Tuesday’s Tidbits

Congress

Tuesday’s Tidbits

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

From Washington, DC,

  • Fierce Healthcare reports,
    • “The House Ways and Means Committee advanced bipartisan legislation on Thursday [June 28] that would grant Medicare coverage to novel medical technologies for four years while the Centers for Medicare & Medicaid Services (CMS) makes a national coverage determination. 
    • “The new version of the bill that was voted on by Ways and Means reduces the cost of the bill by 75% of the version that the House Energy and Commerce Committee voted favorably on back in November. It allocates $10 million per year over five years to CMS for the project. 
    • “The Ensuring Patient Access to Critical Breakthrough Products Act of 2024, if passed, would give any device designated as “breakthrough” from the Food and Drug Administration (FDA) four years of Medicare coverage. Co-sponsor of the bill Rep. Susan DelBene, R-Washington, said during the hearing that it takes CMS an average of more than five years to make a national coverage determination for FDA breakthrough devices.” 
  • BioPharma Dive lets us know,
    • “The Food and Drug Administration on Tuesday approved a new Alzheimer’s disease drug from Eli Lilly, several weeks after a panel of independent experts unanimously recommended its clearance.
    • “The drug, which Lilly will sell as Kisunla, is designed to slow Alzheimer’s progression by clearing from the brain a toxic, sticky protein called amyloid that scientists have long seen as a root cause of the disease. It’s the third of its kind to reach market, following similar medicines from Eisai and Biogen.
    • “In approving Kisunla, the FDA OK’d use in a roughly similar patient population as Eisai and Biogen’s Leqembi. Labeling for the drug, also known as donanemab, recommends doctors start treatment in patients who have mild cognitive impairment or dementia due to Alzheimer’s, and who have confirmed amyloid pathology.
  • Fierce Healthcare points out,
    • “Accountable care organizations concerned they would be held responsible for bad actors exploiting the Medicare system can breathe a sigh of relief.
    • “The Centers for Medicare & Medicaid Services (CMS) stepped in Friday [June 29] and proposed a rule that ensures they are safe from unfair financial ramifications.
    • “The rule (PDF), if finalized, would exclude payment amounts for certain intermittent urinary catheters submitted from suppliers used for assessing performance year 2023 financial performance of Medicare Shared Savings Program (MSSP) ACOs. Benchmarks will be set for 2024, 2025 and 2026, the agency said in a news release.”
  • The Washington Post offers background on the underlying fraud.
    • “Medicare officials this week separately confirmed that 11 companies were collectively responsible for $3.16 billion in questionable bills for urinary catheters between January 2023 and March 2024, saying the agency had successfully blocked payments to the companies.
    • “The ACOs said they identified 12 companies engaged in the alleged fraud, which they say stretches back into late 2022 or even earlier.
    • “Gaus, a 50-year veteran of the health-care industry, said he was not aware of Medicare ever before overhauling its payment rules in response to alleged fraud — a conclusion shared by several current Medicare officials who spoke with The Post. He warned that similar schemes are likely on the horizon.
    • “These fraudsters can get patient IDs, provider IDs, and maybe use AI to glean through these massive files of patient data that they collect from everywhere,” Gaus said.”
    • FEHBlog note: The Post broke the fraud story back in February 2024.}
  • KFF discusses the health policy implications of the June 29 Supreme Court decision dispensing with the Chevron doctrine. The article concludes,
    • “Short of unlikely Congressional action to restore Chevron deference, the Supreme Court in a single decision has shifted many policy decisions from agency technical experts to federal judges, with implications for health policy that will reverberate for years to come.”
    • FEHBlog opinion — The Supreme Court decision does not object to agency fact finding, which is an appropriate field for agency technical experts. The Supreme Court held that judges, not agency technical experts, should interpret the law (see Article III of the U.S. Constitution).
  • Following any decision, the Supreme Court can issue what’s colloquially known as a GVR order in related cases. GVR stands for granting certiorari, vacating the lower court judgment, and remanding for consideration in light of a particular recent decision. Yesterday, the Supreme Court posted an orders list which includes ten Chevron doctrine related GVR decisions in cases from the U.S. Court of Appeals for the D.C. Circuit (several to that Court), plus the Fourth, Fifth, Eighth, Ninth, and Eleventh Circuits. Consequently, we will have a lot of appellate decisions interpreting Loper Bright Enterprises v. Raimondo, 603 U. S. _ (2024) before long.
  • Per an HHS press release,
    • “Following the Supreme Court’s decision in Moyle v. United States, U.S. Department of Health and Human Services Secretary Xavier Becerra and the Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure sent a letter to hospital and provider associations across the country today reminding them that it is a hospital’s legal duty to offer necessary stabilizing medical treatment (or transfer, if appropriate) to all patients in Medicare-participating hospitals who are found to have an emergency medical condition. CMS also announced that the investigation of EMTALA complaints would proceed in Idaho while litigation continues in the lower courts. * * *
    • “In 2022, CMS issued guidance – PDF to reaffirm that EMTALA requires providers offer necessary stabilizing care for patients suffering emergency medical conditions, which might include abortion care in certain situations. Today’s letter reinforces previous letters from Secretary Becerra and Administrator Brooks-LaSure to hospital and provider associations reminding them of their obligations under EMTALA.”
  • The Centers for Medicare Services posted version 7.2 of the Section 111 reporting guidance for group health plan users today.

From the public health and medical research front,

  • Beckers Hospital Review informs us,
    • “Hospitals across the country are finalizing staffing plans and issuing public warnings on fireworks safety ahead of the July Fourth holiday, when an average of around 91,000 patients visit emergency departments. 
    • “We are entirely staffed up for both the Fourth of July as well as the 5th of July,” Aekta Miglani, MD, medical director of the emergency department at Strong Memorial Hospital in Rochester, N.Y., told CBS affiliate WROC. “Every year we work really closely with our trauma division who we’re lucky to collaborate with on a regular basis, but Fourth of July is one of those holidays where we’ll be working [together] my guess is more frequently than others.” 
    • “On average, emergency departments see nearly 45,000 people daily on July 4 and 5, according to a Pew Research Center analysis of injury data from 2000 to 2018. In 2022, fireworks were involved in an estimated 10,200 injuries treated across hospital emergency departments, though physicians believe that number is much greater, since not everyone seeks care.” 
  • The Wall Street Journal compares the two FDA-approved Alzheimer’s Disease drugs – Kisunla Leqembi.
  • STAT News tells us,
    • “As the H5N1 bird flu outbreak in dairy cows enters its fourth month, the Centers for Disease Control and Prevention is taking steps to ramp up the nation’s capacity to test for the virus in people.
    • “In a call with reporters Tuesday, Nirav Shah, the CDC’s principal deputy director, emphasized that the risk to the general public remains low at this time. But given that the virus is showing no signs of slowing its push deeper into the U.S. cattle population — threatening to create lasting risks to dairy workers and giving it more chances to evolve in ways that make it better at spreading to and among humans — the agency is looking to increase the number and types of tests that can effectively detect H5N1 infections in people. * * *
    • “On Tuesday, the federal government also announced plans to support the development of messenger RNA-based pandemic influenza vaccines, including those that target H5 and H7 avian influenza viruses. BARDA, the Biomedical Advanced Research Development Authority, awarded Moderna $176 million to accelerate clinical testing of its pandemic vaccines, which are expected to enter a Phase 3 trial sometime next year. The U.S. government already has vaccine contracts and stockpiles of H5 vaccines made using other platforms by other manufacturers, including CSL Seqirus and Sanofi.”
  • The Washington Post notes,
    • “Only about 18 percent of eligible Americans were up to date with their lung cancer screenings in 2022, with compliance rates varying by state and region, according to a study published in JAMA Internal Medicine. American Cancer Society researchers analyzed data from the 2022 Behavioral Risk Factor Surveillance System, a population-based, nationwide survey of Americans.
    • “Screening eligibility was determined using 2021 U.S. Preventive Services Task Force criteria, which recommend annual lung cancer screening in high-risk individuals — defined as those with a pack-a-day cigarette habit for 20 years or more who are current smokers or have quit within the past 15 years and are between ages 50 and 80. * * *
    • “Screening can prevent deaths from lung cancer because the disease is “usually easier to treat at early stages,” according to the Centers for Disease Control and Prevention.”
  • The Wall Street Journal relates,
    • “Scientists suspect that one culprit behind your new illness might be the infection you got a couple of years ago. 
    • “The link between new health problems and your past health history appears to be particularly prevalent with Covid. A new Nature Medicine study found that health problems stemming from even mild Covid infections can emerge as many as three years afterward. The study found a greater risk three years later of problems in the gut, brain and lungs, including irritable bowel syndrome, mini-strokes and pulmonary scarring.
    • “This is different from what most people think of as “long Covid,” the debilitating chronic condition that can include fatigue, brain fog and racing heartbeat. Instead, the latest study has found an increased risk of new health conditions—things you probably wouldn’t think of as related to a prior illness—developing years later.”
    • FEHBlog note — The article states that a similar phenomenon occurred after the Spanish flu epidemic of 1918.
  • The National Cancer Institute posted new cancer information highlights today.
  • The National Institutes of Health announced,
    • “Scientists at the National Institutes of Health (NIH) have uncovered a brain circuit in primates that rapidly detects faces. The findings help not only explain how primates sense and recognize faces but could also have implications for understanding conditions such as autism, where face detection and recognition are often impaired from early childhood. The newly discovered circuit first engages an evolutionarily ancient part of the brain called the superior colliculus, which can then trigger the eyes and head to turn for a better look. This better view enables different brain areas in the temporal cortex to engage in more complex facial recognition. The study was published in the journal Neuron.
    • “Quick recognition of faces is a key skill in humans and other primates,” said Richard Krauzlis, Ph.D., of NIH’s National Eye Institute (NEI) and senior author of the study. “This newly discovered circuit explains how we’re able to quickly detect and look at faces, even if they first show up in the peripheral visual field where visual acuity is poor. This circuit could be what spotlights faces to help the brain learn to recognize individuals and understand complex facial expressions, helping us acquire important social interaction skills.”
  • The American Medical Association tells us what doctors wish their patients knew about kidney stones.
  • The Institute for Clinical and Economic Review announced,
    • “posting its revised Evidence Report assessing the comparative clinical effectiveness and value of imetelstat (Rytelo, Geron Corporation) for the treatment of anemia in myelodysplastic syndrome (MDS).  
    • “Patients that have anemia related to MDS may have to plan around frequent blood transfusions, which can significantly affect their daily activities,” said ICER’s Chief Scientific Officer and Director of Health Technology Assessment Methods and Engagement, Dan Ollendorf, PhD, MPH. “Imetelstat is a new treatment option for adults with low-to-intermediate MDS and transfusion-dependent anemia. While available clinical evidence suggests that imetelstat may reduce or eliminate the need for transfusions, its impact on the severe fatigue that often accompanies MDS anemia is less clear. There is no evidence to suggest that imetelstat reduces the progression or trajectory of MDS itself, and there are some key side effects of concern. As a result, we view the evidence as promising but inconclusive, and the current list price is not at all aligned with the modest benefit we do see.”
    • “This Evidence Report will be reviewed at a virtual public meeting of the CTAF on July 19, 2024. The CTAF is one of ICER’s three independent evidence appraisal committees comprising medical evidence experts, practicing clinicians, methodologists, and leaders in patient engagement and advocacy.”

From the U.S. healthcare business front,

  • Per Fierce Healthcare,
    • “A new analysis from KFF digs into insurers’ financial performance across multiple markets and found the highest gross margins in the Medicare Advantage (MA) space.
    • “At the end of 2023, gross margins per enrollee in MA were $1,982 on average compared to $1,048 in the individual market. Medicaid was the lowest at $753 in gross margin per enrollee, and group plans fell in the middle at $910. Gross margins are a notable indicator for financial performance, though they’re not necessarily indicative of profitability as they do not account for administrative costs or tax liabilities.
    • “Gross margins in MA were similar in 2023 to those recorded in the 2022 version of the analysis, according to KFF. In 2022, MA plans averaged $1,977 per enrollee. This is despite concerns from multiple major players in this space about a spike in utilization over the course of 2023.
    • “Across most markets, gross margins have been relatively stable in recent years, though they have declined somewhat from spikes that occurred in 2020 during the initial phase of the COVID-19 pandemic,” the researchers wrote.”
  • Beckers Payer Issues lets us know,
    • “Humana provides the best customer experience to its members, according to Forrester’s “U.S. Health Insurers Customer Experience Index Rankings” for 2024.
    • “The June 17 ranking shared with Becker’s found that customer satisfaction with health insurers is on the decline, with half of the named insurers seeing lower scores compared to last year and none with improved scores. The industry’s average CX Index score dropped 2.7 points, a third straight year of declines. Average scores peaked at 70.2 out of 100 in 2021 and declined to 66.6 in 2024. 
    • [The FEHBlog notes that CareFirst, Kaiser Permanente, and UnitedHealthcare came in second, third, and fourth in the rankings.]
  • and
    • “Several Trinity Health hospitals from coast to coast are now out of network with UnitedHealthcare amid reimbursement disputes between the organizations. * * *
    • “Several of Livonia, Mich.-based Trinity’s ministries and hospitals have been renegotiating contracts with UnitedHealthcare to replace deals that expired at midnight on June 30. Deals have been reached in Florida and Iowa, but negotiations are ongoing for facilities located in Connecticut, Massachusetts, New York, Georgia, Indiana and California.”

Weekend Update

David Ermer–CDC, CMS, Congress, Medical / Rx research, Mental health care, U.S. Healthcare–

From Washington, DC,

  • The Supreme Court will end its October 2023 term tomorrow by releasing a final batch of three opinions.
  • The New York Times reports,
    • “The Biden administration said this week that it opposed gender-affirming surgery for minors, the most explicit statement to date on the subject from a president who has been a staunch supporter of transgender rights.
    • “The White House announcement was sent to The New York Times on Wednesday in response to an article reporting that staff in the office of Adm. Rachel Levine, an assistant secretary at the Department of Health and Human Services, had urged an influential international transgender health organization to remove age minimums for surgery from its treatment guidelines for minors.” * * *
    • “The Supreme Court agreed on Monday to hear a challenge — brought in part by the Biden administration — to a Tennessee law that bans treatments including puberty blockers, hormone therapy and surgery for transgender minors. This will be first time the justices will decide on the constitutionality of such statewide bans.”
  • The Washington Post lets us know,
    • House Republican leaders are asking government watchdogs to investigate health insurance sign-ups through the Affordable Care Act, citing reports that allege insurance brokers are fraudulently enrolling customers into some ACA health plans and that millions of Americans may be wrongly benefiting from federal insurance subsidies.
    • The House Energy and Commerce, Ways and Means, and Judiciary Committees requested Friday that the Government Accountability Office and the inspector general at the Department of Health and Human Services open investigations into the “astonishing level” of potential enrollment fraud, according to letters shared with The Washington Post.

From the public health and medical research front,

  • Reuters tells us,
    • “The U.S. Food and Drug Administration has begun testing more dairy products for evidence of the bird flu virus as outbreaks spread among dairy herds across the country.
    • “More than 120 dairy herds in 12 states have tested positive for bird flu since March, according to the U.S. Department of Agriculture. Federal officials have warned that further spread among dairy cows could heighten the risk of human infections.
    • “The focus of additional testing is to ensure that pasteurization inactivates the virus, said Don Prater, acting director of the FDA’s Center for Food Safety and Applied Nutrition, on a call with reporters.
    • “Prior FDA testing of 297 retail dairy samples came back negative for evidence of the virus.
    • “The agency continues to strongly advise against consumption of raw milk products, Prater said.”
  • The Washington Post informs us,
    • “People over 50 with anxiety may be up to twice as likely to develop Parkinson’s disease as their peers without anxiety, a new analysis suggests.
    • “The study, published in the British Journal of General Practice, looked at primary care data from the United Kingdom. Researchers compared a group of 109,435 people 50 and older who were diagnosed with a first episode of anxiety between 2008 and 2018 with a control group of 987,691 people without anxiety.
    • “Researchers said, of those in the study, 331 patients with an anxiety diagnosis developed Parkinson’s disease over the decade, and the average patient who developed the disease did so 4.9 years after their first anxiety diagnosis.
    • “After adjusting for age, lifestyle factors, mental illness and other factors, people with anxiety were still twice as likely to develop Parkinson’s disease than those without an anxiety diagnosis. Those who developed the disease were also likelier to be male and in higher socioeconomic groups.”
  • STAT News adds,
    • “Fighting Alzheimer’s disease is a race against time. By the time most patients are diagnosed and treated, their cognitive symptoms have already advanced significantly.
    • “New research, though, pinpoints protein changes in cerebrospinal fluid highly associated with the development of Alzheimer’s disease. A better biological understanding of the brain disorder could foster new treatments and earlier intervention — as early as 20 years before onset of symptoms according to models from the study.
    • “The findings, published Wednesday in Science Translational Medicine, coincide with revised criteria from the Alzheimer’s Association that lean into the need for biology-based diagnosis and staging of the disease. The underlying biology of Alzheimer’s is still a scientific conundrum, but the approval of a drug targeting the disease’s amyloid pathology has sparked a push for blood and other tests to detect proteins associated with disease progression earlier, when treatment can be more successful.
    • “The study tracked upwards of 5,000 proteins to capture a dynamic picture of protein activity in patients with Alzheimer’s. “We take all these different proteins that we measure and we cluster them into these things called modules, that reflect different biological pathways, or processes, or cell types,” said study author Erik Johnson, assistant professor of neurology at Emory University. Those clusters of protein activity can serve as a springboard for both disease prediction and drug treatment experiments, he said.
  • Per NPR Shots,
    • “About 170 billion cells are in the brain, and as they go about their regular tasks, they produce waste — a lot of it. To stay healthy, the brain needs to wash away all that debris. But how exactly it does this has remained a mystery.
    • “Now, two teams of scientists have published three papers that offer a detailed description of the brain’s waste-removal system. Their insights could help researchers better understand, treat and perhaps prevent a broad range of brain disorders.
    • “The papers, all published in the journal Nature, suggest that during sleep, slow electrical waves push the fluid around cells from deep in the brain to its surface. There, a sophisticated interface allows the waste products in that fluid to be absorbed into the bloodstream, which takes them to the liver and kidneys to be removed from the body.
    • “One of the waste products carried away is amyloid, the substance that forms sticky plaques in the brains of patients with Alzheimer’s disease.
  • Medscape notes,
    • “Certain medications that are used to treat benign prostatic hyperplasia (BPH) are associated with a reduced risk for dementia with Lewy bodies (DLB), the second most common neurodegenerative type of dementia after Alzheimer’s disease. 
    • “Investigators found older men taking alpha-1 blockers terazosin, doxazosin, or alfuzosin (Tz/Dz/Az) were 40% less likely to develop DLB than those taking tamsulosin and 37% less likely than men taking the 5-alpha reductase inhibitors (5ARI) finasteride and dutasteride.
    • “These results are exciting because right now there are no drugs to prevent or treat dementia with Lewy bodies,” study investigator Jacob E. Simmering, PhD, of the University of Iowa in Iowa City, said in a press release. “If we can determine that an existing drug can offer protection against this debilitating disease, that has the potential to greatly reduce its effects.”
    • “The findings were published online on June 19, 2024, in Neurology.”
  • BioPharma Dive discusses “microscopic tunnels [which] are a goldmine for new medicines. Ion channel research made Vertex Pharmaceuticals one of the world’s most valuable biotechs. Now, other drug hunters have joined in, betting the field is ready to treat an array of illnesses.”
    • “It can be difficult to picture just how small a human cell is. On average, it’s one-tenth as wide as a strand of hair and 25 times smaller than a grain of salt. Tinier still are the thousands of ion channels anchored into the fluid, oily shell that encases these microscopic worlds.
    • “The channels act as canals; though, instead of water, they control the movement of electrically charged particles like sodium, potassium, calcium and chloride. When cells are stimulated in certain ways, the canals open, permitting ions to flood in or out. They then shut and return to a “resting” state. The opening and closing happens hundreds of times a second and actually jolts the cell, in essence telling it, “Something is happening, react!”
  • STAT News points out,
    • “A few years ago, the Centers for Medicare and Medicaid Services launched a big experiment. The agency wanted to see if financial incentives and penalties would improve care for people with end-stage kidney disease. So far, it hasn’t worked, a new study finds.
    • “The End-Stage Renal Disease Treatment Choices (ETC) model is a historic effort, both because it’s the largest such experiment in the history of American health care and because, unlike previous CMS Innovation Center pilot programs, it’s mandatory. About 30% of dialysis providers in the country participate, while the other 70% are used as a control group. It’s shaped like a gold-standard, randomized control trial, and run by the entity that covers the majority of health care related to end-stage renal disease, including dialysis. 
    • “Each year, providers are graded on how many patients they can move to home dialysis, which is more affordable for the health care system, and how many people go on to receive kidney transplants, among other metrics. If they do well, they receive some extra money. Those who don’t do well face financial penalties. Both amounts increase with each year of the experiment, up to an 8% bonus or 10% penalty by the end of the program.
    • “Those sticks and carrots don’t seem to be doing much. In a paper published in JAMA Health Forum on Sunday, researchers report a null effect: Providers enrolled in the experiment aren’t moving more patients to home dialysis or transplant than those in the control group.” 

A Busy Thursday

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

From Washington, DC

  • STAT News tells us,
    • “A House committee overwhelmingly passed four bills on Thursday that would expand Medicare coverage of obesity drugs and cancer screening blood tests and place guardrails around Medicare’s discretion in covering drugs and devices approved by the Food and Drug Administration.
    • “[By a 36-4 bipartisan vote],the House Ways & Means Committee passed obesity drug coverage legislation that would offer a limited pathway for adults 65 and older to get their weight loss drugs paid for by Medicare. Right now, Medicare is prohibited from covering medications used for weight loss, like Wegovy and Zepbound. 
    • “However, the new plan is significantly more restrictive than prior proposals. It’s primarily targeted at making sure that people currently taking weight loss drugs don’t get kicked off when they enter the Medicare program, such as by turning 65.” * * *
    • “Another bill that gained even more support would expand Medicare coverage of cancer screening. The legislation passed on a 38-0 vote. 
    • “Medicare is allowed to pay for FDA-approved tests that diagnose diseases, but it doesn’t cover tests that simply screen healthy people for cancer. The bill would open the door for Medicare to pay for cancer screening tests, including Grail’s Galleri.” 
  • MedPage Today informs us,
    • “Value-based care — in which medical practices are paid based on the value of their care, not on volume — is a good idea but the Centers for Medicare & Medicaid Services (CMS) need to improve its implementation, doctors and a healthcare executive told members of the House Ways & Means Health Subcommittee.
    • “I am a proponent of the need to move to value-based care, improving quality while decreasing wasteful spending and ensuring access,” Robert Berenson, MD, an institute fellow at the Urban Institute in Washington, D.C., said at Wednesday’s subcommittee hearing on improving value-based care for patients and providers. “However, I believe that value-based payment as a mechanism to promote better care delivery has gotten off track and needs a thorough reevaluation and reformulation.”
  • Fierce Pharma relates,
    • “Leading health legislators say they are focused on reducing prescription drug prices while minimizing unintended consequences of the Inflation Reduction Act (IRA).
    • “House Rep. Scott Peters, D-California, and Rep. Mariannette Miller-Meeks, R-Iowa, shared their priorities during a program put on by The Hill and the Alliance for Aging Research.
    • “Peters stressed that the drug manufacturing industry needs to stay in the U.S., unlike how the country let chip manufacturing business slip away and go offshore. He also wants lawmakers to budget healthcare expenditures differently.
    • “Innovation might cost more money upfront, even if it saves money down the line,” he said. “In the Budget Committee, which I also serve on, we’re talking about how to think about balancing the budget over time. If we don’t think about the future costs of all these diseases, as part of that calculation, I think we’re going to miss the mark.”
  • Per CMS fact sheets,
    • On June 26, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2025 Home Health Prospective Payment System (HH PPS) proposed rule, which would update Medicare payment policies and rates for Home Health Agencies (HHAs). These changes can support timely admission to home health services, which has demonstrated improvements for patient outcomes and reducing risk of hospital readmissions. 
  • and
    • “On June 27, 2024, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to update payment rates and policies and includes requests for information under the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for renal dialysis services furnished to Medicare beneficiaries on or after January 1, 2025.
    • “For CY 2025, CMS is proposing to increase the ESRD PPS base rate to $273.20, which would increase total payments to all ESRD facilities, both freestanding and hospital-based, by approximately 2.2%.”
  • HHS’s Office for Civil Rights announced,
    • “At the HHS Office for Civil Rights, we believe patient privacy is essential to ensuring high quality reproductive health care. HHS OCR is encouraging HIPAA covered entities and business associates to begin implementing the new HIPAA Privacy Rule to Support Reproductive Health Care Privacy to help protect patient privacy and ensure compliance later this year. To aid in this, we have compiled resources for both community members and HIPAA Covered Entities or Business Associates. 
      • “For resources to help communicate with stakeholders and community members click here.
      • “For a fact sheet summary of the rule click here (en español).
      • “To hear directly about the rule from Director Melanie Fontes Rainer click here (en español).
      • “To view a recorded briefing by Deputy Director for Health Information Privacy, Data and Cybersecurity Timothy Noonan click here.
      • “For a model attestation for a requested use or disclosure of protected health information potentially related to reproductive health care click here.
    • “The effective date of the Final Rule was June 25, 2024. This is the date that HIPAA covered entities and their business associates may begin implementing the new requirements. Covered entities and business associates are not required to comply with the new requirements until December 23, 2024, except for the new changes to the HIPAA Notice of Privacy Practices which has a compliance date of by February 16, 2026.”
  • Healthcare Dive lets us know,
    • “The U.S. Supreme Court ruled 6-3 on Thursday to allow Idaho doctors to perform abortions to stabilize a patient’s life and health. 
    • “However, the court declined to take up the fundamental legal question underlying the case: whether a federal law mandating hospitals provide medical services during emergencies [known as EMTALA] supersedes near-total state abortion bans.
    • “It is the court’s first ruling on statewide abortion restrictions since Roe v. Wade was overturned in 2022, ending the constitutional right to abortion in the United States.”
  • CMS observed,
    • “CMS’ first responsibility is to the people we serve, including anyone who steps into the emergency department of a Medicare-participating hospital. If any individual believes their EMTALA rights have been violated, they should continue to report the circumstances to CMS or their state survey agency. To the maximum extent permitted by law, we will continue to investigate complaints and hold hospitals accountable to provide the emergency stabilizing treatment that EMTALA has required for decades.”
  • The Wall Street Journal reports,
    • “The Supreme Court rejected a bankruptcy plan for OxyContin-maker Purdue Pharma that would have allocated billions of dollars from members of the wealthy Sackler family to combat opioid addiction in exchange for shielding them from civil lawsuits over their alleged role in fueling the drug epidemic.
    • “The 5-4 decision marks a victory for the minority of opioid victims who voted to reject the settlement plan because they want to continue pressing lawsuits against the Sackler family members who own Purdue, and a loss for the majority of opioid victims and state and local governments who voted to accept it.”
    • “The high court said U.S. bankruptcy law doesn’t allow for a release of the Sacklers’ legal liabilities stemming from their ownership of Purdue when not all opioid-related plaintiffs have accepted the terms offered by the company’s family owners, whose wealth has been estimated at $11 billion.” * * *
    • “Thursday’s ruling—among the highest-profile bankruptcy decisions ever from the high court—weakens the ability of corporations and their insiders to use bankruptcy to resolve mass litigation alleging they harmed consumers. 
    • “The Sacklers didn’t file for bankruptcy themselves and didn’t agree to place “anything approaching their full assets on the table” for distribution to opioid victims, [Justice Gorsuch] wrote [for the Court’s majority]. “Yet they seek a judicial order that would extinguish virtually all claims against them for fraud, willful injury, and even wrongful death, all without the consent of those who have brought and seek to bring such claims,” he wrote. 
    • “Nothing in U.S. bankruptcy law authorizes that outcome, [Justice] Gorsuch said.
  • Fierce Pharma adds,
    • “The Supreme Court decision sends the case back to bankruptcy court for future deliberations, according to a statement from Connecticut Attorney General William Tong.”

From the public health and medical research front,

  • The New York Times reports,
    • “All Americans ages 6 months and older should receive one of the new Covid-19 vaccines when they become available this fall, the Centers for Disease Control and Prevention said on Thursday.
    • “The recommendation comes as the nation faces a summer wave of Covid, with the number of infections rising in at least 39 states and territories.
    • “Most Americans have acquired immunity against the coronavirus from repeat infections or vaccine doses, or both. The vaccines now offer an incremental boost, remaining effective for only a few months as immunity wanes and the virus continues to evolve.
    • “Still, across every age group, a vast majority of Americans who were hospitalized for Covid did not receive one of the shots offered last fall, according to data presented at a meeting on Thursday of the C.D.C.’s Advisory Committee on Immunization Practices.
    • “Dr. Mandy Cohen, the agency’s director, accepted the unanimous advice of the panel on Thursday to recommend another round of immunizations.”
  • The NIH Director writes in her blog,
    • “Cancer arises when changes in genes that normally control cell division lead to unchecked growth at the expense of healthy tissues. One of the most common genetic alterations across human cancers—occurring in 95% of pancreatic cancers but also many non-small cell lung cancers, colorectal cancers, and others—is in a gene known as KRAS. While promising new treatments targeting KRAS to shrink cancerous tumors have recently gained approval, less than 40% of pancreatic cancers respond to treatment with KRAS inhibitors for reasons that aren’t well understood.
    • “There’s much more to learn about how KRAS spurs cancer growth—and how KRAS-mutant cancers resist treatment with existing KRAS inhibitors. To address this need, researchers behind two studies in Science have established the most comprehensive molecular portrait yet of the workings of KRAS and how its many downstream impacts may influence outcomes for people with pancreatic cancer. The findings could lead to new treatment approaches, including ways to potentially guide treatment for individuals with pancreatic cancer, the third leading cause of cancer-related death in the U.S.
    • “These studies, supported in part by NIH, come from a team led by Channing Der  and Adrienne Cox, together with Jeffrey Klomp, Clint Stalnecker, and Jennifer Klomp, at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill. The researchers were inspired in part by the Food and Drug Administration’s recent approval of treatments that block a mutated version of KRAS that drives many pancreatic cancers. The team was also motivated by the realization that many patients whose cancers initially respond to the new treatments relapse rather quickly as the cancers find ways to reactivate underlying growth pathways.” * * *
    • “Importantly, the researchers found that the molecular signatures they’ve uncovered may predict tumor responses in patients treated with KRAS inhibitors or ERK inhibitors. Based on their findings, they suspect that the reason so many pancreatic cancers don’t respond to KRAS inhibitors may be because the drugs simply don’t block KRAS well enough—and not because the cancers no longer depend on KRAS signals for their growth. The researchers suggest it may be beneficial to monitor these underlying molecular pathways in patients to better understand treatment outcomes and guide treatment decisions.
    • “The team plans to continue exploring the role of these and other important drivers of cancer growth and treatment resistance. Ultimately, their goal is to help advance the development of the next generation of KRAS inhibitors that will work even better for many more people with pancreatic or other KRAS-driven cancers.”
  • Health Day notes,
    • “A full third of American adults take multivitamins, despite prior studies suggesting they do little to boost health.
    • “Now, a study involving almost 400,000 people finds zero benefit from multivitamin use in helping folks live longer.
    • “Among people “without a history of major chronic diseases, we did not find evidence to support improved longevity among healthy adults who regularly take multivitamins,” concluded a team led by Erikka Loftfield. She’s with the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute (NCI).
    • “Her team published its findings June 26 in the journal JAMA Network Open.
  • Healio calls to our attention a study finding
    • “Alcohol intake of more than 12 g per day was associated with increased risk for hypertension.
    • “Hypertension risk plateaued at higher levels of alcohol intake for men, but risk continued to rise for women.”
  • STAT News offers a detailed article titled “By the numbers: America’s alcohol-related health problems are rising fast.”

From the U.S. healthcare business front,

  • Per Healthcare Dive,
    • “Walgreens is pulling back its focus on healthcare services after the strategic shift failed to bolster the struggling retailer’s financial health.
    • “Walgreens plans to reduce its stake in value-based medical chain VillageMD, and will no longer be the company’s majority owner, CEO Tim Wentworth told investors on a Thursday morning call after announcing third quarter earnings below analyst expectations.
    • “Walgreens also plans to close a “significant portion” of its roughly 8,700 stores in the U.S., Wentworth said. The company didn’t share a specific figure, but said it is reviewing one-quarter of its stores that are underperforming financially. Walgreens has already closed hundreds of stores over the past few years.” * * *
    • “Walgreens plans to launch a retail pharmacy action plan to improve customer experience in its stores, better align its pharmacy and healthcare businesses and focus on reliable products in areas like women’s health, Wentworth said.
    • “The company is also in discussions with health insurers and pharmacy benefit managers to change how its pharmacies are paid, to create more stability in a challenging reimbursement environment.”
  • Modern Healthcare reports,
    • “At-home emergency care is gaining momentum — and could cost millions less — but reimbursement challenges create an access barrier for some patients.
    • “Deploying healthcare in patients’ homes gained traction during the COVID-19 pandemic as a way to ease overcrowding at hospitals and prevent the virus from spreading. Emergency department care at home lets patients bypass the waiting room through referrals from hospitals or primary care providers if they determine patients do not have life-threatening illnesses or injuries. While many private insurers reimburse for such care, traditional fee-for-service Medicare and Medicaid do not pay for it as a stand-alone service.
    • “Emergency department-at-home programs deploy paramedics or nurses to check vital signs, draw blood and take x-rays with portable imaging devices. Physicians supervise the visits via telehealth, then refer patients to primary care providers for further treatment or to hospital emergency departments if more complex care is needed.
    • “Healthcare technology company Medically Home and primary care provider Atrius Health, a division of UnitedHealth Group’s Optum Health, offer emergency department-care-at-home through a partnership in the Boston area. A study they published last week in the New England Journal of Medicine found more than 83% of 3,668 patients who received emergency care at home over two years did not require a trip to the hospital, saving Atrius approximately $4.5 million.
    • “Medically Home launched its service in 2020 and has served approximately 7,000 patients through contracts with three provider groups, including Atrius. The primary care provider has value-based care contracts with most of its patients and takes on the full risk for their care.”
  • FEHBlog observation: Intriguing!
  • Per Fierce Healthcare,
    • “Nineteen rural Minnesota hospitals and their 50-plus clinics have banded together to form a clinically integrated network (CIN) serving more than 750,000 people.
    • “The so-called Headwaters High-Value Network, announced Thursday, stitches the independent hospitals’ services together so that Minnesotans can coordinate their care across care sites. Together, the member groups employ about 9,000 people and bring in $1.3 billion of annual net revenue.
    • “Members of the network also said the approach will help their hospitals control rising care costs through reduced administrative burden and shared services. The CIN said it is “in discussions” with other interested rural Minnesota hospitals and “expects to grow.”
  • Beckers Hospital Review identifies the ten best states for hospital experience. Nevada leads the pack.
  • Beckers Hospital Review adds,
    • “Mark Cuban Cost Plus Drug Co. will serve as a wholesale drug distributor for all 71 hospitals affiliated with Community Health Systems, the organizations announced June 27. 
    • ‘Cost Plus Drugs launched the wholesale services in early 2024, but for the first time, the company is rolling out the offering to a large health system.
    • “The pharmaceutical company has direct relationships with 38 of the 40 largest generic manufacturers and multiple secondary distributors, according to Cost Plus Drugs’ CEO and co-founder, Alex Oshmyansky, MD, PhD.

Midweek Update

David Ermer–ACA, Congress, FDA, Federal employment benefits, Medical / Rx research, SDOH, U.S. Healthcare–
Photo by Manasvita S on Unsplash

From Washington, DC

  • Beckers Payer Issues reports,
    • “Making expanded ACA subsidies permanent would add $335 billion to the national deficit between 2025 and 2034, the Congressional Budget Office estimated. 
    • “Premium tax credits have spurred record enrollment in ACA marketplace plans. These subsidies, implemented in 2021, are set to expire at the end of 2025 unless Congress votes to extend them. 
    • “In a June 24 letter to the chairs of the House ways and means and budget committees, the CBO estimated making subsidies permanent would cost $415 billion overall — the result of a $250 billion increase in spending and a $164 billion decrease in tax revenue. 
    • “These costs would partially be offset by a decline in offers of employment-based insurance, the CBO estimated, resulting in a total add of $335 billion to the budget.  * * *
    • “Payer executives have told investors they are optimistic Congress will cut a deal to extend the subsidies or make them permanent.”
  • Fierce Healthcare tells us,
    • “A leading Democrat and health legislator is urging the Centers for Medicare & Medicaid Services (CMS) to better enforce Medicare Part D program requirements for pharmacy benefit managers.
    • “By evading such requirements, PBMs are threatening the financial health of the country’s smaller pharmacies, Senate Finance Committee Chair Ron Wyden, D-Oregon, wrote to the agency in a letter (PDF).
    • “I am alarmed to hear reports that PBM contracting practices are straining the finances of pharmacies and directly contributing to their closures,” he said. “Specifically, I am concerned PBMs are not adhering to the new rule reining in direct and indirect remuneration (DIR) fees that took effect on January 1 and undermining Medicare’s pharmacy access standards as intended by Congress.”
  • The National Academies of Sciences, Engineering, and Medicine released a report titled “Ending Unequal Treatment: Strategies to Achieve Equitable Health Care and Optimal Health for All” which follows up on a well-known 2003 report on social determinants of health.
  • Per an FDA press release,
    • “Today, the U.S. Food and Drug Administration issued a draft guidance, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” to assist medical product sponsors in submitting Diversity Action Plans to support certain clinical studies. Diversity Action Plans are intended to increase clinical study enrollment of participants of historically underrepresented populations to help improve the data the agency receives about the patients who may potentially use the medical product. * * *
    • “Comments on the draft guidance should be submitted within 90 days after publication in the Federal Register to Regulations.gov. All written comments should be identified with the docket number and with the title of the guidance document.”
  • Federal News Network informs us,
    • “For more than a week, federal employees enrolled in FSAFEDS have not been receiving payments for approved reimbursement claims made in their Flexible Spending Accounts.
    • “The program suspended all reimbursement payments beginning June 16 as an effort to further strengthen anti-fraud and security measures, Federal News Network confirmed with a government source who explained the issue on the condition of anonymity.
    • “At this time, the FSAFEDS is holding all claims payments out of an abundance of caution,” FSAFEDS wrote Tuesday in a post on X. “FSAFEDS has taken this action due to recently discovered fraudulent claims activity. We are working to resolve and restore all claims payment activities as soon as possible.”
    • “The pause on reimbursement payments, however, has been lifted and payments to employees should resume soon, Federal News Network has learned. FSAFEDS plans to process all reimbursements currently on hold by the end of the week.

From the public health and medical research front,

  • MedPage Today tells us,
    • “All adults ages 75 years and older should receive a single dose of any respiratory syncytial virus (RSV) vaccine, and adults ages 60 to 74 years who are at increased risk of severe RSV disease should receive a vaccine, according to a unanimous 11-0 vote by the CDC’s Advisory Committee on Immunization Practices (ACIP).
    • “Also, people who have already received the RSV vaccine are not recommended to receive a booster, based on data that showed another dose did not improve outcomes.
    • “These recommendations supplant the current recommendation that adults ages 60 and older may receive RSV vaccination after engaging in shared clinical decision-making with their healthcare provider.
    • “There are currently three RSV vaccines available for use in older adults — GSK’s adjuvanted RSV prefusion F protein-based vaccine (Arexvy) Pfizer’s unadjuvanted, bivalent RSV prefusion F protein vaccine (Abrysvo), and Moderna’s mRNA-1345 vaccine (mRESVIA).
  • The American Hospital Association News notes,
    • “The Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of H5N1 bird flu in humans. The strategy, released through ASPR’s Biomedical Advanced Research and Development Authority, has four objectives: strategic implementation and deployment of the national pre-pandemic influenza vaccine stockpile; enhanced protection through novel vaccines; leverage therapeutics through deployment, early availability and development of novel products; and ensure rapid and effective diagnostics tools to inform rapid antiviral prescription and treatment.” 
  • BioPharma Dive calls attention to the fact “Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help? There are no drugs specifically for polycystic ovary syndrome, a chronic condition that can cause infertility. One study is testing whether Wegovy might be beneficial.”
  • Per Fierce Pharma,
    • “[Verona Pharma’s] Ohtuvayre [which the FDA approved for marketing today] becomes the first novel treatment advance in more than a decade for COPD, an inflammatory condition which restricts airflow from the lungs and leaves patients struggling to breathe. Ohtuvayre is approved as an add-on medicine with current therapies.
    • “As a selective dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, Ohtuvayre combines two properties in one medicine, setting it apart in COPD for its ability to both open the airways of patients and reduce their inflammation.
    • “It’s really the first novel mechanism as an inhaled therapy in over 20 years for COPD,” David Zaccardelli, Verona’s CEO said in an interview with Fierce Pharma. “We believe its bronchodilator and non-steroidal anti-inflammatory activity has the potential to change the treatment paradigm.”
  • The Washington Post reports,
    • “A few of your favorite ice cream products might no longer be in the freezer this summer after a prominent supplier to brands such as Hershey’s and Friendly’s issued a recall notice over a potential listeria contamination.
    • “Maryland-based Totally Cool recalled products from 13 brands distributed nationwide in retail locations and through direct delivery after sampling by the Food and Drug Administration discovered the presence of Listeria monocytogenes, the bacterium that causes listeria infections, the agency said Monday.
    • “The brands involved were Abilyn’s Frozen Bakery, Amafruits, Chipwich, Cumberland Farms, Dolcezza Gelato, Friendly’s, Hershey’s Ice Cream, Jeni’s, LaSalle, Marco, Taharka Brothers, the Frozen Farmer and Yelloh. More than 65 products were recalled, including ice cream cakes and sandwiches, as well as sorbets, according to a list published by the FDA that includes expiration dates.”

From the U.S. healthcare business front,

  • Kaufmann Hall discusses the state of play in healthcare antitrust enforcement.
  • The Wall Street Journal predicts “The War Over Cheaper Ozempic Won’t End Well for Some Investors. Once Eli Lilly and Novo Nordisk increase supply of weight-loss medications, companies such as Hims & Hers may find it trickier to sell compounded versions of the drugs [due to the nuances of FDA law.]”
  • MedTech Dive points out “Abbott and Dexcom are launching the first over-the-counter CGMs. Here are 7 questions on the new tech. Experts expect the release of new over-the-counter glucose monitors in the U.S. to fuel more widespread use of the devices.”
  • Per Fierce Healthcare,
    • “Blue Shield of California is making it easier for members to access their personal health data through its new Member Health Record.
    • “The platform will combine health data both from claims as well as from providers in one place and is available both online and through Blue Shield’s app so members can connect virtually. The Member Health Record will first launch for a “select group” of Medicare Advantage members and will be rolled out to all of its members by the end of the year.
    • “The health record will include information on lab results, immunizations, diagnoses and conditions alongside historical health data that have been shared with the plan, including details tallied before the member joined Blue Shield.”

Weekend Update

David Ermer–Congress, Mental health care, SCOTUS, U.S. Healthcare–

From Washington, DC,

From the public health and medical research front,

  • CNN reports
    • “For some people with depression, finding the right medication can be a process of trial-and-error lasting for months or even years, which can worsen symptoms.
    • “But what if doctors, when diagnosing someone with depression, could assess exactly how depression is affecting a patient’s brain and prescribe a treatment that gets it right the first time?
    • “Scientists may be a step closer to that reality, thanks to new research that has identified six subtypes — or “biotypes” — of major depression via brain imaging combined with machine learning. The study, published Monday in the journal Nature Medicine, also tested how three of those biotypes responded to different antidepressants and therapies.”
  • The Washington Post published one of its occasional Medical Mysteries articles. In this case, the Post explains why a breastfeeding mother experience crippling back pain.

From the U.S. health business front,

  • NPR Shots’ “bill of the month” features a Texas urgent care center bill.
    • “One evening last December, Tieqiao Zhang felt severe stomach pain.
    • “After it subsided later that night, he thought it might be food poisoning. When the pain returned the next morning, Zhang realized the source of his pain might not be as “simple as bad food.”
    • “He didn’t want to wait for an appointment with his regular doctor, but he also wasn’t sure if the pain warranted emergency care, he said.
    • “Zhang, 50, opted to visit Parkland Health’s Urgent Care Emergency Center, a clinic near his home in Dallas where he’d been treated in the past. It’s on the campus of Parkland, the city’s largest public hospital, which has a separate emergency room.
    • “He believed the clinic was an urgent care center, he said.”
  • In short, this in-network facility, which Mr. Zhang visited. twice, turned out to be an extension of Parkland’s emergency room, and he was hit with a $19,543 bill on which he owed $1,000 in copayments. People should be placed on notice when they will be billed at hospital rates.
  • The Wall Street Journal adds,
    • “Rising healthcare prices have long eroded American wages. They are doing that by eating into jobs. 
    • “Companies shed workers in the year after local hospitals raise their prices, new research found. Higher hospital prices pushed up premiums for employees’ health insurance, which businesses help pay for. 
    • “The new study, scheduled to be published Monday as a National Bureau of Economic Research working paper, is a comprehensive look at one-way companies manage those higher premiums: cutting payrolls. 
    • “Employers that face increases in healthcare spending respond by laying off workers who they can no longer afford to retain,” said Zarek Brot-Goldberg, an economist at the University of Chicago and one of the researchers involved in the study. 
  • Fortune Well points out,
    • “Just what is the wellness level of today’s corporate workforce? That all depends on who you ask.
    • “Because while C-suite executives overwhelmingly believe their employees are feeling mentally healthy, professionally fostered, and personally satisfied and included, many workers themselves would beg to differ.
    • “That’s according to the findings of the third annual Workplace Well-being report from Deloitte. The audit and tax consultancy firm collaborated with independent researchers Workplace Intelligence to survey 3,150 executives, managers and workers across four countries (with 57% of respondents from the U.S., and others from the U.K., Canada, and Australia) to check in on the state of human sustainability—which is the degree to which an organization values people and leaves them with greater health and well-being, stronger skills for employability, opportunities for advancement, and a heightened connection to purpose. 
    • “A whopping 82% of executives believe their company is advancing human sustainability in general—but only 56% of workers agree.
    • “Other gulfs in understanding, according to the findings: Around 90% of executives believe working for their company has a positive effect on worker well-being, skills development, career advancement, inclusion and belonging, and their sense of purpose and meaning; only 60% of workers agree.
  • On the bright side, a majority of the workers are in the agreement with the C-suite execs. It could be worse.

Friday Factoids

David Ermer–AHRQ, CDC, Congress, Employee Wellness Programs, Medical / Rx research, Telehealth, U.S. Healthcare–
Photo by Sincerely Media on Unsplash

From Washington, DC,

  • STAT News reports,
    • “A House panel is exploring holding a vote on scaled-back versions of two major health care bills that would expand Medicare’s coverage of cancer screening tests and hugely popular weight loss drugs, five sources familiar with the planning told STAT. * * *
    • The two pieces of legislation are the Treat and Reduce Obesity Act, which would allow Medicare to cover obesity drugs and enable more health care providers to provide intensive behavioral therapy for obesity to Medicare patients, and the Nancy Gardner Sewell Medicare Multi-Cancer Early Detection Screening Coverage Act, which would allow Medicare to cover multi-cancer blood tests to screen healthy people for cancer. * * *
    • “Full Medicare coverage for both items has broad bipartisan support, but the expansion has been hampered by the likely exorbitant price tags to the federal government. If the House Ways and Means Committee is able to scale back the measures to a more palatable price point, it could increase their chance of passage.
    • “It is unclear how the bills could be limited to decrease their cost, and whether such pared-down proposals could achieve the bipartisan support that would be necessary to make the bills candidates for inclusion in a health care package that’s expected at the end of the year.”
  • BioPharma Dive informs us,
    • “Peter Marks is again at the center of a controversial Food and Drug Administration decision on a gene therapy for Duchenne muscular dystrophy. Twice now, the high-ranking FDA leader has pushed aside objections from agency reviewers to grant an approval to Sarepta Therapeutics’ treatment for the muscle-wasting condition.
    • “On Thursday, the FDA substantially broadened use of that treatment, called Elevidys. The decision makes Elevidys available to approximately 80% of people in the U.S. with Duchenne, which has limited treatment options and no cure. The agency also converted Elevidys’ accelerated approval to full, securing its place on the market. Previously, Elevidys was only approved for a specific group of boys 4 or 5 years of age.
    • “[D]ocuments published by the FDA expose a rift within the agency over Elevidys. Three FDA review teams and two top officials recommended Sarepta’s application be rejected due to insufficient and conflicting clinical data. They were overruled by Marks, head of the FDA center that reviews gene therapies, who found the results supportive enough to broaden Elevidys’ label. It’s now cleared for Duchenne patients over the age of 4 with mutations to a specific gene, regardless of whether they can still walk.
    • “I come to a different conclusion regarding the overall interpretation of the data,” Marks wrote in a memo. * * *
    • “The lasting impact of the approval will likely shape the FDA and gene therapy space for some time,” wrote Tim Lugo, an analyst at the investment bank William Blair, in an investor note Thursday. “We believe a more patient focused and less adversarial FDA review process is likely to continue across several areas in the agency, especially for heterogenous and deadly diseases with few good treatment options.”
  • This morning, the 5th Circuit issued in its opinion in a case challenging the authority of the U.S. Preventive Services Task Force (USPSTF) to make binding preventive services recommendations under the Affordable Care Act. The Court agreed with the lower court that USPSTF members are principal officers of the U.S. due to the binding nature of their recommendations. (HHS argued unsuccessfully that they were inferior officers.). Under the Constitution, the President must appoint principal officers with the advice and consent of the Senate. 
  • The Court granted relief to the individual plaintiffs but rejected the district court’s grant of universal injunction against enforcement of USPSTF recommendations since ACA enactment. The Court remanded the case to the district court for further proceedings.
  • The political ball is in the Biden Administration’s court.

From the public health and medical research front,

  • The Centers for Disease Control tells us,
    • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
    • “COVID-19
      • “COVID-19 test positivity has increased to 6.6% from 5.4% in the previous week. Emergency department visits for COVID-19 are also increasing nationally. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 39 states and territories, declining or likely declining in 0 states or territories, and are stable or uncertain in 10 states and territories, based on CDC modeled estimates of epidemic growth. KP.3 and LB.1 are projected to continue increasing as proportions of the variants that cause COVID-19 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Health Day lets us know,
    • “A medication used to manage type 2 diabetes has been found effective in treating sleep apnea.
    • “The worldwide clinical trial demonstrates that tirzepatide significantly lowers breathing interruptions during sleep, a key indicator of the severity of a patient’s obstructive sleep apnea (OSA).
    • “Tirzepatide is one of the class of blockbuster GLP-1 medicines, sold as Mounjaro to fight diabetes and as Zepbound to help with weight loss.
    • “This study marks a significant milestone in the treatment of OSA, offering a promising new therapeutic option that addresses both respiratory and metabolic complications,” said study leader Dr. Atul Malhotra, director of sleep medicine at UC San Diego Health. * * *
    • “The findings, published June 21 in the New England Journal of Medicine, add to evidence that a drug targeting both apnea and obesity is better than treating either condition on its own. Researchers said the drug therapy improved other aspects related to OSA, such as improving weight. Some patients, however, had mild stomach issues.”
  • Medscape notes, “Individuals on an intermittent-fasting and protein-pacing (IF-P) diet had fewer gastrointestinal symptoms and increased diversity in gut microbiota than those on a calorie-restricted (CR) Mediterranean-style diet in a small, randomized trial.”
  • The Assistant Secretary of Labor for Employee Benefit Security writes in her blog that “For Men, Taking Care of Your Family Means Taking Care of Yourself.”

From the U.S. healthcare business front,

  • Beckers Hospital Review reports,
    • “Risant Health, a nonprofit formed under Oakland, Calif.-based Kaiser Permanente, has signed a definitive agreement to acquire Greensboro, N.C.-based Cone Health.
    • “The news comes less than three months after Risant acquired its first health system, Danville, Pa.-based Geisinger Health. 
    • “If the transaction closes, Cone Health will operate independently as a regional and community-based health system under Risant, which supports organizations with technology and services to improve outcomes and lower care costs in diverse business models.
    • “Cone Health’s impressive work for decades in moving value-based care forward aligns so well with Risant Health’s vision for the future of healthcare. Their longstanding success and deep commitment to providing high-quality care to North Carolina communities make them an ideal fit to become a part of Risant Health,” CEO, Jaewon Ryu, MD, said in a June 21 news release. “We will work together to share our industry-leading expertise and innovation to expand access to value-based care to more people in the communities we serve.” 
    • “Cone Health includes four acute-care hospitals, a behavioral health facility, three ambulatory surgery centers, eight urgent care centers and more than 120 physician practices, according to its website. It has more than 13,000 employees and over 700 physicians, along with 1,800 partner physicians.” 
  • Per Healthcare Dive,
    • “Steward Health Care this week pushed back the auction timeline for the sale of its physician group and about half of its hospitals — less than a week before bids were due.
    • “The delay impacts the sale of Arizona and Massachusetts hospitals as well as the St. Joseph Medical Center in Texas. The new deadline for bids is July 15, with an auction following July 18 and a proposed sales hearing on July 31. Steward did not change the timeline for the sale of its other assets.
    • “One expert told Healthcare Dive it was “very possible” Steward would delay the sale timeline again if creditors agreed it was the best business move — especially since the company just re-upped its debtor-in-possession financing, which provides cash to fund operations through restructuring.”
  • and
    • “Telehealth use declined across most sociodemographic groups from 2021 to 2022, according to a survey published Thursday by the National Center for Health Statistics.
    • “Thirty-seven percent of adults reported using telemedicine in the past 12 months in 2021, compared with just over 30% in 2022.
    • “Researchers noted the decline across nearly all groups studied, including sex, family income, education and region. Women, adults with at least a college degree and people living in more urban areas were more likely to use telehealth in 2022.” 
  • Per Fierce Healthcare,
    • “An innovation council brought together some of the nation’s largest health plans to raise issues and look for ways to improve complex processes, including credentialing and provider data management.
    • “It’s one of the first times payers have sat down together to solve these pain points, CAQH CEO Sarah Ahmad told Fierce Healthcare in an interview. The health plan representatives met in-person just one day before AHIP 2024 kicked off in Las Vegas last week.
    • “You don’t see that in healthcare these days,” said Ahmad, whose company assembled the leaders.
    • “CAQH is a provider data management company that works on the provider side to credential and handle directory management, and on the member side to handle coordination of benefits.”
  • HR Dive offers five stories on the rise of wellness benefits.

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.”

Weekend Update

David Ermer–CDC, Congress, COVID-19, Medicare, NIH, U.S. Healthcare–

From Washington, DC,

  • Last Thursday, June 13, the House Appropriations Committee met to consider “Fiscal Year 2025 Financial Services and General Government Appropriations Act.” The measure was approved by the Committee with a vote of 33 to 24. The Committee adopted an amendment that “Requires the Office of Personnel Management (OPM) to submit a report on the coverage options currently available to federal employees that include assisted reproductive technology services and procedures.” 
  • Healthcare Dive tells us,
    • “Members of Congress are questioning the CMS Innovation Center’s progress in moving the nation’s health system to value-based care after a report found the center has increased federal spending instead of lowering it.”
    • “The Center for Medicare and Medicaid Innovation, or CMMI, was created by the Affordable Care Act more than a decade ago. The center is tasked with testing new healthcare payment and delivery models to lower costs and improve quality in government health programs.
    • “However, during at House Energy and Commerce subcommittee hearing on Thursday, some lawmakers — particularly Republicans — stressed that CMMI has failed to save money during its first 10 years and could continue to increase spending over the next decade. * * *
    • “Some legislators raised concerns about a lack of provider input into CMMI models. But a new strategic direction for CMMI, announced in 2021, should improve transparency and lay out the center’s priorities, Fowler said.
    • “Many stakeholders, including healthcare providers and various industry stakeholders, have expressed concern about the complexity, administrative burden and perceived lack of transparency involved when participating in the CMMI models,” said Rep. Bob Latta, R-Ohio.”
  • The American Medical Association lets us know,
    • “Just months after Congress again failed to stop in its entirety a pay cut that threatens Medicare patients’ access to high-quality physician care, the AMA House of Delegates made crystal clear the imperative to step up the pressure on the nation’s lawmakers and boost patient awareness about the dire need for Medicare payment reform.
    • “In a federal budget deal struck to continue operating the government, Congress in March reduced to less than 2% the 3.37% across-the-board physician pay cut that took effect in January.
    • “The House of Delegates (HOD) directed the AMA to:
      • “Increase media awareness around the 2024 AMA Annual Meeting about the need for Medicare payment reform, eliminating budget-neutrality reductions, and instituting annual cost-of-living increases.
      • ‘Step up its public relations campaign to get more buy-in from the general public about the need for Medicare payment reform.
      • “Increase awareness to all physicians about the efforts of our AMA on Medicare payment reform.
      • “Advocate for abolition of all Merit-based Incentive Payment System (MIPS) penalties in light of the current inadequacies of Medicare payments.
    • “This direction from the HOD bolsters the AMA’s aggressive efforts in leading the charge to reform the Medicare payment system.

From the public health and medical research front,

  • The Hill takes a look at the CDC’s current Covid statistics. Here’s the sentence that grabbed the FEHBlog’s attention: “[H]ospitalizations for COVID-19 remain very low nationwide. Only 0.6% of all emergency department visits were diagnosed as COVID cases last week.
  • A Buffalo, NY, television station WGRZ offers tips on how to reduce the risk of falling as you age, which is useful information for FEHB plans to share given the FEHB’s older demographics.
  • The National Institutes of Health announced today,
    • A data-driven intervention that engaged communities to rapidly deploy evidence-based practices to reduce opioid-related overdose deaths – such as increasing naloxone distribution and enhancing access to medication for opioid use disorder – did not result in a statistically significant reduction in opioid-related overdose death rates during the evaluation period, according to results(link is external) from the National Institutes of Health’s HEALing (Helping to End Addiction Long-Term) Communities Study. Researchers identified the COVID-19 pandemic and increased prevalence of fentanyl in the illicit drug market – including in mixtures with cocaine and methamphetamine – as factors that likely weakened the impact of the intervention on reducing opioid-related overdose deaths.
    • The findings were published in the New England Journal of Medicine and presented at the College on Problems of Drug Dependence (CPDD) meeting on Sunday, June 16, 2024. Launched in 2019, the HEALing Communities Study is the largest addiction prevention and treatment implementation study ever conducted and took place in 67 communities in Kentucky, Massachusetts, New York, and Ohio – four states that have been hard hit by the opioid crisis.
  • STAT News promptly followed up with an article about this NIH announcement.
    • “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  “In statements, federal health officials cast the study as at least a partial victory. While the interventions did not meaningfully reduce overdose deaths, the officials argued, they set the stage for future action and created a framework to help hard-hit communities choose new policy approaches and begin to implement them, with the hope that with more time and without Covid-19, deaths would fall.  
    • “[Nora] Volkow, the NIDA director, said that increasing use of stimulants like methamphetamine and cocaine, and the proliferation of fentanyl, mean society must “continue developing new tools and approaches” for preventing overdose deaths. Miriam Delphin-Rittmon, the administrator of the Substance Abuse and Mental Health Services Administration, said the study “recognizes there is no quick fix.” 
    • “And in an interview, [Redonna] Chandler, the director of the study, stressed that the results should not challenge what research has long demonstrated: There is a “mountain of evidence,” she said, supporting the belief that tools like naloxone, medications for opioid use disorder, and safer prescribing techniques, save lives. The challenge, Chandler said, lies in implementation — not the strategies themselves. 
    • “The study released Sunday, she said, “doesn’t negate, in any way, the evidence that suggests the strengths of those interventions.”

Happy Flag Day!

David Ermer–CDC, CMS, Congress, COVID-19, FDA, Medical / Rx research, Medicare, No Surprises Act, Telehealth, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal confirms,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, a move that will deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services was announced late Thursday, after The Wall Street Journal reported the agency’s plans. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “The agency said it would recalculate all of the 2024 quality ratings, but only apply the results if a plan’s ratings go up under the new methodology. If a plan’s ratings go down, the change won’t be implemented, CMS said in a guidance document.”
  • STAT News reports,
    • “Novo Nordisk CEO Lars Fruergaard Jørgensen will testify before the Senate after Sen. Bernie Sanders threatened to subpoena the company over its pricing of the popular diabetes drug Ozempic and the obesity drug Wegovy, the Senate health committee announced Friday.
    • “The agreement is a finale to a farcical public back-and-forth over apparent difficulties between the Senate health committee and Novo in scheduling a hearing. Sanders’ team claimed that Novo was uncooperative with his requests, but the company said they had told the senator’s team that the company was willing to testify.”
  • The American Hospital Association News lets us know,
    • “The Departments of Health and Human Services, Labor and the Treasury today announced a 120-day extension for parties impacted by the cyberattack on Change Healthcare to open disputes under the No Surprises Act independent dispute resolution process. Parties have until Oct. 12 to file disputes and must attest that their ability to open a dispute was impacted by the incident, the Centers for Medicare & Medicaid Services said. The departments published an attestation that parties must submit along with the standard IDR form during the extension period. The AHA previously advocated for the departments to create the extension.”
  • Bloomberg News adds,
    • “Medical providers continue to beat out insurers in most surprise billing arbitration disputes, often pocketing awards of at least double the in-network rate for a given service, according to new federal agency data.
    • “Providers were the prevailing party in about 82% of payment determinations made in No Surprises Act arbitration in the second half of 2023, according to a data report released Thursday by the Centers for Medicare and Medicaid Services. A total of 125,478 disputes resulted in award decisions in that period, the report showed, a 50% increase from the first half of 2023.”
  • Per a Department of Health and Human Services press release,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA), announced notices of funding opportunities aimed at improving behavioral health for racial and ethnic minorities, and other underserved populations, providing training and technical assistance to programs serving these populations, and integrating primary and behavioral health care. The funding totals $31.4 million and supports the Biden-Harris Administration’s efforts to address the mental health and overdose crises, two key pillars of the President’s Unity Agenda for the nation, as well as continuing efforts to advance heath equity and address the consistent and disproportionate impact of HIV on racial and ethnic minorities.  
    • “These grant programs additionally support HHS’ Overdose Prevention Strategy, the HHS Roadmap for Behavioral Health Integration, and SAMHSA’s strategic priorities: preventing substance use and overdose; enhancing access to suicide prevention and mental health services; promoting resilience and emotional health for children, youth, and families; integrating behavioral and physical health care; and strengthening the behavioral health workforce. ”   
  • The Labor Department’s Assistant Secretary for Employee Benefit Security, Lisa Gomez, writes in her blog about “avoiding elder financial abuse.”

From the public health and medical research front,

  • The Centers for Disease Control tells us today,
    • “Summary
      • “Seasonal influenza, COVID-19, and RSV activity is low nationally.
    • “COVID-19
      • “Most key indicators are showing low levels of activity nationally. However, COVID-19 test positivity has increased to 5.4% from 4.6% in the previous week. Wastewater viral activity is showing increases in some states. We also estimate that COVID-19 infections are growing or likely growing in 34 states and territories, declining or likely declining in 1 state or territory, and are stable or uncertain in 14 states and territories, based on CDC modeled estimates of epidemic growth. An increasing proportion of the variants that cause COVID-19 are projected to be KP.3 and LB.1 (CDC COVID Data Tracker: Variant Proportions).
    • “Influenza
    • “RSV
      • “Nationally, RSV activity remains low.
    • “Vaccination
  • Radiology Business informs us,
    • “Gen X is experiencing larger cancer incidence increases than generations before it, according to a new analysis published Monday in JAMA Network Open.
    • “Increases among this group (born between 1965 to 1980) are “substantial” when compared to the baby boomers who came before them (1936 to 1960). For instance, Gen X Hispanic women have seen a nearly 35% increase in cancer incidence while Latino men have recorded a 14% uptick.
    • “The findings are based on an analysis of data from 3.8 million individuals with invasive cancer.”
    • “The substantial increases we identified in Generation X versus both the baby boomers and their proxy parents surprised us,” lead author Philip S. Rosenberg, PhD, principal investigator at the National Cancer Institute, wrote June 10. “Numerous preventable causes of cancer have been identified. Cancer control initiatives have led to substantial declines in tobacco consumption. Screening is well accepted for precancerous lesions of the colon, rectum, cervix, uterus and breast. However, other suspected carcinogenic exposures are increasing.”
    • “For the study, Rosenberg and the NCI’s Adalberto Miranda-Filho, PhD, gathered data from the institute’s Surveillance, Epidemiology and End Results (SEER) Program spanning 1992-2018. They used a tool called the age-period-cohort model to project cancer incidence among the varying generations.”
  • Health Day notes,
    • “The death rate for type 1 diabetes has fallen 25% over the past few decades, and there are more seniors than ever with the illness
    • “Uncontrolled blood sugar was the prime driver behind poor outcomes with type 1.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Lilly’s Weight-Loss Drug Is a Huge Hit. Its CEO Wants to Replace It ASAP.
    • “Dave Ricks is pushing his scientists to find an even more potent anti-obesity treatment. ‘Lilly’s got a lead, and we plan to exploit that lead.’”
  • Beckers Hospital Review explains how “Kaiser Permanente’s phone and video visit rates remain significantly higher than pre-pandemic levels.” Check it out.
  • mHealth Intelligence relates,
    • “Most Americans said they would be willing to participate in hospital-at-home programs to return home sooner, according to a new survey.
    • “The survey, conducted by remote patient monitoring (RPM) technology developer Vivalink, polled 1,025 United States adults over 40.
    • “An overwhelming majority of US adults are likely to participate in a hospital-at-home monitoring program to get back home more quickly, with 39.15 percent saying they are very likely and 45.27 percent saying they are somewhat likely to participate in these programs. Only 15.58 percent said they are not likely to participate in a hospital-at-home program to return home sooner.”
  • Per BioPharma Dive,
    • “AbbVie is securing its place in an emerging gastrointestinal disease drug field, paying China-based FutureGen Biopharmaceutical $150 million in immediate and near-term fees for rights to an antibody drug targeting TL1A, a molecule linked to heightened immune responses in inflammatory bowel disease.
    • “The Illinois-based drugmaker is following rivals like Merck, Roche, Teva and Sanofi, which have piled billions of dollars into acquisitions to gain ownership of TL1A-targeting drugs.
    • “Per terms of the deal announced Thursday, AbbVie will gain global rights to the drug, called FG-M701, and will be responsible for its development, manufacturing and commercialization. FutureGen could receive up to $1.56 billion in additional fees based on hitting development, regulatory and sales milestones.”
  • and
    • “The failure of a Pfizer medicine for Duchenne muscular dystrophy adds new uncertainty around the effectiveness of gene therapy for the muscle-wasting condition, days before the Food and Drug Administration is expected to decide on expanding use of a similar treatment from Sarepta Therapeutics.
    • “On Wednesday, Pfizer said the treatment missed its mark in a definitive Phase 3 study of boys between 4 and 7 years of age with Duchenne. Pfizer didn’t disclose specifics, but said the therapy didn’t lead to a significant difference versus placebo on a measure of motor function, or on key secondary measures such as timed tests for how quickly study participants could stand or walk. The results will be presented at future medical and patient advocacy meetings.”
    • “The study’s failure makes it much less likely there will soon be a second gene therapy option for people with Duchenne, a progressive and deadly condition with no cure and limited treatment options. Pfizer had previously expected to file for a regulatory approval of its medicine if study results were positive. Now the company says it is “evaluating appropriate next steps” for the program. Multiple Wall Street analysts expect Pfizer to discontinue research.
    • “The results are “a discouraging blow to our community, particularly devastating to those who participated in the study,” said Parent Project Muscular Dystrophy, a patient advocacy group, in a statement.”

Thursday Miscellany

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Medical / Rx research, Medicare, NIH, Obesity, Rx coverage, U.S. Healthcare, Uncategorized–
Photo by Josh Mills on Unsplash

From Washington DC,

  • Federal News Network lets us know,
    • “For federal employees, a bill pending in the Senate would bring expanded coverage of fertility treatments through the Federal Employees Health Benefits (FEHB) program.
    • “But the Right to IVF Act, which Sens. Tammy Duckworth (D-Ill.), Patty Murray (D-Wash.) and Cory Booker (D-N.J.) introduced last week, did not garner the 60 votes needed to move forward with a floor vote Thursday afternoon. Almost all Republicans voted against the measure to advance the legislation, resulting in a 48-47 tally.
    • “The legislation rolls together three previous bills all aiming to improve access and insurance coverage for in-vitro fertilization (IVF). In part, the bill would have impacts specifically on FEHB enrollees. One component of the Right to IVF Act aims to set higher requirements for FEHB carriers to offer IVF coverage.
    • “The Office of Personnel Management increased FEHB carrier requirements for IVF treatments for plan year 2024. But the legislation looks to further extend the requirements of IVF to cover both treatments and medications, as well as expanding to more types of assisted reproductive technology (ART).”
  • Many large FEHB plans cover ART procedures. Competition will cause other plans to follow their lead.
  • Federal News Network also identifies House of Representatives policy riders to FY 2025 appropriations bills that are relevant to federal employees and their benefit programs.
  • The American Hospital Association News relates,
    • “The House Energy and Commerce Health Subcommittee June 13 held a hearing about transitioning to value-based care. The AHA submitted a statement to the subcommittee for the hearing, expressing support for value-based care and sharing principles the Center for Medicare and Medicaid Innovation should consider when designing alternative payment models. Those principles include adequate on-ramp and glidepath to transition to risk; adequate risk adjustment; voluntary participation and flexible design; balanced risk versus reward; guardrails to ensure participants don’t compete against themselves when they achieve optimal cost savings and outcomes; and upfront investment incentives.” 
  • Healthcare Dive informs us,
    • “The Supreme Court on Thursday unanimously ruled an anti-abortion group contesting the Food and Drug Administration’s approval of the abortion pill mifepristone does not have a legal basis to sue, putting an end to a drawn-out and high-profile court battle.
    • “The court held the plaintiffs’ “desire to make a drug less available to others” did not give them standing to challenge the FDA’s actions around mifepristone.
    • “The plaintiffs have failed to demonstrate that FDA’s relaxed regulatory requirements likely would cause them to suffer an injury in fact,” Justice Brett Kavanaugh wrote in the court’s opinion. “For that reason, the federal courts are the wrong forum for addressing the plaintiffs’ concerns about FDA’s actions.”
  • The Wall Street Journal adds,
    • “An appeals panel [in August 2023] rolled back much of the [district court’s] ruling, saying it was too late to challenge the drug’s original approval. But the appeals court did find that the plaintiffs had standing to sue, and it ruled the FDA’s efforts beginning in 2016 to make the pill more available were unlawful. The Supreme Court had previously put that ruling on hold, preserving the status quo of widespread mifepristone access while it considered the case. * * *
    • “The pill case won’t be the last time the justices weigh in on abortion access this term. The court in the next couple of weeks is expected to decide a separate case out of Idaho that centers around the question of whether a federal law that requires hospitals to provide stabilizing care for patients at risk of death or serious injury trumps state abortion bans that allow doctors to perform the procedure only if a woman’s life is in jeopardy.”
  • STAT News notes,
    • “Both President Biden and former President Trump love to claim credit for getting more Americans $35 insulin.
    • “But the credit should actually go to a giant pharmaceutical company — just the type that both men claim to have challenged.
    • “Eli Lilly, an $800 billion pharma giant and one of three insulin manufacturers in the United States, first proposed an experiment allowing Medicare insurance plans to offer $35 monthly insulin in 2019, CEO David Ricks and former Medicare agency chief Seema Verma said in interviews with STAT.
    • “It is true. We approached CMS with that idea,” Ricks said, referring to the government Medicare agency.
    • “Verma gave Ricks credit. “He is an unsung hero. He was actually the mastermind of all of this,” she said.”
  • Per Department of Health and Human Services press releases,
    • “Today, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), awarded more than $11 million to 15 organizations to establish new residency programs in rural communities. HHS Secretary Xavier Becerra and White House Domestic Policy Advisor Neera Tanden announced the new awards while visiting rural health clinic in Wisconsin Rapids, Wisconsin today. Building on HRSA’s Enhancing Maternal Health Initiative, one program will create the first obstetrics and gynecology Rural Track Program in the country, and six others will develop new family medicine residency programs with enhanced obstetrical training in rural communities.”
    • “For more information about the Rural Residency Planning and Development Program, visit https://www.hrsa.gov/rural-health/grants/rural-health-research-policy/rrpd.”
  • and
    • “The Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), is announcing up to $500 million in Project NextGen funding to plan and execute multiple Phase 2b clinical trials evaluating novel vaccines administered as a nasal spray or as a pill to protect against symptomatic COVID-19.
    • “We learned a lot during the COVID-19 pandemic that we can use to better prepare for future public health crises. That includes finding new ways to administer vaccines to make it even easier for everyone to protect themselves from illness,” said HHS Secretary Xavier Becerra. “We are making progress on the development of cutting-edge treatments, such as vaccines administered as a nasal spray or as a pill. The Biden-Harris Administration won’t stop until we have the next generation of innovative vaccines, therapeutics, and other tools to protect against COVID-19, or any other pathogen that could threaten the American public.”

From the public health and medical research front,

  • The Wall Street Journal reports,
    • “Avoid raw milk. Lay off cheeses made with unpasteurized milk. And cook your beef to medium- or well-done temperatures.
    • “These are the precautions that public health officials and doctors recommend as they track the H5N1 bird flu outbreak in U.S. cattle. Ten states have H5N1 outbreaks in cows, according to the Centers for Disease Control and Prevention, and at least three U.S. dairy farmworkers have been diagnosed with bird flu. 
    • “A man in Mexico contracted a different strain of bird flu—H5N2—earlier this month and died, though he died from underlying conditions, according to the Mexican government.
    • “Doctors and federal officials say the public health risk of getting H5N1 is currently very low unless you work on a farm, and stress that there has been no evidence of human-to-human transmission. What’s raised concern is that the most recent case—found in a dairy worker in Michigan earlier this month—had respiratory symptoms unlike the previous two cases where the primary symptom was pinkeye. 
    • “Viruses with respiratory symptoms are more contagious and transmissible than conjunctivitis, or pinkeye, so doctors and scientists say they are watching closely. For now, it has been more than a week since the worker tested positive and there have been no known cases of transmission.”  
  • The NIH director in her weekly blog tells us,
    • We know stress can take a toll on our mental health. Yet, it’s unclear why some people develop stress-related mental health disorders and others don’t. The risk for developing a stress-related mental health disorder such as post-traumatic stress disorder (PTSD) or major depressive disorder (MDD) depends on a complex interplay between the genetic vulnerabilities we are born with and the impact of traumatic stress we experience over our lifetimes.
    • Given this complexity, it’s been difficult for researchers to pinpoint the underlying biological pathways in the body that ultimately produce changes associated with PTSD, major depression, or other mental health conditions. Now, a study reported in a special issue of Science on decoding the brain uses a comprehensive approach to examine multiple biological processes across brain regions, cell types, and blood to elucidate this complexity. It’s an unprecedented effort to understand in a more holistic way the essential biological networks involved in PTSD and MDD. * * *
    • “There’s clearly much more to discover in the years ahead. But these insights already point to important roles for known stress-related pathways in fundamental brain changes underlying PTSD and MDD, while also revealing more novel pathways as potentially promising new treatment targets. With further study, the researchers hope these findings can also begin to answer vexing questions, such as why some people develop PTSD or major depression after stressful events and others don’t.”
  • STAT News points out that “With placenta-on-a-chip, researchers hope to gauge how drugs and toxins impact pregnancy.”
    • “[Mechanical engineer Nicole] Hashemi and her colleagues received a three-year, $350,000 grant from the National Science Foundation to advance their current placenta-on-a-chip model. They plan on designing systems that can be integrated into the model to help collect data in real time. Hashemi told STAT that one system could look at changes in the shapes of cells when exposed to chemicals or physical stressors.
    • “The placenta-on-a-chip technology is simple but potentially powerful, and similar efforts are being made to replicate the environments of other human organs. The small chip is usually about the size of a rubber eraser, etched with tiny channels through which fluids move — offering a simplified, functional model of an organ to test drugs or to study the progression of disease. Researchers can grow cells and run fluids that act like blood through chambers in the chip to create environments similar to those in the human body.
    • “According to Dan Huh, a professor of bioengineering at the University of Pennsylvania and a leader in developing many organs-on-a-chip including the placenta and lung, maintaining the environment is almost like tricking the cells into thinking that they’re still in the body so that they “do what they’re supposed to do.”
  • MedPage Today tells us,
    • “Disrupted access to prescription stimulants for patients with attention deficit-hyperactivity disorder (ADHD) may increase risks of injury or overdose, the CDC warned on Thursday following the indictment of an online ADHD medication prescriber over fraud allegations.
    • “Several ADHD stimulants such as immediate-release amphetamine (Adderall) are already in shortage, and the new federal healthcare fraud indictment may further disrupt care for as many as 50,000 patients with ADHD, the CDC detailed.
  • The Journal of the American Medical Association released a research letter about trends in Naloxone dispensing from U.S. retail pharmacies.
    • “Naloxone prescriptions dispensed from retail pharmacies increased from 2019 to 2023, with the largest single-year increase observed in 2022. This increase may reflect efforts to expand naloxone prescribing, including state-level standing orders3 and clinical practice guidelines. Although statistically significant increases were observed among most prescriber specialties between 2019 and 2023, nearly two-thirds of dispensed naloxone was prescribed by advanced practitioners and primary care specialties in 2023. Continued efforts such as evidence-based academic detailing and electronic health record alerts can support clinicians in prescribing naloxone.
    • “The observed decrease in retail pharmacy–dispensed naloxone prescriptions during Q3 and Q4 2023 may be due to naloxone becoming available over the counter,4 though trend analysis indicated the decline was not statistically significant. Studies have found that over-the-counter naloxone has a higher out-of-pocket cost than insurance-paid naloxone prescriptions,5 indicating the continued importance of prescribed naloxone and naloxone accessed in community-based settings. * * *
    • “Although naloxone dispensing has increased in recent years, opportunities remain to expand access given the continued high burden of opioid overdoses,1 such as by increasing co-prescribing of naloxone for patients with high-risk opioid prescriptions2,6 and reducing financial barriers.5“

From the U.S. healthcare business front,

  • The Wall Street Journal reports good news for Medicare Advantage insurers,
    • “The federal government plans to redo this year’s quality ratings of private Medicare plans, according to people familiar with the matter, a move that would deliver hundreds of millions in additional bonus payments to insurers next year.
    • “The decision by the Centers for Medicare and Medicaid Services could be announced as soon as Thursday. It comes in the wake of two court rulings that faulted the agency’s ratings, in cases filed by insurers SCAN Health Plan and Elevance Health.
    • “By paving the way for higher payments, the CMS move would provide a win for Medicare insurers at a time when their business is under pressure from rising healthcare costs and rates for next year that came in lower than investors had expected.'”
  • Mercer Consulting explores “Unlocking the power of [healthcare] price transparency data.”
  • MedTech Dive informs us,
    • “Philips has launched its Duo Venous Stent System in the U.S. to treat patients with blockages in their veins, the company said Wednesday.
    • “The implant, which won approval in December, is designed to address the root cause of chronic deep venous disease and comes in two forms for use in different types of veins. 
    • “Philips acquired the device in its 2022 takeover of Vesper Medical. The company paid 227 million euros upfront for Vesper to expand its image guided therapy business.”
  • and
    • “Medline has asked hospitals to remove thousands of endotracheal tubes because of a risk that components can tear or detach, blocking a patient’s airway. 
    • “The company recalled more than 168,000 Medline Sub-G Endotracheal Tubes and more than 13,000 kits, according to a Food and Drug Administration notice posted on May 28. The tubes are used for mechanical ventilation and have ports to prevent fluid from draining into patients’ lungs and causing pneumonia. 
    • “Medline recalled the products because the inflation tube and other components can detach or tear from the main tube, causing it to leak or deflate. If the device comes apart during use, it could also obstruct the patient’s airway or cause choking, the FDA said in a Tuesday notice.
  • and
    • “Abbott is recalling a system monitor used with the Heartmate cardiac pump because screen display issues could pose a risk to patients. The Class 1 recall affects 4,842 monitors distributed in the U.S. and worldwide, according to a June 7 database entry by the Food and Drug Administration.
    • “In an urgent medical device correction letter to physicians in May, Abbott said no serious adverse health consequences were reported and no devices are being removed from the market.
    • “The latest recall follows three others from earlier this year involving the Heartmate left ventricular assist system, the only such mechanical circulatory support device on the U.S. market after Medtronic stopped selling its Heartware pump in 2021.”