Friday Factoids

CDC

Friday Factoids

David Ermer–CDC, COVID-19, FDA, Generative AI, HSA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC

  • The Washington Post reports,
    • On Thursday, FDA Commissioner Robert Califf appeared before the panel for the first time this Congress, facing a roughly four-hour grilling on a wide range of issues, from the infant formula crisis to tobacco regulation to an abortion pill. 
    • * * * Of note,
      • “The composition of a highly pathogenic strain of bird flu doesn’t appear to be resistant to current treatments already on the market for the flu, Califf said. This comes after a dairy worker in Texas was recently treated for bird flu, which has been identified in dairy cattle for the first time. 
      • “It’s always the case that when you have an actual illness you have to empirically prove that it works,” Califf said. “Fortunately right now, there’s really only one infected human that we know of, so it’s not something that we can test. But it looks good at this point.”
  • House Budget Committee Health Care Task Force (HCTF) Chair Rep. Michael C. Burgess, M.D. (R-TX) wrote an op-ed in the Hill about how to pay for 21st Century medicine.
    • “Medical advances have opened a new world of hope for patients suffering from serious and life-threatening diseases. We need to match our 21st century science with 21st century payment models and offer patients hope without breaking the budget.
    • “My legislation, the Preventive Health Savings Act, offers another new tool to help Congress identify the long-term savings generated by some of these novel therapies and assist in implementing new payment pathways.
    • “We can keep marching forward and saving lives, or we can turn the clock back. Congress needs to address these challenges by anticipating the future instead of wallowing in the past.”
  • Fierce Healthcare adds,
    • Instead of enacting public option plans, states should target reinsurance programs, a new report from the Partnership for America’s Health Care Future argues.
    • The group includes a collection of health plans, hospital groups and pharma companies brought together largely to oppose Medicare for All. This study was authored by three policy experts with the Hoover Institution at Stanford University.
  • OPM could encourage Congress to create a reinsurance pool for gene therapy treatments within FEHBP and PSHBP using the unused portion of the 1% surcharge on FEHB premiums intended to fund OPM’s FEHB / PSHB administrative costs.
  • Assistant Secretary of Labor for Employee Benefit Security Lisa Gomez wrote in her blog about how to unlock the power of prevention in the fight against cancer.
  • The Washington Post points out,
    • “Covid forced the public health field and health-care sector to work toward a shared goal of keeping people from becoming so ill that they overwhelm hospitals. Now, a group of health-care leaders — the Common Health Coalition, which represents physicians, hospitals and insurers — is trying to build upon these collaborations to better prepare localities for future health threats.”
  • Govexec.com informs us,
    • “The Office of Personnel Management issued a final rule Friday that would cull Social Security numbers from any mailed document in an effort to prevent fraud. 
    • “The rule, which was published in the Federal Register, is part of the implementation of the 2017 Social Security Number Fraud Prevention Act and is designed to help protect the identifiers, which can be used in various forms of identity theft. 
    • “The theft and fraudulent use of SSNs can result in significant repercussions for the SSN holder, as well as the entities from which SSNs were stolen,” OPM officials said in the Federal Register notice. “This direct final rule formalizes in regulation OPM’s current practice of safeguarding SSNs in mailed documents and will support efforts to protect individual privacy.”

From the public health and medical research front,

  • The Centers for Disease Control let us know earlier today,
    • “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, 1 jurisdiction experienced high activity compared to 6 jurisdictions experiencing high activity the previous week. [The outlier jurisdiction is North Dakota.]  No jurisdictions experienced 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.”
  • The Washington Post offers detailed background on prostate cancer following former NIH Director Francis Collins announced that he has the disease.
  • The Wall Street Journal reports,
    • “The European Union’s drug regulator found no link between the class of medicines behind 
    • “Novo Nordisk’s blockbuster Ozempic and Wegovy treatments and reports of suicidal thoughts in patients.
    • “A study by a European Medicines Agency committee had been looking at potential links between the popular weight-loss and diabetes drugs and reports of suicidal and self-harming thoughts from people using them, but it said Friday that the evidence doesn’t support a causal association.
    • “The U.S. Food and Drug Administration came to the same conclusion in January while British health authorities are carrying out their own review.”
  • Today, the FEHBlog heard an OptumRx speaker at a local conference describe the following demographic characteristics of members of employer sponsored plans who use GLP-1 weight loss drugs.
    • 4 out of 5 are women
    • Average age range is 35-54 with a concentration in the 45 to 54 age range.
    • Average BMI is 35. According to the Cleveland Clinic, “Class III obesity, formerly known as morbid obesity, is a complex chronic disease in which a person has a body mass index (BMI) of 40 or higher or a BMI of 35 or higher and is experiencing obesity-related health conditions.”
  • Bear in mind that most employer sponsored plans do not cover retirees while the FEHBP does. The FEHBlog expects that the speaker provided a useful perspective on GLP-1 use among active employees participating the FEHP. KFF remind us the there are plenty of Medicare beneficiaries using GLP-1 drugs for diabetes.
    • In 2022, Medicare gross total spending reached $5.7 billion on Ozempic (semaglutide), Rybelsus (semaglutide), and Mounjaro (tirzepatide), all of which it covered for diabetes that year, according to just-released Medicare drug spending data [before manufacturer rebates]. That was up from $57 million in 2018. 
  • The Optum speaker also remarked that biosimilar competition caused Abbvie to lower the price of its blockbuster Humira drug by 30% in 2023. He explained that it takes time for biosimilars to gain market share when the brand drug drops its price substantially.
  • Per Fierce Healthcare,
    • “Approximately 40,000 women die of breast cancer in the U.S. each year.
    • “One way of reducing that number is ensuring access to preventive screenings such as mammograms. But health-related social needs can have an impact on a woman’s chance of being up to date with her mammogram. For example, women are less likely to get a mammogram if they feel socially isolated, have lost a job or don’t have reliable transportation, according to a recent Centers for Disease Control and Prevention (CDC) Vital Signs report.”
  • The New York Times provides expert opinions on whether artificial intelligence mammograms are worth the cost.
    • “The Food and Drug Administration has authorized roughly two dozen mammography A.I. products. Some of these are being rolled out to patients in a small number of clinics and tested by other hospitals that want to be certain of the value these tools provide before offering them to patients. 
    • “There is currently no billing code that radiologists can use to charge insurance providers for the technology. That means some centers may punt the cost to patients, charging between $40 to $100 out of pocket for an A.I. analysis. Other hospitals may absorb the cost and offer the additional analysis for free. Still others may keep the technology for research until they are more certain of the value it can provide to patients.
    • “It will take some time for A.I. to become part of routine care, which would lead insurance companies to consider reimbursing their cost. Until then, most patients don’t need A.I. for their mammograms, said Dr. Katerina Dodelzon, a radiologist who specializes in breast imaging at NewYork-Presbyterian/Weill Cornell Medical Center, though it might provide some extra reassurance for those who are particularly anxious about their results.”
  • Medscape tells us,
    • “Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.
    • “Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower income countries.
    • “The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. 
    • “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “More than three-fourths of all U.S. doctors are now employed by hospitals, health insurers, private equity or other corporate entities, as rampant consolidation continues to shrink the number of independent physicians, according to new data.
    • “Between 2019 and 2024, more than 44,000 medical practices were acquired, according to the report published Thursday by Avalere Health, commissioned by the Physicians Advocacy Institute. As a result, nearly 60% of medical practices are now owned by corporations.
    • “As of January 2024, physician practice ownership by corporations — including health insurers, pharmacy chains and PE firms — exceeded ownership by hospitals and health systems for the first time, 30.1% to 28.4%. However, hospitals employ more than half of all U.S. physicians, while other corporations employ a little over one-fifth.”
  • MedTech Dive informs us,
    • “Roche has received the Food and Drug Administration’s breakthrough device designation for a blood test to support earlier diagnosis of Alzheimer’s disease, the Swiss drug and diagnostics company said Thursday.
    • “The test, once approved, could help healthcare providers identify whether amyloid pathology, a marker for Alzheimer’s disease, is present or absent in patients.
    • “The Elecsys pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly. * * *
    • “New and emerging Alzheimer’s therapies aimed at slowing cognitive decline in the earlier stages of the disease call for confirmation of amyloid pathology, yet the only methods currently cleared for that task are cerebrospinal fluid (CSF) tests and amyloid positron emission tomography, or PET, scan imaging, according to Roche.”
  • Per BioPharma Dive, while “new postpartum depression drugs are here, diagnosis, treatment hurdles still stand in the way. Two Sage Therapeutics medicines are approved for the condition. But uptake of the first has been minimal, while the launch of the second [which is a pill] is still getting off the ground.”
  • The Employee Benefit Research Institute made available a new paper on high deductible health plans with health savings accounts.
    • “The purpose of this paper is to examine the impact of plan type on use of health care services and spending. The analysis focuses on enrollees in HSA plans and PPO enrollees who are in health plans with deductibles large enough to be HSA eligible as a way of isolating the impact of the HSA on use of health care services.”

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.”

Tuesday Tidbits

David Ermer–CDC, COVID-19, Cybersecurity, FDA, Medical / Rx research, Obesity, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • The American Hospital News reports,
    • “Health care leaders and other officials April 9 discussed challenges to rural health care access and potential solutions during an event in Washington, D.C. sponsored by the Coalition to Strengthen America’s Health Care: Protecting 24/7 Care. The AHA is a founding member of the Coalition, which recently rebranded to reflect its renewed focus to protect and strengthen patients’ access to 24/7 care. 
    • “Today’s event hosted by Punchbowl News involved discussions on a range of topics including access, the importance of telehealth, health care innovations and Medicare underpayment, among others. 
    • “You can watch a video of today’s event here. “
  • The Wall Street Journal lets us know,
    • “The U.S. Postal Service said Tuesday it is seeking to raise the price of a stamp by 5 cents, in what would be the fourth increase since the start of 2023. 
    • “The proposed price of 73 cents, up 7.4% from the current price of 68 cents, would still need to be approved by the Postal Regulatory Commission. 
    • “The last increase happened in January 2024, when the cost of a stamp rose from 66 cents to 68 cents. Before that, the agency hiked prices in July 2023 by 3 cents. * * *
    • “The new 5-cent increase would go into effect July 14, the Postal Service said. 
    • “The Postal Service said it also wants to raise prices for other services, including sending a letter outside the U.S., which would cost $1.65, up from $1.55. Mailing a postcard within the U.S. would cost 3 cents more at 56 cents. And sending metered letters, a service used by small businesses, would cost 5 cents more at 69 cents.”
  • MedTech Dive relates,
    • “The Department of Justice filed a consent decree of permanent injunction against Philips on Tuesday in response to the company’s ongoing recall of sleep apnea and respiratory devices.
    • “The settlement would restrict Philips from producing or selling new continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and other devices in the U.S. until the company meets certain requirements. Philips also faces restrictions on exporting devices that are being provided to patients impacted by the recall “to help ensure remediation of U.S. patients is prioritized over export for commercial distribution.” 
    • “Philips is required to implement a recall remediation plan that the Food and Drug Administration must agree on, including providing patients with new or reworked devices, or a partial refund. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a Tuesday statement that the finalization of the decree is a “significant milestone.” 

From the public health and medical research front,

  • KFF notes,
    • “Rates of long COVID have begun to flatten. About 1 in 10 adults with COVID have reported having long COVID since rates fell in 2023, according to a KFF analysis of the latest data from the Centers for Disease Control and Prevention. If the rate continues to hold steady, new forms of prevention or treatment may be important to achieve future reductions in long COVID.
    • “As of March 2024, 7% of all adults (17 million people) reported that they have long COVID. Among the 60% of adults who reported ever having had COVID, roughly 3 in 10 reported having long COVID at some point and about 1 in 10 reported currently having it. The ongoing gap between the two long COVID rates indicates that people are continuing to recover, even as rates stabilize.”
  • US News and World Report informs us,
    • “Measles infections have continued to spread in pockets of the U.S., as the latest nationwide count shows the number of cases have now reached more than 100.
    • “A total of 113 cases have been reported across 17 states as of April 5, according to the most recent figures from the Centers for Disease Control and Prevention, nearly double the total of 58 that for all of 2023.
    • “So far, seven outbreaks have occurred – defined by the CDC as three or more related cases – up from four in 2023. More than 70% of all cases this year have been associated with an outbreak, and approximately half of patients are children under the age of five.
    • “More than 80% of measles infections are among those who are either unvaccinated or with an unknown vaccination status, according to the CDC, while 12% of cases are those who have received only one dose of the measles, mumps and rubella vaccine.
    • “Chicago has had the majority of U.S. cases, with 58 infections as of April 8, according to the most recent figures from the Chicago Department of Public Health.
    • “The majority of measles infections in Chicago have been tied to an outbreak at one of the city’s largest migrant shelters.
    • “In an update released on April 5, CDPH stated measles cases were decreasing in the city, with a total of five new cases reported during the week of March 31 through April 5, compared to 23 infections reported from March 24 through March 30.”
  • The Wall Street Journal reminds us,
    • The fight against dementia actually starts in your 40s.
    • Midlife, not your 70s or 80s, is when brain changes start to occur that can pave the way toward dementia, Alzheimer’s disease and cognitive decline later, according to a growing body of research. 
    • Intervening earlier to improve brain health—and studying the midlife brain more closely—might help people stay sharper in their later years, researchers say. Regular exercise, getting enough sleep and doing activities that keep your brain stimulated are all steps that can help you combat dementia later in life.
    • “Middle age is an opportune time to make lifestyle choices and obtain treatment that will bring an enormous return on investment in old age,” says Terrie Moffitt, a professor of psychology and neuroscience at Duke University.
    • More scientists are looking for clues in the midlife brain because efforts to target dementia in older people have largely failed, says Ahmad Hariri, a professor of psychology and neuroscience also at Duke.
  • Beckers Hospital Review points out,
    • “Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.”Surprise pregnancies may be an unexpected side effect experienced by women who use Ozempic or other GLP-1 medications, The Washington Post reported April 5.
    • “Numerous social media platforms include posts and discussions about unplanned pregnancies while on Ozempic or similar drugs. Although the reports of a possible Ozempic “baby boom” are anecdotal, it is a phenomenon researchers and experts are watching closely. 
    • “Experts speculate that weight loss drugs may impact the absorption of contraceptives, causing birth control failures or that they can affect ovulation and fertility. Others say losing weight can improve chances of pregnancy.”
  • According to Fierce Healthcare,
    • “Supplemental benefits administrator Avesis and Elevance Health subsidiary Amerigroup Georgia have teamed up with Uber Health in a pilot project to tackle the state’s maternal health crisis.
    • “Utilizing community health partners like the Georgia Primary Care Association and federally qualified health centers (FQHCs), hundreds of Amerigroup’s Medicaid members in December 2022 started receiving two individualized nutritional counseling sessions, a scale and $300 of Uber Eats vouchers.
    • “Though the program’s results have not been shared yet, Avesis Senior Manager of Care Transformation Don Trainor said the program has had promising results so far.”
  • The AHA News tells us,
    • “Women with health-related social needs such as food insecurity, housing instability and lack of transportation were less likely to report receiving a mammogram in the past two years when surveyed in 2022, according to a report  released April 9 by the Centers for Disease Control and Prevention. About 66% of women aged 50-74 with at least three health-related social needs were up to date with their mammograms, compared with 83% of women with no health-related social needs. Mammography use also was lower among women without health insurance and a usual source of care.”  

From the U.S. healthcare business front,

  • United Health Group has refreshed its response to the cyberattack against Change Healthcare website.
  • Per Fierce Healthcare,
    • “Artificial intelligence categorization can help stem the flood of patient messages that would otherwise demand physicians’ expensive time, Kaiser Permanente researchers report.
    • “In a recently published JAMA Network Open research letter, members of the system’s research division and medical group outlined a strategy that used real-time natural language processing (NLP) algorithms to attach category labels to messages and then direct them to an appropriate respondent.
    • “The approach, they wrote, allowed 31.9% of the more than 4.7 million patient messages reviewed by program staff to be resolved before reaching the inbox of a specific physician. Instead, these messages were handed by a “regional team” made up of medical assistants or teleservice representatives, pharmacists and other doctors.”
  • and
    • “Consumers expect a simple and easy digital experience, and health plans have plenty of room to improve on that front, according to a new report.
    • “J.D. Power released its inaugural U.S. Health Insurance Experience Study on Tuesday, where it found that 42% of adults with insurance ran into issues using their plan’s website and/or mobile app in the past year.
    • “The study is based on responses from more than 5,500 people enrolled in the 14 largest Medicare Advantage (MA) plans and 15 largest commercial plans. It was conducted alongside Corporate Insight.”
  • Beckers Hospital Review names the “25 drugs at Mark Cuban’s online pharmacy with biggest cost reductions.”

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.

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.”

Monday Roundup

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

From Washington, DC,

  • American Hospital News tells us,
    • “The Centers for Medicare & Medicaid Services April 1 finalized proposed changes to Medicare Advantage plan capitation rates and Part C and Part D payment policies for calendar year 2025, which the agency estimates will increase MA plan revenues by an average 3.7% from 2024 to 2025.
    • “The notice implements expected changes to the Part C risk adjustment model that were finalized in the CY 2024 final rule and are being phased-in over three years, such as transitioning the model to reflect ICD-10 condition categories and using more recent data available for fee-for-service diagnoses and expenditures, in addition to providing technical updates to the methodology for CY 2025.
    • “It also finalizes technical updates to the Part C and D star ratings; includes certain adjustments to provide stability for the MA program in Puerto Rico; and implements changes to the standard Part D drug benefit required by the Inflation Reduction Act of 2022, including capping annual out-of-pocket costs for people with Medicare Part D at $2,000 in 2025.” 
  • Per an AHIP press release,
    • “Following the release of the final Medicare Advantage and Part D rate notice from the Centers for Medicare & Medicaid Services (CMS), AHIP President and CEO Mike Tuffin issued the following statement:
      • “These policies will put even more pressure on the benefits and premiums of 33 million Medicare Advantage beneficiaries who will be renewing their coverage this fall. It is important to note that the Medicare Advantage and Part D programs are already undergoing a number of significant regulatory and legislative changes. Moreover, the cost of caring for Medicare Advantage beneficiaries is steadily rising.
      • “Over the past several weeks, scores of bipartisan members of Congress and a diverse array of stakeholders have reinforced their strong support for Medicare Advantage. We appreciate these policymakers and organizations who stood up for the high-quality, affordable coverage and care seniors and people with disabilities count on in Medicare Advantage.”
    • “To view AHIP’s comment letter to CMS, click here.”
  • BioPharma Dive identifies five FDA decisions to watch in the second quarter of 2024, which began today.
  • Federal News Network tells us,
    • “The National Association of Letter Carriers tracks about 150 of these acts of heroism from its members every year. But each year, the union recognizes a select few for extraordinary acts of service.”The National Association of Letter Carriers tracks about 150 of these acts of heroism from its members every year. But each year, the union recognizes a select few for extraordinary acts of service.
    • “Some of NALC’s Letter Carrier Heroes of the Year put their own safety on the line to help save lives. Others led toy drives in their community and held annual charity concerts to make the holiday season extra special for families in need.
    • “NALC National President Brian Renfroe said letter carriers provide an essential service to their customers, and are the “eyes and ears of their communities.”
    • “No one knows our communities and our neighborhoods like letter carriers. We deliver on our routes six and even seven days a week. We get to know our customers. We get to know them better each and every day,” Renfroe said during an award ceremony last Wednesday.”
  • OPM offers a “Readout: OPM Director Kiran Ahuja Visits Houston to Tour NASA Space John Center and Deliver Remarks at the U.S. Customs and Immigration Services Naturalization Ceremony.”  
    • “Director Ahuja delivered remarks at a Naturalization Ceremony at the M.O. Campbell Educational Center. Ahuja welcomed 1,304 new citizens and presented certificates to members of the military and citizens with disabilities.   
      • “In her remarks, Ahuja shared her story and her parent’s journey to the United States, “I can still hear the pride in their voices when they spoke about coming to America and the opportunities this country opened for them. That gratitude led to a sense of purpose – to be engaged citizens; to always vote, because democracy is a gift that so many around the world live without; and to become meaningful part of the communities that we called home.”   
      • “Ahuja encouraged the group of newly naturalized citizens to be empowered by their diverse background and experiences, saying that “now that you’re here, know that you are every bit as important to America as America is to you. You are the future of this country – you will carry on the rich history of a nation made vibrant by the contributions of immigrant communities.”  
      • “Ahuja shared a note for those as new citizens looking to serve their communities and make an impact – stating, “there’s no better place to make a difference than the federal government.  We have influence in every sector and every corner of the country. Whatever your dream job is, there’s a version of it with the federal government. And no matter where you live, there are federal opportunities right there in your community.” 
  • Medscape calls attention to red flags to quicken ovarian cancer diagnosis.

From the public health and medical research front,

  • ABC News reports,
    • “Mpox, formerly known as monkeypox, cases are on the rise here in the U.S., with nearly double the number of infections compared to the same time last year, according to Centers for Disease Control and Prevention data.
    • “While the magnitude of the outbreak experienced in 2022 – where national cases topped 32,000 – is largely over, some high-risk groups need to continue taking precautions, experts say.
    • “Most of the cases that we’re seeing reported are either unvaccinated or under-vaccinated, meaning they either never received a vaccine, or they only got one dose,” Dr. Jenni McQuiston, deputy director of the CDC’s high consequence pathogens and pathology division told ABC News.
    • “The Jynneos vaccine comes in two doses and is recommended for those who have been exposed to someone with mpox as well as those who had a sex partner in the past 2 weeks who was infected. There are currently no recommendations for a booster. Locations offering the free vaccine can be found on the CDC website.
    • “Others eligible for the shot are those who identify as gay, bisexual, or a man who has sex with other men who have had more than one sexual partner or been diagnosed with more than one sexually transmitted disease in the past six months. Those with immune-compromising conditions, such as HIV, are also eligible.”
  • The American Medical Association tells us what doctors wish their patient knew about the contagious norovirus.
  • The Hill informs us,
    • “Sexually transmitted disease rates are rising among adults 55 years old and older, according to data from the Center for Disease Control and Prevention (CDC).
    • “Cases of gonorrhea have grown roughly sevenfold since 2010 among American adults older than 55, per the data.
    • “Meanwhile, the CDC numbers also show cases of chlamydia have more than quadrupled since 2010 among the same age group and syphilis cases in 2022 were nearly eight times higher.  
    • “Some researchers think STD rates are climbing in this age group because older adults are having more sex than in years past, according to reporting from The Washington Post. 
    • “On top of this, older adults rarely use protection, which increases the odds of spreading disease, according to a 2023 study published in peer-reviewed medical journal The Lancet. 
    • “This generation rarely considers using protection because they came of age at a time when sex education in school did not exist, HIV was virtually unheard of, and their main concern in seeking protection was to avoid pregnancy,” Janie Steckenrider, associate professor of political science at Loyola Marymount University and lead author of the study, writes.”
  • The Wall Street Journal reports,
    • “A person in Texas tested positive for avian influenza after exposure to dairy cattle presumed to be infected with the H5N1 bird flu, the Centers for Disease Control and Prevention said Monday. 
    • “The case marks the second known instance that a person in the U.S. has been infected with H5N1 bird flu. The person reported eye redness, or conjunctivitis, as their only symptom and is being treated with an antiviral drug. The human health risk of the bird flu remains low for the U.S. general public, the CDC said, but people with close, prolonged exposures to infected animals or their environments are at higher risk. 
    • “At this point, there’s nothing that suggests that there is any serious risk of a larger human outbreak,” said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security. “I’m trying to understand why the cows are getting infected. That’s a really important scientific question right now.”
  • Health Day lets us know,
    • “U.S. rates of suicide by all methods rose steadily for adolescents between 1999 and 2020, a new analysis shows.
    • “During those two decades, over 47,000 Americans between the ages 10 and 19 lost their lives to suicide, the report found, and there have been sharp increases year by year. 
    • “Girls and minority adolescents have charted especially steep increases in suicides, said a team led by Cameron Ormiston, of the U.S. National Institute on Minority Health and Health Disparities.
    • “An overall increasing trend was observed across all demographics,” the researchers wrote in a study published March 29 in the journal JAMA Network Open.”
  • and
    • “There are sociodemographic disparities in human papillomavirus (HPV) vaccine uptake among 27- to 45-year-olds, according to a study published online March 28 in Human Vaccines & Immunotherapeutics.
    • “Natalie L. Rincon, from Duke University in Durham, North Carolina, and colleagues explored any sociodemographic disparities in HPV vaccine uptake among 27- to 45-year-olds using data from the 2019 National Health Interview Survey (9,440 participants).
    • “The researchers found that women had more than three times greater odds of vaccine uptake versus men (adjusted odds ratio [aOR], 3.58). Non-Hispanic Blacks were more likely (aOR, 1.36) and Hispanics were less likely (aOR, 0.73) to receive the vaccine, compared with non-Hispanic Whites. Lower odds of uptake were seen among individuals without a usual place of care (aOR, 0.72) and in those with lower educational levels (highs school: aOR, 0.62; some college: aOR, 0.83).
    • “Males are in particular need of increased knowledge of the vaccine. For oropharyngeal cancer, about 75 percent of new cases are in males,” lead author Nosayaba Osazuwa-Peters, M.D., also of Duke University, said in a statement. “As oral HPV is the primary cause of HPV-associated oropharyngeal cancer, providing the HPV vaccine to middle-aged individuals is undoubtedly an important strategy to decreasing risk of infection, persistence, and eventual HPV-associated oropharyngeal malignancy.”
  • MedPage Today notes,
    • “Dropping pack-years for lung cancer screening eligibility in favor of a simpler 20-year history of smoking could substantially increase the number of cancers detected and eliminate racial disparities as well, according to an analysis of smokers from two large cohort studies.
    • “Under current screening criteria from the U.S. Preventive Services Task Force (USPSTF), which call for a 20-pack-year history of smoking, researchers found that 58% of Black patients with lung cancer in the Southern Community Cohort Study (SCCS) would have been eligible for screening, compared with 74% of white patients with lung cancer in SCCS.
    • “But these percentages would increase to 85.3% and 82%, respectively, with the proposed 20-year duration of smoking criteria, “thus eliminating the racial disparity in screening eligibility,” reported Chi-Fu Jeffrey Yang, MD, of Massachusetts General Hospital in Boston, and colleagues in the Journal of Clinical Oncologyopens in a new tab or window.
    • “Additionally, an analysis of the Black Women’s Health Study (BWHS) showed a switch to the simpler requirement would have increased the percentage of Black women who qualified for screening from 43% to 64%.”
  • The Wall Street Journal relates,
    • “Behind the blockbuster success of drugs like Ozempic and Wegovy is a less-noticed phenomenon: Some people don’t lose much weight on them.
    • “There is wide variation in weight loss on these types of drugs, called GLP-1s. Doctors say roughly 10% to 15% of people who try them are “non-responders,” typically defined as those who lose less than 5% of their body weight. These patients, doctors say, don’t experience enough appetite reduction to result in significant weight loss.
    • “Researchers are studying why some people drop a lot of weight on them while others lose little. The answers might yield broader clues about weight loss and provide more insight into these medications, which have transformed the way Americans lose weight.
    • “Doctors believe some people might be resistant to the drugs as a result of genetic differences. Other possible reasons could include certain medical conditions and medications, how much weight a person lost before taking the drugs, and differences in how people metabolize them.”

From the U.S. healthcare business front,

  • STAT News reports,
    • “The net prices that health plans paid for medicines — after subtracting rebates, discounts, and fees — fell by 2.8% in last year’s fourth quarter, the largest decline ever measured by SSR Health, a research firm that tracks the pharmaceutical industry and its pricing trends.
    • “A key reason for the big drop — which dwarfed the 0.4% decline seen at the same time a year earlier — was pricing pressure on the Humira treatment for rheumatoid arthritis and psoriasis. Over the past year, nine biosimilar versions of the medicine were launched by other companies seeking favorable placement on formularies, the lists of drugs for which health insurance coverage is available.
    • “As these companies battled to win placement, the Humira net price fell to roughly $29,800 at the end of last year from $48,000 at the end of 2022, a nearly 38% drop, the SSR analysis found. In fact, the entire category of rheumatoid arthritis medicines saw a 30% decline in annual net pricing, the largest such drop among all type of drugs. Meanwhile, net prices for psoriasis treatments fell nearly 10%. * * *
    • There were net price gains in two categories, however, which helped offset the declines elsewhere at the end of 2023. Notably, there was a 15.4% net price increase for GLP-1 medicines, which are used to treat diabetes and obesity. This group includes Wegovy and Ozempic, which are sold by Novo Nordisk, and Mounjaro and Zepbound, which are sold by Eli Lilly.
  • Beckers Hospital Review points out ten drugs now in shortage in the U.S.
  • The Wall Street Journal reports,
    • “Mental-health urgent-care sites are proliferating across the U.S. to treat the spiraling numbers of children and adults who need mental-health care and ease a shortage of therapists that has caused many people to wait months for appointments or go to the nearest emergency room to find help.
    • “The sites are starting to change the face of mental-health treatment, offering a much-needed alternative to emergency departments—long the first point of contact for people in mental-health straits—that have become strained by an increase in visits during the pandemic. 
    • “More than 20 mental-health urgent-care centers have opened in the past year alone from Colorado to Virginia. A letter published in the journal Psychiatric Services in 2021 identified 77 of the clinics across the U.S.”
    • “The sites can provide therapy and prescribe drugs or refer patients to a higher level of care if needed, said Katherine Du, a University of Pittsburgh School of Medicine student who was lead author on the letter. Some are run by hospitals, while others were established by private-equity firms. Many are in wealthy areas, but most accept Medicaid. 
    • “We want to get upstream to prevent the crisis,” said Dr. Aliya Jones, executive medical director of behavioral health at the Luminis Health Behavioral Health Urgent Walk-In Clinic in Lanham, Md., which opened in August 2022 and serves ages 4 and older.”
  • BioPharma Dive notes,
    • “The Food and Drug Administration has approved a first-of-its-kind drug for people with the rare and serious blood disease paroxysmal nocturnal hemoglobinuria, or PNH.
    • “Called Voydeya and owned by AstraZeneca, the drug is cleared for use as an add-on therapy to the standard PNH treatments, Ultomiris and Soliris, the pharmaceutical company already sells. It’s meant for the estimated 10% to 20% of people with PNH who still experience significant “hemolysis,” or premature destruction of red blood cells, despite treatment with those other drugs.
    • “The approval builds up a business AstraZeneca inherited when it bought Alexion Pharmaceutical for $39 billion in 2020. That deal established AstraZeneca as a player in rare disease research due to Ultomiris and Soliris, which are each approved for PNH as well as other conditions. The two drugs are among AstraZeneca’s top-selling products, generating more than $6 billion in combined sales in 2023.
    • “Alexion also had drugs in its pipeline, such as Voydeya, that were meant to defend against rising competition from companies like Novartis, Roche and Amgen. The company had acquired Voydeya, previously known as danicopan, when it bought Achillion Pharmaceuticals for nearly $1 billion in 2019.”

Friday Factoids

David Ermer–CDC, Government Contracting, Medical / Rx research, Rx coverage, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The New York Times reports,
    • A troubled heart pump that has now been linked to 49 deaths and dozens of injuries worldwide will be allowed to remain in use, despite the Food and Drug Administration’s decision to issue an alert about the risk that it could puncture a wall of the heart.
    • The tiny Impella pumps, about the width of a candy cane, are threaded through blood vessels to take over the work of the heart in patients who are undergoing complex procedures or have life-threatening conditions. * * *
    • “When reporting on outsize bleeding rates related to the Impella devices, Dr. Desai, of Yale, has also noted that its payments are far higher than the balloon pump, creating an urgent need for rigorous studies of how to best treat patients.
    • “You hate to think this is part of that story, but I think we would be naïve to think that that couldn’t be part of the story,” he said.”
  • The Labor Department’s Office of Federal Contractor Compliance Programs announced,
    • “Contractors that meet certain jurisdictional thresholds have an obligation to develop and maintain written Affirmative Action Programs (AAPs).
    • “The Contractor Portal is OFCCP’s platform where covered federal contractors and subcontractors must certify, on an annual basis, whether they are meeting their requirement to develop and maintain annual AAPs. The portal allows multiple users from individual organizations to register, manage records, and certify each establishment and/or functional/business unit, as applicable.
    • “Beginning April 1, 2024, federal contractors will be able to certify the status of their AAPs for each establishment and/or functional/business unit, as applicable. The deadline for certifying compliance is July 1, 2024.”

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “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, 9 jurisdictions experienced high activity compared to 10 jurisdictions experiencing high or very high activity the previous week. This 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, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, remains low.
    • “Reported on Friday, March 29th, 2024.“
  • The Hill informs us,
    • “Tuberculosis rates in the U.S. rose by 16 percent in 2023, marking the third year that cases went up following nearly 30 years of decline.
    • In the most recent Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC), the number of TB cases in 2023 totaled at 9,615, a jump of 1,295 over 2022.
    • “The last time annual TB cases in the U.S. were higher than 9,500 was in 2012, when 9,906 were detected. As the report noted, TB cases had declined for 27 years, reaching a record low of 7,171 in 2020 before creeping back up.
    • “While there is a vaccine for tuberculosis, the CDC notes that it’s mostly used in countries with a high prevalence of TB and isn’t recommended for use in the U.S. due to low risk of infection.
    • “In a January report to Congress, the United States Agency for International Development attributed the rise in TB cases globally to the disruptions brought on by the COVID-19 pandemic.
    • “After two years of COVID-19-related disruptions to TB prevention, diagnosis, and treatment efforts, 2023 had the highest number of people diagnosed and started on treatment since the beginning of the disease’s global monitoring in 1995 that affected access to and provision of health services – due in part to concerted efforts to recover from the pandemic’s devastating global impact,” the agency said.”
  • The Washington Post reports,
    • “The Centers for Disease Control and Prevention issued a health advisory Thursday [March 27] about a rise in rare but severe forms of meningococcal infections. These bacterial infections can cause potentially life-threatening inflammation of the membranes surrounding the brain and spinal cord.
    • “The CDC says 422 cases were reported in 2023, the highest annual number seen since 2014. Of the 94 cases with known outcomes, 17 died. Since March 25, 143 cases have been reported to the CDC — 62 more cases than what was seen over the same time period in 2023.
    • “The spike is notable in part because infections are disproportionately affecting people ages 30 to 60, as well as African American individuals and those with HIV. Typically, infants younger than 1, teenagers and young adults ages 16 to 23 as well as individuals older than 85 have a higher risk of contracting meningococcal disease.
    • “The agency says health-care experts should increase monitoring for meningitis symptoms, and the public should take steps to prevent its spread.
    • “We’re not recommending any unusual precautions,” said Lucy McNamara, an epidemiologist in the meningitis and vaccine-preventable diseases branch at the CDC.
    • “We would like for the general public to be aware of the symptoms of meningococcal disease and to contact their health-care provider if they or members of their family have those symptoms,” she said, adding that officials also “want to make sure that they’re up to date for meningococcal vaccinations.”
  • Per BioPharma Dive,
    • “Bristol Myers Squibb’s cancer pill Krazati helped people with a certain kind of non-small cell lung cancer live longer without their disease progressing and shrank tumors at a higher rate than those given chemotherapy, the company said Thursday.
    • “The data could help Bristol Myers persuade the Food and Drug Administration to convert Krazati’s conditional approval into a full clearance, potentially giving it an advantage over Amgen’s rival drug Lumakras. Amgen’s bid to gain confirmatory approval was unsuccessful, and the company has four years to complete another trial testing its pill.
    • “Both Krazati and Lumakras target tumors harboring a mutation in a gene called KRAS — a long-sought goal of drugmakers. While their uptake is currently modest, both Bristol Myers and Amgen are working to expand their use into earlier lines of treatment and other types of cancer.”

From the U.S. healthcare business front,

  • CNN calls our attention to the fact
    • “For the first time, women in the US can walk into a store and buy a supply of birth control pills right off the shelf, without the need for a prescription or health insurance.
    • “Opill, the first oral contraceptive approved by the US Food and Drug Administration for over-the-counter use, has arrived at most stores in certain retail pharmacy chainssuch as CVS, Walgreens and Walmart.
    • “The product is “is now available at CVS.com and through the CVS Pharmacy app and is arriving at more than 7,500 CVS Pharmacy stores in the coming weeks,”spokesperson Matt Blanchette said in an email. “For added privacy and convenience, customers will be able to choose same-day delivery or buy online and pick-up in store.”
    • “Walgreens began offering Opill in late March, spokesperson Samantha Stansberry said.
    • “The product “will be available at Walgreens nationwide in the family planning aisle and behind the pharmacy,” Stansberry said in an email. “Customers can also purchase the product online for 30-minute Pickup, 1-hour Delivery, or ship to home.”
    • “At Walmart, “it is currently available on walmart.com and will be in stores in early April,” spokesperson Tricia Moriarty said in an email.”
  • Kaufmann Hall issued its March National Hospital Flash Report on March 27.
    • “Key Takeaways
      • “Margins this month were at 3.96%, continuing a strong start to 2024. However, data
        this month do not reflect the full impact of the Change Healthcare outage, which
        began February 21st.
      • “Gross revenue continues to rise at a faster rate than net revenue, highlighting payer
        mix changes. Bad debt and charity care have also risen over the last few years.
      • “Revenue growth is primarily being driven from the outpatient setting. There
        continues to be a decline in inpatient revenue and increase in outpatient revenue.”
  • STAT News lets us know,
    • “Diabetes drugs are too expensive in the U.S., and insulin is infamously six to 13 timesmore expensive here than in comparable high-income countries. And blockbuster GLP-1 drugs, too, could be a lot less expensive, according to an investigationpublished this week in JAMA Network Open, with a simple change: robust generic competition.
    • “The study, led by Melissa Barber, a Yale postdoctoral fellow, and conducted in collaboration with Doctors Without Borders, a nonprofit medical organization working in low-resource and emergency settings, found that making a generic vial of insulin could cost $61 to $111 per year — 97% less than than the current market price in the U.S., based on an estimate that factors in a 10% to 50% profit margin. * * *
    • “Findings for the cost of making GLP-1 biosimilars were along the same lines. Researchers calculated that the cost of producing a patient’s monthly supply of a GLP-1 drug would range from $0.75 to $72.50; currently, Ozempic costs about $1,000 a month in the U.S, $155 in Canada, and less than $60 in Germany, according to a statement by Sen. Bernie Sanders, who cited the study as evidence of pharmaceutical overpricing and called on Novo Nordisk to lower the price of Ozempic.”
  • and
    • “The staff of the Institute for Clinical and Economic Review, or ICER, are known as the nerds of the drug industry: bespectacled killjoys who emerge a few times a year to scold drugmakers for pricing their latest cancer or MS advance far beyond reason.
    • “But last year, they sat down and concluded a forthcoming treatment was worth up to $3.9 million — more than any medicine in history, more than a 45-year supply of Humira, the autoimmune drug often held up as an emblem of America’s runaway drug spending. 
    • “It was a testament to the power of a new class of gene therapies to deliver something pharma so rarely does: Genuine cures. The treatment, approved last week as Lenmeldy, may allow some babies born with an ultra-rare neurodegenerative disease called metachromatic leukodystrophy, or MLD, to grow up and live essentially normal lives.
    • “David Rind, ICER’s chief medical officer, compared Lenmeldy to Zolgensma, a gene therapy approved in 2019 for spinal muscular atrophy that the nonprofit estimated could be worth up to $2.1 million. * * *
    • “Lenmeldy, Rind said, is still overpriced. Orchard Therapeutics, Lenmeldy’s developer, is tacking on an additional $325,000, for a $4.25 million total. But its price falls closer to those estimates, as a percentage, than the vast majority of medicines it reviews.”
  • Healthcare Dive brings us “inside CVS Health’s push to transform customer experience. The transformation, led by Deloitte Digital, focused on increasing customer feedback to identify pervasive issues and closing the loop on customer inquiries.”
  • Beckers Payer Issues relates,
    • “UnitedHealth Group has named CFO John Rex as president of the company. 
    • “Mr. Rex is taking over the president role from COO Dirk McMahon, who plans to retire. UnitedHealth Group has not announced a successor in the COO role. Mr. McMahon spent 20 years in various leadership positions at UnitedHealth Group, and was named president and COO in 2021.  
    • “According to a March 28 regulatory filing, Mr. Rex will assume the president role April 1, in addition to his current position as CFO.” 

Thursday Miscellany

David Ermer–CDC, CMS, COVID-19, Medical / Rx research, Medicare, NCQA, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Per HHS press releases, HHS issued the following proposed rules released today (links are to fact sheets);
    • a proposed rule to update Medicare payment policies and rates for the Inpatient Psychiatric Facilities Prospective Payment System (IPF PPS) for fiscal year (FY) 2025,
  • and
    • a proposed rule (CMS-1810-P) that would update Medicare hospice payments and the aggregate cap amount for fiscal year (FY) 2025,
  • and
    • “a proposed rule that would update Medicare payment policies and rates for skilled nursing facilities under the Skilled Nursing Facility Prospective Payment System (SNF PPS) for fiscal year (FY) 2025.” 
  • Here is the fact sheet for the Departments of Health and Human Services (HHS), Labor, and the Treasury (collectively, the Departments) final rules regarding short-term, limited-duration insurance (STLDI) and independent, noncoordinated excepted benefits coverage under the Affordable Care Act released today. 
  • Per the American Medical Association News,
    • The Office of Management and Budget March 28 released its final updated standards for Federal agencies on maintaining, collecting and presenting data on race and ethnicity. Last updated in 1997, the revised Statistical Policy Directive Number 15 is the product of an OMB Interagency Technical Working Group on Race and Ethnicity Standards. While SPD 15 does not mandate race and ethnicity data collection by federal agencies, it requires federal agencies to adhere to standardized data definitions, collection and presentation practices wherever they do collect or use such data. Among other changes, the revised SPD 15 requires that race and ethnicity be collected using a single question with multiple responses, superseding OMB’s previous requirement to collect Hispanic ethnicity as a separate question. In addition, SPD 15 adds a category for Middle Eastern or North African (MENA) as a minimum reporting category and requires federal agencies to collect more detailed information on race and ethnicity beyond the seven minimum reporting categories. However, agencies may request and receive exemptions from OMB in instances where the potential benefit of more detailed data do not justify the additional burden to the agency or the public, or where the collection of more detailed data would threaten privacy or confidentiality. 
    • The updated SPD 15 is effective immediately. However, federal agencies have until March 28, 2029, to bring existing data collection and reporting activities into compliance with the updated SPD 15 and must submit action plans to OMB on how they will comply with the requirements by Sep. 28, 2025.
  • OPM made a passing reference to this guidance today on the second day 0f the OPM carrier conference.
  • The Labor Department’s Office of Federal Contractor Compliance Programs issued “Updated Annual Hiring Benchmark and New Benchmark Resources” for the veteran’s affirmative action in employment law that applies to FEHB carriers.

From the public health and medical research front,

  • Mercer discusses weight management in the era of GLP-1 drugs.
  • The NIH Director, in her blog, points out that an “Immune Checkpoint Discovery Has Implications for Treating Cancer and Autoimmune Diseases.”
  • The Washington Post reports,
    • “Diabetes, air pollution and alcohol consumption could be the biggest risk factors for dementia, study has found.
    • “Researchers compared modifiable risk factors for dementia — which is characterized by the impairment of memory, thinking and reasoning — and studied how these factors appear to affect certain brain regions that are already particularly vulnerable to Alzheimer’s disease and schizophrenia.
    • “The research, based on brain scans of nearly 40,000 adults, between ages 44 and 82, in Britain was published Wednesday in Nature Communications.”
  • Health Day informs us,
    • “Some folks struggling with obesity appear to be hampered by their own genes when it comes to working off those extra pounds, a new study finds.
    • “People with a higher genetic risk of obesity have to exercise more to avoid becoming unhealthily heavy, researchers discovered.
    • “Genetic background contributes to the amount of physical activity needed to mitigate obesity. The higher the genetic risk, the more steps needed per day,” said senior researcher Douglas Ruderfer, director of the Center for Digital Genomic Medicine at Vanderbilt University Medical Center in Nashville, Tenn.”
  • MedPage Today lets us know,
    • “For adults who are immunocompromised, the updated 2023-2024 COVID-19 vaccine reduced risk of hospitalization compared with not getting the shot, according to CDC data.
    • “Vaccine effectiveness against hospitalization was 38% in the first 7 to 59 days after receipt of the updated monovalent XBB.1.5 COVID vaccine, and 34% in the 60 to 119 days after receipt, reported Ruth Link-Gelles, PhD, of the CDC’s National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.
    • “However, despite the positive effect, only 18% of people in this high-risk population had received the updated COVID vaccine, “representing a missed opportunity to prevent severe COVID-19,” the authors wrote.”
  • Medscape notes,
    • “Starting an exercise regimen with others can be a powerful fitness motivator, and new research spotlights the strategy’s particular importance for older adults.
    • “In a randomized clinical trial in JAMA Network Open, older adults who talked with peers about their exercise program were able to increase and sustain physical activity levels much better than those who focused on self-motivation and setting fitness goals.
    • “Such self-focused — or “intrapersonal” — strategies tend to be more common in health and fitness than interactive, or “interpersonal,” ones, the study authors noted. Yet, research on their effectiveness is limited. Historically, intrapersonal strategies have been studied as part of a bundle of behavioral change strategies — a common limitation in research — making it difficult to discern their individual value.
    • “We’re not saying that intrapersonal strategies should not be used,” said study author Siobhan McMahon, PhD, associate professor and codirector of the Center on Aging Science and Care at the University of Minnesota, in Minneapolis, Minnesota, “but this study shows that interpersonal strategies are really important.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “The first major U.S. health insurers have agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions.
    • “CVS Health,  Elevance Health, and Kaiser Permanente said they would cover 
    • “Novo Nordisk’s Wegovy for the use of reducing the risk of heart attacks and strokes in people who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan.
    • “Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan.
    • “Some of the plans, including Kaiser Permanente’s, are making the coverage change effective immediately, while others, including those served by Elevance, will do so in the coming weeks.”
  • Axios informs us,
    • “The federal process for resolving billing disputes for out-of-network care has to date yielded payouts well above what Medicare and most in-network private insurers would pay providers, according to a new Brookings Institution analysis provided first to Axios. 
    • “Why it matters: That could lead to downstream effects like higher premiums — quite the opposite of what Congress intended when it passed a law banning surprise medical bills in 2020.
    • “What they found: Brookings analyzed Centers for Medicare and Medicaid Services data on arbitration decisions to settle disputed claims during the first half of 2023. 
    • “Researchers specifically focused on emergency care, imaging and neonatal and pediatric critical care.
    • “Across the three categories, median payouts were at least 3.7 times what Medicare would pay, Brookings found. 
    • “For emergency care and imaging, the median decision was at least 50% higher than the most generous payments commercial plans historically made, on average, for in-network care. 
    • “Similar estimates weren’t available for neonatal and pediatric critical care.
    • “The analysis concludes that there is a “realistic possibility” that the law will wind up raising in-network prices and, in turn, premiums.
    • “That’s the opposite of what the Congressional Budget Office predicted would happen.”
  • Interesting study but its conclusion is undercut by the fact that many providers accept the qualifying payment amount the the plans initially pay under the No Surprises Act.
  • Per Healthcare Dive,
    • Walgreens reported an almost $6 billion net loss in the second quarter, according to financial results released Thursday. Nearly all of that sum was attributable to the declining value of a single play: VillageMD, the primary care chain into which Walgreens has poured billions of dollars, but which has generated disappointing returns to date.
    • Walgreens was forced to write down VillageMD’s value after its financial team flagged a mismatch in the subsidiary’s value as recorded in its balance sheet and its value in the market, CFO Manmohan Mahajan told investors on a Thursday morning call. That discrepancy led Walgrens to record a $5.8 billion goodwill impairment charge.
  • and
    • “UCI Health has completed its $975 million purchase of four Southern California hospitals from Tenet Healthcare, the academic health system said Tuesday. Tenet announced the sale in February as part of an ongoing effort to fund debt repayment.”
  • and
    • “Ascension has signed a definitive agreement to divest three hospitals and an ambulatory surgical center in northern Michigan to MyMichigan Health, the health systems said Tuesday. 
    • “The deal includes Ascension St. Mary’s in Saginaw, Ascension St. Joseph in Tawas City, Ascension St. Mary’s in Standish and ambulatory surgery center and emergency department Ascension St. Mary’s Towne Center in Saginaw. Related care sites and physician practices are also included. 
    • “Ascension has recently sold other hospitals as the nonprofit expands its ambulatory and telehealth footprint.”

Friday Factoids

David Ermer–ACA, CDC, Congress, COVID-19, FDA, Generative AI, Medical / Rx research, Mental health care, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • The Wall Street Journal reports,
    • “House lawmakers approved a $1.2 trillion package of spending bills Friday over significant Republican opposition in the GOP-led chamber—sending the bill to the Senate, where lawmakers were working to pass the measure by a midnight deadline to avoid a partial government shutdown.
    • “The House vote was 286 to 134, barely exceeding the two-thirds supermajority needed to approve the bill under a special procedure needed by House Speaker Mike Johnson (R., La.) to bypass internal GOP divisions in his razor-thin majority.” * * *
    • “With the House done with the measure, Senate Majority Leader Chuck Schumer(D., N.Y.) took steps to begin the process of considering the bills. This typically takes several days, but could happen within hours if all 100 senators agree to a quicker voting timeline. Funding is scheduled to run out for the Defense Department and several other agencies at 12:01 a.m. on Saturday, which would force them to shut down nonessential operations.
    • “President Biden has said he would sign the legislation.”
  • Beckers Payer Issues informs us,
    • “A group of Republican lawmakers are asking CMS to reconsider its proposed 2025 rates for Medicare Advantage. 
    • “Forty-five lawmakers signed a letter to CMS Administrator Chiquita Brooks-LaSure expressing concerns the proposed rates could lead health plans to cut benefits for older adults and harm the viability of the program. 
    • “It is baffling that CMS has proposed a nearly 0.2% cut to the Medicare Advantage insurer reimbursement rate for 2025,” the lawmakers wrote. 
    • “CMS proposed cutting benchmark payments for Medicare Advantage plans by 0.2% in 2025. The agency says plans should expect to see 3.7% higher revenue overall, with an MA risk score trend of 3.86% — the average increase in risk adjustment payments year over year — offsetting risk model revisions and a projected decline in star rating bonuses. 
    • “The insurance industry has decried the rate notice, calling it insufficient to cover rising medical costs among MA beneficiaries. Some insurers have said they will likely cut supplemental benefits for beneficiaries to offset decreasing benchmark payments.” 
  • The Centers for Medicare and Medicaid Services announced,
    • “Today, the U.S. Department of Health and Human Services (HHS) issued four new reports showing that President Biden’s efforts to strengthen the Affordable Care Act (ACA) are linked to historic gains in Americans’ health insurance coverage. Today’s announcements include a report from the Centers for Medicare & Medicaid Services (CMS) showing that over 21 million consumers selected or were automatically re-enrolled in health insurance coverage through HealthCare.gov and State-based Marketplaces during 2024’s Open Enrollment Period (OEP). Three reports from HHS’s Office of the Assistant Secretary for Planning and Evaluation (ASPE) highlight current enrollment trends, enrollment trends broken down by race and ethnicity, and how the ACA Marketplaces have evolved and strengthened during the first ten years. ASPE analysis shows that today over 45 million people have coverage thanks to the Affordable Care Act’s Marketplaces and Medicaid expansion.” 
    • People buy it because of the low price but do they use it effectively?

From the public health and medical research front,

  • The Centers for Disease Control inform us
    • “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, 9 jurisdictions experienced high or very high activity compared to 17 jurisdictions the previous week.
    • “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, COVID-19 wastewater viral activity levels, which reflects both symptomatic and asymptomatic infections, is low.
    • “Reported on Friday, March 22nd, 2024.”
  • The New York Times considers “What’s Next for the Coronavirus? Scientists studying the virus’s continuing evolution, and the body’s immune responses, hope to head off a resurgence and to better understand long Covid.”
    • “We’re not in the acute phases of a pandemic anymore, and I think it’s understandable and probably a good thing” that most people, including scientists, have returned to their prepandemic lives, said Jesse Bloom, an evolutionary biologist at the Fred Hutchinson Cancer Center in Seattle.
    • “That said, the virus is still evolving, it’s still infecting large numbers of people,” he added. “We need to keep tracking this.”
  • That’s a reassuring statement.
  • The Wall Street Journal tells us,
    • “Grief is well recognized as a process people go through after losing a loved one. But less attention is paid to the grief of people with chronic illnesses and disabilities for the losses they’ve suffered. 
    • “The grief of those with chronic health issues—for the loss of capabilities, for changed or ruptured relationships, for changes in appearance, for the forced end of a career, or for former dreams for the future—can last for long periods and recur often, as losses and uncertainty become a constant feature of life.
    • “What’s the next thing that [my conditions are] going to take from me?” asks Andrew Gurza, a disability-awareness consultant who has cerebral palsy and chronic illness. “What’s the next thing that I’m not able to do anymore?”
    • “People who have intimate knowledge of the grief that comes with chronic health issues say it has a trajectory all its own—a trajectory that many mental-health professionals, friends and family often don’t understand. The idea that everyone goes through five stages of grief—denial, anger, bargaining, depression and acceptance—doesn’t ring true for many disabled people. Chronic illness, other disabilities and the grief they bring often run an unpredictable course, easing but then flaring up again, a cycle that can recur over time. * * *
    • “Mel Sebastiani, an end-of-life doula and former chaplain who is seeking diagnosis for her own neurological illness, says that with her clients, she emphasizes “deep listening and finding out what that person likes, misses—and [finding] a way to weave it back into their lives in a way that they can manage.” 
    • “For Sebastiani herself, that meant coping with new symptoms by switching from steep mountain-trail hikes to walks on the beach to collect and photograph sea glass and other natural treasures near her home in Rehoboth Beach, Del.  
    • “While grief will persist, it may not always be a negative or debilitating experience. “You can be in grief and be a strong person,” Sebastiani says.
    • “Grief is a powerful tool and coping mechanism to realize where you are in the moment, where your life is a reflection on your life in the past,” she says. “And it’s kind of a gift in that sense, because many healthy people never reflect on any of that.”
  • The International End of Life Doula Association discusses their profession.
    • “A doula can become involved any time in a person’s life. We offer support when people are impacted by a life changing illness, after a terminal diagnosis, when death is imminent, or even after a death—to help with light grief support. Sometimes family members or loved ones of the person dying seek support and guidance from end-of-life doulas.
    • “Doulas normalize deathcare by creating spaces to hold conversations leading to increased communication and increased spiritual and emotional well being. When individuals plan for death, they have autonomy over their decisions and are able to clearly define their end-of-life wishes with family and loved ones. While there are alternative names for end-of-life doulas like death doula, death midwife, death coach, end-of-life coach—we all seek to provide compassionate deathcare.”
  • Medscape lets us know,
    • “Use of statin drugs was associated with improved mortality in older nursing home residents, regardless of dementia status, a new study showed.
    • “The study is among the first to explore whether statin use in older nursing home residents offers a mortality benefit, especially among individuals with dementia, a group largely excluded from earlier statin trials.
    • “Investigators’ analysis of 4 years of data on nearly 300,000 nursing home residents revealed that statin use was associated with a 40% lower risk for all-cause mortality than statin nonuse in those without dementia and a 20% lower risk in those with dementia.
    • “These findings may provide evidence that supports the continued use of statins in older nursing home patients with multiple medical conditions,” lead author Julie Lorraine O’Sullivan, PhD, of the Charité – Universitatsmedizin Berlin, Freie Universität Berlin, German Center for Mental Health, Berlin, Germany, and colleagues wrote.
    • “The study was published online on February 27 in Neurology.”
  • and
    • “A new way of using artificial intelligence (AI) can predict breast cancer five years in advance with impressive accuracy — and unlike previous AI models, we know how this one works.
    • “The new AI system, called AsymMirai, simplifies previous models by solely comparing differences between right and left breasts to predict risk. It could potentially save lives, prevent unnecessary testing, and save the healthcare system money, its creators say.
    • “With traditional AI, you ask it a question and it spits out an answer, but no one really knows how it makes its decisions. It’s a black box,” said Jon Donnelly, a PhD student in the Department of Computer Science at Duke University, Durham, North Carolina, and first author on a new paper in Radiology describing the model.
    • “With our approach, people know how the algorithm comes up with its output so they can fact-check it and trust it,” he said.”
  • mHealth Intelligence relates,
    • “Direct-to-consumer (DTC) telehealth visits resulted in higher rates of antibiotic prescriptions for pediatric patients than telehealth visits conducted by primary care physicians (PCPs), according to a new study by UPMC.
    • “Published in JAMA Open Network, the study aimed to assess antibiotic prescriptions for pediatric acute respiratory tract infections during telehealth visits with PCPs compared with virtual visits conducted by commercial DTC telehealth companies.
    • “High rates of antibiotic prescriptions raise concerns about antibiotic resistance, which occurs when germs develop the ability to defeat the drugs designed to kill them. Antibiotic-resistant infections can be challenging to treat, often requiring second- and third-line treatments that can have harmful side effects. In some cases, these infections have no treatment options.”

From the Food and Drug Administration (FDA) front,

  • Per an FDA press release,
    • “Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). 
      Pemgarda is authorized for individuals:
      • “who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2; 
      • “and who have moderate-to-severe immune compromise due to a medical condition or due to taking immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. 
    • “For more information about Pemgarda and its authorization, please see the resources available on the FDA’s Emergency Use Authorization webpage.”
  • Per Medpage Today,
    • “The FDA approved label expansions for bempedoic acid (Nexletol) and bempedoic acid/ezetimibe (Nexlizet) so they can be used more broadly as cardiovascular prevention drugs, Esperion announced Fridayopens in a new tab or window.
    • “Based on the CLEAR Outcomes trialopens in a new tab or window, the two adenosine triphosphate (ATP) citrate lyase inhibitor drugs are now indicated for adults with either established atherosclerotic cardiovascular disease (CVD) or high risk for a CVD event to reduce the risk of myocardial infarction (MI) and coronary revascularization. Approval does not require patients to be on existing statin therapy.”
  • Per MedTech Dive,
    • “The Food and Drug Administration’s plan to expand oversight of laboratory-developed tests threatens to prevent or delay patient access to innovative diagnostics, industry groups warned in congressional testimony Thursday.
    • “The FDA’s final rule on LDT regulation, which could come as soon as April, has unleashed a fierce debate over how to protect the health and safety of patients by ensuring tests developed in a single laboratory are accurate and reliable but still reach the market quickly. The agency received nearly 7,000 comments on the proposed rule, which would broaden its authority to regulate the tests.
    • “Laboratory-developed tests really are the cutting edge when it comes to leading the foundational work for personalized medicine,” Susan Van Meter, president of the American Clinical Laboratory Association, told a House Energy and Commerce health subcommittee hearing. The Clinical Laboratory Improvement Amendments program certifies LDTs under the current regulatory framework.”

From the U.S. healthcare business front,

  • Beckers Hospital Review points out,
    • Jellico (Tenn.) Regional Hospital, a 25-bed critical access facility, closed March 9, making it the 36th rural hospital to shutter or no longer provide inpatient services since 2020, according to data compiled by the University of North Carolina’s Cecil G. Sheps Center for Health Services Research. 
    • The closures highlight the heightened financial challenges that rural hospitals face amid persisting workforce shortages, rising costs and leveling reimbursement. In addition, only 45% of rural hospitals now offer labor and delivery services, and in 10 states, less than 33% do, according to the Center for Healthcare Quality and Payment Reform.
    • The article lists the rural hospitals that have closed.
  • Per Fierce Healthcare,
    • “Uncomfortable waiting rooms. Revealing hospital gowns. Confusing insurance. Exhausting travel between appointments.
    • “These are just some reasons cancer is in desperate need of a rebrand, experts said at this year’s SXSW conference.
    • “Oncology was a major focus across multiple sessions, where clinicians and patient advocates called for better access to specialty care, more thoughtful communication with patients and continued collaboration across stakeholders.”
  • Per HR Dive,
    • “Seventy-one percent of senior finance leaders plan to give raises of at least 4% in 2024, outpacing inflation in most areas, according to the results of a survey by Gartner, Inc., which were released March 20. The majority (58%) said they intended to raise compensation by between 4% and 9% this year. 
    • “Compensation ranked second among the areas where leaders said they planned to increase budgets this year, beaten only by technology investments, which were a priority for 82% of the 296 CFOs and senior finance leaders surveyed in December. However, fewer leaders intended to award raises of 10% or more, the survey found. 
    • “Even with tighter economic policy and pressure from boards and investors on profitable growth and employee productivity, CFOs are outpacing inflation that has now almost returned to a neutral rate below 3%,” Alexander Bant, chief of research in the Gartner finance practice, said in a statement. “The fact that most CFOs are planning for pay growth that exceeds the level of inflation indicates how tight the labor market is right now and how important it is to find and retain top talent.”
  • Mercer Consulting informs us,
    • “Gen Z is redefining the employer-employee relationship and that includes how voluntary benefits are structured and offered.  
    • “By 2025, Gen Z (those born 1997−2021) will comprise 27% of the workforce, and this group has far different expectations than their older peers. With voluntary benefits supporting all aspects of total rewards, the right solutions can help solve the most pressing talent questions — including how to resonate with the newbies in the workplace. Mercer’s latest National Survey of Employer-Sponsored Health Plans found that as employers have broadened the range of voluntary benefits offered, a growing portion of their workers are choosing to enroll in them – 45% of eligible employees on average, up sharply from 36% in 2022. * * *
    • “Gen Z respondents in the survey were more likely than older workers to say that benefits are a reason to stay with their employer. Designing the right benefits program is a way to partner with Gen Z on improving their physical, mental and emotional health and their financial well-being — and it shows that their employer is listening and cares about their holistic experience.”   
  • Per Healthcare Dive,
    • “Consumers are willing to share their health data, but they’re becoming pickier about which entities they’ll provide that information to, according to a survey from consultancy and digital health venture capital firm Rock Health. 
    • “Ninety percent of respondents said they’d share their data with at least one healthcare entity, the survey found. While 64% reported they’d offer data to a doctor or clinician, only 7% would share with a technology company.
    • “Consumers were also willing to share data with fewer entities in 2023 compared with 2020. The wariness is a warning for the sector, as data sharing is key to informing new treatments, studying disease trends and training healthcare artificial intelligence models, the report said.” 

Thursday Miscellany

David Ermer–AHRQ, CDC, CMS, Congress, Cybersecurity, Electronic health records, FDA, HSA, Medical / Rx research, Medicare, Mental health care, NCQA, U.S. Healthcare–
Photo by Josh Mills on Unsplash

From Washington, DC,

  • Roll Call reports,
    • “Lawmakers released a more than $1.2 trillion, six-bill appropriations package early Thursday morning, less than 48 hours ahead of a Friday night deadline for this second and final wrapup measure for the fiscal year that began Oct. 1. 
    • “Both parties were touting “wins” in the package well before unveiling the massive 1,012-page bill, which had already won President Joe Biden’s blessing and pledge to sign it “immediately.” That, plus the lure of a two-week recess, should help get the package over the finish line, though it seems likely to slip past the 11:59 p.m. Friday cutoff for the current stopgap spending law.
    • “But lawmakers weren’t really sweating the prospect of a weekend funding lapse, given its limited impact on government operations — especially with Friday’s expected House passage likely to be a strong signal of congressional intent to keep the lights on.”
  • The bill includes appropriations for OPM (pages 247 – 250) and its Inspector General (page 250) plus the three now standard appropriations measures:
    • A prohibition against imposing full Cost Accounting Standards coverage on FEHB carriers. Division B, Section 611, page 268.
    • The Hyde amendment limiting FEHB coverage of abortions to cases “where the life of the mother would be endangered if the fetus were carried to term, or the pregnancy is the result of an act of rape or incest.” Division B, Section 613 and 614, pages 268 – 269.
    • A contraceptive prescription drug coverage mandate with conscience protections for FEHB plans and healthcare providers. Division B, Section 726, page 298.
  • The American Hospital Association News discusses HHS appropriations, which also are included in this bill.
    • “The House may vote on the measure Friday, with Senate action expected over the weekend. A short government shutdown may occur over the weekend, depending how long it takes both chambers to pass the measure and for President Biden to sign it into law.” 
  • Govexec points out “the nine biggest agency and program reforms in the final FY24 spending package.”
  • The Wall Street Journal scoops,
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday. * * *
    • “Some Medicare members could get help paying for the popular new weight-loss drug Wegovy—as long as they have a history of heart disease and are using it to prevent recurring heart attacks and strokes.
    • “Medicare Part D drug-benefit plans—which are administered by private insurers—may cover anti-obesity medications if the drugs receive approval for an additional use that is considered medically accepted under federal law, the Centers for Medicare and Medicaid Services told The Wall Street Journal on Thursday.”
  • STAT News adds,
    • “Early data regarding the use of GLP-1 medications like Ozempic and Wegovy to treat addiction is “very, very, exciting,” Nora Volkow, the director of the National Institute on Drug Abuse, said Thursday.
    • “But even as she expressed enthusiasm for the new drugs’ potential, Volkow criticized pharmaceutical companies for neglecting a moral imperative to develop new addiction treatments — but acknowledged that the health system more broadly doesn’t incentivize drug companies to treat the U.S. drug crisis with urgency.”
  • The U.S. Preventive Services Task Force finalized its research plan for re-evaluating its September 2019 recommendations on the topic of medications to reduce the risk of breast cancer.
  • Beckers Health IT interviews Alexandra Mugge, chief health informatics officer at CMS, about the agency’s efforts “to expedite prior authorizations, through digitization and better data exchange, saving the healthcare industry $15 billion over a decade — in the hopes of one day having the decisions made instantaneously, right in the EHR.”

From the Food and Drug Administration front,

  • Per a press release,
    • “Today, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.
    • “DMD denies the opportunity for a healthy life to the children it affects. The FDA is committed to advancing the development of new therapies for DMD,” said Emily Freilich, M.D., director of the Division of Neurology 1, Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research. “This approval provides another treatment option to help reduce the burden of this progressive, devastating disease for individuals impacted by DMD regardless of genetic mutation.”
  • MedTech Dive informs us,
    • Johnson & Johnson subsidiary Abiomed recalled its Impella left sided blood pumps for risk that the devices could perforate the heart during a procedure. The recall began on Dec. 27 with Abiomed updating its instructions for use.
    • The Food and Drug Administration identified the recall as a Class I event, the most serious type of recall, in a Thursday notice. The agency has received 129 reports of serious injuries, including 49 deaths, related to the problem. 
    • Abiomed’s Impella heart pumps, which are used to support the heart during procedures or during cardiogenic shock, were the subject of four Class I recalls last year, including the latest recall. The company also received an FDA warning letter for quality problems with Impella and software used in the device that had not been authorized by the agency.

From the public health and medical research front,

  • The CDC shares with us,
    • Data from the National Vital Statistics System
      • Life expectancy for the U.S. population in 2022 was 77.5 years, an increase of 1.1 years from 2021.
      • The age-adjusted death rate decreased by 9.2% from 879.7 deaths per 100,000 standard population in 2021 to 798.8 in 2022.
      • Age-specific death rates increased from 2021 to 2022 for age groups 1–4 and 5–14 years and decreased for all age groups 15 years and older.
      • The 10 leading causes of death in 2022 remained the same as in 2021, although some causes changed ranks. Heart disease and cancer remained the top 2 leading causes in 2022.
      • The infant mortality rate was 560.4 infant deaths per 100,000 live births in 2022, an increase of 3.1% from the rate in 2021 (543.6).
  • STAT News adds,
    • “The U.S. recorded 107,941 drug overdose deaths in 2022, according to a new federal report — a total that marks an all-time record but also shows signs that the country’s overdose rate may finally be leveling off after years of steady increase.
    • “The 2022 total marks only a slight increase from the drug death toll of 106,699 the year before, according to the Centers for Disease Control and Prevention. The flattening of drug death rates could provide a rare glimmer of hope amid the bleak U.S. drug crisis, which has seen overdose rates rise inexorably for the past two decades and especially during the Covid-19 pandemic.
    • “A large majority of those deaths were driven by the potent synthetic opioid fentanyl. Since emerging in the drug supply in the mid-2010s, fentanyl has increasingly come to dominate the U.S. illicit drug market. Even as fentanyl deaths have skyrocketed, the share of deaths involving other opioids — like heroin, methadone, and prescription painkillers — has decreased.”
  • The Washington Post reports,
    • “After once losing hope because of end-stage kidney disease, a 62-year-old man is now the first living person to receive a genetically edited kidney from a pig, according to doctors at Massachusetts General Hospital who performed the landmark surgery Saturday.
    • “Richard Slayman, whom doctors praised for his courage, is doing well after the four-hour surgery and is expected to be discharged from the Boston hospital soon, officials said.
    • “The advance, which builds on decades of work, gives hope to the hundreds of thousands of Americans who depend on dialysis machines to do the work of their failing kidneys. Each day, 17 Americans die awaiting a kidney transplant, a problem further complicated by unequal access given to Black and other patients. Doctors expressed hope that using pigs to vastly increase the supply of kidneys might correct the inequity.”
  • The Wall Street Journal lets us know,
    • “A new class of anticoagulant drugs on the horizon is taking fresh aim at one of cardiology’s toughest challenges: how to prevent blood clots that cause heart attacks and strokes, without leaving patients at risk of bleeding.
    • “At least a half-dozen experimental blood thinners are in development that inhibit a protein called factor XI, one of several blood factors that regulate how the body forms clots. * * *
    • “Any factor XI agent that reaches the market would likely represent an important advance over drugs called factor Xa inhibitors, a blockbuster class of medicines dominated by Eliquis and Xarelto. Since they were approved just over a decade ago, these drugs have supplanted warfarin as the standard-of-care anticoagulant to prevent stroke in patients with the heart-rhythm disorder atrial fibrillation as well as other indications.”
  • HealthDay informs us,
    • “About 1 in every 10 U.S. children ages 5 to 17 has been diagnosed with attention deficit hyperactivity disorder (ADHD), according to the latest government statistics.
    • “The data from the National Health Interview Survey covers the years 2020 through 2022 and came from in-person or phone interviews involving a representative sample of American homes.
    • “It found that 11.3% of school-age children have been diagnosed with ADHD, with boys more likely to have this diagnosis (14.5%) than girls (8%), according to report authors Cynthia Reuben and Nazik Elgaddal, of the National Center for Health Statistics (NCHS).
    • “ADHD is diagnosed more often among white children (13.4%) than Black youngsters (10.8%) or Hispanic (8.9%) kids, the survey also showed. 
    • “Family income seemed to matter, too:  As income levels rose, the rate of child ADHD diagnoses declined.”
  • WTW, an actuarial consulting firm, offers insights on hepatitis C, HPV vaccine and value based insurance design.

From the U.S. healthcare business front,

  • STAT News reports,
    • “The last decade has seen billions of dollars flow into digital health companies that promise to improve outcomes for the 38 million Americans living with type 2 diabetes. Their products aren’t cheap, but in the long term, they pitch to health plans and employers that these digital tools will help cut health care costs by preventing serious complications like amputation and kidney failure.
    • “A systematic review by the Peterson Health Technology Institute found, though, that digital tools used to manage diabetes with the help of finger-stick blood glucose readings don’t result in clinically meaningful improvements over standard care. As a result, they don’t reduce health care spending — they drive it up.
    • “Most of the solutions in this category do not deliver clinical benefits that justify their cost,” Caroline Pearson, executive director of the institute, told STAT. Despite finding that some populations may benefit, the report concludes that current evidence doesn’t support broader adoption for most products.”
  • Plan Sponsor notes,
    • “In the face of rising health care expenditures and out-of-pocket spending, average health savings account balances have also steadily increased since the COVID-19 pandemic, according to new data from the Employee Benefit Research Institute.
    • “The average HSA balance rose to $4,418 at the end of 2022 from $2,711 at the start of the year, the most recent data available in EBRI’s database, given that participants can still contribute to 2023 HSAs until taxes are due in April.
    • “Jake Spiegel, a research associate at EBRI, says he sees this trend continuing in 2023 and into the start of 2024 as well.
    • “EBRI’s analysis revealed two predominant factors associated with higher average account balances. The first was that age is strongly associated with higher HSA balances: the older the accountholder, the higher the average balance.”
  • Beckers Hospital Review lets us know,
    • “Change Healthcare said it has reinstated Amazon cloud services for two of its platforms a month into a cyberattack against the company.
    • “The UnitedHealth Group and Optum subsidiary said March 20 it restored Amazon Web Services from backups for Assurance, a claims and remittance management program, and claims clearinghouse Relay Exchange. Change said it rebuilt authentication services for the solutions on a new network with the help of cybersecurity firms Palo Alto Networks and Mandiant, a Google subsidiary. The company said it is also testing the security of the external-facing parts of those applications.”
  • Per the Society for Human Resource Management,
    • “Employees are experiencing more mental health struggles and overall negative feelings about their work, underscoring an “urgent need” for employers to take more aggressive measures to help with their benefits offerings.
    • “Employees are now more likely to experience negative feelings at work, including stress (12 percent more likely) and burnout (17 percent more likely) than they were pre-pandemic (2019), according to new data from MetLife. Employees are also 51 percent more likely to feel depressed at work than they were pre-pandemic as they face what the insurer calls a “complex macro environment and permacrisis state”—a state which has included the pandemic, persistent high inflation, international turmoil and war, and more.
    • “Those are among the findings in MetLife’s 22nd annual U.S. Employee Benefit Trends Study, released March 18—data indicating that employers may have to revisit benefits offerings to not only support employees, but retain them.”
  • HR Dive explains “How menopausal and other reproductive health benefits can help retain women” and “Data shows that fertility treatments are extremely valuable to workers who need them. Here’s why one people officer is working on integrating them.”
  • STAT News relates,
    • “Just as Pfizer spooked Wall Street after its record pandemic revenue came parabolically back to earth, BioNTech, the company’s Covid-19 vaccine partner, is now dealing with investor malaise of its own.
    • “Shares in the German firm fell about 5% yesterday, hitting a 52-week low, after the company reported disappointing financials. BioNTech’s cut of Covid vaccine revenue fell by about more than three-quarters last year, missing analyst estimates and leading the company to lower its projections for 2024.
    • “Now BioNTech, much like Pfizer, is making the case that its future in oncology will compensate for the rapid erosion in demand for Covid vaccines. The company has more than 20 cancer medicines in its pipeline, including late-stage treatments for tumors of the breast and lung that could hit the market in the next two years.”
  • Per Healthcare Dive,
    • “Walgreens-backed VillageMD sold 11 locations in Rhode Island to Boston-based medical group management firm Arches Medical Partners for an undisclosed sum, Arches said Wednesday.
    • “The practices, which include about 75,000 patients, joined Arches on March 2, according to VillageMD’s website. 
    • “The deal follows VillageMD clinic closures. The primary care chain recently exited Florida — once one of chain’s largest markets — and plans to withdraw from its home state in Illinois next month.”