records were included with claims data, the percentage of people who completed a vaccine series increased from 24.4% to 41.9%, varying by state.”
  • Per FCW
    • The Food and Drug Administration is looking to develop standardized “supersets of data” and improve data interoperability, analysis and management across the agency, an official said on Wednesday. 
    • The agency is planning to gather information and seek public input on the use of real-world data in its decision-making processes, according to Jose Galvez, deputy director for the office of strategic programs of the FDA’s Center for Drug Evaluation and Research. 
    • Galvez said at the Professional Services Council 2023 FedHealth Summit that the FDA is set to release a Federal Register notice “very shortly” to gain industry input on evaluating new types of data analysis.

Monday Roundup

David Ermer–Congress, Federal employment benefits, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC, the Wall Street Journal reports

“President Biden and House Speaker Kevin McCarthy (R., Calif.) opened a high-stakes meeting on Monday evening, as negotiators worked to get back on track on reaching a debt-ceiling deal that could pass both the Republican-led House and Democratic-led Senate by the end of the month. 

“Central to the talks is setting a top-line spending level for the next year and deciding how long to lift the debt ceiling until having to raise it again. The two sides are aiming to reach a deal by June 1, when the Treasury Department estimates the U.S. could run out of money to pay all of its bills, leading to a first-ever default. Treasury Secretary Janet Yellen repeated that estimate Monday.”

About 90 minutes later, Politico adds, “President Joe Biden and Speaker Kevin McCarthy ended their one-on-one meeting Monday [with a “better tone” yet] still short of a deal to avoid a U.S. debt default that could come as soon as June 1.”

From the Rx coverage front —

  • STAT News informs us,
    • “An oral version of semaglutide, the drug marketed as Ozempic and Wegovy, led to dramatic weight loss in a trial enrolling people with obesity, manufacturer Novo Nordisk said Monday, data that could bolster what is already a blockbuster medicine.
    • “In the study, which enrolled nearly 700 adults classified as overweight or obese, patients treated with a daily semaglutide tablet lost 15.1% of their body weight over the course of 17 months, while those on placebo lost 2.4%, Novo Nordisk said. The result is comparable to weekly injections of Wegovy, which in an earlier study led to 14.9% weight loss over the same period of time. In both studies, the most common side effects were gastrointestinal distress, with the majority of cases graded mild or moderate, the company said.
    • “Novo Nordisk said it plans to submit oral semaglutide for U.S. and E.U. approvals later this year. A lower-dose version of the drug is already approved as a treatment for type 2 diabetes under the brand name Rybelsus.”
  • Reuters tells us,
    • “Taking Novo Nordisk’s new obesity drug may help reduce the risk of heart disease as well as boosting weight loss, according to new research from the United States.
    • “After a year of taking semaglutide, marketed as Wegovy, patients’ risk of suffering from conditions like a heart attack or a stroke over the next ten years dropped to 6.3% from 7.6% when measured by a commonly used calculator, researchers at the Mayo Clinic found.
    • “The results, which were presented this week at the European Congress on Obesity in Dublin, are among the first indication that the weight loss induced by the new GLP-1 agonist drugs like Wegovy also brings heart health benefits – something scientists expected, but do not yet have much comprehensive data to prove.
    • “The study was only done among 93 patients, and the researchers said that more and larger studies were needed to see if the risk reduction score actually meant less illness and death long-term.
    • “Novo is expected to release results from its 5-year SELECT trial looking into the health impact of its injectable drug, particularly around heart disease, later this year. Investors, governments and insurers alike are keenly watching the data.
  • FiercePharma offers a special report about the most expensive drugs in our country.

From the U.S. healthcare business front —

  • Fierce Healthcare relates
    • Found, a company that offers an evidence-based weight loss management program for consumers, is launching a new platform that aims to help employers manage services and cost for workers struggling with weight, including GLP-1 drugs like Ozempic and Wegovy.
    • With medication-assisted obesity care in the headlines, Found for Business offers employers a solution that’s based on clinical best practices and is cost-effective and medication-agnostic. Found’s approach combines virtual clinical care with personalized medication regimens and behavioral health change, according to an announcement
  • Healthcare Dive reports
    • HCA Healthcare, one of the nation’s largest for-profit health systems, has agreed to acquire 41 urgent care centers in Texas.
    • The deal includes 19 FastMed and 22 MedPost clinics in Dallas, Austin, San Antonio, Houston and El Paso, HCA said Thursday.
    • Terms of the deal were not disclosed, but the buy is expected to close this summer, according to the operator.

In federal employee benefits news

  • OPM released “the OPM Retirement Quick Guide, a three-page guide to voluntary retirement that walks federal employees through what to expect as a retirement application is processed and benefits are determined, including helping employees estimate when they can expect to receive their interim and first annuity payments. OPM Retirement Services (RS) developed the guide in partnership with the Lab at OPM, using human-centered design principles.” 
  • Federal News Network discusses “OPM’s new approach to modernizing retirement services [which] is all about small bites.”

Thursday Miscellany

David Ermer–Congress, End of the PHE, NE, FDA, Medical / Rx research, OPM, SCOTUS, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC, Roll Call reports

“Lawmakers from both parties suggested negotiators were making progress Thursday toward a bipartisan deal that would raise the $31.4 trillion debt limit, though days of talks still lie ahead.

“Scrambling to avert a debt limit breach that Treasury Secretary Janet L. Yellen said could hit as early as June 1, negotiators are attempting to reach a framework for a deal by Sunday, when President Joe Biden returns from a trip to the G-7 summit in Japan.

“Speaker Kevin McCarthy, who is negotiating with Biden through proxies, said he is hopeful that a deal could come as soon as this weekend. In a sign of progress, the two parties have begun to exchange offers, said House Rules Chairman Tom Cole, R-Okla.

“We’ve made good progress this week, but the work continues,” said Senate Majority Leader Charles E. Schumer. “ No one will get everything they want.”

“If a deal is reached by Monday, the House would vote next week, with 72 hours notice after the text is posted. While the Senate is scheduled to be in recess next week, Schumer said his chamber would be prepared to reconvene with 24 hours’ notice to schedule a vote.”

Per STAT News

“Pharmacy benefit managers would be subject to new transparency rules under a bill that cleared a key House subcommittee, Modern Healthcare says. The Transparent PRICE Act of 2023, which received a unanimous vote in the House Energy and Commerce Committee’s Health Subcommittee, would require pharmacy benefit managers to annually provide employers with detailed data on drug spending, including acquisition costs, out-of-pocket spending, formulary-placement rationale, and aggregate rebate information. The bill also would order the Government Accountability Office to report on group health plan pharmacy networks, including those owned by health insurers.”

Fierce Healthcare discusses other healthcare actions taken by this subcommittee yesterday.

BioPharma Dive tells us

“The U.S. Supreme Court on Thursday ruled against Amgen in its decade-long battle with Sanofi and Regeneron, affirming a lower court’s decision that Amgen’s rivals did not infringe on patents the biotechnology company held on a cholesterol-lowering medicine.

“In a unanimous decision authored by Justice Neil Gorsuch, the court said two Amgen patents on its PCSK9 inhibitor Repatha fell short of a legal standard known as enablement, which requires the claimed invention be described well enough to allow a skilled person in the field to use it. * * *

“The court’s ruling could open the door for challenges to older classes of antibody therapies, [University of Illinois law professor Jacob]Sherkow said. “This decision is probably going to give challengers solace. They’re going to have good options when working with the enablement requirements to challenge competitors’ patents out there.”

From the public health front —

  • The Robert Wood Johnson Foundation released its 2023 U.S. county health rankings while the UnitedHealthFoundation issued its 2023 Seniors Report from its America’s Health Rankings Services.
  • MedPage Today informs us
    • “The CDC encouraged populations at risk of contracting mpox, formerly known as monkeypox, to get fully vaccinated against the disease as part of preparations for summer during a briefing Thursday morning.
    • “Demetre Daskalakis, MD, the White House National Mpox Response Deputy Coordinator, noted that with summer gatherings on the horizon, mpox vaccination should be considered, as should overall sexual health and wellness.
    • “Getting ‘summer ready’ means mpox vaccination, but that’s not all it means — it also means to be up to date on all of your sexual health, and that includes HIV and STIs [sexually transmitted infections] like syphilis, gonorrhea, and chlamydia,” he said.”
  • The Department of Health and Human Services posted a fact sheet with “Resources on Ways Communities Can Stay Protected from Mpox in Advance of Summer Months.”
  • The Wall Street Journal points out the important medical tests that Americans should consider undergoing over the decades of life.
  • The U.S. Preventive Services Task Force notified the public about a draft research plan concerning “Weight Loss to Prevent Obesity-Related Morbidity and Mortality in Adults: Interventions” that is open for comment until June 14, 2023.

From the Food and Drug Administration front, the Wall Street Journal reports

“The Food and Drug Administration for the first time cleared a test to gauge a mother’s risk of severe preeclampsia, a leading cause of pregnancy-related illness and death in the U.S.  

“Thermo Fisher Scientific said Thursday that the blood test it already sells in Europe could be available in the U.S. soon. Its introduction could transform prenatal care in the U.S., doctors and maternal-health advocates said.”

Bravo.

From the U.S. healthcare business front —

  • Beckers Hospital Review notes five new details about Kaiser Permanente’s Risant Health deal.
  • Fierce Healthcare discusses provider objections to what appears to the FEHBlog to be a reasonable new prior authorization program that UnitedHealthcare is introducing. No good deed goes unpunished.

From the miscellany department —

  • STAT News relates that
    • “A multibillion-dollar science agency tasked with slashing through research bureaucracy will start its work with a plan to help people regenerate bone.
    • “The Advanced Research Projects Agency for Health, launched a little more than a year ago, announced Thursday that its first official program would target bone and joint damage from osteoarthritis, a condition affecting more than 32 million Americans.”
  • Govexec discusses FEHB coverage of Covid tests and vaccines following the end of the PHE.
  • The Equal Employment Opportunity Commission weighs in on the Title VII compliance implications of employer use of artificial intelligence to make employment decisions.

Weekend update

David Ermer–Congress, OPM, U.S. Healthcare–
Photo by Michele Orallo on Unsplash

Happy Mothers’ Day! Here’s a reminder that on June 27, 2023, two new federal employment laws will take effect — the Pregnant Workers Fairness Act and the PUMP Act (fairness for nursing mothers).  

OPM shares excerpts from OPM Director Kiran Ahuja’s commencement address to the graduating class of the University of Georgia’s School of Public and International Affairs.

The House of Representatives and the Senate will be in session this week for Committee business and floor voting.

The Wall Street Journal reports

  • The Biden administration and congressional Republicans are making progress in their negotiations over federal spending and raising the debt limit, Treasury Secretary Janet Yellen said, adding that she believes the talks could result in an agreement.
  • “I’m hopeful. I think the negotiations are very active. I’m told they have found some areas of agreement,” Ms. Yellen said in an interview Saturday at the end of a gathering of finance ministers from the Group of Seven advanced democracies in Japan.
  • Republicans and Democrats are racing to find a compromise for raising the nation’s roughly $31.4 trillion debt limit. Republicans say lifting the debt ceiling should be paired with cuts to federal spending, while Democrats say raising the cap shouldn’t be contingent on broader budget negotiations.

Axios tells us that “The Biden administration is pouring billions of dollars into the development of future coronavirus vaccines, trying to develop a sequel to Operation Warp Speed even as the public health emergency ends.”

Also, from the research front, Biopharma Dive informs us

  • Sanofi and AstraZeneca released new study results on Friday [May 11] that showed their antibody drug for respiratory syncytial virus reduced hospitalizations for infection-related respiratory disease by 83% in infants.
  • The drug, sold as Beyfortus, won approval in Europe in November as a preventive treatment for babies in their first RSV season and is due a decision by U.S. regulators in the third quarter. The results released Friday add to earlier data that showed the drug to be 75% effective in reducing RSV-related hospitalizations over a placebo.
  • RSV is a leading cause of hospitalization in infants, often overlapping with seasonal patterns for influenza and now COVID-19, too. It is estimated that more than 25,000 children under 5 years old die from RSV infections globally each year, with millions hospitalized.

and MedTech Dive points out,

  • Guardant Health on Tuesday presented the results of a pivotal study of Shield, its blood-based test for colorectal cancer, demonstrating an overall sensitivity of 83% and specificity of 90%.
  • Looking at the results by stage, the test only detected 55% of stage I cancers. Its detection of later-stage cancers was 100%.
  • The test should meet the criteria to gain FDA approval and Medicare reimbursement, but its early-stage performance will likely make Shield less competitive against Exact Sciences’ stool-based test, Cologuard, to start, analysts with Craig Hallum wrote in a research note on Wednesday. 

From the SDOH front, Healthcare Finance relates,

  • CVS Health said this week it’s adding mental health screenings to Project Health, the company’s free, community-based health screening program. 
  • It will kick-start its mental health screenings in Greensboro, North Carolina and Petersburg, Virginia. Over the course of the year it will also add nearly 100 organizations to host its mobile units in under-resourced communities.
  • CVS Health plans to host nearly 2,000 Project Health screening events across the U.S. in 2023. The company hosts these events at CVS Pharmacy locations and community organizations, offering free biometric screenings, including blood pressure, cholesterol, glucose level and body mass index, to detect early risks of chronic conditions such as diabetes, hypertension and heart disease.
  • The screenings will now also offer PHQ-2 assessments – screenings to help identify people who require additional evaluation for depression. Following these screenings, participants have the opportunity to meet with a nurse practitioner who can provide referrals for treatment and advice on follow-up care.