Monday Roundup

Congress

Monday Roundup

David Ermer–Congress, COVID-19 vaccine, FDA, Medical / Rx research, Mental health care, NIH, OPM, Rx coverage, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC,

  • Federal News Network tells us,
    • “The Biden administration has now ended many of the policies that previously dictated agencies’ health and safety responses to the COVID-19 pandemic. But for federal employees, the administration is still offering some on-the-job flexibility for the foreseeable future.
    • “One of the few remaining policies from a series of 2021 executive orders lets federal employees still take up to four hours of paid administrative leave to get COVID-19 vaccine booster shots, the Office of Personnel Management said in an April 12 memo.
    • “The administration strongly encourages federal employees to get recommended doses of updated COVID-19 vaccines even when receiving those vaccines is not a job requirement,” OPM Director Kiran Ahuja said in the memo addressed to agency heads. “Vaccines remain the best tool we have in our toolbox to combat COVID-19. They are safe, effective and free.”
    • “For federal employees, the offered administrative leave will cover the time it takes to get the COVID-19 booster shot, as well as feds’ travel time to and from the vaccination site. As is standard, employees should get approval from their supervisors before taking leave for this purpose, OPM said. Four hours is the maximum OPM is allotting, but federal employees should only take off as much time as they actually need to get the shot.”
  • OPM should take the same approach with cancer screening services, such as colonoscopies and mammographies.
  • The American Hospital Association News reports,
    • “The Change Healthcare cyberattack was a significant event that caught many off guard, said the Centers for Medicare & Medicaid Services Administrator Chiquita Brooks-LaSure, reiterating the agency’s commitment to supporting impacted hospitals. Brooks-LaSure stated the Administration is listening to stakeholders and when possible, facilitating solutions, noting the importance of meeting the needs of providers.
    • “In addition, Brooks-LaSure celebrated important improvements CMS made to promote greater transparency for prior authorization criteria. CMS took steps earlier this year finalizing new regulations to streamline and reduce burden associated with the prior authorization process in Medicare Advantage and fee-for-service and managed care programs for Medicaid and the Children’s Health Insurance Program.  
    • “CMS continues to hear from patients and providers over some commercial insurer prior authorization denials and delays, Brooks-LaSure said, noting that the volume of frustration has “just exploded.” The private sector, she said, has an opportunity to step up with solutions of their own to address concerns.
    • “I’ve told the health plans this: it doesn’t have to all be regulated [by the federal government], there may be things that they can do,” Brooks-LaSure said.”
  • Beckers Payer Issues adds,
    • “AHIP’s chief executive criticized the hospital lobby’s response to the Change Healthcare cyberattack as “opportunistic” and “maintaining the status quo.”
    • “AHIP President and CEO Mike Tuffin pointed to comments that hospital lobbyists made to the media about the hack being “another talking point” to prevent health systems from implementing site-neutral payments, as well as an industry association’s opposition to cybersecurity mandates.
    • “Insisting on maintaining the status quo simply makes the healthcare system a more inviting target for the ever-more sophisticated hacking operations targeting the sector,” Mr. Tuffin wrote in the April 12 article. “Instead of taking a constructive leadership role in what can be done to protect consumers and the system moving forward, the hospital lobby chooses to use the moment to point fingers and shirk responsibility.”
    • “Rather than “playing politics,” all industry stakeholders should be focusing on preventing and preparing for future healthcare cyberattacks, he said.”
  • HR Dive reports,
    • “The U.S. Equal Employment Opportunity Commission announced on Monday its final rule implementing the Pregnant Workers Fairness Act, clarifying that abortion is included under “pregnancy, childbirth or related medical conditions” that are protected under the PWFA.
    • “EEOC said this interpretation of the law’s text is “consistent with the Commission’s and courts’ longstanding interpretation of the same phrase in Title VII.” It also noted that employees are entitled to the law’s provisions even if they have not worked for an employer for a specific length of time.
    • “EEOC had originally slated the rule for publication at the end of 2023, but the commission’s deadline passed without a rule in place. The rule is scheduled to be published in the Federal Register Friday, and will take effect 60 days after publication, approximately mid-June.”
  • The Government Accountability Office released a report on selected States regulation of pharmacy benefit managers.

From the public health and medical research front,

  • The Washington Post considers why
    • “Rural Americans ages 25 to 54 — considered the prime working-age population — are dying of natural causes such as chronic diseases and cancer at wildly higher rates than their age-group peers in urban areas, according to the report. * * *
    • “The USDA researchers analyzed mortality data from the Centers for Disease Control and Prevention from two three-year periods — 1999 through 2001, and 2017 through 2019. In 1999, the natural-cause mortality rate for rural working-age adults was only 6 percent higher than that of their city-dwelling peers. By 2019, the gap had widened to 43 percent.” * * *
    • “The USDA’s findings were shocking but not surprising, said Alan Morgan, CEO of the National Rural Health Association. He and other health experts have maintained for years that rural America needs more attention and investment in its health care systems by national leaders and lawmakers.”
  • “MedPage Today editor-in-chief Jeremy Faust, MD, talks with Monica Bertagnolli, MD, the 17th director of the National Institutes of Health (NIH), about the day-to-day work at the NIH on pandemic preparedness, the importance of looking for new approaches to testing, and the status of long COVID research.”
  • Healio points out,
    • “Physical activity patterns that included vigorous exercise, housework or walking were associated with lower stroke risk.
    • “Watching TV and commuting were linked to higher risk for stroke.”
  • Per Medscape,
    • “Low- to moderate-intensity physical exercise in patients with severe mental illness is linked to improved medication adherence, regardless of medication type or duration of illness, new research shows.
    • “The positive association between adherence and moderate physical activity emphasizes that physical activity improves overall health and functional status. Promoting physical activity can be a valuable and integrated strategy that can be easily implemented into our routine clinical practice,” said study investigator Rebecca Silvestro, MD, Department of Psychiatry, Università degli studi della Campania Luigi Vanvitelli in Naples, Italy.
    • “The findings were presented at the European Psychiatric Association 2024 Congress.” 

From the U.S. healthcare business front,

  • STAT News reports,
    • “The number of new prescriptions written for biosimilar versions of the Humira rheumatoid arthritis treatment, one of the best-selling medicines in the U.S., surged to 36% from just 5% during the first week of April, thanks to the expanding reach that CVS Health has over the prescription drug market.
    • “The big jump was attributed to one particular biosimilar called Hyrimoz, which is manufactured by Sandoz, a former unit of Novartis that is a leading supplier of generic and biosimilar medicines. However, Hyrimoz is jointly marketed with Cordavis, a new subsidiary that CVS created last August specifically to sell any number of biosimilar medicines in the U.S.
    • “This connection is crucial to the sudden jump in Hyrimoz prescriptions. How so? On April 1, CVS Caremark, which is one of the largest pharmacy benefit managers in the U.S., removed Humira from its major national formularies for health plans that cover about 30 million lives. Formularies are the lists of medicines that are covered by health insurance.
    • “The move quickly shifted market share to Hyrimoz. During the week ending March 29, the number of new prescriptions written for the biosimilar was about 640, but rose to nearly 8,300 in the week ending April 5, according to a report to investors by Evercore ISI analyst Elizabeth Anderson. That pushed the share for all Humira biosimilars to 36%, with Hyrimoz contributing 93% of the growth.”
  • Health Leaders Media discusses three ways that independent physician practices can maintain their independence.
  • According to BioPharma Dive,
    • “Roche’s new dual-acting blood cancer drug Columvi combined with chemotherapy helped people with a type of lymphoma live longer than people given Rituxan and chemo, the company said Monday. The data could help Roche persuade the Food and Drug Administration to convert Columvi’s conditional OK into a full approval.
    • “Roche didn’t disclose full data from the Phase 3 “Starglo” trial in people with diffuse large B-cell lymphoma whose disease advanced after initial treatment and who weren’t eligible for stem cell transplants. The results will be presented at an upcoming medical meeting, the company said.
    • “Columvi is a new type of drug called a “bispecific” antibody that triggers an immune response to cancer cells. A competitor developed by Genmab and AbbVie has also gained accelerated approval and could have confirmatory data later this year, while the FDA rejected a bispecific from Regeneron because its confirmatory trial isn’t far enough advanced.”
  • MedTech Dive reports,
    • “Abbott is recalling thousands of Heartmate II and Heartmate 3 left ventricular assist systems because biological material can build up and obstruct the devices, making them less effective at pumping blood, the Food and Drug Administration said Monday.
    • “Reports of 273 injuries and 14 deaths have been linked to the problem, with the material typically taking two or more years to accumulate, according to the recall notice. The FDA identified the action as a Class I recall, the most serious type.
    • “Heartmate devices are used to support patients with severe left ventricular heart failure who are awaiting a heart transplant, or the device can be permanently implanted when a transplant isn’t an option. In February, Abbott told customers in an urgent correction letter there is no need to return any products to the company.”

Weekend Update

David Ermer–Congress, Medical / Rx research, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • The Supreme Court holds its final two weeks of oral arguments for the current term this month.

From the public health and medical research front,

  • The Wall Street Journal discusses advances in Alzheimer’s Disease care.
  • NPR Shots explains new approaches to treating lung cancer.
  • Fortune Well lets us know –
    • “Can’t focus on the task at hand or feeling sluggish beyond the afternoon slump? One possible cause: iron-deficiency anemia (IDA). 
    • “About 3 million Americans have anemia, according to the U.S. Centers for Disease and Prevention Disease and Prevention (CDC), and those are just the people who’ve been diagnosed. Many others live with the condition for years without realizing it. * * *
    • “After figuring out the underlying cause, the next plan of action is treatment. For many, iron supplements are the answer. Your doctor may recommend over-the-counter iron pills to replenish the iron stores in your body. However, these tablets are not a one-size-fits-all solution.”  
  • STAT News reports,
    • “Amid the many demands of practicing medicine, doctors can have less time and energy for their patients, and those relationships can suffer. Yet research has shownthat when physicians show empathy, that can generally lead to better clinical outcomes, at least over the near-term. Now, a new study, published Thursday in JAMA Network Open, demonstrates that those benefits can extend longer and be even more effective than some clinical therapies in dealing with lower back pain, which affects half of the U.S. population in any given year.
    • “Researchers at the University of North Texas Health Science Center at Fort Worth, observing patients with lower back pain over the course of 12 months, found that treatment by a “very empathic” physician was associated with better outcomes at the end of that year than treatment by a “slightly empathic” physician. And those positive outcomes were greater than those associated with nonpharmacological treatments (exercise therapy, yoga, massage therapy, spinal manipulation, acupuncture, cognitive behavioral therapy), opioid therapy, and lumbar spine surgery.”

From the U.S. healthcare business front,

  • Beckers Hospital Review lists “27 critical access hospitals to know for 2024.”
    • “These hospitals are vital components of the overall healthcare delivery system, providing quality care to the residents and visitors of rural areas. The small but mighty organizations are working to expand access to specialty care, cut down on patient travel times, and improve community health. 
    • “Critical access hospitals are those that offer 24/7 emergency care and have no more than 25 inpatient beds. While compiling this list, the editorial team examined rankings and awards from several respected organizations, including Healthgrades, the National Rural Health Association and the Chartis Center for Rural Health.”
  • Fierce Healthcare reports,
    • “A year ago, Blue Shield of California joined forces with Accolade and TeleMed2U to launch Virtual Blue, a new plan that centers on virtual care for members with the goal of boosting access.
    • “And with that first year on the books, the insurer is seeing positive results in Virtual Blue, it revealed Friday. Members were more likely to visit their primary care doctors compared to those in a more traditional PPO plan. Blue Shield saw primary care claims increase by 31% in 2023 compared to 2022.
    • “People who enroll in Virtual Blue are able to secure virtual visits with a $0 copayment and can schedule appointments online with their clinician, making it easier to fit critical visits into their daily lives. In-person care is available whenever appropriate or when the member prefers, Blue Shield said.”

Thursday Miscellany

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

From the legal news front,

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

Midweek Update

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

From Washington, DC

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Weekend Update

David Ermer–Congress, Federal employment benefits, Medical / Rx research, OPM, SDOH, U.S. Healthcare, Uncategorized–

Today is World Health Day.

  • McKinsey & Co. tells us,
    • “The good news: People are living longer. The bad news: People are spending more time in poor health. Global longevity has risen substantially in the past 60 years, increasing life spans by 20 years on average, but every additional year of life is paid for with an average of six months in ill health. According to a recent report from the McKinsey Health Institute (MHI), a focus on immediately influenceable interventions at the city level can add approximately 20 billion to 25 billion years of higher-quality life at a global level—that’s an average of five additional years per person living in urban areas. All organizations across sectors have a role to play to capture this opportunity, write McKinsey’s Hemant Ahlawat, Erica Hutchins Coe, Pooja Kumar, and Drew Ungerman.”
  • On April 5, 2024, “House Committee on Oversight and Accountability Chairman James Comer (R-Ky.) announced a markup will take place on Wednesday, April 10 at 10:00 am ET to consider a series of legislation,” including
    • H.R. 7868, the FEHB Protection Act: The bill requires federal agencies to verify that an employee is eligible to add a family member to their Federal Employees Health Benefits Program (FEHBP) health coverage plan. This bill also requires the Office of Personnel Management (OPM) to consider coverage of ineligible individuals when conducting FEHBP fraud risk assessments and requires a comprehensive audit be conducted of employee family members currently enrolled in the FEHBP. Finally, the bill requires OPM to disenroll any ineligible individual found to be receiving FEHBP coverage.
  • Congress should be including in H.R. 7868 a provision requiring federal agencies to use the HIPAA 820 electronic enrollment roster transaction which would allow carriers to systematically reconcile individual enrollees with their premium payments. None of the provisions in HR 7868 would provide a greater improvement in internal controls than implementing the HIPAA 820 because half of the FEHB enrollment is self only. Moreover, what is the sense of confirming family member enrollment if the enrollee in question is not paying for family coverage?
  • The current premium reconciliation process known as CLER was implemented in 2001, eleven years before the HIPAA 820 was introduced. The time has long passed for CLER to be replaced by the much more efficient HIPAA 820.

From the FEHB front,

  • FedWeek highlights how FEHB plans coordinate their benefits with other coverage.
  • Tammy Flanagan writing in Govexec discusses the importance of knowing Medicare and FEHB coordination of benefit rules before requesting agency help.
  • In the Federal Times, Reg Jones answers the following question “Will my spouse be covered once I qualify for Medicare Part B?

From the public health and medical research front,

  • The National Institutes of Health announced today,
    • “Adults with heart disease risks who received daily reminders or incentives to become more active increased their daily steps by more than 1,500 after a year, and many were still sticking with their new habit six months later, according to a study supported by the National Institutes of Health that published in Circulation(link is external).
    • “The improvements, which also resulted in an extra 40 minutes of moderate exercise each week, correlated with a 6% reduced risk of premature death and a 10% reduced risk of cardiovascular-related deaths, compared to data from prior studies. The Department of Health and Human Services recommends(link is external) that most adults should get at least 150 minutes of moderate aerobic exercise per week, such as brisk walking, or 75 minutes of vigorous exercise, like fast cycling, or a combination of the two, paired with twice-weekly strength sessions.
    • “Researchers found that while a simple daily reminder was effective in helping people move more, offering financial incentives or point-based rewards, such as in a game, was even more effective. However, combining the two incentives proved most effective. Participants who got both were still logging improvements in activity levels six months after the rewards stopped.
    • “Even moderate exercise can drastically reduce cardiovascular risk, so finding low-cost ways to get people moving and stay in a fitness program that they can do at home is a huge win for public health,” said Alison Brown, Ph.D., R.D., a program officer at the National Heart, Lung, and Blood Institute (NHLBI), part of NIH.”
  • The New York Times offers an interview with Dr. Nora Volkow, the director of the National Institute on Drug Abuse.
    • What’s the big picture on teens and drug use?
      • People don’t really realize that among young people, particularly teenagers, the rate of drug use is at the lowest risk that we have seen in decades. And that’s worth saying, too, for legal alcohol and tobacco.
    • What do you credit for the change?
      • One major factor is education and prevention campaigns. Certainly, the prevention campaign for cigarette smoking has been one of the most effective we’ve ever seen.
      • Some of the policies that were implemented also significantly helped, not just making the legal age for alcohol and tobacco 21 years, but enforcing those laws. Then you stop the progression from drugs that are more accessible, like tobacco and alcohol, to the illicit ones. And teenagers don’t get exposed to advertisements of legal drugs like they did in the past. All of these policies and interventions have had a downstream impact on the use of illicit drugs. * * *
      • “But we don’t want to become complacent. The supply of drugs is more dangerous, leading to an increase in overdose deaths. We’re not exaggerating. I mean, taking one of these drugs can kill you.”
  • Fortune Well explores the non-invasive colorectal cancer screening alternatives to a full blown colonoscopy.
  • The Washington Post reports,
    • “Black and White patients face significant disparities in access to kidney transplants depending on whether their residential neighborhoods and transplant centers were racially segregated, a recent study has found.
    • “The study, published in JAMA Internal Medicine, looked at 162,587 first-time live-donor kidney transplantation candidates in the national transplant registry from January 1995 through December 2021. Participants were tracked for an average of 1.9 years. * * *
    • “Overall, 7.1 percent of Black candidates in segregated neighborhoods received a live kidney transplant over a three-year period, while 9 percent of their Black counterparts in less segregated areas received a transplant. The percentage of White candidates who received similar transplants was similar in highly segregated neighborhoods and more diverse areas during the period — 19.7 percent and 20.1 percent, respectively. * * *
    • “The analysis adds to a growing body of literature about social disparities that affect Black patients’ access to kidney transplantation in the United States. Overall, Black patients are likelier to develop kidney failure than their White counterparts, yet they experience treatment delays and are less likely to get kidneys from live donors.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Four in 10 therapists are planning to raise their fees in 2024, a new survey has found.
    • “Heard, a bookkeeping and accounting firm for therapy practices, surveyed more than 2,260 therapists across all 50 states and D.C. The findings were published in a report on the financial state of private practices. It found that half of therapists are somewhat or very concerned about the economy impacting their practice in the coming year.
    • “At the same time, in last year’s report, 64% of therapists said they were planning to raise their fees in 2023. Yet only a third did.
    • “Despite cash pay popularity, three-quarters of therapists still accept some form of insurance. Aetna was the most common payer with which therapists paneled, followed by Cigna, Blue Cross Blue Shield, Anthem and Oxford. Aetna also had the highest average reimbursement rate at $141 per session, while Humana had the lowest at $96.’ 

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.

Weekend update

David Ermer–Congress, Medical / Rx research, OPM, U.S. Healthcare–

Happy Easter! Yesterday, the FEHBlog read about a 1964 Italian film called the Gospel According to St. Matthew. The FEHBlog found and watched the film on the Concierge Channel following two UConn basketball victories. The film is available on YouTube.

From Washington, DC,

  • Congress continues it break from Capitol Hill this week.
  • Last Wednesday, OPM’s PBM pharmacy benefits panel at the FEHB carrier conference featured a New Jersey attorney who was warning that plan sponsors can be held liable for PBM contracting mismanagement, pointing to the Lewandowski v. Johnson & Johnson case.   Here is a link to the defense counsel’s letter to the federal district court in New Jersey describing Johnson & Johnson’s strong (in my opinion) defenses in that ERISA case and a link to a related 1st Circuit ERISA opinion from earlier this year.  In any case, as the FEHBlog pointed out at the conference, FEHB plans are exempt from ERISA as governmental plans.

From the public health and medical research front,

  • The Washington Post reports,
    • “More than three-quarters of sudden infant deaths involved multiple unsafe sleep practices, including co-sleeping, a recent analysis suggests.
    • “A study published in the journal Pediatrics looked at 7,595 sudden infant death cases in a Centers for Disease Control and Prevention registry between 2011 and 2020. The majority of deaths occurred in babies less than 3 months old.
    • “The statistics revealed that 59.5 percent of the infants who died suddenly were sharing a sleep surface at the time of death, and 75.9 percent were in an adult bed when they died. Though some demographic factors such as sex and length of gestation were not clinically significant, the researchers found that the babies sharing a sleep surface were more likely to be Black and publicly insured than those who didn’t share sleep surfaces. Soft bedding was common among all the infants who died, and 76 percent of the cases involved multiple unsafe practices.
    • “The analysis mirrors known risk factors for sudden infant death. Current recommendations direct parents and other caretakers to provide infants with firm, flat, level sleep surfaces that contain nothing but a fitted sheet. Though room sharing reduces the risk of sudden infant death, CDC officials discourage parents from sharing a sleep surface with their child.”
  • Fortune Well tells us,
    • “Oral health isn’t one of the most exciting self-care practices—but it’s an important one. What’s going on in your mouth is a strong indicator of your overall well-being. So, brushing and flossing every day isn’t just a bid for your dentist’s approval, it’s a win for your overall health. 
    • “Experts say there’s one more way to look after your teeth and gums: rinsing your mouth with water after you eat. * * *
    • “Every time you eat, your saliva breaks food down for digestion which will create an acid byproduct,” explains Lilya Horowitz, DDS, of Domino Dental in Brooklyn, New York. “This leads to more biofilm and plaque buildup, so rinsing with a neutral or basic water can help lower the pH in the mouth.” In an acidic environment or an environment below 4.5 pH, the enamel of the teeth will start to break down.”
  • MedPage Today lets us know,
    • Starting medication for alcohol use disorder (MAUD) at hospital discharge reduced readmission risk, a cohort study suggested.
    • Of nearly 10,000 alcohol-related hospitalizations of Medicare beneficiaries, only 2% (192) involved initiation of MAUD at the time of discharge, Eden Bernstein, MD, of Massachusetts General Hospital in Boston, and colleagues found.
    • In this small number, MAUD initiation at discharge was linked with a 42% decreased incidence of returning to the hospital within 30 days (incident rate ratio [IRR] 0.58, 95% CI 0.45-0.76, the researchers reported in JAMA Network Open. 
  • MedTech Dive informs us,
    • “Exact Sciences shared early results of a test it is developing with Mayo Clinic to screen for esophageal cancer and its precursors.
    • “The test, called Oncoguard Esophagus, uses an encapsulated sponge device to collect esophageal cells. DNA is extracted from the cells and processed in a PCR assay. The results from the assay are run through an algorithm, which provides a positive or negative result, Paul Limburg, Exact Sciences’ chief medical officer of screening, wrote in an email. 
    • “The test, which is designed to be less invasive than an endoscopy, detected esophageal adenocarcinoma and Barrett’s esophagus, a known precursor to the cancer, according to results published in Clinical Gastroenterology and Hepatology. The National Institutes of Health and Exact Sciences funded the study.”
  • Per Medscape,
    • “Artificial intelligence (AI) has identified two plant-based bioactive compounds with potential as glucagon-like-peptide-1 receptor (GLP-1R) agonists for weight loss as possible alternatives to pharmaceutical weight-loss drugs, but with potentially fewer side effects and oral administration.
    • “Using AI, the work aimed to identify novel, natural-derived bioactive compounds that may activate the GLP-1R, which is the site of action of existing weight loss pharmaceutical drugs including semaglutide (Wegovy, Novo Nordisk) and dual agonist tirzepatide (Zepbound, Eli Lilly).
    • “Presenter Elena Murcia, PhD, of the Structural Bioinformatics and High-Performance Computing Research Group & Eating Disorders Research Unit, Catholic University of Murcia, Murcia, Spain, will be sharing her work at the upcoming European Congress on Obesity (ECO 2024) in May.”

From the U.S. healthcare business front,

  • Beckers Payer Issues relates,
    • “UnitedHealthcare’s Surest is the organization’s fastest growing commercial health plan, boasting no deductibles and a shoppable healthcare experience built around price transparency.
    • “In March, Aon published an analysis of medical and pharmacy spending among Surest members in 2021 and 2022, totaling more than 92,000 and 156,000, respectively. Aon compared the experience of Surest members to that of a control group composed of members from a multi-employer database with matching geography, demographics, and medical and mental health comorbidities during the same time periods.
      • “Surest members had $365 lower total spend per-member per-year in 2021 and $412 lower spend in 2022.
      • “Surest’s total cost of care was 7.5% lower in 2021 and 7.7% lower in 2022.
      • “Results in 2022 were driven by 96.7% lower allowed medical claims and 78.8% lower allowed drug claims.
      • “Key drivers of cost efficiencies in 2022 were 93.1% lower professional spend and 71.5% lower specialty pharmacy spend.”
  • Healthexec and KFF discuss the state of concierge medicine.
    • “Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.
    • “It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.”

Midweek Update

David Ermer–Congress, Federal employment benefits, Medicare, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • From a Senate press release,
    • Today, Senator Rick Scott and Senator Tom Carper announced the bipartisan FEHB Protection Act to stop fraud within the Federal Employee Health Benefits (FEHB) program, the largest employer-sponsored health insurance program in the country which covers eight million federal employees, retirees and family members. The FEHB Protection Act will codify Government Accountability Office (GAO) and Office of Inspector General (OIG) recommendations to require the Office of Personnel Management (OPM) to verify eligibility before adding family members, additionally, the bill requires an audit and removal of those ineligible for the program to ensure taxpayer dollars are used wisely and program benefits are protected for truly eligible individuals. This legislation follows a study conducted by the GAO at Senator Scott’s request, which revealed that OPM’s mismanagement of the FEHB program allowed ineligible individuals to obtain employer-sponsored health coverage at the hefty price tag of approximately $1 billion in taxpayer dollars every year.
    • The FEHBlog doubts the accuracy of GAO’s projection because half of the FEHB enrollment is self only and FEHB family sizes are notoriously small. In any case, this approach will not solve the problem because OPM reports enrollment actions and premiums separately even though using the HIPAA 820 electronic enrollment roster transaction would allow carriers to confirm receipt of premium for each enrollee systematically.
  • From the American Hospital Association News,
    • The Centers for Medicare & Medicaid Services March 27 finalized a rule proposed in 2022 to standardize Medicaid and CHIP enrollment and renewal processes and make it easier for eligible children and adults to stay covered. According to CMS, the final rule eliminates CHIP waiting periods, annual and lifetime coverage limits and the practice of locking children out of coverage if a family is unable to pay premiums; improves the transfer of children from Medicaid to CHIP when a family’s income rises; gives individuals at least 15 days to provide additional information when applying for the first time and 30 days to return documentation when renewing coverage; prohibits conducting renewals more often than every 12 months; and prohibits in-person interviews for older adults and those with disabilities. The rule takes effect 60 days after publication in the April 2 Federal Register.
  • and
    • The Centers for Medicare & Medicaid Services March 27 released the fiscal year 2025 proposed rule for inpatient rehabilitation facilities, which would update IRF payments by an estimated 2.8% overall (or $280 million) in FY 2025. This includes a 3.2% market basket update, which is reduced by a 0.4% productivity adjustment. IRF payments would be further decreased by an estimated $25 million due to the proposed update for outlier payments.
  • and
    • The Department of Health and Human Services’ Administration for Strategic Preparedness and Response and Centers for Medicare & Medicaid Services this week released a guide to health plan resources for health care providers impacted by the Change Healthcare cyberattack, including health plan contact information, noting in an accompanying letter that many providers continue to face significant disruptions as a result of the cyberattack or difficulty getting information from health plans about prospective payments and other flexibilities. The letter also encourages providers to review HHS’ voluntary cybersecurity performance goals.
  • It is worth adding that the United Healthcare Group updated its Change Healthcare Cyberattack response page today.

From the public health front,

  • The Washington Post reports,
    • “On Monday, government leaders in Puerto Rico declared a dengue epidemic after a spike in cases of the mosquito-borne disease hit the island.
    • “From the start of the year through March 10, there were 549 cases, including 341 hospitalizations and 29 severe cases, according to the most recent data provide by the Puerto Rico Department of Health. Cases are concentrated in cities including San Juan, Bayamon, Guaynabo and Carolina.
    • “Between 2010 and 2020, more than 30,000 dengue cases were reported from four U.S. territories, with Puerto Rico reporting the most. In 2012, Puerto Rico reported 199 deaths, which was the last time the commonwealth declared a dengue epidemic.”
  • The Wall Street Journal ponders,
    • “How closely should you be tracking your blood-sugar levels? * * *
    • “Soon, people without diabetes will be able to buy a monitor without needing to cajole a doctor into prescribing them one. The Food and Drug Administration recently approved the over-the-counter sale of a continuous glucose monitor, also known as a CGM. The devices allow people to continuously monitor their blood sugar levels.
    • “People who obsess over their health data or have an unhealthy relationship with food should avoid CGMs, most doctors say. Users might misinterpret normal glucose fluctuations as unhealthy, causing anxiety and prompting them to restrict certain foods. It isn’t clear that healthy patients would benefit from using a CGM over the long term.
    • “However, people at higher risk of developing diabetes, and those who are interested in working with their doctors to make lifestyle changes, might find it helpful. The technology could spot early signs of insulin resistance, possibly helping otherwise healthy people avoid Type 2 diabetes, some doctors say. 
    • “If we identify these patients sooner, we can suggest lifestyle modifications as well as maybe the initiation of weight-loss medications,” says Dr. Brenda Dorcely, an endocrinologist at NYU Langone Health.” 

Tidbits from the OPM FEHB carrier conference

  • The FEHBlog attended OPM’s virtual FEHB carrier conference today. Here are some tidbits.

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Beleaguered health system Steward Health Care has agreed to sell its physician network, Stewardship Health, to healthcare behemoth UnitedHealth Group for an undisclosed sum, according to documents filed with Massachusetts regulators on Tuesday.
    • “Under the deal, UnitedHealth’s care delivery subsidiary Optum Care would acquire Steward’s nine-state footprint of primary care providers and clinicians. It will also acquire all of Stewardship’s stock. 
    • “The Health Policy Commission, an independent Massachusetts agency tasked with monitoring state healthcare spending, will have 30 days to assess the potential impact of a Optum-Steward deal on healthcare costs, quality and access, HPC director David Seltz said in a statement. Already, some legislators and health M&A experts are urging a close review of the transaction, citing antitrust concerns.”
  • Per MedTech Dive,
    • “Johnson & Johnson is in talks to acquire Shockwave Medical, The Wall Street Journal reported Tuesday, citing people familiar with the matter.
    • “A deal could come in the next few weeks. However, the report noted that talks could fall through, or another company could pick up Shockwave. J&J and Shockwave both told MedTech Dive they do not comment on market rumors or speculation.
    • “Shockwave makes medical devices that break up calcium deposits in coronary arteries using sound pressure waves, a technique called intravascular lithotripsy (IVL).”
  • Beckers Payer Issues offers an interview with Aetna’s chief medical officer about managed care lessons from Medicaid to Medicare.

Weekend Update

David Ermer–Congress, Generative AI, Medical / Rx research, Mental health care, Obesity, Telehealth, U.S. Healthcare–

From Washington, DC,

  • Govexec tells us,
    • “The Senate approved a $1.2 trillion spending package early Saturday shortly after a portion of the government was set to shut down, staving off the threat for the remainder of fiscal 2024. 
    • “The upper chamber moved to approve the measure after funding had lapsed, though shutdown procedures never commenced because an agreement was imminent. President Biden’s was expected to quickly sign the measure, which the House passed on Friday. The spending bill includes funding for the remaining parts of government that have not yet received full-year appropriations, including the departments of Defense, Treasury, Homeland Security, Labor, Health and Human Services, Education and State. 
  • Federal News Network notes,
    • “Congress is looking for details on federal telework as part of the latest government spending agreement — echoing months of return-to-office scrutiny from the House Oversight and Accountability committee.
    • “Among its many provisions, the agreement congressional appropriators reached Thursday for the back half of fiscal 2024 government spending bills lays out six new requirements on federal telework and return-to-office for federal employees.
    • “Within 90 days of the legislation’s enactment, the Office of Management and Budget will have to turn over all agencies’ return-to-office “action plans” outlined earlier this year, lawmakers said in an explanatory statement for the 2024 Financial Services and General Government bill.”
  • The House of Representatives and the Senate are on a two week long break. For those who are interested in an inside baseball approach, the Wall Street Journal examines the coalition government operating in the House of Representatives. Of course, the Democrats have a narrow majority in the Senate. All of that may change as a result of November’s national election.
  • OPM’s FEHB carrier conference will be held on Wednesday and Thursday this week.

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Catherine, Princess of Wales, who Friday announced a cancer diagnosis, said she is getting preventative chemotherapy—a treatment that is given after surgery in hopes that it will increase the odds of a cure. 
    • “That the princess is undergoing preventative chemotherapy “suggests to me this is a curable cancer,” said Dr. Angela Jain, an assistant professor in the department of hematology and oncology at Fox Chase Cancer Center in Philadelphia. Jain and other doctors who spoke with The Wall Street Journal aren’t involved in Catherine’s care.
    • “Such chemotherapy, which oncologists call “adjuvant” therapy, is routinely given after surgical removal of a tumor for several months or for as long as a year, Jain said. Patients often get the treatment every two or three weeks. It doesn’t always stop the cancer from returning, but it can increase the odds of eliminating the disease.
    • “Not all cancers need chemo after surgery, but some do,” she said. “And usually you give that treatment with the hope and intention that this is a curable cancer, and chemo will reduce the risk of it coming back.” 
  • The Washington Post adds,
    • “In a recent panel at SXSW in Austin earlier this month, [Katie] Couric spoke about the rise in colorectal cancer. In particular, she hopes women better understand their risks. The risk of developing colorectal cancer is 1 in 23 for men and 1 in 25 for women, according to the American Cancer Society.  
    • “Women, especially younger women, believe this is an old man’s disease, and that’s simply not true,” she says. “Women are diagnosed with colorectal cancer as often as men. I think sometimes people get colons and prostates confused.”
    • “Less than half—44%—of Gen X women have gotten screened for colon cancer, and yet, “they are right in the sweet spot,” Couric says. And 43% of young women believe colon cancer is a men’s disease, of which nearly half think men are impacted two to three times as much as women, which is not correct, according to Medtronic, a health care technology company implementing AI in screening protocols.”  
  • and
    • “The Cancer Detectives,” a new American Experience documentary on PBS, tracks the fascinating and surprisingly frustrating backstory of the Pap smear, a cervical cancer screening test that’s now routine but was once anything but.
    • “The film takes viewers back to the days before Pap smears, a time when cervical cancer was rightfully feared by patients and doctors alike. A century ago, cervical cancer was a major killer of women. Early detection was impossible, and sexual stigma and shame kept women from discussing it.
    • “So it’s not surprising that when an immigrant physician from Greece, George Papanicolaou, nicknamed “Dr. Pap,” discovered a way to detect changes in cervical cells, his breakthrough was largely disregarded by the scientific community.
    • “It would take a massive public relations war against the unspeakable cancer to make the Pap smear a routine part of cervical cancer screening — a war waged in part by Black OB/GYN Helen Dickens, Japanese American illustrator Hashime Murayama and a group of women committed to cancer prevention.”
  • Fortune Well offers tips on how to stay in shape in your thirties, forties, and fifties. Gook luck.
  • The New York Times informs us,
    • “Most people, study after study shows, don’t take the medicines prescribed for them. It doesn’t matter what they are — statins, high blood pressure drugs, drugs to lower blood sugar, asthma drugs. Either patients never start taking them, or they stop.
    • “It’s a problem that doctors call nonadherence — the common human tendency to resist medical treatment — and it leads to countless deaths and billions of dollars of preventable medical costs each year.
    • “But that resistance may be overcome by the blockbuster obesity drugs Wegovy and Zepbound, which have astounded the world with the way they help people lose weight and keep it off. Though it’s still early days, and there is a paucity of data on compliance with the new drugs, doctors say they are noticing another astounding effect: Patients seem to take them faithfully, week in and week out.”
  • Per mHealth Intelligence,
    • “Using telehealth to provide palliative care support to rural family caregivers is a low-cost and feasible strategy for transitioning patients from hospital to home-based care, new research reveals.
    • “Conducted by researchers from the Mayo Clinic, Duke University, and the Minneapolis Veterans Affairs Health Care System, the study examines a telehealth-based palliative care support program for rural family caregivers who face challenges in accessing coordinated care for their loved ones during and after hospitalization. It also evaluated resource use, health system costs, and Medicare reimbursement pathways for this approach. Results were published in the American Journal of Hospice and Palliative Medicine.”
  • The MIT Technology News points out,
    • “Alex Zhavoronkov has been messing around with artificial intelligence for more than a decade. In 2016, the programmer and physicist was using AI to rank people by looks and sort through pictures of cats.
    • “Now he says his company, Insilico Medicine, has created the first “true AI drug” that’s advanced to a test of whether it can cure a fatal lung condition in humans. 
    • “Zhavoronkov says his drug is special because AI software not only helped decide what target inside a cell to interact with, but also what the drug’s chemical structure should be.”
  • From the Wall Street Journal,
    • “Elon Musk’s Neuralink introduced the first patient to receive its brain-computer implant, a 29-year-old diving-accident victim who showed during a livestream that he can now move a computer cursor using the device.
    • “In a nine-minute presentation streamed on Musk’s X platform Wednesday, Neuralink showed Noland Arbaugh directing the cursor around a screen to play a game of chess. Arbaugh said it feels like “using the force on a cursor,” referring to a concept from movies such as “Star Wars.” He said his surgery went well and he left the hospital after one day.
    • “Moving a computer cursor isn’t a big technical leap for brain-computer interfaces. An older brain chip first implanted in a human in 2004 also helped a paralyzed person move a cursor with only their thoughts. But the older chip must be attached to a device on the outside of the brain to transmit data, requiring wires protruding through the skin.
    • “Neuralink’s device transmits data wirelessly, and it can be used at home, outside of a laboratory setting.
    • “Another notable feature of Neuralink’s presentation was that Arbaugh was multitasking: playing chess while speaking about his experience getting the implant. Prior demonstrations of brain-computer interfaces have required dedicated attention to a particular task.”
  • and
    • “The more time you spend alone, the more likely you are to be lonely, right?
    • “Seems obvious. But it isn’t always true, according to a new study. For instance, it found that although, in general, those who spend the most time alone are the loneliest, that isn’t the case for young people; their time alone has little impact on how lonely they feel. What’s more, people who spend the least time alone tend to be slightly lonelier than those between the extremes. * * *
    • “Relationship status also was significant. Single people tended to spend more time alone than those in relationships and reported greater loneliness. Gender wasn’t a significant predictor of loneliness, the study found.
    • “The bottom line is that loneliness can’t simply be measured by the degree of a person’s social interaction.
    • “The degree of loneliness a person experiences is influenced by how much social interactions they have and by how much social interactions they feel they need,” Mehl says. “Beyond that, an important determinant of feelings of loneliness is the perceived meaning that a person derives from the social interactions they have.”

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.”