Midweek update

Medicare

Midweek update

David Ermer–CDC, CMS, Congress, Federal employment benefits, Medical / Rx research, Medicare, OPM, Telehealth, U.S. Healthcare–
OPM Headquarters a/k/a the Theodore Roosevelt Building

From Washington, DC,

  • At long last, the federal employee press is publicizing the Part D opt out penalty found in the proposed supplemental Postal Service Health Benefits (PSHB) Program rule.
  • Federal News Network reports, “There’s a catch in USPS insurance program for Medicare-eligible retirees. USPS annuitants who opt out of Medicare Part D will lose underlying prescription drug coverage, according to OPM’s [proposed] regulations.” Those opt out annuitants will continue to pay the full premium.
  • OPM reads the PSHB law as only offering Part D EGWP benefits to Part D eligible annuitants in the PSHBP. There is no underlying Rx coverage according to the agency’s FAQs. That statutory interpretation puts federal employees who live overseas in quite a pickle because Part D coverage is not available outside the United States.
  • In any case, it’s the FEHBlog’s legal opinion that the opt out penalty may not survive judicial review in our post-Chevron era, and because the penalty is roughly 20% of the premium, annuitants may be incented to bring a lawsuit challenging the penalty. Time will tell.
  • Govexec tells us,
    • “The Office of Personnel Management is opening a channel to provide federal employees affected by Hurricane Beryl to obtain emergency paid leave.  FEHBlog note: Beryl hit Houston TX hard.
    • “Acting OPM director Robert Shriver said in a July 19 memo that the agency had established an emergency leave transfer program, by which other federal employees may donate unused annual leave to impacted employees through the creation of agency leave banks. 
    • “Through the agency leave banks, impacted employees “who are adversely affected by a major disaster or emergency, either directly or through adversely affected family members, and who need additional time off from work” can utilize donated leave without having to use their own.” 
  • Per Fierce Healthcare,
    • “The Centers for Medicare & Medicaid Services (CMS) has released new data on risk adjustment payments for 2023.
    • “The agency said (PDF) insurers participating on the Affordable Care Act’s exchanges will pay $10.3 billion as part of the risk adjustment program. Risk adjustment state transfers as a percent of premiums declined from 2022, according to the report.
    • “This trend is likely driven by shifts in the risk pools, according to CMS, which are likely impacted by ongoing insurer expansion into new regions.”
  • The American Hospital Association News informs us,
    • “The Substance Abuse and Mental Health Services Administration July 24 announced it is awarding $45.1 million in grants toward various behavioral health initiatives. The funding includes $15.3 million specifically planned to support children through mental health services in schools, services for those who have experienced traumatic events, and services specific to those at risk for or with serious mental health conditions.” 
  • Roll Call reports,
    • “House leaders canceled votes scheduled for next week as the GOP majority struggles to pass its fiscal 2025 appropriations bills.
    • “The decision to scrap next week’s session came a day after Republican leaders had to yank the Energy-Water spending bill from the floor amid growing doubts they could muster enough votes to pass it with their razor-thin majority. * * *
    • “GOP leaders all week had been mulling the possibility of sending members home early rather than remain in session next week as previously scheduled. Speaker Mike Johnson, R-La., said Wednesday that the decision to cancel votes next week wasn’t a direct result of problems with the appropriations bills.
    • “It’s not related to that. We’ve had a tumultuous couple of weeks in American politics and everybody’s, to be honest, still tired from our convention, and it’s just a good time to give everybody time to go home to their districts and campaign a little bit. We’ll come back and regroup and continue to work on this.”
    • “Johnson also said funeral arrangements for Rep. Sheila Jackson Lee, D-Texas, who died last weekend after a battle with pancreatic cancer, would pose logistical challenges next week. Johnson said a lot of members would want to attend the events, to be held in Houston, which could keep members away from Washington for three days.”
  • Per a Senate press release,
    • “Senate Finance Committee Chair Ron Wyden, D-Ore., and five senators today introduced a bill to apply criminal penalties to rogue insurance brokers who are changing Americans’ Affordable Care Act (ACA) marketplace plans without their knowledge or consent, and take other steps to strengthen consumer health insurance protections. * * *
    • “The one-pager is available here. A summary of the bill is available here. The bill text is available here.”

From the public health and medical research front

  • ABC News relates,
    • “So far, only 25 cases of West Nile virus have been reported in 14 states, according to data from the Centers for Disease Control and Prevention. This is lower than the 117 cases reported at the same time last year. * * *
    • “Mosquitoes typically become infected with the virus after feeding on infected birds and then spread it to humans and other animals, the federal health agency said. Cases typically begin rising in July and are highest in August and September, CDC data shows.
    • “The majority of people with the virus do not have symptoms, but about one in five will experience fever along with headaches, body aches, joint pain, diarrhea, vomiting or a rash. Most symptoms disappear but weakness and fatigue may last for weeks or months.
    • “About one in 150 will develop severe disease leading to encephalitis, which is inflammation of the brain, or meningitis, which is inflammation of the membranes that surround the brain and spinal cord — both of which can lead to death. So far this year, 11 of the 25 cases have resulted in neuroinvasive disease, according to the CDC.
    • “There are currently no vaccines or specific treatments available for West Nile virus. The CDC recommends rest, fluids and over-the-counter medications. For those with severe illness, patients often need to be hospitalized and receive support treatments such as intravenous fluids.
    • “To best protect yourself, the CDC suggests using insect repellant, wearing long-sleeved shirts and pants, treating clothing and gear and taking steps to control mosquitoes. This last step includes putting screens on windows and doors, using air conditioning and emptying out containers with still water.”
  • The New York Times adds,
    • “As the bird flu outbreak in dairy cows has ballooned, officials have provided repeated reassurances: The virus typically causes mild illness in cows, they have said, and because it spreads primarily through milk, it can be curbed by taking extra precautions when moving cows and equipment.
    • “A new study, published in Nature on Tuesday, presents a more complex picture.
    • “Some farms have reported a significant spike in cow deaths, according to the paper, which investigated outbreaks on nine farms in four states. The virus, known as H5N1, was also present in more than 20 percent of nasal swabs collected from cows. And it spread widely to other species, infecting cats, raccoons and wild birds, which may have transported the virus to new locations.
    • “There’s probably multiple pathways of spread and dissemination of this virus,” said Diego Diel, a virologist at Cornell University and an author of the study. “I think it will be really difficult to control it at this point.” * * *
    • Although many infected cows did recover on their own, the researchers found, two farms reported a spike in cow deaths. On the Ohio farm, 99 cows died over the course of a three-week outbreak, a mortality rate roughly twice as high as normal.
    • “I think the potential for this virus to cause very serious disease has been downplayed a bit,” said Richard Webby, an influenza expert at St. Jude Children’s Research Hospital, who was not involved in the new study. “That has probably hurt the response.”
    • “Still, Dr. Diel noted, the cause of these deaths remains unknown. “Whether the mortality observed in those cases was due directly to influenza or whether the influenza infection led to a secondary bacterial infection, I think that’s a question that remains to be answered,” he said.”
  • Per BioPharma Dive,
    • “An experimental gene therapy from Pfizer succeeded in a Phase 3 study of people with hemophilia A, overcoming safety concerns that had put the trial on hold for almost a year.
    • “The treatment, giroctocogene fitelparvovec, is a one-time infusion designed to help patients produce a protein called Factor VIII that’s needed for normal blood clotting. Currently, people with hemophilia A use infusions of Factor VIII to prevent bleeding episodes.
    • “In the AFFINE study, researchers followed 75 patients for at least 15 months after they received Pfizer’s therapy. Study participants had fewer bleeding episodes and higher levels of Factor VIII, compared with standard prophylactic treatment before the infusion, Pfizer said Wednesday. Only one treated patient returned to prophylactic infusions.”
  • Healio notes that “In a single-center cohort of patients with heart failure and obesity, weight-loss surgery led to improved clinical outcomes including reduced BMI and HbA1c and less reliance on diuretics, researchers reported.”
  • mHealth Intelligence reports,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

From the U.S. healthcare business front,

  • Fierce Healthcare lets us know,
    • “Humana’s CenterWell is planning to open 23 clinics at Walmart locations in four states, the company announced Wednesday.
    • “The health clinics will operate in space that previously held Walmart’s own clinics, according to the announcement. CenterWell intends to have the locations across Florida, Georgia, Missouri and Texas fully equipped, staffed and opened by the first half of 2025.
    • “The locations will operate under both the CenterWell and Conviva brands, providing senior-focused primary care. CenterWell is the fastest-growing senior-focused primary care provider in the nation, Humana said.”
  • Per Healthcare Dive,
    • “S&P Global Ratings analysts have downgraded Walgreens Boot Alliance by two notches, to ‘BB’ from ‘BBB-’, which puts the drugstore company into speculative-grade territory.
    • ‘Analysts Diya Iyer and Hanna Zhang cited guidance for the year “notably below” their expectations, and said “material strategic changes, limited cash flow generation, and large maturities in coming years are key risks to the business.”
    • “The company is struggling in its retail business as well as its pharmacy operations, they said in a Friday client note. In the U.S., margins are taking a hit on the pharmacy side from reimbursement pressure and on the retail side from declining sales volume and higher shrink. They expect Walgreens’ S&P Global Ratings-adjusted EBITDA margin to decline more than 100 basis points this fiscal year, dipping below 5%, from 6% last year, though the company’s cost cuts will counter that somewhat.”
  • MedTech Dive points out the top five medtech deals in the first half of 2024.
  • Per HR Dive,
    • “There has been a “notable jump” in the percentage of employers offering deductibles of $4,000 or more — from 36% to 45% — according to a survey of more than 6,000 employers conducted by employee benefits firm Alera Group. 
    • “More companies are also offering qualified high-deductible health plans (up from 47% to 52%), Alera Group found. The survey also found, perhaps unsurprisingly, that 4 in 5 medical plans experienced a rate increase over the past year.
    • “Employers appear to be managing increased costs by providing more choices, with more than half of large employers offering three or more plan options. More employers are also exploring self-funding, Alera Group found.”

    Monday Roundup

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

    From Washington, DC,

    • Healthcare Dive reports,
      • “The Biden administration is making it harder for insurance agents and brokers to change people’s plans on the federal Affordable Care Act marketplace following mounting consumer complaints about unauthorized changes.
      • “On Friday, the CMS announced agents can’t make changes to a consumer’s enrollment in the federal exchanges unless they’re already associated with that consumer. If agents and brokers are unassociated, they have to take additional steps to update a consumer’s marketplace enrollment — even with that consumer’s consent, according to the notice.
      • “Unassociated brokers will have to have a three-way call with the beneficiary and the marketplace’s call center, or have the beneficiary change their enrollment themselves through HealthCare.gov or another approved portal. The changes, which don’t apply to the 18 states (and Washington, D.C.) that run their own insurance marketplaces, took effect immediately.”
    • Per an HHS press release,
      • “The Biden-Harris Administration’s Kids Online Health and Safety Task Force, co-led by the U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Commerce’s (DOC) National Telecommunications and Information Administration (NTIA), released a new report today with recommendations and best practices for safer social media and online platform use for youth. The recommendations in the report, Online Health and Safety for Children and Youth: Best Practices for Families and Guidance for Industry, underscore the Administration’s efforts to address the ongoing youth mental health crisis and support the President’s Unity Agenda for the nation. Task Force members also committed to future actions, including providing more resources for kids, teenagers and families, guidance for pediatricians and conducting more research.”
    • Healthcare Innovation lets us know,
      • “On July 17, the Office of the National Coordinator for Health IT (ONC) released the agency’s latest Data Brief and Quick Stat. According to ONC’s survey findings, 64 percent of U.S. hospitals plan to participate in TEFCA™, the Trusted Exchange Framework and Common Agreement. The agency notes that “This is an increase over 2022, when 51 percent of U.S. hospitals said they planned to participate.”
      • “Other findings:
        • “Approximately 7 out of 10 hospitals that participated in national networks or health information exchanges (HIEs) planned to participate in TEFCA, compared to 4 out of 10 hospitals that did not participate in either type of network.
        • “Hospitals with more resources, such as those that are larger, non-critical access, and affiliated with health systems, indicated greater awareness and had higher levels of planned participation in TEFCA when compared to smaller, critical access, and independent hospitals with fewer resources.
        • “The percent of hospitals that were aware of TEFCA but did not know if they would participate decreased from 23% to 9% from 2022 to 2023.”
      • FEHBlog Note — TEFCA is the government’s backbone for the healthcare electronic medical records system.

    From the public health and medical research front,

    • The Washington Post reports,
      • “More than 40 percent of women said they skipped or delayed a screening recommended by a health professional, according to a recent survey by Gallup for the medical technology company Hologic.
      • “In the survey of 4,001 adult women across the United States, 90 percent of respondents agreed that it is important to get regular preventive health screenings for cancer, heart disease, sexually transmitted infections and other key health conditions. But 43 percent also said they skipped or delayed a recommended screening, including for breast cancer, cervical cancer and colorectal cancer.
      • “The respondents cited multiple reasons for doing so: anxiety about medical tests, pain concerns, cost, lack of time or not believing a screening was necessary.
      • “In addition, only 42 percent of the participants said they were “very confident” about which health screenings they needed. Many women also had trouble finding pertinent information, with 31 percent of Gen Z women saying it was hard for them to find relevant health information.”
    • Medscape tells us,
      • “Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.
      • “A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.” * * *
      • “Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” said Millennium Health Chief Clinical Officer Angela Huskey, PharmD, in a press release.”

    From the U.S. healthcare business front,

    • Fierce Healthcare names the most influential minority executives in healthcare. Kudos to that group.
    • Beckers Payer Issues points out recent physician hires to executive roles at payer organizations.
    • Fierce Healthcare informs us,
      • “Embattled Steward Health Care has canceled auctions for its hospitals in Ohio and Pennsylvania after it did not receive qualified bids for those facilities, according to a court filing.
      • “The health system said in a document filed Sunday with bankruptcy court in Texas that it is working to determine alternatives for those facilities and expects to make an announcement at a later date. It had initially set a bid deadline for June 24 for these assets, which was later pushed back to July 15.
      • “Steward filed for chapter 11 bankruptcy in the Southern District of Texas in May.”
    • Fierce Healthcare also relates,
      • “Cigna has created a new impact fund that aims to address health disparities commonly impacting local communities.
      • “The insurer’s philanthropic arm, the Cigna Group Foundation, will operate the Cigna Group Health Equity Impact Fund. Through the program, Cigna will contribute $9 million over the next three years to tackle disparities and inequities across priority states.
      • “According to an announcement, the program will initially focus in Houston, Texas and Hartford, Connecticut. By drilling down to these specific communities, Cigna said it can “optimize” the level of assistance needed to put toward the unique equity challenges they’re facing.”

    Weekend update

    David Ermer–CDC, Congress, Medicare, U.S. Healthcare–

    From Washington, DC,

    • The House Oversight and Accountability Committee will hold its third hearing on prescription benefit managers this Tuesday July 23 at 10 am.
    • Over the past two weeks —
      • Tammy Flanagan, writing in Govexec, offered tips on creating a smooth transition from federal employee to federal annuitant.
      • Kevin Moss, writing in the Federal Times, discusses the pros and cons of paying for both FEHB and Medicare Part B coverage. He summarizes as follows:
        • “The main reason to not consider enrolling in Part B is the cost of the extra premium. For federal annuitants that are not subject to IRMAA, adding Part B will most likely be worth it. Having Part B gives you the option to see doctors outside of the plan network and if you enroll in an FEHB plan that waives some out-of-pocket costs or consider MA plans offered by FEHB plans, you could see a reduction in your total healthcare spending.
        • “For federal annuitants that are subject to IRMAA, most of the benefits of enrolling in Part B will erode by having to pay more. This is especially true if your income places you in the second tier or higher of IRMAA and you expect that level of income throughout your retirement.”
      • The FEHBlog points out that the IRMAA tax is temporary because incomes usually subside in retirement below the IRMAA relatively high thresholds while the Medicare Part B late enrollment penalty is forever.

    From the public health and medical research front,

    • Fortune Well lets us know,
      • “As U.S. health officials investigate a fatal outbreak of listeria food poisoning, they’re advising people who are pregnant, elderly or have compromised immune systems to avoid eating sliced deli meat unless it’s recooked at home to be steaming hot.”
      • “The U.S. Centers for Disease Control and Prevention didn’t mandate a food recall as of early Saturday, because it remains unclear what specific products have been contaminated with the bacteria now blamed for two deaths and 28 hospitalizations across 12 states. This means the contaminated food may still be in circulation, and consumers should consider their personal risk level when consuming deli meats.
      • “Federal health officials warned on Friday that the number of illnesses is likely an undercount, because people who recover at home aren’t likely to be tested. For the same reason, the outbreak may have spread wider than the states where listeria infections have been reported, mostly in the Midwest and along the U.S. eastern coast.
      • “The largest number known to get sick — seven — were in New York, according to the CDC. The people who died were from Illinois and New Jersey.
      • “Of the people investigators have been able to interview, “89% reported eating meats sliced at a deli, most commonly deli-sliced turkey, liverwurst, and ham. Meats were sliced at a variety of supermarket and grocery store delis,” the CDC said.”
    • The Wall Street Journal reports,
      • “How much drinking is bad for you?
      • “Though more people are calling themselves sober-curious or are trying zero-proof replacements for alcohol, drinking is a regular part of social life for most of us. A coupe of champagne can add fun to a celebration. A cocktail can take the edge off a tough day. And a cold beer can liven up a sports game. 
      • “Yet scientists’ warnings about the potential health problems of even small amounts of alcohol are growing more dire. For moderate drinkers, it can be hard to know what’s actually OK to consume: Is two a day that much worse than one? Are two drinks over a week the same as two in a day? 
      • “Averaging no more than about one drink a day is relatively low risk, according to scientists who study alcohol. They warn the risk of cancer rises significantly when you exceed that. Studies have suggested that alcohol contributes to about half a dozen types of cancers, including breast and colorectal, as well as heart and liver disease, among other conditions.” 
    • MedPage Today reports,
      • “U.S. health officials on Friday said a new study in Michigan suggested the bird flu virus is not causing asymptomatic infections in people, while also announcing two new human cases in Colorado.
      • “Last month, the Michigan Department of Health and Human Services launched a study of workers who were around cows sickened by the bird flu. The researchers drew blood from 35 people.
      • “One goal was to determine if there were people who never had any symptoms but did have evidence of past infections. None of the blood testing showed antibodies that would indicate infections with the highly pathogenic avian influenza (HPAI) A(H5N1) virus circulating among dairy cattle and poultry, the CDC reported on Friday.
      • “The lack of antibodies to avian influenza A(H5N1) virus suggests these people were not previously infected with an avian influenza A(H5N1) influenza virus,” the agency said. “These data are consistent with other dataopens in a new tab or window demonstrating the seroprevalence to HPAI A(H5N1), even among workers with known exposures, is low.”
      • “Many of the workers did show antibodies to seasonal flu, which was used as a control virus in the study. Researchers will continue to sample workers, and the data will be analyzed and prepared for a peer-reviewed publication, the CDC said.
    • Per Medscape,
      • “One in five children (20.2%) who have an older sibling with autism spectrum disorder (ASD) are likely to be diagnosed with the disorder as well, according to a study published in Pediatrics.
      • “When a baby had more than one older sibling with autism, the family recurrence rate rose to 36.9%, the study found. * * *
      • “Dr Ozonoff’s team found that sex and race played a part in likelihood of recurrence. Younger siblings of females with ASD were much more likely to develop the disorder (34.7%) than siblings of boys (22.5%). And male younger siblings were more likely to have ASD than girls (25.3% vs 13.1%).”

    Tuesday’s Tidbits

    David Ermer–CDC, CMS, Congress, COVID-19, Medical / Rx research, Medicare, Mental health care, NIH, U.S. Healthcare, Uncategorized–
    Photo by Patrick Fore on Unsplash

    From Washington, DC,

    • Fierce Healthcare tells us
      • “A bipartisan quartet of House representatives have introduced a bill peeling back restrictions on new or expanded physician-owned hospitals.
      • “The Physician Led and Rural Access to Quality Care Act, brought late last week, would create an exception to an Affordable Care Act’s ban that aimed to reduce conflicts of interest in care. Specifically, it would permit new physician-owned hospitals to open in rural areas that are at least 35 miles from another existing hospital or critical access hospital (or 15 miles in difficult-to-traverse areas).
      • “The new bill would also sunset a prohibition on expanding any existing physician-owned hospitals.”
      • FEHBlog note: The bill pits the American Medical Association (pro) against the American Medical Association (con).
    • Per a Department of Health and Human Services press release,
      • “Today, CMS is releasing the final part two guidance – PDF regarding plan outreach and education for the Medicare Prescription Payment Plan, which aims to ensure that people with Medicare prescription drug coverage, especially those most likely to benefit, are aware of the payment option. Starting in 2025, the Medicare Prescription Payment Plan provides the option to people with Medicare prescription drug coverage to spread the costs of their prescription drugs over the calendar year rather than paying in full at the pharmacy counter each time they fill a prescription. People with Medicare must opt into the Medicare Prescription Payment Plan to utilize the new benefit. Notably, this payment option launches at the same time that all individuals with Medicare prescription drug coverage will begin to have their annual out-of-pocket prescription drug costs capped at $2,000, providing needed financial relief for high prescription drug costs.” * * *
      • “Today’s Medicare Prescription Payment Plan final part two guidance, which complements the final part one guidance – PDF released on February 29, is also accompanied by the release of the final Medicare Prescription Payment Plan model materials. Medicare Part D plans can use the model materials when communicating to Part D enrollees about the Medicare Prescription Payment Plan.” * * *
      • “For the fact sheet on the final part two guidance for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/fact-sheet-medicare-prescription-payment-plan-final-part-two-guidance.pdf – PDF
      • “For the updated Information Collection Request (ICR) for the Medicare Prescription Payment Plan model plan materials, please visit: https://www.cms.gov/files/zip/medicare-prescription-payment-plan-model-materials.zip
      • “For an updated implementation timeline for the Medicare Prescription Payment Plan, please visit: https://www.cms.gov/files/document/medicare-prescription-payment-plan-timeline.pdf – PDF“
    • Another HHS press release brings us up to date on improvements to the 988 mental health lifeline which was launched two years ago today.
    • Healio adds,
      • “Since the launch of the 988 Suicide & Crisis Lifeline in 2022, counselors have answered more than 10 million calls, texts and chats from people seeking help for suicidal thoughts and mental health crises, according to HHS officials.
      • “During a press conference, HHS Deputy Secretary Andrea Palm said the lifeline “has become one of the most effective first-line responses that we have to help individuals who feel alone and without options.” * * *
      • “HHS has invested nearly $1.5 billion into the lifeline, according to an agency press release. It has lines that are tailored to people who speak Spanish, veterans, American Sign Language (ASL) users and the LGBTQI+ community. Since these lines were added to the 988 lifeline in 2023, there have been about 20,000 chats and texts with Spanish speakers, more than 475,000 texts, calls and chats with LGBTQI+ individuals and approximately 20,000 videophone contacts with ASL users.
      • “Among all contacts over the past 2 years, about 1.7 million were texts, according to the release. In the past year, HHS reported a 51% increase in texts and a 34% increase in calls, with support provided by more than 200 contact centers nationwide.”
    • CMS shares the following statement from CMS Administrator Chiquita Brooks-LaSure:
      • “Remembering Gail R. Wilensky, Ph.D., a health care policy savant who knew how to work across the aisle. Her Influence and leadership can still be felt today. She was very generous to the CMS leaders who served after her, including me. My deepest condolences to her loved ones. CMS is grateful for her service to our country.”
      • FEHBlog note — Dr. Wilensky, who passed away on July 11 at age 81, served as CMS (then HCFA) Administrator for President George H. W. Bush.
    • Per the AHA News,
      • “The AHA July 16 urged the Center for Medicare and Medicaid Innovation not to implement its newly proposed Increasing Organ Transplant Access Model as currently constructed, expressing concerns about many of its design features. The proposed mandatory payment model would test whether performance-based incentive payments paid to or owed by participating kidney transplant hospitals would increase access to kidney transplants while preserving or enhancing the quality of care and reducing Medicare expenditures. AHA said that IOTA features could exacerbate inequities and negatively impact quality of care. Specifically, AHA said the IOTA model would add unnecessary disruption and uncertainty to the transplant ecosystem, potentially incentivize sub-par matches given the heavy emphasis on volume and would be discordant with other regulatory requirements.” 

    From the public health and medical research front,

    • Per a press release, the Institute for Clinical and Economic Review published its Final Evidence Report on Treatment for Chronic Obstructive Pulmonary Disease 
      • “Independent appraisal committee voted that current evidence is adequate to demonstrate superior net health benefits for ensifentrine added to maintenance therapy compared to maintenance therapy alone; ICER calculated a health-benefit price benchmark (HBPB) for ensifentrine between $7,500 to $12,700 per year, and the therapy is priced at $35,400 per year.
    • The National Institutes of Health announced,
      • “In a new analysis of data, researchers at the National Institutes of Health (NIH) have found that taking a daily supplement containing antioxidant vitamins and minerals slows progression of late-stage dry age-related macular degeneration (AMD), potentially helping people with late-stage disease preserve their central vision. Researchers reviewed the original retinal scans of participants in the Age-Related Eye Diseases Studies (AREDS and AREDS2) and found that, for people with late-stage dry AMD, taking the antioxidant supplement slowed expansion of geographic atrophy regions towards the central foveal region of the retina. The study was published in the journal Ophthalmology.
      • “We’ve known for a long time that AREDS2 supplements help slow the progression from intermediate to late AMD. Our analysis shows that taking AREDS2 supplements can also slow disease progression in people with late dry AMD,” said Tiarnan Keenan, M.D., Ph.D., of NIH’s National Eye Institute (NEI) and lead author of the study. “These findings support the continued use of AREDS2 supplements by people with late dry AMD.”
    • Beckers Hospital Review shares ophthalmologist organization opinions on eye conditions and Ozempic use.
      • A week after a study connected Ozempic and Wegovy to an eye condition that can cause partial blindness, two ophthalmology organizations said they have “been aware of other vision changes for some time.”
      • Changing sugar levels can affect the shape of the eye’s lens, according to the American Academy of Ophthalmology and North American Neuro-Ophthalmology Society. Because of this, semaglutide, the active ingredient of Type 2 diabetes drug Ozempic and weight loss medication Wegovy, might lead to blurry vision. 
      • The ophthalmology groups said previous studies have also found that semaglutide can exacerbate diabetic retinopathy and macular complications. 
      • “The medical community has been aware of other vision changes with semaglutide for some time,” the organizations said in a July 8 joint statement. However, the research associating the drug to non-arteritic anterior ischemic optic neuropathy [NAION] is the first of its kind. 
      • “The condition restricts blood flow to the optic nerve, which causes sudden, painless loss of vision in one eye, the statement said. The research did not confirm a causal relationship between the medications and NAION, but it identified a potential link.: * * *
      • “The subjects in this study were either overweight or obese or had Type 2 diabetes. People who have diabetes are already at risk of NAION,” the organizations said. “Other risk factors for NAION include heart disease, history of heart attack, high blood pressure and sleep apnea” — health risks that also are tied to diabetes and obesity. 
      • “In response to the study, Novo Nordisk, the manufacturer of Ozempic and Wegovy, said it takes adverse event reports seriously. 
      • “The ophthalmology groups said they recommend patients continue taking the medications unless they experience a sudden vision loss.”  
    • The AHA News points out,
      • “Antimicrobial-resistant infections remained above pre-pandemic levels in 2022, the Centers for Disease Control and Prevention reported July 16. CDC data show that infections, which increased 20% during the pandemic compared to the pre-pandemic period — peaked in 2021.
      • “The increases in antimicrobial resistance (AR) burden seen in 2020 and 2021 are likely due in part to the impact of COVID-19, which pushed healthcare facilities, health departments and communities near their breaking points,” the agency notes. “This resulted in longer hospital stays for hospitalized patients (including those diagnosed with COVID-19), challenged the implementation of infection prevention and control practices and increased inappropriate antibiotic use.” 
      • “The AHA provides resources which promote the appropriate use of medical resources.”
    • Medscape summarized the June meeting decisions of the CDC’s Advisory Committee on Immunization Practices and identifies the five immunizations that adults need beyond Covid and the flu vaccines.
    • Medscape also discusses the use of remote trials to accelerate the testing of new long Covid treatments.

    From the U.S. healthcare business front,

    • Beckers Payer Issues and Fierce Healthcare report on UnitedHealthcare’s second quarter financial results announced today.
      • BPI – “UnitedHealth Group posted $4.2 billion in net income during the second quarter of 2024, a 23% decline year over year.
      • “The company said it has restored the majority of affected Change Healthcare services and has provided more than $9 billion in advance funding and loans to providers. The total full year impact of the breach is estimated at $1.90 to $2.05 per share, with the company raising the estimated total cost of the attack to around $2.45 billion.”
      • FH – “UnitedHealth saw an elevated medical loss ratio in Q2, and executives pointed to the Change Healthcare cyberattack as a key factor.
      • “UnitedHealthcare had an MLR of 85.1% in the second quarter, compared to 83.2% in the prior year quarter. The insurer called out multiple elements that contributed to the elevated ratio in its earnings call on Tuesday morning. For one, UHC CEO Brian Thompson said there’s a clear difference in coding intensity after the insurer ended care waivers offered following the cyberattack.
      • “Amid the cyberattack, UnitedHealth eased prior authorization and utilization management to support cash flow to providers.”
    • Beckers Hospital Review provides details on U.S. News and World Report’s latest U.S. hospital rankings by State and by specialty.
    • pwc reports,
      • “Commercial health care spending growth is estimated to grow to its highest level in 13 years, according to PwC’s newest research into annual medical cost trend. PwC’s Health Research Institute (HRI) is projecting an 8% year-on-year medical cost trend in 2025 for the Group market and 7.5% for the Individual market. This near-record trend is driven by inflationary pressure, prescription drug spending and behavioral health utilization.
      • “HRI is also restating the 2023 and 2024 medical cost trends as higher than previously reported based on the input of health plans we surveyed and their trend experience. This unfavorable trend reflects higher than expected utilization of glucagon-like peptide-1 (GLP-1) drugs as well as higher acuity (higher levels of care) inpatient and outpatient utilization. Inpatient and outpatient utilization were driven by demand from care deferred since the pandemic, which was met by newly created capacity as sites of care shifted to outpatient, professional and ambulatory care settings.
      • “The same inflationary pressure the healthcare industry has felt since 2022 is expected to persist into 2025, as providers look for margin growth and work to recoup rising operating expenses through health plan contracts. The costs of GLP-1 drugs are on a rising trajectory that impacts overall medical costs. Innovation in prescription drugs for chronic conditions and increasing use of behavioral health services are reaching a tipping point that will likely drive further cost inflation.
      • “Meanwhile, cost deflators are not enough to offset cost inflators. The growing adoption of biosimilar medications may provide some relief, while many health plans are looking inward to find opportunities across business operations to generate additional cost savings. Today’s medical cost trend is an urgent call to action for healthcare organizations to rethink their strategies to manage the total cost of care more effectively – a challenge that is inextricably linked to the broader challenge of affordability, defined by the Affordable Care Act as the percentage of a member’s household income used for healthcare expenses.”
    • FEHBlog note — OUCH!
    • MedCity News discusses the improving state of the digital health fundraising market.

    Monday Roundup

    David Ermer–CDC, Congress, COVID treatment, Medical / Rx research, Medicare, Rx coverage, U.S. Healthcare–
    Photo by Sven Read on Unsplash

    From Washington, DC,

    • Reuters reports,
      • “Democratic U.S. Senate aides will meet with Novo Nordisk executives on Tuesday to discuss fallout from its decision to stop selling one of its long-acting insulins in the country, two sources familiar with the meeting told Reuters.
      • “Novo Nordisk (NOVOb.CO), opens new tab will meet with the aides for Senators Jeanne Shaheen, Raphael Warnock, and Elizabeth Warren. In April, the lawmakers wrote to the company expressing alarm at its decision, announced in November, that it would permanently discontinue Levemir by the end of 2024.
      • “Novo said it has given patients enough time to switch to other options, according to a May letter seen by Reuters. The company is unaware of plans for drug manufacturers to produce a biosimilar version of the insulin, the letter said, adding Novo would not assert any patent against such a version.
      • “The sources declined to be named citing the sensitivity of the matter.”
    • STAT News lets us know,
      • “For now, the doctor groups are lobbying [Congress] in unison toward the same goal of increasing the pot of money for physician services, which stood at about $71 billion in 2022, or 16% of Medicare fee-for-service spending. A Medicare spokesperson said that number is expected to reach about $90 billion this year. Doctors would also like to get credit for saving money by keeping patients out of the hospital.
      • “Those demands would pit doctors against others in the health care system, including hospitals, because Congress typically requires that increases in Medicare spending be paid for by cuts elsewhere in the program. That’s a heavy lift. Congress has been considering equalizing certain Medicare payments between hospitals and physicians’ offices to save money, but that site-neutral policy has faltered.
      • “That’s not the only thing working against doctors. If Congress increases spending on physician services, seniors’ Medicare Part B premiums will go up, according to the nonpartisan research arm of Congress. Congress could prevent premiums from increasing, but that would add to the government tab.
      • “For those reasons, doctor lobbyists privately doubt Congress will meaningfully increase physician pay rates overall, leaving doctors to fight over how a fixed sum of money should be split up.
      • “Courtney Savage, founder of Savage Health Policy, said she sees signs of trouble ahead for specialists. Republicans and Democrats in the Senate want to boost primary care pay. Sens. Bill Cassidy (R-La.) and Sheldon Whitehouse (D-R.I.) unveiled a plan to “improve the adequacy of pay for primary care providers in Medicare.” Two days later, Senate Finance Committee Chair Ron Wyden (D-Ore.) and the committee’s ranking Republican, Idaho’s Sen. Mike Crapo, published their plan to improve chronic care, which would likely favor primary care doctors, too.”
    • In this regard, the American Hospital News tells us,
      • The AHA July 15 commented to Sens. Sheldon Whitehouse, D-R.I., and Bill Cassidy, R-La., responding to a request for information based on the Pay PCPs Act, legislation designed to improve support and pay for primary care providers. The AHA expressed concerns that its proposed hybrid per-member-per-month and fee-for-service payment structure in the physician fee schedule for primary care could result in payment cuts, and that there may be variation in the PMPM depending on the type of provider. The bill also has language implying that there is latitude for the PMPM to not be risk-adjusted and possibly restrict what could be included in the risk adjustment, AHA said. 
      • The AHA voiced support for a provision in the legislation that would reduce beneficiary cost-sharing for primary care services by 50% under the hybrid payment model. The association also shared principles for Congress to consider when designing alternative payment models to make participation more attractive for potential participants.
    • Per Axios,
      • “The Centers for Medicare and Medicaid Services last week proposed creating three new payment codes that would allow physicians to get paid for incorporating digital therapies into patients’ mental health treatment, starting in 2025. 
      • “The codes would only apply to products approved by the Food and Drug Administration.
      • “Insurers have so far been reluctant to pay for apps, video games and other therapeutic software. There isn’t long-term data on the effectiveness, and differences in the therapies make it difficult to standardize billing.
      • “The first company to get FDA clearance for a digital therapy, Pear Therapeutics, declared bankruptcy last year after struggling to secure insurance coverage for its products.”

    From the public health and medical research front,

    • The AHA News points out,
      • “The Centers for Disease Control and Prevention July 14 announced four confirmed human cases of H5N1 bird flu among farm workers who were working at a Colorado poultry facility. The agency is also aware of a fifth presumptive-positive case, which is pending confirmation. All of the workers who tested positive reported having a mild illness, with symptoms that include conjunctivitis, eye tearing, fever, chills, coughing, sore throat and a runny nose. The CDC said they believe a risk to the public remains low.” 
    • STAT News adds,
      • The announcement of the fourth [H5N1 bird flu] case, on the eve of the July 4 holiday, led Adam Kucharski, the co-director of the Centre for Epidemic Preparedness & Response, at the London School of Hygiene and Tropical Medicine, to ask on the social platform X: “What’s the plan?”
      • Kucharski posed a bunch of hypotheticals — What if there are clusters of cases? Cases among people who haven’t had contact with cows? Cases exported to other countries? — to convey the point that a mere four years after the start of the worst pandemic since the 1918 Spanish Flu, the world does not appear to be grappling with the fact that H5 virus spreading in cows could lead to H5 virus spreading in people.
      • “What, here in 2024, is the plan for dealing with an outbreak of a potentially pandemic pathogen like H5N1?” he asked.”
    • Medscape notes,
      • “Parkinson’s disease (PD) and dementia with Lewy bodies are currently defined by clinical features, which can be heterogeneous and do not capture the presymptomatic phase of neurodegeneration.
      • “Recent advances have enabled the detection of misfolded and aggregated alpha-synuclein protein (synucleinopathy) — a key pathologic feature of these diseases — allowing for earlier and more accurate diagnosis. This has led two international research groups to propose a major shift from a clinical to a biological definition of the disease.
      • “Both groups emphasized the detection of alpha-synuclein through recently developed seed amplification assays as a key diagnostic and staging tool, although they differ in their approaches and criteria.” * * *
      • “Commenting for Medscape Medical News, James Beck, PhD, chief scientific officer at the Parkinson’s Foundation, said the principle behind the proposed classifications is where “the field needs to go.”
      • “Right now, people with Parkinson’s take too long to get a confirmed diagnosis of their disease, and despite best efforts, clinicians can get it wrong, not diagnosing people or maybe misdiagnosing people,” Beck said. “Moving to a biological basis, where we have better certainty, is going to be really important.”
    • The New York Times reports, “Families pay thousands of dollars to store their children’s stem cells with the hope of a healthier future. But the cells are rarely useful, and sometimes contaminated.” No bueno.
    • A STAT News journalist observes,
      • If you read Derek Lowe — and come on, you must read the bearded chemist who has been blogging about pharma for two decades — you’ve already thought about ibuzatrelvir, Pfizer’s potential heir to Paxlovid, which would be given as a single pill and potentially without that metallic taste.
      • “I read this eagerly, but I had another question that I asked virologist Michael Mina when he posted Derek’s article on X. How do we test it?
      • “Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.“Plenty of people still get Covid and die from it. But I’ve been watching clinical trials of Paxlovid and other antivirals. And these drugs keep failing in studies. Even Paxlovid worked best when it was given to high-risk people who have not been vaccinated. Shionogi’s Paxlovid follow-up recently failed in a large study.
      • “It’s very hard to prove an antiviral drug works, a problem that has long dogged Tamiflu. The benefit only shows up if people are at very high risk, or if the study is very big. Otherwise, it just appears the drug is reducing symptoms a very tiny bit.
      • “On this, David Boulware of the University of Minnesota had one perspective: Shionogi’s drug failed because regulators wanted its study to contain too few high-risk patients. But my suspicion is that getting better Covid drugs will be less a problem of chemistry than of clinical trials. This is part of why we don’t have more monoclonal antibodies against new strains. Paxlovid sales have come in higher than many analysts were expecting so far this year. Maybe that will encourage drug.” companies to solve this problem.
    • The Washington Post and Consumer Reports explain “what to do when you need medical care fast,”
      e.g., self-triage.
    • Per MedPage Today,
      • “A mammography screening decision aid with information about the benefits and harms of screening increased the percentage of average-risk women in their 40s who wanted to delay mammography, according to a national online survey.
      • “Before viewing the decision aid, 27% of women ages 39 to 49 preferred to delay screening. The decision aid raised that percentage to 38.5%, reported Laura Scherer, PhD, of the University of Colorado in Aurora, and colleagues.
      • “The survey also showed a narrower majority of women preferred to undergo mammography at their current age after viewing the decision aid (57.2% vs 67.6% beforehand) and more preferred to wait until age 50 (18% vs 8.5%).
      • “As to what information shifted their view, 37.4% of women surveyed said they found the information about overdiagnosis in the decision aid “surprising,” and 28.1% said it differed from what their doctor had told them, Scherer and colleagues reported in the Annals of Internal Medicine.
      • “While the U.S. Preventive Services Task Force (USPSTF) recommends biennial screenings starting at age 40 years — compared with a previous recommendation that screening begin at 50 — it “endorses informed choice and shared decision making at all levels of its recommendations,” Scherer’s group wrote.
      • “However, “a lack of language promoting informed choice in the guideline itself may create confusion among clinicians about whether they should discuss both screening benefits and harms with patients or instead provide only information that maximizes screening uptake,” they added.”

    From the U.S. healthcare business front,

    • AIS Daily reports,
      • “Blue Shield of California caught the attention of the industry last August when it announced a switch to a pharmacy benefits model using five vendors. While some insurers and plan sponsors have considered a similar move following Blue Shield’s revelation, benefits consultants tell AIS Health that most payers continue to have a traditional arrangement where one PBM handles all pharmacy-related activities. They add that Blue Shield’s so-called unbundled approach could be difficult to manage and may not achieve significant cost savings.”
    • Per Fierce Pharma,
      • “While patent cliffs are looming for many of biopharma’s top-selling products, the industry has enormous capacity to respond as “conditions for M&A are favorable,” according to a research note from Morgan Stanley.
      • “In the July 11 report, the analysts calculate that products losing exclusivity through 2030 are generating a combined $183.5 billion in annual sales, with Amgen, Bristol Myers Squibb and Merck facing the most exposure of their revenue.
      • “Meanwhile—citing company financial reports and data from Visible Alpha and FactSet—Morgan Stanley estimates that Big Pharma has $383.1 billion of firepower available for dealmaking. The companies sitting on the most dry powder are Johnson & Johnson, Merck and Novo Nordisk, the analysts said.
      • “We continue to see the conditions as generally favorable for bolt-on M&A as large-cap pharma companies have balance sheet capacity and a need to acquire outer-year revenue,” the Morgan Stanley team, led by Terence Flynn, Ph.D., wrote.”
    • BioPharma Dive offers a chart with “Years of expiration for principal patents protecting the top 30 pharmaceutical products by 2023 sales.”
    • Beckers Hospital Review discloses the gender breakdown of physicians across the fifty states and DC.
    • Per MedCity News, “Walgreens’ Finances Are in Dire Straits — But All Hope Is Not Lost. Walgreens’ financial performance is still rocky, but experts agree there is a good chance that CEO Tim Wentworth can lead the company to recovery. To make this happen, Walgreens will have to let go of its retail clinic dreams and focus more on making its core pharmacy business as strong as possible.”

    Midweek update

    David Ermer–CDC, Medical / Rx research, Medicare, OPM, Rx coverage, Telehealth, U.S. Healthcare, Wellness–
    Photo by Manasvita S on Unsplash

    From Washington, DC,

    • The American Hospital Association (“AHA”) News tells us,
      • “The House Appropriations Committee July 10 voted 31-25 to approve legislation that would provide $185.8 billion in funding for the departments of Labor, Health and Human Services, and Education in fiscal year 2025, an 11% cut below the prior fiscal year. * * *
      • “The bill would also prohibit any funding from being used to implement or enforce the final rule issued by the Administration relating to minimum staffing levels for long-term care facilities.
      • “The full House may consider the bill in August.”
    • The AHA News also reports on several CMS/HHS rule makings that occurred today.
      • “The Centers for Medicare & Medicaid Services July 10 released its calendar year 2025 proposed rule for the physician fee schedule. The rule proposes to cut the conversion factor by 2.8%, to $32.36 in calendar year 2025, as compared to $33.29 in CY 2024. This reflects the expiration of the 2.93% statutory payment increase for CY 2024; a 0.00% conversion factor update under the Medicare Access and Children’s Health Insurance Program Reauthorization Act; and a .05% budget-neutrality adjustment.” * * *
      • “CMS will accept comments on the proposed rule through Sept. 9.” 
        • Here is a link to the CMS fact sheet on the proposed rule plus a link to the CMS fact sheet on proposed rule’s shared savings program.
        • Per Fierce Healthcare,
          • “In statements quickly released after the proposed rule dropped, frustrated physician and industry groups contrasted the “dangerous” baseline reimbursement cut against financial pressures weighing on practices.”
      • “The Centers for Medicare & Medicaid Services July 10 issued a proposed rule that would increase Medicare hospital outpatient prospective payment system rates by a net 2.6% in calendar year 2025 compared to 2024. This includes a proposed 3.0% market basket update, offset by a 0.4 percentage point cut for productivity.” * * *
      • “CMS will accept comments on the proposed rule through Sept. 9.” 
        • Here is a link to the CMS fact sheet on the proposed rule.
        • STAT News adds,
          • “The federal government will not modify regulations that dictate how hospitals publish their prices for consumers, ignoring pleas from patient advocates who have said hospitals still are not fully complying with the 3-year-old law.
          • “The Biden administration on Wednesday proposed an annual rule that sets payment rates for hospitals. This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition.
        • Per Fierce Healthcare,
          • “In reaction statements, industry groups like the American Hospital Association (AHA) and hospital group purchasing organization Premier said that the “inadequate” pay update proposal and called for an upward adjustment in the final version of the rule.”
      • “The Department of Health and Human Services July 10 released a proposed rule designed to improve health information sharing and interoperability. The Health Data, Technology, and Interoperability: Patient Engagement, Information Sharing, and Public Health Interoperability (HTI-2) proposed rule includes two sets of certification criteria designed to enable health information technology for public health and payers to be certified under the Office of the National Coordinator for Health Information Technology’s Health IT Certification Program. The criteria would improve public health response, advance value-based care delivery and focus on standards-based application programming interfaces to improve end-to-end interoperability between health care providers and public health organizations or payers. 
      • The rule proposes a new set of certification criteria to support the technical requirements included in the Centers for Medicare & Medicaid Services’ Jan. 2024 Interoperability and Prior Authorization final rule to facilitate electronic prior authorization. The proposed rule also responds to patient, provider and other communities’ concerns about patient privacy and care access by expanding exceptions and clarifying the definitions of information blocking. HHS plans to publish the notice in the Federal Register with a 60-day comment period.
    • Following up on yesterday post about the FTC interim staff report on its PBM investigation, the Wall Street Journal reports,
      • “The Federal Trade Commission is preparing to sue the largest three pharmacy-benefit managers over their tactics for negotiating prices for drugs including insulin, after a two-year investigation into whether the companies steer patients away from less-expensive medicines. 
      • “The agency plans to file lawsuits taking aim at business practices related to rebates brokered with drug manufacturers, people familiar with the matter said. The FTC is also investigating the role that insulin manufacturers play in the negotiations, one of the people said.”
    • STAT News adds,
      • “The lawsuits are expected to focus on the controversial role of rebates, according to the source, who spoke on condition of anonymity. These are paid by drugmakers to PBMs to win favorable placement on formularies, which are the lists of medicines covered by health plans. In general, drugmakers argue they must raise prices to compensate for rebates, while PBMs maintain drug companies raise prices to boost profits.”
    • Bloomberg provides context to the situation by noting
      • “States and municipalities have also filed suits against both pharmacy benefit managers and drugmakers alleging that they drove up insulin costs for public-sector health plans. Many of those cases have been consolidated in a New Jersey federal court managing the litigation.”
    • Federal New Network digs into Fed Scope and discovers, among other things, that “Nearly half of all civilian feds are new hires since 2019. Agencies hired more than 1 million federal employees since October 2019, and it’s almost an even split between competitive and excepted service.”

    From the public health and medical research front,

    • The New York Times reports,
      • “A 54-year-old New Jersey woman who was the second person to receive a kidney transplanted from a genetically modified pig, and who lived with the organ for 47 days, died on Sunday, surgeons at NYU Langone Health announced on Tuesday.
      • “The patient, Lisa Pisano, was critically ill, suffering from both kidney failure and heart failure. She received the pig kidney on April 12, just eight days after implantation of a mechanical heart pump.
      • “Surgeons were forced to remove the kidney on May 29 after it was damaged by inadequate blood flow related to the heart pump. After the explantation, Ms. Pisano resumed kidney dialysis but eventually was transitioned to hospice care.
      • “Ms. Pisano made medical history as the first person with a heart pump who is known to have also received an organ transplant. Patients with kidney failure are usually ineligible to receive a heart pump because of the high risk of dying.”
      • RIP, Ms. Pisano.
    • CNN tells us,
      • “An estimated 72 million women in the United States have skipped or delayed a recommended health screening, according to a new survey. This poll, conducted by Gallupfor medical technology company Hologic, found that 90% of women acknowledged the importance of regular health screenings — but more than 40% have skipped or delayed a test.
      • “Women have trouble prioritizing their own health, the survey found, with over 60% of women responding that it was hard to make their own health a priority. The numbers are particularly striking among younger women; 74% of women in Generation Z and 70% of millennials said it was hard to prioritize their health, compared with 52% of baby boomers and 39% of the Silent Generation.
      • The journalist also interviews CNN wellness expert Dr. Leana Wen about these findings.
    • Healio informs us,
      • “[R]esearchers utilized National Violent Death Reporting System (NVDRS) data to assess the number, circumstances and characteristics of violence-related deaths in 2021.
      • “Overall, there were 68,866 fatal incidents involving 70,688 deaths that occurred in 48 states and Washington, D.C. Among the deaths:
        • 58.2% were suicides;
        • 31.5% were homicides;
        • 8.2% were deaths of undetermined intent that could have been due to violence;
        • 1.3% were deaths due to “legal intervention,” like law enforcement using deadly force in the line of duty; and
        • less than 1% were unintentional firearm deaths.
      • “Nguyen and colleagues also found that 59.2% of deaths involved firearms.
      • “Among suicide victims, when the circumstances were known (84.4%), the suicide was often preceded by mental health conditions, as 49% of victims were currently diagnosed with a mental health problem and 29.2% experienced a depressed mood at the time of death.” * * *
      • “Violence is preventable and reducing deaths in communities is possible with evidence-based approaches,” the researchers wrote.
      • “They added that such interventions can include “social-emotional learning programs, enhanced parenting skills and family relationships, treatment for persons at risk for suicide, and treatment to prevent reattempts.”
    • and
      • “Patients with chronic kidney disease or transplant should have ongoing access to telehealth to help manage care, according to results of a qualitative meta-analysis. 
      • “One group in need of telemedicine services is chronic kidney disease (CKD) and transplant patients,” Christopher D. Manko, BS, of the Geisinger Commonwealth School of Medicine in Scranton, Pennsylvania, wrote with colleagues. They added, “[P]atients need frequent appointments to manage all related conditions. Similarly, transplant patients need close monitoring of the grafted organ and immunosuppressant therapy.” But Manko and colleagues noted that “prior systematic reviews focused on telehealth and eHealth interventions in dialysis patients have shown conflicting results with potential benefits [and] more adequately powered prospective studies are needed.”

    From the U.S. healthcare business front,

    • STAT News reports,
      • “Fourth time’s the charm? Sanford Health is hoping so.
      • “Less than a year after scrapping its proposed merger with a Minnesota health system— its third failed deal since 2019 — South Dakota’s Sanford is attempting a new, multibillion-dollar mashup. The $7 billion, 45-hospital system plans to absorb Marshfield Clinic Health System, a $3 billion system of 11 hospitals across Wisconsin and northern Michigan.
      • “The proposed deal would make Sanford Marshfield’s parent company, creating a 56-hospital system with Sanford’s name, CEO, and headquarters in Sioux Falls, S.D. The combined system would have about 56,000 employees, 4,300 doctors and advanced practice providers, two health plans with more than 425,000 members, specialty pharmacies, and research institutions. The systems said they plan to close the deal by the end of the year.
      • “Sanford CEO Bill Gassen told STAT in an interview that Sanford and Marshfield are a good fit not only from a regulatory perspective — they have no overlapping coverage areas — but more importantly, from a cultural one. He said both nonprofit systems strive to deliver world-class care in rural areas. They both want strong physician leaders. They both have big health plans. They both do research and train doctors.”
    • Bloomberg relates,
      • “Purdue Pharma LP secured a two-month window to negotiate a new pact with members of the Sackler family as the OyxContin maker and its owners brace for a potential wave of civil opioid lawsuits after the US Supreme Court scuttled an earlier $6 billion settlement.
      • “Judge Sean Lane said during a Tuesday court hearing in New York that he’d extend for 60 days an injunction that, for years, has paused opioid litigation against the billionaire family while Purdue, government authorities and victims lawyers attempted to effectuate the earlier settlement.
      • “Advisers who negotiated the earlier deal will attempt to cut a new agreement during the two-month window that complies with the Supreme Court’s ruling. Such a settlement, if successful, would likely compensate victims and provide billions of dollars to fund programs to combat the nation’s opioid addiction crisis.” 
    • Healthcare Dive lets us know,
    • and
      • offers more insights into the 2024 Medicare Advantage star rating changes that CMS made recently in response to court decision.
    • The New York Times points out that “In Constant Battle With Insurers, Doctors Reach for a Cudgel: A.I. As health plans increasingly rely on technology to deny treatment, physicians are fighting back with chatbots that synthesize research and make the case.”
    • ICD-10 Monitor asks us whether we are ready for the new ICD-10 diagnosis codes that take effect October 1, 2024.
    • Drug Channel peers into its crystal ball to project prescription drug spending in 2032.

    Monday Roundup

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

    From Washington, DC,

    • Roll Call lets us know,
      • “Senate Appropriations Committee leaders have agreed to add $34.5 billion in emergency spending to their fiscal 2025 bills on top of levels agreed to in last year’s debt limit negotiations, sources familiar with the talks said Monday. 
      • “Under the pact between Senate Appropriations Chair Patty Murray, D-Wash., and ranking member Susan Collins, R-Maine, defense accounts would receive an extra $21 billion in emergency spending while nondefense programs would get $13.5 billion.” 
    • Taking a gander at reginfo.gov led the FEHBlog to discover that on July 1, the final version of the simply infeasible federal mental health parity rule changes was submitted to OIRA for its review.
    • In yesterday’s post, the FEHBlog called attention to the new CMS GUIDE program. The post noted that program details would be released in early July. What do you know? Those details were posted today. The American Hospital News tells us,
      • “The Centers for Medicare & Medicaid Services July 8 announced over 400 participants in a new model focused on improving dementia care. The Guiding an Improved Dementia Experience (GUIDE) Model began July 1 and seeks to reduce strain on unpaid caregivers as well as offer care coordination and management, caregiver education and support, and respite services. CMS will also test an alternative payment for participants delivering key support services to people with dementia, including comprehensive, person-centered assessments and care plans, care coordination, and 24/7 access to a support line. People with dementia and their caregivers will have access to a care navigator to help them access services and support, including clinical services and non-clinical services such as meals and transportation through community-based organizations.”
    • The HHS Inspector General posted an impact brief on Medicare Advantage program fraud involving its risk adjustment program. The Wall Street Journal published an article the same type of fraud today.
    • STAT News informs us,
      • “The Biden administration has appealed a decision in which a federal court jury last year sided with Gilead Sciences over the rights to a pair of groundbreaking HIV pills — and at least $1 billion in royalties may be at stake.
      • “At issue is a battle over patents for Truvada and a newer, upgraded version called Descovy — two highly effective and lucrative medications — as well as the role played by the federal government in making it possible to prevent transmission of a highly infectious disease that plagued the American public for decades.
      • “The U.S. Centers for Disease Control, which had funded academic research into HIV prevention that later formed the basis for the pills, maintained that Gilead infringed its patent rights. The U.S. Department of Health and Human Services also contended that the company refused to reach a licensing agreement despite several attempts to strike a deal.” * * *
      • “U.S. District Court Judge Maryellen Noreika narrowed the Gilead victory last March when she set aside the jury finding that CDC patents were not infringed. So the appeal filed by the U.S. Department of Justice — on behalf of HHS — refers to the only portion of the jury finding that remains, which is that the patents were invalid.”
    • Per an FDA press release,
      • “Today, the U.S. Food and Drug Administration is advancing its mission of ensuring the public has access to accurate, up-to-date science-based information to inform decisions about FDA-regulated medical products to maintain and improve their health. The agency is providing updated recommendations to empower industry seeking to voluntarily address misinformation about or related to their approved/cleared medical products.” * * *
      • “Specifically, the revised draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs Questions and Answers, sets out a policy that supports companies that issue certain kinds of internet-based communications (“tailored responsive communications”) to address internet-based misinformation about or related to their approved/cleared medical products when that misinformation is created or disseminated by an independent third party. For example, a company might choose to use this type of communication when a celebrity, healthcare provider or influencer, not acting on behalf of the company, posts false, inaccurate and/or misleading representations of fact about the company’s approved/cleared medical product on social media. Additionally, this revised draft guidance provides companies with many examples that illustrate the types of misinformation found online that a company might choose to address with a tailored responsive communication, along with some considerations relevant to the current digital information environment.”
    • Govexec tells us,
      • “The Office of Personnel Management lost a small modicum of ground in its fight to reduce the backlog of pending retirement claims from federal employees as the agency’s backlog of cases inched back over 15,000.
      • “In June, OPM received 6,919 new retirement requests from departing federal workers, a slight increase over the 6,751 claims it received the previous month. But the agency’s pace in processing those claims fell precipitously, completing only 5,614 claims last month compared to the 8,793 it processed in May.
      • “That deficit led to OPM’s overall backlog of pending claims to climb from 14,035—an eight-year low—in May to 15,340 at the end of June. Consequently, the monthly average processing time for a retirement application ticked up four days, from 60 in May to 64 last month, though measured since the beginning of fiscal 2024, the average processing time has remained static at 61 days for four months running.”
    • The U.S. Preventive Services Task Force is celebrating its 40th anniversary. The FEHBlog is reminded that the FEHB Act will be 65 years old on September 28, 2024.

    From the public health and medical research front,

    • The New York Times reports,
      • “The process for diagnosing a child with autism heavily relies on a parent’s description of their child’s behavior and a professional’s observations. It leaves plenty of room for human error.
      • “Parents’ concerns may skew how they answer questionnaires. Providers may hold biases, leading them to underdiagnose certain groups. Children may show widely varying symptoms, depending on factors like culture and gender.
      • “A study published Monday in Nature Microbiology bolsters a growing body of research that suggests an unlikely path to more objective autism diagnoses: the gut microbiome.
      • “After analyzing more than 1,600 stool samples from children ages 1 to 13, researchers found several distinct biological “markers” in the samples of autistic children. Unique traces of gut bacteria, fungi, viruses and more could one day be the basis of a diagnostic tool, said Qi Su, a researcher at the Chinese University of Hong Kong and a lead author of the study.”
    • The American Medical Association tells us what doctors wish their patient knew about heat stroke.
    • The Wall Street Journal discusses the right and wrong ways for people to snack.
      • “America is a nation of snackers. A lot of us are doing it wrong. 
      • “Noshing outside of traditional mealtimes isn’t inherently bad. A snack can stave off hunger, boost energy, provide important nutrients and keep us from overeating later. But snacking can also lead us to eat extra calories and overdo it on sodium, added sugars and saturated fats, which can raise our risk of heart disease and obesity. 
      • “How to snack better? Reach for food combinations that keep you fuller longer: Pair carbs like apple slices with protein and fats, like peanut butter. Or try yogurt with berries. Then plan your snack times, and watch out for the minefield that is evening snacking.”
    • The Washington Post and Consumer Reports offer information about “an aggressive tick species spreading across the U.S. Lone star ticks don’t spread Lyme disease, but they can transmit other serious diseases and are linked to a mysterious meat allergy. And the threat is growing.”
      • “Lone star ticks have long been firmly established in the Southeastern United States. In recent decades, however, their numbers have been increasing in Midwestern and Northeastern states. Between 2017 and 2021, according to CDC data, nearly half of reported ehrlichiosis cases were in five states: Arkansas, Missouri, New York, North Carolina and Tennessee.”
    • The CDC has posted FAQs on infertility. “This page has definitions and frequently asked questions related to infertility. It has important information about infertility, including common misconceptions, risk factors, and treatment options.”
    • Beckers Hospital Review points out,
      • “GLP-1 drugs such as Ozempic and Wegovy may lower the risk of developing certain obesity-related cancers, according to a new study from researchers at Case Western Reserve University in Cleveland. 
      • “Researchers found people with type 2 diabetes who were being treated with the medications were significantly less likely to develop 10 of 13 obesity-associated cancers than those taking insulin, according to the findings published July 5 in JAMA Network Open. The retrospective study is based on an analysis of the medical records of over 1.6 million type 2 diabetes patients from 2005 to 2018.
      • “The risk was reduced by more than half for gallbladder cancer, meningioma, pancreatic cancer and hepatocellular carcinoma. Esophageal, colorectal, endometrial, ovarian, multiple myeloma and kidney were among the other cancers for which there was a significant risk reduction. The study did not find a difference in cancer risk reduction among those treated with GLP-1s compared with those taking metformin, an older diabetes drug. 
      • “In an interview with Bloomberg, Arif Kamal, MD, chief patient officer at the American Cancer Society and who was not involved in the research, called the new evidence on GLP-1s “compelling.”
    • Per Fierce Pharma,
      • “In examining the electronic records of more than 18,000 overweight or obese adults in the United States, health data analytics company Truveta found that Lilly’s tirzepatide helped patients lose more weight than Novo’s semaglutide, with the effects growing over time.
      • “Results of the study, which looked at data from May of 2022 and September of 2023, were published Monday in the JAMA Internal Medicine monthly review.
      • “”After use of tirzepatide for three months, patients lost an average of 5.9% of their body weight compared to 3.6% for semaglutide. Over a year’s time, those on tirzepatide lost an average of 15.3% of their body weight compared to 8.3% for semaglutide users.
      • Additionally, tirzepatide patients were much more likely to lose 15% of their body weight than those using semaglutide. While 42% of those on tirzepatide reached the benchmark after one year of treatment, only 18% of those on semaglutide could say the same. 
      • “Lilly’s tirzepatide is the active ingredient found in its diabetes product Mounjaro and its obesity treatment Zepbound, while Novo’s semaglutide is the compound used to make its diabetes blockbuster Ozempic and its obesity follow-on Wegovy.
      • “Importantly, the Truveta study looked at the drugs that are approved for diabetes. The authors noted that “future studies are needed to compare versions labeled for weight loss.”
    • Per an NIH press release,
      • “A series of experiments with highly pathogenic H5N1 avian influenza (HPAI H5N1) viruses circulating in infected U.S. dairy cattle found that viruses derived from lactating dairy cattle induced severe disease in mice and ferrets when administered via intranasal inoculation. The virus from the H5N1-infected cows bound to both avian (bird) and human-type cellular receptors, but, importantly, did not transmit efficiently among ferrets exposed via respiratory droplets. The findings, published in Nature, suggest that bovine (cow) HPAI H5N1 viruses may differ from previous HPAI H5N1 viruses and that these viruses may possess features that could facilitate infection and transmission among mammals. However, they currently do not appear capable of efficient respiratory transmission between animals or people.”
    • MedPage Today lets us know,
      • “Extended-release 7-day injectable buprenorphine was safe and tolerable for most patients who had minimal-to-mild opioid withdrawal, a nonrandomized trial found.
      • “Among 100 adult patients with minimal-to-mild opioid withdrawal scores who were given a 24-mg dose of extended-release buprenorphine, only 10 people (10%, 95% CI 4.9%-17.6%) saw a 5-point or greater jump in withdrawal symptoms within 4 hours of injection, reported Gail D’Onofrio, MD, of the Yale School of Medicine in New Haven, CT, and colleagues.” * * *
      • “The study examined whether patients with untreated opioid use disorder (OUD) and minimal-to-mild withdrawal could tolerate a 7-day dose of buprenorphine. Patients with OUD typically aren’t treated with medication until they are in significant withdrawal, due to fear of precipitated withdrawal. For that reason, “[n]o one has ever even attempted to give buprenorphine in that [0 to 7] range,” D’Onofrio said.” * * *
      • “[This is a real game-changer for emergency physicians and clinicians, even in the clinic, who would be able to induce people on buprenorphine much earlier than they previously could have,” D’Onofrio said.”

    From the U.S. healthcare business front,

    • The Wall Street Journal reports,
      • “Eli Lilly LLY has agreed to buy biopharmaceutical company Morphic Holding MORF for $3.2 billion in a deal that bolsters the drugmaker’s immunology pipeline.
      • “Eli Lilly on Monday said it would pay $57 a share for Morphic, a 79% premium to Friday’s closing price of $31.84 for the Waltham, Mass., company.
      • “Morphic is developing therapies for the treatment of serious chronic diseases, with a lead program targeting the inflammatory bowel diseases ulcerative colitis and Crohn’s disease.
      • “Eli Lilly late last year won U.S. Food and Drug Administration approval of its Omvoh treatment for moderately to severely active ulcerative colitis in adults.
      • “Indianapolis-based Eli Lilly said it expects to complete the acquisition, which isn’t subject to any financing conditions, in the third quarter.”
    • Modern Healthcare relates,
      • “More than half of people surveyed would feel just as safe getting hospital-level care at home as they would in a facility, according to the University of Southern California’s Schaeffer Center for Health Policy and Economics.
      • “Healthcare systems across the country are placing big bets on hospital-at-home programs, pushing access to more rural communities and lobbying state Medicaid programs to reimburse for the service. A Centers for Medicare and Medicaid Services waiver reimbursing for acute care at home expires at the end of this year, but bipartisan members of Congress are backing legislation that would provide Medicare reimbursement for another five years. More than 330 hospitals across 37 states offer hospital-level care at-home programs through the CMS Acute Hospital Care at Home waiver.” * * *
      • “The survey did not require participants to have prior experience with hospital-level care at home or knowledge of the service. It did provide participants with a brief explanation of how hospital-at-home programs operate.”
    • Per Fierce Healthcare,
      • “A recent proposal to report prior authorization to insurance plans through CPT codes was withdrawn at the eleventh hour when its physician advocate made an unexpected discovery: For certain codes and in very narrow circumstances, the prior auth requirements were already in place.
      • “Alex Shteynshlyuger, M.D., director of urology with New York Urology Specialists, had previously brought forward a time-based proposal that would ensure physicians are compensated for time spent on prior auth claims. He believed the changes would also reduce the number of claim requirements imposed by plans and limit the amount of appeals and could lead to better patient outcomes.
      • “Following the proposal, however, the American Medical Association (AMA) informed Shteynshlyuger that prior authorization is already explicitly mentioned in official procedure descriptions for half a dozen CPT codes. This required Shteynshlyuger to withdraw the proposal so he could revise and resubmit at a later date.
      • “Each CPT code includes a short description detailing the type of visit or examination. Longer descriptions—where the prior auth mentions were contained—are also stored in databases that can be purchased, but those are rarely encountered.
      • “As a matter of fact, I’ve never seen the long description in my lifetime,” said Shteynshlyuger.”
    • and
      • “Nearly 5 million fewer people delayed care from 2019 to 2022, a study from the Urban Institute with funding from the Robert Wood Johnson Foundation revealed.
      • “The study shows 4.75 million non-elderly Americans skipped necessary medical care, dropping from 12.1% to 9.7% in 2022.
      • “For families below 138% of the federal poverty line, there was a 27% reduction in cost barriers. A 19% reduction was evident for families between 138% and 249% of the federal poverty line.
      • “Researchers say these outcomes are a direct result of the Medicaid continuous coverage requirements and enhanced tax credits.
      • “Our findings show significant improvements in health insurance coverage and healthcare access under federal and state policy changes enacted during the public health emergency,” said Michael Karpman, principal research associate at the Urban Institute, in a statement. “The continued unwinding of the Medicaid continuous coverage requirement and the potential expiration of enhanced Marketplace subsidies after 2025 could make these gains in coverage and access difficult to sustain.”

    Weekend Update

    David Ermer–Congress, COVID-19, Medical / Rx research, Medicare, U.S. Healthcare–
    Photo by Dane Deaner on Unsplash

    From Washington, DC

    • NPR Shots lets us know,
      • “Medicare, the federal government’s health insurance program for people 65 and over, is launching an eight-year pilot project this summer with a groundbreaking plan. * * *
      • “Medicare’s pilot, called Guiding an Improved Dementia Experience – or GUIDE – is modeled on a handful of promising, smaller programs linked to academic institutions, including UCLA, UC-San Francisco, and Emory and Indiana universities.
      • “In Medicare’s version, each family will get a care coordinator — a sort of coach trained in dementia care, who knows the patient and the caregiver and can offer guidance and troubleshoot problems before they escalate. The coach or other member of the care team will be on call, 24/7. They will also help coordinate doctors’ visits and identify some adult day care or in-home care for the patient for up to a few hours a week, to lighten the caregiver’s load. * * *
      • “Medicare has yet to reveal exactly which health systems will be included in its pilot project, or how many families will be eligible; the agency promises more details in early July. In the meantime, Medicare has spelled out some eligibility criteria for patients:
        • “The patient must have a dementia diagnosis.”
        • “They must have traditional Medicare insurance — that’s only about half of people over 65. Seniors on a Medicare Advantage plan aren’t eligible.
        • “The patient must be living in their own home, in a family member’s home, or in an assisted care facility — but not in a nursing home. 
    • HR Dive offers updates on the status of three pending federal court lawsuits challenging the Fair Labor Standards Act changes that took effect last Monday.

    From the public health and medical research front

    • The FEHBlog ran across this WasteWaterSCAN website which provides wastewater reporting on eleven infectious diseases including Covid.
      • We monitor infectious diseases through municipal wastewater systems to inform public health responses at a local, regional, and national level. Our goal is to show that a national wastewater monitoring system is a valuable part of our public health infrastructure, can inform public health responses, and will help us prepare for future pandemics.
      • WastewaterSCAN is based at Stanford University, in partnership with Emory University, and funded through philanthropy. We are committed to transparency, scientific rigor, and open science. We make our methods public and publish our research in scholarly journals to subject them to peer review.
    • Fortune Well points out that “July has the highest number of drowning deaths. Here’s how to keep kids safe around water.”
    • The New York Times discusses brain donation for medical research. The article focuses on an 82-year-old woman whose father recently passed away at age 110.
      • “[As] he was nearing death, enrolled in home hospice care, “In the middle of the night, I thought, ‘Dad’s brain is so great,’” said Ms. Hansen, 82, a retired librarian in Seattle. “I went online and looked up ‘brain donation.’”
      • “Her search led to a National Institutes of Health web page explaining that its NeuroBioBank, established in 2013, collected post-mortem human brain tissue to advance neurological research.
      • “Through the site, Ms. Hansen contacted the nonprofit Brain Donor Project. It promotes and simplifies donations through a network of university brain banks, which distribute preserved tissue to research teams.
      • “Tish Hevel, the founder of the project, responded quickly, putting Ms. Hansen and her brother in touch with the brain bank at the University of California, Los Angeles. Brain donors may have neurological and other diseases, or they may possess healthy brains, like Mr. Markoff’s.
      • “We’re going to learn so much from him,” Ms. Hevel said. “What is it about these super-agers that allows them to function at such a high level for so long?”
    • Medscape notes,
      • “Lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, has shown 100% efficacy in preventing HIV in women at a high risk for infection, according to an interim analysis of the phase 3 PURPOSE 1 trial.
      • “The results were so promising that the independent data monitoring committee recommended that Gilead Sciences stop the blinded phase of the trial and offer open-label lenacapavir to all participants.
      • “The results were both unexpected and exciting. “I’ve been in the HIV field for a really long time, and there’s no other phase 3 PrEP trial that found zero infections,” said Moupali Das, MD, PhD, executive director of clinical development at Gilead Sciences, Foster City, California.

    From the U.S. healthcare business front,

    • Healthcare Dive reports,
      • “Cano Health has emerged from bankruptcy as a private company, months after the primary care chain said it would restructure and delist from the New York Stock Exchange. 
      • “The company said Friday it converted more than $1 billion of funded debt into common stock and warrants as part of bankruptcy proceedings. The chain’s existing investors also committed to provide more than $200 million to support Cano’s business plan going forward. 
      • “Cano will take a “disciplined and strategic approach” to growth over the next few years, focusing on improving services at their 80 clinics in Florida, CEO Mark Kent said in a statement. The company had 172 medical centers at the end of 2022, according to a securities filing.” 

    Friday Factoids

    David Ermer–CDC, COVID-19, FDA, Medical / Rx research, Medicare, Rx coverage, Telehealth, U.S. Healthcare–

    From Washington, DC,

    • Federal News Network tells us,
      • “Although the federal workforce on the whole is relatively diverse, much of that diversity is condensed on the lower end of the General Schedule.
      • “It’s a demographic trend that has persisted for years, but there may be a few early signs of change, according to a July 1 workforce report from the Partnership for Public Service that uses data from FedScope.
      • “Data from fiscal 2023 shows that 60% of the federal workforce is white, 19% of federal employees are Black and 10% are Hispanic. By comparison, for the nationwide workforce, 76% of employees are white, 13% are Black and 19% are Hispanic.
      • “Breaking down diversity by GS level, the Partnership’s data report shows that white federal employees make up a much larger portion of the workforce at GS-7 and up through the Senior Executive Service, taking up many mid- and top-level technical roles as well as many supervisory positions.” * * *
      • “The long-time workforce trend is beginning to change, albeit slowly, the Partnership said. Between 2022 and 2023, the percentage of people of color in the SES rose 1%, from 25% to 26%.
      • “Similar trends occur when breaking down the workforce by gender. Overall, women make up 45% of the federal workforce, while men comprise 55%. But again, men make up a larger portion of higher-level GS positions as well as SES roles. There appears to be a similar trend toward a more equal balance between men and women in the SES, the Partnership’s report showed.”
    • STAT News informs us,
      • “A federal judge ruled against Boehringer Ingelheim’s challenge to the new Medicare drug price negotiation program, handing the pharmaceutical industry its latest in a string of legal losses.
      • “The company had argued before the U.S. District Court of Connecticut that the drug pricing law was unconstitutional under four different parts of the Constitution, and also that Medicare officials had violated procedural laws. Judge Michael Shea ruled against Boehringer Ingelheim on each point in a decision published late Wednesday.
      • “Boehringer Ingelheim did not immediately respond to a request for comment on the ruling. The company’s diabetes drug Jardiance was one of the first medicines selected for the negotiation program.
      • “Federal judges have also ruled against drugmakers including AstraZeneca, Bristol Myers Squibb, and Johnson & Johnson, and trade groups including the brand-drug lobby PhRMA and the U.S. Chamber of Commerce in their lawsuits challenging the law.”
    • HR Dive lets us know,
      • “A Texas federal judge on Wednesday granted a tax services firm’s motion for a preliminary injunction of the Federal Trade Commission’s nationwide ban on noncompete agreements in employment contracts and has stayed its effective date for the plaintiffs.
      • “Judge Ada E. Brown of the U.S. District Court for the Northern District of Texas held that FTC violated the Administrative Procedure Act and exceeded its statutory authority by issuing the ban, which she said has a “substantial likelihood” of being found arbitrary and capricious.
      • “Brown said the injunction is limited in scope to the plaintiffs and plaintiff-intervenors named in the suit; it is not a nationwide injunction. She added that the court would rule on the merits of the agency’s action on or before Aug. 30, 2024.”

    From the public health and medical research front,

    • The Centers for Disease Control announced today,
      • “Summary
        • “Seasonal influenza and RSV activity are low nationally, but COVID-19 activity is increasing in some areas.
      • “COVID-19
        • “Some areas of the country are experiencing consistent increases in COVID-19 activity, including increases in COVID-19 test positivity and emergency department visits and increases in rates of COVID-19–associated hospitalizations among adults 65+ at several sites. However, nationally COVID-19 activity remains low. Recent increases in activity level are from very low levels in April and May 2024, when they were lower than at any time since March 2020. CDC will continue to closely monitor trends in COVID-19 activity.
      • “Influenza
      • “RSV
        • Nationally, RSV activity remains low.
      • “Vaccination
    • The New York Times adds,
      • “Many of us associate Covid with respiratory issues. But some people who get sick with the virus never experience a sore throat, coughing or body aches, said Dr. Peter Chin-Hong, an infectious disease specialist at the University of California, San Francisco. Certain people end up feeling more like they have food poisoning than anything else.
      • “That’s because coronavirus is “like throwing a bomb in your body,” said Dr. Ken Cadwell, a professor of medicine at the University of Pennsylvania who studies how Covid affects the gut. “You’re going to feel that in multiple different organs, not just the lungs.”
      • The article offers tips on how to spot Covid symptoms.
    • The Washington Post discusses cancerphobia in an era when cancer deaths have been falling and provides cancer prevention tips.
    • The Food and Drug Administration announced,
      • “On Wednesday, the FDA updated the advisory for the investigation of Salmonella illnesses linked to cucumbers. The FDA and CDC, in collaboration with state and local partners, are investigating a multistate outbreak of Salmonella Africana and Salmonella Braenderup infections with 449 illnesses in 31 states and the District of Columbia.
      • “While originally reported as two separate outbreaks, CDC and FDA combined these two outbreak investigations as they shared several similarities, including when and where illnesses occurred, the demographics of ill people, and the foods they reported eating before they became sick.
      • “Laboratory, epidemiological, and traceback data have determined that cucumbers from Bedner Growers, Inc., of Boynton Beach, Florida, are a likely source of illnesses in this outbreak; however, this grower does not account for all the illnesses in this outbreak. Bedner Growers, Inc.’s cucumber growing and harvesting season is over. There is no product from this farm on the market and likely no ongoing risk to the public.”
    • Per MedPage Today,
      • “GLP-1 receptor agonists lowered the risk of several obesity-associated cancers, a retrospective analysis of electronic health records suggested.
      • “Compared with insulin, GLP-1s were associated with a lower risk for developing 10 of 13 cancers in people with type II diabetes, reported Nathan Berger, MD, of the Case Western Reserve University in Cleveland, and colleagues in JAMA Network Open.
      • “No decrease in cancer risk was associated with GLP-1 receptors compared with metformin.
      • “This study adds to the growing body of evidence supporting the pleiotropic effects of GLP-1 receptor agonists on cancer prevention, including obesity-associated cancers,” co-author and medical student Lindsey Wang, also of Case Western Reserve University School of Medicine, told MedPage Today. (Berger passed away before the study was published.)
    • Per Healio,
      • “Many women aged 75 years and older are aware of the importance of breast cancer screening and desire to continue screening regardless of health status or age, according to a scoping review published in BMC Women’s Health.
      • “Very few studies have been undertaken to understand the motivations of women to screen or to establish screening participation rates among women aged 75 and older,” Virginia Dickson-Swift, PhD, senior research fellow at the Violet Vines Centre for Rural Health Research at La Trobe Rural Health School at La Trobe University, Australia, and colleagues wrote. “This is surprising given that increasing age is recognized as a key risk factor for the development of breast cancer, and that screening is offered in many locations around the world every 2 years up until age 74 years.” * * *
      • “Decision aids may be effective in improving knowledge of the benefits and harms of breast screening as many women reported poor knowledge, according to the authors. A pilot study of eight women in the U.S. utilizing decision aids demonstrated that 62.5% of women planned to continue receiving mammography. In this study, agreeing that their physician would recommend mammography dropped from 80% to 62.5% after exposure to the decision aid. These results suggest that decision aids might result in fewer women continuing breast cancer screening beyond age 75 years.”

    From the U.S. healthcare business front,

    • STAT News reports,
      • “Pharmaceutical giant AbbVie paid health care providers roughly $145.7 million last year to promote its drugs, according to a STAT analysis of newly released government data.”
      • “The massive sum spent by AbbVie, the maker of the mega blockbuster anti-inflammatory drug Humira, is the most a pharmaceutical company has spent on marketing to doctors since such data became available in 2017. The figure includes compensation for consulting and other services like speaking fees, lodging and travel for doctors, and meals, as well as a small number of payments made directly to hospitals.
      • “The payments, made public by the Centers for Medicare and Medicaid Services, provide an insight into AbbVie’s marketing in the immediate aftermath of the company losing its monopoly on Humira, which dominated the company’s balance sheets for the better part of the last two decades. The payments show that the company is being far more aggressive in targeting doctors than competitors of comparable size.
      • “Pfizer, whose revenues are on par with AbbVie’s, spent roughly $32 million last year. Merck spent about $22 million. These totals don’t include subsidiaries that are reported separately from their parent companies.”
    • Managed Care Executive assures us that notwithstanding this colossal effort, biosimilars to Humira are gaining market share due to PBM actions and legal changes.
    • PCMA points out various PBM efforts to reach out to the rural community.
    • The Wall Street Journal suggests that the Walmart model does not work in healthcare.
      • “To put it bluntly, primary care is hard,” said Stephanie Davis, an analyst at Barclays. The problem for Walmart, said Craig Garthwaite, a strategy professor at Northwestern University, is that in medicine you can’t really build economies of scale by driving the costs of such things as purchasing and advertising down to charge lower prices and gain market share. In a doctor’s office, your big-ticket costs are the people: A family physician might make something like $250,000, while a nurse practitioner is paid around $150,000. 
      • “None of that is scalable,” he said. “Each one of those doctors can only work eight to 10 hours a day. So you can’t run the business the same way.” * * *
      • “That doesn’t mean that there isn’t plenty of money to be made from the doctor’s office. But the value won’t come from charging a flat fee for, say, an annual checkup. Instead, for large companies, the doctor needs to be a conduit for capturing value elsewhere. Big hospital systems have been at this for a long time. They acquire or join with doctor groups to control patient traffic to higher-margin procedures. A primary-care doctor controlled by New Jersey-based Atlantic Health System, for instance, might refer a patient to a urologist within that same system.  
      • “That approach really hasn’t helped patients. Instead, it has raised the cost of care, giving giant hospitals billions of dollars in additional revenue.” 
    • Similarly, mHealth Intelligence examines the limitations of the current telehealth market.

    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.”