Midweek Update

Electronic health records

Midweek Update

David Ermer–ACA, CDC, Congress, Electronic health records, FDA, Medical / Rx research, NIH, U.S. Healthcare–

From Washington, DC

  • The Wall Street Journal reported this morning
    • “A bipartisan group of lawmakers introduced legislation to break up pharmacy-benefit managers, the drug middlemen that have now faced yearslong scrutiny from Congress and the Federal Trade Commission.
    • “A Senate bill, sponsored by Sens. Elizabeth Warren (D., Mass.) and Josh Hawley (R., Mo.), would force the companies that own health insurers or pharmacy-benefit managers to divest their pharmacy businesses within three years.
    • “A companion bill, which sponsors say draws on a history of government prohibitions on joint ownership within industries, was also introduced in the House on Wednesday.
    • “If passed, the legislation would be the most far-reaching intervention yet into the operations of pharmacy-benefit managers, known as PBMs, and their parent companies, cutting off a major source of revenue for the companies and frustration for patients.”
  • STAT News added this afternoon,
    • “A proposed Senate bill that would prohibit companies that control health insurers or pharmacy benefit managers from owning pharmacies rattled investors on Wednesday, but some Wall Street analysts believe the legislation is unlikely to gain much traction, at least for now.
    • “The bipartisan bill, which would require divestiture within three years, is aimed at what the lawmakers call an “inherent conflict of interest” that has forced Americans to pay more for medicines and hastened the demise of independent pharmacies. A companion bill, that refers to a history of government prohibitions on joint ownership within industries, is scheduled to be introduced in the House.” * * *
    • Wall Street watchers believe the lower stock prices are an overreaction. Although the insurers are a juicy target, various factors suggest the bill is far from a sure bet, given the upcoming change in administrations. Securities analysts believe other legislative priorities will get more attention, despite a focus on health care matters more broadly.”
  • The Wall Street Journal also lets us know,
    • “The House voted Wednesday to approve a nearly $900 billion annual defense policy bill that includes a controversial provision that would block some transgender medical care for minors covered by the military’s healthcare program.
    • “The package, which sets national defense standards and priorities for the 2025 fiscal year, notably calls for a 14.5% pay raise for junior enlisted service members, dwarfing the 4.5% pay raise included for all other members of the armed forces. The package passed 281-140, with most Republicans voting for the bill but more than half of Democrats voting no.
    • “The 1,800-page National Defense Authorization Act would increase the national security budget to $895 billion, about a 1% increase from last year’s total, less than inflation. * * *
    • “The NDAA authorizes appropriations but doesn’t provide budget authority, making it a guide to what military spending is ultimately passed separately by Congress. It is set to be the 64th consecutive NDAA successfully passed through Congress—a rarity in what has increasingly become a divided and chaotic legislature. 
    • “The bill is now expected to be fast-tracked in the Senate, where the chamber will likely pass it before Congress leaves at the end of next week. From there, it would go to President Biden’s desk, where he is expected to sign it.”
  • Federal News Network tells us,
    • “With just a few weeks left in the year for President Joe Biden to finalize the 2025 federal pay raise, House and Senate Democrats are calling for a larger pay boost than the currently planned raise for civilian federal employees on the General Schedule.
    • “In a letter sent to Biden Wednesday morning, a group of 22 Democrats pushed for what they said should be “pay parity” between civilian and military federal employees. Currently, civilian and military personnel are slated for likely different pay raises for 2025.
    • “We believe it is imperative you revise your budget to align military and civilian employee pay raises,” the lawmakers, led by Sens. Tim Kaine (D-Va.) and Mark Warner (D-Va.), and Rep. Steny Hoyer (D-Md.), wrote in the letter, shared with Federal News Network.
    • “Currently, most civilian employees are on track to receive a 2% federal pay raise beginning in January, according to the alternative pay plan Biden sent to congressional leaders in August. In contrast, military personnel are expected to likely receive a 4.5% raise for 2025. Although the raise amounts appear to be heading in those two directions, neither raise amount is final just yet. Unless Congress or Biden opts for a different pay plan, the 2% raise is expected to become final through signing an executive order by the end of December.”
  • The American Hospital Association News informs us,
    • The Senate Dec. 10 unanimously passed legislation reauthorizing the Emergency Medical Services for Children Program (H.R. 6960) for an additional five years. The program provides funding for equipment and training to help hospitals and paramedics treat pediatric emergencies. The program was authorized at $24.3 million per year from 2025-2029. The bill was passed by the House in May.”
  • and
    • “The Department of Health and Human Services Dec. 11 published a final rule implementing provisions related to the Trusted Exchange Framework and Common Agreement. The rule is intended to advance equity, innovation and interoperability by promoting the use and exchange of electronically captured health information as specified in certain provisions of the Health Information Technology for Economic and Clinical Health Act of 2009.  
    • “The provisions today’s final rule adopts were first proposed in August as part of a much larger rule and will be effective 30 days after it is officially published in the Federal Register.”
  • The New York Times relates,
    • “In the final days of the Biden administration, the Food and Drug Administration is seeking White House approval to propose a drastic reduction in the amount of nicotine in cigarettes, a longstanding goal of public health experts that has faced stiff opposition from the powerful tobacco lobby.
    • “The F.D.A. submitted the proposal to the Office of Management and Budget only on Tuesday, a sign that the move was perhaps more wishful and symbolic than realistic for a White House juggling many late-term agenda items. And traditionally, the budget office’s review of agency proposals can take months.”
  • Per Fierce Pharma,
    • “As Donald J. Trump gradually fills out his cabinet, the President-elect’s latest pick could bode well for biopharma business development over the next four years.
    • “Trump on Tuesday nominated Andrew Ferguson to lead the U.S. Federal Trade Commission (FTC). Ferguson is one of two Senate-confirmed Republican FTC commissioners appointed by President Joe Biden, Reuters notes.
    • “At the same time, Trump said in a post on Truth Social that he plans to nominate Mark Meador, a partner at the law firm Kressin Meador Powers, to become an FTC commissioner. Should he be confirmed for the job, Meador will take over the spot currently filled by FTC chair Lina Khan, whose term at the antitrust agency has expired, the news agency said.”

From the public health and medical research front,

  • Per MedPage Today,
    • “A possible case of H5N1 bird flu virus in a California child has been linked to raw milk consumption and is under investigation by state health officials and the CDC.
    • “The patient experienced fever and vomiting after drinking raw milk and has since recovered, according to an announcement by Marin County Public Health. Officials said that the risk to the public remains low, as there was no evidence of person-to person transmission between the child and her family members.
    • “The case stands out for being outside the usual farm work setting.”
  • The New York Times adds,
    • “Domestic cats could provide an unexpected new route for the bird flu virus H5N1 to evolve into a more dangerous form, according to a new study published on Monday.
    • “In the year since the virus began circulating in dairy cattle, it has killed many cats, primarily on farms with affected herds. It has also sickened at least 60 people, most of whom had close contact with infected dairy cows or poultry.
    • “So far, H5N1 does not spread easily among people, although studies have suggested that just one or two key mutations could allow the virus to make that leap.
    • “There is no evidence that cats have spread H5N1 to people and they may not represent a major avenue for the evolution of bird flu, experts said. Still, if a cat were simultaneously infected with H5N1 and a seasonal flu virus, the H5N1 virus could potentially acquire the mutations it needed to spread efficiently among people.”
  • ABC News reports,
    • “The rates of late-stage breast cancer at diagnosis have risen among women in all racial and ethnic groups, but Black women have been hit the hardest, according to a new study published in the journal Radiology.
    • “The study, which looked at data from 2004 to 2021, found that advanced breast cancer rates have risen among women of all ages, with the sharpest increases in young women aged 20 to 39, and women over 75.
    • “Black women experience advanced diagnoses 55% more often than white women and are more likely to die from the disease, the study found.
    • “While mammography does save lives by catching cancer earlier, fewer than 70% of eligible women are up to date on their screenings, the study found.
    • “This trend is particularly alarming because early detection significantly improves survival. Five-year survival rates drop drastically from 99% for early-stage breast cancer to just 31% when the cancer is more advanced and has already spread to other parts of the body, the study found.”
  • BioPharma Dive adds,
    • “An experimental breast cancer drug developed by Eli Lilly met its main goal in a Phase 3 study, helping people with a form of HER2-negative, ER-positive disease stay alive and progression free for longer than standard hormone-suppressing therapies, according to data disclosed Wednesday.
    • “When combined with Lilly’s approved medicine Verezenio, the experimental drug, called imlunestrant, also helped women stay alive and progression free longer than treatment with imlunestrant alone regardless of their mutation status, according to results of the EMBER-3 trial presented at the San Antonio Breast Cancer Symposium. The data were also published in The New England Journal of Medicine.”
  • Per a National Institutes of Health press release,
    • “National Institute of Health (NIH) scientists have made a significant breakthrough in understanding how “bad” cholesterol, known as low-density lipoprotein-cholesterol or LDL-C, builds up in the body. The researchers were able to show for the first time how the main structural protein of LDL binds to its receptor – a process that starts the clearing of LDL from the blood – and what happens when that process gets impaired.
    • “The findings, published in Nature, further the understanding of how LDL contributes to heart disease, the world’s leading cause of death, and could open the door to personalizing LDL-lowering treatments like statins to make them even more effective.
    • “LDL is one of the main drivers of cardiovascular disease which kills one person every 33 seconds, so if you want to understand your enemy, you want to know what it looks like,” said Alan Remaley, M.D., Ph.D., co-senior author on the study who runs the Lipoprotein Metabolism Laboratory at NIH’s National Heart, Lung, and Blood Institute.” * * *
    • “The study findings could open new avenues to develop targeted therapies aimed at correcting these kinds of dysfunctional interactions caused by mutations. But, as importantly, the researchers said, they could also help people who do not have genetic mutations, but who have high cholesterol and are on statins, which lower LDL by increasing LDLR in cells. By knowing precisely where and how LDLR binds to LDL, the researchers say they may now be able to target those connection points to design new drugs for lowering LDL from the blood.” 
  • STAT News points out,
    • “Gilead said Tuesday that it will soon begin Phase 3 testing for a drug it believes could prevent HIV infection with just a single shot every year.
    • “Such a medicine, if proven effective, would be the closest thing to a vaccine the HIV field has produced in four decades of research. The company plans to begin the trial next year, with an eye toward regulatory filings in late 2027.”

From the U.S. healthcare business report,

  • Health Affairs reports,
    • “Numerous studies show that employer plans pay providers significantly more than Medicare, but less is known about prices in nongroup plans sold both on and off the Marketplaces established by the Affordable Care Act (ACA), where narrow networks and low-cost insurers are more prevalent.
    • “We estimated prices for three market segments (Marketplace nongroup, off-Marketplace nongroup, and employer small group) and three types of services (professional, outpatient hospital, and inpatient hospital) relative to a Medicare benchmark.
    • “We used 2021 claims data covering virtually all enrollment in ACA risk-adjusted plans. In aggregate, in 2021, Marketplace prices were 152 percent of Medicare prices, whereas the prices paid in small-group employer plans were 179 percent of Medicare prices.
    • “Comparing across market segments, relative to employer small-group plans, Marketplace professional prices were 6.9 percent lower, inpatient prices were 13.3 percent lower, and outpatient prices were 26.3 percent lower. Off-Marketplace prices fell between Marketplace and employer small-group prices.
    • “The finding that nongroup prices were significantly lower than prices paid by employer small-group plans—more so than indicated by prior research—is important for understanding federal subsidies and affordability for nongroup coverage and evaluating policies such as a nongroup public option with prices capped at a percentage of Medicare prices.”
  • Per Healthcare Dive,
    • “For the first time in 27 months, Fitch Ratings is revising its credit outlook for the nonprofit hospital sector — lifting it from deteriorating to neutral in its 2025 outlook report and adding that hospitals have made “enough meaningful strides” to warrant the revision.
    • “Hospitals have seen “steady improvement” on operating margins, according to the Monday report. The trend is attributable to providers’ success controlling labor expense growth, as well as stronger cash flows and equity returns.
    • “Fitch predicts margins will continue to improve, with operators reporting median operating figures between 1% and 2% in 2025. However, if President-elect Donald Trump announces cuts to Medicaid or supplemental Medicaid funds, margins could be adversely impacted and the sector’s outlook may be reverted to deteriorating.”
  • Modern Healthcare informs us,
    • “Labcorp has completed its acquisition of select non-hospital lab assets from Ballad Health, the independent laboratory company said Wednesday. A purchase price was not immediately available.
    • “Johnson City, Tennessee-based Ballad Health will retain operations of its inpatient and emergency department laboratory services, as well as lab services for hospital-based practices, according to a news release.” * * *
    • “The latest deal continues a trend of health systems selling off parts of their laboratory business to save on costs and focus on other areas of their operations. Independent lab companies often can provide a higher volume of tests at a lower cost compared with hospitals performing tests at their own facilities.” 

Tuesday Tidbits

David Ermer–AHRQ, CDC, CMS, Electronic health records, Federal employment benefits, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, Rx coverage, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Healthcare Dive lets us know,
    • “President-elect Donald Trump has nominated Dr. Mehmet Oz, a physician, TV personality and former Republican candidate for Senate, to run Medicare and Medicaid as administrator for the CMS.
    • “America is facing a Healthcare Crisis, and there may be no Physician more qualified and capable than Dr. Oz to Make America Healthy Again,” Trump said in his announcement on social media platform Truth Social.
    • “The CMS oversees the healthcare coverage of more than 160 million Americans, or around half the U.S. population, through Medicare, Medicaid, the Children’s Health Insurance Program and Affordable Care Act plans.”
  • Per an HHS press release,
    • “Today, the Surgeon General released a new report on health disparities related to tobacco use, which finds that despite the nation’s substantial progress in reducing cigarette smoking and secondhand smoke exposure in the overall U.S. population, that progress has not been equal for all population groups. Disparities in tobacco use persist by race and ethnicity, income, education, sexual orientation and gender identity, occupation, geography, behavioral health status, and other factors. Additionally, cigarette smoking and secondhand smoke exposure continue to cause nearly half a million deaths a year in the United States—nearly one in five of all deaths.
    • “This report expands upon the 1998 Surgeon General’s report on tobacco use among U.S. racial and ethnic groups to include data and trends by additional demographic factors and their intersection. This report also summarizes research on factors that influence tobacco-related disparities, and outlines actions everyone can take to eliminate these disparities and advance health equity in the United States.” * * *
    • “For Surgeon General’s report information and resources, including the full report, a report executive summary, a consumer guide, and fact sheets, visit www.SurgeonGeneral.gov
      or www.CDC.gov/EndTobaccoDisparities“
  • FedManager offers its take on the ongoing Federal Employee Benefits Open Season while Serving Those Who Serve delves into Medicare Part D EGWPs participating in the FEHB and PSHB Programs.
  • HealthITBuzz reflects on a “Year of Movement in Pharmacy Interoperabiilty.” The more electronic health record interoperability, the better, after all.
  • The American Hospital Association News tells us,
    • Data released Nov. 18 by the University of Pennsylvania found that 15% of U.S. adults are familiar with the 988 Suicide and Crisis Lifeline, a 1% increase from last year. Those individuals from the survey reported that they knew the number and correctly stated it when asked in an open-ended format. One percent of respondents inaccurately reported the number was 911, an improvement from 4% in 2023. The 988 hotline launched in July 2022.”
    • The FEHBlog wonders if 911 operators transfer appropriate calls to 988 operators.
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR), announced a $100,000 civil monetary penalty against Rio Hondo Community Mental Health Center (“Rio Hondo”) in California. The penalty resolves an investigation into Rio Hondo over a failure to provide a patient with timely access to their medical records. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule’s right of access provisions require that individuals or their personal representatives have timely access to their health information (within 30 days, with the possibility of one 30-day extension) and for a reasonable, cost-based fee. OCR enforces the HIPAA Privacy Rule, which establishes national standards to protect individuals’ medical records; sets limits and conditions on the uses and disclosures of protected health information; and gives individuals certain rights, including the right to timely access and to obtain a copy of their health records.” * * *
    • “The Notice of Final Determination may be found at: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/rio-hondo/notice-final-determination/index.html“

From the public health and medical research front,

  • The New York Times reports,
    • “If I drew you a graph that showed the death rate among American kids, you would see a backward check mark: Fewer kids died over the last several decades, thanks to everything from leukemia drugs to bicycle helmets. Then, suddenly, came a reversal.
    • “I first noticed this in 2021 while poking around in mortality data from the virus-ridden year before. It looked bad. I knew that kids who contracted Covid tended to fare better than older people, but was the virus killing them, too?
    • “Nope. It wasn’t the virus. It was injuries — mostly from guns and drugs. From 2019 to 2021, the child death rate rose more steeply than it had in at least half a century. It stayed high after that. Despite all of the medical advances and public health gains, there are enough injuries [from firearms, traffic, drugs and drowning] to have changed the direction of the chart.”
  • Consumer Reports, writing in the Washington Post, informs us about “microplastics, phthalates, BPA and PFAS. We encounter these potentially toxic materials in everyday life. Here’s the difference among them.”
  • BioPharma Dive let us know,
    • “An experimental under-the-skin injection of Merck & Co.’s cancer immunotherapy Keytruda showed similar characteristics as the current intravenous formulation in a Phase 3 clinical trial, the company said Tuesday.
    • “The drugmaker plans to discuss data from the trial, which it didn’t disclose in full, with the Food and Drug Administration and other regulators. The intravenous form of Keytruda is expected to lose U.S. patent protection in 2028, which would open the door to biosimilar competitors.
    • “Rival Roche has already gained FDA approval for a subcutaneous version of its competing immunotherapy Tecentriq, while Bristol Myers Squibb is awaiting an FDA decision on an under-the-skin injection of Opdivo. Merck could be as much as a year or more away from approval of subcutaneous Keytruda.”
  • and
    • “An experimental pill developed by Johnson & Johnson and Protagonist Therapeutics significantly cleared skin in most people with moderate-to-severe plaque psoriasis who enrolled in a Phase 3 trial run by J&J.
    • “Treatment with the drug, called icotrokinra, led to clear or almost clear skin in about two-thirds of participants after four months of testing. Just under half experienced a 90% or greater reduction in their scores on another measure of psoriasis plaque coverage and severity. Only 8% and 4%, respectively, of study participants on placebo hit those same marks.
    • “Responses to icotrokinra improved further through six months and, according to a Monday statement from J&J, a similar percentage of participants in both trial groups experienced side effects. The company plans to present detailed results at an upcoming medical meeting.”
  • The National Institutes of Health offers information about “Weight-loss surgery in teens | Sugar intake and chronic disease risk | Mapping cancer formation and spread.”
  • Per an NIH press release,
    • “Experts convened by the National Institutes of Health (NIH) have identified five elements of a brain-based condition that has emerged as a leading cause of vision impairment starting in childhood in the United States and other industrialized nations. Known as cerebral (or cortical) visual impairment (CVI), some estimates suggest that at least 3% of primary school children exhibit CVI-related visual problems, which vary, but may include difficulty visually searching for an object or person or understanding a scene involving complex motion. Their report, based on evidence and expert opinion, was published today in Ophthalmology.
    • “Lack of awareness about CVI is a large factor leading to it to be misdiagnosed or undiagnosed, which can mean years of frustration for children and parents who are unaware of an underlying vision issue and don’t receive help for it,” said report co-author, Lotfi B. Merabet, O.D., Ph.D., associate professor of ophthalmology, Massachusetts Eye and Ear and Harvard Medical School, Boston.
    • “Clarifying the factors for suspecting CVI should help build awareness and help eye care providers identify children for further assessment so they can benefit from rehabilitation and accommodation strategies as early as possible,” said report co-author, Melinda Y. Chang, M.D., assistant professor of clinical ophthalmology at the University of Southern California, Los Angeles.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • ICER will assess the comparative clinical effectiveness and value of tolebrutinib (Sanofi) for the treatment of secondary progressive multiple sclerosis (SPMS).
    • The assessment will be publicly discussed during a meeting of the CTAF in June 2025, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • ICER’s website provides timelines of key posting dates and public comment periods for this assessment.
  • The U.S. Preventive Services Task Force opened a public comment period of its Grade A recommendation that all pregnant women undergo early screening for syphilis infection. This recommendation confirms an earlier decision made in 2018. The public comment period ends on December 23, 2024.

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “UnitedHealth Group’s Optum Rx, CVS Health’s Caremark and Cigna’s Express Scripts have sued the Federal Trade Commission alleging the agency’s in-house case over insulin prices is unconstitutional.
    • “The companies, the three largest pharmacy benefit managers by market share, are suing to block the administrative proceedings, according to a complaint filed Tuesday in the U.S. District Court for the Eastern District of Missouri. The PBMs’ associated group purchasing organizations Emisar Pharma Services, Zinc Health Services and Ascent Health Services, respectively, are also plaintiffs in the case.” * * *
    • “The PBMs allege the FTC’s claims — which they deny — involve private rights that should be heard in a federal court and allege the administrative proceeding violates their due process rights under the Fifth Amendment.”
  • and
    • “Change Healthcare’s vital clearinghouse platform has been restored after a cyberattack on the UnitedHealth Group subsidiary caused unprecedented billing and payment disruptions for providers nationwide, the company announced on its status webpage.
    • “This is a big step for the technology company after its systems were taken offline following a February ransomware attack that caused widespread disruptions throughout the healthcare system. Change Healthcare operates as the largest clearinghouse for billing and payments in the U.S., processing 15 billion transactions annually and managing about one-third of patient records.” 
  • and
    • “CVS Health is the first company to earn a Health Equity Accreditation from URAC.
    • “The independent nonprofit accrediting organization said CVS was the first to apply to the program, which started in 2023.” * * *
    • “CVS’ social determinants of health dashboard — aimed at helping identify individuals who are at risk of poor outcomes and refer them to community-based programs and screening options — contributed to its accreditation, URAC said. The company’s work in addressing health-related cost and access barriers played a role too, according to URAC.”
  • Fierce Healthcare adds,
    • “Mike Pykosz, the former CEO of Oak Street Health, will leave CVS Health as part of the company’s latest leadership shake-up.
    • “CVS announced Tuesday that Sree Chaguturu, M.D., will step into the role of president for healthcare delivery alongside his existing title as chief medical officer. In the announcement, CEO David Joyner said that Pykosz let the company’s top brass know “earlier in the year that he planned to move on from the company and we appreciate him helping to lead a smooth transition.”
    • “As CMO, Chaguturu oversees CVS’ medical affairs organization and is responsible for clinical quality, patient outcomes, addressing access gaps and managing health costs across the enterprise. He was also previously the chief medical officer at CVS’ Caremark pharmacy benefit manager.”
  • Fierce Pharma identifies the 2024’s Fiercest Women in Life Sciences. Kudos to them!
  • KFF brings us up to date on the national IV fluid shortage created by Hurricane Helene.
    • “[H]ospitals are facing seasonal strains on their already limited IV fluid resources, said Sam Elgawly, chief of resource stewardship at Inova, a health system in the Washington, D.C., area.
    • “We’ve been very aggressive in our conservation measures,” Elgawly said, stressing that he does not believe patient care has been compromised. He told KFF Health News that across the system IV fluid usage has dropped 55% since early October.
    • “Elgawly called the shortage a crisis that he expects to have to continue managing for some time. “We are going to operate under the assumption that this is going to be the way it is through the end of 2024 and have adopted our demand/conservation measures accordingly,” he said.”
  • MedTech Dive tells us,
    • “The Food and Drug Administration alerted healthcare providers Friday about the safety and supply of Getinge/Maquet vessel harvesting devices.
    • “The letter to providers describes issues with Getinge/Maquet VasoView Hemopro Endoscopic Vessel Harvesting (EVH) Systems. Getinge recalled the devices in September after receiving 18 complaints about Hemopro 1.5 devices in four months, including reports of 17 serious injuries.
    • “The FDA letter addresses the injury reports and warns the removal of Hemopro 1.5 may interrupt the supply of EVH devices. The devices are now on the FDA’s device shortage list.”

Happy Halloween

David Ermer–CMS, COVID-19, Electronic health records, FDA, Medical / Rx research, Medicare, NIH, Obesity, Telehealth, U.S. Healthcare–
Photo by Toa Heftiba on Unsplash

From Washington, DC,

  • Tammy Flanagan, writing in Govexec, answers Federal Benefits Open Season questions from readers.
  • Bloomberg reports,
    • “The [U.S. Court of Appeals for the] Third Circuit [sitting in Philadelphia] Wednesday wrestled with the constitutionality of a government drug price negotiation plan, hearing arguments from three drugmakers and the Biden administration over alleged industry harm and violations of property and speech. 
    • “Drugmakers Johnson & Johnson, Bristol-Myers Squibb Co., and AstraZeneca PLC took their challenge against the US government’s Medicare Drug Price Negotiation Program to the US Court of Appeals for the Third Circuit. The plan, created under President Joe Biden’s landmark Inflation Reduction Act, is part of the administration’s efforts to rein in high prescription drug costs by allowing the government to negotiate prices for certain drugs with manufacturers.” 
    • This is the first federal appellate court oral argument on this issue.

From the public health and medical research front,

  • Dr. Monica Bertagnollo, the NIH Director, writes in her blog,
    • “In 2021, NIH launched the Researching COVID to Enhance Recovery (RECOVER) Initiative , a nationwide research program, to fully understand, diagnose, and treat Long COVID. We continue to learn more about this condition, in which some people experience a variety of symptoms for weeks, months, or even years after infection with SARS-CoV-2, the virus that causes COVID-19. But we’re still working to understand the underlying reasons why people develop Long COVID, who is most likely to get it, and how best to treat or prevent it.
    • “Studies have shown that for some people, SARS-CoV-2 doesn’t completely clear out after acute infection. Scientists have observed signs that the virus may persist in various parts of the body, and many suspect that this lingering virus, or remnants consisting of SARS-CoV-2 protein, may be causing Long COVID symptoms in some individuals. Now, in a new study supported by RECOVER, scientists found that people with Long COVID were twice as likely to have these viral remnants in their blood as people with no lingering symptoms. The findings, reported in Clinical Microbiology and Infection, add to evidence that Long COVID may sometimes stem from persistent infection or SARS-CoV-2 protein remnants.” * * *
    • “More study is needed to understand the causes of Long COVID symptoms in people who test negative for persistent infection, the researchers note. They are conducting follow-up studies in even more people with Long COVID, including those with compromised immune systems. They hope to learn more about what causes some people to be at higher risk for retaining some SARS-CoV-2 protein remnants and Long COVID.”
  • Per an NIH press release,
    • “Young people with severe obesity who underwent weight-loss surgery at age 19 or younger continued to see sustained weight loss and resolution of common obesity-related comorbidities 10 years later, according to results from a large clinical study funded by the National Institutes of Health (NIH).
    • “Study participants with an average age of 17 underwent gastric bypass or sleeve gastrectomy weight-loss surgery. After 10 years, participants sustained an average of 20% reduction in body mass index (BMI), 55% reduction of type 2 diabetes, 57% reduction of hypertension, and 54% reduction of abnormal cholesterol. Both gastric bypass and sleeve gastrectomy had similar results.
    • “The 55% reduction in type 2 diabetes was much higher than the rates observed in adults after weight-loss surgery (18% at seven years and 12.7% at 12 years) in a recently published NIH-funded study.
    • “Type 2 diabetes tends to progress more rapidly when it occurs in young people, and these findings demonstrate the greater health benefits and durability of bariatric surgery in youth than would be expected in similarly treated adults.”
  • JAMA Open Network tells us,
    • Question  How have autism diagnosis rates changed over time among children and adults seeking care from a network of health systems in the US?
    • Findings  In this cross-sectional study of electronic US health and insurance claims records for over 9 million individuals per year from 2011 to 2022, relative increases in autism diagnosis rates were greatest among young adults compared with all other age groups, female compared with male individuals, and some racial and ethnic minority groups compared with White individuals among children but not adults.
    • Meaning  Patterns of increase in autism diagnosis rates reflect a need for expanded health care services and continued research on sociodemographic disparities among this growing population.
  • The Institute for Clinical and Economic Review published an Evidence Report on Treatment for Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease
    • Current evidence suggests that tabelecleucel provides a substantial net health benefit when compared to usual care; treatment would achieve common thresholds for cost-effectiveness if priced between $143,900 to $273,700 per treatment cycle. * * *
    • “EBV+ PTLD is a rare and often fatal cancer associated with solid organ transplant and stem cell transplant,” said ICER’s Vice President of Research Foluso Agboola, MBBS, MPH. “Unfortunately, approximately half of EBV+ PTLD cases are refractory to initial treatment or relapse, resulting in a poor prognosis. The limited evidence on tabelecleucel suggests that it provides important clinical benefits in patients with relapsed refractory EBV+ PTLD, extending survival for patients who otherwise do not usually survive beyond a few weeks to months, with few harms.” 
    • “This Evidence Report will be reviewed at a virtual public meeting of the New England CEPAC on November 14, 2024. The New England CEPAC is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”
  • STAT News informs us,
    • After spending decades fixated on a single hypothesis, Alzheimer’s researchers are increasingly searching for new ways to combat the devastating neurologic disease. One such approach — precisely targeting the brain with magnetic pulses — got a boost when mid-stage trial data was presented Thursday.
    • Scientists reported that patients with mild or moderate Alzheimer’s who received the therapy, known as transcranial magnetic stimulation (TMS), experienced a 44% slowing in their rate of disease progression after a year compared to those given a sham intervention, which mimicked the procedure but delivered no treatment. That finding, which was the study’s main endpoint and was statistically significant, was based on a commonly used disease metric known as Clinical Dementia Rating sum of boxes (CDR-SB).” * * *
    • “But outside experts were quick to caution that the new results, announced at the Clinical Trials on Alzheimer’s Disease conference in Madrid, should be taken with a grain of salt. That’s because the findings come from a small Phase 2 trial conducted at a single medical center in Italy, with 32 patients completing the trial. Sinaptica, a private biotech in Cambridge, Mass. that is developing the treatment and sponsored the trial, is now planning a larger, multicenter pivotal study in hopes of confirming its findings.”

From the U.S. healthcare business front,

  • The American Hospital News lets us know,
    • “Baxter announced Oct. 31 that it has restarted its North Cove, N.C. facility’s highest-throughput IV solutions manufacturing line, which normally accounts for nearly 25% of the site’s total production and approximately 50% of its one-liter IV solutions — the most commonly used size by hospitals and clinics. The earliest new products could begin shipment is late November, Baxter said. The company is continuing to assess and repair equipment at the facility and is working with the Food and Drug Administration to resume operation in phases. Baxter said it does not have a timeline on when production at the facility will be restored to pre-Hurricane Helene levels.” 
  • Healthcare Dive relates,
    • “Cigna CEO David Cordani threw cold water on speculation that the health insurer is interested in acquiring rival Humana during a call with investors on Thursday.
    • “Despite reports earlier this fall that the two payers had reopened deal talks, Cigna plans to use excess cash to buy back shares, Cordani said while discussing Cigna’s third quarter results.
    • “Cigna handily beat Wall Street expectations in the quarter with revenue of $63.7 billion, up 30% year over year after strong demand for specialty drugs spurred growth in its health services division. However, an investment loss of $1 billion tied to the waning value of primary care chain VillageMD drove Cigna’s profit down to $739 million, compared to $1.4 billion same time last year.”
  • Risk & Insurance points out,
    • “Employers that implement strategies like value-based drug formularies and tiered provider networks are experiencing lower health care costs, according to a survey by the National Alliance of Healthcare Purchaser Coalitions.
    • “The survey, which included responses from 188 employers, sheds light on the ongoing challenge of rising health care costs and the various approaches being taken to address this issue, which has significant implications for both businesses and employees.”
  • Modern Healthcare informs us,
    • “Steward Health Care completed the $245 million sale of its physician group, Stewardship Health, to private equity-owned Rural Healthcare Group.
    • “As part of the transaction, Kinderhook Industries, the private equity firm that owns Rural Healthcare Group, plans to rebrand the combined company as Revere Medical, Kinderhook said Thursday in a news release. The acquisition adds about 5,000 employed and affiliated Stewardship physicians across nine states to Revere’s network of 17 primary care clinics in Tennessee and North Carolina.
    • “Revere plans to invest in Stewardship infrastructure and technology and has pledged to allow patients to stay with their doctors, according to the release.
    • “The Stewardship team is excited for this next chapter with Revere Medical as it provides a committed partner focused on quality care and improving the clinic experience for providers, clinic teams, and patients,” Dr. Joseph Weinstein, president of Stewardship, said in the release.
    • “The Stewardship sale is one of the last remaining transactions in Steward’s Chapter 11 bankruptcy restructuring.”
  • Per Fierce Healthcare,
    • “Optum Rx is rolling out a slate of new programs that seek to support independent pharmacies in managing costs and more complex patient needs.
    • “The first offering under this initiative is Optum’s new Independent Pharmacy Network, which is available as an add-on for its pharmacy benefit management clients. In contracts that select this option, independent and community pharmacies will receive 5% higher reimbursements for generics and 0.2% higher for branded drugs.
    • “The PBM said this program follows other changes enacted to support independent pharmacies; for instance, it does not collect direct and indirect remuneration, or DIR, fees and removed clawbacks for independent facilities.”
  • and
    • “Teladoc Health had a better quarter than Wall Street expected, posting $640.5 million in revenue and losing less per share than expected, at $0.19. Quarterly revenue decreased by 3% from 2023 and was down slightly from Q2’s $642.4 million.
    • “In the Q3 earnings call, Teladoc executives stressed the stability of the U.S. virtual care segment, which has gained millions of users since last year. It called BetterHelp a “company in transition,” as the company pivots hard to offset the cost of a $790 million impairment charge in the second quarter.
    • “BetterHelp, Teladoc’s virtual mental health solution, continue to drag down its performance as the segment’s revenue fell 10% year-over-year, coming in at $256.8 million in Q3.”
  • Per Fierce Pharma,
    • “Bristol Myers’ $1.5 billion restructuring initiative that runs through 2025 may not be the end of the company’s ongoing efficiency push. 
    • “BMS management is “reviewing overall spending and prioritizing investments that will deliver the best long-term returns,” CEO Chris Boerner, Ph.D., said during a call Thursday. The New Jersey-based pharma is on track to deliver on its existing $1.5 billion cost-saving target by the end of next year, the CEO confirmed.
    • “We see the drive for greater operational excellence as a continuous process,” Boerner continued. “As such, we are exploring opportunities to further improve productivity and efficiency over the coming quarters.”
    • “Later during the call, CFO David Elkins said BMS is “continuing to look for efficiencies in our cost base, and you’ll continue to hear more about that.”
  • Per BioPharma Dive,
    • “Sales of GSK’s top-selling vaccines fell sharply during the third quarter amid lower demand, sending shares in the British pharmaceutical company down 3% in U.S. trading Wednesday.
    • “GSK, which had downgraded its vaccine sales forecasts in July, did so again Wednesday in reporting earnings for the third quarter. The company now expects vaccine sales to decline by low single digits versus last year.
    • “During the third quarter, sales of GSK’s shingles vaccine dropped by 7% compared to the same period in 2023, while sales of its shot for respiratory syncytial virus, Arexvy, plunged by 72% year over year.
    • “In a presentation, GSK attributed the drop of Arexvy to several factors, including a narrower recommendation from the Centers for Disease Control and Prevention, prioritization of COVID vaccinations in the U.S. and lower rates of RSV infections this season.
    • “The decline mirrored that of Pfizer’s competing vaccine Abrysvo, sales of which came in lower this quarter compared to last year’s. Pfizer also cited the CDC recommendation, which focuses on vaccination for adults 75 years or older, as well as those between 60 and 74 years who are at higher risk of disease. Previously, the CDC had urged all adults 60 and older — for whom both Arexvy and Abrysvo are approved — to discuss vaccination with their doctor.”
  • Per Healthcare Dive,
    • “Oracle will launch a new artificial intelligence-backed electronic health record next year, the technology giant said Tuesday.
    • “The EHR will allow clinicians to use voice for navigation and search. It will also integrate the company’s clinical AI agent and tools for data analysis and tracking patient flow through the hospital.
    • “The new record marks a major health initiative for Oracle, which acquired EHR vendor Cerner for more than $28 billion in 2022. “This isn’t a refurbished Cerner EHR,” Seema Verma, executive vice president and general manager of Oracle Health and Life Sciences, said during the Oracle Health Summit on Tuesday. “Because in this day and age, you can’t leverage modern technology by bolting new innovation to something built in the 1990s.”

Monday Roundup

David Ermer–CMS, Congress, Electronic health records, FDA, Medical / Rx research, Mental health care, U.S. Healthcare–
Photo by Sven Read on Unsplash

From Washington, DC

  • The House of Representatives and the Senate are in session this week for Committee business and floor voting. The members of Congress hit the campaign trail next week until they return to Capitol Hill in November following the national election for a lame duck session.
  • Per an HHS press release,
    • “In its ongoing commitment to support women’s health, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), today launched an innovative grant program to provide almost $9 million to improve women’s health coverage and access to critical health benefits. These funds may be used to develop activities and launch educational campaigns to address disparities in access to reproductive health care and maternal health outcomes – many of which often result from challenges women face when trying to access information about available benefits or coverage, including for contraception and other family planning services. The Expanding Access to Women’s Health program grantees include the District of Columbia and the following 14 states: Arkansas, Colorado, Hawaii, Massachusetts, Maine, Mississippi, Nebraska, New Hampshire, New Jersey, New Mexico, Pennsylvania, Vermont, Washington, and Wisconsin.”
  • Modern Healthcare reports,
    • “Fewer hospitals will face high readmissions penalties in 2025 as rates of reimbursement cuts stabilize for providers.
    • “It is the third consecutive year in which the percentage of hospitals assessed penalties of 1% or more moderated, according to preliminary data released Friday by the Centers for Medicare and Medicaid Services. Penalties reduce the Medicare fee-for-service payments CMS makes to hospitals.
    • “For fiscal 2025, the number of hospitals included in the agency’s Hospital Readmissions Reduction Program is the lowest it has been in five years, with 100 fewer facilities participating than in fiscal 2021.
    • “The hospital readmissions performance period for fiscal 2025 pulls in claims from July 2020 through June 2023. The report is based on a rolling three-year time period, so the most recent one is the first to only include data generated after the start of the COVID-19 pandemic.”
  • FiercePharma tells us,
    • “For trade group the Pharmaceutical Research and Manufacturers of America (PhRMA), the fight against pricing provisions in the Inflation Reduction Act isn’t over yet.
    • “Late last week, the U.S. Court of Appeals for the Fifth Circuit reversed (PDF) a previous dismissal of PhRMA’s Inflation Reduction Act (IRA) lawsuit from February [2024 for lack of standing and proper venue], punting the complaint back to a lower Texas court.
  • and
    • “Less than a year after snagging its first FDA approval in psoriasis, UCB’s blockbuster hopeful Bimzelx has picked up three more indications to add to its growing resume of inflammatory disease treatment.
    • “The FDA cleared Bimzelx to treat adults with active psoriatic arthritis (PsA), active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and active ankylosing spondylitis (AS). The med is the first IL-17A/F inhibitor approved to treat the three indications, UCB noted in a press release.”

From the public health and medical research front,

  • The Washington Post informs us,
    • “About 37 percent of Gen Z men in the United States do not have an established primary care provider, according to a recent survey from the Cleveland Clinic. The survey, conducted this summer, involved 1,000 American men 18 or older living in the continental United States.
    • “Researchers assessed how different generations of men responded to questions about their health and health care, including whether they obtain yearly physicals, get screened based on doctors’ recommendations, and avoid smoking or vaping.
    • “The 37 percent of adult Gen Z men (born from 1997 through 2005) without a regular primary care provider compared with 27 percent of millennials (born from 1981 through 1996), 17 percent of Gen X respondents (1965 to 1980) and 7 percent of baby boomers and older (born before 1965).
    • “Nearly all the respondents said living a healthy lifestyle was a top priority, and 87 percent were concerned about how their current health habits would affect their future health. Millennials and adult Gen Zers were more likely to take care of their mental health (59 percent) than Gen X and boomers (53 percent), according to the survey.”
  • Consumer Reports, writing in The Washington Posts, offers tips on how to alleviate hip pain.
  • STAT News informs us,
    • “Of the roughly 15 million Americans who tried to quit smoking in 2022, 5 in 6 failed. It’s a jarring statistic — and an indictment of the treatment options for an addiction that kills 480,000 people in the U.S. each year.
    • “The smoking-cessation drugs on the market don’t work well for the majority of people, and they come with side effects and reputations that keep some smokers from ever trying them. Despite this, there hasn’t been a new class of drug approved for the condition in nearly two decades.” * * * 
    • “Chantix increases smokers’ success at quitting when compared to a placebo — but for every 100 people who use it, just 21 to 25 successfully stop, a recent meta-analysis found. It’s also associated with a raft of side effects, ranging from nausea to vivid dreams. Chantix, also known by its chemical name, varenicline, went generic in 2021 and can be purchased without insurance for roughly $68 for a one month supply, according to GoodRx.”  * * *
    • “In 2019, GlaxoSmithKline wrote to the FDA urging the agency to take several steps that would align its approach toward regulating NRT products with other nations’. Specifically, the drugmaker requested that the agency embrace a “Reduce to Quit” approach, whereby smokers are encouraged to use products like nicotine gum as they gradually reduce their cigarette consumption. 
    • “While the FDA has said it is open to this approach, which is used in countries like Germany, Canada, and the United Kingdom, the agency issued a guidance last year instructing drugmakers they would need to conduct a trial to evaluate the proposed regimen. GSK has warned that the need for another study “will make it less likely for innovator companies to pursue this indication in the U.S.”
  • Per KFF,
    • “A new KFF analysis examines the recent decline in opioid overdose deaths, with a focus on how trends vary by age, race, gender and state.
    • “Provisional data from the Centers for Disease Control and Prevention show a 20% decline in deaths during the latter half of 2023 compared to the same period from the previous year.
    • “In the second half of 2023, White people saw the largest decline (-14%) in opioid overdose deaths while declines among Black people were about half that (-6%), compared to the same period the year before.
    • “All age groups experienced declines in opioid overdose deaths except one. Among people 65 and older, opioid deaths rose by 9% percent in late 2023, with factors such as low detection of substance use concerns potentially playing a role.
    • “In three-quarters of states, opioid deaths declined in the last six months of 2023 compared to the same period in 2022. In 2023, opioid death rates were the highest in West Virginia, Washington D.C. and Delaware, while states with the lowest opioid death rates included Nebraska, South Dakota and Iowa.
    • “Newer provisional and partial data for the first quarter of 2024, which is not included in this analysis, point to a continuation of the overall downward trend in opioid overdose deaths through early 2024.”

From the U.S. healthcare business front,

  • Managed Healthcare Executive points out,
    • “Employers expect prescription drug costs to increase an average of 8% in 2025, making prices the highest they’ve been in 15 years, according to a news release published yesterday. Data was taken from the results of the 2025 Segal Health Plan Cost Trend Survey, an annual survey of managed care organizations, health insurers, prescription drug benefit managers (PBMs) and third party administrators (TPAs). Price inflation is the biggest factor on medical costs.
    • “Respondents predict that the highest rates will be reflected in all outpatient prescription drugs with an 11.4% increase, up from last year’s projected rate of 9.9%, calculated before PBM rebates. Outpatient prescription drugs trends are affected by factors such as drug price inflation, direct-to-consumer advertising and a changing drug mix.
    • “The increased use of drugs with the glucagon-like peptide 1 (GLP-1s) is a driving force in drug prices, due to their effectiveness in treating both type 2 diabetes and obesity, the survey reports. In 2023, obesity management was the top medical condition driving costs at 255.3%, followed by migraines at 31.4%.”
  • Per Fierce Healthcare,
    • “What began as a dispute between two health tech companies over healthcare data exchange practices has now led to a federal lawsuit alleging antitrust violations.
    • “Venture-backed health tech company Particle Health filed an antitrust lawsuit against Epic in the Southern District of New York alleging that the electronic health records (EHR) giant is trying to muscle out competition in the payer platform market.
    • “The 81-page lawsuit (PDF), filed today [in the U.S. District Court for the Southern District of New York], alleges Epic engaged in monopolistic, anti-competitive practices, using its “power over EHRs to expand its dominance into the fledgling market for payer platforms,” according to the lawsuit, which was reviewed by Fierce Healthcare.
    • “Particle Health argues in its federal complaint that Epic has not only engaged in anticompetitive behavior but has purposefully blocked the exchange of patient information.
    • “In an emailed response to Fierce Healthcare, an Epic spokesperson said Particle’s claims are baseless.”
  • MedTech Dive lets us know,
    • “Stryker has struck its fourth takeover in as many months, acquiring Nico Corporation to add minimally invasive solutions for brain tumor removal and stroke care to its portfolio.
    • “Nico sells devices for navigating through the brain, visualizing the organ, removing tumors and clots and collecting tissue. The company received clearance for a device that allows visualization of the surgical field during brain surgery in 2012 and has since expanded its portfolio.
    • “Stryker will slot the products into a neurocranial business that reported U.S. organic sales growth of almost 11% in the second quarter. Specifically, the devices will form part of a neurosurgical unit that Stryker called out as a growth driver in the fourth quarter of 2023. Stryker did not disclose the terms of the deal.”

Tuesday Tidbits

David Ermer–Congress, Electronic health records, Mental health care, OPM, Rx coverage, Telehealth, U.S. Healthcare, Uncategorized–
Photo by Patrick Fore on Unsplash

From Washington, DC

  • Modern Healthcare reports,
    • “Lawmakers and executives from three major pharmacy benefit managers presented diametrically opposing views at a heated Capitol Hill hearing Tuesday, as major bills aimed at reining in the organizations remain stalled in Congress. 
    • “Members of the House Committee on Oversight and Accountability blamed the highly concentrated PBM industry for raising drug prices and running independent pharmacies out of business, while leaders from CVS Caremark, Express Scripts and Optum Rx all countered that the sector in fact lowers prices and supports local pharmacies.
    • “The hearing accompanied the committee’s release of a report detailing what its investigators characterized as abuses by the three large companies.”
  • Govexec lets us know,
    • “A federal employee group within the Justice Department last week made its final pitch to the federal government’s dedicated HR agency to boost the federal government’s coverage of in vitro fertilization and other assisted reproductive technology through the Federal Employees Health Benefits Program.
    • “The Department of Justice Gender Equality Network, an employee association representing nearly 2,000 workers at the Justice Department, sent acting Office of Personnel Management Director Rob Shriver three dozen testimonials from members describing the hardships they endured while trying to conceive. The move comes amid OPM’s final round of negotiations with insurance carriers over what FEHBP plans will cover next year.”
  • Federal News Network tells us,
    • “More than 15 years in the making, plans to update the federal pay system for blue-collar government employees are finally gaining some traction.
    • “A proposal to reform the Federal Wage System (FWS) has moved into the early stages of the government’s rulemaking process, the Federal Prevailing Rate Advisory Committee (FPRAC) announced during a public meeting Thursday morning.
    • “The proposal, if finalized, would amend the federal pay system for blue-collar government workers, more closely aligning it with the locality pay areas for the General Schedule (GS). An estimated 15,000 blue-collar feds would see their pay rates increase.”
  • Fierce Healthcare informs us,
    • “Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections. 
    • “The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess correlates of protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
    • “The initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.”
  • The Office of National Coordinator for Health Information Technology issued a standards bulletin that is “a companion to the USCDI v5 standard document published in July 2024. This issue provides background of USCDI v5 and the new data classes and elements that support improved patient care and advance the Administration’s goals of equity, diversity, and access to health care.”
  • The Food and Drug Administration announced,
    • On Monday, [July 22,] the FDA approved Femlyv (norethindrone acetate and ethinyl estradiol), the first orally disintegrating tablet approved for the prevention of pregnancy. Norethindrone acetate and ethinyl estradiol, the main ingredients in Femlyv, have been approved in the U.S. for the prevention of pregnancy as a swallowable tablet since 1968.
    • “Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication,” said Janet Maynard, M.D., M.H.S., director of the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine in the FDA’s Center for Drug Evaluation and Research. “There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges.”
    • The most common adverse reactions to Femlyv are headache, vaginal candidiasis, nausea, menstrual cramps, breast tenderness, bacterial vaginitis, abnormal cervical smear, acne, mood swings, and weight gain. See full prescribing information for additional information on the safety and effectiveness of Femlyv.

From the public health and medical research front,

  • The American Hospital Association News relates,
    • “The Department of Health and Human Services July 23 released an amendment to a 2013 emergency declaration under the Food, Drug and Cosmetic Act that broadens the scope in which the agency can help facilitate certain medical countermeasures in response to a public health emergency such as a pandemic. The amendment now applies to pandemic influenza A viruses and others with pandemic potential, such as the current H5N1 strain of bird flu that has infected cattle and subsequently humans in some states. Previously, the declaration specifically covered just the H7N9 strain of bird flu. The declaration would allow the Food and Drug Administration to extend the expiration date of certain medical products and allow HHS to issue an emergency use authorization for unapproved drugs, devices or products, among other actions.”
  • Per BioPharma Dive,
    • “An experimental Merck & Co. drug designed to protect infants from illness caused by respiratory syncytial virus succeeded in a late-stage trial, the company said Tuesday.
    • “In a statement, Merck said the therapy, an antibody called clesrovimab, met its main safety and efficacy objectives in a placebo-controlled trial involving more than 3,600 healthy or preterm infants. Those goals included the incidence of RSV-associated lower respiratory infections requiring medical attention over the course of five months, compared to placebo, as well as the percentage of patients experiencing certain types of adverse events.
    • “A spokesperson told BioPharma Dive in an email that clesrovimab met a key secondary measure by reducing the risk of hospitalization from RSV in the trial. But the company didn’t provide specifics on that result or the rest of the study findings, which will be presented at a future medical meeting. In the meantime, Merck plans to share the data with global health authorities.”
  • Per National Institutes of Health press releases,
    • “Long-acting injectable cabotegravir (CAB-LA) was safe and well tolerated as HIV pre-exposure prophylaxis (PrEP) before and during pregnancy in the follow-up phase of a global study among cisgender women. The analysis of outcomes from more than 300 pregnancies and infants will be presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
    • “Cisgender women experience biological changes and social dynamics that can increase their likelihood of acquiring HIV during pregnancy and the postnatal period, and we need to offer them evidence-based options when they may need them most,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “These data provide reassurance about long-acting injectable cabotegravir for HIV prevention during pregnancy.”
  • and
    • “A single laboratory-based HIV viral load test used by U.S. clinicians who provide people with long-acting, injectable cabotegravir (CAB-LA) HIV pre-exposure prophylaxis (PrEP) did not reliably detect HIV in a multi-country study. In the study, a single positive viral load test was frequently found to be a false positive result. However, a second viral load test with a new blood sample was able to distinguish true positive results from false positive results for all participants whose initial viral load test was positive. The findings were presented at the 2024 International AIDS Conference (AIDS 2024) in Munich, Germany.
    • “We are still learning how to optimize the package of services that accompany long-acting PrEP, including HIV testing,” said Jeanne Marrazzo, M.D., M.P.H., director of the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID). “The viral load testing findings observed in this study illuminate performance gaps in the current U.S. HIV testing algorithm for injectable cabotegravir PrEP.”
  • and
    • “Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model solved medical quiz questions—designed to test health professionals’ ability to diagnose patients based on clinical images and a brief text summary—with high accuracy. However, physician-graders found the AI model made mistakes when describing images and explaining how its decision-making led to the correct answer. The findings, which shed light on AI’s potential in the clinical setting, were published in npj Digital Medicine.  The study was led by researchers from NIH’s National Library of Medicine (NLM) and Weill Cornell Medicine, New York City.
    • “Integration of AI into health care holds great promise as a tool to help medical professionals diagnose patients faster, allowing them to start treatment sooner,” said NLM Acting Director, Stephen Sherry, Ph.D. “However, as this study shows, AI is not advanced enough yet to replace human experience, which is crucial for accurate diagnosis.”
  • Per MedPage Today,
    • “Patients with dementia may instead have hepatic encephalopathy (HE) and should be screened with the Fibrosis-4 (FIB-4) index for cirrhosis, one of the main causes of the condition, new research suggests.
    • “The study of more than 68,000 individuals in the general population diagnosed with dementia between 2009 and 2019 found that almost 13% had FIB-4 scores indicative of cirrhosis and potential HE.
    • “The findings, recently published online in The American Journal of Medicine, corroborate and extend the researchers’ previous work, which showed that about 10% of US veterans with a dementia diagnosis may in fact have HE.”

From the U.S. healthcare business front,

  • Healthcare Dive reports,
    • “HCA Healthcare reported second-quarter earnings that handily beat Wall Street expectations.
    • “The Nashville, Tennessee-based operator posted $17.5 billion in revenue, a net income of $1.5 billion and a 5.8% increase in same facility admissions. During a call Tuesday, HCA’s executive team attributed the company’s success to broad demand for services and an ability to manage expenses.
    • “HCA updated its full-year revenue guidance following the results. It now expects to draw between $69.8 billion and $71.8 billion, up from the originally forecast $67.8 billion to $70.3 billion.”
  • Modern Health points out,
    • “Molina Healthcare said Tuesday it is expanding into Connecticut through an agreement to acquire EmblemHealth subsidiary ConnectiCare Holding Co., for $350 million.
    • “The Farmington, Connecticut-based health insurer has approximately 140,000 members in marketplace, Medicare and other health insurance plans across the state, according to a news release. Molina said the purchase price represents a quarter of ConnectiCare’s $1.4 billion in expected 2024 revenue. The company said it will fund the deal with cash on hand and plans to close it in the first half of 2025.
    • “The ConnectiCare purchase is part of Long Beach, California-based Molina’s strategy to develop stable revenue streams and deploy capital more efficiently, President and CEO Joe Zubretsky said in the news release.
    • “The deal is Molina’s second acquisition this year. In January it completed the purchase of Bright Health Group’s California Medicare Advantage business for $425 million.”
  • Beckers Hospital Review identifies fifteen health systems that are dropping certain Medicare Advantage plans and notes,
    • Medicare Advantage accounted for around 1 in 4 inpatient hospitals days in 2022, according to a report from KFF published July 23.  * * *
    • In rural and micropolitan counties, the share of inpatient days from Medicare Advantage enrollees doubled between 2015 and 2022. 
    • Read more here. 
  • Behavioral Health Business discusses virtual applied behavioral therapy.
    • “It’s no secret that there is a steep supply-and-demand issue for applied behavior analysis (ABA) services nationwide. 
    • “The industry is relatively new, which means the pool of qualified professionals is still small compared to the need. There are less than70,000 board-certified behavior analysts in the U.S. Still, autism impacts 1 in 36 children, according to the CDC. 
    • “Many of those qualified clinicians are prioritizing flexibility in the workplace and turning to telehealth.”

Thursday Miscellany

David Ermer–Congress, Electronic health records, FDA, Medical / Rx research, Mental health care, NIH, Obesity, U.S. Healthcare–
Photo by Josh Mills on Unsplash

Happy Summer Solstice in our northern hemisphere of Mother Earth.

From Washington, DC,

  • Federal News Network lets us know,
    • “With both Senate and House lawmakers advancing legislation that aligns with President Joe Biden’s 2% federal pay raise request, civilian federal employees appear to be a step closer to a smaller pay bump for 2025.
    • “The Senate Armed Services Committee’s version of the fiscal 2025 National Defense Authorization Act last week showed support for a 2% raise for DoD civilian workers and a 4.5% raise for military members. In a vote of 22-3 on June 13, committee lawmakers advanced the 2025 NDAA to the full Senate for consideration. The House passed its version of the NDAA last week.
    • “Although the NDAA’s provisions only apply to Defense Department employees, both civilian DoD workers and the rest of the civilian federal workforce on the General Schedule would see the same percentage added to their paychecks, if the raise is enacted.
    • “In House appropriations legislation, committee lawmakers remained silent on the topic of the federal pay raise, indicating a likely alignment with the president’s raise proposal. The GOP-led committee advanced legislation for a fiscal 2025 spending package last week along party lines. The Senate Appropriations Committee has not yet released its versions of fiscal 2025 spending legislation.”
  • The American Hospital Association News tells us,
    • “A United States District Court Judge in Texas today ruled in favor of the AHA, Texas Hospital Association, and hospital plaintiffs, agreeing that Department of Health and Human Services “bulletins” that restrict health care providers from using standard third-party web technologies that capture IP addresses on portions of their public-facing webpages were unlawful final rules and vacating the March 2024 Revised Bulletin.
    • “It’s easy for eyes to glaze over at a thirty-page opinion discussing the administrative esoterica accordant with HIPAA compliance,” United States District Court Judge Mark Pittman wrote today. “But this case isn’t really about HIPAA, the Proscribed Combination, or the proper nomenclature for PHI in the Digital Age. Rather, this is a case about power.…  While the Proscribed Combination may be trivial to HHS, it isn’t for covered entities diligently attempting to comply with HIPAA’s requirements.…  The Court GRANTS the Hospitals’ request for declaratory judgment and DECLARES that the Proscribed Combination, as set forth in the HHS Bulletin of March 18, 2024, is UNLAWFUL, as it was promulgated in clear excess of HHS’s authority under HIPAA.”
  • Bravo!
  • In an interview with Healthcare Dive, Micky Tripathi, the National Coordinator for Health Information Technology, discusses his agency’s artificial intelligence strategy.
  • The House Committee on Education and the Workforce announced that “On Thursday, June 27, at 10:15 a.m., the Subcommittee on Health, Employment, Labor, and Pensions, chaired by Rep. Bob Good (R-VA), will hold a hearing titled “Examining the Policies and Priorities of the Employee Benefits Security Administration.”
  • Kevin Moss, writing in the Federal Times, reminds postal annuitants over the age of 65 and without Medicare Part B about the ongoing, late enrollment penalty free Special Enrollment Period. available to future PSHBP members.
  • BioPharma Dive reports,
    • “The Food and Drug Administration has substantially loosened limits on the first gene therapy for Duchenne muscular dystrophy in a decision that could greatly expand its use even as questions remain about its effectiveness.
    • “The agency on Thursday made the therapy, called Elevidys and sold by biotechnology company Sarepta Therapeutics, available to people with Duchenne who are at least four years of age and have mutations in a specific gene, regardless of whether they can still walk.
    • “For those who are still ambulatory the agency also converted Elevidys’ conditional approval to full, meaning its market availability in that setting is no longer contingent on additional tests. The clearance for Duchenne patients who are non-ambulatory is conditioned on the results of a Phase 3 study called Envision that’s currently underway.”

From the public health and medical research front,

  • Cardiology Business informs us,
    • “The American College of Cardiology (ACC) this week published a report card on the excess cardiovascular mortality among Black Americans between 2000-2022.[1] The ACC said it highlights the “persistent and tragic inequities” in cardiovascular care and outlines the years of life lost to the Black community because of higher cardiovascular disease death rates.
    • “The report showed the Black population experienced 1.6 million excess deaths overall and millions of potential life-years lost. Heart disease was the leading cause of age-adjusted excess mortality among Black Americans. This includes deaths due to ischemic heart disease, hypertension, cerebrovascular disease and heart failure.
    • “Our study reveals that Black Americans, because of their higher cardiovascular mortality rates compared with white Americans, have suffered almost 800,000 excess deaths, which translates to about 24 million additional years of life lost between 2000 and 2022,” Journal of the ACC incoming editor-in-chief Harlan M. Krumholz, MD, SM, FACC, who is also senior author of the study, said in a statement. “This staggering figure highlights the critical need for systemic changes in addressing cardiovascular inequities.”
    • “Krumholz said the goal of the report card is to promote accountability and serve as a catalyst for action that addresses the ongoing problem.”
  • The National Institutes of Health’s Director writes in her blog,
    • “Drug-resistant bacteria are responsible for a rise in serious, hospital-acquired infections, including pneumonia and sepsis. Many of these bacteria are classified as “gram-negative,” and are harder to kill than “gram-positive” bacteria. Unfortunately, the limited number of antibiotics that can help combat these dangerous infections can also damage healthy microbes in the gut, leaving people at risk for other, potentially life-threatening infections. Such antibiotic-induced disruption has also been linked in studies to irritable bowel syndrome, colon cancer, and many other health conditions.
    • “There’s a great need for more targeted antibiotics capable of fending off infectious gram-negative bacteria while sparing the community of microbes in the gut, collectively known as the gut microbiome. Now, in findings reported in the journal Nature , a research team has demonstrated a promising candidate for the job. While the antibiotic hasn’t yet been tested in people, the findings in cell cultures suggest it could work against more than 130 drug-resistant bacterial strains. What’s more, the study, supported in part by NIH, shows that this compound, when given to infected mice, thwarts potentially life-threatening bacteria while leaving the animals’ gut microbiomes intact. * * *
    • “These new findings, while promising, are at an early stage of drug discovery and development, and much more study is needed before this compound could be tested in people. It will also be important to learn how rapidly infectious gram-negative bacteria may develop resistance to lolamicin. Nevertheless, these findings suggest it may be possible to further develop lolamicin or related antibiotic compounds targeting the Lol system to treat dangerous gram-negative infections without harming the microbiome.”
  • Per an NIH press release,
    • “Researchers at the National Institutes of Health (NIH) have developed a non-chemotherapy treatment regimen that is achieving full remissions for some people with aggressive B-cell lymphoma that has come back or is no longer responding to standard treatments. The five-drug combination targets multiple molecular pathways that diffuse large B-cell lymphoma (DLBCL) tumors use to survive.
    • “In a clinical trial at NIH’s National Cancer Institute, researchers tested the combination of venetoclax, ibrutinib, prednisone, obinutuzumab, and lenalidomide (called ViPOR) in 50 patients with DLBCL, the most common type of lymphoma. The treatment shrank tumors substantially in 26 of 48 (54%) evaluable patients, with 18 (38%) of those patients’ tumors disappearing entirely, known as a complete response. At two years, 36% of all patients were alive and 34% were free of disease. These benefits were seen mainly in people with two specific subtypes of DLBCL.
    • “The findings were published June 20, 2024, in the New England Journal of Medicine.
  • NIH also posted the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)  Director’s Update for Summer 2024.
  • STAT News points out,
    • “Gestational diabetes affects one in seven expecting women globally and rates of this troubling condition are rising. Blood glucose levels that become elevated for the first time during pregnancy can lead to severe complications, such as preeclampsia, and increase the risk of stillbirth. And while the condition typically resolves after birth, it is linked to a tenfold increase in the risk of developing type 2 diabetes, along with risks for the child including obesity, cardiovascular disease, and neurodevelopmental disorders. 
    • “Gestational diabetes has long been diagnosed between weeks 24 and 28 of pregnancy. But a recent randomized control study called Treatment of Booking Gestational Diabetes Mellitus, or TOBOGM, which was started in 2018 and whose results were published earlier this year, found that treating gestational diabetes before week 20 reduced the risk of severe perinatal complications, including preterm birth, low birthweight, stillbirth, and respiratory distress. The early treatment was most effective in women who had high blood glucose levels after an oral glucose tolerance test, which measures how well the body can metabolize the sugar in a very sweet, Gatorade-like drink. 
    • “In some cases, women are tested early when they have risk factors such as high blood pressure, obesity, or previous gestational diabetes. But between 30% and 70% of all gestational diabetes cases could be detected much earlier — by the twentieth week of a pregnancy, according to a series published on Thursday in The Lancet by an international group of gestational diabetes researchers.” 
  • and
    • When they work, immunotherapy drugs called checkpoint inhibitors can shrink cancers and, in some cases, eradicate tumors altogether. These drugs, which include Keytruda and Opdivo, are prescribed to hundreds of thousands of patients a year for dozens of different kinds of cancer — but they only work for a minority of them. Most patients ultimately end up progressing or relapsing.
    • In two separate [small] clinical trials published in Science on Thursday, researchers found that adding a drug called a JAK inhibitor created an unexpected synergy with checkpoint inhibitor therapy. The combination helped a majority of patients respond to the immunotherapy and, in one trial, overcome resistance to checkpoint inhibitors.
  • Per Biopharma Dive,
    • “Twice-yearly shots of a Gilead Sciences HIV drug were so effective at preventing infections in a large late-stage clinical trial that study monitors recommend the company stop testing early and offer the drug to all participants.
    • “The trial, called Purpose 1 and run in South Africa and Uganda, compared Gilead’s medicine lenacapavir to once-daily Truvada and background HIV infection rates among cisgender women. Lenacapavir proved superior to both, with zero HIV infections reported in the study group, Gilead said Thursday.
    • “Gilead hopes testing of twice-yearly lenacapavir will prove it an effective and more convenient preventive option for people at risk of HIV infection. The company expects data late this year or early next from another study that involves cisgender men who have sex with men as well as certain groups of people who are transgender or gender non-binary.”
  • Optum discusses “New innovative treatments for hemophilia B, RSV, COPD” in its new edition of its Drug Pipeline Insights Report.
  • Per Medscape,
    • “A single course of treatment with emotional awareness and expression therapy (EAET) was associated with a significantly greater reduction in chronic pain severity than cognitive-behavioral therapy (CBT), the current psychotherapeutic gold standard, a new study suggested.”
    • “Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.
    • The study is one of only a few to directly compare EAET with CBT.”

From the U.S. healthcare business front,

  • Mercer Consulting notes,
    • “Despite higher healthcare cost trends, fewer than half of large employers (those with 500 or more employees) are likely to take cost-cutting measures next year like raising deductibles or copays, according to Mercer’s new Survey on Health and Benefit Strategies for 2025, with nearly 700 employer participants.
    • “Heading into 2025, employers face the challenge of addressing sharply faster cost growth while keeping healthcare affordable for their workers and offering a competitive benefit package. The survey found that medical plan options that save money by steering employees to quality, cost-efficient health providers — and potentially offer members more affordable coverage – now have significant traction with employer health plan sponsors.
    • “These plans take different forms, but over a third of large employers (36%) are now utilizing high-performance network plans or other alternative medical plans, and 29% are considering it in the near-term. * * *
    • “Many large employers indicated they want a consistent offering nationally. If this is a key priority, then an employer could explore the newer variable copay health plan options or high-performance network products offered by certain national carriers that can backfill with their broad network as needed in some geographies for a consistent national offering. Further, while considering disruption to members is important, it shouldn’t mean avoiding change entirely. A high-performance network option could be offered as a choice at enrollment that provides a richer benefit design or lower payroll contribution option as a tradeoff for the different network.
    • “Additionally, the prevalent variable copay plan options are built on top of national broad network options, so in most cases provider disruption would be minimal.
  • Newfront discusses ten spousal incentive HRA compliance considerations. Spousal incentive HRAs are health reimbursement accounts offered to employees who elect primary coverage from their spouse’s group health plan.
  • Beckers Payer Issues relates,
    • “Humata Health, a company that uses AI and machine learning to streamline prior authorization for payers and providers, has closed a $25 million investment. 
    • “The funding was led by Blue Venture Fund (majority of BCBS plans) and LRVHealth (nearly 30 health systems and payers), with participation from Optum Ventures, .406 Ventures, Highmark Ventures and VentureforGood, according to a June 20 news release.
    • “The company said it will use the funding to broaden the scope of its generative AI technologies, expand its customer base, and begin partnering with payers and other entities. Founded in 2023, the company has already partnered with 225 hospitals.”
  • The Wall Street Journal reports,
    • “Eli Lilly is stepping up its campaign against fake and counterfeit weight-loss drugs with more lawsuits against sellers of unapproved products that market themselves as Mounjaro and Zepbound.
    • “The pharmaceutical company said Thursday that it has filed legal actions against med-spas, wellness centers and other entities that sell products purportedly containing tirzepatide, the antidiabetic medication Eli Lilly sells under the brand names Mounjaro and Zepbound.”
  • STAT News interviews Bold Health’s CEO Amanda Rees on “fall prevention, ageism in health care, and ‘movement is medicine’.”
    • “When Amanda Rees was in her twenties she moved in with her grandmother, who was in her 80s, and saw first-hand the issues older adults face with falls and balance. “It really radicalized how I thought about aging,” she said. Serving as her grandmother’s caretaker inspired her to shift into health care and start Bold, a health tech startup that provides at-home digital exercise programs targeted at adults 65 and older.  
    • “Falls among older adults cost the health care system about $50 billion annually, according to the CDC. Rees hopes Bold can help older adults build strength, prevent falls and reduce hospitalizations. The Los Angeles-based startup works with Medicare Advantage members and raised $17 million during its Series A. Rees sat down with STAT to discuss building Bold, the concept of  “movement is medicine,” and the public health crisis of falls.”

Midweek Update

David Ermer–AHRQ, CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Medical / Rx research, NIH, No Surprises Act, Obesity, OPM, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC,

  • The House Appropriations Committee tells us, “Today, the House Appropriations Financial Services and General Government Subcommittee met to consider its Fiscal Year 2025 bill. The measure was approved by the Subcommittee.”
  • This bill provides appropriations for OPM and the FEHBP. The Committee summary of the bill describes its OPM appropriations as follows —
    • “Provides $477 million for the Office of Personnel Management (OPM), which is $31.4 million below the FY25 Budget Request and $29.1 million above the FY24 enacted level.”
  • Govexec informs us,
    • “Senate Democrats have vowed to move quickly on legislation protecting Americans’ access to in vitro fertilization and other forms of assistive reproductive technology, including a provision expanding federal workers’ access to those treatments as part of the government’s employer-sponsored health insurance program.
    • “On Monday, Sens. Tammy Duckworth, D-Ill., Patty Murray, D-Wash., and Cory Booker, D-N.J., introduced the Right to IVF Act, a repackaging of three separate previously introduced bills on reproductive health services.
    • “Included is the Family Building FEHB Fairness Act, first introduced last year by Duckworth, which would require the Federal Employees Health Benefits Program to cover additional costs associated with IVF, and would expand coverage to all types of assisted reproductive technology, such as gamete and zygote intrafallopian transfer.”
  • Govexec also pointed out this OPM Inspector General brief that summarizes OPM OIG recommendations that have been open for more than six months as of March 31, 2024. The FEHBlog understands why the FEHB open recommendations remain outstanding
  • Healthcare Dive lets us know,
    • “Congress appears to be inching toward injecting more transparency into a controversial program that forces drugmakers to give safety-net hospitals steep discounts on drugs.
    • “It would be a win for pharmaceutical manufacturers, which have long lobbied that hospitals be required to account for their savings in the 340B program — or that it be overhauled entirely.
    • “The latter appears unlikely, after lawmakers on both sides of the aisle expressed blanket support for 340B during a House Oversight and Investigations subcommittee hearing on Tuesday. However, members said they approved of more oversight to try and stop financial gaming in the program.
    • “Though “we’re all in support of 340B … I think nearly all of us agree that the status quo is not acceptable,” said Rep. Larry Bucshon, R-Ind.”
  • Yesterday, the U.S. Preventive Services Task Force released a final recommendation concerning “Falls Prevention in Community-Dwelling Older Adults: Interventions.” Its recommendations align with the recommendations currently in force.
  • Thompson Reuters Practical Law relates,
    • “In litigation under the No Surprises Act (NSA), a district court concluded that there is no cause of action for health providers to enforce awards involving surprise billing disputes under the NSA’s independent dispute resolution (IDR) process (Guardian Flight LLC & Med-Trans Corp. v. Health Care Serv. Corp., (N.D. Tex. May 30, 2024)).”
  • The American Hospital Association News shares the organization’s “comments [submitted’ June 5 on the Centers for Medicare & Medicaid Services’ inpatient prospective payment system proposed rule for fiscal year 2025, expressing support for several provisions, including certain policies supporting low-volume and Medicare-dependent hospitals, and several aspects of CMS’ quality-related proposals. However, AHA raised concerns about the rule’s proposed payment updates.”

From the public health and medical research front,

  • CNN reports,
    • “About 61% of US adults will have cardiovascular disease by 2050, new research from the American Heart Association predicts. The biggest driver of this trend will be the large number of people who have or will develop high blood pressure, which makes them much more likely to develop dangerous problems like a heart attack or stroke.
    • “Other cardiovascular problems include heart attacks, arrhythmias like atrial fibrillation or a-fib, heart failure and congenital heart disease. * * *
    • In the research published Tuesday, the association predicts that 45 million adults will have some form of cardiovascular disease – excluding high blood pressure – or will have a stroke in 2050, up from 28 million in 2020.
  • The New York Times reports,
    • One of the nation’s premier medical advisory organizations has weighed in on long Covid with a 265-page report that recognizes the seriousness and persistence of the condition for millions of Americans.
    • More than four years since the start of the coronavirus pandemic, long Covid continues to damage many people’s ability to function, according to the National Academies of Sciences, Engineering and Medicine, a nongovernmental institution that advises federal agencies on science and medicine.
  • and
    • “A committee of advisers to the Food and Drug Administration voted on Wednesday to update the formula for the Covid vaccine ahead of an anticipated fall immunization campaign, now an annual step to try to offer better protection against versions of the virus in circulation.
    • “The unanimous vote by the 16 advisers recommends a formula aimed at combating the variant JN.1, which dominated infections in the United States in February, or a version of it. In recent weeks, JN.1 has been overtaken by descendants known as KP.2 and KP.3.
    • “In the coming weeks, the F.D.A. is expected to formally recommend a variant target for vaccine makers for the next round of shots in the late summer or early fall. Any decision involves some educated guesswork, given that any new vaccine formula won’t be available until months after a variant becomes dominant.
    • “It’s becoming clear that the ideal timing for a vaccine composition decision remains elusive,” said Jerry Weir, an official with the F.D.A.’s vaccine division.”
  • Per Biopharma Dive,
    • “A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.”A saliva test may improve screening for prostate cancer by identifying people at higher risk based on genotype, researchers said Friday.
    • “Data presented at the American Society of Clinical Oncology annual meeting suggest the test can support prostate cancer diagnosis in people who are missed by other screening methods.
    • “The researchers are now comparing the saliva test to several screening methods such as fast MRI scans and prostate-specific antigen (PSA) blood tests to determine the best approach.”
  • and
    • “Eli Lilly’s drug tirzepatide — sold as Zepbound for obesity — continues to show promise in the liver disease MASH. Clinical trial data disclosed in an abstract ahead of a European medical conference indicates that, after one year, the shot helped improve liver fibrosis without worsening MASH in just over half of treated participants, compared with 30% of those given placebo. Lilly had hinted at the study’s success earlier this year, but the full data will provide a more complete view of tirzepatide’s potential. The abstract’s release comes one day after Viking Therapeutics released trial data for its MASH pill VK2809 and less than two months after Madrigal Pharmaceuticals won U.S. approval of the first MASH drug.”
  • The Institute for Clinical and Economic Research “today posted a Protocol outlining how it will conduct the fourth annual assessment of how well major insurers’ prescription drug coverage policies align with a set of fair access standards. These standards were developed by ICER with expert input from patient advocates, clinician specialty societies, payers, pharmacy benefit managers, and life science companies.”
  • Per MedPage Today,
    • “The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).”The CDC finalized new guidelines that recommend doxycycline post-exposure prophylaxis (doxy PEP) for at-risk gay, bisexual, and other men who have sex with men (MSM) and transgender women (TGW) to prevent bacterial sexually transmitted infections (STIs).
    • “Healthcare providers should discuss and offer doxy PEP to people in these populations with a history of at least one bacterial STI — specifically syphilis, chlamydia, gonorrhea — in the last 12 months, Lindley Barbee, MD, of the CDC’s National Center for HIV, Viral Hepatitis, STD, and TB Prevention, and colleagues wrote in Morbidity and Mortality Weekly Report.”
    • “Doxy PEP represents the first new STI prevention tool in decades, at a time when innovation in the nation’s fight against STIs is desperately needed,” said Barbee in a CDC statement.
  • The National Institutes of Health announced,
    • “The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has released its plan for advancing H5N1 influenza basic research and translating those findings into strategies and interventions that can benefit people. The research agenda focuses on four key objectives: increasing understanding of the biology of H5N1 viruses and the factors that influence their ability to transmit and cause disease; developing and evaluating prevention strategies, such as vaccines; advancing existing and novel treatments, including antivirals and monoclonal antibodies; and supporting strategies for detecting H5N1 virus. The NIAID Research Agenda for 2024 H5N1 Influenza – May 2024 aligns with the NIAID role in the federal public health response to the U.S. outbreak of H5N1 influenza in people, dairy cows and other animals.”
  • The Washington Post reports, “Male birth control gel shows promise in early-stage clinical trials. “A National Institutes of Health official said the findings marked a milestone, even if the product is probably years away.”

From the U.S. healthcare business front,

  • KFF informs us,
    • The Medical Loss Ratio (MLR) provision of the Affordable Care Act (ACA) limits the amount of premium income that insurers can keep for administration, marketing, and profits. Insurers that fail to meet the applicable MLR threshold are required to pay back excess profits or margins in the form of rebates to individuals and employers that purchased coverage.
    • In the individual and small group markets, insurers must spend at least 80% of their premium income on health care claims and quality improvement efforts, leaving the remaining 20% for administration, marketing expenses, and profit. The MLR threshold is higher for large group insurers, which must spend at least 85% of their premium income on health care claims and quality improvement efforts. MLR rebates are based on a 3-year average, meaning that rebates issued in 2024 will be calculated using insurers’ financial data in 2021, 2022 and 2023 and will go to people and businesses who bought health coverage in 2023.
    • This analysis, using preliminary data reported by insurers to state regulators and compiled by Mark Farrah Associates, finds that insurers estimate they will issue a total of about $1.1 billion in MLR rebates across all commercial markets in 2024. Since the ACA began requiring insurers to issue these rebates in 2012, a total of $11.8 billion in rebates have already been issued to individuals and employers, and this analysis suggests the 2012-2024 total will rise to about $13 billion when rebates are issued later this year.
  • TechTarget calls our attention to the fact that “As providers seek to advance patient-centered care, many behavioral health organizations are turning to their EHR vendors to support integrated care models, according to a KLAS report.” Yippee.
  • Beckers Hospital Review lets us know,
    • “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. “U.S. bankruptcy Judge Chris Lopez authorized the sale dates for Dallas-based Steward Health Care’s 31 hospitals during a June 3 hearing. 
    • “The sales will be conducted in two rounds. The first round, which includes the health system’s physician group, Stewardship Health, and all Steward hospitals excluding its Florida facilities and some of the Texas hospitals, will have a bid deadline of June 24 and a first sale hearing July 11.
    • “The second round includes Steward’s Florida hospitals and four of its Texas facilities, with a bid deadline of Aug. 12 and a sale hearing of Aug. 22.”
  • Beckers Payer Issues tells us about the payers that landed on the 2024 Fortune 500.

Thursday Miscellany

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

From Washington, DC,

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

From the Food and Drug Administration front,

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

From the public health and medical research front,

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

From the U.S. healthcare business front,

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

Tuesday Tidbits

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, Electronic health records, FDA, Generative AI, HIPAA Privacy and Security Rules, Medical / Rx research, Medicare, U.S. Healthcare–
Photo by Maddy Weiss on Unsplash

Happy First Day of Spring!

From Washington, DC,

  • The Wall Street Journal reports,
    • “Lawmakers who are finishing writing six annual spending bills have resolved a last-minute roadblock over border funding, setting the stage for Congress to review and approve the legislation on a tight timeline that could take them to the brink of a partial government shutdown this weekend. 
    • “Congressional negotiators late Monday reached a deal on the provisions within the Department of Homeland Security’s funding bill. That bill got caught in an 11th-hour tangle with the White House over border spending, which has become a top issue in many swing states during the 2024 presidential-election year.
    • “In a statement Tuesday morning, Speaker Mike Johnson (R., La.) said an agreement has been reached on the Homeland Security funds, and House and Senate committees have begun drafting bill text to be “prepared for release and consideration by the full House and Senate as soon as possible.”
    • “President Biden said Tuesday that a path on the remaining funding legislation had been finalized and he would sign the measure immediately when it gets to his desk.”
  • Per a House Budget Committee press release,
    • “Today, the House of Representatives advanced House Budget Committee legislation, H.R. 766, the Dr. Michael C. Burgess Preventative Health Savings Act (PHSA), to the Senate by a voice vote. 
    • “The historic accomplishment marks the first time in history that a bipartisan bill with sole Budget Committee jurisdiction has been brought to the Floor under a suspension of the House rules. * * *
    • “One of the major barriers to deploying modernized and innovative policies that would unequivocally curb the cost of health care is the antiquated process used for calculating congressional cost estimates on proposed health care legislation.
    • “Congressional scorekeepers have traditionally focused solely only on the short-term valuation of a policy rather than capturing the long-term economic impact.
    • “But today, with passage of H.R. 766, that changes. This bill seeks to improve the methodology of Congress’ broken budgetary process by providing policymakers with a more accurate cost estimate of the long-term cost savings from preventive health care policies.”
  • Per an HHS press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), announced a new voluntary model that empowers primary care providers in eligible Accountable Care Organizations (ACOs) to treat people with Medicare using innovative, team-based, person-centered proactive care. A key part of the Biden-Harris Administration’s efforts to further promote competition in health care, the ACO Primary Care Flex Model (ACO PC Flex Model) will provide a one-time advanced shared savings payment and monthly prospective primary care payments (PPCPs) to ACOs. The advanced shared savings payments provide ACOs with needed resources and flexibility to cover costs associated with forming an ACO (where relevant) and administrative costs for required model activities. PPCPs will be distributed by ACOs to primary care practices, giving them improved resources and flexibility to provide care that best suits individuals’ needs.” * * *
    • “The ACO PC Flex Model is a five-year voluntary model that will begin on January 1, 2025. CMS is planning to select approximately 130 ACOs to participate in the model. Organizations interested in participating must first apply — either as new ACOs or renewing ACOs — to the Shared Savings Program. Shared Savings Program Applications are open May 20, 2024 – June 17, 2024. The ACO PC Flex Model Request for Applications (RFA) is planned to be released in the second quarter of 2024.
    • “For Frequently Asked Questions about the Primary Care Flex Model, please visit: https://www.cms.gov/priorities/innovation/innovation-models/aco-primary-care-flex-model/faqs.
    • “For a fact sheet on the model, please visit: https://www.cms.gov/files/document/aco-pc-flex-fs.pdf – PDF.”
  • Yesterday, HHS’s Office for Civil Rights offered guidance to HIPAA covered entities and business associates about their use of online tracking technologies.
    • “Compliance with the Security Rule helps lower the risk of unauthorized access to ePHI collected through a regulated entity’s website or mobile app that could lead to harm to individuals. Therefore, OCR is prioritizing compliance with the HIPAA Security Rule in investigations into the use of online tracking technologies. OCR’s principal interest in this area is ensuring that regulated entities have identified, assessed, and mitigated the risks to ePHI when using online tracking technologies and have implemented the Security Rule requirements to ensure the confidentiality, integrity, and availability of ePHI. OCR investigations are fact-specific and may involve the review of technical information regarding a regulated entity’s use of any tracking technologies. OCR considers all of the available evidence in determining compliance and remedies for potential noncompliance.”
  • The U.S. Preventive Services Task Force issued the following final recommendation today:
    • “For children and adolescents younger than 18 years without signs and symptoms of or known exposure to maltreatment: The evidence is insufficient to assess the balance of benefits and harms of primary care interventions to prevent child maltreatment. [Grade I]”
  • Beckers Payer Issues discusses what fifteen insurers and trade associations explored with Biden Administration officials yesterday about the Change Healthcare situation.
    • During the meeting, stakeholders discussed how progress has been made in reestablishing claims processing systems, though small, rural and safety-net providers specifically are still reporting issues with cash flow.
    • Many healthcare organizations will require third-party certification of Change’s cybersecurity before reconnecting to its systems, in which UnitedHealth was urged to provide a timeframe around. Payers were also asked to analyze their internal data to determine which providers need more support and to engage with them directly.
    • According to Reuters, payers said they would accelerate payments to Medicare and Medicaid providers, along with providing loans to Medicaid providers.”
  • Here is a link to the HHS readout from this meeting.
  • The U.S. Postal Service reminded its retirees with Part A only about the opportunity to enroll for Medicare Part B with no late enrollment penalty during a special enrollment period beginning April 1, 2024. The Postal Service is picking up the late enrollment penalty cost. This is a good deal.
    • “The one-time PSHB SEP is from April 1, 2024, to Sept. 30, 2024. Individuals eligible for the PSHB SEP will receive notification by U.S. Mail™ in March 2024.
    • “All required information must be returned in the envelope provided and postmarked by Sept. 30, 2024.”
  • The Food and Drug Administration announced,
    • “On Monday, the FDA launched a new portal for patients, consumers and health care professionals to report potential drug shortage issues directly into CDER’s NextGen system without creating a NextGen account. 
    • “Since 2017, NextGen has been a way for regulated industry to communicate with the FDA, including submitting information on shortages, discontinuations, and anticipated supply disruptions. Non-industry stakeholders without a NextGen account previously reported information about potential shortages to the FDA’s Drug Shortages Staff by email. The new public portal allows anyone to submit shortage information through an online form directly into NextGen.  
    • “Expanding access to NextGen’s shortage reporting beyond regulated industry will allow for greater consistency and ease of reporting by outside stakeholders, and greater efficiency in tracking and responding to these reports.” 

From the public health and medical research front,

  • MedPage Today informs us,
    • “Investigation of an early signal for stroke associated with COVID-19 bivalent vaccines turned into suspicion of high-dose or adjuvanted flu shots instead, based on a large U.S. population-based study.
    • “When researchers inspected a large Medicare database, they found no evidence of a significantly elevated risk for stroke at 1-21 days or 22-42 days after vaccination with either of the mRNA COVID vaccines distributed for the 2022-2023 respiratory season when compared with the 43-90 day control window, reported researchers led by Yun Lu, PhD, a statistician of the FDA in Silver Spring, Maryland.
    • “There was a significant excess of nonhemorrhagic stroke for people with concomitant administration of Pfizer-BioNTech’s bivalent vaccine plus a high-dose or adjuvanted influenza vaccine during the 22-42 days risk window (risk difference of 3.13 out of 100,000 doses); and a significant excess of transient ischemic attack for people with concomitant administration of Moderna’s bivalent COVID vaccine plus a high-dose or adjuvanted influenza vaccine during the 1-21 days risk window (risk difference of 3.33 out of 100,000 doses).
    • “But the researchers found that people with administration of a high-dose or adjuvanted influenza vaccine alone (without concomitant COVID vaccination) had an elevated risk for the combined outcome of nonhemorrhagic stroke or transient ischemic attack in both the 1-21 days risk window (risk difference of 1.65 per 100,000 doses) and 22-42 days risk window (risk difference of 1.60 per 100,000 doses).
    • “This finding suggests that the observed association between vaccination and stroke in the concomitant subgroup was likely driven by a high-dose or adjuvanted influenza vaccination,” the investigators reported in JAMA.”
  • Medscape lets us know,
    • “The US Food and Drug Administration (FDA) has cleared the twiist automated insulin delivery (AID) system (Sequel Med Tech, LLC; Manchester, NH) for people aged 6 years or older with type 1 diabetes. 
    • “The system comprises a novel insulin pump developed by Sequel’s research and development partner DEKA and uses the FDA-cleared Tidepool Loop algorithmthat was originally developed through patient-led, open-source initiatives.
    • “The twiist AID system has the capacity to work interchangeably with different integrated continuous glucose monitors (iCGMs), and Sequel will announce their initial iCGM partner closer to market launch, Sequel CEO and co-founder Alan Lotvin, MD, told Medscape Medical News. 
    • “It is the first AID system that directly measures volume and flow of insulin delivery, which enables it to rapidly detect obstructions or occlusions, usually within about 20 minutes, Lotvin explained. “

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “Elevance Health has inked a deal to acquire Kroger Specialty Pharmacy.
    • “The grocery chain announced Monday that an agreement is in place, saying it’s expected to close in the back half of 2024 pending regulatory approvals. Elevance intends to add Kroger Specialty Pharmacy to its CarelonRx business, which houses its pharmacy benefit management services.
    • “Financial terms of the sale were not disclosed.”
  • Per BioPharma Dive,
    • “AstraZeneca is the latest large pharmaceutical company to make a sizable bet on radiopharmaceutical drugs for cancer, agreeing on Tuesday to acquire longtime biotechnology partner Fusion Pharmaceuticals in a deal worth up to $2.4 billion.
    • “AstraZeneca will acquire all of Fusion’s shares for $21 apiece, or about $2 billion. The British drugmaker could add another $3 per share via a financial instrument known as a “contingent value right” if Fusion meets an unspecified regulatory milestone. Should Fusion hit that mark, the buyout would be worth $2.4 billion.” 
  • Beckers Health IT offers six takeaways from last month’s HIMSS conference.

Tuesday Tidbits

David Ermer–COVID-19, Cybersecurity, Electronic health records, FDA, Generative AI, Medical / Rx research, Medicare, NIH, Obesity, OPM, Patient safety, U.S. Healthcare–
Photo by Patrick Fore on Unsplash

From Washington, DC,

  • Because this is the FEHBlog, the lede tonight necessarily is OPM’s announcement naming the carriers who are currently prepared Postal Service Health Benefit Program benefit and rate proposals. Good luck to them all.
  • FedWeek notes,
    • “President Biden has issued an open letter to federal employees thanking them for their “tireless service on behalf of our country.”
  • and
    • “While seeking a January 2025 raise of 2 percent (see related story), the White House’s fiscal 2025 budget proposal cites several initiatives related to federal pay.
    • “In addition to year-to-year pay increases, the Administration is pursuing structural reforms to enhance the competitiveness of the Federal pay system,” it says.
  • Reg Jones, writing in Fedweek, fills us in on benefits available upon the death of a federal employee or annuitant.
  • The Department of Health and Human Services provided a readout from “Biden-Harris Administration Convening with Health Care Community Concerning Cyberattack on Change Healthcare. Leaders from HHS, White House, DOL, and the health care community convened to discuss ways to mitigate harms to patient and providers caused by the cyberattack.”
  • The Food and Drug Administration “advised consumers in Some Medicines and Driving Don’t Mix to make sure they know if their prescription or over-the-counter medication can cause side effects that may make it unsafe to drive. Most medications won’t affect consumers’ ability to drive safely or operate other heavy machinery, but some do.”
  • The Buck consulting firm points out why “maintaining creditable coverage may prove difficult for some employer sponsored plans in 2025.”
  • STAT News discusses the treatment impact of new federal methadone rules.
    • “The federal government is reforming methadone care for the first time in over two decades. But how far do the changes actually go?
    • “To many methadone clinics, the Biden administration’s recent refresh of the rules governing opioid treatment programs represents an unprecedented opportunity to offer care that is more compassionate and responsive to patients’ needs. To many patient advocates, however, it simply nibbles around the edges. 
    • “The reality is likely somewhere in between: It will depend, in large part, on whether state-level regulators embrace the changes, and whether individual clinics actually implement them. In reform-oriented states, and at patient-centered clinics, the new rules could make a world of difference for people seeking addiction treatment.” 
  • The Office of National Coordinator for Healthcare Information Technology, Micky Tripathi, in his blog, looks forward to “HTI-2 & ONC’s Commitment to Furthering the Vision of Better Health Enabled by Data.”

From the public health and medical research front,

  • BioPharma Dive reports,
    • “Roche’s experimental Alzheimer’s disease drug trontinemab showed “best-in-class” potential based on its ability to quickly clear clumps of amyloid protein from the brains of patients enrolled in a small clinical trial, the company said Monday.
    • “A majority of patients receiving the highest dose of the drug, which is specially designed to penetrate brain tissue, saw their amyloid levels drop below detectable levels after 12 weeks, Roche executives said in an investor presentation on the pharmaceutical giant’s neurology pipeline.”
  • Reuters tells us, “Pfizer  said on Tuesday its drug, Adcetris, extended survival in patients with the most common type of lymphoma in a late-stage study, bolstering efforts to expand the use of the treatment gained through its $43 billion purchase of Seagen [in 2023].
  • MedPage Today lets us know,
    • “Pragmatic implementation of an automated online behavioral obesity treatment program that included 9 months of active maintenance helped people with overweight or obesity lose a clinically significant amount of weight by 12 and 24 months, a randomized trial showed. * * *
    • “This pattern persisted at 24 months, reported J. Graham Thomas, PhD, of the Weight Control and Diabetes Research Center in Providence, Rhode Island, and colleagues in JAMA Internal Medicine.
    • “This study shows that a fully automated online obesity treatment program can produce beneficial results for many patients in real-world primary care settings,” Thomas told MedPage Today. “We were encouraged to find that the online weight-loss program performed just as well in real-world primary care practices as it does in our previous highly controlled clinical trials.”
    • “These patients lost weight “at rates comparable” to those seen in studiesopens in a new tab or window in which the researchers were completely hands-on in every aspect of the program, he added.
    • “Because the treatment program is online and fully automated, Thomas said it is quite practical for widespread implementation across primary care practices. “The data show that the primary care clinicians were able to implement the program independently, and patients were able to use it successfully.”
  • Beckers Hospital Review adds,
    • “Hospital transplant departments have strict cutoffs for patients with higher body mass indexes because of the increased risk of complications, but GLP-1s such as Ozempic and Wegovy are helping more patients be eligible for surgery. 
    • “Potential transplant donors and diabetic patients who otherwise would not be able to undergo surgery because of their BMI are now quickly dropping weight. Popular GLP-1s, including Ozempic, and GLP-1s and glucose-dependent insulinotropic polypeptides, such as Mounjaro and Zepbound, are dramatically helping these weight loss efforts.” 
  • Medscape cautions,
    • “Novo Nordisk’s CEO on Friday said the company was working with authorities in several countries to tackle counterfeit versions of its popular diabetes drug Ozempic, as new reports emerge of patient harm across the world.
    • “This is something we take very seriously,” Lars Fruergaard Jorgensen, CEO of the Danish drugmaker, told Reuters. * * *
    • “Jorgensen, echoing comments from the FDA’s Califf, also said compounded semaglutide in the United States was a serious health issue, and that the raw materials, or active pharmaceutical ingredients (API), for these products were coming from unregulated facilities in Asia and elsewhere. 
    • “We don’t know them, and we have really no insights or ability to understand what the API is in a certain compounded product,” he said.
    • “While fake drugs often do not contain any of the medication advertised, compounded drugs are custom-made medicines that are based on the same ingredients as branded drugs. Because Wegovy and Ozempic are in short supply, they can be legally produced by licensed pharmacies in the U.S.
    • “Further reports obtained by Reuters through FOIA requests show that one person died last year from abnormal blood clotting after taking a drug that was advertised as compounded semaglutide. Three others suffered severe vomiting and nausea, sensory loss in their legs, and a drop in blood platelet levels.”
  • The U.S. Census Bureau announced,
    • “An additional 573,000 people died in the United States during the first year of the COVID-19 pandemic but “excess mortality” at the national level masks substantial variations by state, age, sex, and race and ethnicity, according to new U.S. Census Bureau research recently published in Demography.
    • “Excess mortality” refers to deaths from any cause above what is expected from recent mortality trends.
    • “This research shows the pandemic widened the mortality gap between the nation’s Black and White populations and completely erased the mortality advantage of the Hispanic population in relation to the non-Hispanic White population.”
  • The National Institutes of Health announced‘,
    • “Two phase 2 clinical trials to test the safety and effectiveness of three treatments for adults with autonomic nervous system dysfunction from long COVID have begun. The autonomic nervous system acts largely unconsciously and regulates bodily functions, such as heart rate, digestion and respiratory rate. Symptoms associated with autonomic nervous system dysfunction have been among those that patients with long COVID say are most burdensome. The trials are part of the National Institutes of Health’s Researching COVID to Enhance Recovery (RECOVER) Initiative, a nationwide research program to fully understand, diagnose and treat long COVID. Other RECOVER phase 2 clinical trials testing treatments to address viral persistence and neurological symptoms, including cognitive dysfunction (like brain fog), launched in July 2023. * * *
    • “People 18 years of age and older who are interested in learning more about these trials can visit https://trials.RECOVERCovid.org/autonomic or ClinicalTrials.gov and search identifier NCT06305793, NCT06305806 and NCT06305780. Please do not contact the NIH media phone number or email to enroll in these trials.”
  • The Wall Street Journal warns,
    • “Ultra-processed foods may not only affect our bodies, but our brains too.
    • “New research suggests links between ultra-processed foods—such as chips, many cereals and most packaged snacks at the grocery store—and changes in the way we learn, remember and feel. These foods can act like addictive substances, researchers say, and some scientists are proposing a new mental-health condition called “ultra-processed food use disorder.” Diets filled with such foods may raise the risk of mental health and sleep problems. 
    • “The science is still early and researchers say there is a lot they don’t know. Not all ultra-processed foods are equal, some scientists say, adding that some might be good for you. A diet high in ultra-processed foods has been linked with obesity, Type 2 diabetes, cancer and cardiovascular disease, but researchers are still figuring out exactly why, beyond calorie counts and nutrient composition. 
    • “Makers of foods such as processed meats and muffins defend their products, and note that there isn’t a consistent, universally accepted definition of ultra-processed food.”

From the HIMSS Conference in Orlando,

  • HIMSS offers an article about “Google Cloud’s debut of new genAI advancements for healthcare at HIMSS24. In total, the company is offering its cloud clients updates to Vertex AI Search, Healthcare Data Engine and MedLM, designed to improve patient care.”

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Nearly half of U.S. workers don’t have the benefits they need at work, according to the results of a survey by Perceptyx, an employee experience company. Of the 1,500 full-time employees surveyed, 59% said they had “benefits envy” of friends’ and family members’ healthcare coverage.
    • “When it comes to benefits equity, the survey found that medical, maternity and mental health are the “magic trifecta,” Emily Killham, senior director of people analytics, research and insights at Perceptyx, said. “When employees have access to all three, women and men feel equally that their needs are met.”
    • “Yet 53% of those surveyed said they don’t have mental health coverage, 51% don’t have maternity leave, and 25% don’t have any medical benefits, per the results.”
  • Beckers Hospital Review informs us,
    • “Healthgrades recognized 832 hospitals with its 2024 Patient Safety Excellence Awards and Outstanding Patient Experience Award. Only 79 of those hospitals received both awards. 
    • “The dual recipients spanned 27 states. Texas had the most dual recipients with 13 honorees — including four Baylor Scott and White Health and four Houston Methodist hospitals.”
    • The article lists the dual recipients.
  • Beckers Payer Issues relates,
    • “Selective contracting with primary care physicians may be one factor behind lower per-patient expenses in Medicare Advantage, a study published in the March edition of Health Affairs found. 
    • “The study examined 4,456,037 traditional Medicare patients who visited 151,679 primary care physicians. The physicians who participated in Medicare Advantage networks had $433 lower costs per patient than the regional average of physicians. 
    • “The quality measures for physicians participating in Medicare Advantage were similar to the regional average, the study found. 
    • “Physicians who did not participate in any MA networks cost $1,617 more per patient per year than those participating in MA networks, and they had lower quality measures. 
    • “The findings suggest that “managed care tools, particularly selective contracting with primary care physicians” contribute to lower costs in Medicare Advantage, the authors concluded. Though the differences in cost are most likely attributable to differences in practice style, that could also serve as a mechanism for plans to select healthier patients, the authors wrote.” 
  • Health Payer Intelligence adds,
    • “The average Medicare Advantage premium has remained low and stable, with many beneficiaries choosing plans with a zero-dollar monthly premium, according to data from eHealth, Inc.
    • “eHealth’s seventh annual Medicare Index Report includes data from over 190,000 applications for Medicare insurance products submitted to eHealth during the annual enrollment period for 2024 coverage.
    • “The average monthly premium for Medicare Advantage plans chosen by eHealth customers for 2024 is $9, the same as last year and up slightly from $6 in 2022. The popularity of plans with zero-dollar premiums contributed to the low average.”
  • HealthDay informs us,
    • “The cost to American families of caring for a child with a mental health condition jumped by almost a third between 2017 and 2021.
    • “It now costs an average $4,361 more per year for a U.S. family to care for a child with a mental health condition, compared to families without such children, a new study has found.”